Salbutamol sulfate solution for inhalation and preparation method thereof

A technology of salbutamol sulfate and solution, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve problems such as poor stability, improve tolerance, improve stability, The effect of ensuring stability

A technology of salbutamol sulfate and solution, which is applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve problems such as poor stability, improve tolerance, improve stability, The effect of ensuring stability

CN110898042AActive Publication Date: 2020-03-24深圳大佛药业股份有限公司
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  • Salbutamol sulfate solution for inhalation and preparation method thereof
  • Salbutamol sulfate solution for inhalation and preparation method thereof
  • Salbutamol sulfate solution for inhalation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] prescription:

[0030] Salbutamol Sulfate 1.0g

[0031] Ipratropium Bromide 0.2g

[0032] Sodium Hyaluronate 0.4g

[0033] Carboxymethyl Chitooligosaccharide 0.2g

[0034] Sodium chloride 8.0g

[0035] The pH regulator is 8% hydrochloric acid solution.

[0036] Makes 1000ml.

[0037] Preparation Process:

[0038] S1. Weighing and dispensing: Prepare raw and auxiliary materials according to the prescription amount in the D-level clean area, and transfer them to the C-level clean area after exposure and sterilization;

[0039] S2. Dosing: In the C-level clean area, add albuterol sulfate, ipratropium bromide, isotonic regulator, sodium hyaluronate, and carboxymethyl chitosan oligosaccharide to the liquid mixing tank in sequence, and the liquid mixing tank is added in advance Water for injection, fully stirred and mixed after filling with nitrogen;

[0040] S3, adjust the pH: adjust the pH to 4 with a pH regulator;

[0041] S4. Filtration: pass the solution through...

Embodiment 2

[0044] prescription:

[0045] Salbutamol Sulfate 1.0g

[0046] Ipratropium Bromide 0.3g

[0047] Sodium Hyaluronate 0.5g

[0048] Carboxymethyl Chitooligosaccharide 0.25g

[0049] Sodium chloride 7.8g

[0050] The pH regulator is citric acid-sodium citrate solution.

[0051] Makes 1000ml.

[0052] The preparation method is the same as in Example 1.

Embodiment 3

[0054] prescription:

[0055] Salbutamol Sulfate 1.0g

[0056] Ipratropium Bromide 0.125g

[0057] Sodium Hyaluronate 0.3g

[0058] Carboxymethyl Chitooligosaccharide 0.15g

[0059] Sodium chloride 8.2g

[0060] The pH regulator is 10% hydrochloric acid solution.

[0061] Makes 1000ml.

[0062] The preparation method is the same as in Example 1.

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Abstract

The invention provides a salbutamol sulfate solution for inhalation and a preparation method thereof. The prescription of the salbutamol sulfate solution comprises salbutamol sulfate, ipratropium bromide, an isoosmotic adjusting agent, a pH adjusting agent, sodium hyaluronate, carboxymethyl chitosan oligosaccharide and water for injection. The preparation process comprises the following steps: weighing, preparing a solution, adjusting the pH value, filtering, encapsulating, carrying out quality inspection and the like. According to the prescription and the preparation method, the stability ofthe preparation can be improved, meanwhile, the preparation has a good permeation effect, the salbutamol sulfate tolerance can be improved, and the preparation can better play a role.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a salbutamol sulfate solution for inhalation and a preparation method thereof. Background technique [0002] Salbutamol sulfate is a β2 adrenergic receptor agonist. It is a white or almost white powder. It is highly soluble in water, slightly soluble in ethanol, and almost insoluble in chloroform or ether. Its role is to relax the smooth muscle of the airway. It acts on all smooth muscles from the main trachea to the terminal alveoli, and has antagonizing effect on bronchoconstriction. It has a fast onset time, but it is prone to β2 receptor resistance. [0003] Ipratropium bromide is a quaternary ammonium compound with anticholinergic (parasympathetic) properties. Preclinical studies have shown that it inhibits vagal reflexes by antagonizing the transmitter acetylcholine released from the vagus nerve. Anticholinergic drugs prevent the intracellular increase...

Claims

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Application Information

Patent Timeline
24 Mar 2020
Publication
CN110898042A
IPC
A61K9/72; A61K9/08; A61K31/137; A61K31/46; A61K47/36; A61P11/08
CPC
A61K9/007; A61K9/08; A61K31/137; A61K31/46; A61K47/36; A61K47/61; A61P11/08; A61K2300/00
Inventors
杨瑞雄