云南化工2025，Vol.52Issue(4)：34-38,5.DOI:10.3969/j.issn.1004-275X.2025.04.08
新止咳合剂稳定性的初步研究
Preliminary Study on stability of Xin Zhike Mixture
摘要
Abstract
[Objective]To investigate the stability and validity of Xin zhike He Ji.[Methods]The stability test of Xin Zhike Mixture was carried out in accordance with the requirements of the stability test method of the preparation in the general rule of the fourth part of the Chinese Phar-macopoeia(2020 edition),The influencing factors test,accelerated test and long-term test were carried out in the preparation,and the charac-ters,identification,loading,relative density,pH value and microbial limit were examined according to the quality standard of the new cough mix-ture.Minitab analysis was used to estimate the period of validity of the preparation.[Results]The color of the preparation became darker under the condition of strong light test(the illuminance was 4500 lx±500 lx).Under the condition of long-term test(temperature 25℃±2℃,rel-ative humidity 60%±10%),the color of the preparation became darker after36 months,and the other indexes were in accordance with the reg-ulations.[Conclusion]Xin Zhi ke Mixture is stable and can be stored stably under the normal temperature,seal up,dark area.The term of validi-ty can be set at 24 months.关键词
新止咳合剂/稳定性试验/医院制剂/有效期/储存Key words
Xin ZhikeMixture/Stability Test/Hospital Preparations/Term of Validity/Stored分类
中医学引用本文复制引用
杨晓峰,李惠英,李聃,代泽友,李瑞芸,秦利芬..新止咳合剂稳定性的初步研究[J].云南化工,2025,52(4):34-38,5.基金项目
昆明市科技计划项目(编号:2024-1-NS-21). （编号:2024-1-NS-21）
