莪术油葡萄糖注射液灭菌前后指纹图谱相关性研究

目的:研究灭菌前后的莪术油葡萄糖注射液指纹图谱的相关性,为建立莪术油葡萄糖注射液指纹图谱的检测标准提供依据。方法:采用高效液相色谱法分离测定,色谱柱为Zorbax EclipseXDB-C1(8250mm×4.6mmID,5μm),流动相为乙腈-0.1%磷酸水溶液(梯度洗脱),流速为1mL·min-1,柱温为30℃,检测波长为210nm。通过共有模式方法比较指纹图谱的相关性;用成对比较t检验法比较单一色谱峰强度的变化。结果:莪术油葡萄糖注射液灭菌后较灭菌前多数色谱峰峰面积明显变小,并增加了一些小峰。结论:莪术油葡萄糖注射液灭菌前后的指纹图谱间均有较好的相关性。

Study on Fingerprints Correlation of Zedoary Turmeric Oil and Glucose Injection before and after Sterilization

OBJECTIVE：To study fingerprints correlation of Zedoary turmeric oil and glucose injection before and after steriliza-tion,and to provide reference for the establishment of detecting standard of fingerprints of Zedoary turmeric oil and glucose injection.METHODS：HPLC method was used.The separation was performed on Zorbax Eclipse XDB-C18（250 mm×4.6 mm ID,5 μm） column with mobile phase consisted of acetonitrile-0.1% phosphoric acid water（gradient elution） at flow rate of 1 mL·min-1.The column temperature was set at 30 ℃ and detection wavelength was 210 nm.The fingerprints correlation was compared by the method of common pattern.The change of the unity chromatographic peak was analyzed by paired t-test.RESULTS：After sterilization,the chromatographic peak areas of the injection were obviously diminished and some tiny chromatographic peaks appeared.CONCLUSION：There is a good relationship between the fingerprints of Zedoary turmeric oil and glucose injection before and after sterilization.