Albuterol sulfate atomizing inhalation solution and preparation method thereof

Abstract

The invention belongs to the technical field of medicines, and particularly relates to an albuterol sulfate atomizing inhalation solution and a preparation method thereof. The albuterol sulfate atomizing inhalation solution is prepared from albuterol sulfate, sodium gluconate and a pH regulator. The albuterol sulfate atomizing inhalation solution provided by the invention has excellent stability,the content of the related substances is less, the ingredients are simple, excipients, such as a preservative, a stabilizer, an antioxidant, an osmotic pressure regulator and a metal ion complexing agent (edetate disodium), are not contained, consequently, the risk of clinical medication is decreased, and the safety of medication is improved; moreover, the preparation process is simple, high-temperature sterilization is not required, energy consumption is low, and the cost of mass production is reduced.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a salbutamol sulfate atomized inhalation solution and a preparation method thereof. Background technique [0002] Salbutamol sulfate, also known as albuterol, is a highly selective bronchial smooth muscle β2-adrenergic receptor agonist. It has clear activity for relaxing bronchial smooth muscle and contacting bronchial smooth muscle spasm. It is a safe , Effective anti-asthmatic drugs. Clinically, it is often used to treat various types of airway obstruction, such as bronchial asthma, chronic obstructive pulmonary disease, asthmatic bronchitis, and bronchospasm in patients with emphysema. The molecular formula of salbutamol sulfate is (C 13 H 21 NO 3 ) 2 .H 2 SO 4 , The structural formula is as follows: [0003] [0004] At present, a variety of formulations of salbutamol sulfate have appeared on the market. Among them, salbutamol sulfate in the form of an inhaled solution...

AI Technical Summary

Problems solved by technology

[0005] In order to make the solution exhibit better long-term stability, auxiliary materials such as preservatives, stabilizers, antioxidants, osmotic pressure regulators, metal ion complexing agents (edetate disodium) are usually added, and the addition of the above auxiliary materials It has played a role in improving the stability of salbutamol sulfate atomized inhalation solution, but the addition of many auxiliary materials has affected the quality of the product and increased the risk of clinical medication. Even if the above auxiliary materials are added, the data in the stability investigation test also supports up to 12 month, the stabilization effect still needs room for improvement

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