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Method for rapid detection of phenytoinum natricum analogues in product

A technology of phenytoin and phenytoin, applied in the direction of material electrochemical variables, can solve problems such as unsatisfactory effect, interference with the conductivity of sample solution, total dissolved solids, technical difficulties, etc.

Active Publication Date: 2014-12-17
BEIJING INST FOR DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Then, is it possible to directly detect antiepileptic drugs, health products or foods suspected of adding phenytoin sodium or similar substances by electrochemical methods that detect the conductivity or total dissolved solids in water? It was found that the effect was not ideal, because the complex matrix of anti-epileptic drugs, health products or food that may add phenytoin or similar substances contains other hydrophilic substances, which will seriously interfere with the conductivity of the sample solution and in the solution. Total Dissolved Solids (TDS), resulting in no correlation with whether phenytoin or similar substances were added
Therefore, it is technically difficult to directly detect whether phenytoin or similar substances are illegally added to antiepileptic drugs, health products or food by directly using the electrochemical method of detecting the conductivity or total dissolved solids in the solution.

Method used

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  • Method for rapid detection of phenytoinum natricum analogues in product
  • Method for rapid detection of phenytoinum natricum analogues in product
  • Method for rapid detection of phenytoinum natricum analogues in product

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Example 1. General operating conditions for detecting whether phenytoin or similar substances are contained in medicines / health products

[0063] 1. Sampling volume:

[0064] Sampling recommendations for different types of samples are as follows:

[0065] sample type

Sampling volume

tablet

One oral dose (need to be crushed)

Capsules

Oral dose at one time (take the contents and grind them)

big honey pill

One-time oral dose (need to be crushed)

Granules

One-time oral dose (need to be crushed)

other solid

oral dose

[0066] This shows that the amount of the product to be inspected that the inventive method uses is few, so that the interests of innocent operators are damaged as little as possible, the dosage of the above various types of samples is about 0.5~5g at a time, such as capsules and tablets at a time of about 0.5-5g. 0.5g, while the dosage of granules and big honeye...

Embodiment 2

[0072] Embodiment 2. General operating conditions for detecting whether phenytoin or similar substances are contained in medicines / health products

[0073]1. Sampling volume:

[0074] Sampling recommendations for different types of samples are as follows:

[0075] sample type

Sampling volume

tablet

One oral dose (need to be crushed)

Capsules

Oral dose at one time (take the contents and grind them)

big honey pill

One-time oral dose (need to be crushed)

Granules

One-time oral dose (need to be crushed)

other solid

oral dose

[0076] This shows that the amount of the sample to be inspected used by the method of the present invention is small, so as to damage the interests of innocent operators as little as possible.

[0077] 2. Preparation of the test solution

[0078] Take medicine, health food or food, add 20ml of 95% ethanol, and shake for 1 minute.

[0079] 3. Measure and judge the result

[0080] U...

Embodiment 3

[0081] Embodiment 3, test whether there is phenytoin sodium or similar substance in detection medicine, health food and food

[0082] Adopt the method of embodiment 1 to detect 20 batches of samples rapidly (all are the sampling samples of drug supervision department). In addition, in accordance with the "Supplementary Inspection Methods and Inspection Items Approval Documents 2006005 and 2007003 of the State Drug and Food Administration", the HPLC method was used to test the samples to verify the screening results.

[0083] The HPLC detection methods recorded in the drug inspection supplementary inspection methods and inspection items approval documents 2006005 and 2007003 are as follows:

[0084] Column: XB-C18, 5μm, 4.6×200mm; (provided by Yuexu Technology)

[0085] Detection wavelength: 215nm;

[0086] Mobile phase: methanol: water = 57: 43;

[0087] Temperature: room temperature 23°C;

[0088] Flow rate: 1.0ml / min; injection volume: 5μl.

[0089] According to the t...

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Abstract

The invention relates to a method for rapid detection of phenytoinum natricum analogues in a product, and particularly relates to the method for detection whether the product suspected to be mixed with phenytoinum natricum or the analogues thereof contains phenytoinum natricum or the analogues thereof. The method comprises the following steps: (1) taking a proper amount of the product, mixing with a special solvent, shaking or carrying out ultrasonic assisted dissolution, and thus obtaining a mixed test solution; (2) detecting specific electrochemical parameters of the mixed test solution by using a proper detector based on a specific electrochemical method; and (3) according to the value of the parameters, judging whether antiepileptic substances of phenytoinum natricum or the analogues thereof are possibly added illegally in the product. The method has no need of filtering the sample solution; time consuming of the whole detection processes is only 2-3 min; and the method is rapid, convenient and safe, and is high in sensitivity and friendly to the environment.

Description

technical field [0001] The invention relates to the technical field of analysis of medicines, health food or food, in particular to a method for quickly screening illegally added phenytoin or similar antiepileptic drugs in medicines, health food or food based on an electrochemical method. Background technique [0002] The phenytoin compound has a selective antagonism effect on the tonic phase of super-strong electric shock and convulsions, but it is ineffective or intensified on the clononic phase, so it has a good effect on grand mal seizures, but has no effect on absence seizures. Its antiepileptic mechanism has not been elucidated yet. It is generally believed that it increases the outflow of sodium ions in cells and reduces the inflow of sodium ions, thereby stabilizing nerve cell membranes, increasing the excitation threshold, and reducing the spread of high-frequency discharges in lesions. [0003] The chemical name of phenytoin sodium is 5,5-diphenyl-2,4-imidazolidine...

Claims

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Application Information

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IPC IPC(8): G01N27/26
Inventor 王铁松车宝泉尹光
Owner BEIJING INST FOR DRUG CONTROL
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