Method for assaying cedinafei and derivative thereof

A technology for sildenafil and derivatives, applied in the field of detection of sildenafil citrate and its derivatives, can solve the problems of lack of testing equipment, difficulty in screening, etc., achieve a wide control range, simple preparation, and eliminate false negatives the effect of the result

Active Publication Date: 2007-08-22
BEIJING INST FOR DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, the situation of unauthorized addition of sildenafil in food, traditional Chinese medicine preparations and health food is still very serious, and offenders continue to produce derivatives of sildenafil in order to avoid inspection. As a reference substance, it is at a loss to use TLC or HPLC methods for these new derivatives
For pharmacies and primary drug inspection institutes, due to the lack of advanced inspection equipment, it is difficult to identify whether illegal drugs are contained in food, traditional Chinese medicine preparations, and health products. Therefore, it is of special significance to establish a simple, accurate, and rapid identification method

Method used

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  • Method for assaying cedinafei and derivative thereof
  • Method for assaying cedinafei and derivative thereof
  • Method for assaying cedinafei and derivative thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Embodiment 1, detection method

[0022] The inventive method concrete operation is as follows:

[0023] 1. Sampling volume

[0024] For different types of samples to be tested, the recommended sampling volume is shown in Table 1 below.

[0025] Table 1 Recommended sampling scale

[0026] dosage form

Sampling volume

tablet

1

capsule

Contents of 1 capsule

honey pill

1 / 4

single dose oral solution

1 / 2 stick

other solid

0.1～0.2g

[0027] 2. Preparation of the test article

[0028] Preparation of solid test sample Add 6-12ml of methanol to the finely ground or chopped sample, grind to dissolve, filter or centrifuge, divide the filtrate or supernatant into three parts, and put them in three test tubes respectively;

[0029] Preparation of liquid test product Measure the samples directly and place them in three test tubes respectively;

[0030] 3. Color reaction

[0031] Add ① bismuth potassium io...

Embodiment 2

[0041] Embodiment 2, the accuracy test that the inventive method detects sildenafil

[0042] 40 batches of samples are detected by the method of the present invention, and at the same time according to the State Drug Administration Drug Inspection Supplementary Inspection Method and Inspection Item Approval Document (2006009, issued on March 14, 2006), the HPLC-MS-MS method is used to check other methods. Lafei, sildenafil, vardenafil, hongdenafil and Huanyang base, the results are shown in Table 3.

[0043] Table 3: Test results of multiple batches of samples

[0044] product name

dosage form

Sampling volume

Color rendering result

mass spectrometry results

sample 1

capsule

Contents of 1 capsule

①Orange precipitate

②No precipitation

③No precipitation

tadalafil

sample 2

pill

1 pill

①No precipitation

②No precipitation

③No precipitation

Does not contain * ...

Embodiment 3

[0049] Embodiment 3, the detection of sildenafil derivative

[0050] The method of the present invention can not only detect sildenafil, but also detect sildenafil derivatives, see formula II, formula III, formula IV, formula V and formula VI. The detection method and positive result judgment are the same as the detection of sildenafil.

[0051]

[0052]

[0053] Get vardenafil hydrochloride reference substance (formula V), reddenafil (formula IV) and reddenafil (formula VI) raw materials, adopt the method of the present invention to detect, all show positive reaction.

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Abstract

The invention discloses a method to test Sildenafil citrate and its ramifications. It contains steps: (1) Color reaction. Make color reaction of test sample with bismuth potassium iodide, silico-tungstic acid and Hager's reagent to observe result. (2) Result estimation. If above three color reactions appear deposit, there are Sildenafil citrate and its ramifications in test samples. If just one, two or none color reaction appear deposit, there is no Sildenafil citrate and its ramifications in test samples. The method has merits of quick, simple, strong property, high accuracy, extensive application and testing range.

Description

technical field [0001] The invention relates to a method for detecting sildenafil citrate and its derivatives. Background technique [0002] Sildenafil was developed by Pfizer Pharmaceuticals of the United States and entered clinical research as a 5-phosphodiesterase inhibitor for the treatment of cardiovascular diseases. In 1991, researchers found that sildenafil improved the sexual life of patients. On March 27, 1998, it was approved by the US Federal Food and Drug Administration for the treatment of male erectile dysfunction (ED). Its structural formula is shown in formula I, and molecular formula is C 22 h 30 N 6 o 4 S. [0003] [0004] Sildenafil is listed as a prescription drug, but some food, traditional Chinese medicine preparations, and health food manufacturers are trying to add sildenafil ingredients in their products in order to make users obtain more obvious effects. The fact that producers and distributors did not indicate the illegal doping of silden...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/77G01N33/15G01N1/28
Inventor 张喆高青车宝泉周立春代红王志斌赵明方颍郭洪祝
Owner BEIJING INST FOR DRUG CONTROL
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