一测多评法同时测定糖足酊剂中10种化学成分
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摘要
目的:建立同时测定糖足酊剂中巴西苏木素、原苏木素B、儿茶素、表儿茶素、芒柄花素、绿原酸、咖啡酸、阿魏酸、当药苷和毛蕊异黄酮葡萄糖苷的一测多评法,验证该方法在控制糖足酊剂质量标准中应用的可行性和科学性。方法:采用HPLC法,以毛蕊异黄酮葡萄糖苷为内参物(ZS),建立该成分与巴西苏木素、原苏木素B、儿茶素、表儿茶素、芒柄花素、绿原酸、咖啡酸、阿魏酸和当药苷等成分的相对校正因子(RCFs),采用相对校正因子计算各成分的质量分数,同时以外标法(ESM)测定上述10种化学成分的质量分数,将糖足酊剂一测多评法的计算结果与外标法的测定值进行对比,通过两者的余弦相似度评价一测多评法用于糖足酊剂质量控制的准确性与科学性。结果:各相对校正因子的RSD值均<2%,一测多评法的计算结果与外标法的测定值的余弦相似度均为1. 000 0。结论:以毛蕊异黄酮葡萄糖苷为内标物同时测定巴西苏木素、原苏木素B、儿茶素、表儿茶素、芒柄花素、绿原酸、咖啡酸、阿魏酸和当药苷含量的一测多评法准确可行,可用于糖足酊剂的质量控制。
Objective: To establish a quantitative analysis of multi-components with single marker (QAMS)for the simultaneous determination of brazilin,protosappanin B,catechin,l-epicatechin,formononetin,chlorogenic acid,caffeic acid,ferulic acid,sweroside and calycosin-7-glucoside,and then verify the feasibility and scientificity of this method in controlling the quality standard of diabetic foot tincture. Methods: With calycosin-7-glucoside as the internal standard (IS),the relative correction factors (RCFs) of brazilin,protosappanin B,catechin,l-epicatechin,formononetin,chlorogenic acid,caffeic acid,ferulic acid and sweroside were established by HPLC method,which were used to calculate the mass fractions of each component. At the same time,the mass fractions of the 10 chemical constituents were measured by the external standard method (ESM). By comparing the cosine similarity of the content results of the ESM and QAMS,to evaluate the accuracy and scientificity of QAMS method for quality control of diabetic foot tincture. Results: The RSD values of the relative correction factors (RCFs) were less than 2%. The cosine similarity of the content results determined by QAMS and ESM were 1. 000 0. Conclusion: The method with a single marker,using the calycosin-7-gLucoside as IS,is accurate and feasible for the quantitative analysis of brazilin,protosappanin B,catechin,l-epicatechin,formononetin,chlorogenic acid,caffeic acid,ferulic acid and sweroside in diabetic foot tincture,which can be used for the quality control of this tincture.
Objective: To establish a quantitative analysis of multi-components with single marker (QAMS)for the simultaneous determination of brazilin,protosappanin B,catechin,l-epicatechin,formononetin,chlorogenic acid,caffeic acid,ferulic acid,sweroside and calycosin-7-glucoside,and then verify the feasibility and scientificity of this method in controlling the quality standard of diabetic foot tincture. Methods: With calycosin-7-glucoside as the internal standard (IS),the relative correction factors (RCFs) of brazilin,protosappanin B,catechin,l-epicatechin,formononetin,chlorogenic acid,caffeic acid,ferulic acid and sweroside were established by HPLC method,which were used to calculate the mass fractions of each component. At the same time,the mass fractions of the 10 chemical constituents were measured by the external standard method (ESM). By comparing the cosine similarity of the content results of the ESM and QAMS,to evaluate the accuracy and scientificity of QAMS method for quality control of diabetic foot tincture. Results: The RSD values of the relative correction factors (RCFs) were less than 2%. The cosine similarity of the content results determined by QAMS and ESM were 1. 000 0. Conclusion: The method with a single marker,using the calycosin-7-gLucoside as IS,is accurate and feasible for the quantitative analysis of brazilin,protosappanin B,catechin,l-epicatechin,formononetin,chlorogenic acid,caffeic acid,ferulic acid and sweroside in diabetic foot tincture,which can be used for the quality control of this tincture.
引文
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[10]纪瑞锋,刘素香,刘毅,等. HPLC法测定不同产地忍冬藤中4种环烯醚萜苷[J].药物评价研究,2013,36(4):289-292.
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[12]吴建良,沈敏敏,杨水新,等.阿魏酸对小胶质细胞炎性反应的抑制作用[J].中国药理学通报,2015,31(1):97-102.
[13]王宁,鞠上,杨博华,等.复方黄柏液涂剂治疗糖尿病足溃疡的有效性和安全性Meta分析[J].中国新药杂志,2018,27(15):1771-1775.
[2]张士芬,丁晨婕,朱燕芬.糖足消足浴治疗早期糖尿病足47例[J].中国实验方剂学杂志,2011,17(10):225-227.
[3]岳仁宋,毛黎黎,黄俊莉.糖足煎剂治疗糖尿病高危足近期疗效观察[J].时珍国医国药,2014,25(10):2434-2436.
[4]周园,董秋菊,冯薇,等.一测多评法测定南方菟丝子中7种活性成分的含量[J].中草药,2018,49(1):227-232.
[5]王智民,高慧敏,付雪涛,等.“一测多评”法中药质量评价模式方法学研究[J].中国中药杂志,2006,31(23):1925-1928.
[6]刘小妹,程中琴,施崇精,等.一测多评法同时测定人参中人参皂苷Rb_1、Rg_1、Re、Rc、Rb_2、Rd[J].中草药,2018,49(6):1413-1417.
[7]王龙星,肖红斌,梁鑫淼,等.一种评价中药色谱指纹谱相似性的新方法:向量夹角法[J].药学学报,2002,37(9):713-717.
[8]刘宽芝,李静波,吕海莉,等.黄芪、三七总皂苷对2型糖尿病大血管病变患者MMP-9的影响[J].中国中药杂志,2004,29(3):76-78.
[9]符影,程悦,陈建萍,等.鸡血藤活性成分及药理作用研究进展[J].中草药,2011,42(6):1229-1234.
[10]纪瑞锋,刘素香,刘毅,等. HPLC法测定不同产地忍冬藤中4种环烯醚萜苷[J].药物评价研究,2013,36(4):289-292.
[11]牟艳玲,王鑫,李杰,等.苏木不同提取物行血祛瘀活性研究[J].中国药理学通报,2013,29(10):1479-1480.
[12]吴建良,沈敏敏,杨水新,等.阿魏酸对小胶质细胞炎性反应的抑制作用[J].中国药理学通报,2015,31(1):97-102.
[13]王宁,鞠上,杨博华,等.复方黄柏液涂剂治疗糖尿病足溃疡的有效性和安全性Meta分析[J].中国新药杂志,2018,27(15):1771-1775.