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  • Committee of Hospital Pharmacy of China Pharmaceutical Society, Special Committee of Clinical Pharmacy, Chinese Medical Association, Professional Committee of Drug-induced Diseases, Chinese pharmacological society, Pharmaceutical Professional Committee of China Hospital Association, Consensus on the Management of Category Ⅱ Psychotropic in Healthcare Institutions Writing Group
    Chinese Journal of Hospital Pharmacy. 2023, 43(6): 591-596. https://doi.org/10.13286/j.1001-5213.2023.06.01
  • The pharmaceutical management committee of Beijing Chinese Medicine Association, the pharmaceutical professional committee of Beijing Association of Integrated Chinese and Western medicine, and the research center of Chinese medicinepharmacovigilance and rational use of Beijing University of traditional Chinese Medicine
    Chinese Journal of Hospital Pharmacy. 2023, 43(8): 827-834. https://doi.org/10.13286/j.1001-5213.2023.08.01
    Borneol has the effects of awakening the mind,clearing away heat and relieving pain.There are many varieties of Chinese patent medicines containing borneol,which are widely used in clinical practice,butthe unreasonable use of these drugs is prominent,such as the use on incorrect syndrome,the repeated medication,and the long-term use.At the same time,the improper use of borneol recorded in many ancient Chinese medicine books has a high safety risk,and modern toxicology experiments have also been reported,which make this kind of drugs be the focus of rational drug use in hospitals.This consensus is aim to regulate the rational use of Chinese patent medicines containing borneol.This consensus is in the form of "consensus report",which is formed by 28 pharmaceutical experts from three-level medical institutions in many places across the country through Delphi method.The relevant Questionnaire was carried out before the formation of the consensus.The literature statistical analysis and evidence-based evaluations of relevant issues were also carried out during the formation of the consensus,and the expert opinions were synthesized by using the recognition and recommendation scores.Finally,21 statements and explanatory texts were formed in two parts of "basic principles for rational use" and "key principles for pharmaceutical evaluation and drug use guidance" of Chinese patent medicines containing borneol.The purpose of this work is to provide reference opinions on rational use and pharmaceutical evaluation of Chinese patent medicines containing borneol for pharmacists,doctors and medical insurance administrators in medical institutions.
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    ZHANG Yan-rong, ZHEN Jian-cun
    Chinese Journal of Hospital Pharmacy. 2015, 35(2): 156-160. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.02.16

    OBJECTIVE To investigate how to utilize authoritative information resources, such as BULLETIN ABOUT INFORMATION OF ADR issued by the National Center for ADR Monitoring, to define monitoring focuses to intervene prescriptions, to avoid recurrence of ADR.METHODS Drugs, distribution frequency, involved organs or systems, clinical manifestations and causes listed in 58 issues of BULLETIN ABOUT INFORMATION OF ADR from 2001 to 2013 were retrospectively analyzed, to define major monitoring items in prescription intervention and to take measures for preventing serious ADR. RESULTS There were 115 drugs listed, including 97 chemical drugs accounting for 84.35%, involving 15 drug categories; 18 TCM drug accounting for 15.65%. In the chemical drugs listed, anti-infective drugs occupied the largest proportion of 30.93%. Injection and oral preparations of chemical drugs and TCM drugs induced relatively equivalent ADR. Major organs or systems or clinical manifestations involved in ADR included injuries or allergies of skin and its appendages, systemic injuries, impairments of urinary system and renal functions, hepatic functions, etc. Besides of drug and individual differences, ADR was also closely correlated with irrational drug use, including drug administration beyond indications, irregular usage and dosage, contraindicated medication, drug compatibility, irregular medication in children, etc. CONCLUSION ADRs are caused by irregular medication besides of drug natures and individual differences. Monitoring focuses can be defined for prescription intervention by utilizing official information resources, such as BULLETIN ABOUT INFORMATION OF ADR, which will help to lower ADR rate to the lowest level. During this process, TCM pharmacist can play a major role professionally.

  • Pharmaceutical Service Professional Committee of Chinese Pharmaceutical Society, China-japan Friendship Hospital, The First Affiliated Hospital of the University of Science and Technology of China, Suggestions on Clinical Management of Inpatients' Own Medications in Chinese Medical Institutions Writing Group
    Chinese Journal of Hospital Pharmacy. 2023, 43(15): 1651-1656. https://doi.org/10.13286/j.1001-5213.2023.15.01
     
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    SUN Shi-guang
    Chinese Journal of Hospital Pharmacy. 2015, 35(5): 369-374. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.05.01

    OBJECTIVE To systemically analyze the species of traditional Chinese medicine injections (TCMIs) marketed in China, including species distribution, national inclusion and adverse reactions/events.METHODS By searching database on the website of State Food and Drug Administration, distribution of TCMI products were systemically rearranged; the marketed TCMI products were analyzed in details for whether listed in Pharmacopoeia of People's Republic of China (CP), National Essential Drugs List (NED) and Catalogue of National Essential Drugs for Medical, Work Injury and Maternity Insurance (NEDMWM); by referring to historical editions of National Adverse Drug Reaction Monitoring Report (NADRMR) and three major Chinese databases (CNKI database, VIP database, WANFANG database) in recent 13 years, the reports on adverse reactions/events of TCMI products were comprehensively summarized.RESULTS There were 134 generic names of TCMIs marketed in China, involving 923 TCMIs approval numbers and 216 TCMIs manufacturers, 7 species of freeze-dried powder and 74 exclusive varieties, most of which were formula for heat clearing, blood regulating, desiccating, supplementing and anti-tumor. There were 7 major approaches for administration including intramuscular injection, intravenous injection, intravenous bolus injection, special approach, subcutaneous injection, acupoint injection and sheath injection, 94 drugs were administrated by a single approach, and 40 drugs by the mixed approaches. Different TCMI products were included in CPs of different version, but tended to be reasonable. TCMI products basically maintained unchanged in NEDs, but gradually increased in NEDMWMs. NADRMRs of varied editions showed a higher and higher proportion of reports on adverse reactions/events for TCMI, which was also the fact in the three major domestic journal databases, especially since 2009, number of reports on adverse reactions/events for TCMI reached a peak plateau phase.CONCLUSION Report of analysis on TCMI species marketed in China can provide basis and reference for further systemic study on TCMI, especially the study on reevaluation of reasonability and safety of TCMI.

  • ZHOU Ling-yun, DENG Sheng, XU Ping, LI Xin, YAN Ying, OUYANG Lin-qi, LIU Xiang, HE Ge-fei, CHEN Yan-ping, SHI Zhi-hua, WANG An-fa, HUANG Yu, WANG Li-xin, HE Yi-feng, ZHANG Ji-hong, GUO Yan, ZUO Xiao-cong
    Chinese Journal of Hospital Pharmacy. 2023, 43(7): 711-733,737. https://doi.org/10.13286/j.1001-5213.2023.07.01
    Oral calcium channel blocker (CCB) is the most common long-term medication for cardiovascular diseases. Consequently, it is essential to construct a scientific and standardized clinical comprehensive evaluation system, and then formulate Expert Consensus on Clinical Comprehensive Evaluation of Oral CCBs to assist decision-making for the government and clinicians. The Third Xiangya Hospital of Central South University has organized the formulation of this expert consensus based on the Guideline for Clinical Comprehensive Evaluation of Medicine and Technical Guidelines for Clinical Comprehensive Evaluation of Medicine of Cardiovascular Diseases with the participation of 16 representative medical institutions in Hunan. The expert consensus systematically evaluated oral CCBs, especially in the therapy of hypertension and coronary artery diseases, from 6 dimensions, including safety, effectiveness, economy, accessibility, suitability and innovation. This expert consensus can provide a decision-making basis for the clinical rational drug use and selection of drugs for medical institutions, and provide reference for the construction of comprehensive evaluation system of other drugs.
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    ZHANG Juan-hong, WANG Rong, XIE Hua, YIN Qiang, JIA Zheng-ping, LI Wen-bin
    Chinese Journal of Hospital Pharmacy. 2015, 35(2): 95-99. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.02.02

    OBJECTIVE To investigate the pharmacokinetics of aminophylline in rats living at low altitude (P) and after acutely exposed to high altitude (H).METHODS Aminophylline tablet 0.0038 g was intragastrically administered to rats at low altitude (~50 m) and exposed to high altitude (~4100 m): rats residing at low altitude,and these after exposed for 1-week washout period to high altitude. Blood samples were collected from venous plexus posterior to socket and put into heparinized centrifuge tubes 0, 0.33, 0.66, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours after drug administration. Plasma concentration of aminophylline was determined by LC-MS/MS.RESULTS Concentration of aminophylline in plasma ultrafiltrate decreased significantly after exposure to high altitude, therefore, the protein binding was significantly higher after acutely exposed to high altitude (74.17%) compared with those at low altitude (37.05%). Aminophylline pharmacokinetic parameters at low altitude were significantly different from those of rats acutely exposed to high altitude. The Ka of compartmental model was significantly higher in rats exposed to high altitude compared with those at low altitude. Comparison of the t1/2 obtained in plasma in the 2 groups of this study showed an increase from 2.365±0.448 to 2.944±0.694 hours in rats acutely exposed to high altitude. The MRT was prolonged and the Clz/F was lower in rats exposed to high altitude. The Cmax was significantly higher in rats acutely exposed to high altitude than those at low altitude. We also observed shortened Tmax and decreased total clearance rate.CONCLUSION This study shows significant changes in disposition of aminophylline in rats acutely exposed to high altitude, which will provide reference for clinical rational application of aminophylline at low altitude and after acute exposure to high altitude.

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    ZHU Lei, HUANG Ping, LI Ying
    Chinese Journal of Hospital Pharmacy. 2015, 35(2): 147-152. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.02.14

    OBJECTIVE To investigate the clinical characteristics and occurrence laws of serious adverse drug reactions (ADR) to provide reference for clinical rational drug use.METHODS A total of 519 cases of serious ADR were selected from Anhui's ADR database in 2012, and retrospective study methods were used to analyze these cases of ADR.RESULTS In 519 cases of serious ADR, a high proportion of serious ADR occurred in patients older than 40 years of age, accounting for 75.3%. Among drugs resulting in serious ADR, the first three were antineoplastic of 153 cases (23.25%), antibiotics of 118 cases (17.93%) and Chinese medicine injection of 41 cases (6.23%). Drug combination was a valuable risk factor of serious ADR. The most common route of administration resulting in serious ADR was intravenous administration, accounting for 76.75%. Occurring time of serious ADR varied quite differently, the shortest was on the administration day, or even a few minutes later, and the longest was 993 days. Clinical symptoms varied greatly, with most systems involved. For system-organ involved, the systemic impairment had the highest proportion, followed by skin and its appendages. Most cases were improved after symptomatic treatment.CONCLUSION The clinical staff should improve their understanding on serious ADR and must take symptomatic treatment actively once serious ADR occurs. Monitoring of ADR should also be enhanced to improve the level of rational use of the drugs.

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    LI Wei, WANG Ji-feng, NIU Jian-zhao, SHEN Li-xia
    Chinese Journal of Hospital Pharmacy. 2015, 35(2): 91-95. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.02.01

    OBJECTIVE To investigate the phytoestrogenic effects and its possible receptor mechanism of quercetin.METHODS Effects of quercetin on the cell proliferation were tested in ER-positive T47D cells and ER-negative MDA-MB231 cells by MTT measurement. Cell cycle was examined by flow cytometry. And T47D cells were treated with quercetin for 48h, total cell extracts were examined for the levels of ERα and ERβ protein by Western blot analysis. The estrogen-like effects of quercetin and the its relationship with estrogen-receptors were evaluated by pure estrogen receptor antagonist ICI182,780.RESULTS Quercetin (10, 20, 40 μmol·L-1) stimulated proliferation of ER-positive T47D cells compared with solvent control, whereas ER-negative MDA-MB231 cell was inhibited, and the cell cycle was impelled from G1 to S to synthesize DNA, and PI also increased. The bossting function on T47D cell proliferation was inhibited by estrogen receptor antagonist ICI182,780. Quercetin (10 μmol·L-1) could evidently induce expression of ERα protein, but without any effect on ERβ protein levels. When jointly incubated with ICI182,780, ERα protein could be inhibited.CONCLUSION Quercetin has the estrogen-like activities which are induced by affecting expression of ERα protein.

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    LU Zhi-gang, LIU Yun, YI Ji-long
    Chinese Journal of Hospital Pharmacy. 2015, 35(2): 141-144. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.02.12

    OBJECTIVE To observe the effects of Qingkailing on suppressor of cytokine signaling-3 (SOCS-3), tumor necrosis factor (TNF-α) and interleukin-6 (IL-6) in patients with cerebral vasospasm (CVS) after spontaneous subarachnoid hemorrhage (SAH). METHODS Sixty-eight patients with SAH were randomly assigned to treatment group (36 patients) and control group (32 patients).With routine treatment as the basic therapy, 30 ml of Qingkailing mixed into 100 ml of normal saline was intravenously dripped once daily to patients in treatment group.The drug was given immediately after disease onset, and continued for 21 days consecutively. The serum levels of SOCS-3, TNF-α and IL-6, transcranial Doppler sonography, glasgow outcome scale before and after treatment were compared between the two groups.RESULTS Compared with control group, the serum levels of hs-CRP, TNF-α and IL-6 decreased in the Qingkailing group (P<0.05), SOCS-3 increased (P<0.05). In middle cerebral artery (MCA), anterior cerebral artery (ACA) and posterior cerebral arteries (PCA), mean flow rate decreased (P<0.05), and GOS increased (P<0.05).CONCLUSION In patients with CVS after SAH, Qingkailing may increase the levels of SOCS-3, decrease the levels of TNF-α and IL-6 as well as cerebral blood flow rate, to alleviate cerebral vascular convulsion, and improve cerebral functions and prognosis. It is an effective agent for CVS in patients after SAH.

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    CHU Jian-jie, WANG Ming-ming, WANG Yan-hua, YANG Zhi-fu, WEN Ai-dong
    Chinese Journal of Hospital Pharmacy. 2015, 35(1): 36-39. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.01.10

    OBJECTIVE To reasonably analyze medications for stress ulcer (SU) prophylaxis in patients receiving laparoscopic cholecystectomy (LC), to promote clinical rational drug use. METHODS A hospital regulatory system for rational use of drugs was utilized and a retrospective survey method adopted, to collect medical cases of patients receiving LC from 2012 to 2013 in a hospital, for statistics and analysis of drugs application against SU. RESULTS A total of 1935 LC patients from 2012 to 2013 were found out, 1600 of them were finally included into the study. Of these patients, 682 patients (42.63%) received acid inhibitor, 99.27% of them used proton pump inhibitors (PPIs); 466 patients (68.33%) received acid inhibitors without indications. All preventive drugs were administered via intravenous injection, and 1 patient simultaneously received PPI and H2 receptor antagonists (H2RAs). CONCLUSION This hospital has phenomena of overuse of acid inhibitor PPIs against SU, irregular selection of drug category and dosage form. It is suggested that the indications should be strictly followed for acid inhibitor PPIs for SU prophylaxis, and medication should be standardized to promote clinical rational drug use.

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    DONG Ling-fang, DUAN Hong-fei, ZHANG Hai-feng, ZHAO Ning-min, MA Ai-ling, ZHAO Hong-Wei, ZHANG Wei, QIN Yu-hua
    Chinese Journal of Hospital Pharmacy. 2015, 35(1): 6-9. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.01.02

    OBJECTIVE To establish a high performance liquid chromatography (HPLC) method for determination of plasma concentration of imipenem, and investigate the stability of imipenem in plasma. METHODS HPLC was performed on a C18 column (Venusil XBP, 5 μm, 4.6 mm × 250 mm), phosphate buffer 10 mmol·L-1 (pH=7.2) and tetraethyl ammonium bromide in methanol (0.3 mmol·L-1) (96:4,V:V) as the mobile phase, 5-hydroxy indole-3-acetic acid as the internal standard, a mixture of 0.5mol·L-1 3-morpholine propanesulfonic acid buffer (pH6.8), glycol and pure water (2:1:1, V:V:V) as the stabilizer. The column temperature was set at 30℃, detection wavelength at 300 nm, and flow rate at 1.0 ml·min-1. RESULTS The extraction recovery rates were (89.6±1.7)%, (93.9±2.2)% and (91.4±0.4)% respectively for low, moderate and high concentrations, intra-batch and inter-batch RSDs were all < 15%. A good linearity was shown in the concentration range of 0.1-100 μg·ml-1 (r =0.995-0.996), with limit of quantitation of plasma imipenem concentration as 0.1μg·ml-1. Imipenem could maintain stable at room temperature, 4℃ and -30℃ for 2, 6 and 8 hours with stabilizer added, 6, 12 and 48 hours respectively without stabilizer.CONCLUSION The method has a wide linear range, simple operating process and high accuracy, and can be used to determine plasma concentration of imipenem, and is suitable for the therapeutic drug monitoring (TDM) for patients with severe infections.

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    ZHANG Qing-ye, TU Xing, FAN Li-xia, HE Jia-lun
    Chinese Journal of Hospital Pharmacy. 2015, 35(1): 19-23. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.01.06

    OBJECTIVE To develop a cutaneous microdialysis to study the characteristics of percutaneous absorption of evodia rutaecarpa extract.METHODS By using nude mice, we developed the sampling technology of cutaneous microdialysis. Evodiamine (EVO) and rutaecarpine (RUT) were used the indes, HPLC method was used to determine the drug concentrations in dialysate after percutaneous absorption of evodia rutaecarpa extract, non compartment model fitting was performed for cutanoeus drug concentration and time by using Kinetica 5.0, to calculate relevant statistical moment parameters.RESULTS The time to peak (tmax) of EVO was (150±15.3) min and its half time (t1/2) (263.7±41.6)min; tmax of RUT was (90±2.1)min and its t1/2 was (194±17.3) min. Both extracts could reach the peak concentration quickly and release steadily in a relatively long period, to maintain a relatively constant drug concentration in subcutaneous tissues.CONCLUSION The microdialysis method in this study can be applied to investigate the cutaneous pharmacokinetics of evodia rutaecarpa extract. And EVO and RUT can exert clinical effects by percutaneous absorption.

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    TANG Hui, HOU Ning
    Chinese Journal of Hospital Pharmacy. 2015, 35(3): 256-261. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.03.21

    OBJECTIVE To analyze the medication errors in a first-class provincial hospital to improve service level of pharmacy and preparation quality of pharmacist, reduce hidden dangers of medical security, and promote improvement of medical quality in hospitals. METHODS Medication errors between September 1st, 2012 and August 31st, 2013 were summarized in the hospital. All the medication errors were categorized and analyzed according to the method development by National Coordinating Council for Medication Error Reporting and Prevention (NCC-MERP) to analyze the reasons for medication errors, and propose proper countermeasures. RESULTS A total of 332 medication errors were collected, accounted for 0.11% of total number of dispensation . According to the different categorizing methods, 98.2% (326) had not caused harm to patients. The ratio of internal error and external error was 291:41. Dispensing error by pharmacist accounted the highest proportion, accounting for 33.4%. By fish bone analysis, people, event and item were the three major reasons for dispensing errors. CONCLUSION Medication errors are objective. The hospital should establish modern non-punitive error event reporting system, adopt encouraging measures to promote medical staff to voluntarily report medication errors, and utilize quality administration tolls to comprehensively analyze and prevent medication errors.

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    WANG Min, XIE Peng, YANG Yi-min, LI Qiu-yan
    Chinese Journal of Hospital Pharmacy. 2015, 35(1): 31-35. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.01.09

    OBJECTIVE To prepare celecoxib (CXB) solid lipid nanoparticle (CXB-SLN) and study the pharmacokinetic behaviors of CXB-SLN in rats. METHODS CXB-SLN was prepared by melt-emulsion ultrasonication and low temperature-solidification methods. The CXB-SLN was characterized. 12 Wistar rats were randomly divided into CXB API group and CXB-SLN group, and gavaged at a dose of 100 mg·kg-1. HPLC was used to determined Plasma CXB concentration, and 3P97 program to calculate pharmacokinetic parameters. RESULTS For particle size, polydispersion index and Zeta potential of CXB-SLN were (183.6±44.5)nm, (0.217±0.052) and (-30.4±5.2) mV, respectively. For CXB API and CXB-SLN, AUC0-t values were (4.47±0.72) and (11.64±2.01) mg·L-1·h, t1/2 were (13.45±1.89) and (10.12±1.24) h, tmax were (2.33±0.21) and (1.31±0.14) h,Cmax were (0.86±0.12) and (2.14±0.46) mg·L-1, respectively. CONCLUSION Compared to CXB API, CXB-SLN has significantly improved pharmacokinetic behaviors, obviously delayed release and improved bioavailability in rats.

  • Hospital Pharmacy Professional Committee of Chinese Pharmaceutical Association, The Cardio-Oncology Group of the Chinese Society of Cardiovascular Diseases of Chinese Medical Association, Writing Group of Chinese Expert Consensus on Pharmaceutical Management of Cardiovascular Toxicity of Tyrosine Kinase Inhibitors
    Chinese Journal of Hospital Pharmacy. 2023, 43(19): 2119-2135. https://doi.org/10.13286/j.1001-5213.2023.19.01
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    SUN Meng-ru, CHEN Rong, QIAN Qing, WANG Ming-li, ZOU Su-lan
    Chinese Journal of Hospital Pharmacy. 2015, 35(2): 136-141. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.02.11

    OBJECTIVE To construct a population pharmacokinetics model of piperacillin tazobactam in patients in department nephrology by applying optimized dosing regimen of piperacillin tazobactam to promote individualized medication. METHODS From 50 patients in department of nephrology intravenously dripped piperacillin-tazobactam, a total of 310 blood samples were collected to determine relevant clinical parameters. Nonlinear mixed-effect model (NONMEM) was used to construct a population pharmacokinects model. Monte Carlo simulation (MCS) was performed to evaluate whether pharmacodynamics targets were achieved in different MIC populations in different dosing regimens of piperacillin/tazobactam. RESULTS The pharmacokinetic profile of piperacillin and tazobactam fitted best to one-compartment model. The population typical values and between subject variability were CL/F=13.74 L·h-1, BSV=11.1%; V/F=21.69 L, BSV=8.0% for piperacillin, and CL/F=9.32 L·h-1, BSV=9.11%;V/F=16.0 L, BSV=5.28% for tazobactam. In fixed effect variables, creatinine clearance had significant effects on pharmacokinetic parameters. Prolonged infusion of piperacillin-tazobactam yielded greater cumulative fraction of response (CFR) for bacteria with higher MIC values.CONCLUSION The population pharmacokinetics and Monte Carlo simulation can provide useful analytic measures for adjusting therapeutic regimen of piperacillin tazobactam.

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    CHEN Ming, ZHONG Jie-min, LIU Guan-ping, LI Bo-lin, CHEN Xin
    Chinese Journal of Hospital Pharmacy. 2015, 35(9): 846-850. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.09.21

    OBJECTIVE The pathogenesis of psoriasis has not been completely elucidated. But extensive experimental and clinical evidences obtained in recent years suggest that psoriasis may be a T cell mediated autoimmune disorder. The activation of targets, proliferation of T cells and effects of cytokines are involved in this disease. Development of new drugs for psoriasis which base on these targets have been made great progresses in recent years. In this paper, the psoriasis drugs developed through different targets have been reviewed to provide some references for researches on new drugs for psoriasis treatment.

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    SUN Wen-juan, ZHANG Bo, LI Da-kui, MEI Dan
    Chinese Journal of Hospital Pharmacy. 2015, 35(9): 850-857. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.09.22

    OBJECTIVE To investigate probiotics development status and clinical application progress, to provide comprehensive and effective references for clinical medication.METHODS Probiotics products were collected by searching official websites and authority literatures at home and abroad. The latest progresses of clinical application evidence, product status and safety were introduced and summarized for probiotics products.RESULTS Probiotics products are widely used in China and abroad. It has guiding significance for clinical medication through exploring the products through product feature, relevant evidences and safety. CONCLUSION The probiotic preparation has the varying degree progerss in clinical application around the world,International orgnization increasingly great importance to the development of probiotic different fields and probiotic safety study probiotics treatment of clinical research shows a great prospect in china,but many fields need to be improved like the size of study,methodology design,quality evaluation and so on.

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    WANG Yu, YANG Guang-zhao, KANG Wan-jun, YU Shi-long, ZHANG Xu, MA Ying
    Chinese Journal of Hospital Pharmacy. 2015, 35(9): 805-808. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.09.11

    OBJECTIVE To establish a high performance liquid chromatography (HPLC) method for determination of nucleosides from natural and cultured Cordyceps sinensis and Cordyceps militaris, and compare their contents.METHODS The contents of nucleosides were determined using HPLC on Hypersil C18 column with pH 6.0 phosphate-methanol (85:15) as mobile phase and detected at 260 nm.RESULTS Under the optimized conditions, the three nucleosides reached baseline separation in 25 minutes. Adenosine, Cordycepin and Adenine showed good linear relationship in the range of 5.0-80.0 μg·ml-1 (r=0.999 3), 4.37-70.0 μg·ml-1 (r=0.999 7) and 6.75-108.0 μg·ml-1 (r=0.999 7), respectively.CONCLUSION Similar nucleosides have been obtained from natural Cordyceps sinensis and cultured Cordyceps militaris, but with relatively great differences in their contents. This method can be utilized for quantitative analysis of nucleosides in natural and cultured Cordyceps and its substitutes, and it is helpful to control their quality. The method is accurate, fast, and convenient.

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    LIU Jun, ZHU Yan-hong, LUAN Jia-jie, XU Wen-ke, QIAN Hong-bo, WEI Jun, ZHANG Da-fa
    Chinese Journal of Hospital Pharmacy. 2015, 35(3): 249-253. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.03.19

    OBJECTIVE To establish an individualized anticoagulant therapy mode based on pharmacogenomics in order to improve curative efficacy and reduce risks for patients. METHODS Clinical pharmacists participated in the anticoagulant management for patients after cardiac valve replacement to actively explore the influences of genotypes on anticoagulation response of warfarin. RESULTS The patients after cardiac valve replacement received warfarin anticoagulant therapy. There were evidently individualized differences in curative efficacy of warfarin, and gene polymorphism was the major cause. CONCLUSION Traditional empirical anticoagulant therapy has certain blindness and potential danger.

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    ZHANG Juan-juan, ZHANG Li-chao, ZHU Quan-gang
    Chinese Journal of Hospital Pharmacy. 2015, 35(4): 292-296. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.04.04

    OBJECTIVE To study the controllability of pressure, reproducibility of drug release and skin irritation of modified microneedle roller for transdermal delivery of triamcinolone acetonide. METHODS The commercially available microneedle roller was modified. Controllability of pressure was evaluated before and after modification, and pore depths under different pressure (2.5, 5.0, 7.5, 10.0, 12.5, 15.0, 17.5 and 20.0 N) were observed by utilizing paraffin sections and HE staining method. The in vitro permeation characteristics of triamcinolone acetonide through isolated nude mouse skin were studied by Franz diffusion cell before and after modification. Scoring method was used to investigate the skin irritation. RESULTS The pore depth increased as pressure increased. The range of pore depth narrowed from 65.28-106.25 to 71.53-97.92 micrometers by the modified microneedle roller. The range of RSD significantly decreased from 10.45%-19.69% to 2.33%-9.21% in the modified group. At the same pressure of microneedle roller, RSD range of accumulative penetration amount of triamcinolone acetonide decreased markedly from 34.75%-55.92% to 14.29%-29.73%. The mild stimulus intensity was observed one hour after administration using modified microneedle roller, and then all irritation symptoms disappeared.CONCLUSION Compared with commercially available microneedle roller, the modified one shows better controllability of pressure, reproducibility of drug release, but less skin irritation.

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    LIU Ya-ni, YANG Chun-xiao, SHEN Ru-fei, ZHOU Jia-li, LUO Xiao-mei, ZHANG Yu, SHI Shao-jun
    Chinese Journal of Hospital Pharmacy. 2015, 35(1): 1-5. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.01.01

    OBJECTIVE To study the distributions of 10 single nucleotide polymorphisms (SNPs) of Nm23 gene in Hubei Han patients after renal transplantation. METHODS The 10 SNPs of Nm23 gene in 150 renal transplant patients (114 men & 36 women) and 150 healthy subjects (112 men & 38 women) were genotyped by real time TaqMan-MGB genotyping assay. RESULTS The genotype distribution for the assayed loci followed the Hardy-Weinberg equilibrium. Strong linkage disequilibriums were observed in rs7207370 with rs1694969, rs34214448, and rs2318785, respectively; as well in rs8075231 with rs2302254, rs2041296, rs8071647 and rs2159359, respectively. And rs7207370, rs8075231, and rs11868380 were selected as Tag SNPs. CONCLUSION There are no significant differences in the genotypic and allelic distributions of SNPs between the renal transplant patients and healthy subjects. No significant differences in the distribution of Nm23 gene polymorphism were noted by gender.

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    Chinese Journal of Hospital Pharmacy. 2015, 35(1): 89-90. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.01.24
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    LI Guang-sheng, HAN Yong-cheng
    Chinese Journal of Hospital Pharmacy. 2015, 35(6): 503-506. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.06.08

    OBJECTIVE To establish the quality control standards for Tongluo pills.METHODS Dendrobium nobile,Lonicera Japonica and Achyranthes bidentata Bl were identified by TLC.Scoparone and chlorogenic acid were determined by HPLC.RESULTS The results of TLC showed that the relevant spots were clear without interference in the blank reference. Good linear relationships between the peak area and contents of scoparone and chlorogenic acid were achieved when the dose was within 4.4-66.0 μg·ml-1,36.0-540.0 μ g·ml-1.The recovery rates were 93.89% and 94.17%.RSDs were 2.37% and 1.99%,respectively (n=6). CONCLUSION The established qualitative and quantitative methods are simple,accurate,reliable and reproducible, and can be effectively used for quality control of anti-inflammative pills.

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    SU Zhi-qiang, XU Su-ying, ZHANG Cheng-liang, HUANG Rui
    Chinese Journal of Hospital Pharmacy. 2015, 35(6): 532-535. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.06.15

    OBJECTIVE The literatures in the past thirty years about the clinical pharmacy practice in primary medical institutions in China were retrospectively analyzed, to define the development status and direction of the clinical pharmacy practice in primary medical institutions, and finally promote its construction.METHODS Relevant terminologies were screened such as primary medical institutions and clinical pharmacy as keywords, and relevant literatures were retrieved from 1984 to 2013 in common Chinese databases. Papers was statistically analyzed according to published time, area, journal and content.RESULTS A total of 315 literatures were retrieved and screened. The number of the clinical pharmacy related papers in primary medical institutions showed a gradual growth trend in the thirty years. There existed regional differences in the author's province, which slightly favored costal area. Only 26.03% of literatures were published in the chinese statistical source journals. The clinical pharmacy practice in primary medical institutions had obvious regional differences. The literatures' contents about clinical pharmacy practice status and approaches in primary medical institutions were more explored, followed by cultivation of clinical pharmacists and pharmaceutical management.CONCLUSION The clinical pharmacy practice in primary medical institutions has made some progresses in recent years in China, but the foundation is still relatively weak and the technical force is still lacked. The personnel training should be strengthened. There exists a large development space for clinical pharmacy practice in primary medical institutions.

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    LI De-lin, XU Liang, GAO Jian, LI Liu-Cheng, ZHAO Ping, Zhang Guo-qing, HUANG Zhao-gang, NIU Hai-jun, LI Xiao-liang, SHAO Xu, QI Lian-wen
    Chinese Journal of Hospital Pharmacy. 2015, 35(3): 205-209. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.03.06

    OBJECTIVE To establish fingerprint of total glucosides of Yupingfeng by AstragalosideⅡ as the reference peak,and control the quality of total glucosides of Yupingfeng.METHODS HPLC-ELSD was used on an Aglient column (4.6 mm×250 mm,5 μm),with gradient mobile phase composed of acetonitrile and 0.1% formic acid.The column temperature was set at 40℃ and flow rate of mobile phase 1.0 mL·min-1.The tube temperature of detector was 110℃,and flow rate of N2 was 3.30 L·min-1. RESULTS HPLC-ELSD fingerprint of the total glucosides of Yupingfeng was established,which determined 17 common peaks from 10 batches of the total glucosides of Yupingfeng and indentified 4 of them.RSD values of relative retention times for peaks and peak areas were respectively in the range of 0.1%~0.75% and 1.68%~4.82%.The similarity of 10 batches of total glucosides was all greater than 0.94.CONCLUSION The established HPLC-ELSD fingerprint is simple and has desirable precision,stability,reproducibility,and it can be applied to determine the fingerprints of total glucosides of Yupingfeng.

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    SHA Hong-yu, ZHENG Wen-wen, GUO Chen-yu, ZHU Wei-wei, SUN Yong-xu, LI Kang-qi, LI Hong-yan, LU Cong-xiao
    Chinese Journal of Hospital Pharmacy. 2015, 35(6): 536-539. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.06.16

    OBJECTIVE To promote the rational use of docetaxel, the characteristics of adverse drug reactions (ADR) induced by docetaxel and clinical symptoms were analyzed to provide references for docetaxel administration.METHODS A retrospective analysis was performed according to ADR report forms collected from 2007 to 2013.RESULTS The probability of ADR occurrence was the highest in patients ≥45 years. In all ADR cases, the diseases of patients were mainly focused on lung cancer (32.26%), mammary cancer (27.42%) and gynecological oncology (24.19%). Thus, most of the patients were female. The most common clinical symptoms for ADR were anaphylactic reaction, gastrointestinal toxicity and bone marrow depression.CONCLUSION Preventive measures should be adopted according to the patients' conditions before using docetaxel. Once ADR occurs, effective treatments must be performed immediately based on ADR type to ensure the drug safety for patients.

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    HAN Xiao-nian, MA Li, ZHANG Hong-li, YOU Hai-sheng
    Chinese Journal of Hospital Pharmacy. 2015, 35(1): 57-60. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.01.15

    OBJECTIVE To analyze the adverse drug reactions (ADR) induced by valproate sodium and to investigate the relevant factors to provide reference for rational medication. METHODS All the clinical data were collected from 561 patients < 60 years monitored valproate serum concentration from 2010.9-2013.9 in our hospital. All the general condition, medication, seizure control, serum concentration of valproate sodium, ADR and clinical outcomes were recorded, and the ADR and related factors were summarized. RESULTS There were 59 cases of ADR occurred in 561 patients. The top three ADRs were nervous system (24 cases, 40.67%), digestive system (17 cases, 28.81%), and skin and subcutaneous tissue (7 cases, 11.87%), respectively. The rare ADR (2 case, 3.39%) included hearing loss (1 case) and poor control of urination (1 case), and the serious ADR (2 case,3.39%) included epidermal necrolysis (1 case) and severe hepatotoxicity (1 case). In 59 cases of ADR, after adjusting the dose, stopping or withdrawing drugs and administering symptomatic treatment, the patients with ADR recovered well except for two cases of hair whitening, two cases of serious ADR (epidermal necrolysis and hepatotoxicity) recovered after hospitalization and three cases of alopecia patients recovered partially.CONCLUSION The major population of valproate ADR is children(<10 years). Special constitution is a risk factor for serious valproate ADR.

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    LIU Guang-xuan, ZHAO Qian, QI Xian-fu, SUN Bo, GUAN Ding-yue, ZHU Dan-tong
    Chinese Journal of Hospital Pharmacy. 2015, 35(1): 76-79. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.01.20

    OBJECTIVE To investigate the stability of docetaxel injection mixed with 0.9% sodium chloride injection, 5% glucose injection and long chain fat emulsion-injection, respectively.METHODS The appearances, undissolved particle distribution, particle size and pH values of docetaxel injection mixed with different solvents were observed at 0, 1, 2, 4, 6, 8, 10, 12, 16, 20, 24 h under room temperature. HPLC method was used to determine the content of docetaxel. RESULTS Within 24 hours, in mixture of docetaxel with 0.9% sodium chloride injection or 5% glucose injection, no significant change in the appearance or pH value was observed, but the content of docetaxel declined after 8 h (RSD>2%). In the mixture of docetaxel and long chain fat emulsion-injection, no significant change in appearance or pH value was observed within 24 h, but content of docetaxel significantly declined 20 hours later (RSD>2%). CONCLUSION At room temperature, the stability of docetaxel injection in long chain fat emulsion injection is significantly superior.

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    MENG Guang-yi, LUO Xue-lan, WANG Dong-xiao, PANG Jia-lian, PENG Ping-zhi, MO Jin-quan, YAN Hao-lin
    Chinese Journal of Hospital Pharmacy. 2015, 35(2): 164-168. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.02.18

    OBJECTIVE To analyze and evaluate the rational use of antibacterials in perioperative period of type Ⅱ incision surgery and promote the development of rational use of antibacterials in type Ⅱ incision surgery.METHODS A total of 240 patients with class Ⅱ incision discharged in 2013 were checked randomly, medication and rationality of antibaceterials were retrospectively analyzed and evaluated. The difference of costs was compared between antibacterial group (drug group) and no bacterial group (untreated group).RESULTS Among 240 patients, 189 patients had antibacterial during perioperative period (75.83%), and 64 patients of them had not used antibacterials rationally (33.86%). The total cost of hospitalization, the inspection fee, operation treatment fee, total cost of western medicine and cost of antibiotics were higher and average hospitalization duration was longer in drug group than untreated group, with significant difference between the two groups (P<0.01). The main antibiotics used included cephalosporins (75.83%), cephamycin (11.37%) and nitroimidazoles (9.48%) etc. The irrational use of drugs mainly included prolonged course of treatment (93.75%), improper choice of drugs (46.88%), improper administration time (31.25%), improper drug combination (25.00%) and large dose (21.88%), etc. CONCLUSION Excessive and irrational use of antibacterials for prevention in perioperative period of type Ⅱ incision surgery is still the prominent problem in our hospital, and generally rational and regular medication is insufficient. Hospital should further implement relevant laws and regulations, promote rational use of antibacterials to reduce medical cost and economic burden.

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    Chinese Journal of Hospital Pharmacy. 2015, 35(3): 277-278. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.03.27
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    ZOU Guo-fang, QIAN Wen-jing, LI Wei, JIAN Yan-lin
    Chinese Journal of Hospital Pharmacy. 2015, 35(1): 68-71. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.01.18

    OBJECTIVE To compare the results of serum vancomycin concentration determined by high performance liquid chromatography (HPLC) and fluorescence polarization immunoassay (FPIA), and the correlation between the two methods. METHODS Forty-three serum samples from vancomycin treating patients were collected, and serum vancomycin concentrations were determined by HPLC and FPIA, respectively. The results of both methods were analysed by paired t-test, linear-regression analysis and Bland-Altman plots analysis. RESULTS The outcomes of FPIA and HPLC methods showed good linear correlation and the linear regression equation was YFPIA=1.103XHPLC+0.831 5(R2=0.957 2). Bland-Altman plots analysis showed the two methods were consistent.Paired t-test showed statistically significant difference between the two methods (P<0.01). CONCLUSION Compared to FPIA method, HPLC method is not interfered with metabolism and degradation products, can accurately determine serum vancomycin concentrations, and is suitable for routine monitoring of drug therapy.

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    TAN Bo-yu, WEI Hong-yan, LUO Yi, DENG Nan
    Chinese Journal of Hospital Pharmacy. 2015, 35(4): 344-346. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.04.18

    OBJECTIVE To design prescription custom screening system (PCSS) to reduce prescription errors and improve the screening efficiency in pharmacy intravenous admixture services (PIVAS). METHODS Based on PIVAS information management, drug attributes database and PCSS for screening prescription were designed to realize custom screening function of prescription.RESULTS PCSS could not only check the rationality of ordinary prescription, which included drug imcompatibility, inappropriate selection of solvent, inappropriate routes of administration and inappropriate concentration of drug, but also evaluate the relevance of reasons and interrelated factors about inappropriate TPN prescription. CONCLUSION PCSS can flexibly build screening rules and has definite evaluation parameters, which is helpful for reducing prescription errors, improving the screening efficiency and ensuring safety of drug use.

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    Chinese Journal of Hospital Pharmacy. 2015, 35(6): 563-563. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.06.23
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    HAN Yi, HUANG Xin, ZHAO Xia, LI Hong-jian, SU Le-qun, YANG Rui
    Chinese Journal of Hospital Pharmacy. 2015, 35(6): 539-543. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.06.17

    OBJECTIVE To investigate the patterns, standards and difficulties of prescription comments in patients with chronic renal disease (CKD),and promote the implementation of 'hospital prescription comment management practice'.METHODS Based on analysis of the characters of medication, difficulties of prescription comments, comment standards and patterns were investigated for inappropriate prescription and unusual prescription in CKD.RESULTS A practice standard and a preliminary pattern were provided for checking prescription in CKD.CONCLUSION Prescription comment in CKD inpatient needs further improvement on specified criteria and a unified model, which will be helpful for rational drug use in CKD.

  • GAO Yang, YU Ai-ping, JIANG Yu-feng, YU Lu-hai
    Chinese Journal of Hospital Pharmacy. 2016, 36(2): 110-114. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2016.02.08

    OBJECTIVE To systematically evaluate relationship between HLA-B*1502 allele and lamotrigine-induced cutaneous adverse reactions in Southern Han Chinese with epilepsy. METHODS Pubmed, Embase, Cochrane Library, CNKI, VIP and WanFang Data (from their inception to May 31, 2015) were searched for RCTs. Statistical analyses were performed by using STATA 12.0 SE software.RESULTS Seven eligible case-control studies with 107 LTG-cADRs patients (including 25 LTG-SJS/TEN patients, 1 LTG-HSS patient, 81 LTG-MPE patients) and 213 LTG-tolerant patients were included. Meta-analysis results indicated that HLA-B*1502 allele was associated with LTG-SJS/TEN (OR=4.44, 95% CI: 1.66-11.87; P=0.003), but not with LTG-MPE (OR=0.85, 95% CI: 0.29-2.48; P=0.759) in Southern Han Chinese with epilepsy.CONCLUSION HLA-B*1502 may be significantly associated with lamotrigine-induced cutaneous adverse reactions in Southern Han Chinese with epilepsy.

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    JIN Rui, WANG Yu-guang, XUE Chun-miao, ZENG Wei-xin, SUN Lu-lu
    Chinese Journal of Hospital Pharmacy. 2015, 35(6): 473-477. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.06.01

    The prescription comment of Chinese patent medicine is the important part of clinical pharmacy in Traditional Chinese medicine (TCM),which promotes the rational drug use in hospitals.However,due to the special therapeutic backgrounds and real-world features of TCM,only instructions of TCM patent medicines cannot be used as the only criteria for prescription comment,especially for drug use at overdoses.Based on the current status of TCM prescription comment mainly by instructions of TCM patent medicines,by combining comparison of ancient and modern doses,considering the unstable quality and efficacy of TCM drugs and substandard instructions, and introducing cases of overdose from clinical application,we dry to investigate the potential “rationality” for overdoses of TCM drugs.Moreover,three suggestions are proposed including setting the upper and lower limits for drug doses,distinguishing the drugs of low and high risks,and adopting graded doses according to different indications.In summary,we will try to elucidate the comment criteria to regulate and evaluate TCM overdose,and provide thoughts for rational use of TCM patient drugs.

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    LIU Bei, MA Guo
    Chinese Journal of Hospital Pharmacy. 2015, 35(16): 1515-1518. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.16.20

    Neonatal jaundice is a physiological phenomenon in early neonatal stage, and one of clinical symptoms of various pathological disease after birth. If not actively treated, it can cause serious sequelae such as kernicterus. Drug treatment is one of main therapeutic approaches for neonatal jaundice. This paper summarized recent progresses in therapeutic drugs against neonatal jaundice by inhibiting bilirubin generation, accelerating bilirubin transportation, blocking bilirubin enterohepatic circulation, increasing bilirubin conjugation and promoting bilirubin excretion. Aim of this review is to provide reference for prevention and treatment of neonatal jaundice, and to achieve rational application of related drugs.

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    CHENG Ling, WANG Bo-tao
    Chinese Journal of Hospital Pharmacy. 2015, 35(6): 518-522. https://doi.org/10.13286/j.cnki.chinhosppharmacyj.2015.06.11

    OBJECTIVE To establish an HPLC method for determination of content and percutaneous absorption of self-made terbinafine hydrochloride cream and original cream.METHODS Kromasil C18(5 μm, 4.6 mm×250 mm) was used as column, with methanol-acetonitrile-pH 7.5 triethylamine acetate buffer (55:35:10) as mobile phase, flow rate at 1 ml·min-1 and detection wavelength at 282 nm. In percutaneous absorption study, Franz intelligent instrument was used with in vitro suckling pig skin as transdermal barrier.The similarity of self-made creams to original cream was evaluated by cumulative amount of penetration and 24 h retention in skin.RESULTS The calibration curves were linear between 4-150 ng·ml-1 and 20-400 μg·ml-1 (r=0.999 6,0.999 8).The average recovery of terbinafine hydrochloride solution was 98.88% while the average recovery of terbinafine hydrochloride cream was 100.4%.The average content of three batches of seif-made creams was 97.2%.The cumulative amount of penetration and 24 h retention in skin had no significant differences (P >0.05). CONCLUSION HPLC method is fast,accurate and can be used for content determination and percutaneous absorption of terbinafine hydrochloride.Transdermal absorption characteristics of self-made creams are similar to original creams, and the content meets the requirements.