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目的:优选调脂片成型工艺。方法:以制粒和压片过程的工艺参数为评价指标,选择适宜的辅料及其用量。结果:最优成型工艺条件为:干膏粉、淀粉、乳糖的配比为7∶1.5∶1.5,用1.5%PVP乙醇液作为黏合剂制湿粒(用量约为粉料总量25%),加入1%的CMS-Na为崩解剂,0.7%的硬脂酸镁和0.5%的微粉硅胶分别作为润滑剂与助流剂。结论:该成型工艺可用于调脂片的工业生产。
Objective: Optimize the lipid-regulating tablet molding process. Methods: Taking the process parameters of pelletizing and tabletting as the evaluation indexes, the suitable excipients and their dosage were selected. Results: The optimal molding conditions were as follows: the ratio of dry powder, starch and lactose was 7: 1.5: 1.5, wet granulation was made with 1.5% PVP solution as binder (the dosage was about 25% of the total amount of powder) Add 1% CMS-Na as disintegrating agent, 0.7% magnesium stearate and 0.5% powdered silica as lubricant and glidant, respectively. Conclusion: This molding process can be used for the industrial production of lipid-regulating tablets.