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Method for detecting chlorpheniramine maleate

A technology for the detection of chlorpheniramine and its detection method, which is applied in the field of detection of chlorpheniramine maleate in medicine, can solve the problems of high analysis cost, expensive instrument, and great influence on the separation effect, and achieve low analysis cost , strong specificity and high accuracy

Inactive Publication Date: 2010-10-20
广东省药品检验所
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  • Abstract
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AI Technical Summary

Problems solved by technology

[0012] The advantage of thin-layer chromatography is that it does not need to use expensive analytical instruments, but it has the following disadvantages: (1) The chromatographic resolution is low, the composition of traditional Chinese medicine preparations is complex, and there are many interference factors, so it is easy to misjudge some coexisting components as horses. Chlorpheniramine maleate, some co-existing components will interfere with the detection of target components if the amount is large and the chromatographic shift value is close to that of chlorpheniramine maleate
(2) The time for chromatographic development and drying is long, which cannot meet the requirements of rapid determination
(3) TLC plates need to be paved by themselves, dried and stored dry (prefabricated TLC plates need to be stored dry), the ambient temperature and humidity have a great influence on the separation effect
(5) A fixed site is required, and it is not suitable for on-site testing with high mobility
[0015] The advantages of high performance liquid chromatography are high chromatographic separation efficiency, high precision of chromatographic retention time, and high sensitivity; the disadvantages are: (1) the instrument is expensive, the sample pretreatment time is long, the chromatographic column is easily polluted, the analysis cost is high, and it is not easy to popularize ; (2) Need to use expensive analytical instruments, high requirements on the environment, need to be fixed and placed, not suitable for on-site testing with large mobility
Therefore, this type of test can only be carried out in a small number of laboratories with good technical conditions, and is not suitable for rapid on-site inspection by drug supervision departments

Method used

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  • Method for detecting chlorpheniramine maleate
  • Method for detecting chlorpheniramine maleate
  • Method for detecting chlorpheniramine maleate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Sample: UB Younasal Spray (spray, labeled as produced by Guizhou Miao Ren Tang Biomedical Technology Co., Ltd., batch number: 20091012, as determined by HPLC, this product contains 0.7 mg / ml of chlorpheniramine maleate) .

[0044] Detection steps:

[0045] (1) get sample 3ml, place in 10ml sample bottle 1;

[0046] (2) In the sample bottle 1, dripping mass concentration is 2 drops of aqueous sodium hydroxide solution of 2%, shake up;

[0047] (3) add ethyl acetate 3ml to sample bottle 1, screw cap tightly, shake and make two-phase mixed contact, leave standstill layering, upper liquid is colorless and clear;

[0048] (4) Use a straw to absorb 2ml of the upper layer liquid, place it in a 10ml sample bottle II, add 2ml of phosphoric acid aqueous solution with a volume concentration of 3%, tighten the bottle cap, shake to make the two phases mix and contact, let stand for stratification, and the lower layer of liquid is colorless and clear;

[0049] (5) Use a straw to ...

Embodiment 2

[0051] Sample: UB You Nasal Spray (spray, labeled Guizhou Miao Ren Tang Biomedical Technology Co., Ltd., batch number: 20091020, the result of HPLC determination, this product contains 0.8 mg / ml of chlorpheniramine maleate) .

[0052] Detection steps:

[0053] (1) get sample 3ml, place in 10ml sample bottle 1;

[0054] (2) In the sample bottle 1, dripping mass concentration is 2 drops of aqueous sodium hydroxide solution of 2%, shake up;

[0055] (3) add ethyl acetate 3ml to sample bottle 1, screw cap tightly, shake and make two-phase mixed contact, leave standstill layering, upper liquid is colorless and clear;

[0056] (4) Use a straw to absorb 2ml of the upper layer liquid, place it in a 10ml sample bottle II, add 2ml of phosphoric acid aqueous solution with a volume concentration of 3%, tighten the bottle cap, shake to make the two phases mix and contact, let stand for stratification, and the lower layer of liquid is colorless and clear;

[0057] (5) Use a straw to abs...

Embodiment 3

[0059] Sample: UB Younasal Spray (spray, labeled as produced by Guizhou Miao Ren Tang Biomedical Technology Co., Ltd., batch number: 20091115, as determined by HPLC, this product contains 0.7 mg / ml of chlorpheniramine maleate) .

[0060] Detection steps:

[0061] (1) get sample 3ml, place in 10ml sample bottle 1;

[0062] (2) In the sample bottle 1, dripping mass concentration is 2 drops of aqueous sodium hydroxide solution of 2%, shake up;

[0063] (3) add ethyl acetate 3ml to sample bottle 1, screw cap tightly, shake and make two-phase mixed contact, leave standstill layering, upper liquid is colorless and clear;

[0064] (4) Use a straw to absorb 2ml of the upper layer liquid, place it in a 10ml sample bottle II, add 2ml of phosphoric acid aqueous solution with a volume concentration of 3%, tighten the bottle cap, shake to make the two phases mix and contact, let stand for stratification, and the lower layer of liquid is colorless and clear;

[0065] (5) Use a straw to ...

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Abstract

The invention discloses a rapid detection method of chlorpheniramine maleate doped in drugs, Chinese patent medicines and health products, which comprises the following steps: (1) taking a solid sample, adding 3-10 times the weight of water, shaking and dissolving, and then taking 3mL of extract, adding 2 drops of 2% (w / v) of sodium hydroxide solution and uniformly shaking to be used as a solution to be detected; or taking 3mL of liquid sample, and then adding 2 drops of 2% (w / v) of sodium hydroxide solution and uniformly shaking to be used as a solution to be detected; (2) adding 3mL of ethyl acetate in the solution to be detected to extract, standing and layering; (3) taking 2mL of upper ethyl acetate extract, adding 2mL of phosphoric acid water solution of 3% of volume concentration to extract, standing and layering; and (4) taking 1mL of lower phosphoric acid stripping solution, and adding 1-2 drops of trinitrophenol saturated water solution drop by drop, if a yellow precipitate is generated, then judging that the sample contains chlorpheniramine maleate. The detection method of the invention has simple operation, strong specificity and rapid color reaction, and can be suitable for rapidly detecting whether the drugs, the Chinese patent medicines and the health products are doped with chlorpheniramine maleate or not.

Description

technical field [0001] The invention relates to the detection of non-biological materials by means of precipitation, in particular to the detection of chlorpheniramine maleate in medicines. Background technique [0002] Chlorphenamine maleate (N, N-dimethyl-gamma-(4-chlorophenyl)-2-pyridine propylamine maleate), its English name is: Chlorphenamine Maleate; 2-(p -chloro-alpha-(2-(dimethylamino)ethyl)benzyl)-pyridin maleate. The structural formula of chlorpheniramine maleate is shown in the following formula I, and molecular formula is C 16 h 19 ClN 2 ·C 4 h 4 o 4 , the molecular weight is 390.87, and the CAS number is 113-92-8. Chlorpheniramine maleate is white crystalline powder, odorless, bitter taste, melting point 131-135°C; easily soluble in water, ethanol, chloroform, slightly soluble in ether. [0003] [0004] Chlorpheniramine maleate can treat allergic rhinitis: It is effective for nasal congestion caused by allergic rhinitis and upper respiratory tract in...

Claims

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Application Information

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IPC IPC(8): G01N21/82
Inventor 梁祈雷毅李杨杰邱蕴绮谢艳康
Owner 广东省药品检验所
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