pH值对氟罗沙星注射液可见异物的影响

pH value to fluoride LuoSha star injection of foreign influence is visible

目的:研究pH值对氟罗沙星注射液可见异物的影响。方法:用药用乳酸调节氟罗沙星注射液的pH值,观察氟罗沙星在水中的溶解情况,以及低温(2～8℃)的稳定性。结果:注射液pH值在4.0～4.4,室温下可见异物符合规定,低温(2～8℃)24h后依然稳定,且121℃、15分钟灭菌,按《中国药典》2010年版二部氟罗沙星注射液质量标准检测均符合质量标准规定。结论:pH值对氟罗沙星注射液可见异物有明显影响。

Objective： to study the pH value of fluoride LuoSha stars visible the influence of the injection foreign body. Methods： in the medicinal lactic acid LuoSha fluorine star injection adjust pH value, observe LuoSha star in fluorine dissolved in water, and low temperature （2-8℃）stability. Results： in injection pH 4.0-4.4, room temperature visible foreign matter in conformity with the provisions, low temperature（2-8℃）24 h after still stable, and 121℃, 15 minutes sterilization, according to the China phamlacopeia 2010 edition of the LuoSha star quality standard of fluoride injection detection are to meet the quality standard. Conclusion： the pH value of fluoride LuoSha star injection visible foreign matter have obvious influence.