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Medical combination of teniposide, the preparing method and use thereof

A teniposide and composition technology, which is applied in the field of teniposide pharmaceutical compositions, can solve the problems of high cost, complicated preparation process and the like, and achieve the effects of less irritation, reduced allergic reaction and convenient clinical use

Active Publication Date: 2010-01-06
河北道恩药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In order to solve the solubility problem of teniposide, many literatures have reported 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 complex preparation processes and high costs. shortcoming

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Teniposide 50mg

[0031] Tween-80 1200mg

[0032] N,N-Dimethylacetamide 200mg

[0033] Macrogol 200 450mg

[0034] Sodium chloride 800mg

[0035] Mannitol 800mg

[0036] Water for injection to 9ml

[0037]Dissolve teniposide in N, N-dimethylacetamide, then mix and stir with Tween 80 and polyethylene glycol 200, add sodium chloride and mannitol aqueous solution, mix, adjust pH with maleic acid 5, the solution was added with 0.1% activated carbon and stirred 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 then packed 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 ro...

Embodiment 2

[0039] Teniposide 50mg

[0040] Tween-80 1600mg

[0041] Macrogol 400 350mg

[0042] N,N-Dimethylacetamide 150mg

[0043] Sodium Sulfate 500mg

[0044] Mannitol 900mg

[0045] Water for injection to 10ml

[0046] Dissolve teniposide in N, N-dimethylacetamide, then mix and stir with Tween 80 and polyethylene glycol 400, add sodium chloride and mannitol aqueous solution, mix, adjust pH with maleic acid 5, the solution was added with 0.1% activated carbon and stirred 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 then packed 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 r...

Embodiment 3

[0048] Teniposide 50mg

[0049] Macrogol 400 500mg

[0050] Tween-80 1300mg

[0051] N,N-Dimethylacetamide 100mg

[0052] Potassium chloride 700mg

[0053] Mannitol 900mg

[0054] Water for injection to 10ml

[0055] Prepare teniposide 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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Abstract

The invention discloses a medicinal component of substitute nipa glycosides, which is characterized by the following: incorporating substitute nipa glycosides, Tuwen surface activator, assisting solvent and inorganic salt; choosing the assisting solvent as mixture of dimethyl ethanolamine and carbowax; choosing the inorganic salt from one or multiple common salt, potassium chloride, sulphate and sulphate; setting this component as injection or freeze dry powder needle; adding into Tuwen and the assisting dissolvent; adding into the inorganic salt at the same time; increasing solubility of substitute nipa glycosides. This invention also relates to the preparing method and usage of this medicinal component.

Description

technical field [0001] The invention relates to a pharmaceutical composition of teniposide, a preparation method and application of the composition. Background technique [0002] Teniposide is a cycle-specific cytotoxic drug that inhibits topoisomerase II, causes DNA fragmentation, and blocks mitosis in the S and G2 phases of the cell cycle. For experimental mouse tumors, teniposide has a broad spectrum of anti-tumor activity in vivo; clinically, teniposide is mainly used for malignant lymphoma, acute lymphoblastic leukemia, central nervous system malignant tumors such as neuroblastoma Treatment of cell tumors, gliomas, astrocytomas and metastases, bladder cancer and neuroblastoma. [0003] However, teniposide has extremely low solubility in water, so there are certain difficulties in preparing it into a preparation. For example, the teniposide injection currently on the market is 50 mg of teniposide dissolved in 5 ml of organic solvents: N, N-dimethylacetamide, benzyl alc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7048A61K9/08A61K9/19A61K47/34A61P35/00A61K47/10A61K47/18A61K47/26
Inventor 郝守祝
Owner 河北道恩药业有限公司
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