拉米夫定片剂制备工艺研究

Study on the preparation of Lamivudine Tablets

目的筛选拉米夫定片剂处方,确定其最佳制备工艺。方法参照《化学药物制剂研究基本技术指导原则》,采用单因素法筛选处方,优化制备工艺。结果优选出拉米夫定片剂的适宜处方为拉米夫定100g、乳糖44g、羧甲淀粉钠4.5g、硬脂酸镁1.5g,确定制备工艺为湿法制粒压片。制备的拉米夫定片剂照《中华人民共和国药典》2005年版片剂常规项目检查,均符合质量要求。结论拉米夫定片剂的处方组成合理,制备工艺切实可行,可满足工业化大生产的要求。

Objective To optimize the formulation of Lamivudine Tablets and determine the suitable preparation tech- nology. Methods Single factor method was applied to choose formulation and optimize preparation technology of Lamivudine Tablets referring to the Elementary Instruction Principles for Chemical Drug Research. Results The final fomulation of Lamivudine Tablets was determined with 100 g of amivudine, 44 g of lactose, 4.5 g of CMC-Na and 1.5 g of magnesium stearate. Wet granulation was used to prepare the tablets. Lamivudine Tablets prepared could meet the request when inspected according to routine item for tablets in Chinese Pharmacopoeia, 2005 edition. Conclusion The formulation and the preparation technology of the lamivudine tablets are rational and practical respectively.