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Reference substance for measuring relative molecular weight and molecular weight distribution of heparin and salt thereof

A technology of molecular weight distribution and molecular weight, which is applied in the field of reference substances used to determine the relative molecular weight and molecular weight distribution of heparin and its salts, can solve problems such as inaccurate measurement results, inability to cover heparin molecules in the molecular weight range, and inaccurate relative molecular weight, etc., to achieve The determination method is simple, the prospect of popularization and application is good, and the effect of high practical value

Inactive Publication Date: 2013-04-03
SHANDONG UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, its molecular weight range cannot cover all heparin molecules, so the determination results are not accurate
There are also reports in the literature that the relative molecular weight of heparin is determined using pullulan as a standard, but because the structure of pullulan is essentially different from that of heparin, the relative molecular weight determined is not accurate

Method used

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  • Reference substance for measuring relative molecular weight and molecular weight distribution of heparin and salt thereof
  • Reference substance for measuring relative molecular weight and molecular weight distribution of heparin and salt thereof
  • Reference substance for measuring relative molecular weight and molecular weight distribution of heparin and salt thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Preparation process of heparin molecular weight reference substance

[0037] Materials and reagents: 10 batches of heparin sodium samples were selected, all of which were domestic heparin sodium injection grade raw materials; sodium nitrate, sodium azide, domestic analytical grade; triple distilled water.

[0038] Preparation of mobile phase: Accurately weigh 34g of sodium nitrate and 0.4g of sodium azide, dissolve them in 2L of triple distilled water. Suction filter twice with a double-layer 0.22 μm aqueous microporous membrane.

[0039] Preparation of sample solution: Accurately weigh 6 mg of heparin sodium raw material drug sample and dissolve in 4 mL of mobile phase. Double-layer 0.22μm aqueous microporous membrane filtration once.

[0040]Chromatography system: Waters515HPLC pump, Wyatt Optilab rEX parallax refractive index detector, Wyatt DAWN HELEOS II multi-angle laser scattering instrument.

[0041] The molecular weight and molecular weight distrib...

Embodiment 2

[0055] Example 2 Determination of relative molecular weight and molecular weight distribution of heparin sodium test product by using heparin molecular weight reference substance

[0056] (1) HPSEC analysis of heparin molecular weight reference substance and heparin test substance

[0057] Materials and reagents: 10 batches of heparin sodium samples were selected, all of which were domestic heparin sodium injection grade raw materials; sodium nitrate, sodium azide, domestic analytical grade; triple distilled water.

[0058] Chromatographic system: Waters2695, 2414.

[0059] The chromatographic conditions are as shown in Table 7:

[0060] Table 7

[0061]

[0062] Preparation of mobile phase: Accurately weigh 34g of sodium nitrate and 0.4g of sodium azide, dissolve them in 2L of triple distilled water. Suction filter twice with a double-layer 0.22 μm aqueous microporous membrane.

[0063] Preparation of the reference substance and the test solution: 10 mg of the samples ...

Embodiment 3

[0076] Embodiment 3 Precision experiment

[0077] Take 5 batches of heparin sodium samples, all of which are domestic injection-grade heparin sodium raw materials. Using the experimental conditions and methods in Example 2, each batch of samples was continuously injected 5 times to determine their relative molecular weight. The results are shown in Tables 11-20. Show:

[0078] Table 11 Batch 1 Molecular Weight Determination Precision Experimental Results

[0079]

[0080]

[0081] Table 12 Batch 1 molecular weight distribution precision test results

[0082]

[0083] Table 13 Batch 2 Molecular Weight Determination Precision Experimental Results

[0084]

[0085] Table 14 Batch 2 molecular weight distribution precision test results

[0086]

[0087] Table 15 Batch 3 Molecular Weight Determination Precision Experimental Results

[0088]

[0089] Table 16 Batch 3 molecular weight distribution precision test results

[0090]

[0091]

[0092] Table 17 ...

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Abstract

The invention discloses a reference substance for measuring the relative molecular weight and the molecular weight distribution of heparin and salt thereof. The reference substance comprises heparin sodium and a molecular weight range distribution standard sample list thereof, wherein heparin sodium is solid; and the molecular weight of heparin sodium, measured according to HPSEC (high performance size exclusion chromatography)-MALLS (Multi-angle Laser Light Scattering), is 3000 to 40000. The invention further discloses a method for measuring the relative molecular weight and the molecular weight distribution of heparin samples. The method comprises the following steps: (1), taking heparin samples of which the molecular weights range from 3000 to 40000 as reference substances; (2), drawing a molecular weight range distribution standard sample list; and (3), measuring the heparin samples according to HPSEC, and calculating the relative molecular weight and the molecular weight distribution, so as to carry out quality control. The reference substance and the method for measuring the relative molecular weight and the molecular weight distribution of the heparin samples according to the reference substance are the first in the world, and have higher utility values; the method is strict, scientific and simple; the measured results are accurate; and the popularization and application prospect is excellent.

Description

technical field [0001] The invention relates to a reference substance used for high-performance gel exclusion chromatography (HPSEC) to determine the relative molecular weight and molecular weight distribution of heparin and its salts, as well as its preparation method and application. Background technique [0002] Heparin is a glycosaminoglycan existing in mammals, which is formed by connecting hexuronic acid and glucosamine through 1,4-glycosidic bonds. Its relative molecular weight is mainly distributed between 3000 and 30000, and it is a mixture. Since 1937, heparin has been used as an anticoagulant in clinical treatment. [0003] A large number of studies have shown that various physiological activities of heparin and its in vivo processes are molecular-weight dependent. First, the anticoagulant activity of heparin is molecular weight dependent. A pentasaccharide structure in the heparin molecule can specifically catalyze the combination of ATⅢ and blood coagulation f...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 崔慧斐赵娜曹吉超
Owner SHANDONG UNIV
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