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Sterilization technology of prostadil fatty emulsion and method of determination

A fat emulsion and alprostadil technology, which is applied in the field of sterilization process and determination of alprostadil fat emulsion, can solve the problems of emulsion structure damage, oil drift, layering and the like, and achieves the effects of good recovery rate and accurate quantification

Inactive Publication Date: 2006-08-30
SHENYANG WANJIA INST OF BIOLOGICAL TECH RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Microwave sterilization has different sterilization conditions for different medium solutions. Because the injection of alprostadil fat is an emulsion and has an oil-in-water microsphere structure, the absorption of microwave energy is completely different from that of ordinary aqueous solutions. The heating and sterilization process The changes will also be different. It has a certain tolerance limit to microwave radiation. When this limit is exceeded, the emulsion structure will be destroyed, resulting in floating oil, stratification and other phenomena.
On the other hand, the fat main drug of alprostadil will also degrade when the microwave radiation heats up and the time exceeds the limit.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029]The sterilization process of the alprostadil fat emulsion of the present invention is as follows: the alprostadil fat emulsion injection prepared by a high-pressure milk homogenizer is filled, and 2450MKz microwave sterilization equipment is used to sterilize, and the process is to be heated to 80° C. 200 seconds, that is.

Embodiment 2

[0031] According to Example 1, the temperature was raised to 65° C. and maintained for 300 seconds. All the other are with embodiment 1.

Embodiment 3

[0033] According to Example 1, the temperature was raised to 70° C. and maintained for 240 seconds. All the other are with embodiment 1.

[0034] Example 3:

[0035] According to Example 1, the temperature was raised to 75° C. and maintained for 180 seconds. All the other are with embodiment 1.

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PUM

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Abstract

A bactericiding process for the fatty emulsion of prostaglandin E1 features that said fatty emulsion in the ampules is heated to 65-140 deg.C for 10s-5 min by microwaves at 915 or 2450 MH2. A method for measuring its main component PGE1 and impurity PGA1 includes such steps as freeze drying for demulsifying to obtain oily sample, extracting in organic solvent, and efficient liquid-phase chromatography at 204-214 nm in wavelength to measure PGE1 and PGA1.

Description

technical field [0001] The present invention relates to a kind of alprostadil fat emulsion (alprostadil injection) sterilization technology and the method for measuring, and alprostadil fat emulsion is a kind of prostaglandin E containing 1 The fat emulsion microsphere preparation is mainly used for treating extremity ischemia, diabetic complications, vasculitis and some cardiovascular diseases, and belongs to the technical field of medicines. Background technique [0002] The preparation method of alprostadil fat emulsion has been disclosed in Japan's open patent bulletin 58-222014, is to adopt the high-pressure homogenizer equipment to make main drug alprostadil (PGE 1 ) is dissolved in soybean oil and emulsified under high pressure under the action of phospholipid emulsifier. In this patent, the sterilization method is not described. The variety currently on the market usually adopts a full-process aseptic operation method, that is, it is produced in a 100-level purifica...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5575A61K9/107A61P3/10A61P9/14A61P9/00
Inventor 董英杰
Owner SHENYANG WANJIA INST OF BIOLOGICAL TECH RES