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Determination method of methoxyaniline value of fat emulsion

A technology of methoxyaniline and fat emulsion, which is applied in the preparation of test samples, measurement of color/spectral characteristics, etc., can solve problems such as inaccurate measurement results, shorten extraction time, improve detection efficiency, and improve accuracy Effect

Active Publication Date: 2016-05-25
JIANGSU JIUXU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The oil phase in fat emulsions such as soybean oil and phospholipids cannot withstand high temperatures, especially phospholipids. If they are operated under high temperature conditions, the oxidation of unsaturated fatty acid esters in soybean oil and phospholipids may be accelerated, resulting in an increase in peroxides. This method uses vacuum rotary evaporation in a water bath at 60°C to remove moisture. If the temperature is too high and the rotary evaporation time is too long, the peroxide may continue to be degraded into aldehydes, ketones and small molecule aldehydes, which may be removed by high temperature vacuum rotary evaporation, resulting in inaccurate results. Inaccurate

Method used

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  • Determination method of methoxyaniline value of fat emulsion
  • Determination method of methoxyaniline value of fat emulsion
  • Determination method of methoxyaniline value of fat emulsion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] The assay method of fat emulsion methoxyaniline value, the steps are as follows:

[0063] Precisely measure 10 mL of fat emulsion (etomidate fat emulsion injection) and place it in a separatory funnel;

[0064] Add 5 mL of ethanol to the separating funnel, mix well, then add 0.1 g of sodium chloride and 20 mL of ether, and shake vigorously;

[0065] Stand to separate and separate, transfer the upper oil phase to a 250mL flask, and extract the lower water phase with diethyl ether twice, each time with 10mL of diethyl ether, and combine the oil phases to obtain the diethyl ether phase;

[0066] Under the condition of lower than 40°C, the ether phase was subjected to vacuum rotary evaporation to dryness to obtain a residue 1;

[0067] Residue 1 was dissolved in 10 mL of ethyl acetate to obtain the ethyl acetate phase, and the ethyl acetate phase was subjected to vacuum rotary evaporation at a temperature lower than 40° C. to obtain residue 3;

[0068] Residue 3 was disso...

Embodiment 2～6

[0076] Embodiments 2 to 6 adopt the fat emulsion used in Example 1, and only the amounts of fat emulsion, demulsifier, extractant and ethanol are different in the initial addition of the separatory funnel, as shown in Table 1. Those skilled in the art can According to common sense, the consumption of rotary steaming agent is adjusted accordingly, and the operation steps are exactly the same as in Example 1.

[0077] The consumption table of fat emulsion, demulsifier, extractant and ethanol in the embodiment 2~6 of table 1

[0078] The dosage in the example

[0079] Adopt the assay method of the present invention to measure the methoxyaniline value of the fat emulsion of different volumes, know through calculation, the volume (V) of the fat emulsion that measures takes and 1.2A 2 -A 1 There is a linear relationship, the correlation coefficient R 2 Reach 0.993, therefore, the methoxyaniline value of the fat emulsion that adopts how many volumes of fat emulsion to mea...

Embodiment 7

[0081] Embodiment 7 is only different from the operating temperature of Embodiment 1, and all the other are the same as Embodiment 1. Embodiment 7 is operated below 20°C, and the results of measuring 6 samples at the same time are respectively: 1.22, 1.17, 1.19, 1.25, 1.20, 1.15.

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Abstract

The invention relates to the technical field of determination methods for anisidine value, and discloses a determination method for the anisidine value of lipid emulsion. The determination method comprises the steps of performing extraction treatment on the lipid emulsion by using an alkali metal salt as a demulsifier and diethyl ether as an extracting agent to obtain a diethyl ester phase and a water phase; carrying out vacuum rotary evaporation treatment on the diethyl ester phase at a temperature lower than 40 DEG C to obtain a residue I; dissolving the residue I with ethyl acetate to obtain an ethyl acetate phase; carrying out vacuum rotary evaporation treatment on the ethyl acetate phase at the temperature lower than 40 DEG C to obtain a residue II which is to be used as a sample. In a technical solution provided by the invention, vacuum rotary evaporation is carried out at the temperature lower than 40 DEG C, so that the problems of oxidation and degradation of unsaturated fatty acid esters caused by high temperature can be prevented; and accuracy for measurement of the anisidine value can be increased.

Description

technical field [0001] The invention relates to the technical field of measuring the methoxyaniline value, in particular to a method for determining the methoxyaniline value of a fat emulsion. Background technique [0002] Fat emulsions for intravenous injection are mainly oil-in-water emulsions made by emulsifying an oil phase, such as soybean oil, medium-chain triglycerides, phospholipids, and an aqueous phase. The oil phase and phospholipids contain unsaturated bonds, which are easily oxidized and converted into peroxides. The methoxyaniline value is an index reflecting the decomposition of peroxides into aldehydes and ketones. If the value is high, it may damage the liver function of the human body. [0003] The determination method of the methoxyaniline value of the existing fat emulsion refers to the "Quality Standards for Fat Emulsion Injection (C14-C24)" (draft for comments) issued by the Chinese Pharmacopoeia Commission. This method has the following disadvantages...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/33G01N1/28
Inventor 陈沛单李宏晏敏红陈应林岳昌林
Owner JIANGSU JIUXU PHARMA
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