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

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.