摘要
目的中药口服液在放置过程中易产生沉淀,导致澄明度下降,试验以参芝安神口服液为例,优选单宁-明胶澄清参芝安神口服液的工艺。方法在单因素试验基础上,以单宁明胶用量比(A)、温度(B)、时间(C)为自变量,以蛋白去除率、多糖保留率、浊度值为响应值,选择最佳工艺条件进行预测分析和试验验证,对澄清前后口服液中有效成分云芝多糖、人参茎叶皂苷含量进行测定,并对絮体形态及澄清机制进行初步分析。结果确定最优澄清工艺条件∶V(单宁)∶V(明胶)(A)为1. 2∶1. 0、温度(B)为50℃、时间(C)为5. 5 h。絮体在显微镜下呈深色,尺寸大小不等,澄清机制为带正电荷的明胶与带负电荷的单宁相聚合形成明胶单宁络合物,使口服液中的悬浮颗粒及易使该口服液产生沉淀的蛋白类物质随络合物的沉降而缠绕下沉,加快了澄清速度。澄清后口服液中有效成分含量符合限度要求。结论采用单宁明胶复配澄清参芝安神口服液操作简单,将用于果汁及水质澄清中的单宁明胶复配澄清法应用于口服液中,澄清效果好,有效成分损失小,可为该类口服液澄清提供参考。
Objective To improve the clarity of Traditional Chinese medicine oral liquid,Shenzhi Anshen oral liquid was used as an example to optimize clarification process by using tannin-gelatin. Methods Based on the single factor experiment,the optimum condition was selected as the independent variables,the protein removal rate,the polysaccharide retention rate and the turbidity value as the response values. The content of polysaccharide and ginsenoside were determined before and after clarification. The flocculation morphology and clarification mechanism were analyzed preliminarily. Results The results showed that the optimum condition for clarification was that tannin∶ gelatin（ A） was 1. 2∶ 1,temperature（ B） was at 50 ℃,and time（ C）was chosen at 5. 5 h. The floc under microscope was dark with different sizes. The clarification mechanism was the positively charged of gelatin and negatively charged of tannin polymerization to form gelatin-tannin complex,so that the suspension particles and proteins can precipitate,speeding up the clarification rate. After clarification,the effective ingredient content could meet the limit requirement. Conclusion Tannin-gelatin compound clarification is simple and easy to use. The clarification method of tannin-gelatin used in clarification of fruit juice and water is applied to oral liquid,and the effect of clarification is good. The effective ingredient loses less. This method can provide a reference for clarification of oral liquid.
作者
赵丹
李媛媛
赵娜
王中彦
朱澄云
ZHAO Dan;LI Yuanyuan;ZHAO Na;WANG Zhongyan;ZHU Chengyun(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;School of Traditional Chinese Materia Medica,Shenyang Pharmaceutical University,Shenyang 110016,China)
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2018年第11期921-930,共10页
Journal of Shenyang Pharmaceutical University
关键词
参芝安神口服液
星点设计-效应面优化法
澄清工艺
澄清机制
Shenzhi Anshen oral liquid
central composite design（CCD）
response surface method（RSM）
clarification process
clarification mechanism
