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A kind of ambroxol hydrochloride solution for inhalation

A technology of ambroxol hydrochloride and solution, applied in the field of medicine, can solve problems such as lack of effective evidence for respiratory system safety, lack of uniform standards for drug concentration and course of treatment, and lack of uniform standards for preparation concentration and course of treatment, so as to improve drug absorption. Efficiency, less contamination or oxidative deterioration, less adverse reactions

Active Publication Date: 2016-12-28
赛隆药业集团股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ambroxol hydrochloride injection directly replaces the atomized inhalation solution dosage form to carry out atomization treatment, and there are many problems as follows: first, lack the uniform standard of drug concentration and course of treatment, clinically use ambroxol hydrochloride injection dosage form to carry out the preparation concentration of atomization inhalation treatment There is no unified standard for the course of treatment, lack of stability and maximization of curative effect
Secondly, lack of safety, ambroxol hydrochloride injection still lacks effective evidence on the safety of the nasal cavity and the whole respiratory system
Finally, the lack of convenience
Ambroxol hydrochloride injection or injection needs to be prepared by adding an appropriate amount of normal saline before aerosol inhalation, which is not convenient for clinical use

Method used

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  • A kind of ambroxol hydrochloride solution for inhalation
  • A kind of ambroxol hydrochloride solution for inhalation
  • A kind of ambroxol hydrochloride solution for inhalation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Add 15g of ambroxol hydrochloride to 5000ml of water for injection, stir to dissolve, add 0.5g of sodium sulfite, 0.5g of benzoic acid, and 0.75g of tyloxapol to dissolve completely, add an appropriate amount of phosphate to adjust the pH value, and then add an appropriate amount of water for injection to make the solution system to 10000mL, then filtered through a microporous membrane, and then packed in medical control bottles, each bottle was filled with 10mL, the concentration of ambroxol hydrochloride in each bottle was 1.5mg / mL, and the pH value was 4.6.

Embodiment 2

[0022] Add 30g of ambroxol hydrochloride to 6000mL of normal saline, stir to dissolve, add 0.8g of gallic acid, 0.8g of sorbic acid, and 1.5g of povidone, dissolve completely, add an appropriate amount of hydrogen phosphate to adjust the pH value, and then add an appropriate amount of normal saline to make The solution system is up to 10000mL, then filtered through a microporous membrane, and then packed in medical control bottles, each bottle is filled with 5mL, the concentration of ambroxol hydrochloride in each bottle is 3mg / mL, and the pH value is 5.8.

Embodiment 3

[0024] Ambroxol hydrochloride 20g, add 6000mL isotonic glucose solution, stir to dissolve, add 0.3g sodium sulfite and 0.5g ascorbic acid, 0.6g peppermint oil, 1g polyethylene glycol, dissolve completely, add appropriate amount of sodium acetate to adjust the pH value, then add Take an appropriate amount of water for injection to make the solution system reach 10000mL, then filter through a microporous membrane, and pack in medical control bottles, each bottle is packed with 8mL, the concentration of ambroxol hydrochloride in each bottle is 2mg / mL, and the pH value is 5.1.

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PUM

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Abstract

The invention discloses an ambroxol hydrochloride solution for inhalation, which is characterized in that: every 100mL of solvent contains 0.15-0.3g of ambroxol hydrochloride, a surfactant whose mass is 4-6% of ambroxol hydrochloride and an appropriate amount of antioxidant and preservatives, the pH value of the solution is 4.6-5.8, wherein the solvent is selected from water for injection, physiological saline, and isotonic glucose solution. The ambroxol hydrochloride solution for inhalation of the present invention is sprayed into the oral cavity of a patient to form an aerosol, which directly enters the respiratory tract, has a high inhalation rate and a high local concentration, achieves safe and targeted treatment purposes, and effectively promotes the discharge of sputum in patients. The dosage is small, the drug effect is high, and the safety and stability are good, it is not easy to be polluted or oxidized and deteriorated, and the storage time is long.

Description

technical field [0001] The invention belongs to the technical field of medicine and relates to an ambroxol hydrochloride solution for inhalation. Background technique [0002] Ambroxol hydrochloride is a new generation of respiratory mucus regulator, used for expectorant and cough. The source of ambroxol hydrochloride is Indian natural herbal duckbill flower, and the duckbill flower alkaloid extracted from duckbill flower is molecularly modified to obtain ambroxol hydrochloride. Ambroxol hydrochloride dosage forms listed at home and abroad include oral solutions, tablets, capsules, sustained-release capsules, injections, and freeze-dried powder injections for injection. The administration methods of these dosage forms are oral or injection administration. Injection and oral dosage forms have systemic effects, large adverse reactions, low utilization rate, and even bring certain pain and inconvenience to patients. [0003] The solution for inhalation is sprayed into the mou...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/72A61K31/137A61P11/14A61P11/10
Inventor 李剑峰
Owner 赛隆药业集团股份有限公司
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