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目的:优选毛冬青分散片的处方工艺,为毛冬青的临床应用提供新选择。方法:选择毛冬青醇提物为原料,采用单因素试验筛选填充剂、崩解剂及润湿剂;以崩解时限为因变量,采用星点设计-效应面法考察微晶纤维素(MCC)、交联聚维酮(PVPP)及羧甲基淀粉钠(CMS-Na)用量对毛冬青分散片处方工艺的影响。结果:最佳工艺条件为毛冬青醇提物40%,磷酸氢钙27%,18%MCC,9%PVPP,5%CMS-Na,0.2%三氯蔗糖,3%聚维酮,0.8%硬脂酸镁。崩解时限84.7 s,与预测值的偏差3.3%。结论:毛冬青分散片制备工艺简单、崩解时限短、制剂稳定性好,适合工业化生产。
Objective: To optimize the prescription of Mao Dong Qing Dispersible Tablets, and to provide a new choice for the clinical application of Mao Dong Qing. Methods: The alcohol extract of Mao Dongqing was selected as raw material, and the filler, disintegrant and wetting agent were screened by single factor test. The disintegration time was taken as the dependent variable, and the microcrystalline cellulose (MCC ), Crospovidone (PVPP) and sodium carboxymethyl starch (CMS-Na) on the prescription of Mao Dong Qing Dispersible Tablets. Results: The optimum conditions were as follows: 40% alcohol extract of Mao Dongqing, 27% DCP, 18% MCC, 9% PVPP, 5% CMS-Na, 0.2% sucralose, 3% Magnesium stearate. Disintegration time 84.7 s, with the deviation of 3.3%. Conclusion: The preparation process of Mao Dongqing dispersible tablets is simple, the disintegration time is short, the stability of preparation is good and it is suitable for industrial production.