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Injection for treating advanced ovarian cancer and preparation method thereof

A technology for injection and ovarian cancer, applied in the field of medicine, can solve problems such as hidden dangers and drug safety, and achieve the effects of improving safety, stable preparation quality and simple process

Inactive Publication Date: 2016-07-06
周英杰
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Because carboplatin injection is affected by temperature and light, during the storage of carboplatin injection preparations, the impurity 1,1-cyclobutanedicarboxylic acid and other impurities increase with the prolongation of storage time, thus causing Potential safety hazards in the clinical use of drugs

Method used

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  • Injection for treating advanced ovarian cancer and preparation method thereof
  • Injection for treating advanced ovarian cancer and preparation method thereof
  • Injection for treating advanced ovarian cancer and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] prescription

[0028]

[0029] Preparation Process

[0030] a. Ampoule treatment: Wash the ampoule through an ultrasonic bottle washing machine, sterilize and dry it in a tunnel-type sterilizing dryer at a temperature not lower than 290°C, and transfer it to the filling room for later use.

[0031] b. Preparation: 1. Take the prescribed amount of Tween-20 and ammonia water and dissolve it in an appropriate amount of water for injection, stir and mix evenly, add the prescribed amount of carboplatin, and stir to dissolve;

[0032] 2. After stirring and dissolving, adjust the pH value with 0.1mol / L dilute hydrochloric acid solution;

[0033] 3. 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.

[0034] c. Filling: The solution is filtered to the filling room (PVDF filter element), and filled in neutral borosilicate glass ampoules acc...

Embodiment 2

[0039] prescription

[0040]

[0041] Preparation process: with embodiment 1

Embodiment 3

[0043] prescription

[0044]

[0045] Preparation process: with embodiment 1

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Abstract

The invention belongs to the technical field of medicines, in particular to an injection for treating advanced ovarian cancer and a preparation method thereof.The injection is mainly prepared from the active ingredients including carboplatin, twain-20, ammonia water, a pH regulator and water for injection.The injection is stable in quality and simple in process, an impurity 1,1-cyclobutane dicarboxylic acid and other impurities do not change obviously, and the safety of the injection in clinical use is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an injection for treating advanced ovarian cancer and a preparation method thereof. Background technique [0002] Ovarian cancer is one of the three major malignant tumors of female genitalia, but its mortality rate ranks first among gynecological malignant tumors. In recent years, the incidence of ovarian cancer has increased year by year. The early symptoms of ovarian cancer are hidden, and abdominal metastases often appear before the symptoms appear. 60% to 70% of the patients are already in the advanced stage when they go to the doctor. Epithelial ovarian tumor is the most common ovarian tumor, accounting for 85%-90% of ovarian malignancies, more common in middle-aged and elderly women, mostly over 50 years old. 60-70% of the lesions have extended beyond the pelvic area when they see a doctor, and the 5-year survival rate hovers around 25-30%. [0003] Carbopl...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/282A61K47/26A61P35/00
CPCA61K9/0019A61K9/08A61K31/282A61K31/555A61K47/26
Inventor 夏建明
Owner 周英杰
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