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Medical composition of Carmustine, the preparing method and use thereof

A carmustine and composition technology, which can be used in pharmaceutical combinations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problems of complex, unstable, difficult preparation and the like in the preparation process

Active Publication Date: 2009-09-30
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 in preparing it into formulations
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] Polyethylene glycol 200 450mg

[0032] Tween-80 1200mg

[0033] Mannitol 800mg

[0034] Water for injection to 7ml

[0035]Carmustine was mixed with polyethylene glycol 200 and Tween 80 and stirred, added mannitol aqueous solution, mixed, adjusted pH to 4 with 1% hydrochloric acid solution, and the solution was added with 0.1% activated carbon and stirred for 20 minutes. After the solution is coarsely filtered and decarbonized by a 0.8μm filter membrane, it is then sterilized with a 0.22μm filter membrane and packed into vials. According to the method in Appendix IX B of "Chinese Pharmacopoeia 2005 Edition (Part Two)", put the prepared solution and the same amount of turbidity standard solution in matched glass tubes for turbidity, and 5 minutes after preparing the turbidity standard solution, In the dark room, it is placed vertically under the umbrella canopy lamp, and the illuminance is 1000Lx. Observed and compared from the horizontal direction,...

Embodiment 2

[0037] Carmustine 125mg

[0038] Polyethylene glycol 400 350mg

[0039] Tween-80 1600mg

[0040] Mannitol 1000mg

[0041] Water for injection to 10ml

[0042] Carmustine was mixed with polyethylene glycol 400 and Tween 80 and stirred, added with mannitol aqueous solution, mixed, adjusted to pH 4 with 1% hydrochloric acid, and the solution was added with 0.1% activated carbon and stirred for 20 minutes. After the solution is coarsely filtered and decarbonized by a 0.8μm filter membrane, it is then sterilized with a 0.22μm filter membrane and packed into vials. According to the method in Appendix IX B of "Chinese Pharmacopoeia 2005 Edition (Part Two)", put the prepared solution and the same amount of turbidity standard solution in matched glass tubes for turbidity, and 5 minutes after preparing the turbidity standard solution, In the dark room, it is placed vertically under the umbrella canopy lamp, and the illuminance is 1000Lx. Observed and compared from the horizontal direction, ...

Embodiment 3

[0044] Carmustine 125mg

[0045] Polyethylene glycol 400 500mg

[0046] Tween-80 1300mg

[0047] Mannitol 900mg

[0048] Water for injection to 8ml

[0049] Carmustine injection was prepared according to the method of Example 1. According to the method in Appendix IX B of "Chinese Pharmacopoeia 2005 Edition (Part Two)", the prepared solution and the same amount of turbidity standard solution were placed in the matched turbidity In the glass tube, after preparing the turbidity standard solution for 5 minutes, place it in the dark room under the umbrella canopy lamp vertically, with an illuminance of 1000Lx. Observing and comparing from the horizontal direction, the prepared solution is clear and not deeper than No. 1 turbidity standard liquid.

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PUM

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Abstract

The invention discloses a medicinal composition of carmustine, comprising cure effective quantity of carmustine, Tween type surface active agent and latent solvent. The latent solvent is chosen from one or more of glycerin or polyethyleneglycol. This composition can be injection or frozen powder injection. Solubility of carmustine can be increased by adding Tween and latent solvent. This invention further discloses method of preparing this medicinal composition.

Description

Technical field [0001] The invention relates to a medicinal composition of carmustine, a preparation method and application of the composition. Background technique [0002] Carmustine is a nitrosourea alkylating agent, which can covalently bind to DNA and destroy the structure and function of DNA; it can also inhibit DNA polymerase and inhibit DNA and RNA synthesis. It has cell cycle non-specificity. It has the strongest effect on the cells in the G-S transition phase, delays the S phase, and can also act on the G 2 period. The function of this drug is characterized by a wide anti-tumor spectrum, rapid effect, high fat solubility, and incomplete cross-resistance among other alkylating agents. Carmustine can pass through the blood-brain barrier, so it is effective against brain tumors (malignant glioma, brainstem glioma, medulloblastoma, astroglioma, ependymoma), brain metastases It is effective for meningeal leukemia, for malignant lymphoma and multiple myeloma, and for malignan...

Claims

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Application Information

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Patent Type & Authority Patents(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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