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Ambroxol hydrochloride containing hydroxypropyl beta-cyclodextrin and its preparation

A technology of ambroxol hydrochloride injection and ambroxol hydrochloride, which is applied in the field of medicine to achieve the effect of facilitating clinical medication and solving water-soluble problems

Inactive Publication Date: 2003-06-18
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It utilizes the inclusion effect of hydroxypropyl β-cyclodextrin on ambroxol, thereby completely solving its water solubility problem, making ambroxol hydrochloride compatible with alkaline drugs and convenient for clinical use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0005] Example 1: Weigh 6 parts of 200mg ambroxol hydrochloride, place them in 100ml beakers respectively, add 20ml of distilled water to dissolve, add 1000mg, 2000mg, 3000mg, 4000mg and 5000mg of 2-hydroxypropyl β- Cyclodextrin, after being dissolved, adjust the pH value to about 8.5 with 0.01mol / L sodium hydroxide solution, the results are shown in Table 1.

[0006] Table 1. Drug precipitation when the pH value is around 8.5 pH value 8.51 8.54 8.53 8.56 8.58 8.56 Hydroxypropane β-cyclodextrin 0 1000 2000 3000 4000 5000 (mg) Precipitation Precipitation Precipitation Precipitation No Precipitation No Precipitation No Precipitation

[0007] It can be seen from the table that when the pH value is greater than 8.5, the weight ratio of the drug to hydroxypropyl β-cyclodextrin is less than 1:15, and the precipitate is folded; while the weight ratio of the drug to hydroxypropyl β-cyclodextrin is greater than 1:15 When (including 1:15), no precipitation is folded out. ...

Embodiment 2

[0008] Example 2: When the weight ratio of drug to 2-hydroxypropyl β-cyclodextrin is 1:3, drug precipitation under different pH conditions is investigated. The method is the same as "Example 1", and the results are shown in Table 2.

[0009] Table 2. Drug precipitation under different pH conditions pH value 5.15 5.18 5.46 6.06 Ratio of drug to hydroxypropyl β-cyclodextrin (w / w) 1:0 1:3 1:3 1:3 Precipitation does not precipitate no precipitation precipitation

Embodiment 3

[0010] Example 3: When the weight ratio of drug to 2-hydroxypropyl β-cyclodextrin is 1:5, drug precipitation under different pH conditions is investigated. The method is the same as "Example 1", and the results are shown in Table 3.

[0011] Table 3. The pH value of drug precipitation under different pH conditions

[0012] Not sinking Not sinking Not sinking Precipitation situation Precipitation Precipitation

[0013] starch starch

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PUM

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Abstract

An ambroxol hydrochloride injection containing hydroxypropyl beta-dextrin in the form of "liquid injection", "freeze dried powder injection", "aseptic powder injection", etc is composed of the ambroxol hydrochloride and 2-hydroxypropyl beta-dextrin in Wt ratio of 1:(3-50). Its advantage is high solubility in water, especially in high-pH water.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to ambroxol hydrochloride injection containing hydroxypropyl beta-cyclodextrin and a preparation method thereof. Background technique: [0002] Ambroxol hydrochloride is a metabolite of bromhexine, and its expectorant effect is stronger than that of bromhexine. Ambroxol hydrochloride has been widely used in the treatment of respiratory diseases in many countries such as the United States, Britain, Germany, Japan, etc., with excellent clinical effects and almost no toxic side effects. Its efficacy and safety have been clinically confirmed. The pharmacological effects include: 1. Dissolving mucus; 2. Promoting the synthesis of pulmonary surfactant; 3. Activating the purification function of mucus cilia; 4. Reducing the adhesion between sputum and cilia, making sputum easy to cough up. Tests have shown that ambroxol can protect against peroxide-induced lung damage including asthma, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/13A61P11/10
Inventor 邓意辉
Owner SHENYANG PHARMA UNIVERSITY
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