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A propofol composition used for injection, a preparing method thereof and uses of the propofol composition

A technology for propofol and injection, applied in the field of its preparation and injection of propofol for injection, can solve problems such as hidden dangers of drug safety

Inactive Publication Date: 2015-01-21
天津迈迪瑞康生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Such preparations cannot be tested for clarity, and clarity testing is a must-test item for injections, which brings hidden dangers to drug safety.
Also, existing fat emulsions require specialized equipment to sterilize under high pressure

Method used

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  • A propofol composition used for injection, a preparing method thereof and uses of the propofol composition
  • A propofol composition used for injection, a preparing method thereof and uses of the propofol composition
  • A propofol composition used for injection, a preparing method thereof and uses of the propofol composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] Embodiment 1: Preparation of Propofol Composition Sample 1 for Injection

[0090] Its composition is as follows:

[0091] (1)

[0092]

[0093]

[0094] The preparation method of the propofol composition for injection is as follows:

[0095] 1) under the condition of 75°C, mix the above-mentioned weight of soybean lecithin, soybean oil and medium-chain fatty acid triglyceride, and stir at 8000rpm until a transparent and clear solution is formed;

[0096] 2) At 20°C, add the above weight of propofol to the product of 1), and keep stirring at 200rpm until the whole system is transparent;

[0097] 3) At 45°C, add the above-mentioned weight of propylene glycol, Tween 80, polyethylene glycol lauryl hydroxystearate, and vitamin E to the product of step 2), and continue stirring at 200 rpm until a single Phase, transparent and clear homogeneous preparation, after sterilization by 0.22 μm microporous membrane, finally obtain the fat emulsion concentrate for injection....

Embodiment 2

[0098] Embodiment 2: Preparation of Propofol Composition Sample 2 for Injection

[0099] Its composition is as follows:

[0100]

[0101] The preparation method of the propofol composition for injection is as follows:

[0102] 1) At 60°C, mix the above-mentioned weight of soybean lecithin, polyglycerol oleate, soybean oil and caprylic capric glyceride, and stir at 6000 rpm until a transparent and clear solution is formed;

[0103]2) At 45°C, add the above weight of propofol to the product of 1), and keep stirring at 1000rpm until the whole system is transparent;

[0104] 3) At 35°C, add the above-mentioned weight of propylene glycol, Tween 80, polyethylene glycol lauryl hydroxystearate, and vitamin E to the product of step 2), and continue stirring at 800 rpm until a single Phase, transparent and clear homogeneous preparation, after sterilization by 0.22 μm microporous membrane, finally obtain the fat emulsion concentrate for injection.

Embodiment 3

[0105] Embodiment 3: Preparation of Propofol Composition Sample 3 for Injection

[0106] Its composition is as follows:

[0107]

[0108] The preparation method of the propofol composition for injection is as follows:

[0109] 1) At 20°C, mix the above-mentioned weight of soybean lecithin, polyglycerol oleate and soybean oil, and stir at 6000rpm until a transparent and clear solution is formed;

[0110] 2) Add the above-mentioned weight of propofol to the product of 1) at 4°C, and keep stirring at 2000rpm until the whole system is transparent;

[0111] 3) At 40°C, add the above-mentioned weight of propylene glycol, polyethylene glycol lauryl hydroxystearate, Tween 80, vitamin E, and oleic acid into the product of step 2), and continue stirring at 600 rpm, Until a single-phase, transparent and clear homogeneous preparation is formed, after being sterilized by a 0.22 μm microporous membrane, a fat emulsion concentrate for injection is finally obtained.

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Abstract

The invention belongs to the field of pharmacology and pharmaceutics, and relates to a propofol composition used for injection, a preparing method thereof and uses of the propofol composition. A product of the propofol composition is good in fluidity and free of wall hanging, has a single-phase, transparent, clear and bright appearance, can be subjected to clarity detection, and is free of preparation layering phenomena after the product is repeatedly frozen and thawed. In a process of forming a propofol fat emulsion system when the product encounters water, homogenization treatment is not needed, and spontaneous emulsification can occur only by slight oscillation. During clinical using, the product can spontaneously emulsify to form a fat emulsion system meeting injection requirements after the product is diluted with normal saline or a glucose solution, and other aqueous solutions and is slightly oscillated. A preparation process is simple. Only a common physical stirring step is needed, and a homogenizing step or a water removing step is not needed. A prepared propofol fat emulsion concentrate liquid can be sterilized by passing through a microporous filtration membrane having a size of 0.22 [mu]m. After emulsification, the content of free propofol is low, and the phenomenon of pain during administration caused by existence of the free propofol is reduced. The propofol composition, the preparing method and uses have advantages of simple preparation process, low production cost, and easy transportation and storage, and have a good application prospect.

Description

technical field [0001] The invention belongs to the field of pharmacy and pharmacy, and relates to propofol for injection, its preparation method and application. Background technique [0002] The chemical name of propofol is 2,6-diisopropylphenol (Propofol, 2,6-disopropylphenol), which belongs to alkylphenol. It is widely used by anesthesiologists for induction of general anesthesia, assisted sedation with epidural anesthesia, painless abortion, painless gastroscopy and other fields. Its postoperative nausea and vomiting rate is low, which further establishes its position as the first choice of general anesthesia for outpatient surgery. In 1981, AstraZeneca (Italy) Co., Ltd. used soybean oil as an excipient to develop a fat emulsion propofol injection, which was launched in 1986 under the trade name "Diprivan". In 1989, it passed the US FDA and recommended clinical use. In December 1993, it was approved by the Chinese SFDA to go on the market in the Mainland. Since prop...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/05A61K9/107A61P23/00A61P25/20
CPCA61K31/05A61K9/0019A61K9/107A61K2300/00
Inventor 杨杰
Owner 天津迈迪瑞康生物医药科技有限公司
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