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Clevidipine butyrate freeze-dried emulsion

A technology of clevidipine butyrate and freeze-dried emulsion, which is applied in the field of clevidipine butyrate freeze-dried emulsion, can solve the problems of particle aggregation increase, harm, fat emulsion instability, etc., and achieve low toxic and side effects, high curative effect, good stability effect

Inactive Publication Date: 2013-06-26
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is always the problem of fat emulsion instability in various methods. Long-term storage or temperature changes can cause particles to aggregate and increase, produce some unknown toxic or irritating substances, and even demulsify oil slicks, etc., posing potential hazards

Method used

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  • Clevidipine butyrate freeze-dried emulsion
  • Clevidipine butyrate freeze-dried emulsion
  • Clevidipine butyrate freeze-dried emulsion

Examples

Experimental program
Comparison scheme
Effect test

preparation Embodiment 1

[0036] prescription:

[0037]

[0038] Preparation:

[0039] Add glycerin, poloxamer, dextran, and calcium sodium edetate into 300ml of water for injection, dissolve, add sodium hydroxide to adjust the pH to 6.0-7.0, boil for 15 minutes, fill with nitrogen, cool and keep warm to 50°C.

[0040] Heat soybean oil for injection to 60°C, dissolve lecithin and clevidipine butyrate in soybean oil for injection under high shear at 7000rpm, keep warm at 50°C, and continuously fill with nitrogen during the preparation of the oil phase.

[0041] The water phase and the oil phase were sheared and mixed evenly, supplemented with water for injection to the formula quantity, and the high-pressure homogenization pressure was 700 bar, and homogenized until a fat emulsion with a particle size of less than 220nm was obtained.

[0042] Pass the above-mentioned fat emulsion through a 0.22 μm filter, filter and sterilize, fill in vials, place the filled and semi-stoppered semi-finished product ...

preparation Embodiment 2

[0044] prescription:

[0045]

[0046]

[0047] Preparation:

[0048] Add glycerin, sodium oleate, and sodium bisulfite to 300ml of water for injection, dissolve, add sodium hydroxide to adjust the pH to 8.0-9.0, boil for 15 minutes, fill with nitrogen, cool and keep warm to 55°C.

[0049] Heat soybean oil and medium-chain triglycerides for injection to 60°C, dissolve cholesterol and clevidipine butyrate in soybean oil and medium-chain triglycerides for injection under high shear at 8000rpm, and keep warm at 50°C , continuous nitrogen filling during oil phase preparation.

[0050] The water phase and the oil phase were sheared and mixed evenly, supplemented with water for injection to the formula amount, and the pressure of high-pressure homogenization was 600 bar, and homogenized until a fat emulsion with a particle size of less than 220nm was obtained, and lactose was added and stirred to dissolve.

[0051] Pass the above-mentioned fat emulsion through a 0.22 μm filt...

preparation Embodiment 3

[0053] prescription:

[0054]

[0055]

[0056] Preparation:

[0057]Add glycerin, poloxamer, mannitol, and vitamin C into 300ml of water for injection, dissolve, add sodium hydroxide to adjust the pH to 6.0-7.0, boil for 15 minutes, fill with nitrogen, cool and keep warm to 50°C.

[0058] Heat soybean oil for injection to 60°C, dissolve lecithin and clevidipine butyrate in soybean oil for injection under high shear at 7000rpm, keep warm at 50°C, and continuously fill with nitrogen during the preparation of the oil phase.

[0059] The water phase and the oil phase were sheared and mixed evenly, supplemented with water for injection to the formula quantity, and the high-pressure homogenization pressure was 700 bar, and homogenized until a fat emulsion with a particle size of less than 220nm was obtained.

[0060] Pass the above-mentioned fat emulsion through a 0.22 μm filter, filter and sterilize, fill in vials, place the filled and semi-stoppered semi-finished product o...

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Abstract

The invention discloses a clevidipine butyrate freeze-dried emulsion, and belongs to the field of a pharmaceutical preparation. The freeze-dried emulsion is prepared from clevidipine butyrate, glycerol, an acidity regulator, a stabilizing agent, a freeze-drying protecting agent, injection oil, a water-phase surfactant and an oil-phase surfactant. The clevidipine butyrate freeze-dried emulsion disclosed by the invention is free from high-temperature sterilization, and is under a dry state in the storage process; compared with other clevidipine butyrate dosage forms, the clevidipine butyrate freeze-dried emulsion has characteristics of good stability, low toxic and side effects, good curative effect, and the like, and is better applicable to critical injection; and the emulsion has great popularization and application values.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a clevidipine butyrate freeze-dried emulsion. Background technique [0002] According to epidemiological data, there are 200 million hypertensive patients in my country. Hypertension is a common disease with a very high prevalence rate. At present, there is no effective way to cure it. endanger people's living standards and health. [0003] Among all kinds of antihypertensive drugs, calcium antagonists account for more than 40% of the market, ranking first. Calcium antagonists can be used for various degrees of hypertension, especially for elderly patients with hypertension or complicated with stable angina. Clevidipine butyrate is a third-generation novel short-acting dihydropyridine calcium channel antagonist developed by AstraZeneca in the United Kingdom. It was first launched in the United States in August 2008 under the trade name Cleviprex. Common name: clevidip...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/107A61K31/4422A61P9/12
Inventor 李明丽孙峰京刘婷卢秀莲
Owner CISEN PHARMA
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