Nano emulsion injection of alprostadil and preparation method

A technology of nano-dil and alprostadil, which is applied in the direction of pharmaceutical formula, emulsion delivery, medical preparations containing active ingredients, etc., can solve the problems of poor absorption effect and large milk particles, so as to improve distribution, improve curative effect, The effect of simple and feasible quality control method

Inactive Publication Date: 2006-12-06
广州中大创新药物研究与开发中心有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the preparation method is only to remove moisture from the coarse emulsion by freeze-drying to obtain a freeze-dried emulsion. The particle size of the milk particles in the coarse emulsion itself is relatively large, and further agglomeration or agglomeration will occur after freeze-drying; thus freeze-drying After the emulsion is reconstituted into an emulsion, the milk particles are larger and the absorption effect is poor

Method used

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  • Nano emulsion injection of alprostadil and preparation method
  • Nano emulsion injection of alprostadil and preparation method
  • Nano emulsion injection of alprostadil and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Prepare raw materials, excipients and other components according to the quantity of components:

[0064] Alprostadil 0.5mg

[0065] Soybean oil for injection 3.0g

[0066] Poloxamer 188 1.0g

[0067] Lecithin for Injection 1.0g

[0068] Add water for injection to 100g

[0069] The following steps were all carried out under nitrogen protection. Add 0.5 mg of PGE1 to 3.0 g of soybean oil for injection, stir until PGE1 dissolves, and obtain solution (1), which is an oil phase. Add 1.0g of poloxamer 188 into water for injection to dissolve, under high-speed homogenization, add 1.0g of lecithin for injection, disperse for 3-6 minutes, heat the solution to 70°C, keep it warm for later use, and obtain solution (2) , is the water phase. Add the water phase solution (2) into the high-speed homogenizer, then slowly add the oil phase solution (1) into the stirring water phase, keep the temperature of the dispersion at 55°C, disperse for 3 minutes, and then add water for inje...

Embodiment 2

[0072] Prepare raw materials, excipients and other components according to the quantity of components:

[0073] Alprostadil 0.5mg

[0074] Soybean oil for injection 5.0g

[0075] Poloxamer 188 3.0g

[0076] Lecithin for Injection 1.0g

[0077] Glycerin for injection 2.25g

[0078] Oleic acid 0.5g

[0079] Add water for injection to 100g

[0080] The following steps were all carried out under nitrogen protection. Add 0.5 mg of PGE1 to 5.0 g of soybean oil for injection, stir until PGE1 dissolves, and obtain solution (1), which is an oil phase. Add 3.0g of poloxamer 188 into water for injection to dissolve, under the action of high-speed homogenization, add 2.25g of glycerin for injection, add 0.5g of oleic acid, add 1.0g of lecithin for injection, disperse for 3-6 minutes, and lower the temperature of the solution Heat to 65°C, keep warm for later use, and obtain solution (2), which is an aqueous phase. Add the water phase solution (2) into the high-speed homogenizer, t...

Embodiment 3

[0083] Prepare raw materials, excipients and other components according to the quantity of components:

[0084] Alprostadil 0.5mg

[0085] Soybean oil for injection 10.0g

[0086] Poloxamer 188 2.5g

[0087] Lecithin for Injection 2.0g

[0088] Glycerin for injection 2.5g

[0089] Oleic acid 1.0g

[0090] Add water for injection to 100g

[0091] Other steps are the same as in Example 2 to obtain the alprostadil nanoemulsion injection of the present invention. For the stability test of the alprostadil nanoemulsion injection in this example, refer to Example 7.

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Abstract

A nano-emulsion injection of prostaglandin E1 contains the nano-emulsion particles of rostaglandin E1, the oil for injection, hydrophilic emulsifier, lipophilic emulsifier, isotonic agent, and stabilizer. Its preparing process and its quality control method are also disclosed.

Description

technical field [0001] The present invention relates to a kind of alprostadil injection and preparation method thereof, more specifically, the present invention relates to a kind of alprostadil nanoemulsion injection and preparation method thereof. Background technique [0002] Alprostadil, also known as prostaglandin E1 (Prostagland E1, PGE1), is a highly active physiologically active substance that can inhibit platelet aggregation, thromboxane A2 generation, atherosclerotic lipid plaque formation and immune complexes. Function, and can expand the pharmacological effect of peripheral and coronary blood vessels, mainly used for the treatment of limb ulcers caused by chronic arterial occlusive disease and April branch rest pain caused by microcirculation disturbance. [0003] The molecular formula of alprostadil is: C 20 h 34 o 5 , the structural formula is as follows: [0004] [0005] PGE1 metabolizes very quickly in the body, and under the action of lung oxidase, 60...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5575A61K9/107A61P7/02A61P9/14
Inventor 冯敏汤毅高越张霖泽
Owner 广州中大创新药物研究与开发中心有限公司
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