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Injection-purpose freeze-drying composition for treating advanced ovarian cancer and preparing method thereof

A technology for injection and composition, which is applied in the field of medicine, can solve the problems of reduced curative effect of preparations and increased hidden dangers of patients, and achieve the effects of improved safety, stable quality and simple process

Inactive Publication Date: 2018-06-12
夏建明
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Because carboplatin is very susceptible to the influence of temperature and light in the environment during storage, its impurity 1,1-cyclobutanedicarboxylic acid and related substances increase with the prolongation of storage time, and carboplatin for injection also has similar This has resulted in a reduction in the efficacy of the preparation in clinical use, and at the same time increased the safety hazards of patients in clinical use

Method used

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  • Injection-purpose freeze-drying composition for treating advanced ovarian cancer and preparing method thereof
  • Injection-purpose freeze-drying composition for treating advanced ovarian cancer and preparing method thereof
  • Injection-purpose freeze-drying composition for treating advanced ovarian cancer and preparing method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] prescription

[0041]

[0042] Preparation Process

[0043] 1. Preparation

[0044] a. Weigh maltose and Tween-80 of the prescribed amount, dissolve them in an appropriate amount of water for injection, stir and mix evenly, add the carboplatin of the prescribed amount, and stir to dissolve;

[0045] b. After stirring and dissolving, adjust the pH value with 0.1mol / L dilute hydrochloric acid solution or 0.1mol / L dilute ammonia solution;

[0046] c. After adjusting the pH value, dilute to the full volume with water for injection, take a sample to test the intermediate product solution, and prepare for potting after passing the test.

[0047] 2. Bottle washing and drying

[0048] The neutral borosilicate glass control injection bottle is washed by a bottle washing machine, sterilized and dried above 300°C, and transferred to the filling room for later use.

[0049] 3. Rubber stopper treatment

[0050] Use a bromobutyl rubber stopper to clean the freeze-dried steril...

Embodiment 2

[0067] prescription

[0068]

[0069] Preparation process: with embodiment 1

Embodiment 3

[0071] prescription

[0072]

[0073] Preparation process: with embodiment 1

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to an injection-purpose freeze-drying composition for treating advanced ovarian cancer and a preparing method thereof. The injection-purpose freeze-drying composition is mainly composed of active components of carboplatin, excipient, tween-80 and pH regulator. The injection-purpose freeze-drying composition preparation is stable in quality and simple in technology, in the storage process of the injection-purpose freeze-drying composition preparation, an impurity 1,1-cyclobutane dicarboxylic acid and related substances are all not obviously changed, and the clinical application safety of the preparation is improved.

Description

[0001] This application is a divisional application of an invention patent application titled: A freeze-dried composition for injection for the treatment of advanced ovarian cancer and its preparation method, application number: 201610225160.5, and application date: April 12, 2016. technical field [0002] The invention belongs to the technical field of medicine, and in particular relates to a freeze-dried composition for injection for treating advanced ovarian cancer and a preparation method thereof. Background technique [0003] At present, more than 200,000 women suffer from ovarian cancer every year in the world. Although its morbidity is relatively low, its case fatality rate is high. Among female cancers, its fatality rate ranks seventh. Among American women, it ranks fifth, with more than 15,000 deaths per year. In 2008, its case fatality rate even surpassed that of lung cancer. One of the main reasons for the high mortality rate of ovarian cancer is the difficulty ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/555A61K47/26A61P35/00
CPCA61K9/0019A61K9/145A61K9/19A61K31/555A61K33/24A61K47/26
Inventor 夏建明
Owner 夏建明
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