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Novel method for detecting dissolution curve of glycosaminoglycan preparation

A detection method, glycosaminoglycan technology, applied in the field of multi-component biochemical drug analysis, can solve the problems of long detection cycle, large detection error, unsuitable for determination of oral preparations, etc.

Pending Publication Date: 2020-07-24
YANTAI DONGCHENG PHARMA GRP
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Glycosaminoglycans are mostly quantified by potency, but potency determination has problems such as long detection cycle and large detection error, so it is not suitable for the determination of the dissolution curve of oral preparations

Method used

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  • Novel method for detecting dissolution curve of glycosaminoglycan preparation
  • Novel method for detecting dissolution curve of glycosaminoglycan preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: the selection of detection wavelength

[0023] Take 25mg of glycosaminoglycan raw material, add water to dilute to 100ml, as 200% linear stock solution, and accurately measure 0.25ml, 0.5ml, 1.0ml, 2.0ml, 3.0ml, 4.0ml, 5.0ml of 200% linear stock solution respectively , 6.0ml, and 7.0ml were placed in different 10ml volumetric bottles, and diluted with water to the scale, respectively, to obtain linearity of 5%, 10%, 20%, 40%, 60%, 80%, 100%, 120%, and 140%. Reference substance solution. Accurately measure 0.3ml each of water and linear reference solution, add 5ml of chromogenic agent, and carry out ultraviolet scanning at 400-800nm ​​respectively. Select three obvious absorption peaks at 535nm, 595nm, and 648nm, record their absorbance, and perform linear regression calculations on the concentration and absorbance after deducting the blank. The specific results are shown in Table 1.

[0024] Table 1 Detection wavelength selection linear results

[0025]...

Embodiment 2

[0028] Example 2: Methodological Validation

[0029] (1) Specificity: Take the blank auxiliary material of the preparation, put it in the dissolution cup, add 500ml of water, set the temperature at 37°C, paddle method, rotate at 50 rpm, take a sample at 60 minutes, filter, and accurately measure 0.3ml of the subsequent filtrate to match the marked 5ml of the color agent was reacted, and 0.3ml of water was taken to react with 5ml of the chromogenic agent at the same time. The absorbance values ​​at 648nm of the two were 0.557 and 0.554 respectively.

[0030] (2) Solution stability: take reference substance solution and get 0.3ml to react with chromogenic agent 5ml respectively at 0 hour, 1 hour, 4 hours, 6 hours, absorbance is respectively 0.226, 0.225, 0.227, 0.228, illustrates that reference substance solution 6 The solution has good stability within hours.

[0031] (3) Linearity: According to the method in Example 1, the correlation coefficient between the concentration and...

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Abstract

The invention aims to provide a method which is high in detection speed, good in sensitivity, high in accuracy and good in reproducibility and is particularly used for detecting a dissolution curve ofa glycosaminoglycan preparation. A result of detection of the dissolution curve of the glycosaminoglycan preparation can be rapidly and accurately obtained, so that the prescription optimization efficiency is improved. The novel method for detection is developed as follows: glycosaminoglycan and basic dyes are subjected to a reaction, light absorption of the dyes is influenced, 648nm is selectedas detection wavelength, and a dissolution quantity is calculated with a reference substance external standard method. The method is high in detection speed, high in accuracy, good in reproducibilityand simple to operate.

Description

technical field [0001] The invention relates to a method for detecting dissolution curves in glycosaminoglycan preparations, belonging to the technical field of multi-component biochemical drug analysis. Background technique [0002] Glycosaminoglycan is a naturally extracted polysaccharide, the main function is antithrombotic, and it has a strong antithrombotic effect on both arteries and veins. Indicated for the treatment of vascular diseases with a risk of thrombosis. Its pharmacological effects include: anticoagulation, factor Xa inhibitor; anti-platelet aggregation; thrombolysis, factor IIa inhibitor (act on thrombin bound to fibrin through heparin factor II (HCII), degrade the formed thrombus); Blood lipids, improve blood circulation by reducing high blood fibrinogen and very low-density lipoprotein concentrations, and restore blood viscosity parameters to normal in patients with vascular lesions at risk of thrombosis. It is clinically used for the prevention of athe...

Claims

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Application Information

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IPC IPC(8): G01N21/31G01N21/78
CPCG01N21/31G01N21/78
Inventor 刘军妮王东武刘遂库仰振球
Owner YANTAI DONGCHENG PHARMA GRP
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