丹参酮IIA滴丸制备工艺的研究

Study on Preparation of Tanshinone ⅡA Dropping Pills

研究新药丹参酮ⅡA滴丸的制备工艺,确立最佳工艺条件.设计正交实验考察滴丸制备工艺中各影响因素.以聚乙二醇4 000为基质,二甲基硅油为冷凝液,滴制工艺为:滴制温度80℃,冷凝液5～25 ℃梯度冷却,滴距4 cm,滴速60滴/min.该工艺制得的滴丸成型性好,丸种差异小,崩解时限为17 min,符合药典规定.该工艺适合丹参酮ⅡA滴丸的制备,且适宜工业化生产.

To study the technological parameters of the new drug Tanshinone ⅡA Dropping Pills and to establish the best conditions,the preparation conditions were optimized by orthogonal design.PEG4000 was an optimal base and methyl-silicon oil was an optimal refrigerant.The preparation process was as follows: The dropping system temperature was 80℃,the condensate temperature was 5~25℃ by gradient cooling,the dropping distance was 4cm,and 60 drops/min.The dropping pills made by this technology had good properties of shaping and small weight deviation.The disintegration time was 17min,which conformsd to the standad pharmacopoeia.This method is suitable for the preparation of TanshinoneⅡA Dropping Pills and industial production.