Preparation method of calcium levofolinate impurity and impurity calcium salt

A technology for calcium levofolinate and impurities, applied in the field of chemical pharmacy, can solve the problems of low purity of 10-formyl dihydrofolate, etc., and achieve the effects of low equipment requirements, simple process and high calibration content
CN110229155AActive Publication Date: 2019-09-13CHONGQING HUABANGSHENGKAI PHARM
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
CHONGQING HUABANGSHENGKAI PHARM
Publication Date
2019-09-13

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Abstract

Belonging to the field of chemical pharmacy, the invention relates to a preparation method of a standard drug impurity substance, in particular to the preparation method of a calcium levofolinate impurity and an impurity calcium salt. Firstly, the invention provides a preparation method of calcium levofolinate impurity, and the method includes: taking the compound folic acid shown as formula I asthe raw material for reaction with a reductant in an aqueous solution, and adjusting the pH value of the reaction solution with an alkali aqueous solution and inorganic acid respectively to obtain thecompound dihydrofolic acid shown as formula II; and reacting the compound shown as II with formic acid, adding purified water, and performing stirring and filtering to obtain the compound 10-formyl dihydrofolate shown as formula III. The invention also provides a preparation method of 10-calcium formyl dihydrofolate, and the method includes: taking folic acid as the raw material, firstly preparing dihydrofolic acid, then reacting dihydrofolic acid with formic acid to obtain 10-formyl dihydrofolate, then adding a calcium salt, and carrying out reaction to obtain 10-calcium formyl dihydrofolate.
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Description

technical field

[0001] The invention belongs to the field of chemical pharmacy, and relates to a preparation method of a drug impurity standard product, in particular to a preparation method of calcium levofolinate impurity and impurity calcium salt. Background technique

[0002] Calcium levofolinate is a drug mainly used to treat symptoms related to folic acid antagonism after high-dose methotrexate treatment of osteosarcoma. It can also be used to treat giant cell anemia caused by folic acid deficiency. It can also be used in combination with fluorouracil to prolong Survival or remission of symptoms in patients with advanced colon cancer.

[0003] In the European Pharmacopoeia, it is stipulated that the impurity of calcium levofolinate, that is, 10-formyl dihydrofolate should be quantitatively studied and included in the quality standard. The prior art has its own advantages and disadvantages for the preparation methods of 10-formyl dihydrofolate. For example, in the pate...

Claims

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