注射用盐酸大观霉素细菌内毒素检测方法的研究

Study of Bacterial Endotoxin Testin Spectinom ycin Hydrochloride for Injection

参照美国药典 Ｘ ＸⅢ版及中国药典１９９５ 年版二部细菌内毒素检查法中干扰试验的基本原理，对注射用盐酸大观霉素 Ｓｐｅｃｔｉｎｏｍ ｙｃｉｎ Ｈｙｄｒｏｃｈｌｏｒｉｄｅ ｆｏｒ Ｉｎｊｅｃｔｉｏｎ （简称 Ｓ Ｐ）进行了细菌内毒素检查法的研究，实验结果表明，浓度为１．８８ｕ／ｍ ｌ的样品溶液对鲎试验不存在干扰因素。

According to the principle of interference test in Bacterial Endotoxin in U S P23rd edition and Chinese Pharm acopoeia 1995, Spectinom ycin Hydrochloride w as stud ied w ith bacterialendotoxin test using L A L m ethod. The results show ed that there w as nointerference factor on 0.125 E U/m l La L in concentration of 1.88u/m l. In conclusion, L A Lm ethod w ould be usefulin pyrogen testof spectinom ycin hydrochloride for injection.