载香显色微丸的制备工艺研究  

Study on Preparation Technology of Fragrance Carrying Color Developing Pellets

作　　者：付君毅 朱天红 施璐 FU Junyi;ZHU Tianhong;SHI Lu(Department of Pharmacy,College of Medicine,Jianghan University,Hubei Wuhan 430000,China)

机构地区：[1]江汉大学医学院药学系,湖北武汉430000

出　　处：《广州化工》2024年第19期68-72,共5页GuangZhou Chemical Industry

摘　　要：制备具有载香和显色双功能的微丸;运用滴丸剂制备工艺将茜草素、薄荷油香精乳液和明胶甘油混合制得载香显色微丸,以成品的溶散时限和外观质量的总评归一化值(OD)为评价指标,以单因素试验为基础,采用三因素三水平星点试验考察原料与基质配比、药液温度、滴距对载香显色微丸制备工艺的影响,对实验数据进行项式拟合,构建回归模型,运用响应面法确定最优成型工艺,并进行实验验证。制备载香显色微丸的最优成型工艺为:原料与基质比例为1∶6,药液温度为60℃,滴制距离为6 cm。筛选出的微丸溶散时限符合2020版《中华人民共和国药典》的规定,且外观圆整、硬度适中、无粘连拖尾现象。本研究选择的滴丸剂制备工艺简单,价格低廉,所建模型具有较好的预测性,其最佳成型工艺的合理性和可行性也得到了充分验证。制得的载香显色微丸具有一定的应用前景,可为微丸制剂产业化研究提供科学的实验支持和理论依据。The aromatic and color bearing pellets were prepared.By using the preparation technology of dripping pills,madder,peppermint oil essence emulsion and gelatin glycerin were mixed to prepare perfumed colored pellets.The dissolution time of finished products and the overall evaluation normalization value(OD)of appearance quality were used as evaluation indexes.Three-factor and three-level star point test was used to investigate the effects of the ratio of raw material and substrate,liquid temperature and drop distance on the preparation process of the perfumed chromogenic pellets.The experimental data were fitted in terms of terms,a regression model was established,and the optimal forming process was determined by the effect surface method,and experimental verification was carried out.The optimal forming process for preparing perfumed chromogenic pellets was as follows:the ratio of raw material to substrate was 1∶6,the temperature of liquid was 60℃,and the drop distance was 6 cm.The dissolution time limit of the screened pellets was in line with the provisions of the 2020 edition of the Pharmacopoeia of the People s Republic of China,and the appearance was round,moderate hardness and no adhesion trailing phenomenon.The preparation process of the selected dropping pills was simple and the price was low.The established model had good predictability,and the rationality and feasibility of the optimal forming process were fully verified.The perfumed color developing pellets had a certain application prospect,and can provide scientific experimental support and theoretical basis for the industrialization of pellets preparation.

关 键 词：微丸 色素 薄荷油香精 星点设计-响应面 

分 类 号：R944[医药卫生—药剂学]