【摘要】：目的:建立蔗糖鐵注射液過(guò)濾除菌前配制液的微生物限度檢查方法。方法:按照2015版《中國(guó)藥典》(四部)"通則1005"和"通則1006"微生物限度檢查方法,分別采用平皿法和薄膜過(guò)濾法檢查需氧菌(金黃色葡萄球菌、銅綠假單胞菌、枯草芽孢桿菌、白色念珠菌、黑曲霉)數(shù)、霉菌及酵母菌(白色念珠菌、黑曲霉)數(shù),通過(guò)比較試驗(yàn)菌回收率來(lái)確定適宜的方法,并進(jìn)行方法驗(yàn)證。結(jié)果:以平皿法進(jìn)行試驗(yàn),銅綠假單胞菌和枯草芽孢桿菌的回收率分別為2%、5%,用p H 7.0氯化鈉-蛋白胨緩沖液稀釋樣品原液10倍后,試驗(yàn)菌回收率范圍為88%～96%,但培養(yǎng)基顏色較深。以薄膜過(guò)濾法不加沖洗液進(jìn)行試驗(yàn),試驗(yàn)菌回收率范圍為88%～95%;加入沖洗液后,試驗(yàn)菌回收率范圍為91%～103%。經(jīng)驗(yàn)證,加入沖洗液的薄膜過(guò)濾法回收率為50%～200%,符合規(guī)定。結(jié)論:本試驗(yàn)建立的薄膜過(guò)濾法較平皿法試驗(yàn)菌回收率高且加入沖洗液后,試驗(yàn)菌回收率更高,濾膜表面均無(wú)顏色較深的物質(zhì)殘留影響計(jì)數(shù),適用于蔗糖鐵注射液過(guò)濾除菌前配制液的微生物限度檢查。
[Abstract]:Objective: to establish a microbiological limit test method for the preparation of iron sucrose injection before filtration and sterilization. Methods: according to the microbiological limit test methods of 2015 edition of Chinese Pharmacopoeia (four parts), "General Rule 1005" and "General Rule 1006", aerobic bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus subtilis) were examined by plate method and membrane filtration method, respectively. The number of Candida albicans and Aspergillus Niger, the number of mold and yeast (Candida albicans, Aspergillus Niger) were determined by comparing the recovery rate of the tested bacteria, and the method was verified. Results: the recoveries of Pseudomonas aeruginosa and Bacillus subtilis were 2% and 5%, respectively. After diluting the sample solution with pH 7.0 sodium chloride-peptone buffer solution for 10 times, the recovery rate of Pseudomonas aeruginosa and Bacillus subtilis was 10 times. The recovery rate of the tested bacteria was 88% and 96%, but the color of the culture medium was dark. The results showed that the recovery rate of the bacteria was 88% 95% by membrane filtration without flushing liquid, and 911% 103% after the addition of the washing liquid. It was verified that the recovery rate of the membrane filtration method was 50 ~ 200, which was in accordance with the regulations. Conclusion: the membrane filtration method established in this study has a higher recovery rate than the flat-dish method, and the recovery rate of the tested bacteria is higher than that of the flushing solution, and the surface of the filter membrane does not have the effect of dark color substance residue count. It is suitable for microbial limit examination of the preparation liquid before filtration and sterilization of iron sucrose injection.
【作者單位】： 廣州中醫(yī)藥大學(xué)中藥學(xué)院;解放軍第458醫(yī)院;廣東天普生化醫(yī)藥股份有限公司;
【分類號(hào)】：R927.1

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