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Interference from Filter Film Adsorption for Dissolution of Clarithromycin

Xuemei CHI ; Aqin WANG ; Xinyue WANG ; Feng YAN ; Zhongli YAO ; Hongji ZHANG

China Pharmacist.2014;(5):875-878.

Objective:To find the reasons for the low dissolution of clarithromycin tablets and study the interference from filter film adsorption at various time points to explore the appropriate processing approach for dissolution solution of clarithromycin tablets. Meth-ods:Clarithromycin tablets from two different manufacturers were used. The dissolution solution was prepared according to Japanese Orange Book. The dissolution was determined after different processing and the adsorption rate of the filter film was calculated. Re-sults:Totally 14 kinds of filter films were tested with different adsorption for clarithromycin, and the adsorption rate of some kinds of filter films exceeded the prescribed limit. Conclusion:The absorption rate of filter films for clarithromycin can be decreased by boiling the films and using American membranes. The interference from filter film adsorption can be reduced and inhibited by rejecting the first filtrate above 5ml or centrifuging dissolution solution.

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Determination of Paeonol in Cynanchum Paniculatum from Different Habitats

Shanyuan LIN

China Pharmacist.2014;(5):871-872.

Objective:To determine paeonol in Cynanchum paniculatum from different habitats by HPLC to provide better quality evaluation for Cynanchum paniculatum. Methods:A Promosil C18 column (200 mm × 4. 6 mm, 5 μm) was adopted, methanol-water (55∶45) was used as the mobile phase, the flow rate was 1. 0 ml·min-1 , the detection wavelength was at 274 nm, and the injection volume was 10μl. Results:Paeonol showed a good linearity(r=0. 999 9) within the range of 0. 049 4-0. 790 8 mg·ml-1,and the re-covery was 99. 98% with RSD of 0. 17%. The content of paeonol in Cynanchum paniculatum from different habitats showed significant difference. Conclusion:The method is simple, accurate and reproducible, which can be used to determine the content of paeonol in Cynanchum paniculatum from different habitats.

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Study on Problems and Countermeasures of Communication Management in Clinical Trials

Fan YANG ; Hua XING ; Xiaofeng GAO

China Pharmacist.2014;(5):865-867.

Clinical trials are important means to push forward the development of human health. Every new drug needs to under-take clinical trials eventually to determine the efficacy and safety. In the paper, through our clinical trial experiences and extensive lit-erature retrieval, some problems of the communication management in clinical trials were analyzed and relevant countermeasures were suggested to improve the communication management in clinical trials in order to help the development of clinical trials.

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Analysis and Evaluation on Degassing Effect of Vacuum Degassing Apparatus

Bin CHEN ; Baoming NING ; Long ZHANG

China Pharmacist.2014;(5):880-881.

Objective:To analyze and evaluate the degassing effect of vacuum degassing apparatus through the determination of ox-ygen content in pure water, gas pressure and air volume, and compare with suction filtration, boiling and ultrasonic methods to choose the appropriate degassing method for dissolution medium and guide the daily inspection work. Methods: The water residual oxygen, gas pressure and air volume were determined using a single water quality on-line monitoring instrument and a Carbo QC Anton Pear in-strument. The degassing effect of the vacuum degassing apparatus was detected under the conditions of negative pressure and certain de-gassing time. The degassing effect was also compared with that of suction filter, boiling and ultrasonic methods. Results: Under the conditions of 0. 06 MPa negative pressure, 41℃ medium temperature and 30 min degassing time, the degassing effect of the vacuum degassing apparatus was obvious. The degassing effect of suction filter and boiling methods was similar to that of the vacuum degassing apparatus, while that of ultrasonic method wasn't obvious. Conclusion:The use of vacuum degassing apparatus is simple and efficient with obvious degassing effect, which is suitable for the degassing process of dissolution medium.

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Quality Study of Marketed Rose Bengal Agar Culture Medium for Drug Control

Wen XIE ; Hongda ZHAO ; Wenping FAN

China Pharmacist.2014;(5):873-875.

Objective:To investigate overall quality status of rose bengal agar culture medium for drug control in China to provide technical support for the drug standard revision. Methods:Four quality control microorganisms, namely Aspergillus niger, Candida al-bicans, Staphylococcus aureus and Escherichia coli, were used to evaluate the quality of rose bengal agar culture medium from 7 domes-tic and foreign manufacturers. Results:Including the control medium, the pH value of all the 8 media was different. The growth rate of Aspergillus niger and Candida albicans in the seven tested media were all above 0. 7 without significant difference (P>0. 05). The selectivity factors of Staphylococcus aureus in the seven media and the control medium was more than 6. The eight media showed differ-ences in the selectivity factors of Escherichia coli. Among them, A, B, C, E, G and the control medium had no inhibitory ( selectivi-ty) , while D and F showed certain selectivity. Conclusion:The rose bengal agar media from different manufacturers for drug control show similar growth-promoting ability with different pH value and selectivity to Escherichia coli.

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Study Status of Quality Control and Analysis Methods for Vitamin C Injections

Chunyan SUN ; Tianming DING ; Ninglin CHEN

China Pharmacist.2014;(5):868-870.

Vitamin C injections are a national essential drug with wide clinical applications and instable property. In order to pro-vide the reference for further analysis on the quality status of vitamin C injections and improve the quality,the research on the stability, quality control and analysis methods was summarized in the study.

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Efficacy and Safety of Ornidazole in the Treatment of Trichomonal Vaginitis

Chunyan ZHANG ; Furong JIN ; Xiuzhen LIN

China Pharmacist.2014;(5):857-859.

Objective:To explore the efficacy and safety of ornidazole in the treatment of trichomonal vaginitis. Methods:Totally 112 cases of trichomonal vaginitis from February 2011 to December 2012 in our hospital were selected and randomly divided into the ob-servation group and the control group with 56 cases in each. The control group was treated with metronidazole tablets 200mg, po,tid, and the observation group was treated with ornidazole tablets 500mg, po,bid. The treatment course was 7 days. The clinical effect, score of clinical symptoms and incidence of adverse reactions of the two groups were compared. Results:The total effective rate of the observation group was 96. 4%, which was higher than that of the control group (82. 1%), and the difference was statistically signifi-cant (P<0. 05). The symptom scores of the two groups were significantly improved after the treatment (P<0. 05), however, the score between the two groups showed no significant difference (P>0. 05). The incidence rate of adverse reactions in the observation group was 10. 71%, which was significantly lower than that in the control group (37. 5%), and the difference was statistically signifi-cant (P<0. 05). Conclusion:The clinical curative effect of ornidazole in the treatment of trichomonal vaginitis is notable with faster onset, shorter treatment course, lower adverse reaction rate and better patient tolerance,which is valuable in the clinical promotion.

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Calculation of Personnel Arrangement in Outpatient Pharmacy of a Large General Hospital by Working Hour Measurement

Qibiao LUO ; Xinming XU ; Tao WANG ; Mei ZHANG ; Ying CHEN

China Pharmacist.2014;(4):699-701.

Objective:To explore the personnel arrangement in the outpatient pharmacy by calculating working hour to provide ref-erence for the rational staffing in hospital. Methods:The daily work content and working hour of 18 pharmacists in the outpatient phar-macy of a large general hospital from January to March in 2013 were following-up observed and recorded using the working hour meas-urement. The data were input the EXcellsoftware to establish the database, and the workload in various positions was collected and sorted. The obtained relative parameters were used to calculate the needed worker number on the basis of manpower planning model. Results:The research confirmed the mean operation time for 9 work programs in the outpatient pharmacy, and the time for drug dispen-sing and distributing was detailed. The needed number of pharmacists was 13. 29 according to the calculation, plus the officer-in-charge and sanitation workers, the total number was 15. 29(approx. 16). Conclusion:The working hour measurement can scientifically de-termine the time for each job, and the workload should be used as the foundation for configuring personnel qualification and the number in outpatient pharmacy.

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Determination of Osthole and Columbianadin in Wangbi Tablets by HPLC

Leibing XUE ; Yan ZHOU ; Peifen JIN

China Pharmacist.2014;(4):697-699.

Objective:To establish an HPLC method for the determination of osthole and columbianadin in Wangbi tablets. Meth-ods:The column was an Agilent XDB C18(150 mm ×4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-water(49∶51)with gradient elution. The flow rate was 1. 0 ml·min-1 and the detection wavelength was at 330 nm. Results: The calibration curve was linear within the range of 0. 060-0. 597 μg(r=0. 999 9) for osthole and 0. 010-0. 102 μg(r=0. 999 9) for columbianadin. The aver-age recovery was 99. 12% and 98. 98%, respectively. Conclusion:The method is simple, practicable, accurate and rapid. It can be applied in the content determination of osthole and columbianadin in Wangbi tablets.

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Determination of Benzoic Acid and Cinnamic Acid in Suhexiang Pills by HPLC with Dual Wavelength De-tection

Muhammat AZIZ ; Dongyun CHEN ; Weiping WANG ; Ming ZHANG ; Lina SHA

China Pharmacist.2014;(4):692-694.

Objective:To establish an HPLC method with dual wavelength detection for the determination of benzoic acid and cin-namic acid in Suhexiang pills. Methods:A Waters Sun Fire TM C18 column(150 mm × 4. 6 mm,5 μm) was adopted with 0. 1% ace-tic acid-methanol(60∶40) as the mobile phase at a flow rate of 1. 0 ml·min-1 . The detection wavelength was set at 228nm for benzoic acid(0-18min) and 285nm for cinnamic acid (18. 1-35min). The injection volume was 10μl, and the column temperature was room temperature. Results:The linear range of benzoic acid and cinnamic acid was 1. 0-50. 0 μg·ml-1(r=0. 999 7) and 0. 2-10. 0 μg· ml-1, respectively(r=0. 999 9). The average recovery was 96. 88%(RSD=1. 6%, n=9) and 99. 35%(RSD=1. 7%, n=9), re-spectively. Conclusion:The method is accurate, fast and simple in the determination of benzoic acid and cinnamic acid in Suhexiang pills.

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