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Ambroxol hydrochloride injection and preparation method

A technology of ambroxol hydrochloride and injection, which is applied in the field of ambroxol hydrochloride injection, and can solve problems such as pH stability and impurity increase of ambroxol hydrochloride injection

Active Publication Date: 2018-07-31
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In order to avoid pH value changes caused by sterilization, thereby affecting the pH value stability and impurity increase of ambroxol hydrochloride injection, the invention provides a preparation method of ambroxol hydrochloride injection with stable pH

Method used

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  • Ambroxol hydrochloride injection and preparation method
  • Ambroxol hydrochloride injection and preparation method
  • Ambroxol hydrochloride injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Embodiment 1: preparation ambroxol hydrochloride injection

[0087] formula:

[0088]

[0089] Preparation method:

[0090] (1) 55% water for injection (water temperature is below 40 ℃, the same below) dissolves the ambroxol hydrochloride, citric acid, disodium hydrogen phosphate, sodium chloride of prescription quantity with prescription quantity;

[0091] (2) Add 0.05% active carbon for needles according to the weight / volume percentage of the medicinal solution, stir evenly, add an acid-base regulator to adjust the pH of the medicinal solution within the range of 7.5 to 8.0 (actually adjusted pH7.8), and make the medicinal solution at room temperature Stir for 30min, filter and decarbonize;

[0092] (3) Add water for injection to about the full amount, and add an acid-base regulator to adjust the pH of the liquid in the range of 4.8 to 5.2 (pH 5.0 after actual adjustment);

[0093] (4) After the preparation is completed, the medicinal solution is sent to the fil...

Embodiment 2

[0094] Embodiment 2: preparation ambroxol hydrochloride injection

[0095] formula:

[0096]

[0097] Preparation method:

[0098] (1) 50% water for injection (water temperature is below 40 ℃, the same below) dissolves the ambroxol hydrochloride, citric acid, disodium hydrogen phosphate, sodium chloride of prescription quantity with prescription quantity;

[0099] (2) Add 0.05% active carbon for needles according to the weight / volume percentage of the medicinal solution, stir evenly, add an acid-base regulator to adjust the pH of the medicinal solution within the range of 7.5 to 8.0 (actually adjusted pH7.8), and make the medicinal solution at room temperature Stir for 30min, filter and decarbonize;

[0100] (3) Add water for injection to about the full amount, and add an acid-base regulator to adjust the pH of the liquid in the range of 4.8 to 5.2 (the actual pH is 4.8);

[0101] (4) After the preparation is completed, the medicinal solution is sent to the filling and s...

Embodiment 3

[0102] Embodiment 3: preparation ambroxol hydrochloride injection

[0103] formula:

[0104]

[0105] Preparation method:

[0106] (1) Ambroxol hydrochloride, citric acid, disodium hydrogen phosphate, sodium chloride of prescription quantity are dissolved with 60% water for injection (water temperature is below 40 ℃, the same below) of prescription quantity;

[0107] (2) Add 0.05% active carbon for needles according to the weight / volume percentage of the medicinal solution, stir evenly, add an acid-base regulator to adjust the pH of the medicinal solution within the range of 7.5 to 8.0 (actually adjusted pH7.8), and make the medicinal solution at room temperature Stir for 30min, filter and decarbonize;

[0108] (3) Add water for injection to about the full amount, and add an acid-base regulator to adjust the pH of the liquid in the range of 4.8 to 5.2 (the actual pH is 5.2);

[0109](4) After the preparation is completed, the medicinal solution is sent to the filling and...

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Abstract

The invention relates to ambroxol hydrochloride injection and a preparation method. Specifically, the present invention relates to a kind of ambroxol hydrochloride injection, which comprises ambroxol hydrochloride, citric acid, disodium hydrogen phosphate, sodium chloride and water for injection. Wherein the concentration of citric acid is less than 1mg / ml. The ambroxol hydrochloride injection prepared by the invention has excellent pharmaceutical properties.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical engineering, in particular to an ambroxol hydrochloride product and its preparation method, in particular to an ambroxol hydrochloride injection and its preparation method. 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 diff...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/137A61P11/10A61P11/00A61P11/06
Inventor 方专张莲莲陈娟吴国庆伍龙霞王敬赵东明
Owner CHENGDU TIANTAISHAN PHARMA