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Pharmaceutical composition containing calcium folinate and fluorouracil

A technology of calcium folinate and fluorouracil, which is applied in the field of medicine, can solve the problems of hard shell and brittleness, shrinkage of freeze-dried powder injection, poor water solubility, etc., and achieve the effects of quick onset, improved water solubility, and improved stability

Inactive Publication Date: 2013-11-20
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] In order to overcome a series of problems in the prior art, the inventors creatively discovered the combined application of calcium folinate injection and fluorouracil injection using specific excipients, which not only completely solved the water solubility and stability problems of calcium folinate , convenient for clinical use, and because of the addition of stevioside in calcium folinate injection, it can enhance the anti-tumor activity of 5-fluorouracil and reduce the side effects of methotrexate more than calcium folinate alone
[0011] The stevioside added in the present invention has a good solubilizing effect on calcium folinate, solves the problem of its poor water solubility, avoids the introduction of too many impurities, and the addition of some inorganic salt co-solvents will cause the freeze-dried powder to shrink in size, Hard shell and brittleness; at the same time, stevioside also has a good bulking effect. By adding stevioside, the prepared freeze-dried calcium folinate powder basically maintains the original volume, uniform color, and is easy to dissolve to form a clear solution.

Method used

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  • Pharmaceutical composition containing calcium folinate and fluorouracil
  • Pharmaceutical composition containing calcium folinate and fluorouracil
  • Pharmaceutical composition containing calcium folinate and fluorouracil

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1 Preparation of Calcium Folinate Freeze-dried Powder for Injection

[0041] prescription:

[0042]

[0043] making process:

[0044] (1) First add 7200ml of water for injection into the container;

[0045] (2) Add 450g of calcium folinate (calculated as folinic acid) and 270g of stevioside, stir to dissolve completely, and adjust the pH to 7.5 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;

[0046] (3) Add 2.7g of activated carbon for injection, add the remaining water for injection, set the volume to 9000ml, stir and absorb for 30 minutes;

[0047] (4) The solution is decarbonized by coarse filtration, coarsely filtered through a 0.45 μm cartridge filter, and then sterilized and filtered with a 0.22 μm microporous membrane until the visible foreign matter is qualified;

[0048] (5) Filling, 1ml / bottle or 2ml / bottle or 6ml / bottle;

[0049] (6) Freeze drying

[0050] ① During the pre-freezing period, lower the shelf temperat...

Embodiment 2

[0053] Example 2 Preparation of Calcium Folinate Injection

[0054] prescription:

[0055]

[0056] making process:

[0057] (1) First add 14400ml water for injection into the liquid mixing tank;

[0058] (2) Add 180g of calcium folinate (calculated as folinic acid) and 180g of stevioside, stir to dissolve completely, and adjust the pH to 7.7 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;

[0059] (4) Add 5.4g of activated carbon for injection, add the remaining water for injection, set the volume to 18000ml, stir and absorb for 30 minutes;

[0060] (5) The solution is decarbonized by coarse filtration, coarsely filtered through a 0.45 μm cartridge filter, and then sterilized and filtered with a 0.22 μm microporous membrane until the visible foreign matter is qualified;

[0061] (6) Filling, 3ml / bottle or 50ml / bottle or 10ml / bottle, seal, sterilize to obtain calcium folinate injection.

Embodiment 3

[0062] Example 3 Preparation of Fluorouracil Injection

[0063] prescription:

[0064]

[0065] making process:

[0066] (1) First add 8000ml of water for injection into the container;

[0067] (2) Add 250g of fluorouracil, stir to dissolve completely, and adjust the pH to 8.7 with 1mol / L sodium hydroxide solution;

[0068] (3) Add 5g of activated carbon for injection, add the remaining water for injection, constant volume, stir and absorb for 30 minutes;

[0069] (4) The solution is decarbonized by coarse filtration, coarsely filtered through a 0.45 μm cartridge filter, and then sterilized and filtered with a 0.22 μm microporous membrane until the visible foreign matter is qualified;

[0070] (5) Filling, 10ml / bottle, sealing, and sterilizing to obtain fluorouracil injection.

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Abstract

The invention relates to a pharmaceutical composition containing calcium folinate and fluorouracil, and particularly relates to a combined application package comprising a calcium folinate injection and an injection containing fluorouracil. When the combined application package is in use, the calcium folinate injection is intravenously injected and then the fluorouracil injection is intravenously injected.

Description

technical field [0001] The invention relates to a pharmaceutical composition of calcium folinate and fluorouracil, in particular to a combined application package of calcium folinate injection and injection containing fluorouracil, belonging to the technical field of medicine. Background technique [0002] Calcium folinate is a formylated derivative of the reduced form of folic acid, which is the activated form of folic acid in the body. Folate antagonists such as methotrexate block the conversion of folic acid to tetrahydrofolate by binding to dihydrofolate reductase. Calcium folinate can directly provide the activated form of folic acid in the body, which can "rescue" the toxic reaction of excessive folic acid antagonists in the body, and is beneficial to the synthesis of thymine nucleotides, DNA, RNA and even protein. Calcium folinate can limit the damage of methotrexate to normal cells, through mutual competition, and can reverse the response of methotrexate to bone mar...

Claims

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Application Information

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IPC IPC(8): A61K31/519A61K47/26A61P35/00A61K31/513
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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