山葛降脂滴丸的制备工艺及其含量测定

Studies on Preparation Technique and Content Determination of Shange Lipid-lowering Dropping Pills

目的确立山葛降脂滴丸的最佳制备工艺,并对其进行总黄酮含量测定。方法以外观圆整度、平均丸重差异系数、硬度、溶散时限为评价指标,通过单因素考察和正交实验设计优选最佳制备工艺,并采用紫外分光光度法测定山葛降脂滴丸中的总黄酮含量。结果最佳制备工艺条件为药物含量35%,基质比例PEG6000∶PEG4000为2∶1,药液温度80℃,滴速20滴/min,二甲基硅油冷凝剂,冷凝温度14℃,滴距5cm;山葛降脂滴丸中总黄酮含量(以芦丁计)为48.72mg·g-1。结论优选的制备工艺方法简便可行,且含量测定方法准确、可靠。

OBJECTIVE To establish the optimum preparation process of shange lipid-lowering dropping pills, and carry on the general flavone content determination. METHODS Appearance of roundness, average coefficient of pill weights difference, hardness, melting time were used as comprehendsive evaluation indicator to select dropping conditions by influential factors test and orthogonal design, and using ultraviolet spectrophotometry to measure flavonoids content of shange lipid-lowering dropping pills. RESULTS The optimized preparation process was as follows：the drug content was 35%, the mixture of polyethylene glycol 6000 and polyethylene glycol 4000 was 2： 1, the drug temperature was 80%, dropping speed was 20 drops - min-1, dimethyl silicone oil condensing agent was used with condensation temperature of 7℃ and dropping distance of 5cm;The content of general flavone of shange lipidlowering dropping pills was 48.72mg · g^-1. CONCLUSION The optimization of the preparation method is simple and feasible ,and the content determination method is accurate and reliable.