扶正化瘀复方多元释药系统的疗效评价

To evaluate the therapeutic effect of the Fuzheng Huayu compound multiunit drug delivery system

目的:综合评价扶正化瘀复方多元释药系统制剂的疗效。方法:大鼠随机分为正常组和模型组。模型组以二甲基亚硝胺诱导形成大鼠肝纤维化模型,4周造模成功后,将存活的造模大鼠随机分为扶正化瘀原方浸膏组(以下简称"原方组",34.52 g/kg,相当于体60kg正常成人每天的用量)、扶正化瘀复方多元释药系统39.218 g/kg组(等同于扶正化瘀原方剂量)、19.609 g/kg组、9.805g/kg组、模型组。4周后处死,通过检测生化指标(肝功能和肝组织羟脯氨酸)、肝脏病理等变化,对照原方评价该制剂的疗效。结果:较模型组相比,原方组与扶正化瘀复方多元释药系统19.609 g/kg组各组肝组织羟脯氨酸(215.69±13.05 vs167.38±17.38、161.95±6.20)、血清丙氨酸氨基转移酶(101.67±13.42 vs 76.03±8.08、75.90±6.16)、血清门冬氨酸氨基转移酶(150.36±19.55vs 123.35±7.29、117.23±5.39)均有明显降低;较模型组相比,扶正化瘀复方多元释药系统19.609 g/kg组肝组织血清白蛋白(26.81±1.5632.24±0.54)、血清总胆红素(11.57±2.93 vs 7.33±0.31)有显著改变,原方组有明显改变,扶正化瘀复方多元释药系统39.218g/kg组的血清白蛋白含量也较模型组有明显改变;对大鼠肝纤维化胶原沉积半定量Ridit分析则仅有扶正化瘀复方多元释药系统19.609g/kg组有显著意义;图像分析则以原方组(14.43%)、扶正化瘀复方多元释药系统39.218g/kg组(13.28%)、19.609g/kg组(10.23)、9.805g/kg组(25.63)和模型组(23.124%)均有显著意义。结论:19.609 g/kg扶正化瘀复方多元释药系统制剂治疗DMN大鼠肝纤维化疗效明确,并且所含生药量约是扶正化瘀原方的一半,虽然临床上从未发生过患者因服用扶正化瘀复方出现中毒的事件,但提示潜在的氢氰酸毒性较扶正化瘀原方大为减少,并且有增效的趋势。

Objectives： To evaluate the therapeutic effect of the Fuzheng Huayu compound multiunit drug delivery system（ DDS of FZHY） curing liver fibrosis induced by dimethylnitrosamine（ DMN） in mice comprehensively. Methods： The male SD mice were randomly divided into 2groups： nomal group and model group. Use the DMN induced a liver fibrosis model,4 weeks later,randomly divided the mice still alive into Fuzhenghuayu Capsules（ FZHY,34. 52 g / kg,as a normal 60 kg human being＇s daily dose） group,DDS of FZHY39. 218 g / kg group（ the same dosage as the FZHY group）,19. 609 g / kg group,9. 805 g / kg group and model group. Liver functions in serum,hyp content of hepatic tissue and liver pathological changes were observed to compare and validate the effects of DDS of FZHY. Results： Compared with model group,the liver hyp contents,serum ALT and Serum AST of FZHY and 19. 609 g / kg group decreased significantly; Serum ALB and of 19. 609 g / kg group increased significantly by compared with the model group（ P〈0. 01）,also both the FZHY group and the 39. 218 g / kg group（ P 0.05） increased too. Serum TBiL of FZHY（ P〈0. 05）,19. 609 g / kg（ P〈0. 01） groups decreased significantly by compared with the model group; The collagen deposition in rat liver analyzed by Ridit indicated the MD group have a significant effect against liver fibrosis. And the collagen deposition in rat liver analyzed by Image-pro plus 6. 1 and manifested that the groups of FZHY,39. 218 g / kg,19. 609 g / kg,9.805 g / kg were significantly less than the model group（ 23. 12%）（ P〈0. 01）. Conclusion： 19. 609 g / kg Fuzheng Huayu compound multiunit drug delivery system curing liver fibrosis induced by dimethylnitrosamine（ DMN） in mice has been approved medically effective through extensive evidences,and half dosage of the the Fuzheng Huayu capsules makes the potential toxicity of hydrocyanic acid reduce too,though until now there is no drug poisoning happened in patients who have taken Fuzheng Huayu capsules. In sort,the 19. 609 g / kg Fuzheng Huayu compound multiunit drug delivery system outperform the Fuzheng Huayu capsules.