Propofol composition for injection and preparation method thereof

A technology of propofol and its composition, which is applied in the field of propofol composition for injection and its preparation, and can solve the problems of endangering health, producing toxic substances and carcinogens, etc.

Inactive Publication Date: 2016-03-16
SICHUAN BAILI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In addition, it will also produce toxic substances...

Method used

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  • Propofol composition for injection and preparation method thereof
  • Propofol composition for injection and preparation method thereof
  • Propofol composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Composition prescription:

[0038] Propofol 5.0kg

[0039] Soybean oil 50kg

[0040] Lecithin 6.0kg

[0041] Glycerin 12.5kg

[0042] Appropriate amount of sodium hydroxide

[0043] Water for injection up to 500L.

[0044] Preparation:

[0045] (1) Empty tank and pipeline treatment: Use 0.01-5% EDTA solution to clean the pipeline and liquid distribution tank, and repeatedly remove oxygen in the pipeline and tank through nitrogen-vacuum mode to make the oxygen content less than 1%;

[0046] (2) Oil phase preparation: Inhale the oil for injection into the oil phase tank by vacuum feeding, continue vacuuming to remove the air suspended in the oil phase, heat to 60 degrees, put in emulsifier under nitrogen protection, and stir evenly;

[0047] (3) Water phase preparation: Add appropriate amount of water for injection in a vacuum state, the water temperature is 70 degrees, the vacuum reduces the dissolved oxygen in the water to below 1ppm, and then puts in the prescrib...

Embodiment 2

[0053] Composition prescription:

[0054] Propofol 5.0kg

[0055] Soybean oil 50kg

[0056] Lecithin 6.0kg

[0057] Glycerin 12.5kg

[0058] Appropriate amount of sodium hydroxide

[0059] Water for injection up to 500L.

[0060] Preparation:

[0061] (1) Empty tank and pipeline treatment: traditional nitrogen filling process;

[0062] (2) Oil phase preparation: Inhale the oil for injection into the oil phase tank by vacuum feeding, heat to 60 degrees, add emulsifier, stir evenly, and protect the whole process with nitrogen. After online dissolved oxygen monitoring, the dissolved oxygen in the oil phase is about 7ppm ,

[0063] (3) Preparation of water phase: add appropriate amount of water for injection under vacuum state, water temperature is 70 degrees, put in the prescribed amount of glycerin and other water-soluble components under nitrogen protection, and the dissolved oxygen in the water phase is about 7ppm through online dissolved oxygen monitoring.

[0064] (4...

Embodiment 3

[0087] Oxygen removal process

[0088] thermal oxygen removal

[0089] Add 500L of water for injection (water temperature 78°C) into the liquid mixing tank, heat the water for injection to boiling, start the self-circulation pump and time it, and record the online dissolved oxygen detection data. The measurement results are shown in figure 1 .

[0090] Conclusion: It can be seen from the above data that as the heating and boiling time increases, the amount of dissolved oxygen in water gradually decreases. Under normal pressure, 500L of water for injection needs to be heated and boiled for more than 120 minutes, so that the dissolved oxygen can be maintained at about 1ppm. It can be seen that although the theoretical water temperature is 100°C, the solubility of oxygen in water is 0ppm. However, there is a reversible dynamic equilibrium between the dissolved oxygen in the water and the gaseous oxygen in the liquid distribution tank, and they will be converted into each other...

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Abstract

The invention discloses a propofol composition for injection. The composition is prepared from, by mass, 0.1-0.5% of propofol, 0.1-2% of emulsifier, 5-30% of oil for injection, 2-3% of osmotic pressure regulator, an appropriate amount of pH value regulator and an appropriate volume of water for injection. All links of the production process of propofol injection are strictly controlled so that the core quality of propofol fat emulsion injection can be remarkably improved; in addition, the process is easy to implement, and the industrialization of the high-quality propofol fat emulsion injection is achieved.

Description

technical field [0001] The invention belongs to the technical field of chemical pharmacy, and relates to a propofol composition for injection and a preparation method thereof. Background technique [0002] Propofol injection is a new type of alkylbenzene intravenous anesthetic, which can be used for rapid induction of anesthesia or maintenance of anesthesia and sedation. Its induction of anesthesia is fast and stable, and its excitatory effect is less than that of methadone sodium. But higher than thiopental sodium. [0003] The main advantage of propofol injection is that it induces anesthesia quickly, wakes up and recovers quickly after administration, and is used for induction of anesthesia for short-term operations. The recovery of consciousness is faster than thiopental sodium. It is used for general anesthesia or sedation. Awakening is significantly better than other commonly used intravenous anesthetics [0004] Patent application CN200610025320 (Propofol Injection ...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/05A61P23/00
Inventor 朱义王一茜范鹏
Owner SICHUAN BAILI PHARM CO LTD
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