抗肝炎病毒冲剂的研制与临床应用

The Preparation and Clinical Observation of Anti-hepatitis-virus Inustant Graunie

本文介绍抗肝炎病毒冲剂的处方组成、制备工艺、质量标准以及临床应用研究。HPLC法对主药之一芍药的有效成分芍药甙进行含量测定，重现性良好，平均回收率98．69％，RSD=1．61％。据33cd分组观察，治疗组HBV－DNA阴转率52．9％，对照组为16．7％；HBeAg阴转率和抗-HBe阳转率分别为76．8％和39．2％，对照组分别为19．5％和20．0%。

Anti-hepatitis-virus instant granule is a traditionall Chinese medicinal complex preparation, which is composed of17 traditional Chinese herbs, such as Bupleurum Chinese DC, paeonia lactiflora Pall et, al. This paper discribes the composition,preparation process, quality control standard and therapeutic effect of anti-hepatitis-virus instant granule. Paeoniflorin, the activecomponent of one of the main herbs of the preparation, was determined by HPLC method with a good reproducibility and anaverage recovery of 98.69%(RSD=1.61%). 330 patients with chronic hepatitis B or C were divided into two groups and thetherapeutic effects of this preparation were observed. As a result, the rate of negativezation of HBV-DNA of therapeutic group (170cases) was 52.9% and that of control group (160 cases)was i6.7%;the rates of negativezation of HBeAg and the positivezation ofanti-HBe of therapeutic group were 76.8% and 39.2 % and those of control group were 19.5 % and 20.2%, respectively.