基于时间优势描述结合多元统计分析法构建中药含片制剂处方的优选模式:以复方草珊瑚含片为例
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摘要
口感是中药含片制剂处方研究设计的关键。中药含片在口腔中含化与释药同步进行,为各种基础味觉、触觉、滞留度的感知提供了充足的"时间窗",整体口感是多种味感竞争抑制、综合叠加、动态变化的结果。传统的评价方法多依赖回忆性的经验评分,难以反映含片口感动态变化的特点。因此,亟需针对中药含片的剂型特性,建立新的口感评价与制剂处方的优化新模式。为此,该文首次提出构建以时间优势描述结合多元统计分析法的中药含片最佳制剂处方研究方法:以时间优势描述分析法进行志愿者感官试验,将含化过程中的时间和口感进行要素拆分,形成多时间点多感官属性的时间优势描述评分,最终以多元统计分析法优选出最佳制剂处方。并以复方草珊瑚含片制剂处方优选过程为例,对该方法的研究思路进行阐释,得到最优制剂处方为:肿节风浸膏20. 0 g,甘露醇24. 0 g,微晶纤维素12. 0 g,阿斯巴甜1. 0%,薄荷脑0. 7%,薄荷素油0. 7%。该研究为中药含片的口感评价与制剂处方研究提供了新方法,为中药含片在新时代的精细制造与创新发展提供了新思路。
The taste is the key to the research and design for formulation prescription of traditional Chinese medicine buccal tablets( TCMBTs). TCMBTs are dissolved in the oral cavity in parallel with the release of the drug,providing a sufficient " time window" for the perception of various basic taste,tactile and retention. The overall taste is the result of competitive inhibition,comprehensive superposition and dynamic change of multiple tastes. Traditional evaluation methods rely mostly on recalled experience score,difficult to reflect the dynamic changes of taste for buccal tablets. Therefore,it is urgent to establish a new optimized model for taste evaluation and formulation prescription according to the formulation characteristics of TCMBTs. To this end,this paper proposed for the first time to construct a research method for the optimal formulation of TCMBTs based on temporal dominant description of sensations combined with multivariate statistical analysis: the sensory test of volunteers was carried out by temporal dominant description analysis method,and elements separation was conducted for the time and taste in the process of inclusion to form a temporal dominant descriptive score of multi-time points and multi-sensory attributes. Finally,the optimal formulation was obtained by multivariate statistical analysis. Taking the formulation prescription of Compound Caoshanhu Buccal Tablets as an example,the research ideas of this method were explained,and the optimal formulation prescription was obtained as follows,Glabrous Sarcandra Extract of 20. 0 g,mannitol of 24. 0 g,microcrystalline cellulose of 12. 0 g,aspartame of 1. 0%,menthol of 0. 7%,and menthol oil of 0. 7%. This study provides a new method for the taste evaluation and formulation research of TCMBTs,providing a new idea for the fine manufacturing and innovative development of TCM buccal tablets in the new era.
The taste is the key to the research and design for formulation prescription of traditional Chinese medicine buccal tablets( TCMBTs). TCMBTs are dissolved in the oral cavity in parallel with the release of the drug,providing a sufficient " time window" for the perception of various basic taste,tactile and retention. The overall taste is the result of competitive inhibition,comprehensive superposition and dynamic change of multiple tastes. Traditional evaluation methods rely mostly on recalled experience score,difficult to reflect the dynamic changes of taste for buccal tablets. Therefore,it is urgent to establish a new optimized model for taste evaluation and formulation prescription according to the formulation characteristics of TCMBTs. To this end,this paper proposed for the first time to construct a research method for the optimal formulation of TCMBTs based on temporal dominant description of sensations combined with multivariate statistical analysis: the sensory test of volunteers was carried out by temporal dominant description analysis method,and elements separation was conducted for the time and taste in the process of inclusion to form a temporal dominant descriptive score of multi-time points and multi-sensory attributes. Finally,the optimal formulation was obtained by multivariate statistical analysis. Taking the formulation prescription of Compound Caoshanhu Buccal Tablets as an example,the research ideas of this method were explained,and the optimal formulation prescription was obtained as follows,Glabrous Sarcandra Extract of 20. 0 g,mannitol of 24. 0 g,microcrystalline cellulose of 12. 0 g,aspartame of 1. 0%,menthol of 0. 7%,and menthol oil of 0. 7%. This study provides a new method for the taste evaluation and formulation research of TCMBTs,providing a new idea for the fine manufacturing and innovative development of TCM buccal tablets in the new era.
引文
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[13]李美云,雷小小,苏艳莹,等.芦笋总酚酸口含片处方工艺的星点设计-效应面法优化[J].时珍国医国药,2017,28(6):1344.
[14]陈淼,赵建琪,陈耀华.清喉咽含片的制备工艺研究[J].当代医药论丛,2017,15(14):126.
[15] Borrelli M P,Setacci F,De D G,et al. Patient discomfort during carotid artery stenting:a comparison study between iodixanol versus iopamidol[J]. Ann Vasc Surq,2017,39:167.
[16] Nakamura H,Uchida S,Sugiura T,et al. The prediction of the palatability of orally disintegrating tablets by an electronic gustatory system[J]. Int J Pharm,2015,493(1/2):305.
[17]李潘,韩雪,林俊芝,等.志愿者感官试验在药物味觉评价的运用及发展研究[J].中国药学杂志,2017,52(22):1971.
[18] Oliver P,Cicerale S,Pang E,et al. A comparison of temporal dominance of sensation(TDS)and quantitative descriptive analysis(QDATM)to identify flavors in strawberries[J]. J Food Sci,2018,83(4):1094.
[19] Labbe D,Schlich P,Pineau N,et al. Temporal dominance of sensations and sensory profiling:a comparative study[J]. Food Qual and Prefer,2009,20:216.
[20] Ng M,Lawlor J B,Chandra S,et al. Using quantitative descriptive analysis and temporal dominance of sensations analysis as complementary methods for profiling commercial blackcurrant squashes[J]. Food Qual and Prefer,2012,25:121.
[21]楼云雁,石婷婷,陈立兵,等.复方草珊瑚含片物质组释放特征的研究[J].中华中医药学刊,2011,29(6):1287.
[22] Ma W,Guo A,Zhang Y,et al. A review on astringency and bitterness perception of tannins in wine[J]. Trends Food Sci Tech,2014,40(1):6.
[23] Liman E R,Zhang Y V,Montell C. Peripheral coding of taste[J]. Neuron,2014,81(5):984.
[24] Margolskee R F. Molecular mechanisms of bitter and sweet taste transduction[J]. J Biol Chem,2002,277(1):1.
[2]胡蝶,刘慧,范燕梅,等.芫荽感冒止咳含片提取和成型工艺研究[J].亚太传统医药,2018,14(2):32.
[3]俞皎皎,玄振玉,阮岩,等.清喉咽含片治疗急性咽炎的临床研究[J].中国中药杂志,2015,40(2):351.
[4]中国药典.一部[S]. 2000.
[5]王鑫,张定堃,林俊芝,等.口腔给药系统中口感的评价方法研究进展[J].中草药,2015,46(14):2167.
[6]姜红,张定堃,林俊芝,等.生物检测方法在制剂口感评价中的应用进展[J].中成药,2017,39(3):588.
[7]韩北忠,童华荣.食品感官评价[M].北京:中国林业出版社,2009.
[8]徐天才,杨少华,赵菊,等.正交试验法优化玛咖含片配方[J].中国农学通报,2014,30(18):315.
[9]王文津,王亚静,方晓玉,等.模糊综合评价法在清降口腔崩解片处方优化中的应用[J].中国实验方剂学杂志,2016,22(14):1.
[10]王优杰,冯怡,章波.模糊数学在中药口服液矫味中的应用[J].中国中药杂志,2009,34(2):152.
[11]李学林,桂新景,刘瑞新,等.基于电子舌法对中药苦味化合物苦度的预测[J].中国新药杂志,2016,25(11):1307.
[12]刘瑞新,陈鹏举,李学林,等.人工智能感官:药学领域的新技术[J].药物分析杂志,2017,37(4):559.
[13]李美云,雷小小,苏艳莹,等.芦笋总酚酸口含片处方工艺的星点设计-效应面法优化[J].时珍国医国药,2017,28(6):1344.
[14]陈淼,赵建琪,陈耀华.清喉咽含片的制备工艺研究[J].当代医药论丛,2017,15(14):126.
[15] Borrelli M P,Setacci F,De D G,et al. Patient discomfort during carotid artery stenting:a comparison study between iodixanol versus iopamidol[J]. Ann Vasc Surq,2017,39:167.
[16] Nakamura H,Uchida S,Sugiura T,et al. The prediction of the palatability of orally disintegrating tablets by an electronic gustatory system[J]. Int J Pharm,2015,493(1/2):305.
[17]李潘,韩雪,林俊芝,等.志愿者感官试验在药物味觉评价的运用及发展研究[J].中国药学杂志,2017,52(22):1971.
[18] Oliver P,Cicerale S,Pang E,et al. A comparison of temporal dominance of sensation(TDS)and quantitative descriptive analysis(QDATM)to identify flavors in strawberries[J]. J Food Sci,2018,83(4):1094.
[19] Labbe D,Schlich P,Pineau N,et al. Temporal dominance of sensations and sensory profiling:a comparative study[J]. Food Qual and Prefer,2009,20:216.
[20] Ng M,Lawlor J B,Chandra S,et al. Using quantitative descriptive analysis and temporal dominance of sensations analysis as complementary methods for profiling commercial blackcurrant squashes[J]. Food Qual and Prefer,2012,25:121.
[21]楼云雁,石婷婷,陈立兵,等.复方草珊瑚含片物质组释放特征的研究[J].中华中医药学刊,2011,29(6):1287.
[22] Ma W,Guo A,Zhang Y,et al. A review on astringency and bitterness perception of tannins in wine[J]. Trends Food Sci Tech,2014,40(1):6.
[23] Liman E R,Zhang Y V,Montell C. Peripheral coding of taste[J]. Neuron,2014,81(5):984.
[24] Margolskee R F. Molecular mechanisms of bitter and sweet taste transduction[J]. J Biol Chem,2002,277(1):1.
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