复方阿胶浆质量标准提升研究  

Promotion on quality standard of Fufang E’jiao Jiang

作　　者：许啸 张淹 刘晓云 王宇 刘越 董英 宋若兰 于啊香 马嘉慕 折改梅[1] XU Xiao;ZHANG Yan;LIU Xiao-yun;WANG Yu;LIU Yue;DONG Ying;SONG Ruo-lan;YU A-xiang;MA Jia-mu;SHE Gai-mei(School of Chinese Pharmacy,Beijing University of Chinese Medicine,Beijing 100102,China;Analysis and Test Center,Chinese Academy of Tropical Agricultural Sciences,Haikou 571101,China;National Engineering Research Center for Gelatin-based Traditional Chinese Medicine,Dong-E-E-Jiao Co.,Ltd.,Liaocheng 252201,China)

机构地区：[1]北京中医药大学中药学院,北京100102 [2]中国热带农业科学院分析测试中心,海南海口571101 [3]东阿阿胶股份有限公司国家胶类中药工程技术研究中心,山东聊城252201

出　　处：《中草药》2021年第20期6226-6233,共8页Chinese Traditional and Herbal Drugs

基　　金：国家重点研发计划项目(2018YFC1707300);国家重点研发计划项目(2018YFC1706300)。

摘　　要：目的提升复方阿胶浆质量标准。方法基于中药复方制剂"整体鉴别"新模式,对复方阿胶浆中植物来源中药采用一板多鉴法,红参、党参使用同一供试品溶液、同一展开剂,采用对照品和对照药材双对照(红参使用人参皂苷Rg1对照品和红参对照药材;党参使用党参炔苷对照品和党参对照药材)进行鉴别;熟地黄、山楂使用2种供试品溶液、同一展开剂,采用对照品和对照药材双对照(熟地黄使用毛蕊花糖苷对照品和熟地黄对照药材;山楂使用牡荆素鼠李糖苷对照品和山楂对照药材)进行鉴别。对复方阿胶浆中动物药阿胶建立L-羟脯氨酸、甘氨酸、丙氨酸、脯氨酸4种氨基酸含量测定。并采用一测多评法,以L-羟脯氨酸为内标,确定甘氨酸、丙氨酸、脯氨酸的相对校正因子并计算含量。结果建立了复方阿胶浆中植物药鉴别的"4-3-2-2"模式,即4味中药,3种供试品溶液制备方法、2种展开剂,2种对照物的双对照方法,斑点清晰且专属性强。建立了复方阿胶浆中动物药阿胶一测多评法含量测定,15批样品中L-羟脯氨酸、甘氨酸、丙氨酸、脯氨酸的质量浓度分别为2.73-3.37、4.61-6.99、2.64-3.97、3.58-4.46 mg/mL。以L-羟脯氨酸为内标建立的甘氨酸、丙氨酸、脯氨酸的相对校正因子分别为0.651、0.958、0.857。采用t检验、相对偏差法和Pearson相关系数法对2种方法的含量测定结果进行比较分析,15批复方阿胶浆一测多评法计算值与外标法实测含量值无显著差异。结论建立了复方阿胶浆中植物药来源中药鉴别的"4-3-2-2"模式。对处方中动物来源中药阿胶建立了4种氨基酸的一测多评法含量测定。通过"一板、一测",达到"多鉴、多评"整体药味质量控制的目的,科学合理地提升复方阿胶浆的质量标准。Objective To improve the quality standard of Fufang E’jiao Jiang(复方阿胶浆, FEJ). Methods Identification of FEJ was based on the novel model of "holistic identification". Identification of multi-herbal medicines by a single-thin layer chromatography(IMMS) was used to identify the herbal medicines in FEJ. Hongshen(Ginseng Radix et Rhizoma Rubra, GRRR) and Dangshen(Codonopsis Radix, CR) used the same sample and developing solvent. Both reference substances and reference material were used to control GRRR(ginsenoside Rg1 and GRRR reference material) and CR(lobetyolin and CR reference material).Shudihuang(Rehmanniae Radix Preparata, RRP) and Shanzha(Crataegi Fructus, CF) used different samplesand the same developing solvent. Both reference substances and reference material were used to control RRP(acteoside and RRP reference material) and CF(vitexin rhamnoside and CF reference material). The method of multi-components by a single-marker(QAMS) was used to determining four amino acids in E’jiao(Asini Corii Colla, ACC). With L-hydroxyproline as the internal reference substance, the relative correction factors(RCF) of glycine, proline, and alanine were determined by HPLC to calculate corresponding contents. Results A "4-3-2-2"model was established for the identification of herbal medicines in FEJ, including four herbal medicines, three samples preparation methods, two developing solvents, and all of them were controlled by both reference substance and reference medicine. The identification spots were clear and exclusive. The method of QAMS for the determination of four amino acids in FEJ was established.The contents of L-hydroxyproline, glycine, alanine and proline in 15 batches of samples were 2.73—3.37, 4.61—6.99, 2.64—3.97, and 3.58—4.46 mg/mL, respectively. The RCF of glycine, alanine, and proline were 0.651, 0.958 and 0.857, respectively. Using t-test,relative deviation method and Pearson correlation coefficient method to compare the contents of four components. The results showed no significant di

关 键 词：复方阿胶浆 整体质量控制 一板多鉴法 一测多评法 相对校正因子 质量标准提升 整体鉴别 红参 党参 熟地黄 山楂 阿胶 人参皂苷Rg1 党参炔苷 毛蕊花糖苷 牡荆素鼠李糖苷 L-羟脯氨酸 甘氨酸 丙氨酸 脯氨酸 

分 类 号：R286.02[医药卫生—中药学]