Pharmaceutical composition of hemocoagulase and application of pharmaceutical composition

The technology of a composition and hemagglutinase is applied in the field of pharmaceutical composition of snake venom hemagglutinase, which can solve the problem of lack of radical cure for hemophilia

Pending Publication Date: 2018-11-13
ZHAOKE PHARMA HEFEI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there is still no effective cure for hemophilia. Hemostasis and transfusion of blood products are still the main symptomatic treatment methods. Effective hemostasis plays a vital role in the treatment of hemophilia.

Method used

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  • Pharmaceutical composition of hemocoagulase and application of pharmaceutical composition
  • Pharmaceutical composition of hemocoagulase and application of pharmaceutical composition
  • Pharmaceutical composition of hemocoagulase and application of pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Freeze-dried powder formulation

[0045] Snake Venom Hemagglutinin 2.5mg

[0046] Glycine 2g

[0047] Mannitol 10g

[0048] Preparation:

[0049] 1. Weigh 10g of mannitol, add 300ml of water for injection, heat and stir to dissolve completely;

[0050] 2. Weigh 2g of glycine, add it to the above solution, stir to dissolve completely;

[0051] 3. After the solution is allowed to cool, add water for injection to make up to 500ml, and filter with a 0.22μm filter membrane;

[0052] 4. After sterile filtration, add 2.5 mg of snake venom hemocoagulase (the mass ratio of coagulation factor X activator and batroxobin is 1:1), mix well, quantitatively fill 0.5ml / cartridge, and fill a total of 1000 Put the half-pressed rubber stopper into the freeze dryer for freeze-drying;

[0053] 5. Freeze-drying parameters: Pre-freezing temperature is preferably -30°C, pre-freezing time is 2 hours, freeze-drying temperature is -20°C, freeze-drying time is 6 hours, secondary freeze-dryin...

Embodiment 2

[0055] Freeze-dried powder formulation

[0056] Snake venom hemagglutinin 0.25mg

[0057] Glycine 8g

[0058] Mannitol 60g

[0059] Preparation:

[0060] 1. Weigh 60g of mannitol, add 300ml of water for injection, heat and stir to dissolve completely;

[0061] 2. Weigh 8g of glycine, add it to the above solution, stir to dissolve completely;

[0062] 3. After the solution is allowed to cool, add water for injection to make up to 500ml, and filter with a 0.22μm filter membrane;

[0063] 4. After sterile filtration, add 0.25 mg of snake venom hemagglutinin (the mass ratio of blood coagulation factor X activator and snake venom batroxobin is 1:8), mix well, quantitatively fill 0.5ml / cartridge, and fill together 1000 pieces, half-pressed rubber stoppers are placed in a freeze dryer for freeze-drying;

[0064] 5. Freeze-drying parameters: Pre-freezing temperature is preferably -30°C, pre-freezing time is 2 hours, freeze-drying temperature is -20°C, freeze-drying time is 6 hou...

Embodiment 3

[0066] Freeze-dried powder formulation

[0067] Snake Venom Hemagglutinin 1.05mg

[0068] Glycine 6g

[0069] Mannitol 15g

[0070] Preparation:

[0071] 1. Weigh 15g of mannitol, add 300ml of water for injection, heat and stir to dissolve completely;

[0072] 2. Weigh 6g of glycine, add it to the above solution, stir to dissolve completely;

[0073] 3. After the solution is allowed to cool, add water for injection to make up to 500ml, and filter with a 0.22μm filter membrane;

[0074] 4. After sterile filtration, add 1.05 mg of snake venom hemocoagulase (the mass ratio of blood coagulation factor X activator and Agkistrodon brasiliensis batroxobin is 1:5), mix evenly, quantitatively fill 0.5ml / cartridge, total Fill 1000 pieces, put the semi-pressed rubber stopper into the freeze dryer for freeze drying;

[0075] 5. Freeze-drying parameters: Pre-freezing temperature is preferably -30°C, pre-freezing time is 2 hours, freeze-drying temperature is -20°C, freeze-drying time ...

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Abstract

The invention discloses a pharmaceutical composition of hemocoagulase. The pharmaceutical composition is characterized in that the pharmaceutical composition is prepared from 0.00005 to 0.0005 percentof a hemocoagulase composition and the balance of a pharmaceutically acceptable carrier. The composition is applied to preparation of a medicine for treating Haemophilia B (coagulation factor IX deficiency). Active components in the hemocoagulase comprise hemocoagulase, i.e., a thrombin-like enzyme (batroxobin), and a phospholipid dependent coagulation factor X activating agent (FXA). A bleedingstopping process of the hemocoagulase does not depend on a coagulation factor IX and is mainly used for fibrin and an activated coagulation factor X, and has the effect of treating bleeding of the haemophilia B. After the hemocoagulase is used for treating, platelet aggregation can be remarkably enhanced, and the formation of blood clots or fibrin clots in a patient with the haemophilia B is recovered.

Description

technical field [0001] The invention belongs to the field of medicines, and in particular relates to a pharmaceutical composition of snake venom hemagglutinin and its application. Background technique [0002] Hemophilia is a group of X-chromosome-linked hereditary recessive bleeding diseases caused by the abnormal quality or quantity of a single blood coagulation factor. According to the different types of abnormal blood coagulation factors, common hemophilia Divided into hemophilia A (HA) and hemophilia B (HB), the former is abnormal coagulation factor VIII, the latter is abnormal coagulation factor IX. Clinically, HB is characterized by joint, muscle and visceral bleeding spontaneously or externally after trauma. It was first diagnosed and reported by Aggeler et al. in 1952. The main pathogenesis of HB is the mutation of the coagulation factor Ⅸ gene on the X chromosome, which affects the normal blood coagulation and causes hemorrhage. The vast majority of HB patients a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/48A61K9/00A61P7/04
CPCA61K9/0014A61K9/0019A61K38/4806A61P7/04C12Y304/00
Inventor 热合满阿迪力李小羿戴向荣热合满 阿迪力
Owner ZHAOKE PHARMA HEFEI
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