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Etomidate pharmaceutical composition and preparation method thereof

A technology of etomidate and composition, which is applied in the field of etomidate pharmaceutical composition and its preparation, can solve problems such as the increase of emulsion particle size, achieve increased stability, reduce the amount of impurity etomidate, and reduce safety hidden effect

Active Publication Date: 2015-05-27
BEIJING LANDAN PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, the present invention solves the problem of etomidate stability by the type and proportioning of the components in the phospholipid, and solves the problem that the emulsion particle size increases

Method used

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  • Etomidate pharmaceutical composition and preparation method thereof
  • Etomidate pharmaceutical composition and preparation method thereof
  • Etomidate pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028]

[0029] The content of phosphatidylcholine in phospholipids is 75%, the content of phosphatidylethanolamine is 18%, and it does not contain phosphatidylglycerol.

[0030] Process steps:

[0031] (1) Take water for injection, heat it to 65°C, add glycerin to dissolve it, and use it as the water phase;

[0032] (2) Take soybean oil, heat it to 65°C, add phospholipid and etomidate, stir and dissolve, and use it as the oil phase;

[0033] (3) Under high-speed stirring, slowly inject the oil phase into the water phase kept at 65°C, and shear at 10,000 rpm for 10 minutes to form uniform colostrum;

[0034] (4) Adjust the pH value of the colostrum to 7.4-7.6, and add water for injection to the full amount;

[0035] (5) Transfer the colostrum to a high pressure homogenizer for emulsification, the homogenization pressure is 1200bar, 3 cycles;

[0036] (6) Filtration: the essence milk is filtered through a 0.45 μm microporous membrane, and potted to obtain etomidate inject...

Embodiment 2

[0039]

[0040]

[0041] The content of phosphatidylcholine in phospholipids is 75%, the content of phosphatidylethanolamine is 15%, and it does not contain phosphatidylglycerol.

[0042] Process steps:

[0043] (1) Take water for injection, heat it to 65°C, add glycerin to dissolve it, and use it as the water phase;

[0044] (2) Take soybean oil, heat it to 65°C, add emulsifier and etomidate, stir and dissolve, and use it as the oil phase;

[0045] (3) Under high-speed stirring, slowly inject the oil phase into the water phase kept at 65°C, and shear at 10,000 rpm for 10 minutes to form uniform colostrum;

[0046] (4) Adjust the pH value of the colostrum to 7.4-7.6, and add water for injection to the full amount;

[0047] (5) Transfer the colostrum to a high pressure homogenizer for emulsification, the homogenization pressure is 1200bar, 3 cycles;

[0048] (6) Filtration: the essence milk is filtered through a 0.45 μm microporous membrane, and potted to obtain etomid...

Embodiment 3

[0051]

[0052] The content of phosphatidylcholine in phospholipids is 75%, the content of phosphatidylethanolamine is 10%, and it does not contain phosphatidylglycerol.

[0053] Process steps:

[0054] (1) Take water for injection, heat it to 65°C, add glycerin to dissolve it, and use it as the water phase;

[0055] (2) Take soybean oil, heat it to 65°C, add emulsifier and etomidate, stir and dissolve, and use it as the oil phase;

[0056] (3) Under high-speed stirring, slowly inject the oil phase into the water phase kept at 65°C, and shear at 10,000 rpm for 10 minutes to form uniform colostrum;

[0057] (4) Adjust the pH value of the colostrum to 7.4-7.6, and add water for injection to the full amount;

[0058] (5) Transfer the colostrum to a high pressure homogenizer for emulsification, the homogenization pressure is 1200bar, 3 cycles;

[0059] (6) Filtration: the essence milk is filtered through a 0.45 μm microporous membrane, and potted to obtain etomidate injectio...

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Abstract

The invention relates to an etomidate pharmaceutical composition, which comprises the following raw materials in parts by weight: 1 part of etomidate, 50-100 parts of injection oil, 3-9 parts of phospholipid and 250-1,000 parts of injection water, wherein the content of phosphatidylcholine in the phospholipid is greater than or equal to 75% (w / w); and the content of phosphatidyl ethanolamine is smaller than or equal to 15 (w / w). The etomidate pharmaceutical composition provided by the invention has relatively high stability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an etomidate pharmaceutical composition and a preparation method thereof. Background technique [0002] Etomidate [R(+)-1-(1-phenylethyl)-1hydro-imidazole-5-carboxylate ethyl ester] is a unique general anesthesia inducer and sedative, and its safety is significantly higher than that of barbaric Bitrates. The therapeutic index of etomidate R was significantly higher than that of other general anesthetics. Preclinical animal studies have also shown that injection of etomidate causes only minimal hemodynamic changes and respiratory depression. Etomidate has a large safety limit, wakes up quickly and safely, has no obvious inhibition on breathing, has no memory of the operation, and has a stable cardiovascular system. It is especially suitable for the elderly, frail, low blood volume, and patients with cardiovascular diseases. [0003] [0004] There are mainly two do...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/4174A61K47/24A61P23/00A61P25/20
Inventor 不公告发明人
Owner BEIJING LANDAN PHARMA TECH
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