CN1579542A - Lugua polypeptides for injection and its preparing process - Google Patents
Lugua polypeptides for injection and its preparing process Download PDFInfo
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- CN1579542A CN1579542A CN 200410013602 CN200410013602A CN1579542A CN 1579542 A CN1579542 A CN 1579542A CN 200410013602 CN200410013602 CN 200410013602 CN 200410013602 A CN200410013602 A CN 200410013602A CN 1579542 A CN1579542 A CN 1579542A
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- 238000005516 engineering process Methods 0.000 claims description 31
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Abstract
The invention is an injection lugua multi-peptide and its manufacturing process. The primary ingredients of the lugua extract are peptide substance and biology alkali and tannin in white melon seed. The peptide substance is apt to be polymerized into high molecular, and the biology alkali and tannin in white melon seed can advance the reaction, thus the liquid lugua multi-peptide extract is apt to be polymerized in storing process, and causes the increase of clinic hypersusceptibility reaction. Its ingredients include: multi-peptide substance and excepient, the multi-peptide substance is extracted from deer animal bones and cucurbitaceous melon seed, its weight shares are: multi-peptide substance 5-100, excepient 20-90, the molecular weight of the multi-peptide is 3000-10000 Dalton, the pH value is 3.5-9.0, it represents fuchsia when reacting with biuret, the character is white blocks or formless powder, it soluble in water. The product can be applied to cure rheumatoid arthritis, and osteoporosis, and cervical spondylosis.
Description
Technical field: the present invention relates to a kind of cervus and cucumis polypeptide for injection and its prepration technology.
Background technology: the cervus cucumls extract main component is contained multiple alkaloid and a tannin in peptide matters and the Semen Benincasae, peptide matters easily aggregates into macromole, alkaloid in the Semen Benincasae and tannin can be quickened this polyreaction, therefore, liquid cervus and cucumis polypeptide extract is easily polymerization in the preservation process, cause that polymer substance increases, cause clinical anaphylaxis to increase.
Summary of the invention: the purpose of this invention is to provide that a kind of technology is simple, the cervus and cucumis polypeptide for injection and its prepration technology of drug safety.
The object of the present invention is achieved like this:
The injection cervus and cucumis polypeptide, its composition comprises: polypeptides matter and excipient, described polypeptides matter is to extract to form from animal in deer family skeleton and cucurbitaceous plant muskmelon seeds, its parts by weight are polypeptides matter 5～100, excipient 20～90, the molecular weight of polypeptides matter is 3000～10000 dalton, and pH value is 3.5～9.0, with biuret reaction solution displaing amaranth, character is off-white color block or amorphous powder, and is soluble in water.
Above-mentioned injection cervus and cucumis polypeptide, described excipient can be mannitol, Polyethylene Glycol, glucosan, lactose, glycine and colloidal substance.
The preparation technology of above-mentioned injection cervus and cucumis polypeptide gets cervus and cucumis polypeptide solution and excipient and by above-mentioned described parts by weight preparation, gets Os Cervi bone 17500～63000, the water for injection that adds 3～8 times of amounts, hot pressing is extracted, and the extracting solution adjust pH to alkalescence, is obtained the Os Cervi extracting solution after the filtration; Get Semen Melo 3000～10000 by weight, add behind the water hot pressing and extract, and filter and obtain the Semen Melo extracting solution; Above-mentioned described Os Cervi extracting solution and Semen Melo extracting solution are pressed 1～10: 1 mixed, make cervus and cucumis polypeptide solution, add the excipient aqueous solution, its parts by weight are polypeptides matter 5～100, excipient 20～90, utilize freeze drying process that described cervus and cucumis polypeptide solution is made lyophilized injectable powder.Its packing specification has 2.5mg, 5.0mg, 10mg, 20mg, 50mg, 100mg, this product 8mg is dissolved with the 4ml sterilized water for injection, intramuscular injection, 1～2 time on the one, this product 16～24mg is dissolved in 250ml, 0.9% sodium chloride injection, vein slowly instils, and 1 time on the one, 15 days is a course of treatment.
The preparation technology of above-mentioned injection cervus and cucumis polypeptide, the preparation technology of described cervus and cucumis polypeptide solution is: get Os Cervi bone 17500～63000 by weight, add the water for injection of 3～8 times of amounts, 80 ℃～120 ℃ hot pressing are extracted 2～4 times, merge extractive liquid,, sediment is removed in adjust pH to 3.5～4.5, supernatant is transferred alkaline pH value to 8.5～9.0, remove sediment, supernatant is used the ultrafilter membrane ultrafiltration after transferring pH neutral, molecular cut off is 3000～10000 dalton relatively, and it is standby to make the Os Cervi extracting solution; Get Semen Melo 3000～10000 by weight, add the water for injection of 3～8 times of amounts, 80 ℃～120 ℃ hot pressing are extracted 2～4 times, and merge extractive liquid, removes sediment, ultrafiltration, and molecular cut off is 3000～10000 dalton relatively, it is standby to make the Semen Melo extracting solution; Above-mentioned described Os Cervi extracting solution and Semen Melo extracting solution are pressed 1～10: 1 mixed, make cervus and cucumis polypeptide solution.
The preparation technology of above-mentioned injection cervus and cucumis polypeptide, the preparation technology of described excipient aqueous solution is: get excipient by above-mentioned described parts by weight, adding the injection water makes its solution concentration reach 20%～90%, add 0.01%～5% active carbon, filter, take off charcoal, make apyrogeneity excipient aqueous solution.
The preparation technology of above-mentioned injection cervus and cucumis polypeptide, described freeze drying process is: goods are refrigerated to-50 ℃～-20 ℃, and make condenser temperature be cooled to-50 ℃～-20 ℃, the beginning 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, up to up to specification.
The invention has the advantages that:
1. injection cervus and cucumis polypeptide of the present invention, because of containing inorganic elementss such as the bioactive peptide material of multiple bone metabolism and calcium, phosphorus, ferrum, Semen Melo extract, multiple free amino acids etc., its pharmacological action are to regulate bone metabolism and alcium and phosphor metabolization, stimulating osteoblast propagation, promote new bone formation and regulate calcium, phosphorus metabolism, increase bone calcium, phosphorus deposition, prevent osteoporosis, have analgesia, antiinflammatory action; With Semen Melo extract fused after, under both synergism, can obviously reduce the local capillary permeability of fracture, reduce inflammatory exudation, promote local blood circulation, for osteocyte provides a good blood supply environment, can also suppress the release of prostaglandin in addition, reach analgesic effect, in promoting fracture heals in early days, Semen Melo extract induces peptide growth factor to have synergism with the bone that replenishes, and promotes the synthetic of bdgf; Polypeptides matter participates in the generation of metabolism of bone tissue and lapses to, zoopery shows, the cervus and cucumis polypeptide injection can be facilitated the osteocyte growth, promote intermembranous ossification and endochondral ossification, disease is evident in efficacy to fracturing, fracturing, clinical application research shows that the cervus and cucumis polypeptide injection can promote union of fracture, and multiple bone injury disease is had significant curative effect.
2. for increasing the stability of cervus cucumls extract injection, reduce adverse reaction rate, improve drug safety, for numerous doctors and patient provide high-quality medicine, my company begins to carry out the development work of injection cervus and cucumis polypeptide, compare with the cervus cucumls extract injection, the injection cervus and cucumis polypeptide is because of being aseptic freeze-dried injectable powder, micromolecule polypeptide class material is difficult for taking place polymerization, can long preservation, and adverse reaction rate is greatly reduced, and curative effect is constant, and the raising of medicine inherent quality more helps promoting the use of of this medicament, for doctor and patient provide more selection, this product is to rheumatism, rheumatoid arthritis, osteoarthritis, lumbago and skelalgia, diseases such as trauma fracture reparation have curative effect preferably.
3. this product contains multiple free amino acid, is the synthetic BMP of osteocyte
s, bone source property biotic factors such as TGF-β, FGF supply raw materials, and promote the synthetic of bone source property biotic factor, organic calcium, phosphonium ion can participate in alcium and phosphor metabolization, keep bone volume.
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:
Cervus and cucumis polypeptide for injection and its prepration technology, its composition comprises: polypeptides matter and excipient, described polypeptides matter is to extract to form from animal in deer family skeleton and cucurbitaceous plant muskmelon seeds, its parts by weight are polypeptides matter 5, excipient 20, the molecular weight of polypeptides matter is 3000 dalton, and pH value is 3.5, with biuret reaction solution displaing amaranth, character is off-white color block or amorphous powder, and is soluble in water.Its preparation technology is: get Os Cervi bone 17500 by weight, the water for injection that adds 3 times of amounts, merge extractive liquid, is extracted in 80 ℃ of hot pressing 2 times, adjust pH to 3.5, remove sediment, supernatant is transferred alkaline pH value to 8.5, removes sediment, after supernatant is transferred pH neutral, use the ultrafilter membrane ultrafiltration, molecular cut off is 3000 dalton relatively, and it is standby to make the Os Cervi extracting solution; Get Semen Melo 3000 by weight, add the water for injection of 3 times of amounts, 80 ℃ of hot pressing are extracted 2 times, and merge extractive liquid, removes sediment, ultrafiltration, and molecular cut off is 3000 dalton relatively, it is standby to make the Semen Melo extracting solution; Above-mentioned described Os Cervi extracting solution and Semen Melo extracting solution are pressed 1: 1 mixed, make the cervus and cucumis polypeptide solution for standby; Get excipient by above-mentioned described parts by weight, add the injection water and make its solution concentration reach 20%, add 0.01% active carbon, filter, take off charcoal, it is standby to make the apyrogeneity excipient; Get cervus and cucumis polypeptide solution and excipient and, goods are refrigerated to-50 ℃, and make condenser temperature be cooled to-50 ℃ by the preparation of above-mentioned described parts by weight, the beginning 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 ℃, continues dry, up to up to specification, make off-white color block or amorphous powder.Its packing specification has 2.5mg, 5.0mg, 10mg, 20mg, 50mg, 100mg, this product 8mg is dissolved intramuscular injection with the 4ml sterilized water for injection, 1 time on the one, this product 16mg is dissolved in 250ml, 0.9% sodium chloride injection, vein slowly instils, 1 time on the one, 15 days is a course of treatment.
Embodiment 2:
Cervus and cucumis polypeptide for injection and its prepration technology, its composition comprises: polypeptides matter and excipient, described polypeptides matter is to extract to form from animal in deer family skeleton and cucurbitaceous plant muskmelon seeds, its parts by weight are polypeptides matter 100, excipient 90, the molecular weight of polypeptides matter is 10000 dalton, and pH value is 9.0, with biuret reaction solution displaing amaranth, character is off-white color block or amorphous powder, and is soluble in water.Its preparation technology is: get Os Cervi bone 63000 by weight, the water for injection that adds 8 times of amounts, merge extractive liquid, is extracted in 120 ℃ of hot pressing 4 times, adjust pH to 4.5, remove sediment, supernatant is transferred alkaline pH value to 9.0, removes sediment, after supernatant is transferred pH neutral, use the ultrafilter membrane ultrafiltration, molecular cut off is 10000 dalton relatively, and it is standby to make the Os Cervi extracting solution; Get Semen Melo 10000 by weight, add the water for injection of 8 times of amounts, 120 ℃ of hot pressing are extracted 4 times, and merge extractive liquid, removes sediment, ultrafiltration, and molecular cut off is 10000 dalton relatively, it is standby to make the Semen Melo extracting solution; Above-mentioned described Os Cervi extracting solution and Semen Melo extracting solution are pressed 10: 1 mixed, make the cervus and cucumis polypeptide solution for standby; Get excipient by above-mentioned described parts by weight, add the injection water and make its solution concentration reach 90%, add 5% active carbon, filter, take off charcoal, it is standby to make the apyrogeneity excipient; Get cervus and cucumis polypeptide solution and excipient and, goods are refrigerated to-20 ℃, and make condenser temperature be cooled to-20 ℃ by the preparation of above-mentioned described parts by weight, the beginning evacuation, make 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 ℃, continues dry, up to up to specification, make off-white color block or amorphous powder.Its packing specification has 2.5mg, 5.0mg, 10mg, 20mg, 50mg, 100mg, this product 8mg is dissolved intramuscular injection with the 4ml sterilized water for injection, 2 times on the one, this product 24mg is dissolved in 250ml, 0.9% sodium chloride injection, vein slowly instils, 1 time on the one, 15 days is a course of treatment.
Embodiment 3:
Cervus and cucumis polypeptide for injection and its prepration technology, its composition comprises: polypeptides matter and excipient, described polypeptides matter is to extract to form from animal in deer family skeleton and cucurbitaceous plant muskmelon seeds, its parts by weight are polypeptides matter 50, excipient 70, the molecular weight of polypeptides matter is 5000 dalton, and pH value is 5.0, with biuret reaction solution displaing amaranth, character is off-white color block or amorphous powder, and is soluble in water.Its preparation technology is: get Os Cervi bone 43000 by weight, the water for injection that adds 6 times of amounts, merge extractive liquid, is extracted in 100 ℃ of hot pressing 3 times, adjust pH to 4.0, remove sediment, supernatant is transferred alkaline pH value to 8.6, removes sediment, after supernatant is transferred pH neutral, use the ultrafilter membrane ultrafiltration, molecular cut off is 5000 dalton relatively, and it is standby to make the Os Cervi extracting solution; Get Semen Melo 5000 by weight, add the water for injection of 6 times of amounts, 100 ℃ of hot pressing are extracted 3 times, and merge extractive liquid, removes sediment, ultrafiltration, and molecular cut off is 5000 dalton relatively, it is standby to make the Semen Melo extracting solution; Above-mentioned described Os Cervi extracting solution and Semen Melo extracting solution are pressed 3: 1 mixed, make the cervus and cucumis polypeptide solution for standby; Get excipient by above-mentioned described parts by weight, add the injection water and make its solution concentration reach 60%, add 3% active carbon, filter, take off charcoal, it is standby to make the apyrogeneity excipient; Get cervus and cucumis polypeptide solution and excipient and, goods are refrigerated to-30 ℃, and make condenser temperature be cooled to-30 ℃ by the preparation of above-mentioned described parts by weight, the beginning evacuation, make 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 ℃, continues dry, up to up to specification, make off-white color block or amorphous powder.Its packing specification has 2.5mg, 5.0mg, 10mg, 20mg, 50mg, 100mg, this product 8mg is dissolved intramuscular injection with the 4ml sterilized water for injection, 1～2 time on the one, this product 20mg is dissolved in 250ml, 0.9% sodium chloride injection, vein slowly instils, 1 time on the one, 15 days is a course of treatment.
Embodiment 4:
Above-mentioned injection cervus and cucumis polypeptide, described excipient can be mannitol, Polyethylene Glycol, glucosan, lactose, glycine and colloidal substance.
Embodiment 5:
Cervus and cucumis polypeptide for injection and its prepration technology, its composition comprises: polypeptides matter and excipient, described polypeptides matter is to extract to form from animal in deer family skeleton and cucurbitaceous plant muskmelon seeds, its parts by weight are polypeptides matter 5, mannitol 20, the molecular weight of polypeptides matter is 3000 dalton, and pH value is 3.5, with biuret reaction solution displaing amaranth, character is off-white color block or amorphous powder, and is soluble in water.Its preparation technology is: get Os Cervi bone 17500 by weight, be broken into fritter, add the purified water of 3 times of amounts, extract 2 times 105 ℃ of hot pressing, merge extracted twice liquid, extracting solution 1MHCl solution adjust pH to 4.0, centrifugal, get supernatant, supernatant is with 1MNaOH solution adjust pH to 8.5, and is centrifugal, get supernatant, adjust pH to 7.1, the 8K membrane ultrafiltration, it is standby to make the Os Cervi extracting solution; Get Semen Melo 3000 by weight, after rinsing well with drinking water, pulverize, add the purified water of 3 times of amounts, extract 2 times, merge extracted twice liquid 105 ℃ of hot pressing, centrifugal, get supernatant, the 8K membrane ultrafiltration, it is standby to make the Semen Melo extracting solution; Above-mentioned described Os Cervi extracting solution and Semen Melo extracting solution are pressed 3: 1 mixed, make the cervus and cucumis polypeptide solution for standby; Get mannitol by above-mentioned described parts by weight, add the injection water and make its solution concentration reach 50%, add 0.3% injection-use activated carbon, sucking filtration takes off charcoal, and it is standby to make the mannitol sterile solution; Get cervus and cucumis polypeptide solution and mannitol and, goods are refrigerated to-50 ℃, and make condenser temperature be cooled to-50 ℃ by the preparation of above-mentioned described parts by weight, the beginning evacuation makes drying baker vacuum reach 10Pa, 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, up to up to specification, the total head plug, roll lid, the injection cervus and cucumis polypeptide is made in visual inspection.Its packing specification has 2.5mg, 5.0mg, 10mg, 20mg, 50mg, 100mg, this product 8mg is dissolved intramuscular injection with the 4ml sterilized water for injection, 1 time on the one, this product 16mg is dissolved in 250ml, 0.9% sodium chloride injection, vein slowly instils, 1 time on the one, 15 days is a course of treatment.
Embodiment 6:
Cervus and cucumis polypeptide for injection and its prepration technology, its composition comprises: polypeptides matter and excipient, described polypeptides matter is to extract to form from animal in deer family skeleton and cucurbitaceous plant muskmelon seeds, its parts by weight are polypeptides matter 100, mannitol 90, the molecular weight of polypeptides matter is 10000 dalton, and pH value is 9.0, with biuret reaction solution displaing amaranth, character is off-white color block or amorphous powder, and is soluble in water.Its preparation technology is: get Os Cervi bone 63000 by weight, be broken into fritter, add the purified water of 8 times of amounts, extract 2 times 105 ℃ of hot pressing, merge extracted twice liquid, extracting solution 1MHCl solution adjust pH to 4.0, centrifugal, get supernatant, supernatant is with 1MNaOH solution adjust pH to 8.5, and is centrifugal, get supernatant, adjust pH to 7.1, the 8K membrane ultrafiltration, it is standby to make the Os Cervi extracting solution; Get Semen Melo 10000 by weight, after rinsing well with drinking water, pulverize, add the purified water of 8 times of amounts, extract 2 times, merge extracted twice liquid 105 ℃ of hot pressing, centrifugal, get supernatant, the 8K membrane ultrafiltration, it is standby to make the Semen Melo extracting solution; Above-mentioned described Os Cervi extracting solution and Semen Melo extracting solution are pressed 3: 1 mixed, make the cervus and cucumis polypeptide solution for standby; Get mannitol by above-mentioned described parts by weight, add the injection water and make its solution concentration reach 50%, add 0.3% injection-use activated carbon, sucking filtration takes off charcoal, and it is standby to make the mannitol sterile solution; Get cervus and cucumis polypeptide solution and mannitol and, goods are refrigerated to-20 ℃, and make condenser temperature be cooled to-20 ℃ by the preparation of above-mentioned described parts by weight, the beginning evacuation makes drying baker vacuum reach 20Pa, 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, up to up to specification, the total head plug, roll lid, the injection cervus and cucumis polypeptide is made in visual inspection.Its packing specification has 2.5mg, 5.0mg, 10mg, 20mg, 50mg, 100mg, this product 8mg is dissolved intramuscular injection with the 4ml sterilized water for injection, 2 times on the one, this product 24mg is dissolved in 250ml, 0.9% sodium chloride injection, vein slowly instils, 1 time on the one, 15 days is a course of treatment.
Embodiment 7:
Cervus and cucumis polypeptide for injection and its prepration technology, its composition comprises: polypeptides matter and excipient, described polypeptides matter is to extract to form from animal in deer family skeleton and cucurbitaceous plant muskmelon seeds, its parts by weight are polypeptides matter 50, mannitol 60, the molecular weight of polypeptides matter is 5000 dalton, and pH value is 5.0, with biuret reaction solution displaing amaranth, character is off-white color block or amorphous powder, and is soluble in water.Its preparation technology is: get Os Cervi bone 53000 by weight, be broken into fritter, add the purified water of 6 times of amounts, extract 2 times 105 ℃ of hot pressing, merge extracted twice liquid, extracting solution 1MHCl solution adjust pH to 4.0, centrifugal, get supernatant, supernatant is with 1MNaOH solution adjust pH to 8.5, and is centrifugal, get supernatant, adjust pH to 7.1, the 8K membrane ultrafiltration, it is standby to make the Os Cervi extracting solution; Get Semen Melo 5000 by weight, after rinsing well with drinking water, pulverize, add the purified water of 6 times of amounts, extract 2 times, merge extracted twice liquid 105 ℃ of hot pressing, centrifugal, get supernatant, the 8K membrane ultrafiltration, it is standby to make the Semen Melo extracting solution; Above-mentioned described Os Cervi extracting solution and Semen Melo extracting solution are pressed 3: 1 mixed, make the cervus and cucumis polypeptide solution for standby; Get mannitol by above-mentioned described parts by weight, add the injection water and make its solution concentration reach 50%, add 0.3% injection-use activated carbon, sucking filtration takes off charcoal, and it is standby to make the mannitol sterile solution; Get cervus and cucumis polypeptide solution and mannitol and, goods are refrigerated to-30 ℃, and make condenser temperature be cooled to-30 ℃ by the preparation of above-mentioned described parts by weight, the beginning evacuation makes drying baker vacuum reach 15Pa, 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, up to up to specification, the total head plug, roll lid, the injection cervus and cucumis polypeptide is made in visual inspection.Its packing specification has 2.5mg, 5.0mg, 10mg, 20mg, 50mg, 100mg, this product 8mg is dissolved intramuscular injection with the 4ml sterilized water for injection, 2 times on the one, this product 20mg is dissolved in 250ml, 0.9% sodium chloride injection, vein slowly instils, 1 time on the one, 15 days is a course of treatment.
Claims (6)
1. injection cervus and cucumis polypeptide, its composition comprises: polypeptides matter and excipient, it is characterized in that: described polypeptides matter is to extract to form from animal in deer family skeleton and cucurbitaceous plant muskmelon seeds, its parts by weight are polypeptides matter 5～100, excipient 20～90, the molecular weight of polypeptides matter is 3000～10000 dalton, and pH value is 3.5～9.0, with biuret reaction solution displaing amaranth, character is off-white color block or amorphous powder, and is soluble in water.
2. injection cervus and cucumis polypeptide according to claim 1 is characterized in that: described excipient can be mannitol, Polyethylene Glycol, glucosan, lactose, glycine and colloidal substance.
3. the preparation technology of an injection cervus and cucumis polypeptide according to claim 1, it is characterized in that: get cervus and cucumis polypeptide solution and excipient and by above-mentioned described parts by weight preparation, get Os Cervi bone 17500～63000, the water for injection that adds 3～8 times of amounts, hot pressing is extracted, the extracting solution adjust pH to alkalescence, is obtained the Os Cervi extracting solution after the filtration; Get Semen Melo 3000～10000 by weight, add behind the water hot pressing and extract, and filter and obtain the Semen Melo extracting solution; Above-mentioned described Os Cervi extracting solution and Semen Melo extracting solution are pressed 1～10: 1 mixed, make cervus and cucumis polypeptide solution, add the excipient aqueous solution, its parts by weight are polypeptides matter 5～100, excipient 20～90, utilize freeze drying process that described cervus and cucumis polypeptide solution is made lyophilized injectable powder.
4. the preparation technology of injection cervus and cucumis polypeptide according to claim 3, it is characterized in that: the preparation technology of described cervus and cucumis polypeptide solution is: get Os Cervi bone 17500～63000 by weight, the water for injection that adds 3～8 times of amounts, 80 ℃～120 ℃ hot pressing are extracted 2～4 times, merge extractive liquid,, adjust pH to 3.5～4.5, remove sediment, supernatant is transferred alkaline pH value to 8.5～9.0, remove sediment, supernatant is used the ultrafilter membrane ultrafiltration after transferring pH neutral, molecular cut off is 3000～10000 dalton relatively, and it is standby to make the Os Cervi extracting solution; Get Semen Melo 3000～10000 by weight, add the water for injection of 3～8 times of amounts, 80 ℃～120 ℃ hot pressing are extracted 2～4 times, and merge extractive liquid, removes sediment, ultrafiltration, and molecular cut off is 3000～10000 dalton relatively, it is standby to make the Semen Melo extracting solution; Above-mentioned described Os Cervi extracting solution and Semen Melo extracting solution are pressed 1～10: 1 mixed, make cervus and cucumis polypeptide solution.
5. the preparation technology of injection cervus and cucumis polypeptide according to claim 3, it is characterized in that: the preparation technology of described excipient aqueous solution is: get excipient by above-mentioned described parts by weight, adding the injection water makes its solution concentration reach 20%～90%, add 0.01%～5% active carbon, filter, take off charcoal, make apyrogeneity excipient aqueous solution.
6. the preparation technology of injection cervus and cucumis polypeptide according to claim 3, it is characterized in that: described freeze drying process is: goods are refrigerated to-50 ℃～-20 ℃, and make condenser temperature be cooled to-50 ℃～-20 ℃, the beginning 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, up to up to specification.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2004100136027A CN100352496C (en) | 2004-03-04 | 2004-03-04 | Lugua polypeptides for injection and its preparing process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100136027A CN100352496C (en) | 2004-03-04 | 2004-03-04 | Lugua polypeptides for injection and its preparing process |
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| Publication Number | Publication Date |
|---|---|
| CN1579542A true CN1579542A (en) | 2005-02-16 |
| CN100352496C CN100352496C (en) | 2007-12-05 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100363019C (en) * | 2005-10-09 | 2008-01-23 | 黑龙江迪龙制药有限公司 | Cervus and cucumis polypeptide injection composition and preparing method |
| CN100382842C (en) * | 2006-05-31 | 2008-04-23 | 哈尔滨吉尔生物科技有限公司 | Orally administered cervus and cucumis polypeptide composition and preparation method thereof |
| CN103040910A (en) * | 2012-12-17 | 2013-04-17 | 海南百思特医药科技有限公司 | Cervus and cucumis polypeptide liposome injection |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1207022C (en) * | 2002-07-26 | 2005-06-22 | 哈尔滨誉衡药业有限公司 | Medicinal composition for promoting bone-fracture healing and bone-joint injure repairing |
-
2004
- 2004-03-04 CN CNB2004100136027A patent/CN100352496C/en not_active Expired - Lifetime
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100363019C (en) * | 2005-10-09 | 2008-01-23 | 黑龙江迪龙制药有限公司 | Cervus and cucumis polypeptide injection composition and preparing method |
| CN100382842C (en) * | 2006-05-31 | 2008-04-23 | 哈尔滨吉尔生物科技有限公司 | Orally administered cervus and cucumis polypeptide composition and preparation method thereof |
| CN103040910A (en) * | 2012-12-17 | 2013-04-17 | 海南百思特医药科技有限公司 | Cervus and cucumis polypeptide liposome injection |
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| Publication number | Publication date |
|---|---|
| CN100352496C (en) | 2007-12-05 |
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