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Method for detecting content of glucose in peritoneal dialysis solution

A technology of peritoneal dialysis fluid and detection method, which is applied in the field of detection of glucose content in peritoneal dialysis fluid, can solve the problems of high glucose recovery data, error, and difficult drop rate, etc., to optimize the process, improve product quality and safety effect

Inactive Publication Date: 2015-12-30
HUAREN PHARMACEUTICAL CO LTD
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Problems solved by technology

In addition, when adding sodium hydroxide solution dropwise, the rate of addition is not easy to be too fast, otherwise 10 - It is too late to react with glucose and disproportionate to IO 3- and I - , resulting in incomplete oxidation of glucose
The above-mentioned conditions will have a great impact on the determination of glucose content, resulting in large errors, so that the glucose recovery data is high or low when the method is validated, which cannot accurately reflect the glucose content in the sample.
[0004] Glucose is usually measured using the specific rotation method, but because the prescription of peritoneal dialysis solution contains sodium lactate with optical activity, the specific rotation method has interference in the determination of glucose

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  • Method for detecting content of glucose in peritoneal dialysis solution
  • Method for detecting content of glucose in peritoneal dialysis solution
  • Method for detecting content of glucose in peritoneal dialysis solution

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Embodiment Construction

[0014] The present invention will be further described below in conjunction with specific embodiments.

[0015] A detection method for glucose content in peritoneal dialysis fluid, it comprises the following steps:

[0016] (1) Preparation of reference substance solution: Accurately weigh anhydrous glucose reference substance, dissolve and dilute with deionized water, and make a solution containing 5.0-6.5 mg of glucose per 1 ml;

[0017] (2) Prepare the test solution: accurately measure the neutral peritoneal dialysate, dilute it with deionized water to make a solution containing 5.0-6.5 mg of glucose per 1 ml;

[0018] (3) Extract 20 μl each of the control solution and the test solution, inject them into the chromatograph, record the chromatogram, and calculate the peak area according to the external standard method to obtain the labeled amount of glucose.

[0019] Wherein, the chromatographic conditions are chromatographic column: WatersSugarParkI column, 300mm × 6.5mm, 6....

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Abstract

The invention relates to a method for detecting the content of glucose in a peritoneal dialysis solution. The method comprises the following steps: precisely weighing an anhydrous glucose reference substance, and dissolving and diluting through deionized water so as to obtain a solution, wherein 1 ml of the solution contains 5.0-6.5 mg of glucose; precisely weighing a neutral peritoneal dialysis solution and diluting through deionized water so as to obtain another solution, wherein 1 ml of the solution contains 5.0-6.5 mg of glucose; respectively and precisely taking 20 [mu]l of a reference solution and a test solution, injecting the reference solution and the test solution into a chromatographic instrument, recording a chromatogram, and calculating as a peak area according to an external standard method so as to obtain labelled amount of glucose, wherein chromatographic conditions are as follows: the chromatographic column is a WatersSugarParkI column, 300 mm*6.5 mm, 6.5 [mu] m; a mobile phase is deionized water; the flow velocity is 0.5+ / -0.1 ml / min; the column temperature is 80+ / -5 DEG C; the set temperature of a refractive index detector is 40+ / -5 DEG C and the sample amount is 20 [mu]l. According to the invention, the content of glucose in the peritoneal dialysis solution is detected through the high performance liquid chromatography, the quality of the peritoneal dialysis solution is controlled precisely, the process optimization is facilitated and the product quality and safety are improved.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a method for detecting glucose content in peritoneal dialysis fluid. Background technique [0002] In the draft national quality standard for peritoneal dialysis fluid (lactate), the glucose content was determined by indirect iodometric method and back titration method. The specific method is: accurately measure the appropriate amount of this product, precisely add 25ml of iodine titration solution (0.1mol / L), add 50ml of sodium hydroxide titration solution (0.1mol / L) dropwise while shaking, shake well, and place in a dark place After 30 minutes, add 5ml of dilute sulfuric acid, and titrate with sodium thiosulfate titration solution (0.1mol / L). When the end point is reached, add 2ml of starch indicator solution, continue titration until the blue color disappears, and correct the titration result with a blank test. That is, every 1ml of iodine titration solution (0.1mol / L) is eq...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 唐素华刘春霞陈红妍
Owner HUAREN PHARMACEUTICAL CO LTD
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