摘要
目的:确立复方岩白菜素滴丸的最佳制备工艺。方法:采用L9(34)正交试验法,以滴丸的溶散时限、圆整度、沉降情况、硬度、重量差异变异作为衡量指标,优选出滴丸的成型工艺。结果:最佳制备工艺为:聚乙二醇-6000为基质,药物与基质配比为1∶2,药液温度70℃,液体石蜡为冷却剂,滴头内外径比2.0mm/3.0mm,滴速60滴/min,滴距6cm,冷却剂温度(8±0.3)℃。结论:该制备工艺可行,质量指标符合2005年版《中华人民共和国药典》滴丸剂质量标准。
Objective： To optimize the best preparation technology of ChlorphenamineMaleate dropping pills. Methods： It was studied with L9（34） orthogonal design, dissolution, integrality, subside ,hardness and weight variation was used as evaluation indicator to select good dropping conditions. Results： The optimized preparation conditions were as follows： PEG 6000 was the optimal base, the proportion of optimal drugs to the bases being 1：2; the temperature of liquid was 70℃ and liquid paraffin was condensate; the internal and external diameter of burette was 2. 0 mm and 3. 0 mm respectively; the dropping speed was 60 drop/min and the temperature of refrigerant was （8±0.3）℃; the dropping distance was 6 cm. Conclusion： The preparation technology was feasible, which met the criterion of Chinese Pharmacopoeia 2005.
出处
《大理学院学报（综合版）》
CAS
2010年第2期11-13,共3页
Journal of Dali University
关键词
复方岩白菜素滴丸
制备工艺
聚乙二醇
正交试验
ChlorphenamineMaleate dropping pills
preparation technology
polyglycol
orthogonal test
