基于粗糙集理论和正交设计的冠心苏合滴丸制药生产工艺参数优选的方法研究  

Optimization of pharmaceutical production process parameters for Guanxin Suhe drop pills based on rough set theory and orthogonal design

作　　者：崔红新[1,2,3] 郭颖 陈晓莹 朱芳静 韩景仁 赵迪 黄琼[1] CUI Hong-xin;GUO Ying;CHEN Xiao-ying;ZHU Fang-jing;HAN Jing-ren;ZHAO Di;HUANG Qiong(Henan University of Chinese Medicine,Zhengzhou 450046;Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province&Education Ministry,Zhengzhou 450046;Henan Engineering Research Center of Modern Chinese Medicine Research,Development and Application,Zhengzhou 450046)

机构地区：[1]河南中医药大学,郑州450046 [2]呼吸疾病中医药防治省部共建协同创新中心,郑州450046 [3]河南省现代中药研发与应用工程研究中心,郑州450046

出　　处：《中南药学》2024年第9期2410-2414,共5页Central South Pharmacy

基　　金：河南省科技攻关项目(No.212102311095)。

摘　　要：目的利用粗糙集理论和正交设计研究制药生产工艺参数之间的规律,探求优选生产工艺参数优选的数学方法。方法采用粗糙集理论方法,以冠心苏合滴丸生产工艺参数优选为案例,利用正交设计试验预处理数据,建立决策表,通过粗糙集规则模型动态分析工艺参数对结果的影响,优选最佳工艺参数。结果当冠心苏合滴丸生产工艺的参数药物与基质的配比分别与药液温度和冷却剂温度的水平逐渐增高时,溶散时限的平均水平呈现低-高-低的动态变化趋势;但当药液温度和冷却剂温度水平逐渐增高时,溶散时限的平均水平呈现动态的递减变化趋势。药物与基质的配比为1∶2,药液温度为70℃,冷却剂温度为12~14℃时,为冠心苏合滴丸生产工艺的参数的最佳组合。结论粗糙集理论能够动态、全面地分析制药生产工艺参数与试验指标之间的内在关系,提供了一种研究提高制药生产工艺质量的数学方法。Objective To determine the law between pharmaceutical production process parameters based on rough set theory and orthogonal design,and explore the mathematical method for optimal selection of parameters.Methods The optimization of process parameters of Guanxin Suhe drop pills was used as an example.The decision table was established via the pretreatment data from orthogonal design experiment.The effect of process parameters on the results was dynamically analyzed with the rule model of rough set theory,and the parameters were optimized.Results When the parameters for the production of Guanxin Suhe drop pills gradually increased respectively,such as the proportion of drug and base material,the liquid temperature and the coolant temperature,the average level of dissolution time limit displayed low-high-low pattern;when the liquid temperature and the coolant temperature increased gradually,the average level of dissolution time limit dynamically decreased.The best combination included the proportion of drug and base material at 1∶2,liquid temperature at 70℃,and coolant temperature at 12~14℃.Conclusion Rough set theory can dynamically and comprehensively analyze the internal relationship between pharmaceutical production parameters and test indexes,offering a mathematical method to improve the quality of pharmaceutical production.

关 键 词：粗糙集理论 正交设计 决策规则模型 冠心苏合滴丸 

分 类 号：R943[医药卫生—药剂学]