Box-Behnken响应面法优化参附滴丸的成型工艺  

Optimization of the molding technology of Shenfu Dropping pills by Box-Behnken response surface experiment

作　　者：王晶华[1] 于凤波[1] 佟雷[1] 侯甲福[1] 杨琦 WANG Jinghua;YU Fengbo;TONG Lei;HOU Jiafu;YANG Qi

机构地区：[1]牡丹江医学院药学院,黑龙江牡丹江157011

出　　处：《中医临床研究》2022年第33期142-145,共4页Clinical Journal Of Chinese Medicine

基　　金：黑龙江省省属高等学校基本科研业务费科研项目(2018-KYYWFMY-0016)。

摘　　要：目的:优选参附滴丸的成型工艺。方法:采用单因素法分别考察了基质种类、参附提取物与基质的配比、熔融温度、冷却剂的种类、冷却柱的高度及冷却剂的温度对滴丸质量的影响,要满足2020版《中华人民共和国药典》规定的滴丸外观、重量差异、溶散时限的要求;在单因素研究基础上再选取熔融温度、冷却剂温度、参附提取物与基质的配比三个主要因素进行BoxBehnken响应面实验,以滴丸的质量变异系数、外观评价、溶散时限作为评价指标。结果:单因素考察显示选用聚乙二醇4000和聚乙二醇6000混合基质、参附提取物与聚乙二醇比例在1∶2和1∶3、熔融温度控制在80~100℃、冷却剂选择二甲基硅油、冷却柱的高度为40 cm、冷却剂的温度在10~20℃时制成的滴丸质量更好;Box-Behnken响应面实验结果显示参附提取物与聚乙二醇基质配比为1∶2.5、熔融温度为90℃、冷却剂温度为15℃时参附滴丸成型效果较好。结论:Box-Behnken响应面法能够对原料液与基质的配比、熔融温度、冷却剂温度三个因素进行连续分析,找到最优化条件,故可用于参附滴丸成型工艺的优化,该工艺条件温和,适合工业化生产。Objective:To optimize the molding technology of Shenfu(参附)Dropping Pills.Methods:The single factor method was used to investigate the effects of the type of matrix,the ratio of Shenfu extract and matrix,the melting temperature,the type of coolant,the height of the cooling column and the temperature of the coolant on the quality of the dropping pills,so as to meet the requirements of the appearance,weight variation and dissolution time of the dropping pills stipulated in the 2020 edition of People’s Republic of China Pharmacopoeia.Based on the single-factor study,the three main factors of melting temperature,coolant temperature,and the ratio of Shenfu extract to matrix were then selected for Box-Behnken response surface experiments,and the quality coefficient of variation,appearance evaluation,and dissolution time of the dropping pills were used as evaluation indexes.Results:The single factor study showed that the quality of dripping pills was better when the mixture matrix of polyethylene glycol 4000 and polyethylene glycol 6000 was selected,the ratio of Shenfu extract to polyethylene glycol was 1:2 and 1:3,the melting temperature was controlled at 80-100℃,the coolant was dimethylsilicone oil,the height of cooling column was 40cm,and the temperature of coolant was 10-20℃.The results of Box-Behnken response surface experiments showed that when the extract of Shenfu and polyethylene glycol was melted at 90℃in the ratio of 1:2.5 and condensed in the cooling box at 15℃,the forming effect of the dropping pills was good.Conclusion:The Box-Behnken response surface method can continuously analyze the three factors,namely the ratio of raw material liquid to matrix,melting temperature and coolant temperature,to find the optimal conditions,so it can be used to optimize the molding process of Shenfu Dropping Pills,which is mild and suitable for industrial production.

关 键 词：人参 附子 参附滴丸 成型工艺 响应面实验 

分 类 号：R932[医药卫生—生药学]