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Method for removing free sulphur in enoxaparin sodium raw material

A technology of enoxaparin sodium and free state, which is applied in the field of removing free sulfur in enoxaparin sodium raw materials, can solve the problems of high cost, group shedding, hidden dangers of drug use, etc., achieve good industrial application value, and improve the effect of clinical drug safety

Active Publication Date: 2015-04-22
山东辰龙药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The reaction conditions of the enzymatic degradation method are relatively mild, but due to the high cost, it cannot be industrialized. The chemical degradation method is a method commonly used in industry, but whether it is an enzymatic hydrolysis method or a chemical cleavage method, the two are different in the early and late preparation processes degree of causing SO 3 The Na group falls off, causing certain hidden dangers in medication

Method used

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  • Method for removing free sulphur in enoxaparin sodium raw material

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] 1. Preparation before ultrafiltration:

[0026] Main equipment: ultrafiltration machine 1 (1KD molecular weight polyethersulfone plate ultrafiltration membrane 5m 2 ), enamel tank 2 with stirring, pump 3.

[0027] Initial material: raw material of enoxaparin sodium (30kg)

[0028] Initial material related quality indicators:

[0029] ①Average molecular weight——4184

[0030] ②Molecular weight distribution——<2K: 22.0%; 2K~8K: 67.5%

[0031] ③Mass percentage content of free sulfur——0.60%

[0032] 2. Specific operation

[0033] 1. Dissolve and dilute enoxaparin sodium raw material to 300L, filter through 0.22μm micropore to obtain raw material solution A;

[0034] 2. Adjust the ultrafiltration machine 1, set the pump speed, open the feed port 4, the retained liquid outlet 5, and the permeate outlet 6, and place the catheter in the raw material liquid A, and circulate for 30 minutes (pump speed 40r / min) ;

[0035] 3. Start ultrafiltration: reduce the pump speed to 30...

Embodiment 2

[0050] 1. Preparation before ultrafiltration:

[0051] Main equipment: the same as the main equipment in Embodiment 1, the ultrafiltration machine adopts the plate membrane of 1KD molecular weight polyethersulfone

[0052] Initial material: raw material of enoxaparin sodium (25kg)

[0053] Initial material related quality indicators:

[0054] ①Average molecular weight——4100

[0055] ②Molecular weight distribution——<2K: 22.0%; 2K~8K: 67.5%

[0056] ③Free sulfur content——0.60%

[0057] 2. Specific operation

[0058] 1. Dissolve and dilute enoxaparin sodium raw material to 250L, filter through 0.22μm micropore to obtain raw material solution A;

[0059]2. Adjust the ultrafiltration machine 1, set the pump speed, open the feed port 4, the retained liquid outlet 5, and the permeate outlet 6, and place the catheter in the raw material liquid A, and circulate for 40 minutes (pump speed 40r / min) ;

[0060] 3. Start ultrafiltration: reduce the pump speed to 35r / min, the inlet pr...

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Abstract

The invention discloses a method for removing free sulphur in an enoxaparin sodium raw material, and belongs to the field of biological medicines. The method comprises the following steps of: removing free sulphur in the enoxaparin sodium raw material through adopting a circulation ultrafiltration method, so as to satisfy quality requirements on controlling the free sulphur content in the enoxaparin sodium raw material. Compared with the prior art, the method has the characteristics of safety, high efficiency, convenience in large-scale industrial production and the like as well as good popularization and application values.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a method for removing free sulfur (Free Sulphate) in enoxaparin sodium raw materials. 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, and easy abs...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/10
Inventor 周霞郭恩中
Owner 山东辰龙药业有限公司
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