消毒护肤喷雾剂的研制

Preparation of the Skin-protective and Disinfectant Spray

关键词:  消毒护肤喷雾剂  处方工艺  质量控制  杀菌效果  稳定性  安全性  腐蚀性

Key words:  skin-protective and disinfectant spray  prescription process  quality control  bactericidal effect  stability  security  corrosive

摘要:

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。

Abstract:

OBJECTIVE To prepare a spray solution for skin-protective and disinfectant spray. METHODS To develope the prescription composition and preparation process, and to conduct a quality study of character, identification, inspection, and content determination, et al. An acceleration method was used to investigate its stability, vector spray quantitative germicidal test to observe its bactericidal effect, acute oral toxicity test, stimulation test, the micronucleus test, subacute toxiciteit and corrosiveness test to evaluate the safety. RESULTS The quality test results of the sample were in line with provisions. The killing logarithm value of samples after 0.5 min reaction to Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Candida albicans were >3.00. Its validity was determined to be 2 years by accelerated stability test. It was non-toxic of acute toxicity test orally, and it had no irritation to several intact skin of rabbits, a broken skin and eyes. The results of micronucleus test were negative. The subacute toxicity test of the sample showed that it was not harmful to male and female SD rats until the maximum dose was 1 000 mg·kg-1 by oral. The sample had no corrosion to stainless steel and carbon steel, while slight corrosion on aluminum and copper. CONCLUSION The formulation is reasonable in formulation, feasible in preparation technique, accurate in quality control, good in stablility and effective for multiplication of bacteria and fungus, and it is non-toxic and non-irritating.