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Alprostadil medium-and-long-chain lipid emulsion for injection and preparation method thereof

An alprostadil and fat emulsion technology, applied in the field of biomedicine, can solve the problems of hypertriglyceridemia, increased liver load, poor solubility of long-chain triglycerides, etc. irritating effect

Active Publication Date: 2015-04-15
JILIN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Long-chain triglycerides, such as soybean oil, have a good encapsulation effect on insoluble drugs, but due to the relatively poor solubility of long-chain triglycerides, if used for a long time, they have certain liver toxicity and increase the burden on the liver. hypertriglyceridemia

Method used

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  • Alprostadil medium-and-long-chain lipid emulsion for injection and preparation method thereof
  • Alprostadil medium-and-long-chain lipid emulsion for injection and preparation method thereof
  • Alprostadil medium-and-long-chain lipid emulsion for injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0022] This embodiment is the preparation experiment of alprostadil medium and long-chain fat emulsion, prepared according to the following implementation scheme:

[0023] In the sterile room, accurately weigh 0.4g of glycerol (glycerol), stir and dissolve in 50mL of water for injection as the water phase; weigh 2g of medium-chain triglycerides (purchased from Guangzhou Erlong Jingcheng Trading Co., Ltd. , containing 8 to 10 carbon atoms) heated to 40°C to completely dissolve, add 0.002g alprostadil, dissolve, add 0.4g egg yolk lecithin and 0.02g oleic acid, stir to dissolve, finally add 2g long-chain triglycerides (Soybean oil) was used as the oil phase after stirring; the obtained oil phase was added to the water phase using a peristaltic pump (control speed was 5mL / min), high-speed shearing, the speed was 5000 rpm, and the time was 20 minutes to obtain the initial Milk; add 0.1M sodium hydroxide solution to adjust the pH of the colostrum to 7.0; repeat the homogenization of...

Embodiment 2

[0025] This example is an experiment on the preparation of alprostadil medium and long-chain fat emulsion, and the influence of different phospholipids on the preparation process of the emulsion is investigated. Prepare according to the following scheme:

[0026] In a sterile room, accurately weigh 0.4g of glycerol (glycerol), stir and dissolve in 50mL of water for injection as the water phase; weigh 2g of medium-chain triglycerides, mix and heat to 50°C for complete dissolution, then add 0.002g Alprostadil, dissolve, add 0.4g soybean lecithin and 0.02g oleic acid, stir to dissolve, finally add 2g long-chain triglyceride (soybean oil), stir and use it as the oil phase; use a peristaltic pump to add the obtained oil phase to the water phase Medium (control speed is 10mL / min), high-speed shearing, rotating speed is 8000 rpm, time is 20 minutes, to obtain colostrum; add 0.1M sodium hydroxide solution to adjust the pH of colostrum to 7.5; The milk is repeatedly homogenized in the...

Embodiment 3

[0028] This example is an experiment on the preparation of alprostadil medium- and long-chain fat emulsions, investigating the influence of the addition order of medium-chain and long-chain triglycerides on the preparation process, and preparing according to the following implementation scheme:

[0029] In a sterile room, accurately weigh 0.4g of glycerol (glycerin), stir and dissolve in 50mL of water for injection as the water phase; weigh 2g of long-chain triglycerides, mix and heat to 40°C for complete dissolution, then add 0.002g Alprostadil, dissolve, add 0.4g egg yolk lecithin and 0.02g oleic acid, stir to dissolve, finally add 2g medium-chain triglyceride (soybean oil), stir and use it as the oil phase; use a peristaltic pump to add the obtained oil phase to the water In phase (control speed is 10mL / min), high speed shearing, rotating speed is 6000 rev / min, time is 30 minutes, obtains colostrum; Add 0.1M sodium hydroxide solution to adjust the pH of colostrum to be 8.5; T...

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Abstract

The invention discloses an alprostadil medium-and-long-chain lipid emulsion for injection and a preparation method thereof, belonging to the technical field of biological medicines. The lipid emulsion is composed of the following components in parts by weight: 0.01-0.1 part of alprostadil, 10-100 parts of long-chain triglycerides, 10-100 parts of medium-chain triglycerides, 1-20 parts of phospholipids, 0.01-1 part of oleic acid, 5-20 parts of glycerol and 300-2500 parts of water for injection. The particle size of the lipid emulsion is 50-200 nm, the lipid emulsion has good stability while the pH value is 5.0-8.0, and the contents of degradation products including prostaglandin A1 and prostaglandin B1 of alprostadil measured by using an HPLC (High Performance Liquid Chromatography) method are respectively below 1%. Compared with traditional alprostadil long-chain lipid emulsions, aqueous-phase alprostadil is significantly decreased, so that the vascular stimulation is reduced, and the liver load is reduced, therefore, the lipid metabolism can be accelerated, and the triglyceride level of plasma can be reduced.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to an alprostadil medium-long-chain fat emulsion for injection and a preparation method thereof. Background technique [0002] Atherosclerosis obliterans is a systemic, degenerative disease. With the increase of age, the incidence gradually increases, and it is more common in patients over 60 years old. According to the Chinese survey report, the incidence rate of atherosclerosis in people over 60 years old reaches 79.9%. With the arrival of an aging society, the development of drugs for the treatment of arteriosclerosis obliterans is becoming more and more important. [0003] Alprostadil (alprostadil) is a kind of prostaglandin, which has a wide range of physiological activities, can dilate blood vessels, inhibit platelet aggregation, and inhibit atherosclerosis. It is used for myocardial infarction, thromboangiitis, obliterative arteriosclerosis and acute Cerebr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K47/14A61K31/5575A61P9/08A61P7/02A61P9/10
Inventor 滕利荣杨爽杨雪薇孟庆繁滕乐生逯家辉谢晶王贞佐刘艳程瑛琨王迪权宇彤
Owner JILIN UNIV
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