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Detection method of boron content in the production process of dalteparin sodium

A production process, the technology of dalteparin sodium, applied in the field of biomedicine, can solve the problems of ineffective detection of boron element, reproductive system and endocrine system toxicity, etc., and achieve the goal of facilitating industrial promotion and application, reducing the risk of unqualified products, and reducing the risk of drug use Effect

Active Publication Date: 2017-08-29
SHANDONG CHENZHONG BIOPHARM +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The addition of sodium borohydride will introduce boron into the product. Boron is an accumulative toxin in the human body and can cause toxicity to the reproductive system and endocrine system. Boron needs to be removed in the follow-up process. At present, in the production process of dalteparin sodium There is no effective method for the detection of boron

Method used

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  • Detection method of boron content in the production process of dalteparin sodium
  • Detection method of boron content in the production process of dalteparin sodium
  • Detection method of boron content in the production process of dalteparin sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] 1. Instruments and utensils:

[0035] Inductively coupled ion spectrometer, electronic balance, volumetric flask (10ml, 25ml, 50ml, 100ml, 500ml, 1000ml), beaker (500ml, 1000ml), pipette gun.

[0036] 2. Reagents and reagents:

[0037] Nitric acid (analytical pure), boric acid (analytical pure), enoxaparin sodium.

[0038] 3. Solution preparation:

[0039] Control solution a: prepare 1% (v / v) nitric acid aqueous solution (blank);

[0040] Control solution b: prepare 5.7μg / mL boric acid solution with 1% nitric acid solution (STD cal );

[0041] Control solution c: Weigh 0.25g of enoxaparin sodium and dissolve it in 2mL of water, add 100μL of pure nitric acid, and dilute to 10mL with water (STD 0 );

[0042] Linear solution 1: Weigh 0.25g enoxaparin sodium and dissolve in 2mL 1% nitric acid, add 2.0μL 5.7mg / mL boric acid, and dilute to 10mL (0.2ppm) with 1% nitric acid solution;

[0043] Linear solution 2: Weigh 0.25g enoxaparin sodium and dissolve in 2mL 1% nitric...

Embodiment 2

[0060] The sample IZDA140328 was detected according to the method described in Example 1.

[0061] Table 2 data

[0062] project

value

Linear solution 4 (STD 1 )

2058

STD 0

235

STD cal

1851

blank

116

Linear Solution 1

687

Linear Solution 2

1031

[0063] Linear solution 3

1719

Linear solution 5

2417

sample solution

380

[0064] Calculation: Correction factor f:

[0065]

[0066] Draw a standard curve, as shown in the accompanying drawing figure 2 (Boron content and response value linear relationship diagram) as shown:

[0067] According to the standard curve, the linear equation obtained is: y=1724.9x+340.44, R 2 =0.9999

[0068] Boron content: [(380-340.44) / 1724.9]*1.02=0.023ppm.

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Abstract

The invention discloses a method for detecting the content of boron in a dalteparin sodium production process, belonging to the field of biological medicines. The method disclosed by the invention comprises the following steps of: preparing a solution at first, detecting the corresponding intensity of boron in the solution by utilizing an inductively coupled ion spectrometer, and finally, processing data to obtain the content of boron in the dalteparin sodium production process. The method for detecting the content of boron in the dalteparin sodium production process disclosed by the invention is capable of detecting the content of boron simply, rapidly and accurately; therefore, the problem of unqualified finished products due to the fact that the content of boron cannot be detected in the dalteparin sodium production process is overcome; the product qualification rate can be effectively increased; the unqualified risk of heparin sodium products and the production cost of enterprises are greatly reduced; simultaneously, the drug use risk of people is greatly reduced; furthermore, the method is simple to operate; and thus, industrial popularization and application are facilitated.

Description

technical field [0001] The invention belongs to the field of biomedicine, and in particular relates to a method for detecting boron content in the production process of dalteparin sodium. Background technique [0002] Heparin drugs are the first choice of anticoagulant drugs. They have been used for more than 70 years. In addition to anticoagulant and antithrombotic effects, they also have blood lipid-lowering effects, but they have defects such as low bioavailability and large side effects. Clinical application of heparin. In recent years, a new generation of anticoagulant drugs with high antithrombotic activity and low bleeding side effects - low molecular weight heparin (LMWH) has been developed and marketed. The antithrombotic effect of the new generation of anticoagulant drugs is better than that of heparin, but the anticoagulant effect is lower than that of heparin, and has the characteristics of high bioavailability, long half-life in vivo, small bleeding tendency, a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/73
Inventor 周霞林勇雷晓刚郭维乔德强郭恩中
Owner SHANDONG CHENZHONG BIOPHARM
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