苦碟子注射液的安全性研究

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 MTT method was used to detect half inhibitory concentration (IC₅₀)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 IC₅₀ of Kudiezi injection produced by two manufacturers showed no significant difference (P>0.05).The toxicity of the stock solution in L929 was Grade 4,and was Grade 1 when diluted 64 times. Conclusion: The maximum dose of Kudiezi injection in mice is 40 mL·kg^-1,and there is basically no toxicity in L929 when Kudiezi injection is diluted 64 times.

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