摘要
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AlCI3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.
Abstract
Objective:To study the factors which affect the preparation of dropping pills of Flos Sophorae Immaturus and acquire the optimum preparation process. Method: The main evaluation criteria include the apparent quality, melting time and difference between pill weights by using orthogonal design. The substrate was a mixture of polyethylene glycol 6 000 and polyethylene glycol 4 000(with a ratio of 9:1 ); the mass ratio of rutin to substrate was 1 : 3 at the temperature of 82 ℃; condensate was dimethicone at 7 ℃. The dropping speed is 50 drops per minute and the inside diameter of the dropping tip was 4. 5 mm. Result: The content of rutin in pill was determined with absorbency at 410 nm by using the ultraviolet spectrophotometry-AlCl3 method; and the linear range was from 10 to 60 mg.L-1 (r =0. 999 7). Conclusion:Under the above preparation process,the type of dropping pills had stable rutin,a fine appearance,a short melting time and subtle difference between pill weights; in the mean time the above preparation process is accurate ,convenient and can be used as quality control method for Flos Sohporae Immaturus.
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