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Bone growth factor injection and its preparation method

A bone growth factor and injection technology, which is applied in bone diseases, pharmaceutical formulations, aerosol delivery, etc., can solve the problems of weakening osteoinductive effect, complicated preparation and use, and difficult retention of protein, so as to reduce surgical complications, Wide range of uses, minimal disturbance of blood supply and joint muscle function

Inactive Publication Date: 2003-09-24
李亚非
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Problems solved by technology

As a result, bone morphogenetic protein may not easily remain in the fracture area, weaken the osteoinductive effect, or be lost to the muscle space to cause heterotopic ossification
Another Chinese patent also discloses the technology of using human fibrin as a bone growth factor carrier. The disadvantages are that the preparation and use are complicated, expensive, and blood products have the risk of spreading diseases such as hepatitis and AIDS.

Method used

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preparation example Construction

[0017] The preparation method of bone growth factor injection of the present invention comprises the following steps:

[0018] A. Prepare bone growth factor solution or suspension.

[0019] B. Preparation of thermosensitive hydrogel carrier solution.

[0020] C. Compounding of bone growth factor and thermosensitive hydrogel carrier solution.

[0021] D. Forming of liquid or freeze-dried bone growth factor injection.

[0022] Step A of preparing the bone growth factor solution or suspension: bone growth factors are divided into water-soluble and water-insoluble according to their water solubility. The water-soluble bone growth factor is prepared as a solution, and the water-insoluble bone growth factor is prepared as a suspension. Include the following steps

[0023] A1. If the bone growth factor used is water-insoluble, such as animal bone bone morphogenetic protein, weigh 400 mg, dissolve with 4 mol / L urea, homogenate, install with a dialysis membrane, and dialyze with di...

Embodiment ( 2

[0042] Example (2) Preparation of water-soluble gene recombinant bone morphogenetic protein injection preparation

[0043] 1. Preparation of water-soluble bone morphogenetic protein solution: Weigh 40 mg of genetically recombinant bone morphogenetic protein, add 5 ml of distilled water, fully stir, dissolve, and set aside.

[0044] 2. Prepare an appropriate amount of HPMC with a concentration of 5%, or prepare an appropriate amount of POLOXAMERS with a concentration of 25%. The concentration of HPMC is 1%-12%, the best is 8%, and the concentration of POLOXAMERS is 15%-40%, the best is 25%. Adjust the pH of the gel to 6.5-7.3 with 2 mol / L sodium hydroxide or 0.6N hydrochloric acid, and the best is 6.9.

[0045] 3. Add 5 ml of bone morphogenetic protein hydrogel composite bone morphogenetic protein solution, add 15 ml of 8% HPMC or 25% POLOXAMERS to obtain 20 ml of bone morphogenetic protein solution and HPMC or POLOXAMERS mixed liquid. Mix well with ultrasonic or magnetic sti...

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Abstract

The present invention discloses a bone growth factor injection and its preparation method. It includes the following steps: firstly, preparing bone growth factor into solution or mixed suspension; then preparing heat-sensitive hydrogel carrier solution; combining above-mentioned two solutions and making them into injection liquor or freeze-dried product. After the injection is injected into the fracture zone, the coagulated gel can be quickly formed, the bone growth factor and gel composite can be retained in bone repairing zone so as to fully produce slowly-releasing effect-increasing and effect-prolonging action and can raise biological utilization rate of the bone growth factor can raise its bone-forming action.

Description

technical field [0001] The invention relates to a bone repair material, in particular to an injection for injecting bone growth factor into a fracture area to promote fracture repair and a preparation method thereof. Background technique [0002] The treatment of delayed fracture union and nonunion is a difficult problem in orthopedics. For the treatment of delayed union nonunion, the traditional method is to reduce the weight-bearing intensity or prolong the non-weight-bearing time, add external fixation, or use electromagnetic therapy. But these methods may recover slowly and take a long time to treat. The disadvantage of surgical bone grafting is that surgical implantation is required, which has the disadvantages of increasing trauma, inducing infection, and affecting joint and muscle functions. [0003] The lack of bone growth factor is one of the main causes of abnormal fracture healing. Bone growth factor has a strong osteoinductive effect, can act on mesenchymal ce...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/12A61K38/18A61P19/08
Inventor 李亚非
Owner 李亚非
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