CN1839773B - Method for making heterogeneous bone free of antibody - Google Patents
Method for making heterogeneous bone free of antibody Download PDFInfo
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- CN1839773B CN1839773B CN2005100314052A CN200510031405A CN1839773B CN 1839773 B CN1839773 B CN 1839773B CN 2005100314052 A CN2005100314052 A CN 2005100314052A CN 200510031405 A CN200510031405 A CN 200510031405A CN 1839773 B CN1839773 B CN 1839773B
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- xenogenesis
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- 210000000988 bone and bone Anatomy 0.000 title claims abstract description 70
- 238000000034 method Methods 0.000 title claims abstract description 15
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- 241000700605 Viruses Species 0.000 claims abstract description 6
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- 239000000427 antigen Substances 0.000 claims abstract 8
- 102000036639 antigens Human genes 0.000 claims abstract 8
- 108091007433 antigens Proteins 0.000 claims abstract 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 14
- 238000002360 preparation method Methods 0.000 claims description 11
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 10
- 230000001054 cortical effect Effects 0.000 claims description 10
- 238000004140 cleaning Methods 0.000 claims description 8
- 230000001954 sterilising effect Effects 0.000 claims description 6
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- 230000001476 alcoholic effect Effects 0.000 claims description 5
- 238000002604 ultrasonography Methods 0.000 claims description 5
- 230000002742 anti-folding effect Effects 0.000 claims description 4
- 230000006835 compression Effects 0.000 claims description 4
- 238000007906 compression Methods 0.000 claims description 4
- 238000007789 sealing Methods 0.000 claims description 4
- 241001465754 Metazoa Species 0.000 claims description 3
- 208000006735 Periostitis Diseases 0.000 claims description 3
- 239000013527 degreasing agent Substances 0.000 claims description 3
- 210000003460 periosteum Anatomy 0.000 claims description 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 2
- 238000004321 preservation Methods 0.000 claims description 2
- 238000005238 degreasing Methods 0.000 claims 1
- 239000000463 material Substances 0.000 abstract description 19
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- 230000002159 abnormal effect Effects 0.000 description 3
- 238000006243 chemical reaction Methods 0.000 description 3
- 229920003023 plastic Polymers 0.000 description 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 description 2
- 206010002198 Anaphylactic reaction Diseases 0.000 description 2
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- Materials For Medical Uses (AREA)
Abstract
This invention relates to a method for preparing replanting filling materials and synthetism fixity materials used in bone surgery treatment, also this invention relates to the method for making bone replanting filling stuff and synthetism fixity from those materials and the products. Besides normal quarantine entries, this invention can also inspect crazy heifer disease virus. By a preparing method of antigens heterogeneity bone, this invention can guarantee the products takes no crazy heifer disease virus or other diseases. Cost low but provide better products.
Description
Technical field
The present invention relates to a kind of preparation and be used for preparing the replanting filling material of Orthopeadic Surgery processing and the method for synthetism fixity material.The present invention simultaneously also further relates to method and prepared bone graft and the bone fixture with such material preparation bone replanting filling material and synthetism fixity.
Technical background
The material of using in the bone surgery mainly is two classes.
One class is a fixture materials.Except that being the nonmetallic materials seldom partly, most fixtures are metal material.Class of metal materials: as screw, round needle, intramedullary pin, blade plate, Cage etc., still in occupation of domestic and international greatly part market.Though they have higher mechanical strength and anti-fatigue performance, but satisfy the fixed needs of bone surgery, but complication such as they also may exist that implant is deteriorated, metal anaphylaxis and embedded material tumorigenesis; Generally all need second operation to take out; Especially on biomechanics, because the elastic modelling quantity gap of metal material and skeleton is too big, stress force shelter reaction is too strong, and on inside-fixture (steel plate) plane, cortical bone disuse atrophy and pine that the metal material below easily takes place become, and cause refracture; On the screw plane, easily fatigue fracture takes place or screw fractures; At the steel plate two ends, also easily fracture.Complication such as Cage has displacement, sinking, do not merge, infection and nerve root irritation take place.DIKFIX (Di Kang) screw that nonmetallic materials class fixture has BIOFIX (hundred is excellent) that Finland made by SR-PGA and SR-PLLA material and China to be made by super high molecular weight PDLLA material.They all are a kind of high molecular polymers, the reaction of local hydrops is often arranged and cause the aseptic cyst, can not secondary sterilization, cost an arm and a leg.The bone implant material of the same race that also has the Shanxi bone bank to produce in addition, but there is bone source difficulty in this material and may causes that human diseases propagates.Or utilize from the body bone, but this method has been damaged the healthy bone of patient from body.
Another kind of is replanting filling material, as the golden generation bone grafting spirit (RBX) of Kiel bone (moral), Oswestry bone (U.S.) and China.These materials all can only be used for " filling is damaged " and " promoting healing ".
Chinese patent ZL 98112370.8 discloses a kind of preparation method of xenogenesis bone fixture.It is to adopt qualified animal, gets its long bone in back 6 hours slaughtering, and divests periosteum, removes organic principles such as bone internal protein, fat, and preliminary working becomes rectangular, dull and stereotyped, the block blank of semicircle is inserted after the cleaning in 75% ethanol.Arrive this, made the material that is suitable for making xenogenesis bone fixture.Then, be machined into the fixture such as screw, pole of different size in the week, cleaning is placed on and seals in the container that fills with Precerving liquid, and with the Co of 15KGY
60Irradiation sterilization.
The xenogenesis bone fixture that foregoing invention provides our experiments show that it has enough mechanical strengths and anti-fatigue performance, and is good, nontoxic with the compatibility of tissue, non-carcinogenesis and anaphylaxis, no immunological rejection.
At present, because the appearance of bovine spongiform encephalopathy, countries in the world especially are the goods in source with the cattle to animal product, and quarantine control is very strict.
Summary of the invention
The present invention is the further improvement on the above-mentioned patent ZL98112370.8 of applicant basis.
Technical scheme of the present invention is outside common quarantine item, also increases crazy heifer disease virus and detects.
Need the regular hour because crazy heifer disease virus detects, therefore original technical scheme was got bone in interior 6 hours and is difficult to realize, through discovering, preserved under refrigerated condition, can prolong and get the bone time, and product quality is not all had influence.
In the former technical scheme, adopt 75% alcohol-pickled.Find after deliberation, adopt to be not less than 50% and can to realize goal of the invention to ethanol less than 75% concentration.And mechanical strength slightly improves, and the tension as 75% when alcohol-pickled, resistance to compression, anti-folding, antitorque ultimate load are respectively 139.9MPa, 178.42MPa, 22.2MPa, 117.77MPa; 50% tension, resistance to compression, anti-folding, antitorque ultimate load when alcohol-pickled then is 142.8MPa, 181.77MPa, 167.4MPa, 50MPa.Because the ethanol consumption that is used to soak is big, thereby adopt the ethanol of low concentration to reduce production costs significantly.
The present invention further provides the method for preparing bone transplanting or bone fixture with the heterogeneous bone free of antibody of above-mentioned preparation, concrete step is:
(1) get as stated above, in the four stars phase with interior preparation heterogeneous bone free of antibody, be processed into the fixture or the graft of required form;
(2) after water cleans, under aseptic condition, use the degreaser defat;
(3) reuse water cleans after the defat, and single preservation in the environment that normal saline or water are arranged; Use Co after the sealing
60Store for future use under the irradiation sterilization, room temperature.
Further improving is that processed and molded product first water in 2 hours cleans 2 times at least, and the product after the cleaning is changed clean container and entered aseptic by pass-through box, adds water with ultrasound wave then and cleans 2 times, continues 5 minutes at least at every turn.
The time of defat is not less than 24 hours in the 2nd step.
To in above-mentioned the 3rd step after defat, said cleaning is that ultrasound wave adds water and cleans 2 times and continue 5 minutes at least at every turn.
Degreaser can be general chloroform, acetone, chloroform, methanol etc.Co
60Irradiation sterilization can carry out according to national standard.
According to Chinese patent ZL98112370.8, the prepared fixture that just is used for bone surgery.The present invention then discloses with prepared heterogeneous bone free of antibody can also be used to prepare the bone surgery graft.The shape of graft can be graininess, also can be powder.
Heterogeneous bone free of antibody be can prepare with method provided by the invention and bone transplanting or bone fixture prepared,
The preparation method of a kind of heterogeneous bone free of antibody provided by the invention guarantees that the product of producing does not have crazy heifer disease virus and other eqpidemic diseases, and production cost is low than existing methods.The preparation method of bone transplanting or bone fixture is more perfect, and product quality is more secure.
Specific embodiment
Select to have more than 1 years old " the top grade cattle " of accurate government official's card and do not have " the first-class cattle " of extremity physiological defect to be the raw material object.Butchering mode (the clean body of shower, electric fiber crops cause dusk, assassinate blood-letting, clean thorax etc. is shedded, begun to speak in peeling) all carries out by the NY467-2001 standard.Get cerebral tissue behind the government official immediately and do pathology inspection and Western detection, cattle is temporarily put freezer, just gives after the feminine gender as a result and gets bone.When getting bones of limbs, peeling hair, meat, hoof and joint stay long bone of limbs to do.Cattle slaughter to the time of getting the bone immersion treatment should be less than 24 hours.Select fresh gloss, no abnormal mottle, deformity and defective, no fur muscle and dirt stick, the skeleton of no abnormal abnormal smells from the patient.Os Bovis seu Bubali packed into fill in the 50% alcoholic acid Plastic Drum.Fresh Os Bovis seu Bubali need be removed periosteum, muscle, spongy bone, only keeps cortical bone, handles and wants clean, thorough.The Os Bovis seu Bubali that pretreatment is good is processed into rectangular, dull and stereotyped, nahlock shape blank.After cleaning up with 50% alcoholic solution, classification is packed into and is filled in the 50% alcoholic acid different vessels.
Defat is carried out at aseptic.After the defat 24 hours, reuse ultrasound wave and water clean 2 times.
Product carries out single packing at aseptic, contains Precerving liquid in the plastic bag, adds 2 layers of plastic bag packaging, sealing after the sealing again.Use Co
60Store for future use under the room temperature behind the irradiation sterilization.
Resistance to compression ultimate load with the heterogeneous bone free of antibody of rectangular, dull and stereotyped, the nahlock shape blank of heterogeneous bone free of antibody preparation is 186.4～205.2MPa, anti-folding ultimate load 154.7～179.8MPa, tension ultimate load 117.1～139.1MPa, antitorque ultimate load 53.5～55MPa.Detection method is:
Heterogeneous bone free of antibody is successively in the attached sweet spring water of Shanghai Tongji University hospital, attached four hospitals of Dalian Medical Univ, Affiliated Hospital of Guangdong Pharmaceutical University, the Zhejiang Prov. Hospital of Traditional Chinese Medicine, Xiangye No. 2 Hospital of Central South University, an attached hospital of Hunan College of Traditional Chinese Medicine, People's Hospital, Hunan Prov., an attached hospital of University Of Nanhua, Guangdong Shi Jie hospital, Shaoshan City institute of traditional Chinese medicine, Yiyang City institute of traditional Chinese medicine, second the People's Hospital, Shaodong city, Changsha the 4th hospital, Changsha the 7th hospital, Yueyang Affiliated Hospital of Vocationl Technical College, First People's Hospital, Hengyang City, Chenzhou railway hospital, Zhangjiajie railway hospital etc. is distributed in more than 20 tame hospital clinicals of 5 provinces and regions and uses example (wherein being used to transplant 15 examples) surplus in the of about 400 altogether, through following up a case by regular visits to for many years, effect is satisfied: patient's whole body is all right, does not have because of product the bacterium person that causes the postoperative infection is arranged; The person of immediately pyrogen reaction thing take place after do not have implanting; Do not have the back of implantation acute general toxic reaction person is taken place; Do not have the back of implantation acute haemolysis person is taken place; Nothing is carcinogenic because of product, the teratogenesis person; Otch does not have infection; Press Yang Li people's standard, fracture is healing all, no delayed union, disunion and malunion.The 15 routine patients that are used to transplant observed 6～18 months, and bone merges, no prosthetic loosening, and no bone dissolving, no sequestrum forms.
Claims (6)
1. one kind is removed antigen xenogenesis cortical bone, it is characterized in that preparing as follows, select the qualified animal of quarantine, get bone, remove the periosteum on the bone, the organic principles such as protein-fat-in the bone, only keep cortical bone, that preliminary working becomes is rectangular, the dull and stereotyped or block blank of semicircle, and places alcoholic solution to soak; Wherein outside common quarantine item, also increase crazy heifer disease virus and detect, and in the described alcoholic solution concentration of ethanol for being not less than 50% to less than 75%.
2. utilize the prepared method of going antigen xenogenesis cortical bone to prepare bone transplanting or bone fixture of claim 1, it is characterized in that
(1) be taken at the four stars phase with interior preparation remove antigen xenogenesis cortical bone, be processed into required fixture or graft;
(2) after water cleans, under aseptic condition, use the degreaser defat;
(3) reuse water cleans after the defat, and single preservation in the environment that normal saline or water are arranged;
(4) use Co after the sealing
60Store for future use under the irradiation sterilization, room temperature.
3. method of going antigen xenogenesis cortical bone to prepare bone transplanting or bone fixture according to claim 2, it is characterized in that said be processed into required fixture or graft after, first water cleans 2 times at least in 2 hours, product after the cleaning passes through pass-through box, change clean container and enter aseptic, add water with ultrasound wave then and clean 2 times, continue 5 minutes at least at every turn.
4. method of going antigen xenogenesis cortical bone to prepare bone transplanting or bone fixture according to claim 2 is characterized in that said degreasing time is not less than 24 hours in (2) step.
5. method of going antigen xenogenesis cortical bone to prepare bone transplanting or bone fixture according to claim 2 is characterized in that said cleaning is that ultrasound wave adds water cleaning 2 times in (3) step, continues 5 minutes at least at every turn.
6. remove antigen xenogenesis cortical bone graft or bone fixture, it is characterized in that it is by claim 2,3,4 or 5 described method preparations, its resistance to compression ultimate load is 186.4～205.2MPa, anti-folding ultimate load 154.7～179.8MPa, tension ultimate load 117.1～139.1MPa, antitorque ultimate load 53.5～55MPa.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2005100314052A CN1839773B (en) | 2005-04-01 | 2005-04-01 | Method for making heterogeneous bone free of antibody |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2005100314052A CN1839773B (en) | 2005-04-01 | 2005-04-01 | Method for making heterogeneous bone free of antibody |
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| Publication Number | Publication Date |
|---|---|
| CN1839773A CN1839773A (en) | 2006-10-04 |
| CN1839773B true CN1839773B (en) | 2011-05-04 |
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Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1188015A (en) * | 1996-12-09 | 1998-07-22 | 中国人民解放军第四军医大学第一附属医院 | Lump type defatted antigen-removing heterogenic bone grafting material and preparing method thereof |
| CN1228292A (en) * | 1998-03-09 | 1999-09-15 | 长沙铁路总公司长沙医院 | Heterogenic cortical endosteal fixator |
| CN1290182A (en) * | 1998-02-06 | 2001-04-04 | 骨科技术公司 | Osteoimplant and method for its manufacture |
| CN1463756A (en) * | 2002-06-06 | 2003-12-31 | 北京市创伤骨科研究所 | Method for preparation of artificial bone antigen for biological origin |
| CN1507925A (en) * | 2002-12-20 | 2004-06-30 | 上海组织工程研究与开发中心 | Use of decellularized, decalcitied bone as tissue engineered material |
-
2005
- 2005-04-01 CN CN2005100314052A patent/CN1839773B/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1188015A (en) * | 1996-12-09 | 1998-07-22 | 中国人民解放军第四军医大学第一附属医院 | Lump type defatted antigen-removing heterogenic bone grafting material and preparing method thereof |
| CN1290182A (en) * | 1998-02-06 | 2001-04-04 | 骨科技术公司 | Osteoimplant and method for its manufacture |
| CN1228292A (en) * | 1998-03-09 | 1999-09-15 | 长沙铁路总公司长沙医院 | Heterogenic cortical endosteal fixator |
| CN1463756A (en) * | 2002-06-06 | 2003-12-31 | 北京市创伤骨科研究所 | Method for preparation of artificial bone antigen for biological origin |
| CN1507925A (en) * | 2002-12-20 | 2004-06-30 | 上海组织工程研究与开发中心 | Use of decellularized, decalcitied bone as tissue engineered material |
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| Publication number | Publication date |
|---|---|
| CN1839773A (en) | 2006-10-04 |
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Effective date of registration: 20120511 Address after: 412007 A1-3 building, small and medium-sized enterprise promotion zone, Tianyuan District, Zhuzhou, Hunan Patentee after: Hunan Hengtian Biological Technology Co., Ltd. Address before: 410001 Changsha seventh hospital, 39 Wuyi Road, Hunan, Changsha, China Patentee before: Zhu Tianjing |