A kind of preparation method of propofol medium/long chain fat emulsion injection

A long-chain fat emulsion and propofol technology, applied in the field of medicine, can solve the problems of affecting the emulsification effect, affecting the stability and safety of the emulsion, and reducing the encapsulation rate, achieving better stability and safety, and avoiding local The effect of over-alkaline

Active Publication Date: 2022-03-22
YANGTZE RIVER PHARM GRP CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

When the batch is enlarged to 1000L and above, it is difficult to stir evenly with high-speed stirring, and it is directly homogenized by a high-pressure homogenizer, and the part of the mixed phase where the oil phase accounts for a large proportion is difficult to form a stable oil-in-water emulsion, which ultimately affects the emulsification effect
In addition, adding sodium hydroxide solution to the colostrum or final milk to adjust the pH value will lead to local over-alkali, destroy the stability of the co-emulsifier on the oil-water interface, and may cause local demulsification, reduce the encapsulation efficiency, and affect the stability of the emulsion. sex and security

Method used

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  • A kind of preparation method of propofol medium/long chain fat emulsion injection
  • A kind of preparation method of propofol medium/long chain fat emulsion injection
  • A kind of preparation method of propofol medium/long chain fat emulsion injection

Examples

Experimental program
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Effect test

Embodiment 1

[0033] Propofol medium / long chain fat emulsion injection, batch 1000L, the prescription is as follows:

[0034]

[0035] The preparation method is as follows:

[0036] 1. Under the protection of nitrogen, add glycerin and sodium hydroxide to the water for injection of 90% by volume of the prescription, make up the remaining water for injection, stir and mix evenly, and heat to 65°C±2°C to obtain the water phase;

[0037] 2. Under nitrogen protection, add soybean oil, medium chain triglycerides, egg yolk lecithin, oleic acid, and propofol into the oil phase tank, heat to 65°C±2°C, and cut at 1000rpm Cut and stir to dissolve to obtain the oil phase;

[0038] 3. Under the protection of nitrogen, the oil phase and the water phase are mixed at a weight ratio of 1:6, and sheared at a speed of 2000 rpm by a pipeline type high-shear dispersing emulsifier to obtain colostrum;

[0039] 4. Under the protection of nitrogen, the colostrum is homogenized once by a homogenizer with a ho...

Embodiment 2

[0042] Propofol medium / long chain fat emulsion injection, batch 1000L, the prescription is as follows:

[0043]

[0044] The preparation method is as follows:

[0045] 1. Under the protection of nitrogen, add glycerin and sodium hydroxide to the water for injection of 90% by volume of the prescription, make up the remaining water for injection, stir and mix evenly, and heat to 65°C±2°C to obtain the water phase;

[0046] 2. Under nitrogen protection, add soybean oil, medium chain triglycerides, egg yolk lecithin, oleic acid, and propofol into the oil phase tank, heat to 65°C±2°C, and cut at 1000rpm Cut and stir to dissolve to obtain the oil phase;

[0047] 3. Under the protection of nitrogen, the oil phase and the water phase are mixed online at a weight ratio of 1:5, and sheared at a speed of 2000 rpm by a pipeline type high-shear dispersing emulsifier to obtain colostrum;

[0048] 4. Under the protection of nitrogen, the colostrum is homogenized once by a homogenizer wi...

Embodiment 3

[0051] Propofol medium / long chain fat emulsion injection, batch 1000L, the prescription is as follows:

[0052]

[0053] The preparation method is as follows:

[0054] 1. Under the protection of nitrogen, add glycerin and sodium hydroxide to the water for injection of 90% by volume of the prescription, make up the remaining water for injection, stir and mix evenly, and heat to 65°C±2°C to obtain the water phase;

[0055] 2. Under nitrogen protection, add soybean oil, medium chain triglycerides, egg yolk lecithin, oleic acid, and propofol into the oil phase tank, heat to 65°C±2°C, and cut at 1000rpm Cut and stir to dissolve to obtain the oil phase;

[0056] 3. Under the protection of nitrogen, the oil phase and the water phase are mixed online at a weight ratio of 1:6, and sheared at a speed of 2000 rpm by a pipeline type high-shear dispersing emulsifier to obtain colostrum;

[0057] 4. Under the protection of nitrogen, the colostrum is homogenized once by a homogenizer wi...

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Abstract

The invention discloses a preparation method of propofol medium / long-chain fat emulsion injection, which comprises: under the protection of nitrogen, dissolving glycerin and sodium hydroxide in water for injection, and controlling the temperature of the water phase to 50-80°C; Under the protection of nitrogen, dissolve propofol, oleic acid, and egg yolk lecithin in soybean oil and medium-chain triglycerides, heat the oil phase to 50-80 ° C, shear and stir to dissolve; under the protection of nitrogen, the oil phase Mix with the water phase at a weight ratio of 1:4~6, and shear to obtain colostrum; the colostrum is homogenized once at 5~20bar homogenizing pressure, once at 200bar homogenizing pressure, once at 400bar homogenizing pressure 7 times to prepare the final milk; the final milk was filtered through a 1 μm filter element; filled into glass infusion bottles or ampoules, sterilized at 121°C for 10 minutes, and cooled to room temperature. The preparation method of the invention avoids local over-alkali of the emulsion, has better stability and safety, and has remarkable commercial production feasibility.

Description

technical field [0001] The invention belongs to the technical field of medicine, and more specifically relates to a preparation method of propofol medium / long-chain fat emulsion injection. Background technique [0002] Propofol is currently widely used clinically for induction and maintenance of general anesthesia, and sedation for assisted ventilation in intensive care patients. It is a new type of rapid and short-acting intravenous anesthetic. It has the advantages of fast onset of anesthesia induction, rapid recovery and complete functional recovery, without coughing and vomiting. [0003] The chemical name of propofol is 2,6-diisopropylphenol, which is very slightly soluble in water. Therefore, the current dosage form of propofol is fat emulsion. [0004] The preparation methods disclosed in Chinese patent applications CN102366404 A and CN102805728 A are that the oil phase and the water phase are mixed to make colostrum, the pH value is adjusted with 1mol / L sodium hydr...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K47/14A61K47/24A61K31/05A61P23/00
CPCA61K47/14A61K47/24A61K47/44A61K9/0019A61K9/107A61K31/05A61P23/00
Inventor 范录云徐镜人蔡伟吕慧敏张海波王德国缪世峰顾孝红肖志超
Owner YANGTZE RIVER PHARM GRP CO LTD
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