CN108606955A - The Pharmaceutical composition and preparation method thereof of trainingization Xihai sea horse peptide - Google Patents
The Pharmaceutical composition and preparation method thereof of trainingization Xihai sea horse peptide Download PDFInfo
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- CN108606955A CN108606955A CN201611126981.XA CN201611126981A CN108606955A CN 108606955 A CN108606955 A CN 108606955A CN 201611126981 A CN201611126981 A CN 201611126981A CN 108606955 A CN108606955 A CN 108606955A
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- Prior art keywords
- trainingization
- sea horse
- xihai sea
- horse peptide
- xihai
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
- A61K38/1816—Erythropoietin [EPO]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
Abstract
The invention discloses the Pharmaceutical compositions and preparation method thereof of trainingization Xihai sea horse peptide, more particularly to a kind of using trainingization Xihai sea horse peptide as the pharmaceutical composition of active constituent, including active constituent and pharmaceutically acceptable pharmaceutic adjuvant, the auxiliary material is selected from excipient and pH adjusting agent, optionally includes isotonic regulator.Pharmaceutical composition provided by the invention is better than existing preparation without adding stabilizer, stability.
Description
Technical field
The invention belongs to field of medicine preparations, more particularly, to the preparation side of a kind of trainingization Xihai sea horse peptide formulations and its preparation
Method.
Background technology
The chemical constitution of trainingization Xihai sea horse peptide is：
Chinese chemical name：{ 2 '-acetyl [the ε "-amido-(acetyl-glycyl-glycyl-L- threonyl-L- network ammonia of N, N- bis-
Acyl-L- seryl-L- cysteinyl-L- histidyl--L- benzos aminoacyl-glycyl-L- alanyl-L- leucyl-L- threonyls-
L- tryptophanyl-L- valyl-L- cysteinyl-L- arginyls-L- prolyls-L-Glutamine acyl-L- argininyl-glycyls-
β-alanyl -6 → 15 disulphide of L-lysine ring)] } -3- polyethylene glycol ammonia propionamides
Trainingization Xihai sea horse peptide is polyethyleneglycol modified Erythropoietin mimetic peptide derivative, and wherein EPO is acted on
Myeloid element stimulates the differentiation of mitosis and erythrocyte precursor cell, promotes erythron stem cell proliferation, differentiation,
It is final ripe for endocrine hormone.Since EPO is required in erythrocyte forming process, it can promote red blood cell proliferation,
Hemoglobin (Hb) total amount of body is improved, improves body oxygen carrying capacity, so the hormone is in diagnosing and treating RBC acceptor garland rate
It has a wide range of applications in the hematologic disease of insufficient or red blood cell generation defect.In addition, it can also be used to preoperative self
Recovery, myelodysplastic syndrome anaemia, the dresbach's syndrome of hemoglobinopathy and the β-of blood transfusion and hand postoperative anemia
Anaemia, spinal cord injury, renal anemia, aplastic caused by thalassemia, anemia of prematurity, chronic inflammation or infection are poor
Blood etc..
Trainingization Xihai sea horse peptide is easy degradation under illumination, high humidity and oxidizing condition, is easy under the conditions of peracid, alkali excessively
Degradation, the above problem perplex application of the trainingization Xihai sea horse peptide in pharmacy.Patent CN 201210245744.0 is disclosed to moor
Luo Shamu 188, L-arginine, mannitol, potassium dihydrogen phosphate etc. are auxiliary material preparation trainingization Xihai sea horse peptide injection, but said preparation
Including various ingredients, are not suitable for injection application, therefore the training Xihai sea that a kind of prescription is simple and stability is good is badly in need of in this field
Horse peptide ejection preparation.
Invention content
It is an object of the present invention to can provide the training Xihai sea horse peptide system that a kind of component is simple and stability is good
Agent so that applied well on medicament.
To achieve the above object, the present invention uses following scheme：
A kind of trainingization Xihai sea horse peptide formulations, including active constituent and auxiliary material, the active constituent are trainingization Xihai sea horse peptide,
The auxiliary material includes excipient and pH adjusting agent.
Trainingization Xihai sea horse peptide formulations according to the present invention, the excipient be selected from mannitol, lactose, sorbierite, xylitol,
One or more, or the one or two selected from mannitol or lactose of glucose or dextran.
Trainingization Xihai sea horse peptide formulations according to the present invention, the pH adjusting agent are selected from acetic acid, hydrochloric acid, citric acid, phosphoric acid, wine
Stone acid, citric acid, glutamic acid, histidine, sodium hydroxide and/or its buffer salt, such as acetic acid/acetate, phosphate or phosphoric acid
Salt/alkali metal hydroxide, the phosphate are further selected from dihydric phosphate, phosphoric acid hydrogen disalt, alkali metal be selected from lithium, sodium or
Potassium.Such as acetic acid/acetate, dihydric phosphate, phosphoric acid hydrogen disalt or alkali metal hydroxide it is one or more, further such as
In acetic acid/sodium acetate, sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, sodium hydroxide or potassium hydroxide
It is one or more.
Trainingization Xihai sea horse peptide formulations according to the present invention, the isotonic regulator are selected from sodium chloride, glycerine or polyethylene glycol.
Trainingization Xihai sea horse peptide formulations according to the present invention, the trainingization Xihai sea horse peptide formulations finished product are lyophilized preparation, are frozen
The moisture of dry preparation is≤3%, or is 0.5%~3%, furthermore is 0.8%~2.5%, does not include process for preparation and filling
Etc. other nonterminal processes.
Trainingization Xihai sea horse peptide formulations according to the present invention adjust trainingization Xihai sea horse peptide system in process for preparation by pH adjusting agent
The pH of agent is in the range of 3.0~7.0, or in the range of 5.0~7.0.
The weight ratio of trainingization Xihai sea horse peptide formulations according to the present invention, the trainingization Xihai sea horse peptide and excipient is 1:2~
20, or can be 1:2.5~10, furthermore can be 1:2.5~5.
Trainingization Xihai sea horse peptide formulations according to the present invention, the preparation is lyophilized preparation, and the moisture of lyophilized preparation is
0.8%~2.5%.Including trainingization Xihai sea horse peptide, mannitol and pH adjusting agent, by pH adjusting agent adjust pH to 5.0~
7.0, the pH adjusting agent is one or more in acetic acid, sodium acetate, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium hydroxide, training
Change the weight ratio 1 of Xihai sea horse peptide and excipient:2.5 or 1:3.75 or 1:5 or 1:10, wherein excipient is mannitol or breast
Sugar.
Trainingization Xihai sea horse peptide formulations according to the present invention, the preparation be lyophilized preparation, and the moisture of lyophilized preparation be≤
3%, including trainingization Xihai sea horse peptide, excipient and pH adjusting agent, pH to 3.0~7.0 is adjusted by pH adjusting agent, preferably 5.0~
7.0, the pH adjusting agent is acetic acid/acetate, phosphate or phosphate/alkali metal hydroxide, and the phosphate is further
Selected from dihydric phosphate, phosphoric acid hydrogen disalt, alkali metal hydroxide is selected from sodium hydroxide, potassium hydroxide, trainingization Xihai sea horse peptide with
The weight percent of excipient is as follows：
Trainingization Xihai sea horse peptide：5%~35%
Excipient：65%~95%.
Trainingization Xihai sea horse peptide formulations according to the present invention, the preparation is lyophilized preparation, and the moisture of lyophilized preparation is
0.8%~2.5%.Including trainingization Xihai sea horse peptide, mannitol and pH adjusting agent, by pH adjusting agent adjust pH to 5.0~
7.0, the pH adjusting agent is one or more in acetic acid, sodium acetate, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium hydroxide, training
The weight percent for changing Xihai sea horse peptide and excipient is as follows：
Trainingization Xihai sea horse peptide：15%~30%
Mannitol：70%~85%.
Trainingization Xihai sea horse peptide formulations according to the present invention, the preparation is lyophilized preparation, and the moisture of lyophilized preparation is
0.8%~2.5%.Including trainingization Xihai sea horse peptide, lactose and pH adjusting agent, pH 5.0~7.0 is adjusted by pH adjusting agent,
The pH adjusting agent is one or more in acetic acid, sodium acetate, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium hydroxide, trainingization west
The weight percent of hippocampus peptide and excipient is as follows：
Trainingization Xihai sea horse peptide：15%~30%
Lactose：70%~85%.
The second object of the present invention is to provide a kind of preparation method of trainingization Xihai sea horse peptide formulations.The technical solution of use
It is as follows：
A the excipient for) weighing recipe quantity, is dissolved in water for injection, and active component trainingization Xihai sea horse peptide is added, and dissolving is mixed
It is even；
B pH adjusting agent pH value, constant volume) are used；
C) filtering, filling, freeze-drying are to get to trainingization Xihai sea horse peptide formulations.
Specifically, include the following steps：
A excipient) is weighed according to formula, is dissolved in sterile water for injection, after ultrafiltration goes out pyrogen removal, is added by formula
Active component dissolves mixing；
B) pH is reconciled to 3~7 with pH adjusting agent, 5~7 is preferably adjusted to, is settled to prescribed volume；
C it) dispenses after PVDF is filtered, is aseptically freeze-dried, pre-freeze 2-5 is small at -30 DEG C to -70 DEG C
When, then carry out vacuum freezedrying；Primary drying is 10-30 hours dry at 0 DEG C to 10 DEG C, and redrying is at 25 DEG C to 35 DEG C
Dry 2-15 hours, holding stage was 2-10 hours dry at 30 DEG C to 35 DEG C, make dried frozen aquatic products moisture reach requirement≤3% to get
To trainingization Xihai sea horse peptide formulations.
The lyophilized technique of trainingization Xihai sea horse peptide preparation process according to the present invention, the freeze-drying are at -30 DEG C to -50
Pre-freeze 2-5 hours at DEG C, primary drying is 10-30 hours dry at 0 DEG C to 10 DEG C, and redrying is in 25 DEG C to 35 DEG C dry 5-15
Hour, holding stage is 2-10 hours dry at 30 DEG C to 35 DEG C.
Trainingization Xihai sea horse peptide preparation process according to the present invention, the freeze-drying are small in -30 DEG C to -40 DEG C pre-freeze 3-5
When, the primary drying time is 15-25 hours dry at 5 ± 2 DEG C, and redrying is 10-15 hours dry at 25 ± 2 DEG C, holding stage
It is 5-8 hours dry at 30 ± 2 DEG C.
The present invention determines the study found that by prescription screening using mannitol or lactose as excipient, by further excellent
Change, without adding stabilizer, you can greatly improve the stability of trainingization Xihai sea horse peptide formulations, under the same conditions the drug effect phase obtain
Greatly extend.
Trainingization Xihai sea horse peptide formulations according to the present invention, the training Xihai sea horse peptide formulations are red thin for treating in preparation
Purposes in the drug for the hematologic disease that born of the same parents' generation is insufficient or red blood cell generates defect, such as myelodysplastic syndrome are poor
It is poor caused by blood, the dresbach's syndrome of hemoglobinopathy and β-thalassemia, anemia of prematurity, chronic inflammation or infection
Blood, spinal cord injury, renal anemia or alpastic anemia.
Specific implementation mode
Embodiment 1：
Lactose 15g is weighed, is dissolved in sterile water for injection, after ultrafiltration goes out pyrogen removal, the raw material of 4g is added by formula
Medicine dissolves mixing, pH value is adjusted to 4.0 with acetic acid and sodium acetate, is settled to 1000ml. and is filtered through 0.22 micron of PVDF, is pressed
Every bottle of 4mg bulk pharmaceutical chemicals are sub-packed in vial, are aseptically freeze-dried,
Then freeze-drying was freeze-dried in -36 DEG C of pre-freezes 5 hours；The primary drying time, drying 20 was small at 5 DEG C
When, redrying is 10 hours dry at 25 DEG C, and holding stage is 5 hours dry at 30 DEG C.
Embodiment 2：
Lactose 10g is weighed, is dissolved in sterile water for injection, after ultrafiltration goes out pyrogen removal, the raw material of 4g is added by formula
Medicine dissolves mixing, pH value is adjusted to 5.0 with acetic acid and sodium acetate, is settled to 1000ml. and is filtered through 0.22 micron of PVDF, is pressed
Every bottle of 4mg bulk pharmaceutical chemicals are sub-packed in vial, are aseptically freeze-dried,
Then freeze-drying was freeze-dried in -40 DEG C of pre-freezes 5 hours；The primary drying time, drying 25 was small at 5 DEG C
When, redrying is 10 hours dry at 25 DEG C, and holding stage is 5 hours dry at 30 DEG C.
Embodiment 3：
Lactose 15g is weighed, is dissolved in sterile water for injection, after ultrafiltration goes out pyrogen removal, 4mg raw materials are added by formula
Medicine dissolves mixing, pH value is adjusted to 5.0 with sodium dihydrogen phosphate and sodium hydroxide, is settled to 1000ml. through 0.22 micron of PVDF
Filtering, is sub-packed in vial by every bottle of 4mg bulk pharmaceutical chemicals, is aseptically freeze-dried,
Then freeze-drying was freeze-dried in -36 DEG C of pre-freezes 3 hours；The primary drying time, drying 20 was small at 5 DEG C
When, redrying is dried 10 hours at 25 DEG C, and holding stage dries 5 hours at 30 DEG C to get injection trainingization Xihai sea horse peptide.
Embodiment 4：
Mannitol 15g is weighed, is dissolved in sterile water for injection, after ultrafiltration goes out pyrogen removal, 4mg raw materials are added by formula
Medicine dissolves mixing, pH value is adjusted to 5.0 with sodium dihydrogen phosphate and sodium hydroxide, is settled to 1000ml. through 0.22 micron of PVDF
Filtering, is sub-packed in vial by every bottle of 4mg bulk pharmaceutical chemicals, is aseptically freeze-dried,
Then freeze-drying was freeze-dried in -36 DEG C of pre-freezes 5 hours；The primary drying time, drying 20 was small at 5 DEG C
When, redrying is dried 10 hours at 25 DEG C, and holding stage dries 5 hours at 30 DEG C to get injection trainingization Xihai sea horse peptide.
Embodiment 5：
Mannitol 15g is weighed, is dissolved in sterile water for injection, after ultrafiltration goes out pyrogen removal, the original of 20g is added by formula
Expect medicine, dissolves mixing, pH value is adjusted to 6.0 with sodium dihydrogen phosphate and sodium hydroxide, is settled to 1000ml. through 0.22 micron
PVDF is filtered, and is sub-packed in vial by every bottle of 4mg bulk pharmaceutical chemicals, is aseptically freeze-dried,
Then freeze-drying was freeze-dried in -36 DEG C of pre-freezes 5 hours；The primary drying time, drying 20 was small at 5 DEG C
When, redrying is dried 15 hours at 25 DEG C, and holding stage dries 5 hours at 30 DEG C to get injection trainingization Xihai sea horse peptide.
Embodiment 6：
Lactose 15g is weighed, is dissolved in sterile water for injection, after ultrafiltration goes out pyrogen removal, is added by formula a certain amount of
Bulk pharmaceutical chemicals dissolve mixing, pH value are adjusted to 7.0 with disodium hydrogen phosphate and sodium hydroxide, is settled to 1000ml. through 0.22 micron
PVDF is filtered, and is sub-packed in vial by every bottle of 4mg bulk pharmaceutical chemicals, is aseptically freeze-dried,
Then freeze-drying was freeze-dried in -36 DEG C of pre-freezes 5 hours；The primary drying time, drying 20 was small at 5 DEG C
When, redrying is dried 10 hours at 25 DEG C, and holding stage dries 7 hours at 30 DEG C to get injection trainingization Xihai sea horse peptide.
Embodiment 7：
Mannitol 15g is weighed, is dissolved in sterile water for injection, after ultrafiltration goes out pyrogen removal, is added by formula a certain amount of
Bulk pharmaceutical chemicals, dissolve mixing, pH value is adjusted to 5.0 with sodium dihydrogen phosphate and sodium hydroxide, is settled to 1000ml. through 0.22 micron
PVDF filtering, be sub-packed in vial by every bottle of 4mg bulk pharmaceutical chemicals, be aseptically freeze-dried,
Then freeze-drying was freeze-dried in -20 DEG C of pre-freezes 5 hours；The primary drying time, drying 5 was small at -5 DEG C
When, redrying is dried 10 hours at 35 DEG C, and holding stage dries 5 hours at 30 DEG C to get injection trainingization Xihai sea horse peptide.
Embodiment 8
Mannitol 15g is weighed, is dissolved in sterile water for injection, after ultrafiltration goes out pyrogen removal, is added by formula a certain amount of
Bulk pharmaceutical chemicals, dissolve mixing, pH value is adjusted to 5.0 with sodium dihydrogen phosphate and sodium hydroxide, is settled to 1000ml. through 0.22 micron
PVDF filtering, be sub-packed in vial by every bottle of 4mg bulk pharmaceutical chemicals, be aseptically freeze-dried,
Then freeze-drying was freeze-dried in -36 DEG C of pre-freezes 5 hours；The primary drying time, drying 35 was small at 5 DEG C
When, redrying is dried 20 hours at 25 DEG C, and holding stage dries 5 hours at 30 DEG C to get injection trainingization Xihai sea horse peptide.
Embodiment 9：
Mannitol 40g is weighed, is dissolved in sterile water for injection, after ultrafiltration goes out pyrogen removal, 4mg raw materials are added by formula
Medicine dissolves mixing, pH value is adjusted to 5.0 with sodium dihydrogen phosphate and sodium hydroxide, is settled to 1000ml. through 0.22 micron of PVDF
Filtering, is sub-packed in vial by every bottle of 4mg bulk pharmaceutical chemicals, is aseptically freeze-dried,
Then freeze-drying was freeze-dried in -36 DEG C of pre-freezes 5 hours；The primary drying time, drying 20 was small at 5 DEG C
When, redrying is dried 10 hours at 25 DEG C, and holding stage dries 5 hours at 30 DEG C to get injection trainingization Xihai sea horse peptide.
Comparative example 1
Trainingization Xihai sea horse peptide injection is prepared according to the method for patent CN103536900 embodiments 1：
Trainingization Xihai sea horse peptide, 8g
PLURONICS F87,15g
L-arginine, 15g
Mannitol, 42g
Potassium dihydrogen phosphate, 20g.
Comparative example 2
Stabilizer L-arginine is removed, trainingization Xihai sea horse peptide note is prepared according to the method for patent CN103536900 embodiments 1
Penetrate liquid：
Trainingization Xihai sea horse peptide, 8g
PLURONICS F87,20g
Mannitol, 50g
Potassium dihydrogen phosphate, 20g.
Claims (12)
1. a kind of trainingization Xihai sea horse peptide formulations, including active constituent and pharmaceutically acceptable pharmaceutic adjuvant, the active constituent
For trainingization Xihai sea horse peptide, the auxiliary material is selected from excipient and pH adjusting agent, optionally includes isotonic regulator.
2. trainingization Xihai sea horse peptide formulations according to claim 1, which is characterized in that the excipient is selected from mannitol, breast
One or more, or one kind selected from mannitol or lactose or two of sugar, sorbierite, xylitol, glucose or dextran
Kind.
3. trainingization Xihai sea horse peptide formulations according to claim 2, which is characterized in that the pH adjusting agent is selected from acetic acid, salt
Acid, citric acid, phosphoric acid, tartaric acid, citric acid, glutamic acid, histidine, alkali metal hydroxide and/or its buffer salt, such as vinegar
Acid/acetate, phosphate or phosphate/alkali metal hydroxide, the phosphate are selected from dihydric phosphate, phosphoric acid hydrogen disalt,
Alkali metal is selected from lithium, sodium or potassium.
4. trainingization Xihai sea horse peptide formulations according to claim 1, which is characterized in that the isotonic regulator is selected from chlorination
Sodium, glycerine or polyethylene glycol.
5. according to claim 1-4 any one of them trainingizations Xihai sea horse peptide formulations, which is characterized in that the trainingization Xihai sea horse peptide
Preparation is lyophilized preparation, and the moisture of lyophilized preparation is≤3%, or is 0.5%~3%, furthermore is 0.8%~2.5%.
6. according to trainingization Xihai sea horse peptide formulations according to claim 5, which is characterized in that the trainingization Xihai sea horse peptide formulations
PH be 3.0~7.0, or be 5.0~7.0.
7. training Xihai sea horse peptide formulations according to claim 1 or 6, which is characterized in that the trainingization Xihai sea horse peptide and tax
The weight ratio of shape agent is 1:2~20, or can be 1:2.5~10, furthermore can be 1:2.5~5.
8. according to claim 1-7 any one of them trainingizations Xihai sea horse peptide formulations, which is characterized in that the trainingization Xihai sea horse peptide
Weight percent with excipient is：
Trainingization Xihai sea horse peptide：5%~35%
Excipient：65%~95%,
Or it is
Trainingization Xihai sea horse peptide：15%~30%
Excipient：70%~85%.
9. a kind of method preparing trainingization Xihai sea horse peptide formulations, includes the following steps：
A the excipient for) weighing recipe quantity, is dissolved in water for injection, and active component trainingization Xihai sea horse peptide is added, dissolves mixing；
B pH adjusting agent pH value, constant volume) are used；
C) filtering, filling, freeze-drying are to get to trainingization Xihai sea horse peptide formulations.
10. according to the preparation method of trainingization Xihai sea horse peptide formulations according to claim 9, which is characterized in that the freezing is dry
Dry lyophilized technique is pre-freeze 2-5 hours at -30 DEG C to -70 DEG C, and primary drying is 10-30 hours dry at 0 DEG C to 10 DEG C, two
Secondary drying is 2-15 hours dry at 25 DEG C to 35 DEG C, and holding stage is 2-10 hours dry at 30 DEG C to 35 DEG C.
11. the preparation method of trainingization Xihai sea horse peptide formulations according to claim 9, which is characterized in that the freeze-drying
Lyophilized technique is pre-freeze 2-5 hours at -30 DEG C to -50 DEG C, and primary drying is 10-30 hours dry at 0 DEG C to 10 DEG C, secondary dry
Dry 5-15 hours dry at 25 DEG C to 35 DEG C, holding stage is 2-10 hours dry at 30 DEG C to 35 DEG C, or freeze-drying is -30
DEG C to -40 DEG C of pre-freezes 3-5 hours, the primary drying time is 15-25 hours dry at 5 ± 2 DEG C, and redrying is in 25 ± 2 DEG C of dryings
10-15 hours, holding stage was 5-8 hours dry at 30 ± 2 DEG C.
12. the training Xihai sea horse peptide formulations according to claim 1-11 any one are being prepared for treating RBC acceptor garland rate
Insufficient or red blood cell generates the purposes in the drug of the hematologic disease of defect, such as myelodysplastic syndrome anaemia, blood red
Anaemia, spinal cord caused by the dresbach's syndrome and β-thalassemia of albumen disease, anemia of prematurity, chronic inflammation or infection
Damage, renal anemia or alpastic anemia.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019129278A1 (en) * | 2017-12-29 | 2019-07-04 | 江苏豪森药业集团有限公司 | Pharmaceutical composition of pegol-sihematide and preparation method therefor |
| CN110732020A (en) * | 2019-11-25 | 2020-01-31 | 江苏豪森药业集团有限公司 | Stable pharmaceutical formulation containing polyethylene glycol loxapine |
| CN114601916A (en) * | 2022-04-12 | 2022-06-10 | 江苏豪森药业集团有限公司 | Pedized hippocampus japonicus peptide injection preparation and preparation method thereof |
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| WO2019129278A1 (en) * | 2017-12-29 | 2019-07-04 | 江苏豪森药业集团有限公司 | Pharmaceutical composition of pegol-sihematide and preparation method therefor |
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| CN110214019B (en) * | 2017-12-29 | 2021-07-30 | 江苏豪森药业集团有限公司 | Pharmaceutical composition for cultivating hippocampus japonicus peptide and preparation method thereof |
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| CN110732020B (en) * | 2019-11-25 | 2023-10-03 | 江苏豪森药业集团有限公司 | Stable pharmaceutical formulation containing polyethylene glycol lozenges |
| CN114601916A (en) * | 2022-04-12 | 2022-06-10 | 江苏豪森药业集团有限公司 | Pedized hippocampus japonicus peptide injection preparation and preparation method thereof |
| CN114601916B (en) * | 2022-04-12 | 2024-04-16 | 江苏豪森药业集团有限公司 | Pegylated hippocampus peptide injection and preparation method thereof |
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