Establishment of Microbial Counting Method for Pre-sterilization Products of Tinidazole and Sodium Chlo-ride Injection

VernacularTitle:替硝唑氯化钠注射液灭菌前产品微生物计数法的建立
Author: Ying TIAN ¹ ; Lin WANG ; Jiaxiu HUANG
Author Information

1. 扬子江药业集团有限公司江苏泰州225321
Keywords: Tinidazole and sodium chloride injection; Microbial counting method; Method validation
From: China Pharmacist 2018;21(1):168-170
CountryChina
Language:Chinese
Abstract: Objective:To establish a microbial counting method for pre-sterilization products of tinidazole and sodium chloride in-jection.Methods:Pre-sterilization product was taken out 100 ml, and according to the established verification test method , the test bacteria were added to the samples and the recovery rate of the tested bacteria was measured .Results: The recoveries of all the test bacteria ( Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis, Candida albicans and Aspergillus brasiliensis) in the vali-dation test were within the range of 50％-200％, and the results met the requirements of Chinese Pharmacopoeia.Conclusion: The method is effective and feasible , and can be used for the microbiological count of pre-sterilization products .