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Ambroxol hydrochloride injection and preparation method thereof

A technology of ambroxol hydrochloride and injection, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problem of liposomes containing impurities, low stability, easy oxidation, etc. problem, to achieve the effect of increasing hydrophobicity, ensuring stability, and a single component

Active Publication Date: 2022-06-24
HAINAN JINXING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] CN102429879B discloses a kind of ambroxol hydrochloride liposome injection, selects soybean phosphatidylserine and cholesterol as liposome main components, but because soybean phosphatidylserine comes from natural phospholipids, it is difficult to improve the purity, and the liposome prepared by it contains Impurities lead to low stability; in addition, it maintains liposome membrane fluidity and morphological integrity through soybean sterol, Tween 80, trehalose, but through experiments, it is found that this method does not solve the problem of ambroxol hydrochloride. Stability; in the process of preparing ambroxol hydrochloride liposome injection injection, ambroxol hydrochloride is fully exposed without protection, and is also easily oxidized, making the main raw material impure

Method used

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  • Ambroxol hydrochloride injection and preparation method thereof
  • Ambroxol hydrochloride injection and preparation method thereof
  • Ambroxol hydrochloride injection and preparation method thereof

Examples

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Embodiment 1

[0022] A kind of ambroxol hydrochloride injection, comprising the following raw materials by weight: 2 parts of ambroxol hydrochloride, 4 parts of dipalmitoyl phosphatidylethanolamine, 1 part of cholesterol, 0.5 parts of astaxanthin, 1.5 parts of disodium hydrogen phosphate, ascorbic acid 1 part, 7 parts sodium chloride and 900 parts water.

Embodiment 2

[0024] A kind of ambroxol hydrochloride injection, comprising the following raw materials by weight: 3 parts of ambroxol hydrochloride, 5 parts of dipalmitoyl phosphatidylethanolamine, 1 part of cholesterol, 0.8 parts of astaxanthin, 2 parts of disodium hydrogen phosphate, ascorbic acid 1.5 parts, 10 parts sodium chloride and 1000 parts water.

Embodiment 3

[0026] A kind of ambroxol hydrochloride injection, comprising the following raw materials by weight: 5 parts of ambroxol hydrochloride, 6 parts of dipalmitoyl phosphatidylethanolamine, 2 parts of cholesterol, 1 part of astaxanthin, 2.5 parts of disodium hydrogen phosphate, ascorbic acid 2 parts, 12 parts sodium chloride and 1300 parts water.

[0027] The preparation method of above-mentioned a kind of ambroxol hydrochloride injection, comprises the following steps:

[0028] (1) mix disodium hydrogen phosphate, ascorbic acid, sodium chloride and water to make buffer solution;

[0029] (2) adding dipalmitoyl phosphatidylethanolamine, cholesterol and astaxanthin into the buffer solution, and ultrasonically dispersing to make an empty liposome solution;

[0030] (3) mixing ambroxol hydrochloride and astaxanthin again and adding to the empty liposome solution, and sterilizing after ultrasonic dispersion to obtain ambroxol hydrochloride injection.

[0031] The pH range of the buff...

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Abstract

The invention discloses an ambroxol hydrochloride injection. The ambroxol hydrochloride injection is prepared from the following raw materials: ambroxol hydrochloride, dipalmitoyl phosphatidyl ethanolamine, cholesterol, astaxanthin, disodium hydrogen phosphate, ascorbic acid, sodium chloride and water. The invention further discloses a preparation method of the ambroxol hydrochloride injection, the stability of the ambroxol hydrochloride injection to light is improved through combination of astaxanthin and ambroxol hydrochloride, three anti-oxidation barriers are arranged for the ambroxol hydrochloride injection, the outer layer of lipidosome is resistant to oxidation, the inner layer of lipidosome is resistant to oxidation, and the anti-oxidation effect on ascorbic acid is buffered, so that the stability of the ambroxol hydrochloride injection to light is improved. The stability of the ambroxol hydrochloride injection to light and oxygen is comprehensively ensured.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an ambroxol hydrochloride injection and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride can promote the elimination of viscous secretions in the respiratory tract and reduce the retention of mucus, thus significantly promoting expectoration. It is suitable for acute and chronic respiratory diseases with abnormal sputum secretion and poor expectoration function. [0003] Ambroxol hydrochloride is the hydrochloride of bromocyclohexylamine alcohol, the Cl existing in its molecule - There are incompatibility with many drugs, such as: oxaliplatin, lobaplatin, pefloxacin, fleroxacin, trovafloxacin, etc. because Cl - It will lead to the degradation of oxaliplatin and lobaplatin, resulting in decreased efficacy or even failure. while Cl - For pefloxacin, fleroxacin and trovafloxacin, insoluble salts are formed and precipitation ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K9/127A61K47/02A61K47/10A61K47/22A61K47/24A61K47/28A61P11/00A61P11/10
CPCA61K31/137A61K9/0019A61K9/08A61K9/127A61K47/10A61K47/24A61K47/28A61K47/22A61K47/02A61P11/00A61P11/10
Inventor 刘全胜刘春燕邢贞凯邱燕萍吴莲容杜经娟
Owner HAINAN JINXING PHARMA
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