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目的:制备甲氧氯普胺口崩片并优化处方,并对其体外溶出度进行考察。方法:采用全因子试验设计,以填充剂配比(X1)、崩解剂(X2,%)用量为影响因素,以脆碎度(Y1,%)、崩解时限(Y2,s)、甲氧氯普胺在15 min的溶出度(Y3,%)为片剂考察指标优化处方;并考察其在4种溶出介质中的溶出行为。结果:甲氧氯普胺口崩片的最优处方组成为:填充剂甘露醇与微晶纤维素比例为2.5∶1、崩解剂占片重为6.5%。甲氧氯普胺口崩片在4种溶出介质中累积溶出度均大于80%。结论:甲氧氯普胺口崩片处方设计合理,制备工艺可行,质量可控。
OBJECTIVE: To prepare metoclopramide orally disintegrating tablets and optimize the prescription, and to investigate its in vitro dissolution. Methods: The full factorial design was adopted to study the effects of the factors such as the ratio of filler (X1) and disintegrant (X2,%) on the factors of friability (Y1,%), disintegration time Oxycycline in 15 min dissolution (Y3,%) for the tablet study to optimize the prescription; and investigate its dissolution in four dissolution media behavior. Results: The optimal formulation of metoclopramide orally disintegrating tablets was as follows: the ratio of mannitol to microcrystalline cellulose was 2.5: 1 and the disintegrant was 6.5%. The cumulative dissolution of metoclopramide orally disintegrating tablets in all four dissolution media was more than 80%. Conclusion: The formulation of metoclopramide orally disintegrating tablets is reasonable in design, the preparation process is feasible and the quality is controllable.