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A kind of detection method of additive in sufentanil medicine

A detection method and drug technology, applied in the field of sufentanil purity, can solve the problems of low recovery rate, secondary pollution, large consumption of organic solvents, etc., and achieve the effect of low cost

Active Publication Date: 2022-07-12
上海微谱检测科技集团股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its advantage is simple operation, but there are also disadvantages such as large consumption of organic solvents, secondary pollution to the environment, long time consumption, low recovery rate, serious emulsification phenomenon, and difficulty in automatic operation.

Method used

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  • A kind of detection method of additive in sufentanil medicine

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] A detection method for additives in sufentanil medicine, comprising the following steps:

[0068] (1) Sample processing:

[0069] S1. after 75mg of sufentanil citrate is dissolved in 900mL of water, the pH is adjusted to 3.7 with citric acid solution, and water is added to 1000mL to obtain the sample mother liquor;

[0070] S2. Take 10 mL of the sample mother liquor in an analysis bottle, add 10 mL of an organic solvent for extraction, separate the organic phase, add anhydrous magnesium sulfate for dehydration, and then test;

[0071] (2) Prepare standard solution; prepare 5 gradient standard series solutions of dibutyl phthalate; the concentrations are 20, 40, 60, 80, 100 μg / L;

[0072] (3) Carry out GC-MS test. The chromatographic conditions of GC-MS are: column is HP-5MS; specification: 30m*0.25mm*0.25μm; carrier gas is high-purity helium, purity ≥99.999%; inlet temperature The injection volume is 1 μL; the injection mode is splitless; the transfer line temperature...

Embodiment 2

[0077] A detection method for additives in sufentanil medicine, comprising the following steps:

[0078] (1) Sample processing:

[0079] S1. after dissolving 75mg of sufentanil citrate in 900mL of water, adjust the pH to 4.2 with citric acid solution, add water to 1000mL to obtain the sample mother liquor;

[0080] S2. Take 10 mL of the sample mother liquor in an analysis bottle, add 10 mL of an organic solvent for extraction, separate the organic phase, add anhydrous magnesium sulfate for dehydration, and then test;

[0081] (2) Prepare standard solution; prepare 5 gradient standard series solutions of dibutyl phthalate; the concentrations are 20, 40, 60, 80, 100 μg / L;

[0082] (3) Carry out GC-MS test. The chromatographic conditions of GC-MS are: column is HP-5MS; specification: 30m*0.25mm*0.25μm; carrier gas is high-purity helium, purity ≥99.999%; inlet temperature The injection volume is 1 μL; the injection mode is splitless; the transfer line temperature is 300°C; the c...

Embodiment 3

[0087] A detection method for additives in sufentanil medicine, comprising the following steps:

[0088] (1) Sample processing:

[0089] S1. after 75mg of sufentanil citrate is dissolved in 900mL of water, the pH is adjusted to 4.0 with citric acid solution, and water is added to 1000mL to obtain the sample mother liquor;

[0090] S2. Take 10 mL of the sample mother liquor in an analysis bottle, add 10 mL of an organic solvent for extraction, separate the organic phase, add anhydrous magnesium sulfate for dehydration, and then test;

[0091] (2) Prepare standard solution; prepare 5 gradient standard series solutions of dibutyl phthalate; the concentrations are 20, 40, 60, 80, 100 μg / L;

[0092] (3) Carry out GC-MS test. The chromatographic conditions of GC-MS are: column is HP-5MS; specification: 30m*0.25mm*0.25μm; carrier gas is high-purity helium, purity ≥99.999%; inlet temperature The injection volume is 1 μL; the injection mode is splitless; the transfer line temperature...

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Abstract

The present invention relates to the technical field of sufentanil purity, and more particularly, to a method for detecting additives in sufentanil medicine. The present invention relates to a method for detecting additives in sufentanil medicine, comprising the following steps: (1) sample processing: S1. dissolving sufentanil citrate in water, adjusting the pH, and adding water to 1000 mL to obtain a sample mother liquor, S2. Extract the sample mother liquor with an organic solvent, separate the organic phase, add a dehydrating agent and take the supernatant to be tested; (2) prepare a standard solution; prepare a standard series solution of dibutyl phthalate; (3) Perform GC‑MS testing. The method can accurately detect the content of dibutyl phthalate in sufentanil, and has the advantages of low cost, simplicity and speed.

Description

technical field [0001] The present invention relates to the technical field of sufentanil purity, and more particularly, the present invention relates to a method for detecting additives in sufentanil medicine. Background technique [0002] Phthalates (PAEs) are an important class of endocrine disruptors. Trace amounts of PAEs will accumulate in water, soil, animals and plants, are difficult to degrade in the environment, interfere with the human endocrine system, and directly affect the metabolism of the human body. The plasticizer phthalate bis(2-ethylhexyl) Ester (DEHP) is 20 times more toxic than melamine. Studies have shown that plasticizers can also increase the burden on the liver and kidneys, cause chronic damage to the immune system, digestive system, and even lead to liver cancer. In the liquor storm in 2012, the highest detection value of dibutyl phthalate (DBP) detected in the samples was 1.04 mg / kg. With the large-scale use of plastic packaging products, the ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/042
Inventor 贾梦虹吴杰秦秋明杨潇军
Owner 上海微谱检测科技集团股份有限公司