摘要
为优化山楂多糖分散片的制备工艺,对其进行了质量控制。在单因素试验的基础上,以崩解时间为评价指标,选用压片压力、崩解剂用量、乙醇溶液浓度为因素,利用正交试验对山楂多糖分散片的制备工艺进行优化;按照《中华人民共和国药典》的方法,对主药含量、崩解时间、分散均匀性、溶出度等指标进行测定,以期对山楂多糖分散片的质量进行控制。得到山楂多糖分散片的最优制备工艺如下:采用交联聚乙烯基吡咯烷酮(PVPP)为崩解剂,碳酸钙为填充剂,体积分数为65%的乙醇溶液为黏合剂,滑石粉为润滑剂,压片的压力为6kg。研究表明,该分散片每片含山楂多糖40mg,崩解时间为65s,分散均匀性良好,15min溶出度为标示量的75.40%。
To optimize the preparation technics of dispersible tablets of polysaccharides isolated from Crataegus pinnatifida Bunge, quality control is implemented. On the basis of single factor test, with the disintegration time as evaluation index, and the pressure tableting, the amount of disintegrant and the concentration of ethanol as factors, the formulation of polysaccha- rides dispersible tablets is optimized by orthogonal design; according to the method in Chinese Pharmacopoeia, the main ingre- dients, disintegration, dispersion uniformity, dissolution and other indicators are measured to control the quality of the dispers- ible tablet. The optimal formulation is conducted using polyvingypyrrolidone （PVPP） as disintegrator, CaCO3 as fillers, 65% （volume fraction） ethanol as adhesive, and pulvistalci as lubricant under the pressure of 6 kg. The research shows that the dis- persible tablets contain 40 mg polysaccharides from Crataegus pinnatifida Bunge, the disintegration time is 65 seconds and the dissolution rate is 75.40% in 15 minutes.
出处
《河北工业科技》
CAS
2016年第1期35-39,共5页
Hebei Journal of Industrial Science and Technology
基金
河北省食品药品监督管理局食品药品安全科技项目(QN2015016)
河北科技大学"五大平台开放基金"(2014PT96)
关键词
中药药剂学
山楂
多糖
分散片
制备
质量控制
traditional chinese medicine pharmaceutics
Crataegus pinnatifida Bunge
polysaccharides
dispersible tablets
preparation
quality control
