Study on quality control of Xinnaoling granules

REN Xinxin; WANG Xianyou; LU Wenquan; Piao Shujuan; GAO Shouhong

doi:10.3969/j.issn.1006-0111.2016.04.014

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Objective To establish quality control of Xinnaoling granules. Methods Thin layer chromatography (TLC) methods were used to identify Rhizoma Corydalis, Radix Angelicae dahuricae, Cortex Magnoliae officinalis, Radix Glycyrrhizae, Rhizoma Ligusticum, Ligusticum wallichii, Schisandra Chinensis, Dendranthema morifolium. The concentration of salvianolic acid B was determined by high performance liquid chromatography (HPLC). The method employed a column of Agilent Eclipse XDB-C₁₈(4.6 mm×250 mm,5 μm) with a mobile phase of 0.5% formic acid (A)-acetonitrile (B) at a temperature 25℃. The gradient elution program was as follow:0~5 min 24% B, 5~6 min 24%~19% B, 6~25 min 19~20% B. The flow rate was 1.0 ml/min, and the injection volume was 10 μl and the detection wavelength was 286 nm. Results The spots in TLC plates were clear and specific. As for salvianolic acid B, the linear range was 20-1280 μg/ml and the equation of linear regression of salvianolic acid B was Y=13.304 X-117.50 (r=0.9999, n=7). The average recovery rate was 96.17% (RSD=1.10%). Conclusion The method was proved to be simple, reliable, reproducible, and could be used in the quality control of Xinnaoling granules.

Study on quality control of Xinnaoling granules

1. Department of Pharmacy, Changzheng Hospital Affiliated to Second Military Medical University, Shanghai 200433, China;School of Pharmacy, Henan University, Kaifeng 475000, China

2. School of Pharmacy, Henan University, Kaifeng 475000, China

3. Department of Pharmacy, Changzheng Hospital Affiliated to Second Military Medical University, Shanghai 200433, China

Received Date: 2015-09-28

Rev Recd Date: 2015-12-01

Key words:

Abstract: Objective To establish quality control of Xinnaoling granules. Methods Thin layer chromatography (TLC) methods were used to identify Rhizoma Corydalis, Radix Angelicae dahuricae, Cortex Magnoliae officinalis, Radix Glycyrrhizae, Rhizoma Ligusticum, Ligusticum wallichii, Schisandra Chinensis, Dendranthema morifolium. The concentration of salvianolic acid B was determined by high performance liquid chromatography (HPLC). The method employed a column of Agilent Eclipse XDB-C₁₈(4.6 mm×250 mm,5 μm) with a mobile phase of 0.5% formic acid (A)-acetonitrile (B) at a temperature 25℃. The gradient elution program was as follow:0~5 min 24% B, 5~6 min 24%~19% B, 6~25 min 19~20% B. The flow rate was 1.0 ml/min, and the injection volume was 10 μl and the detection wavelength was 286 nm. Results The spots in TLC plates were clear and specific. As for salvianolic acid B, the linear range was 20-1280 μg/ml and the equation of linear regression of salvianolic acid B was Y=13.304 X-117.50 (r=0.9999, n=7). The average recovery rate was 96.17% (RSD=1.10%). Conclusion The method was proved to be simple, reliable, reproducible, and could be used in the quality control of Xinnaoling granules.

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Reference (7)

[1]	国家药典委员会.中华人民共和国药典2010年版一部[S].北京:中国医药科技出版社, 2010:附录VI B.
[2]	Koon CM,Woo KS,Leung PC,et al.Salviae Miltiorrhizae Radix and Puerariae Lobatae Radix herbal formula mediates anti-atherosclerosis by modulating key atherogenic events both in vascular smooth muscle cells and endothelial cells[J].J Ethnopharmacol, 2011, 138(1):175-183.
[3]	Ren ZZ, Wang X, Wang SF, et al. Mechanism of action of salvianolic acid B by module-based network analysis[J]. Bio-med Mater Engineer, 2014, 23(1):S1385-S1392.
[4]	王俊杰, 刘弘, 于天杰,等. HPLC法同时测定精制冠心颗粒中芍药苷与丹酚酸B含量[J]. 中国药师, 2013, 16(8):1175-1177.
[5]	谢琳, 庄满贤, 王亚琦,等. HPLC法同时测定养心宁神丸中丹参酮ⅡA和丹酚酸B的含量[J]. 广东药学院学报, 2015, 31(1):58-61.
[6]	李怀斌, 王毅. 丹芍生脉胶囊中丹酚酸B与芍药苷的含量测定[J]. 陕西中医, 2013, 34(8):1059-1061.
[7]	马慧萍, 李兰茹, 董志臣,等. HPLC法测定安神益智胶囊中丹酚酸B的含量[J]. 中国药师, 2014, 17(2):314-316.

[1]	国家药典委员会.中华人民共和国药典2010年版一部[S].北京:中国医药科技出版社, 2010:附录VI B.
[2]	Koon CM,Woo KS,Leung PC,et al.Salviae Miltiorrhizae Radix and Puerariae Lobatae Radix herbal formula mediates anti-atherosclerosis by modulating key atherogenic events both in vascular smooth muscle cells and endothelial cells[J].J Ethnopharmacol, 2011, 138(1):175-183.
[3]	Ren ZZ, Wang X, Wang SF, et al. Mechanism of action of salvianolic acid B by module-based network analysis[J]. Bio-med Mater Engineer, 2014, 23(1):S1385-S1392.
[4]	王俊杰, 刘弘, 于天杰,等. HPLC法同时测定精制冠心颗粒中芍药苷与丹酚酸B含量[J]. 中国药师, 2013, 16(8):1175-1177.
[5]	谢琳, 庄满贤, 王亚琦,等. HPLC法同时测定养心宁神丸中丹参酮ⅡA和丹酚酸B的含量[J]. 广东药学院学报, 2015, 31(1):58-61.
[6]	李怀斌, 王毅. 丹芍生脉胶囊中丹酚酸B与芍药苷的含量测定[J]. 陕西中医, 2013, 34(8):1059-1061.
[7]	马慧萍, 李兰茹, 董志臣,等. HPLC法测定安神益智胶囊中丹酚酸B的含量[J]. 中国药师, 2014, 17(2):314-316.

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Study on quality control of Xinnaoling granules

doi: 10.3969/j.issn.1006-0111.2016.04.014

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