正交实验法优选左羟丙哌嗪滴丸的处方及制备工艺

Study on the optimal formulation and preparation process of levodropropizin dropping pills by orthogonal design

目的优选左羟丙哌嗪(LP)滴丸的处方及制备工艺。方法以水溶性高分子材料PEG6000和PEG4000为主要基质,采用正交实验方法,以滴丸的圆整度、光洁度、丸重差异为主要验证指标,优选LP滴丸的最佳处方及制备工艺。结果最佳处方为:以PEG6000∶PEG4000(2.5∶1)为混合滴丸基质,液体石蜡为冷凝液,药物与基质配比为1∶4;最佳工艺为:药液温度95℃,冷凝液温度10℃,滴速50滴/m in,滴头内外径为1.2和1.4 mm。结论优选出的处方及工艺制备的LP滴丸质量理想,值得进一步研究。

Objective To optimize the formulation and preparation process of Levodropropizin（LP） dropping pills by orthogonal design.Methods Water-soluble PEG6000 and PEG4000 were used as the main matrix with rounding and finishing degree,and weight as indices.Results The optimum was following： the matrix of PEG6000 and PEG4000（2.5∶1）,liquid paraffin as cooling solution and the ratio of drug and matrix of 1∶4,the temperature before dropping of 95 ℃,cooling solution of 10 ℃,at the dropping rate of 50 d/min and the diameter ratio of dropping tip of 1.2/1.4 mm.Conclusion This preparation of LP dropping pills was promising and deserved further study.