Propofol phosphate for injection and preparation method and application thereof

A technology for propofol phosphate and injection, which is applied in the field of medicine, can solve the problems of low bioavailability and limited treatment development, and achieve the effect of easy operation, wide application range and good appearance

Inactive Publication Date: 2010-07-21
HC SYNTHETIC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the low bioavailability of propofol when administered by means other than the intravenous route has limited the development of such treatments

Method used

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  • Propofol phosphate for injection and preparation method and application thereof
  • Propofol phosphate for injection and preparation method and application thereof
  • Propofol phosphate for injection and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1: Preparation of Propofol Phosphate for Injection

[0028] Prescription: Propofol Phosphate 200g

[0029] Water for injection 2000ml

[0030]

[0031] Makes 1000 bottles

[0032] Add 1500ml of water for injection in the liquid preparation container, add propofol phosphate of accurate prescription amount, stir to dissolve, slowly add sodium hydroxide, adjust the pH to 8.0, add water to the full amount, then add 0.05%% (W / V) medicinal charcoal, stirred for 60 minutes, decarbonized by coarse filtration with a sand filter rod, and finely filtered with a 0.22 μm microporous membrane until the clarity was qualified; Add half stopper to the bottle, decarburize the sample by coarse filtration with a sand filter rod, and fine filter with a 0.22 μm microporous membrane until the clarity is qualified; after the determination of the intermediate content is qualified, the fixed amount is divided into vials, and the sample P...

Embodiment 2

[0033] Embodiment 2: Preparation of Propofol Phosphate Disodium for Injection

[0034] Prescription: Propofol Phosphate Disodium 200g

[0035] Water for injection 2000ml

[0036]

[0037] Makes 1000 bottles

[0038] Add 1500ml of water for injection in the liquid preparation container, add disodium propofol phosphate of accurate prescription amount, stir to dissolve, slowly add acetic acid, adjust the pH to 8.5, add water to the full amount, then add 0.05%% (W / V) medicinal charcoal, stirred for 60 minutes, decarbonized by coarse filtration with a sand filter rod, and finely filtered with a 0.22 μm microporous membrane until the clarity was qualified; Add half stopper to the bottle, decarburize the sample by coarse filtration with a sand filter rod, and fine filter with a 0.22 μm microporous membrane until the clarity is qualified; after the determination of the intermediate content is qualified, the fixed amount is divided into via...

Embodiment 3

[0039] Embodiment 3: Preparation of Propofol Phosphate for Injection

[0040] Prescription: Propofol Phosphate 200g

[0041] Mannitol 2g

[0042] Water for injection 2500ml

[0043]

[0044] Makes 1000 bottles

[0045] Add 2000ml of water for injection into the liquid preparation container, add propofol phosphate and mannitol 2g in the exact prescription amount, and slowly add sodium bicarbonate under stirring, adjust the pH to 7.8, add water to the full amount, and then add 0.05% % (W / V) medicinal charcoal, stirred for 60 minutes, decarbonized by coarse filtration with a sand filter rod, and finely filtered with a 0.22 μm microporous membrane until the clarity was qualified; Put it in a vial, add a half stopper, decarbonize the sample by coarse filtration with a sand filter, and fine filter it with a 0.22 μm microporous membrane until the clarity is qualified; after the determination of the intermediate content is qualif...

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Abstract

The invention relates to propofol phosphate for injection, pharmaceutical salt thereof and a preparation method thereof. The preparation method comprising the following steps: adding 5-98 percent of water for injection into a preparation container, adding propofol phosphate and pharmaceutical salt thereof of 90-110 percent of accurate prescriptions, slowly dropping a pH value regulator while stirring so as to adjust the pH to be 6.0-11, adding water to the full volume, then adding medicinal carbon of 0.01-1.0 percent (W / V), stirring for 15-60 minutes, roughly filtering with a sand filter rod to remove the carbon, and finely filtering with a 0.22mum microporous membrane until the clarity is qualified; and measuring until the intermediate content is acceptable, fixing the filling amount, sub-packaging into cillin bottles, plugging in plugs by half, freezing and drying samples to control the moisture content being 0.1-8 percent, pressing the plugs, and capping.

Description

Technical field: [0001] The invention belongs to the technical field of medicine, and relates to propofol phosphate for injection or a medicinal salt thereof, a preparation method and application thereof. technical background: [0002] During the last 15 years of anesthesia therapy, the use of injectable anesthetics, especially propofol, for the induction and maintenance of general anesthesia has gained wide acceptance. Intravenous anesthesia with propofol has several advantages over previous methods: such as a more tolerable induction because the patient does not have to worry about wearing a mask, suffocation, or the strong odor of the volatile anesthetic; rapid and predictable recovery; The dose of pofol is easy to adjust the depth of anesthesia; it has a low incidence of adverse reactions compared with inhalational anesthetics; it has reduced anxiety, nausea and vomiting during the recovery phase of anesthesia [Padfield NL, Induction, history and development, In: Padfiel...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/661A61K9/19A61P23/00
Inventor 杨成施维
Owner HC SYNTHETIC PHARMA CO LTD
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