陈希;吴鑫;鄢雷娜;储梅君;
CHEN Xi;WU Xin;YAN Leina;CHU Meijun;Jiangxi Institute For Drug Control,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality;Jiang Xi Institute for Food Control;

• 1:江西省药品检验检测研究院江西省药品与医疗器械质量工程技术研究中心
• 2:江西省食品检验检测研究院

摘要(Abstract)：

目的评价国产青霉素V钾片的质量状况及存在的问题。方法采用法定标准方法和探索性研究(费休氏法测定水分)对青霉素钾片进行相关检验。结果 216批样品依据法定标准检验合格率为99.1%。不同厂家样品间的有关物质、平均片质量和水分数据差异显著,且存在一定相关性。结论目前国产青霉素V钾片产品质量基本符合法定标准要求,但探索性研究提示某些厂家应改进处方工艺,标准应增加对水分的检测,以减少有关物质的总杂质量。
OBJECTIVE To evaluate the quality status of domestic phenoxymethylpenicillin potassium tablets and existing problems. METHODS Official standard method and exploratory study( water determination by Fischers method) were used to examine samples. RESULTS 99.1% of 216 batches were in accordance with the official standard. Related substances,average weight and water content data from different manufacturer were significantly different,and there was some correlation. CONCLUSION The quality of domestic phenoxymethylpenicillin potassium tablets can basically meet requirements of official standard. However,exploratory study suggests that some of the manufacturers should improve the processing technique and control water content,in order to reduce total impurities.

关键词(KeyWords)： 青霉素V钾片;质量评价;杂质
phenoxymethylpenicillin potassium tablets;quality evaluation;impurities

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 陈希;吴鑫;鄢雷娜;储梅君;
CHEN Xi;WU Xin;YAN Leina;CHU Meijun;Jiangxi Institute For Drug Control,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality;Jiang Xi Institute for Food Control;

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