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目的:考察强光、高温、高湿条件下注射用复方荭草冻干粉针的稳定性,为该制剂的临床用药安全性和有效性提供参考。方法:根据注射用复方荭草冻干粉针质量标准草案的规定对本品进行稳定性影响因素试验,检测药物含量、可见异物、不溶性微粒、吸湿增重、无菌、热原等指标的变化情况。采用HPLC测定异荭草素、荭草素、野黄芩苷含量,流动相乙腈-0.1%磷酸溶液(18∶82),检测波长350 nm。结果:样品均为棕黄色疏松状物,色泽均为黄色标准溶液7号色,可见异物、无菌、热原和吸湿增重均符合规定;10批样品在高温条件下17个色谱峰峰面积和保留时间相对稳定,相似度均>0.99,无血管刺激性,无溶血与凝聚现象;每瓶样品中异荭草素、荭草素、野黄芩苷质量分别约5.80,3.90,16.50 mg;各项指标均达到注射用复方荭草冻干粉针质量标准草案的规定。结论:注射用复方荭草冻干粉针稳定性良好。
OBJECTIVE: To investigate the stability of freeze-dried compound hay fever tablets for injection under bright light, high temperature and high humidity, and to provide reference for the safety and effectiveness of the preparation. Methods: According to the prescription of compound hay-dried freeze-dried powder injection standard for injection, the stability of the product was tested, and the content of the drug, the change of visible foreign matter, insoluble particles, moisture absorption, weight gain, Happening. The contents of isoorientin, turmeric and baicalin were determined by HPLC. The mobile phase was acetonitrile-0.1% phosphoric acid solution (18:82) and the detection wavelength was 350 nm. Results: The samples were brown yellow loose, the color is the yellow standard solution No. 7 color, visible foreign body, sterile, pyrogen and moisture absorption weight are in line with regulations; 10 batches of samples at high temperature under 17 chromatographic peak area And retention time were relatively stable, the similarity were> 0.99, no vascular irritation, no hemolysis and coagulation phenomenon; each bottle sample isoentigmine, triticolin, wild baicalin quality were about 5.80,3.90,16.50 mg; Item indicators have reached the injection of compound hay dry lyophilized powder quality standards draft provisions. Conclusion: The injection of compound hay fever freeze-dried powder has good stability.