Levobupivacaine Hydrochloride

Details:

Bupivacaine (bupivacaine) is currently the most commonly used in clinical anesthesia local anesthetic, and included in the National Essential Drugs List. Bupivacaine as a potent amide local anesthetic widely used in clinical, but during surgery can lead to myocardial depression, refractory arrhythmias and other side effects on the central nervous system has a certain toxicity. Racemate bupivacaine system, its toxicity is mainly composed of R (+) optical isomers caused, S (-) optical isomers widely distributed in the body, removing slow, low free plasma concentration, less toxic . Hydrochloric acid levobupivacaine (S (-) optical isomers) are long-acting amide local anesthetic, has a similar mechanism of action and bupivacaine and pharmaceutical properties, it is mainly through action on cardiac sodium channel pair cardiac conduction system generate excitement dose-dependent inhibition of impulses. Cellech Chiroscience originally developed by the British company developed, in March 2000 for the first time in the United States, the country has the trade name "Yi Jieka", "quick cards" and marketed. The animal experiments and clinical applications show that its pharmacological properties similar to bupivacaine, anesthetic potency similar, then remove the R (+) isomer after the optical nerve and cardiac toxicity were significantly lower, safer, and feel resistance lag time is longer, the clinical effect than bupivacaine, with good value in the clinical treatment.

1.2 Product name, code, specifications and standard batch

English Generic Name:Levobupivacaine Hydrochloride

Chinese Pinyin Name:Yansuanzuobubikayin

Chemical Name:S - (-) - 1- butyl -N- (2,6- dimethylphenyl) -2-piperidinecarboxamide hydrochloride

Product Code:0409001

Product Specification: raw medicine

Standard Batch:3-4kg/Batch

1.3 Chemical Structure:

Structural Formula:

Molecular Formula: C₁₈H₂₈N₂O•HCl

Molecular Weight: 324.89

1.4 Physicochemical Property:

White crystalline powder. Soluble in ethanol, soluble in water; slightly soluble in chloroform, almost insoluble in ether.

1.5 Quality Standard

In line with the quality standard declaration, see section 5.2.

1.6 Clinical Application

Bupivacaine hydrochloride as a potent amide local anesthetic widely used in clinical, but during surgery can lead to myocardial depression, refractory arrhythmias and other side effects on the central nervous system has a certain toxicity. Left bupivacaine hydrochloride because bupivacaine S (-) optical isomers, the animal experiments and clinical applications show that its pharmacological properties similar to bupivacaine, anesthetic potency similar, then remove the R (+) optical after isomer, neurological and cardiac toxicity were significantly lower, safer to use, has good value in the clinical treatment.

1.7 Packaging specification

Packaging specification: Levobupivacaine hydrochloride API multilayer packaging, pharmaceutical packaging is double density polyethylene bags, with inner plastic bag with outer vacuum sealed, with drum packaging.

Packaging specification:3-4kg / barrel.

1.8 Storage:sealed and stored in a shade

1.9 Validity: 24 months (tentative)