注射用复方荭草冻干粉针稳定性影响因素考察

Influencing Factors Investigation of Stability of Compound Hongcao Freeze-dried Powder for Injection

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 stability of compound Hongcao freeze-dried powder for injection under strong light, high temperature and humidity conditions, and provide a reference for clinical drug safety and efficacy of this formulation. Method： According to the draft quality standards of compound Hongcao freeze-dried powder for injection, influencing factors test on its stability was carried out, changes of indexes including drug content, visible particles, particulate matter, hygroscopic weight, asepsis, pyrogen etc were determined. HPLC was employed to determine contents of isoorientin, orientin and scutellarin with mobile phase of acetonitrile-0.1% phosphoric acid （18：82） and detection wavelength at 350 nm. Result： Samples were loose-like brown substance, color was the 7th yellow standard solution, visible foreign matter, sterile, pyrogen and moisture absorption weight gain were in line with procisions. Peak areas and retention times of 17 chromatographic peaks in 10 batches of samples at high temperatures was stable with similarity of 〉 0.99, no vascular irritation, no hemolysis and agglomeration. Contents of isoorientin, orientin and scutellarin in samples were 5.80, 3.90, 16.50 rag, respectively. Each indicators all reached provisions of quality standards draft of compound Hongcao freeze-dried powder. Conclusion： Compound Hongcao freeze-dried powder for injection has good stability.