曲安奈德原料药微生物总数检查法验证

Validation Tests for microbiological examination of Triamcinolone acetonide API

目的建立曲安奈德的微生物限度检查法并进行验证。方法按平皿法对大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌、白色念珠菌、黑曲霉5种试验菌分别进行3次独立的平行试验,并分别计算各试验菌每次试验的回收率,以验证细菌、霉菌及酵母菌计数方法的可行性。结果营养琼脂培养基中添加0.001%TTC菌体显色剂能有效地对细菌着色,保证细菌计数的准确性;用p H7.0无菌氯化钠-蛋白胨缓冲液100 m L加10 g聚山梨酯80的方法制备样品液,5种试验菌均取得了很好的回收率(>70%)。结论所建立的曲安奈德原料药的细菌、霉菌及酵母菌的计数方法是可行的。

Objective To establish a microbiological limit test for Triamcinolone acetonide API and verify it. Methods Three independent parallel tests were performed on five test strains of Escherichia. coli, Staphylococcus aureus, Bacillus subtilis, Candida albicans, and Aspergillus niger according to the plate method. The recovery of each test strain was calculated, to verify the feasibility of bacteria, molds and yeasts count methods. Results The addition of 0.001% TTC bacterial chromogenic reagent to the nutrient agar medium could effectively stain the bacteria and ensure the accuracy of the bacterial count. The sterile p H 7.0 sodium chloride-peptone buffer 100 m L plus 10 g of polysorbate 80 was used to prepare the sample solution, and all the five test strains achieved good recovery（〉70%）. Conclusion The methods for counting the bacteria, molds and yeasts of Triamcinolone acetonide API was feasible.