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Preparation method of ambroxol and salbutamol enteric coatel tablet

A technology of ambroxol salbutamol and salbutamol sulfate is applied in directions such as medical preparations with non-active ingredients, medical preparations containing active ingredients, pharmaceutical formulas, etc., and can solve the problem that the product stability is not ideal, and there is no report on enteric-coated tablets. 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

Inactive Publication Date: 2016-03-30
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 are no reports of enteric-coated 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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  • Preparation method of ambroxol and salbutamol enteric coatel tablet
  • Preparation method of ambroxol and salbutamol enteric coatel tablet
  • Preparation method of ambroxol and salbutamol enteric coatel tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Prescription: (1000 tablets)

[0053] Chip:

[0054] Salbutamol sulfate: 8g;

[0055] Ambroxol hydrochloride: 12g;

[0056] Poloxamer 188: 15g;

[0057] Meglumine: 10g;

[0058] Mannitol: 15g;

[0059] Lactose: 60g;

[0060] Sodium carboxymethyl starch: 8g;

[0061] Hypromellose: appropriate amount;

[0062] Magnesium Stearate: Appropriate amount.

[0063] Enteric coating layer: cellulose acetate phthalate 15g.

[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 enteric-coated material cellulose acetate phthalate 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...

Embodiment 2

[0071] Prescription: (1000 tablets)

[0072] Chip:

[0073] Salbutamol sulfate: 6g;

[0074] Ambroxol hydrochloride: 15g;

[0075] Poloxamer 188: 12g;

[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 hydroxypropyl cellulose phthalate.

[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 enteric-coated material hydroxypropyl cellulose phthalate 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 materi...

Embodiment 3

[0090] Prescription: (1000 tablets)

[0091] Chip:

[0092] Salbutamol sulfate: 8g;

[0093] Ambroxol hydrochloride: 15g;

[0094] Poloxamer 188: 15g;

[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: cellulose acetate trimellitate 20g.

[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 enteric-coated material cellulose acetate trimellitate 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...

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PUM

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Abstract

The invention relates to an ambroxol and salbutamol enteric coatel tablet, and belongs to the field of pharmaceutic preparations. Due to poloxamer 188, meglumine and mannitol which are appropriately added to the enteric coatel tablet, the stability and bioavailability of ambroxol hydrochloride and salbutamol sulfate in the preparation can be remarkably improved, quality is stable, the effect is remarkable, and respiratory system diseases such as acute and chronic bronchitis and asthma can be effectively treated.

Description

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

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/30A61K31/137A61K47/34A61K47/26A61P11/00A61P11/06A61K47/10
CPCA61K9/2866A61K9/2018A61K9/2031A61K9/284A61K31/137A61K2300/00
Inventor 王明刚陈阳生任莉
Owner CP PHARMA QINGDAO CO LTD
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