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A kind of preparation method of alprostadil injection

A technology of alprostadil and injection, which is applied in the field of medicine, can solve the problems of reducing the stability of alprostadil emulsion, achieve the effects of stable encapsulation rate and drug content, high encapsulation rate, and little vascular stimulation

Active Publication Date: 2020-11-03
FUBICHENG SHANGHAI PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thereby, based on this property of alprostadil and the distribution in the emulsion, the state of this distribution in the interface still has the situation that alprostadil diffuses weakly to the water phase, which causes alprostadil to further decompose into the prostate gland in the water phase. Factor A, which reduces the stability of alprostadil emulsions

Method used

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  • A kind of preparation method of alprostadil injection
  • A kind of preparation method of alprostadil injection
  • A kind of preparation method of alprostadil injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1: Emulsion injection prescription and preparation method thereof

[0052] Press the prescription of table 1, take each raw material by prescription respectively, (1) add 15mg phospholipid and polyethylene glycol 2000 after dissolving in the mixed solvent of ethanol and ether (volume ratio 1:1), add 5mg alprostadil and stir Dissolve, recover ethanol and ether under reduced pressure, and dry to obtain powder; (2) Mix soybean oil and medium-chain triglycerides and heat to 50°C, add 15g egg yolk lecithin and the powder prepared in step (1) in sequence, Under a high-shear dispersing emulsifier, high-speed shearing and dispersing for 15 minutes to prepare an oil phase; (3) adding glycerin to water for injection, and shearing and dispersing for 10 minutes under a high-shear dispersing and emulsifying machine to prepare an aqueous phase; (4) Under high-speed shear dispersion, slowly add the oil phase into the water phase, and then continue high-speed shear dispersio...

Embodiment 2

[0072] prescription:

[0073]

[0074] Preparation method: Weigh each raw material according to the prescription, (1) add 10 mg of egg yolk lecithin and 3 mg of polyethylene glycol 2000 into a mixed solvent of ethanol and ether (1:1 by volume) to dissolve, add 4 mg of alprostadil and stir Dissolve, recover ethanol and ether under reduced pressure, and dry to obtain powder; (2) Mix soybean oil and medium-chain triglycerides and heat to 45°C, add 10g of lecithin and the powder prepared in step (1) successively, Under the shear dispersing emulsifier, high-speed shearing and dispersing for 25 minutes to prepare an oil phase; (3) adding glycerin to water for injection, under a high-shear dispersing emulsifier, shearing and dispersing for 10 minutes to prepare an aqueous phase; ( 4) Under high-speed shear dispersion, slowly add the oil phase to the water phase, and then continue high-speed shear dispersion at 45°C for 20 minutes to prepare colostrum; (5) Add water for injection t...

Embodiment 3

[0076] prescription:

[0077]

[0078] Preparation method: Weigh each raw material according to the prescription, (1) add 12 mg egg yolk lecithin and 2 mg polyethylene glycol 2000 to ethanol for dissolution, add 4 mg alprostadil and stir to dissolve, recover ethanol under reduced pressure, and dry to obtain powder; (2) Mix soybean oil and medium-chain triglycerides and heat to 55°C, add 15g of egg yolk lecithin and the powder prepared in step (1) in sequence, and disperse under high-shear dispersing emulsifier for 25 minutes at high speed , prepared into an oil phase; (3) adding glycerin to water for injection, and shearing and dispersing for 10 minutes under a high-shear dispersing emulsifier to prepare an aqueous phase; (4) under high-speed shearing and dispersing, the oil phase was slowly Add it into the water phase, and then continue high-speed shear dispersion at 40°C for 20 minutes to prepare colostrum; (5) Add water for injection to the full amount of colostrum, adju...

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Abstract

The invention relates to a preparation method of an alprostadil injection. The preparation method comprises the following steps: adding egg yolk lecithin and polyethylene glycol 2000 into an organic solvent to dissolve, adding alprostadil to stir and dissolve, decompressing and drying to obtain alprostadil compound powder, and further preparing into an emulsion injection. Active ingredients have high affinity with an oil phase, the alprostadil is enabled to be wrapped in emulsion stably, at the same time the metabolic inactivation of the alprostadil injection emulsion in alkaline environment is reduced, so that the stability and safety of drugs are improved, and the toxic and side effects of the drugs are reduced.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a preparation method of alprostadil injection. Background technique [0002] Alprostadil is prostaglandin E1. At present, alprostadil has been widely used clinically, such as the treatment of cardiovascular diseases such as arterial occlusive disease, coronary heart disease, angina pectoris, heart failure, peripheral vascular disease, and acute cerebral infarction, cerebral infarction, etc. Infarction, prevention of cerebrovascular diseases such as vasospasm after subarachnoid hemorrhage, respiratory system diseases, digestive system diseases such as hepatitis, renal function diseases such as renal insufficiency, diabetes and erectile dysfunction. [0003] Clinically, about 5-6 minutes after the alprostadil emulsion injection was put into the pot, redness of 10-15 cm appeared at the puncture site of the hand along the direction of the blood vessel, and some patients complained o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K31/5575A61K47/24A61K47/10A61K47/14A61K47/12A61P9/10A61P9/04A61P9/00A61P11/00A61P1/16A61P13/12A61P3/10A61P15/10
CPCA61K9/0019A61K9/1075A61K31/5575A61K47/10A61K47/12A61K47/14A61K47/24
Inventor 甘莉刘杰刘月华张红芹钱滢赵韬
Owner FUBICHENG SHANGHAI PHARMA TECH CO LTD
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