CN1239201C - Bone peptide for injection and its preparation method - Google Patents
Bone peptide for injection and its preparation method Download PDFInfo
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- CN1239201C CN1239201C CNB2004100135081A CN200410013508A CN1239201C CN 1239201 C CN1239201 C CN 1239201C CN B2004100135081 A CNB2004100135081 A CN B2004100135081A CN 200410013508 A CN200410013508 A CN 200410013508A CN 1239201 C CN1239201 C CN 1239201C
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- bone peptide
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- 210000000988 bone and bone Anatomy 0.000 title claims abstract description 118
- 108090000765 processed proteins & peptides Proteins 0.000 title claims abstract description 112
- 239000007924 injection Substances 0.000 title claims abstract description 38
- 238000002347 injection Methods 0.000 title claims abstract description 38
- 238000002360 preparation method Methods 0.000 title claims abstract description 29
- 239000000243 solution Substances 0.000 claims abstract description 37
- 239000000284 extract Substances 0.000 claims abstract description 33
- 229920001184 polypeptide Polymers 0.000 claims abstract description 33
- 102000004196 processed proteins & peptides Human genes 0.000 claims abstract description 33
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 27
- 239000000203 mixture Substances 0.000 claims abstract description 19
- 238000006243 chemical reaction Methods 0.000 claims abstract description 11
- FEMOMIGRRWSMCU-UHFFFAOYSA-N ninhydrin Chemical compound C1=CC=C2C(=O)C(O)(O)C(=O)C2=C1 FEMOMIGRRWSMCU-UHFFFAOYSA-N 0.000 claims abstract description 10
- 239000000126 substance Substances 0.000 claims abstract description 9
- 239000000843 powder Substances 0.000 claims description 21
- 238000001556 precipitation Methods 0.000 claims description 21
- 238000001035 drying Methods 0.000 claims description 20
- 239000002253 acid Substances 0.000 claims description 9
- 238000005352 clarification Methods 0.000 claims description 9
- 239000007788 liquid Substances 0.000 claims description 9
- 239000012528 membrane Substances 0.000 claims description 9
- 230000007935 neutral effect Effects 0.000 claims description 9
- 238000000108 ultra-filtration Methods 0.000 claims description 9
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 8
- 238000000605 extraction Methods 0.000 claims description 5
- 238000004108 freeze drying Methods 0.000 claims description 5
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 4
- 229920001503 Glucan Polymers 0.000 claims description 4
- 239000004471 Glycine Substances 0.000 claims description 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 4
- 229930195725 Mannitol Natural products 0.000 claims description 4
- 239000008101 lactose Substances 0.000 claims description 4
- TWNIBLMWSKIRAT-VFUOTHLCSA-N levoglucosan Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@H]2CO[C@@H]1O2 TWNIBLMWSKIRAT-VFUOTHLCSA-N 0.000 claims description 4
- 239000000594 mannitol Substances 0.000 claims description 4
- 235000010355 mannitol Nutrition 0.000 claims description 4
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 3
- 241000283898 Ovis Species 0.000 claims description 3
- 241000282894 Sus scrofa domesticus Species 0.000 claims description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 3
- 239000003814 drug Substances 0.000 abstract description 9
- 102000008186 Collagen Human genes 0.000 abstract description 2
- 108010035532 Collagen Proteins 0.000 abstract description 2
- 208000012659 Joint disease Diseases 0.000 abstract description 2
- 206010039073 rheumatoid arthritis Diseases 0.000 abstract description 2
- 208000036487 Arthropathies Diseases 0.000 abstract 1
- 206010020751 Hypersensitivity Diseases 0.000 abstract 1
- 241000124008 Mammalia Species 0.000 abstract 1
- 230000004071 biological effect Effects 0.000 abstract 1
- 229920001436 collagen Polymers 0.000 abstract 1
- 206010020718 hyperplasia Diseases 0.000 abstract 1
- 238000011084 recovery Methods 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 11
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 8
- 238000010255 intramuscular injection Methods 0.000 description 8
- 239000007927 intramuscular injection Substances 0.000 description 8
- 238000001990 intravenous administration Methods 0.000 description 8
- 238000002560 therapeutic procedure Methods 0.000 description 7
- 230000000694 effects Effects 0.000 description 4
- 238000007731 hot pressing Methods 0.000 description 4
- 239000008223 sterile water Substances 0.000 description 4
- 229940079593 drug Drugs 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 206010067484 Adverse reaction Diseases 0.000 description 2
- 206010002198 Anaphylactic reaction Diseases 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 2
- 208000001132 Osteoporosis Diseases 0.000 description 2
- 230000006838 adverse reaction Effects 0.000 description 2
- 230000036783 anaphylactic response Effects 0.000 description 2
- 208000003455 anaphylaxis Diseases 0.000 description 2
- 230000004097 bone metabolism Effects 0.000 description 2
- 239000011575 calcium Substances 0.000 description 2
- 229910052791 calcium Inorganic materials 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 230000001605 fetal effect Effects 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- 208000010392 Bone Fractures Diseases 0.000 description 1
- 241000283690 Bos taurus Species 0.000 description 1
- 206010017076 Fracture Diseases 0.000 description 1
- 206010020880 Hypertrophy Diseases 0.000 description 1
- 208000001953 Hypotension Diseases 0.000 description 1
- 235000019687 Lamb Nutrition 0.000 description 1
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 1
- 206010037660 Pyrexia Diseases 0.000 description 1
- 206010061363 Skeletal injury Diseases 0.000 description 1
- 241000282898 Sus scrofa Species 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000000975 bioactive effect Effects 0.000 description 1
- 210000003557 bones of lower extremity Anatomy 0.000 description 1
- 238000005138 cryopreservation Methods 0.000 description 1
- 230000008021 deposition Effects 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000036543 hypotension Effects 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000011164 ossification Effects 0.000 description 1
- 210000000963 osteoblast Anatomy 0.000 description 1
- 239000003186 pharmaceutical solution Substances 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 238000006116 polymerization reaction Methods 0.000 description 1
- 230000004936 stimulating effect Effects 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
The present invention relates to a bone peptide for injection and a preparation method thereof. Bone peptide solution has a main component of a micromolecule polypeptide class substance which is small peptide class mixture decomposed from collagen. Because a small peptide substance has long storage time, the small peptide substance is easily polymerized into a high molecular substance to be separated out or generates antigenicity and causes the descending of the biological properties of a medicine so as to cause the increase of allergic reactions in clinical application. The bone peptide for injection is prepared from a bone peptide, the bone peptide contains bone extract and excipient at a content ratio of 1 to 100:0.01, the bone extract is a polypeptide substance which is extracted from mammal bones and has molecular weight of 3000 to 10000, a pH value is 3.5 to 9.0, and a ninhydrin reaction is positive. The bone peptide for injection is used for treating hyperplasia bone arthropathy, rheumatism, rheumatoid arthritis, etc., and can promote fracture recovery.
Description
Technical field: the present invention relates to a kind of Bone Peptide for injection and its prepration technology.
Background technology: bone peptide solution main component is a micromolecule polypeptide class material, be to decompose and next small peptide mixture by collagen protein, the small peptide material holding time is long then to be easy to regroup into polymer substance and to separate out or produce antigenicity and cause the biological decline of medicine, thereby cause anaphylaxis increase and curative effect decline in the clinical practice, in clinical practice, find, growth along with the medicine holding time, adverse reaction rate also increases thereupon, reach as high as 1.0%, untoward reaction mainly is anaphylaxis, generally be after medication 5, begin to occur erythra in the time of 6 days, fever, symptoms such as hypotension have influenced using and promoting of bone peptide pharmaceutical solutions.
Summary of the invention: the purpose of this invention is to provide that a kind of technology is simple, the Bone Peptide for injection and its prepration technology of drug safety.
The object of the present invention is achieved like this:
Injection bone peptide, its composition comprises: bone peptide, described bone peptide comprises bone extract and excipient, described bone extract is the polypeptides matter that extracts from mammiferous bone, the molecular weight of described polypeptides matter is 3000-10000, and described polypeptide is 1-100 with the content ratio of described excipient: 0.01, and pH value is 3.5-9.0, ninhydrin reaction is positive, and character is that white or little Huang arrive light yellow block or powder.
The preparation technology of described injection bone peptide, get the bone peptide extracting solution, add excipient, mix, prepare, lyophilization, its cryodesiccated condition is: goods are refrigerated to-50～-25 ℃, and make condenser temperature be cooled to-50～-20 ℃, evacuation, make drying baker vacuum reach 10～20Pa, during primary drying, the flaggy temperature is set at-30～-10 ℃, during redrying, the flaggy temperature is set at 15～50 ℃, when products temperature reaches 15～50 ℃, continues dry, up to up to specification, make white or little Huang to light yellow block or powder.Intravenous drip, a 50-100mg once-a-day, is dissolved in the 200ml normal saline, and 15-30 days is a course of treatment; Intramuscular injection, a 10mg, once-a-day, 20-30 days is a course of treatment.
The preparation technology of above-mentioned bone peptide extracting solution is: get mammiferous bone, pressurised extraction 1～2 time, merge extractive liquid,, acid adjustment pH value are 2.0-5.0, go precipitation, transfer alkaline pH value 8.0-9.5, go precipitation, transfer pH neutral, to precipitate clarification, use the ultrafilter membrane ultrafiltration, molecular cut off is 3000～10000 dalton, makes the bone peptide extracting solution.
The preparation technology of above-mentioned bone peptide extracting solution, described mammiferous bone comprises Os Bovis seu Bubali, Os Sus domestica, Os Caprae seu Ovis, Os Equi, described excipient comprises mannitol, glucosan, lactose, glycine, polyvinylpyrrolidone and colloidal substance.
The invention has the advantages that:
1. injection bone peptide of the present invention is aseptic freeze-dried injectable powder, micromolecule polypeptide class material is difficult for taking place polymerization, therefore can be in the room temperature storage and transport, and adverse reaction rate is reduced and the maintenance curative effect of medication, and bone peptide solution needs cryopreservation, so the present invention has reduced the medicine operation cost, injection bone peptide improves the inherent quality of medicine, help promoting the use of of this medicament,, will have broad application prospects for doctor and patient provide more selection.
2. this product contains the bioactive peptide of multiple bone metabolism, has the adjusting bone metabolism, stimulating osteoblast propagation promotes new bone formation, and regulates calcium, phosphorus metabolism, increase bone calcium deposition, prevent and treat osteoporosis, have antiinflammatory, analgesic activity, fracture, osteoporosis, hypertrophy joint disease and rheumatism, rheumatoid arthritis etc. are had curative effect preferably, and can promote union of fracture, multiple bone injury disease there is significant curative effect.
3. it is simple that preparation technology of the present invention has technology, operation easily, the characteristics of efficacy stability, safety.
Description of drawings: accompanying drawing 1 is technology path of the present invention and process chart.
Below in conjunction with description of drawings the specific embodiment of the present invention:
Embodiment 1:
Bone Peptide for injection and its prepration technology, its composition comprises: bone peptide, described bone peptide comprises bone extract and excipient, described bone extract is the polypeptides matter that extracts from mammiferous bone, content of effective is calculated as 0.025 with polypeptides matter in its lyophilized injectable powder, 0.5 or the numerical value between 1.0 milligrams, the molecular weight of described polypeptides matter is 3000, described polypeptides matter is 1: 0.01 with the content ratio of described excipient, pH value is 3.5, ninhydrin reaction is positive, character is that white or little Huang arrive light yellow block or powder, its preparation technology is: get the bone peptide extracting solution, add excipient, mix, preparation, lyophilization, its cryodesiccated condition is: goods are refrigerated to-50 ℃, and make condenser temperature be cooled to-50 ℃, evacuation, make drying baker vacuum reach 10Pa, during primary drying, the flaggy temperature is set at-30 ℃, during redrying, the flaggy temperature is set at 15 ℃, when products temperature reaches 15 ℃, continue drying, up to up to specification, make white or little Huang to light yellow block or powder, intravenous drip, a 50mg, once-a-day, be dissolved in the 200ml normal saline, 15 days is a course of treatment; Intramuscular injection, a 10mg, once-a-day, 20 days is a course of treatment, also can or follow the doctor's advice at pain spot and acupoint injection therapy.
Embodiment 2:
Bone Peptide for injection and its prepration technology, its composition comprises: bone peptide, described bone peptide comprises bone extract and excipient, described bone extract is the polypeptides matter that extracts from mammiferous bone, the molecular weight of described polypeptides matter is 10000, described polypeptide is 100: 0.01 with the content ratio of described excipient, pH value is 9.0, ninhydrin reaction is positive, character is that white or little Huang arrive light yellow block or powder, its preparation technology is: get the bone peptide extracting solution, add excipient, mix, preparation, lyophilization, its cryodesiccated condition is: goods are refrigerated to-25 ℃, and make condenser temperature be cooled to-20 ℃, evacuation makes drying baker vacuum reach 20Pa, during primary drying, the flaggy temperature is set at-10 ℃, during redrying, the flaggy temperature is set at 50 ℃, when products temperature reaches 50 ℃, continue dry, up to up to specification, make white or little Huang to light yellow block or powder, intravenous drip, a 100mg, once-a-day, be dissolved in the 200ml normal saline, 30 days is a course of treatment; Intramuscular injection, a 10mg, once-a-day, 30 days is a course of treatment, also can or follow the doctor's advice at pain spot and acupoint injection therapy.
Embodiment 3:
Bone Peptide for injection and its prepration technology, its composition comprises: bone peptide, described bone peptide comprises bone extract and excipient, described bone extract is the polypeptides matter that extracts from mammiferous bone, the molecular weight of described polypeptides matter is 5000, described polypeptide is 50: 0.01 with the content ratio of described excipient, pH value is 6.0, ninhydrin reaction is positive, character is that white or little Huang arrive light yellow block or powder, its preparation technology is: get the bone peptide extracting solution, add excipient, mix, preparation, lyophilization, its cryodesiccated condition is: goods are refrigerated to-40 ℃, and make condenser temperature be cooled to-40 ℃, evacuation makes drying baker vacuum reach 15Pa, during primary drying, the flaggy temperature is set at-20 ℃, during redrying, the flaggy temperature is set at 30 ℃, when products temperature reaches 30 ℃, continue dry, up to up to specification, make white or little Huang to light yellow block or powder, intravenous drip, a 50mg, once-a-day, be dissolved in the 200ml normal saline, 15 days is a course of treatment; Intramuscular injection, a 10mg, once-a-day, 20 days is a course of treatment, also can or follow the doctor's advice at pain spot and acupoint injection therapy.
Embodiment 4:
The preparation technology of above-mentioned bone peptide extracting solution gets mammiferous bone, pressurised extraction 1 time, merge extractive liquid,, the acid adjustment pH value is 2.0, goes precipitation, transfers alkaline pH value 8.0, go precipitation, transfer pH neutral,, use the ultrafilter membrane ultrafiltration described precipitation clarification, molecular cut off is 3000 dalton, makes the bone peptide extracting solution.
Embodiment 5:
The preparation technology of above-mentioned bone peptide extracting solution gets mammiferous bone, pressurised extraction 2 times, merge extractive liquid,, the acid adjustment pH value is 5.0, goes precipitation, transfers alkaline pH value 9.5, go precipitation, transfer pH neutral,, use the ultrafilter membrane ultrafiltration described precipitation clarification, molecular cut off is 10000 dalton, makes the bone peptide extracting solution.
Embodiment 6:
The preparation technology of above-mentioned bone peptide extracting solution gets mammiferous bone, pressurised extraction 1 time, merge extractive liquid,, the acid adjustment pH value is 3.0, goes precipitation, transfers alkaline pH value 9.0, go precipitation, transfer pH neutral,, use the ultrafilter membrane ultrafiltration described precipitation clarification, molecular cut off is 5000 dalton, makes the bone peptide extracting solution.
Embodiment 7:
The preparation technology of above-mentioned bone peptide extracting solution, described mammiferous bone comprises Os Bovis seu Bubali, Os Sus domestica, Os Caprae seu Ovis, Os Equi, described excipient comprises mannitol, glucosan, lactose, glycine, polyvinylpyrrolidone and colloidal substance.
Embodiment 8
Bone Peptide for injection and its prepration technology, its composition comprises: bone peptide, described bone peptide comprises bone extract and excipient, described bone extract is the polypeptides matter that extracts from mammiferous bone, the molecular weight of described polypeptides matter is 3000, described polypeptide is 1: 0.01 with the content ratio of described excipient, pH value is 3.5, ninhydrin reaction is positive, character is that white or little Huang arrive light yellow block or powder, its preparation technology is: get fetal lamb bones of limbs 65.0Kg, add the 80L pure water, hot pressing extracts twice, merges extracted twice liquid, with 3MHCl solution 1160ml, acid adjustment pH value to 3.0, go precipitation, transfer alkaline pH value to 8.5, go precipitation, transfer pH neutral to 7.0, to precipitate clarification, and use the ultrafilter membrane ultrafiltration, the molecular weight that dams is 5000 dalton, get bone extracting solution 57400ml, get bone peptide extracting solution 9000ml, add injection water 1000ml and 20% glucosan sterile water solution 2000ml and mix, preparation is refrigerated to goods-50 ℃, and make condenser temperature be cooled to-50 ℃, evacuation makes drying baker vacuum reach 10Pa, during primary drying, the flaggy temperature is set at-30 ℃, during redrying, the flaggy temperature is set at 40 ℃, when products temperature reaches 40 ℃, continue dry, up to up to specification, make the injection bone peptide of white or off-white color block or powder, intravenous drip, a 50mg, once-a-day, be dissolved in the 200ml normal saline, 15 days is a course of treatment; Intramuscular injection, a 10mg, once-a-day, 20 days is a course of treatment, also can or follow the doctor's advice at pain spot and acupoint injection therapy.
Embodiment 9:
Bone Peptide for injection and its prepration technology, its composition comprises: bone peptide, described bone peptide comprises bone extract and excipient, described bone extract is the polypeptides matter that extracts from mammiferous bone, the weight proportion of contained polypeptides matter is 1: 0.025 in its lyophilized injectable powder, the molecular weight of described polypeptides matter is 3000, described polypeptide is 1: 0.01 with the content ratio of described excipient, pH value is 3.5, ninhydrin reaction is positive, character is that white or little Huang arrive light yellow block or powder, its preparation technology is: get fetal bovine limb bone 32.5Kg, hot pressing extracts twice, merges extracted twice liquid, with 3MHCl solution 405ml, acid adjustment pH value to 2.0, go precipitation, transfer alkaline pH value to 8.0, go precipitation, transfer pH neutral to 6.9, to precipitate clarification, and use the ultrafilter membrane ultrafiltration, the molecular weight that dams is 3000 dalton, get bone extracting solution 28700ml, get bone peptide extracting solution 4500ml, add injection water 500ml and 20% mannitol sterile water solution 1000ml and mix, preparation is refrigerated to goods-25 ℃, and make condenser temperature be cooled to-20 ℃, evacuation makes drying baker vacuum reach 10Pa, during primary drying, the flaggy temperature is set at-10 ℃, during redrying, the flaggy temperature is set at 50 ℃, when products temperature reaches 50 ℃, continue dry, up to up to specification, make the injection bone peptide of white or off-white color block or powder, intravenous drip, a 50mg, once-a-day, be dissolved in the 200ml normal saline, 15 days is a course of treatment; Intramuscular injection, a 10mg, once-a-day, 20 days is a course of treatment, also can or follow the doctor's advice at pain spot and acupoint injection therapy.
Embodiment 10:
Bone Peptide for injection and its prepration technology, its composition comprises: bone peptide, described bone peptide comprises bone extract and excipient, described bone extract is the polypeptides matter that extracts from mammiferous bone, the molecular weight of described polypeptides matter is 5000, described polypeptide is 50: 0.01 with the content ratio of described excipient, pH value is 6.0, ninhydrin reaction is positive, character is that white or little Huang arrive light yellow block or powder, its preparation technology is: get tire horse bones of limbs 97.5Kg, add the 120L pure water, hot pressing extracts twice, merges extracted twice liquid, with 3MHCl solution 1740ml, acid adjustment pH value to 4.0, go precipitation, transfer alkaline pH value to 9.0, go precipitation, transfer pH neutral to 7.2, to precipitate clarification, and use the ultrafilter membrane ultrafiltration, the molecular weight that dams is 6000 dalton, get bone peptide extracting solution 86100ml, get bone peptide extracting solution 13500ml, add injection water 1500ml and 20% lactose sterile water solution 3000ml and mix, preparation is refrigerated to goods-30 ℃, and make condenser temperature be cooled to-35 ℃, evacuation makes drying baker vacuum reach 15Pa, during primary drying, the flaggy temperature is set at-20 ℃, during redrying, the flaggy temperature is set at 35 ℃, when products temperature reaches 35 ℃, continue dry, up to up to specification, make the injection bone peptide of white or off-white color block or powder, intravenous drip, a 50mg, once-a-day, be dissolved in the 200ml normal saline, 15 days is a course of treatment; Intramuscular injection, a 10mg, once-a-day, 20 days is a course of treatment, also can or follow the doctor's advice at pain spot and acupoint injection therapy.
Embodiment 11:
Bone Peptide for injection and its prepration technology, its composition comprises: bone peptide, described bone peptide comprises bone extract and excipient, described bone extract is the polypeptides matter that extracts from mammiferous bone, the molecular weight of described polypeptides matter is 3000, described polypeptide is 1: 0.01 with the content ratio of described excipient, pH value is 3.5, ninhydrin reaction is positive, character is that white or little Huang arrive light yellow block or powder, its preparation technology is: get tire pig limbs bone 130.0Kg, add the 160L pure water, hot pressing extracts twice, merges extracted twice liquid, with 3MHCl solution 2320ml, recording pH value is 4.7, acid adjustment pH value to 5.0 is transferred alkaline pH value to 9.5, goes precipitation, transfer pH neutral to 7.1, to precipitate clarification, and use the ultrafilter membrane ultrafiltration, the molecular weight that dams is 7000 dalton, get bone peptide extracting solution 114800ml, get bone peptide extracting solution 18000ml, add injection water 2000ml and 20% glycine sterile water solution 4000ml and mix, preparation is refrigerated to goods-40 ℃, and make condenser temperature be cooled to-45 ℃, evacuation makes drying baker vacuum reach 25Pa, during primary drying, the flaggy temperature is set at-25 ℃, during redrying, the flaggy temperature is set at 35 ℃, when products temperature reaches 35 ℃, continue dry, up to up to specification, make the injection bone peptide of white or off-white color block or powder, intravenous drip, a 50mg, once-a-day, be dissolved in the 200ml normal saline, 15 days is a course of treatment; Intramuscular injection, a 10mg, once-a-day, 20 days is a course of treatment, also can or follow the doctor's advice at pain spot and acupoint injection therapy.
Claims (4)
1. the preparation technology of an injection bone peptide, it is characterized in that: get the bone peptide extracting solution, add excipient, mix, prepare, lyophilization, its cryodesiccated condition is: goods are refrigerated to-50～-25 ℃, and make condenser temperature be cooled to-50～-20 ℃, evacuation, make drying baker vacuum reach 10～20Pa, during primary drying, the flaggy temperature is set at-30～-10 ℃, during redrying, the flaggy temperature is set at 15～50 ℃, when products temperature reaches 15～50 ℃, continue drying, make white or little Huang to light yellow block or powder.
2. the preparation technology of injection bone peptide according to claim 1, it is characterized in that: the preparation technology of described bone peptide extracting solution is: get mammiferous bone, pressurised extraction 1～2 time, merge extractive liquid,, the acid adjustment pH value is 2.0-5.0, goes precipitation, transfers alkaline pH value 8.0-9.5, go precipitation, transfer pH neutral,, use the ultrafilter membrane ultrafiltration described precipitation clarification, molecular cut off is 3000～10000 dalton's parts, promptly makes the bone peptide extracting solution.
3. the preparation technology of injection bone peptide according to claim 1 and 2, it is characterized in that: among the preparation technology of described bone peptide extracting solution, described mammiferous bone comprises Os Bovis seu Bubali, Os Sus domestica, Os Caprae seu Ovis, Os Equi, and described excipient comprises mannitol, glucosan, lactose, glycine, polyvinylpyrrolidone and colloidal substance.
4. injection bone peptide with claim 1 or 2 or 3 described prepared, it is characterized in that: described injection bone peptide comprises bone extract and excipient, described bone extract is the polypeptides matter that extracts from mammiferous bone, the molecular weight of described polypeptides matter is 3000-10000 dalton, described polypeptide is 1-100 with the content ratio of described excipient: 0.01, pH value is 3.5-9.0, ninhydrin reaction is positive, and character is that white or little Huang arrive light yellow block or powder.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2004100135081A CN1239201C (en) | 2004-01-12 | 2004-01-12 | Bone peptide for injection and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2004100135081A CN1239201C (en) | 2004-01-12 | 2004-01-12 | Bone peptide for injection and its preparation method |
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| CN1569218A CN1569218A (en) | 2005-01-26 |
| CN1239201C true CN1239201C (en) | 2006-02-01 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1318085C (en) * | 2005-06-09 | 2007-05-30 | 赵红梅 | Ossotide injection and preparation method thereof |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100417415C (en) * | 2006-06-28 | 2008-09-10 | 文彦春 | Soakage of medication for treating arthritis |
| CN102212106A (en) * | 2011-04-15 | 2011-10-12 | 安徽宏业药业有限公司 | Production process for preparing bone peptide from mammalian limb bones |
| CN102675413A (en) * | 2012-05-27 | 2012-09-19 | 淮安麦德森制药有限公司 | Method for preparing lyophilized powder of polypeptide active substance |
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2004
- 2004-01-12 CN CNB2004100135081A patent/CN1239201C/en not_active Expired - Lifetime
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1318085C (en) * | 2005-06-09 | 2007-05-30 | 赵红梅 | Ossotide injection and preparation method thereof |
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| Publication number | Publication date |
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| CN1569218A (en) | 2005-01-26 |
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Assignee: Heilongjiang Jiang Shi Pharmaceutical Co.,Ltd. Assignor: Jiang Yong Contract fulfillment period: 2008.8.18 to 2018.8.18 Contract record no.: 2008230000003 Denomination of invention: Bone peptide for injection and its preparation method Granted publication date: 20060201 License type: Exclusive license Record date: 20080923 |
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