清胰颗粒制备工艺优选与含量测定  

Optimization of Preparation Technology and Content Determination of Qingyi Granules

作　　者：欧水平 郑小翠 陈灵 王森 任丽 蔡迎迎 OU Shuiping;ZHENG Xiaocui;CHEN Ling;WANG Sen;REN Li;CAI Yingying(Department of Pharmacy,Affiliated Hospital of Zunyi Medical University,Zunyi 563000,China;School of Pharmacy,Zunyi Medical University,Zunyi 563003,China;Pharmaceutical Laboratory,the First People’s Hospital of Bijie City,Guizhou Province,Bijie 551700,China)

机构地区：[1]遵义医科大学附属医院药剂科,遵义563000 [2]遵义医科大学药学院,遵义563003 [3]贵州省毕节市第一人民医院药学实验室,毕节551700

出　　处：《医药导报》2020年第3期365-369,共5页Herald of Medicine

基　　金：贵州省科技厅中药现代化项目(黔科合SY字[2014]3005号);贵州省毕节市第一人民医院院士工作站(黔科合平台人才[2018]5621);遵义医科大学附属医院硕士生科研启动基金(院字[2017]46号)。

摘　　要：目的优化清胰颗粒处方与制备工艺,并测定其中蒽醌类成分含量。方法以颗粒成型率、溶化率、含水量、休止角为评价指标,以填充剂与浸膏粉配比、乙醇浓度、黏合剂PEG6000浓度及用量、制粒筛目、干燥温度为考察因素,采用Plackett-Burman(PB)设计优化清胰颗粒的处方与成型工艺。高效液相色谱(HPLC)法测定其中蒽醌类成分含量。结果最佳处方和工艺为:糊精:浸膏粉=0.5:1,乙醇浓度95%,PEG6000浓度1.0%,用量25%,16目筛(筛孔内径:1 180μm)制粒,干燥温度65℃;按此工艺制得清胰颗粒成型率、溶化率、含水量、休止角、吸湿率分别为(94.83±0.47)%,(75.15±0.44)%,(5.96±0.15)%,(22.55°±0.22°),(12.78±0.33)%;芦荟大黄素、大黄酸、大黄素、大黄酚均在2.5~40.0μg·mL^-1、大黄素甲醚在2.0~32.0μg·mL^-1范围内线性关系良好。结论该成型工艺合理、可行、稳定,所建立的HPLC法准确,简便,重复性好,可用于清胰颗粒的质量控制。Objective To optimize the prescription and forming process of Qingyi granules and determine the content of anthraquinones. Methods With the formability,solubility,water content and angle of repose as the indexs,the ratio of the extract powder to the filler,the ethanol concentration,the concentration and amount of the binder PEG6000,the size of granulation sieve and the drying temperature were taken as the investigation factors,the formulation and molding process of Qingyi granules were optimized by Plackett-Burman(PB) design.The content of the anthraquinones were determined by HPLC. Results The best prescription and process were as follows:dextrin: powder extract=0.5:1,preparation of 1% PEG6000 with 95% ethanol as solvent, and the dosage of 25%,granulation sieve of 16 mesh,and drying temperature of 65 °C.According to this process,the forming rate,solubility,water content,angle of repose and moisture absorption rate of Qingyi granules were(94.83±0.47)%,(75.15±0.44)%,(5.96±0.15)%,(22.55°±0.22°) and(12.78±0.33)%,respectively.Aloeemodin,rhein,emodin and chrysophanol showed a good linear relationship in the range of 2.5-40.0 μg·mL^-1,A good linearity of physcion was in the range of 2.0-32.0 μg·mL^-1. Conclusion The molding process was reasonable,feasible and stable.The established HPLC method which was accurate,simple and reproducible,can be used for the quality control of Qingyi granules.

关 键 词：清胰颗粒 成型率 相对湿度 临界 色谱法 高效液相 

分 类 号：R286[医药卫生—中药学] TQ460.1[医药卫生—中医学]