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Alpostadil freeze-dried emulsion and its preparing method

A technology of alprostadil and freeze-dried emulsion, which is applied in the field of medicine, can solve the problems of short validity period and instability of alprostadil, and achieve the effects of improved stability, controllable drug content, and simple production process

Inactive Publication Date: 2005-01-12
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] There are certain shortcomings in the existing alprostadil injection: alprostadil is very unstable in water, will degrade in the injection, and has a short validity period

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] 1) In the preparation equipment, 5 mg of alprostadil is dissolved in 1 ml of soybean oil for injection;

[0036] 2) Mix 0.2 g of soybean lecithin for injection with an appropriate amount of water for injection, and add 0.1 g of anhydrous sodium sulfite;

[0037] 3) Add 2) into 1) under the condition of stirring, and after stirring at 20° C., pass through a homogenizer to homogenize the solution repeatedly to obtain a uniform solution. Prepare 1000ml of liquid medicine;

[0038] 4) adding 4% mannitol as a freeze-drying protectant, removing moisture through freeze-drying to obtain dry alprostadil freeze-dried emulsion;

[0039] 5) Add water to the prepared freeze-dried emulsion according to the required amount, hydrate and shake, and restore to emulsion.

Embodiment 2

[0041] 1) In the preparation equipment, dissolve 20 mg of alprostadil in 10 ml of tea oil for injection;

[0042] 2) Mix 5 g of egg yolk lecithin for injection with an appropriate amount of water for injection, and add 0.1 g of ethylparaben;

[0043] 3) Add 1) to 2) under the condition of stirring, and after stirring at 40° C., pass through a homogenizer to homogenize the solution repeatedly to obtain a uniform solution. Prepare 2000ml of liquid medicine;

[0044] 4) adding 5% glucose and 2% mannitol as a freeze-drying protective agent, removing moisture through freeze-drying to obtain dry alprostadil freeze-dried emulsion;

[0045] 5) Add water to the prepared freeze-dried emulsion according to the required amount, hydrate and shake, and restore to emulsion.

Embodiment 3

[0047] 1) in the preparation equipment, dissolve alprostadil 400mg in 50ml olive oil for injection;

[0048] 2) Mix 10 g of poloxamer with an appropriate amount of water for injection, and add 1 g of ethylparaben;

[0049] 3) Add 2) into 1) under the condition of stirring, and after stirring at 60° C., pass through a homogenizer to homogenize the solution repeatedly to obtain a uniform solution. Prepare 5000ml of liquid medicine;

[0050] 4) adding 40% sucrose as a freeze-drying protective agent, removing moisture through freeze-drying to obtain dry alprostadil freeze-dried emulsion;

[0051] 5) Add water to the prepared freeze-dried emulsion according to the required amount, hydrate and shake, and restore to emulsion.

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Abstract

A freeze-dried emulsion of prostaglandin E1 is prepared from prostaglandin E1, the oil for injection, stabilizer, emulsifier, pH regulator, freeze-drying protector and the waer for injection. Its preparing process is also disclosed.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to an alprostadil freeze-dried emulsion and a preparation method thereof. Background technique: [0002] Alprostadil inhibits platelet aggregation, thromboxane A 2 Generation, atherosclerotic plaque formation and the role of immune complexes, and can expand peripheral and coronary vessels. This product is exogenous alprostadil E 1 (PGE 1 ), is a vasodilator and inhibitor of platelet aggregation. PGE 1 By activating intracellular adenylate cyclase, the level of cyclic adenosine monophosphate (cAMP) in platelets and vascular smooth muscle is doubled, resulting in the production of inert platelets and vasodilation. After the patients were injected with this product, the in vitro platelet experiments showed low response to general inducers. The drug is white needle-like crystal, easily soluble in ethanol, slightly soluble in water, and dissolved in phosphate buffer solution with...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/5575A61P7/02
Inventor 邓意辉雷杰杰郑少辉赵妍吴琼王绍宁
Owner SHENYANG PHARMA UNIVERSITY
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