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Tanshinone II A sodium sulfonate and method of determining tanshinone I sodium sulfonate in its preparation

A method of determination, the technology of sodium sulfonate, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of measurement content deviation, low sensitivity of impurity detection, poor reproducibility and quantitative accuracy, etc., and achieve measurement easy effect

Active Publication Date: 2006-11-22
SHANDONG BESTCOMM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Through experimental inspection, it is found that the detection sensitivity of impurities in this method is low, and the reproducibility and quantitative accuracy are not good.
In addition, spectrophotometry is used in the above-mentioned national standards to determine the content of tanshinone IIA sulfonate sodium and its preparations by absorption coefficient. There are certain errors in the determination of this method, because the impurities such as tanshinone IIA sulfonate sodium, etc. There is absorption at the determination wavelength of tanshinone IIA sodium sulfonate, which causes the deviation of the determination content
In the prior art, there are many reports about adopting high performance liquid chromatography (HPLC) to detect tanshinone IIA, but basically adopting methanol-water as mobile phase, it is difficult to carry out tanshinone IIA sodium sulfonate, tanshinone IIA and tanshinone I sulfonate sodium. Effective separation, but the method of controlling Tanshinone IIA sodium sulfonate content and its preparations with HPLC has no report
And to above-mentioned three kinds of substances (sodium tanshinone IIA sulfonate, tanshinone IIA and sodium tanshinone I sulfonate) adopt the method of HPLC to control content in the same system method also has no report

Method used

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  • Tanshinone II A sodium sulfonate and method of determining tanshinone I sodium sulfonate in its preparation
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  • Tanshinone II A sodium sulfonate and method of determining tanshinone I sodium sulfonate in its preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0020] Example 1 Chromatographic conditions Chromatographic column: diamonsil ODS (250×4.6mm, 5μm); mobile phase: acetonitrile-phosphate buffer (take 2.0g potassium dihydrogen phosphate, add 1000ml of water, adjust the pH to 3.0 with phosphoric acid) (two Component volume ratio 8:2), flow rate: 1ml / min; detection wavelength: 270nm; injection volume 20μl. Under this chromatographic condition, the retention times of tanshinone I sodium sulfonate, tanshinone IIA sodium sulfonate and tanshinone IIA were 5.2 minutes, 6.0 minutes and 12.5 minutes, respectively, and the substances were separated well. The peak area of ​​tanshinone I sodium sulfonate was plotted against the concentration, and the regression equation and correlation coefficient were calculated according to the least square method. The correlation coefficient r = 0.9994, indicating that the peak area has a good linear relationship with the concentration. (See attached figure 1 )

Embodiment 2

[0021] Example 2 Chromatographic conditions Chromatographic column: symmetryshield RP 18 (3.9×150mm, 5μm); mobile phase: methanol-phosphate buffer (take 3.45g of ammonium dihydrogen phosphate, add 1000ml of water, adjust the pH to 3.3 with phosphoric acid) (volume ratio of the two components 65:35), flow rate: 1ml / min; detection wavelength: 270nm; injection volume 20μl. Under this chromatographic condition, the retention times of tanshinone I sodium sulfonate, tanshinone IIA sodium sulfonate and tanshinone IIA were 3.7 minutes, 4.4 minutes and 21.8 minutes, respectively, and the substances were separated well. The peak area of ​​tanshinone I sodium sulfonate was plotted against the concentration, and the regression equation and correlation coefficient were calculated according to the least square method. The correlation coefficient r = 0.9992, indicating that the peak area has a good linear relationship with the concentration. (See attached figure 2 )

Embodiment 3

[0022] Example 3 Chromatographic conditions Chromatographic column: inertsil CN-3 (4.6×150mm, 5μm); mobile phase: methanol-phosphate buffer (take 3.45g of ammonium dihydrogen phosphate, add 1000ml of water, adjust the pH to 3.3 with phosphoric acid) ( The volume ratio of the two components is 65:35), the flow rate: 1ml / min; the detection wavelength: 270nm; the injection volume is 20μl. Under this chromatographic condition, the retention times of tanshinone IIA, tanshinone IIA sodium sulfonate and tanshinone I sodium sulfonate were 4.1 minutes, 6.0 minutes and 6.6 minutes, respectively, and the substances were separated well. The peak area of ​​tanshinone I sodium sulfonate was plotted against the concentration, and the regression equation and correlation coefficient were calculated according to the least square method. The correlation coefficient r = 0.9987, indicating that the peak area has a good linear relationship with the concentration. (See attached image 3 )

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Abstract

The invention relates to a method for qualitative and quantitative determination of tanshinone IIA sodium sulfonate and tanshinone IIA sodium sulfonate in its preparation. The present invention is made up of following steps: 1) adopt high performance liquid chromatography, use octadecylsilane bonded silica gel, hexadecylsilane bonded silica gel, octylsilane bonded silica gel or cyano group bonded silica gel as Packing agent; methanol-acetonitrile-buffer is used as the mobile phase, the volume ratio of methanol in the mobile phase is 0% to 90%, the volume ratio of acetonitrile is 0% to 90%, and the volume ratio of buffer is 5% to 90%. , the pH value of the buffer solution is 2-5; 2) Inject the sample into a high-performance liquid chromatograph for chromatographic separation and ultraviolet detection. The invention has the characteristics of high precision, convenient and reliable measurement.

Description

Technical field [0001] The invention relates to a method for the qualitative and quantitative determination of the tanshinone IIA sodium sulfonate and the tanshinone I sodium sulfonate in its preparation. Background technique [0002] Tanshinone IIA is the active ingredient of Danshen, a traditional Chinese medicine for promoting blood circulation and removing blood stasis, and has natural antioxidant effects. Due to its insoluble in water and poor intestinal absorption, after sulfonation, tanshinone IIA sodium sulfonate is obtained. It has good water solubility and can be injected intramuscularly and intravenously. It can increase coronary flow and improve myocardial damage in ischemic areas Collateral circulation and local blood supply, improve the metabolic disorder of hypoxic myocardium, improve myocardial resistance to hypoxia, inhibit platelet aggregation and anti-thrombosis, reduce the area of ​​ischemic myocardial infarction, and enhance myocardia...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/26G01N30/60G01N30/88
Inventor 孟凡清蔡西武
Owner SHANDONG BESTCOMM PHARMA CO LTD