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Salbutamol sulfate inhalation preparation and preparation method thereof

A technology of albuterol sulfate and inhalation preparations, which is applied in the direction of medical formulas, respiratory diseases, and medical preparations of non-active ingredients, etc., which can solve the problems of reduced drug compliance, bitter taste of erythromycin, and unacceptable children, and achieve a reduction Toxic and side effects, eliminate fear, improve the effect of stability

Active Publication Date: 2020-09-15
深圳大佛药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although salbutamol sulfate and erythromycin can improve the effective rate of treating wheezing disease to a certain extent, the inhalation preparations prepared by salbutamol sulfate and erythromycin still have problems such as poor acid stability, difficult quality control, and unstable effect. In addition, erythromycin has a bitter taste and poor taste, which is difficult for children to accept and the compliance of medication is reduced. Therefore, there is still room for improvement

Method used

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  • Salbutamol sulfate inhalation preparation and preparation method thereof
  • Salbutamol sulfate inhalation preparation and preparation method thereof
  • Salbutamol sulfate inhalation preparation and preparation method thereof

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Effect test

Embodiment 1

[0029] Embodiment 1, salbutamol sulfate inhalation preparation of the present invention and preparation method thereof

[0030] formula:

[0031] Salbutamol Sulfate 1.5g

[0032] Erythromycin 0.1g

[0033] L-fucose 0.3g

[0034] Taste masking agent 2g

[0035] Magnesium chloride 4g

[0036] 8% hydrochloric acid solution 2g

[0037] Make 1000ml;

[0038] Wherein the taste-masking agent comprises maltodextrin and polyethylene glycol-600, and the mass ratio of maltodextrin and polyethylene glycol-600 is 1:0.5;

[0039] The preparation method comprises the following steps:

[0040] S1. Dissolve the prescribed amount of maltodextrin in water for injection, add the prescribed amount of salbutamol sulfate, erythromycin, L-fucose, polyethylene glycol and osmotic pressure regulator, fill with nitrogen and stir to dissolve, the stirring speed 800rpm / min, stirring time is 30min, cooled to room temperature, to obtain a mixed solution;

[0041] S2. Regulate the pH value of the mix...

Embodiment 2

[0043] Embodiment 2, salbutamol sulfate inhalation preparation of the present invention and preparation method thereof

[0044] formula:

[0045] Salbutamol Sulfate 1.8g

[0046] Erythromycin 0.3g

[0047] L-fucose 0.2g

[0048] Taste masking agent 1g

[0049] Glucose 5g

[0050] Citric Acid-Sodium Citrate 2g

[0051] Make 1000ml;

[0052] Wherein the taste-masking agent comprises maltodextrin and polyethylene glycol-600, and the mass ratio of maltodextrin and polyethylene glycol-600 is 1:0.6;

[0053] The preparation method comprises the following steps:

[0054]S1. Dissolve the prescribed amount of maltodextrin in water for injection, add the prescribed amount of salbutamol sulfate, erythromycin, L-fucose, polyethylene glycol and osmotic pressure regulator, fill with nitrogen and stir to dissolve, the stirring speed 600rpm / min, stirring time is 30min, cooled to room temperature, to obtain a mixed solution;

[0055] S2. Use a pH regulator to adjust the pH value of th...

Embodiment 3

[0057] Embodiment 3, albuterol sulfate inhalation preparation of the present invention and preparation method thereof

[0058] formula:

[0059] Salbutamol Sulfate 0.5g

[0060] Erythromycin 0.2g

[0061] L-fucose 0.4g

[0062] Taste masking agent 2.5g

[0063] Glucose 8g

[0064] Citric Acid - Disodium Hydrogen Citrate 2g

[0065] Make 1000ml;

[0066] Wherein the taste-masking agent comprises maltodextrin and polyethylene glycol-600, and the mass ratio of maltodextrin and polyethylene glycol-600 is 1:0.7;

[0067] The preparation method comprises the following steps:

[0068] S1. Dissolve the prescribed amount of maltodextrin in water for injection, add the prescribed amount of salbutamol sulfate, erythromycin, L-fucose, polyethylene glycol and osmotic pressure regulator, fill with nitrogen and stir to dissolve, the stirring speed 900rpm / min, stirring time is 30min, cooled to room temperature, to obtain a mixed solution;

[0069] S2. Use a pH regulator to adjust the...

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Abstract

The invention relates to the technical field of a medicine preparation, in particular to a salbutamol sulfate inhalation preparation and a preparation method thereof. Per 1000 ml of the salbutamol sulfate inhalation preparation is prepared from the following ingredients: 0.5 to 2.0 g of salbutamol sulfate, 0.1 to 0.4 g of erythromycin, 0.2 to 0.6 g of L-fucose, 1 to 3 g of a taste-masking agent, 4to 8 g of an osmotic pressure regulator, 1 to 5 g of a pH regulator and the balance of injection water. The salbutamol sulfate inhalation preparation has the advantages that the stability is good under the acid condition; the quality control is accurate; the effect is stable; the mouthfeel is good; and the drug compliance is improved.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a salbutamol sulfate inhalation preparation and a preparation method thereof. Background technique [0002] Wheezing disease is a common disease in children, such as bronchitis, bronchial asthma (asthma for short), and many other children's respiratory diseases can be manifested as continuous, high-pitched, rough sounds during breathing (that is, the main clinical feature of wheezing, which is It is caused by gas passing through the narrow airway of the child to form turbulent flow, in addition, it is accompanied by shortness of breath, cough, wheezing sound of both lungs, etc. According to foreign data, children who have wheezed ≥ 1 time before the age of 3 The proportion of children with asthma is about 34%, and it is close to 50% before the age of 6. In view of the fact that the pathogenesis of wheezing disease in children mainly involves four aspects: bron...

Claims

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Application Information

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IPC IPC(8): A61K31/7048A61K31/137A61K9/72A61K47/26A61K47/36A61K47/10A61P11/06A61P31/04
CPCA61K9/007A61K31/137A61K31/7048A61K47/10A61K47/26A61K47/36A61P11/06A61P31/04A61K2300/00
Inventor 杨瑞雄
Owner 深圳大佛药业股份有限公司
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