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The preparation method of Ambroxol albuterol controlled-release capsules

A technology of ambroxol salbutamol and salbutamol sulfate is applied in directions such as non-active ingredients medical preparations, active ingredients-containing medical preparations, pharmaceutical formulas, etc., and can solve the problem that product stability is not ideal, and no controlled-release capsule report has been reported. Easy to produce by-products and other problems, to achieve the effect of increasing the content of active ingredients, treating respiratory diseases, and improving stability

Active Publication Date: 2018-06-01
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Dosage forms such as solutions and granules containing ambroxol hydrochloride and salbutamol sulfate already exist in the prior art, but there is no report of controlled-release capsules
[0007] In addition, albuterol sulfate and ambroxol hydrochloride are the active ingredients in the same minimum preparation unit. During long-term storage, due to possible chemical compatibility changes between the ingredients, by-products are likely to be produced, which will reduce the effect or increase side effects. Product stability not ideal

Method used

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  • The preparation method of Ambroxol albuterol controlled-release capsules
  • The preparation method of Ambroxol albuterol controlled-release capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] prescription:

[0050] The core is made of the following components by weight:

[0051] Salbutamol sulfate: 8g;

[0052] Ambroxol hydrochloride: 15g;

[0053] Poloxamer 188: 8g;

[0054] Meglumine: 12g;

[0055] Mannitol: 18g;

[0056] Lactose: 60g;

[0057] Sodium carboxymethyl starch: 5g;

[0058] Hydroxypropyl Cellulose: Appropriate amount.

[0059] The controlled-release coating layer is made of the following components by weight: 15 g of ethyl cellulose.

[0060] Preparation:

[0061] 1) Weigh the raw and auxiliary materials of the prescription amount, pass through a 100-mesh sieve for subsequent use;

[0062] 2) Take the sieved hydroxypropyl cellulose and ethyl cellulose and add distilled water respectively to make a binder solution and a coating solution;

[0063] 3) Mix the sieved salbutamol sulfate, ambroxol hydrochloride, poloxamer 188, meglumine, mannitol, lactose and carboxymethyl starch sodium in equal increments, and add the above adhesive solution...

Embodiment 2

[0067] prescription:

[0068] Core:

[0069] Salbutamol sulfate: 8g;

[0070] Ambroxol hydrochloride: 15g;

[0071] Poloxamer 188: 5g;

[0072] Meglumine: 15g;

[0073] Mannitol: 15g;

[0074] Dextrin: 80g;

[0075] Microcrystalline cellulose: 2g;

[0076] Hypromellose: Appropriate amount.

[0077] Coating layer: 10 g of methacrylate copolymer.

[0078] Preparation:

[0079] 1) Weigh the raw and auxiliary materials of the prescription amount, pass through a 100-mesh sieve for subsequent use;

[0080] 2) taking the sieved hypromellose and methacrylate copolymer and adding distilled water respectively to make a binder solution and a coating solution;

[0081] 3) Mix the sieved salbutamol sulfate, ambroxol hydrochloride, poloxamer 188, meglumine, mannitol, dextrin and microcrystalline cellulose in equal increments, and add the above adhesive solution to prepare into soft material;

[0082] 4) After granulating with a 40-mesh sieve, dry at 60°C for 30 minutes, pass thr...

Embodiment 3

[0085] prescription:

[0086] Core:

[0087] Salbutamol sulfate: 6g;

[0088] Ambroxol hydrochloride: 15g;

[0089] Poloxamer 188: 10g;

[0090] Meglumine: 12g;

[0091] Mannitol: 20g;

[0092] Starch: 60g;

[0093] Microcrystalline cellulose: 4g;

[0094] Povidone: Appropriate amount.

[0095] Coating layer: 20g of methylcellulose.

[0096] Preparation:

[0097] 1) Weigh the raw and auxiliary materials of the prescription amount, pass through a 100-mesh sieve for subsequent use;

[0098] 2) Take povidone and methylcellulose after sieving and add distilled water respectively to make binder solution and coating solution;

[0099] 3) Mix the sieved albuterol sulfate, ambroxol hydrochloride, poloxamer 188, meglumine, mannitol, starch and microcrystalline cellulose in equal increments, and add the above binder solution to prepare soft material;

[0100] 4) After granulating with a 40-mesh sieve, dry at 60°C for 60 minutes, pass through a 20-mesh sieve for granulation; ...

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Abstract

The invention relates to controlled release capsules containing ambroxol hydrochloride and salbutamol sulfate and belongs to the field of medicinal preparations. Poloxamer188, meglumine and mannitol are properly added into the controlled release capsules so that the stability and bioavailability of ambroxol hydrochloride and salbutamol sulfate in the preparation can be remarkably improved, and the controlled release capsules have stable quality and a remarkable effect and can effectively treat acute or chronic bronchitis, asthma and other respiratory diseases.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an ambroxoxalbutamol controlled-release capsule and a preparation method thereof. Background technique [0002] Respiratory system disease is a common and frequently-occurring disease. The main lesions are in the trachea, bronchi, lungs, and chest cavity. Mild cases often cause coughing, chest pain, and respiratory problems. Severe cases have dyspnea, hypoxia, and even death due to respiratory failure. The death rate in the city is the third, while in the countryside it is the first. What should be paid more attention to is that due to air pollution, smoking, population aging and other factors, chronic obstructive pulmonary disease (referred to as COPD, including chronic bronchitis, emphysema, pulmonary heart disease), bronchial asthma, lung cancer, etc. , Pulmonary diffuse interstitial fibrosis, and the morbidity and mortality of diseases such as pulmonary infection a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K31/137A61K47/10A61K47/18A61P11/00A61P11/06
Inventor 王明刚陈阳生任莉
Owner CP PHARMA QINGDAO CO LTD
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