舒筋片定性定量方法研究
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摘要
目的建立舒筋片的定性定量研究方法。方法应用TLC鉴别方内麻黄、大黄、红花和牡丹皮;采用HPLC对舒筋片中士的宁、丹皮酚、盐酸小檗碱和芍药苷进行含量测定。结果 TLC图谱中呈现出这4种物质的特征性斑点,且斑点显色清晰,分离度好;士的宁在4.18~37.58μg·mL~(-1)与峰面积线性关系良好,r=1.000,平均加样回收率102.3%,RSD=0.59%(n=6)。盐酸小檗碱在34.5~172.5μg·mL~(-1)与峰面积线性关系良好,r=1.000,平均加样回收率97.7%,RSD=0.88%(n=6)。丹皮酚在4.09~36.79μg·mL~(-1)与峰面积线性关系良好,r=0.9999,平均加样回收率99.8%,RSD=0.62%(n=6)。芍药苷在7.24~65.16μg·mL~(-1)与峰面积线性关系良好,r=0.9996,平均加样回收率99.6%,RSD=1.9%(n=6)。结论本法简单易行,重复性好,可以作为舒筋片的质量控制的标准,为医院制剂定性定量方法研究提供了科学依据。
Objective To establish a qualitative and quantitative standard for the quality control of Shujin tablets. Methods The Ephedra sinica Stapf, Rheum officinale, Safflower carthamus and Moutan bark were identified by thin layer chromatography(TLC), and the main content of strychnine, paeonol, berberine hydrochloride and paeoniflorin in Shujin tablets was tested by high performance liquid chromatography(HPLC). Results The characteristic spots were detected on the TLC atlas. The spots developed clearly and were well separated. Strychnine gained a good linearity at 4.18-37.58 μg·mL~(-1), r = 1.000, and the average recovery was 102.3%, RSD = 0.59%(n = 6). Berberine hydrochloride was linearity at 34.5-172.5 μg·mL~(-1), r =1.000, and the average recovery was 97.7%, RSD = 0.88%(n = 6). Paeonol gained a good linearity at 4.09-36.79 μg·mL~(-1), r = 0.9999, and the average recovery was 99.8%, RSD = 0.62%(n = 6). Paeoniflorin was linearity at 7.24-65.16 μg·mL~(-1), r = 0.9996, and the average recovery was 99.6%, RSD = 1.9%(n = 6). Conclusion The method is feasible and reproducible, and can be used as the quality control standard for Shujin tablets, and to provide a scientific basis for the qualitative and quantitative study of hospital preparations.
Objective To establish a qualitative and quantitative standard for the quality control of Shujin tablets. Methods The Ephedra sinica Stapf, Rheum officinale, Safflower carthamus and Moutan bark were identified by thin layer chromatography(TLC), and the main content of strychnine, paeonol, berberine hydrochloride and paeoniflorin in Shujin tablets was tested by high performance liquid chromatography(HPLC). Results The characteristic spots were detected on the TLC atlas. The spots developed clearly and were well separated. Strychnine gained a good linearity at 4.18-37.58 μg·mL~(-1), r = 1.000, and the average recovery was 102.3%, RSD = 0.59%(n = 6). Berberine hydrochloride was linearity at 34.5-172.5 μg·mL~(-1), r =1.000, and the average recovery was 97.7%, RSD = 0.88%(n = 6). Paeonol gained a good linearity at 4.09-36.79 μg·mL~(-1), r = 0.9999, and the average recovery was 99.8%, RSD = 0.62%(n = 6). Paeoniflorin was linearity at 7.24-65.16 μg·mL~(-1), r = 0.9996, and the average recovery was 99.6%, RSD = 1.9%(n = 6). Conclusion The method is feasible and reproducible, and can be used as the quality control standard for Shujin tablets, and to provide a scientific basis for the qualitative and quantitative study of hospital preparations.
引文
[1]宋玉国,彭振雨,张新茹.HPLC法测定风湿福音丸中马钱子碱、士的宁的含量[J].中国药事,2010,24(5):507-513.
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[11]李向阳,屠万倩.RP-HPLC法测定六味地黄丸中丹皮酚、芍药苷和乌苏酸[J].中成药,2012,34(2):277-282.
[12]冯发青,王恩源,伍庆,等.HPLC法同时测定麦味地黄胶囊中马钱苷、芍药苷和丹皮酚含量[J].中成药,2012,34(12):2339-2342.
[13]杜蓉,张孟佑.HPLC法测定加味逍遥丸中芍药苷与甘草苷的含量[J].中国药房,2015,26(18):2571-2572.
[14]陈玲,敖利.RH-HPLC测定通络解毒凝胶剂中士的宁和盐酸小檗碱的含量[J].中国中医急症,2012,2(8):1259-1260.
[15]鲁燕俠,崔佳,刘鹰.反高效液相色谱法同时测定祛痹丹胶囊中士的宁和马钱子碱的含量[J].中国医院药学杂志,2001,21(8):474-475.
[2]王雪,金郎,王柄强.HPLC法测定接骨丸中马钱子士的宁含量[J].河南中医,2016,36(6):1102-1104.
[3]中国药典2015年版.一部[S].2015:50-345.
[4]于智敏,王克林,李海玉,等.常用有毒中药的毒性分析与配伍宜忌[M].北京:科学技术文献出版社,2005:59.
[5]陈卫平,王伟影,毛菊华.HPLC法测定追风舒筋活血片中马钱子碱、士的宁的含量[J].中国药师,2016,19(1):191-195.
[6]王洪福,陈晓伟.消银片中丹皮酚含量测定方法学研究[J].黑龙江医药,2014,27(1):29-30.
[7]乐建荣.牡丹皮的薄层鉴别方法[J].中国民族民间医药,2015,24(16):20.
[8]高倩.黄马缓释喷膜剂的研制[D].重庆:重庆医科大学,2016.
[9]顾伟伟,许恒,江国荣,等.HPLC法同时测定骨折合剂中6种化学成分的含量[J].中南药学,2017,15(2):210-213.
[10]赵佳丽,肖国栋,徐宏祥,等.HPLC法测定咽炎片中的黄芩苷、芍药苷和丹皮酚[J].华西药学杂志,2014,29(4):476-477.
[11]李向阳,屠万倩.RP-HPLC法测定六味地黄丸中丹皮酚、芍药苷和乌苏酸[J].中成药,2012,34(2):277-282.
[12]冯发青,王恩源,伍庆,等.HPLC法同时测定麦味地黄胶囊中马钱苷、芍药苷和丹皮酚含量[J].中成药,2012,34(12):2339-2342.
[13]杜蓉,张孟佑.HPLC法测定加味逍遥丸中芍药苷与甘草苷的含量[J].中国药房,2015,26(18):2571-2572.
[14]陈玲,敖利.RH-HPLC测定通络解毒凝胶剂中士的宁和盐酸小檗碱的含量[J].中国中医急症,2012,2(8):1259-1260.
[15]鲁燕俠,崔佳,刘鹰.反高效液相色谱法同时测定祛痹丹胶囊中士的宁和马钱子碱的含量[J].中国医院药学杂志,2001,21(8):474-475.