猫爪草滴丸的制备工艺优化  

Optimization of the Preparation Technology of Ranunculi ternati Radix Dropping Pills

作　　者：陈琼[1] 李娟[1] 李阳[1] 杨俊杰[1] 余红霞[1] 

机构地区：[1]信阳农林学院信阳市中药资源开发工程技术研究中心/信阳市中药质量分析检测重点实验室,河南信阳464000

出　　处：《中国药房》2015年第22期3122-3124,共3页China Pharmacy

基　　金：河南省科技攻关项目(No.132102310266)

摘　　要：目的:优选猫爪草滴丸的最优制备工艺并进行质量评价。方法:在单因素考察的基础上,以滴丸的外观、重量差异、溶散时限组成的综合评分为考察指标,采用正交试验设计对影响猫爪草滴丸成型工艺的4个因素(药物干浸膏与基质质量比、冷凝介质温度、滴速、滴距)进行考察,优选猫爪草滴丸的制备工艺并进行验证试验及质量考察。结果:最优成型工艺为药物干浸膏与基质(聚乙二醇6000)质量比1∶1.5、冷凝介质(二甲基硅油)温度8℃、滴速40滴/min、滴距150 mm。验证试验结果显示3批滴丸综合评分分别为94.05、93.78、94.12(RSD<3%,n=3)。该工艺制备的滴丸外观圆整度良好、硬度较好、色泽均一;平均丸质量为60mg,溶散时限为5 min,每丸猫爪草多糖含量为20.20 mg。结论:优选的猫爪草滴丸制备工艺简单、可行,重现性好。OBJECTIVE：To optimize the preparation technology of Ranunculi ternati radix dropping pills and evaluate the quality.METHODS：Based on single factor test,with the overall score of the appearance,weight difference and dissolution time of the dropping pills as the evaluated index,orthogonal test design was adopted to investigate 4 factors such as weight ratio of substrate to drugs dry extract,temperature of condensation medium,dropping rate and dropping distance which would affect the molding technology of Ranunculi ternati radix dropping pills,to optimize the preparation technology of Ranunculi ternati radix dropping pills,and verification tests and quality investigation were carried out.RESULTS：The optimal molding technology was as follows as the weight ratio of drugs dry extract to substrate（polyethylene glycol 6000）of 1 ∶ 1.5,the temperature of condensation medium（simethicone）of 8 ℃,dropping rate of 40 drops/min,dropping distance of 150 mm.The overall scores of the dropping pills by 3 verification tests were 94.05,93.78 and 94.12（RSD3%,n=3）respectively.The dropping pills prepared by the above-mentioned technology had good round appearance,appropriate hardness and uniform color.The average weight of pills was 60 mg,dissolution time was 5 min and the content of polysaccharides in each Ranunculi ternati radix dropping pill was 20.20 mg.CONCLUSIONS：The optimal preparation technology of Ranunculi ternati radix dropping pills is simple and feasible with good reproducibility.

关 键 词：猫爪草 滴丸 制备工艺 正交试验 优化 质量评价 

分 类 号：R283[医药卫生—中药学]