扶正解毒颗粒的提取工艺研究  

Preparation Process of Fuzheng Jiedu Granules

作　　者：朱志坤 王飘 郭媛媛 杨唯 陈凌云 康绍建 ZHU Zhikun;WANG Piao;GUO Yuanyuan;YANG Wei;CHEN Lingyun;KANG Shaojian(College of Traditional Chinese Medicine, Yunnan University of Traditional Chinese Medicine, Yunnan Kunming 650500, China;Key Laboratory for External Drug Delivery System and Preparation Technology Research in Universities of Yunnan Province,Yunnan Kunming 650500, China;Yunnan Food and Drug Inspection Center, Yunnan Kunming 650011, China)

机构地区：[1]云南中医药大学中药学院,云南昆明650500 [2]云南省高校外用给药系统与制剂技术研究重点实验室,云南昆明650500 [3]云南省食品药品审核查验中心,云南昆明650011

出　　处：《中国医药导刊》2022年第2期174-178,共5页Chinese Journal of Medicinal Guide

基　　金：昆明市中药(民族药)医院制剂研发科技创新团队(项目编号:2018-1-R-17245);昆明市医院制剂质量控制模式创新中心(项目编号:2019-1-N-25318000002943)。

摘　　要：目的:优选扶正解毒颗粒的最佳提取工艺条件,以期为扶正解毒颗粒医疗机构制剂申报提供参考。方法:首先建立芍药苷的高效液相色谱(HPLC)检测方法,Diamonsil C_(18)(250 mm×4.6 mm,5μm)色谱柱,流动相为甲醇-0.05 mol·L^(-1)磷酸二氢钾(21∶79),检测波长230 nm,流速1.0 mL·min^(-1),柱温30℃。利用HPLC法测定提取液中芍药苷的含量,并作为提取液考察指标。以干膏得率、芍药苷转移率为指标,采用正交设计试验考察加水倍数、提取时间及提取次数对以上指标的影响,确定扶正解毒颗粒的最佳提取工艺。结果:扶正解毒颗粒正交设计试验考察因素中,加水倍数对综合评分影响最大,其次是提取时间、煎煮次数。最佳提取工艺为:加水煎煮3次,每次加10倍量水,煎煮2 h。结论:扶正解毒颗粒提取工艺稳定有效,质量可控。Objective:To optimize the extraction process of fuzheng jiedu granules in order to provide reference for the declaration of fuzheng jiedu granules for medical institutions.Methods:HPLC method for determination of paeoniflorin was established.Diamonsil C18(250 mm×4.6 mm,5μm)column with a mobile phase of methanol-0.05 mol·L^(-1) potassium dihydrogen phosphate(21∶79),detection wavelength 230 nm,flow rate 1.0 mL·min^(-1) and column temperature 30℃.The content of paeoniflorin in the extraction solution was determined by HPLC and used as the index of the extraction solution.The dry paste yield and the transfer rate of paeoniflorin were used as the indexes and the orthogonal design test was used to investigate the water multiples,extraction time and times of extractions to determine the optimal extraction process of fuzheng jiedu granules.Results:Among the factors investigated in the orthogonal design test of fuzheng jiedu granules,the water addition ratio had the greatest influence on the comprehensive score,followed by the extraction time and times of decoctions.The best extraction process of fuzheng jiedu granules was:adding water and decocting 3 times,each time adding 10 times the amount of water and decocting for 2 h.Conclusion:The extraction process of fuzheng jiedu granules is stable and feasible,and the quality is controllable.

关 键 词：扶正解毒颗粒 提取工艺 芍药苷 正交设计 

分 类 号：R283.6[医药卫生—中药学]