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A colorimetric method for fast and efficient determination of Tween 80 content and its application

A high-quality, high-efficiency technology, applied in the colorimetric field of fast and efficient determination of Tween 80 content, can solve the problems affecting the precision, accuracy and reproducibility of the measurement results, long color reaction time, and poor process controllability, etc. Achieve the effects of shortening the color reaction time, avoiding long-term contact, and reducing volatilization loss

Active Publication Date: 2020-01-07
YANTAI UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

First, the color reaction is carried out at room temperature, the reaction process is slow, and is significantly affected by room temperature changes. As a result, the color reaction time is long (up to 7h), and it needs to be shaken from time to time during the reaction (once every 15-30 minutes) ) to promote the reaction; on the other hand, the organic solvent for extracting the chromogenic product is added to the aqueous reaction medium simultaneously with the chromogenic agent, which may cause losses due to frequent shaking operations during the long-term chromogenic reaction process, As a result, the operation is cumbersome and the process is poorly controllable, which affects the precision, accuracy and reproducibility of the determination results (Zhang Qiao, Shi Wenjing, Cao Ailan. Determination of Tween 80 content in Yejuhua injection[J]. Asia Pacific Traditional Medicine, 2012,8(6):39-40; Liu Yanmei, Pu Xufeng, Zhang Liang, et al. Determination of polysorbate 80 content in Houttuynia cordata injection by colorimetry[J]. Chinese Drug Standards, 2008, 9( 6): 434-437.)

Method used

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  • A colorimetric method for fast and efficient determination of Tween 80 content and its application
  • A colorimetric method for fast and efficient determination of Tween 80 content and its application
  • A colorimetric method for fast and efficient determination of Tween 80 content and its application

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1 The effect of the sequence of adding the extraction solvent on the speed of the color reaction at room temperature

[0026] Take Tween 80 reference substance solution (2.18mg / ml) 1.2ml, parallel 14, divide into I, II two groups (n=7). Among them, group I added 3ml of chromogenic agent cobalt ammonium thiocyanate solution, sealed it tightly, shook it well, put it at room temperature for color reaction, and added 5ml of dichloromethane precisely; group II added chromogenic agent cobalt ammonium thiocyanate solution 3ml, and at the same time, 5ml of dichloromethane was precisely added, sealed, and placed at room temperature for color reaction. During the two groups of reactions, they were shaken for 30 seconds at intervals of 0.5h, and at 0.5h, 1h, 2h, 3h, 4h, 5h, and 6h, the absorbance was measured at a wavelength of 623nm with a blank solvent as a reference. Draw the kinetic curve of the room temperature chromogenic reaction in the order of adding the extracti...

Embodiment 2

[0029] Color reaction kinetics comparison under embodiment 2 different temperatures

[0030] Take Tween 80 reference substance solution (2.18mg / ml) 1.2ml, parallel 16 parts, divide into two groups (n=8), add chromogenic agent cobalt ammonium thiocyanate solution 3ml, seal tightly, shake well, place respectively Boiling water bath and room temperature (shaking from time to time) for color development, and when reacting for 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, then cool to room temperature, add 5ml of dichloromethane precisely, and seal , fully shake until the colored precipitate in the test tube is completely dissolved, let stand to separate layers, absorb the lower layer solution, use the blank solvent as a reference, and measure the absorbance value at a wavelength of 623nm. Draw the color reaction kinetic curve of the absorbance value changing with time at different reaction temperatures, such as figure 2 shown.

[0031] The results show that: compared with the reaction at...

Embodiment 3

[0032] Embodiment 3 method verification and application

[0033] Bitter wood injection is a kind of unilateral traditional Chinese medicine injection made from bitter wood medicinal materials. It has the effects of clearing away heat, detoxification, and anti-inflammation. It is clinically used for colds, upper respiratory tract infections, acute tonsillitis, enteritis, bacillary dysentery, etc. The curative effect is exact. According to the standard issued by the Ministry of Health of the People's Republic of China, the eighteenth volume of traditional Chinese medicine preparations WS 3 -B-3887-98, Tween 80 is added as a solubilizer of the active ingredient in the amount of 8g / L in the formulation of Kumu injection, but the standard has not yet set a limit for Tween 80.

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Abstract

The invention discloses a colorimetric method for rapidly and efficiently testing the content of Tween-80. The method comprises the following steps: in an aqueous medium, performing a rapid developing reaction on poly-ethyoxyl and thiocyanic acid cobalt amine salts of Tween-80 under a boiling water bath heating condition so as to quantitatively generate a blue developing product which is not dissolved in water; and cooling to the room temperature, quantitatively adding an organic solvent, extracting the developing product, and testing the content of Tween-80 by using the colorimetric method. The colorimetric method disclosed by the invention is applicable to rapid quantitative test on the Tween-80 of a medicinal auxiliary material in various medicinal preparations, and a convenient and reliable detection method is provided for quantitative control on Tween-80 in related products.

Description

technical field [0001] The invention relates to a colorimetric method for quickly and efficiently measuring the content of Tween 80 and its application in the quantitative control of Tween 80, a medicinal auxiliary material in various pharmaceutical preparations, belonging to the technical field of drug quality control. Background technique [0002] Tween 80 (Tween80, CASNo.9005-65-6), also known as polysorbate 80 (Polysorbate 80), is a polyoxyethylene 20 sorbitan oleate polymerized from sorbitan oleate and ethylene oxide. It uses sorbitan as the backbone, and the side chain is connected with three oxyethylene chains with hydrophilic properties and one fatty chain with lipophilic properties, with an average relative molecular mass of 1309.7. [0003] Tween 80 is a non-ionic surfactant with good emulsifying and solubilizing effects. It is widely used as an emulsifier, dispersant, solubilizer or stabilizer in pharmaceutical, food and cosmetic industries, and its usage is 1%~ ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/78G01N21/31
CPCG01N21/3103G01N21/78
Inventor 许卉杨昕杨倩文许茜张杰
Owner YANTAI UNIV
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