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Entecavir dispersible tablet and its preparation process

A technology of entecavir and dispersible tablets, which is applied in the field of entecavir dispersible tablets for the treatment of hepatitis B and its preparation, and can solve the problems that many pharmaceutical factories, government departments, scientific research institutes and other institutions are conducting research work on the drug

Active Publication Date: 2013-05-08
HAINAN ZHONGHE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no dosage form of Entecavir on the market in the domestic market, but many pharmaceutical companies, government departments, scientific research institutes and other institutions are conducting research on this drug

Method used

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  • Entecavir dispersible tablet and its preparation process
  • Entecavir dispersible tablet and its preparation process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] prescription:

[0024] Entecavir 0.5g

[0025] Mannitol 25g

[0026] Microcrystalline Cellulose 137.5g

[0027] Croscarmell Starch Sodium 19g

[0028] Cross-linked polyvinylpyrrolidone 8g

[0029] Starch slurry 7g (calculated as starch)

[0030] Magnesium Stearate 3g

[0031] A total of 1000 pieces were made

[0032] Preparation:

[0033] First, the above-mentioned materials were crushed through a 100-mesh sieve, and after entecavir, mannitol, and microcrystalline cellulose were fully mixed, an appropriate amount of starch slurry was added to make a soft material, granulated with a 16-mesh sieve, and dried at 60°C for 3-4 hours. Hours later, the granules were sized through a 16-mesh sieve, and disintegrants cross-linked carboxymethyl starch sodium, cross-linked polyvinylpyrrolidone and lubricant magnesium stearate were added, mixed evenly, and compressed into e...

Embodiment 2

[0035] prescription:

[0036] Entecavir 0.25g

[0037] Mannitol 36g

[0038] Microcrystalline Cellulose 45g

[0039] Cross-linked sodium carboxymethyl starch 6g

[0040] Aspartame 3.6g

[0041] Lemon essence 1.2g

[0042] Talc powder 1.8g

[0043] Starch slurry 6g (calculated as starch)

[0044] A total of 1000 pieces were made

[0045] Preparation:

[0046]First, the above materials were crushed through a 100-mesh sieve, and entecavir, mannitol, and microcrystalline cellulose were fully mixed, and then an appropriate amount of starch slurry was added to make a soft material, granulated with a 16-mesh sieve, and dried at 80°C for 3 hours. , 16-mesh sieve, add disintegrant cross-linked carboxymethyl starch sodium, flavoring agent aspartame, lemon essence, lubricant talcum powder, after mixing, press into entecavir dispersible tablets.

Embodiment 3

[0048] prescription:

[0049] Entecavir 2g

[0050] Xylitol 40g

[0051] Microcrystalline Cellulose 42g

[0052] Cross-linked polyvinylpyrrolidone 12g

[0053] L-HPC 6g

[0054] Polyvinylpyrrolidone 50% alcohol solution 1.8g (calculated as polyvinylpyrrolidone)

[0055] Stevioside 2.5g

[0056] Cherry essence 2.5g

[0057] PEG6000 1.5g

[0058] A total of 1000 pieces were made

[0059] Preparation:

[0060] First, the above-mentioned materials are respectively crushed through a 100-mesh sieve, and after entecavir, xylitol, and microcrystalline cellulose are fully mixed, an appropriate amount of polyvinylpyrrolidone 50% ethanol solution is added to make a soft material, granulated with a 24-mesh sieve, 60 After drying at ℃ for 2-3 hours, sieve the granule with 20 mesh, add disintegrating agent cross-linked polyvinylpyrrolidone, L-HPC, flavor...

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Abstract

The invention relates to an Entecavir dispersible tablet for treating hepatitis B and process for its preparation by using Entecavir as raw material, charging auxiliary materials of specific species and proportions, and preparing tablet through the conventional techniques in the pharmaceutical industry.

Description

technical field [0001] The invention relates to a novel pharmaceutical preparation, in particular to an entecavir dispersible tablet for treating hepatitis B and a preparation method thereof. Background technique [0002] The morbidity and mortality caused by hepatitis B virus ((HBV) in the world is the most serious among liver viruses. According to the statistics of the World Health Organization, there are about 350 million HBV carriers in the world, causing about 100-200 deaths per year At present, there are two kinds of serum vaccines and DNA recombinant vaccines for prophylaxis; and what is commonly used for therapeutic drugs is alpha-interferon, which is not only expensive and difficult to tolerate, but also has low effective rate (only 25%-40 % of patients had remission). [0003] Entecavir (entecavir) is epoxy hydroxycarbodeoxyguanosine, a deoxyguanosine analogue that can effectively inhibit the replication of hepatitis B virus, and has a strong anti-HBV effect. The...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/522A61K9/20A61P1/16A61P31/20
Inventor 严轶东
Owner HAINAN ZHONGHE PHARM CO LTD
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