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High-purity strontium ranelate and preparation method thereof

A high-purity strontium ranelate technology, applied in the field of high-purity strontium ranelate and its preparation, can solve the problems of low product purity and lack of single impurity control

Inactive Publication Date: 2010-06-23
CHONGQING PHARMA RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] Therefore, in the existing strontium ranelate preparation technology, there is product purity not high, or though can control higher purity, but lacks the deficiencies such as the control of single impurity

Method used

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  • High-purity strontium ranelate and preparation method thereof
  • High-purity strontium ranelate and preparation method thereof
  • High-purity strontium ranelate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0106] HPLC Analysis of Strontium Ranelate and Related Substances

[0107] Octadecylsilane bonded silica gel was used as filler (AQ-C18); detection wavelength was 210nm; flow rate was 1.0ml / min, and 0.1% phosphoric acid solution-acetonitrile (84:16) was used as mobile phase. The limit of detection is lower than 0.001%, and the limit of quantification is lower than 0.005%.

[0108] Assay method: Take an appropriate amount of this product, weigh it accurately, add mobile phase to dissolve and quantitatively dilute to make a solution containing 100 μg of strontium ranelate (calculated as dry product) per 1 ml, and accurately measure 20 μl and inject it into a high-performance liquid chromatograph. Record the chromatogram; use the area normalization method to calculate the peak area. The chromatographic peak of the impurity 4-cyano-5-[bis(carboxymethyl)amino]-3-thiopheneacetic acid can be effectively separated from the main peak.

Embodiment 2

[0109] The preparation of embodiment 2 high-purity strontium ranelate

Embodiment 2a

[0111]In a 2L reaction flask, add 2-[N, N-di(carboxymethyl)amino]-3-cyano-4-carboxymethylthiophene-5-carboxylic acid tetraethyl ester (formula II compound) 100g (0.22mol) and ethanol 850ml, stirring and dissolving, cooling system internal temperature to 10~20 ℃, adding sodium hydroxide solution prepared by sodium hydroxide 61.6g (1.54mol) and purified water 300ml; Stir and react at ~20°C for 6 hours, add 195.5g (0.55mol) of strontium bromide (hexahydrate), stir at 20~25°C for about 2 hours, and precipitate a solid; Wash with water until the pH of the water layer is about 7, and drain; the filter cake is dried at 60-70°C under reduced pressure (vacuum degree 0.080-0.095MPa) to obtain strontium ranelate tetrahydrate. Properties: white powder; loss on drying: 12.1%; HPLC purity 99.6%, 4-cyano-5-[bis(carboxymethyl)amino]-3-thiopheneacetic acid 0.27%, other maximum impurities 0.08%.

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Abstract

The invention relates to high-purity strontium ranelate and a preparation method thereof. The high-purity strontium ranelate is characterized in that the purity of the strontium ranelate is not lower than 99.5%, and a single impurity is not greater than 0.4%. The high-purity strontium ranelate is suitable for medicinal use and can effectively control the quality of products. The invention also relates to a medicine composition prepared by mixing a medicinal carrier and the high-purity strontium ranelate.

Description

Technical field: [0001] The invention relates to the fields of medicine and chemistry, in particular to a high-purity strontium ranelate and a preparation method thereof. Background technique: [0002] Strontium ranelate (Strontium Ranelic, structural formula shown in formula I) is a new generation of anti-osteoporosis drugs, and is the first drug with dual mechanisms of inhibiting bone resorption and promoting bone formation. On the one hand, strontium ranelate increases the synthesis of collagen and non-collagen in osteoblast-rich cells, and promotes osteoblast-mediated bone formation by enhancing the proliferation of pre-osteoblasts; Reduce osteoclast differentiation and resorption activity, reduce bone resorption, so that bone renewal can be rebalanced, which is beneficial to bone formation. Therefore, strontium ranelate has the advantages of significant curative effect, high safety and good tolerance. This product needs to be taken for a long time, the dosage is 2g / da...

Claims

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Application Information

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IPC IPC(8): C07D333/38G01N30/02A61K31/381A61P19/10
Inventor 罗斌罗杰叶文润蒋勇李煌李佳岳杨
Owner CHONGQING PHARMA RES INST
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