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Method for determination of content of icodextrin in icodextrin peritoneal dialysis solution

A technology of peritoneal dialysis fluid and icodextrin, which is applied in the direction of polarization influence characteristics, etc., can solve the problems of inaccurately reflecting glucose content, glucose cannot be completely oxidized, and high glucose recovery data, and achieves a simple, fast and cost-effective measurement method. Human and material resources, the effect of improving product quality and safety

Inactive Publication Date: 2017-03-22
HUAREN PHARMACEUTICAL CO LTD
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  • Description
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Problems solved by technology

In addition, when sodium hydroxide solution is added dropwise, the rate of addition should not be too fast, otherwise IO- will not have time to react with glucose and disproportionate into IO3- and I-, resulting in that glucose cannot be completely oxidized
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.

Method used

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  • Method for determination of content of icodextrin in icodextrin peritoneal dialysis solution
  • Method for determination of content of icodextrin in icodextrin peritoneal dialysis solution
  • Method for determination of content of icodextrin in icodextrin peritoneal dialysis solution

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Embodiment 1

[0029] The assay method of icodextrin content in the icodextrin peritoneal dialysate of the present embodiment comprises the following steps:

[0030] Step 1: Take 3ml of the icodextrin peritoneal dialysate sample to be tested, place it in a 10ml measuring bottle, and dilute to the mark with distilled water;

[0031] Step 2: take 0.134% sodium lactate aqueous solution as blank, measure and calculate according to polarimetry, promptly get the content of icodextrin in the icodextrin peritoneal dialysate; Calculation formula is

[0032]

[0033] Where L is the length of the optical tube, in decimeters;

[0034] DF is the dilution factor for sample preparation;

[0035] The specific optical rotation of SOR(ID) icodextrin raw material.

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Abstract

The invention belongs to the technical field of medical testing, and relates to a method for determination of content of icodextrin in an icodextrin peritoneal dialysis solution, and the method comprises the following steps: taking 3ml of a to-be-measured icodextrin peritoneal dialysis solution sample into a 10ml measuring flask, adding distilled water to dilute to a scale; and measuring and calculating on the basis of a 0.134% sodium lactate solution as a blank according to a rotation determination method to obtain the content of the icodextrin in the icodextrin peritoneal dialysis solution, accurate determination of the content of the icodextrin in the icodextrin peritoneal dialysis solution can be achieved, and the method is simple and quick, can save manpower and material resources, is helpful for reduction of test cost, and improves product quality and safety.

Description

technical field [0001] The invention belongs to the technical field of medical testing, and in particular relates to a method for determining the content of icodextrin in peritoneal dialysis fluid. Background technique [0002] Peritoneal dialysis solution is one of the important elements to ensure the smooth progress of peritoneal dialysis. So far, glucose dialysate is still the most used peritoneal dialysate, and it is currently the only dialysate in my country. With the improvement of dialysis technology, new types of dialysates are constantly appearing clinically, and the icodextrin dialysate with polydextrose as the osmotic agent is one of them. Icodextrin is its main component, and it is of great significance to carry out accurate quantitative analysis of its content. [0003] 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 ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/21
Inventor 张旭东冯新光
Owner HUAREN PHARMACEUTICAL CO LTD
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