2种苄星青霉素产品的晶体特性和抽针试验分析

Analysis of Crystal Properties and Pumping Needle Experiment of 2 Kinds of Benzathine Benzylpenicillin

目的:探寻苄星青霉素肌肉注射时堵塞针头的原因。方法:以苄星青霉素样品A和B为研究对象,采用偏光显微镜法、红外分光光度法、拉曼光谱法、X射线粉末衍射法、差示扫描量热分析与粒度和粒度分布测定等方法分析晶体特性,结合抽针试验进行综合评价。结果:产品A和B经偏光显微镜观察分别呈板状和针状结晶,红外分光光度法、拉曼光谱法、X射线粉末衍射法、差示扫描量热分析与粒度和粒度分布检测结果未见明显差异,抽针试验显示产品B较产品A更易堵塞针头。结论:苄星青霉素的针状结晶和粒径分布不均是其堵塞针头的重要原因。

OBJECTIVE：To find the causes of blocking needle during intramuscular injection with benzathine benzylpenicillin.METHODS：With products A and B as the research object,crystal properties analysis was developed by microscope,IR,Raman,X-ray diffraction,DSC and particle size distribution methods.Pumping needle experiment was carried out for comprehensive evaluation.RESULTS：Product A and B were needle-like and plate-like crystals respectively observed through microscope.The results of IR,Raman,X-ray diffraction,DSC and particle size distribution had no significant difference.Product B blocked needle more easily than product A.CONCLUSIONS：Needle-like crystals and unever particle size distribution of benzathine benzylpenicillin are the important causes of blocking needle.