Preparation method of propofol fat emulsion injection

A technology for propofol fat and injection, which is applied in the directions of emulsion delivery, devices for making medicines into special physical or taking forms, and active ingredients of hydroxyl compounds, etc. Excessive deviation, easy demulsification of the emulsion, etc., to achieve the effects of stable physical and chemical properties, enhanced particle size uniformity, and reduced pain

Active Publication Date: 2015-04-08
HEBEI YIPIN PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The invention provides a production process of propofol fat emulsion to overcome the defects that the particle size deviation of colostrum is too large, the emulsion is easy to break, and the particle size deviation of the emulsion is too large after high-pressure homogenization

Method used

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  • Preparation method of propofol fat emulsion injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] a. Under the protection of nitrogen, mix 103 grams of soybean oil, 12 grams of lecithin and 1.0 grams of oleic acid and heat up to 70 ℃ ~ 85 ℃, then add 10 grams of propofol to prevent premature oxidation of propofol , so as to achieve an effective therapeutic dose, after the propofol is uniformly dispersed, a clear oil phase is obtained for subsequent use;

[0018] b. Under the protection of nitrogen, mix 22.0 g of glycerin and 880 ml of water for injection, adjust the pH to 7.0 with sodium hydroxide aqueous solution and filter, then heat the filtrate to 45°C-60°C for later use;

[0019] c. Under the protection of nitrogen, the water phase is sheared at a speed of 10000rpm / min, and at the same time, the oil phase at 70 ° C to 85 ° C under the protection of nitrogen is pumped into the FD high-pressure sprayer under the water surface through a peristaltic pump. The sprayer uses a nozzle with a 0.3mm aperture , Spray with a spray volume of 80-145 ml / min, and the atomized ...

Embodiment 2

[0022] Embodiment 2: The difference between this embodiment and Embodiment 1 is that the prescription amount is enlarged by 2 times.

[0023] a. Under the protection of nitrogen, mix 204 grams of soybean oil, 24 grams of lecithin and 2.0 grams of oleic acid and heat up to 70 ℃ ~ 85 ℃, then add 20 grams of propofol, after the propofol is evenly dispersed, Obtain the clarified oil phase for subsequent use;

[0024] b. Under the protection of nitrogen, mix 44.0 g of glycerin and 1760 ml of water for injection, adjust the pH to 7.0 with aqueous sodium hydroxide solution and filter, then heat the filtrate to 45°C to 60°C for later use;

[0025] c. Under the protection of nitrogen, the water phase is sheared at a speed of 10000rpm / min, and at the same time, the oil phase at 70 ° C to 85 ° C under the protection of nitrogen is pumped into the FD high-pressure sprayer under the water surface through a peristaltic pump. The sprayer uses a nozzle with a 0.3mm aperture , Spray with a sp...

Embodiment 3

[0028] Embodiment 3: The difference between this embodiment and Embodiment 1 is that the prescription amount is enlarged by 3 times.

[0029] a. Under the protection of nitrogen, mix 306 grams of soybean oil, 36 grams of lecithin and 3.0 grams of oleic acid and heat up to 70 ℃ ~ 85 ℃, then add 30 grams of propofol, after the propofol is evenly dispersed, Obtain the clarified oil phase for subsequent use;

[0030] b. Under the protection of nitrogen, mix 66.0 g of glycerin and 2640 ml of water for injection, adjust the pH to 7.0 with aqueous sodium hydroxide solution and filter, then heat the filtrate to 45°C to 60°C for later use;

[0031] c. Under the protection of nitrogen, the water phase is sheared at a speed of 10000rpm / min, and at the same time, the oil phase at 70 ° C to 85 ° C under the protection of nitrogen is pumped into the FD high-pressure sprayer under the water surface through a peristaltic pump. The sprayer uses a nozzle with a 0.3mm aperture , Spray with a sp...

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Abstract

The invention discloses a preparation method of a propofol fat emulsion injection. The preparation method comprises the following steps: uniformly mixing soybean oil, lecithin and oleic acid and adding propofol; spraying an oil phase into a water phase under the protection of nitrogen gas to prepare emulsion; shearing the emulsion to obtain primary emulsion; homogenizing the primary emulsion under the pressure of 10000psi-20000psi to prepare an emulsion semi-finished product; and filtering, inflating nitrogen and sterilizing to prepare the propofol fat emulsion injection. According to the preparation method, the grain diameter uniformity is enhanced and the disadvantage that the grain diameter deviation of the primary emulsion is too great is improved; the stability of finished-product emulsion is improved; the average grain diameter of the detected emulsion is 210nm-230nm and the grain diameter deviation is 0.20-0.30; the requirements on the grain diameters by the fat emulsion injection are met; the emulsion grains with the size being more than 1 micron are not detected, and the grain diameters are obviously better than the standards that the content of the emulsion grains with the size being 1 micron in emulsion large grains of national drug standards is not more than 3%; the physicochemical properties are stable, the toxic side effect is low, the pains caused by injection are reduced, and the compliance of using drugs by patients is increased, so that the application prospect is very good.

Description

technical field [0001] The invention relates to the preparation of water emulsion, in particular to the preparation process of propofol fat emulsion injection. Background technique [0002] Propofol is an induction drug for intravenous general anesthesia. It is clinically suitable for various operations of different ages and locations. It is widely used in clinical practice because of its fast onset of action, rapid recovery, and small and mild side effects. In the 1980s, AstraZeneca developed propofol in the form of fat emulsion injection, and it was marketed under the trade name "Diprivan". At present, propofol has been widely used in more than 100 countries and regions around the world. my country began to import propofol from abroad in the mid-1990s. Since propofol was launched in my country, it was favored by the market soon, and its application continued to rise. [0003] At present, the preparation process of propofol fat emulsion injection is prepared by ordinary e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/05A61P23/00A61J3/00
Inventor 可方远武玉洁王丽娜赵翠然张晓倩张晓彩程瑶
Owner HEBEI YIPIN PHARMA
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