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Alprostadil lipid nanosphere gel and preparation method thereof

A technology of dil lipid and alprostadil, which is applied in the directions of pharmaceutical formulations, inactive medical preparations, oil/fat/wax inactive ingredients, etc., can solve the problems of chemical and physiological instability, low target organ concentration, Vascular irritation and other problems, to achieve the effect of enhancing in vitro stability, improving drug efficacy, and increasing stability

Inactive Publication Date: 2011-08-03
SHENYANG WANJIA INST OF BIOLOGICAL TECH RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The above-mentioned technologies that have been disclosed, whether it is fat emulsion injection, liposome injection, cyclodextrin inclusion compound freeze-dried powder injection, or the chemically stable alprostadil inclusion compound ointment, have adopted the technology of protecting the main drug. , there are certain defects in the treatment of ulcer disease, such as chemical and physiological instability, low concentration of target organs, greater vascular irritation, etc.

Method used

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  • Alprostadil lipid nanosphere gel and preparation method thereof
  • Alprostadil lipid nanosphere gel and preparation method thereof
  • Alprostadil lipid nanosphere gel and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0032] Alprostadil lipid nanosphere gel of the present invention is prepared by weight from the following raw materials: 0.015g of alprostadil, 45g of medium chain oil, 12g of soybean lecithin, 25g of polyethylene glycol lauryl hydroxystearate , glycerin 10g, water 408g, excipient gel base 500g. The excipient gel base is prepared from 15g of sodium carboxymethylcellulose, 119g of glycerin and 366g of water.

[0033] In a sterile workshop or a 100-grade purification workshop, take 45g of medium-chain oil for injection according to the weight ratio, add 12g of sterile soybean lecithin and 25g of sterile polyethylene glycol lauryl hydroxystearate to it, and Heat it to 60-70°C, mix well, then add 15mg of the main drug alprostadil to it to dissolve; add 408g of water for injection at 60-70°C and 10g of injection-grade glycerin, keep warm at 60-70°C, Shear and stir to form colostrum, then put it into a high-pressure homogenizer, cycle 3-4 times under a pressure of 20-100MPa, cool t...

Embodiment 2

[0035] Alprostadil lipid nanosphere gel of the present invention is prepared by weight from the following raw materials: 0.001 g of alprostadil, 20 g of medium chain oil, 10 g of egg yolk lecithin, polyethylene glycol lauryl hydroxystearate 15g, glycerin 10g, water 445g, excipient gel base 500g.

[0036]In a sterile workshop or a class 100 purification workshop, weigh 20 g of medium-chain oil for injection according to the weight ratio, add 10 g of sterile egg yolk lecithin and 15 g of sterile polyethylene glycol lauryl hydroxystearate to it, Heat it to 60-70°C, mix well, then add 0.001g of the main drug alprostadil to it, dissolve it, keep warm at 60-70°C; add 445g of water for injection at 60-70°C and 10g of injection-grade glycerin , keep warm to 60-70°C, shear and stir to form colostrum, then put it into a high-pressure homogenizer, cycle 8 times under a pressure of 20-100MPa, cool to room temperature, filter with a 0.22μm filter membrane, and prepare an emulsion for later...

Embodiment 3

[0038] Alprostadil lipid nanosphere gel of the present invention is prepared by weight from the following raw materials: 0.1 g of alprostadil, 50 g of medium chain oil, 20 g of soybean lecithin, polyethylene glycol lauryl hydroxystearate 25g, glycerin 11g, water 394g, excipient gel base 500g.

[0039] In a sterile workshop or a class 100 purification workshop, weigh 50 g of medium-chain oil for injection according to the weight ratio, add 20 g of sterile soybean lecithin and 25 g of sterile polyethylene glycol lauryl hydroxystearate to it, Heat it to 60-70°C, mix well, then add 100mg of the main drug alprostadil to it, dissolve it, keep warm at 60-70°C; add 394g of water for injection at 60-70°C and 11g of injection-grade glycerin, Keep warm at 60-70°C, shear and stir to form colostrum, then put it into a high-pressure homogenizer, cycle 10 times under a pressure of 20-100MPa, cool to room temperature, filter with a 0.22μm filter membrane, and prepare an emulsion for later use...

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Abstract

The invention discloses alprostadil lipid nanosphere gel and a preparation method thereof, and belongs to the technical field of medicines. The alprostadil lipid nanosphere gel is prepared from the following raw materials in part by weight: 0.001 to 0.1 part of alprostadil, 20 to 50 parts of oil for injection, 10 to 20 parts of emulsifier, 15 to 25 parts of aid emulsifier, 10 to 15 parts of glycerol, 390 to 445 parts of water and 500 parts of excipient gel substrate. In the alprostadil lipid nanosphere gel, the grain diameter is less than 100 nanometers, and bacteria can be removed in a mode of aseptic filtration, so the defect that the alprostadil is unstable is overcome, and the stability of products is enhanced. Simultaneously, lipid microspheres have smaller grain diameters of less than 100 nanometers, so the alprostadil lipid nanosphere gel is favorable for distributing the alprostadil in vivo and gathering the alprostadil to target organs easily, reduces the inactivation of pulmonary circulation and clearance in blood, is favorable for long-term circulation, increases the transdermal absorption of the medicines and improves the medicinal effect.

Description

technical field [0001] The invention relates to an alprostadil lipid nanosphere gel and a preparation method thereof. The preparation is mainly used for transdermal administration, and is used for treating diabetic ulcers, extremity ischemia, burns and other diseases, and belongs to the pharmaceutical technology field. Background technique [0002] Alprostadil is a vasodilator with definite curative effect and is a human physiological substance, which is widely used in the treatment of coronary heart disease, vasculitis, thrombosis and erectile dysfunction clinically. It also has a good effect on ulcer diseases, such as diabetic ulcers, extremity ischemia, burns, and ulcers caused by trauma. The drug is currently administered mainly in the form of injections, including urethral suppositories and ointments for mucosal administration. Among them, ointment is mainly used to treat diabetic ulcers. The main cause of diabetic ulcers is microcirculation disturbance. At present, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/5575A61K47/44A61P3/10A61P9/14A61P17/02A61K47/10A61K47/14A61K47/24A61K47/38
Inventor 董英杰艾莉王荟芳李乐
Owner SHENYANG WANJIA INST OF BIOLOGICAL TECH RES
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