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目的对低密度聚乙烯滴眼剂瓶装复方碘口服溶液的含量变化作出评价。方法将复方碘口服溶液装入低密度聚乙烯滴眼剂瓶进行模拟使用操作,按照中国药典方法,在不同时间点进行含量测定并作统计分析。结果复方碘口服溶液装入低密度聚乙烯滴眼剂瓶后,贮存≥72h,其碘(I)含量即与实验开始时刻含量有显著差异,但3,5,7,10d间I含量变化无显著差异;贮存10d,I含量最大下降值为3.45%,KI含量无显著差异;模拟多次使用结果对I和KI含量影响均不显著。结论采用低密度聚乙烯滴眼剂瓶作复方碘口服溶液分装容器,应控制贮存和使用期限≤10d,并保证该制剂配制时I含量不低于标示量的95.0%。
OBJECTIVE To evaluate the changes of the contents of the bottled compound iodine oral solution of low-density polyethylene eye drops. Methods The compound iodine oral solution was loaded into low-density polyethylene eye drop bottles for simulation and operation. According to the method of Chinese Pharmacopoeia, the content of compound iodine was determined and analyzed statistically at different time points. Results After the oral solution of compound iodine was filled into low-density polyethylene eye drop bottles, the content of iodine (I) was significantly different from that at the beginning of the experiment when stored for ≥72h, but the change of I content between days 3,5,7,10d Significantly different; 10d storage, the maximum decrease of I content was 3.45%, KI content was no significant difference; simulated results of repeated use of I and KI content were not significant. Conclusion Low-density polyethylene eye drops bottles for compound iodine oral solution dispensing containers should be controlled storage and use of deadline ≤ 10d, and to ensure that the preparation of formulations I content of not less than 95.0% of the labeled amount.