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Solid preparation of oseltamivir phosphate

A technology of oseltamivir phosphate and solid preparations, applied in the field of solid preparations of oseltamivir phosphate and its preparation, can solve the problems of easy generation of impurities, unfavorable drug storage, poor compatibility, etc., and achieve stable quality and patient compliance Good sex and a wide range of drug users

Inactive Publication Date: 2015-09-30
SUNSHINE LAKE PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among them, on the one hand, the compatibility between sucrose and API is poor, and impurities are likely to be produced during storage, which affects the quality stability of the product and the safety of medication; on the other hand, sucrose is a highly hygroscopic sugar. Especially when used in granules, which have a large surface area, it is easier to absorb moisture, which is not conducive to the storage of drugs; finally, sucrose has high calories and is not suitable for obese and diabetic patients.

Method used

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  • Solid preparation of oseltamivir phosphate
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  • Solid preparation of oseltamivir phosphate

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preparation example Construction

[0043] Another aspect of the present invention provides a preparation method of oseltamivir phosphate solid preparation, said method comprising mixing oseltamivir phosphate, diluent, binder and optional edible essence, and / or sweetener , sieving, adding binder solution to make soft material, sieving and drying, granulation and other steps.

[0044] In some embodiments, the solid preparation of oseltamivir phosphate can be prepared according to the following method:

[0045] 1) Pass oseltamivir phosphate and maltitol through a 100-mesh sieve, and mix well;

[0046] 2) adding the binder into the solvent to form a binder solution;

[0047] 3) Add the binder solution to the mixed material in 1) to make a soft material, and use a 30-mesh screen to make wet granules;

[0048] 4) Optionally add sweeteners and / or food flavors; dry the wet granules at a temperature of 60°C, and control the moisture content of the granules below 2%;

[0049] 5) Sizing through a 20-mesh sieve, mixing ...

specific Embodiment approach

[0053] In order to enable those skilled in the art to better understand the technical solutions of the present invention, some non-limiting examples are further disclosed below to further describe the present invention in detail.

[0054] All the reagents used in the present invention can be purchased from the market.

[0055]In the present invention, mg means milligram, g means gram, RT means retention time, and RRT means relative retention time.

Embodiment 1

[0056] Embodiment 1 Oseltamivir Phosphate and Diluent Compatibility Experiment

[0057] 1) Compatibility test of API and sucrose, mannitol, fructose raw materials and excipients

[0058] Weigh an appropriate amount of raw materials and a mixture of raw and auxiliary materials into a vial, add an appropriate amount of purified water (w / w), seal it (simulating a high-temperature and high-humidity environment), and place it in an oven at 60°C. Take a sample on the 10th day to detect its related substances (Content data expressed in percentage, %).

[0059] Table 1. Compatibility results of API with sucrose, mannitol, and fructose at high temperature and high humidity for 10 days

[0060]

[0061] Table 2. Compatibility results of API with water-soluble starch, maltodextrin, and maltitol at high temperature and high humidity for 10 days

[0062]

[0063]

[0064] Note: ND stands for "Not Detectable"

[0065] discuss:

[0066] The APIs in Table 1 and Table 2 are not th...

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Abstract

The invention provides a solid preparation of oseltamivir phosphate; the solid preparation contains oseltamivir phosphate and a diluent with the effective treatment or prevention amount, wherein the diluent is maltitol; and the solid preparation further contains an adhesive and a selectable sweetening agent and / or edible essence. The solid preparation has the characteristics of being steady in quality, safe, effective, good in patient compliance and wide in drug application crowd. The invention further provides a preparation method of the solid preparation of oseltamivir phosphate. The preparation method is simple and feasible and is applied to industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a solid preparation of oseltamivir phosphate and a preparation method thereof. Background technique [0002] Oseltamivir (oseltamivir), the chemical name is (3R, 4R, 5S)-acetamide-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid ethyl ester, The structural formula is as follows: [0003] [0004] Oseltamivir phosphate is a new type of neuraminidase (NA) inhibitor with high selectivity. It can be used for influenza virus infection, bronchitis, pneumonia, general pain and severe fever. Treatment and prevention, especially effective against influenza A and B viruses. Oseltamivir was launched in Switzerland in 1999. A large number of clinical practices have proved that it has the advantages of high efficiency, low drug resistance, good patient tolerance, and high safety. It is widely used in clinical practice to prevent and treat influenza. [0005] At presen...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/16A61K9/20A61K47/26A61K47/32A61K31/215A61P31/16A61P11/00A61P29/00
Inventor 鲁科明刘维郜秋果张亮陆平王小芹黄芳芳
Owner SUNSHINE LAKE PHARM CO LTD
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