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Preparation method of alprostadil injection

A technology of alprostadil and injection, applied in the field of medicine, can solve problems such as reducing the stability of alprostadil emulsion, achieve the effects of stable encapsulation rate and drug content, reducing metabolic inactivation, and controlling degradation

Active Publication Date: 2017-09-22
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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  • Preparation method of alprostadil injection
  • Preparation method of alprostadil injection
  • Preparation method of alprostadil injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Example 1: Emulsion injection prescription and its preparation method

[0052] According to the prescription in Table 1, weigh the raw materials according to the prescription, (1) Add 15 mg of phospholipid and polyethylene glycol 2000 to the mixed solvent of ethanol and ether (volume ratio 1:1) to dissolve, then add 5 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 50°C, add 15g egg yolk lecithin and the powder obtained in step (1) in sequence, Under the high-shear dispersing emulsifier, high-speed shearing and dispersing for 15 minutes to prepare the oil phase; (3) adding glycerin to the water for injection, under the high-shearing dispersing emulsifying machine, shearing and dispersing for 10 minutes to prepare the water phase; (4) Under high-speed shear dispersion, slowly add the oil phase to the water phase, and then continue high-speed shear ...

Embodiment 2

[0072] prescription:

[0073]

[0074] Preparation method: Weigh each raw material according to the prescription, (1) Add 10mg egg yolk lecithin and 3mg polyethylene glycol 2000 into the mixed solvent of ethanol and ether (volume ratio 1:1) to dissolve, add 4mg prostadil 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 lecithin and the powder obtained in step (1) successively, Under the shear dispersion emulsifier, high-speed shear dispersion for 25 minutes to prepare the oil phase; (3) Add glycerin to the water for injection, under the high shear dispersion emulsifier, shear and disperse for 10 minutes to prepare the water 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) After adding water for injection to the full amount of...

Embodiment 3

[0076] prescription:

[0077]

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

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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 method for preparing alprostadil injection. Background technique [0002] Alprostadil is prostaglandin E1. Alprostadil has been widely used in clinical practice, such as the treatment of arterial occlusive disease, coronary heart disease, angina pectoris, heart failure, peripheral vascular disease and other cardiovascular diseases, treatment of acute cerebral infarction, brain Infarction, prevention of cerebrovascular diseases such as vasospasm after subarachnoid hemorrhage, respiratory diseases, digestive diseases such as hepatitis, renal dysfunction such as renal insufficiency, diabetes and erectile dysfunction. [0003] Clinically, about 5-6 minutes after the alprostadil emulsion injection was put into the pot, the puncture site of the hand showed redness of 10-15 cm along the blood vessel. Some patients complained of pain and itching. In addition, after intravenous administration...

Claims

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Application Information

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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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