复方银杏滴丸制备工艺研究

Study on Preparation of Compound Ginkgo Dripping Pills(复方银杏滴丸)

目的:确定复方银杏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、熔融方式、成形状况及沉降情况、丸重差异作为考察指标,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,药液温度为65℃,二甲基硅油为冷却剂,滴头内外径比4.5 mm/5.5 mm,滴速50滴/min,滴距6 cm,冷却剂温度(4±0.5)℃。结论:该制备工艺可行,质量指标符合《中国药典》滴丸剂质量标准。

Objevtive： To determine the optimum preparation process of compound Ginkgo dripping pills （复方银杏滴丸, CGDP）. Methods： L9 （34） orthogonal test was used to choose the dripping pills dissolution time, the molten way, the molded and settlement condition, pill weight difference as the indexes, and to decide the best preparation process of CGDP. Results： The optimum dripping conditions were as follows：the matrix was PEG- 6000, the ratio of drug and matrix was 1：2,the temperature of drug was 65℃, the refrigerant is simethicone, the internal and extemal diameter of burette was 4.5 mm/5.5 mm, the dripping speed was 20 drops per minute, the burette was 6 cm, the temperature of the refrigerant was （4±0.5） ℃oConclusions： It has been proved that the preparation is available, and these quality indexes were consistent with the requirements from Pharmacopoeia of the People＇s Republic of China （2010 edition）.