CN100342923C - Compound coral artificial bone suspension for injection and its prepn process - Google Patents

Compound coral artificial bone suspension for injection and its prepn process Download PDF

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Publication number
CN100342923C
CN100342923C CNB02134874XA CN02134874A CN100342923C CN 100342923 C CN100342923 C CN 100342923C CN B02134874X A CNB02134874X A CN B02134874XA CN 02134874 A CN02134874 A CN 02134874A CN 100342923 C CN100342923 C CN 100342923C
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China
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coral
injection
bone
cha
rhbmp
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CNB02134874XA
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CN1486749A (en
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张余
尹庆水
李旭麟
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Abstract

The present invention relates to composite coral artificial bone turbid liquor for injection and a preparing method thereof, which is characterized in that the composite coral artificial bone turbid liquor for injection is prepared from 0.1 to 0.3 g of granules of coral hydroxyapatite CHA, 10 to 15 mg of recombined human bone morphogenetic protein-2, 2 to 4 ml of chitosan solution with the concentration of 2%, and 2 to 4 ml of salt water of heparin, wherein the recombined human bone morphogenetic protein-2 is abbreviated as rhBMP-2. The present invention has the obvious advantages that the original artificial bones formed in vitro are changed into bones formed in vivo, and the original bone grafting by operation is changed into bone grafting by injection; the ordered accumulation of granules of coral hydroxyapatite CHA is utilized to form bones, and the sizes of granules of coral hydroxyapatite CHA are determined by frequent tests. If clinically used, the composite coral artificial bone turbid liquor has the advantages of no need of operation, no wound, safety, rapidness and can also be used in small hospitals. The bone healing rate can reach more than 80% if the turbid liquor is injected partially.

Description

Compound coral artificial bone suspension for injection and preparation method thereof
Affiliated technical field
The present invention relates to a kind of compound coral artificial bone suspension for injection and preparation method thereof, belong to field of medical article technology.
Background technology
The artificial bone graft is an ancient and fresh problem, and from autologous bone transplanting, allogenic bone transplantation, artificial bone graft, bone grafting operation is common bone surgery.Because operating difficulty is big, internal fixation is not certain, wound has infection, bone-inducing factor shortage etc., therefore, causes the damaged and bone does not connect of bone easily.Present Therapeutic Method generally is the method treatment of adopting the internal fixation+bone grafting of performing the operation once more.Operate on operation because this method need be carried out surgery, have complicated operation, operating difficulty is big, wound is big, risk is bigger shortcoming, must could implement such operation by large hospital, generally infirmary can not implement such operation, and the course of treatment is long, curative effect is unstable.
Technology contents
The technical issues that need to address of the present invention provide compound coral artificial bone suspension for injection and preparation method thereof, described compound coral artificial bone suspension has the effect of bone inductive effect and accelerated bone healing, adopt the present invention to operate on, wound is little, simple to operate, safe and reliable.
Technical problem of the present invention can solve by taking following measure: compound coral artificial bone suspension for injection, be characterized in: formulated by coral hydroxyapatite CHA granule, rhBMP-2, chitosan solution and heparin saline, the rhBMP-2 simply claims rhBMP-2, the content of each raw material is in one dosage: rhBMP-2 is 10~15mg, 2% chitosan solution 2ml~4ml, coral hydroxyapatite CHA granule 0.1~0.3g, heparin saline 2ml~4ml.
Technical problem of the present invention can also solve by taking following measure:
Described its particle diameter of coral hydroxyapatite CHA granule is 0.2~0.4mm.
The concentration of described heparin saline is 1: 1000.
The preparation method of foregoing compound coral artificial bone suspension is characterized in:
1) is ready to raw material by aforementioned specification and weight proportion;
2) above-mentioned four kinds of materials are put into measuring cup simultaneously, reuse magnetic cup shakes up, and makes the compound coral artificial bone suspension for injection of a dosage;
3) aforementioned compound coral artificial bone suspension for injection is put into glass syringe, use the oxirane disinfection film seal, 37 ℃ of sterilizations down, it is standby to place 4 ℃ of refrigerators to preserve.
The present invention has following beneficial effect:
1, the most outstanding advantage of the present invention is to change original external molding artificial bone in body molding, change original bone grafting of operating on into the injection bone grafting, utilize the particulate orderly heap-shaped of coral hydroxyapatite CHA to become bone, the particulate size of coral hydroxyapatite CHA is through experiment is definite repeatedly, clinical just the application need not to operate on, do not have wound, safe and efficient, and infirmary also can use.
2, the dosage form of injection is used for clinically, so the patient absorbs easily, knitting is easy, clinical easy to use.According to zoopery and clinical principium test, use this suspension and can easy, effectively be applied to the damaged case of suitable bone does not connect or bone.In zoopery and Preliminary clinical test, this suspension of local injection can reach the knitting rate more than 80%.
Preferred embodiment
Embodiment 1: by coral hydroxyapatite CHA, rhBMP-2 is that rhBMP-2,2% chitosan solution and heparin saline are formulated; The percentage composition of each material is respectively coral hydroxyapatite CHA0.2g, the rhBMP-2 is rhBMP-215mg, 2% chitosan 3ml, heparin saline 3ml.Concrete compound method and descending:
1) prepare raw material by above-mentioned percentage composition, wherein the CHA granule is that graininess, its particle diameter are 0.2~0.4mm, and the concentration of heparin saline is 1: 1000;
2) above-mentioned four kinds of materials are put into measuring cup simultaneously, reuse magnetic cup shakes up, and makes the compound coral artificial bone suspension for injection of a dosage;
3) aforementioned compound coral artificial bone suspension for injection is put into glass syringe, use the oxirane disinfection film seal, 37 ℃ of sterilizations down, it is standby to place 4 ℃ of refrigerators to preserve.
The application process of present embodiment is as follows:
Select suitable bone does not connect, the damaged case of bone, X line perspective is the location down, earlier with anesthesia spinal needle to bone does not connect, bone defect, and carry out bone does not connect or the damaged place of bone subperiosteum soft tissue is peeled off with needle point, anesthesia spinal needle is kept somewhere motionless; The reuse marrow puncture needle punctures on the ilium ridge, after success back is extracted red bone marrow and is reached the 20ml scale and shake up with the syringe that contains suspension, inject bone does not connect or the damaged place of bone through original anesthesia spinal needle, can finish the injection suspension treatment, then pressurized wrapping 2~3 weeks of immobilization of the wounded limb.
Extraction mainly is in order to obtain seed cell from body through bone marrow, and the red bone marrow seed cell is a key factor of knitting.
Hassan Green is keeping under the constant situation of pre-existent pore rate Hassan Green through " through the hydrothermal solution exchange reaction ", and composition changes hydroxyapatite CHA into, and the degradation speed of objective reality is descended.Not only porosity is extremely similar to the human body spongy bone for Hassan Green like this, and inorganic composition is also similar
Bone morphogenetic protein (BMP) is present unique somatomedin that has the induced osteogenesis effect certainly.Zoopery proof BMP is for promoting the efficiency factor of knitting.Then, people have begun the clinical practice of natural B MP.But because extraction process complexity, the extracted amount of BMP are limited, purity is not high, and its application is restricted.Along with development of molecular biology, the appearance of clone technology, people recognize that gradually people's BMP is an extended family, comprise 16-20 different albumen, and find that the BMP-2 activity is the strongest.Then try the production of BMP is put into laboratory.Zhao Ming finished the gene expression of people BMP-2 mature peptide large intestine sense bacterium in the world at first in 1994.Purifiedly obtain highly purified people BMP-2, be rhBMP-2.
Chitosan (shell tetrose) but prove that biocompatibility is good, the good slow reagent of the degradation in vivo that has no side effect.The Hou Chunlin of China in 1996 has done the bacteriostatic experiment of chitosan.Chitin is as the slow releasing agent of grand celebration mycin since 1997.
Embodiment 2: by coral hydroxyapatite CHA, rhBMP-2 is that the heparin saline of rhBMP-2,2% chitosan solution and 1: 1000 is formulated; The percentage composition of each material is respectively coral hydroxyapatite CHA 0.3g, the rhBMP-2 is rhBMP-2 10mg, 2% chitosan 4ml, heparin saline 4ml.Compound method is with embodiment 1.
Embodiment 3: by coral hydroxyapatite CHA, rhBMP-2 is that the heparin saline of rhBMP-2,2% chitosan solution and 1: 1000 is formulated; The percentage composition of each material is respectively coral hydroxyapatite CHA 0.1g, the rhBMP-2 is rhBMP-2 13mg, 2% chitosan 2ml, heparin saline 2ml.Compound method is with embodiment 1.

Claims (2)

1, compound coral artificial bone suspension for injection, it is characterized in that: by coral hydroxyapatite CHA granule, to be recombined into bone morphogenesis protein-2, chitosan solution and heparin saline formulated, the rhBMP-2 simply claims rhBMP-2, the content of each raw material is in one dosage: rhBMP-2 is 10~15mg, 2% chitosan solution 2ml~4ml, coral hydroxyapatite CHA granule 0.1~0.3g, heparin saline 2ml~4ml; Described its particle diameter of coral hydroxyapatite CHA granule is 0.2~0.4mm; The concentration of described heparin saline is 1: 1000.
2, the preparation method of compound coral artificial bone suspension for injection as claimed in claim 1 is characterized in that:
1) is ready to coral hydroxyapatite CHA granule, rhBMP-2, chitosan solution and heparin saline by specification and weight proportion;
2) above-mentioned four kinds of materials are put into measuring cup simultaneously, reuse magnetic cup shakes up, and makes the compound coral artificial bone suspension for injection of a dosage;
3) aforementioned compound coral artificial bone suspension for injection is put into glass syringe, use the oxirane disinfection film seal, 37 ℃ of sterilizations down, it is standby to place 4 ℃ of refrigerators to preserve.
CNB02134874XA 2002-09-30 2002-09-30 Compound coral artificial bone suspension for injection and its prepn process Expired - Fee Related CN100342923C (en)

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CNB02134874XA CN100342923C (en) 2002-09-30 2002-09-30 Compound coral artificial bone suspension for injection and its prepn process

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Application Number Priority Date Filing Date Title
CNB02134874XA CN100342923C (en) 2002-09-30 2002-09-30 Compound coral artificial bone suspension for injection and its prepn process

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CN100342923C true CN100342923C (en) 2007-10-17

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1273976A (en) * 2000-04-21 2000-11-22 西南药业股份有限公司 Process for preparing recombined morphogenetic protein (rhOP-1) of human bone
CN1087633C (en) * 1998-12-21 2002-07-17 冶金工业部钢铁研究总院 Method for preparing bone morphogenesis protein and hydroxyapatite compound dosage form

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1087633C (en) * 1998-12-21 2002-07-17 冶金工业部钢铁研究总院 Method for preparing bone morphogenesis protein and hydroxyapatite compound dosage form
CN1273976A (en) * 2000-04-21 2000-11-22 西南药业股份有限公司 Process for preparing recombined morphogenetic protein (rhOP-1) of human bone

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