西他沙星細粒微生物限度檢查方法的研究
發(fā)布時間:2018-02-22 07:10
本文關鍵詞: 西他沙星細粒 微生物限度檢查 中和劑 薄膜過濾法 沖洗溫度 硫酸錳 出處:《中國抗生素雜志》2015年06期 論文類型:期刊論文
【摘要】:目的建立西他沙星細粒微生物限度檢查法并對其進行驗證。方法按2010年版中國藥典微生物限度檢查法驗證實驗的有關要求,對離心法、薄膜過濾、添加中和劑等去除西他沙星細?咕钚缘膶嶒灧椒ê蜅l件進行驗證,逐步建立西他沙星細粒微生物限度檢查的標準操作方法。結果在對西他沙星細粒適當?shù)奶幚砘A上,采用薄膜過濾法,用45℃含4.0%聚山梨酯80的p H7.0無菌氯化鈉-蛋白胨緩沖液600m L分次沖洗(每次100m L)后,每100m L培養(yǎng)基中加入2%硫酸錳溶液1m L可去除西他沙星對細菌的抑菌作用。結論西他沙星具有較強的抑菌活性,通過適當?shù)臉悠诽幚、薄膜過濾法和添加硫酸錳溶液作為重金屬絡合劑,去除西他沙星抑菌活性,可對解決喹諾酮類抗生素微生物限度檢查問題起到較好的參考作用。
[Abstract]:Objective to establish and verify the microbiological limit test of cetafloxacin. Methods according to the requirements of the microbiological limit test of Chinese Pharmacopoeia on 2010, the centrifugation method and membrane filtration were used. The experimental methods and conditions for removing the antimicrobial activity of cetafloxacin fine particles were verified by adding neutralizer, and the standard operating methods for microbial limit examination of cetafloxacin fine particles were gradually established. Results on the basis of proper treatment of litafloxacin fine particles, The method of membrane filtration was used to wash the water with pH 7.0 aseptic sodium chloride peptone buffer (600ml) containing 4.0% polysorbate 80 at 45 鈩,
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