不同灭菌工艺对生川乌中乌头类双酯型生物碱成分及产品质量影响研究
Study on the Effects of Different Sterilization Processes on the Composition and Product Quality of Aconitum Diester Alkaloids in Shengchuanwu
俸雅娟 1邹赣昌 1龙珍君 1覃语燕 1罗凯璇1
作者信息
- 1. 桂林三金药业股份有限公司,广西桂林 541199
- 折叠
摘要
目的:在保证生川乌药效的前提下,筛选最优灭菌工艺.方法:分别采用热压灭菌、干热灭菌、钴-60 辐照灭菌三种方法进行灭菌处理,采用HPLC法考察灭菌后乌头类双酯型生物碱含量变化情况,同步考察药材及其产品微生物数量是否符合标准,以综合评估大生产适用工艺.结果:3 种灭菌方法均能使产品符合成品质量标准,综合考虑灭菌后样品微生物数量、指标成分含量、效率等因素,干热灭菌工艺是最优工艺.结论:在干热灭菌条件下,产品微生物限度符合要求,乌头类双酯型生物碱转移率较优,生产效率可接受,可作为工业生产最优工艺.
Abstract
Objective:On the premise of ensuring the efficacy of Shengchuanwu,the optimal sterilization process is screened.Methods:Hot-press sterilization,dry-heat sterilization and 60Co irradiation sterilization are used to sterilize the product respectively.The content changes of Aconitum diester alkaloids after sterilization are studied by HPLC.At the same time,the number of microorganisms in medicines materials and their products is investigated to meet the standards,so as to comprehensively evaluate the applicable process for large-scale production.Results:The three sterilization methods can make the finished product meet the quality standard,and the dry heat sterilization process is the best one considering the microorganism,content and efficiency.Conclusion:Under the condition of dry heat sterilization,the microbial limit of product meets the requirements,the transfer rate of Aconitum diester alkaloid is better,and the production efficiency is acceptable,which can be used as an optimal process for industrial production.
关键词
乌头类双酯型生物碱/转移率/灭菌工艺/微生物限度Key words
Aconitum diester alkaloids/transfer rate/sterilization process/microbial limits引用本文复制引用
出版年
2024
NETL
NSTL
万方数据