开心散^(60)Co-γ射线辐照灭菌工艺优化及不同灭菌方式对其质量影响研究  

Optimization of ^(60)Co-γ irradiation sterilization technology for Kaixin Powder and quality impact research for different sterilization methods

作　　者：尚炳娴 李军[1] 张佟 高丰 徐冰[1] 雷海民[1] SHANG Bing-xian;LI Jun;ZHANG Tong;GAO Feng;XU Bing;LEI Hai-min(Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[1]北京中医药大学,北京102488

出　　处：《中草药》2023年第8期2408-2416,共9页Chinese Traditional and Herbal Drugs

基　　金：科技部重大专项“科技助力经济2020重点专项清肺排毒5号中药复方制剂研发及产业化”(2020YFF0426288)。

摘　　要：目的 优选开心散最佳^(60)Co-γ射线辐照灭菌工艺,并对比不同灭菌方式对开心散的灭菌效果及质量的影响。方法 以西伯利亚远志糖A5、西伯利亚远志糖A6、远志(口山)酮Ⅲ、3,6’-二芥子酰基蔗糖、人参皂苷Rb_(1)、β-细辛醚、α-细辛醚、去氢茯苓酸的含量和灭菌率的综合评分为指标,采用层次分析(analytic hierarchy process,AHP)法确定各指标权重系数,考察开心散不同辐照剂量的灭菌效果,优化开心散辐照灭菌工艺参数;通过微生物限度检测、指标成分含量及特征图谱检测,并结合灭菌后的制剂性状,对比辐照灭菌、湿热灭菌、干热灭菌和乙醇灭菌的灭菌效果和对开心散质量的影响。结果 按照确定的权重系数进行综合评价,确定开心散最佳^(60)Co-γ射线辐照灭菌工艺条件为辐照剂量6 kGy;不同方式灭菌样品的微生物限度检查均符合药典规定;与未灭菌制剂相比,经辐照灭菌后样品中西伯利亚远志糖A6、3,6’-二芥子酰基蔗糖含量降低,人参皂苷Rb_(1)、β-细辛醚和α-细辛醚含量增加;与辐照灭菌相比,经干热灭菌后多种指标成分含量降低,经乙醇灭菌后多种指标成分含量增加;特征图谱结果显示,各种灭菌方式样品与未灭菌样品相比相似度皆>0.99。结论 ^(60)Co-γ射线辐照剂量在6 kGy及以上时能完全杀灭制剂中的微生物,工艺稳定可行、重复性好,且辐照灭菌法与其他灭菌方法相比,在保证灭菌效果的同时能更大程度地保留开心散制剂中的主要成分,得到符合规定的开心散制剂。Objetcive To optimize the sterilization process of Kaixin Powder,and compare the effect of different sterilization methods on the sterilization effect and quality of Kaixin Powder.Method With the content of sibiricose A5,sibiricose A6,polygalaxanthone III,3,6′-disinapoyl sucrose,ginsenoside Rg1,β-asarone,α-asarone,dehydropachymic acid and the sterilization rate as comprehensive evaluation indexes,weight coefficient of indicators were determined by analytic hierarchy process(AHP)to investigate the sterilization effect of Kaixin Powder with different irradiation doses,and optimize the irradiation sterilization process parameters of Kaixin Powder;The sterilization effect and quality of Kaixin Powder before and after sterilization were compared by irradiation sterilization,moist heat sterilization,dry heat sterilization and ethanol sterilization through microbial limit detection,index component content and characteristic map detection.Results According to the comprehensive evaluation of determined weight coefficient,the optimal 60Co-γ-ray irradiation sterilization process conditions for Kaixin Powder were determined to be 6 kGy.The microbial limit inspection of each sterilized sample complies with the pharmacopoeia regulations.Compared with the unsterilized preparation,after irradiation sterilization,the contents of sibiricose A6 and 3,6′-disinapoyl sucrose were decreased,while the contents of ginsenoside Rb1,β-asarone andα-asarone were increased.Compared with radiation sterilization,the content of multiple index components was decreased after dry heat sterilization,but increased after ethanol sterilization.The specific chromatogram results showed that the similarity of the samples with different sterilization methods was more than 0.99 compared with the unsterilized samples.Conclusion Irradiation dose greater than or equal to 6 kGy can completely kill the microorganisms in the preparation,and the process is stable and feasible with good repeatability.Compared with other sterilization methods,the irradiation

关 键 词：开心散 ^(60)Co-γ射线 辐照灭菌 西伯利亚远志糖A5 西伯利亚远志糖A6 远志(口山)酮Ⅲ 3 6’-二芥子酰基蔗糖 人参皂苷Rb_(1) β-细辛醚 Α-细辛醚 去氢茯苓酸 层次分析法 湿热灭菌 干热灭菌 乙醇灭菌 

分 类 号：R283.6[医药卫生—中药学]