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Cyclophosphamide composition freeze-dried powder for injection

A technology of cyclophosphamide and freeze-dried powder injection, which is applied in the direction of freeze-dried delivery, drug combination, powder delivery, etc., can solve the problems of shortening the dissolution time, achieve the effects of improving chemical stability, enhancing activity, and reducing side effects

Inactive Publication Date: 2014-01-29
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Chitosan nanoparticles are particles with a particle size of less than 100nm, which can replace mannitol as a freeze-dried skeleton agent for freeze-dried powder injections, eliminate the active effect of mannitol on the human body, and enhance the solubility of the main drug in water. Shorten its dissolution time, as a drug carrier, it has slow-release and targeting effects, and has antibacterial activity, and has a certain inhibitory effect on the growth of various bacteria, but there is no clinically available chitosan nanoparticles. Pharmaceutical dosage form

Method used

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  • Cyclophosphamide composition freeze-dried powder for injection
  • Cyclophosphamide composition freeze-dried powder for injection
  • Cyclophosphamide composition freeze-dried powder for injection

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Effect test

Embodiment 1

[0027] The preparation of the freeze-dried powder injection of embodiment 1 injection cyclophosphamide composition (with 2000)

[0028] prescription

[0029] Cyclophosphamide 200g

[0030] Chitosan 100g

[0031] Water for injection 4000mL

[0032] Preparation Process

[0033] (1) Weigh 200g of cyclophosphamide and 100g of chitosan nanoparticles, slowly add a certain amount of water for injection cooled to room temperature, and stir until dissolved at 20°C±2°C.

[0034] (2) Weigh 150g of potassium hydroxide to prepare a solution, adjust the pH of the sample solution to 8.0, add water for injection to the resulting solution to the full amount, then add 2g of activated carbon and stir for 30min, filter to remove the activated carbon, and pass the liquid through 0.45μm and 0.22 After the μm microporous membrane is filtered, the content of the intermediate is detected, and the filling amount is calculated as 0.1g (calculated as cyclophosphamide) per bottle.

[0035] (3) Fill a...

Embodiment 2

[0036] The preparation of the freeze-dried powder injection of embodiment 2 injection cyclophosphamide composition (with 2000)

[0037] prescription

[0038] Cyclophosphamide 400g

[0039] Chitosan 200g

[0040] Water for injection 8000mL

[0041] Preparation Process

[0042] (1) Weigh 400g of cyclophosphamide and 200g of chitosan nanoparticles, slowly add a certain amount of water for injection cooled to room temperature, and stir until dissolved at 20°C±2°C.

[0043] (2) Weigh 150g of potassium hydroxide to prepare a solution, adjust the pH of the sample solution to 8.0, add water for injection to the resulting solution to the full amount, then add 4g of activated carbon and stir for 30min, filter to remove the activated carbon, and pass the liquid through 0.45μm and 0.22 After the μm microporous membrane is filtered, the intermediate content is detected again, and the filling amount is calculated as 0.2g (calculated as cyclophosphamide) per bottle.

[0044] (3) Fill ac...

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Abstract

The invention provides a cyclophosphamide composition freeze-dried powder for injection, and belongs to the field of medicine and medicine preparation technology. The cyclophosphamide composition freeze-dried powder comprises following raw material ingredients, by weight, 200 to 400 parts of cyclophosphamide, 100 to 200 parts of chitosan nanoparticle, and 4000 to 8000 parts of injection water. The cyclophosphamide composition is prepared by mixing cyclophosphamide with the chitosan nanoparticle at an appropriate ratio, and is made into freeze-dried powder injection so as to be used as a novel antibacterial medicine in clinic, wherein cyclophosphamide and the chitosan nanoparticle possess synergistic effect. Advantages of the cyclophosphamide composition freeze-dried powder are that: (1) composition is reasonable, and medicine solubility is increased; (2) chemical stability of freeze-dried cyclophosphamide is increased as high as possible; and (3) medication reconciliation is capable of increasing medicine activity, and reducing medicine toxic and side effect.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a cyclophosphamide composition freeze-dried powder for injection. Background technique: [0002] The chemical name of cyclophosvnamide (cyclophosvnamide, CTX) is P-[N,N-bis(β-chloroethyl)]-1-oxo-3-nitrogen-2-phosphorinane-P-oxide. This product is white crystal or crystalline powder (it will liquefy when losing crystal water), stable at room temperature. Insoluble in ether and acetone, slightly soluble in water, but not very soluble. The aqueous solution is unstable, so it should be used within a short time after dissolving. Soluble in ethanol. Cyclophosphamide is a bifunctional alkylating agent and a non-specific cell cycle drug, which can interfere with DNA and RNA functions, especially the former. It cross-links with DNA and inhibits DNA synthesis. It has the most obvious effect on S phase. It is the most commonly used latent nitrogen mustard alky...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/675A61K31/722A61K47/36A61P35/00A61P35/02A61P29/00A61P19/02A61P13/12A61P37/02A61P31/04
Inventor 汪六一汪金灿李彪
Owner HAINAN WEI KANG PHARMA QIANSHAN
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