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目的:研究心脑苏滴丸的最佳制备工艺。方法:采用滴制法制备心脑苏滴丸,以滴丸的外观质量、丸重差异、硬度、银杏内酯溶出度及溶散时限作为指标,采用单因素考察和正交试验筛选出制备心脑苏滴丸的最佳制备工艺。结果:最佳工艺为:以PEG 4000∶PEG 6000=4∶1为基质,二甲基硅油为冷凝液,药物与基质比为1∶5,15%Poloxamer 188为表面活性剂,滴制温度为85℃,冷凝温度为(20±2)℃,冷凝液高度为40cm,滴距为5cm,滴速为15~20滴/min。结论:心脑苏滴丸为棕色滴丸,表面光滑,色泽均匀,丸重差异与溶出情况理想。优化的工艺条件简单稳定可靠,符合《中国药典》中滴丸剂的质量规定。
Objective: To study the best preparation process of Xinnaosu pills. Methods: XINNAUBI Pills were prepared by dropping method. The appearance quality, difference of pill weight, hardness, dissolution rate of ginkgolide and dissolution time of dropping pills were taken as indexes. Single factor test and orthogonal experiment were used to select the preparation heart The best preparation process of brain Su drop pills. Results: The optimum conditions were as follows: PEG 4000: PEG 6000 = 4: 1 as matrix, dimethylsilicone as condensate, drug to matrix ratio of 1: 5, 15% Poloxamer 188 as surfactant, 85 ℃, the condensation temperature is (20 ± 2) ℃, the condensate height is 40cm, the dripping distance is 5cm, the dropping speed is 15-20 drops / min. Conclusion: Xinnaosu Dripping Pill is a brown drip pill with smooth surface, uniform color, ideal difference of pellet weight and dissolution. Optimized process conditions simple and reliable, in line with “Chinese Pharmacopoeia” pills in the quality requirements.