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作 者:赵伟[1] 曹宇虹[1] 朱玲[1] 戴峻[1] 李新祝[1] 胡明通[1] 李其德[1]
机构地区:[1]江苏正大天晴药业股份有限公司研究院,江苏南京210042
出 处:《药物生物技术》2012年第4期348-351,共4页Pharmaceutical Biotechnology
摘 要:采用萃取法去除琥珀酰明胶中内毒素。通过调整温度条件,以Triton X-114为萃取剂对琥珀酰明胶中内毒素进行萃取,对萃取前后供试品内毒素含量、琥珀酰明胶含量以及分子质量进行测定,考察工艺过程对上述指标的影响。萃取法可显著降低琥珀酰明胶中内毒素含量,通过2次萃取后,琥珀酰明胶中内毒素含量可由2500~5 000 EU/mL降至0.25~2.5 EU/mL,且经过萃取前后的琥珀酰明胶含量及分子质量无明显变化。萃取法可有效去除琥珀酰明胶中内毒素含量,并可能开发为一种工业化去除琥珀酰明胶注射液中内毒素的方法。To develop an extraction method to remove endotoxin from succinylated gelatin. Using Triton X-114 as extractor, endotoxin in succinylated gelatin was extracted by controlling the temperature. Quantity of endotoxin and succinylated gelatin, and the molecular weight of the gelatin were measured before and after extraction to evaluate the efficiency of the extraction. Result : amount of endotoxin was lowered from 2500 - 5000 EU/mL to 0.25 - 2.5EU/mL without influence on the quantity and molecular weight of the sucei-nylated gelatin. Extraction by Triton X-114 was an effective method in reducing the amount of endotoxin present in the succinylated gelatin. It can be developed to be an endotoxin removal process for manufacture.
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