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Method for improving content uniformity of entecavir tablets

A technology for Entecavir and Cavir tablets, which is applied in the field of improving the content uniformity of Entecavir tablets, can solve the problems of cumbersome operation and loss in the equal-volume incremental method, and achieve the effects of improving content uniformity, improving mixing uniformity, and simple preparation process

Inactive Publication Date: 2019-11-08
ZHEJIANG AINUO BIOLOGICAL PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, the method to improve the content uniformity of tablets is mainly to granulate after mixing in equal increments. However, the equal increment method is cumbersome to operate and will cause certain losses in the process.

Method used

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  • Method for improving content uniformity of entecavir tablets
  • Method for improving content uniformity of entecavir tablets
  • Method for improving content uniformity of entecavir tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026]

[0027] Preparation process: make sodium alginate into a 3% solution with distilled water, add entecavir, and stir well to obtain a mixed solution; mix the above mixed solution with lactose, microcrystalline cellulose, and crospovidone to granulate, 20 Mesh sieve for granulation, after drying at 60°C, add micro-powder silica gel, mix well, and press to make 2500 tablets. The main pressure of tablet pressing is 4-8KN; ±2kg.

Embodiment 2

[0029]

[0030] Preparation process: make sodium alginate into a 3% solution with distilled water, add entecavir, and stir well to obtain a mixed solution; mix the above mixed solution with lactose and pregelatinized starch to granulate, granulate with a 20-mesh sieve, and granulate with 60 After drying at ℃, add micro-powder silica gel, mix well, and press to make 2500 tablets. The main pressure of tablet pressing is 4-8KN;

Embodiment 3

[0032]

[0033] Preparation process: make sodium alginate into a 2.5% solution with distilled water, add entecavir, and stir well to obtain a mixed solution; mix the above mixed solution with microcrystalline cellulose and low-substituted hydroxypropyl cellulose to granulate, 20 Mesh sieve for granulation, after drying at 60°C, add magnesium stearate, mix well, and tablet to make 2500 tablets. Hardness 7.5±2kg.

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Abstract

The invention discloses a method for improving the content uniformity of entecavir tablets. The prescription is prepared from the following components: entecavir, sodium alginate, a filler, a glidant,a disintegrating agent and pharmaceutically acceptable ingredients, the entecavir and a water solution of the sodium alginate are mixed, and the mixture and the other ingredients are granulated and tableted. By selecting the materials and optimizing the preparation process, the entecavir tablets have good dissolution and high content uniformity, a general preparation process is used, complicatedpreparation equipment is not required to be used, and industrialization and mass production are achieved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a method for improving the content uniformity of entecavir tablets, Background technique [0002] Entecavir (Entecavir) is a nucleoside analog independently developed by Bristol-Myers Squibb, which was approved by the FDA in 2005. Its dosage forms include tablets and oral solutions. Its chemical name is: 2-amino-9-[(1S , 3R, 4S)-4-hydroxy-3-hydroxymethyl-2-methylenecyclopentyl]-1,9-dihydro-6H-purin-6-one monohydrate; Molecular formula: C 12 h 15 N 5 o 3 h 2 O; molecular weight: 295.3; chemical structural formula: [0003] [0004] Entecavir is an effective selective inhibitor of hepatitis B virus replication of guanosine nucleoside analogues, has inhibitory effect on hepatitis B virus polymerase, Canadian hepatitis B treatment guidelines evaluation Entecavir has the strongest antiviral ability and the lowest incidence of drug resistance Antiviral drugs can be u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/36A61K31/522A61P31/20A61P1/16
CPCA61K9/205A61K31/522A61P1/16A61P31/20
Inventor 裴晓旻费状丽金华燕施杰赵子越
Owner ZHEJIANG AINUO BIOLOGICAL PHARMA CO LTD
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