目的 建立曲安奈德的微生物限度檢查法并進(jìn)行驗(yàn)證。方法 按平皿法對大腸埃希菌、金黃色葡萄球菌、枯草芽孢桿菌、白色念珠菌、黑曲霉5種試驗(yàn)菌分別進(jìn)行3次獨(dú)立的平行試驗(yàn)，并分別計(jì)算各試驗(yàn)菌每次試驗(yàn)的回收率，以驗(yàn)證細(xì)菌、霉菌及酵母菌計(jì)數(shù)方法的可行性。結(jié)果 營養(yǎng)瓊脂培養(yǎng)基中添加0.001% TTC菌體顯色劑能有效地對細(xì)菌著色，保證細(xì)菌計(jì)數(shù)的準(zhǔn)確性；用pH7.0無菌氯化鈉-蛋白胨緩沖液100 mL加10 g聚山梨酯80的方法制備樣品液，5種試驗(yàn)菌均取得了很好的回收率（>70%）。結(jié)論 所建立的曲安奈德原料藥的細(xì)菌、霉菌及酵母菌的計(jì)數(shù)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 pH 7.0 sodium chloride-peptone buffer 100 mL 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.