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Stable PGE1 lyophilized emulsion and preparation method thereof

A freeze-dried milk, stabilized technology, applied in the field of medicine

Active Publication Date: 2014-03-19
BEIJING TIDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the problem of clinical application of alprostadil freeze-dried powder injection, PGE1 injection was successfully developed by Japanese scientists and was launched in Japan in the 1980s

Method used

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  • Stable PGE1 lyophilized emulsion and preparation method thereof
  • Stable PGE1 lyophilized emulsion and preparation method thereof
  • Stable PGE1 lyophilized emulsion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Weigh 10g of soybean lecithin and 20g of glycerin into a beaker, add 400ml of purified water, and shear and stir at 15,000rpm for 5 minutes to form a water phase; weigh 60g of soybean oil into a beaker, and add 5mg of PGE1 and 50mg of vitamin E while heating and dissolving in water at 60°C while stirring , Stir to disperse evenly to form an oil phase. Slowly drop the water phase into the oil phase under low-speed stirring. After adding completely, shear and stir at 10,000 rpm for 5 minutes to obtain colostrum, adjust the pH to 8 with sodium hydroxide; homogenize the colostrum solution through a high-pressure milk homogenizer, 100bar, 8 laps of homogenization under high pressure of 1000bar to obtain a fine emulsified emulsion; weigh 50g of refined sucrose into a beaker, add 300ml of purified water, stir, dissolve, and set the volume to 400ml after the dissolution is complete; after the above prepared fine emulsification Mix the emulsion and the solution prepared from ref...

Embodiment 2

[0034]Weigh 15g of egg yolk phospholipids and 25g of glycerin into a beaker, add 400ml of purified water, and shear and stir at 15,000rpm for 5 minutes to form a water phase; weigh 80g of soybean oil into a beaker, heat and dissolve in water at 60°C while stirring, add 5mg of PGE1 and 200mg of vitamin E , Stir to disperse evenly to form an oil phase. Slowly drop the water phase into the oil phase under low-speed stirring. After adding completely, shear and stir at 10,000 rpm for 5 minutes to obtain colostrum, adjust the pH to 8 with sodium hydroxide; homogenize the colostrum solution through a high-pressure milk homogenizer, 100bar, 8 laps of homogenization under high pressure 1000bar to obtain a fine emulsified emulsion; weigh 150g of refined sucrose into a beaker, add 300ml of purified water, stir, dissolve, and set the volume to 400ml after the dissolution is complete; after the above prepared fine emulsification Mix the emulsion and the solution prepared from refined sucro...

Embodiment 3

[0036] Weigh 20g of soybean lecithin and 40g of glycerin into a beaker, add 400ml of purified water, and shear and stir at 15,000rpm for 5 minutes to form a water phase; weigh 70g of soybean oil into a beaker, heat and dissolve in water at 60°C while stirring, add 5mg of PGE1 and 300mg of vitamin E , Stir to disperse evenly to form an oil phase. Slowly drop the water phase into the oil phase under low-speed stirring. After adding completely, shear and stir at 10,000 rpm for 5 minutes to obtain colostrum, adjust the pH to 8 with sodium hydroxide; homogenize the colostrum solution through a high-pressure milk homogenizer, 100bar, 8 laps of homogenization under high pressure of 1000bar to obtain a refined emulsified emulsion; weigh 100g of glucose and 100g of refined sucrose into a beaker, add 300ml of purified water, stir, dissolve, and set the volume to 400ml after the dissolution is complete; Mix the refined emulsified emulsion with the solution made from refined sucrose, set ...

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Abstract

The invention provides a stable PGE1 lyophilized emulsion and a preparation method thereof. In particular, by adding vitamin E and refined cane sugar or glucose or a mixture composed of refined sugar and glucose according to a certain ratio, the PGE1 lyophilized emulsion is substantially improved in physical and chemical stability, and thus is capable of bearing severe variation of conditions during freeze drying. The prepared lyophilized product is plump in appearance, is white loose blocks or powder, is good in redissolving property, controllable in quality, good in reappearance and low in rejection rate; also because the usage amount of auxiliary agents is reduced, the production cost of the product is reduced, and the side effects caused by too much added lyophilized preparation auxiliary agents are overcome; and the product is relatively safe to use by patients, and the product is prolonged in validity period and reduced in requirements on production, transportation and storage conditions.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a stable PGE1 freeze-dried milk and a preparation method thereof. Background technique [0002] PGE1, also known as prostaglandin E1, is a biologically active substance widely present in the body. swedish scientist [0003] Burgstrom and others won the Nobel Prize in Medicine in 1982 for their discovery of PGE1 and their related pharmacological research. Contents of the invention [0004] Because PGE1 has a strong drug mechanism of dilating blood vessels and can effectively treat diseases such as chronic arterial occlusive disease, it began to be developed as a drug as early as the 1970s. Since PGE1 is almost insoluble in water and has poor stability, it was mainly coated with co-solvent or cyclodextrin in the early stage and made into a freeze-dried powder injection. Freeze-dried powder injection belongs to systemic administration, and its concentration is relatively large...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/5575A61K47/26A61K47/22A61P9/08
Inventor 胡子睿王伟卢迪杨青松刘玉静肖萱
Owner BEIJING TIDE PHARMA
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