Method for improving stability of benzoxy-formaldimine hydrochlorate in packaging and transmitting process

Abstract

The invention discloses a method for improving the stability of Benylformimidate Hydrochloride during the processes of packaging, storing and transporting, and the method is applied in the pharmaceutical production industry. The method is characterized in that when the produced Benylformimidate Hydrochloride pharmaceutical crystals are the finished product, the relative humidity of the production environment is controlled below 30%; the finished product is packaged by medicinal aluminum bottles, in which inert gas is filled; and the prepared Benylformimidate Hydrochloride finished product are stored at 0-8 DEG C. The method has the advantages that the technical scheme is scientific and reasonable; the application effect is ideal; by adopting inert gas protection to improve the stability of Benylformimidate Hydrochloride during the processes of packaging and storing; the method is economic, simple and feasible and is easy to be industrially utilized; and the method can effectively reduce degradation and dissolution of Benylformimidate Hydrochloride, so that the product quality of the pharmaceutical can be reliably ensured in a specified effective period.

Description

Technical field: [0001] The invention relates to a drug with active chemical properties, which is used in the drug manufacturing industry. Background technique: [0002] The Chinese name of Benylformimidate Hydrochloride is benzyloxymethylimine hydrochloride, which is the first carbapenem antibiotic that has been successfully marketed and applied clinically --- an intermediate compound of imine compound. Due to the relatively active nature of the drug itself, it is very unstable, and its storage conditions require low-temperature storage and transportation below -20°C to control its degradation and melting. [0003] In response to the above situation, low temperature, low humidity and oxygen prevention measures are usually taken in the production process at present. Generally, the relative humidity of the production environment of the manufacturer is controlled at 45%-60%, and Benylformimidate Hydrochloride will degrade quickly under this relative humidity. In order to pre...

AI Technical Summary

Problems solved by technology

In order to prevent its degradation, the manufacturer uses the aluminum-plastic composite bag containing the drug to be vacuumed. However, when the vacuum degree is generally below -0.09MPa, it will affect the particle distribution of Benylformimidate Hydrochloride, and the result is serious agglomeration of the drug. , affect the quality, and directly endanger the drug sales in the market and the drug safety of patients

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