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[摘要]
目的 优化元胡止痛口腔崩解片(YZODT)最佳处方。方法 采用单因素实验、星点设计-效应面优化法,以片剂润湿时间、崩解时限为评价指标,对YZODT的处方进行优化,以确定最佳制备工艺。结果 优化的处方用量为微晶纤维素(MCC)30%,低取代羟丙基纤维素(L-HPC)15%,交联聚维酮(PVPP)5%,优化后YZODT的平均崩解时限为42.89 s,与预测值的偏差为3.27%。结论 制备的YZODT崩解迅速,硬度适宜,服用方便,工艺简便易行。
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[Abstract]
Objective To optimize the best prescription of Yuanhu Zhitong Oral Disintegrating Tablets (YZODT). Methods Using the single factor test, the prescription of the tablets was optimized by central composite design-response surface methodology (CCD-RSM) with the tablet wetting time and the disintegration time limit as evaluation index, so as to determine the best preparation process. Results The dosages of the optimized prescription of MCC, L-HPC, and PVPP were 30%, 15%, and 5%, respectively. The average disintegration time of the optimized YZODT was 42.89 s, and the deviation from the predicted value was 3.27%. Conclusion The optimized YZODT has the advantages of fast disintegration, moderate hardness, convenient use, and simple process.
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