水分活度在枫蓼肠胃康制剂微生物控制策略中的应用
Application of Water Activity to Microbial Control Strategy of Fengliao Changweikang Preparations
李国琼 1林昌文 1黄有兴 2黄杨叶 2张海伦3
作者信息
- 1. 海南省药品查验中心,海南海口 570216
- 2. 海南海灵化学制药有限公司,海南海口 570311
- 3. 海口市制药厂有限公司,海南海口 570311
- 折叠
摘要
由于非无菌药品的质量和安全性受微生物污染影响,因此控制微生物污染是保障药品安全性的重要措施.水分活度是影响微生物生长和繁殖的关键物理化学参数,具有测定简便、准确、快速等优势.控制水分活度在适宜范围内,有助于抑制微生物的生长和繁殖.该研究通过测定枫蓼肠胃康制剂中药材和辅料、中间产品以及成品的水分活度,结合生产过程的风险评估,建立了枫蓼肠胃康制剂的微生物控制策略,为非无菌药品的微生物控制和标准制定提供了新的思路.
Abstract
The quality and safety of non-sterile pharmaceutical products are affected by microbial contamination,so the microbial contamination control is an important measure to ensure the safety of pharmaceuticals.Water activity is a key physicochemical parameter that affects the growth and reproduction of microorganisms,and it can be easily,accurately and rapidly determined.Controling the water activity in an appropriate range would help to inhibit the growth and reproduction of microorganisms.This study established a microbial control strategy by determining water activity values of herbs and excipients,intermediate products,and final products of Fengliao Changweikang preparations,and combining with the risk assessment of the production process.This study provided a new idea for the microbial control of non-sterile pharmaceutical products and the development of standards.
关键词
水分活度/枫蓼肠胃康制剂/水分吸附等温曲线/微生物控制/质量控制Key words
water activity/Fengliao Changweikang preparation/isothermal curve of water adsorption/microbial control/quality control引用本文复制引用
基金项目
海南省自然科学基金面上项目(821MS0817)
海口市重点科技创新项目(HKGX01)
出版年
2024
NETL
NSTL
万方数据