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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, making it difficult to stir evenly, and destroying the stability of co-emulsifiers, so as to avoid local over-alkali, better stability and safety Effect

Active Publication Date: 2019-04-30
YANGTZE RIVER PHARM GRP CO LTD
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  • Summary
  • 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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  • Preparation method of propofol medium/long-chain fat emulsion injection
  • Preparation method of propofol medium/long-chain fat emulsion injection
  • Preparation method of propofol medium/long-chain fat emulsion injection

Examples

Experimental program
Comparison scheme
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 a propofol medium / long-chain fat emulsion injection. The method comprises the following steps: dissolving glycerin and sodium hydroxide in water for injection under nitrogen protection, and controlling the temperature of a water phase at 50 to 80 DEG C; under the protection of nitrogen, propofol, oleic acid, egg yolk lecithin are dissolved in soybeanoil and medium-chain triglyceride, an oil phase is heated to 50-80 DEG C, and the material is stirred to dissolve; under the protection of nitrogen, the oil phase and the water phase are mixed in a weight ratio of 1:4 to 6, and the colostrum is obtained by shearing; the colostrum is homogenized by 5 to 20 bar homogenization pressure for one time, is homogenized by the 200 bar homogenization pressure for one time, and is homogenized by the 400 bar homogenization pressure for 7 times to obtain the final milk; the final milk is filtered through a 1 [mu]m filter core; a glass infusion bottle or ampoule is filled with the final milk, the material is sterilized at 121 DEG C for 10 min, 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 Applications(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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