加味左金丸胶囊剂的药效学及含量测定研究

加味左金丸由黄连、吴茱萸、木香组成,本文将原处方制备成胶囊剂后,进行了药效学和含量测定的研究,检验制备工艺对药效和主要成分含量的影响。胶囊剂对大鼠应激性溃疡发生指数抑制率为66.86％,与雷尼替丁类似。对盐酸—乙醇所致大鼠胃粘膜损伤的溃疡指数抑制率为99.38％。以上药效有剂量依赖性。实验结果与加味左金丸汤剂的结果(已发表资料)基本一致。根据《药典》的技术方法,测定胶囊剂中小檗碱的含量,结果为6.6％。参考《药典》对类似处方制剂的规定(香连丸小檗碱含量不得少于6.0％,左金丸不得少于5.6％),提示胶囊剂的小檗碱含量符合要求,可作为质量标准控制的参考。

Pharmacodynamics and Content Determination of Jiawei Zuojinwan Capsule

In this study a standard capsule form of Jiawei Zuojinwan was prepared and given to rats with stress-induced peptic ulcer and rats with severe damage of the gastric mucosa induced by ethanol and hydrochloric acid. The inhibition rate of ulcer index was 66.86% (similar to Ranitidine) and 99.38% respectively. The above effect bears a dose-dependent manner. The concentration of berberine, a principal active component of Zuojinwan, was 6.6%, and its concentration in Zuojinwan regulated by Chinese Parmacopoeia should not be less than 5.6%. It is shown that the berberine content of the Capsule accords the regulation and may serve as a standard of quality control of the preparation.