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Medicine calcium folinate composition for treating leukocyte anemia

A technology of calcium folinate and its composition, which is applied in the field of medicine, can solve the problems of increased preparation cost, poor storage stability, instability, etc., and achieve the effects of low content of insoluble particles, improved fluidity, and good stability

Inactive Publication Date: 2015-11-18
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The solubility of calcium folinate in water is not ideal. In practice, it is found that calcium folinate is not easy to dissolve when the water temperature is lower than 30°C. If the dissolution is not good, the content will decrease. It is sensitive to factors such as temperature, pH value, and oxygen, resulting in the increase of related substances. , unstable, easy to decompose when exposed to light, and poor storage stability, which limits the application and clinical application of its preparations, and increases the cost of preparations
Although calcium folinate reduces the toxic effect of the antineoplastic drug MTX, its toxic effect cannot be ignored
The existing technology solves the problems of water solubility and stability by changing the excipients and preparation methods of the preparation. It must rely on specific prescriptions and processes to achieve its stable effect, which brings certain limitations to the preparation of preparations and the selection of excipients. sex

Method used

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  • Medicine calcium folinate composition for treating leukocyte anemia
  • Medicine calcium folinate composition for treating leukocyte anemia
  • Medicine calcium folinate composition for treating leukocyte anemia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1: Preparation of calcium folinate crystals

[0023] (1) Dissolve calcium folinate in a mixed solvent of acetone and water, the required amount of solvent per gram of calcium folinate is 80ml, and the volume ratio of acetone and water is 1:5;

[0024] (2) After heating to 35°C to dissolve, cooling to room temperature and adding seed crystals;

[0025] (3) Cool to below 0°C, stir for crystallization, the temperature of crystallization is -10°C, filter, dry, and collect the crystals to obtain calcium folinate crystals.

[0026] The X-ray powder diffraction pattern of the prepared calcium folinate crystals measured by Cu-Kα rays is as follows figure 1 shown.

Embodiment 2

[0027] Example 2: Preparation of calcium folinate composition

[0028] The composition is as follows: 1 part by weight of calcium folinate crystals prepared in Example 1 of the present invention, and 0.04 part by weight of sodium chloride.

[0029] The preparation method is:

[0030] (1) Weigh calcium folinate crystals and sodium chloride in proportion, and mix them thoroughly;

[0031] (2) Dispense into sterilized vials and stopper.

Embodiment 3

[0032] Example 3: Preparation of calcium folinate composition

[0033] The composition is as follows: 1 part by weight of calcium folinate crystals prepared in Example 1 of the present invention, and 0.05 part by weight of sodium chloride.

[0034] The preparation method is:

[0035] (1) Weigh calcium folinate crystals and sodium chloride in proportion, and mix them thoroughly;

[0036] (2) Dispense into sterilized vials and stopper.

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Abstract

The invention discloses a medicine calcium folinate composition for treating leukocyte anemia, and belongs to the technical field of medicines. The composition is prepared form calcium folinate and sodium chloride; an X-ray powder diffraction pattern measured by a Cu-Kalpha ray is as shown in the figure 1. The novel crystal form of the calcium folinate disclosed by the invention is different from the crystal form structure in the prior art. Compared with the prior art, the calcium folinate composition disclosed by the invention is low in impurity content and better in stability; the solubility and the mobility of the calcium folinate compound are obviously improved in comparison with the prior art; convenience is provided for preparation of a preparation; the medicine effect is also greatly improved; a powder injection prepared from the novel crystal form compound is good in stability, and has good stability after being combined with a solvent; and the insoluble particle content is extremely low, so that the medicinal calcium folinate composition is very suitable for clinical application.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a drug calcium folinate composition for treating leukocytic anemia. 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 form of folic acid in ...

Claims

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Application Information

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IPC IPC(8): A61K33/14A61K31/519A61K9/00C07D475/04A61P35/00
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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