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Ambroxol hydrochloride injection with small volume and preparation method thereof

A technology of ambroxol hydrochloride and small capacity, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve medical accidents, limited application, and a stable period of less than 2 years, etc. problem, achieve good buffer capacity, improve safety and stability

Inactive Publication Date: 2010-02-17
HEILONGJIANG FUHE HUAXING PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the stable period of ambroxol hydrochloride injection in China is less than 2 years, which greatly limits its clinical application
Although Chinese patent 200710059969 discloses a kind of ambroxol hydrochloride injection, adding corresponding substances with pH buffering capacity, but as disclosed in this patent, its effect is to improve the stability of the preparation in order to adjust the appropriate pH value, Its citric acid and sodium dihydrogen phosphate do not form a buffer pair (because both are acidic substances, and cannot form a buffer pair), so there is no buffering capacity for plasma, and there is no solution to the intravenous injection of ambroxol hydrochloride injection. During bolus injection, it can buffer the problem of alkaloid precipitation in ambroxol hydrochloride injection due to the pH value of plasma being greater than 6.3. It can only be controlled by the speed of intravenous bolus injection. If it is used improperly, medical accidents will occur

Method used

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  • Ambroxol hydrochloride injection with small volume and preparation method thereof
  • Ambroxol hydrochloride injection with small volume and preparation method thereof
  • Ambroxol hydrochloride injection with small volume and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1 2ml: 15mg ambroxol hydrochloride

[0036] prescription

[0037] Ambroxol hydrochloride 15g

[0038] Citric acid 7.0g

[0039] Disodium hydrogen phosphate 4.6g

[0040] Sodium chloride 12.6g

[0041] Activated carbon

[0042] Add water for injection to 2000ml

[0043] -------------------

[0044] Made into 1000

[0045] Take 1200ml of water for injection, fill the water for injection with carbon dioxide for 20-30 minutes to cool down to about 50-60℃, add 7.0 grams of citric acid and 4.6 grams of disodium hydrogen phosphate under stirring, and wait for citric acid and disodium hydrogen phosphate After all the dissolution, add 15.75g ambroxol hydrochloride (active carbon adsorption of ambroxol hydrochloride is about 5%), after all ambroxol hydrochloride is dissolved, add 12.6g sodium chloride, after all the raw materials are dissolved, the solution is heated to At about 80°C, add 1g of activated carbon and continue stirring at 80°C for about 10 minutes. When the temperature d...

Embodiment 4

[0047] The test method of Example 4 is basically the same as that of Example 1, except that carbon dioxide is not used for preparation.

[0048] The beneficial effects of the present invention are described below in combination with test examples:

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PUM

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Abstract

The invention discloses an ambroxol hydrochloride injection with small volume and high stability and a preparation method thereof. In the ambroxol hydrochloride injection with small volume, the weightpercentage concentration of ambroxol hydrochloride is 0.3-4 percent, the ambroxol hydrochloride solution comprises a component capable of forming acid-base buffer pairs and further comprises carbon dioxide, and a part of space in an ampoule is filled with nitrogen gas. By utilizing carbon dioxide to remove oxygen from the solution, the invention provides the ambroxol hydrochloride injection whichhas small volume and longer stable phase and can be prepared by ambroxol hydrochloride material in different syntheticroutes. The ambroxol hydrochloride injection with small volume can be directly injected into a vein and has good buffering capacity for pH value of blood plasma.

Description

Technical field [0001] The invention relates to a small-volume ambroxol hydrochloride intravenous injection, in particular to a high-stability ambroxol hydrochloride small-volume injection and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride is currently the most widely used expectorant in clinical practice. It can stimulate the formation of respiratory tract surfactants and regulate the secretion of serous and mucus. It can simultaneously improve the elimination of ciliated and non-ciliated areas of the respiratory tract, reduce the adhesion of sputum and cilia, and further make sputum easier to expectorate and reduce The phenomenon of coughing. Due to its rapid and reliable effect, good tolerance and long-term use, this product is an ideal and excellent expectorant. [0003] Ambroxol hydrochloride is currently made into multiple dosage forms such as large-volume injections, small-volume injections, tablets, and granules. Among them, the small-...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/04A61K47/12A61K47/24A61P11/10
Inventor 吴光彦
Owner HEILONGJIANG FUHE HUAXING PHARMA GROUP
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