黄芪乌梅降糖颗粒的制备工艺与质量分析  

Preparation Process and Quality Analysis of Huangqi Wumei Jingtang Granules

作　　者：倪琳 魏学冰 陈德道 宋治荣 张晓惠 田向斌 NI Lin;WEI Xue-bing;CHEN De-dao;SONG Zhi-rong;ZHANG Xiao-hui;TIAN Xiang-bin(The pharmaceutical inspection institute of gansu province,Lanzhou 730070,China;Gansu Province Traditional Chinese Medicine Modern Pharmaceutical Engineering Institute,Lanzhou 730000,China;Gansu Traditional Chinese Medicine University Affiliated Hospital,Lanzhou 730030,China)

机构地区：[1]甘肃省药品检验研究院,甘肃兰州730070 [2]甘肃省中药现代制药工程研究院,甘肃兰州730000 [3]甘肃中医药大学附属医院,甘肃兰州730030

出　　处：《海峡药学》2020年第1期6-11,共6页Strait Pharmaceutical Journal

摘　　要：目的优选黄芪乌梅降糖颗粒的制备工艺,并考虑其质量,为该制剂的质量标准制订提供参考。方法建立HPLC-ELSD法检测黄芪乌梅降糖颗粒中黄芪甲苷的含量;建立紫外-分光光度法测定黄芪乌梅降糖颗粒中总黄酮的含量,通过单因素和正交设计试验,确定最佳提取工艺。考察不同辅料、润湿剂用量,以成型率、溶化性及吸湿率为指标,筛选处方中加入辅料的品种、配比及最佳成型工艺。结果确定黄芪乌梅降糖颗粒的最佳水提工艺为10倍量的水,煎煮3次,1次60min。黄芪乌梅降糖颗粒的最佳制备工艺为微晶纤维素-聚维酮科K30-二氧化硅(3.5∶1∶0.5),浸膏粉-辅料(10∶1),85%乙醇,用量50%。结论本实验确定的提取工艺和制备工艺稳定可行,质量可控。OBJECTIVE To optimize preparation process of Huangqi Wumei Jiangtang granules(HWJG)and set up its quality standard.METHODS HPLC-ELSD was employed to determine contents of astragaloside IV.UV analytical methods of total flavonoids in HWJG were established,the optimal water extraction process were confirmed according to single factor and orthogonal design test.The influence of different excipients and wetting agents were investigated,taking forming rate,solubility,and absorption rate as indexes,the materials added prescription varieties,ratio,and optimummolding process were screened.RESULTS The optimal water extraction technology was 10-fold,decocting 3 times,30min once.The optimized conditions of HWJG were obtained within following conditions:accessories for the microcrystalline cellulose∶povidone K30∶silicon dioxide(3.5∶1∶0.5),maidrug-accessories(10∶1),with 85%ethanol as wetting agent which accounted for 50%of the main drug.CONCLUSION The extraction process and forming process are feasible and stable,and the quality is controllable.

关 键 词：黄芪乌梅降糖颗粒 水提 正交设计 制备工艺 

分 类 号：R94[医药卫生—药剂学]