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Esmolol fat emulsion and preparation method thereof

A fat emulsion and emulsifier technology, applied in the directions of oil/fat/wax inactive ingredients, pharmaceutical formulations, emulsion delivery, etc., can solve problems such as edema, skin necrosis, skin discoloration, etc., to improve redness, reduce irritation, Reduce irritating effects

Inactive Publication Date: 2015-04-01
BEIJING JINGKE TAILAI TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, during the infusion of these preparations, about 8% of patients developed inflammation and induration at the injection site, and less than 1% of patients developed injection site edema, erythema, skin discoloration, burning, and exudative skin necrosis

Method used

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  • Esmolol fat emulsion and preparation method thereof
  • Esmolol fat emulsion and preparation method thereof
  • Esmolol fat emulsion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] prescription:

[0031]

[0032] Preparation Process:

[0033] (1) Take water for injection and heat it to 70°C as the water phase;

[0034] (2) Take soybean oil, heat it to 70°C, add esmolol and egg yolk lecithin (PL-100M), stir and dissolve, and use it as the oil phase;

[0035] (3) Slowly inject the oil phase into the water phase kept at 70°C under high-speed stirring conditions, high-speed shearing, the shearing speed is 10000 rpm, and the shearing time is 15 minutes, so that uniform colostrum is formed;

[0036] (4) Adjust the pH value of the colostrum to 4.5-8.5, and add water for injection to 100ml;

[0037] (5) Transfer the colostrum to a high-pressure homogenizer with a pressure of 1000 bar and circulate 3 times to obtain esmolol fat emulsion.

Embodiment 2

[0039] prescription:

[0040]

[0041] Preparation Process:

[0042] (1) Take water for injection, add glycerin, and heat to 60°C as the water phase;

[0043] (2) Take soybean oil and medium-chain triglycerides, heat to 60°C, add esmolol, egg yolk lecithin (PL-100M), and egg yolk phosphatidylglycerol (EPG), stir to dissolve, and use it as the oil phase;

[0044] (3) Inject the oil phase into the water phase kept at 60°C under high-speed stirring conditions, high-speed shearing, the shearing speed is 12000rpm, and the shearing time is 10min, so that uniform colostrum is formed;

[0045] (4) Adjust the pH value of the colostrum to 4.5-8.5, and add water for injection to 100ml;

[0046] (5) Transfer the colostrum to a high-pressure homogenizer with a pressure of 1000 bar and cycle 10 times to obtain essence milk;

[0047] (6) potting to obtain esmolol fat emulsion injection.

Embodiment 3

[0049] prescription:

[0050]

[0051] Preparation Process:

[0052] (1) Take water for injection, heat it to 60°C, add glycerin to dissolve it, and use it as the water phase;

[0053] (2) Take olive oil and soybean oil, heat to 60°C, add esmolol, phosphatidylcholine (PC-98T), oleic acid, stir to dissolve, and use it as the oil phase;

[0054] (3) Inject the oil phase into the water phase kept at 60°C under high-speed stirring conditions, high-speed shearing, the shearing speed is 15000 rpm, and the shearing time is 12 minutes, so that uniform colostrum is formed;

[0055] (4) Adjust the pH value of the colostrum to 4.5-8.5, and add water for injection to 100ml;

[0056] (5) Transfer the colostrum to a high-pressure homogenizer with a pressure of 800 bar and cycle 12 times to obtain essence milk;

[0057] (6) potting to obtain esmolol fat emulsion injection.

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Abstract

The invention relates to an esmolol fat emulsion and a preparation method thereof; the esmolol fat emulsion contains esmolol, oil for injection, an emulsifier and water for injection, wherein the percentage by volume of the esmolol is 0.3-3%, preferably 0.5-1.5%, more preferably 0.8-1.2%; the percentage by volume of the oil for injection is 5-20%, preferably 10%; and the percentage by volume of the emulsifier is 0.5-3%, preferably 1-2%, more preferably 1.2-1.8%. According to the invention, the stability problem of drugs is solved; the intravenous administration irritation is reduced; and the drug use safety is increased.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an esmolol fat emulsion and a preparation method thereof. Background technique [0002] Today, coronary heart disease, hypertension, heart failure, and arrhythmia have become the four major cardiovascular diseases with high incidence and great harm. Few drugs have important therapeutic effects on these four diseases at the same time, and β receptors Blockers deservedly so. As a safe, ultra-short-acting, and highly selective beta-blocker, esmolol has been in clinical use for thirty years. In 1987, esmolol was listed in the U.S. for the first time (Brevibloc, Baxter Company), and was listed as (I A) class recommended drug by the U.S. FDA. In 1996, Qilu Pharmaceutical was approved to produce the drug (trade name: Ailuo) for the first time in my country. It is mainly used for the prevention and treatment of tachycardia or hypertension caused by perioperative period, sinus...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/216A61K47/44A61K47/34A61K47/14A61P9/06A61P9/12
Inventor 马海波李胜强其他发明人请求不公开姓名
Owner BEIJING JINGKE TAILAI TECH
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