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复方碘口服溶液在低密度聚乙烯滴眼剂瓶中的含量变化考察 刘正军 1 2 ，徐晓理 (1.海宁市人民医院，浙江 海宁 314400 ；2.海宁市中医院, 浙江 海宁 314400) 摘要：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≥72 h ，其碘(I)含量即与实验开始时刻含量有显著差异，但 3 ，5 ，7 ，10 d 间 I 含 量变化无显著差异；贮存 10 d，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≤ 10 d，并保证该制 剂配制时 I 含量不低于标示量的 95.0% 。 关键词：复方碘口服溶液；低密度聚乙烯滴眼剂瓶；含量测定 中图分类号：R917.4; TQ460.69 文献标志码：B 文章编号：1007-7693(2010)06-0545-03 作者简介：刘正军，男，主管药师 Tel: (0573E-mail: hyzlzjun@ 中国现代应用药学2010 年 6 月第 27 卷第 6 期 Chin JMAP, 2010 June, Vol.27 No.6 ·545 · Research on the Content Changes of Compound Iodine Oral Solution Packaged in LDPE Bottles for Eye Drops 1 2 LIU Zhengjun , XU Xiaoli (1.People’ Hospital of Haining City, Haining 314400, China; 2. Traditional Chinense Medical Hospital of Haining City, Haining 314400, China) ABSTRACT: OBJECTIVE To evaluate the content changes of compound iodine oral solution packaged in LDPE bottles for eye drops. METHODS Put compound iodine oral solution into LDPE bottles for eye drops to simulate use and operation, implement determination and statistical analysis at different time points in accordance with Chinese pharmacopoeia methods. RESULTS After being put into LDPE bottles for eye drops, the storage of physic liquor was greater than or equal to 72 h, and its iodine (I) concent was significantly different from the starting point immediately, however there was no significant deviation among 3 d, 5 d, 7 d and 10 d in I content; the biggest drop-out value of I content storaged 10d was 3.45%, and there was no significant difference in KI content; the frequency of simulation uses did not significantly affect I and KI content. CONCLU