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目的建立天麻素注射液细菌内毒素的快速检查法,并进行标准化研究,以利于产品质控。方法按《中国药典》2010年版(二部)附录收载的细菌内毒素检查方法进行。结果不同生产厂家不同灵敏度的鲎试剂进行干扰试验,提示供试品1∶20稀释液无干扰作用。建立试验方法,选取10批供试品进行检查,并与家兔法对比,二者结果一致。结论该制剂以鲎试剂细菌内毒素检查法作为标准方法进行热原检查是可行的。细菌内毒素限值可定为0.1EU/mg。
Objective To establish a rapid test for bacterial endotoxin in gastrodin injection and conduct standardization research to facilitate product quality control. Methods According to “Chinese Pharmacopoeia” 2010 edition (two) appendix bacterial endotoxin screening method. The results of different manufacturers of different sensitivity 鲎 reagent interference test, suggesting that the test sample 1:20 dilution without interference. The establishment of test methods, select 10 batches of test products for inspection, and compared with the rabbit law, the two results are the same. Conclusion It is feasible to use this reagent to carry out the pyrogen test with the method of bacterial endotoxin test as the standard method. Bacterial endotoxin limits may be set at 0.1 EU / mg.