基于HPLC指纹图谱考察3种复合掩味佐剂对御寒颗粒汤剂成分的影响
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摘要
目的:探究3种复合掩味佐剂——咖啡味中药伴侣、巧克力味中药伴侣、甜橙味中药伴侣掩味前后御寒颗粒汤剂中化学成分的变化,揭示3种复合掩味佐剂对御寒颗粒汤剂的化学成分的影响。方法:以单味配方颗粒组成的御寒颗粒方为苦味载体,采用高效液相色谱法参考指纹图谱技术建立其化学成分的特征图谱测定方法,以掩味前后共有峰相对保留时间、相对峰面积的变化率以及总峰面积为指标,比较御寒颗粒汤剂掩味前后化学成分的变化。结果:掩味前后的御寒颗粒汤剂,特征图谱共有峰有22个,与原液相比,加入3类中药伴侣后的样品的共有峰相对保留时间变化率的绝对值均值分别为(0.18±0.04)%、(0.11±0.04)%、(0.17±0.06)%,均<0.2%;共有峰相对峰面积变化率的绝对值均值甜橙味为(1.81±1.26)%,<5%;咖啡味和巧克力味相对峰面积的变化率绝对值用中位数(四分位数间距)表示分别为:2.30%(1.45%-3.99%)、3.73%(2.70%-6.68%);与原液相比,总峰面积均无显著性差异。结论:3种复合掩味佐剂中,甜橙味对御寒颗粒汤剂的化学成分几乎没有影响;咖啡味和巧克力味对其汤剂的某些成分有微小的影响,但对其汤剂中化学成分的总量无显著影响,是否会影响到其汤剂的药效有待进一步临床药效学方面的研究。
Objective: To reveal the effects of three compound masking adjuvants on Yuhan Granules decoction chemical composition through exploring the chemical composition changes of Yuhan Granules was masked before and after by three compound masking adjuvants including coffee flavour, orange flavor and chocolate flavor. Methods: The chemical composition changes of Yuhan Granules are compared by taking Yuhan Granules that is composed of single dispensing particles as bitter carrier, establishing a determination method of chemical compositions characteristic fingerprint through HPLC and referencing the technology of fingerprint and taking value of relative retention time of common peak, the rate of change of relative peak area and the total peak area as the targets at before and after masking taste. Results: There are 22 common peaks of characteristic fingerprint in Yuhan Granules at masking before and after. Compared with original decoction after masking by three compound masking adjuvants, the mean absolute value of change rate about relative retention time of common peak are respectively(0.18±0.04)%,(0.11±0.04)%,(0.17±0.06)%, all less than 0.2%. Orange's mean absolute value of change rate about relative peak area is(1.81±1.26)%, all less than 5%. The coffee and chocolate's change rate of relative peak area is expressed by median(four quantile interval) as: 2.30%(1.45%-3.99%) and 3.73%(2.70%-6.68%), which is compared with original decoction shows that is no significant difference in total peak area. Conclusion: Among of the three compound masking adjuvants, the orange flavor has almost no effect on the chemical composition of the Yuhan Granules. Although the coffee and chocolate flavor have slight impact on some chemical composition of the Yuhan Granules, but there was no significant effect on the total amount of chemical components in the Yuhan Granules, so it needs further clinical pharmacodynamic study to explore whether it will affect the efficacy of the decoction.
Objective: To reveal the effects of three compound masking adjuvants on Yuhan Granules decoction chemical composition through exploring the chemical composition changes of Yuhan Granules was masked before and after by three compound masking adjuvants including coffee flavour, orange flavor and chocolate flavor. Methods: The chemical composition changes of Yuhan Granules are compared by taking Yuhan Granules that is composed of single dispensing particles as bitter carrier, establishing a determination method of chemical compositions characteristic fingerprint through HPLC and referencing the technology of fingerprint and taking value of relative retention time of common peak, the rate of change of relative peak area and the total peak area as the targets at before and after masking taste. Results: There are 22 common peaks of characteristic fingerprint in Yuhan Granules at masking before and after. Compared with original decoction after masking by three compound masking adjuvants, the mean absolute value of change rate about relative retention time of common peak are respectively(0.18±0.04)%,(0.11±0.04)%,(0.17±0.06)%, all less than 0.2%. Orange's mean absolute value of change rate about relative peak area is(1.81±1.26)%, all less than 5%. The coffee and chocolate's change rate of relative peak area is expressed by median(four quantile interval) as: 2.30%(1.45%-3.99%) and 3.73%(2.70%-6.68%), which is compared with original decoction shows that is no significant difference in total peak area. Conclusion: Among of the three compound masking adjuvants, the orange flavor has almost no effect on the chemical composition of the Yuhan Granules. Although the coffee and chocolate flavor have slight impact on some chemical composition of the Yuhan Granules, but there was no significant effect on the total amount of chemical components in the Yuhan Granules, so it needs further clinical pharmacodynamic study to explore whether it will affect the efficacy of the decoction.
引文
[1]陈少芳,梁惠卿.中药汤剂掩味探讨.中华中医药杂志,2016,31(6):2348-2350
[2]Walsh J,Cram A,Woertz K,et al.Playing hide and seek with poorly tasting paediatric medicines:Do not forget the excipients.Adv Drug Deliv Rev,2014(73):14-33
[3]Preis M,Grother L,Axe P,et al.In-vitro and in-vivo evaluation of taste-masked cetirizine hydrochloride formulated in oral lyophilisates.Int J Pharm,2015,491(1-2):8-16
[4]Saharan V A,Singh A.Fast Dissolving/disintegrating dosage forms:Growth from immediate release to sustained release and traditional medicines.Recent Pat Drug Deliv Formul,2015,9(3):189-191
[5]刘聪燕,瞿鼎,黄萌萌.中药配方颗粒掩味技术研究的思考.中华中医药杂志,2016,31(9):3658-3661
[6]刘瑞新,李学林,吴子丹,等.论中药煎剂掩味研究的必要性、现状与对策.中国药房,2012,23(27):2497-2500
[7]施钧瀚,张杏芬,仇继玺,等.β-环糊精对几种苦味中药的掩味作用考察.中国实验方剂学杂志,2013,19(12):1-4
[8]李学林,仇继玺,刘瑞新,等.龙胆掩味前后指纹图谱变化的研究.中国实验方剂学杂志,2013,19(17):104-106
[9]Liu R,X Zhang,L Zhang,et al.Bitterness intensity prediction of berberine hydrochloride using an electronic tongue and a GA-BP neural network.Experimental&Therapeutic Medicine,2014,7(6):1696-1702
[10]康冰亚,施钧瀚,张璐,等.两种掩味剂对苦参水煎液的掩味作用考察.中国实验方剂学杂志,2014,20(15):4-7
[11]张璐,施钧瀚,康冰亚,等.纽甜对5种苦味中药的掩味效果.世界科学技术-中医药现代化,2014,16(9):1904-1907
[12]李学林.咖啡味中药伴侣:ZL 2014 1 0054585.5.2015-4-29
[13]李学林.甜橙味中药伴侣:ZL 2014 1 0054974.8.2015-11-11
[14]李学林.巧克力味中药伴侣:ZL2014 1 0054975.2.2015-11-11
[15]李学林,王盼盼,刘瑞新,等.3种掩味剂单独或联合应用对黄柏的掩味作用探究及掩味前后化学成分的比较.中国实验方剂学杂志,2017,23(2):7-11
[16]刘东方,赵丽娜,李银峰,等.中药指纹图谱技术的研究进展及应用.中草药,2016,47(22):4085-4093
[17]丁红霞,杨静,吴宗耀,等.中药质量控制中色谱指纹图谱技术探究.河南中医,2013,29(7):1155-1156
[18]胡伊力格其.β-环糊精包合技术在中药制剂中的应用概述.山东中医杂志,2015,34(11):892-894
[2]Walsh J,Cram A,Woertz K,et al.Playing hide and seek with poorly tasting paediatric medicines:Do not forget the excipients.Adv Drug Deliv Rev,2014(73):14-33
[3]Preis M,Grother L,Axe P,et al.In-vitro and in-vivo evaluation of taste-masked cetirizine hydrochloride formulated in oral lyophilisates.Int J Pharm,2015,491(1-2):8-16
[4]Saharan V A,Singh A.Fast Dissolving/disintegrating dosage forms:Growth from immediate release to sustained release and traditional medicines.Recent Pat Drug Deliv Formul,2015,9(3):189-191
[5]刘聪燕,瞿鼎,黄萌萌.中药配方颗粒掩味技术研究的思考.中华中医药杂志,2016,31(9):3658-3661
[6]刘瑞新,李学林,吴子丹,等.论中药煎剂掩味研究的必要性、现状与对策.中国药房,2012,23(27):2497-2500
[7]施钧瀚,张杏芬,仇继玺,等.β-环糊精对几种苦味中药的掩味作用考察.中国实验方剂学杂志,2013,19(12):1-4
[8]李学林,仇继玺,刘瑞新,等.龙胆掩味前后指纹图谱变化的研究.中国实验方剂学杂志,2013,19(17):104-106
[9]Liu R,X Zhang,L Zhang,et al.Bitterness intensity prediction of berberine hydrochloride using an electronic tongue and a GA-BP neural network.Experimental&Therapeutic Medicine,2014,7(6):1696-1702
[10]康冰亚,施钧瀚,张璐,等.两种掩味剂对苦参水煎液的掩味作用考察.中国实验方剂学杂志,2014,20(15):4-7
[11]张璐,施钧瀚,康冰亚,等.纽甜对5种苦味中药的掩味效果.世界科学技术-中医药现代化,2014,16(9):1904-1907
[12]李学林.咖啡味中药伴侣:ZL 2014 1 0054585.5.2015-4-29
[13]李学林.甜橙味中药伴侣:ZL 2014 1 0054974.8.2015-11-11
[14]李学林.巧克力味中药伴侣:ZL2014 1 0054975.2.2015-11-11
[15]李学林,王盼盼,刘瑞新,等.3种掩味剂单独或联合应用对黄柏的掩味作用探究及掩味前后化学成分的比较.中国实验方剂学杂志,2017,23(2):7-11
[16]刘东方,赵丽娜,李银峰,等.中药指纹图谱技术的研究进展及应用.中草药,2016,47(22):4085-4093
[17]丁红霞,杨静,吴宗耀,等.中药质量控制中色谱指纹图谱技术探究.河南中医,2013,29(7):1155-1156
[18]胡伊力格其.β-环糊精包合技术在中药制剂中的应用概述.山东中医杂志,2015,34(11):892-894