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Batroxobin freeze-dry powder injection and preparation method thereof

A technology of freeze-dried powder injection and batroxobin, which is applied in freeze-dried delivery, powder delivery, and pharmaceutical formulations. Achieve the effects of improving peripheral and microcirculation disorders, facilitating transportation and storage, and expanding the scope of clinical application

Active Publication Date: 2009-02-11
BEIJING SAISHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

", so the batroxobin water injection with antibacterial agent cannot be used for intravenous infusion, which greatly limits the clinical application of batroxobin

Method used

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  • Batroxobin freeze-dry powder injection and preparation method thereof
  • Batroxobin freeze-dry powder injection and preparation method thereof
  • Batroxobin freeze-dry powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] 1. DEAE-Sepharose Fast Flow Chromatography

[0056] Weigh 6 g of Agkistrodon moojeni (Bothrops atrox moojeni, Sigma reagent catalog number: V5500), extract with 200 ml of 0.02mol / L pH7.4 Tris-HCl buffer for 4 hours, centrifuge at 4000rpm / min for 20 minutes, and take the supernatant ; Precipitate was extracted once again with 50ml of 0.02mol / L pH7.4 Tris-HCl buffer in the same way, and the supernatants were combined, and the pH was adjusted to 7.4 to obtain the extract. Put the extract on a well-balanced DEAE-Sepharose Fast Flow chromatography column, first use 0.02mol / L Tris-HCl buffer to elute unadsorbed impurities, and then use a buffer solution containing 0-0.6mol / L NaCl for gradient washing Remove, collect batroxobin activity peak, obtain active component collection solution A 300ml.

[0057] 2. Affinity chromatography

[0058] Put the above-mentioned active component collection solution A on a well-balanced affinity chromatography column, and first use 1.0mol / L N...

Embodiment 2

[0069] Get batroxobin crude drug (prepared by embodiment 1, the same below) 10000BU, it is added to dissolve in 5mmol / L citrate buffer (pH5.0) 1000ml, obtains solution, adds sucrose in solution 1g, 80g of mannitol, stirred and dissolved and shaken evenly, sterilized and filtered, the filtrate was aseptically divided into 2000 tubes, each containing 5BU, freeze-dried to obtain batroxobin freeze-dried powder preparation.

[0070] The preparation was placed at room temperature for 2 years, and the titer was determined to be 4.5 BU.

Embodiment 3

[0072] Take batroxobin crude drug 10000BU, add it to 1000ml of 10mmol / L citrate buffer solution (pH5.4) and dissolve it to obtain a solution, add 0.5g of glycine and 50g of dextran to the solution, stir to dissolve and shake well , sterilized and filtered, and the filtrate was aseptically divided into 2000 tubes, each with a content of 5 BU, and freeze-dried to obtain batroxobin freeze-dried powder preparation.

[0073] The preparation was placed at room temperature for 2 years, and the titer was determined to be 4.4BU.

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PUM

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Abstract

The invention relates to a Batroxobin freeze-dried powder preparation and a preparation method thereof. The Batroxobin freeze-dried powder preparation comprises Batroxobin and freeze-dried protecting agent and excipient which are pharmaceutically acceptable. The ratio of Batroxobin to freeze-dried protecting agent is 10BU:0.01-10mg, and the ratio of Batroxobin to excipient is 10BU:2-200mg. The Batroxobin freeze-dried powder preparation is characterized by simple preparation process, adaptability to scale production, high stability and long-term storage and can be used for intravenous injection due to adding no preservative simultaneously, thus expanding the clinical application range.

Description

technical field [0001] The invention relates to batroxobin freeze-dried powder injection preparation and a preparation method thereof. Background technique [0002] Batroxobin (Batroxobin) is a thrombin-like enzyme extracted and purified from Agkistrodon lanceolata venom by means of modern biotechnology. This product is a glycoprotein, its peptide chain is composed of 231 amino acid residues, and its molecular weight is 36000D. It can specifically act between the N-terminal arginine and glycine of the Aα chain of the fibrinogen molecule, releasing fibrin peptide A, This is similar to thrombin, but does not activate factor XIII and does not cross-link fibrin into an insoluble clot. This fibrin is unstable and easily degraded by plasmin and cleared from the blood circulation. Therefore, this product has no thrombin-like coagulation effect but has the effect of reducing fibrinogen and anticoagulation. A large number of studies have shown that batroxobin has a significant eff...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/43A61P7/02A61P9/10
Inventor 马骉王天燕孙作朋
Owner BEIJING SAISHENG PHARMA
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