Dextromethorphan hydrobromide oral solution

Abstract

The invention relates to a dextromethorphan hydrobromide oral solution. Specifically, the invention provides the pharmaceutical composition, and the pharmaceutical composition comprises dextromethorphan hydrobromide, a flavoring agent, a stabilizer, a complexing agent, an antioxidant and a solvent. The dextromethorphan hydrobromide oral solution disclosed by the invention has excellent mouth feel and stability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a dextromethorphan hydrobromide oral solution. Background technique [0002] Dextromethorphan hydrobromide, the chemical name is 3-methoxy-17-methyl-(92,132,142) morphinan hydrobromide, the CAS number is 125-69-9, and the structural formula is as follows: [0003] [0004] Dextromethorphan Hydrobromide [0005] Dextromethorphan hydrobromide is often used as an antitussive for the central nervous system, mainly for dry cough, suitable for coughs caused by colds, acute or chronic bronchitis, bronchial asthma, pharyngitis, tuberculosis and other upper respiratory tract infections. [0006] Existing dextromethorphan hydrobromide preparations mainly include tablet, capsule, injection and oral solution. Among various dosage forms, tablets and capsules involve the dissolution of the drug, and the onset of action is slow. Tablets and capsules cannot guarantee the complete ...

AI Technical Summary

Problems solved by technology

[0007] Yet existing dextromethorphan hydrobromide oral solution still has many disadvantages, such as dextromethorphan hydrobromide has bitter taste, and bitter taste causes poor oral compliance of patients, especially children, even if existing dextromethorphan hydrobromide is oral The solution increases the sweetness of the oral solution by adding sweeteners such as sucrose, glucose, etc., and improves the mouthfeel. However, even the addition of sweeteners still has the problem of bitterness and bitterness. In order to further overcome the bitterness of the oral solution, now Some dextromethorphan hydrobromide oral solutions usually cover the bitter taste by adding various essences such as orange essence, zest essence and lemon essence etc. to improve the taste and local flavor of the oral solution. problems, and the flavor has a toxic effect, which is not conducive to the health of the human body, especially for underdeveloped children

In addition, the stability of dextromethorphan hydrobromide oral solution is easily affected by various factors, especially factors such as light and heat, resulting in reduced content and increased impurities, poor stability, and prone to precipitation and crystallization. Therefore, in order to improve the stability of dextromethorphan hydrobromide oral solution in existing listing dextromethorphan hydrobromide oral solution, dextromethorphan hydrobromide oral solution is filled in brown bottle and adds a large amount of preservatives, And it needs to be stored under shading and avoiding high temperature, thereby increasing the packaging, transportation and storage costs of dextromethorphan hydrobromide oral solution, and because dextromethorphan hydrobromide oral solution is sub-packed in brown bottles, the patient buys dextromethorphan hydrobromide oral solution Or before use, it is difficult to observe the properties of the dextromethorphan hydrobromide oral solution in the brown bottle such as clarity, whether there are precipitated particles, mildew, rancidity, discoloration, foreign matter, gas generation and other deterioration phenomena. Therefore, , it is difficult to observe the safety of dextromethorphan hydrobromide oral solution, which may easily lead to drug safety problems

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