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目的:确定香砂养胃片的最佳制剂成型工艺,提高其硬度,降低其崩解度。方法:采用正交试验设计法,分别考察崩解剂、填充剂、润滑剂用量对片剂硬度和崩解度的影响,分别赋予硬度和崩解度0.3和0.7的权重,进行多指标综合评分。结果:处方中选用5%羧甲基淀粉钠为崩解剂,预胶化淀粉∶微晶纤维素(1∶1)作为填充剂,0.5%硬脂酸镁作为润滑剂。结论:筛选的辅料性能优良,优选的片剂处方合理,制得的片剂硬度和崩解度均符合要求,适合工业化生产。
Objective: To determine the best formulation of Xiangsha Yangwei Tablets, to improve its hardness and reduce its disintegration. Methods: The effects of disintegrants, fillers and lubricants on the tablet hardness and disintegratability were investigated by orthogonal experimental design method. The weights of 0.3 and 0.7 of hardness and disintegratability were respectively assigned to them. The multi-index comprehensive score . Results: 5% sodium carboxymethyl starch was selected as the disintegrant, pregelatinized starch: microcrystalline cellulose (1: 1) as filler and 0.5% magnesium stearate as lubricant. CONCLUSION: The screening materials have excellent performance and the preferable tablet prescription is reasonable. The hardness and disintegration of the prepared tablets meet the requirements and are suitable for industrialized production.