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Oxaliplatin pharmaceutical composition for injection

A technology of oxaliplatin and composition, which is applied in the field of oxaliplatin pharmaceutical composition for injection and its preparation, can solve the problems of poor solubility and poor stability, achieve stable quality, good stability, and simple and easy method line effect

Inactive Publication Date: 2015-03-25
TIANJIN SONGRUI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that its preparation has poor stability and poor solubility

Method used

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  • Oxaliplatin pharmaceutical composition for injection
  • Oxaliplatin pharmaceutical composition for injection
  • Oxaliplatin pharmaceutical composition for injection

Examples

Experimental program
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Embodiment 1

[0075] The described oxaliplatin pharmaceutical composition of every 1000 bottles, its formula consists of:

[0076]

[0077] Preparation methods include:

[0078] 1) Take 70% of the prescribed amount of water for injection, at a temperature of 50-70°C, add the prescribed amount of sodium hydroxide, meglumine, calcium sodium edetate and stir until dissolved, then add the prescribed amount of Oxali to the solution Platinum, stirred until completely dissolved, then added the prescribed amount of mannitol, stirred until completely dissolved;

[0079] 2) Add 0.1% medicinal charcoal by the volume of the liquid medicine to item 1), stir well, and let stand for 30 minutes;

[0080] 3) Filter item 2) with a filter, decarbonize, add water for injection to 97%, mix well, and measure the initial pH value. According to the initial pH value, use 10% sodium hydroxide solution to adjust the pH value range to 6.8± 0.2;

[0081] 4) Central control: carry out intermediate product inspecti...

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Abstract

The invention aims to provide an oxaliplatin pharmaceutical composition for injection and a preparation method thereof. A certain amount of sodium calcium edetate, meglumine and sodium hydroxide are used, the pH value of a solution is regulated firstly, and then oxaliplatin is dissolved, so that the stability of the preparation can be effectively improved, the preparation is unlikely to precipitate and relevant substances are free of changes. The provided new oxaliplatin pharmaceutical composition can be used for completely realizing stability of a preparation solution of oxaliplatin in clinical application.

Description

technical field [0001] The invention relates to an oxaliplatin pharmaceutical composition for injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Oxaliplatin belongs to the third-generation platinum anticancer drug. Because the side chain is replaced by DACH (diaminocyclohexane) group, it is very different from cisplatin in terms of DNA complex composition and anticancer spectrum. same. The results of multiple phase II clinical studies have shown that the curative effect of oxalate platinum alone in the treatment of newly diagnosed colorectal cancer can reach 22%, which is close to that of 5-FU or 5-FU plus folic acid. Since the research at the cell level suggests that oxalate platinum has a significant synergistic effect with 5-FU, the clinical application turns to the combination with 5-FU or 5-FU / FA. At first, it was only used for second-line retreatment chemotherapy, and not only had good cura...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/282A61K31/194A61K47/18A61P35/00
Inventor 张昊
Owner TIANJIN SONGRUI MEDICAL TECH
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