| 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=21),14% 预胶化淀粉(内加外加=21),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。 |
| 关键词: 射干 异黄酮 分散片 制药工艺学 质量控制 |
| DOI：10.3724/SP.J.1008.2011.0779 |
| 投稿时间：2011-03-09修订日期：2011-05-11 |
| 基金项目: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） |
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| Preparation and quality evaluation of dispersible tablets of isoflavonoids from Belamcanda chinensis |
| XU Na1△,ZHAO Ping2△,YANG Hang1,CHEN Hai-sheng1*,CHEN Yan1* |
| (1. Department of Natural Medicinal Chemistry, School of Pharmacy, Second Military Medical University, Shanghai 200433, China) |
| Abstract: |
| [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. |
| Key words: Rhizoma Belamcandae Isoflavonoids Dispersible tablets Preparation method Quality evaluation |
