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目的研究射干异黄酮分散片的制备工艺及质量。方法以崩解时间为指标,采用正交设计法考察处方组分和筛选处方,并对优选处方的3批样品进行崩解时限、溶出度、分散均匀性等质量评价。结果优选的射干分散片处方为:12%交联聚乙烯吡咯烷酮(内加:外加=2:1),14%预胶化淀粉(内加:外加=2:1),3%微粉硅胶。射干分散片可在30 s内完全崩解,在45 m in内可释放完全,分散均匀性等符合分散片各项质量指标。结论本实验制备的射干分散片崩解快,溶出度高,制备工艺较简单,适用于工业化生产。
Objective To study the preparation process and quality of isofenone dispersible tablets. Methods Taking the disintegration time as the index, orthogonal design method was used to investigate prescription components and screening prescriptions. The quality evaluation of disintegration time, dissolution rate and dispersion uniformity of three batches of prescriptions were conducted. Results The best formulation of pericardin dispersible tablets was: 12% cross-linked polyvinylpyrrolidone (internal plus: additional = 2: 1), 14% pregelatinized starch (plus: additional = 2: 1), 3% Shegan dispersible tablets can be completely disintegrated within 30 s, 45 m in fully released within the dispersion uniformity in line with the various quality indicators dispersible tablets. Conclusions The pericardial dispersible tablets prepared in this experiment have the advantages of quick disintegration, high dissolution rate, simple preparation process and being suitable for industrialized production.