头孢地尼口服固体制剂的质量分析与评价

Quality analysis of cefdinir oral preparations

目的评价头孢地尼口服固体制剂(头孢地尼胶囊、头孢地尼分散片、头孢地尼片)的质量现状。方法采用法定检验方法结合探索性研究,对2021年国家药品抽检工作中获得的样品的质量状况及质量标准的合理性进行了分析。结果按法定标准检验160批次样品,合格率为100%。但现行质量标准存在检验方法不一致、个别项目限度不合理等问题。探索性研究建立了可同时测定有关物质和聚合物类杂质的RP-HPLC法,对产品中杂质谱的差异进行了比较;通过溶出度试验考察头孢地尼口服制剂在不同介质中的溶出行为,并同日本橙皮书中参比制剂的溶出行为进行了比较,发现国内制剂的溶出速率更快。结论目前国内市场流通的头孢地尼胶囊(片剂、分散片)质量总体较好,现行标准基本可行,部分检验项目需进一步完善统一。

Objective To evaluate the quality status of domestic cefdinir capsules,cefdinir dispersible tablets,and cefdinir tablets.Method According to the general requirements of national assessment programs,the statutory specification methods combined with exploratory researches were used to evaluate the quality of cefdinir oral solid preparations.Results 160 batches of cefdinir oral solid preparations were determined according to the legal specification.The qualified rate was 100%.However,some methods and limits in different specifications have some differences.The further approach showed that the specifications used had some problems,such as unreasonable limit.Based on the comparisons of some related substance methods with the method in ChP,an optimal RP-HPLC method for the determination of impurities including the polymers was established.The method was used to compare the differences of impurity profiles of different products.Additionally,the dissolution profiles of cefdinir oral solid preparation in different dissolution media were investigated and compared with the reference preparation recorded in the Japanese Orange Book.Conclusion The quality of cefdinir oral solid preparations was generally good,and the current statutory specifications should be unified and further improved.