Preparator of naloxone hydrochloride injection and preparation method thereof

Abstract

The invention discloses a preparator of a naloxone hydrochloride injection and a preparation method thereof. The preparation method comprises the steps that a certain amount of water for injection, sodium chloride and naloxone hydrochloride are added into an upper tank body of the preparator, nitrogen is introduced, mixing and stirring are performed to obtain a mixed solution, then edetate disodium is added to regulate a pH value, and the mixed solution is filtered by a first filter membrane in the middle of the preparator and delivered to a lower tank body; a certain amount of water for injection is added into the lower tank body, stirring is performed under the situation that nitrogen is introduced, and a hydrochloric acid solution is used for regulating the pH value; finally, visible foreign matter checking is performed after filtration of a second filter membrane at the lower portion of the lower tank body, nitrogen charging is performed for filling encapsulation after qualification, and sterilization is performed to obtain the sterilization. No auxiliary material is added, and the purity and use safety of the prepared injection are ensured. The preparation method is simple and easy to operate, and the preparation cost is effectively reduced. In addition, the invention provides the preparator of the naloxone hydrochloride injection. Device replacement in the preparation process of the naloxone hydrochloride injection is avoided, the drug quality is improved, and drug safety is ensured.

Description

technical field [0001] The invention relates to the technical field of medicine processing, in particular to a preparation device for naloxone hydrochloride injection and a preparation method thereof. Background technique [0002] The main ingredient of naloxone hydrochloride injection is naloxone hydrochloride, and its chemical name is: 17-allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride di Hydrate, indicated for opioid receptor antagonists. It is mainly used to antagonize the respiratory depression caused by opioids combined with anesthetics, promote the patient's recovery, opioid overdose, completely or partially reverse the respiratory depression caused by opioids, and rescue acute alcohol poisoning and acute opioids. Diagnosis of drug overdose. Due to the large first-pass effect of the liver, naloxone is basically ineffective when taken orally in tablets. Currently, there are two dosage forms of injection and sublingual tablets in clinical use. However, su...

AI Technical Summary

Problems solved by technology

However, although there are many preparation methods for naloxone hydrochloride injection at present, most of them need to add auxiliary materials. After various auxiliary materials are mixed with naloxone hydrochloride, the clinical effects on drug efficacy are not the same, and the use of injections is caused. Therefore, it is urgent to prepare a high-purity, stable-quality naloxone hydrochloride injection, which has far-reaching clinical significance

[0003] In addition, there is currently no special equipment for the preparation of naloxone hydrochloride injection. Therefore, during the preparation of the injection, the drug needs to be transferred to different equipment for subsequent processing, which has a certain impact on the quality of the drug and has a negative impact on the safety of the drug. serious safety hazard

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