Prostaglandin E1 liposome frozen dry powder injection and production technology thereof

A prostaglandin and injection technology, applied in the field of medicine, can solve the problems such as the inability to exert the curative effect well and the large difference in the effect.

Inactive Publication Date: 2003-10-22
CHEM PHARMA FACTORY NANYANG PUKANG GROUP
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Problems solved by technology

Therefore, the effect of patients after medication is quite diffe

Method used

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  • Prostaglandin E1 liposome frozen dry powder injection and production technology thereof
  • Prostaglandin E1 liposome frozen dry powder injection and production technology thereof

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Embodiment Construction

[0032] (1) Prostaglandin E1 with a purity of more than 84.0% is dissolved in chloroform (analytical pure), adsorbed on a high performance liquid phase preparative chromatography column, and through eluent A (chloroform: methanol = 90: 10), Eluent B (chloroform:methanol=95:5) was eluted sequentially, and ethyl acetate (analytical grade) was recrystallized to obtain prostaglandin E1 with a purity of more than 92.0%.

[0033] (2) Dissolve soybean lecithin (injection grade) and cholesterol (injection grade) in chloroform (analytical pure) in a sterile room, and evaporate chloroform under reduced pressure rotation to make lipids form a film on the wall .

[0034] (3) Prostaglandin E1 is prepared in the aseptic room, calculated by 10,000 pieces, weighing 1 gram of high-purity prostaglandin E1 (above 92.0%), dissolving with a small amount of absolute ethanol, and adding phosphate buffer solution of pH 7.8 under stirring (PBS) 1000ml, slowly add the PBS containing prostaglandin E1 in...

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Abstract

The present invention provides a prostaglandin E1 liposome fronen dry powder injection and its production process. It is mainly characterized by that it uses soya lectithin and cholesterol to cover high-purity prostaglandin E1 so as to make them into freeze-dried powder injection. Said process can greatly raise stability of the finished product in production, can prolong expiry date, and can reduce side reaction.

Description

Technical field: [0001] The invention belongs to the technical field of medicine and relates to a prostaglandin E1 liposome freeze-dried powder for injection and a production process thereof. Background technique: [0002] Prostaglandins are a group of 20-carbon unsaturated fatty acids containing a five-carbon ring and two side chains. According to the different substituents on the five-carbon ring and the position of the double bond, it can be divided into more than 10 types, and each type is divided into two groups according to the number of double bonds. 3 categories. The chemical name of prostaglandin E1 (PGE1) is 11(a), 15(s)-dihydroxy-9-keto-13-antiprostenic acid, which can be synthesized by normal human tissue cells and is the main substance to regulate cell function. Internationally, it is regarded as a new generation of endogenous cardiovascular drugs. It can directly act on vascular smooth muscle, expand arteries, inhibit platelet aggregation, thromboxane A2 gene...

Claims

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Application Information

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IPC IPC(8): A61K31/5575A61P9/10
Inventor 赵晴冯剑波曹中祥路建同马丽娜党柯赵玉涛
Owner CHEM PHARMA FACTORY NANYANG PUKANG GROUP
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