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Enoxaparin injection preparation and industrial production method thereof

A technology for injection preparations and enoxaparin, which is applied in the direction of pharmaceutical formulations, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., which can solve the problem that enoxaparin sodium injection is prone to deterioration and cannot fully improve the product Stability, instability to heat and oxidants, etc., to achieve superior stability, avoid impurities, and cost-effective effects

Active Publication Date: 2016-03-02
CHENGDU BAIYU JINGELAI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] There is an unsaturated hemiacetal structure in the molecular structure of enoxaparin sodium. This compound is extremely unstable to heat and oxidants in aqueous solution, which makes enoxaparin sodium injection prone to deterioration during storage, such as a significant drop in pH and color change. Significant changes, significant reduction in biological potency and other quality problems
[0004] Patents CN102085178A and CN104013570A aim at the problem that the hemiacetal structure in the structure of enoxaparin sodium is extremely unstable to heat and oxidants, and the stability of the preparation is improved by adding antioxidants, nitrogen protection and adjusting the pH value of the preparation, but the above scheme In the actual production process, the stability of the product cannot be fully improved, and the actual operation is cumbersome, which brings inconvenience to production

Method used

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  • Enoxaparin injection preparation and industrial production method thereof
  • Enoxaparin injection preparation and industrial production method thereof
  • Enoxaparin injection preparation and industrial production method thereof

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Embodiment 1

[0033] Embodiment 1 Preparation of enoxaparin injection preparation of the present invention

[0034] Preparation prescription: enoxaparin sodium 800g, mannitol 40g, activated carbon 4g, add water for injection to 8000ml

[0035] Preparation method: 1) Take 80% of the prescribed amount of water for injection, boil it and keep it in the batching tank. When the temperature drops below 60°C, add enoxaparin sodium and mannitol and stir to dissolve it, and add 5.0% sodium hydroxide Or hydrochloric acid to adjust the pH value to 6.0-7.0; 2) Add water for injection to the full amount, stir for 30 minutes, add medicinal charcoal at a dosage of 0.05% (w / v), and absorb for 10 minutes below 60°C; 3) The liquid is heated through 0.45 The μm filter element is used for coarse filtration and decarbonization, and the filtrate is transferred to the dilution tank; 4) Sampling and inspection of intermediate products; 5) After passing the test, fine filtration is carried out with a 0.22 μm filter...

Embodiment 2

[0038] Embodiment 2 Preparation of enoxaparin injection preparation of the present invention

[0039] Preparation prescription: enoxaparin sodium 800g, mannitol 40g, activated carbon 4g, add water for injection to 8000ml

[0040] Preparation method: 1) Take 80% of the prescribed amount of water for injection, boil it and keep it in the batching tank. When the temperature drops below 60°C, add enoxaparin sodium and mannitol and stir to dissolve it, and add 5.0% sodium hydroxide Or hydrochloric acid to adjust the pH value to 6.0-7.0; 2) Add water for injection to the full amount, stir for 30 minutes, add medicinal charcoal at a dosage of 0.05% (w / v), and absorb for 10 minutes below 60°C; 3) The liquid is heated through 0.45 The μm filter element is used for coarse filtration and decarbonization, and the filtrate is transferred to the dilution tank; 4) Sampling and inspection of intermediate products; 5) After passing the test, fine filtration is carried out with a 0.22 μm filter...

Embodiment 3

[0043]Example 3 Preparation of Enoxaparin Injection Preparation of the Present Invention

[0044] Preparation prescription: enoxaparin sodium 800g, mannitol 40g, activated carbon 4g, add water for injection to 8000ml

[0045] Preparation method: 1) Take 80% of the prescribed amount of water for injection, boil it and keep it in the batching tank. When the temperature drops below 60°C, add enoxaparin sodium and mannitol and stir to dissolve it, and add 5.0% sodium hydroxide Or hydrochloric acid to adjust the pH value to 6.0-7.0; 2) Add water for injection to the full amount, stir for 30 minutes, add medicinal charcoal at a dosage of 0.05% (w / v), and absorb for 10 minutes below 60°C; 3) The liquid is heated through 0.45 The μm filter element is used for coarse filtration and decarbonization, and the filtrate is transferred to the dilution tank; 4) Sampling and inspection of intermediate products; 5) After passing the test, fine filtration is carried out with a 0.22 μm filter mem...

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Abstract

The invention provides an enoxaparin injection preparation. The enoxaparin injection preparation is prepared from, by weight, 20 parts of enoxaparin sodium and 1-2 parts of stent agent. The invention further provides an industrial production method of the enoxaparin sodium injection preparation. The enoxaparin injection preparation is good in stability and clinical safety, simple in preparation technology, appropriate in cost and suitable for mass industrial production.

Description

technical field [0001] The invention relates to an enoxaparin injection preparation and an industrial production method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Enoxaparin sodium is a sodium salt of low-molecular-weight heparin. It is the sodium salt of aminodextran sulfate fragments obtained by alkali degradation of heparin extracted from pig small intestinal mucosa after benzyl esterification. It is a polysaccharide mixture with an average molecular weight of 4500 Dalton or so. Enoxaparin sodium is mainly used as an anticoagulant for the prevention and treatment of deep vein thrombosis or pulmonary embolism, and its usage is subcutaneous injection. The main mechanism of action of enoxaparin sodium is to strengthen the inhibitory effect on factor Xa and thrombin (factor IIa) by combining with antithrombin III and its complex. Compared with unfractionated heparin, enoxaparin sodium has the advantages of strong antithromb...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/727A61K47/26A61P7/02
CPCA61K9/0019A61K9/19A61K31/727A61K47/26
Inventor 赖庆宽俞飚刘文秀孙琦
Owner CHENGDU BAIYU JINGELAI PHARMA CO LTD
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