Paroxetine hydrochloride time-controlled release pharmaceutical composition and preparation method thereof

A technology of paroxetine hydrochloride and its composition, which is applied in the field of paroxetine hydrochloride timed release pharmaceutical composition and its preparation, can solve the problems of paroxetine hydrochloride timed release, etc., and achieve the goal of solving the problem of timed release, stable product quality, and optimized prescription quantity Effect

Inactive Publication Date: 2015-03-25
TIANJIN SONGRUI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0024] The object of the present invention is to provide a kind of paroxetine hydrochloride timing release pharmaceutical composition and preparation method thereof, it can overcome the deficiencies in the prior art, effectively solve the problem of paroxetine hydrochloride timing release

Method used

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  • Paroxetine hydrochloride time-controlled release pharmaceutical composition and preparation method thereof
  • Paroxetine hydrochloride time-controlled release pharmaceutical composition and preparation method thereof
  • Paroxetine hydrochloride time-controlled release pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Prepare 1000 tablets of paroxetine hydrochloride time-release pharmaceutical composition, the composition formula is as follows:

[0046] A particle

[0047]

[0048] B particle isolation layer

[0049]

[0050] When making:

[0051] 1) Take the prescribed amount of paroxetine hydrochloride and pregelatinized starch, mix well, use 3% methylcellulose solution, granulate with a 20-mesh sieve, dry at 50±5°C, granulate, and set aside;

[0052] 2) Add the remaining prescription amount of pregelatinized starch, sodium carboxymethyl starch, crospovidone, and magnesium stearate to 1), and mix to make Granule A;

[0053] 3) Mix the hydroxypropyl cellulose K15M, hydroxypropyl cellulose K4, mannitol, talcum powder, and blue lake in the prescribed amount evenly, use 8% povidone ethanol solution, granulate with a 20-mesh screen, 50± Drying at 5°C and sizing the granules to obtain granules B;

[0054] 4) Tablet compression: compressed into a cylindrical three-layer tablet w...

Embodiment 2

[0058] Simulate the large-scale production scale, with each batch of 30,000 pieces, scale up and produce 3 batches.

[0059] Sample trial batch number

[0060] It has been proved by experiments that the product prescription process is simple and feasible. More than three batches of products have been packaged in the accelerated test conditions of 40°C±2°C and relative humidity of 75%±5% for 6 months and long-term test conditions for 6 months. The results show that the quality is relatively stable and meets the production requirements.

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PUM

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Abstract

The invention relates to the technical field of drug dosage form structure, and in particular relates to a paroxetine hydrochloride time-controlled release pharmaceutical composition and a preparation method thereof. The paroxetine hydrochloride time-controlled release medicinal composition comprises a paroxetine hydrochloride drug release layer, a coated isolation layer and a coated paroxetine hydrochloride drug release layer. Through a large number of tests and prescription screening, the invention provides the paroxetine hydrochloride time-controlled release pharmaceutical composition for the majority of patients, and fills the domestic blank to meet the needs of clinical medication.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical dosage forms, in particular to a paroxetine hydrochloride time-release pharmaceutical composition and a preparation method thereof. Background technique [0002] According to statistics from the World Health Organization in 2005, the prevalence of various depressions accounts for about 11% of the global population. In China, at present, the prevalence of depression is about 3%-5%, and there are an estimated 36 million people with depression. In stark contrast to the high incidence, the identification of depression in hospitals above the prefecture and city level is currently The rate is less than 20%. In the existing depression patients, less than 10% of people receive relevant drug treatment. The direct economic burden caused by depression in my country is about 14.1 billion yuan, the indirect economic loss is about 48.1 billion yuan, and the total economic burden reaches 62.1 billion yu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/4525A61K47/38A61P25/24A61P25/22A61P25/18
Inventor 张昊
Owner TIANJIN SONGRUI MEDICAL TECH
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