壬基酚聚氧乙烯醚络合碘消毒液的研制及其效果和安全性评价

Development of Polyoxyethylene Nonylphenol Ether Complex Iodine Disinfectant and the Evaluation of Its Efficacy and Safety

目的:研制开发一种适用于皮肤及创面外用的聚醇醚碘消毒液,并评价其效果及安全性。方法:拟定处方与工艺,制备消毒液并考察样品质量,采用加速法测定样品置于37℃温箱中0、90 d的有效碘含量,考察其稳定性;悬液定量杀菌试验计算样品作用0.5、1.5、3.0 min对金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌、白色念珠菌的杀灭对数值,考察其杀菌效果;计算样品作用1.0min对人皮肤上自然菌的杀灭对数值,考察其皮肤消毒效果;急性经口毒性实验考察样品对小鼠的毒性;考察样品对家兔的皮肤刺激性;微核实验考察样品对小鼠的消毒效果。结果:样品的各项质量检查均符合规定;0 d和90 d有效碘的平均含量分别为5 276mg/L和5 140 mg/L,其有效碘下降率为2.58%,暂定该产品有效期为2年;含有效碘2 110 mg/L的消毒液作用0.5 min对金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌的杀灭对数值各次均>5.00,对白色念珠菌的杀灭对数值各次均>4.00;对人皮肤上自然菌的平均最低杀灭对数值为1.21(>1.00);对小鼠急性经口无毒,对家兔无刺激性;微核实验结果呈阴性。结论:该制剂处方合理,制备工艺简单可行,质量可控,杀菌效果好,无毒,无刺激性,安全性较好。

OBJECTIVE： To develop Polyethylene glycol ethers iodine disinfectant for external use of skin and wound, and to evaluate the efficacy and safety of it. METHODS： The formulation and technology were formulated, and the disinfectant was prepared and investigated in quality. The contents of iodine in samples at 37℃ for 0 and 90 days were determined by accelerated methods, and the stability of the tablet was investigated. Quantitative germicidal test was adopted to calculate the killing logarithm of samples after treated for 0.5, 1.5 and 3.0 rain against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Candida albicans and observe its bactericidal effect. The killing logarithm of samples after treated for 1.0 rain against natural bacteria on the skin of person was calculated to investigate the disinfection efficacy. Acute oral toxicity test was adopted to investigate the toxicity of sample to mice. The skin irritation of samples to rabbits was also investigated. Micronucleus test was used to investigate disinfection effects of sample against mice. RESULTS ： The quality tests of samples were all in line with the requirements. Average content of iodine in samples was 5 276 mg/L after treated for 0 day and 5 140 mg/L for 90 day, decreasing by 2.58%, Its validity was temporarily set at 2 years. The killing logarithm values of disinfectant containing available iodine 2 110 mg/L to Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa were greater than 5.00 after 0.5 min of treatment, and to Candida albicans was greater than 4.00. The minimal killing logarithm value of samples to natural bacteria on the skin was 1.21 （〉 1.00）. It had no acute oral toxicity to mice and no irritation to rabbits. The results of micronucleus test were negative. CONCLUSIONS ： The formulation is reasonable, feasible in preparation technology, controllable in quality and good in bactericidal effect; it is non-toxic or no irritant with sound safety.