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3-hydroxytanshinone IIA sodium sulfonate as well as preparation method and application thereof

A technology of hydroxysalvia and sodium sulfonate, applied in steroids, measuring devices, instruments, etc., can solve the problems of non-therapeutic related substances affecting product quality or product purity, etc.

Active Publication Date: 2013-02-13
SPH NO 1 BIOCHEM & PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem to be solved by this invention is to provide a kind of tanshinone II A sodium sulfonate in order to overcome the defect that non-therapeutic related substances in the tanshinone II A sulfonate raw materials and injections affect product quality or product purity in the prior art. The impurity compound 3-hydroxytanshinone II A sodium sulfonate and its preparation method and use

Method used

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  • 3-hydroxytanshinone IIA sodium sulfonate as well as preparation method and application thereof
  • 3-hydroxytanshinone IIA sodium sulfonate as well as preparation method and application thereof
  • 3-hydroxytanshinone IIA sodium sulfonate as well as preparation method and application thereof

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Experimental program
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Effect test

Embodiment 13

[0033] The separation and purification of embodiment 13-hydroxytanshinone II A sodium sulfonate

[0034]Get batch number and be 0908205 tanshinone IIA sodium sulfonate raw material 10g, dissolve with 20% methanol, adopt low-pressure reverse-phase column chromatography to separate, column chromatography filler is reverse-phase silica gel ODS-A (50 μ m, produced by YMC Company), and the packing quality used is 1000g , the packed column height is 1.2m, the mobile phase is 20% methanol solution, and the flow rate is 2 ml / s. Finally, pure methanol is used to flush the column. Two times of the column volume is a mobile phase fraction, and 7 groups of fractions are collected; The 2 streams were combined, and the above-mentioned low-pressure reversed-phase column chromatography was separated again, the mobile phase was 15% methanol solution, and the flow rate was 4 ml / s. Finally, pure methanol was used to flush the column, and 4 groups of fractions were collected; the second fraction w...

Embodiment 23

[0035] The structural identification of embodiment 23-hydroxytanshinone II A sodium sulfonate

[0036] Adopt Varian Inova-400 type nuclear magnetic resonance instrument (Varian company) to detect above-mentioned separation product, take TMS (tetramethylsilane) as internal standard substance, frequency 400MHz, solvent CD 3 OD, the detection data are as follows:

[0037] carbon number

Embodiment 33

[0038] Example 33-Hydroxytanshinone II A sodium sulfonate is used as a reference substance to determine related substances of tanshinone II A sodium sulfonate raw material

[0039] Use octadecylsilane bonded silica gel as filler, Diamonsil, C 18 (4.6×250mm, 5μm) chromatographic column, using methanol: 0.02mol / L disodium hydrogen phosphate solution as 65:35, dilute phosphoric acid to adjust the pH to 6.0 as the mobile phase; the detection wavelength is 271nm, and the flow rate is 1.0ml / min; The injection volume is 20 μl; take this product (see below for the batch number), which is equivalent to 2 mg of Tanshinone II A sodium sulfonate, put it in a 10 ml measuring bottle, add mobile phase to dissolve and dilute to the mark, shake well, and use it as the test solution; take 3 -Hydroxytanshinone II A sodium sulfonate reference substance 20mg is placed in a 100ml measuring bottle, diluted to the mark with mobile phase, shaken up, and used as a contrast solution; according to the ch...

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Abstract

The invention discloses a chemical compound shown in the specification, namely 3-hydroxytanshinone IIA sodium sulfonate, and also discloses a preparation method and application of the 3-hydroxytanshinone IIA sodium sulfonate. The 3-hydroxytanshinone IIA sodium sulfonate of the invention can serve as a reference substance so as to detect and control the contents of the raw materials of sodium Tanshinone IIA and the 3-hydroxytanshinone IIA sodium sulfonate in the preparation.

Description

technical field [0001] The present invention specifically relates to 3-hydroxytanshinone II A sodium sulfonate and its preparation method and application. Background technique [0002] Salvia miltiorrhiza is the dry root and rhizome of Salvia miltiorrhiza Bge. The chemical components of Danshen are mainly fat-soluble tanshinone and water-soluble phenolic acid. These two types of compounds have been confirmed by many medical literature and clinical applications. Tanshinone II A, the representative substance in fat-soluble components, undergoes a sulfonation reaction to generate sodium tanshinone II A sulfonate, which greatly increases water solubility and obtains a new drug with higher efficacy. The drug is mainly used for the treatment and prevention of cardiovascular and cerebrovascular diseases. After Tanshinone II A Sodium Sulfonate Injection was introduced to the market, its definite curative effect has been recognized by the majority of doctors and patients. [0003] T...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07J73/00G01N30/02G01N30/36
Inventor 黄臻辉琚姝陈建涛
Owner SPH NO 1 BIOCHEM & PHARMA CO LTD