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Nelarabine parenteral solution and method for preparing same

A technology for injection and drug nerabine, applied in the field of medicine, can solve problems such as poor solubility

Inactive Publication Date: 2010-03-31
北京福瑞康正医药技术研究所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The deoxyguanosine analogue 9-β-D-arabinofuranosylguanine (ara-G) was discovered in the 1960s, but it has not been used clinically due to poor solubility

Method used

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  • Nelarabine parenteral solution and method for preparing same
  • Nelarabine parenteral solution and method for preparing same
  • Nelarabine parenteral solution and method for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0094] Add nelarabine and sodium chloride with a weight ratio of 10:9 to 50°C water for injection, stir to dissolve completely, add hydrochloric acid to adjust the pH value to 5.0, add 50°C water for injection, stir evenly, add activated carbon, and stir Evenly, stand at 50°C, coarse filter to remove activated carbon, keep the liquid medicine at 50°C, filter the liquid medicine while it is hot with a 0.22μm filter membrane, pour the liquid medicine into the infusion bottle, use the treated rubber stopper to press the stopper, the temperature Keep it at 50°C with an aluminum cover, put the sample into a sterilizer, and sterilize it with autoclaved steam.

Embodiment 2

[0096] Add nelarabine and sodium chloride with a weight ratio of 10:9 to 90°C water for injection, stir to dissolve completely, add hydrochloric acid to adjust the pH value to 5.0-7.0, add 90°C water for injection, stir evenly, add activated carbon , stir evenly, stand at 90°C, coarse filter to remove activated carbon, keep the liquid medicine at 90°C, filter the liquid medicine while it is hot with a 0.22μm filter membrane, pour the liquid medicine into the infusion bottle, and press the stopper with the treated rubber stopper , the temperature is kept at 90°C, and the aluminum cover is rolled on, the sample is put into a sterilizing pot, and autoclaved and steam sterilized, and the obtained product is obtained.

Embodiment 3

[0098] Add nelarabine and sodium chloride with a weight ratio of 10:9 to 60°C water for injection, stir to dissolve completely, add hydrochloric acid to adjust the pH value to 5.0-7.0, add 60°C water for injection, stir evenly, add activated carbon , stir evenly, stand at 60°C, coarsely filter to remove activated carbon, keep the liquid medicine at 60°C, filter the liquid medicine while it is hot with a 0.22μm filter membrane, pour the liquid medicine into the infusion bottle, and use the treated rubber stopper to press the stopper , the temperature is kept at 60°C, and an aluminum cover is rolled on, the sample is put into a sterilizing pot, and autoclaved steam is sterilized, and the obtained product is obtained.

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Abstract

The invention discloses nelarabine parenteral solution and a method for preparing the same. In the process for preparing the parenteral solution, temperature is kept at 50 to 90 DEG C at which the yield of the prepared nelarabine parenteral solution is greatly improved, which provides a good illustration for the influence of the temperature on the stability of the solution of basic medicament andpharmaceutical adjuvant in the process for preparing the nelarabine parenteral solution, and the nelarabine parenteral solution prepared at the temperature is of great scientific significance.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a nelarabine injection and a preparation method thereof. Background technique [0002] T-ALL and T-LBL are two rapidly deteriorating diseases that seriously affect the body's hematopoietic function. The incidence of T-ALL in my country is second only to common acute lymphoblastic leukemia (C-ALL), accounting for the second place in the incidence of acute lymphoblastic leukemia. T-cell ALL usually affects older children, adolescents, and young adults and is less common than B-cell ALL. Approximately 1,600 adults and children in the United States are diagnosed with T-ALL or T-LBL each year. With the application of cyclophosphamide, cytarabine, and L-asparaginase, the response rate and survival rate of T-cell lymphoblastic leukemia and T-cell lymphoblastic tumor have been greatly improved. However, the effect of salvage chemotherapy for relapsed patients is limited, and the resp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/708A61P35/02
Inventor 顾群金治刚米长江姜威李志刚
Owner 北京福瑞康正医药技术研究所
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