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Acotiamide hydrochloride medicinal preparation and preparation method thereof

A technology of acotiamide hydrochloride and acotiamide hydrochloride trihydrate, applied in the field of medicine

Active Publication Date: 2015-04-22
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, the solubility and the dissolution rate of the existing acotiamide hydrochloride tablets still need to be further improved

Method used

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  • Acotiamide hydrochloride medicinal preparation and preparation method thereof
  • Acotiamide hydrochloride medicinal preparation and preparation method thereof
  • Acotiamide hydrochloride medicinal preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1 (1000 pieces amount)

[0029]

[0030]Put the raw materials into a common pulverizer to pulverize and pass through a 80-mesh sieve. Weigh the prescribed amount of acotiamide hydrochloride trihydrate and lactose in a wet granulator and pre-mix until the uniformity RSD value of the mixture is less than 3.0%, add microcrystalline cellulose and low-substituted hydroxypropyl cellulose and mix evenly, add viscose The mixture is made of soft material, granulated with a 20-mesh sieve, dried in a constant temperature oven (fluidized bed drying), granulated with a 20-mesh sieve, added with the prescribed amount of magnesium stearate, blended, tabletted, coated, and packaged.

Embodiment 2

[0031] Embodiment 2 (quantity of 1000 pieces)

[0032]

[0033] Put the raw materials into a common pulverizer to pulverize and pass through a 80-mesh sieve. Weigh the prescribed amount of acotiamide hydrochloride trihydrate and sucrose in a wet granulator and pre-mix until the uniformity RSD value of the mixture is less than 3.0%, add microcrystalline cellulose and low-substituted hydroxypropyl cellulose and mix evenly, add viscose The mixture is made of soft material, granulated with a 20-mesh sieve, dried in a constant temperature oven (fluidized bed drying), granulated with a 20-mesh sieve, added with the prescribed amount of magnesium stearate, blended, tabletted, coated, and packaged.

Embodiment 3

[0034] Embodiment 3 (quantity of 1000 pieces)

[0035]

[0036]

[0037] Put the raw materials into a common pulverizer to pulverize and pass through a 80-mesh sieve. Weigh the prescribed amount of acotiamide hydrochloride trihydrate and glucose in a wet granulator and pre-mix until the uniformity RSD value of the mixture is less than 3.0%, add microcrystalline cellulose and low-substituted hydroxypropyl cellulose and mix evenly, add viscose The mixture is made of soft material, granulated with a 20-mesh sieve, dried in a constant temperature oven (fluidized bed drying), granulated with a 20-mesh sieve, added with the prescribed amount of magnesium stearate, blended, tabletted, coated, and packaged.

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Abstract

The invention provides an acotiamide hydrochloride medicinal preparation and a preparation method thereof. The acotiamide hydrochloride medicinal preparation comprises acotiamide hydrochloride and / or a hydrate thereof, at least one diluent, at least one disintegrating agent, at least one adhesive and at least one lubricant, the diluent includes a first diluent and is a hydrophilic instant component, and a weight ratio of the hydrophilic instant component to acotiamide hydrochloride and / or the hydrate thereof is 2:5-4:5. The acotiamide hydrochloride medicinal preparation is prepared by introducing a specific proportion of the hydrophilic instant component to a medicinal preparation and by mixing the hydrophilic instant component among the above acotiamide hydrochloride effective component. When the acotiamide hydrochloride medicinal preparation is dissolved and a material accumulation phenomenon appears, an external layer hydrophilic instant auxiliary material is treated as a pore forming agent, and an internal layer hydrophilic instant auxiliary material is treated as capillaries in a raw material with the dissolving of the external layer hydrophilic instant auxiliary material, and can guide a dissolution medium to rapidly enter the raw material in order to increase the dissolution and improve the dissolution speed.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a cotiamide hydrochloride pharmaceutical preparation and a preparation method thereof. Background technique [0002] Functional dyspepsia is a group of clinical syndromes caused by gastric and duodenal dysfunction. The main symptoms include one or more of upper abdominal pain, burning sensation, postprandial fullness, and early satiety. Upper abdominal distension may also exist at the same time. , belching, loss of appetite, nausea, vomiting, etc., the organic diseases that cause these symptoms can be ruled out after examination. The prevalence of functional dyspepsia in different populations is different, and the prevalence in Western countries is about 20%-25%. There are few relevant epidemiological data in my country. A recent epidemiological survey conducted on college students in northern my country showed that the prevalence of functional dyspepsia was 9.25%...

Claims

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Application Information

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IPC IPC(8): A61K31/426A61K47/26A61K47/38A61K47/36A61P1/14
Inventor 曲继广赵晓雷孙立杰许燕芹刘芳菊程彦超杨帆李彪张玉红
Owner SHIJIAZHUANG NO 4 PHARMA
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