摘要
目的优选二岩虎果无糖颗粒处方工艺。方法采用湿法制粒,以制粒吸湿性评分、流动性评分、溶解性评分、成型性评分及浸膏辅料比的综合评分筛选湿润剂(乙醇)体积分数、辅料及其用量、质量比,并验证;筛选矫味剂及其用量和制粒生产环境相对湿度。结果筛选出辅料为糊精和可溶性淀粉。最佳处方工艺为,浸膏、糊精、可溶性淀粉按1∶1.7∶0.3的质量比混合均匀,以80%乙醇溶液为润湿剂,成品质量0.5%的阿斯巴甜为矫味剂。验证试验制得的二岩虎果无糖颗粒的成型性好,吸湿率、成型率、休止角、溶解率分别为7.44%,91.98%,26.46°,91.47%;临界相对湿度为69%。结论该处方工艺合理、可行,可为二岩虎果无糖颗粒的医院制剂及工业化生产提供一定参考。
Objective To optimize the formulation process of Eryanhuguo Sugar-Free Granules.Methods Wet granulation was used.The volume fraction of wetting agent(ethanol),excipients,and their dosage and mass ratio were screened and verified by the comprehensive scores of hygroscopicity,fluidity,solubility,formability,and the ratio of extract to excipients of the granules.The flavoring agent and its dosage,and the relative humidity(RH)of the granulation production environment were selected.Results Dextrin and soluble starch were selected as excipients.The optimal formulation process was as follows:the extract,dextrin and soluble starch were evenly mixed at the mass ratio of 1∶1.7∶0.3,80% ethanol solution was used as the wetting agent,and aspartame with the dosage of 0.5% of the final granules was used as the flavoring agent.The verification test showed that the Eryanhuguo Sugar-Free Granules prepared by the test had good formability with moisture absorption rate,molding rate,angle of repose and dissolution rate of 7.44%,91.98%,26.46°and 91.47% respectively.The critical RH was 69%.Conclusion The formulation process is reasonable and feasible,which can provide a reference for the hospital preparation and industrial production of Eryanhuguo Sugar-Free Granules.
作者
饶海
罗忠圣
梁芳瑜
徐昌艳
戴洪青
覃容贵
RAO Hai;LUO Zhongsheng;LIANG Fangyu;XU Changyan;DAI Hongqing;QIN Ronggui(Guiyang Yunyan District People's Hospital,Guiyang,Guizhou,China 550001;State Key Laboratory for the Effectiveness and Utilization of Medicinal Plants,Guizhou Medical University,Guiyang,Guizhou,China 550025;The Key Laboratory of Chemistry for Natural Products of Guizhou Province and Chinese Academy of Sciences,Guiyang,Guizhou,China 550014;School of Pharmacy,Guizhou Medical University,Guiyang,Guizhou,China 550025)
出处
《中国药业》
CAS
2022年第16期49-52,共4页
China Pharmaceuticals
基金
贵州省中药现代化科技产业研究开发专项[黔科合SY字〔2014〕3008-5]。
关键词
处方
湿法制粒
浸膏
无糖颗粒
优化
formulation
wet granulation
extract
sugar-free granules
optimization
