不同厂家复方丹参片的有效成分含量考察

Investigation of the Active Ingredients Contents in Compound Danshen Tablets from Different Manufacturers

目的考察复方丹参片有效成分含量的厂间一致性与批间稳定性。方法采用高效液相色谱法测定A,B,C 3个厂家、不同批次复方丹参片有效成分丹参酮ⅡA和丹酚酸B的含量,分析含量变化情况。结果3个厂家共18个批次样品有效成分含量均符合中国药典规定。除B厂和C厂产品在丹参酮ⅡA含量上存在明显差异外,各厂产品之间在丹参酮ⅡA和丹酚酸B含量上无明显不同。但有效成分含量随批次波动较大,各厂家6批次样品中有效成分丹参酮ⅡA、丹酚酸B含量变异系数分别为11.9%～22.9%和13.8%～26.5%。结论受检厂家复方丹参片有效成分含量符合药典标准,同一厂家生产的复方丹参片有效成分含量批间稳定性差。

Objective To investigate the content uniformity of major active ingredients in Compound Danshen Tablets between the differ- ent manufacturers and the content stability among various batches of Compound Danshen Tablets. Methods The high performance liquid chromatograpby（HPLC） method was established and used to determine the content of major active ingredients, salvianolic acid B and tanshinone ⅡA, in different batches of Compound Danshen Tablets from three manufacturers. The variation of the content among manufac- tures or batches from the same manufacturer was analyzed and compared. Results The content of major active ingredients of total 18 batches of Compound Danshen Tablets from three manufacturers all complied with the standard test scope of Compound Dansben Tablet in Chi- nese Pharmacopoeia （Part one, 2010）. There was no significant difference in the contents of active ingredients in Compound Danshen Tablets between different manufacturers, except that significant difference was observed in the content of tanshinone ⅡA between manu- facturer B and C. But the content fluctuated greatly with batches. Among 6 batches of Compound Dansben Tablets from every manufacturer, RSD of the content of tanshinone ⅡA and salvianolic acid B ranged 11.9%-22.9% and 13.8%-26.5%, respectively. Conclusion The content of major active ingredients of all tested Compound Danshen Tablets comply with the standard of Chinese Pharmacopoeia. But the stability of the content in Compound Danshen Tablets among batches from the same manufacturer is poor.