呋喃西林溶液的制备及稳定性考察

目的制备呋喃西林溶液,对该制剂进行稳定性考察。方法采用紫外分光光度法测定呋喃西林的含量,考察温度、光线、灭菌条件及贮存时间对呋喃西林溶液质量的影响。结果呋喃西林溶液经40℃加热10 d,溶液黄色略加深,相对含量为99.06%;60℃加热10 d,溶液黄色加深,相对含量为91.83%;经强光照射,溶液颜色逐渐变深至橙红色,5 d相对含量为80.84%。采用流通蒸汽灭菌,溶液的颜色、澄明度无明显变化,相对含量下降<3%,热压灭菌后其颜色加深,相对含量下降在10%以内。室温留样6个月,外观、含量均符合规定。结论温度、光线、灭菌条件及贮存时间对呋喃西林溶液的质量均有影响。呋喃西林溶液不宜长期受高热;应避免阳光直射、强日光灯照射;宜选用流通蒸汽灭菌法;若采用热压灭菌应严格操作。呋喃西林溶液有效期确定为6个月。

Study on preparation and stability of nitrofurazone solution

Objective To prepare nitrofurazone solution and observe the stability of the solution.Methods The relative content of nitrofurazone was determined by UV spectrophotometry,the influence of temperature,light,sterilization and storage time on the quality of nitrofurazone solution was investigated.Results After 10 d of heating,the color of nitrofurazone solution darkened slightly and the relative content was 99.06%(40 ℃);the color of the solution darkened and the relative content was 91.83%(60 ℃).During strong lighting period,the color of the solution gradually changed to orange-red and the relative content was 80.84% after 5 d.After the circulating steam sterilization,the solution had no significant difference in color,clarity,the relative content decreased(<3%).After hot sterilization,the color of nitrofurazone solution darkened,the relative content decreased(<10%).After 6 months storage at room temperature,the appearance and content of the samples were in conformity with the requirements.Conclusion The quality of nitrofurazone solution can be affected by the temperature,light,sterilization and storage time.Nitrofurazone solution is not suitable to long-term excessive heat.It should be avoided that the direct sunlight and strong fluorescent light.Circulating steam sterilization is recommended.The operation should be strictly controlled when hot sterilization.The expiry term was 6 months.