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Clevidipine butyrate medium-length chain fat emulsion and preparation method thereof

A technology of clevidipine butyrate and medium-long chain, which is applied in the direction of non-active ingredients of oil/fat/wax, pharmaceutical formula, emulsion delivery, etc.

Inactive Publication Date: 2011-04-06
辽宁中海康生物制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] At present, there is no long-chain triglyceride and medium-chain triglyceride combined in clevidipine butyrate fat emulsion.

Method used

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  • Clevidipine butyrate medium-length chain fat emulsion and preparation method thereof
  • Clevidipine butyrate medium-length chain fat emulsion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] prescription

[0030] Clevidipine Butyrate 0.5g

[0031] Refined soybean oil 200g

[0032] Egg yolk lecithin 12g

[0033] Glycerin 22.5g

[0034] Appropriate amount of sodium hydroxide

[0035]

[0036] Add water for injection to 1000ml

[0037] Process:

[0038] (1) Preparation of water phase: add glycerin to water to dissolve, heat to 75°C, and set aside;

[0039] (2) Preparation of oil phase: heat refined soybean oil to 75°C, add egg yolk lecithin (with a phosphatidylcholine content of more than 80%) to dissolve, add clevidipine butyrate, and stir to dissolve;

[0040] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 75° C., high-speed shear dispersion, shear speed of 8000 rpm, and time of 15 minutes to form colostrum;

[0041] (4) Adjusting the pH value: rapidly cooling the colostrum in step (3) below 30°C, and adjusting the pH value to 6.0-8.0 with sodium hydr...

Embodiment 2

[0046] prescription

[0047] Clevidipine Butyrate 0.5g

[0048] Medium Chain Triglycerides 200g

[0049] Egg yolk lecithin 12g

[0050] Glycerin 22.5g

[0051] Appropriate amount of sodium hydroxide

[0052]

[0053] Add water for injection to 1000ml

[0054] Process:

[0055] (1) Preparation of water phase: add glycerin to water to dissolve, heat to 75°C, and set aside;

[0056] (2) Preparation of oil phase: heat refined soybean oil to 75°C, add egg yolk lecithin (with a phosphatidylcholine content of more than 80%) to dissolve, add clevidipine butyrate, and stir to dissolve;

[0057] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 75° C., high-speed shear dispersion, shear speed of 8000 rpm, and time of 15 minutes to form colostrum;

[0058] (4) pH value adjustment: quickly cool the colostrum in step (3) below 30°C, and adjust the pH value to 6.0~ with sodium hydroxide

...

Embodiment 3

[0063] prescription:

[0064] Clevidipine Butyrate 0.5g

[0065] Refined soybean oil 100g

[0066] Medium Chain Triglycerides 100g

[0067] Egg yolk lecithin 12g

[0068] Glycerin 22.5g

[0069] Appropriate amount of sodium hydroxide

[0070]

[0071] Add water for injection to 1000ml

[0072] Process:

[0073] (1) Preparation of water phase: add glycerin to water to dissolve, heat to 75°C, and set aside;

[0074] (2) Preparation of oil phase: heat refined soybean oil and medium-chain triglycerides to 75°C, add egg yolk lecithin (more than 80% phosphatidylcholine content) to dissolve, add clevidipine butyrate, and stir to make it dissolve;

[0075] (3) Preparation of colostrum: Add the oil phase of step (2) into the water phase of step (1), at a temperature of 75° C., high-speed shear dispersion, shear speed of 8000 rpm, and time of 15 minutes to form colostrum;

[0076] (4) pH value adjustment: quickly cool down the colostrum in step (...

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PUM

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Abstract

The invention relates to a clevidipine butyrate medium-length chain fat emulsion comprising the following components: 0.05-0.1% (w / v) of clevidipine butyrate, 0.5-1.0% (w / v) of long chain oil for injection, 0.5-1.0% (w / v) of medium-chain oil for the injection, 1.0-2.0% (w / v) of emulsifying agents, 1.0-5.0% (w / v) of isotonic agents, pH regulating agents and water for the injection.

Description

technical field [0001] The invention relates to a clevidipine butyrate medium and long-chain fat emulsion and a preparation method thereof. Background technique [0002] During heart and brain surgery, it is required to quickly and safely lower blood pressure to a predetermined level and maintain it for a predetermined time, and then quickly restore blood pressure to normal. The drugs currently used for the above indications mainly include sodium nitroprusside, nitroglycerin and nicardipine. But none of them can really effectively control blood pressure. The main disadvantage of sodium nitroprusside is the risk of cyanide poisoning, followed by the effect on regional myocardial blood flow in patients with coronary artery disease. Nitroglycerin is also very short-acting, but the effect is too low and needs to be used in very high doses, which can easily cause a decrease in cardiac output. Nicardipine is a dihydropyridine calcium antagonist with high vascular selectivity, b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/4422A61K47/44A61K47/34A61K47/14A61P9/12
Inventor 黄海宋华先郑建华王娟伞红男马红萍徐庆春孙欣
Owner 辽宁中海康生物制药股份有限公司
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