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Improved entecavir oral disintegrating tablet and its preparing method

A technology of orally disintegrating tablets and entecavir, which is applied in the field of improved entecavir orally disintegrating tablets and its preparation, can solve problems such as single method

Inactive Publication Date: 2006-06-07
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Although the existing patent (CN1317309) reports that entecavir is prepared into oral fast-melt tablets, the preparation of oral fast-melt tablets is only carried out by adding a large amount of disintegrants and granulating and compressing tablets in this patent, and the method is single

Method used

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  • Improved entecavir oral disintegrating tablet and its preparing method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] prescription:

[0030] Entecavir 0.5g

[0031] Crospovidone 60g

[0032] Microcrystalline Cellulose 40g

[0033] Lactose 15g

[0034] Sucrose 15g

[0035] Sodium saccharin 0.5g

[0036] Eudrgit L30D 7.5g

[0037]Orange essence 0.5g

[0038] A total of 1000 pieces were made

[0039] Preparation:

[0040] Add Entecavir to Eudrgit L30D suspension, add appropriate amount of water, stir evenly, then add crospovidone, microcrystalline cellulose, lactose, sucrose, sodium saccharin, orange essence, and stir while adding to form a suspension , pouring into a suitable mold, freeze-drying, pressing and sealing, and packaging.

Embodiment 2

[0042] prescription:

[0043] Entecavir 0.1g

[0044] Mannitol 20g

[0045] 20g pregelatinized starch

[0046] Guar gum 8g

[0047] Gum Arabic 12g

[0048] Xylitol 30g

[0049] Microcrystalline Cellulose 15g

[0050] Lemon essence 1g

[0051] A total of 1000 pieces were made

[0052] Preparation:

[0053] Add entecavir to the mixture of guar gum and gum arabic, stir evenly, then add mannitol, pregelatinized starch, xylitol, microcrystalline cellulose, lemon flavor, stir while adding, after forming a suspension, pour Put in a suitable mold, freeze-dry, press seal, and pack.

Embodiment 3

[0055] prescription:

[0056] Entecavir 0.25g

[0057] Gelatin 25g

[0058] Xylitol 20g

[0059] Microcrystalline Cellulose 40g

[0060] Aspartame 2.5g

[0061] Cross-linked sodium carboxymethyl starch 8.0g

[0062] Peach flavor 0.5g

[0063] A total of 1000 pieces were made

[0064] Preparation:

[0065] Add entecavir into the gelatin liquid, stir evenly, add xylitol, microcrystalline cellulose, aspartame, croscarmellose sodium starch, peach essence, stir while adding, and pour into Put in a suitable mold, freeze-dry, press seal, and pack.

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Abstract

The present invention relates to entecavir soft capsule for treating hepatitis B and its preparation process, and aims at providing oral disintegrating entecavir tablet with fast absorption, high bioavailability, convenient taking, less intestinal residue, less side and no first pass effect of liver and intestine. The present invention is prepared with entecavir as main material and certain amount of supplementary material.

Description

technical field [0001] The invention relates to a medicine convenient for taking and a preparation method thereof, in particular to a preparation method and application of entecavir orally disintegrating tablets for treating various hepatitis. Background technique [0002] Chronic hepatitis B is a serious disease caused by hepatitis B virus HBV, and it is also one of the diseases with high morbidity and mortality in the world. The virus can cause lifelong infection, liver fibrosis or cirrhosis, liver cancer, liver failure and death. According to the US Centers for Disease Control and Prevention, about 1.25 million people in the United States are infected with HBV virus, and more than 5,000 people die from hepatitis B and HBV infection-related diseases every year, and there are 100,000 new cases every year; about 100 people in Europe every year 10,000 to 2 million people are infected with HBV, of which about 90,000 people are persistently infected, and about 22,000 people ev...

Claims

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Application Information

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IPC IPC(8): A61K31/522A61K9/20A61P1/16A61P31/20
Inventor 严轶东
Owner FUKANGREN BIO PHARMA
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