清开灵注射液护肝药效限值测定法的建立

Establishing of the pharmacodynamic limit method of Qingkailing Injection on hepatoprotective effect

目的研究清开灵注射液在小鼠四氯化碳(CCl4)急性肝损伤模型的保护作用,探讨其护肝药效测定的限值法。方法小鼠腹腔注射清开灵注射液进行预处理后口服灌胃给予0.5%CCl4,检测血清谷丙转氨酶(ALT)和谷草转氨酶(AST)活性,确认肝保护作用的限值剂量。以20 mL/kg作为限值剂量对2个厂家共4个批次的清开灵注射液的药效进行比较。结果阴性对照组的ALT活性为(30.70±9.93)U/L,AST活性为(68.90±13.54)U/L,小鼠给予CCl4后,ALT活性为(761.60±80.80)U/L,AST活性为(1442.70±546.62)U/L,均高于对照组(P<0.01);4个批次的清开灵注射液组的ALT活性分别为(378.00±29.47)、(287.80±107.74)、(289.70±26.84)、(312.10±76.22)U/L,AST活性分别为(524.30±241.09)、(400.40±253.71)、(513.80±211.89)和(548.60±263.61)U/L,均显著低于CCl4组(P<0.01)。结论 20 mL/kg可考虑作为限值剂量在CCl4致小鼠急性肝损伤模型对清开灵注射液护肝作用进行药效的限值法测定。

Objective To establish a pharmacodynamic limit research method for Qingkailing （QKL） Injection with carbon tetrachloride （CC14）-induced acute liver injury mouse. Methods Mice were given QKL Injection by intraperitoneal injection before 0.5% CC14 was given by oral gavage. Serum alanine aminotransferase （ALT）, aspartate aminotransferase （AST） were determined to study the protective effect of 4 batches of QKL Injections against CC14- induced liver injury. Results In control group, ALT activity was （30.70 ± 9.93） U/L and AST activity was （68.90 ± 13.54） U/L. CC14 increased the activities of ALT and AST significantly when compared with control group, ALT and AST activity in CC14 group was （761.60 ± 80.80） U/L and （1442.70 ± 546.62） U/L respectively （P 〈 0.01）. In four QKL Injection-treated groups, ALT activity was （378.00 ± 29.47）, （287.80 ± 107.74）, （289.70 v26.84）, （312.10 ±76.22） U/L respectively, AST activity was （524.30 ± 241.09）, （400.40 ± 253.71）, （513.80 v 211.89）, （548.60 ± 263.61） U/L respectively. They were all lower than those in CC14 group （P 〈 0.01）. Conclusion 20 mL/kg is an appropriate limit dose for testin~ heoatoorotective effect of 0KL Injection in CC14-induced mouse acute liver iniury model.