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Injection composition of pemetrexed disodium and preparation method of injection composition

A technology of pemetrexed disodium and water for injection, which is applied in the field of pemetrexed disodium injection composition and its preparation, can solve the problems of complicated preparation process and increased cost, and achieve simple preparation process and reduced manufacturing cost , the effect of improving economic benefits

Active Publication Date: 2013-01-02
DEZHOU DEYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, its preparation process is still relatively complicated, resulting in an increase in cost

Method used

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  • Injection composition of pemetrexed disodium and preparation method of injection composition
  • Injection composition of pemetrexed disodium and preparation method of injection composition
  • Injection composition of pemetrexed disodium and preparation method of injection composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Under light-proof operation, add mannitol and β-cyclodextrin in the amount described in Table 1 into the liquid mixing tank, add about 80% water for injection, stir to dissolve, and add 500 g of pemetrexed disodium in the amount described in Table 1 , Stir to dissolve. Adjust the pH to 7.0-8.2 with 0.1 mol / L hydrochloric acid solution or sodium hydroxide solution, add water for injection to the full amount, and stir evenly. Then add 0.1% (g / ml) activated carbon, stir at room temperature for 30 minutes, filter and remove the carbon with a titanium filter rod, and use a double-layer 0.15 μm microporous membrane to remove bacteria.

[0048] Then freeze-dry.

[0049] (1) Pre-freezing period: Put it in a freeze-drying box, set the shelf temperature to -40°C, and pre-freeze for 3.5 hours after the shelf temperature drops to -40°C.

[0050] (2) Sublimation period: After pre-freezing, vacuumize and set the shelf temperature to 0°C. When the shelf temperature rises to this temperatur...

Embodiment 2-5

[0053] Except that the amount of each raw material is weighed according to Table 1, the remaining steps are the same as those of Example 1. The freeze-dried powder injections of Examples 2-5 were prepared respectively.

Embodiment 6

[0055] Study on the stability of pemetrexed disodium freeze-dried powder for injection

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PUM

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Abstract

The invention relates to an injection composition, and in particular relates to an injection composition of pemetrexed disodium and a preparation method of the injection composition. The injection composition is prepared from pemetrexed disodium, mannitol and beta-cyclodextrin. The injection composition of pemetrexed disodium is simple in preparation process and effectively reduces the preparation cost. The pemetrexed disodium freeze-dried powder prepared by the invention has the advantages of excellent dissolvability, few impurity content, low moisture content and good stability.

Description

Technical field [0001] The invention relates to a composition for injection, in particular to a composition for injection of pemetrexed disodium and a preparation method thereof. Background technique [0002] Pemetrexed disodium (Pemetrexed disodium), the chemical name is N-(4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrole[2,3-d]pyrimidine -5-yl)ethyl]benzoyl)-L-glutamic acid disodium salt double hemihydrate. It is a new pyrimidine analog, thymidylate synthase inhibitor. It plays an anti-tumor effect by interfering with folate-dependent metabolic processes during cell replication. Studies have shown that pemetrexed produces cytotoxic effects through intracellular polyglutamate. Polyglutamate inhibits several folate-dependent enzymes including thymidylate synthase, dihydrofolate reductase, and glycine ribose. Nucleoside formyltransferase. [0003] Pemetrexed disodium has a certain therapeutic effect on non-small cell lung cancer, head and neck cancer, colon cancer and breast cancer. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/519A61K47/40A61P35/00
Inventor 卞建钢潘秀芝李成文王金宝赵金水李吉林胡敏
Owner DEZHOU DEYAO PHARMA
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