妇康草本速溶膜的安全性实验研究

Experimental Study on the Safety of Fukang Caoben Surongmo

目的对妇康草本速溶膜阴道黏膜中药制剂的安全性进行研究。方法将大黄、黄芩、蛇床子、地肤子等药材按比例混合,经回流提取出有效部位,以聚乙烯醇为成膜材料,制成缓释性膜剂,进行用药安全性考察。结果经口急性毒性试验、皮肤刺激实验及黏膜刺激性试验表明,中药缓释性妇科消炎膜剂妇康草本速溶膜使用安全。结论用于阴道黏膜的妇康草本速溶膜作为中药新药开发,对其制剂的经口毒性、对粘膜的刺激性、局部给药的过敏性等情况经过综合考察,为其安全性评价提供了科学依据。

Objective To research the safety of Fukang Caoben Surongmo . Methods The rawmaterials was dispensed according to the ratio of recipe, to extract the effective part of medicine materils by reflux extraction, sustained-release film was prepared with PVA membrane material for safety experiment. Results The experiment indicates that Fukang Caoben Surongmo was safe to use by the acute peroral toxicity test and the skin stimulate test. Conclusion This experiment provides scientific basis on the safety for research and development of new drug.