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A kind of prostaglandin-containing fat emulsion and preparation method thereof

A prostaglandin and fat emulsion technology, which is applied in the field of medicine, can solve the problems of easy decomposition of prostaglandins, increase the difficulty of distribution, clinical management and use, and achieve the effects of improving drug quality, ensuring emulsification stability, and reducing losses

Active Publication Date: 2021-03-23
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Prostaglandins are easy to decompose, and the validity period of prostaglandin fat emulsions on the market is only one year, and must be stored at 0-5°C, which increases the difficulty of distribution, clinical management and use

Method used

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  • A kind of prostaglandin-containing fat emulsion and preparation method thereof
  • A kind of prostaglandin-containing fat emulsion and preparation method thereof
  • A kind of prostaglandin-containing fat emulsion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Take 100g of soybean oil, heat it to 80°C, add 7mg of prostaglandin E1, stir to dissolve, then add 17.86g of lecithin (PC) and 36mg of phosphatidylglycerol (PG) (PC:PG is about 99.8:0.2), stir dispersed to obtain an oil phase;

[0078]Take 22.1g of glycerin for injection and add it to an appropriate amount of water for injection, stir and dissolve, then heat to 80°C to prepare the water phase;

[0079] Mix and stir the oil phase and the water phase, add water for injection to 1000ml, enter a high-pressure homogenizer for homogenization treatment, the homogenization pressure is 750bar / 100bar, homogenize 4 times, and the homogenization temperature is 50°C to obtain a uniform emulsion. Use hydrochloric acid or sodium hydroxide to adjust its pH value to 5.5, fill the emulsion into an ampoule bottle, fill it with nitrogen and seal it, and keep it in a rotary sterilizer at 121°C for 8 minutes to obtain a fat emulsion containing prostaglandin

Embodiment 2

[0081] Take 100g of soybean oil, heat it to 80°C, add 7mg of prostaglandin E1, stir to dissolve it, then add 17.87g of lecithin and 27mg of phosphatidylglycerol (PC:PG about 99.85:0.15), stir and disperse to obtain an oil phase ;

[0082] Take 22.1g of glycerin for injection and add it to an appropriate amount of water for injection, stir and dissolve, then heat to 80°C to prepare the water phase;

[0083] Mix and stir the oil phase and the water phase, add water for injection to 1000ml, enter a high-pressure homogenizer for homogenization treatment, the homogenization pressure is 750bar / 100bar, homogenize 4 times, and the homogenization temperature is 50°C to obtain a uniform emulsion. Adjust the pH to 5.5 using hydrochloric acid or sodium hydroxide. The emulsion was filled in ampoules, filled with nitrogen and sealed, and kept in a rotary sterilizer at 121° C. for 8 minutes to obtain a prostaglandin-containing fat emulsion.

Embodiment 3

[0085] Take 100g of soybean oil, heat it to 80°C, add 7mg of prostaglandin E1, stir to dissolve it, then add 17.85g of lecithin and 45mg of phosphatidylglycerol (PC:PG about 99.75:0.25), stir and disperse to obtain the oil phase ;

[0086] Take 22.1g of glycerin for injection and add it to an appropriate amount of water for injection, stir and dissolve, then heat to 80°C to prepare the water phase;

[0087] Mix and stir the oil phase and the water phase, add water for injection to 1000ml, enter a high-pressure homogenizer for homogenization treatment, the homogenization pressure is 750bar / 100bar, homogenize 4 times, and the homogenization temperature is 50°C to obtain a uniform emulsion. Use hydrochloric acid or sodium hydroxide to adjust the pH to 5.5, fill the emulsion into an ampoule, fill it with nitrogen and seal it, and keep it in a rotary sterilizer at 121°C for 8 minutes to obtain a prostaglandin-containing fat emulsion.

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Abstract

The invention discloses a lipid emulsion containing prostaglandin and a preparation method thereof. The lipid emulsion contains the prostaglandin, oil for injection, an emulsifying agent and water for injection, wherein the prostaglandin serves as an active ingredient, and the oil for injection, the emulsifying agent and the water serve as adjuvant materials. According to the lipid emulsion containing prostaglandin, loss of the active ingredient of the lipid emulsion after heating is effectively reduced, and not only is the emulsion stability of the lipid emulsion ensured, but also a high residual rate of the prostaglandin is ensured, quality of medicine is improved effectively, and the side effects of the lipid emulsion are reduced, so that medication safety is enhanced.

Description

technical field [0001] The invention relates to the technical field of medicines, in particular to a prostaglandin-containing fat emulsion capable of being administered through intravenous injection and a preparation method thereof. Background technique [0002] Prostaglandin is an endogenous physiologically active substance, which can be used for limb ulcers caused by chronic arterial occlusive disease and for improving resting pain in limbs, and for improving systemic sclerosis and systemic lupus erythematosus, skin ulcers in patients with diabetes, vibration disease Symptoms related to peripheral circulation disorders, repair of peripheral circulation, nerve and motor dysfunction, ductus arteriosus-dependent congenital heart disease, improvement of indirect portal angiography via superior mesenteric artery, etc. [0003] Prostaglandins are easy to decompose, and the validity period of prostaglandin fat emulsions on the market is only one year, and they must be stored at 0...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K47/24A61K31/5575A61P9/14A61P9/00
CPCA61K9/0019A61K9/107A61K31/5575A61K47/24
Inventor 韩剑锋孔繁贵赵栋胡思玉王利春王晶翼
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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