The preparation method of ambroxoxalbutamol enteric-coated granules

A technology of ambroxoxalbutamol and salbutamol sulfate, which is applied in the field of ambroxoxalbutamol enteric-coated granules and its preparation, can solve the problems of unsatisfactory product stability, no report of enteric-coated granules, and easy production of by-products, etc., and achieve active The effect of increasing the content of ingredients, treating respiratory diseases, and improving stability

Active Publication Date: 2018-06-05
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the prior art, dosage forms such as solutions and granules containing ambroxol hydrochloride and salbutamol sulfate have existed, but there are no reports of enteric-coated granules
[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 ambroxoxalbutamol enteric-coated granules
  • The preparation method of ambroxoxalbutamol enteric-coated granules
  • The preparation method of ambroxoxalbutamol enteric-coated granules

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: 12g;

[0052] Ambroxol hydrochloride: 15g;

[0053] Poloxamer 188: 8g;

[0054] Meglumine: 12g;

[0055] Mannitol: 18g;

[0056] Lactose: 60g;

[0057] Sodium carboxymethyl starch: 5g;

[0058] Povidone: Appropriate amount.

[0059] The enteric coating layer is made of the following components by weight: 15 g of cellulose acetate phthalate.

[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) Add distilled water to the sieved povidone and cellulose acetate phthalate 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 to prepare into soft...

Embodiment 2

[0067] prescription:

[0068] Core:

[0069] Salbutamol sulfate: 10g;

[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 cellulose acetate trimellitate.

[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) Take the sieved hypromellose and cellulose acetate trimellitate and add 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 minut...

Embodiment 3

[0085] prescription:

[0086] Core:

[0087] Salbutamol sulfate: 15g;

[0088] Ambroxol hydrochloride: 20g;

[0089] Poloxamer 188: 10g;

[0090] Meglumine: 12g;

[0091] Mannitol: 20g;

[0092] Starch: 60g;

[0093] Microcrystalline cellulose: 4g;

[0094] Povidone: Appropriate amount.

[0095] Coating layer: 20 g of hydroxypropyl cellulose phthalate.

[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 hydroxypropyl cellulose phthalate 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 thr...

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Abstract

The invention relates to ambroxol and salbutamol enteric-coated granules, and belongs to the field of a pharmaceutical preparation. The enteric-coated granules, which are added with proper amounts of poloxamer 188, meglumine and mannitol, can significantly improve the stability and the bioavailability of ambroxol hydrochloride and salbutamol sulfate in a preparation; and the enteric-coated granules are stable in quality and significant in effect, and the enteric-coated granules are capable of effectively treating such diseases of respiratory system as acute and chronic bronchitis, asthma and the like.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an ambroxoxalbutamol enteric-coated granule 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 are i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K9/16A61K31/137A61P11/00A61P11/06
CPCA61K9/1623A61K9/1641A61K9/2866A61K31/137A61K2300/00
Inventor 王明刚陈阳生任莉
Owner CP PHARMA QINGDAO CO LTD
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