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Method for determining value of anisidine in drug-loaded lipid emulsion

A method of measuring methoxyaniline, which is applied in the field of medical testing, can solve problems such as large operating errors, test failures, and easy turbidity, and achieve the goals of improving precision and accuracy, easy operation, and guaranteed success rate Effect

Active Publication Date: 2018-01-05
HUAREN PHARMACEUTICAL CO LTD
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  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] But above-mentioned method when utilizing the absorbance measured at 350nm place to calculate the methoxyaniline value, it is only applicable to non-drug-loaded nutrition milk and drug-loaded fat emulsion without interference at 350nm wavelength place, and has stronger near 350nm wavelength place For the drug-loaded fat emulsion with UV absorption, because the absorbance of the test product at 350nm wavelength is too large, which exceeds the range of accurate measurement of the UV spectrophotometer, the value of methoxyaniline cannot be accurately measured.
Moreover, the above method is prone to turbidity when using isopropanol-isooctane (2:8) mixed solvent to dissolve the residue, and the turbidity cannot be completely removed after filtering with a 0.45um syringe filter, resulting in a negative measurement result , the test fails
[0007] The second method is derived from "Measurement Method of Methoxyaniline Value of Fat Emulsion" (patent application number: 201210298673.0), and its drawback is also that: for the drug-loaded fat emulsion with strong ultraviolet absorption near the wavelength of 350nm, due to the The absorbance of the sample at 350nm wavelength is too large, which exceeds the range of accurate measurement by the ultraviolet spectrophotometer, and the value of methoxyaniline cannot be accurately measured.
[0008] The third method is derived from "Method for Determination of Methoxyaniline Value of Fat Emulsion" (patent application number: 201310664114.1). In this method, a multi-step extraction method is used to separate the analyte from the fat emulsion. The disadvantage lies in the operation Complex and prone to large operational errors

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  • Method for determining value of anisidine in drug-loaded lipid emulsion
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  • Method for determining value of anisidine in drug-loaded lipid emulsion

Examples

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Embodiment 1

[0060] Precisely measure 10 mL of clevidipine butyrate fat emulsion injection, put it in a 250 mL round bottom flask, add 20 mL of absolute ethanol, and rotate in a water bath at 60°C for 15 minutes under reduced pressure (vacuum degree above -0.095 MPa). From "adding 20mL of absolute ethanol", repeat the operation three times according to the law to remove the water. Add glacial acetic acid-isopropanol-isooctane (2:2:7) to dissolve the residue and quantitatively transfer it to a 25mL measuring bottle, add the above solvent to dilute to the mark, shake well, and use it as the test solution.

[0061] Take an appropriate amount of clevidipine butyrate reference substance, put it in a 25mL measuring bottle, add glacial acetic acid-isopropanol-isooctane (2:2:7) to make a solution containing about 0.18mg / mL of clevidipine butyrate ( If A 0 If the measurement result is not within the range of 0.2 to 0.7, then adjust the concentration of the blank solution appropriately so that A 0...

Embodiment 2

[0069] Precisely measure 10 mL of nimodipine fat emulsion injection, put it in a 250 mL round bottom flask, add 20 mL of absolute ethanol, and rotate in a water bath at 60°C for 15 minutes under reduced pressure (vacuum degree above -0.095 MPa). From "adding 20mL of absolute ethanol", repeat the operation three times according to the law to remove the water. Add glacial acetic acid-isopropanol-isooctane (2:2:7) to dissolve the residue and quantitatively transfer it to a 25mL measuring bottle, add the above solvent to dilute to the mark, shake well, and use it as the test solution.

[0070] Take an appropriate amount of nimodipine reference substance, put it in a 25mL measuring bottle, add glacial acetic acid-isopropanol-isooctane (2:2:7) to make a solution containing about 0.30mg / mL of nimodipine (if A 0 If the measurement result is not within the range of 0.2 to 0.7, then adjust the concentration of the blank solution appropriately so that A 0 fall within the range of 0.2 to...

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Abstract

The invention provides a method for determining the value of anisidine in a drug-loaded lipid emulsion, belonging to the technical field of medical examination. The method can improve the determination accuracy of the value of anisidine in the drug-loaded lipid emulsion and increase the success rate of testing. The method can be applied to determination of the value of anisidine in drug-loaded lipid emulsions, especially to determination of the value of anisidine in drug-loaded lipid emulsions.

Description

technical field [0001] The invention belongs to the technical field of medical inspection, and relates to a method for determining the value of methoxyaniline in a drug-loaded fat emulsion. Background technique [0002] At present, there are probably the following three methods for determining the value of methoxyaniline in fat emulsions: [0003] The first method is derived from the Chinese Pharmacopoeia Commission’s “Medium / Long-Chain Fat Emulsion Injection” quality standard draft and “Propofol Emulsion Injection” quality standard draft (the fourth public announcement). The measurement methods are basically the same. Specifically: Take 10mL of this product precisely, put it in a 250mL round bottom flask, add 20mL of absolute ethanol, and evaporate in a water bath at 60°C for 15 minutes under reduced pressure. From "adding 20mL of absolute ethanol", repeat the operation three times according to the law to remove the water. Add isopropanol‐isooctane (2:8) to dissolve the ...

Claims

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Application Information

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IPC IPC(8): G01N21/31
Inventor 夏菁
Owner HUAREN PHARMACEUTICAL CO LTD