Nasal drops used for anesthesia and preparation method of nasal drops

Abstract

The invention provides nasal drops used for anesthesia. The nasal drops are characterized in that dexmedetomidine hydrochloride injection and ketamine hydrochloride are adopted as the raw materials, an osmotic pressure regulator, a bacteriostatic agent, an antioxidant, a cosolvent and a pH value regulator with certain amount are added, the steps including concentrated preparation, diluted preparation, filling, sterilizing and externally packaging are carried out, and thus the nasal drops are obtained. For the nasal drops used for anesthesia, a special administration channel does not need to beestablished, so that no pain exists during the medication process of a patient, the compliance is good, the stability is good during the storage process of the product, deterioration due to crystallization does not exists, within the period of validity, the pH of the solution basically has no change, the microbial limit is qualified, the validity period of the product is as long as 24 months or alonger time, the increased amount of impurities during the preparation process is small, the increased amount of impurities during the whole preparation process is only 0.01%, the preparation processis simple and feasible, and the nasal drops are worthy of market promotion.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a nasal drop for anesthesia and a preparation method thereof. Background technique [0002] Pre-examination sedation, especially for children, is a clinical problem that needs to be solved urgently. The use of safe and effective drugs is the key to ensure that children can successfully complete various examinations. [0003] At present, the commonly used sedative drugs before examination in China are oral chloral hydrate or midazolam, and intramuscular injection of sodium lumina. The efficacy and use of these sedatives have the following problems: (1) chloral hydrate oral agent: it is the most commonly used sedative agent for children before examination in outpatient clinics. Because its mouthfeel is very bitter, many children refuse to take it or cause vomiting after taking it. Increased risk of aspiration, even life threatening. In addition, the metabolites of chloral...

AI Technical Summary

Problems solved by technology

The efficacy and use of these sedatives have the following problems: (1) chloral hydrate oral agent: it is the most commonly used sedative agent for children before examination in outpatient clinics. Because its mouthfeel is very bitter, many children refuse to take it or cause vomiting after taking it. Increased risk of aspiration, even life-threatening

In addition, the metabolites of chloral hydrate are active and sometimes cause delayed awakening; at the same time, the first-pass effect of the drug is obvious, and the sedative effect is uncertain, which often leads to sedation failure, and many children often need repeated medications

(2) Oral midazolam: the sedative effect is not good, and the success rate is only 60-75%

(3) Lumin sodium intramuscular injection: the success rate of sedation is about 80%, but it is accompanied by painful stimulation, which will cause harm to children

[0007] In summary, the prior art research on dexmedetomidine hydrochloride and ketamine can not meet the needs of clinical use, and there is an urgent need to develop a compound anesthetic nasal drop that is convenient for clinical use, has a rapid onset of effect, is safe and effective; At present, nasal drops still have poor storage stability, easy crystallization, large changes in solution pH, difficult control of microbial limit, short shelf life, and obvious increase in impurities in the preparation process. Technical problems need to be solved urgently

Images