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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, poor reproducibility and quantitative accuracy, and low sensitivity of impurity detection, and achieve the goal of measuring easy effect

Active Publication Date: 2005-06-08
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, 5 μm); mobile phase: acetonitrile-phosphate buffer (take 2.0 g of potassium dihydrogen phosphate, add 1000 ml of water, adjust the pH value to 3.0 with phosphoric acid) (two Component volume ratio 8:2), flow rate: 1ml / min; detection wavelength: 270nm; injection volume 20μl. Under the chromatographic conditions, the retention times of sodium tanshinone I sulfonate, sodium tanshinone IIA sulfonate, and tanshinone IIA were 5.2 minutes, 6.0 minutes, and 12.5 minutes, respectively, and the substances were well separated. The peak area of ​​sodium tanshinone I sulfonate was plotted against the concentration, and the regression equation and correlation coefficient were calculated by the least square method. The correlation coefficient r=0.9994, indicating that the peak area had a good linear relationship with the concentration. (See Attachment 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 value to 3.3 with phosphoric acid) (volume ratio of the two components is 65:35), flow rate: 1ml / min; detection wavelength: 270nm; injection volume 20μl. Under these chromatographic conditions, the retention times of sodium tanshinone I sulfonate, sodium tanshinone IIA sulfonate and tanshinone IIA were 3.7 minutes, 4.4 minutes and 21.8 minutes, respectively, and the substances were well separated. The peak area of ​​tanshinone I sulfonate sodium was plotted against the concentration, and the regression equation and correlation coefficient were calculated by the least square method. The correlation coefficient r=0.9992, indicating that the peak area had a good linear relationship with the concentration. (See Attachment 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 value 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 these chromatographic conditions, the retention times of tanshinone IIA, sodium tanshinone IIA sulfonate and sodium tanshinone I sulfonate were 4.1 minutes, 6.0 minutes and 6.6 minutes, respectively, and the substances were well separated. The peak area of ​​sodium tanshinone I sulfonate was plotted against the concentration, and the regression equation and correlation coefficient were calculated by the least square method. The correlation coefficient r=0.9987, indicating that the peak area had a good linear relationship with the concentration. (See Attachment 3)

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Abstract

The invention relates to a qualitative and quantitative measuring method for tanshinone IIA sodium mercuric thiocyana and tanshinone I sodium mercuric thiocyana in its preparation, including the following steps: 1) use highly efficient liquid phase chromatography method, choose at least one as filling material from octadecyl silane linking aerosol, and aerosol linking aerosol,; make methyl alcohol- -buffer solution as mobile phase 6 in which the volume rate of methyl alcohol is 9-90%, 8 is 0-90%, buffer solution is 5-90% and the PH value of it is 2-5; 2) inject the sample into the highly efficient liquid phase chromatograph to do chromatographic fractionation and ultraviolet test. The advantages are high accuracy, simple measurement and high reliability.

Description

technical field [0001] The invention relates to a method for qualitative and quantitative determination of tanshinone IIA sodium sulfonate and tanshinone IIA 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 effect. Because it is insoluble in water and has poor intestinal absorption, tanshinone IIA sodium sulfonate is obtained after sulfonation, which has good water solubility and can be administered intramuscularly and intravenously. It can increase coronary flow and improve myocardial ischemia. Collateral circulation and local blood supply can improve the metabolic disorder of hypoxic myocardium, improve the ability of myocardium to withstand hypoxia, inhibit platelet aggregation and anti-thrombosis, reduce the size of ischemic myocardial infarction, and at a certa...

Claims

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Application Information

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IPC IPC(8): G01N30/60G01N30/88
Inventor 孟凡清蔡西武
Owner SHANDONG BESTCOMM PHARMA CO LTD
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