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Ambroxol salbutamol controlled release tablet

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

Active Publication Date: 2016-03-02
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 tablets
[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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  • Ambroxol salbutamol controlled release tablet
  • Ambroxol salbutamol controlled release tablet
  • Ambroxol salbutamol controlled release tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Prescription: (1000 tablets)

[0053] Chip:

[0054] Salbutamol sulfate: 8g;

[0055] Ambroxol hydrochloride: 16g;

[0056] Poloxamer 188: 8g;

[0057] Meglumine: 10g;

[0058] Mannitol: 15g;

[0059] Lactose: 60g;

[0060] Sodium carboxymethyl starch: 8g;

[0061] Hypromellose: appropriate amount;

[0062] Magnesium Stearate: Appropriate amount.

[0063] Controlled release coating layer: 15g of methylcellulose.

[0064] Preparation:

[0065] 1) Weigh the raw and auxiliary materials of the prescription amount, pass through a 100-mesh sieve for subsequent use;

[0066] 2) Take the sieved hypromellose and the controlled-release material methylcellulose and add distilled water respectively to make a binder solution and a coating solution;

[0067] 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 m...

Embodiment 2

[0071] Prescription: (1000 tablets)

[0072] Chip:

[0073] Salbutamol sulfate: 10g;

[0074] Ambroxol hydrochloride: 20g;

[0075] Poloxamer 188: 10g;

[0076] Meglumine: 12g;

[0077] Mannitol: 15g;

[0078] Starch: 80g;

[0079] Microcrystalline cellulose: 8g;

[0080] Povidone: appropriate amount;

[0081] Magnesium Stearate: Appropriate amount.

[0082] Coating layer: 15 g of methacrylate copolymer.

[0083] Preparation:

[0084] 1) Weigh the raw and auxiliary materials of the prescription amount, pass through a 100-mesh sieve for subsequent use;

[0085] 2) Take the sieved povidone and the controlled-release material methacrylate copolymer and add distilled water respectively to make a binder solution and a coating solution;

[0086] 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;

[0087] 4) ...

Embodiment 3

[0090] Prescription: (1000 tablets)

[0091] Chip:

[0092] Salbutamol sulfate: 8g;

[0093] Ambroxol hydrochloride: 18g;

[0094] Poloxamer 188: 8g;

[0095] Meglumine: 10g;

[0096] Mannitol: 20g;

[0097] Dextrin: 80g;

[0098] Low-substituted hydroxypropyl cellulose: 10g;

[0099] Hypromellose: appropriate amount;

[0100] Micronized silica gel: appropriate amount.

[0101] Coating layer: 20g of methylcellulose.

[0102] Preparation:

[0103] 1) Weigh the raw and auxiliary materials of the prescription amount, pass through a 100-mesh sieve for subsequent use;

[0104] 2) Take the sieved hypromellose and the controlled-release material methylcellulose and add distilled water respectively to make a binder solution and a coating solution;

[0105] 3) Mix the sieved albuterol sulfate, ambroxol hydrochloride, poloxamer 188, meglumine, mannitol, dextrin and low-substituted hydroxypropyl cellulose in equal increments, and add the above-mentioned adhesive agent solutio...

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PUM

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Abstract

The invention relates to an ambroxol salbutamol controlled release tablet and belongs to the field of pharmaceutical preparations. The controlled release tablet is suitably added with poloxamer 188, meglumine and mannitol, significant improvement can be given to the stability and bioavailability of ambroxol hydrochloride and salbutamol sulfate in a preparation, the quality is stable, the effect is significant, and effective treatment may be given to respiratory diseases such as acute and chronic bronchitis and asthma.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an ambroxoxalbutamol controlled-release tablet 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 ar...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/137A61K47/10A61K47/26A61P11/00A61P11/06
CPCA61K9/2018A61K9/2031A61K9/2054A61K9/2846A61K9/2866A61K31/137A61K2300/00
Inventor 王明刚陈阳生任莉
Owner CP PHARMA QINGDAO CO LTD
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