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Solution preparation for atomizing and inhaling ambroxol and preparation method thereof

A technology of atomized inhalation and ambroxol, which is applied in the field of pharmacy, can solve the problems of off-label medicine, unclear usage and dosage, lack of research data, etc., and achieve the effects of reducing irritation, clinical application safety, and improving safety

Inactive Publication Date: 2009-12-23
BEIJING HANMI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Hospitals usually use injections, but this kind of usage has many risks such as off-label use, lack of research data, and unclear usage and dosage. Therefore, the solution preparation for aerosol inhalation of ambroxol will meet the strong demand for clinical medication

Method used

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  • Solution preparation for atomizing and inhaling ambroxol and preparation method thereof
  • Solution preparation for atomizing and inhaling ambroxol and preparation method thereof
  • Solution preparation for atomizing and inhaling ambroxol and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1 : Prepare 30 mg / 2 ml single-dose ambroxol atomized inhalation solution (1000 sticks)

[0048] prescription:

[0049] Ambroxol Hydrochloride 30.0g

[0050] Sodium chloride 30.0g

[0051] Citric acid 1.80g

[0052] Disodium hydrogen phosphate solution (0.4mol / l) appropriate amount

[0053] Add purified water to 2000ml

[0054] Preparation:

[0055] Take ambroxol hydrochloride by prescription quantity, join in the water for injection of 1600ml, stir and dissolve completely, obtain solution 1; Get prescription quantity citric acid and sodium chloride separately, add 100ml water for injection, after stirring and dissolving, obtain solution 2; Combine the two solutions and stir evenly to obtain solution 3; then weigh an appropriate amount of disodium hydrogen phosphate, add water for injection to prepare a 0.4mol / L solution, stir slowly and add it to solution 3, and adjust the pH to 4.5-5.5; Add purified water to the solution to 2000ml, fill and seal, 2ml pe...

Embodiment 2

[0062] Example 2 : Prepare 30mg / 2ml single-dose ambroxol atomized inhalation solution (10000 sticks)

[0063] prescription:

[0064] Ambroxol Hydrochloride 300g

[0065] Sodium chloride 300g

[0066] Citric acid 18.0g

[0067] Disodium hydrogen phosphate solution (0.4mol / l) appropriate amount

[0068] Add purified water to 20000ml

[0069] Preparation:

[0070] Take ambroxol hydrochloride by prescription quantity, join in the water for injection of 16000ml, stir and dissolve completely, obtain solution 1; Get prescription quantity citric acid and sodium chloride separately, add 1000ml water for injection, after stirring and dissolving, obtain solution 2; Combine the two solutions and stir evenly to obtain solution 3; then weigh an appropriate amount of disodium hydrogen phosphate, add water for injection to prepare a 0.4mol / L solution, stir slowly and add it to solution 3, and adjust the pH to 4.5-5.5; Add purified water to the solution to 20000ml, use the aseptic blow...

Embodiment 3

[0077] Example 3 : Prepare 30mg / 4ml single-dose ambroxol nebulized inhalation solution (1000 sticks)

[0078] prescription:

[0079] Ambroxol Hydrochloride 30.0g

[0080] Sodium chloride 48.0g

[0081] Citric acid 2.22g

[0082] Disodium hydrogen phosphate solution (0.4mol / l) appropriate amount

[0083] Add purified water to 4000ml

[0084] Preparation:

[0085]Weigh ambroxol hydrochloride and sodium chloride according to the prescription quantity, add 2000ml of purified water to dissolve to obtain solution 1; take another prescription quantity of citric acid and dissolve it in 1000ml of purified water to obtain solution 2; combine the two solutions and stir to obtain solution 3. Weigh an appropriate amount of disodium hydrogen phosphate, add water for injection to make a 0.4mol / L solution, stir slowly and add it to solution 3, adjust the pH to 5.5-6.0, add 0.2% activated carbon and boil for 30 minutes, filter through sand Stick filter decarburization, add purified wat...

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Abstract

The invention relates to a solution preparation for atomizing and inhaling ambroxol, and belongs to the field of pharmaceutics. The solution preparation for atomizing and inhaling the ambroxol comprises (1) ambroxol or medicinal salt thereof with single medicinal dosage, (2) isotonic agent and solvent, (3) buffer solution and (4) medicinal package with single dosage; and in terms of the ambroxol, the mass ratio of the medicinal components to the isotonic agent is 1:1.1-1:3.3.The invention provides the solution preparation for atomizing and inhaling the ambroxol with single dosage and the medicinal package adopting blowing-filling-sealing (BFS) integrative full-automatic production, which have the advantages that the medicinal package is designed and manufactured for patients special for atomizing and inhaling; the solution preparation does not contain preservative, and is used with disposable single dosage; the using process is convenient and does not need dilution and preparation; and the microbe pollution, waste and the like during using can be greatly reduced. The medicinal preparation provides a treatment medicament and a treatment proposal with accurate medicinal dosage, good-quality and stable medicament quality, and safe and simple clinical application lacking in the prior art.

Description

technical field [0001] The invention relates to a solution preparation of ambroxol for nebulization and inhalation, which belongs to the field of pharmacy. Background technique [0002] Ambroxol is an expectorant widely used clinically at present, suitable for acute and chronic respiratory diseases (such as acute and chronic bronchitis, bronchial asthma, bronchiectasis, chronic obstructive pneumonia, tuberculosis, emphysema, pneumoconiosis, etc.) Thick sputum, difficulty breathing. At the same time, ambroxol can also be used for the preventive treatment of postoperative pulmonary complications and the treatment of infant respiratory distress. [0003] Respiratory diseases are one of the common frequently-occurring diseases, among which bronchitis, asthma and pneumonia are the main ones. According to statistics, the incidence rate of acute bronchitis in China in 2000 was about 1%, the incidence rate of chronic bronchitis was 3.8%, and the incidence rate of people over 50 ye...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/12A61K31/137A61P11/10
Inventor 刘奇志李晓涛
Owner BEIJING HANMI PHARMA CO LTD
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