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Method of preparing sodium levofolinate and applications thereof on preparing tumour-curing medicines

The technology of sodium levofolinate and medicine is applied in the field of medicine for preparing medicines for treating tumors, can solve the problem of not using sodium levofolinate and the like, and achieve the effects of fast onset, effective treatment and safe use

Inactive Publication Date: 2008-07-30
齐建新
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there are calcium folinate, calcium leucovorin and sodium folinate on the market at home and abroad, but there is no report of using sodium folinate

Method used

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Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0010] The preparation method of medicine sodium levofolinate of the present invention has two kinds:

[0011] Method 1: Weigh the prescribed amount of levofolinic acid, add water for injection to make a suspension, add sodium hydroxide solution (or sodium carbonate, sodium bicarbonate solution) and stir to completely dissolve, add mannitol, dextran, glucose , sodium chloride, and at least one excipient of hydrolyzed protein, and the injection preparation includes dried powder injection and directly prepared liquid preparation.

[0012] Method 2. Weigh the prescribed amount of sodium levofolinate, add water for injection, then add at least one auxiliary material containing mannitol, dextran, glucose, sodium chloride, and protein hydrolyzate, and stir to completely dissolve to form a solution. The injection includes Powder injection after drying and liquid preparation directly prepared.

[0013] The applicant has done pharmacodynamics test to folinic acid:

[0014] Folinic ac...

example 1

[0022] Example 1. Sodium levofolinate freeze-dried powder injection

[0023] Prescription 1 (specification: each bottle contains 50 mg of sodium folinate, calculated as folinic acid), weigh 25 g of freeze-dried matrix agent mannitol and add it to 125 ml of water for injection to dissolve, add 0.3% activated carbon and boil for 20 minutes, filter to remove carbon; Take 50g of levofolinic acid and add it into 400m water for injection at 60°C to make a suspension, add 5% NaOH dropwise, stir to dissolve, and mix with decarbonized mannitol, control the pH value between 7.0-8.0, and then Add 0.05% activated carbon, stir for 15 minutes, filter to remove carbon, filter the filtrate through a 0.8u microporous membrane to clarify, then filter through a 0.22u microporous membrane, let it cool, add water for injection to 600ml, stir, and mix well. Measure the content of intermediates, aseptically pack in 1000 vials, determine the filling volume of each bottle according to the results of t...

example 2

[0026] Example 2. Sodium levofolinate freeze-dried powder injection

[0027] Prescription 1 (specification: each tube contains 50 mg of sodium levofolinate in terms of folinic acid), the same as prescription 1 of Example 1, the difference is that 25 g of the freeze-dried skeleton agent mannitol was weighed and dissolved in 125 ml of water for injection, and 53 g was weighed Add sodium levofolinate to 400ml water for injection at 60°C to make a solution, let it cool, add water for injection to 600ml, and determine the filling volume of each bottle to be about 0.6ml according to the results of the intermediate determination.

[0028] Prescription 2 (specification: each bottle contains 100 mg of sodium levofolinate in terms of folinic acid), the same as prescription 1 of Example 1, the difference is that 50 g of the freeze-dried skeleton agent mannitol was weighed and dissolved in 250 ml of water for injection, and 106 g was weighed Add sodium levofolinate to 800ml of water for i...

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PUM

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Abstract

The invention provides a preparation method of medical left folinic acid sodium and an application in preparation of tumor treatment medicine, relating to a preparation method of the medical left folinic acid sodium in tumor treatment medicine preparation. Two preparation methods of the medical left folinic acid sodium are that: firstly, the left folinic acid sodium of prescription dosage are weighed, water for injection is added to prepare a suspension solution, sodium hydroxide solution (or sodium carbonate, sodium bicarbonate solution) is added, the suspension solution is stirred for total dissolution, and then at least one supplement containing mannitol, dextran, glucose, sodium chloride or protein hydrolysate is added; the injecting agents comprise the dried powder injection and the directly prepared liquid formulation. Secondly, the left folinic acid sodium of prescription dosage are weighed, water for injection is added, and at least one supplement containing mannitol, dextran, glucose, sodium chloride or protein hydrolysate are added and stirred for total dissolution to prepare the solution; the injecting agents comprise the dried powder and the directly prepared liquid formulation. The left folinic acid sodium is applied in preparing medicine of tumor treatment.

Description

technical field [0001] The invention relates to a preparation method of sodium levofolinate, which is used to prepare medicines for treating tumors. Background technique [0002] Calcium leucovorin is the left-handed isomer of calcium folinate. Calcium leucovorin was first successfully developed by Wyeth Pharmaceutical Company of the United States. It was first listed in the UK in 1994. It is mainly used for anti-anemia and as a detoxification antagonist in tumor drug treatment. , has been listed in more than 10 countries including Italy, Canada, Japan, South Africa, Finland, Iceland, etc. Its preparations include tablets, water injections and freeze-dried injections, which have been included in the "European Pharmacopoeia" and are clinically used abroad. The safety and effectiveness of the drug has been fully confirmed. [0003] Another form of folinic acid is dl body, that is, dl-LV, which cannot be used by dl body in the body. It is just to de...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/519A61P35/00C07D475/04
Inventor 齐建新
Owner 齐建新
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