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。
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.
作者
李国琼
林昌文
黄有兴
黄杨叶
张海伦
LI Guoqiong;LIN Chengwen;HUANG Yuoxing;HUANG Yangye;ZHANG Hailun(Hainan Center for Drug Inspection,Haikou 570216;Hainan Hailing Chemipharma Co.,Haikou 570311;Haikou Pharmaceutical Factory Co.,Ltd.,Haikou 570311)
出处
《中国医药工业杂志》
EI
CAS
CSCD
2024年第4期578-583,共6页
Chinese Journal of Pharmaceuticals
基金
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)。
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
water activity
Fengliao Changweikang preparation
isothermal curve of water adsorption
microbial control
quality control
