头孢氨苄系列制剂质量评价分析  

Quality Analysis of Cefalexin Preparations

作　　者：巩丽萍 谢元超 杨娜 李玉杰 徐晓洁 

机构地区：[1]山东省食品药品检验研究院,济南250101

出　　处：《中国药事》2015年第8期845-849,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:对头孢氨苄系列制剂质量及其质量标准进行评价和分析,为头孢氨苄系列制剂安全监管和质量标准提高提供参考。方法:依据法定标准对抽样进行检验,对含量测定和有关物质等检验结果进行分析;并进行了如下探索性研究:2-萘酚、有关物质、溶出度和聚合物检测,头孢氨苄铝塑胶囊的定量近红外(NIR)模型研究。结果:按法定标准检验,373批样品检验结果全部符合规定;探索性研究结果表明,现行标准尚存在不足,部分产品质量还存在一定的问题。结论:虽然按法定标准检验,头孢氨苄系列制剂结果全部符合规定,但探索性研究结果表明,产品质量和现行标准还有待于进一步提高。Objective： To evaluate and analyze quality and quality standards of cefalexin preparations so as to provide references for safety supervision and standard improvement of cefalexin preparations. Methods： The samples were tested according to the statutory test criteria, and the assay and test results were analyzed. The exploratory study was conducted on the tests of 2-isonaphthol, related substances, dissolution and polymers as well as the 1NR model of aluminum-plastic cefalexin tablets. Results： The 373 samples were all qualified under the existing standard. However, the exploratory study showed the existing standards were inadequate, and there were some problems as for the quality of certain products. Conclusion： Although cefalexin preparations met all requirements by the statutory test criteria, the results of the exploratory study showed that the quality of cefalexin preparations and the current standards needed further improvement.

关 键 词：药品安全监测 药品质量评价 药品评价性抽验 药品质量分析 药品质量标准提高 头孢氨苄胶囊 头孢氨苄片 头孢氨苄颗粒 

分 类 号：R927.1[医药卫生—药学]