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Stable ambroxol hydrochloride huge capacity injection and preparation method thereof

A technology of ambroxol hydrochloride and injection, applied in the field of medical injection, can solve problems such as inconvenience of use, increased pollution opportunities and the like

Inactive Publication Date: 2015-09-09
ANHUI DOUBLE CRANE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Clinical use requires secondary preparation to increase the chance of contamination and is inconvenient to use. It is generally a helpless choice when there is no better solution for unstable samples.

Method used

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  • Stable ambroxol hydrochloride huge capacity injection and preparation method thereof

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Effect test

Embodiment 1

[0032] A stable large volume injection of ambroxol hydrochloride, comprising the following substances: 0.15 g of ambroxol hydrochloride, 25 g of fructose, 1.8 g of gallic acid, 6.5 g of citric acid, 13.8 g of disodium hydrogen phosphate, and adding water for injection to 500 ml.

[0033] A kind of stable ambroxol hydrochloride large volume injection, comprises the following steps:

[0034] (1) Concentrated formulation: add water for injection of 30% of the prescription amount into the concentrated formulation tank, and control the temperature at 50-60°C; add the fructose of the prescription amount, stir to dissolve it, add 0.1% (g / ml) Wet medicinal charcoal, stir for 30 minutes, filter for decarbonization, filter into the dilute preparation tank, rinse the concentrated preparation tank with water for injection several times, and filter into the dilute preparation tank;

[0035] (2) Dilute formulation: add water for injection to 80% of the prescription volume in the dilute form...

Embodiment 2

[0039] A stable ambroxol hydrochloride large-volume injection comprises the following substances: 0.30 g of ambroxol hydrochloride, 50 g of fructose, 3.6 g of gallic acid, 18 g of sodium acetate, and 9.8 ml of glacial acetic acid. Water for injection 1000mL.

[0040] A kind of stable ambroxol hydrochloride large volume injection, comprises the following steps:

[0041] (1) Concentrated formulation: Add water for injection of 50% of the prescription amount into the concentrated formulation tank, and control the temperature at 70-80°C; add the fructose of the prescription amount, stir to dissolve it, add 0.1% (g / ml) Wet medicinal charcoal, stir for 30 minutes, filter for decarbonization, filter into the dilute preparation tank, rinse the concentrated preparation tank with water for injection several times, and filter into the dilute preparation tank;

[0042] (2) Dilute formulation: add water for injection up to 90% of the prescription volume to the dilute formulation tank, adj...

Embodiment 3

[0046] A kind of stable ambroxol hydrochloride large-capacity injection comprises the following materials: ambroxol hydrochloride nanoparticles (containing ambroxol hydrochloride 150mg), fructose 25g, gallic acid 1.8g, citric acid 6.5, disodium hydrogen phosphate 13.8 g, 500 mL of water for injection.

[0047] The preparation method of described ambroxol hydrochloride nanoparticles is:

[0048] A, medicine ambroxol hydrochloride 0.15g and macromolecule auxiliary material polylactic acid 1.0g are dissolved respectively and become drug solution and macromolecule auxiliary material solution;

[0049] B, mixing the drug solution and the polymer auxiliary material solution; the weight ratio of the drug and the polymer auxiliary material is 15-85:100;

[0050] C. The mixed solution is ultrasonically emulsified, and the emulsification time is 5-60 minutes to obtain an emulsion;

[0051] D. Stir the emulsion at 200-1000 rpm for 0.5-2 hours to obtain coagulation;

[0052] E. Add glu...

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Abstract

The invention discloses a stable ambroxol hydrochloride huge capacity injection and a preparation method thereof. According to the preparation method, a buffer system is added to ensure that the pH value of an ambroxol hydrochloride solution is stable before and after sterilization, so that an obvious change of the pH value is avoided before and after sterilization, and impurities generated are reduced; a special stabilizer is adopted; the pH value range is selected to be 3.8-4.5. The key step of the preparation method lies in that: a special buffer salt system is adopted to ensure that the pH value of the solution is stable to reduce or avoid the impurity generation caused by ambroxol hydrochloride degradation, so that the medicine curative effect is facilitated, and the side effect caused by impurity generation is avoided.

Description

technical field [0001] The invention belongs to a medical injection, in particular to a stable ambroxol hydrochloride large-capacity injection and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride is a new generation of respiratory mucus regulator. It has the function of promoting mucus elimination and dissolving secretions. It can promote the elimination of viscous secretions in the respiratory tract and reduce the retention of mucus, thus significantly promoting expectoration and improving respiratory conditions. . It is suitable for acute and chronic respiratory diseases accompanied by abnormal sputum secretion and poor expectoration function. It is one of the widely used expectorant drugs in clinical practice, with positive curative effect and good safety. [0003] Existing ambroxol hydrochloride clinical commonly used dosage form comprises oral dosage forms such as tablet, capsule, granule, solution, syrup and small-capacity injection,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/137A61K47/12A61P11/10
Inventor 胡容峰曹宗培何玲利陈芽陆文捷周红王蓉
Owner ANHUI DOUBLE CRANE PHARMA
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