Stable ambroxol hydrochloride injection and preparation method thereof

A technology for the preparation of ambroxol hydrochloride and injections, which is applied to medical preparations containing no active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., can solve problems such as differences in the content of insoluble particles, and reduce production costs. The effect of improving safety

Inactive Publication Date: 2020-12-18
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are significant differences in the content of insoluble particles in different brands of ambroxol hydrochloride injection

Method used

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  • Stable ambroxol hydrochloride injection and preparation method thereof
  • Stable ambroxol hydrochloride injection and preparation method thereof
  • Stable ambroxol hydrochloride injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0053] A stable ambroxol hydrochloride injection, comprising: ambroxol hydrochloride 7.5g / L, disodium hydrogen phosphate 1.8g / L, citric acid 1.5g / L, methionine 0.3g / L, edetate dicalcium 0.05g / L.

[0054] The above-mentioned stable preparation method of ambroxol hydrochloride injection comprises the following steps: dissolving disodium hydrogen phosphate, citric acid, methionine and dicalcium edetate in water to make the pH value of the system 6.0, then adding ambroxol hydrochloride The cable was completely dissolved, then glucose was added to adjust the osmotic pressure to isotonicity, constant volume, and then filtered with a 0.22 μm filter membrane, filled with nitrogen, and sterilized at 120°C for 20 minutes.

Embodiment 2

[0056] A stable ambroxol hydrochloride injection, comprising: ambroxol hydrochloride 7.5g / L, disodium hydrogen phosphate 2.2g / L, citric acid 0.66g / L, methionine 0.1g / L, edetate dicalcium 0.1g / L.

[0057] The above-mentioned stable preparation method of ambroxol hydrochloride injection comprises the following steps: dissolving disodium hydrogen phosphate, citric acid, methionine and dicalcium edetate in water to make the system pH value 4.0, then adding ambroxol hydrochloride The cable was completely dissolved, then glucose was added to adjust the osmotic pressure to isotonicity, constant volume, and then filtered with a 0.22 μm filter membrane, filled with nitrogen, and sterilized at 125°C for 15 minutes.

Embodiment 3

[0059] A stable ambroxol hydrochloride injection, comprising: ambroxol hydrochloride 7.5g / L, disodium hydrogen phosphate 2.0g / L, citric acid 0.75g / L, cysteine ​​0.3g / L, edetine Disodium acid 0.1g / L, sodium chloride 7g / L.

[0060] The preparation method of above-mentioned stable ambroxol hydrochloride injection comprises the steps of: adding disodium hydrogen phosphate, citric acid, cysteine ​​and edetate disodium into water and dissolving completely, making the system pH value 5.0~5.5, Then add ambroxol hydrochloride to completely dissolve, then add sodium chloride to adjust the osmotic pressure, dilute to 1000mL with water for injection, then filter twice with a 0.22μm filter membrane, fill it with nitrogen and seal it in a 2mL brown ampoule, 121 Sterilize at ℃ for 15 minutes.

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Abstract

The invention belongs to the technical field of medicine, relates to the technical field of an ambroxol hydrochloride injection, and particularly relates to a stable ambroxol hydrochloride injection and a preparation method thereof. The invention discloses a stable ambroxol hydrochloride injection which comprises 7.5 g/L of ambroxol hydrochloride, 1.8 g/L to 2.2 g/L of disodium hydrogen phosphate,0.6 g/L to 1.8 g/L of citric acid, 0.1 g/L to 0.3 g/L of amino acid antioxidant and 0.05 g/L to 0.1 g/L of edetate. The invention discloses a preparation method of the stable ambroxol hydrochloride injection. The preparation method comprises the following steps of: adding the disodium hydrogen phosphate, the citric acid, the amino acid antioxidant and the edetate into water to completely dissolve; then adding the ambroxol hydrochloride to completely dissolve; then regulating an osmotic pressure to an isotonic pressure; making up to a volume; then carrying out filtering; carrying out nitrogencharging and potting; and carrying out sterilization.

Description

technical field [0001] The invention relates to the technical field of medical technology, in particular to a stable ambroxol hydrochloride injection and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride, also known as bromcyclohexyl hydrochloride, chemical name: trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride. Modern pharmacological studies have shown that ambroxol hydrochloride has a good dissolving effect on mucus phlegm, lubricates the patient's respiratory tract, significantly improves the movement of lung cilia, and significantly increases the actual secretion speed of respiratory fluid. Reduce the amount of mucus adhesion on the trachea, further strengthen the function of expectoration, and effectively improve the respiratory function. [0003] So far, there are 70 domestic manufacturers of ambroxol preparations, which have approved tablets, sustained-release tablets, dispersible tablets, effervescent tablets, ora...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/18A61K47/12A61K31/137A61P11/00A61P11/10
CPCA61K9/08A61K9/0019A61K47/183A61K47/12A61K31/137A61P11/00A61P11/10
Inventor 曹丽华贺莲杨世平张静刘娟
Owner KAMP PHARMA
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