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Dry suspension containing oseltamivir phosphate and preparation method of dry suspension

A technology of oseltamivir phosphate and dry suspension, which is applied in the field of dry suspension containing oseltamivir phosphate and its preparation, can solve the problem that qualified preparations cannot be obtained smoothly, hydrophilic auxiliary materials are easy to form agglomerates, and the content Unqualified uniformity and other problems, to achieve the effect of easy granulation, good quality uniformity and reduction of batch differences

Pending Publication Date: 2021-03-16
江苏万珺医药科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The invention provides a method for preparing a dry suspension containing oseltamivir phosphate, which solves the problem that the hydrophilic auxiliary materials in the prescription are easy to form agglomerates during the preparation process, an

Method used

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  • Dry suspension containing oseltamivir phosphate and preparation method of dry suspension
  • Dry suspension containing oseltamivir phosphate and preparation method of dry suspension
  • Dry suspension containing oseltamivir phosphate and preparation method of dry suspension

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Effect test

Embodiment 1

[0027]

[0028]

[0029] Preparation:

[0030] 1) dissolving the oseltamivir phosphate bulk drug in 40% ethanol to obtain a solution;

[0031] 2) Put the sorbitol, sodium benzoate, anhydrous monosodium citrate, and sodium saccharin in the drug-containing granules in a wet mixing granulator according to the ratio in the table and mix them for 5 minutes or more to obtain the drug-containing granules. Dry powder of granular excipients;

[0032] 3) Add the dry powder of drug-containing granules and auxiliary materials obtained in step 2 into the solid feeder, connect the solution obtained in step 1 with the extruder through a low-pulse peristaltic pump, and control the granulation temperature of the twin-screw extruder at 20-25 ℃, adjust the feeding speed of dry powder to 2.0-5.0kg / hr, the speed of peristaltic pump to 4rpm-10rpm, and the speed of twin-screw to 300rpm-600rpm; start feeding after discarding the material 5 minutes before extrusion to obtain wet granules;

[0...

Embodiment 2

[0041]

[0042] Preparation:

[0043] 1) Put the oseltamivir phosphate bulk drug, sorbitol, sodium benzoate, anhydrous monosodium citrate, and sodium saccharin in a wet mixing granulator and mix evenly;

[0044] 2) Add 40% ethanol water in step 1 to carry out wet granulation, set the stirring speed to 300rpm, and the shearing speed to 2000rpm; the obtained wet granules form agglomerates, and then pass through a sieve with an aperture of 1.0mm for 3 times;

[0045] 3) Put the wet granules in an oven and dry at 40-50°C for 2 hours to obtain dry granules;

[0046] 4) The dried granules are passed through a sieve with an aperture of 1.0mm for granulation,

[0047] 5) Sorbitol and titanium dioxide in the non-medicinal granules are placed in a mixing granulator and mixed evenly;

[0048]6) Add 40% ethanol water to step 5 to carry out wet granulation, set the stirring speed to 300rpm, and the shearing speed to 2000rpm; the obtained wet granules form agglomerates, and then pass t...

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Abstract

The invention belongs to the field of medicine processing, and relates to a dry suspension containing oseltamivir phosphate and a preparation method of the dry suspension. The dry suspension comprisesraw materials containing drug-containing particles and non-drug-containing particles, wherein the drug-containing particles are prepared from the following raw materials: oseltamivir phosphate, sorbitol, sodium benzoate, anhydrous sodium citrate, saccharin sodium and an ethanol aqueous solution; and the non-drug-containing particles are prepared from the following raw materials: sorbitol, titanium dioxide and an ethanol aqueous solution. According to the dry suspension and the preparation method, a twin-screw extrusion granulation technology is adopted to solve the problems that hydrophilic auxiliary materials in a prescription are easy to agglomerate in the preparation process, the content uniformity is unqualified through detection, a qualified preparation cannot be smoothly obtained, and by means of the preparation method, granulation is enabled to be easier during preparation, the process can be continuously operated, and the stability is better.

Description

technical field [0001] The invention belongs to the field of pharmaceutical processing, and relates to a dry suspension containing oseltamivir phosphate and a preparation method thereof. Background technique [0002] Oseltamivir phosphate is the most commonly used and one of the most effective drugs against avian influenza, influenza A H1N1 virus and influenza B virus, which can greatly reduce the occurrence of influenza complications. Its mechanism of action is through oral administration of oseltamivir phosphate, which is metabolized in the human body to produce a substance similar to viral neuraminidase, which competes in the process of virus reproduction and interferes with the release of the virus from infected cells, thereby reducing the spread of influenza virus . [0003] At present, the formulations of oseltamivir phosphate listed in my country are mainly capsules, which are mainly used for adult patients. On the one hand, because the dose is too large, it is not ...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/215A61P31/16A61J3/00
CPCA61K31/215A61K9/1623A61K9/1682A61P31/16A61J3/00
Inventor 伍贤志宋先宏柏丹丹
Owner 江苏万珺医药科技有限公司
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