两煎常压煎药机制备复方丹参汤剂的稳定性研究

目的 研究两煎常压煎药机所制复方丹参汤剂在储存期间的稳定性,保证临床用药安全有效.方法 采用高效液相色谱法,以复方丹参汤剂为研究对象,于制备后第1、3、5、7、14 d进行丹酚酸B含量测定及对比分析;同时进行微生物限度检查.结果 所制复方丹参汤剂于制备第14 d丹酚酸B含量下降4.46％,微生物限度检查均符合药品卫生标准.结论 两煎常压煎药机制备复方丹参汤剂室温下保存14 d有效成分稳定,符合标准.

Study on Stability of Salvia Compound Decoction in Chinese Herb Double Decocting Machine in Normal Pressure

Objective To research the stability of Salvia compound decoction in Chinese Herb Double Decocting Machine in normal pressure,in order to make sure the safety and effectiveness of clinical drug application.Methods The extraction of Salvianolic acid B was used as the inspection target to analyze the change of the Salvia compound decoction in 1,3,5,7,and 14 d by HPLC,and a microbial limit test was performed at the same time.Results The content of Salvianolic acid B in Salvia compound decoction have decreased 4.46% in 14th day,but the result of microbial limit test conform to the normal standard of drugs.Conclusion The content of Salvia compound decoction in Chinese Herb Double Decocting Machine in normal pressure is steady in normal temperature,and conform to the normal standard within 14 d.