Medicinal composition containing tanshinon II A sodium sulfonate and its quality control method

A technology of tanshinone and sodium sulfonate, applied in the field of medicine, can solve the problems of inability, high polarity, and difficult retention of octadecylsilane-bonded silica gel column, and achieves strong controllability, high accuracy and reproducibility. Good results

Inactive Publication Date: 2005-10-26
SICHUAN UNIV
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is because the structure of sodium tanshinone IIA sulfonate and sodium tanshinone I sulfonate is relatively similar, both are in the form of diterpene quinone sulfonate, with high polarity, and will dissociate into sodium ions and diterpene quinone sulfonate ions in water, so it is difficult to Retained on octadecylsilane bonded silica column, cannot be determined

Method used

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  • Medicinal composition containing tanshinon II A sodium sulfonate and its quality control method
  • Medicinal composition containing tanshinon II A sodium sulfonate and its quality control method
  • Medicinal composition containing tanshinon II A sodium sulfonate and its quality control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] Example 1 Related substance inspection and content determination of Tanshinone IIA sodium sulfonate bulk drug

[0072] relative substance

[0073]Determined by high performance liquid chromatography (Chinese Pharmacopoeia 2000 edition two appendix V D), using octadecylsilane bonded silica gel as filler, methanol-water (volume ratio 70:30) (every 100mL water contains tetrabutyl hydroxide Ammonium (2mmol) was used as the mobile phase, the flow rate was 1mL / min, and the detection wavelength was 246nm. Get an appropriate amount of tanshinone I sulfonate sodium reference substance (self-made, confirmed by structure), accurately weighed, add mobile phase to make a solution containing 20 μg of tanshinone I sulfonate sodium in every 1 mL, and accurately measure the tanshinone I sulfonate sodium reference substance solution 10 μL was injected into the chromatograph, the chromatogram was recorded, and the peak area was calculated. Another take tanshinone IIA sodium sulfonate cr...

Embodiment 2

[0079] Example 2 Related substance inspection and content determination of tanshinone IIA sodium sulfonate bulk drug

[0080] relative substance

[0081] Determined by high performance liquid chromatography (Chinese Pharmacopoeia 2000 edition two appendix V D), with octadecylsilane bonded silica gel as filler, methanol-water (volume ratio 75:25) (every 100mL of water containing tetrabutyl hydroxide Ammonium (2mmol) was used as the mobile phase, the flow rate was 1mL / min, and the detection wavelength was 250nm. Take an appropriate amount of tanshinone I sulfonate reference substance (self-made, confirmed by structure) and tanshinone IIA reference substance, accurately weighed, add dichloromethane and methanol to dissolve, add mobile phase to make each 1mL containing tanshinone I sulfonate sodium 20 μg and Tanshinone IIA 20μg mixed reference substance solution, accurately measure 10μL of mixed reference substance solution and inject it into the chromatograph, record the chromat...

Embodiment 3

[0083] Example 3 Inspection and Content Determination of Related Substances of Tanshinone IIA Sodium Sulfonate Powder Injection

[0084] relative substance

[0085] Measured by high performance liquid chromatography (Chinese Pharmacopoeia 2000 edition two appendix V D), with octadecylsilane bonded silica gel as filler, with acetonitrile-water (volume ratio 50:50) (every 100mL water contains tetramethyl Ammonium bisulfate (0.2mmol) was the mobile phase, the flow rate was 2mL / min, and the detection wavelength was 246nm. Get an appropriate amount of tanshinone I sulfonate sodium reference substance (self-made, confirmed by structure), accurately weighed, add mobile phase to make a solution containing 20 μg of tanshinone I sulfonate sodium in every 1 mL, and accurately measure the tanshinone I sulfonate sodium reference substance solution 10 μL was injected into the chromatograph, the chromatogram was recorded, and the peak area was calculated. Take another tanshinone IIA sodium...

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Abstract

A medicinal composition is prepared from tanshinone II A-sodium sulfonate and the pharmacologically acceptable carrier, auxiliary and additive. Its quality control method features that the efficient liquid-phase chromatography is used to measure the content of tanshinone IIA-sodium sulfonate in it and the limited contents of tanshinone I-sodium sulfonate and tanshinone IIA.

Description

technical field [0001] The invention relates to a medicinal composition containing sodium tanshinone IIA sulfonate and a quality control method thereof, belonging to the field of medicine. Background technique [0002] Tanshinone IIA is the main component of the traditional Chinese medicine Salvia miltiorrhiza Bunge. Due to its poor intestinal absorption and slow clinical onset, it was sulfonated into a water-soluble sodium salt-DS-201 by Qian Mingkun et al., namely Tanshinone IIA Sodium sulfonate was successively produced by Shanghai No. 1 Pharmaceutical Factory and No. 3 Traditional Chinese Medicine Factory as injections for animal experiments and clinical use. [0003] Sodium tanshinone IIA sulfonate has strong anti-hypoxia, improving cardiac function, reducing thrombosis, etc., can reduce the content of myocardial mitochondrial lipid peroxide produced by ischemia-reperfusion, and improve the fluidity of myocardial mitochondrial membrane. It also has the effect of increa...

Claims

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Application Information

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IPC IPC(8): A61K31/343
Inventor 金辉毛声俊梁臻吴宇
Owner SICHUAN UNIV
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