Ropivacaine hydrochloride and sodium chloride injection and preparation method

Abstract

The invention relates to the field of medicines, in particular to a ropivacaine hydrochloride and sodium chloride injection and a preparation method. The ropivacaine hydrochloride and sodium chlorideinjection is prepared from ropivacaine hydrochloride, sodium chloride and water for injection. The preparation process is mature, the product quality is stable and the use safety is high. Influences of activated carbon on element impurities of an injector, on insoluble microparticles of the injector and the content of a main drug of the injector are avoided, besides, the medication safety of a patient is greatly reduced, and various risks caused by an activated carbon process are avoided.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a ropivacaine hydrochloride sodium chloride injection and a preparation method thereof. Background technique [0002] Ropivacaine is the first new long-acting amide local anesthetic synthesized in pure isomers. Its pharmacological properties are low cardiotoxicity, more obvious separation of sensory block and vasoconstriction. Ropivacaine has dual effects of anesthesia and analgesia, and its lower concentration can effectively block sensory nerve transmission to produce analgesic effect, and it has less influence on motor nerves. [0003] Ropivacaine hydrochloride sodium chloride injection in the prior art all uses activated carbon to remove bacterial endotoxin. However, the use of activated carbon has the following problems: [0004] 1. The influence of activated carbon on elemental impurities in injections: Activated carbon has various sources of raw materials and production processes...

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Problems solved by technology

[0005] 2. Activated carbon can adsorb impurities in the liquid medicine, but at the same time it has the risk of introducing impurities. During use, it is necessary to combine the properties of the drug, fully consider the risk-benefit ratio, and choose activated carbon carefully.

[0006] 3. The effect of activated carbon on insoluble particles in injections: Insoluble particles in injections refer to the properties of particles produced or mixed in through various channels during the production or use of drugs, with a particle size of 1-50 μm , Invisible to the naked eye, but because it can flow with the blood but cannot be metabolized, it may cause difficult to detect and potentially serious harm to the human body

This method has certain requirements on the amount and source of activated carbon, product batches, etc., and there are certain risks in production.

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