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Determination method of anion and cation content in polyethylene glycol electrolyte preparation

An anion and cation and determination method technology, which is applied in the field of medicine, can solve the problems of different anion and cation determination methods, affect the service life of chromatographic columns, and the deviation of ion content results, so as to save detection time, stabilize retention time, and small deviation of test results. Effect

Active Publication Date: 2018-11-30
STAIDSON (BEIJING) BIOPHARMACEUTICALS CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Moreover, the stability of flame photometry and atomic absorption spectrophotometry is poor, and the judgment of the end point of titration method also has errors. The above methods will cause the possibility of deviation in the results of ion content, which in turn will cause the risk of quality control of preparations; , the operation is complex and cumbersome; at the same time, due to the viscosity of polyethylene glycol, the column efficiency is significantly reduced, which affects the service life of the column

Method used

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  • Determination method of anion and cation content in polyethylene glycol electrolyte preparation
  • Determination method of anion and cation content in polyethylene glycol electrolyte preparation
  • Determination method of anion and cation content in polyethylene glycol electrolyte preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Embodiment 1: external standard method measures sodium, potassium, chloride ion content in polyethylene glycol electrolyte powder

[0047] 1. Chromatographic conditions:

[0048] Instrument: Wantong 940 ion chromatograph;

[0049] Chromatographic column: Wantong ion exchange column, cation column 4.6×150mm, anion column 4.6×100mm;

[0050] Detector: conductivity detector;

[0051] Eluent: cationic 2.7mM nitric acid aqueous solution with addition of 10% acetonitrile, anionic 3.5mM sodium carbonate and 1.0mM sodium bicarbonate aqueous solution

[0052] Flow rate: cation 1.0ml / min, anion 0.7ml / min;

[0053] Column temperature: 40°C;

[0054] Injection volume: 20 μl.

[0055] 2. Experimental steps:

[0056] 1. Determination of control spectrum

[0057] Take standard solutions of sodium, potassium, and chloride ions (purchased from China Institute of Metrology) with known contents respectively, and prepare solutions containing sodium 10 μg / ml, potassium 1.25 μg / ml, and ...

Embodiment 2

[0085] Embodiment 2: external standard method measures sodium, potassium, chloride ion content in polyethylene glycol electrolyte oral liquid

[0086] 1. Chromatographic conditions:

[0087] Instrument: Wantong 940 ion chromatograph;

[0088] Chromatographic column: Wantong ion exchange column, cation column 4.6×150mm, anion column 4.6×100mm;

[0089] Detector: conductivity detector;

[0090] Eluent: cationic 2.3mM nitric acid aqueous solution + 5% acetonitrile, anionic 3.2mM sodium carbonate and 0.9mM sodium bicarbonate

[0091] aqueous solution

[0092] Flow rate: cation 0.8ml / min, anion 0.8ml / min;

[0093] Column temperature: 35°C; injection volume: 20 μl.

[0094] 2. Experimental steps:

[0095] 1. Determination of control spectrum

[0096] The experimental procedure is the same as in Example 1. Anion and cation eluents have no interference to the detection of each ion content, polyethylene glycol electrolyte oral liquid excipients (i.e. polyethylene glycol, acesul...

Embodiment 3

[0115]Embodiment 3: external standard method measures sodium, potassium, chloride ion content in polyethylene glycol electrolyte oral liquid

[0116] 1. Chromatographic conditions:

[0117] Instrument: Wantong 940 ion chromatograph;

[0118] Chromatographic column: Wantong ion exchange column, cation column 4.6×150mm, anion column 4.6×100mm;

[0119] Detector: conductivity detector;

[0120] Eluent: cationic 2.5mM nitric acid aqueous solution + 20% isopropanol, anionic 3.8mM sodium carbonate and 1.1mM sodium bicarbonate aqueous solution

[0121] Flow rate: cation 1.2ml / min, anion 0.6ml / min;

[0122] Column temperature: 45°C;

[0123] Injection volume: 20 μl.

[0124] 2. Experimental steps:

[0125] Experimental procedure is with embodiment 2, detects the chromatogram that obtains according to above-mentioned detection condition, as Figure 13 . The measured sodium, potassium and chloride ion content results are shown in Table 8, and the inspection results such as symme...

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Abstract

The invention belongs to the field of medicine, and specifically provides a method of using HPLC (High Performance Liquid Chromatography) to measuring the contents of cations and anions in a polyethylene glycol electrolyte preparation. The chromatographic conditions are as follows: the cation eluent is a nitric acid water solution (2.3-2.7 M) containing a water soluble organic solvent accounting for 5 to 20 vol.% of the eluent; the flowing speed is 0.8 to 1.2 mL / min; the anion eluent is a water solution of sodium carbonate (3.2-3.8 mM) and sodium bicarbonate (0.9-1.1 mM), the flowing speed is 0.6 to 0.8 mL / min, and the detector is an electrical conductivity detector. The measuring method has the advantages of strong specificity, simple and quick operation, capability for prolonging the service life of chromatographic column, and high sensitivity.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a method for determining the content of anions and cations in a polyethylene glycol electrolyte preparation. Background technique [0002] Polyethylene Glycol (PEG) is a high molecular polymer obtained by polymerization of ethylene oxide. It has the effect of laxative and bowel cleansing clinically. The specific mechanism of action is: after polyethylene glycol enters the body through oral administration, it binds and fixes the inherent water molecules in the intestinal cavity through hydrogen bonds, increases the water content of the feces, increases the volume and weight of the feces, softens the feces, and promotes the stool in the intestinal cavity. It can improve constipation, restore stool volume and weight to normal, and promote the final completion of defecation, thereby improving constipation symptoms; at the same time, because its laxative and bowel cleansing effect...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/96
CPCG01N30/96
Inventor 张帆冯彩丽
Owner STAIDSON (BEIJING) BIOPHARMACEUTICALS CO LTD
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