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Pharmaceutical preparation for resisting tuberculosis and preparation method thereof

A pharmaceutical preparation, anti-tuberculosis technology, applied in the field of medicine

Active Publication Date: 2014-04-09
HAINAN PULIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, none of the existing technologies can solve this problem well. Therefore, there is an urgent need to research and develop FDCs preparations that meet the latest WHO-regulated dosage strength and solve the interaction between drugs and the high bioavailability of rifampicin.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1: This embodiment prepares 1000 pharmaceutical preparations for the treatment of tuberculosis, using the following prescription: Rifampicin 150g sucrose ball core 13g PVPk30 15g

[0022] Pyrazinamide 400g Isoniazid 75g Ethambutol hydrochloride 275g

[0023] MCC 40g PVPP 50g Magnesium Stearate 10g

[0024] Preparation Process:

[0025] 1. Rifampicin is passed through a 120 mesh sieve, and it is used as a medicine powder for subsequent use; 5% PVPk30 liquid (ethanol: water=1: 1) is prepared in proportion for subsequent use;

[0026] 2. Put the sucrose-removed ball core in the centrifugal granulator, adjust the parameters: speed 200rpm / min, fan, atomization pressure 0.3Mpa, spray liquid 10rpm; sprinkle powder while spraying the binder until the powder is added, take it out Pellets, placed in an oven at 60°C for 2 hours, set aside;

[0027] 3. Prepare coating solution: HPMC 4.5g, talc powder 2.25g, add water 143.25g, stir to dissolve; put the pellets in a cen...

Embodiment 2

[0031] Embodiment 2: This embodiment prepares 1000 pharmaceutical preparations for the treatment of tuberculosis, using the following prescription: Rifampicin 100g sucrose ball core 15g PVPk30 20g

[0032] Pyrazinamide 450g Isoniazid 100g Ethambutol hydrochloride 220g

[0033] MCC 30g PVPP 60g Magnesium Stearate 10g

[0034] Preparation Process:

[0035] 1. Rifampicin is passed through a 120 mesh sieve, and it is used as a medicine powder for subsequent use; 5% PVPk30 liquid (ethanol: water=1: 1) is prepared in proportion for subsequent use;

[0036] 2. Put the sucrose-removed ball core in the centrifugal granulator, adjust the parameters: speed 250rpm / min, fan, atomization pressure 0.4Mpa, spray liquid 10rpm; sprinkle powder while spraying the binder until the powder is added, take it out Pellets, placed in an oven at 60°C for 2 hours, set aside;

[0037] 3. Prepare coating solution: HPMC 3.5g, talc powder 2.0g, add water 140g, stir to dissolve; put the pellets in a centri...

Embodiment 3

[0040] Embodiment 3: This embodiment prepares 1000 tablets of pharmaceutical preparations for the treatment of tuberculosis, using the following prescription: Rifampicin 200g sucrose ball core 10g PVPk30 12g

[0041] Pyrazinamide 350g Isoniazid 60g Ethambutol hydrochloride 320g

[0042] MCC 60g PVPP 40g Magnesium Stearate 10g

[0043] The preparation process is the same as in Example 1.

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Abstract

The invention relates to a pharmaceutical preparation for resisting tuberculosis, which comprises rifampin, isoniazid, pyrazinamide and ethambutol hydrochloride, wherein the rifampin or the isoniazid is prepared into micropills and residual materials are prepared into granules. According to the invention, one of the rifampin and the isoniazid is prepared into micropills which are separated by isolation gown and the other one is prepared into granules, so that the rifampin and the isoniazid cannot be mutually influenced, the rifampin is ensured to not be basically degraded in the use process, and the bioavailability of the rifampin is improved.

Description

technical field [0001] The invention relates to the field of medicine, in particular to an anti-tuberculosis drug preparation and a preparation method thereof. Background technique [0002] Tuberculosis is a chronic infectious disease that seriously endangers people's health. Since the mid-to-late 1980s, the global epidemic situation has deteriorated sharply and the new rising peak. my country is also one of the countries with high incidence of tuberculosis. The compound preparation containing rifampicin and isoniazid is clinically used to treat tuberculosis. It is recommended by WHO as the first choice drug for the treatment of tuberculosis worldwide. Its advantages are patient compliance, less adverse reactions, and reduced drug resistance. , the recurrence rate is reduced, and it is easy to monitor clinically. [0003] Since the mid-1990s, the World Health Organization has recommended the use of multi-drug combination therapy (also known as fixed-dose combination therap...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4965A61K31/496A61K31/4409A61K31/133A61K9/20A61P31/06
Inventor 范敏华徐海刘华
Owner HAINAN PULIN PHARMA
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