Alprostadil freeze-drying cream and preparation method thereof

A technology of alprostadil and freeze-dried milk, which is applied in the direction of freeze-dried transportation, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of widening particle size distribution, improve stability and increase operability Effect

Active Publication Date: 2014-12-03
BEIJING LANDAN PHARMA TECH
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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 and provide a kind of alprostadil freeze-dried milk with good safety and stability, which not only improves the product stability, but also solves the problem of particle size distribution change after freeze-drying. Wide range of problems, to ensure that the key indicators (such as particle size) of the product after reconstitution are basically the same as those before freeze-drying, so as to ensure the equivalent clinical use

Method used

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  • Alprostadil freeze-drying cream and preparation method thereof
  • Alprostadil freeze-drying cream and preparation method thereof
  • Alprostadil freeze-drying cream and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] prescription:

[0039]

[0040] Process:

[0041] (1) Preparation of the water phase: add sucrose and glycerin into water to dissolve, heat to 65°C, and set aside;

[0042] (2) Preparation of the oil phase: heat the refined soybean oil to 65°C, add phosphatidylcholine (PC-98T, Shanghai Everite) and dissolve phosphatidylinositol respectively, add alprostadil, and stir to dissolve;

[0043] (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

[0044] (4) High-pressure homogenization: adjust the pH of the colostrum in step (3) to 5.0-7.0, and then homogenize it through a microfluidizer for 3 times at a pressure of 1000-1200 bar;

[0045] (5) Preliminary filtration: Prefilter the refined milk in step (4) through a 0.45 μm filter membrane;

[0046] (6) Sterile filtration: the emulsion obtained in step (5) ...

Embodiment 2

[0074] prescription:

[0075]

[0076]

[0077] Process:

[0078] (1) Preparation of water phase: add sucrose into water to dissolve, heat to 65°C, and set aside;

[0079] (2) Preparation of the oil phase: heat the refined soybean oil to 65°C, add phosphatidylcholine (PC-98T, Shanghai Everite) and dissolve phosphatidylinositol respectively, add alprostadil, and stir to dissolve;

[0080] (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

[0081] (4) High-pressure homogenization: adjust the pH of the colostrum in step (3) to 5.0-7.0 with sodium hydroxide, and then use a microfluidizer for high-pressure homogenization 3 times at a pressure of 1000-1200 bar;

[0082] (5) Preliminary filtration: Prefilter the refined milk in step (4) through a 0.45 μm filter membrane;

[0083] (6) Sterile filtration: the em...

Embodiment 3

[0098] prescription:

[0099]

[0100] Process:

[0101] (1) Preparation of water phase: add sucrose into water to dissolve, heat to 65°C, and set aside;

[0102] (2) Preparation of oil phase: heat refined soybean oil to 65°C, add phosphatidylcholine (PC-98T) and phosphatidylinositol (PI) to dissolve respectively, add alprostadil, stir to dissolve;

[0103] (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

[0104] (4) High-pressure homogenization: adjust the pH of the colostrum in step (3) to 5.0-7.0, and homogenize it through a microfluidizer for 3 times at a pressure of 1000-1200bar:

[0105] (5) Preliminary filtration: Prefilter the refined milk in step (4) through a 0.45 μm filter membrane;

[0106] (6) Sterile filtration: the emulsion obtained in step (5) is sterilized by filtration through a 0.22 μm...

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Abstract

The invention discloses alprostadil freeze-drying cream which comprises the following components in parts by weight: 1 part of alprostadil, 2000-20000 parts of injection oil, 400-4000 parts of phosphatidylcholine as emulsifier, 12-120 parts of phosphatidylinositol as phosphatidyl glycerol, and 6000-60000 parts of freeze-drying protecting agent. A prepared product is good in quality stability, the encapsulation efficiency is improved, and a cream grain is not remarkably changed before and after freeze-drying.

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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IPC IPC(8): A61K9/19A61K31/5575A61K47/24
Inventor 不公告发明人
Owner BEIJING LANDAN PHARMA TECH
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