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目的研制开发一种消毒护肤喷雾型溶液剂。方法拟定处方组成与制备工艺,进行性状、鉴别、检查、含量测定等质量研究,采用加速法考察其稳定性,观察载体喷雾杀菌试验的杀菌效果,评价急性经口毒性试验、刺激试验、微核试验以及亚急性毒性试验的安全性,并进行样品腐蚀性试验。结果样品的各项质量检测结果均符合规定。样品原液作用0.5 min对金黄色葡萄球菌、大肠杆菌、铜绿假单胞菌、白色念珠菌的杀灭对数值各次均>3.00。经稳定性加速试验确定其有效期为2年。对昆明种小鼠急性经口无毒,对家兔多次完整皮肤、1次破损皮肤及急性眼刺激试验均无刺激性。微核试验结果呈阴性。样品亚急性经口毒性试验对♀♂SD大鼠未观察到有害作用的最大剂量为1 000 mg·kg-1,对不锈钢、碳钢基本无腐蚀,对铝、铜有轻度腐蚀。结论该制剂处方合理,制备工艺简便可行,质量可控,对细菌繁殖体和真菌杀菌效果好,无毒、无刺激性、性能稳定。
Objective To develop a disinfectant skin spray solution. Methods The composition and preparation process of prescription were developed. The quality of the preparation was evaluated. The stability was tested by accelerated method. The bactericidal effect of carrier spray bactericidal test was observed. The acute oral toxicity test, stimulation test, micronucleus test Tests and sub-acute toxicity safety tests, and sample corrosion test. Results The quality of the sample test results are in line with the provisions. The killing logarithm of Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Candida albicans were all> 3.00 after 0.5 min of sample stock solution action. Stability accelerated test to determine the validity of 2 years. Kunming mice acute oral non-toxic, repeated multiple intact skin, a damaged skin and acute eye irritation test irritation. Micronucleus test results were negative. The subacute oral toxicity test of the sample did not observe the harmful effects of ♂ ♂ SD rats maximum dose of 1 000 mg · kg-1, almost no corrosion of stainless steel, carbon steel, mild corrosion of aluminum, copper. Conclusion The formulation is reasonable, the preparation process is simple and feasible, the quality is controllable, the bactericidal effect on bacterial propagules and fungi is good, non-toxic, non-irritating and stable.