A sterilization process for reducing the content of 5-hydroxymethylfurfural in sugar-containing injection solutions

By employing a sterilization process with multiple stages of temperature increases, the problem of high 5-hydroxymethylfurfural content caused by large temperature differences within the sterilization chamber was solved. This process achieved rapid sterilization, reduced 5-hydroxymethylfurfural content, and improved product quality.

CN117159754BActive Publication Date: 2026-07-21HUAREN PHARMA (RIZHAO) CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
HUAREN PHARMA (RIZHAO) CO LTD
Filing Date
2023-09-07
Publication Date
2026-07-21

AI Technical Summary

Technical Problem

In the sterilization process of sugar-containing injections, the temperature difference within the sterilization chamber is too large, resulting in a high content of 5-hydroxymethylfurfural, which makes it difficult to meet drug quality standards.

Method used

The sterilization process employs multiple stages of temperature increases. First, the sterilization chamber is preheated to 65-72℃, then gradually increased to 90-95℃. Next, the heat source temperature is controlled to ensure that the temperature inside the sterilization chamber rises evenly to 116-118℃. Finally, the sterilization process is maintained at 121-123℃ for 8 minutes, and then the process ends after cooling down.

Benefits of technology

It effectively shortens sterilization time, reduces the content of 5-hydroxymethylfurfural, improves product quality stability, and reduces the impact of high temperature on plastic packaging.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application belongs to the technical field of medicine manufacturing, and particularly relates to a sterilization process for reducing the content of 5-hydroxymethylfurfural in sugar-containing injection, and the specific steps are as follows: first, the sterilization chamber is heated to 65-72 DEG C, the product to be sterilized is sent into the sterilization chamber, the opening degree of the heat source valve is controlled, the temperature of the heat source entering the sterilization chamber is increased to 100-105 DEG C, the heat source valve is fully opened when the temperature in the sterilization chamber is increased to 90-95 DEG C; the heat source valve is closed when the temperature of the heat source entering the sterilization chamber is increased to 127-130 DEG C and the temperature at any position in the sterilization chamber reaches 116-118 DEG C; the opening degree of the heat source valve is controlled when the temperature in the sterilization chamber reaches more than 121 DEG C, the temperature of the heat source entering the sterilization chamber is 122-123 DEG C, and the sterilization is performed for 8 minutes under the condition that the temperature in the sterilization chamber is 121-123 DEG C; finally, the sterilization chamber is cooled and depressurized, and the sterilized product is taken out. The process adopts the mode of multiple-stage temperature increase, shortens the temperature increase time for reaching the sterilization setting temperature, and can effectively reduce the content of 5-hydroxymethylfurfural.
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