105批国产盐酸头孢他美酯口服固体制剂质量分析

发布时间：2018-05-26 06:38

本文选题：盐酸头孢他美酯 + 口服固体制剂　；参考：《中国药房》2017年13期

【摘要】：目的:为提高盐酸头孢他美酯口服固体制剂质量的均一性、稳定性及其质量控制标准提供参考。方法:采用法定检验方法对105批盐酸头孢他美酯制剂(片剂、胶囊剂、干混悬剂和分散片)的性状、鉴别、重量差异或装量差异、水分、微生物限度、有关物质、溶出度和含量等进行常规检验,并对检验结果进行分析;另对其杂质来源、溶出度一致性评价、样品剩余有效期与有关物质及含量的相关性等进行探索性研究。结果:法定检验结果显示,105批样品中103批合格(合格率98.1%),不合格项目为性状及有关物质,其他项目均符合相关规定;分散片的有关物质测定方法与其他剂型差别较大。探索性研究结果表明,制剂中的有关物质来源于原料以及生产和贮存过程中发生的降解反应;与国产参比片剂与胶囊剂比较,其他厂家产品溶出度的相似因子(f2)大多小于50;盐酸头孢他美酯制剂的有关物质、含量与剩余有效期未见相关性。结论:105批国产盐酸头孢他美酯口服固体制剂质量基本合格;片剂、胶囊和干混悬剂现行检验标准基本可行,但分散片的检验标准亟需提高。
[Abstract]:Objective: to improve the quality uniformity, stability and quality control of ceftamet hydrochloride oral solid preparation. Methods: 105 batches of ceftamet hydrochloride preparations (tablets, capsules, dry suspension and dispersible tablets) were determined by using the method of legal examination, including identification, weight difference or volume difference, moisture content, microbial limit and related substances. The dissolution and content of the samples were tested by routine methods, and the results were analyzed. The sources of impurities, the consistency evaluation of dissolution, the correlation between the remaining validity period of samples and the related substances and contents were also studied. Results: the results of legal examination showed that 103 of 105 samples were qualified (the qualification rate was 98.1%), the unqualified items were characters and related substances, the other items were in accordance with the relevant regulations, and the determination methods of related substances in dispersible tablets were quite different from those of other dosage forms. The results of exploratory study showed that the related substances in the preparation originated from raw materials and degradation reactions during production and storage, and were compared with those of domestic reference tablets and capsules. Most of the similar factors (F _ 2) of other products were less than 50, and there was no correlation between the content of ceftamet hydrochloride and the remaining period of validity. Conclusion the quality of 105-batches of domestic ceftamet hydrochloride oral solid preparations is basically up to standard, the present standard of tablets, capsules and dry suspensions is basically feasible, but the standard of dispersible tablets needs to be improved.
【作者单位】：广西壮族自治区食品药品检验所;
【分类号】：R927.1

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