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Injectable temozolomide powder injection preparation and preparation method thereof

A technology for temozolomide and pharmaceutical preparations, applied in the field of medicine, can solve problems such as discomfort, and achieve the effects of simple preparation process, strong operability, and long storage period

Inactive Publication Date: 2014-06-11
杭州容立医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the domestic clinical use of temozolomide preparations is mainly oral solid preparations. Although it has the characteristics of good clinical effect, low toxicity, and high absorption and utilization, oral temozolomide solid preparations are more uncomfortable for some patients with dysphagia or postoperative patients.
Therefore, Temozolomide injection powder was developed for intravenous injection in patients who are clinically unsuitable for oral medication.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] CN 100346784 C, Schering company prescription:

[0033] Raw materials Dosage (g) Proportion (w / t%) Temozolomide 2.50 8.00 Mannitol 15.00 48.00 L-threonine 4.00 13.00 Polysorbate-80 3.00 9.00 Sodium Citrate Dihydrate 5.88 19.00 hydrochloric acid 1.48 5.00 Water for Injection 1000ml /

[0034] The implementation prescription of this patent:

[0035] Raw materials Dosage (g) Proportion (w / t%) Temozolomide 2.50 7.00 Mannitol 15.00 41.98 Glycine dipeptide 7.30 20.43 Polysorbate-80 2.25 6.30 Sodium Citrate Dihydrate 5.88 16.46 hydrochloric acid 2.80 7.84 Water for Injection 1000ml /

[0036] The polysorbate-80 used in this program is about 25% lower than that of foreign patented prescriptions. On the one hand, it can effectively prove that dipeptide has a better solubilizing effect than L-threonine; on the other hand, due to the re...

Embodiment 2

[0038] Effects of different types and ratios of solubilizers on drug solubility:

Embodiment 2-1

[0040] Raw materials Dosage (g) Proportion (w / t%) Temozolomide 2.50 7.00 Mannitol 15.00 41.98 Glycine dipeptide 7.30 20.43 Polysorbate-80 2.25 6.30 Sodium Citrate Dihydrate 5.88 16.46 hydrochloric acid 2.80 7.84 Water for Injection 1000ml /

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PUM

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Abstract

The invention discloses an injectable anticancer drug temozolomide freeze-dried powder injection preparation and its preparation method. The powder injection preparation is stable, controllable in quality, simple in preparation process and strong in operability, and a prepared product has the characteristics of good solubility, convenient clinical use, a long period of storage and the like.

Description

technical field [0001] The invention relates to a freeze-dried powder preparation of the antineoplastic drug temozolomide for injection in the technical field of medicine and a preparation method thereof. Background technique [0002] Temozolomide (Temozolomide, trade name Temodar), produced by Schering, is a new anticancer drug for the treatment of glioma and malignant melanoma. It was approved by the FDA in 1999 and launched in the United States. Temozolomide is a white or light brown or light pink powder with a relative molecular weight of 194.5. Its aqueous solution is relatively stable at pH<5 and easily decomposed when pH>7. Temozolomide is an imidazole tetrazine compound with low toxicity, good tolerance, high bioavailability (up to 90% after oral administration), and good tissue distribution in the body. Based on the above advantages, temozolomide can be administered for a long time, which can significantly improve the physical and health status of patients, t...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4188A61K47/42A61P35/00
Inventor 唐勇施水萍孙晓玲
Owner 杭州容立医药科技有限公司
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