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

A technology of stability, storage and transportation, applied in the direction of organic chemical methods, chemical instruments and methods, purification/separation/stabilization of organic compounds, etc. and other problems, to achieve the effect of easy industrial implementation and utilization, reducing degradation and melting, and reliable product quality assurance.

Inactive Publication Date: 2008-12-03
穆坤芳
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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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  • Method for improving stability of benzoxy-formaldimine hydrochlorate in packaging and transmitting process

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Embodiment Construction

[0010] Below in conjunction with embodiment the present invention is described in further detail:

[0011] The crystallization of Benylformimidate Hydrochlorid generated in the last step of the reaction in the pharmaceutical production process is packed into a medicinal aluminum bottle under nitrogen protection, and the medicinal aluminum bottle is filled with nitrogen with a purity of 99.8%. Nitrogen is prepared by an air nitrogen generator, sterilized and filtered through a hose system, and then passed into a clean aluminum bottle. Add Analytical Instrument Factory) to control the residual oxygen value in the aluminum bottle, and control the residual oxygen value in the aluminum bottle to 0.8% (volume percentage). Store the packaged finished product at 0-8°C.

[0012] The above-mentioned whole packaging process is carried out under nitrogen protection. Nitrogen is produced by an air nitrogen generator (standard model used in this embodiment: FDA, manufactured by Beijing Fe...

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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...

Claims

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Application Information

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IPC IPC(8): C07C257/06C07B63/00
Inventor 穆坤芳张力张丹参牛春雨李喜旺袁光耀吉梅白迎春张立永尹秀玲
Owner 穆坤芳
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