医院制剂祛风颗粒浸出物质量研究标准

A study on extract quality standards of the Qufeng granules

目的:建立和完善祛风颗粒剂的质量标准。方法:按《中国药典》2010年版一部附录ⅩA浸出物测定法热浸法操作测定[1]。以正丁醇为溶剂,采用醇溶性浸出物测定法(热浸法)测定祛风颗粒剂中的浸出物含量。结果:实验表明本方法可作为祛风颗粒剂醇溶性浸出物的含量检查。结论:建议医院中药制剂注册增加浸出物的检测方法。

Objective：To establish and improve the quality standards of the Qufeng granules.Methods：According to Chinese Pharmacopoeia 2010 appendix X A version of an extract determination of hot-dip method is determination.N-butanol as the solvent,alcohol-soluble extract of determination（hot dip） determination of extract content in the Qufeng granules.Results：The experiments show that this method can be used as content inspection of the alcohol-soluble extract of the Qufeng granules.Conclusion：It is recommended that the hospitals of TCM preparations registration detection methods to increase the extract.