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响应面法优化青钱柳多糖片的处方工艺研究
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Abstract:
目的：对青钱柳多糖片剂处方工艺进行优化。方法：以青钱柳多糖粉为原料，采用湿法制粒压片。在单因素试验基础上，以主药与填充剂比例、黏合剂浓度及崩解剂用量为影响因素，片剂外观、脆碎度及崩解时限的综合评分为评价指标，熵权法结合Box-Behnken响应面法筛选最优工艺。结果：青钱柳多糖片剂最佳配方为主药与填充剂比例1:1.179，粘合剂浓度8.879%，崩解剂用量6.719%。在此条件下，青钱柳多糖片综合评分为17.163分。结论：通过工艺优化得到的青钱柳多糖片理论值与模型预测值相吻合。其处方工艺稳定可行，且片形外观、脆碎度、崩解时限等指标都达到了片剂相应质量要求。
Objective: To optimize the prescription technology of Cyclocarya paliurus pol-ysaccharide tablets. Methods: Cyclocarya paliurus polysaccharide powder was used as raw material and granulated by wet method. On the basis of single factor test, the ratio of main drug to filler, binder concentration and disintegrating agent dosage were taken as the influencing factors, and the comprehensive score of tablet appearance, friability and disintegrating time was taken as the eval-uation index. Entropy weight method combined with Box-Behnken response surface method was used to screen the optimal process. Results: The optimal formulation of Cyclocarya paliurus poly-saccharide tablet was the ratio of main drug to filler 1:1.179, adhesive concentration 8.879% and disintegrating agent addition 6.719%. Under these conditions, the comprehensive score of Cy-clocarya paliurus polysaccharide tablets was 17.163. Conclusion: The theoretical values obtained by process optimization are consistent with the predicted values of the model. The prescription tech-nology is stable and feasible, and the shape appearance, fragility, disintegration time and other in-dicators met the corresponding quality requirements of the tablets.
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