中国药事
中國藥事
중국약사
Chinese Pharmaceutical Affairs
2015年
8期
845-849
,共5页
巩丽萍%谢元超%杨娜%李玉杰%徐晓洁
鞏麗萍%謝元超%楊娜%李玉傑%徐曉潔
공려평%사원초%양나%리옥걸%서효길
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
藥品安全鑑測%藥品質量評價%藥品評價性抽驗%藥品質量分析%藥品質量標準提高%頭孢氨芐膠囊%頭孢氨芐片%頭孢氨芐顆粒
약품안전감측%약품질량평개%약품평개성추험%약품질량분석%약품질량표준제고%두포안변효낭%두포안변편%두포안변과립
drug safety monitoring%drug quality evaluation%drug sampling for evaluation%drug quality analysis%drug standard improvement%cefalexin capsules%cefalexin tablets%cefalexin granules
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。
目的：對頭孢氨芐繫列製劑質量及其質量標準進行評價和分析，為頭孢氨芐繫列製劑安全鑑管和質量標準提高提供參攷。方法：依據法定標準對抽樣進行檢驗，對含量測定和有關物質等檢驗結果進行分析；併進行瞭如下探索性研究：2-萘酚、有關物質、溶齣度和聚閤物檢測，頭孢氨芐鋁塑膠囊的定量近紅外（NIR）模型研究。結果：按法定標準檢驗，373批樣品檢驗結果全部符閤規定；探索性研究結果錶明，現行標準尚存在不足，部分產品質量還存在一定的問題。結論：雖然按法定標準檢驗，頭孢氨芐繫列製劑結果全部符閤規定，但探索性研究結果錶明，產品質量和現行標準還有待于進一步提高。
목적：대두포안변계렬제제질량급기질량표준진행평개화분석，위두포안변계렬제제안전감관화질량표준제고제공삼고。방법：의거법정표준대추양진행검험，대함량측정화유관물질등검험결과진행분석；병진행료여하탐색성연구：2-내분、유관물질、용출도화취합물검측，두포안변려소효낭적정량근홍외（NIR）모형연구。결과：안법정표준검험，373비양품검험결과전부부합규정；탐색성연구결과표명，현행표준상존재불족，부분산품질량환존재일정적문제。결론：수연안법정표준검험，두포안변계렬제제결과전부부합규정，단탐색성연구결과표명，산품질량화현행표준환유대우진일보제고。
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 INR model of aluminum-plastic cefalexin tablets.Results:The 373 samples were all qualiifed 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.
