Method for detecting nadroparin calcium product

A technology of heparin calcium and its products, which is applied in the direction of color/spectral characteristic measurement, etc. It can solve the problems that the production process of heparin drugs cannot be applied, the preparation procedure of auxiliary detection reagents is complicated, and the detection cost is high, so as to achieve production process monitoring and strong anti-interference ability , good selective effect
CN103398960AActive Publication Date: 2013-11-20广东三生制药有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
广东三生制药有限公司
Publication Date
2013-11-20

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Abstract

The invention relates to the technical field of ultraviolet-visible spectrophotometric method detection and particularly relates to a method for rapidly detecting a nadroparin calcium product. The method comprises the step of detecting the concentration of nadroparin calcium in a solution through detecting the absorbance of a mixed solution in a range of 200nm-800nm by a spectrophotometric method, wherein the mixed solution contains fluorescein, the nadroparin calcium and a buffering solution; preferably, the mixed solution is formed by mixing an ethanol solution of the fluorescein, a nadroparin calcium solution, a sodium sulfate solution and the buffering solution. According to the method disclosed by the invention, an applied instrument is simple and the operation is simple and convenient; the concentration of the nadroparin calcium solution can be rapidly determined. The detection method provided by the invention is strong in anti-interference capability and strong in selectivity, and can be used for monitoring whether the contents of nitrite ions and calcium ions in the nadroparin calcium solution seriously exceed the standard or not. According to the detection method provided by the invention, a linear range is 3.0*10<-3>mol / L-4.5*10<-2>mol / L and a detection limit is 1.0*10<-3>mol / L; the detection method is completely applicable to the detection of a nadroparin calcium middle product and a nadroparin calcium final product and can be used for effectively monitoring a medicine production process of the nadroparin calcium.
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Description

technical field

[0001] The invention relates to the technical field of ultraviolet-visible spectrophotometry detection, in particular to a method for rapidly detecting nadroparin calcium products. Background technique

[0002] Heparin drugs are highly sulfated mucopolysaccharide sulfates, which are widely used in the treatment of cardiovascular and cerebrovascular diseases and hemodialysis. Among them, in the treatment of severe hemodialysis, they are currently the only specific drugs available. At present, low molecular weight heparin (Low Molecular Weight Heparin, LMWH) is dominant in the heparin drug market, that is, heparin derivatives with an average molecular weight distribution of 3500-6500Da. Because compared with unfractionated heparin (UFH), LMWH has many obvious advantages in clinical application, including clearer pharmacological effects, greatly reduced side effects, longer duration of antithrombotic activity, and higher bioavailability. There are five common L...

Claims

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