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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 and existing problems of domestic penicillin V potassium tablets. Methods The legal standard methods and exploratory studies (Fisher’s method for the determination of moisture) penicillin potassium tablets related tests. Results 216 batches of samples according to statutory standards test pass rate was 99.1%. There was a significant difference between the related substances among different manufacturers’ samples, the average piece quality and the moisture data, and there was some correlation between them. Conclusion At present, the product quality of domestic penicillin V potassium tablets basically meets the statutory standards. However, exploratory research suggests that some manufacturers should improve the prescription process. The standard should increase the detection of moisture to reduce the total impurity content of related substances.