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Medical combination of Carmustine, the preparing method and use thereof

A carmustine and composition technology, which can be applied to pharmaceutical combinations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. inconvenience etc.

Active Publication Date: 2007-09-12
MUDANJIANG HENGYUAN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, carmustine has extremely low solubility in water and is unstable, so there are certain difficulties when it is prepared into a preparation
For example, the currently marketed carmustine injection is a solution made by dissolving 125 mg of carmustine raw material in 2 g of polyethylene glycol 400. The validity period is only 6 months, and it needs to be protected from light, sealed, and stored in a cold place. Very inconvenient for clinical application
[0004] In order to solve the solubility and stability problems of carmustine, many documents have reported that it is made into powder injections with phospholipids, sterols, etc., and mixed with aqueous solution and powder injections to form carmustine liposomes. Injection; another document reports that it is made into preparations such as anti-cancer sustained-release injections composed of sustained-release microspheres and solvents. However, the above preparations have the disadvantages of complicated preparation process and high cost.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Carmustine 125mg

[0031] Macrogol 200 450mg

[0032] Tween-80 1200mg

[0033] Mannitol 800mg

[0034]Water for injection to 7ml

[0035] Mix and stir carmustine, polyethylene glycol 200 and Tween 80, add mannitol aqueous solution, mix, adjust pH to 4 with 1% hydrochloric acid solution, add 0.1% activated carbon to the solution and stir for 20 minutes. After the solution was decarbonized by coarse filtration with a 0.8 μm filter membrane, it was sterilized with a 0.22 μm filter membrane and dispensed into vials. According to " Chinese Pharmacopoeia 2005 edition (two) " appendix IX B method, the solution prepared and the turbidity standard solution of equal amount are respectively placed in paired turbidimetric glass tubes, after the turbidity standard solution is prepared 5 minutes, Place them vertically under the canopy lamp in the dark room, the illumination is 1000Lx, observe and compare from the horizontal direction, the prepared ...

Embodiment 2

[0037] Carmustine 125mg

[0038] Macrogol 400 350mg

[0039] Tween-80 1600mg

[0040] Mannitol 1000mg

[0041] Water for injection to 10ml

[0042] Mix and stir carmustine, polyethylene glycol 400 and Tween 80, add mannitol aqueous solution, mix, adjust pH to 4 with 1% hydrochloric acid, add 0.1% activated carbon to the solution and stir for 20 minutes. After the solution was decarbonized by coarse filtration with a 0.8 μm filter membrane, it was sterilized with a 0.22 μm filter membrane and dispensed into vials. According to " Chinese Pharmacopoeia 2005 edition (two) " appendix IX B method, the solution prepared and the turbidity standard solution of equal amount are respectively placed in paired turbidimetric glass tubes, after the turbidity standard solution is prepared 5 minutes, Place them vertically under the canopy lamp in the dark room, the illumination is 1000Lx, observe and compare from the horizontal direction, the prepare...

Embodiment 3

[0044] Carmustine 125mg

[0045] Macrogol 400 500mg

[0046] Tween-80 1300mg

[0047] Mannitol 900mg

[0048] Water for injection to 8ml

[0049] Prepare carmustine injection according to the method of embodiment 1, according to " Chinese Pharmacopoeia 2005 edition (two) " appendix IX B method, the solution prepared and the turbidity standard solution of equal amount are respectively placed in paired turbidimetric use In the glass tube, 5 minutes after the preparation of the turbidity standard solution, place it vertically under the canopy lamp in the dark room, the illumination is 1000Lx, observe and compare from the horizontal direction, the prepared solution is clear, not deeper than No. 1 turbidity standard liquid.

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PUM

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Abstract

The present invention discloses one kind of carmustine medicine composition, which includes carmustine in effective treating amount, surfactant of Tween, and cosolvent of glycerin and / or polyglycol. The carmustine medicine composition may be injection or freeze dried powder for injection. The addition of Tween and cosolvent can raise the solubility of carmustine. The present invention also discloses the preparation process of the carmustine medicine composition.

Description

technical field [0001] The invention relates to a pharmaceutical composition of carmustine, a preparation method and application of the composition. Background technique [0002] Carmustine is a nitrosourea alkylating agent that can covalently bind to DNA, destroying the structure and function of DNA; it can also inhibit DNA polymerase and inhibit DNA and RNA synthesis. It is cell cycle non-specific and has the strongest effect on cells in the G-S transition phase, delays the S phase, and can also act on G 2 Expect. The characteristics of this drug are broad anti-tumor spectrum, rapid effect, high fat solubility, and incomplete cross-resistance between other alkylating agents. Because carmustine can pass through the blood-brain barrier, it is effective against brain tumors (malignant glioma, brainstem glioma, medulloblastoma, astroglioma, ependymoma), brain metastases It is effective for meningeal leukemia, malignant lymphoma and multiple myeloma, and effective for malign...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/17A61K31/337A61K9/19A61K47/34A61K47/28A61P35/00
CPCA61K9/0019A61K9/19A61K31/17A61K9/08A61P35/00
Inventor 郝守祝
Owner MUDANJIANG HENGYUAN PHARMA CO LTD
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