定量法（动态比浊法）测定注射用头孢曲松钠中细菌内毒素的研究

注射用头孢曲松钠 (Ｃｅｆｔｒｉａｘｏｎｅｆｏｒｉｎｊｅｃｔｉｏｎ)为长效、广谱的头孢菌素类抗生素 ,它对大多数革兰氏阴性杆菌具有高效的抗菌活性。目前无任何一种抗生素在对奇异变性杆菌的杀菌活性方面 ,可以和头孢曲松钠相比。 2 0 0 0版中国药典收载的方法为凝胶法 ,此法为限量检查法 ,不能准确测定样品中的内毒素含量 ,而定量法则可提供更灵敏而准确的内毒素检测方法。本文采用定量法 (动态比浊法 )来测定注射用头孢曲松钠的细菌内毒素含量。1　材料与仪器细菌内毒素检查用水Ｌｏｔ.Ｎｏ .0 0 1 2 2 70 ,规格5 0ｍｌ/Ａｍｐ湛江安…

Application of the Kinetic Turbidimetric Limulus Test to Determine Ceftriaxone for Injection

AIM The kinetic turbidimetric limulus test was used in the endotoxin assay of Ceftriaxone for injection. METHODS The validation test was fulfilled, when the amount of endotoxin spiked in Ceftriaxone for injection sample (Lot. No. 001103) whose concentration of its diluted solution was 10 mg per ml, 5, 2, 1, 0.5 mg/ml. They were recovered in 24.71%,58.71%,88.70%,97.57%,96.79%; with the amount of endotoxin spiked in Ceftriaxone sample (Lot. No. 001103,001106,010106), their 1 mg/ml dilution was recovered in 77 06%,76.17% and 66.71%. RESULTS The standard endotoxin working curve is 5.00,0.500,0.0500 Eu/ml. The 1 mg/ml solution to Ceftriaxone is effective to eliminate the interference in Limulus test. CONCLUSION The kinetic turbidimetric Limulus test provides a new way to the detection of endotoxin in Ceftriaxone for injection.