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Enticawer release-controllable tablet and its preparation

A technology of entecavir and controlled-release tablets, which is applied in the field of medicine and its preparation, can solve the problems of blood drug concentration peak and valley, fast drug absorption, short half-life, etc., and achieve peak-valley avoidance, stable blood concentration, and high drug efficacy Effect

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

Among the many tablet medicines for the treatment of chronic hepatitis B, the medicine is absorbed too fast, the peak and valley phenomenon of blood drug concentration is serious, the half-life is short, and frequent administration is required.

Method used

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  • Enticawer release-controllable tablet and its preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Entecavir Controlled Release Tablets

[0025] 1. Tablet core composition:

[0026] Name of raw material

[0027] Entecavir 1%

[0028] Lactose 46%

[0029] Starch 35%

[0030] Hypromellose 4%

[0031] Magnesium Stearate 1%

[0032] Talc 4%

[0033] 2. Membrane controlled release coating composition:

[0034] Ethylcellulose 5%

[0035] Methylcellulose 3%

[0036] Glycerin 1%

[0037] Preparation:

[0038] 1. According to the above formula amount, crush entecavir and filler, sieve and mix them evenly, make soft material with binder, granulate, granulate after drying, add lubricant and glidant and mix evenly, and press into tablet core.

[0039] 2. Prepare the controlled-release coating solution according to the above-mentioned film controlled-release coating composition prescription, put the prepared tablet cores in the coating pan, and coat with the coating solution.

[0040] 3. Drying, product packaging.

Embodiment 2

[0042] Entecavir Controlled Release Tablets

[0043] 1. Tablet core composition:

[0044] Name of raw material

[0045] Entecavir 1%

[0046] Microcrystalline Cellulose 46%

[0047] Starch 28%

[0048] Polyvinylpyrrolidone 5%

[0049] Polyethylene glycol 4%

[0050] Talc 6%

[0051] 2. Membrane controlled release coating composition:

[0052] Cellulose acetate 5%

[0053] Hypromellose 4%

[0054] Diethyl phthalate 1%

[0055] Preparation:

[0056] 1. According to the above formula amount, crush entecavir and filler, sieve and mix them evenly, make soft material with binder, granulate, granulate after drying, add lubricant and glidant and mix evenly, and press into tablet core.

[0057] 2. Prepare the controlled-release coating solution according to the above-mentioned film controlled-release coating composition prescription, put the prepared tablet cores in the coating pan, and coat with the coating solution.

[0058] 3. Drying, product packaging.

[0059] ...

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PUM

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Abstract

A release-controlled tablet of entecavir for treating hepatitis B and its preparing process are disclosed. Its advantages are smooth release, stable blood concentration and low by-effect.

Description

technical field [0001] The invention belongs to a medicine and a preparation method thereof, in particular to a controlled-release tablet for treating chronic hepatitis B with an entecavir tablet and a preparation method thereof. Background technique [0002] There are various tablet products in current medicines, and entecavir tablet is an effective medicine for treating chronic hepatitis B. 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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/522A61K9/22A61K9/28A61K47/32A61K47/34A61K47/36A61K47/38A61P1/16A61P31/20A61K47/10
Inventor 文力奇
Owner SUNSHINE LAKE PHARM CO LTD
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