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Double-element solution type preparation for intravenous injection and intracerebral injection

A binary solution and solvent technology, applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, drug delivery, etc., can solve the problems such as it is difficult to meet the quality stability requirements of temozolomide, and achieve the addition of ingredients. single effect

Inactive Publication Date: 2009-07-01
北京京卫燕康药物研究所有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, temozolomide prepared with common solvents will be significantly degraded in just a few hours during the infusion period, and it is difficult to meet the quality stability requirements of temozolomide. Therefore, it is necessary to study a solvent technology that makes temozolomide stable and non-irritating.

Method used

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  • Double-element solution type preparation for intravenous injection and intracerebral injection
  • Double-element solution type preparation for intravenous injection and intracerebral injection
  • Double-element solution type preparation for intravenous injection and intracerebral injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 Temozolomide Powder Injection

[0031] Temozolomide was vacuum-dried and dispensed into brown injection vials of 10ml in volumes of 50, 100 and 200mg.

Embodiment 2

[0032] Embodiment 2 Temozolomide solvent

[0033] Take 3.9ml of glacial acetic acid and add water for injection to make up to 2500ml, and divide it into vials for injection, the filling volume is 2.5, 5 and 10ml.

Embodiment 3

[0034] Example 3 Take 2.5ml / bottle and add to 50mg / bottle Temozolomide solvent to dissolve, and the content is not less than 99% within 48 hours at room temperature.

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PUM

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Abstract

The invention discloses a binary solution type formulation for intravenous and intracerebral injection, shown as right. The main active component thereof is temozolomide with the binary system and having temozolomide sterile powder and solvent for dissolving medicaments. The operating temozolomide solution agent can be obtained through the combination of the solvent. The invention is characterized in that, 1, the binary formulation is stable at the room temperature for over 2 years; 2, the prepared medicaments liquid is stable at the room temperature at least for 48h to meet the operating requirement of injection administration; 3, the solvent is nontoxic and non-irritant, and the prepared medicaments can be used for the intracerebral injection during the operation and stereotaxic intraturmor injection of local chemotherapy.

Description

Technical field: [0001] The invention relates to a solution type preparation of medicine, in particular to a new preparation composed of Temozolomide and a solvent for dissolving Temozolomide for intravenous and intracerebral local application. technical background: [0002] Temozolomide (Temozolomide) chemical name 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]-1,2,3,5-tetrazine-8-amide, by Schering- Developed by Plow Company. In 1999, the FDA approved its oral capsule formulation for the treatment of adult glioblastoma and melanoma, especially the first-line treatment of glioblastoma multiforme or anaplastic astrocytoma. According to clinical statistics in Europe and the United States, the incidence of primary intracranial malignant tumors is 21 / 100,000, and gliomas account for about 60%, of which highly malignant gliomas account for 70%-85%. The tumor is incompletely differentiated and penetrates deep into the nerve cells, so it is impossible to completely remove it by surger...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4188A61K47/12A61P35/00
Inventor 张秀国冯志媛陈圆圆
Owner 北京京卫燕康药物研究所有限公司
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