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Ambroxol hydrochloride osmotic pump controlled-release tablet and preparation method thereof

A controlled-release technology of ambroxol hydrochloride and osmotic pumps, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problem of the decrease in the release rate of ambroxol hydrochloride at the end and the unfavorable Patients have problems such as swallowing and incomplete drug release, so as to achieve stable and long-lasting blood drug concentration, maintain blood drug concentration, and reduce the number of medications

Active Publication Date: 2015-03-25
HEFEI HUAFANG PHARMA SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Existing ambroxol hydrochloride sustained-release preparations have deficiencies such as a decline in the terminal release rate of ambroxol hydrochloride and incomplete drug release or excessive tablet weight, which is not conducive to swallowing by patients.

Method used

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  • Ambroxol hydrochloride osmotic pump controlled-release tablet and preparation method thereof
  • Ambroxol hydrochloride osmotic pump controlled-release tablet and preparation method thereof
  • Ambroxol hydrochloride osmotic pump controlled-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] The preparation of embodiment 1 ambroxol hydrochloride osmotic pump controlled release tablet

[0058] (1) Drug-containing layer

[0059]

[0060] (2) booster layer

[0061]

[0062] (3) Coating solution

[0063] Cellulose acetate 40g

[0064] Polyethylene glycol 8g

[0065] Proper amount of acetone

[0066] (4) Prescription of moisture-proof coating solution

[0067] Gastric-soluble coating powder 18g

[0068] Purified water 82g

[0069] Made a total of 100g

[0070] Preparation of drug-containing layer granules: Weigh ambroxol hydrochloride, povidone, copovidone, sodium chloride, and iron oxide yellow according to the stated ratio, pulverize them through a 120-mesh sieve, mix well, and use a concentration of not less than 40% The adhesive soft material prepared by ethanol solution, 20-mesh sieve to make wet granules, dry at 50°C until the water content is 3-5%, granulate, add magnesium stearate and micro-powder silica gel in the proportion described abov...

Embodiment 2

[0075] The preparation of embodiment 2 ambroxol hydrochloride osmotic pump controlled-release tablets

[0076] (1) Drug-containing layer

[0077]

[0078]

[0079] (2) booster layer

[0080]

[0081] (3) Coating solution

[0082] Cellulose acetate 40g

[0083] Polyethylene glycol 6g

[0084] Proper amount of acetone

[0085] (4) Prescription of moisture-proof coating solution

[0086] Gastric-soluble coating powder 18g

[0087] Purified water 82g

[0088] Made a total of 100g

[0089] Preparation of drug-containing layer granules: Weigh ambroxol hydrochloride, povidone, poloxamer, sodium chloride, and iron oxide yellow according to the stated ratio, crush them through a 120-mesh sieve, mix well, and use a concentration of not less than 40 % ethanol solution to prepare soft materials made of adhesives, 20 mesh sieves to make wet granules, dry at 50°C until the water content is 3% to 5%, granulate, add magnesium stearate and micropowder silica gel in the stated ...

Embodiment 3

[0094] The preparation of embodiment 3 ambroxol hydrochloride osmotic pump controlled-release tablets

[0095] (1) Drug-containing layer

[0096]

[0097] (2) booster layer

[0098]

[0099] (3) Coating solution

[0100] Cellulose acetate 40g

[0101] Polyethylene glycol 8g

[0102] Proper amount of acetone

[0103] (4) Prescription of moisture-proof coating solution

[0104] Gastric-soluble coating powder 18g

[0105] Purified water 82g

[0106] Made a total of 100g

[0107] Preparation of drug-containing layer granules: Weigh ambroxol hydrochloride, povidone, polyoxyethylene, sodium chloride, and iron oxide yellow according to the stated ratio, crush them through a 120-mesh sieve, mix well, and use a concentration of not less than 40% The adhesive soft material prepared by ethanol solution, 20 mesh sieve to make wet granules, dry at 40°C until the water content is 3-5%, granulate, add magnesium stearate and micro-powder silica gel in the proportion described ab...

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Abstract

The invention discloses an ambroxol hydrochloride osmotic pump controlled-release tablet and belongs to the field of preparation of ambroxol hydrochloride osmotic pump controlled-release tablets. The ambroxol hydrochloride osmotic pump controlled-release tablet comprises a tablet core composed of a drug-loading layer and a boosting layer; the tablet core is covered with a semipermeable film coating; one or more drug release pores is / are formed in the surface of the semipermeable film coating, and the semipermeable film coating is covered with a moisture-proof coating; the drug-loading layer is prepared from ambroxol hydrochloride, a suspending aid, a penetration enhancer, an osmotic pressure active material, a binder, a colorant and a lubricant; the boosting layer is prepared from the penetration enhancer, a macromolecular swelling material, the osmotic pressure active material, the colorant, the binder and the lubricant; the semipermeable film coating is prepared from a film material, a plasticizer, a pore-foaming agent and a solvent. The ambroxol hydrochloride osmotic pump controlled-release tablet has the advantages of convenient administration, long acting, release at an approximately constant rate in 0-12 hours, maintaining of stable blood concentration and reduction of toxic and side effects, decrease of times of taking medicine, appropriate table weight, enhancement of patient elasticity, and the like.

Description

technical field [0001] The present invention relates to osmotic pump controlled-release tablets, in particular to ambroxol hydrochloride osmotic pump controlled-release tablets. The present invention also relates to a preparation method of ambroxol hydrochloride osmotic pump controlled-release tablets, which belongs to the preparation of ambroxol hydrochloride osmotic pump controlled-release tablets field. Background technique [0002] Ambroxol Hydrochloride (Ambroxol Hydrochloride) is a mucolytic agent, which can increase the secretion of serous glands in the respiratory mucosa and reduce the secretion of mucous glands, thereby reducing the viscosity of sputum; it can also promote the secretion of pulmonary surfactant, increase bronchial ciliary movement, and make sputum The liquid is easy to cough up, and is suitable for thick sputum and difficulty in expectoration caused by acute and chronic bronchitis, bronchial asthma, bronchiectasis, tuberculosis, etc. [0003] Ambrox...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/44A61K31/137A61K47/32A61K47/36A61P11/12
Inventor 张亮亮何勇杨贤龙吴宗好
Owner HEFEI HUAFANG PHARMA SCI & TECH
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