【摘要】 [目的]研究西地碘粉在不同温度、湿度和光照条件下的稳定性,确定药品的最佳贮存条件及有效期。[方法]对山东昊泰科技药业有限公司生产的3批西地碘粉分别在高温(60℃)、高湿[相对湿度(90±5)%]和强光照[照度(4 500±500)lx]条件下放置10 d,于第5天和第10天取样并检测其稳定性。[结果]高温试验结果表明,60℃条件下放置10 d后所有指标均符合质量标准规定,没有发现供试品质量有较大改变;高湿条件下供试品有吸潮现象,而且在相对湿度(90±5)%条件下放置10 d后吸湿增重超过5%,降低了有效成分的含量。光加速试验结果表明,供试品在照度(4 500±500)lx条件下放置10 d后炽灼残渣与有效碘含量均有所降低,影响供试品的消毒效果。[结论]该产品可以在常温条件下密封避光保存。更多还原

【Abstract】 [Objective] To study the stability of cydiodine powder under the conditions of different temperature, humidity and light, and determine the optimal storage conditions and expiration date of the medicine.[Method] Three batches of cydiodine powder produced by Shandong Haotai Technology Pharmaceutical Co., Ltd. were placed for 10 days under the conditions of 60 ℃,relative humidity（90±5）%, and illumination of（4 500±500）lx.The samples were collected on the 5^th and 10^th days to detect the stability.[Result]The results of high temperature test showed that all indicators met the quality standards after cydiodine powder was stored at 60 ° C for 10 days, no significant change of product quality was found.The moisture-absorbing phenomenon of cydiodine powder was found under high humidity conditions, and the moisture-absorbing weight gain exceeded 5% after cydiodine powder was stored under the relative humidity conditions of（90±5）% for 10 days, which reduced the content of active ingredients.The results of the light acceleration test showed that the contents of ignition residues and available iodine decreased after cydiodine powder was stored under the illumination conditions of（4 500±500）lx for 10 days, which influenced the disinfection effect of the product.[Conclusion]This product can be stored in a sealed and protected from light at room temperature.更多还原