Study On Preparation And Optimal Combination Of Compound Qishen Injection

Compound recipe of traditional Chinese medicine possess two properties: the complexity of chemical composition and therapy entirety. To make the effect of compound recipe more specific and main pharmacodynamic action more significant, which are beneficial to the study on pharmacodynamics and enhance safety, efficacy, the controllability of quality, on the basis of compound Qishen, we studied on the new medicine—compound Qishen injection with treating chronic hepatitis and anti-hepatic fibrosis. The main parts of this work were as follows.(1)Study on bioactive fraction of traditional Chinese medicineTaking the content of bioactive fraction as index, Orthogonal design law was applied to optimize the process conditions of purifying bioactive fraction of Astragalus and Radix Salvia Miltiorrhizae with macroporous adsorption resin.Using colorimetric method as the detection method of cell proliferation, we investigated the effect of total saponins and total salvianolic acid(TSA) on proliferation of hepatic stellate cell (HSC-T₆) stimulated by serum. The resulting indicated that the two bioactive fractions could inhibit proliferation of HSC-T₆ in a concentration-dependent manner.(2) Study on the compatibility of bioactive fractionsThe compatibility of bioactive fractions in compound Qishen injection was close to pharmacodynamic action, so we studied on the compatibility of bioactive fractions by choosing pharmacodynamic index. Six compatibility groups were designd to investigate the effects of total saponins and TSA in combination on the proliferation of serum-driven HSC-T₆ cells by the weighted modification method. Results: The optimal combination of compound Qishen injection was total saponins 8mg/L+TSA 20mg/L. Total saponins in combination was more important than TSA and there was a additivity between total saponins and TSA.(3) Study on the pharmacodynamicsCCl₄ (ip)-induced acute hepatic injury model was made in rats. Results: Compared with model group ,three dosage groups of compound Qishen and positive control group could decrease indices of hepatic and spleen obviously, but could not decrease ALT level significantly; The statistical result of pathohistology showed that CCl₄ could induce the changes significantly such as hepatic cell injury, cell regeneration and matix inflammatory cells infiltration. Three dosage groups and positive control group could decrease hepatic cell injury, matix inflammatory cells infiltration and promote cell regeneration slightly, which had not statistically significant. It was showed that compound Qishen had not apparent protective effect against CCl₄-induced acute hepatic injury.