复方三七吴茱萸滴丸制备方法的优选及其质量标准的初探  

Preparation and quality control for the Fufang Sanqi Wuzhuyu Wan

作　　者：任燕[1,2] 田源[2] 黄明进[2] 罗春丽[2] 

机构地区：[1]成都中医药大学,四川成都610072 [2]贵州大学,贵州贵阳550025

出　　处：《中医临床研究》2015年第26期6-9,共4页Clinical Journal Of Chinese Medicine

摘　　要：目的:探索复方三七吴茱萸滴丸的制备工艺。方法:通过三七吴茱萸滴丸制备实验,用单因素和正交实验的方法,以滴丸的成型性、圆整度、硬度、重量差异、崩解时限为筛选指标,以基质的选择、药物与基质的配比、药液的保温温度、冷凝剂、冷凝剂的温度、滴头内外径大小、滴距、滴制速度为主要考察因素,对三七吴茱萸滴丸的制备工艺进行优选,并用HPLC法对最佳的优选结果进行含量测定。结果:基质为PEG4000:PEG6000=3∶1,药物与基质的最佳配比为1∶5,滴制温度为80℃,冷凝剂为甲基硅油,冷凝剂温度为12℃,滴头内外径大小为3.7/4.4mm,滴距为20cm,滴速为40滴/min,用HPLC法测定三七吴茱萸滴丸中三七皂苷R1、吴茱萸次碱的含量分别为:0.578%、9.429×10-3%。结论:该工艺制备的滴丸的成型效果最佳。Objective： To explore the best forming techniques for the Fufang Sanqi Wuzhuyu Wan. Methods： By single factor and orthogonal test, the formations, roundness, hardness, weight variation, the disintegration time of Sanqi Wuzhuyu Wan were selected as the screening index; and the type of base material, the temperature of physic liquor, the ratio of drug to base material, the type of the cooling agent, the temperature of the cooling agent, the diameters of dropper, the distance, the speed were selected as the main factors; the best forming techniques for the Fufang Sanqi Wuzhuyu Wan was selected. Then HPLC was used to determine the content of the best optimized results. Results： The ratio of base material （PEG4000 ： PEG6000） was 3 ： 1, the ratio of drug to base material was 1 ; 5, the temperature of drug solution was 80℃, the cooling agent was methyl silicone oil, the temperature of the cooling agent was 12℃, the diameters of dropper was 3.7/4.4 mm, the distance was 20cm,the speed was 40 drops per rain. The content of notoginsenoside R1 and rutaecarpine in the Fufang Sanqi Wuzhuyu Wan was 0.578% and 9.429 × 10^3%. Conclusion： The preparation method was the optimum forming condition.

关 键 词：三七吴茱萸滴丸 制备工艺 HPLC 

分 类 号：R286[医药卫生—中药学]