从葛根素的异常毒性实验看药用辅料的重要性

目的：探讨葛根素注射剂出现毒性反应的原因。方法：参照《中国药典》2005年版，附录Ⅺ C异常毒性检查法，按照尾静脉注射给药法试验，平行检测不同厂家和剂型的葛根素注射剂和不同浓度的丙二醇溶液的毒性反应。结果：葛根素注射剂的毒性反应和其中所含丙二醇的量呈正相关。结论：丙二醇对于葛根素注射剂的毒性反应有很大影响。改进制剂工艺，加强对制剂辅料的监管非常必要。

The importance of pharmaceutical excipients according to the abnormal toxicity of Puerarin

Objective： To study the reasons of Puerarin Injection occuring toxicity. Methods： According to the Chinese Pharmacopoeia 2005 edition, Appendix XI C test for abnormal toxicity, in accordance with tail intravenous injection test, parallel detect different manufacturers and dosage forms of Puerarin Injection and different concentrations of propylene glycol solution toxicity. Results： Puerarin Injection of toxic reactions and the amount of propylene glycol contained in them showed positive correlation. Conclusion： Propylene glycol has great influence on Puerarin Injection toxicity. Improving preparation process, strengthening the supervision and management of pharmaceutical excipients are very necessary.