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Enticawer release-controllable capsules and their preparation

A technology for entecavir and capsules, which is applied in the field of entecavir controlled-release capsules and their preparation, and can solve the problems of low variation rate and the like

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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  • Enticawer release-controllable capsules and their preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Entecavir Controlled Release Capsules

[0025] 1. Ball core composition:

[0026] Name of raw material

[0027] Entecavir 1%

[0028] Lactose 46%

[0029] Starch 35%

[0030] Hypromellose 4%

[0031] 2. Membrane controlled release coating composition:

[0032] Ethylcellulose 5%

[0033] Methylcellulose 3%

[0034] Glycerin 1%

[0035] Talc 4%

[0036] 3. Capsule contents:

[0037] Coated core 90%

[0038] Polyethylene glycol 4%

[0039] Talc 6%

[0040] Operation method:

[0041] 1. According to the above formula amount, crush and sieve entecavir and filler, mix them evenly, make soft material with binder, granulate, dry and granulate, and use 12 mesh and 40 mesh sieves to sieve out 12 mesh to 40 mesh. The purpose is to round the particles as pellet cores.

[0042] 2. Prepare the controlled-release coating solution according to the above-mentioned film controlled-release coating composition prescription, put the prepared pellet cores in the coating pan, a...

Embodiment 2

[0046] Entecavir Controlled Release Capsules

[0047] 1. Ball core ingredients:

[0048] Name of raw material

[0049] Entecavir 1%

[0050] Microcrystalline Cellulose 46%

[0051] Starch 28%

[0052] Polyvinylpyrrolidone 5%

[0053] 2. Membrane controlled release coating composition:

[0054] Cellulose acetate 5%

[0055] Hypromellose 4%

[0056] Diethyl phthalate 1%

[0057] Talc 2%

[0058] 3. Capsule contents:

[0059] Coated core 92%

[0060] Polyethylene glycol 4%

[0061] Micronized silica gel 4%

[0062] Preparation method is the same as example 1.

[0063] time (small

Time)

4

8

12

16

24

Release

(%)

25.89

56.28

74.36

84.67

95.03

[0064]The stability test report of the Entecavir controlled-release capsules made by the method is as follows:

[0065] Storage stability data at room temperature

[0066] Sample packaging: Capsules are pa...

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PUM

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Abstract

A release-controlled capsule 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 relates to a medicine which is convenient to take and a preparation method thereof, in particular to an entecavir controlled-release capsule 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. Anti-HBV is the main method for the treatment of chronic hepatitis B, that is, to block or permanently inhibit the replication of hepatitis B virus HBV in the body, so as to reduce or terminate liver inflammation, necrosis and fibrosis, and prevent the disease from progressing to liver function decompensation, cirrhosis, liver disease, etc. Functional failure and liver cancer development. Commonly used effective drugs for the treatment of chroni...

Claims

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Application Information

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