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Calcium folinate drug composition freeze-dried powder injection for treating leukocytopenia

A technology for leukopenia and freeze-dried powder injection, applied in the field of medicine, can solve problems such as unqualified and foreign body clarity, and achieve the effects of improving fluidity, improving drug efficacy and good stability

Inactive Publication Date: 2015-11-25
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] 200910001262.9 discloses a composition of calcium folinate and phenylalanine, a freeze-dried powder injection and a preparation method thereof, although the composition of calcium folinate and phenylalanine solves the problem of water solubility during preparation, but It is difficult to solve the problems of visible foreign matter and unqualified clarity during reconstitution

Method used

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  • Calcium folinate drug composition freeze-dried powder injection for treating leukocytopenia
  • Calcium folinate drug composition freeze-dried powder injection for treating leukocytopenia
  • Calcium folinate drug composition freeze-dried powder injection for treating leukocytopenia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Example 1: Preparation of Calcium Folinate Crystals

[0028] (1) Prepare water, N,N-dimethylformamide as a mixed solvent, and the volume ratio of water and N,N-dimethylformamide is 2:1;

[0029] (2) Take the calcium folinate raw material, dissolve it in the mixed solvent of water and N,N-dimethylformamide whose volume is 6 times the weight of calcium folinate in step (1), heat up to 35°C, and stir until All dissolved to obtain calcium folinate solution;

[0030] (3) Under the condition of a stirring speed of 560r / min, add the calcium folinate solution in step (2) into ethanol whose volume is 5 times the weight of calcium folinate at 40°C, mix to form a suspension, and heat at 10°C Cool down to -10°C at a rate of / min;

[0031] (4) Perform suction filtration, wash the filter cake, and then vacuum-dry the filter cake to obtain a crystalline powder, which is the calcium folinate compound.

[0032] The X-ray powder diffraction pattern obtained by the prepared calcium f...

Embodiment 2

[0033] Example 2: Preparation of calcium folinate freeze-dried powder injection:

[0034] Prescription: in parts by weight, 0.8 parts by weight of the calcium folinate crystal compound prepared in Example 1, and 0.4 parts by weight of low molecular weight dextran.

[0035] Take the calcium folinate compound of the present invention, stir and dissolve it with water for injection, add the prescribed amount of low-molecular-weight dextran, adjust the pH value to 6.0-8.0, then stir until the pH remains constant, then add water for injection until the volume of the solution is folinic acid 150 times the weight of calcium, then coarsely filter with activated carbon, pass through 1.0μm, 0.45μm, 0.22μm microporous membranes in turn to sterilize and filter, filter into a sterile room, measure the pH and content to pass, fill, and press half the plug , put it into a freeze-drying box that has been cooled to -35°C, freeze-dry at low temperature, press the plug out of the box, and cover...

Embodiment 3

[0038] Example 3: Preparation of calcium folinate freeze-dried powder injection:

[0039] Prescription: in parts by weight, 0.8 parts by weight of the calcium folinate compound prepared in Example 1, and 0.6 parts by weight of low molecular weight dextran.

[0040]Take the calcium folinate compound of the present invention, stir and dissolve it with water for injection, add the prescribed amount of low-molecular dextran, adjust the pH value to 6.0-8.0, then stir until the pH remains constant, then add water for injection until the volume of the solution is folinic acid 150 times the weight of calcium, then coarsely filter with activated carbon, then pass through 1.0μm, 0.45μm, 0.22μm microporous membranes to sterilize and filter, filter into a sterile room, measure the pH and content to pass, fill, and press half the plug , put it into a freeze-drying box that has been cooled to -35°C, freeze-dry at low temperature, press the plug out of the box, and cover it.

[0041] Desc...

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Abstract

The invention relates to a calcium folinate drug composition freeze-dried powder injection for treating leukocytopenia, and belongs to the technical field of medicines. The calcium folinate drug composition freeze-dried powder injection comprises calcium folinate and an excipient, wherein the excipient is low molecular dextran; calcium folinate is a novel crystal compound which is different from that reported in the prior art, and the X-ray powder diffraction pattern obtained through measurement by using Cu-K-alpha rays is as shown in the figure 1. Experiments show that compared with the prior, the calcium folinate crystal compound provided by the invention, is lower in impurity content, better in stability, and obviously improved in solubility in water and mobility, solves the problems in the prior art that calcium folinate is poor in solubility, poor in stability and high in content of related substances, provides convenience for preparation of preparations, and greatly improves the curative effect; besides, the freeze-dried powder injection prepared by utilizing the novel crystal compound is good in re-dissolution, good in stability, good in stability after being compounded with a solvent, extremely low in content of insoluble particles and particularly suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a calcium leucovorin composition freeze-dried powder injection for treating leukopenia. Background technique [0002] Calcium folinate has a detoxifying effect on methotrexate (MTX). MTX is a folic acid antagonist. The anti-tumor mechanism of MTX is that its structure is similar to folic acid, which can inhibit the activity of dihydrofolate reductase, resulting in the lack of tetrahydrofolate (FH4) in cells, thereby affecting the synthesis of purine and pyrimidine nucleotides. Inhibits tumor cell growth. While MTX inhibits the growth of tumor cells, it also makes normal cells, especially fast-growing cells, lack FH4, resulting in greater toxicity. Therefore, the anti-tumor effect of MTX not only depends on its inhibition of tumor cells, but also the body's tolerance to MTX affects its final result. CF is a formylated derivative of folic acid reduction, which is the activated fo...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/519C07D475/04A61P7/00
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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