多波长串联指纹图谱结合紫外全指纹溶出度测定评价复方两面针含片质量

Evaluation of compound Liangmianzhen tablets quality by multi-wavelength series fingerprint combined with UV overall components dissolution method

目的:建立复方两面针含片五波长高效液相色谱(HPLC)指纹图谱及其串联谱,结合紫外全指纹溶出度测定来评价6批复方两面针含片质量。方法:用HPLC采集6批复方两面针含片在210、220、240、260和326 nm的指纹图谱并建立串联谱,采用比率指纹定量法(quantified ratio fingerprint method,QRFM)对其进行评价。紫外全溶出度测定法测定样品溶出度,计算6批复方两面针含片的相似因子(F2)。结果:QRFM评价6批样品的宏定性相似度(Sm)≥0.99,宏定量相似度(Pm)≥90%,样品质量等级分别为2、1、1、2、2、1级。以紫外全指纹溶出度测定6批样品,结果在30 min内溶出度≥80%,F2均>50,表明6批样品溶出行为一致。结论:串联谱及组分全溶出度测定可从质量和疗效2个方面来评价复方两面针含片质量。

Objective:To establish the five wavelength high performance liquid chromatographic fingerprints and series fingerprint of compound Liangmianzhen tablets,combining UV overall components dissolution to evaluate the quality consistency of 6 batches of compound Liangmianzhen tablets.Methods:The fingerprints at 210,220,240,260 and 326 nm for 6 batches of sample were collected by HPLC and the series fingerprint were established.Quantified ratio fingerprint method (QRFM) was used to assess the five wavelengths series fingerprint.And the dissolution of 6 batches of sample was determined by UV overall components dissolution determined (DUV) and the similarity factor(F2) was calculated for 6 batches of sample.Results:Macro-qualitative similarities(Sm) of 6 batches of sample were above 0.99,the macro-quantitative similarities(Pm) were above 90%;the quality grades of the 6 batches samples were 2,1,1,2,2 and 1.The results of DUV showed that the dissolution was greater than 80%within 30 minutes,F2>50,and the dissolution behavior of 6 batches of sample was consistent.Conclusion:The five wavelength series chromatogram combined with the DUV can effectively evaluate the quality consistency of TCM compound preparation form two aspects of quality and curative effect.