调压颗粒精制工艺研究  

Study on the purification process of Tiaoya granules

作　　者：闫明[1,2,3] 韦迎春[1,2,3] 李雪峰[1,2,3] 吴云[1,2,3] 萧伟[1,2,3] YAN Ming WEI Ying-chun LI Xue-feng WU Yun XIAO Wei(Jiangsu State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, Lianyungang 222001, China The Key Laboratory for the New Technique Research of TCM Extraction and Purification, Lianyungang 222001, China)

机构地区：[1]江苏康缘药业股份有限公司,连云港222001 [2]中药制药过程新技术国家重点实验室,连云港222001 [3]中药提取精制新技术重点研究室,连云港222001

出　　处：《中国新药杂志》2017年第3期274-278,共5页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项资助项目(2013ZX09402203)

摘　　要：目的:筛选调压颗粒的最佳精制工艺。方法:以23-乙酰泽泻醇B的保留率与除杂率综合评价的方式,对醇提水沉法、管式离心法、陶瓷膜微滤法3种精制方式进行评价,得到调压颗粒的最佳精制工艺。结果:采用醇提水沉法,除杂率高,但是23-乙酰泽泻醇B的保留率最低;而采用管式离心+陶瓷膜微滤的方式,能够明显提高提取液的澄明度,并较高地保留23-乙酰泽泻醇B,制备得到的颗粒溶化性最好,且浅绿色絮状物去除效果明显。结论:采用离心结合陶瓷膜技术作为调压颗粒的精制工艺,能有效去除大分子的杂质,选择性保留小分子有效成分,提高产品的稳定性,可作为调压颗粒的精制工艺应用于实际生产。Objective：To optimize the purification process of Tiaoya granules. Methods：Using the retention rate of 23-acetyl alisol B and the rate of removal as the evaluation indexes,the optimal refining process was chosen among the alcohol extraction method,tubular centrifugal method,and ceramic membrane microfiltration method for the production engineering of Tiaoya granules. Results：Alcohol extraction method could remove more impurities,but lost target components too. Tubular centrifugation followed by ceramic membrane microfiltration could improve the clarity of the extract and the retention of the index 23-acetyl alisol B and remove the impurities obviously.Conclusion：Using tubular centrifugation and ceramic membrane microfiltration as the purification process of Tiaoya granules can improve the retention of the index component 23-acetyl alisol B and the stability of the product,which can be used in the actual production.

关 键 词：陶瓷膜 微滤 超滤 精制工艺 23-乙酰泽泻醇B 除杂 

分 类 号：R284.2[医药卫生—中药学]