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Temozolomide suppository content measuring method by utilization of reversed-phase ion-pair chromatography method

A technology of temozolomide suppository and temozolomide, which is applied in the field of medicine and can solve the problems of inability to accurately obtain the actual content of the medicine and the like

Inactive Publication Date: 2014-12-03
JIANGSU TASLY DIYI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because the main impurities and degradation products also have absorption at the maximum absorption wavelength of temozolomide, the actual content of the drug cannot be accurately obtained by using ultraviolet spectrophotometry; The test components are extracted from the preparation to remove unnecessary interfering substances

Method used

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  • Temozolomide suppository content measuring method by utilization of reversed-phase ion-pair chromatography method
  • Temozolomide suppository content measuring method by utilization of reversed-phase ion-pair chromatography method
  • Temozolomide suppository content measuring method by utilization of reversed-phase ion-pair chromatography method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] The preparation of embodiment 1 temozolomide suppository

[0072] prescription:

[0073]

[0074] Weigh the temozolomide raw materials and auxiliary materials according to the prescription amount, heat to melt, and stir evenly; inject the prepared medicinal liquid into the suppository mold, the medicinal liquid slightly overflows the mold, cool; cut off the overflowing part, demould, and pack.

Embodiment 2

[0075] The detection of embodiment 2 temozolomide suppositories

[0076] (1) Preparation of reference solution

[0077] Accurately weigh an appropriate amount of temozolomide reference substance, dissolve and dilute it into a solution containing 0.05 mg of temozolomide in every 1 ml, and obtain the product.

[0078] (2) Preparation of the test solution

[0079] Take 10 capsules of the test product, accurately weigh them, chop them up, mix them evenly, accurately weigh an appropriate amount (about 50 mg of temozolomide), put them in a 100ml volumetric flask, add acetonitrile to the mark, and shake in a 45°C water bath to make temozolomide Dissolve, shake on the shaker for 2 minutes, then freeze in the refrigerator (-18°C) for 1 hour and filter immediately, accurately measure 1ml of the filtrate that has been brought to room temperature, put it in a 10ml volumetric flask, dilute to the mark with mobile phase, and shake Evenly, filter through a 0.45μm microporous membrane, take...

Embodiment 3

[0081] The detection of embodiment 3 temozolomide suppositories

[0082] (1) Preparation of reference solution

[0083] Precisely weigh an appropriate amount of temozolomide reference substance, dissolve and dilute it into a solution containing 0.025 mg of temozolomide in every 1 ml, and obtain the product.

[0084] (2) Preparation of the test solution

[0085] Take 10 capsules of the test product, accurately weigh them, chop them up, mix them evenly, accurately weigh an appropriate amount (about 50 mg of temozolomide), put them in a 100ml volumetric flask, add acetonitrile to the mark, and shake in a 45°C water bath to make temozolomide Dissolve, shake on the shaker for 2 minutes, then freeze in the refrigerator (-18°C) for 1 hour and filter immediately, accurately measure 1ml of the filtrate that has been brought to room temperature, put it in a 10ml volumetric flask, dilute to the mark with mobile phase, and shake Evenly, filter through a 0.45μm microporous membrane, take...

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Abstract

A temozolomide suppository content measuring method by utilization of a reversed-phase ion-pair chromatography method is disclosed. The measuring method is characterized by comprising: (1) a step of preparing a reference substance solution; (2) a step of preparing a solution of a sample to be measured; and (3) a step of content measuring, namely a step of drawing 10-20 [mu]L of the reference substance solution and 10-20 [mu]L of the solution of the sample to be measured separately, injecting into a high performance liquid chromatograph, recording chromatograms, and calculating the content of the temozolomide in the sample to be measured according to the peak area in the chromatograms.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a method for determining the content of a temozolomide suppository. Background technique [0002] Cervical cancer is one of the main malignant tumors that seriously threaten the health of women in my country. There are 150,000 new cases every year, accounting for 1 / 3 of the global incidence. Although the trend of death data shows that the mortality rate of cervical cancer in my country has declined in recent years, it can still be seen from the sample survey data that there are areas with high incidence of cervical cancer, especially in rural areas in the central and western regions, and patients tend to be younger. With the widespread development of cervical cancer screening, more and more early cervical cancer patients will be screened out, and the demand for drugs for early treatment of cervical cancer is also becoming increasingly prominent. [0003] Temozolomide Hexyl Ester belongs ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/89
Inventor 王国成陈莹李德馨王永峰
Owner JIANGSU TASLY DIYI PHARMA CO LTD
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