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机构地区:[1]广东药学院,广东广州510006 [2]广东省食品药品检验所,广东广州510180
出 处:《中国现代中药》2015年第6期596-600,共5页Modern Chinese Medicine
基 金:国家自然科学基金资助项目(81102146)
摘 要:目的:建立咳特灵胶囊一测双评法,并进行方法学考察。方法:以牡荆苷为研究对象,建立牡荆苷与异牡荆苷的相对校正因子(RCF),并利用校正因子对异牡荆苷进行含量测定,实现一测双评;采用外标法测定牡荆苷与异牡荆苷的含量,比较计算值与实测值间的差异。结果:在一定线性范围内,牡荆苷与异牡荆苷的RCF为0.9,不同厂家的咳特灵胶囊中两个成分的计算值与实测值无明显差异。结论:本研究建立的一测双评法准确、可行,可为中药制剂多指标质量评价提供新思路。Objective: To establish a quantitative assay of double-components by single-marker for determination of two components in Keteling capsules and and conduct the method validation test. Methods: Vitexin was selected as an internal reference substance, RCF of isovitexin was calculated. The contents of two components were determined by both external standard method and Double-Components Assay by Single Marker. The validity of the QAMS method was evaluated by comparison of their quantitative results of both methods. Results: RCF of isovitexin with reference to vitexin were 0. 90 and the quantitative results of both external standard method and QAMS had no significant difference. Conclusion: The established method is accurate and feasible, and can provide a new mind for the quality assess of preparation of Chinese traditional medicine.
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