CN107823626A - A kind of preparation method of compound cerebroprotin hydrolysate piece - Google Patents
A kind of preparation method of compound cerebroprotin hydrolysate piece Download PDFInfo
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- CN107823626A CN107823626A CN201711256003.1A CN201711256003A CN107823626A CN 107823626 A CN107823626 A CN 107823626A CN 201711256003 A CN201711256003 A CN 201711256003A CN 107823626 A CN107823626 A CN 107823626A
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- hydrolysate
- cerebroprotin
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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
- A61K38/01—Hydrolysed proteins; Derivatives thereof
- A61K38/012—Hydrolysed proteins; Derivatives thereof from animals
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2873—Proteins, e.g. gelatin
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
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- Epidemiology (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Zoology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of preparation method of compound cerebroprotin hydrolysate piece, first pass through to add hydroxyapatite micro-sphere and absorption is vibrated in Cerebrolysin Vial solution, then it is freeze-dried, part Cerebrolysin Vial is supported on hydroxyapatite micro-sphere, obtain Cerebrolysin Vial micro mist, then with the granulation drying of the auxiliary material mixed atomizing such as sodium chondroitin sulfate, glutamic acid, microcrystalline cellulose, obtain Cerebrolysin Vial particle, it is coated after tabletting with coating material, obtains compound cerebroprotin hydrolysate piece.The present invention can promote the absorption of medicine, and and can reduces drug inactivation, so as to improve the bioavilability of Cerebrolysin Vial oral formulations, reaches the effect of good.
Description
Technical field
The present invention relates to technical field of medicine, more particularly to a kind of preparation method of compound cerebroprotin hydrolysate piece.
Background technology
Cerebrolysin Vial is that the several amino acids and low molecular peptide obtained by animal brain's albumen by enzyme hydrolysis are mixed
The aqueous solution of compound, it is peptidergic nerve nutrient drug specific to a kind of brain, nervous centralis can be acted in many ways, adjusts
Section and improve neuron metabolism, promote the formation of cynapse, the differentiation of Induction of neuronal, and further protect nerve cell from
The infringement of various ischemics and neurotoxin.For improving the symptoms such as insomnia, headache, decrease of memory, dizziness and agitation, can promote
Post-traumatic brain syndrome, sequal of cerebrovascular diseases, postencephalitis, Patients With Acute Cerebral Infarction and acute cerebral trauma rehabilitation.
At present, conventional pharmaceutics of hydrolysate of brain protein formulation mainly has parenteral solution, oral tablet etc., and wherein oral tablet is
Film coated tablets, by after Cerebrolysin Vial and auxiliary material etc. are mixed by spraying granulation drying, whole grain, tabletting, coating, packaging
Be made etc. step, although resulting product have the advantages that it is easy to carry and use, easy to maintain, due to amino acid and
Polypeptide easily by formulation process and takes rear gastrointestinal tract environment and is influenceed and inactivate, and causes Cerebrolysin Vial mouth
The bioavilability of formulation is low, affects the treatment.Therefore, it is necessary to the preparation method of brain protein hydrolysate tablet is made improvements.
The content of the invention
A kind of the defects of the object of the invention is exactly to make up prior art, there is provided preparation of compound cerebroprotin hydrolysate piece
Method.
The present invention is achieved by the following technical solutions：
A kind of preparation method of compound cerebroprotin hydrolysate piece, comprises the following steps：
（1）180-200 parts by weight Cerebrolysin Vial is added in the phosphate buffer that concentration is 0.01-0.015mol/L and filled
Divide dissolving, prepare and obtain the Cerebrolysin Vial solution that mass fraction is 3-5%, then add equivalent to Cerebrolysin Vial weight
It is micro- to obtain Cerebrolysin Vial in 20-25 DEG C of vibration absorption 4-6h after freeze-drying for the hydroxyapatite micro-sphere of 0.5-1 times of amount
Powder；
（2）By step（1）Obtained Cerebrolysin Vial micro mist and 20-30 parts sulfuric acid chondroitins sodium, 20-30 parts by weight paddy
Propylhomoserin, 35-45 parts by weight microcrystalline cellulose, 1-1.5 part by weight of vitamin B1,0.5-1 part by weight of vitamin B6,21-24 weight
Part dextrin, 25.5-28.5 weight parts of calcium carbonate, 30-40 parts by weight Corn starch are added in Fluidbedgranulatingdrier, and unlatching is drawn
Wind, and at the uniform velocity spray into the ethanol that 100-120 parts by weight concentration is 50-60% and carry out spraying granulation drying, terminate rear whole grain, obtain
Cerebrolysin Vial particle；
（3）By step（2）Obtained Cerebrolysin Vial particle and 3-4 parts by weight magnesium stearate mixing 1-2h, then tabletting, with
100-120 parts by weight of sucrose, 60-80 parts by weight talcum powder, 1-1.5 parts by weight insect wax, 1.2-1.6 parts by weight gelatin and 4-5
Parts by weight red ferric oxide is coated as coating material, and compound cerebroprotin hydrolysate piece is obtained after packaging.
The pH of the phosphate buffer is 5.5-6.0.
The average grain diameter of the hydroxyapatite micro-sphere is 5-10 μm.
The step（1）Middle vibration absorption rotating speed is 50-100r/min.
The step（2）In spraying granulation drying temperature be 60-80 DEG C.
The step（2）In whole grain use 14-16 mesh sieves.
It is an advantage of the invention that：
The present invention, which first passes through to add hydroxyapatite micro-sphere, vibrates absorption in Cerebrolysin Vial solution, be then freeze-dried,
Part Cerebrolysin Vial is supported on hydroxyapatite micro-sphere, obtains Cerebrolysin Vial micro mist, then with chondroitin sulfate
The granulation drying of the auxiliary material such as plain sodium, glutamic acid, microcrystalline cellulose mixed atomizing, obtains Cerebrolysin Vial particle, with bag after tabletting
Clothing material is coated, and obtains compound cerebroprotin hydrolysate piece.The present invention utilizes hydroxyapatite micro-sphere good dispersion, to polypeptide
With good adsorption load performance, and the characteristics of polypeptide drug mucosal absorption can be promoted, by the way that some drugs are supported on
On hydroxyapatite micro-sphere, the dispersive property of Cerebrolysin Vial when can improve oral administration, promote the absorption of medicine, and can
Certain protective effect is played to the medicine of load, drug inactivation is reduced, so as to improve the life of Cerebrolysin Vial oral formulations
Thing availability, reaches the effect of good.
Embodiment
A kind of preparation method of compound cerebroprotin hydrolysate piece, comprises the following steps：
（1）180kg Cerebrolysin Vials are added in the phosphate buffer that concentration is 0.01mol/L and fully dissolved, with obtained
To the Cerebrolysin Vial solution that mass fraction is 3%, hydroxyl phosphorus of 0.5 times equivalent to Cerebrolysin Vial weight is then added
Lime stone microballoon obtains Cerebrolysin Vial micro mist in 20 DEG C of vibration absorption 4h after freeze-drying；
（2）By step（1）Obtained Cerebrolysin Vial micro mist and 20kg sodium chondroitin sulfates, 20kg glutamic acid, 35kg crystallites
Cellulose, 1kg vitamin B1s, 0.5kg vitamin B6s, 21kg dextrin, 25.5kg calcium carbonate, 30kg cornstarch add boiling system
In grain drying machine, air inducing is opened, and at the uniform velocity sprays into the ethanol that 100kg concentration is 50% and carries out spraying granulation drying, is terminated rear whole
Grain, obtains Cerebrolysin Vial particle；
（3）By step（2）Obtained Cerebrolysin Vial particle and 3kg magnesium stearate mixing 1h, then tabletting, with 100kg sugarcanes
Sugar, 60kg talcum powder, 1kg insect waxes, 1.2kg gelatin and 4kg red ferric oxides are coated as coating material, are obtained after packaging
Compound cerebroprotin hydrolysate piece.
The pH of the phosphate buffer is 5.5.
The average grain diameter of the hydroxyapatite micro-sphere is 5 μm.
The step（1）Middle vibration absorption rotating speed is 50r/min.
The step（2）In spraying granulation drying temperature be 60 DEG C.
The step（2）In whole grain use 14 mesh sieves.
Claims (6)
1. a kind of preparation method of compound cerebroprotin hydrolysate piece, it is characterised in that comprise the following steps：
（1）180-200 parts by weight Cerebrolysin Vial is added in the phosphate buffer that concentration is 0.01-0.015mol/L and filled
Divide dissolving, prepare and obtain the Cerebrolysin Vial solution that mass fraction is 3-5%, then add equivalent to Cerebrolysin Vial weight
It is micro- to obtain Cerebrolysin Vial in 20-25 DEG C of vibration absorption 4-6h after freeze-drying for the hydroxyapatite micro-sphere of 0.5-1 times of amount
Powder；
（2）By step（1）Obtained Cerebrolysin Vial micro mist and 20-30 parts sulfuric acid chondroitins sodium, 20-30 parts by weight paddy
Propylhomoserin, 35-45 parts by weight microcrystalline cellulose, 1-1.5 part by weight of vitamin B1,0.5-1 part by weight of vitamin B6,21-24 weight
Part dextrin, 25.5-28.5 weight parts of calcium carbonate, 30-40 parts by weight Corn starch are added in Fluidbedgranulatingdrier, and unlatching is drawn
Wind, and at the uniform velocity spray into the ethanol that 100-120 parts by weight concentration is 50-60% and carry out spraying granulation drying, terminate rear whole grain, obtain
Cerebrolysin Vial particle；
（3）By step（2）Obtained Cerebrolysin Vial particle and 3-4 parts by weight magnesium stearate mixing 1-2h, then tabletting, with
100-120 parts by weight of sucrose, 60-80 parts by weight talcum powder, 1-1.5 parts by weight insect wax, 1.2-1.6 parts by weight gelatin and 4-5
Parts by weight red ferric oxide is coated as coating material, and compound cerebroprotin hydrolysate piece is obtained after packaging.
A kind of 2. preparation method of compound cerebroprotin hydrolysate piece according to claim 1, it is characterised in that the phosphoric acid
The pH of salt buffer is 5.5-6.0.
A kind of 3. preparation method of compound cerebroprotin hydrolysate piece according to claim 1, it is characterised in that the hydroxyl
The average grain diameter of apatite microballoon is 5-10 μm.
A kind of 4. preparation method of compound cerebroprotin hydrolysate piece according to claim 1, it is characterised in that the step
（1）Middle vibration absorption rotating speed is 50-100r/min.
A kind of 5. preparation method of compound cerebroprotin hydrolysate piece according to claim 1, it is characterised in that the step
（2）In spraying granulation drying temperature be 60-80 DEG C.
A kind of 6. preparation method of compound cerebroprotin hydrolysate piece according to claim 1, it is characterised in that the step
（2）In whole grain use 14-16 mesh sieves.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711256003.1A CN107823626A (en) | 2017-12-04 | 2017-12-04 | A kind of preparation method of compound cerebroprotin hydrolysate piece |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711256003.1A CN107823626A (en) | 2017-12-04 | 2017-12-04 | A kind of preparation method of compound cerebroprotin hydrolysate piece |
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| Publication Number | Publication Date |
|---|---|
| CN107823626A true CN107823626A (en) | 2018-03-23 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711256003.1A Pending CN107823626A (en) | 2017-12-04 | 2017-12-04 | A kind of preparation method of compound cerebroprotin hydrolysate piece |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112076171A (en) * | 2020-09-22 | 2020-12-15 | 安徽金太阳生化药业有限公司 | Compound cerebroprotein hydrolysate tablet and preparation process thereof |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1546063A (en) * | 2003-12-05 | 2004-11-17 | 吉林省辽源亚东药业股份有限公司 | Encephalic proteolytic products of compound Piracetam and its preparation |
| CN101756908A (en) * | 2010-01-25 | 2010-06-30 | 沈阳药科大学 | Hydroxyapatite micro-sphere with polyester coating and preparation method thereof |
| US20120083450A1 (en) * | 2010-10-01 | 2012-04-05 | Phillips Ii Douglas James | Cerebroprotein hydrolysate for treating brain injuries and neurodegenerative conditions effecting the brain |
| CN104096213A (en) * | 2013-04-07 | 2014-10-15 | 长春海悦药业有限公司 | Pharmaceutical composition containing brain protein hydrolysate and preparation thereof |
| CN104474525A (en) * | 2014-06-09 | 2015-04-01 | 邓学峰 | Cerebroprotein hydrolysate combinatorial drug and preparation method thereof |
| CN104909346A (en) * | 2015-06-24 | 2015-09-16 | 浙江理工大学 | Spherical hollow hydroxyapatite particle and preparation method thereof |
-
2017
- 2017-12-04 CN CN201711256003.1A patent/CN107823626A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1546063A (en) * | 2003-12-05 | 2004-11-17 | 吉林省辽源亚东药业股份有限公司 | Encephalic proteolytic products of compound Piracetam and its preparation |
| CN101756908A (en) * | 2010-01-25 | 2010-06-30 | 沈阳药科大学 | Hydroxyapatite micro-sphere with polyester coating and preparation method thereof |
| US20120083450A1 (en) * | 2010-10-01 | 2012-04-05 | Phillips Ii Douglas James | Cerebroprotein hydrolysate for treating brain injuries and neurodegenerative conditions effecting the brain |
| CN104096213A (en) * | 2013-04-07 | 2014-10-15 | 长春海悦药业有限公司 | Pharmaceutical composition containing brain protein hydrolysate and preparation thereof |
| CN104474525A (en) * | 2014-06-09 | 2015-04-01 | 邓学峰 | Cerebroprotein hydrolysate combinatorial drug and preparation method thereof |
| CN104909346A (en) * | 2015-06-24 | 2015-09-16 | 浙江理工大学 | Spherical hollow hydroxyapatite particle and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 王跃生等: "《中药固体制剂工》", 30 November 2009, 中国中医药出版社 * |
| 石海涛等: ""胰岛素口服缓释给药系统的制备"", 《华西药学杂志》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112076171A (en) * | 2020-09-22 | 2020-12-15 | 安徽金太阳生化药业有限公司 | Compound cerebroprotein hydrolysate tablet and preparation process thereof |
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Application publication date: 20180323 |
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