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Adefovir dipivoxil composition and preparation method thereof

A technology of adefovir dipivoxil and prescription, which is applied in the field of adefovir dipivoxil tablets and its preparation, can solve the problems of poor stability of adefovir dipivoxil tablets, and achieve improved anti-hepatitis B, fewer procedures, and blood drug concentration increased effect

Inactive Publication Date: 2013-09-11
YOUCARE PHARMA GROUP +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to overcome the deficiency of poor stability of adefovir dipivoxil tablets caused by wet granulation, and two new preparation techniques are provided to obtain adefovir dipivoxil tablets with good performance

Method used

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  • Adefovir dipivoxil composition and preparation method thereof
  • Adefovir dipivoxil composition and preparation method thereof
  • Adefovir dipivoxil composition and preparation method thereof

Examples

Experimental program
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Embodiment Construction

[0042] Implementation example 1

[0043] Every 1000 adefovir dipivoxil tablets, weigh materials according to the following formula:

[0044] Tablet prescription:

[0045]

[0046] Coating Solution Prescription:

[0047]

[0048] making process:

[0049]1. Grind adefovir dipivoxil with an ultrafine pulverizer until the average particle size is less than 50 μm, pass through a 60-mesh sieve for Ludipress LCE and sodium carboxymethyl starch respectively, and set aside;

[0050] 2. Weigh the prescribed amount of adefovir dipivoxil and sodium carboxymethyl starch into the wet mixing granulator, set the stirring speed to 450r / min, the chopping speed to 1200r / min, mix for 180s, and add the prescribed amount after discharging Mix Ludipress LCE for 300s, then add the prescribed amount of magnesium stearate and mix for 50s;

[0051] 3. Take the mixture in step 2 to measure the fluidity of the powder (indicated by the angle of repose θ), moisture and the content of the main drug...

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Abstract

The invention discloses an adefovir dipivoxil composition and a preparation method thereof. The adefovir dipivoxil composition is prepared from the following components in percentage by weight: 5-15% of adefovir dipivoxil, 20-80% of filler, 4-15% of a disintegrating agent, 0-5% of a surfactant, 0-5% of a lubricant, and 1-10% of a coating material. The preparation method is implemented through carrying out direct tabletting or dry granulation and tabletting on raw materials and supplementary materials. The adefovir dipivoxil composition prepared by using the method disclosed by the invention is reliable in quality, stable in properties, simple in production process and low in cost, and satisfies the requirements of preparation mass-production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to adefovir dipivoxil tablets and a preparation method thereof. Background technique [0002] Adefovir dipivoxil is a new anti-hepatitis B virus (HBV) drug and another oral anti-HBV drug after lamivudine. The drug is a purine derivative, which can competitively inhibit HBV polymerase and stop the extension of HBV DNA chain. It is a new type of open-chain nucleotide broad-spectrum antiviral drug. The drug was approved by the U.S. Food and Drug Administration (FDA) for marketing in the U.S. in September 2002, and phase II and III clinical registration trials in China were also launched in December 2002. Suitable for long-term medication and lamivudine resistance. Adefovir dipivoxil has a relatively slow onset time for HBV, but the probability of drug resistance is low, the drug effect is strong, and it is also effective for those who have mutated the virus. It is currently...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/675A61K47/38A61K47/36A61K47/34A61K47/32A61J3/10A61P31/20A61P1/16
Inventor 李琦杨磊
Owner YOUCARE PHARMA GROUP
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