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Prostaglandin E1 long-circulation fat microsphere preparation for intravenous injection and preparation method thereof

A technology of alprostadil and lipid microspheres, which can be applied to medical preparations containing active ingredients, pharmaceutical formulations, inactive ingredients of oil/fat/wax, etc., which can solve the problem that the therapeutic effect of alprostadil is not very satisfactory to patients, etc. question

Active Publication Date: 2012-04-11
XIAN LIBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Through clinical experiments, the therapeutic effect of the alprostadil drug prepared by the prior art is not very satisfactory to the patients, so we have invented a kind of alprostadil with good therapeutic effect and solved the existing problems of the prior art through long-term research preparation

Method used

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  • Prostaglandin E1 long-circulation fat microsphere preparation for intravenous injection and preparation method thereof
  • Prostaglandin E1 long-circulation fat microsphere preparation for intravenous injection and preparation method thereof
  • Prostaglandin E1 long-circulation fat microsphere preparation for intravenous injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0098] The most preferred alprostadil lipid microsphere preparation of the present invention of embodiment 1

[0099] Alprostadil 5.0mg

[0100] Soybean oil (for injection) 100.0g

[0101] Lecithin (for injection) 18.0g

[0102] Sodium Oleate 2.4g

[0103] Polyethylene glycol-phospholipids 20.0g

[0104] Vitamin E (for injection) 5.0g

[0105] Glycerin 22.1g

[0106] Add water for injection to 1000ml

[0107] Take alprostadil and soybean oil, add lecithin, vitamin E, polyethylene glycol-phospholipid (PEG-DSPE), under the condition of nitrogen protection, heat to 75 ℃, stir for about 10min to make the various lipid compounds added Fully dissolve, dissolve and mix well. Take another 800ml of water for injection, add glycerin and sodium oleate. Under the condition of nitrogen protection, the oil solution containing the drug was added into the aqueous solution of glycerin and sodium oleate under the condition of shearing and stirring to prepare colostrum, and the total amo...

example 2

[0108] The long circulation alprostadil lipid microsphere pharmaceutical preparation of the highest alprostadil content of example 2 (only with soybean oil as embodiment)

[0109] prescription:

[0110] Alprostadil 1.0g

[0111] Soybean oil (for injection) 100.0g

[0112] Lecithin (for injection) 18.0g

[0113] Sodium Oleate 2.4g

[0114] Polyethylene glycol-phospholipids 20.0g

[0115] Vitamin E (for injection) 5.0g

[0116] Glycerin 22.1g

[0117] Add water for injection to 1000ml

[0118] Take 1.0g of alprostadil, 100.0g of soybean oil, add 18.0g of lecithin, 20.0g of polyethylene glycol-phospholipid (PEG-DSPE), under the condition of nitrogen protection, heat to 75 ℃, stir for about 10min to make the added Various lipid compounds are fully dissolved, then add 5.0g vitamin E, dissolve and mix well. Take another 800ml of water for injection, add 22.1g of glycerin and 2.4g of sodium oleate. Under the condition of nitrogen protection, the oil solution containing the d...

example 3

[0120] The long-circulation alprostadil lipid microsphere pharmaceutical preparation of the minimum polyethylene glycol-phospholipid content of example 3 (only with soybean oil as embodiment)

[0121] prescription:

[0122] Alprostadil 5.0mg

[0123] Soybean oil (for injection) 100.0g

[0124] Lecithin (for injection) 18.0g

[0125] Sodium Oleate 2.4g

[0126] Polyethylene glycol-phospholipids 2.0g

[0127] Vitamin E (for injection) 5.0g

[0128] Glycerin 22.1g

[0129] Add water for injection to 1000ml

[0130] Take 5.0 mg of alprostadil, 100.0 g of soybean oil, add 18.0 g of lecithin, 2.0 g of polyethylene glycol-phospholipid (PEG-DSPE), and heat to 75 ° C under the condition of nitrogen protection, and stir for about 10 min to make the added Various lipid compounds are fully dissolved, then add 5.0g vitamin E, dissolve and mix well. Another 800ml of water for injection was taken, and 22.1g of glycerol was added. Under the condition of nitrogen protection, the oil s...

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Abstract

The invention relates to a formula and a preparation method of a prostaglandin E1 long-circulation fat microsphere for intravenous injection. The preparation comprises the following components: (1) a prostaglandin E1 medicine; (2) vegetable oil (dissolving oil diluted by a medicine); (3) an emulsion surfactant; (4) an emulsion preparation stabilizing agent, an emulsifying agent, a particle diameter control agent and a polyoxyalkylene phospholipid derivative increasing the half life of the fat microsphere in blood; (5) oleic acid or oleate which is used as the emulsion preparation stabilizing agent or the emulsifying agent; (6) an antioxidant; and (7) a complex compound (glycerol) controlling the cation concentration.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a lipid microsphere preparation of alprostadil for intravenous injection and a preparation method thereof. technical background [0002] Alprostadil (prostaglandin E1, PGE1) is a kind of prostaglandin, which can expand blood vessels, inhibit platelet aggregation, inhibit gastric acid secretion, stimulate intestinal and uterine smooth muscle, protect liver and kidney function, inhibit pancreatic exocrine, and resist lipid oxidation role, stimulate insulin secretion and other effects. Main clinical applications: 1) Treat limb ulcers caused by chronic arterial occlusive disease (thromboangiitis obliterans, arteriosclerosis obliterans, etc.) obstacle. 2) Treatment of skin ulcers caused by progressive systemic sclerosis, Kaplan syndrome, and diabetes. 3) Recover the subjective symptoms associated with the peripheral blood flow disorder caused by tremor disease, and the reco...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/5575A61K47/44A61P9/00A61P9/10A61P17/00A61P43/00G01N30/36
Inventor 陈涛王汝涛王惟娇张阳
Owner XIAN LIBANG PHARMA
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