Entecavir soft capsule and its preparation method

A technology of entecavir and soft capsules, which is applied in the field of entecavir soft capsules for the treatment of hepatitis B and its preparation, and can solve the problems that many pharmaceutical factories, government departments, scientific research institutes and other institutions are conducting research work on the drug

Inactive Publication Date: 2006-02-15
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no dosage form of Entecavir on the market in the domestic market, but many pharmaceutical compani

Method used

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  • Entecavir soft capsule and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0020] Example 1:

[0021] prescription:

[0022] Entecavir 0.5g

[0023] PEG400 190g

[0024] Propylene glycol 9.5g

[0025] 1000 capsules total

[0026] Preparation:

[0027] First heat about 80% PEG400 to 40-60°C, add entecavir, stir to dissolve, then add the prescription amount of propylene glycol, after stirring, add the remaining amount of PEG400 to obtain a clear solution; adjust the temperature control system of the dropping pill machine, The temperature of the dripper of the dripping pill machine is heated and maintained at 50-90℃, and the temperature of the condensate is cooled and maintained at -5-40℃; the size of the dripper is adjusted to control the weight of the soft capsule content, and it is pressed.

Example Embodiment

[0028] Example 2:

[0029] prescription:

[0030] Entecavir 1g

[0031] PEG400 190g

[0032] Propylene glycol 7g

[0033] Tween-80 2

[0034] 1000 capsules total

[0035] Preparation:

[0036] First heat about 80% PEG400 to 40-60°C, add entecavir, stir to dissolve, then add the prescription amount of propylene glycol and Tween-80, after stirring, add the remaining amount of PEG400 to obtain a clear solution; adjust the dropping pill machine The temperature control system makes the dripper temperature of the dripping pill machine heated and maintained at 50-90℃, and the temperature of the condensing agent is cooled and maintained at -5-40℃. Adjust the size of the dripper to control the weight of the soft capsule content and suppress , That is.

Example Embodiment

[0037] Example 3:

[0038] prescription:

[0039] Entecavir 1g

[0040] Edible vegetable oil 494.5

[0041] Beeswax 2.5g

[0042] Tween-80 2.0g

[0043] 1000 capsules total

[0044] Preparation:

[0045] Crush Entecavir into ultra-fine powder, add it to edible vegetable oil, stir to make it evenly suspended, add prescription amount of beeswax and Tween-80, continue to stir to obtain a good oily suspension; adjust the temperature control of the dropping pill machine The system makes the dripper temperature of the dripping machine heated and maintained at 50-90℃, and the temperature of the condensing agent is cooled and maintained at -5-40℃; adjust the size of the dripper to control the weight of the soft capsule content, press, that is Got.

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Abstract

The invention relates to an Entecavir soft capsule for treating hepatitis B and process for its preparation, by using Entecavir as raw material, charging auxiliary materials of specific species and proportions, and preparing soft capsule through the conventional techniques in the pharmaceutical industry.

Description

technical field [0001] The invention relates to a novel pharmaceutical preparation, in particular to entecavir soft capsules for treating hepatitis B and a preparation method thereof. Background technique [0002] The morbidity and mortality caused by hepatitis B virus ((HBV) in the world is the most serious among liver viruses. According to the statistics of the World Health Organization, there are about 350 million HBV carriers in the world, causing about 100-200 deaths per year At present, there are two kinds of serum vaccines and DNA recombinant vaccines for prophylaxis; and what is commonly used for therapeutic drugs is alpha-interferon, which is not only expensive and difficult to tolerate, but also has low effective rate (only 25%-40 % of patients had remission). [0003] Entecavir (entecavir) is epoxy hydroxycarbodeoxyguanosine, a deoxyguanosine analogue that can effectively inhibit the replication of hepatitis B virus, and has a strong anti-HBV effect. The chemica...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61P1/16A61K31/522A61P31/20
Inventor 严轶东
Owner FUKANGREN BIO PHARMA
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