A method for detecting nadroparin calcium products

A technology of heparin calcium and determination method, which is applied in the measurement of color/spectral properties, etc., can solve the problems of inability to apply the production process of heparin drugs, complicated preparation procedures of auxiliary detection reagents, and narrow application range, and achieves production process monitoring, anti-interference and other problems. Powerful, easy-to-use effects
CN103398960BActive Publication Date: 2016-01-20广东三生制药有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
广东三生制药有限公司
Publication Date
2016-01-20

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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 spectrophotometric 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, it is currently the only specific drug available in the treatment of severe hemodialysis. Currently, low molecular weight heparin (LMWH), which is a heparin derivative with an average molecular weight distribution of 3500-6500Da, is dominant in the heparin drug market. Because compared with unfractionated heparin (UFH), LMWH has many obvious clinical application advantages, including clearer pharmacological effects, greatly reduced side effects, long duration of antithrombotic activity, and higher bioavailability. There are mainly 5 kinds of common LMWH preparations, namely Nadro...

Claims

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