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Method for rapidly detecting mifepristone

A technology for mifepristone and medicine, which is applied in the field of rapid detection of mifepristone and authenticity identification

Active Publication Date: 2012-07-11
BEIJING INST FOR DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These methods require professionals to use modern analytical instruments, and can only be identified in the laboratory.

Method used

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  • Method for rapidly detecting mifepristone
  • Method for rapidly detecting mifepristone
  • Method for rapidly detecting mifepristone

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Embodiment 1, detect whether medicine contains the general operating condition of mifepristone

[0069] 1. Sampling volume

[0070]Sampling recommendations for different types of samples are as follows:

[0071] sample type

Sampling volume

raw material

5mg-20mg

10mg tablet

Take 2 pieces, crushed

25mg strength tablet

Take 1 piece, crushed

200mg tablet

Take half a slice, crushed

[0072] It can be seen that the amount of the sample to be inspected used by the method of the present invention is very small, so as to damage the interests of innocent operators as little as possible.

[0073] 2. Preparation of the test solution

[0074] After taking the medicine and grinding it, add 2ml of organic solvent (trichloromethane is used in the following test), and shake for 1 minute without filtering.

[0075] 3. Operation steps:

[0076] (1) Take a sample (5-100 mg containing the labeled mifepristone) and add 2 ml...

Embodiment 2

[0081] Embodiment 2, the test of whether mifepristone is contained in the detection medicine

[0082] Adopt the method of embodiment 1, detect 20 batches of commercially available samples (comprising the unilateral preparation and the raw material that label contains mifepristone, omit manufacturer and production batch number, expressed with serial number), and with reference to " Chinese Pharmacopoeia 2005 edition two " The HPLC method chromatographic conditions under the related substance item of mifepristone raw material, use LCMS method to detect sample, specifically as follows:

[0083] Take the sample according to the table, add 2ml of chloroform, and shake for 1 minute. Then add 0.2ml of newly prepared sulfuric acid-acetic anhydride mixed developer into the sample solution, observe within 10 seconds, if the sample solution suddenly shows obvious yellow, orange yellow and / or orange red, then the tested sample can be judged may contain mifepristone; if there is no chan...

Embodiment 3

[0093] Embodiment 3, the performance of the inventive method

[0094] The present embodiment investigates the minimum detection limit of inventive method to detection mifepristone reference substance and sample, specifically as follows:

[0095] Take 10 mg of mifepristone reference substance provided by China National Institute of Pharmaceutical and Biological Products Identification, add chloroform to dissolve and dilute to a solution containing 0.25 mg of mifepristone in every 1 ml. Then add 0.2ml of newly prepared sulfuric acid-acetic anhydride mixed developer into the sample solution, and the sample solution turns yellow within 10 seconds.

[0096] Take 10 mg mifepristone tablets, grind finely, add chloroform to dissolve and dilute to a solution containing 0.25 mg mifepristone per 1 ml. Then add 0.2ml of newly prepared sulfuric acid-acetic anhydride mixed developer into the sample solution, and the sample solution turns yellow within 10 seconds.

[0097] According to t...

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Abstract

The invention relates to a method for rapidly detecting mifepristone, in particular to a method for detecting mifepristone in medicines. The method comprises the steps that (1) proper amount of medicine to be detected is mixed with an extraction solvent, the mixture is shaken, and extract is obtained; (2) the extract obtained in the step 1 is mixed with sulfuric acid-acetic anhydride reagent, and mixed liquid is obtained; (3) the color change of the mixed liquid obtained in step 2 is observed, if the color of the mixed liquid suddenly changes to obvious yellow, orange yellow and / or orange red, a judgment is made that the medicine possibly contains mifepristone; and if the color of the mixed liquid has no change, a judgment is made that the medicine does not contain mifepristone. The method has the characteristics of accuracy, simplicity, rapidness, low specialty requirement and the like.

Description

technical field [0001] The invention belongs to the technical field of medicine detection, and relates to a detection method for authenticity identification of medicines containing mifepristone. It particularly relates to a method for rapidly detecting mifepristone. Background technique [0002] Mifepristone is a new type of anti-progestin, without progesterone, estrogen, androgen and anti-estrogen activity, can bind to progesterone receptor and glucocorticoid receptor, and has affinity for endometrial progesterone receptor It is 5 times stronger than progesterone, and has labor-inducing effect on all stages of pregnancy of pregnant animals, and can be used as a non-surgical anti-early pregnancy drug. Mifepristone is a common contraceptive and anti-early pregnancy drug in China. Taking different doses of mifepristone will achieve different effects, usually, each dose of mifepristone 10 to 25 mg can be used for emergency contraception; taking 150 mg can terminate pregnancy ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/78
Inventor 王铁松张喆车宝泉王威高青陈安东王志斌方颖郭洪祝赵明
Owner BEIJING INST FOR DRUG CONTROL
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