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正交实验法优选清心沉香八味滴丸制备工艺.doc

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正交实验法优选清心沉香八味滴丸制备工艺.doc

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正交实验法优选清心沉香八味滴丸制备工艺.doc

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文档介绍:1 正交实验法优选清心沉香八味滴丸制备工艺【关键词】清心沉香八味滴丸; ,, 正交实验; ,, 制备工艺摘要:目的采用正交实验法优选清心沉香八味滴丸的制备工艺。方法以基质种类、药物与基质配比、药液温度、冷却剂温度作为考察因素进行正交实验,用3 个指标评定工艺的优劣。结果最佳制备工艺条件为:以 PEG4000PEG6000 (2∶1) 为基质, 药物与基质配比为 1∶ , 药液温度为 95 ℃, 冷却剂温度为 8~10 ℃。结论优选得到的工艺简便易行, 有良好的重现性和可操作性。关键词:清心沉香八味滴丸; 正交实验; 制备工艺 Optimization of the Preparation Process of Qingxin Chenxiang BawEi Dropping Pills by Orthogonal Design Abstract : ObjectiveTo optimize the preparation process of Qingxin Chenxiang BawEI dropping pills by orthogonal the kind of base, ratio between drug and 2 base, the temperature of drug solution and the temperature of cooler as affecting factors, the orthogonal test was conducted, to assess the preparation process good or bad in the three The optimized preparation process was as follows : PEG4000PEG6000 (2∶1) was optimal bases, ratio between drug and base was 1∶ ,the temperature of drug solution was 95℃, the temperature of cooler was 8~10 ℃.ConclusionThe optimized preparation process is simple and practicable, with good reproducibility. Key words : Qingxin Chenxiang Bawei dropping pills; Orthogonal design; Preparation process 蒙药清心沉香八味滴丸原方收载于我国部颁药品标准《蒙药分册》[1] 。处方由沉香、广枣、檀香、肉豆蔻等 8 味药组成, 具有清心肺、理气、镇静安神之功能, 主治心肺火盛, 胸闷不舒, 胸肋闷痛, 心慌气短等病症。原剂型为传统水丸, 服用剂量较大, 药效发挥较慢, 不利于急症治疗。为此,我们采用固体分散技术,将其改制成溶出速度快、吸收好、可发挥速效、高效作用的滴丸新剂型, 并通过正交实验设计优选滴丸成型的最佳工艺条件。 3 1 仪器与试药 DWJ-2000 小型试验滴丸机(烟台康达尔药业有限公司), ZB