摘要
采用减压干燥法制备黄芪生脉(HQSM)速溶片并进行质量评价.以膨胀率和溶解时间为指标,优化处方工艺;以内皮细胞损伤模型评价HQSM速溶片的内皮细胞保护作用;以HPLC法研究HQSM速溶片的主要成份.结果表明:稀释剂种类和质量分数、预制片压缩程度和真空度等因素显著影响膨胀率和溶解时间;HQSM速溶片的水溶液具有抗内皮细胞损伤作用,质量浓度越大,作用越明显;HQSM速溶片含党参炔苷、五味子醇甲和原儿茶酸等成份.HQSM速溶片工艺简单,溶解迅速,有明显活性,含多种有效成份,具有良好的开发前景.
To prepare Huang Qi Sheng Mai(HQSM)fast dissolving tablets by vacuum drying method,and evaluate their properties.The expansivity and dissolution time were used as index to optimize the formulation and technology.The endothelial cytoprotection activity of tablets was evaluated using endothelial cells injured model.Active ingredients in tablets were investigated by HPLC.The results illustrated that diluents type,diluents content,compression extent and vacuum degree had a significant influence on the expansivity and dissolution time.Tablets solutions had endothelial cytoprotection activity, which was increased with the solution concentration.Lobetyolin,schisandrin and protocatechuic acid were found in tablets.HQSM fast dissolving tablets could be easily prepared and had significant advantages,such as fast dissolving,obvious activity and various active ingredients.It had a potential to be used in practice.
引文
[1]刘华刚.中药片剂有效成分溶出速率存在的问题分析及对策思路[J].中成药,2000,22(6):443-445.
[2]胡容峰,朱家壁,彭代银,等.综合评分法优化复方丹参口腔速溶片制剂处方[J].中国中药杂志,2006,31(5):381-382.
[3]陈三宝.西洋参口腔速溶片的研制[J].食品和机械,2015,31(6):212-214.
[4]林茵,刘超平,李国成,等.黄芪有效部位口腔速崩片的研制及其质量评价[J].中药材,2007,30(7):870-872.
[5]杨桂洪.黄芪生脉饮辅助治疗病毒性心肌炎的临床疗效观察[J].2010,16(20):152-153.
[6]吕圭源,李立文,陈素红.黄芪生脉多糖两种给药途径对小鼠免疫功能的影响[J].2006,17(6):402-404.
[7]徐倩,曹凯,周晓慧.丹皮酚对同型半胱氨酸损伤内皮细胞eNOS表达及NO水平的影响[J].中成药,2012,34(12):2286-2289.
[8]楚楚,徐绍静,吴琼琼,等.HPLC同时测定生脉饮(党参方)中多组分的含量[J].中药材,2013,36(5):820-823.
[9]张晓博,谷艳玲,张丽男,等.黄芩素注射用冻干粉针剂的制备[J].中国医药工业杂志,2015,46(11):1202-1207.
[10]VANHOORNE V,VAN BOCKSTAL P J,VAN SNICK B,et al.Continuous manufacturing of delta mannitol by cospray drying with PVP[J].International journal of pharmaceutics,2016,501(1/2):139-247.
[11]王雪茵,胡永华.同型半胱氨酸代谢与脑卒中关系的研究进展[J].中华疾病控制杂志,2013,17(11):988-992.
[12]许栋明,吴丹.盐酸川芎嗪对同型半胱氨酸致ECV304细胞损伤的保护作用[J].中药中药杂志,2012,37(12):1937-1839.
[13]吴琳,刘勇,熊肇军,等.通心络胶囊对同型半胱氨酸诱导的血管内皮细胞损伤的保护作用[J].中国动脉硬化杂志,2011,19(5):385-389.
[14]应国清,郭涛,易喻,等.RP-HPLC法检测华中五味子药材中的五味子醇甲的含量[J].浙江工业大学学报,2009,37(1):6-9.
[15]覃华,张琰,杜小燕,等.原儿茶酸对大鼠心肌缺血/再灌注损伤的保护作用[J].西北药学杂志,2015,30(6):709-712.
[16]聂松柳,徐先祥,夏伦祝.党参总皂苷对实验性高脂血症大鼠血脂和No含量的影响[J].安徽中医学院学报,2002,21(4):40-42.
[17]向辉,邱云波.五味子药效与临床应用研究[J].医药导报,2011,30:89-90.
[18]颜继忠,陈岑,楚楚,等.生脉饮(党参方)中5-羟甲基糠醛的分离及其来源探究[J].浙江工业大学学报,2015,43(4):379-382.
[19]李行诺,马旭,楚楚,等.泽泻指纹图谱研究[J].浙江工业大学学报,2013,41(2):143-146.
[20]陈建真,吕圭源,陈素红,等.黄芪生脉胶囊与组方药材指纹图谱色谱峰相关性研究[J].中国中药杂志,2008,33(23):2769-2771.
[21]陆铖,周盛会,李炜,等.HPLC-DAD同时测定黄芪生脉饮中4种成分含量[J].中国中医药信息杂志,2015,22(7):96-99.