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我们认为右旋糖酐注射液是有抗原性的,但发生率很低。因为右旋糖酐为蔗糖经微生物(Leuconostoc mesenteroides菌属)发酵后生成的聚合物。虽经处理精制,但仍可能混有细菌尸体及其代谢产物。故1974年版上海市药品标准和天津市药品标准都对右旋糖酐(原料)进行“氮”的限度检查,规定含“氮”量不得超过0.02%,目的就是控制右旋糖酐(原料)中的抗原性物质——异性蛋白的含量。而对右旋糖酐注射液(含糖或含盐),则规定要作热原、异性蛋白等的限度试验,目的也是控制注射液的质量,使临床用药安全有效,不致发生热原反应,过敏反应等。供临床应用的右旋糖酐注射液,经过药厂严格把关与检验,再经过药检部门质量监督,一般来说,应该保证做到无热原反应、无抗原反应。(注:右旋糖酐注射液中,不是绝对不允许热原质和异性蛋白
We think dextran injection is antigenic, but the incidence is very low. Because dextran is a polymer produced after fermentation of sucrose by microorganisms (Leuconostoc mesenteroides genus). Although processed refined, but may still be mixed with bacterial cadaver and its metabolites. Therefore, the 1974 edition of the Shanghai Drug Standards and Tianjin Pharmaceutical Standards have carried out the “nitrogen” limit test on dextran (raw material) with the stipulation that the amount of “nitrogen” should not exceed 0.02% in order to control the content of dextran Antigenic material - the content of the opposite sex protein. The right dextran injection (containing sugar or salt), the provisions of pyrogen, heterosexual protein and other limits of the test, the purpose is to control the quality of injection, the clinical medication is safe and effective, does not cause pyrogen reaction, allergic reactions . Dextran injection for clinical application, after strict inspection and inspection by pharmaceutical companies, and then through the quality control of drug inspection departments, in general, should ensure that no pyrogen reaction, no antigen reaction. (Note: Dextran injection is not absolutely not allowed pyrogen and heterosexual protein