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A kind of albuterol sulfate solution for inhalation and preparation method thereof
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A technology of albuterol sulfate and solution, which is applied to medical preparations containing no active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., which can solve problems such as poor stability, achieve good stability, increase stability, and improve effect of tolerance
Active Publication Date: 2020-10-16
深圳大佛药业股份有限公司
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The publication number is that CN19339279A discloses albuterol and ipratropium bromide inhalation solution for alleviating the symptoms of chronic obstructive pulmonary disease. Poor stability
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[0035] The pH adjuster is 8% hydrochloric acid solution.
[0036] Make 1000ml.
[0037] Preparation Process:
[0038] S1. Weighing: prepare raw and auxiliary materials according to the prescribed amount in the D-class clean area, and transfer them to the C-class clean area after exposure and sterilization;
[0039] S2. Dosing: In the C-level clean area, add salbutamol sulfate, ipratropium bromide, isotonicity modifier, sodium hyaluronate, and carboxymethyl chitosan oligosaccharide into the dosing tank in turn, and the dosing tank is pre-filled Water for injection, stir well after nitrogen filling, and mix well;
[0040] S3, adjust pH: adjust pH to 4 with pH adjuster;
[0041] S4. Filtration: Pass the solution through a 0.22 μm microporous membrane;
[0060] The pH adjuster is a 10% hydrochloric acid solution.
[0061] Make 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, and in particular relates to a salbutamol sulfate solution for inhalation and a preparation method thereof. Background technique [0002] Salbutamol sulfate, a β2 adrenergic receptor agonist, is white or almost white powder in appearance, very soluble in water, very slightly soluble in ethanol, almost insoluble in chloroform or ether, and its effect is to relax airway smooth muscle. It acts on all smooth muscles from the main trachea to the terminal alveoli, and has the effect of antagonizing bronchoconstriction. The onset time is fast, but it is prone to β2 receptor tolerance. [0003] Ipratropium bromide is a quaternary ammonium compound with anticholinergic (parasympathetic) properties. Preclinical studies have shown that it inhibits vagal reflexes by antagonizing the neurotransmitter acetylcholine released by the vagus nerve. Anticholinergic drugs prevent the increase in...
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