The Studies On Quality Standard Of Mongolian Medicine GanLekang Capsula

Motivation:To provide a reference for the development of quality standards for the Traditional Mongolian Medicine "Ganlekang Capsule".Methods:Performing quantitative analysis on Swertia geniposide in Lomatogonium, geniposide in gardenia, matrine and oxymatrine in flavescens from the medicine by high performance liquid chromatography. For Swertia geniposide and geniposide, chromatographic conditions:chromatographic column DiamonsilC18(250mmx4.6mm,5μm); mobile phase:methanol-water(25:75); detection wavelength:238nm; temperature:30℃; velocity of flow:1.0mL-min-1; the injection volume:10μl. For matrine and oxymatrine, chromatographic conditions:chromatographic column Inertsil NH2(250mmx4.6mm); mobile phase for those:acetonitrile-ethanol-3%phosphoric acid (80:10:10); detection wavelength:220nm; temperature:30℃; velocity of flow:1.0mL·min-l;the injection volume:10μl. Performing qualitative identification on the coordinate single-agent by TLC method. Performing routine examinations lawfully on contents of arsenic salt, heavy metal, moisture, and total ash, in accordance with the special law in2010edition of "Chinese Pharmacopoeia" with reference from "Technical requirements for Traditional Chinese Drug Research".Results:Results of quantitative analysis on Swertia geniposide in Lomatogonium, geniposide in gardenia, matrine and oxymatrine in flavescens from the medicine by high performance liquid chromatography:the regression equations of Swertia gentiopicroside and geniposide respectively:A=49454C+845.27, r=0.9995; A=11819C-6099.5, r=0.9996; the injection volume for Swertia gentiopicroside is between0.31to1.86μg;within this range thereis a good linear relationship between the injection volume and the peak area, the injection volume for geniposide is between0.01to0.12μg;within this range thereis a good linear relationship between the injection volume and the peak area. The regression equations of matrine and oxymatrine respectively:A=30975C-1543.1, r=0.9998; A=55915C-4977.1, r=0.9996; the injection volume for matrine is between0.2to1.2μg;within this range thereis a good linear relationship between the injection volume and the peak area, the injection volume for oxymatrine is between0.3to1.8μg;within this range thereis a good linear relationship between the injection volume and the peak area. Results of qualitative identification on the coordinate single-agent by TLC method with three commenced systems on every single-agent indicate that the samples showed the same characteristics spots in the corresponding position of the TLC plate with the standards, while absence of characteristics spots in the corresponding position with blank group. Results of routine examinations:arsenic salt examination results of the three batches of test samples:the arsenic salt per1g contents are less than2μg,that are less than two millionths; heavy metal examination results of the three batches of test samples:the heavy metal per1g contents are less than10μg,that are less than ten millionths; moisture examination results of the three batches of test samples:7.16～7.33%; to conclude the results of routine examinations on the three batches of test samples all comply with the regulations.Conclution:the quantitative and qualitative methods of this study are so sensitive, simple, reliable, repeat and accurate as to provide a credible reference for the development of quality standards for the medicine.