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Method for rapid detection of phenytoin analogues in products

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

Active Publication Date: 2016-08-17
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 phenytoin analogues in products
  • Method for rapid detection of phenytoin analogues in products
  • Method for rapid detection of phenytoin analogues in products

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

One-time oral dose (take the content and grind it)

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 honeyed pills is about ...

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

One-time oral dose (take the content and grind it)

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] Usin...

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...

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Abstract

The invention relates to a method for rapidly detecting phenytoin analogues in products. It specifically relates to a method for detecting whether phenytoin sodium or similar substances are contained in products suspected of being mixed with phenytoin sodium or similar substances. (2) Use an appropriate detector based on a specific electrochemical method to measure the specific electrochemical parameters of the mixed test solution; (3) According to the value of the parameter, it can be judged whether the product may be illegally added with phenytoin Sodium or similar antiepileptic substances. The method of the invention does not need to filter the sample solution, and the whole detection process only takes 2 to 3 minutes, and has the advantages of fastness, simplicity, safety, high sensitivity, environmental protection and the like.

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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Patent Type & Authority Patents(China)
IPC IPC(8): G01N27/26
Inventor 王铁松车宝泉吴彬尹光
Owner BEIJING INST FOR DRUG CONTROL
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