Method for detecting molecular weight and molecular weight distribution coefficient of medical sodium hyaluronate gel

A technology of sodium hyaluronate and molecular weight distribution, applied in the field of chemical inspection, can solve problems such as low universality, and achieve the effects of simple operation, good stability and cost saving.

Inactive Publication Date: 2017-01-04
ZHEJIANG JINGJIA MEDICAL TECH CO LTD
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Problems solved by technology

[0006] The technical problem to be solved by the present invention is to provide a medical sodium hyaluronate gel for the determination of the weight average molecular weight and molecular weight distribution coefficient of sodium hyaluronate gel in the medical sodium hyaluronate gel in the existing industry standards. Determination method of weight-average molecular weight and molecular weight distribution coefficient of sodium hyaluronate in glue

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  • Method for detecting molecular weight and molecular weight distribution coefficient of medical sodium hyaluronate gel
  • Method for detecting molecular weight and molecular weight distribution coefficient of medical sodium hyaluronate gel

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Embodiment Construction

[0023] The invention provides a method for detecting the weight-average molecular weight and molecular weight distribution coefficient of sodium hyaluronate in medical sodium hyaluronate gel:

[0024] According to the "Chinese Pharmacopoeia" 2015 edition four general rules 0514 molecular exclusion spectroscopy.

[0025] Experimental method and process:

[0026] 1. Instrument

[0027] Chromatographic instrument: Agilent 1260Infinity high performance liquid chromatography system (Agilent, USA): G1310B unit pump; G1322A online degasser; G1316A column thermostat; G1329B automatic sampler; G1362A differential detector; G7850AA GPC / SEC workstation.

[0028] Analytical balance: BSA224S type (manufacturer: Sartorius)

[0029] Test product: medical sodium hyaluronate gel.

[0030] 2. Chromatographic conditions

[0031] Chromatographic column: gel column Shodex SB-806HQ (8.0mm×300mm);

[0032] Mobile phase: Weigh 11.69g of sodium chloride and 0.2g of sodium azide, add 1000ml of pur...

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Abstract

The invention relates to a method for detecting the weight-average molecular weight and molecular weight distribution coefficient of sodium hyaluronate in medical sodium hyaluronate gel. The method comprises: precisely measuring a proper amount of a medicinal preparation solution, adding a mobile phase to dilute the solution to a to-be-tested sample liquid with the required concentration, performing uniform shaking, performing sample injection, and recording a chromatogram; taking a sodium polystyrenesulfonate reference substance, performing measuring according to the method above, drawing a calibration curve with a GPC software, and using a universal calibration method to obtain weight-average molecular weight and molecular weight distribution coefficient. A laser scattering and gel permeation chromatography combination method is used for detecting the weight-average molecular weight and molecular weight distribution coefficient of sodium hyaluronate in medical sodium hyaluronate gel in the professional standard. The combination method is hard to popularize, for the multi-angle laser light scattering spectrometer is expensive. According to the method, the used device is good in universality, the measurement cost is low, and the result is accurate, reliable and stable.

Description

[0001] Technical field: [0002] The invention relates to the field of chemical testing and the technical field of drug analysis, in particular to a method for detecting the weight-average molecular weight and molecular weight distribution coefficient of sodium hyaluronate in medical sodium hyaluronate gel. [0003] Background technique: [0004] In the existing industry standard, the weight-average molecular weight and molecular weight distribution coefficient of sodium hyaluronate in medical sodium hyaluronate gel are determined by laser scattering-gel permeation chromatography, but the multi-angle laser light scattering instrument is expensive and difficult to popularize. . Therefore be badly in need of inventing a kind of utilizing the method detection of the present invention, the instrument universality that uses is strong, and measurement cost is low, the result is accurate, reliable, good stability in medical sodium hyaluronate gel weight-average molecular weight and mo...

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 王旭敏熊祥龙
Owner ZHEJIANG JINGJIA MEDICAL TECH CO LTD
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