摘要
目的:优选复方茜草片的提取工艺和成型工艺,为该制剂的工业生产和临床推广提供参考。方法:采用药效学试验筛选复方茜草片的提取方式,以大叶茜草素和羟基萘醌总色素提取率的综合评分为指标,通过正交试验考察提取温度、溶剂用量、提取时间对提取工艺的影响。利用单因素试验优选复方茜草片的成型工艺。结果:最佳提取和成型工艺为加10,8倍量95%乙醇于95℃水浴回流提取2次,每次1 h,合并提取液,减压回收溶剂,干燥制成浸膏;取该浸膏适量,加入适量微晶纤维素和羧甲基淀粉钠,混匀,以5%聚维酮-K30为黏合剂,湿法制粒,干燥,过20目筛整粒,加适量硬脂酸镁,压片,包薄膜衣,片剂增重1%,包装。浸膏中大叶茜草素和羟基萘醌总色素质量分数分别为6.68%,10.81%,浸膏得率4.57%,RSD依次为2.4%,4.6%,2.1%。片剂硬度约4.5 kg,崩解时限25 min,包衣效果良好。结论:优化的工艺条件合理可行,适用于复方茜草片的工业化生产。
Objective： To optimize preparation process of compound Qiancao tablets. Method： Pharmacodynamie test was adopted to screen extraction method, orthogonal test was used to optimize conditions of extracting temperature, solvent amount and extracting time in extraction process of compound Qiancao tablets, with extracting rates of mollugin and hydroxynaphthoquinones as indexes. Molding process of compound Qianeao tablets was optimized by single factor tests. Result： Optimal extraction and molding processes were as follows： extracted twice with 10-fold and 8-fold 95% ethanol refluxing at 95℃ , 1 hour for per time, then vacuum dried to obtain extract; added MCC and CMS-Na into extract, mixed with 5% PVP-K30 as an adhesive to obtain wet granules, dried granules and granulated through a twenty-mesh sieve; added proper amount of magnesium 8tearate for tableting with coating weight of 1%. Dry extract rate was 4.57% , contents of mollugin and hydroxynaphthoquinones in extract were 6.68% and 10.81%. Hardness of the tablets was 4.5 kg and disintegration time was 25 min with good coating performance. Conclusion： These optimized processes are reasonably practicable, which can be applicable to industrial production of compound Qiancao tablets.
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2016年第4期11-14,共4页
Chinese Journal of Experimental Traditional Medical Formulae
基金
上海市科委中药现代化专项(11DZ1971500)
上海市卫计委青年项目(20124Y002)
关键词
复方茜草片
出血时间
大叶茜草素
黏合剂
崩解时限
compound Qiancao tablets
bleeding time
mollugin
adhesives
disintegration time
