Sodium tetradecyl sulfate crystal form and preparation method, application and pharmaceutical composition containing sodium tetradecyl sulfate crystal form

A technology of sodium tetradecyl sulfate and composition, applied in the field of medicinal chemistry, achieves the effects of good reproducibility, easy industrialization, and high HPLC purity

Inactive Publication Date: 2017-01-18
SHANGHAI ZIYUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, the synthetic process patent of sodium tetradecyl sulfate has been published and expired, and there is no report on its crystal form, and the existing commercially available sodium tetradecyl sulfate is amorphous

Method used

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  • Sodium tetradecyl sulfate crystal form and preparation method, application and pharmaceutical composition containing sodium tetradecyl sulfate crystal form
  • Sodium tetradecyl sulfate crystal form and preparation method, application and pharmaceutical composition containing sodium tetradecyl sulfate crystal form
  • Sodium tetradecyl sulfate crystal form and preparation method, application and pharmaceutical composition containing sodium tetradecyl sulfate crystal form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Preparation of Sodium Tetradecyl Sulfate Crystal Form:

[0040] Add 20g of sodium tetradecyl sulfate into 180g of purified water, stir and dissolve at room temperature, filter under reduced pressure with a 0.45μm microporous membrane, pour the filtrate into a stainless steel freeze-drying tray, the height of the solution in the freeze-drying tray should not exceed 12cm, and then put Freeze-dry in a freeze-drying oven at -30°C for 38 hours to obtain the crystal form of sodium tetradecyl sulfate.

[0041] The X-ray powder diffraction pattern, infrared spectrogram and differential scanning pattern of this crystal form are as follows: figure 1 , figure 2 and image 3 shown.

Embodiment 2

[0043] Preparation of Sodium Tetradecyl Sulfate Crystal Form:

[0044] Add 20g of sodium tetradecyl sulfate into 180g of purified water, stir at room temperature to dissolve, then add 10g of ethanol and stir evenly, filter under reduced pressure with a 0.45μ microporous filter membrane, pour the filtrate into a stainless steel freeze-drying tray, the solution height in the freeze-drying tray is It should not exceed 12 cm, and then freeze-dried in a freeze-drying oven at -5°C for 37 hours to obtain the crystal form of sodium tetradecyl sulfate.

[0045] The X-ray powder diffraction pattern, infrared spectrogram and differential scanning pattern of this crystal form are as follows: figure 1 , figure 2 and image 3 shown.

Embodiment 3

[0047] Preparation of Sodium Tetradecyl Sulfate Crystal Form:

[0048] Add 20g of sodium tetradecyl sulfate into 180g of purified water, stir at room temperature to dissolve, then add 20g of ethanol and stir evenly, filter under reduced pressure with a 0.45μ microporous filter membrane, pour the filtrate into a stainless steel freeze-drying tray, the solution height in the freeze-drying tray is It should not exceed 12 cm, and then freeze-dried in a freeze-drying oven at -10°C for 36 hours to obtain the crystal form of sodium tetradecyl sulfate.

[0049] The X-ray powder diffraction pattern, infrared spectrogram and differential scanning pattern of this crystal form are as follows: figure 1 , figure 2 and image 3 shown.

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PUM

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Abstract

The invention discloses a new crystal form of sodium tetradecyl sulfate and a preparation method, application and a pharmaceutical composition containing the new crystal form of sodium tetradecyl sulfate. The sodium tetradecyl sulfate crystal form has characteristic peaks at the diffraction angle 2 theta of 4.4+/-0.2 degrees, 31.8+/-0.2 degrees and 45.5+/-0.2 degrees in the X-ray powder diffraction pattern. The sodium tetradecyl sulfate crystal form has good solubility and stability. The preparation method is simple and has good reappearance. The prepared sodium tetradecyl sulfate crystal form has high HPLC purity, is convenient for industrial promotion, and can be used for preparing medicines for treating diseases such as varicocele and vascular malformation of arms and legs and the like.

Description

technical field [0001] The invention relates to the field of medicinal chemistry, in particular to a crystal form of sodium tetradecyl sulfate, a preparation method, an application thereof and a pharmaceutical composition containing the same. Background technique [0002] Sodium tetradecyl sulfate, chemical name: 7-ethyl-2-methylundecyl-4-sodium sulfate, English common name: Sodiumtetradecyl sulfate, English name: 7-ethyl-2methyl-4-hendecanol sulfate sodium salt , Molecular formula: C14H29NaO4S, the structural formula is as follows: [0003] [0004] Sodium Tetradecyl Sulfate was developed by ELKINS SINN Company of the United States and was approved by the FDA on August 13, 1946. On December 12, 2004, Mylan Institutional of the United States was approved to go public by ANDA. The listed preparations are injections with specifications of 20mg / 2mL and 60mg / 2mL. prescription. It is clinically applicable to the treatment of varicocele, vascular malformation of extremities...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C303/24C07C303/44C07C305/06A61K31/255A61P9/14A61P7/04A61P1/16A61P1/02
CPCC07C303/24C07B2200/13C07C303/44C07C305/06
Inventor 刘伟张志刚罗剑飞
Owner SHANGHAI ZIYUAN PHARMA
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