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Preparation method of sterile preparation of lipoalprostadil

A technology of fat emulsion and alprostadil, which is applied in the field of preparation of sterile preparations, can solve problems such as the inability to guarantee the quality of alprostadil injection products

Inactive Publication Date: 2009-12-09
HARBIN PHARMA GROUP BIOLOGICAL ENG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The present invention aims to solve the problem that current known sterilization or degerming methods cannot guarantee the product quality of alprostadil injection (sterility guarantee and content guarantee)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] The preparation method of the aseptic preparation of alprostadil fat emulsion (alprostadil injection) of the present invention is as follows: the alprostadil fat emulsion prepared by a high-pressure homogenizer, with an average particle diameter of 191nm, is subjected to 0.22 μm at a temperature of 50° C. Filtered by microporous membrane or capsule filter, filled under 100-level laminar flow.

Embodiment 2

[0014] According to Example 1, the average particle size of the alprostadil fat emulsion is 240nm, filtered through a 0.22 μm microporous membrane or a capsule filter at a temperature of 60° C., and filled under a hundred-level laminar flow. 100-level laminar flow down filling

Embodiment 3

[0016] According to Example 1, the average particle size of the alprostadil fat emulsion is 204nm, filtered through a 0.22 μm microporous membrane or a capsule filter at a temperature of 70° C., and filled under a hundred-level laminar flow.

[0017] Embodiment 1-3 principal ingredient content and other each index are as follows:

[0018] Main drug dosage

[0019] The above data shows that the alprostadil emulsion injection prepared by the method of embodiment 1-3, compared with sterilization, its main drug content, pH value, particle size change less, and endotoxin and sterility inspection all meet the requirements , while the content of the sterilization process decreased more, and the pH value and particle size changed greatly. It shows that this process is more suitable for the preparation of alprostadil emulsion, the product quality is more stable, and it can be produced on a large scale.

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Abstract

The invention aims at providing a preparation method of a sterile preparation of lipoalprostadil. A sterile filtration method is adopted in a preparation technology of the lipoalprostadil for the first time, a microporous filtering film of 0.22 micrometer or a bag type filter is used for degerming and filtering the lipoalprostadil having an average grain diameter ranging from 100 nm to 300 nm at the temperature between 50 DEG C and 80 DEG C, and the sterile preparation of the lipoalprostadil is filled in hundred-level laminar flow environment. The preparation method can completely eliminate microorganisms in the preparation, ensure that the lipoalprostadil is completely filtered, effectively avoid the main medicine degradation of the lipoalprostadil for the traditional sterilizing technology and ensure that all the lipoalprostadils pass through the filtering film of 0.22 micrometer so as to reach the sterile requirement of the preparation.

Description

technical field [0001] The invention relates to a preparation method of a sterile preparation of alprostadil fat emulsion. Alprostadil fat emulsion is a prostaglandin E 1 The lipid microsphere preparation is mainly used for the treatment of limb ulcers caused by chronic arterial occlusive disease and resting pain of limbs caused by microvascular circulation disturbance, and belongs to the technical field of pharmaceutical production. Background technique [0002] The preparation method of alprostadil fat emulsion has been disclosed in Japan's Open Patent Gazette (Shao 58-222014), and adopts high-pressure homogenizing equipment to seal alprostadil in the soybean oil (lipid microspheres) with diameter, but there is no Describe the sterilization method. At present, the products listed above usually adopt 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. Alprostadil...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127A61K31/5575A61P9/14
Inventor 王孝文葛存慧李郑武赵华南王忠李会成陈玉军冷国庆
Owner HARBIN PHARMA GROUP BIOLOGICAL ENG
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