摘要
目的 :研究甲磺酸伊马替尼片的处方工艺。方法 :以制剂的溶出曲线为指标,筛选甲磺酸伊马替尼片处方和制备工艺。结果 :建立了以微晶纤维素、交联聚维酮和硬脂酸镁为辅料的处方及采用95%乙醇湿法制粒的工艺,制备的3批产品的有关物质、溶出度等指标与参比制剂具有相似性,制剂特性满足制剂质量一致性的要求。结论 :甲磺酸伊马替尼片处方合理,工艺简单,易于工业化生产。
Objective： To optimize the formulation and technology for the preparation of imatinib mesylate tablets. Methods： The formulation and technology for the preparation of imatinib mesylate tablets was screened out based on the dissolution curve. Results： The formulation taking microcrystalline cellulose, polyvinylpolypyrrolidone, and magnesium stearate as excipients and the technology of wet granulation using 95% ethanol were established. The quality indicators such as the related substances, dissolution and so on detected from three batches of self-prepared preparations of imatinib mesylate tablets were similar to those of the reference Glivec and their characteristics could meet the requirements of the consistency of preparation quality. Conclusion： The formulation for the preparation of imatinib mesylate tablets is reasonable and the technology is simple and easy to be applied in industry.
出处
《上海医药》
CAS
2016年第11期69-73,共5页
Shanghai Medical & Pharmaceutical Journal
关键词
甲磺酸伊马替尼片
处方工艺
溶出曲线
imatinib mesylate tablets
formulation and technology
dissolution profile
