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Method for preparing tenofovir disoproxil fumarate tablet

A technology of tenofovir disoproxil fumarate and disoproxil fumarate, which is applied in the field of preparation of tenofovir disoproxil fumarate tablets, can solve the problems of slow disintegration of tablets and affect human absorption, and achieve faster Effects of absorption, accelerated disintegration, and improved bioavailability

Inactive Publication Date: 2015-07-01
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The tablet disintegrates slowly during taking, which affects the body's absorption after taking it

Method used

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  • Method for preparing tenofovir disoproxil fumarate tablet
  • Method for preparing tenofovir disoproxil fumarate tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Tenofovir Disoproxil Fumarate 3000g

[0016] Microcrystalline Cellulose 1000g

[0017] Lactose 800g

[0018] 1300g pregelatinized starch

[0019] Croscarmellose Sodium 500g

[0020] water 1750g

[0021] Magnesium stearate 50 g

[0022] Preparation method: (1) Weigh the micronized tenofovir disoproxil fumarate raw material and pass through a 120 mesh sieve, microcrystalline cellulose, lactose, pregelatinized starch, croscarmellose sodium Cross 80 mesh sieves, magnesium stearate cross 40 mesh sieves for subsequent use;

[0023] (2) Weigh the prescribed amount of tenofovir disoproxil fumarate, microcrystalline cellulose, lactose, croscarmellose sodium, pregelatinized starch, and croscarmellose sodium and mix After uniformity, add the prescribed amount of binder soft material, pass through a 20-mesh sieve and granulate. The prepared wet granules are air-dried at 50-60°C;

[0024] (3) Pass the dry granules through a 18-mesh sieve for granulation, add the prescribed a...

Embodiment 2

[0028] Tenofovir Disoproxil Fumarate 3000g

[0029] Microcrystalline Cellulose 1800g

[0030] Lactose 500g

[0031] 900g pregelatinized starch

[0032] Croscarmellose Sodium 350g

[0033] water 1900g

[0034] Magnesium stearate 50 g

[0035] The preparation method is the same as in Example 1, and 10,000 tenofovir disoproxil fumarate tablets can be obtained.

Embodiment 3

[0037] Tenofovir Disoproxil Fumarate 3000g

[0038] Microcrystalline Cellulose 1650g

[0039] Lactose 600g

[0040] 1000g pregelatinized starch

[0041] Croscarmellose Sodium 350g

[0042] water 2000g

[0043] Magnesium stearate 50 g

[0044] The preparation method is the same as in Example 1, and 10,000 tenofovir disoproxil fumarate tablets can be obtained.

[0045] Select the dissolution curve in the tablet test item.

[0046] Determination method: take this product, according to the dissolution determination method (the second method of appendix X C of the second part of the "Chinese Pharmacopoeia" 2010 edition), using 0.01mol / L hydrochloric acid 900ml as the dissolution medium, and the speed is 50 rpm, according to the law. After 30 minutes, take 10ml of the solution to filter, accurately measure 2.5ml of the filtrate, put it in a 50ml measuring bottle, add 0.01mol / L hydrochloric acid solution to dilute to the mark, shake well, and use it as the test solution.

[00...

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Abstract

The invention discloses a method for preparing a tenofovir disoproxil fumarate tablet. The method comprises the following steps: step a, passing a micronized tenofovir disoproxil fumarate raw material through a 120-mesh sieve; step b, passing microcrystalline cellulose, milk sugar, pregelatinized starch and croscarmellose sodium through a 80-mesh sieve, and passing magnesium stearate through a 40-mesh sieve; step c, after unfiormly mixing tenofovir disoproxil fumarate with a mixture obtained in the step b, adding an adhesive softening material, passing the mixture through a 20-mesh sieve, then pelletizing and blowing to dry the prepared particles at 50-60 DEG C; step d, passing the dry particles through a 20-mesh sieve, adding magnesium stearate, and then uniformly mixing; and step e, pressing into tablets on a tablet press. As the raw material is micronized, the disintegration speed is increased, absorption by a human body is accelerated, and the bioavailability of tenofovir disoproxil fumarate is improved.

Description

technical field [0001] The invention relates to a method for preparing medicine, in particular to a method for preparing tenofovir disoproxil fumarate tablets. Background technique [0002] Tenofovir Disoproxil Fumarate is a new type of nucleotide reverse transcriptase inhibitors (NRTIs), which inhibits HIV virus replication by inhibiting the activity of HIV-1 reverse transcriptase. On October 26, 2001, the U.S. FDA approved GILEAD's tenofovir disoproxil fumarate tablets to go on the market. On June 18, 2008, SFDA approved the import registration of tenofovir disoproxil fumarate tablets in China. Tenofovir is the first-line AIDS antiviral drug recommended by the World Health Organization (WHO) AIDS treatment guidelines. It is currently listed as a second-line drug for national free AIDS antiretroviral treatment in China. [0003] The tablet disintegrates slowly during taking and affects the absorption of the human body after taking. Contents of the invention [0004] T...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/675A61P31/18
Inventor 成瑞明杜振新卢秀莲
Owner CISEN PHARMA