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Acotiamide hydrochloride pharmaceutical composition and preparation method thereof

A technology of acotiamide hydrochloride and its composition, which is applied in the field of acotiamide hydrochloride pharmaceutical composition and its preparation, can solve the problems of reducing the solubility of raw materials and dissolution speed, low solubility, and small solubility, and achieve good dissolution rate, Simple preparation process and good stability

Inactive Publication Date: 2017-01-25
福建生物工程职业技术学院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Invention patent CN104523686A proposes that the possible reason for the low solubility of acotiamide hydrochloride is that its own solubility is small, and it tends to become viscous when mixed with water, so that the solvent cannot enter the interior of the material, so that the dissolution method changes from dissolution to erosion, which greatly reduces the solubility of the raw material and dissolution rate

Method used

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  • Acotiamide hydrochloride pharmaceutical composition and preparation method thereof
  • Acotiamide hydrochloride pharmaceutical composition and preparation method thereof
  • Acotiamide hydrochloride pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] A preparation method of acotiamide hydrochloride pharmaceutical composition is that 0.5 parts by weight of acotiamide hydrochloride and 1 part of polyethylene glycol 4000 are added to ethanol for dissolution, the solution is added to 3 parts of lactose, and stirred After homogeneity, dry at 40° C. under reduced pressure for 8 hours at 0.08 MPa, and pass through an 80-mesh sieve to obtain the acotiamide hydrochloride pharmaceutical composition.

[0019] The obtained acotiamide hydrochloride pharmaceutical composition is mixed with other adjuvants and compressed into tablets to make tablets.

Embodiment 2

[0021] A preparation method of acotiamide hydrochloride pharmaceutical composition is that 1 part by weight of acotiamide hydrochloride and 0.5 parts of polyethylene glycol 1500 are added to ethanol for dissolution, and the solution is added to 1.5 parts of lactose and microcrystalline In the cellulose mixture (ratio 2:1), after stirring evenly, dry under reduced pressure at 0.08MPa at 40°C for 8 hours, and pass the obtained powder through an 80-mesh sieve to obtain the acotiamide hydrochloride pharmaceutical composition.

[0022] The obtained acotiamide hydrochloride pharmaceutical composition is mixed with other auxiliary materials and then filled into gelatin capsules to make capsules.

Embodiment 3

[0024] A preparation method of acotiamide hydrochloride pharmaceutical composition is that 1 part by weight of acotiamide hydrochloride and 4 parts of polyethylene glycol 6000 are added to ethanol for dissolution, and the solution is added to 5 parts of lactose and microcrystalline In the cellulose mixture (ratio 1:1), after stirring evenly, dry under reduced pressure at 0.08MPa at 40°C for 8 hours, and pass the obtained powder through an 80-mesh sieve to obtain the acotiamide hydrochloride pharmaceutical composition.

[0025] The obtained acotiamide hydrochloride pharmaceutical composition is mixed with other adjuvants and packed into bags to make granules.

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PUM

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Abstract

The invention discloses a cotiamide hydrochloride pharmaceutical composition and a preparation method thereof, comprising dissolving acotiamide hydrochloride and polyethylene glycol in ethanol, adding the solution to pharmaceutically acceptable excipients lactose or One or several compositions of microcrystalline cellulose are dried under reduced pressure to make acotiamide hydrochloride pharmaceutical composition. The obtained acotiamide hydrochloride pharmaceutical composition can be mixed with other auxiliary materials, and then directly compressed to make tablets, or filled into gelatin capsules to make capsules, or packed into bags to make granules. The acotiamide hydrochloride pharmaceutical composition prepared by the invention can significantly improve the solubility of the drug, increase the dissolution rate of the drug, improve the bioavailability of the drug, has a simple preparation process, has no special requirements for equipment, and is suitable for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of chemical pharmaceutical preparations, and in particular relates to an acotiamide hydrochloride pharmaceutical composition and a preparation method thereof. Background technique [0002] Functional dyspepsia refers to a group of clinical syndromes originating from the gastroduodenal area, characterized by postprandial fullness and discomfort, early satiety, epigastric pain or burning sensation in the upper abdomen, and belongs to the category of functional gastrointestinal diseases . This disease is clinical common disease and frequently-occurring disease, accounts for the highest proportion in stomach disease, and the course of disease is long, easy to repeat. Foreign epidemiological studies have shown that the prevalence of functional dyspepsia is between 20% and 40%. Therefore, functional dyspepsia has always been a research hotspot in the field of digestive diseases. [0003] Altecolamide Hydrochlor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K47/10A61K31/426A61P1/14
CPCA61K9/146A61K9/16A61K9/20A61K9/48A61K31/426
Inventor 何文胜陈晓英
Owner 福建生物工程职业技术学院
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