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Preparation method for injection phosphorus propofol sodium

A technology for fospropofol sodium and injection, which is applied in the field of preparation preparation of injections, and can solve problems such as limiting treatment development and low bioavailability

Inactive Publication Date: 2010-06-30
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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  • Preparation method for injection phosphorus propofol sodium
  • Preparation method for injection phosphorus propofol sodium
  • Preparation method for injection phosphorus propofol sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Example 1: Preparation of Propofol Sodium Phosphate for Injection

[0021] Prescription: Propofol sodium 372g

[0022] Water for injection 2000ml

[0023] 1000 bottles

[0024] Add 1500ml of water for injection into the liquid preparation container, add the exact prescription amount of propofol sodium, stir to dissolve, slowly add citric acid, adjust the pH to 8.0, add water to the full amount, and then add 0.05%% (W / V) medicinal charcoal, stir for 60 minutes, coarse filter with sand filter to remove carbon, and fine filter with 0.22μm microporous filter membrane to pass the clarity; after the intermediate content is determined to be qualified, the volume is fixed and packed in vials Add a half stopper, decarburize the sample by coarse filtration with a sand filter rod, and finely filter it with a 0.22μm microporous filter membrane until the clarity is qualified; after the intermediate content is determined to be qualified, the amount is fixed and packed...

Embodiment 2

[0025] Example 2: Preparation of Propofol Sodium Phosphate for Injection

[0026] Prescription: Propofol sodium 372g

[0027] Water for injection 2000ml

[0028] 1000 bottles

[0029] Add 1500ml of water for injection to the liquid container, add the exact prescription amount of propofol sodium, stir to dissolve, slowly add acetic acid, adjust the pH to 7.0, add water to the full amount, and then add 0.05%% (W / V ) Medicinal charcoal, stirring for 60 minutes, coarse filtration with sand filter rod, decarburization, and fine filtration with 0.22μm microporous filter membrane until the clarity is qualified; after the intermediate content is determined to be qualified, the volume is fixed and packed in vials , Add a half stopper, and remove the carbon by coarse filtration with the sample sand filter rod, and use a 0.22μm microporous filter membrane to finely filter until the clarity is qualified; after the intermediate content is determined to be qualified, the ...

Embodiment 3

[0030] Example 3: Preparation of Propofol Sodium Phosphate for Injection

[0031] Prescription: Propofol Phosphate Sodium 530g

[0032] Water for injection 2500ml

[0033] 1000 bottles

[0034] Add 2000ml of water for injection into the liquid container, add the exact prescription amount of propofol sodium, stir to dissolve, slowly add lactic acid, adjust the pH to 7.8, add water to the full amount, and then add 0.05%% (W / V ) Medicinal charcoal, stirring for 60 minutes, coarse filtration with sand filter rod, decarburization, and fine filtration with 0.22μm microporous filter membrane until the clarity is qualified; after the intermediate content is determined to be qualified, the volume is fixed and packed in vials , Add a half stopper, and remove the carbon by coarse filtration with the sample sand filter rod, and use a 0.22μm microporous filter membrane to finely filter until the clarity is qualified; after the intermediate content is determined to be qua...

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Abstract

The invention relates to a preparation method for injection phosphorus propofol sodium. The preparation obtained by the method needs no filing auxiliary materials and stabilizes, which reduces qantity of formulation of transfusion preparations. The preparation method for injection phosphorus propofol sodium comprises the following steps of: adding 5% to 98% of water for injection to a solution preparing container; adding 90% to 110% of phosphorus propofol sodium of accurate medical prescription quantity; dissolving the materials by stirring; slowly dripping pH value regulator to regulate the pH value to be 5.0 to 8.5; supplementing water to the full dose; then adding 0.01% to 1.0% (W / V) of medicinal carbon; coarsely filtering and decarbonizing with a sand filtering stick; fine filtering with a 0.22 mum millipore filter unitl the clarity is qualified; determining charge quantity and filling the preparation to cillin bottles after content of midbody is qualified through measurement; blanking the cillin bottles with half-plugs; controlling water in samples to 0.1% to 8% after freezing and drying; plugging by press; and rolling covers.

Description

Technical field: [0001] The invention relates to a preparation method of an injection containing propofol sodium phosphate as the main medicinal ingredient. technical background: [0002] In the last 15 years of anesthesia treatment, injectable anesthetics, especially propofol, have been widely accepted for the induction and maintenance of general anesthesia. Intravenous anesthesia with propofol has several advantages compared with the previous methods: such as easier to tolerate induction, because the patient does not have to worry about wearing a mask, suffocation or the strong smell of volatile anesthetics; rapid and predictable recovery; The dose of poofol is easy to adjust the depth of anesthesia; compared with inhaled anesthetics, it has a lower incidence of adverse reactions; it has reduced anxiety, nausea and vomiting during the recovery phase of anesthesia [Padfield NL, Intrduction, history and development, In: Padfield NL (Ed.) Ed., Total Intravenous Anesthesia, Butter...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/661A61P23/00A61P23/02
Inventor 杨成
Owner HC SYNTHETIC PHARMA CO LTD
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