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A kind of alprostadil fat emulsion for injection and preparation method thereof

A technology of dil fat and alprostadil, applied in the field of alprostadil fat emulsion freeze-dried preparations, can solve problems such as widening particle size distribution, and achieve the effects of improving stability, increasing operability, and reducing potential safety hazards

Active Publication Date: 2018-01-02
内蒙古多肽科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The technical problem to be solved by the present invention is to overcome the defects of the prior art, provide a kind of alprostadil fat emulsion for injection with good safety and stability, adopt the high safety auxiliary material phosphatidylglycerol, not only improve the product stability At the same time, it solves the problem of widening particle size distribution after freeze-drying, and ensures that the key indicators (such as particle size) of the product after reconstitution are basically the same as those before freeze-drying, thus ensuring equivalent clinical use

Method used

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  • A kind of alprostadil fat emulsion for injection and preparation method thereof
  • A kind of alprostadil fat emulsion for injection and preparation method thereof
  • A kind of alprostadil fat emulsion for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] prescription:

[0049]

[0050] Process:

[0051] (1) Preparation of the water phase: add sucrose and glycerin into water to dissolve, heat to 65°C, and set aside;

[0052] (2) Preparation of the oil phase: heat the refined soybean oil to 65°C, add phosphatidylcholine (PC-98T, Shanghai Everett) and egg yolk phosphatidylglycerol (EPG, Shanghai Everett) to dissolve, and add the Dil, stir to dissolve;

[0053] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 65°C, high-speed shear dispersion, shear speed of 10,000 rpm, and time of 15 minutes, to form colostrum

[0054] (4) High-pressure homogenization: adjust the pH of the colostrum in step (3) to 6.9, and high-pressure homogenize 3 times with a microfluidizer at a pressure of 1000-1200 bar;

[0055] (5) Preliminary filtration: Prefilter the refined milk in step (4) through a 0.45 μm filter membrane;

[0056] (6) Sterile filtration: the emulsion obtain...

Embodiment 2

[0059] prescription:

[0060]

[0061] Process:

[0062] (1) Preparation of water phase: add sucrose into water to dissolve, heat to 65°C, and set aside;

[0063] (2) Preparation of the oil phase: heat the olive oil to 65°C, add phosphatidylcholine (PC-98T, Shanghai Aiweite) and egg yolk phosphatidylglycerol (EPG, Shanghai Aiweite) to dissolve respectively, add Qianliedi Er, stir to dissolve;

[0064] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 65°C, high-speed shear dispersion, shear speed of 10,000 rpm, and time of 15 minutes, to form colostrum

[0065] (4) High-pressure homogenization: Adjust the pH of the colostrum in step (3) to 7.1, and then use a microfluidizer for high-pressure homogenization 3 times at a pressure of 1000-1200 bar:

[0066] (5) Preliminary filtration: Prefilter the refined milk in step (4) through a 0.45 μm filter membrane;

[0067] (6) Sterile filtration: the emulsion obtaine...

Embodiment 3

[0084] prescription:

[0085]

[0086]

[0087] Process:

[0088] (1) Preparation of water phase: add sucrose into water to dissolve, heat to 65°C, and set aside;

[0089] (2) Preparation of the oil phase: heat refined soybean oil to 65°C, add phosphatidylcholine (PC-98T) and egg yolk phosphatidylglycerol (EPG, Shanghai Everett) to dissolve, add alprostadil, and stir to make its dissolution;

[0090] (3) Preparation of colostrum: add the oil phase of step (2) to the water phase of step (1), at a temperature of 65°C, high-speed shear dispersion, shear speed of 10,000 rpm, and time of 15 minutes, to form colostrum.

[0091] (4) High-pressure homogenization: adjust the pH of the colostrum in step (3) to 7.2, and high-pressure homogenize 3 times with a microfluidizer at a pressure of 1000-1200 bar;

[0092] (5) Preliminary filtration: Prefilter the refined milk in step (4) through a 0.45 μm filter membrane;

[0093] (6) Sterile filtration: the emulsion obtained in step (...

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Abstract

An alprostadil lipid emulsion for injection and a preparation method therefor. The lipid emulsion contains alprostadil, phosphatidylcholine, phosphatidylglycerol, oil for injection and a lyophilized protective agent. Based on 1 part by weight of the alprostadil, the content of the phosphatidylcholine is 1200 to 4000 parts by weight, the content of the phosphatidylglycerol is 12 to 120 parts by weight, the content of the oil for injection is 2000 to 20000 parts by weight, and the content of the lyophilized protective agent is 16000 to 60000 parts by weight.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a freeze-dried preparation of alprostadil fat emulsion. Background technique [0002] Alprostadil injection was first listed in Japan, using fat emulsion drug loading technology, composed of drug, soybean oil, refined egg yolk lecithin, oleic acid, glycerin and pH regulator, and its preparation method is to dissolve the drug in fatty oil Among them, fine lecithin is used as emulsifier, oleic acid is used as auxiliary emulsifier, O / W type drug-loaded fat emulsion is prepared by high pressure homogenization, and the average particle size of the emulsion is 200nm. Alprostadil injection adopts the drug-loading method of fat emulsion, and the drug is encapsulated in the oil phase, which greatly reduces the occurrence of irritation. It has the following advantages: (1) Targeting: It has a higher affinity to the blood vessel wall of the inflammatory site, can deposit on the w...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K9/107A61K31/5575A61K47/24
CPCA61K9/107A61K9/19A61K31/5575A61K47/24
Inventor 不公告发明人
Owner 内蒙古多肽科技有限公司
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