Bromhexine hydrochloride oral disintegrant tablet

A technology for bromhexine hydrochloride and oral disintegrating tablets is applied in the field of bromhexine hydrochloride oral fast disintegrating tablets and their preparation, which can solve the problems of low dissolution rate and dissolution rate of ordinary tablets, slow release and absorption, and biological problems. Poor utilization, etc.

Inactive Publication Date: 2006-11-29
HONGYI SCI & TECH CO LTD NANCHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] In the present invention, the insoluble bromhexine hydrochloride is dispersed in a non-physiologically active water-soluble carrier to prepare a drug-carrier solid dispersion by means of a hot melt extrusion method, and the bromhexine hydrochloride is dispersed in the carrier in an ultrafine crystal state to form The homogeneous eutectic physical mixture microcrystalline dispersion system enables bromhexine hydrochloride to dissolve, release and absorb quickly, solving the problem of low dissolution rate and dissolution rate, slow release and absorption, and poor bioavailability of bromhexine hydrochloride ordinary tablets The problem

Method used

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  • Bromhexine hydrochloride oral disintegrant tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Prescription: bromhexine hydrochloride 8g

[0038] Macrogol 6000 10g

[0039] Macrogol 4000 10g

[0040] Mannitol 20g

[0041] Microcrystalline Cellulose 60g

[0042] Low-substituted hydroxypropyl cellulose 5g

[0043] Croscarmellose Sodium 10g

[0044] Cross-linked polyvinylpyrrolidone 5g

[0045] Stevia 3g

[0046] Micronized silica gel 1g

[0047] Magnesium Stearate 1g

[0048] Makes 1000 pieces

[0049] Preparation method: Take the prescribed amount of polyethylene glycol 6000 and polyethylene glycol 4000, mix them evenly, heat at 90-100°C to melt, add the prescribed amount of bromhexine hydrochloride, stir well to form a molten mixture, and squeeze it with a plunger The press extrudes the molten mixture in granular form, cools it rapidly into a solid, crushes it, passes through an 80-mesh sieve, and passes through an 80-mesh sieve with the prescribed amount of microcrystalline cellulose, low...

Embodiment 2

[0051] Prescription: bromhexine hydrochloride 8g

[0052] Macrogol 6000 5g

[0053] Macrogol 4000 10g

[0054] Mannitol 50g

[0055] Microcrystalline Cellulose 25g

[0056] Low-substituted hydroxypropyl cellulose 10g

[0057] Croscarmellose Sodium 5g

[0058] Cross-linked polyvinylpyrrolidone 10g

[0059] Stevia 1g

[0060] Micronized silica gel 2g

[0061] Magnesium stearate 0.5g

[0062] Makes 1000 pieces

[0063] Preparation method: take the prescribed amount of polyethylene glycol 6000 and polyethylene glycol 4000, mix them evenly, heat at 60-80°C to melt, add the prescribed amount of bromhexine hydrochloride, stir well to form a molten mixture, and squeeze it with a plunger The press extrudes the molten mixture in granular form, cools it rapidly into a solid, crushes it, passes through an 80-mesh sieve, and passes through an 80-mesh sieve with the prescribed amount of microcrystalline cellulose, lo...

Embodiment 3

[0065] Prescription: bromhexine hydrochloride 8g

[0066] Macrogol 6000 10g

[0067] Macrogol 4000 4g

[0068] Mannitol 40g

[0069] Microcrystalline Cellulose 35g

[0070] Low-substituted hydroxypropyl cellulose 10g

[0071] Croscarmellose Sodium 10g

[0072] Cross-linked polyvinylpyrrolidone 10g

[0073] Stevia 1g

[0074] Micronized silica gel 1.5g

[0075] Magnesium Stearate 1g

[0076] Makes 1000 pieces

[0077] Preparation method: Take the prescribed amount of polyethylene glycol 6000 and polyethylene glycol 4000, mix them evenly, heat at 85-95°C to melt, add the prescribed amount of bromhexine hydrochloride, stir well to form a molten mixture, and squeeze it with a plunger The press extrudes the molten mixture in granular form, cools it rapidly into a solid, crushes it, passes through an 80-mesh sieve, and passes through an 80-mesh sieve with the prescribed amount of microcrystalline cellulose, low-substituted hydroxypropyl cellulose, an...

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Abstract

An oral disintegrating tablet of bromhexine hydrochloride is prepared through heating the water-soluble carrier for fusing it, mixing with bromhexine hydrochloride, stirring, granulating by extruding out, quick cooling, pulverizing, mixing it with filler, disintegrant, flowing aid and lubricant, and tabletting.

Description

technical field [0001] The invention relates to bromhexine hydrochloride oral rapidly disintegrating tablets and a preparation method thereof. Background technique [0002] Bromhexine hydrochloride is an expectorant, which is a semi-synthetic hydrochloride of the derivative of orchidine. It was first used as an active ingredient in the Indian folk expectorant and cough medicine Duckbill. It was first synthesized by Keck in 1963 and launched in 1965. , my country began production in 1973, and the pharmacopoeias of the United Kingdom, France, Germany, Holland, Switzerland, Italy, Portugal, and China have all been recorded. Bromhexine hydrochloride is white or off-white crystalline powder; odorless, tasteless, slightly soluble in water. Bromhexine hydrochloride can crack the polysaccharide fibers of acid glycoprotein in sputum, and can also reduce the synthesis of acid glycoprotein in the mucous glands and goblet cells of the respiratory tract, resulting in reduced sputum visco...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/136A61K47/04A61K47/38A61K47/30A61P11/10
Inventor 刘智钱进陶琳刘孝乐
Owner HONGYI SCI & TECH CO LTD NANCHANG
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