Rifampicin composition freeze-dried orally disintegrating tablet and preparation method thereof

A technology of orally disintegrating tablets and compositions, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, and pill delivery, can solve problems such as low bioavailability, large first-pass effect, and long disintegration time limit, and achieve High safety, good stability, and the effect of increasing the freezing point

Inactive Publication Date: 2012-11-21
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Aiming at the characteristics of large first-pass effect, strong side effects and dysphagia of the elderly and children after repeated administration of common dosage forms of rifampicin, the present invention develops a new freeze-dried orally disintegrating tablet of rifampicin composition; aiming at medication compliance of children and the elderly Adding a new flavoring agent, sucralose, with strong stability and good flavoring effect; Aiming at the long disintegration time and low bioavailability of traditional orally disintegrating tablets on the market, a new preparation method for orally disintegrating tablets was developed ; Aiming at the poor solubility of rifampicin in water, a kind of tert-butanol-water co-solvent is provided as the solvent in the freeze-drying preparation

Method used

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  • Rifampicin composition freeze-dried orally disintegrating tablet and preparation method thereof
  • Rifampicin composition freeze-dried orally disintegrating tablet and preparation method thereof
  • Rifampicin composition freeze-dried orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Taking 150mg / tablet as an example to prepare freeze-dried orally disintegrating tablets of rifampicin composition

[0057] Prescription: 1000 tablets

[0058]

[0059] Preparation Process:

[0060] Dissolve the prescribed amount of rifampicin in the prescribed amount of tert-butanol, stir and dissolve at room temperature, and continue to stir to prepare solution a; dissolve the prescribed amount of mannitol and sucralose in the total amount of prescription water for injection with 70% -80% water for injection, prepare solution b; then dissolve the prescribed amount of gelatin in water for injection with 20%-30% prescription water, heat until completely dissolved, and prepare solution c; combine the above two solutions of b and c Form solution d, and stir evenly, then the mixed solution is cooled to below 5°C; mix the two solutions of a and d, and stir evenly, adjust the pH value to 4.0~6.5 with sodium bicarbonate; freeze according to the rifampicin composition Spec...

Embodiment 2

[0062] Taking 150mg / tablet as an example to prepare freeze-dried orally disintegrating tablets of rifampicin composition

[0063] Prescription: 1000 tablets

[0064]

[0065] Preparation Process:

[0066] Dissolve the prescribed amount of rifampicin in the prescribed amount of tert-butanol, stir and dissolve at room temperature, and continue to stir to prepare solution a; dissolve the prescribed amount of mannitol and sucralose in the total amount of prescription water for injection with 70% -80% water for injection, prepare solution b; then dissolve the prescribed amount of gelatin in water for injection with 20%-30% prescription water, heat until completely dissolved, and prepare solution c; combine the above two solutions of b and c Form solution d, and stir evenly, then the mixed solution is cooled to below 5°C; mix the two solutions of a and d, and stir evenly, adjust the pH value to 4.0~6.5 with sodium bicarbonate; freeze according to the rifampicin composition Spec...

Embodiment 3

[0068] Taking 150mg / tablet as an example to prepare freeze-dried orally disintegrating tablets of rifampicin composition

[0069] Prescription: 1000 tablets

[0070]

[0071] Preparation Process:

[0072] Dissolve the prescribed amount of rifampicin in the prescribed amount of tert-butanol, stir and dissolve at room temperature, and continue to stir to prepare solution a; dissolve the prescribed amount of mannitol and sucralose in the total amount of prescription water for injection with 70% -80% water for injection, prepare solution b; then dissolve the prescribed amount of gelatin in water for injection with 20%-30% prescription water, heat until completely dissolved, and prepare solution c; combine the above two solutions of b and c Form solution d, and stir evenly, then the mixed solution is cooled to below 5°C; mix the two solutions of a and d, and stir evenly, adjust the pH value to 4.0~6.5 with sodium bicarbonate; freeze according to the rifampicin composition Spec...

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Abstract

The invention provides a rifampicin composition freeze-dried orally disintegrating tablet and a preparation method thereof, relates to the technical field of medicines and medicine preparation methods, and mainly solves the problem that a common rifampicin preparation is excessive in first-pass effect and strong in side effect after repeated administration, and is difficultly swallowed by old people and children. The rifampicin composition freeze-dried orally disintegrating tablet is prepared from components including, by weight, 30%-60% of rifampicin, 25%-70% of mannitol, 2%-4% of gelatin, 0.1%-0.15% of sucralose and 50%-70% of tert-butanol-water. The rifampicin composition freeze-dried orally disintegrating tablet prepared from the components according to the weight percent is simple in preparation process and composition, mainly aims to meet the administration requirements of the children, and has the advantages of rapidness in disintegration and effectiveness, sufficiency in medicine absorption, convenience in taking, fine taste and avoidance of the first-pass effect of livers.

Description

Technical field: [0001] The invention relates to the technical field of medicines and preparation methods of medicines, in particular to a freeze-dried orally disintegrating tablet of a rifampicin composition and a preparation method thereof. Background technique: [0002] Rifampicin is bright red or dark red crystalline powder; odorless and tasteless. Soluble in chloroform, soluble in methanol and tert-butanol, almost insoluble in water. The pH value of its 1% aqueous suspension is 4~6.5. It is easy to deteriorate when exposed to light, and the aqueous solution is easy to oxidize and lose potency. Rifampicin has obvious bactericidal effect on Mycobacterium tuberculosis and some non-tuberculous mycobacteria (including Mycobacterium leprae, etc.) inside and outside the host cells. Rifampicin has a good antibacterial effect on aerobic Gram-positive bacteria, including staphylococcal enzyme-producing strains and methicillin-resistant strains, Streptococcus pneumoniae, other ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/496A61P31/06A61P31/04
Inventor 刘海燕汪六一汪金灿
Owner HAINAN WEI KANG PHARMA QIANSHAN
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