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New alfuzosin crystal form

A technology of alfuzosin and crystal form, which is applied in the field of preparation of raw materials, can solve the problems affecting the safety, effectiveness, content uniformity of tablets, difficult to reach the standard, and the increase of related substances, achieves good particle size and fluidity, avoids Material loss, effect of strong moisture resistance

Inactive Publication Date: 2018-05-25
WEIHAI GUANBIAO INFORMATION TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the research process of alfuzosin ordinary tablets, it was found that alfuzosin belongs to small-scale preparations. During the preparation process of ordinary tablets, firstly, the content uniformity is not easy to meet the standard, and secondly, after long-term storage, the tablets are seriously hygroscopic. At the same time, the increase of related substances is prominent, which affects the safety and effectiveness of the tablet
Further studies have found that the existing alfuzosin raw materials are easy to absorb moisture, and the related substances increase after moisture absorption

Method used

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  • New alfuzosin crystal form
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  • New alfuzosin crystal form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The first step 18g alfuzosin crude product is dissolved in the ethanol aqueous solution of 100ml 50%;

[0026] Step 2: At room temperature, add 1.26 g of activated carbon to the solution in Step 1, stir for 1 hour, and filter;

[0027] In the third step, under stirring, cool the filtrate of the second step to -10°C and keep it, and slowly drop 60ml of ethanol-acetone mixed solvent into it, the speed of adding ethanol-acetone mixed solvent is 0.80ml / min, and quickly cool down to - 14°C, a white solid precipitated, and continued to stir for 3 hours at a stirring speed of 160 rpm; during mixing and dissolving, the volume ratio of the two in the ethanol-acetone mixed solvent was 1:0.5;

[0028] The fourth step is to filter, and the filter cake is washed three times with the ethanol-acetone mixed solvent described in the third step at a temperature of -14°C, each time using 8ml, the filter cake is spread out, and vacuum-dried at 40°C.

[0029] The X-ray powder diffraction f...

Embodiment 2

[0031] The first step 26g alfuzosin crude product is dissolved in the aqueous ethanol solution of 100ml 60%;

[0032] Step 2: At room temperature, add 2.6 g of activated carbon to the solution in Step 1, stir for 1.5 hours, and filter;

[0033] In the third step, under stirring, the temperature of the filtrate in the second step is lowered to -3°C and maintained, and 100ml of ethanol-acetone mixed solvent is slowly added dropwise to it. At 18°C, a white solid was precipitated, and the stirring was continued for 6 hours at a stirring speed of 200 rpm; during mixing and dissolving, the volume ratio of the two in the ethanol-acetone mixed solvent was 1:1.0.

[0034] The fourth step is to filter, and the filter cake is washed three times with the ethanol-acetone mixed solvent described in the third step at a temperature of -18°C, each time 10ml, the filter cake is spread out, and vacuum-dried at 35°C.

[0035] The X-ray powder diffraction figure of this embodiment product sees at...

Embodiment 3

[0037] The first step 24g alfuzosin crude product is dissolved in the ethanol of 100ml 55%;

[0038] Step 2: At room temperature, add 2.16 g of activated carbon to the solution in Step 1, stir for 1.2 hours, and filter;

[0039] In the third step, under stirring, the second step filtrate was cooled to -5 and maintained, and 85ml of ethanol-acetone mixed solvent was slowly added dropwise at a speed of 1.3ml / min, and the temperature was quickly lowered to -16 ℃, a white solid was precipitated, and the stirring was continued for 4.5 hours at a stirring speed of 180 rpm; the volume ratio of the two in the ethanol-acetone mixed solvent was 1:0.8.

[0040] The fourth step is to filter, and the filter cake is washed three times with the ethanol-acetone mixed solvent described in the third step at a temperature of -16°C, each time 9ml, the filter cake is spread out, and vacuum-dried at 35°C.

[0041] The X-ray powder diffraction figure of this embodiment product sees attached figure...

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Abstract

The invention relates to a new alfuzosin crystal form and belongs to the technical field of preparation of bulk pharmaceutical chemicals. According to the technical scheme, the X-ray powder diffraction of the new alfuzosin crystal form has strong absorption peaks in positions where 2 theta is 7.78, 9.68, 10.14, 12.40, 13,58, 16.29, 16.78, 18.24, 19.52, 20.63, 22.65, 25.19, 26.82 and 27.16. The newalfuzosin crystal form is good in solubility stable and accordingly provides a good bulk pharmaceutical chemical for preparing alfuzosin preparations.

Description

technical field [0001] The invention relates to a new crystal form of alfuzosin, which belongs to the technical field of preparation of raw materials. Background technique [0002] Hyperplasia of the prostate, often called benign prostatic hyperplasia (BPH), is one of the common diseases of middle-aged and elderly men, and its incidence is increasing with the aging of the global population. The incidence of benign prostatic hyperplasia increases with age, and most patients have symptoms such as dysuria that increase with age. [0003] Prostatic hypertrophy is also called benign prostatic hyperplasia. Symptoms are mainly manifested in two groups of symptoms, one is bladder irritation symptoms; the other is obstructive symptoms caused by prostatic hyperplasia blocking the urinary tract. Bladder irritation symptoms: urinary frequency, urgency, nocturia, and urge incontinence. Frequent urination is an early signal of benign prostatic hyperplasia, especially the increased freq...

Claims

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Application Information

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IPC IPC(8): C07D405/12A61K31/517A61K9/20A61K47/38A61P13/08
CPCA61K9/2059C07B2200/13C07D405/12
Inventor 孙爱梅
Owner WEIHAI GUANBIAO INFORMATION TECH
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