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Improved Enticawer suspension granules and their preparation

A technology of entecavir and suspended granules, applied in the field of entecavir suspended granules and preparation thereof, can solve the problems of low variation rate and the like, and achieve the effect of strong taste masking, increasing particle size and eliminating resistance emotions.

Inactive Publication Date: 2007-09-05
SUNSHINE LAKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Viral mutations caused by entecavir treatment only occurred in patients infected with lamivudine-resistant mutant virus strains, and the mutation rate was low (5.8%)

Method used

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  • Improved Enticawer suspension granules and their preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1 (1000 bags)

[0041] Prescription: Entecavir 0.5g, sucrose 500g, disodium glycyrrhizinate 5g, orange essence 0.5g, red scarlet 0.25g, carboxymethylcellulose sodium 15g, syrup 28g.

[0042] Preparation: (1) Entecavir powder (200 mesh) and sucrose powder (150 mesh) are added in equal amounts and mixed evenly; disodium glycyrrhizinate, sodium carboxymethyl cellulose, orange flavor and red scarlet are used as wetting agent Dissolve 95% ethanol in an appropriate amount, add raw materials and sucrose mixed powder, and then add syrup to make soft material; (2) Dry the wet granules with 18 mesh sieve until the granule drying weight loss is below 2.0%, stop drying, and then Use a 12-mesh to 40-mesh double sieve to sieve.

Embodiment 2

[0043] Embodiment 2 (1000 bags)

[0044] Prescription: Entecavir 0.25g, lactose 200g, aspartame 50g, glycyrrhizin 2.5g, peach flavor 2.5g, orange 0.12g, hydroxypropyl methylcellulose 18g, starch slurry 24g.

[0045] Preparation: (1) Entecavir powder (200 mesh) and aspartame (200 mesh) were added and mixed uniformly in equal amounts, then mixed with lactose (100 mesh) in equal amounts, and then mixed with glycyrrhizin, peach Essence and orange are mixed in equal amounts and mixed evenly, and finally starch slurry is added and stirred evenly, and a wetting agent is added to make a soft material; (2) Wet granules are made with an 18-mesh sieve and dried until the granule drying weight loss is below 2.0%. Stop drying, and then use a 12-mesh to 40-mesh double sieve to sieve.

Embodiment 3

[0046] Embodiment 3 (1000 bags)

[0047] Prescription: Entecavir 0.5g, sucrose 500g, disodium glycyrrhizinate 5g, orange essence 0.5g, red scarlet 0.25g, hydroxypropyl methylcellulose 10g, syrup 15g;

[0048] Preparation: (1) 200 mesh entecavir powder and 150 mesh sucrose powder are added in equal amounts and mixed evenly; disodium glycyrrhizinate, hydroxypropyl methylcellulose, orange flavor and red scarlet are used as a wetting agent 95% ethanol in an appropriate amount Dissolve, add to the above-mentioned mixed powder of entecavir and sucrose, and then add syrup to make a soft material; (2) dry the above-mentioned soft material with an 18-mesh sieve to make wet granules until the weight loss on drying of the granules is below 2.0%, stop drying Dry, and then sieve with a 12-40 mesh double sieve.

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Abstract

An improved mixed particle of entecavir for treating various hepatitides is proportionally prepared from entecavir, suspending aid, flavouring, pigment and adhesive through pulverizing, sieving and granulating.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to an improved entecavir suspension granule for treating various hepatitis and a preparation method thereof. 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 eventually die of liver cirrho...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/522A61K9/16A61K47/38A61P1/16A61P31/20
Inventor 王超志
Owner SUNSHINE LAKE PHARM CO LTD