金蕾胶囊的提取及制备工艺研究

Extraction and preparation process of Jinlei Jiaonang(金蕾胶囊)

目的优选金蕾胶囊的提取及制备工艺。方法采用正交设计,以出膏率、当药黄素和当药醇苷的含量为综合评价指标,优选金蕾胶囊的提取工艺;采用湿法制粒,以合格颗粒得率、流动性、水分为综合评价指标优选金蕾胶囊内容物颗粒的制备工艺;采用手工法填充胶囊,并对装量差异限度进行检查。结果金蕾胶囊的提取工艺为:加8倍量70%乙醇提取2次,每次1.0 h。金蕾胶囊内容物颗粒的制备工艺为:浸膏粉与辅料比为1∶1,麦芽糊精与微粉硅胶比为10∶1,混合后以80%乙醇湿法制粒。所制得的金蕾胶囊装量差异限度符合《中华人民共和国药典》2015年版的规定。结论该法提取工艺简便、稳定,胶囊内容物颗粒的制备工艺符合颗粒剂的制备要求,为金蕾胶囊的生产提供了实验依据。

Objective To optimize the extraction and preparation process of Jinlei Jiaonang(金蕾胶囊) .Methods Orthogonal design was used with extract rate,swertisin and swertianolin content as comprehensive evaluation index to optimize the extraction process of Jinlei Jiaonang. Wet granulation was used with qualified granule yield rate,fluidity and moist as comprehensive evaluation index to optimize the preparation process of Jinlei Jiaonang content granule. Manual method was used to fill capsules and filling variation limit was examined.Results The extraction process of Jinlei Jiaonang was as follows: extraction twice with 8 times of 70% ethanol for 1.0 hour each time. The preparation process of Jinlei Jiaonang content granule was as follows: the ratio of extract powder to excipient was 1 ∶ 1,the ratio of maltodextrin to silica gel micro powder was 10 ∶ 1,and wet granulation with 80% ethanol after mixture.The filling variation limit of the prepared Jinlei Jiaonang conformed to the specifications of the 2015 edition of Pharmacopoeia of the People’s Republic of China. Conclusion This extraction process is simple and stable,and the preparation process of capsule content granules conforms to the preparation requirements of granules,which provides experimental basis for the production of Jinlei Jiaonang.