复方丹参片质量标准的研究及其质量考察

Study on the Standard Specification and Investigation on Quality of Compound Danshen Tablet

为控制复方丹参片的质量 ,建立了HPLC法测定丹参酮ⅡA 、原儿茶醛、三七皂甙R1及GC法测定冰片的含量 ,定量方法简便准确 ,可有效地控制产品质量。本研究同时考察了全国 11个厂家生产的复方丹参片的质量 ,结果发现质量问题严重 ,现行药典质量标准无法真正控制其内在质量 ,标准亟待提高。

The standard specification are established to control the quality of Danshen tablet, in which the HPLC method is studied for determination of main contents including tanshinone Ⅱ A, protocatechuic aldehyde, and notoginsenoside R 1, the GC method is studied for the determination of borneol. These methods showed relatively high sensitivity and accuracy, and could effectively control the product quality. With these methods, products from 11 factories in China was investigated.