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目的:优选六味地黄滴心丸的制备工艺。方法:滴心丸的制备过程分二步:第一步以牡丹皮萃取物、泽泻萃取物为主药制成滴丸,通过单因素试验、正交试验,以多指标综合评分法优选制备条件。第二步以滴丸为母核,采取泛制方法,取混合好的六味地黄方药粉、辅料等包裹于滴丸母核上,成型,盖面,干燥,整丸,选丸,包衣,制成六味地黄滴心丸。结果:滴丸母核制备的最佳工艺条件为:主药与基质配比不得低于1∶2;基质应采用PEG10000与PEG 6 000混合的二种基质,比例为1∶10;冷凝液选择二甲基硅油,温度为10℃;滴头温度85℃;滴距5 cm。泛制法制丸时最适宜的黏合剂为:甘油:95%乙醇=1∶9。结论:用该方法制备的六味地黄滴心丸,质量可控,方法可靠,易于崩解,可防止挥发性及脂溶性物质丢失,适合于含挥发性及脂溶性物质的中药复方的剂型制备。
Objective: To optimize the preparation process of Liuwei Dihuang Dixin Pills. Method: The preparation of Dixin Pill was divided into two steps: the first step was to make dripping pills with the extract of Cortex Moutan and the extract of Alisma orientalis as the main drug. Through single factor test and orthogonal test, condition. The second step is to take the dripping pill as the mother nucleus, take the pan-method, take the mixed Liuwei Rehmannia powder, excipients and the like on the dripping pill mother nucleus, forming, covering the surface, drying, Made of Liu Wei Di Huang Daxin pills. Results: The optimal preparation conditions of the dropping core were as follows: the ratio of the main drug to the matrix was not less than 1: 2; the matrix should use two kinds of matrix mixed with PEG 10000 and PEG 6000 in the proportion of 1:10; the selection of the condensate Dimethicone, temperature 10 ℃; dripper temperature 85 ℃; drip distance 5 cm. The most suitable binders for pan-and-law pills are: Glycerol: 95% ethanol = 1: 9. Conclusion: The Liuwei Dihuang Daxin Pill prepared by this method is of reliable quality and easy to disintegrate. It can prevent the loss of volatile and fat-soluble substances and is suitable for the preparation of dosage forms of traditional Chinese medicine compounds containing volatile and fat-soluble substances.