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

Research on the Content Changes of Compound Iodine Oral Solution Packaged in LDPE Bottles for Eye Drops

关键词:  复方碘口服溶液  低密度聚乙烯滴眼剂瓶  含量测定

Key words:  compound iodine oral solution  LDPE bottles for eye drops  content determination

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%。

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. CONCLUSION　The storage and use duration should be controlled ≤10 d if using LDPE bottles for eye drops as compound iodine oral solution packaging containers, and it should be ensured that I content is not less than 95.0% of the labelled amount when preparing.