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目的:筛选出抗肝纤维化中成药“扶正化瘀胶囊”中主要组分的最佳配伍,优化形成扶正化瘀复方的有效组分配方。方法:1筛选。运用二甲基亚硝胺诱导大鼠肝纤维化模型,以“扶正化瘀胶囊”中主要组成中药的6种提取物(a:虫草粗多糖、b:虫草菌丝体CO2超临界提取物、c:丹参酚酸、d:苦杏仁苷、e:绞股蓝皂苷、f:绞股蓝多糖组)为研究对象,用均匀设计的方法,以大鼠肝脏羟脯氨酸(Hyp)含量为主要筛选指标,用DAS3.0软件NONMEN的方法分析获得最佳有效组分配伍和最佳剂量。2验证。以扶正化瘀浸膏为对照,在最佳组分基础上设计分组,A组(扶正化瘀复方浸膏组)、B组(a+b+c+d+e+f组)、C组(a+b+d+e+f组)、D组(a+b+c+e+f组)、E组(a+b+e+f组)、模型组和正常组。观察大鼠血清肝功能、肝脏Hyp含量、肝组织病理及胶原纤维程度的变化,对所得最佳配伍进行验证,最终确定有效组分配方。结果:1筛选。经统计分析明确了虫草组分为主药,c和d无明显作用。最佳组合为:a 240 mg/kg+b0.1 ml/kg+e 20 mg/kg+f 7.3 mg/kg组分配伍。2验证。模型组ALT、AST、Alb和TBi L与正常组比较差异均有统计学意义(P<0.05,P<0.01);A组、D组和E组的ALT均明显低于模型组(P<0.05,P<0.01);仅E组的AST明显低于模型组(P<0.05);A组、B组和C组的Alb则明显高于模型组(P<0.01,P<0.05);TBi L在A组、B组、C组的含量均显著低于模型组(P<0.01)。模型组肝脏Hyp含量明显高于正常组;A组、B组、C组和E组Hyp含量与模型组相比差异均有统计学意义(P<0.01,P<0.05)。大鼠肝纤维化胶原沉积半定量则仅C组与模型组间差异有显著性统计学意义(P<0.01);各治疗组除A组外胶原纤维面积均比模型组减小(P<0.01,P<0.05)。结论:均匀设计的实验方法可靠,但结果需结合临床进一步优化;扶正化瘀复方有效组分虫草粗多糖、虫草菌丝体CO2超临界提取物、绞股蓝多糖、绞股蓝皂苷、丹参酚酸和苦杏仁苷的合理配伍能重现原复方药效。
OBJECTIVE: To select the best compatibility of the main components of anti-fibrosis proprietary Chinese medicine “Fuzhenghuayu capsule” and to optimize the formula of effective components for forming the compound recipe of Fuzhenghuayu. Method: 1 screening. Using dimethylnitrosamine induced rat liver fibrosis model, “Fuzhenghuayu Capsule” composed mainly of 6 kinds of Chinese herbal extracts (a: Cordyceps polysaccharide, b: Cordyceps mycelium CO2 supercritical fluid extraction , C: salvianolic acid, d: amygdalin, e: gypenoside, f: Gynostemma pentaphyllum group) were selected as the research object. Hyp content in rat liver was used as the main screening method Indicators, using DAS3.0 software NONMEN method analysis to obtain the best effective component compatibility and the best dose. 2 verification. Group A (Fuzheng Huayu Compound Extract), Group B (a + b + c + d + e + f) and Group C (a + b + d + e + f group), D group (a + b + c + e + f group), E group (a + b + e + f group), model group and normal group. The changes of serum liver function, hepatic Hyp content, liver histopathology and collagen fiber degree were observed. The best compatibility was verified, and the formula of effective components was finally determined. Results: 1 Filter. The statistical analysis identified Cordyceps component as the main drug, c and d had no significant effect. The best combination is: a 240 mg / kg + b 0.1 ml / kg + e 20 mg / kg + f 7.3 mg / kg. 2 verification. ALT, AST, Alb and TBi L in model group were significantly lower than those in normal group (P <0.05, P <0.01); ALT in group A, D and E were significantly lower than that in model group (P <0.01, P <0.01). The AST in group E was significantly lower than that in model group (P <0.05). Alb in group A, group B and group C was significantly higher than that in model group In group A, group B, group C were significantly lower than the model group (P <0.01). The content of Hyp in model group was significantly higher than that in normal group. There was significant difference in Hyp content between group A, B, C and E compared with model group (P <0.01, P <0.05). Semiquantitative analysis of collagen deposition in rats with liver fibrosis only C group and the model group, the difference was statistically significant (P <0.01); each treatment group except collagenase A group were smaller than the model group (P <0.01 , P <0.05). Conclusion: The uniform design of the experimental method is reliable, but the results need to be combined with clinical further optimization; effective components of Fuzhenghuayu compound Cordyceps polysaccharide, Cordyceps mycelium CO2 supercritical fluid extract, Gynostemma polysaccharide, gypenosides, salvianolic acid and bitter almond The rational compatibility of glycosides can reproduce the original compound efficacy.