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A deep processing detection method of Allura Red and/or sunset yellow content in gelatin capsules

A detection method and a gelatin capsule technology, applied in the detection field, can solve the problems of inaccurate determination of allura red and sunset yellow, extraction of allura red and sunset yellow, etc., and achieve the effects of high recovery rate, low limit of quantification and good stability.

Active Publication Date: 2019-07-02
BY HEALTH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing detection methods are difficult to fully extract Allura Red and Sunset Yellow from samples, resulting in inaccurate determination of Allura Red and Sunset Yellow content

Method used

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  • A deep processing detection method of Allura Red and/or sunset yellow content in gelatin capsules
  • A deep processing detection method of Allura Red and/or sunset yellow content in gelatin capsules
  • A deep processing detection method of Allura Red and/or sunset yellow content in gelatin capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] 1. Principle

[0044] Allura Red and Sunset Yellow in the sample were extracted with the extract, added ethanol to remove gelatin, detected by high performance liquid chromatography, and quantitatively determined by external standard method.

[0045] 2. Instrument

[0046] Agilent 1260 high performance liquid chromatography, electronic balance, constant temperature water bath, centrifuge

[0047] 3. Reagents

[0048] 3.1 Extract: Take 20g of trisodium citrate and 3g of zinc acetate, add water to dissolve, dilute to 250mL, and mix well.

[0049] 3.2 Allura Red stock solution: Accurately weigh 10mg of Allura Red reference substance, put it in a 50mL volumetric flask, add water to dissolve and adjust the volume to the mark, and shake well to obtain the stock solution.

[0050] 3.3 Mixed standard solution of Allura Red and Sunset Yellow: Pipette 1.0mL of Allura Red stock solution and 1.0mL of 0.5mg / mL Sunset Yellow standard solution into a 50mL volumetric flask, dilute to ...

Embodiment 2

[0075] 1. Principle

[0076] Allura Red and Sunset Yellow in the sample were extracted with the extract, added ethanol to remove gelatin, detected by high performance liquid chromatography, and quantitatively determined by external standard method.

[0077] 2. Instrument

[0078] Agilent 1260 high performance liquid chromatography, electronic balance, constant temperature water bath, centrifuge

[0079] 3. Reagents

[0080] 3.1 Extract: Take 18g of trisodium citrate and 3.5g of zinc acetate, add water to dissolve, dilute to 250mL, and mix well.

[0081] 3.2 Allura Red stock solution: Accurately weigh 10mg of Allura Red reference substance, put it in a 50mL volumetric flask, add water to dissolve and adjust the volume to the mark, and shake well to obtain the stock solution.

[0082] 3.3 Mixed standard solution of Allura Red and Sunset Yellow: Pipette 1.0mL of Allura Red stock solution and 1.0mL of 0.5mg / mL Sunset Yellow standard solution into a 50mL volumetric flask, dilute...

Embodiment 3

[0105] 1. Principle

[0106] Allura Red and Sunset Yellow in the sample were extracted with the extract, added ethanol to remove gelatin, detected by high performance liquid chromatography, and quantitatively determined by external standard method.

[0107] 2. Instrument

[0108] Agilent 1260 high performance liquid chromatography, electronic balance, constant temperature water bath, centrifuge

[0109] 3. Reagents

[0110] 3.1 Extract: Take 25g of trisodium citrate and 4g of zinc acetate, add water to dissolve, dilute to 250mL, and mix well.

[0111] 3.2 Allura Red stock solution: Accurately weigh 10mg of Allura Red reference substance, put it in a 50mL volumetric flask, add water to dissolve and adjust the volume to the mark, and shake well to obtain the stock solution.

[0112] 3.3 Mixed standard solution of Allura Red and Sunset Yellow: Pipette 1.0mL of Allura Red stock solution and 1.0mL of 0.5mg / mL Sunset Yellow standard solution into a 50mL volumetric flask, dilute t...

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Abstract

The invention relates to the technical field of detection, in particular to a deep processing detection method of allura red and / or sunset yellow FCF content in a gelatin capsule. The detection method comprises the steps of adding a gelatin capsule shell sample into a water solution containing trisodium citrate and zinc acetate, keeping warm at the temperature of 70 to 80 DEG C, and dissolving the sample to obtain a sample solution; mixing the sample solution and absolute ethyl alcohol, centrifuging, and filtering, wherein the obtained filter liquor is a sample liquor for test; adopting a high performance liquid chromatography technology for detecting the sample liquor for test, an allura red standard solution and / or a sunset yellow FCF standard solution, and utilizing an external standard method for determining the allura red and / or sunset yellow FCF content in the gelatin capsule shell sample. Compared with the prior art, the detection method provided by the invention can be used for more accurately detecting the allura red and / or sunset yellow FCF content in the gelatin capsule. The detection method provided by the invention is favorable in linear relation, accuracy and stability, free of interference, low in detection limit and quantitation limit, and high in recovery rate.

Description

technical field [0001] The invention relates to the technical field of detection, in particular to a deep processing detection method for the content of allura red and / or sunset yellow in gelatin capsules. Background technique [0002] Gelatin hollow capsule is an extremely important pharmaceutical excipient. It is composed of cap and body two-section capsule shell refined from medicinal gelatin and excipients. It can hold various medicine powders, liquids, semi-solids and tablets. Soft capsules are a packaging method of capsules, which are commonly used in medicines or health foods. It is a capsule made by sealing liquid medicine or liquid fruit medicine in a soft capsule. The soft capsule material is made of capsules with gelatin, glycerin or other suitable pharmaceutical excipients alone or mixed. Hollow capsules can mask the peculiar smell of medicines, are easy to swallow, have good disintegration ability, and have the advantages of long shelf life and so on. At pres...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 孙浩洋杨祖伟
Owner BY HEALTH CO LTD
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