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A kind of alprostadil lipid microsphere injection and preparation method thereof

A technology for alprostadil and injection, which is applied in the field of alprostadil lipid microsphere injection and its preparation, can solve problems such as lack of practicability and unsatisfactory product quality, and achieves enhancement of aseptic control process and improvement of aseptic assurance level and the effect of increasing productivity and stability

Active Publication Date: 2016-02-24
ZHEJIANG SUNDOC PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN102038639A A kind of alprostadil injection preparation 121 DEG C circulation steam sterilization 15 minutes, the result proves, the longer the time, the more alprostadil degrades, does not have practicability, and product quality can not meet current national drug standard WS1-(X- 041) 2002Z-2008

Method used

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  • A kind of alprostadil lipid microsphere injection and preparation method thereof
  • A kind of alprostadil lipid microsphere injection and preparation method thereof
  • A kind of alprostadil lipid microsphere injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] (1) Weigh 7mg of alprostadil, 18g of egg yolk lecithin, 2.4g of oleic acid and 100g of soybean oil into a container, use a high-speed shearing machine to disperse until dissolved to form an oil phase, and heat to 50-70°C for later use;

[0027] (2) Weigh 0.01g of edetate disodium, 22.1g of glycerin and 850g of water for injection into the container. After fully dissolving, adjust the pH value of the water phase to 9.0 with sodium hydroxide solution, and heat to 50-70°C for later use;

[0028] (3) Under the protection of nitrogen, slowly add the oil phase into the water phase under the action of a high-speed shearing machine, the shearing speed is 10000rpm, and the shearing time is 3min to form colostrum;

[0029] (4) Emulsify the prepared colostrum with a high-pressure microfluidizer, the emulsification pressure is 5000-18000psi, and the number of emulsification cycles is 3-8 times;

[0030] (5) Fill the prepared emulsion with nitrogen, fill it, stopper it, and cap it, pu...

Embodiment 2

[0032] (1) Weigh 7mg of alprostadil, 18g of egg yolk lecithin, 2.4g of oleic acid and 100g of soybean oil into a container, use a high-speed shearing machine to disperse until dissolved to form an oil phase, and heat to 50-70°C for later use;

[0033] (2) Weigh 0.05g of edetate disodium, 22.1g of glycerin and 850g of water for injection into the container. After fully dissolving, adjust the pH value of the water phase to 9.0 with sodium hydroxide solution, and heat to 50-70°C for later use;

[0034] (3) Under the protection of nitrogen, slowly add the oil phase into the water phase under the action of a high-speed shearing machine, the shearing speed is 10000rpm, and the shearing time is 3min to form colostrum;

[0035] (4) Emulsify the prepared colostrum with a high-pressure microfluidizer, the emulsification pressure is 5000-18000psi, and the number of emulsification cycles is 3-8 times;

[0036] (5) Fill the prepared emulsion with nitrogen, fill it, stopper it, and cap it, ...

Embodiment 3

[0038] (1) Weigh 7mg of alprostadil, 18g of egg yolk lecithin, 2.4g of oleic acid and 100g of soybean oil into a container, use a high-speed shearing machine to disperse until dissolved to form an oil phase, and heat to 50-70°C for later use;

[0039] (2) Weigh 0.2g of edetate disodium, 22.1g of glycerin and 850g of water for injection into the container. After fully dissolving, adjust the pH value of the water phase to 9.0 with sodium hydroxide solution, and heat to 50-70°C for later use;

[0040] (3) Under the protection of nitrogen, slowly add the oil phase into the water phase under the action of a high-speed shearing machine, the shearing speed is 10000rpm, and the shearing time is 3min to form colostrum;

[0041] (4) Emulsify the prepared colostrum with a high-pressure microfluidizer, the emulsification pressure is 5000-18000psi, and the number of emulsification cycles is 3-8 times;

[0042] (5) Fill the prepared emulsion with nitrogen, fill it, stopper it, and cap it, p...

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Abstract

The invention provides an alprostadil lipid microsphere injection, which is prepared from alprostadil, oil for injection, lecithin for injection, stabilizer, osmotic pressure regulator, metal complexing agent and water for injection. The present invention uses a metal ion complexing agent to protect the main components and auxiliary materials from degradation, and uses a method of pre-adjusting the pH of the water phase to achieve the purpose of controlling the pH of the final preparation, avoiding adjustments in the stage of colostrum or final milk after milk formation. Inconvenience and quality hazards caused by the pH of the preparation, the final preparation is terminally sterilized using a high-temperature, short-time non-conventional sterilization method. The method of the invention simplifies the process, enhances the aseptic control process of the preparation, improves the sterility assurance level and production efficiency, avoids the possibility of the local pH of the preparation being too high instantaneously, fully meets the clinical needs, and is a kind of preparation with less impurities, long validity period and small adverse reactions. preparations.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a safe and stable alprostadil lipid microsphere injection and a preparation method thereof. Background technique [0002] Alprostadil, also known as prostaglandin E1 (PGE1), belongs to natural prostaglandin analogues. It is an endogenous physiologically active substance with strong activity. academic effect and rapidly inactivated. As a vasodilator and inhibitor of platelet aggregation, PGE1 doubles the level of cyclic adenosine monophosphate (CAMP) in platelets and vascular smooth muscle by activating intracellular adenylate cyclase, resulting in the production of inert platelets and vasodilation . Clinically, alprostadil is mainly used to improve cardiovascular and cerebrovascular microcirculation disorders and treat chronic arterial occlusive disease. [0003] The traditional dosage form of alprostadil is freeze-dried powder injection, and its main sid...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K31/5575A61K47/18
Inventor 黄惠锋
Owner ZHEJIANG SUNDOC PHARMA SCI & TECH CO LTD
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