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A high efficient liquid phase analysis method of sodium tanshinone IIA sulfonate

A high-performance liquid analysis and high-performance liquid chromatography technology, applied in the field of medicine, can solve the problems of ineffective analysis, poor precision and sensitivity, and low sensitivity.

Active Publication Date: 2007-04-25
JIANGSU CAREFREE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] Thin-layer analysis method controls the related substances of the drug, the color is judged by naked eyes, the precision and sensitivity are very poor, and the test found that the separation of tanshinone IIA sodium sulfonate and tanshinone I sulfonate sodium on the thin layer is very poor
The raw materials and preparations are all determined by ultraviolet method. The impurity tanshinone I sulfonate sodium and tanshinone IIA are similar to the main drug tanshinone IIA sodium sulfonate in structure, and their UV absorption groups are exactly the same, with poor specificity, low sensitivity and precision. rise
[0013] Now with the advancement of analysis technology and equipment, most of the raw material sellers of tanshinone IIA sodium sulfonate use high performance liquid phase analysis to control the content. Using the high performance liquid phase analysis conditions for content determination, tanshinone IIA does not have a peak, and the relevant The substance tanshinone IIA also exists and should be controlled, so simply using the HPLC analysis conditions for the determination of this content cannot effectively analyze all related substances in this product, and other methods should be used
There is no report on the control of related substances in this product by HPLC analysis

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1 Liquid phase analysis of raw materials and preparations of sodium tanshinone IIA sulfonate.

[0025] Take an appropriate amount of raw materials or preparations of this product, and make a 0.5mg / ml solution with mobile phase for testing.

[0026] Analytical column: reversed-phase chromatographic column, C18 column or C8 column, etc.

[0027] Detection wavelength: 271nm or 228nm.

[0028] Flow rate: 0.5ml / min-1.5ml / min

[0029] High-efficiency liquid phase mobile phase conditions: the organic phase can be methanol or acetonitrile, and the aqueous phase can be phosphate buffer or ion pair test solution;

[0030] The aqueous phase phosphate buffer salt is one or more of phosphate solution of 1-100mmol / L, sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, ammonium dihydrogen phosphate, etc. , adjust the pH value to 2.5-4.0 with phosphoric acid.

[0031] The ion-pair reagent solution in the ...

Embodiment 2

[0034] Example 2 Raw material tanshinone IIA sodium sulfonate related substance specificity test.

[0035] With mobile phase methanol: 20mmol / l sodium dihydrogen phosphate solution pH value 3.5 (70:30) as solvent, prepare the following solutions respectively:

[0036] ① Take tanshinone IIA sodium sulfonate raw material equivalent to about 5mg, add 1ml of 1mol / L hydrochloric acid solution, let it stand for 2-3 hours, add mobile phase to dilute to 10ml;

[0037] ②Take tanshinone IIA sodium sulfonate raw material equivalent to about 5mg, add 1ml of 1mol / L sodium hydroxide solution, let it stand for 2-3 hours, add mobile phase to dilute to 10ml;

[0038] ③ Take about 5 mg of tanshinone IIA sodium sulfonate raw material, add 1 ml of 3% hydrogen peroxide solution, let it stand for 2-3 hours, add mobile phase to dilute to 10 ml;

[0039] ④ Take tanshinone IIA sodium sulfonate raw material to prepare a solution of tanshinone IIA sodium sulfonate equivalent to 0.5mg / ml and place it at...

Embodiment 3

[0043] Example 3 Determination of related substances of Tanshinone IIA sodium sulfonate raw material.

[0044]Take three batches of raw materials of sodium tanshinone IIA sulfonate, the manufacturer Shanghai Ziyuan Pharmaceutical Co., Ltd., accurately weigh an appropriate amount (equivalent to about 5mg), put it in a 10ml measuring bottle, add about 10ml of mobile phase, and ultrasonicate for 20 minutes to make sodium tanshinone IIA sulfonate Dissolve the raw material, add mobile phase to the mark, shake well, and filter. Accurately measure an appropriate amount of continued filtrate, and dilute it with mobile phase into a solution containing 0.5 mg of sodium tanshinone IIA sulfonate per 1 ml, as the test solution; accurately measure 1 ml of need test solution, put in a 100 ml measuring bottle, and dilute with mobile phase To the mark, as a control solution; take 10 μl of the control solution and inject it into the liquid chromatograph, and adjust the detection sensitivity so ...

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Abstract

The invention is a high performance liquidoid analytical method of tanshinone IIA sodium sulfonate which employs the reverse-phase gradient elution method, The proportion of organic phase and aqueous phase is 0-80:20-40 at 0 minute -8 to 20 minutes,the proportion of organic phase and aqueous phase is 80-95:5-20 at 8 minutes to 20 minutes -20 to 40 minutes. The invention can detect the tanshinone IIA, tanshinone I sodium sulfonate and other relative substance in tanshinone IIA sodium sulfonate at the same time, resolve the shortage of general liquid phase analysis, effectively control the quality of raw material of tanshinone IIA sodium sulfonate and its preparation, quickly and conveniently detect the relative substance of raw material of tanshinone IIA sodium sulfonate and its preparation.

Description

technical field [0001] The invention relates to a high-efficiency liquid phase analysis method for sodium tanshinone IIA sulfonate, which has a good effect on the control of related substances of the drug and the improvement of the quality standard of the drug, and belongs to the field of medicine [0002] technology field. Background technique [0003] Salvia miltiorrhiza is the dry root and rhizome of Salvia miltiorrhiza in the labiatae family. It has the effects of removing blood stasis and stopping bleeding, promoting blood circulation and regulating menstruation, clearing heart and eliminating troubles. It is a commonly used traditional Chinese medicine for promoting blood circulation and removing blood stasis. Its active ingredients are fat-soluble diterpene compounds and water-soluble phenolic acids. class of compounds. There is a saying in traditional Chinese medicine that "one flavor of Danshen drink has the same effect as Siwu Decoction", and its efficacy can be s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/34G01N30/28
Inventor 秦引林何龙其
Owner JIANGSU CAREFREE PHARM CO LTD
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