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Pharmaceutical composition containing oseltamivir phosphate and preparation method thereof

A technology of oseltamivir phosphate and composition, which is applied in the field of pharmaceutical composition containing oseltamivir phosphate and its preparation, can solve the problems of complex preparation process, poor patient compliance, poor product stability, etc., and achieve simple preparation process , High patient compliance and good stability

Active Publication Date: 2021-04-30
澳美制药(苏州)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of this application is to provide a pharmaceutical composition containing oseltamivir phosphate and its preparation method, aiming to solve the problem of existing drugs containing oseltamivir phosphate to a certain extent The preparation process of the pharmaceutical composition of Tasvir is complex, the product has poor stability, low purity, and poor patient compliance.

Method used

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  • Pharmaceutical composition containing oseltamivir phosphate and preparation method thereof
  • Pharmaceutical composition containing oseltamivir phosphate and preparation method thereof
  • Pharmaceutical composition containing oseltamivir phosphate and preparation method thereof

Examples

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preparation example Construction

[0022] The first aspect of the embodiment of the present application provides a preparation method of a pharmaceutical composition containing oseltamivir phosphate, comprising the following steps:

[0023] S10. Perform a first mixing treatment on 15-45 parts of oseltamivir phosphate, 40-70 parts of a stabilizer and a first diluent to obtain a first mixture;

[0024] S20. Mix 3-20 parts of suspending agent, 3-20 parts of opacifying agent, 1-5 parts of preservative, 1-10 parts of flavoring agent and 1-5 parts of sweetener with the second diluent second mixing treatment to obtain a second mixture;

[0025] S30. Perform a third mixing process on the first mixture, the second mixture and the third diluent to obtain a pharmaceutical composition containing oseltamivir phosphate;

[0026] Wherein, the total mass parts of the first diluent, the second diluent and the third diluent are 830-920 parts.

[0027] In the preparation method of the pharmaceutical composition containing oselt...

Embodiment 1

[0057] A pharmaceutical composition (in bags) containing oseltamivir phosphate, comprising the following table 1 raw material components:

[0058] Table 1

[0059]

[0060] Its preparation includes steps:

[0061] 1. Dilute the prescribed amount of oseltamivir phosphate (D 90 380 μm), monosodium citrate and 3000g sorbitol (about 1 / 3 prescription quantity) pass through a 60-mesh sieve and mix together to obtain mixture 1;

[0062] 2. Put the prescription amount of xanthan gum, titanium dioxide, sodium saccharin, sodium benzoate, orange flavor and 1000 g of sorbitol (about 12% of the prescription amount) through a 60-mesh sieve and mix to obtain mixture 2;

[0063] 3. Finally, add mixture 1, mixture 2 and 4706g sorbitol into a three-dimensional mixer, and mix at a speed of 15rpm for 20min to obtain a pharmaceutical composition containing oseltamivir phosphate.

[0064] 4. Use a granule packaging machine to pack the mixed powder, use aluminum foil bags, each bag contains 1....

Embodiment 2

[0068] A pharmaceutical composition (bottled) containing oseltamivir phosphate, comprising the following table 2 raw material components:

[0069] Table 2

[0070]

[0071] Its preparation includes steps:

[0072] 1. Dilute the prescribed amount of oseltamivir phosphate (D 90 150 μm), monosodium citrate and 3000g sorbitol (about 1 / 3 prescription quantity) pass through a 60-mesh sieve and mix together to obtain mixture 1;

[0073] 2. Put the prescription amount of xanthan gum, titanium dioxide, sodium saccharin, sodium benzoate, orange flavor and 1000 g of sorbitol (about 12% of the prescription amount) through a 60-mesh sieve and mix to obtain mixture 2;

[0074] 3. Finally, add mixture 1, mixture 2 and 4706g sorbitol into a three-dimensional mixer, and mix at a speed of 15rpm for 20min to obtain a pharmaceutical composition containing oseltamivir phosphate.

[0075] 4. Use a granule packaging machine to sub-package the mixed powder, use glass bottles, each bottle has a ...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a pharmaceutical composition containing oseltamivir phosphate and a preparation method of the pharmaceutical composition. The preparation method comprises the following steps: carrying out first mixing treatment on 15-45 parts of oseltamivir phosphate, 40-70 parts of a stabilizer and a first diluent to obtain a first mixture; carrying out second mixing treatment on 3-20 parts of a suspending aid, 3-20 parts of an opacifying agent, 1-5 parts of a preservative, 1-10 parts of a flavoring agent, 1-5 parts of a sweetening agent and a second diluent to obtain a second mixture; and carrying out third mixing treatment on the first mixture, the second mixture and a third diluent to obtain the oseltamivir phosphate-containing pharmaceutical composition, wherein the total mass part of the diluent is 830-920 parts. The preparation method is simple in process, low in power consumption and suitable for large-scale production and application, and the safety risk of solvent residues and the influence of the drying temperature on the performance of raw material components in the wet granulation process are avoided.

Description

technical field [0001] The application belongs to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition containing oseltamivir phosphate and a preparation method thereof. Background technique [0002] The chemical name of oseltamivir phosphate is (3R,4R,5S)-4-acetylamino-5-amino-3-pent-3-yloxycyclohexene-1-carboxylic acid ethyl ester phosphate, and the molecular formula is C 16 h 28 N 2 o 4 ·H 3 PO 4 . After oral administration, oseltamivir is rapidly catalyzed by liver and intestinal esterases into its active metabolite, oseltamivir carboxylic acid. The configuration of oseltamivir carboxylic acid is similar to the transition state of neuraminic acid, which can competitively Binding to the active site of influenza virus neuraminidase, it is a potent and highly selective inhibitor of influenza virus neuraminidase, which mainly reduces the formazan by interfering with the release of virus from infected host cells Transmissio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K47/12A61K47/02A61K47/36A61K31/215A61P31/16
CPCA61K47/26A61K47/12A61K47/02A61K47/36A61K31/215A61P31/16
Inventor 黄振君魏建华齐丽娜赵小敏张兆珍李海华
Owner 澳美制药(苏州)有限公司
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