CN100377741C - Compound bone peptide for injection and its preparation process - Google Patents
Compound bone peptide for injection and its preparation process Download PDFInfo
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- CN100377741C CN100377741C CNB200410013572XA CN200410013572A CN100377741C CN 100377741 C CN100377741 C CN 100377741C CN B200410013572X A CNB200410013572X A CN B200410013572XA CN 200410013572 A CN200410013572 A CN 200410013572A CN 100377741 C CN100377741 C CN 100377741C
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- 108090000765 processed proteins & peptides Proteins 0.000 title claims abstract description 127
- 210000000988 bone and bone Anatomy 0.000 title claims abstract description 119
- 238000002347 injection Methods 0.000 title claims abstract description 48
- 239000007924 injection Substances 0.000 title claims abstract description 48
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- 150000001875 compounds Chemical class 0.000 title abstract description 8
- 239000000243 solution Substances 0.000 claims abstract description 70
- 229920001184 polypeptide Polymers 0.000 claims abstract description 41
- 102000004196 processed proteins & peptides Human genes 0.000 claims abstract description 41
- 241000124008 Mammalia Species 0.000 claims abstract description 25
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 25
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 24
- 239000007787 solid Substances 0.000 claims abstract description 17
- 238000000605 extraction Methods 0.000 claims abstract description 16
- 238000006243 chemical reaction Methods 0.000 claims abstract description 9
- 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 9
- 239000000126 substance Substances 0.000 claims abstract description 4
- 241000522620 Scorpio Species 0.000 claims description 45
- 239000009490 scorpio Substances 0.000 claims description 45
- 239000006228 supernatant Substances 0.000 claims description 34
- 239000000047 product Substances 0.000 claims description 24
- 238000001035 drying Methods 0.000 claims description 22
- 239000000284 extract Substances 0.000 claims description 20
- 239000007788 liquid Substances 0.000 claims description 18
- 238000007710 freezing Methods 0.000 claims description 16
- 230000008014 freezing Effects 0.000 claims description 16
- 238000000108 ultra-filtration Methods 0.000 claims description 16
- 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 14
- 229930195725 Mannitol Natural products 0.000 claims description 14
- 239000000594 mannitol Substances 0.000 claims description 14
- 235000010355 mannitol Nutrition 0.000 claims description 14
- 238000004321 preservation Methods 0.000 claims description 10
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 8
- 239000000203 mixture Substances 0.000 claims description 8
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 4
- -1 centrifugal Substances 0.000 claims description 4
- 239000000155 melt Substances 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 2
- 241000283690 Bos taurus Species 0.000 claims description 2
- 229920001503 Glucan Polymers 0.000 claims description 2
- 239000004471 Glycine Substances 0.000 claims description 2
- 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 2
- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- 239000008101 lactose Substances 0.000 claims description 2
- 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 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 5
- 241000239226 Scorpiones Species 0.000 abstract description 4
- 238000000034 method Methods 0.000 abstract description 4
- 229940079593 drug Drugs 0.000 abstract description 3
- 208000001132 Osteoporosis Diseases 0.000 abstract description 2
- 206010041591 Spinal osteoarthritis Diseases 0.000 abstract description 2
- 208000036319 cervical spondylosis Diseases 0.000 abstract description 2
- 206010039073 rheumatoid arthritis Diseases 0.000 abstract description 2
- 208000005801 spondylosis Diseases 0.000 abstract description 2
- 229920002521 macromolecule Polymers 0.000 abstract 1
- 239000002504 physiological saline solution Substances 0.000 abstract 1
- 239000012528 membrane Substances 0.000 description 14
- 230000036407 pain Effects 0.000 description 8
- 238000010255 intramuscular injection Methods 0.000 description 7
- 239000007927 intramuscular injection Substances 0.000 description 7
- 238000001990 intravenous administration Methods 0.000 description 7
- 238000012856 packing Methods 0.000 description 7
- 238000002560 therapeutic procedure Methods 0.000 description 7
- 102000007562 Serum Albumin Human genes 0.000 description 6
- 108010071390 Serum Albumin Proteins 0.000 description 6
- 238000007731 hot pressing Methods 0.000 description 6
- 230000000694 effects Effects 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 3
- 238000005303 weighing Methods 0.000 description 3
- 206010061363 Skeletal injury Diseases 0.000 description 2
- 230000004071 biological effect Effects 0.000 description 2
- 230000004097 bone metabolism Effects 0.000 description 2
- 238000009940 knitting Methods 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000006116 polymerization reaction Methods 0.000 description 2
- 239000000843 powder Substances 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 208000020084 Bone disease Diseases 0.000 description 1
- 208000018083 Bone metabolism disease Diseases 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 206010020649 Hyperkeratosis Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 241000699670 Mus sp. Species 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 208000038016 acute inflammation Diseases 0.000 description 1
- 230000006022 acute inflammation Effects 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 230000036592 analgesia Effects 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 230000003412 degenerative effect Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000004108 freeze drying Methods 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
- 239000003102 growth factor Substances 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000009645 skeletal growth Effects 0.000 description 1
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- Peptides Or Proteins (AREA)
Abstract
The present invention relates to a compound bone peptide for injection and a preparation method thereof. Compound bone peptide solution is easily polymerized into macromolecules in the process of storage, and medication safety is influenced. The compound bone peptide for injection is prepared from 1 to 5 parts by weight of polypeptide substances and 20 to 90 parts by weight of excipient, wherein the polypeptide substances are extracted from the bones of the limbs of mammals, and scorpions, have molecular weight of 3000 to 10000 D, compound bone peptide solution prepared by the extraction of the bones of the limbs of the mammals, the scorpions is added to the excipient to be prepared into a sterile freeze dried product, the compound bone peptide for injection has a pH value of 3.5 to 8.5, has solution presenting royal purple through a ninhydrin reaction, is a off-white loose block or amorphous solid, is easily soluble in water or physiological saline, treats rheumatism, rheumatoid arthritis, osteoporosis and cervical spondylosis.
Description
Technical field:
The present invention relates to a kind of Complex Bone Peptide for injection and its prepration technology.
Background technology:
China biochemical pharmacy worker, under the inspiration of motherland's traditional medicine, with mammiferous bones of limbs is raw material, use the modern biotechnology effective component extracting, be developed into biochemical drug-bone peptide injection, in clinical practice, the clinical efficacy of bone peptide injection has obtained numerous doctors, the patient affirms, and complex bone peptide for injection is the compound preparation that adopts modern biotechnology to make with scorpion extraction liquid on the basis of bone peptide injection, the main component of complex bone peptide solution is a micromolecule polypeptide class material, cause very easily that in the preservation process polymerization forms macromole, thereby influence the biological activity and the drug safety of this product.
Summary of the invention:
The purpose of this invention is to provide that a kind of technology is simple, the Complex Bone Peptide for injection and its prepration technology of drug safety.
The object of the present invention is achieved like this:
Complex bone peptide injection, its composition comprises: polypeptides matter and excipient, described polypeptides matter is to extract to form from mammal bones of limbs and Scorpio, the complex bone peptide solution that described mammal bones of limbs and described Scorpio are made through extraction adds described excipient and makes aseptic freeze-dried product, its parts by weight are polypeptides matter 1～5, excipient 20～90, the molecular weight of polypeptides matter is 3000～10000 dalton, pH value is 3.5～8.5, show bluish violet with ninhydrin reaction solution, character is loose block of off-white color or amorphous solid, and is easily molten in water or normal saline.
Above-mentioned complex bone peptide injection, described polypeptides matter 1～5, extraction obtains in mammal bones of limbs 6000～30000, Scorpio 1000～5000.
The preparation technology of above-mentioned complex bone peptide injection, extracting described excipient by above-mentioned described parts by weight adds in the complex bone peptide solution, make the rare dosing of complex bone peptide injection, goods are refrigerated to-50 ℃～-10 ℃, and make condenser temperature be cooled to-50 ℃～-10 ℃, the beginning evacuation, make drying baker vacuum reach 1～15Pa, 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 loose block of off-white color or amorphous solid, its packing specification has 15mg, 30mg, 60mg, intramuscular injection, a 30mg～60mg, once-a-day; Intravenous drip, a 60mg～150mg once-a-day, was a course of treatment or follows the doctor's advice in 15～30 days, also can be at pain spot or acupoint injection therapy.
The preparation technology of above-mentioned complex bone peptide injection, the preparation technology of described complex bone peptide solution is: extract mammiferous bones of limbs by above-mentioned described parts by weight, adding 4～20 times of pure water extracts 2～5 times in 80 ℃～120 ℃, merge extractive liquid,, adjust pH 3.5～6.0, centrifugal, 7.0～9.0 ,-5 ℃～-30 ℃ of supernatant adjust pHs are freezing, melt, centrifugal, supernatant adjust pH 7.0～9.0, centrifugal, with molecular weight is 3000～10000 membrane ultrafiltration, collect ultrafiltrate, get bone peptide solution, standby; Extract Scorpio by above-mentioned described parts by weight and add 4～20 times of pure water, extract merge extractive liquid, 2～5 times in 80 ℃～120 ℃, adjust pH 3.5～6.0, centrifugal, supernatant adjust pH 7.0～9.0,-5 ℃～-30 ℃ freezing, melt, centrifugal, supernatant adjust pH 7.0～9.0, centrifugal, with molecular weight 3000～10000 membrane ultrafiltration, collect ultrafiltrate, get the Scorpio solution for standby; Get described bone peptide solution and described Scorpio solution by 1: 1 mixed, cold preservation, fine straining is made complex bone peptide solution.
Above-mentioned complex bone peptide injection, described mammal comprise pig or tire cattle, and described excipient can be mannitol, Polyethylene Glycol, glucosan, lactose, glycine and colloidal substance.
The invention has the advantages that:
1. Complex Bone Peptide for injection and its prepration technology of the present invention, it is the aseptic freeze-dried injectable powder that adopts modern preparation technique such as low-temperature freeze drying to make, it not only has advantages such as the complex bone peptide for injection effect is direct, quick, and kept the biological activity of component to greatest extent, the stability and the safety of this product have been improved, for numerous doctors, patient provide more convenient, safe and effective medicine.
2. this product is the compound preparation that adopts modern biotechnology to make with scorpion extraction liquid on the basis of bone peptide injection, joint acute inflammation model and immune inflammation model had tangible antiinflammatory action, simultaneously the mice pain model also had significant analgesia role, clinical pharmacology shows, this product contains multiple skeletal growth factor, have the bone metabolism of adjusting and growth effect, can promote knitting, promote bone new life, to bone injury, degenerative osteopathy and bone metabolism disease have good efficacy, can participate in the absorption and the release of bone calcium, promote the formation of callus and new vessels, regulate the bone metabolism balance, thereby performance promotes knitting, to treatment rheumatism, rheumatoid arthritis, osteoporosis, cervical spondylosis and bone injury class disease have curative effect preferably.
3. this product is aseptic freeze-dried injectable powder, micromolecule polypeptide class material is difficult for taking place polymerization, significantly reduce polyreaction, but long preservation, and adverse reaction rate is greatly reduced, and curative effect is constant, and this product can be preserved down and transportation in room temperature, reduce cost of transportation and the stability, safety of this product are increased, be beneficial to Clinical Application and popularization, and provide more selection for doctor and patient.
4. to have preparation technology simple for this product, 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:
Complex Bone Peptide for injection and its prepration technology, its composition comprises: polypeptides matter and excipient, described polypeptides matter (in mammiferous serum albumin) is to extract to form from mammal bones of limbs and Scorpio, the complex bone peptide solution that described mammal bones of limbs and described Scorpio are made through extraction adds described excipient and makes aseptic freeze-dried product, its parts by weight are polypeptides matter 1, excipient 20, the molecular weight of polypeptides matter is 3000 dalton, pH value is 3.5, show bluish violet with ninhydrin reaction solution, character is loose block of off-white color or amorphous solid, and is easily molten in water or normal saline.Its preparation technology is: get parts by weight and be 6000 mammiferous bones of limbs, add 4 times of pure water and extract merge extractive liquid, 2 times in 80 ℃, adjust pH 3.5, centrifugal, supernatant adjust pH 7.0,-5 ℃ freezing, melts, centrifugal, supernatant adjust pH 7.0, centrifugal, be 3000 membrane ultrafiltration with molecular weight, collect ultrafiltrate, get bone peptide solution, standby; Get parts by weight and be 1000 Scorpio and add 4 times of pure water, extract 2 times in 80 ℃, merge extractive liquid,, adjust pH 3.5, centrifugal, 7.0 ,-5 ℃ of supernatant adjust pHs are freezing, melt, and are centrifugal, supernatant adjust pH 7.0, centrifugal, with molecular weight 3000 membrane ultrafiltration, collect ultrafiltrate, get the Scorpio solution for standby; Get described bone peptide solution and described Scorpio solution by 1: 1 mixed, cold preservation, fine straining is made the complex bone peptide solution for standby; Extracting described excipient by above-mentioned described parts by weight adds in the described complex bone peptide solution, make the rare dosing of complex bone peptide injection, goods are refrigerated to-50 ℃, and make condenser temperature be cooled to-50 ℃, the beginning evacuation makes drying baker vacuum reach 1Pa, during primary drying, the flaggy temperature is set at-30, and during redrying, the flaggy temperature is set at 15 ℃, when products temperature reaches 15 ℃, continue drying,, make loose block of off-white color or amorphous solid up to up to specification, its packing specification has 15mg, 30mg, 60mg, intramuscular injection, a 30mg, once-a-day; Intravenous drip, a 60mg once-a-day, was a course of treatment or follows the doctor's advice in 15 days, also can be at pain spot or acupoint injection therapy.
Embodiment 2:
Complex Bone Peptide for injection and its prepration technology, its composition comprises: polypeptides matter and excipient, described polypeptides matter (in mammiferous serum albumin) is to extract to form from mammal bones of limbs and Scorpio, the complex bone peptide solution that described mammal bones of limbs and described Scorpio are made through extraction adds described excipient and makes aseptic freeze-dried product, its parts by weight are polypeptides matter 5, excipient 90, the molecular weight of polypeptides matter is 10000 dalton, pH value is 8.5, show bluish violet with ninhydrin reaction solution, character is loose block of off-white color or amorphous solid, and is easily molten in water or normal saline.Its preparation technology is: get parts by weight and be 30000 mammiferous bones of limbs, add 20 times of pure water and extract merge extractive liquid, 5 times in 120 ℃, adjust pH 6.0, centrifugal, supernatant adjust pH 9.0,-30 ℃ freezing, melts, centrifugal, supernatant adjust pH 9.0, centrifugal, be 10000 membrane ultrafiltration with molecular weight, collect ultrafiltrate, get bone peptide solution, standby; Get parts by weight and be 5000 Scorpio and add 20 times of pure water, extract 5 times in 120 ℃, merge extractive liquid,, adjust pH 6.0, centrifugal, 9.0 ,-30 ℃ of supernatant adjust pHs are freezing, melt, and are centrifugal, supernatant adjust pH 9.0, centrifugal, with molecular weight 10000 membrane ultrafiltration, collect ultrafiltrate, get the Scorpio solution for standby; Get described bone peptide solution and described Scorpio solution by 1: 1 mixed, cold preservation, fine straining is made the complex bone peptide solution for standby; Extracting described excipient by above-mentioned described parts by weight adds in the described complex bone peptide solution, make the rare dosing of complex bone peptide injection, goods are refrigerated to-10 ℃, and make condenser temperature be cooled to-10 ℃, the beginning evacuation makes drying baker vacuum reach 15Pa, during primary drying, the flaggy temperature is set at-10 ℃, and during redrying, the flaggy temperature is set at 50 ℃, when products temperature reaches 50 ℃, continue drying,, make loose block of off-white color or amorphous solid up to up to specification, its packing specification has 15mg, 30mg, 60mg, intramuscular injection, a 60mg, once-a-day; Intravenous drip, a 150mg once-a-day, was a course of treatment or follows the doctor's advice in 30 days, also can be at pain spot or acupoint injection therapy.
Embodiment 3:
Complex Bone Peptide for injection and its prepration technology, its composition comprises: polypeptides matter and excipient, described polypeptides matter (in mammiferous serum albumin) is to extract to form from mammal bones of limbs and Scorpio, the complex bone peptide solution that described mammal bones of limbs and described Scorpio are made through extraction adds described excipient and makes aseptic freeze-dried product, its parts by weight are polypeptides matter 3, excipient 40, the molecular weight of polypeptides matter is 5000 dalton, pH value is 6.5, show bluish violet with ninhydrin reaction solution, character is loose block of off-white color or amorphous solid, and is easily molten in water or normal saline.Its preparation technology is: get parts by weight and be 20000 mammiferous bones of limbs, add 10 times of pure water and extract merge extractive liquid, 3 times in 100 ℃, adjust pH 4.0, centrifugal, supernatant adjust pH 8.0,20 ℃ freezing, melts, centrifugal, supernatant adjust pH 8.0, centrifugal, be 5000 membrane ultrafiltration with molecular weight, collect ultrafiltrate, get bone peptide solution, standby; Get parts by weight and be 3000 Scorpio and add 10 times of pure water, extract 3 times in 100 ℃, merge extractive liquid,, adjust pH 4.0, centrifugal, 8.0 ,-20 ℃ of supernatant adjust pHs are freezing, melt, and are centrifugal, supernatant adjust pH 8.0, centrifugal, with molecular weight 5000 membrane ultrafiltration, collect ultrafiltrate, get the Scorpio solution for standby; Get described bone peptide solution and described Scorpio solution by 1: 1 mixed, cold preservation, fine straining is made the complex bone peptide solution for standby; Extracting described excipient by above-mentioned described parts by weight adds in the described complex bone peptide solution, make the rare dosing of complex bone peptide injection, goods are refrigerated to-30 ℃, and make condenser temperature be cooled to-30 ℃, the beginning evacuation makes drying baker vacuum reach 10Pa, during primary drying, the flaggy temperature is set at-20 ℃, and during redrying, the flaggy temperature is set at 30 ℃, when products temperature reaches 30 ℃, continue drying,, make loose block of off-white color or amorphous solid up to up to specification, its packing specification has 15mg, 30mg, 60mg, intramuscular injection, a 30mg, once-a-day; Intravenous drip, a 60mg once-a-day, was a course of treatment or follows the doctor's advice in 15 days, also can be at pain spot or acupoint injection therapy.
Embodiment 4:
Complex Bone Peptide for injection and its prepration technology, its composition comprises: polypeptides matter and mannitol, described polypeptides matter (in mammiferous serum albumin) is to extract to form from mammal bones of limbs and Scorpio, the complex bone peptide solution that described mammal bones of limbs and described Scorpio are made through extraction adds described mannitol and makes aseptic freeze-dried product, its parts by weight are polypeptides matter 1, mannitol 1000, the molecular weight of polypeptides matter is 6000 dalton, pH value is 4.5, show bluish violet with ninhydrin reaction solution, character is loose block of off-white color or amorphous solid, and is easily molten in water or normal saline.Its preparation technology is: gets parts by weight and is 6000 mammiferous bones of limbs, add 4 times of pure water and extract 2 times, filter, merge extracted twice liquid, be 4.5 with the 3MHCl adjust pH in 105 ℃ of hot pressing, and centrifugal, supernatant 3MN
a8.0 ,-25 ℃ of OH adjust pHs are freezing, and taking-up is melted, and is centrifugal, and supernatant is with 3MHCl adjust pH to 8.0, and is centrifugal, with molecular weight 6000 membrane ultrafiltration, collect ultrafiltrate, get bone peptide solution, and are standby; Get parts by weight and be 1000 Scorpio, add 4 times of pure water and extract 2 times, filter, merge extracted twice liquid, be 4.5 with the 3MHCl adjust pH in 105 ℃ of hot pressing, centrifugal, supernatant 3MN
a8.0 ,-25 ℃ of OH adjust pHs are freezing, and taking-up is melted, and is centrifugal, and supernatant is with 3MHCl adjust pH to 8.0, and is centrifugal, with molecular weight 6000 membrane ultrafiltration, collect ultrafiltrate, get the Scorpio solution for standby; Get above-mentioned described bone peptide solution and Scorpio solution and by 1: 1 mixed, cold preservation, fine straining is made the complex bone peptide solution for standby to clear and bright; Taking by weighing mannitol by above-mentioned described parts by weight adds in the described complex bone peptide solution, make the rare dosing of complex bone peptide injection, goods are refrigerated to-50 ℃, and make condenser temperature be cooled to-50 ℃, the beginning evacuation makes drying baker vacuum reach 1Pa, during primary drying, the flaggy temperature is set at-30 ℃, and during redrying, the flaggy temperature is set at 15 ℃, when products temperature reaches 15 ℃, continue drying,, make loose block of off-white color or amorphous solid agent up to up to specification, its packing specification has 15mg, 30mg, 60mg, intramuscular injection, a 30mg, once-a-day; Intravenous drip, a 60mg once-a-day, was a course of treatment or follows the doctor's advice in 15 days, also can be at pain spot or acupoint injection therapy.
Embodiment 5:
Complex Bone Peptide for injection and its prepration technology, its composition comprises: polypeptides matter and mannitol, described polypeptides matter (in mammiferous serum albumin) is to extract to form from mammal bones of limbs and Scorpio, the complex bone peptide solution that described mammal bones of limbs and described Scorpio are made through extraction adds described mannitol and makes aseptic freeze-dried product, its parts by weight are polypeptides matter 1, mannitol 1000, the molecular weight of polypeptides matter is 6000 dalton, pH value is 4.5, show bluish violet with ninhydrin reaction solution, character is loose block of off-white color or amorphous solid, and is easily molten in water or normal saline.Its preparation technology is: gets parts by weight and is 30000 mammiferous bones of limbs, add 4 times of pure water and extract 2 times, filter, merge extracted twice liquid, be 4.5 with the 3MHCl adjust pH in 105 ℃ of hot pressing, and centrifugal, supernatant 3MN
a8.0 ,-25 ℃ of OH adjust pHs are freezing, and taking-up is melted, and is centrifugal, and supernatant is with 3MHCl adjust pH to 8.0, and is centrifugal, with molecular weight 6000 membrane ultrafiltration, collect ultrafiltrate, get bone peptide solution, and are standby; Get parts by weight and be 5000 Scorpio, add 4 times of pure water and extract 2 times, filter, merge extracted twice liquid, be 4.5 with the 3MHCl adjust pH in 105 ℃ of hot pressing, centrifugal, supernatant 3MN
a8.0 ,-25 ℃ of OH adjust pHs are freezing, and taking-up is melted, and is centrifugal, and supernatant is with 3MHCl adjust pH to 8.0, and is centrifugal, with molecular weight 6000 membrane ultrafiltration, collect ultrafiltrate, get the Scorpio solution for standby; Get above-mentioned described bone peptide solution and Scorpio solution and by 1: 1 mixed, cold preservation, fine straining is clear and bright, makes the complex bone peptide solution for standby; Taking by weighing mannitol by above-mentioned described parts by weight adds in the described complex bone peptide solution, make the rare dosing of complex bone peptide injection, goods are refrigerated to-10 ℃, and make condenser temperature be cooled to-10 ℃, the beginning evacuation makes drying baker vacuum reach 15Pa, during primary drying, the flaggy temperature is set at-10 ℃, and during redrying, the flaggy temperature is set at～and 50 ℃, when products temperature reach～50 ℃ the time, continue drying,, make loose block of off-white color or amorphous solid agent up to up to specification, its packing specification has 15mg, 30mg, 60mg, intramuscular injection, a 60mg, once-a-day; Intravenous drip, a 150mg once-a-day, was a course of treatment or follows the doctor's advice in 30 days, also can be at pain spot or acupoint injection therapy.
Embodiment 6:
Complex Bone Peptide for injection and its prepration technology, its composition comprises: polypeptides matter and mannitol, described polypeptides matter (in mammiferous serum albumin) is to extract to form from mammal bones of limbs and Scorpio, the complex bone peptide solution that described mammal bones of limbs and described Scorpio are made through extraction adds described mannitol and makes aseptic freeze-dried product, its parts by weight are polypeptides matter 1, mannitol 1000, the molecular weight of polypeptides matter is 6000 dalton, pH value is 4.5, show bluish violet with ninhydrin reaction solution, character is loose block of off-white color or amorphous solid, and is easily molten in water or normal saline.Its preparation technology is: gets parts by weight and is 35000 mammiferous bones of limbs, add 4 times of pure water and extract 2 times, filter, merge extracted twice liquid, be 4.5 with the 3MHCl adjust pH in 105 ℃ of hot pressing, and centrifugal, supernatant 3MN
a8.0 ,-25 ℃ of OH adjust pHs are freezing, and taking-up is melted, and is centrifugal, and supernatant is with 3MHCl adjust pH to 8.0, and is centrifugal, with molecular weight 6000 membrane ultrafiltration, collect ultrafiltrate, get bone peptide solution, and are standby; Get parts by weight and be 2000 Scorpio, add 4 times of pure water and extract 2 times, filter, merge extracted twice liquid, be 4.5 with the 3MHCl adjust pH in 105 ℃ of hot pressing, centrifugal, supernatant 3MN
a8.0 ,-25 ℃ of OH adjust pHs are freezing, and taking-up is melted, and is centrifugal, and supernatant is with 3MHCl adjust pH to 8.0, and is centrifugal, with molecular weight 6000 membrane ultrafiltration, collect ultrafiltrate, get the Scorpio solution for standby; Get above-mentioned described bone peptide solution and Scorpio solution and by 1: 1 mixed, cold preservation, fine straining is clear and bright, makes the complex bone peptide solution for standby; Taking by weighing mannitol by above-mentioned described parts by weight adds in the described complex bone peptide solution, make the rare dosing of complex bone peptide injection, goods are refrigerated to-30 ℃, and make condenser temperature be cooled to-30 ℃, the beginning evacuation makes drying baker vacuum reach 10Pa, during primary drying, the flaggy temperature is set at-20 ℃, and during redrying, the flaggy temperature is set at 30 ℃, when products temperature reaches 30 ℃, continue drying,, make loose block of off-white color or amorphous solid agent up to up to specification, its packing specification has 15mg, 30mg, 60mg, intramuscular injection, a 60mg, once-a-day; Intravenous drip, a 150mg once-a-day, was a course of treatment or follows the doctor's advice in 30 days, also can be at pain spot or acupoint injection therapy.
Embodiment 7:
Above-mentioned Complex Bone Peptide for injection and its prepration technology, described polypeptides matter 1, extraction obtains in mammal bones of limbs 6000, Scorpio 1000.
Embodiment 8:
Above-mentioned Complex Bone Peptide for injection and its prepration technology, described polypeptides matter 5, extraction obtains in mammal bones of limbs 30000, Scorpio 5000.
Embodiment 9:
Above-mentioned Complex Bone Peptide for injection and its prepration technology, described polypeptides matter 3, extraction obtains in mammal bones of limbs 20000, Scorpio 3000.
Claims (5)
1. complex bone peptide injection, its composition comprises: polypeptides matter and excipient, it is characterized in that: described polypeptides matter is to extract to form from mammal bones of limbs and Scorpio, the complex bone peptide solution that described mammal bones of limbs and described Scorpio are made through extraction adds described excipient and makes aseptic freeze-dried product, its parts by weight are polypeptides matter 1～5, excipient 20～90, the molecular weight of polypeptides matter is 3000～10000 dalton, pH value is 3.5～8.5, show bluish violet with ninhydrin reaction solution, character is loose block of off-white color or amorphous solid, and is easily molten in water or normal saline.
2. complex bone peptide injection according to claim 1 is characterized in that: the polypeptides matter of described parts by weight 1～5 is that the Scorpio by the mammal bones of limbs of 6000～30000 parts by weight, 1000～5000 parts by weight makes through extraction.
3. the preparation technology of a complex bone peptide injection according to claim 1, it is characterized in that: extract excipient by above-mentioned parts by weight and add in the complex bone peptide solution, make the rare dosing of complex bone peptide injection, goods are refrigerated to-50 ℃～-10 ℃, and when making the goods condenser temperature be cooled to-50 ℃～-10 ℃, the beginning evacuation, make drying baker vacuum reach 1～15Pa, 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 loose block of off-white color or amorphous solid.
4. Complex Bone Peptide for injection and its prepration technology according to claim 3, it is characterized in that: the preparation technology of described complex bone peptide solution is: the mammiferous bones of limbs of getting 6000～30000 parts by weight, adding 4～20 times of pure water extracts 2～5 times in 80 ℃～120 ℃, merge extractive liquid,, adjust pH 3.5～6.0, centrifugal, supernatant adjust pH 7.0～9.0,-5 ℃～-30 ℃ freezing, melt, centrifugal, supernatant adjust pH 7.0～9.0, centrifugal, 50 ℃～100 ℃ concentrating under reduced pressure of supernatant are that 3000～10000 film carries out ultrafiltration with molecular weight, collect ultrafiltrate, get bone peptide solution, standby; Extract Scorpio by 1000～5000 parts by weight and add 4～20 times of pure water, extract merge extractive liquid, 2～5 times in 80 ℃～120 ℃, adjust pH 3.5～6.0, centrifugal, supernatant adjust pH 7.0～9.0,-5 ℃～-30 ℃ freezing, melts, centrifugal, supernatant adjust pH 7.0～9.0, centrifugal, 50 ℃～100 ℃ concentrating under reduced pressure of supernatant carry out ultrafiltration with the film of molecular weight 3000～10000, collect ultrafiltrate, get the Scorpio solution for standby; Get described bone peptide solution and described Scorpio solution by 1: 1 mixed, cold preservation, fine straining is made complex bone peptide solution.
5. complex bone peptide injection according to claim 1 is characterized in that: described mammal comprises pig or tire cattle, and described excipient can be mannitol, Polyethylene Glycol, glucosan, lactose, glycine and colloidal substance.
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| CNB200410013572XA CN100377741C (en) | 2004-02-23 | 2004-02-23 | Compound bone peptide for injection and its preparation process |
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| CNB200410013572XA CN100377741C (en) | 2004-02-23 | 2004-02-23 | Compound bone peptide for injection and its preparation process |
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| CN100377741C true CN100377741C (en) | 2008-04-02 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN100417415C (en) * | 2006-06-28 | 2008-09-10 | 文彦春 | Soakage of medication for treating arthritis |
| CN101732697B (en) * | 2010-01-15 | 2013-05-01 | 门毅 | Compound frozen ossotide preparation |
| CN101822695A (en) * | 2010-04-02 | 2010-09-08 | 石海 | Complex bone peptide injection and preparation method of complex bone peptide for injection |
| CN102988423B (en) * | 2012-12-20 | 2014-09-10 | 海南圣欣医药科技有限公司 | Compound ossotide liposome injection |
| CN115607650B (en) * | 2022-09-30 | 2023-08-15 | 南京新百药业有限公司 | Preparation process of compound bone peptide preparation and equipment for preparation process |
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| CN1153477A (en) * | 1994-04-28 | 1997-07-02 | 莱斯实验室阿特纳公司 | Extracts of shark cartilage having anti-angiogenic activity and effect on tumor regression, process of making thereof |
| JPH09249696A (en) * | 1996-03-14 | 1997-09-22 | Suntory Ltd | Peptidic scorpion toxin |
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| CN1181017A (en) * | 1995-04-11 | 1998-05-06 | S·C·泰曼公司 | Bioactive concentrate, its producing method and certain drug compositions containing also chondroitin sulphate |
| WO2004004630A2 (en) * | 2002-06-20 | 2004-01-15 | Nicolaas Duneas | Osteoinductive biomaterials |
| CN1470256A (en) * | 2002-07-26 | 2004-01-28 | 哈尔滨誉衡药业有限公司 | Medicinal composition for promoting bone-fracture healing and bone-joint injure repairing |
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| CN1153477A (en) * | 1994-04-28 | 1997-07-02 | 莱斯实验室阿特纳公司 | Extracts of shark cartilage having anti-angiogenic activity and effect on tumor regression, process of making thereof |
| CN1177927A (en) * | 1995-02-03 | 1998-04-01 | 莱斯实验室阿特纳公司 | Extracts of shark cartilage, process of production and uses thereof |
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| JPH09249696A (en) * | 1996-03-14 | 1997-09-22 | Suntory Ltd | Peptidic scorpion toxin |
| JPH101500A (en) * | 1996-06-14 | 1998-01-06 | Eisai Co Ltd | New csf and its extraction |
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| CN1470256A (en) * | 2002-07-26 | 2004-01-28 | 哈尔滨誉衡药业有限公司 | Medicinal composition for promoting bone-fracture healing and bone-joint injure repairing |
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| CN1579541A (en) | 2005-02-16 |
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