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Method for detecting esterification rate of heparin benzyl ester in production process of enoxaparin sodium

A technology of heparin benzyl ester and enoxaparin sodium, which is applied in the detection field of esterification rate, can solve the problems of difficult control of esterification rate, restriction of enoxaparin sodium production yield and product cost, etc., and facilitates industrialization and application , reduce the risk of non-conformity and the production cost of the enterprise, and overcome the effect that is difficult to control

Active Publication Date: 2014-12-03
山东辰龙药业有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] The degree of esterification of heparin benzyl ester directly affects the 1,6-anhydrous structure, molecular weight and its distribution, activity and other key indicators in the finished product of enoxaparin, and its esterification rate determines the process parameters of later degradation, thus affecting and restricting The production yield and product cost of enoxaparin sodium, but there is no method for detecting the esterification rate of heparin benzyl ester, which makes it difficult to implement the esterification rate control

Method used

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  • Method for detecting esterification rate of heparin benzyl ester in production process of enoxaparin sodium
  • Method for detecting esterification rate of heparin benzyl ester in production process of enoxaparin sodium
  • Method for detecting esterification rate of heparin benzyl ester in production process of enoxaparin sodium

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Experimental program
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Embodiment 1

[0033] 1. Instruments and utensils:

[0034] Liquid chromatography (VWD detector), electronic balance (1 / 100,000), volumetric flask (10mL, 25mL, 100mL), micropipette (1000μl)

[0035] 2. Reagents and reagents:

[0036] Methanol (chromatographically pure), acetonitrile (chromatographically pure), ultrapure water, benzyl alcohol standard, glacial acetic acid (analytical pure), sodium hydroxide (analytical pure)

[0037] 3. Solution preparation:

[0038] 3.1 Control solution: Accurately weigh 0.5g of benzyl alcohol standard product in a 1000ml volumetric flask, dissolve it with ultrapure water and dilute to the mark to obtain the product.

[0039] 3.2 Preparation of detection solution: Accurately weigh 0.5g of heparin benzyl ester sample (ZKE120709) into a 100ml volumetric flask, add 10ml of 5mol / L sodium hydroxide solution to dissolve, control the temperature in a water bath at 60-70°C, and react for 120 minutes. Add 10ml of glacial acetic acid to terminate the reaction, dilu...

Embodiment 2

[0059] The heparin benzyl ester sample ZKE120715 was detected by the method described in Example 1.

[0060] E% = 1.8%.

[0061] It can be seen from the spectrogram:

[0062] A S =10.6

[0063] C S =4.8mg / ml

[0064] A R =22.2

[0065] C R =0.5mg / ml

[0066] Esterification rate (m / m) X = As × C R A R × C S × ( 1 - E % ) × 100 % = 10.6 × 0.5 22.2 × 4.8 × ( 1 - ...

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Abstract

The invention discloses a method for detecting the esterification rate of heparin benzyl ester in a production process of enoxaparin sodium, belonging to the field of biological medicines. According to the method, by adopting a reversed phase liquid chromatography method and using a high-efficiency liquid chromatograph with an ultraviolet detector, phenylcarbinol generated in a process that heparin benzyl ester drops in an alkaline environment is quantitatively detected and the esterification rate of the heparin benzyl ester is reflected, thus the purpose of controlling the quality of the finished product enoxaparin sodium is reached. Compared with the prior art, the method is capable of simply, rapidly and accurately monitoring the esterification rate of the heparin benzyl ester, thereby reducing the unqualified risk of the finished product enoxaparin sodium and the production cost of enterprises, and achieving great good popularization and application value.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a method for detecting the esterification rate of heparin benzyl ester in the production process of enoxaparin 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, smal...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 周霞林勇
Owner 山东辰龙药业有限公司
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