摘要
目的:应用星点设计-效应面法筛选复方益肾利石颗粒的最佳成型工艺。方法:以成型率、吸湿性、流动性和溶化性为评价指标,采用手工湿法制粒,考察辅料用量、润湿剂用量及浓度等影响颗粒剂成型的关键因素水平。利用星点设计-效应面法,以成型率、水分、吸湿性、溶化性、休止角、卡尔系数的总评归一值为评价指标,对辅料比(麦芽糊精占总辅料量的百分比)、药辅比(辅料量占总制剂处方的百分比)和乙醇含量(润湿剂浓度)等成型参数进行考察。结果:根据综合评分结果,优选得到复方益肾利石颗粒的最佳成型工艺为:辅料比60%,药辅比30%,乙醇浓度24%。3批验证得综合评分平均值为78.96,理论预测值为74.37,偏差率为2.99%,结果与预测值相对标准偏差均小于5%。结论:优化的最佳成型工艺稳定、可行,且得率高,重复性好,为院内制剂复方益肾利石颗粒剂制备工艺的确定及生产条件的控制提供了依据。
Objective:To optimize the preparation process of yishenlishi granules by central composite design-response surface methodology.Methods:Taking formability,hygroscopicity,flowability and solubility as the evaluation indexes of manual wet granulation,to investigate the level of key factors affecting the formation of granules,such as the dosage of auxiliary materials,the dosage and concentration of wetting agent.Using composite design-response surface methodology,taking the overall desirability of forming rate,moisture,hygroscopicity,solubility,angle of repose and the Carr index as the evaluation index,the parameters such as the ratio of excipients(percentage of maltodextrin in the total auxiliary material),auxiliary material proportion(percentage of auxiliary material in the total preparation prescription)and ethanol content(wetting agent concentration)were investigated.Results:According to the comprehensive scoring results,the optimal preparation process of yishenlishi granules is as follows:the ratio of excipients is 60%,auxiliary material proportion is 30%,and the concentration of ethanol is 24%.The average comprehensive score of the three batches validation was 78.96,the theoretical predicted value was 74.37,and the deviation rate was 2.99%.The relative standard deviation between the results and the predicted value was less than 5%.Conclusion:The optimized preparation process is stable and feasible,with high yield and good repeatability,which provides a basis for the determination of the preparation process of yishenlishi granules and the control of production conditions.
作者
覃新华
戴薇萍
胡传义
QIN Xinhua;DAI Weiping;HU Chuanyi(Postgraduate Training Base in Shanghai Pudong New Area Gongli Hospital,Ningxia Medical University,Shanghai 200135,China;Shanghai Traditional Chinese Medicine Pharmaceutical Technology Co.LTD,National Engineering and Research Center for Traditional Chinese Medicine,Shanghai 201210,China;Department of Urology,Shanghai Pudong New Area Gongli Hospital Affiliated to Second Military Medical University,Shanghai 200135,China)
出处
《中国医药导刊》
2022年第3期222-228,共7页
Chinese Journal of Medicinal Guide
基金
上海市浦东新区中医药科技创新项目[项目编号:PDZY-2018-0802,项目名称:院内制剂“复方益肾利石颗粒”的临床前研究,项目编号:ZY(2018-2020)-CCCX-2008,项目名称:中医药科技创新模式机制探索与实践]。
关键词
中药颗粒剂
星点设计-效应面法
制备工艺
Traditional Chinese medicine granules
Central composite design-response surface methodology
Preparation process
