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目的:对格列喹酮分散片的处方工艺进行研究。方法:正交设计L9(34)确定最优处方,并对优选工艺所制格列喹酮分散片进行考察。结果:优化处方工艺为:用交联聚维酮(PVPP)和羧甲基淀粉钠(CMS-Na)作为联合崩解剂,微晶纤维素(MCC)作辅助崩解剂,甘露醇(MNT)、乳糖(SL)(2:1)作为填充剂,0.8%微粉硅胶作为润滑剂,50%乙醇溶液作为黏合剂,制得格列喹酮分散片。结论:本制荆处方工艺简单,制得格列喹酮分散片符合《中国药典》2005版要求。
Objective: To study the prescription of gliquidone dispersible tablets. Methods: Orthogonal design L9 (34) to determine the optimal prescription, and the preferred process of gliquidone dispersible tablets were investigated. Results: The optimum formulation was as follows: PVPP and CMS-Na were used as disintegrating agents, microcrystalline cellulose (MCC) as auxiliary disintegrating agent, mannitol (MNT ), Lactose (SL) (2: 1) as a filler, 0.8% silica powder as a lubricant, and 50% ethanol as a binder. Conclusion: The preparation of this Jing prescription process, prepared gliquidone dispersible tablets in line with the “Chinese Pharmacopoeia” 2005 version of the requirements.