A methodological study on sterile examination of epinephrine hydrochloride eye drops
10.19778/j.chp.2025.02.015
- VernacularTitle:盐酸依匹斯汀滴眼液无菌检查方法学研究
- Author:
Bin WU
1
;
Xiumei LUO
1
;
Xuejie SONG
1
;
Jun CHEN
1
;
Yaodi CHEN
1
Author Information
1. 润尔眼科药物(广州)有限公司,广州 510530
- Publication Type:Journal Article
- Keywords:
epinastine hydrochloride eye drops;
sterility test;
suitability test
- From:
Drug Standards of China
2025;26(2):221-226
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a sterility test method for epinastine hydrochloride eye drops.Methods:Accord-ing to the Pharmacopoeia ofthe People's Republic ofChina 2020,the sterility test method of this product was estab-lished by membrane filtration method,polysorbate 80 was selected as the neutralizing agent,and the washing amount was screened to establish the sterility test method of this variety.Results:Taking 0.1%sterile peptone aqueous solu-tion containing 1%polysorbate 80 as the flushing solution,the flushing volume is 100 mL each time,and the total flushing volume of each membrane is 500 mL,which can eliminate the antibacterial effect.Conclusion:This method can effectively remove the bacteriostasis of epinastine hydrochloride eye drops,and is suitable for the sterility inspec-tion of this variety.
