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目的通过对12个生产企业的187批联苯双酯片及滴丸的评价性抽验结果分析,评价联苯双酯制剂的质量现状。方法采用法定检验方法结合探索性研究进行样品检验,统计分析国产联苯双酯制剂的质量现状并进行评价。探索性地考察在6种溶出介质中的溶出行为,测定全部样品的溶出度,并用HPLC法对全部样品的有关物质进行考察。结果法定检验显示187批样品全部合格;根据探索性研究显示,有关物质均小于0.4%;各剂型间、各企业间溶出度差异较大。结论联苯双酯制剂总体内在质量一般;滴丸剂优于片剂,现行质量标准有待提高。
OBJECTIVE: To evaluate the quality status of bifendate preparations by analyzing the evaluation results of 187 batches of bifendate tablets and dropping pills from 12 manufacturing enterprises. Methods The method of statutory test combined with exploratory research samples were tested, the quality status of domestic bifendate formulations were statistically analyzed and evaluated. The elution behavior of six samples was investigated exploratively, the dissolution of all samples was determined, and the related substances of all samples were investigated by HPLC. Results The statutory test showed that all 187 batches of samples were qualified. According to the exploratory research, all the related substances were less than 0.4%. The dissolution rates among different dosage forms and between enterprises were quite different. Conclusion The overall intrinsic quality of bifendate preparations is generally high; pills are better than tablets, and the current quality standards need to be improved.