基于确定性筛选设计优化榆皇生肌乳膏的制备工艺
Optimization of the preparation process of Yuhuang Shengji Cream based on definitive screening design
钱喜龙 1王可为 2刘政 3周柳 1马瑜璐 3房方 3章阳 2王业皇 2江滨 2刘圣金1
作者信息
- 1. 中药制药过程控制与智能制造技术全国重点实验室/江苏康缘药业股份有限公司/南京中医药大学,南京 210000;南京中医药大学药学院,南京 210023;江苏省中药资源产业化过程协同创新中心,南京 210023
- 2. 南京中医药大学附属南京中医院,南京 210022
- 3. 中药制药过程控制与智能制造技术全国重点实验室/江苏康缘药业股份有限公司/南京中医药大学,南京 210000;南京中医药大学药学院,南京 210023
- 折叠
摘要
目的:在确定性筛选设计的帮助下,系统地研究关键工艺参数,优化榆皇生肌乳膏的制备工艺.方法:依据确定性筛选设计来设计一系列实验,并使用旋转流变仪测试乳膏的流变特性,以获得关键的流变数据.通过对实验数据进行逐步回归拟合分析,探索因子与响应之间的复杂关系.基于这些实验数据进行模拟实验,并利用决策树来确定最合适的因子取值范围,以提高制备工艺的稳定性.应用高斯过程优化方法,在预设范围内寻找最优的参数配置,进一步优化榆皇生肌乳膏的制备工艺.结果:经过优化得到的工艺范围:乳化温度(85±5.5)℃、混合转速(432±51)×g、药物比例(20±2)%、硬脂醇(14.1±1)g、白凡士林(30±2)g、十二烷基硫酸钠(1±0.16)g,在小范围内的波动不会对乳膏产生较大影响.最佳工艺为药物比例20%、乳化温度85℃、混合转速432×g、硬脂醇14g、白凡士林30g、十二烷基硫酸钠1g.在此条件下乳膏生产发生缺陷的概率为0.043 29.结论:确定性筛选设计方法可以有效地优化榆皇生肌乳膏的制备工艺,同时该方法为其他中药复方的乳膏制备工艺优化提供了参考.
Abstract
Objective:With the help of definitive screening design,the key process parameters were systematically optimized for the preparation process of Yuhuang Shengji Cream.Methods:A series of experiments were designed according to the definitive screening design,and the rheological properties of the cream were tested with a rotary rheometer to obtain the key rheological data.The complex relationship between factors and responses was explored by stepwise regression analysis of experimental data,based on which the simulation experiment was carried out,and the decision tree was used to determine the most appropriate range of factors to improve the stability of the preparation process.The Gauss process optimization method was applied to find the optimal parameter configuration in the preset range to further optimize the preparation process of Yuhuang Shengji cream.Results:The optimal process range obtained by optimization is as follows:emulsification temperature at(85±5.5)℃,mixing speed at(432±51)×g,drug proportion of(20±2)%,stearyl alcohol(14.1±1)g,white vaseline(30±2)g,and sodium dodecyl sulfate(1±0.16)g.The fluctuation in a small range did not have a great impact on the cream.The optimal process was as follows:drug proportion of 20%,emulsification temperature at 85℃,mixing speed at 432×g,stearyl alcohol 14 g,white vaseline 30 g,and sodium dodecyl sulfate 1 g.Under this condition,the probability of defect in cream production is 0.04329.Conclusion:The preparation process of Yuhuang Shengji cream was effectively optimized using the definitive screening design method.This method provides a reference for the preparation process optimization of other traditional Chinese medicine compound creams.
关键词
临床经验方/含矿物药中药复方/乳膏/制备工艺/确定性筛选设计/流变学/机器学习Key words
clinical experience formula/traditional Chinese medicine compound containing mineral medicine/cream/preparation process/definitive screening design/rheology/machine learning引用本文复制引用
出版年
2024
NETL
NSTL
万方数据