Method for measuring content of magnesium salt in icodextrin bulk drug

An icodextrin and determination method technology, applied in the field of medicine, can solve the problems of poor precision, low sensitivity, poor repeatability, etc., and achieve the effects of reducing test cost, high sensitivity and simple operation

Inactive Publication Date: 2017-03-22
HUAREN PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, the methods for determining Mg salt content mainly include atomic absorption spectrophotometry (flame atomization method, graphite furnace atomization method), but atomic absorption spectrophotometry has the problems of poor precision, low sensitivity and poor repeatability.

Method used

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  • Method for measuring content of magnesium salt in icodextrin bulk drug
  • Method for measuring content of magnesium salt in icodextrin bulk drug
  • Method for measuring content of magnesium salt in icodextrin bulk drug

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Embodiment 1

[0030] The assay method of magnesium salt content in the icodextrin crude drug of the present embodiment may further comprise the steps:

[0031] Step 1: Sample Pretreatment

[0032] Accurately weigh 0.1g of icodextrin raw material, add it into a microwave digestion tank, add 5ml of water and 8ml of nitric acid with a mass percentage of 65%, shake it well and let it stand for several minutes, then cover it;

[0033] Step 2: Microwave Digestion

[0034] Set the microwave digestion instrument according to the following parameters: set the temperature at 200°C, heat up for 25 minutes, and keep warm for 20 minutes; after the digestion is completed, the temperature will automatically drop, take out the microwave digestion tank, open the lid, and transfer the sample solution to a 100ml PET volume after the nitrogen dioxide gas has evaporated. In a bottle, make up to volume with water;

[0035] Step 3: Prepare standard solution

[0036] Precisely measure 1ml of magnesium single-el...

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Abstract

The invention belongs to the field of medical technology and relates to a method for measuring content of magnesium salt in icodextrin bulk drug. The method comprises the following steps: accurately weighing 0.1 g of icodextrin bulk drug, carrying out microwave digestion, transferring a sample solution into a 100ml PET volumetric flask, and keeping a constant volume by the use of water; preparing standard solutions with magnesium concentrations respectively being 0 ug / ml, 0.05 ug / ml, 0.1 ug / ml, 0.5 ug / ml, 1 ug / ml and 3 ug / ml; successively measuring strengths of the standard solutions and the sample solution under the condition of set inductively coupled plasma emission spectrometer parameters, drawing a calibration curve according to the strengths of the standard solutions, and comparing the calibration curve with a standard curve to obtain content of magnesium salt in the icodextrin bulk drug. The measurement method has high sensitivity and good repeatability, and realizes accurate measurement of magnesium salt in the icodextrin bulk drug. The method is simple to operate, is beneficial to reduce test cost and helps enhance product quality and safety.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a method for determining the content of magnesium salts in icodextrin raw materials. 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. The presence of Mg salt in icodextrin API directly affects the quality of icodextrin peritoneal dialysate, so the control of Mg salt is one of the important contents that need to be studied during the research process. At present, the methods for determining Mg salt content mainly include atomic absorption spectrophotometry (fla...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/73G01N1/44G01N1/38
Inventor 张旭东冯新光
Owner HUAREN PHARMACEUTICAL CO LTD
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