Preparation method of rocuronium bromide

Abstract

The invention provides a preparation method of rocuronium bromide. The preparation method comprises the following steps: step 1, reacting a raw material compound I with acetyl chloride to obtain a compound II; 2, dropwise adding a hydrochloric acid solution into the compound II obtained in the step 1 to carry out a hydrolysis reaction, performing standing for layering, removing part of an organiclayer, adjusting the pH value of the residual reaction solution to 7-9 by using a sodium carbonate aqueous solution, separating out an organic phase, and treating to obtain a compound III; 3, adding dichloromethane, anhydrous magnesium sulfate and alkaline aluminum oxide into the compound III and allyl bromide, carrying out a quaternization reaction under the nitrogen flow, filtering under the protection of nitrogen after the reaction is completed, concentrating a filtrate to obtain a concentrate, pulping the concentrate by using a dichloromethane-methyl tert-butyl ether-ethyl acetate system,separating out solids, and carrying out freeze drying to obtain a rocuronium bromide pure product. The purity of the prepared bulk drug product is greater than or equal to 99.8% (according to a USP40correction result), the maximum impurity content is less than or equal to 0.1% (according to the USP40 correction result), and the solvent residue sum is less than or equal to 0.5%.

Description

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AI Technical Summary

Benefits of technology

This patented technology improves the efficiency of producing ruleronebium products with specific qualifications such as low content of unwanted metals like chromosan or pyrithione. By separating certain components beforehand, these processes become simpler and less expensive compared to existing methods that require multiple steps. Additionally, this new method does not involve harmful chemical reagents while still maintaining their desired properties. Overall, this innovative technical results improve the overall performance and cost reduction potential of ruleronesiodine preparations

Problems solved by technology

This patented describes different methods for producing various substances called rocuronsimodium citronato beta complex salt. These processes involve converting certain molecules into specific forms like salts before adding them together again. However, these techniques have limitations due to their poor yields and excessive amounts of unwanted materials produced from side effects caused by unnatural chemistry interactions between components involved.

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