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难溶性肾上腺素原料药细菌内毒素检查方法学研究

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目的 建立难溶性肾上腺素原料药细菌内毒素检查方法.方法 依照2020年版《中国药典》四部通则1143细菌内毒素检查法,用盐酸溶解肾上腺素,再用细菌内毒素检查用水(BET水)稀释,用凝胶法和动态浊度法进行干扰试验和内毒素回收干扰试验.结果 肾上腺素原料药用0.1 mol·L-1盐酸溶解制成质量浓度10mg·mL-1的溶液,再用BET水稀释200倍及以上作为供试品对细菌内毒素检查法无干扰作用.结论 建立的细菌内毒素检查方法可用于肾上腺素原料药的细菌内毒素检查,控制其产品质量.
Bacterial Endotoxins Test Method Study of Active Pharmaceutical Ingredient of Insoluble Adrenaline
OBJECTIVE To establish a method for bacterial endotoxin test of active pharmaceutical ingredient(API)of insolu-ble adrenaline.METHODS According to the bacterial endotoxin test(BET)method in the general rule 1143 in the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ),adrenaline API was dissolved with hydrochloric acid and diluted with BET water.The gel method and kinetic turbidimetric assay were used to carry out interference test and endotoxin recovery interference verification test.RESULTS Adrenaline API was dissolved with 0.1 mol·L-1 hydrochloric acid to 10 mg·mL-1,and then diluted 200 times or more by BET water,which had no interference effects to bacterial endotoxin test.CONCLUSION The BET method established in this study can be used for the bacterial endotoxin test of adrenaline API of adrenaline to control the product quality.

bacterial endotoxininsolubilityAPIadrenaline

张菊、吕晓君、杨雅婷、何开勇、沈佳特

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湖北省药品监督检验研究院,湖北省药品质量检测与控制工程技术研究中心,国家药品监督管理局血液制品质量控制重点实验室,武汉 430064

细菌内毒素 难溶性 原料药 肾上腺素

2024

中国药学杂志
中国药学会

中国药学杂志

CSTPCD北大核心
影响因子:0.957
ISSN:1001-2494
年,卷(期):2024.59(12)
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