Alprostadil freeze-dried emulsion and its prepn. method

A technology of alprostadil and freeze-dried emulsion, which is applied in the field of alprostadil freeze-dried emulsion and its preparation, can solve the problems of high storage and transportation costs, poor stability of alprostadil injection, etc., to reduce transportation costs and improve stability , The effect of simple preparation process

Active Publication Date: 2007-01-31
上海万特医药科技(集团)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0017] The object of the present invention is to provide a kind of alprostadil freeze-dried emulsion and preparation method thereof, it can make drug content more controllable, and has improved the stability of drug and additive (adjuvant), not only provides safer and more stable and effective freeze-dried emulsion, and thoroughly solved the problems of poor stability of the prior art alprostadil injection and high cost of preservation and transportation

Method used

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preparation example Construction

[0058] The present invention, alprostadil freeze-dried emulsion and preparation method thereof comprise the following steps:

[0059] The first, decompose the emulsifier step; put into the oil for injection in proportion in the preparation tank, the emulsifier is dispersed in the oil for injection of an appropriate amount (the emulsifier can also be dispersed in the step 3 by an appropriate amount in the water phase);

[0060] The second, forming the oil phase step with alprostadil; adding an appropriate amount of alprostadil into the oil for injection with an emulsifier formed in step one and fully stirring and mixing to form an oil phase;

[0061] The third step is to prepare the water phase; add an appropriate amount of glycerin to an appropriate amount of water for injection, then fully stir and mix to form an aqueous phase; in the present invention, in order to fully dissolve glycerin in water for injection, when water for injection When the water temperature is 20-60°C,...

Embodiment 1

[0068] Embodiment 1 Feeding amount is as shown in table 1:

[0069] raw material

Standard feeding amount

Alprostadil (PGE 1 )

200mg

Ethanol (95)

10ml

Refined soybean oil

3kg

Refined egg yolk lecithin (YPL)

500g

Glycerin

600g

Oleic acid

50g

Mannitol

240g

human serum albumin

260g

Water for Injection

26L

[0070] The preparation process is as follows:

[0071] 1. In the preparation tank, mix the refined egg yolk lecithin, PGE1, ethanol and oleic acid in the oil tank, stir at 3000 rpm for 15 minutes, disperse glycerin in water for injection, mix the water phase and oil phase, 200 rpm / minute stirring 15min. Inject the high-pressure homogenizer (NS2006 high-pressure homogenizer of Niro Soavi S.p.A. company) through the infusion pump for emulsification, adjust the pH value to 5-6, pass through the homogenizer, and adjust the homogenization pressur...

Embodiment 2

[0074] Embodiment 2 Feeding amount is as shown in table 2:

[0075] raw material

Standard feeding amount

Alprostadil (PGE 1 )

200mg

Ethanol (95)

10ml

Refined soybean oil

3kg

Refined egg yolk lecithin (YPL)

560g

Glycerin

620g

Oleic acid

48g

Trehalose

250g

human serum albumin

198g

Water for Injection

26L

[0076] The preparation process is as follows:

[0077] 1. In the preparation tank, mix the refined egg yolk lecithin, PGE1, ethanol and oleic acid in the oil tank, stir at 3000 rpm for 15 minutes, disperse glycerin in water for injection, mix the water phase and oil phase, 200 rpm / minute stirring 15min. Inject the high-pressure homogenizer (NS2006 high-pressure homogenizer of Niro Soavi S.p.A. company) through the infusion pump for emulsification, adjust the pH value to 5-6, pass through the homogenizer, and adjust the homogenization pressu...

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Abstract

A freeze-dried emulsion of prostaglandin El contains proportionally prostaglandin El, the oil for injection, emulsifier, stabilizer, and freeze-drying protector. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a freeze-dried emulsion in the technical field of medicine and a preparation method thereof, in particular to an alprostadil freeze-dried emulsion and a preparation method thereof. Background technique [0002] With the development of molecular biology, people have carried out extensive and in-depth research on prostaglandins, and gradually clarified their biological activities, and have been widely used in clinical practice. They have achieved good curative effects in the treatment of many diseases. Among them, alprostadil (prostaglandin E 1 , PGE 1 ) is the more studied one. In 1960, Bergst rom first isolated and purified PGE in human body 1 , followed by revealing its molecular structure. [0003] PGE 1 It is an endogenous substance that is the oxidation product of the polyunsaturated fatty acid di-C linolenic acid (DGLA), which is a component of cell membrane phospholipids. Advances in basic research have prompted cli...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/5575A61K9/19A61K9/107A61P7/02A61P9/10A61P9/04A61P9/12A61P1/16A61P1/18A61P3/10
Inventor 项炜
Owner 上海万特医药科技(集团)有限公司
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