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Lyophilized preparation of temozolomide and its preparation method

A technology for temozolomide and preparations, which is applied in the field of pharmaceutical preparations and can solve problems such as long reconstitution time and insufficient stability

Inactive Publication Date: 2013-03-06
SHANGHAI HUILUN BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The reconstitution time of the above-mentioned methods is relatively long when they are configured into solutions, and they are not stable enough in the actual preservation process. Clinically, it is necessary to develop a preparation with reliable quality and good for preservation

Method used

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  • Lyophilized preparation of temozolomide and its preparation method
  • Lyophilized preparation of temozolomide and its preparation method
  • Lyophilized preparation of temozolomide and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Preparation composition:

[0029] sodium citrate

[0030] Preparation method: Measure 4000ml of water for injection, add 60g of mannitol, 32g of nicotinamide, 12g of polysorbate-80, 24g of sodium citrate, 20g of hydrochloric acid, stir and mix evenly, add 10g of temozolomide, stir to completely dissolve temozolomide, and the solution Sterilize and filter through a 0.22μm microporous membrane, divide into 100ml vials, fill each bottle with 40ml, partially plug with butyl rubber stoppers, and place in a plate; place in a freeze dryer, and reduce the sample temperature to -45°C And keep it for 3 hours, turn on the vacuum system, when the vacuum degree of the front box reaches below 20Pa, start freeze-drying, and raise the temperature of the shelf to -20°C within 1 hour and maintain it for 15 hours, and then make the shelf dry within 1 hour Raise the temperature to -2°C and maintain it for 25 hours, raise the shelf temperature to 30°C within 1 hour and ma...

Embodiment 2

[0032] Preparation composition:

[0033] Preparation method: with embodiment 1

Embodiment 3

[0035] Preparation composition:

[0036] Temozolomide

[0037] Preparation method: with embodiment 1.

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Abstract

The invention discloses a temozolomide lyophilized powder preparation, which includes an antitumor active component temozolomide and its pharmaceutically acceptable salt, an aqueous diluent, a filler, a pH regulator and at least one solubilizing agent. Specifically, the solubilizing agent is one of niacinamide and biuret or is a mixture of them. After optimization, niacinamide or biuret is adopted as the solubilizing agent in the invention. The prepared temozolomide lyophilized powder preparation has the advantages of rapid re-dissolution and good stability during placing. The invention also discloses a preparation method of the temozolomide lyophilized powder preparation.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations. The invention relates to a temozolomide freeze-dried preparation and a preparation method thereof. Background technique [0002] Temozolomide (Temozolomide) is an antineoplastic drug belonging to the alkylating agent class, used to treat malignant glioma and malignant melanoma, other brain tumors, such as lung cancer, breast cancer, testicular cancer, colon cancer and rectal cancer, etc. . [0003] The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazol[5,1-d] and 1,2,3,5-tetrazine-8-carboxamide, CAS number is 85622 -93-1, the molecular formula is C 6 h 6 N 6 o 2 , the molecular weight is 194.15, and the chemical structural formula is: [0004] [0005] Temozolomide is slightly soluble in water with a solubility of about 3.1mg / ml, very slightly soluble in methanol, almost insoluble in ethanol, slightly soluble in acetic acid, and slightly soluble in d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4188A61K47/34A61K47/22A61K47/16A61P35/00
Inventor 秦继红桑海婴
Owner SHANGHAI HUILUN BIOLOGICAL TECH CO LTD
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