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105批国产盐酸头孢他美酯口服固体制剂质量分析
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| 篇名： | 105批国产盐酸头孢他美酯口服固体制剂质量分析 |
| TITLE： | |
| 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 provide reference for improving the homogeneity and stability of domestic cefetamet pivoxil hydrochloride oral solid preparation and its control standrads. METHODS： 105 batches of cefetamet pivoxil hydrochloride preparations （tablets， granules， dry suspensions and dispersible tablets） were tested by statutory inspection test in respects of property， identification， weight difference or load difference， moisture， microbiological limits， related substances， dissolution degree and content， etc.， and results were analyzed. Exploratory research was conducted for its impurity sources， dissolution consistency evaluation， the correlation between the remaining validity period with relative substance and content， etc. RESULTS： Statutory tests showed， 103 batches were qualified in the 105 batches of samples （98.1％）. The unqualified items were property and related substances， the other items met relevant regulations. Besides， the determination method for related substances in dispersed tablets was quite different with other preparations. Results of exploratory research showed the related substances in preparations originated from raw materials， degradation reaction in manufacturing or storage. Compared with domestic reference tablets and granules， f2 of dissolution of other products were mostly less than 50； there was no correlation in related substances， content with the remaining validity period. CONCLUSIONS： The 105 batches of domestic oral solid preparation of cefetamet pivoxil hydrochloride are basically qualified； current standard is basically feasible for tablets， granules and dry suspensions， while the standard for dispersible tablets needed to be improved immediately. |
| 期刊： | 2017年第28卷第13期 |
| 作者： | 李丹凤，朱健萍，朱荣，邓鸣，黄丽丽 |
| AUTHORS： | LI Danfeng，ZHU Jianping，ZHU Rong，DENG Ming，HUANG Lili |
| 关键字： | 盐酸头孢他美酯；口服固体制剂；评价性抽验；探索性研究；质量分析 |
| KEYWORDS： | Cefetamet pivoxil hydrochloride； Oral solid preparation； Evaluative testing； Exploratory research； Quality analysis |
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