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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 the problems of lack of practicability and unsatisfactory product quality, and achieves enhancement of aseptic control process and improvement of aseptic assurance level and production efficiency, the effect of high sterility assurance level

Active Publication Date: 2014-08-20
ZHEJIANG SUNDOC PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN102038639 A 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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  • Alprostadil lipid microsphere injection and preparation method thereof
  • Alprostadil lipid microsphere injection and preparation method thereof
  • Alprostadil lipid microsphere injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

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

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

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

[0030] (5) After filling the prepared emulsion with nitrogen, filling, stoppering, and capping, put it in a rotary water bath sterilization cabine...

Embodiment 2

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

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

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

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

[0036] (5) After filling the prepared emulsion with nitrogen, filling, stoppering, and capping, put it in a rotary water bath sterilization cabine...

Embodiment 3

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

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

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

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

[0042] (5) After filling the prepared emulsion with nitrogen, filling, stoppering, and capping, put it in a rotary water bath sterilization cabinet...

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Abstract

The invention provides an alprostadil lipid microsphere injection. The alprostadil lipid microsphere injection is prepared from alprostadil, oil for injection, lecithin for injection, a stabilizing agent, an osmotic pressure regulating agent, a metal complexing agent and injection water. According to the invention, the metal ion complexing agent is employed and exerts main component protection and adjuvant degradation effects; the pH value of the finished injection is controlled by adjusting the pH value of a water phase in advance, so inconvenience and potential quality hazards resulting from adjusting of the pH value of the finished injection in an initial or final emulsion phase after emulsion formation are prevented; unconventional high temperature instant sterilization is employed for sterilization of the finished injection. The preparation method for the alprostadil lipid microsphere injection is simplified, enhances aseptic control process of the injection, improves a sterility assurance level and production efficiency and avoids possibility of a too high pH value of a local part of the injection at an instant; and the prepared alprostadil lipid microsphere injection completely meet clinical needs and has the advantages of a few impurities, long shelf life and small adverse reaction.

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 si...

Claims

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Application Information

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