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Sustained release preparation for relieving cough and eliminating phlegm and preparation method thereof

A slow-release preparation and expectorant technology, which is applied in the field of medicine, can solve the problems of low toxicity and side effects, and achieve the effects of low irritation, high bioavailability, and improved compliance

Inactive Publication Date: 2017-05-31
JIANGSU XIANKE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The technical problem to be solved is to overcome the shortcomings and deficiencies of the existing technology, to facilitate drug administration, high bioavailability, stable and long-lasting curative effect, and small toxic and side effects, and to solve the effectiveness, safety and compliance of medication for children, the elderly and patients with dysphagia. sexual conundrum

Method used

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  • Sustained release preparation for relieving cough and eliminating phlegm and preparation method thereof
  • Sustained release preparation for relieving cough and eliminating phlegm and preparation method thereof
  • Sustained release preparation for relieving cough and eliminating phlegm and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] prescription:

[0026]

[0027]

[0028] Preparation Process:

[0029] Step 1 Take a prescription amount of styrene cation exchange resin, immerse it in a 30% ethanol aqueous solution, pass it through a 100-mesh wet sieve, and dry it; add ambroxol hydrochloride and dry resin to purified water. After the reaction, remove the water and place Dry in an oven at 70°C.

[0030] Step 2 Dissolve ethyl cellulose and diethyl phthalate in an appropriate amount of 85% ethanol aqueous solution, and use this solution to coat the ambroxol resin obtained in step 1: Place the ambroxol resin in the flow In the fluidized bed coating machine, start the fluidized bed, use the prepared coating liquid to coat the top spray, and collect the obtained ambroxol coated particles.

[0031] Step 3 Add appropriate amount of purified water, hypromellose, sucrose, glycerin, citric acid, ethyl paraben, lemon yellow, flavor to the container, stir and mix thoroughly, and then add ambroxol coated granules , Stir...

Embodiment 2

[0033] prescription:

[0034]

[0035]

[0036] Preparation Process:

[0037] Step 1 Take a prescription amount of acrylic acid cation exchange resin, properly immerse in 25% ethanol aqueous solution, pass through an 80-mesh wet sieve, and dry; add ambroxol hydrochloride and dry resin into purified water, remove water after the reaction, and place it in 60 Dry in an oven at ℃.

[0038] Step 2 Dissolve cellulose acetate and dibutyl sebacate in an appropriate amount of 80% ethanol aqueous solution, and use this solution to coat the ambroxol resin obtained in step 1: Place the ambroxol resin in a fluidized bed In the coating machine, start the fluidized bed, use the prepared coating liquid to coat the top spray, and collect the obtained ambroxol coated particles.

[0039] Step 3 Add proper amount of purified water, hypromellose, glycerin, sorbic acid, aspartame, methyl paraben, propyl paraben, amaranth, flavor to the container, stir and mix thoroughly, then Add ambroxol coated granules...

Embodiment 3

[0041] prescription:

[0042]

[0043]

[0044] Preparation Process:

[0045] Step 1 Take prescription amount of styrene cation exchange resin and acrylic cation exchange resin, properly immerse in 50% ethanol aqueous solution, pass through 80 mesh wet sieve, and dry; take ambroxol hydrochloride and dry resin into purified water, wait for reaction Remove water and place in an oven at 45°C to dry.

[0046] Step 2 Take shellac and triethyl citrate and dissolve them in an appropriate amount of 87% ethanol aqueous solution, and use this solution to coat the ambroxol resin obtained in step 1: Place the ambroxol resin in a fluidized bed package In the coating machine, start the fluidized bed, spray the top spray coating with the prepared coating solution, and collect the obtained ambroxol coated particles.

[0047] Step 3 Add appropriate amount of purified water, tragacanth, high fructose corn syrup, malic acid, sodium benzoate, and carmine into the container in sequence, stir and mix thor...

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Abstract

The invention provides a sustained release preparation for relieving cough and eliminating phlegm and a preparation method thereof. The sustained release preparation is formed by ambroxol coated granules and a suspending system. The ambroxol coated granules are obtained by film-coating medicated particles formed after ion exchange of the ambroxol hydrochloride and resin. The suspending system is formed by a suspending agent, a corrigent, a PH modifier, a preservative, pigment and purified water. The preparation method comprises the following steps: firstly preparing a resin carrier and a film coating of the ambroxol, and adding the ambroxol coated granules to the suspending system so as to prepare medicated suspension. Compared with other dosage forms, the administration is convenient, the bioavailability is high, the curative effect is stable and durable, the toxic and side effect is small, and the administration for the children, the aged and the patients with dysphagia is easy.

Description

Technical field [0001] The invention relates to the technical field of medicine, in particular to a sustained-release preparation for antitussive and expectorant and a preparation method thereof. Background technique [0002] In recent years, my country’s severe air pollution has caused the incidence and mortality of respiratory diseases to remain high. At present, it is the third leading cause of death in our country. Therefore, the development of drugs to treat respiratory diseases has also become an important part of drug research. In the case of respiratory tract infections (such as chronic bronchitis and other respiratory diseases), a large amount of sputum is often produced. The presence of sputum can block the respiratory tract, which can easily cause coughing, wheezing, and even breathing difficulties, especially in children and the elderly. Difficulty. So the application of expectorants is very necessary. Ambroxol hydrochloride series is currently the strongest clinica...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/137A61K9/16A61K47/38A61K47/44A61K47/34A61K47/10A61K47/36A61K47/32A61P11/14A61P11/10
CPCA61K31/137A61K9/0002A61K9/10A61K9/5015A61K9/5031A61K9/5042A61K47/10A61K47/32A61K47/36A61K47/38
Inventor 梁卓旺苏丽徐亮亮
Owner JIANGSU XIANKE PHARMA CO LTD
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