Medicine composition with ambroxol hydrochloride

A technology of ambroxol hydrochloride and a composition, applied in the field of medicine, can solve problems such as no adverse reactions such as stomach discomfort, and achieve the effects of avoiding adverse reactions in the stomach and avoiding oxidative degradation

Inactive Publication Date: 2017-10-10
天津双硕医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] In addition, like other drugs, ambroxol hydrochloride preparations also have some adverse reactions, such as rash, nausea, stomach discomfort, loss of appetite, abdominal pain, and diarrhea. Although the incidence rate is very low, it ...

Method used

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  • Medicine composition with ambroxol hydrochloride
  • Medicine composition with ambroxol hydrochloride
  • Medicine composition with ambroxol hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0111] Example 1 Preparation of Ambroxol Hydrochloride Enteric-Coated Tablets with 15mg Specifications (Unit: g)

[0112]

[0113] Preparation Process:

[0114] 1. Get ambroxol hydrochloride crude drug, pulverize, cross 200 mesh sieves for subsequent use;

[0115] 2. Take lactose monohydrate, microcrystalline cellulose, ascorbic acid, edetic acid, grind them, pass through a 100-mesh sieve for later use;

[0116] 3. Take the crushed ambroxol hydrochloride, lactose monohydrate and microcrystalline cellulose in the prescribed amount and mix them evenly;

[0117] 4. Take the prescribed amount of edetic acid, and prepare it into an aqueous solution with a certain concentration, which is used as an adhesive;

[0118] 5. The material obtained in step 3 is made into a soft material with the adhesive obtained in step 4;

[0119] 6. Use a 24-mesh sieve to make wet granules from the soft material obtained in step 5, dry at 60°C, and granulate with a 24-mesh sieve to obtain dry gran...

Embodiment 2

[0124] Example 2 Preparation of Ambroxol Hydrochloride Enteric-Coated Tablets with 30mg Specifications (Unit: g)

[0125]

[0126] Preparation Process:

[0127] 1. Get ambroxol hydrochloride crude drug, pulverize, cross 200 mesh sieves for subsequent use;

[0128] 2. Take lactose monohydrate, microcrystalline cellulose, ascorbic acid, edetic acid, grind them, pass through a 100-mesh sieve for later use;

[0129] 3. Take the crushed ambroxol hydrochloride, lactose monohydrate and microcrystalline cellulose in the prescribed amount and mix them evenly;

[0130] 4. Take the prescribed amount of edetic acid, and prepare it into an aqueous solution with a certain concentration, which is used as an adhesive;

[0131] 5. The material obtained in step 3 is made into a soft material with the adhesive obtained in step 4;

[0132] 6. Use a 24-mesh sieve to make wet granules from the soft material obtained in step 5, dry at 60°C, and granulate with a 24-mesh sieve to obtain dry granul...

Embodiment 3

[0137] Example 3 Preparation of Ambroxol Hydrochloride Enteric-Coated Tablets with 45mg Specifications (Unit: g)

[0138]

[0139]

[0140] Preparation Process:

[0141] 1. Get ambroxol hydrochloride crude drug, pulverize, cross 200 mesh sieves for subsequent use;

[0142] 2. Take lactose monohydrate, microcrystalline cellulose, ascorbic acid, edetic acid, grind them, pass through a 100-mesh sieve for later use;

[0143] 3. Take the crushed ambroxol hydrochloride, lactose monohydrate and microcrystalline cellulose in the prescribed amount and mix them evenly;

[0144] 4. Take the prescribed amount of edetic acid, and prepare it into an aqueous solution with a certain concentration, which is used as an adhesive;

[0145] 5. The material obtained in step 3 is made into a soft material with the adhesive obtained in step 4;

[0146] 6. Use a 24-mesh sieve to make wet granules from the soft material obtained in step 5, dry at 60°C, and granulate with a 24-mesh sieve to obt...

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Abstract

The invention relates to a medicine composition with ambroxol hydrochloride, and aims to solve the problem that the stomach of a user generates adverse reaction as the user takes common oral ambroxol preparations such as tablets, capsules and oral solution and avoid oxidation degradation of ambroxol raw material medicines in the preparations. According to the medicine composition, the ambroxol hydrochloride is prepared into enteric-coated preparations such as enteric-coated tablet and enteric-coated capsules, the raw material medicines of the ambroxol hydrochloride directly releases in small intestine portion and cannot release in the stomach, the adverse reaction of the stomach is avoided, antioxidants and metal ionic chelating agents are added into the preparations to avoid oxidation degradation of ambroxol raw material medicines in the preparation and storage process of ambroxol hydrochloride preparations, and oxidation reaction and catalytic effect of metal ions on the oxidation reaction are avoided. The prepared enteric-coated preparations are good in stability, and the medicine composition is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a pharmaceutical composition containing ambroxol hydrochloride and a preparation method thereof. Background technique [0002] Respiratory diseases are generally manifested as cough, phlegm, wheezing, and inflammation, especially increased sputum volume and difficulty in expectoration are symptoms of many respiratory diseases such as chronic obstructive pulmonary disease (COPD), bronchial asthma, and cystic pulmonary fibrosis (CF). Common symptoms, children and the elderly often have difficulty spitting, which interferes with people's daily life in mild cases, and even endangers the lives of patients in severe cases. At the same time, in the case of thoracic and abdominal operations, patients often produce a large amount of sputum, which can block the respiratory tract, easily cause coughing, wheezing, and even difficulty in breathing. Sputum obstructs the respiratory tract, l...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K9/48A61K31/137A61K47/22A61K47/18A61K47/26A61K47/38A61P11/10
CPCA61K9/2013A61K9/2018A61K9/2054A61K9/2806A61K9/4858A61K9/4866
Inventor 不公告发明人
Owner 天津双硕医药科技有限公司
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