摘要
目的:建立浊度法测定硫酸奈替米星及其制剂的含量方法,并进行方法学验证。方法:二剂量法:将金黄色葡萄球菌(CMCC(B)26003)制备的菌悬液,接种于抗生素检定ⅡI号培养基中,取9mL培养液和1mL不同浓度的硫酸奈替米星溶液于比色管中,37℃培养4h左右,530nm在线测定。结果:浊度与奈替米星浓度的log值在0.16～2.5μ·mL-1的范围内呈良好的线性关系(r=0.9973);测得注射用硫酸奈替米星的平均回收率为101.1%(RSD=1.47%);硫酸奈替米星注射液的平均回收率为101.2%(RSD=2.14%)。结论:方法准确,灵敏、省时。
Objective：To establish turbidimetric method for determination of Netilmicin Sulfate and its preparations. Method：2-dose assay ： Inoculate medium Ⅲ with a suspension of Staphylococcus aureus （ CMCC （B） 26 003 ）, Distribute 9 mL of the inoculated medium and 1 mL of the Netilmicin Sulfate series of doses＇ solution into test- tubes,determine on-line at 530 nm after an incubation period of about 4 h at 37℃. Result： Linearity of the dose-response relationship about the turbidity and the antibiotic doses＇ log was between 0. 16 -2. 5μ· mL^- 1 （r = 0. 997 3 ） ;The average recoveries of Netilmicin Sulfate for Injection and Netilmicin Sulfate Injection were 101. 10% （RSD = 1.47% ） and 101.2% （RSD = 2. 14% ） respectively. Conclusion：The method is accurate,sensitive and quick.
出处
《中国药品标准》
CAS
2009年第1期27-32,共6页
Drug Standards of China
关键词
二剂量浊度法
硫酸奈替米星
金黄色葡萄球菌
turbidimetric（ 2-dose assay）
Netilmicin Sulfate
Staphylococcus aureus
