胶类中药的质量控制方法研究进展
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摘要
胶类中药包括皮胶、角胶、甲胶和骨胶等,是应用历史悠久、独具特色的一类中药。因其显著的疗效和滋补养生作用,近年来市场需求量逐年增加,由此导致生产原料资源供应不足,伪劣产品大行其道,严重影响了胶类中药的声誉和人民群众的用药安全。在此背景下,针对胶类中药的具体特点,建立专属性较强的胶类中药质量检测方法,将能有效地控制胶类中药的质量,促进合理使用,并将对产业发展产生深远影响。该文介绍了胶类中药的分类及其代表性品种阿胶的生产和应用现状。对胶类中药的质量控制技术进行文献综述,全面总结、分析了胶类中药的传统鉴别经验、真伪鉴别、物理性质测定、蛋白、肽及氨基酸含量测定、元素分析、生物评价、以及品牌保护技术的优缺点,提出必须结合胶类中药物质基础较为复杂、药效成分不够明确、生产工艺存在差别的具体特点,研发信息丰富、方便快速、样品无损的适用分析技术,用于胶类中药的质量控制和名优胶类产品的品牌保护,从而推动胶类中药的健康发展。
Traditional Chinese medicine( TCM) glues,including leather glues,horn glues,nail glues and bone glues,have a long application history and unique characteristics. In recent years,their market demand has increased year by year because of their remarkable curative efficacy and nourishing effects,which leads to insufficient supply of raw material resources,and widespread use of fake and inferior products,seriously affecting the reputation of TCM glues and drug safety. In this context,the establishment of a more specific quality detection method for the TCM glues according to their specific characteristics can effectively improve the quality control level,promote rational use,and have a far-reaching impact on the industrial development of TCM glues. In this paper,the classification of TCM glues,as well as the production and application status of their representative( Ejiao) were briefly introduced; the papers on quality control technologies of TCM glues,including traditional identification experience,authenticity identification,physical property determination,protein,peptide and amino acid contents determination,element analysis,biological evaluation,and brand protection technology of TCM glues,were reviewed,and their advantages and disadvantages were summarized and analyzed comprehensively.Based on the specific characteristics of TCM glues,such as complex material basis,unclear pharmacodynamic components and different production processes,it was proposed in this paper to research and develop information-rich,convenient,fast,and non-destructive analytical techniques for the quality control of TCM glues and brand protection of famous products,thus promoting the healthy development of TCM glues industry.
Traditional Chinese medicine( TCM) glues,including leather glues,horn glues,nail glues and bone glues,have a long application history and unique characteristics. In recent years,their market demand has increased year by year because of their remarkable curative efficacy and nourishing effects,which leads to insufficient supply of raw material resources,and widespread use of fake and inferior products,seriously affecting the reputation of TCM glues and drug safety. In this context,the establishment of a more specific quality detection method for the TCM glues according to their specific characteristics can effectively improve the quality control level,promote rational use,and have a far-reaching impact on the industrial development of TCM glues. In this paper,the classification of TCM glues,as well as the production and application status of their representative( Ejiao) were briefly introduced; the papers on quality control technologies of TCM glues,including traditional identification experience,authenticity identification,physical property determination,protein,peptide and amino acid contents determination,element analysis,biological evaluation,and brand protection technology of TCM glues,were reviewed,and their advantages and disadvantages were summarized and analyzed comprehensively.Based on the specific characteristics of TCM glues,such as complex material basis,unclear pharmacodynamic components and different production processes,it was proposed in this paper to research and develop information-rich,convenient,fast,and non-destructive analytical techniques for the quality control of TCM glues and brand protection of famous products,thus promoting the healthy development of TCM glues industry.
引文
[1]吴亚兰,许霞.胶剂的历史发展[J].中医药临床杂志,2018,30(5):870.
[2]董洪霜,张静娴,胡青,等.胶类中药质量控制研究进展[J].中草药,2018,49(13):3166.
[3]程显隆.胶类药材质量控制关键技术研究[D].北京:北京中医药大学,2014.
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[6]中国药典.一部[S]. 2015:189.
[7]左华丽.中药阿胶质量评价方法研究[D].重庆:重庆大学,2014.
[8]毛跟年,郭倩,瞿建波,等.阿胶化学成分及药理作用研究进展[J].动物医学进展,2010,31(11):83.
[9]李昊,黄美娟,张少权,等.驴真皮中主要蛋白的组成及其相互作用的研究[J].中国中药杂志,2006,31(8):659.
[10]高景会,王蕊,范锋.阿胶现代研究进展[J].中国药事,2011,25(4):396.
[11]李锋,张振秋,任子和.七种动物胶类药材SDS-聚丙烯酰胺凝胶电泳鉴别[J].中药材,1999,22(4):184.
[12]朱连连,窦德强.阿胶、鹿皮胶中蛋白质及氨基酸含量测定[J].亚太传统医药,2018,14(6):48.
[13]陈萍红,王书芳,龚行楚.柱前衍生RP-HPLC法测定阿胶中13种氨基酸[J].中草药,2013,43(14):1995.
[14]程素盼,姜姣姣,赵恒强,等.基于低场核磁共振技术的不同品牌黄明胶的快速鉴别初探[J].食品与药品,2019,21(2):90.
[15]唐敏,严建业,徐博,等.基于UPLC-ESI-QTOF-MS/MS技术检测龟甲胶中新阿胶成分[J].世界科学技术——中医药现代化,2017,19(2):339.
[16]左华丽,赵洁,杨丰庆,等.胶类中药材质量控制方法的研究进展[J].中国药房,2013,24(23):2203.
[17]沙小梅,胡姿姿,涂宗财,等.基于18O标记和液相色谱-高分辨率质谱技术的阿胶定量研究[J].食品科学,2018,39(12):288.
[18]房芳,张九凯,马雪婷,等.基于特征肽段的阿胶中异源性物种鉴别[J].食品科学,http:/kns. cnki. net/kcms/detail/11. 2206.TS.20181218. 1214. 028.html.
[19]王一村,苏本玉,李娜,等.基于微滴数字PCR阿胶定量检测方法的建立[J].食品工业科技,2018,39(14):205.
[20]许长华,周群,孙素琴.二维相关红外光谱法与阿胶的真伪鉴别分析[J].化学研究简报,2005,33(2):221.
[21]翟乙娟,任孝通,都恒青,等.阿胶、鹿角胶、龟甲胶圆二色谱鉴别[J].中药材,1998,21(12):66.
[22]陈栋华,刘雪峰,黄艳,等.阿胶的差示扫描量热鉴别法研究[J].中草药,1993,24(6):314.
[23] Li W L,Han H F,Zhang L,et al. Manufacturer identification and storage time determination of"Dong'e E-jiao"using near infrared spectroscopy and chemometrics[J]. J Zhejiang Univ Sci B,2016,17(5):382.
[24]李春梅,王若光,王陆颖,等.基于激光解析/离子化飞行时间质谱技术的中药龟甲胶蛋白质组分析[J].湖南中医药大学学报,2007,27(6):21.
[25]王若光,尤昭玲,刘小丽,等.基于激光解析/离子化-飞行时间质谱技术的中药阿胶蛋白质组分析[J].中国组织工程研究与临床康复,2007,11(13):2518.
[26]葛正华.中药胶剂成分的分离及测定方法研究[J].中医药学报,2001,29(6):39.
[27]孟正木,潘计俊.鹿角胶与阿胶的成分研究[J].中成药,1979,1(1):1.
[28]汪冰,肖新月,程显隆,等.凝胶排阻色谱法研究阿胶中蛋白质及多肽相对分子质量分布规律[J].药物分析杂志,2009,29(11):1886.
[29]骆达,李惠芬,李秀兰,等.异硫氰酸苯酷衍生化-HPLC法测定龟甲中胶原蛋白[J].中草药,2008,39(6):851.
[30]王晓坤,程秀民,于海英,等.阿胶水溶性成分HPLC指纹图谱研究[J].上海中医药杂志,2008,28(2):66.
[31]于海英,周永妍,程秀民.阿胶、龟甲胶中脂溶性成分的高效液相色谱指纹图谱[J].色谱,2009,27(4):447.
[32]石岩,范晓磊,肖新月,等.鹿角胶中4个主要氨基酸的测定研究[J].药物分析杂志,2012,32(5):783.
[33]朱洪梅,魏立新,杜玉枝,等.牦牛皮胶氨基酸类成分的高效液相色谱指纹图谱[J].中成药,2012,34(2):195.
[34]籍国霞,嵇传良,郭尚伟,等.微波消解-电感耦合等离子体质谱法测定阿胶中14种元素含量[J].明胶科学与技术,2015,35(4):182.
[35]徐清,李梦,张帆,等.采用电感耦合等离子质谱法检测龟甲及龟甲胶药材中重金属元素的含量[J].北京中医药大学学报,2018,41(8):670.
[36]孙大赢,赵文法.微波消解-ICP-MS测定黄明胶中6种有害元素[J].中国现代应用药学,2015,32(10):1227.
[37]贾艾玲,王红梅,李玲玲.电感耦合等离子体质谱法检测阿胶中6种有害元素的含量[J].药物分析杂志,2012,32(3):434.
[38] Yang Y,He J,Huang Z,et al. Analysis of hexavalent chromium in Colla Corii Asini with on-line sample pretreatment valve-switching ion chromatography[J]. J Chromatogr A,2013,1305:171.
[39]王玄,欧阳罗丹,代春美,等.动物类中药质量控制的生物评价研究[J].中国中药杂志,2017,42(12):2228.
[40]李文龙.中药标准化的模式分析及思考[N].中国中医药报,2018-11-15.
[41]秦玉峰.给驴拴一条又长又密的产业链[N].南方日报,2016-05-20(4).
[2]董洪霜,张静娴,胡青,等.胶类中药质量控制研究进展[J].中草药,2018,49(13):3166.
[3]程显隆.胶类药材质量控制关键技术研究[D].北京:北京中医药大学,2014.
[4]张兆旺.中药药剂学[M].北京:中国中医药出版社,2004:340.
[5]何绍奇.血肉有情考略[J].中医杂志,1992,21(10):58.
[6]中国药典.一部[S]. 2015:189.
[7]左华丽.中药阿胶质量评价方法研究[D].重庆:重庆大学,2014.
[8]毛跟年,郭倩,瞿建波,等.阿胶化学成分及药理作用研究进展[J].动物医学进展,2010,31(11):83.
[9]李昊,黄美娟,张少权,等.驴真皮中主要蛋白的组成及其相互作用的研究[J].中国中药杂志,2006,31(8):659.
[10]高景会,王蕊,范锋.阿胶现代研究进展[J].中国药事,2011,25(4):396.
[11]李锋,张振秋,任子和.七种动物胶类药材SDS-聚丙烯酰胺凝胶电泳鉴别[J].中药材,1999,22(4):184.
[12]朱连连,窦德强.阿胶、鹿皮胶中蛋白质及氨基酸含量测定[J].亚太传统医药,2018,14(6):48.
[13]陈萍红,王书芳,龚行楚.柱前衍生RP-HPLC法测定阿胶中13种氨基酸[J].中草药,2013,43(14):1995.
[14]程素盼,姜姣姣,赵恒强,等.基于低场核磁共振技术的不同品牌黄明胶的快速鉴别初探[J].食品与药品,2019,21(2):90.
[15]唐敏,严建业,徐博,等.基于UPLC-ESI-QTOF-MS/MS技术检测龟甲胶中新阿胶成分[J].世界科学技术——中医药现代化,2017,19(2):339.
[16]左华丽,赵洁,杨丰庆,等.胶类中药材质量控制方法的研究进展[J].中国药房,2013,24(23):2203.
[17]沙小梅,胡姿姿,涂宗财,等.基于18O标记和液相色谱-高分辨率质谱技术的阿胶定量研究[J].食品科学,2018,39(12):288.
[18]房芳,张九凯,马雪婷,等.基于特征肽段的阿胶中异源性物种鉴别[J].食品科学,http:/kns. cnki. net/kcms/detail/11. 2206.TS.20181218. 1214. 028.html.
[19]王一村,苏本玉,李娜,等.基于微滴数字PCR阿胶定量检测方法的建立[J].食品工业科技,2018,39(14):205.
[20]许长华,周群,孙素琴.二维相关红外光谱法与阿胶的真伪鉴别分析[J].化学研究简报,2005,33(2):221.
[21]翟乙娟,任孝通,都恒青,等.阿胶、鹿角胶、龟甲胶圆二色谱鉴别[J].中药材,1998,21(12):66.
[22]陈栋华,刘雪峰,黄艳,等.阿胶的差示扫描量热鉴别法研究[J].中草药,1993,24(6):314.
[23] Li W L,Han H F,Zhang L,et al. Manufacturer identification and storage time determination of"Dong'e E-jiao"using near infrared spectroscopy and chemometrics[J]. J Zhejiang Univ Sci B,2016,17(5):382.
[24]李春梅,王若光,王陆颖,等.基于激光解析/离子化飞行时间质谱技术的中药龟甲胶蛋白质组分析[J].湖南中医药大学学报,2007,27(6):21.
[25]王若光,尤昭玲,刘小丽,等.基于激光解析/离子化-飞行时间质谱技术的中药阿胶蛋白质组分析[J].中国组织工程研究与临床康复,2007,11(13):2518.
[26]葛正华.中药胶剂成分的分离及测定方法研究[J].中医药学报,2001,29(6):39.
[27]孟正木,潘计俊.鹿角胶与阿胶的成分研究[J].中成药,1979,1(1):1.
[28]汪冰,肖新月,程显隆,等.凝胶排阻色谱法研究阿胶中蛋白质及多肽相对分子质量分布规律[J].药物分析杂志,2009,29(11):1886.
[29]骆达,李惠芬,李秀兰,等.异硫氰酸苯酷衍生化-HPLC法测定龟甲中胶原蛋白[J].中草药,2008,39(6):851.
[30]王晓坤,程秀民,于海英,等.阿胶水溶性成分HPLC指纹图谱研究[J].上海中医药杂志,2008,28(2):66.
[31]于海英,周永妍,程秀民.阿胶、龟甲胶中脂溶性成分的高效液相色谱指纹图谱[J].色谱,2009,27(4):447.
[32]石岩,范晓磊,肖新月,等.鹿角胶中4个主要氨基酸的测定研究[J].药物分析杂志,2012,32(5):783.
[33]朱洪梅,魏立新,杜玉枝,等.牦牛皮胶氨基酸类成分的高效液相色谱指纹图谱[J].中成药,2012,34(2):195.
[34]籍国霞,嵇传良,郭尚伟,等.微波消解-电感耦合等离子体质谱法测定阿胶中14种元素含量[J].明胶科学与技术,2015,35(4):182.
[35]徐清,李梦,张帆,等.采用电感耦合等离子质谱法检测龟甲及龟甲胶药材中重金属元素的含量[J].北京中医药大学学报,2018,41(8):670.
[36]孙大赢,赵文法.微波消解-ICP-MS测定黄明胶中6种有害元素[J].中国现代应用药学,2015,32(10):1227.
[37]贾艾玲,王红梅,李玲玲.电感耦合等离子体质谱法检测阿胶中6种有害元素的含量[J].药物分析杂志,2012,32(3):434.
[38] Yang Y,He J,Huang Z,et al. Analysis of hexavalent chromium in Colla Corii Asini with on-line sample pretreatment valve-switching ion chromatography[J]. J Chromatogr A,2013,1305:171.
[39]王玄,欧阳罗丹,代春美,等.动物类中药质量控制的生物评价研究[J].中国中药杂志,2017,42(12):2228.
[40]李文龙.中药标准化的模式分析及思考[N].中国中医药报,2018-11-15.
[41]秦玉峰.给驴拴一条又长又密的产业链[N].南方日报,2016-05-20(4).