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目的优选砂仁油滴丸的成型工艺。方法采用正交设计法,对滴丸制备过程中基质配比、滴管内径、挥发油与基质的比例、冷却温度等因素进行考察。通过测定滴丸重量差异,溶散时限以及对滴丸进行外观评价,气相色谱法测定砂仁油滴丸中主要有效成分乙酸龙脑酯的含量,综合确定其最佳成型工艺。结果最佳成型工艺条件为:选择PEG6000/PEG4000(1∶1)为基质,滴管内径为2.0mm,挥发油与基质配比为(1∶2),冷却温度为0～5℃(冰水浴中)。结论此工艺制备的砂仁油滴丸,每丸中乙酸龙脑酯含量高、滴丸重量差异、溶散时限以及外观评价各指标均达到或优于中国药典2005年版一部要求。
Objective To optimize the molding process of Amomum villosum. Methods Orthogonal design was used to investigate the ratio of matrix, the inner diameter of dropper, the ratio of volatile oil to matrix and the cooling temperature in the process of dropping pills. By measuring the weight difference of dripping pills, dissolving time limit and evaluating the appearance of dropping pills, the content of the major active ingredient of amyl acetate in amrinum drops pills was determined by gas chromatography, and the optimum forming process was determined synthetically. Results The optimum conditions were: PEG6000 / PEG4000 (1: 1) as substrate, dropper inner diameter of 2.0 mm, volatile oil to substrate ratio of 1: 2 and cooling temperature of 0-5 ℃ ). CONCLUSION The Amomum villosum dripping pill prepared by this technique has high content of bornyl acetate in each pill, the weight difference of dripping pills, the dissolution time limit and the indexes of appearance evaluation, all of which meet or exceed the requirements of a 2005 edition of Chinese Pharmacopoeia.