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Metadoxine granules and preparation and quality control method thereof

A technology of metadoxine and granules, applied in the field of granules, can solve the problems of poor powder fluidity, unstable light and heat, unstable in the presence of acid and alkali, etc., and achieves easy processing, good stability, The effect of suitable preservation

Inactive Publication Date: 2011-04-13
HEILONGJIANG FUHE HUAXING PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But metadoxine is a white crystalline powder, the fluidity of the powder is not good, it is very easy to dissolve in water and has strong hygroscopicity, it is unstable to light and heat, and it is unstable in case of acid and alkali. , and no granules of metadoxine

Method used

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  • Metadoxine granules and preparation and quality control method thereof
  • Metadoxine granules and preparation and quality control method thereof
  • Metadoxine granules and preparation and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0085] Embodiment 1 metadoxine granule (sugar-free type) 0.5g

[0086] prescription:

[0087] Metadoxine 500g

[0088] Maltodextrin 450g

[0089] Sweet Orange Flavor 30g

[0090] Aspartame 15g

[0091] Pigment 0.2g

[0092] 5%PVPK 30 Proper amount of ethanol solution

[0093]

[0094] Make 1000 bags

[0095] Preparation method:

[0096] Weigh the prescribed amount of metadoxine, maltodextrin, sweet orange essence, and aspartame, pulverize them respectively, pass through an 80-mesh sieve, and set aside.

[0097] After mixing the above raw and auxiliary materials, add the prescribed amount of pigment and continue to mix the materials. After the materials are uniform, use 5% PVPK 30 The ethanol solution was made into wet granules through a 14-mesh sieve, and dried at (40±5)°C for 2 hours.

[0098] The dried granules are passed through a 16-mesh sieve for sizing, a...

Embodiment 2

[0101] Embodiment 2 metadoxine granule 0.25g

[0102] prescription:

[0103] Metadoxine 250g

[0104] Maltodextrin 450g

[0105] Sweet Orange Flavor 30g

[0106] Aspartame 15g

[0107] Pigment 0.2g

[0108] 5%PVPK 30 Proper amount of ethanol solution

[0109]

[0110] Make 1000 bags

[0111] Preparation method:

[0112] Weigh the prescribed amount of metadoxine, sucrose, sweet orange essence, and aspartame, pulverize them respectively, pass through an 80-mesh sieve, and set aside.

[0113] After mixing the above raw and auxiliary materials, add the prescribed amount of pigment and continue to mix the materials. After the materials are uniform, use 5% PVPK 30 The ethanol solution was made into wet granules through a 14-mesh sieve, and dried at (40±5)°C for 2 hours.

[0114] The dried granules are passed through a 16-mesh sieve for sizing, and the granules are drie...

Embodiment 3

[0117] The quality control method of embodiment 3 metadoxine granules

[0118] Identification: Accurately weigh an appropriate amount of metadoxine granules, dissolve in water to make a solution containing about 50 μg of metadoxine per 1 ml, filter, and use the filtrate as the test solution. Take another metadoxine reference substance, dissolve it in water and make a solution containing about 50 μg of metadoxine per 1 ml, as the reference substance solution. In addition, each blank auxiliary material was weighed according to one-tenth of the prescription ratio, mixed evenly, and a blank auxiliary material solution was prepared according to the preparation method of the test solution, and used as a blank auxiliary material. The above solutions were scanned in the wavelength range of 200-400nm. As a result, both the test sample and the reference solution had the maximum absorption at the wavelengths of 291±1nm and 324±1nm, while the blank excipient solution had the maximum absor...

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Abstract

The invention discloses metadoxine soluble granules as well as a preparation method and a quality control method thereof. The granules comprise the following raw and auxiliary materials in parts by weight: 250-500 parts of metadoxine and 350-550 parts of maltodextrin. The granules in the invention have the advantage of stability proved by an accelerated test, in which the granules are kept in an condition with the relative humidity of 75%+ / -5% at 40+ / -2 DEG C for 6 months, and a long-tem test, in which the granules are kept in a thermostat with the relative humidity of 60%+ / -10% and the temperature of 25+ / -2 DEG C for 12 months. A compliance test of the granules indicates the non-compliance rate of the granules in a test group is 3%, and the non-compliance rate of the granules in a control group is 23%. The result of a compatibility test of the granules indicates that the metadoxine soluble granules have no interaction with auxiliary materials in a prescription.

Description

technical field [0001] The invention relates to a granule, in particular to a soluble granule containing metadoxine, a preparation method thereof, and a quality control method of the granule. Background technique [0002] Metadoxine (I) is a metabolic balance drug listed in Italy in the 1980s, and it is a commonly used clinical drug for the treatment of chemical and alcoholic liver diseases. Experimental studies have confirmed that metadoxine has a positive effect on alcoholic liver disease, can increase the concentration of liver ATP and intracellular amino acid transport, and prevent tryptophan pyrrole enzyme from being inhibited by ethanol. It is also effective for acute and chronic alcoholism, especially It can accelerate the elimination of ethanol and acetaldehyde in plasma and urine. [0003] [0004] Molecular formula: C 8 h 11 NO 3 ·C 5 h 7 NO 3 [0005] Molecular weight: 298.30 [0006] CAS number: 74536-44-0 [0007] The dosage forms of metadoxine on t...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/4415A61K31/4015A61K47/36G01N21/31G01N30/02A61P1/16
Inventor 吴光彦
Owner HEILONGJIANG FUHE HUAXING PHARMA GROUP
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