摘要
目的:通过对127批香连制剂样品进行标准检验及探索性研究,对该制剂质量标准中黄连的检测项进行分析和评价,探索香连制剂中黄连新的质量控制方法。方法:标准检验依据《中国药典》2010年版一部(片剂和丸剂)和国家药品标准新药转正标准第65册(胶囊剂),检验项目包括TLC鉴别及HPLC含量测定。探索性研究采用薄层制备、HPLC-DAD、HPLC-MS等检测方法,对香连胶囊中未知成分进行了分析鉴定;采用一测多评技术(QAMS)测定4种黄连生物碱含量。结果:按现行标准,合格率100%;与对照品比对,确认香连胶囊样品中的未知成分为小檗红碱;较多厂家的香连制剂中小檗碱的含量远高于其他黄连生物碱,致使制剂与黄连药材中生物碱的含量比例差异较大,存在非法添加问题。结论:探索性研究为进一步修订标准及有效地控制该制剂质量提供参考依据。
OBJECTIVE To analyze and evaluate the quality control of Coptis chinensis in Xianglian preparation and develop new quality control method of this preparation through 127 batches of samples tested and further investigated. METHODS The current quality standards were Chinese Pharmacopoeia （2010） Volume i （tablet and pill） and the national drug standard for new drug standard （vol. 65） （capsule）, including the TLC method and HPLC method. The exploratory research was to identify an unknown component in Xianglian capsule by PTLC, HPLC-DAD and HPLC-MS. The contents of 4 alkaloids in Xianglian preparation were determined by QAMS method （quantitative analysis of multi-components by single-marker）. RESULTS According to the current standards of quality inspecting, 127 batches of samples were up to standard and the qualified rate of sample was 100% ; the unknown component was identified as berberrubine through the comparison with reference compoundl The contents of berberine in the samples from more companies were much higher than the other alkaloids so that the ratios of alkaloids in the preparation were very different with those in Coptis chinensis. The problem of the illegally addition is very obvious. CONCLUSION The results of test indicate that exploratory research method will provide the reference for further revising drug standard and monitoring quality of this preparation.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2015年第19期1755-1758,共4页
Chinese Journal of Hospital Pharmacy
