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目的:研究影响槐米滴丸制备的各种因素,确立最佳制备工艺。方法:以外观质量、溶散时限和丸重差异为评价指标,采用正交设计试验对各影响因素进行考查,以聚乙二醇6 000-聚乙二醇4 000(9∶1)为基质,药物与基质的质量比1∶3,药液温度82℃,二甲基硅油冷凝剂,冷凝剂温度7℃,滴速50 d·min-1,滴头内径4.5 mm。结果:所制得的滴丸,用紫外分光光度法AlCl3显色,在410 nm测定吸光度,求其芦丁含量,线性范围10～60 mg·L-1(r=0.999 7)。结论:滴丸的芦丁含量均匀,外观质量好,溶散时限短、丸重差异小,重现性好;分光光度法简便快捷,准确度高,可作为槐米滴丸的质量控制方法。
Objective: To study the various factors that affect the preparation of Huopi drop pills and establish the best preparation process. Methods: According to the quality of appearance, the dissolution time limit and the difference of pill weight as the evaluation indexes, orthogonal design test was used to evaluate the influential factors. Polyethylene glycol 6 000-polyethylene glycol 4 000 (9: 1) , The mass ratio of drug to matrix was 1: 3, the temperature of liquid was 82 ℃, the temperature of condensing agent was 7 ℃, the temperature was 7 ℃, the drip rate was 50 d · min-1, and the inner diameter of dripper was 4.5 mm. Results: The dropping pills were prepared by AlCl3 ultraviolet spectrophotometry and the absorbance was measured at 410 nm. The linear range of rutin was 10 ~ 60 mg · L-1 (r = 0.999 7). Conclusion: The dropping pills have uniform rutin content, good appearance quality, short dissolution time limit, small differences in pill weight and good reproducibility. Spectrophotometry is simple, rapid and accurate, and can be used as a quality control method for Huai Mi dropping pills.