Glucose-containing lipid emulsion sterilizing method

A technology of fat emulsion and glucose, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, emulsion delivery, etc., can solve problems such as the inability to guarantee the quality of glucose-containing fat emulsion products, and achieve better sterilization effects and no dead ends , heat transfer fast effect

Inactive Publication Date: 2017-05-24
安徽华明制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The present invention aims to solve the problem that the current traditional steam sterilization or degerming methods cannot guarantee the quality of the glucose-containing fat emulsion product (sterility guarantee and content guarantee)

Method used

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  • Glucose-containing lipid emulsion sterilizing method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] The preparation method of the sterilized preparation of the glucose-containing fat emulsion of the present invention is as follows: the glucose-containing fat emulsion prepared by a high-pressure homogenizer, with an average particle size of 290 nm, is filled into a soft package with a medicinal solution. Put the soft package into the rotary sterilizer, feed high-temperature steam, rapidly raise the temperature inside the sterilizer to 115 ℃ within 3 minutes, maintain the pressure at 0.15 MPa, maintain the time within 45 minutes, and rotate at 5 revolutions per minute . After the sterilization is completed, automatic water spraying is carried out. After about 60 minutes, the temperature drops to 50°C, the pressure is zero, and the door of the disinfection cabinet is opened.

Embodiment 2

[0019] The preparation method of the sterilized preparation of the glucose-containing fat emulsion of the present invention is as follows: the glucose-containing fat emulsion prepared by a high-pressure homogenizer, with an average particle diameter of 305nm, is filled into a soft package with a medicinal solution. Put the soft package into the rotary sterilizer, feed high-temperature steam, and rapidly raise the temperature inside the sterilizer to 121°C within 3 minutes, maintain the pressure at 0.2MPa, maintain the time within 30 minutes, and rotate at 3 revolutions per minute . After the sterilization is completed, automatic water spraying is carried out. After about 60 minutes, the temperature drops to 50°C, the pressure is zero, and the door of the disinfection cabinet is opened.

Embodiment 3

[0021] The preparation method of the sterilized preparation of the glucose-containing fat emulsion of the present invention is as follows: the glucose-containing fat emulsion prepared by a high-pressure homogenizer, with an average particle diameter of 298 nm, is filled into a flexible package with a medicinal solution. Put the soft package into the rotary sterilizer, feed high-temperature steam, and quickly raise the temperature inside the sterilizer to 121°C within 3 minutes, maintain the pressure at 0.2 MPa, and maintain the time within 30 minutes, at a speed of 5 revolutions per minute . After the sterilization is completed, automatic water spraying is carried out. After about 60 minutes, the temperature drops to 50°C, the pressure is zero, and the door of the disinfection cabinet is opened.

[0022] Embodiment 1-3 principal ingredient content and other each index are as follows:

[0023]

[0024] The above data shows that the glucose-containing fat emulsion prepared b...

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Abstract

The invention aims to provide a glucose-containing lipid emulsion sterilizing method. A rotary sterilizing method is applied to a preparation process for a glucose-containing lipid emulsion for the first time. A sterilizing process adopts the rotary sterilizing method to sterilize a soft package bag which is filled with the glucose-containing lipid emulsion, wherein the temperature is maintained at 121 DEG C during a sterilizing process, the pressure is maintained at 0.2 MPa, and the time is maintained for 15 minutes. After sterilizing is completed, the sterilized emulsion is cooled quickly by adopting a spraying device, and the glucose decomposing speed is slowed. According to the glucose-containing lipid emulsion sterilizing method, glucose decomposition of the glucose-containing lipid emulsion caused by the conventional process and post-heat layering of the emulsion can be effectively avoided, and a sterile requirement of a product is met.

Description

technical field [0001] The invention relates to a sterilization method for a fat emulsion containing glucose, belonging to the technical field of pharmaceutical production. Background technique [0002] The above-mentioned emulsion products currently on the market usually use the whole process of aseptic operation, that is, they are produced in a 100-level purification workshop and the raw and auxiliary materials have been sterilized. Or use traditional hot-press sterilization at 115°C for 30 minutes, or 121°C for 15 minutes and steam at 100°C for 30 minutes. Although these fire sterilization methods can achieve complete sterilization. However, for glucose fat emulsion, because it contains glucose, it is affected by many sterilization factors, especially glucose, which is not heat-resistant and easy to decompose under high temperature conditions, resulting in the limit of 5-hydroxymethylfurfural exceeding the standard and the pH value of the preparation. Changes will make t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L2/07A61K9/107A61K31/7004
Inventor 不公告发明人
Owner 安徽华明制药有限公司
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