Sterilization technology of prostadil fatty emulsion and method of determination

Abstract

The invention relates to a sterilization process of alprostadil fat emulsion. Use 915MHz or 2450MHz frequency microwave equipment to irradiate the 1ml and 2ml ampoule alprostadil injection placed in the microwave equipment to raise the temperature of the ampoule to 65-140°C and maintain it for 10 seconds to 5 minutes for sterilization , can completely kill the microorganisms in the preparation. The determination of the main drug PGE1 and impurity PGA1 in the preparation adopts the method of freeze-drying to de-emulsify, so that the sample becomes an oily substance, and then extracts the oily substance with an organic solvent to obtain a test solution. At the place, PGE1 and PGA1 were determined according to the external standard method or internal standard method. The invention effectively reduces the main drug degradation of the alprostadil fat emulsion caused by the traditional sterilization process.

Description

technical field [0001] The present invention relates to a kind of alprostadil fat emulsion (alprostadil injection) sterilization process, 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 purification workshop and the raw and auxili...

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.