射干异黄酮分散片的制备和质量考察  

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

作　　者：徐娜[1] 赵平[2] 杨航[1] 陈海生[1] 陈琰[1] 

机构地区：[1]第二军医大学药学院天然药物化学教研室,上海200433 [2]首都医科大学附属北京同仁医院眼科中心,北京100730

出　　处：《第二军医大学学报》2011年第7期779-782,共4页Academic Journal of Second Military Medical University

基　　金：上海市中药现代化基金(07DZ19721-2);上海市重点学科建设项目(B906)~~

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 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 investigate the preparation technique and quality evaluation of dispersible tablets of isoflavonoids from Belamcanda chinensis.Methods With the disintegrating time taken as index,the formula of isoflavonoid dispersible tablets was optimized by orthogonal experiment,and the influencing factors were observed.Three batches of samples were made using the optimized prescription,and the quality evaluation was done by examining the disintegration time,dissolution rate,and dispersing uniformity.Results The optimized formula was A2B2C2.The contents of crospovidone（A）,gelling starch（B） and gum arabic（C） were 12%,14 % and 3%,respectively.As crospovidone and gelling starch,the ratios before granulation to after pre-compress were all 21.The products formulated by the optimum techniques disintegrated in 30 s and dissolved in 45 min,which,together with the dispersing uniformity,met the quality criteria of dispersed tablets.Conclusion The dispersible tablets prepared in this study have a good distribution homogeneity and a higher dissolution rate.The preparation is simple and suitable for industrial production.

关 键 词：射干 异黄酮 分散片 制药工艺学 质量控制 

分 类 号：R944.4[医药卫生—药剂学]