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Moist heat sterilization method of citicoline and sodium salt injection thereof

A technology of moist heat sterilization and citicoline, which is applied in heating, disinfection, etc., can solve the problems of drug safety risks, accelerate the degradation of main components of drugs, and increase the growth of impurities, so as to shorten the sterilization time, improve safety, and ensure sterilization. The effect of bacteria

Inactive Publication Date: 2020-05-29
BEIJING SIHUAN KEBAO PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The traditional moist heat sterilization process of citicoline and its sodium salt injection needs higher temperature and longer time to achieve a higher level of sterility assurance, but such a sterilization process will accelerate the degradation of the main components of the drug and The growth of impurities, which poses a risk to the safety of the drug

Method used

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  • Moist heat sterilization method of citicoline and sodium salt injection thereof
  • Moist heat sterilization method of citicoline and sodium salt injection thereof
  • Moist heat sterilization method of citicoline and sodium salt injection thereof

Examples

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Embodiment 1

[0043] In the present embodiment, the moist heat sterilization method of the citicoline and its sodium salt injection is a pulsating vacuum sterilization procedure, which specifically includes the following steps:

[0044] S101. Perform no-load preheating on the pulsating vacuum sterilizer; as a preferred implementation of this embodiment, the no-load preheating is performed by pulsating or passing steam into the interlayer; the no-load preheating The box temperature is 100°C-121°C.

[0045] S102, open the box door, put the preparation into the pulsating vacuum sterilizer, and close the box door;

[0046] S103, perform pulsation or replacement; as a preferred implementation of this embodiment, the number of pulsation programs is set to 1-3 times, the replacement time is set to 1s-600s, the upper limit of the pulsation pressure is set to 200Kpa, and the lower limit of the pulsation pressure is set to -95Kpa.

[0047] S104, passing saturated pure steam into the box of the puls...

Embodiment 2

[0057] In this embodiment, the moist heat sterilization method of the citicoline and its sodium salt injection is a steam-air mixture sterilization procedure, which specifically includes the following steps:

[0058] S201. Perform no-load preheating of the mixed steam-air sterilizer; as a preferred implementation of this embodiment, the no-load preheating is performed by pulsating or passing steam into the interlayer; the no-load The temperature of the preheated box is 100°C-121°C.

[0059] S202, open the box door, put the preparation into the mixed steam-air sterilizer, and close the box door;

[0060] S203, passing saturated pure steam into the mixed steam-air box; as a preferred implementation of this embodiment, the saturated pure steam is passed into the box of the sterilizer through a single or multiple pipelines, and the steam The inlet pressure is 0.1Mpa-2.0Mpa, and the heating time is 0.1min-20min;

[0061] S204. Mix and circulate the steam and the air in the mixed ...

Embodiment 3

[0069] In this embodiment, the moist heat sterilization method of the citicoline and its sodium salt injection is a superheated water sterilization procedure, which specifically includes the following steps:

[0070] S301. Preheating the high-pressure superheated water spray sterilizer; as a preferred implementation of this embodiment, in this embodiment, preheating is performed by means of a pulsation program or steam into the interlayer, and the temperature of the preheating box is Raise to 100-121°C, quickly raise the heat penetration temperature of the full load of medicines to close to the sterilization temperature.

[0071] S302. Fix the preparation on the tray and put it into the high-pressure superheated water spray sterilizer, and close the box door;

[0072] S303, passing the sterilizing water into the storage tank of the high-pressure superheated water spray sterilizer, and directly heating the sterilizing water to the sterilizing temperature through a heat exchange...

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Abstract

The invention provides a moist heat sterilization method of citicoline and a sodium salt injection thereof. The method comprises a pulsation vacuum sterilization procedure, a steam-air mixture sterilization procedure, and a superheated water sterilization procedure, wherein the pulsation vacuum sterilization procedure uses a pulsation vacuum sterilizer for sterilization; the steam-air mixture sterilization procedure uses a steam-air mixed sterilizer for sterilization; and the superheated water sterilization procedure uses a high-pressure superheated water spray sterilizer for sterilization. The moist heat sterilization method of citicoline and a sodium salt injection thereof minimizes the degradation of a pharmaceutical component during the sterilization process, and improves the safety ofthe medicine on the basis of fully ensuring the sterilization effect.

Description

technical field [0001] The invention belongs to the technical field of preparations, and in particular relates to a method for damp heat sterilization of citicoline and its sodium salt injection. Background technique [0002] In the production of sterile drugs, the prevention of microbial contamination and endotoxin contamination has always been the focus of manufacturers and regulatory agencies. For the sterilization of injections, it is necessary not only to kill or remove all microbial propagules and spores, to maximize the safety of pharmaceutical preparations, but also to ensure the stability and clinical efficacy of the preparations. [0003] Citicoline is a brain metabolism activator, a derivative of nucleic acid, and the main coenzyme for the synthesis of lecithin. It can promote brain cell respiration, improve brain function, enhance the function of the ascending reticular structure activation system, promote awakening, reduce cerebrovascular resistance, thereby im...

Claims

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Application Information

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IPC IPC(8): A61L2/07A61L2/04
CPCA61L2/0023A61L2202/21
Inventor 盛爱武修成黄靖李明洁蔡晓曦陈娟娟温晓雪刘新新胡国晶
Owner BEIJING SIHUAN KEBAO PHARM CO LTD
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