丹参提取物中脂溶性成分检测及体外溶出行为考察
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摘要
目的建立丹参脂溶性成分丹参酮Ⅰ、丹参酮ⅡA及隐丹参酮高效液相色谱(HPLC)同步测定方法,并考察其体外溶出行为。方法选用Agilent HC-C18(4.6 mm×250 mm,5μm)色谱柱,以乙腈-水(含0.1%甲酸)为流动相梯度洗脱,同时测定丹参酮Ⅰ、丹参酮ⅡA及隐丹参酮含量,考察十二烷基硫酸钠(SDS)浓度、溶出液p H值和溶出仪转速对3种成分溶出行为的影响。结果丹参酮Ⅰ回归方程为Y=0. 202 3X+0. 296 7 (R2=0. 999 2),线性范围为1. 45～93.00μg·m L~(-1);丹参酮ⅡA回归方程为Y=0.445 6X+0.527 2(R2=0.999 4),线性范围1.29～82.50μg·m L~(-1);隐丹参酮回归方程为Y=0.131 8X+0.000 2(R2=1.000),线性范围0.90～57.50μg·m L~(-1),方法精密度和回收率均良好,随着溶出液中SDS浓度的增加,3种脂溶性成分溶出度逐渐增加,溶出液p H值及溶出仪转速对3种成分的体外溶出均无显著影响。结论所建立的HPLC方法能准确、灵敏地同时检测丹参3种脂溶性成分,SDS的加入能促进丹参3种脂溶性成分的溶出,溶出液的p H值和溶出仪转速对3种成分的体外溶出无影响。
Objective To establish a method of simultaneous determination of tanshinone Ⅰ,tanshinon Ⅱ A and cryptotanshinone,three liposoluble constitue of salvia miltiorrhiza and investigate of its dissolution behavior in vitro. Methods An HPLC gradient elution method and Agilent HC-C18( 4. 6 mm×250 mm,5 μm) column was used in this study the mobile phase was acetonitrile-water( 0.1% acetate acid). Contents of the three liposoluble components were determinated simultaneously. And the effects on the three liposoluble components of the SDS concentration,the p H value and the rotation speed of dissolution apparatus were investigated. Results The corresponding linear equation for tanshinoneⅠwas Y = 0.202 3 X+ 0.296 7( R2= 0.999 2),the linear range was 1.45-93.00 μg· m L~(-1); the corresponding linear equation for tanshinone ⅡA was Y= 0.445 6 X+0.527 2( R2= 0.999 4),the linear range was 1.29-82.50 μg·m L~(-1); the corresponding linear equation for cryptotanshinone was Y = 0.131 8 X+0.000 2( R2= 1.000),the linear range was 0.90-57.50 μg· m L~(-1),The method had well accuracy and recovery rate,with the increase of SDS concentration in the solution,the dissolution rate three liposoluble components increased gradually.There was no significant effect on the dissolution of the three components in vitro by the p H value of the solution and the rotating speed of the dissolution apparatus. Conclusion The established HPLC methods can detect three liposoluble components of salvia miltiorrhiza accurately and sensitiviely. The addition of SDS can promote the dissolution of three liposoluble components of salvia miltiorrhiza. The p H value of the dissolution solution and the rotational speed of dissolution apparatus had no effects on the dissolution of the three components in vitro.
Objective To establish a method of simultaneous determination of tanshinone Ⅰ,tanshinon Ⅱ A and cryptotanshinone,three liposoluble constitue of salvia miltiorrhiza and investigate of its dissolution behavior in vitro. Methods An HPLC gradient elution method and Agilent HC-C18( 4. 6 mm×250 mm,5 μm) column was used in this study the mobile phase was acetonitrile-water( 0.1% acetate acid). Contents of the three liposoluble components were determinated simultaneously. And the effects on the three liposoluble components of the SDS concentration,the p H value and the rotation speed of dissolution apparatus were investigated. Results The corresponding linear equation for tanshinoneⅠwas Y = 0.202 3 X+ 0.296 7( R2= 0.999 2),the linear range was 1.45-93.00 μg· m L~(-1); the corresponding linear equation for tanshinone ⅡA was Y= 0.445 6 X+0.527 2( R2= 0.999 4),the linear range was 1.29-82.50 μg·m L~(-1); the corresponding linear equation for cryptotanshinone was Y = 0.131 8 X+0.000 2( R2= 1.000),the linear range was 0.90-57.50 μg· m L~(-1),The method had well accuracy and recovery rate,with the increase of SDS concentration in the solution,the dissolution rate three liposoluble components increased gradually.There was no significant effect on the dissolution of the three components in vitro by the p H value of the solution and the rotating speed of the dissolution apparatus. Conclusion The established HPLC methods can detect three liposoluble components of salvia miltiorrhiza accurately and sensitiviely. The addition of SDS can promote the dissolution of three liposoluble components of salvia miltiorrhiza. The p H value of the dissolution solution and the rotational speed of dissolution apparatus had no effects on the dissolution of the three components in vitro.
引文
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[2]郭增军.丹参提取物中有效成分的质量控制及药动学研究[D].沈阳:沈阳药科大学,2008:7-8.
[3]国家药典委员会.中华人民共和国药典(一部)[M].北京:中国医药科技出版社,2015:76-77.
[4]张涛,张娟红,徐丽婷.中药丹参类制剂临床研究及应用进展[J].实用药物与临床,2015,18(3):330-334.
[5]叶雯,王永禄,李学明.生物药剂学分类系统在难溶性药物处方设计中的应用[J].中国医院药学杂志,2013,33(7):568-570.
[6]赵学友.响应面法优化川丹参总黄酮提取工艺及其体外抗氧化活性评价[J].中国现代应用药学,2017,34(5):686-691.
[7]张晓景,王英瑛,李俊.多波长HPLC梯度洗脱法同时测定眠安宁合剂中7个有效成分含量[J].中国现代应用药学,2015,32(2):194-198.
[8]章靓,严国鸿,江川,等.反向分子对接方法预测丹参酮ⅡB抗血小板潜在作用靶标[J].中国现代应用药学,2017,34(2):221-224.
[9]张继稳.缓控释制剂药物动力学[M].北京:科学出版社,2009:54-55.