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Gemcitabine monophosphate solution preparation and application

A technology of gemcitabine monophosphate and preparation, which is applied in the field of medicine and can solve the problems of few pharmacological and applied researches

Active Publication Date: 2021-03-19
JIANGSU JITRI MOLECULAR ENG INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Gemcitabine monophosphate is the first product of gemcitabine metabolism. It is an old compound, but there are few pharmacological and application studies about it. What is the antitumor effect of gemcitabine monophosphate, especially whether it can meet the requirements of the present invention (1) High solubility (2) is non-irritating, and then can be administered by intravenous rapid injection, improving therapeutic effect, etc. There is no prior art report

Method used

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  • Gemcitabine monophosphate solution preparation and application
  • Gemcitabine monophosphate solution preparation and application
  • Gemcitabine monophosphate solution preparation and application

Examples

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Effect test

Embodiment 1

[0037] Pharmaceutical preparation of the present invention, it consists of:

[0038] Gemcitabine Monophosphate 400g

[0039] Sodium bicarbonate 1g

[0040] Water for injection to 1000ml

[0041] Adjust pH6.0

[0042] Take gemcitabine monophosphate, add 800ml of water for injection, put the above ingredients into a stainless steel container, mix and dissolve, adjust the pH with 10% sodium bicarbonate, make up water to 1000ml; filter, sterilize and degas. Aseptically dispense into 5ml vials, sterilize at 100-121°C, package, and store to obtain an aqueous solution of gemcitabine monophosphate.

Embodiment 2

[0043] Example 2 Gemcitabine monophosphate 400g, get gemcitabine monophosphate, add water for injection 800ml, put the above ingredients into a stainless steel container, mix and dissolve, adjust pH5.0 with 10% sodium bicarbonate solution, make up water to 1000ml; Filtration, sterilization, degassing. Filter again with a 0.22-micron membrane to obtain a sterile solution, which is dispensed into 5ml vials to obtain an aqueous solution of gemcitabine monophosphate.

Embodiment 3

[0044] Example 3 Gemcitabine monophosphate 300g, get gemcitabine monophosphate, add water for injection 800ml, put the above ingredients into a stainless steel container, mix and dissolve, adjust the pH to 5.5, make up water to 1000ml; filter, sterilize, and degas. Aseptically dispense into 10ml vials, sterilize at 100-121°C, package, and store to obtain gemcitabine monophosphate aqueous solution preparation.

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Abstract

The invention relates to a gemcitabine monophosphate solution preparation and application. According to the gemcitabine monophosphate solution preparation, the concentration of gemcitabine monophosphate in an aqueous solution is 400 mg / ml, and the pH value of the solution is 5.0-6.0. The preparation is non-irritant, small in acute toxicity, good in stability and suitable for rapid intravenous administration, and the anti-tumor activity is obviously improved.

Description

Technical field: [0001] The invention relates to the field of medicine, in particular to preparation and therapeutic application of gemcitabine monophosphate preparation. [0002] technical background [0003] Gemcitabine hydrochloride is a nucleotide antineoplastic drug developed by Eli Lilly and Company. It was approved for the treatment of pancreatic cancer in 1996, and later used for non-small cell lung cancer, ovarian cancer, breast cancer, bladder cancer, etc. Under the action of nucleoside phosphorylase in the cell, gemcitabine binds a phosphate group at the 5' position to form gemcitabine monophosphate, diphosphate and triphosphate. Among them, diphosphate and triphosphate are active products. Although gemcitabine hydrochloride is the preferred standard drug for the treatment of pancreatic cancer, the therapeutic effect is not ideal. Severe hematological toxicity limits the dose increase, thereby affecting the therapeutic effect. Tumor pharmacology studies have sh...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7068A61K47/02A61P35/00
CPCA61K9/08A61K9/0019A61K31/7068A61K47/02A61P35/00
Inventor 雷晓光汪晓明廖道红张秀国黄道飞
Owner JIANGSU JITRI MOLECULAR ENG INST CO LTD
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