黄精配方颗粒质量标准研究  

Research on the Quality Standard of Polygonatum Sibiricum Dispensing Granules

作　　者：鲁文洁 万晓莹 宋志前[1] 彭诗涛 刘振丽[1] 宁张弛 王淳[1] LU Wenjie;WAN Xiaoying;SONG Zhiqian;PENG Shitao;LIU Zhenli;NING Zhangchi;WANG Chun(Institute of Basic Theory for Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;Shanghai Linqingxuan Biotechnology Co.,LTD.,Shanghai 201600,China)

机构地区：[1]中国中医科学院中医基础理论研究所,北京100700 [2]上海林清轩生物科技有限公司,上海201600

出　　处：《中国中医基础医学杂志》2023年第9期1526-1530,共5页JOURNAL OF BASIC CHINESE MEDICINE

基　　金：中国中医科学院科技创新工程项目(CI2021A00109);中国中医科学院科技创新工程创新团队项目(CI2021B001);中央级公益性科研院所基本科研业务费专项(YZ202111);深圳市光明区软科学研究项目(2021R01121)。

摘　　要：目的 建立以多糖分子量(molecular weight,Mw)及其分布为质量控制指标的黄精和酒黄精配方颗粒质量标准。方法 通过酶解法考察去除辅料的适用性及其最佳反应条件,选取合适的辅料制备黄精和酒黄精配方颗粒,以多糖MW及其分布情况为指标,采用高效凝胶渗透色谱法(high performance gel permeation chromatography,HPGPC)建立配方颗粒特征图谱。结果高温α-淀粉酶或糖化酶单独使用,均不能将可溶性淀粉和糊精酶解完全,而两种酶协同处理的酶解效果更好。高温α-淀粉酶和糖化酶最佳加酶量分别为辅料:酶用量1:1.5和1:2(g/m L)。黄精和酒黄精多糖的差异主要在MW>10 k Da部分,经酶法协同处理后,可溶性淀粉在MW>10 k Da部分的糖链已完全水解。各批次黄精配方颗粒以及酒黄精配方颗粒间特征图谱的相似度均大于0.9;且黄精与酒黄精配方颗粒之间的相似度均小于0.5。结论 该方法稳定、可靠,重复性好,能很好地区分黄精和酒黄精配方颗粒,可用于黄精和酒黄精配方颗粒的质量控制。Objective To establish the quality standard of Polygonatum Sibiricum(PS)and Processed Polygonatum Sibiricum(PPS)dispensing granules based on the molecular weight(M w)and their distribution of polysaccharides as quality control indexes.Methods The suitability and optimal reaction conditions of excipents removal were investigated by enzymatic hydrolysis method,choosing the appropriate excipents to prepare the PS formula granules and PPS granules.Meanwhile,with the molecular weight(M w)and their distribution of polysaccharides as indicators,the characteristic chromatograms of PS and PPS formula granules were established by high performance gel permeation chromatography(HPGPC).Results Neither high temperatureα-amylase nor glucoamylase alone could completely hydrolyze soluble starch and dextrin,while the synergistic effect of the two enzymes was better.The optimal amount of high temperatureα-amylase(40 U/mL)and glucoamylase(50 U/mL)were 11.5(g/mL)and 12(g/mL),respectively.The differences between the PS and PPS polysaccharides were mainly in the M w>10 kDa fraction,and the sugar chain part with M w>10 KDa were completely hydrolyzed after enzymatic treatment of soluble starch.Moreover,the similarities between PS formula granules were all greater than 0.9,and the similarities between PPS formula granules was also greater than 0.9.Besides,the similarities between PS and PPS formula granules were all less than 0.5.Conclusion This method was stable,reliable and reproducible,which could well distinguish the PS and PPS formula granules and be used for the quality control of PS and PPS formula granules.

关 键 词：黄精 酒黄精 配方颗粒 HPGPC 质量标准 

分 类 号：R283.6[医药卫生—中药学]