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Compound elvucitabine medicine composition as well as preparation method and use for same

A technology of alfcitabine and a composition, which is applied in the field of compound alftabine pharmaceutical composition and its preparation, can solve the problems of reduced curative effect, unstable alfcitabine, and reduced effective content of alftabine, etc. Good stability and ensure the effect of liquidity

Active Publication Date: 2014-03-12
TIANJIN INSTITUTE OF PHARMA RESEARCH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in animal experiments, it was found that eftabine exhibited extremely unstable properties in gastric acid, which greatly reduced the effective content of eftabine in animals, and the curative effect also decreased.

Method used

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  • Compound elvucitabine medicine composition as well as preparation method and use for same
  • Compound elvucitabine medicine composition as well as preparation method and use for same
  • Compound elvucitabine medicine composition as well as preparation method and use for same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] This embodiment is used to illustrate the compound recipe eftabine pharmaceutical composition of the present invention and preparation method thereof, specifically detailed as follows:

[0069]

[0070] Preparation Process:

[0071] Put the blank pellets with a diameter of 0.1-0.5 mm into the fluidized bed (or coating pan) to keep the temperature of the pellets at 40-50°C. Eftabine and arginine were evenly mixed and dissolved in 2 wt % hypromellose aqueous solution. With a flow rate of 5mL / min, spray the mixed solution on the round blank pellets, and obtain the drug-containing pellets after drying.

[0072]

[0073]

[0074] Preparation Process:

[0075]Put the drug-containing pellets into the fluidized bed (or coating pan), and keep the temperature of the pellets at 25-35°C. Spray the enteric-coated aqueous dispersion suspension on the drug-containing pellets at a flow rate of 7 mL / min, and dry in an oven at 40°C for about 3 to 5 hours for aging to obtain e...

Embodiment 2

[0080] This embodiment is used to illustrate the compound recipe eftabine pharmaceutical composition of the present invention and preparation method thereof, specifically detailed as follows:

[0081]

[0082] Preparation Process:

[0083] First put the blank pellets with a diameter of 0.1-0.5mm into the fluidized bed (or coating pan), and keep the temperature of the pellets at 40-50°C. Eftabine and meglumine were evenly mixed and dissolved in 8 wt% povidone aqueous solution. With a flow rate of 5mL / min, spray the mixed solution on the round blank pellets, and obtain the drug-containing pellets after drying.

[0084]

[0085] Preparation Process:

[0086] Put the drug-containing pellets into the fluidized bed (or coating pan), and keep the temperature of the pellets at 25-35°C. Spray the enteric-coated aqueous dispersion suspension on the drug-containing pellets at a flow rate of 7 mL / min, and dry in an oven at 40°C for about 3 to 5 hours for aging to obtain evetabine...

Embodiment 3

[0091] This embodiment is used to illustrate the compound recipe eftabine pharmaceutical composition of the present invention and preparation method thereof, specifically detailed as follows:

[0092]

[0093]

[0094] Preparation Process:

[0095] Mix evetabine and calcium carbonate evenly, then add lactose, microcrystalline cellulose, sodium carboxymethyl starch, etc. in turn and mix well, add 5wt% povidone aqueous solution as a binder, make soft materials and place in In the extrusion granulator, it is pressed into small strips with a diameter of 0.1-1.0mm, placed in a centrifugal granulator to cut and grind, and an appropriate amount of talcum powder is added to make round pellets containing medicine, which are dried and sieved to obtain Ai. Futabine-containing pellets.

[0096]

[0097] Preparation Process:

[0098] Put the drug-containing pellets into the fluidized bed (or coating pan), and keep the temperature of the pellets at 25-35°C. Spray the enteric-coa...

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Abstract

The invention provides a compound elvucitabine medicine composition. The medicine composition comprises elvucitabine or the medicinal salts thereof, entecavir or the medicinal salts thereof and an anti-acid stabilizer. The invention further provides a method for preparing the medicine composition, comprising the following steps of: (1) mixing elvucitabine or the medicinal salts thereof with the anti-acid stabilizer, then mixing elvucitabine or the medicinal salts thereof with one or more adhesives, and attaching the obtained mixture on an empty carrier to prepare a medicated carrier; and (2) mixing the medicated carrier obtained in the step (1) with entecavir or the medicinal salts thereof and one or more pharmaceutical excipients. The invention further provides a use of the compound elvucitabine medicine composition for preparing a medicine for treating hepatitis B virus.

Description

technical field [0001] The present invention relates to a compound evetabine pharmaceutical composition and its preparation method and application, in particular to a stable compound evetabine pharmaceutical composition which can be used for treating hepatitis B virus and its preparation method and application. Background technique [0002] Hepatitis B is caused by hepatitis B virus (HBV). In my country, about 120 million people are hepatitis B virus carriers, and 28 million people are suffering from hepatitis B. A large part of them will develop into chronic hepatitis, liver cirrhosis or liver cancer. It is a disease that seriously endangers human health, so it is of great significance to develop anti-HBV drugs. At present, the main nucleoside antiviral drugs for clinical treatment of hepatitis B include lamivudine, adefovir dipivoxil, entecavir dipivoxil, entecavir, etc., among which entecavir is currently the strongest drug. However, for patients with chronic hepatitis B,...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7068A61K31/522A61K47/18A61K47/02A61P31/20
Inventor 任晓文徐为人邹美香汤立达李洪起王博连潇嫣
Owner TIANJIN INSTITUTE OF PHARMA RESEARCH
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