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Rapid detection method for phenytoin sodium

A technology of phenytoin sodium and detection method, which is applied in the directions of measuring devices, biological tests, material inspection products, etc., can solve the problems of high requirements on the instrument environment, easy contamination of chromatographic columns, and complex composition of Chinese patent medicines. Easy to observe, small sample size effect

Inactive Publication Date: 2016-11-23
广东省药品检验所
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  • Abstract
  • Description
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  • Application Information

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Problems solved by technology

[0007] 3. When other physicians consider adding other antiepileptic drugs, they may repeat the drug because they do not know the western medicine ingredients in the traditional Chinese medicine preparation, which is prone to overdose and poisoning
The disadvantages of this method are: the chromatographic resolution is low, the composition of Chinese patent medicine is complicated, there are many interference factors, and it is easy to cause misjudgment
But there are also the following disadvantages at present: the instrument is expensive, the sample pretreatment time is long, the chromatographic column is easily polluted, and the analysis cost is high; when the chromatographic peak retention time of the coexisting components is close to the phenytoin chromatographic retention time, it is easy to cause misjudgment; The environment has high requirements and needs to be placed fixedly, so it is not suitable for on-site inspection
At present, these tests can only be carried out in a small number of laboratories and are not easy to promote and use
[0020] To sum up, at present, in the detection of whether phenytoin sodium is added in Chinese patent medicines and health foods, there is still a lack of a method with high sensitivity, simple operation, and rapid screening of phenytoin sodium. For pharmacies and basic drug inspection units, it is necessary to develop Chinese patent medicines A rapid screening method for the illegal addition of phenytoin sodium and health food, rapid analysis of samples at the supervision site, timely provision of evidence for the supervision of Chinese patent medicines and health food, it is very necessary to combat the fraudulent behavior of criminals and ensure the drug safety of the people of

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  • Rapid detection method for phenytoin sodium
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  • Rapid detection method for phenytoin sodium

Examples

Experimental program
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Effect test

Embodiment 1

[0060] Example 1 Preparation of Phenytoin Antigen, Immunogen and Antibody

[0061] 1) The preparation method of phenytoin sodium antigen and immunogen is:

[0062] Weigh 1 mg of 5-diphenyl-phenytoin-3-ω-n-valeric acid and add it to 0.6ml of water, add a few drops of pyridine until it is completely dissolved, then add 1 mg of carbodiimide, and slowly add it dropwise to 1mL 10mg / mL of BSA and KLH (BSA and KLH were both dissolved in 0.01mol, pH9.6 carbonate buffer), stirred at room temperature for 2 h, after the reaction was completed, 0.01mol / L, pH7.4 phosphate buffer The dialysate was dialyzed for 3 days, and the dialysate was changed every 8 hours, and the coating antigen and immune antigen were prepared respectively.

[0063] 2) The preparation method of phenytoin sodium antibody is:

[0064] Immunize female mice with phenytoin sodium immunization antigen, the immunization dose of each mouse is 120ug / 0.3mL, using rapid adjuvant, subcutaneous injection on the back, initial i...

Embodiment 2

[0065] Example 2 Rapid detection card for phenytoin sodium

[0066] The rapid test card for sodium phenytoin consists of a PVC board and a sample pad 1, a gold standard binding pad 2, a coating film 3 and a water-absorbing pad 4 connected sequentially on the PVC board 5, see figure 1 , the sample pad 1 is pressed on about 1 / 2 to 1 / 3 of the gold standard binding pad 2, the gold standard binding pad 2 is pressed on the coating film 3 by 0.1 to 0.2 cm, and the T line is 7 mm to 7.5 mm away from the lower end of the coating film 3, C The line is 7mm-7.3mm away from the upper end of the coating film 3, the distance between C and T is 4.5mm, and the water-absorbing pad is pressed on the coating film 1-2mm.

[0067] Among them: the gold label binding pad is a glass fiber cotton that absorbs phenytoin sodium antibody-colloidal gold complex and rabbit-colloidal gold complex, and is printed on the coating film with a solution of phenytoin sodium coupled to carrier protein sequentially. ...

Embodiment 3

[0069] Example 3 The preparation method of the rapid detection card of phenytoin sodium

[0070] The preparation method of the detection card is that a sample pad, a gold standard binding pad, a coating film and a water-absorbing pad are sequentially connected on a PVC board. Include the following steps:

[0071] in:

[0072] 1) The preparation method of the coating film is:

[0073] Dilute the phenytoin sodium antigen to 0.5-1.0mg / ml with pH7.4, 0.01M PBS buffer, 10%-20% sucrose, and spray it on the nitrocellulose membrane. The spray volume per 300mm is 30ul, which is the T line; sheep Dilute the anti-rabbit to 0.3mg / ml~0.5mg / ml, the spray volume per 300mm is 30ul, the running speed is 80mm / s, the pump pressure is 100 pump pressure, the moving length is 290cm, which is the C line, and the distance between the C and T lines is 4.5mm, put in a 45°C oven overnight for 12-18 hours.

[0074] 2) The preparation method of the gold standard binding pad is:

[0075] Dilute 1% chl...

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Abstract

The invention discloses a rapid detection method for phenytoin sodium. A phenytoin sodium antigen and an antibody which are prepared by virtue of the rapid detection method have relatively good specificity. A phenytoin sodium coupled carrier protein is selected from hemocyanin KLH or bovine serum albumin BAS. By virtue of immunization of a mouse by virtue of the antigen, the obtained phenytoin sodium antigen has relatively high valence and relatively good sensitivity. By utilizing a prepared phenytoin sodium detection card, the detection speed is high, a result is easily observed, and the rapid screening of batch samples can be realized, so that the detection cost can be greatly lowered, the workload is reduced, and the phenytoin sodium detection card has practical significance. According to the rapid detection method, aiming at solving the problem that a to-be-detected sample has complex components, a sample pretreatment method is optimized, the required sample amount is low, and the sample pretreatment can be finished only through two steps including extraction and dilution, so that the detection university and the detection efficiency are greatly improved.

Description

technical field [0001] The invention belongs to the field of rapid detection of health food and medicine, and in particular relates to a rapid detection method of sodium phenytoin. Background technique [0002] Phenytoin sodium, white powder, odorless, bitter taste, molecular formula C 15 h 11 o 2 N 2 Na, is a prescription drug used to treat epilepsy. [0003] Epilepsy is one of the most common diseases in the Department of Neurology. It is a chronic disease that requires long-term medication to control the onset. When choosing drugs, patients prefer those "pure Chinese medicines" and "ancestral secret recipes" to treat epilepsy. It is by taking advantage of this psychology of patients that phenytoin is illegally added to some traditional Chinese medicine preparations. [0004] In February 2010, Li Shichuo, president of the Chinese Anti-Epileptic Association, submitted to the Ministry of Health the "Suggestions on Standardizing Three Major Issues in the Diagnosis and Tr...

Claims

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Application Information

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IPC IPC(8): G01N33/94
CPCG01N33/9473
Inventor 邱蕴绮陈国权严全鸿雷毅胡碧波
Owner 广东省药品检验所
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