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Pharmaceutical composition of oseltamivir phosphate coated particles, as well as application and preparation method

A technology of oseltamivir phosphate and oseltamivir phosphate, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, to achieve the effect of stable pharmaceutical composition preparations and low cost

Active Publication Date: 2020-12-25
北京民康百草医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The object of the present invention is to provide a pharmaceutical composition, use and preparation method of oseltamivir phosphate coated granules to solve problems including drug stability, dry suspension Dosage stability and other issues

Method used

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  • Pharmaceutical composition of oseltamivir phosphate coated particles, as well as application and preparation method
  • Pharmaceutical composition of oseltamivir phosphate coated particles, as well as application and preparation method
  • Pharmaceutical composition of oseltamivir phosphate coated particles, as well as application and preparation method

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preparation example Construction

[0035] The present invention also provides a kind of preparation method of dry suspension, described method comprises the following steps:

[0036] (1) Mix oseltamivir phosphate, pH regulator sodium citrate and citric acid, and flavoring agent essence in a weight ratio of 4:6:1 to 1:2:1;

[0037] (2) add pure water to make oseltamivir phosphate drug-containing granule as binder wet method;

[0038] (3) dissolving / suspending xanthan gum and sunscreen agent titanium dioxide in an aqueous solution to obtain a coating solution, the solid concentration of which is 10%-15% (w / w);

[0039] (4) Coating the drug-containing granules with the coating liquid in a fluidized bed after drying to obtain coated granules;

[0040] (5) Weigh the coated granules of the prescribed amount, add the sorbitol granules of the prescribed amount, and mix evenly.

[0041] In the above method, the content of the suspending agent is 60%-80% (w / w). The suspension time of the dry suspension of the present ...

Embodiment 1

[0044] Embodiment 1: Preparation of dry suspension sample 1 containing oseltamivir phosphate

[0045] Preparation prescription for dry suspension:

[0046]

[0047] Preparation Process:

[0048] In addition to the essence, weigh the prescribed amount of oseltamivir phosphate and various auxiliary materials, pass through a 60-mesh sieve, and sorbitol through a 40-mesh sieve, mix uniformly by equal addition method, then add 2.0g of pure water to make a soft material, and pass through a 60-mesh sieve. 30-mesh sieve, dry at 60°C for 1 hour, add essence, pass through 30-mesh sieve for granulation, and mix well.

Embodiment 2

[0049] Embodiment 2: Preparation of dry suspension sample 2 containing oseltamivir phosphate

[0050] Preparation prescription for dry suspension:

[0051]

[0052] Preparation Process:

[0053]All materials are passed through a 40-mesh sieve. Take sodium citrate, citric acid, sorbitol, and xanthan gum and mix evenly, add 2g of pure water as a binder to prepare a soft material, and pass through a 30-mesh sieve to obtain granules. Dry in an oven at 60°C for two hours, then sieve through a 30-mesh sieve, add raw materials, titanium dioxide, and essence to obtain the product.

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Abstract

The invention provides a pharmaceutical composition of oseltamivir phosphate coated particles, as well as application and a preparation method. The pharmaceutical composition comprises coated particles and drug-free particles, and the weight ratio of the coated particles to the drug-free particles is (1: 10) to (1: 2); the coating particles comprise oseltamivir phosphate-containing medicinal particles and a coating layer, and the coating layer comprises xanthan gum and opacifier titanium dioxide; the oseltamivir phosphate-containing medicinal particles comprise oseltamivir phosphate, a pH regulator sodium citrate and citric acid, a flavoring agent essence and an adhesive pure water; and the weight ratio of oseltamivir phosphate to the pH regulator to the flavoring agent is 2: 3: 1. According to the oseltamivir phosphate coated particle pharmaceutical composition, the application and the preparation method provided by the invention, oseltamivir phosphate is prevented from being degradedby related auxiliary materials and external factors, the pharmaceutical composition is ensured to be rapidly dissolved out, and the due preparation effect is ensured; and the preparation operation issimple, the cost is reduced, and the industrial production efficiency is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmacy and pharmacy, and in particular relates to a pharmaceutical composition, application and preparation method of oseltamivir phosphate coated granules. Background technique [0002] Oseltamivir phosphate, chemical name (3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid ethyl ester Phosphate, its structural formula is shown in the following formula I. Oseltamivir phosphate, its preparation and use in therapy have been described in US Patent 5763483. Oseltamivir phosphate is an antiviral drug and a neuraminidase inhibitor, which inhibits the mature influenza virus from leaving the host cell, thereby inhibiting the spread of the virus in the human body. Has inhibitory activity against wild-type and H274y mutants of H1N1 and H5N1 viruses. For the treatment of influenza A and B in adults and children aged 1 and over (oseltamivir phosphate can effectively treat influenza...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K47/36A61K47/02A61K31/215A61P31/16
CPCA61K9/5036A61K9/501A61K31/215A61P31/16
Inventor 肖绪勇喻芳邻刘云涛谷金秒于红霞马海涛
Owner 北京民康百草医药科技有限公司
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