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Method for preparing ambroxol hydrochloride solution for inhalation

A technology of ambroxol hydrochloride and solution, applied in the field of medicine, can solve the problems such as restricted use, low solubility of ambroxol hydrochloride, influence on medication quality and safety, etc., and achieves the effect of high productivity

Inactive Publication Date: 2020-12-04
太阳升(亳州)生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Oral preparations are easy to use, but slow to take effect; injections are fast to take effect, but limited in use; and inhalation solutions are fast-acting, effective, safe, effective and convenient, and are more suitable for young children, postoperative patients and elderly patients, with market potential Big
[0004] The method for producing ambroxol hydrochloride solution of current prior art is prone to impurity, has a strong impact on drug quality and safety
In addition, ambroxol hydrochloride has low solubility in water, which affects production efficiency

Method used

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  • Method for preparing ambroxol hydrochloride solution for inhalation
  • Method for preparing ambroxol hydrochloride solution for inhalation
  • Method for preparing ambroxol hydrochloride solution for inhalation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Example 1 (E1)

[0038] Take by weighing 15.0g ambroxol hydrochloride, 2.0g citrate, 7.5g disodium hydrogen phosphate, 14.2g sodium chloride, standby.

[0039] Measure 1.6L of water for injection into a stainless steel barrel, heat it in a water bath to 60°C, add ambroxol hydrochloride, stir to dissolve completely, and the dissolution time is about 2 minutes. Then add citric acid, stir to make it dissolve completely, and the dissolution time is about 29 seconds. Add sodium chloride again, stir to make it dissolve completely, and the dissolution time is 28 seconds. Finally, add disodium hydrogen phosphate, stir to make it dissolve completely, and the dissolution time is 29 seconds. Add water for injection to 2L and stir evenly. Protect from light for 4 hours during the dosing process. The drug solution is filtered through two 0.2μm PES material filter membranes.

[0040] Fill the medicinal solution in 2ml brown medium borosilicate glass ampoules, the filling volume ...

Embodiment 2

[0042] Example 2 (E2)

[0043] Take by weighing 15.0g ambroxol hydrochloride, 2.0g citrate, 7.5g disodium hydrogen phosphate, 14.2g sodium chloride, standby.

[0044]Measure 1.6L of water for injection into a stainless steel barrel, heat it in a water bath to 60°C, add ambroxol hydrochloride, stir to make it dissolve completely, and the dissolution time is about 2 minutes. Then add citric acid, stir to make it dissolve completely, and the dissolution time is about 29 seconds. Add sodium chloride again, stir to make it dissolve completely, and the dissolution time is 28 seconds. Finally, add disodium hydrogen phosphate, stir to make it dissolve completely, and the dissolution time is 29 seconds. Add water for injection to 2L and stir evenly. Avoid light for 8 hours during the liquid preparation process. The drug solution is filtered through two 0.2μm PES material filter membranes.

[0045] Fill the medicinal solution in 2ml brown medium borosilicate glass ampoules, the fil...

Embodiment 3

[0047] Example 3 (E3)

[0048] Take by weighing 15.0g ambroxol hydrochloride, 2.0g citrate, 7.5g disodium hydrogen phosphate, 14.2g sodium chloride, standby.

[0049] Measure 1.6L of water for injection into a stainless steel barrel, heat it in a water bath to 60°C, add ambroxol hydrochloride, stir to make it dissolve completely, and the dissolution time is about 2 minutes. Then add citric acid, stir to make it dissolve completely, and the dissolution time is about 29 seconds. Add sodium chloride again, stir to make it dissolve completely, and the dissolution time is 28 seconds. Finally, add disodium hydrogen phosphate, stir to make it dissolve completely, and the dissolution time is 29 seconds. Add water for injection to 2L and stir evenly. Avoid light for 12 hours during the liquid preparation process. The drug solution is filtered through two 0.2μm PES material filter membranes.

[0050] Fill the medicinal solution in 2ml brown medium borosilicate glass ampoules, the f...

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Abstract

The invention provides a method for preparing an ambroxol hydrochloride solution for inhalation. The method comprises the following steps of weighing ambroxol hydrochloride, citric acid, disodium hydrogen phosphate and sodium chloride according to a prescription dosage; preparing a solution of ambroxol hydrochloride, citric acid, disodium hydrogen phosphate and sodium chloride in the water for injection, so that the pH of the solution is 4.5-5.5, adding ambroxol hydrochloride, citric acid, disodium hydrogen phosphate and sodium chloride into the water for injection according to the sequence inthe preparation process, and keeping out of the sun at the liquid preparation temperature of 55-65 DEG C for 4 minutes to 24 hours; filtering the solution; filling a container with the filtered solution, and introducing nitrogen while filling; and sterilizing the container filled with the solution. The method can be used for preparing the liquid medicine with relatively low impurity level with high productivity.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a method for preparing an ambroxol hydrochloride solution for inhalation. Background technique [0002] Ambroxol hydrochloride is a mucolytic drug, which is clinically used for expectorant treatment. It mainly enhances cough by promoting bronchial cilia emptying, reducing airway hyperresponsiveness, stimulating the secretion of cell surface active substances, and reducing the release of inflammatory mediators. The scavenging effect is conducive to the discharge of airway secretions, so as to achieve the protective effect on the respiratory system. [0003] Ambroxol hydrochloride preparations include tablets, capsules, syrups, injections, solutions for inhalation, and the like. Oral preparations are easy to use, but slow to take effect; injections are fast to take effect, but limited in use; and inhalation solutions are fast-acting, effective, safe, effective and convenient, an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K47/12A61K47/02A61K31/137A61P11/10A61P11/00
CPCA61K9/08A61K9/0078A61K47/12A61K47/02A61K31/137A61P11/10A61P11/00
Inventor 方小东郭鸿旭
Owner 太阳升(亳州)生物医药科技有限公司