射干异黄酮分散片的制备和质量考察
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上海市中药现代化基金资助项目(07DZ19721-2)及上海市重点学科建设项目资助(No.B906)


Preparation and quality evaluation of dispersible tablets of isoflavonoids from Belamcanda chinensis
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    摘要:

    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 min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。

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    [Abstract] 0bjective To investigate the preparation method of dispersible tablets of isoflavonoids from Rhizoma belamcandae. Methods The formula of isoflavonoid dispersible tablets was optimized by orthogonal experiment with disintegrating time as index and influential factors were observed. According to the optimum prescription we made three batch samples and had quality evaluation such as disintegration time, dissolution rate et. Results The optimized formula was A2B2C2. The contents of crospovidone, gelling starch and gum arabic were 12%,14 %and 3% respectively. As crospovidone and gelling starch,the ratios of before granulation to after pre-compress all were 2:1. The products formulated with the optimum techniques which disintegrated in 30s and dissolved in 45mins met the quality specification of dispersed tablet. Conclusion The dispersible tablets showed good distribution homogeneity and higher dissolution rate. The preparation process is simpler,feasible,and adapt to industrial production.

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  • 收稿日期:2011-03-09
  • 最后修改日期:2011-05-11
  • 录用日期:2011-05-19
  • 在线发布日期: 2011-07-22
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