正交设计优选健脾益肺膏生产工艺研究

Study on Optimizing Production Technology of Jianpi Yifei Ointment by Orthogonal Design

目的在相关中医理论以及临床经验指导下,针对中药复方进行一系列有目的、有步骤、分层次的正交设计,并获得一套最科学、最经济、最简便的试验方案。本项目通过采取正交设计优选中药健脾益肺膏的生产工艺,获得最佳参数,为膏方的制备提供实验数据,从而推进中医药现代化。方法拟采用正交设计,对膏方的生产工艺进行优化,以浸泡时间、加水量、提取时间、提取次数为因素,以浸膏量,膏方中黄芪甲苷和毛蕊异黄酮葡萄糖苷的含量等为指标,优选出其最佳工艺参数,建立其工艺标准,为临床提供质量均一的药品,也为开发膏方新制剂提供实验理论数据。结果C因素(提取次数)对浸膏量、黄芩甲苷含量、毛蕊异黄酮苷含量均影响显著(P<0.05),A因素(中药浸泡时间)、B因素(加水量)、D因素(提取时间)对干膏量、黄芩甲苷含量、毛蕊异黄酮苷含量三项指标影响均不显著(P>0.05)。优化的工艺条件为中药浸泡时间0.5 h,加水量10倍,提取次数3次,提取时间1 h,优化的工艺条件可满足本品中浸膏量、黄芪甲苷含量、毛蕊异黄酮苷含量的质量要求。结论通过正交实验设计优选提取工艺合理可行、可用于健脾益肺膏的生产制备。

Objective Under the guidance of relevant TCM theories and clinical experience,a series of purposeful,step-by-step and hierarchical orthogonal designs were carried out for TCM compound prescriptions,and a set of most scientific,economical and simple experimental schemes were obtained.This project optimized the production process of Jianpi Yifei Ointment by orthogonal design,obtained the best parameters,and provided experimental data for the preparation of the Ointment,so as to promote the modernization of traditional Chinese medicine.Methods Orthogonal design was adopted to optimize the production process of the ointment.Taking soaking time,water addition,extraction time and extraction times as factors,and taking the amount of the extract and the contents of astragaloside A and isoflavone glucoside in the ointment as indexes,the optimum technological parameters were optimized,and the technological standards were established to provide uniform quality drugs for clinical useanddevelop a new preparation of the ointment.The reagent provided the experimental theoretical data.Results Factor C(extraction times)had a significant effect on extract quantity,contents of astragaloside A and pili isoflavone glycoside(P<0.05).Factor A(immersion time of traditional Chinese medicine),factor B(water)and factor D(extraction time)had no significant effect on dry extract quantity,contents of astragaloside A or pili isoflavone glycoside(P>0.05).The optimal technological conditions were soaking for 0.5 h,adding water 10 times,extracting 3 times and extracting for 1 hour.The optimal technological conditions could meet the quality requirements of extract quantity,content of astragaloside A and pili isoflavone glycoside in this product.Conclusion The optimal extraction process by orthogonal design is reasonable and feasible,and can be used for the preparation of Jianpi Yifei Ointment.