CN106290614A - A kind of detection method of Medical sodium hyaluronate gel molecular weight and molecualr weight distribution coefficient - Google Patents
A kind of detection method of Medical sodium hyaluronate gel molecular weight and molecualr weight distribution coefficient Download PDFInfo
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- CN106290614A CN106290614A CN201610606754.0A CN201610606754A CN106290614A CN 106290614 A CN106290614 A CN 106290614A CN 201610606754 A CN201610606754 A CN 201610606754A CN 106290614 A CN106290614 A CN 106290614A
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- molecular weight
- sodium
- hyaluronate
- weight distribution
- average molecular
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
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Abstract
The present invention relates to hyaluronate sodium weight average molecular weight and the detection method of molecular weight distribution index in Medical sodium hyaluronate gel.First, it is appropriate that precision measures pharmaceutical preparation solution, adds flowing phase dilution and becomes the test liquid of desired concn, shakes up, sample introduction, record chromatogram.Separately take kayexalate reference substance, be measured in the same method, with GPC Software on Drawing calibration curve, use universal calibration method and get final product.Industry standard use laser light scattering gel permeation chromatography combination method measure hyaluronate sodium weight average molecular weight and molecular weight distribution index in Medical sodium hyaluronate gel, because of multi-angle laser light scattering instrument costly, it is difficult to universal use.The method utilizing the present invention detects, and the instrument universality of use is strong, and cost of determination is low, result accurately, reliable, have good stability.
Description
Technical field:
The present invention relates to chemical analysis field and pharmaceutical analysis technical field, particularly a kind of Medical sodium hyaluronate gel
Middle hyaluronate sodium weight average molecular weight and the detection method of molecular weight distribution index.
Background technology:
Existing industry standard measures hyaluronate sodium weight average molecular weight and molecular weight in Medical sodium hyaluronate gel divide
Cloth coefficient uses laser light scattering-gel permeation chromatography combination method, but application multi-angle laser light scattering instrument is costly, it is difficult to general
And use.Therefore being badly in need of inventing a kind of method utilizing the present invention to detect, the instrument universality of use is strong, and cost of determination is low, knot
Hyaluronate sodium weight average molecular weight and molecular weight distribution in the Medical sodium hyaluronate gel that fruit is accurate, reliable, have good stability
The detection method of coefficient.
Summary of the invention:
The technical problem to be solved is for measuring Medical sodium hyaluronate gel in existing industry standard
Middle hyaluronate sodium weight average molecular weight and the strongest problem of molecular weight distribution index universality and a kind of medical hyaluronic acid is provided
Hyaluronate sodium weight average molecular weight and the detection method of molecular weight distribution index in sodium gel.This detection method is simple and feasible, surveys
Determine index accurate.
The technical problem to be solved can be achieved through the following technical solutions:
Hyaluronate sodium weight average molecular weight and the detection side of molecular weight distribution index in a kind of Medical sodium hyaluronate gel
Method, has following steps:
(1) need testing solution preparation process
Precision weighs Medical sodium hyaluronate gel 5mg, adds flowing phase dilution and becomes to contain the dense of hyaluronate sodium 0.1mg/ml
Degree, shakes up and i.e. obtains need testing solution；
(2) reference substance solution preparation process
Precision weighs the kayexalate each 10mg of control series product, puts in 10mL measuring bottle, adds flowing phase dilution to carving
Degree, shakes up, as reference substance solution；
(3) determination step:
Chromatographic condition:
Instrument: Agilent 1260Infinity type highly effective liquid phase chromatographic system (Agilent company of the U.S.): G1310B is mono-
Unit's pump；The online degasser of G1322A；G1316A column oven；G1329B automatic sampler；G1362A Composition distribution；G7850AA
GPC/SEC work station；
Chromatographic column: gel column Shodex SB-806HQ (8.0mm × 300mm)
Flowing phase: weigh sodium chloride 11.69g, Hydrazoic acid,sodium salt 0.2g, the purified water adding 1000ml is dissolved, and is
0.2mol/L sodium chloride solution, 0.45um membrane filtration, standby；
Need testing solution prepared by step (1) is taken 100uL sample introduction, records chromatogram；Separately take kayexalate system
Row reference substance, is measured in the same method, and records chromatogram；With GPC Software on Drawing calibration trace.Use universal calibration method, the K value of reference substance
Being 0.00018, α value is 0.65；The K value of hyaluronate sodium is 0.00057, and α value is 0.75.Result of calculation, obtains hyaluronic acid
Sodium weight average molecular weight and molecular weight distribution index.
In a preferred embodiment of the present invention, step (3) uses SEC method (molecular exclusion chromatography).
The present invention is to have changed analysis method on the basis of industry, i.e. saves the cost of inspection, achieves again method operation
Easy, quick, testing instruments are the most common, and result accurately, reliable, have good stability.
Accompanying drawing explanation
Fig. 1 is kayexalate control series product chromatogram of the present invention.
Fig. 2 is test sample chromatogram of the present invention.
Detailed description of the invention
The present invention provides hyaluronate sodium weight average molecular weight and molecular weight distribution system in a kind of Medical sodium hyaluronate gel
Number detection method:
Measure according to " Chinese Pharmacopoeia " 2015 editions four general rule 0514 size-exclusion spectrometries.
Experimental technique and process:
1. instrument
Chromatograph: Agilent 1260Infinity type highly effective liquid phase chromatographic system (Agilent company of the U.S.): G1310B
Modular pump；The online degasser of G1322A；G1316A column oven；G1329B automatic sampler；G1362A Composition distribution；
G7850AA GPC/SEC work station.
Analytical balance: BSA224S type (producer: Sai Duolisi)
Test sample: Medical sodium hyaluronate gel.
2. chromatographic condition
Chromatographic column: gel column Shodex SB-806HQ (8.0mm × 300mm)；
Flowing phase: weigh sodium chloride 11.69g, Hydrazoic acid,sodium salt 0.2g, the purified water adding 1000ml is dissolved, and is
0.2mol/L sodium chloride solution, 0.45um membrane filtration, standby.
3. reference substance solution and the preparation of need testing solution
Precision weighs the kayexalate each 10mg of control series product, puts in 10mL measuring bottle, adds flowing phase dilution to carving
Degree, shakes up, as reference substance solution；
Need testing solution is prepared: precision weighs pharmaceutical preparation 5mg, adds flowing phase dilution and becomes the 0.1mg/ml Han hyaluronate sodium
Concentration, shake up and i.e. obtain need testing solution；
4. assay method:
Take above-mentioned reference substance solution, 100uL sample introduction, record chromatogram.
Reference substance solution chromatogram is as shown in Figure 1.
Take above-mentioned need testing solution, 100uL sample introduction, record chromatogram.
Need testing solution chromatogram is as shown in Figure 2.
With GPC Software on Drawing calibration trace.Using universal calibration method, the K value of reference substance is 0.00018, and α value is 0.65；
The K value of hyaluronate sodium is 0.00057, and α value is 0.75.Result of calculation, obtains hyaluronate sodium weight average molecular weight and molecular weight
Breadth coefficient.
Certainly, described above not restriction to invention, the present invention is also not limited to the example above, the art general
Logical technical staff, the change made, retrofits, adds or replaces in the essential scope of the present invention, also should belong to the guarantor of the present invention
Protect scope.
Claims (1)
1. hyaluronate sodium weight average molecular weight and a detection method for molecular weight distribution index in Medical sodium hyaluronate gel,
It is characterized in that, comprise the steps:
(1) need testing solution preparation process
Precision weighs pharmaceutical preparation 5mg, adds flowing phase dilution and becomes the concentration containing hyaluronate sodium 0.1mg/ml, shakes up and i.e. obtain for examination
Product solution；
(2) reference substance solution preparation process
Take the kayexalate each 10mg of control series product, put in 10mL measuring bottle, add flowing phase dilution to scale, shake up, make
For reference substance solution；
(3) determination step:
Chromatographic condition:
Instrument: Agilent 1260Infinity type highly effective liquid phase chromatographic system (Agilent company of the U.S.): G1310B unit
Pump；The online degasser of G1322A；G1316A column oven；G1329B automatic sampler；G1362A Composition distribution；G7850AA
GPC/SEC work station；
Chromatographic column: gel column Shodex SB-806HQ (8.0mm × 300mm)；
Flowing phase: weigh sodium chloride 11.69g, Hydrazoic acid,sodium salt 0.2g, the purified water adding 1000ml is dissolved, and is 0.2mol/L
Sodium chloride solution, 0.45um membrane filtration, standby；
Need testing solution prepared by step (1) is taken 100uL sample introduction, records chromatogram；Separately take kayexalate series right
According to product, it is measured in the same method, records chromatogram, with GPC Software on Drawing calibration trace.Using universal calibration method, the K value of reference substance is
0.00018, α value is 0.65；The K value of hyaluronate sodium is 0.00057, and α value is 0.75.Result of calculation, obtains hyaluronate sodium
Weight average molecular weight and molecular weight distribution index.
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108333273A (en) * | 2018-03-27 | 2018-07-27 | 上海景峰制药有限公司 | A kind of detection method of sodium hyaluronate molecular weight and molecualr weight distribution |
| CN108872409A (en) * | 2018-03-15 | 2018-11-23 | 浙江工业大学 | A kind of method of specified molecular weight separation purifying hyaluronic acid |
| CN108992369A (en) * | 2018-07-02 | 2018-12-14 | 山东天晟生物科技有限公司 | A kind of hyaluronic acid, preparation method and use |
| CN109459504A (en) * | 2017-09-06 | 2019-03-12 | 上海绿谷制药有限公司 | A method of measurement guluronic acid sulfuric acid weight average molecular weight and content |
| CN109459523A (en) * | 2017-09-06 | 2019-03-12 | 上海绿谷制药有限公司 | A method of measurement acid sugar soluble-salt weight average molecular weight and content |
| CN109580428A (en) * | 2018-12-26 | 2019-04-05 | 华熙福瑞达生物医药有限公司 | A kind of method of hyaluronan molecule amount in simplicity Accurate Determining solution |
| CN111579660A (en) * | 2020-04-24 | 2020-08-25 | 药源生物科技（启东）有限公司 | Detection method for measuring average molecular weight and distribution coefficient of polyethylene glycol 4000 and polyethylene glycol powder |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109459504A (en) * | 2017-09-06 | 2019-03-12 | 上海绿谷制药有限公司 | A method of measurement guluronic acid sulfuric acid weight average molecular weight and content |
| CN109459523A (en) * | 2017-09-06 | 2019-03-12 | 上海绿谷制药有限公司 | A method of measurement acid sugar soluble-salt weight average molecular weight and content |
| CN109459504B (en) * | 2017-09-06 | 2022-05-27 | 绿谷(上海)医药科技有限公司 | Method for measuring weight average molecular weight and content of polyguluronic acid sulfate |
| US11366086B2 (en) | 2017-09-06 | 2022-06-21 | Shanghai Green Valley Pharmaceutical Co., Ltd. | Method for determining weight-average molecular weight and content of soluble salt of acidic carbohydrates |
| CN108872409A (en) * | 2018-03-15 | 2018-11-23 | 浙江工业大学 | A kind of method of specified molecular weight separation purifying hyaluronic acid |
| CN108333273A (en) * | 2018-03-27 | 2018-07-27 | 上海景峰制药有限公司 | A kind of detection method of sodium hyaluronate molecular weight and molecualr weight distribution |
| CN108992369A (en) * | 2018-07-02 | 2018-12-14 | 山东天晟生物科技有限公司 | A kind of hyaluronic acid, preparation method and use |
| CN108992369B (en) * | 2018-07-02 | 2021-07-30 | 山东天晟生物科技有限公司 | Hyaluronic acid, preparation method and application thereof |
| CN109580428A (en) * | 2018-12-26 | 2019-04-05 | 华熙福瑞达生物医药有限公司 | A kind of method of hyaluronan molecule amount in simplicity Accurate Determining solution |
| CN111579660A (en) * | 2020-04-24 | 2020-08-25 | 药源生物科技（启东）有限公司 | Detection method for measuring average molecular weight and distribution coefficient of polyethylene glycol 4000 and polyethylene glycol powder |
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