采用聚酰胺除辛芍冻干粉针中赤芍提取物鞣质的工艺研究

目的:研究注射用辛芍冻干粉针聚酰胺法除鞣质工艺。方法:以有效成分芍药苷转移率、鞣质检查、局部刺激性和小鼠异常毒性试验为评价指标,通过聚酰胺除鞣质吸附、解析工艺优化,比较传统除鞣质法和聚酰胺除鞣质法除鞣质效果。结果:聚酰胺法能有效去除样品中的鞣质,芍药苷的转移率明显高于其他方法,而且异常毒性显著降低,制剂的安全性得到有效保证。结论:聚酰胺法除鞣质为中药注射剂除鞣质技术提供了实验依据。

Technology of eliminating tannin with polyamide-adsorption for preparing Xinshao lyophilization

Objective: To study the process of eliminating tannin with polyamide-adsorption for preparing Xinshao lyophilyzation.Method: The transfer rate of paeoniflorin,tannin examination,the test of the local stimulus and abnormal toxicity on mice were adopted as indexes to optimize the process of tannin adsorption and resolution of polyamide-adsorption,and the effect of eliminating tannin of polyamide-adsorption was compared with traditional methods.Result: The effect of eliminating tannin with polyamide-adsorption was good,and the transfer rate of paeoniflorin with polyamide-adsorption was superior to the other methods.Furthermore,the abnormal toxicity decreased evidently and the security of the preparation was ensured.Conclusion: The method of polyamide-adsorption provides a useful reference to the technique of eliminating tannin in the traditional Chinese medicine injections.