李桂明 黄中利 李颖 林树乾 宋敏训 赵增成 傅剑 杨世发 逯月 杨鹏 刘月月

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，而且在相對湿度（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。

关键词  西地碘粉;温度;湿度;光照

中图分类号  S  859.79文献标识码  A

文章编号  0517-6611（2020）04-0081-03

doi：10.3969/j.issn.0517-6611.2020.04.024

开放科学（资源服务）标识码（OSID）：

Study on the Stability of  Cydiodine Powder under Different Conditions

LI Gui-ming1，2，HUANG Zhong-li1，LI Ying2 et al  （1.Poultry Research Institute，Shandong Academy of Agricultural Sciences，Jinan，Sandong 250023;2.Shandong Haotai Technology Pharmaceutical Co.， Ltd .，Jinan，Shandong 250023）

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 5th and 10th 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.

Key words  Xidi iodine powder;Temperature;Humidity;Light

西地碘粉是山东省家禽研究所等单位研发的具有包被型超分子结构的新型消毒剂产品，具有消毒效果优异、含量稳定、环境友好等优点。为确定该产品的最佳贮存条件，依照《兽用化学药品稳定性研究技术指导原则》[1]的要求，对该产品进行稳定性试验，考察其在不同温湿度和光照条件下的稳定性，为产品的生产运输等条件的确定提供科学依据，同时通过试验确定西地碘粉的有效期和贮存条件。

1  材料与方法

1.1  材料

1.1.1  供试品。西地碘粉，由山东昊泰科技药业有限公司生产，批号分别为CD20150701、CD20150702、CD20150703。……