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Cleviprex fat emulsion concentrated solution, preparation method and application thereof

A technology of clevidipine butyrate and fat emulsion, which can be used in emulsion delivery, cardiovascular system diseases, drug combination and other directions, and can solve problems such as hidden dangers of drug safety

Inactive Publication Date: 2015-06-17
天津迈迪瑞康生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Such preparations cannot be tested for clarity, and clarity testing is a must-test item for injections, which brings hidden dangers to drug safety.
Also, existing fat emulsions require specialized equipment to sterilize under high pressure

Method used

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  • Cleviprex fat emulsion concentrated solution, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0163] Embodiment 1: Preparation of clevidipine butyrate fat emulsion concentrate sample 1

[0164] Its composition is as follows:

[0165] Clevidipine Butyrate 0.35g

[0166] soybean oil 5 grams

[0167] Medium Chain Fatty Acid Triglycerides (Crodamol GTCC) 65g

[0168] 1, 2-Propanediol 8.5g

[0169] Soy lecithin (Epikuron 170, Degussa) 8 grams

[0170] Tween 80 4.3 g

[0171] Polyethylene glycol lauryl hydroxystearate (Solutol HS 15, BASF) 8.5 g

[0172] Vitamin E 0.35g

[0173] The preparation method of this clevidipine butyrate fat emulsion concentrate is as follows:

[0174] 1) At 45°C, mix the above-mentioned weight of soybean lecithin, soybean oil and medium-chain fatty acid triglycerides, and stir at 8000rpm until a transparent and clear solution is formed;

[0175] 2) At 20°C, add the above weight of clevidipine butyrate to the product of 1), and keep stirring at 200rpm until the whole system is transparent and clear;

[0176] 3) At 25°C, add the above-m...

Embodiment 2

[0178] Embodiment 2: Preparation of clevidipine butyrate fat emulsion concentrate sample 2

[0179] Its composition is as follows:

[0180] Clevidipine Butyrate 0.25g

[0181] 30.5g soybean oil

[0182] Glyceryl caprylate (Miglyol 812, SASOL) 30.5g

[0183] 1, 2-Propanediol 7.3g

[0184] Soy Lecithin (Epikuron 170, Degussa) 11.5g

[0185] Polyglyceryl Oleate 4g

[0186] Polyethylene glycol lauryl hydroxystearate (Solutol HS 15, BASF) 11.5 g

[0187] Tween 80 4g

[0188] Vitamin E 0.3g

[0189] Oleic acid 0.15g

[0190] The preparation method of this clevidipine butyrate fat emulsion concentrate is as follows:

[0191] 1) At 20°C, mix the above-mentioned weight of soybean lecithin, polyglycerol oleate, caprylic capric glyceride and soybean oil, and stir at 20,000 rpm until a transparent and clear solution is formed;

[0192] 2) At 45°C, add the above weight of clevidipine butyrate to the product of 1), and keep stirring at 1000rpm until the whole system is trans...

Embodiment 3

[0195] Embodiment 3: Preparation of clevidipine butyrate fat emulsion concentrate sample 3

[0196] Its composition is as follows:

[0197] Clevidipine Butyrate 0.3g

[0198] soybean oil 50g

[0199] 1,2-Propanediol 9.5g

[0200] Soy Lecithin (Epikuron 170, Degussa) 12.5g

[0201] Polyglyceryl Oleate 3 g

[0202] Polyethylene glycol lauryl hydroxystearate (Solutol HS 15, BASF) 13.5 g

[0203] Tween 80 10.5g

[0204] Vitamin E 0.35g

[0205] Oleic acid 0.35g

[0206] The preparation method of this clevidipine butyrate fat emulsion concentrate is as follows:

[0207] 1) At 25°C, mix the above-mentioned weight of soybean lecithin, polyglycerol oleate and soybean oil, and stir at 2000rpm until a transparent and clear solution is formed;

[0208] 2) At 30°C, add the above weight of clevidipine butyrate to the product of 1), and keep stirring at 2000rpm until the whole system is transparent and clear;

[0209] 3) At 20°C, add the above-mentioned weight of 1,2-propane...

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Abstract

A cleviprex fat emulsion concentrated solution, a preparation method and an application thereof belong to the field of pharmacology and pharmaceutics. According to the invention, the defect that a traditional fat emulsion preparation technology is complex and stability is poor is overcome. The preparation technology provided by the invention is simple; the general physical stirring process is only needed; and no homogenization technology is required. A product prepared in the invention can be sterilized through a 0.22-micron microfiltration membrane; in clinical use, the product can be spontaneously emulsified after diluted by the use of an aqueous solution such as normal saline or a glucose solution, etc. and slightly oscillated; and under optimized conditions, average particle size is about 0.2 micron, and injection fat emulsion characteristics are fully embodied. The product has good fluidity, will not be retained on the wall, is single-phase, transparent and clear in appearance, can undergo clarification detection and will not cause preparation stratification after multigelation. The product is used in blood pressure control during surgical operation and control of acute blood pressure elevation after operation, and also can be used in controlling blood pressure of hypertensives who are not suitable for oral administration or fail in oral administration.

Description

Technical field [0001] The present invention is a field of pharmacy and pharmaceuticals, involving a chlorine -butyl -flat fat concentration solution, its preparation methods and uses. Background technique [0002] Clevidipine Butyrate is the third -generation new short -acting dihydrine calcium calcium channel antagonist developed by the British Astrazneca company. It was first listed in the United States in August 2008. The product name Cleviprex?, Is the firstIntravenous injection is blocked with dihydrial hydrogen pyrine calcium channels.CLEVIPREX? It is an injection emulsion, with fast effect and fast effects, and can accurately control blood pressure in the incremental dose.Different from the current intravenous injection of anti -hypertension drugs that have renoma and (or) liver metabolism, they are metabolized in blood and tissue, so they are not accumulated in the body.Banadicate, as a new type of intravenous injection, anti -hypertension drugs represent a major progres...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/4422A61P9/12
Inventor 杨杰其他发明人请求不公开姓名
Owner 天津迈迪瑞康生物医药科技有限公司
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