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Compound antituberculous coating core tablet and preparing method

A chip-packed, anti-tuberculosis technology, applied in the field of medicine, can solve the problems of accelerating RIF degradation, affecting RIF bioavailability, and reducing bioavailability

Active Publication Date: 2012-07-11
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in clinical application, the failure of tuberculosis treatment often occurs due to the decrease of RIF bioavailability in FDCs.
The main reason is that INH significantly accelerates the degradation of RIF under gastric acid conditions, which seriously affects the bioavailability of RIF

Method used

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  • Compound antituberculous coating core tablet and preparing method
  • Compound antituberculous coating core tablet and preparing method
  • Compound antituberculous coating core tablet and preparing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] The prescription of Lifestyle Cigarette Pack Chip is as follows:

[0039] (1) Isoniazid tablet core prescription (75mg / tablet):

[0040] Isoniazid 7.5 g microcrystalline cellulose 1.54g Crospovidone 0.5g dextrin 0.4g Magnesium stearate 0.06g

[0041] Makes 100 tablets (10 g)

[0042] (2) Isoniazid tablet core prescription (100mg / tablet):

[0043] Isoniazid 10 g microcrystalline cellulose 0.95g Crospovidone 0.5g dextrin 0.5g Magnesium stearate 0.05g

[0044] Makes 100 tablets (12 g)

[0045] (3) Prescription of isoniazid tablet core enteric coating solution:

[0046] Eudragit® L30D-55 48g Eudragit™ NE30D 12g PEG6000 1.35g talcum powder 5g water 60ml

[0047] (4) Prescription of rifampicin outer layer tablet:

[0048] rifampicin 15g microcrystalline cellulose 44.4g Crospovidone 0.3g Magnesium stearate 0.3g

[0049] Make...

Embodiment 2

[0062] The prescription of Rifa isoniazid pack chip is as follows:

[0063] (1) Isoniazid tablet core prescription:

[0064] Isoniazid 7.5 g microcrystalline cellulose 1.54g Crospovidone 0.5g dextrin 0.4g Magnesium stearate 0.06g

[0065] Makes 100 tablets (10 g)

[0066] (3) Prescription of isoniazid tablet core enteric coating solution:

[0067] Eudragit® L30D-55 48g Eudragit™ NE30D 12g PEG6000 1.35g talcum powder 5g water 60ml

[0068] (4) Rifampicin and ethambutol hydrochloride outer layer tablet prescription:

[0069] rifampicin 15g ethambutol hydrochloride 27.5 microcrystalline cellulose 33g lactose 16 Low-substituted hydroxypropyl cellulose 10g Magnesium stearate 0.5g

[0070] Makes 100 tablets (102 g)

[0071] (5) Prescription of outer layer film coating solution for rifalisonate-coated chips:

[0072] Opadry II 20g water 100...

Embodiment 3

[0083] The prescription of rifampine diethylpyrazine packet chip is as follows:

[0084] (1) Isoniazid tablet core prescription:

[0085] Isoniazid 7.5 g microcrystalline cellulose 1.54g Crospovidone 0.5g dextrin 0.4g Magnesium stearate 0.06g

[0086] Makes 100 tablets (10 g)

[0087] (3) Prescription of isoniazid tablet core enteric coating solution:

[0088] Eudragit® L30D-55 48g Eudragit™ NE30D 12g PEG6000 1.35g talcum powder 5g water 60ml

[0089] (4) Rifampicin, ethambutol hydrochloride, pyrazinamide outer tablet prescription:

[0090] rifampicin 15g pyrazinamide 40 ethambutol hydrochloride 27.5 microcrystalline cellulose 12.6g Low-substituted hydroxypropyl cellulose 7g Magnesium stearate 0.9g

[0091] Makes 100 tablets (103 g)

[0092] (5) Prescription of outer layer film coating solution for rifalisonate-coated chips:

[0093] Opadry...

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Abstract

The invention relates to a compound antituberculous coating core tablet and a preparing method, and is characterized by improving bioavailability, overcoming drug-resistance and being convenient to take by patients. The compound antituberculous double-release preparation is designed and developed according to the optimum absorbing parts of rifampicin and isoniazide and interaction of the two, the isoniazide and excipient are tabletted in a wet granulation mode and are subjected to enteric coating to be taken as a tablet core, the rifampicin(or the rifampicin and ethambutol hydrochloride, or rifampicin, ethambutol hydrochloride and pyrazinamide) is used as the internal layer which is subjected to dry granulation with the excipient and then is pressed into the compound antituberculous coating core tablet with isoniazide enteric-coated tablet core, so that isoniazide can be released in the small intestine at fixed position, rifampicin can be rapidly disintegrated and released in the stomach, and absorption reduction caused by interaction of rifampicin and isoniazide in the stomach can be effectively avoided. The invention is particularly suitable for being taken by patients suffered from tuberculosis.

Description

technical field [0001] The present invention relates to the technical field of medicine, and relates to a compound anti-tuberculosis package chip and a preparation method thereof, in particular to a novel preparation which uses rifampicin and isoniazid as first-line anti-tuberculosis drugs as compounds, or uses rifampicin and isoniazid as compounds. The basis further includes a compound package chip of ethambutol hydrochloride and pyrazinamide and a preparation method thereof. Background technique [0002] Tuberculosis is a chronic infectious disease caused by Mycobacterium tuberculosis. The records of tuberculosis can be traced back hundreds of years, and it still seriously affects the global human health. Most of the high incidence of tuberculosis is due to the lack of timely and accurate diagnosis and thorough treatment of tuberculosis patients. Therefore, it is easy to produce drug resistance, which poses a severe challenge to the cure of tuberculosis. Therefore, it is ...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/4965A61K31/496A61K47/38A61K47/40A61P31/06A61K31/133
Inventor 孙进张天虹李冰任珊张美玉王珊珊何仲贵
Owner SHENYANG PHARMA UNIVERSITY
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