苦碟子注射液的安全性研究

Study on safety of Kudiezi injection

目的:从体内和体外两方面探讨苦碟子注射液的安全剂量,为临床剂量提供参考依据。方法:采用尾静脉注射法考察苦碟子注射液对小鼠的最大给药剂量,采用MTT法检测苦碟子注射液对小鼠成纤维细胞(L929)的半数抑制浓度(IC50)及细胞毒性级别。结果:苦碟子注射液对小鼠的最大给药剂量为40 mL·kg-1;2个厂家苦碟子注射液的IC50比较并无显著性差异(P>0.05)。原液对L929的细胞毒性级别为4级,稀释64倍时毒性级别为1级。结论:苦碟子注射液对小鼠的最大给药剂量为40 mL·kg-1,当稀释64倍时对L929基本无毒。

Objective：To explore in vivo and in vitro safe doses of Kudiezi injection so as to provide reference for clinical dosage. Methods ：Tail vein injection was performed to test maximum dose of Kudiezi injection in mice. The MTF method was used to detect half inhibitory concentration （ICs0）and cell toxicity level in fibroblasts L929 in mice. Results：The maximum dose of Kudiezi injection in mice was 40 mL · kg-1. Comparison of ICs0 of Kudiezi in- jection produced by two manufacturers showed no significant difference （P 〉 0. 05 ）. The toxicity of the stock solu- tion in L929 was Grade d, and was Grade 1 when diluted 64 times. Conclusion：The maximum dose of Kudiezi in- jection in mice is 40 mL · kg-1 , and there is basically no toxicity in L929 when Kudiezi injection is diluted 64 times.