Objective: To establish a method for bacteria endotoxin test (BET) instead of the pyrogen test (PT) through the study of BET for ranitidine hydrochloride injection.
目的：研究盐酸雷尼替丁注射液细菌内毒素检查（BET）的干扰试验，以便建立用BET代替热原检查（PT）。
The main causes of fever reaction due to intravenous transfusion include pyrogen reaction, particulate contamination, bacteria and virus contamination, and side effect of drugs.
热原反应、微粒污染、细菌病毒污染、药物不良反应是引起静脉输液发热反应的主要原因。
Then, the reverse osmosis (RO) equipment was employed to remove over 95% salt and delete 99% pyrogen and bacteria.
使用反渗透装置作为一级除盐设备，使一级后的产品除盐率在95%以上，阻隔热原和细菌在99%以上；
It has the capability of holding back macromolecular organic matter, particle, bacteria and pyrogen in order to realize the separation, contained in the stock solution.
其对物质大分子有机物、微粒、细菌、热原等具有较高的截留能力，从而实现原液中物质的分离、浓缩和纯化。
Conclusion: The bacteria endotoxin test can be used to monitor pyrogen in Sotalol Hydrochloride injection.
结论：可以用细菌内毒素检查法代替家兔法来控制盐酸索他洛尔注射液的质量。
CONCLUSIONS: Bacteria endotoxin test could be used for pyrogen test.
结论：细菌内毒素检查法可代替家兔法。
CONCLUSIONS: Bacteria endotoxin test could be used for pyrogen test.
结论：细菌内毒素检查法可代替家兔法。
应用推荐