愈康降糖胶囊五波长高效液相色谱数字化定量指纹图谱研究  

Digitized and quantified fingerprints of Yukang Jiangtang capsules by high performance liquid chromatography

作　　者：张旭[1] 孙国祥[1] 武晓[1] 赵龙山[1] 熊志立[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中南药学》2017年第7期873-879,共7页Central South Pharmacy

摘　　要：目的建立愈康降糖胶囊(YKJTC)五波长HPLC指纹图谱,同时测定尿囊素、马钱苷、葛根素、丹酚酸B、小檗碱、人参皂苷Rb_1含量。方法采用RP-HPLC法建立15批愈康降糖胶囊203、236、250、280和320 nm五波长HPLC指纹图谱,以葛根素为参照物峰来确立共有指纹峰,以9级系统指纹定量法全面评价其质量,将五波长指纹图谱按均值法生成对照指纹图谱评价样品质量,再按均值法整合五波长下的宏定性相似度(Sm)、9级宏定量相似度(P9)和指纹均化性变动系数(α),重新评价15批YKJTC的质量。采用均值法、色谱指纹图谱指数权重和信息熵权重对五波长评价结果进行整合,以及HPLC法同时测定7组分含量。结果 236 nm波长下确定了46个共有指纹峰,建立了YKJTC数字化指纹图谱。用9级系统指纹定量法鉴定15批YKJTC中1批为质量极好(1级),1批为很好(2级),5批为好(3级),1批为良好(4级),3批为中(5级),4批为一般(6级)。采用均值法、色谱指纹图谱权重和信息熵权重对五波长评价结果进行整合。除了S03、S04、S05和S06等级稍差,整合前后样品质量等级均在5级以内,无异常样品检出。结论 15批YKJTC质量均一性良好,采用五波长指纹图谱法可准确评价中药复方质量均一性。Objective To establish 5 wavelength HPLC fingerprint chromatography for concentrated Yukang Jiangtang capsules （YKJTC） and simultaneously determine the contents of allantoin, puerarin, salvianolic acid B, berberine, ginsenoside Rb1 and glibenclamide. Methods Chromatographic fingerprints of the 15 batches of YKJTCs were determined by reversed-phase HPLC under 203, 236, 250, 280 and 320 nm simultaneously, in which common peaks were confirmed while the puerarin peak was chosen as the referential peak. All date were assessed by 9th level systematically quantified fingerprint method. We averaged the 15 fingerprint signals to set up the reference fingerprint and calculated Sin, P9 and a also under each one of the 5 wavelengths to evaluate the 15 batches of YKJTCs. The 5 parameters were all taken the root of the mean value of square variable to reassess the quality. The results at 5 wavelengths were integrated by the average method, I weight method and S weight method and the content of 7 components determined by HPLC. Results Digitized high performance liquid chromatography fingerprints were established with 46 co-possessing peaks by HPLC. The quality of 15 batches of YKJTCs was assessed by 9th level systematically quantified fingerprint method. The quality was graded as 1 to 6, with the best quality and 6 the acceptable. Among the 15 batches, grade 1 we found 1 batch, and 1, 5, 1, 3, and 4 batches belonged to grade 2, 3, 4, 5 and 6, respectively. In addition to S03, S04, S05 and S06, the level is somewhat poor. The quality grades of all samples were 5 or less. No abnormal samples were detected. Conclusion The quality of 15 batches of YKJTCs consistent. The method is accurate and reasonable in assessing the quality consistency of traditional Chinese medicine bY 5 wavelength fused fingerprints.

关 键 词：愈康降糖胶囊 9级系统指纹定量法 五波长指纹图谱 宏定量相似度 宏定性相似度 

分 类 号：R284[医药卫生—中药学]