CN1261168C - Bone powder of same bone and preparation method - Google Patents
Bone powder of same bone and preparation method Download PDFInfo
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- CN1261168C CN1261168C CN 03150100 CN03150100A CN1261168C CN 1261168 C CN1261168 C CN 1261168C CN 03150100 CN03150100 CN 03150100 CN 03150100 A CN03150100 A CN 03150100A CN 1261168 C CN1261168 C CN 1261168C
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- bone meal
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Abstract
The present invention discloses bone powder of the same bone and a preparation method thereof, which relates to a filler for bone deficiency caused by various reasons in department of stomatology clinic treatment and a preparation method thereof. The bone powder is prepared through crashing a human bone into particles with particle sizes of 0.125 to 0.9mm, cleaning and degreasing in distilled water and alcohol by a supersonic method, mine elimination in hydrochloric acid with ultrasonic cleaning, hydrochloric acid elimination, pH value regulation, sterilization, finally freeze drying and irradiation. The present invention reduces immunogenicity, reserves adult bone factors and kills pathogenic microorganisms. The present invention can be directly used as the filling material for treating the bone deficiency caused by periodontal diseases in the department of stomatology, tooth extraction, cysts, tumors, etc. The present invention can be remolded into bone transplanting material with non-natural structures together with biological blending agents and is used for treating the bone deficiency caused by other reasons.
Description
Technical field
The present invention relates to-be used for the treatment of damaged embedded material of bone and preparation method thereof on kind of the orthopaedics clinical medicine, be specifically related to a kind of can the replacement from bone bone meal of the same race of body bone-specific drug and preparation method thereof.
Background technology
It is damaged to generally believe both at home and abroad that at present the human homogeneous bone implant material of the clinical usefulness of orthopaedics substitutes the bone that causes from body bone-specific drug a variety of causes, as FD, giant cell tumor of bone, Rachiocampis correction merge, due to the wound the damaged and big section resected bone bone grafting of bone tumor of bone to protect limb art etc. be not only feasible but also economic mode.But the equal non-human of the bone implant material bone of the same race that exists on the present domestic market, as " spirit of golden generation bone grafting " (the having another name called " reconstituted bone xenograft ") of the biological doctor of Zhongjin Pharmaceutical Co., Ltd, Tianjin material science and technology branch company production, " the coral hydroxyapatite artificial bone " that Yihuajian Science ﹠. Trade Co., Ltd., Beijing produces etc., all non-human bone of the same race can't be made big section bone in clinical treatment.And, in the damaged clinical treatment of department of stomatology bone, do not see bone meal packing material of the same race aspect as yet for information about.
Summary of the invention
The objective of the invention is to disclose a kind of bone bone meal of the same race and preparation method thereof, this bone bone meal of the same race not only can by with the compound bone implant material of reinventing various non-natural structures of biological modulated mixture, for material source widely is provided clinically, can also directly be applied to the damaged treatment of department of stomatology bone as packing material.
Said bone bone meal of the same race makes by the following method:
(1) the preparation particle diameter is the bone meal granule of 0.125～0.9mm;
(2) the bone meal granule is successively carried out defat with the ultrasonic method cleaning in distilled water and ethanol;
(3) the bone meal granule after the defat is carried out demineralization with the ultrasonic method cleaning in hydrochloric acid;
(4) rinse out hydrochloric acid, the bone meal granule is put into distilled water clean with ultrasonic method;
(5) the bone meal granule that obtains in the step (4) put into ethanol carry out sterilization treatment after, lyophilization.
Preferred version of the present invention is: used concentration of alcohol is 95% during defat, used concentration of alcohol was 75% when used concentration of hydrochloric acid was 0.6N, sterilization during demineralization, with after the bone meal after the lyophilization packing, carry out the second time with the dosage irradiation of 15～20KGy and sterilize.
Because this bone meal is through abundant defat, the demineralization of the may command degree of depth, thoroughly disacidify and the preparation of lyophilization irradiation sterilization, therefore, both effectively reduce immunogenicity, kept osteogenic factor, thoroughly killed pathogenic microorganism again, avoided the infection and the pathophoresis that cause by bone meal itself.
This bone meal is can be directly damaged as packing material is widely used in department of stomatology periodontal disease, exodontia nest, the capsule, reason such as tumor causes bone, also can reinvent into the bone implant material of various non-natural structures with the biological modulated mixture, be used for the damaged filling reparation of bone that other reason causes.
The specific embodiment
Below by embodiment the present invention is described in more detail.
1. powder process
1.1 utilize engine lathe to revolve into chip the cortex backbone who cleans up, then chip is put into microphyte sample pulverizer and pulverize, make bone meal;
1.2 in bone meal, move issuable ferrum end microgranule in the absorption course of processing with block Magnet;
1.3 prepare the aperture and be each one of the nylon net bag of 0.9mm and 0.125mm, screen out particle diameter respectively greater than 0.9mm with less than the powder of 0.125mm, the bone meal of particle diameter between 0.125～0.9mm is entered subsequent processing as raw material.
2. ungrease treatment
2.1 clean contaminants.Get bone meal raw material 300 grams that made and put into the nylon net bag that the aperture is 0.125mm, this nylon net bag is put into the rustless steel container that contains the 3000ml distilled water, with the conventional ultrasonic cleaning of ultrasonic cleaning machine 30 minutes,, get rid of the branch that anhydrates behind the taking-up mesh bag with the dirt in the flush away bone meal;
2.2 alcohol degreasing.The mesh bag that dries (bone meal is housed, down with) put into to contain 1500ml concentration be 95% alcoholic acid rustless steel container, conventional ultrasonic cleaning 8 hours, middle displacement ethanol is once;
2.3 displacement ethanol.Wash bone meal 4 times with reaching purifying waste water of drinking water standard, take out bone meal and dry.
3. demineralization is handled
Bone meal is poured in the rustless steel container, adding 1500ml, concentration are the hydrochloric acid of 0.6N, in the ultrasonic cleaning machine conventional clean 7 hours (middle displacement 1500ml, concentration be 0.6N hydrochloric acid once), then the hydrochloric acid demineralization liquid in the bone meal is outwelled, bone meal is reentered in the nylon net bag that the aperture is 0.125mm, again mesh bag is put into rustless steel container with the rinsing repeatedly 5 times of purifying waste water, dried behind the preliminary flush away hydrochloric acid.
4. disacidify is adjusted pH value
4.1 nylon net bag is put into rustless steel container, add the 4000ml that purifies waste water, carry out conventional ultrasonic cleaning, per hour replace primary purification water.Super washing after 8 hours replaces purifying waste water with distilled water, per hour replaces first water, super washing 4 hours.
4.2 liquid pH value in the measurement bone meal, when liquid pH value in the bone meal greater than 6.5 the time, take out mesh bag bone meal dried, otherwise proceed super washing, up to pH value greater than 6.5.
5. lyophilization
5.1 first sterilization.Nylon net bag is put into rustless steel container, pour 75% ethanol into, amount is as the criterion to flood bone meal, soaks 30 minutes to kill the microorganism in the bone meal;
5.2 lyophilization.Bone meal is put into the pallet of freezer dryer, spread out and carry out lyophilization.
6. pack and two-stage sterilization
6.1 packing.In ten thousand grades of clean rooms according to clinical needs with bone meal according to specifications such as 0.3 gram, 0.5 gram, 1.0 grams with medical heat-sealing plastic bag packaging;
6.2 two-stage sterilization.Packaged bone meal is put into cobalt 60 gamma-ray irradiation devices carry out sterilization treatment, irradiation dose is 15～20KGy.
7. exfactory inspection
7.1 will in superclean bench, open through the bone meal of radiation treatment, under aseptic condition, put into the culture medium test tube, cultivated (the constant incubator temperature is 37 ℃) 72 hours with the parallel contrast with golden Portugal bacterium of bacillus subtilis, the negative steriling test that is of cultivation results is qualified, otherwise is defective;
7.2 water content is qualified less than 6%, otherwise defective.
8. every index of bone meal product
8.1 particle diameter: bone meal is irregular shape granule, and 80% grain diameter is in 0.1258～0.9mm scope;
8.2 the demineralization degree of depth: detect 50% the bone meal granule demineralization degree of depth greater than 50 microns through the microscopic analysis detection system;
8.3 acidity: the bone meal pH value is greater than 6.5;
8.4 water content: less than 6%;
8.5 steriling test: assay is negative.
About the embodiment several points to note:
1. 1.1 operation can also be " with conventional method with 0.3～0.5cm in " 1. powder process "
3The spongy bone piece directly put into pulverizer pulverize make bone meal ".
2. except that the mesh bag aperture, all operating effect is definite according to actual needs or accordingly in the selection of all the other parameters in operating.As the pH value of the weight of the bone meal of choosing, last bone meal, therefore the amount of used washing liquid during super washing, concentration and superly wash the time, change frequency etc. be not considered as operating the restriction of itself.
Claims (10)
1. bone bone meal of the same race is characterized in that its preparation method is as follows:
(1) the preparation particle diameter is the bone meal granule of 0.125～0.9mm;
(2) the bone meal granule is successively carried out defat with the ultrasonic method cleaning in distilled water and ethanol;
(3) the bone meal granule after the defat is carried out demineralization with the ultrasonic method cleaning in hydrochloric acid;
(4) rinse out hydrochloric acid, the bone meal granule is put into distilled water clean with ultrasonic method;
(5) the bone meal granule that obtains in the step (4) put into ethanol carry out sterilization treatment after, lyophilization.
2. bone bone meal of the same race as claimed in claim 1 is characterized in that: with after the lyophilization and packaged bone meal granule irradiation under the dosage of 15～20KGy carry out second time and sterilize.
3. bone bone meal of the same race as claimed in claim 1 or 2 is characterized in that: step (2) is preceding mobile in the bone meal granule with Magnet earlier carrying out.
4. bone bone meal of the same race as claimed in claim 1 or 2 is characterized in that: repeatedly replace distilled water or ethanol in the ultrasonic cleaning process.
5. bone bone meal of the same race as claimed in claim 1 or 2 is characterized in that: in the step (2) during defat used concentration of alcohol be 95%, in the step (3) during demineralization used concentration of hydrochloric acid be in 0.6N, the step (5) during sterilization used concentration of alcohol be 75%.
6. bone bone meal preparation method of the same race, concrete steps are as follows:
(1) the preparation particle diameter is the bone meal granule of 0.125～0.9mm;
(2) the bone meal granule is successively carried out defat with the ultrasonic method cleaning in distilled water and ethanol;
(3) the bone meal granule after the defat is carried out demineralization with the ultrasonic method cleaning in hydrochloric acid;
(4) rinse out hydrochloric acid, the bone meal granule is put into distilled water clean with ultrasonic method;
(5) the bone meal granule that obtains in the step (4) put into ethanol carry out sterilization treatment after, lyophilization.
7. bone bone meal preparation method of the same race as claimed in claim 6 is characterized in that: with after the lyophilization and packaged bone meal granule irradiation under the dosage of 15～20KGy carry out second time and sterilize.
8. as claim 6 or 7 described bone bone meal preparation methoies of the same race, it is characterized in that: step (2) is preceding mobile in the bone meal granule with Magnet earlier carrying out.
9. as claim 6 or 7 described bone bone meal preparation methoies of the same race, it is characterized in that: in the ultrasonic cleaning process, repeatedly replace distilled water or ethanol.
10. as claim 6 or 7 described bone bone meal preparation methoies of the same race, it is characterized in that: in the step (2) during defat used concentration of alcohol be 95%, in the step (3) during demineralization used concentration of hydrochloric acid be in 0.6N, the step (5) during sterilization used concentration of alcohol be 75%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03150100 CN1261168C (en) | 2003-08-01 | 2003-08-01 | Bone powder of same bone and preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03150100 CN1261168C (en) | 2003-08-01 | 2003-08-01 | Bone powder of same bone and preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1579561A CN1579561A (en) | 2005-02-16 |
| CN1261168C true CN1261168C (en) | 2006-06-28 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 03150100 Expired - Fee Related CN1261168C (en) | 2003-08-01 | 2003-08-01 | Bone powder of same bone and preparation method |
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| Country | Link |
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| CN (1) | CN1261168C (en) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2012018241A2 (en) * | 2010-08-05 | 2012-02-09 | Um In Woong | Method for processing bone graft material using teeth, and bone graft material processed thereby |
| CN102805202A (en) * | 2011-12-22 | 2012-12-05 | 江南大学 | Method for degreasing meat and bone meal raw materials, and removing odor and improving quality of meat and bone meal raw materials |
| CN105126172B (en) * | 2015-09-28 | 2017-12-12 | 武汉大学 | A kind of preparation of the dental branches frame of alveolar augmentation and installation method |
| CN107496988B (en) * | 2017-07-20 | 2020-07-31 | 深圳市光明创博生物制品发展有限公司 | Freeze-dried tooth bone powder material and preparation method thereof |
| CN108785742B (en) * | 2018-09-04 | 2021-06-22 | 南宁越洋科技有限公司 | Preparation method of artificial tooth with good osteogenesis effect |
| CN110075356B (en) * | 2019-03-28 | 2021-08-17 | 中国辐射防护研究院 | Plastic filling material for surgical treatment of bone defects and preparation method thereof |
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2003
- 2003-08-01 CN CN 03150100 patent/CN1261168C/en not_active Expired - Fee Related
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| Publication number | Publication date |
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| CN1579561A (en) | 2005-02-16 |
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