CN101371917B - Brain protein hydrolysate sodium chloride injection - Google Patents
Brain protein hydrolysate sodium chloride injection Download PDFInfo
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- CN101371917B CN101371917B CN2007100726808A CN200710072680A CN101371917B CN 101371917 B CN101371917 B CN 101371917B CN 2007100726808 A CN2007100726808 A CN 2007100726808A CN 200710072680 A CN200710072680 A CN 200710072680A CN 101371917 B CN101371917 B CN 101371917B
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- sodium chloride
- chloride injection
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Abstract
The invention relates to a cerebroprotein hydrolyzate sodium chloride injection and a preparation method thereof. The invention belongs to the cerebroprotein hydrolyzate sodium chloride injection which is processed by industrial method and the improvement of the preparation process of the preparation method thereof. With the natural population growth, the structure aging and the change of the diet structure, geriatric diseases become more and more serious, wherein, the cerebrovascular disease is one of the three main lethal diseases, the cerebroprotein hydrolyzate drug is one of biochemical drugs which are most applied in recent years and occupies important position on the relevant research fields at home and abroad and on the market, so the development and the research of the cerebroprotein hydrolyzate drug have great significances for treating diseases, saving lives and improving the population quality of Chinese nation. The product comprises: 280.8-1,262.5wt% of amino acids, 0.1-2,500wt% of osmotic pressure regulator, 55.0-202.5wt% of total nitrogen. The preparation method is used for producing the cerebroprotein hydrolyzate sodium chloride injection.
Description
Technical field:
The invention belongs to industry law processing brain protein hydrolysate sodium chloride injection.
Background technology:
Along with the change of the natural growth of the population, structure aging and dietary structure, being on the rise of infirmities of age, wherein cerebrovascular disease be three main cause death one of sick.Cerebrovascular disease claims apoplexy again, is mainly in middle-aged and elderly people, because of its morbidity suddenly, change rapidly, still like being the characteristic of nature wind, benefaction and mutability are so be referred to as apoplexy.Common type has transient ischemic attack, cerebral thrombosis, cerebral embolism, cerebral hemorrhage etc.The whole world has 2,000,000 people of surpassing to die from apoplexy every year.Sequela such as the hemiplegia that occurs after the apoplexy, bring great misery not only for patient's body and mind, and all brought huge spirit and financial burden for society and family, cerebrovascular disease generally in the middle-aged and elderly people more than 50 years old sickness rate higher, so be called as senile disease.In the past few years, the between twenty and fifty cerebrovascular disease patient of the right side of fifty has the trend that increases, even in the youngster of one's late 30s, especially also happens occasionally in the white collar worker of the city of youth.
Summary of the invention:
The purpose of this invention is to provide a kind of with healthy mammiferous cerebral tissue through extract, separate, refining and include about 16 kinds of free amino acids, contain osmotic pressure regulator and contain the sterile preparation of a small amount of polypeptide, promptly a kind of brain protein hydrolysate sodium chloride injection.
Above-mentioned purpose realizes by following technical scheme:
A kind of brain protein hydrolysate sodium chloride injection, its composition comprises: aminoacid, osmotic pressure regulator, described amino acid whose parts by weight are 280.8～1262.5, and the parts by weight of described osmotic pressure regulator are 0.1～2500, and the parts by weight of total nitrogen are 55.0～202.5.
The preparation method of above-mentioned brain protein hydrolysate sodium chloride injection, putting into stainless steel cask after freezing health mammal brain cleaned twice with purified water thaws naturally, press 1:1～3 and add purified water stirring 5～30min, colloid mill homogenate twice, fineness 10～20 μ m for the first time, fineness 1～10 μ m for the second time, through primary enzymolysis, secondary enzymolysis, fine straining, after the ultrafiltration, get the recipe quantity osmotic pressure regulator, after dissolving in the adding water for injection, add solution amount 0.01～2% needle-use activated carbon mixing, boiled 10～30 minutes, filtered while hot is got recipe quantity Cerebrolysin Vial solution to clarification, mix with above-mentioned solution, transfer pH6.0～8.0, after-teeming is penetrated water to full dose, filtering with microporous membrane, measure content, after qualified, fill adds isolating membrane in vial, add plug, Zha Gai.
The preparation method of above-mentioned brain protein hydrolysate sodium chloride injection, after described homogenate, homogenate is put and is carried out primary enzymolysis in the hydrolytic decomposition pot, transfer pH value 3.0～6.0 with HCl, be heated to 30～50 ℃, press raw material weight and add 1～10% gastric enzyme enzymolysis, behind the enzymolysis 12～18 hours, be heated to 80～100 ℃ of 15～30min, cool, carry out secondary enzymolysis to 30～50 ℃.
The preparation method of above-mentioned brain protein hydrolysate sodium chloride injection, after described primary enzymolysis, transfer pH value 7.0～9.5 with NaOH, press raw material weight and add 1～10% pancreatin, 30～50 ℃ of hydrolysis temperatures, 1～6 hour post-heating to 80～100 ℃ 15～30min of enzymolysis, filter cloth filters when cooling to 30～50 ℃, gets coarse filtration liquid.
The preparation method of above-mentioned brain protein hydrolysate sodium chloride injection, described fine straining is, coarse filtration liquid put in the jacketed pan by filtrate weight 0.1～1% add after medicinal carbon is heated to 80～100 ℃ of stirring and adsorbing 15～30min, when cooling to 25～35 ℃, with 0.45 μ m filtering with microporous membrane carbon removal, reuse 0.22 μ m filtering with microporous membrane, ultrafiltration behind the fine straining liquid.
Above-mentioned brain protein hydrolysate sodium chloride injection and preparation method thereof, described ultrafiltration are that with fine straining liquid accent pH value 6.0～8.0,20～25 ℃ of fluid temperature are with 3000～10000 dalton's ultrafilter ultrafiltration, pressure 0.05～0.1MPa.
Above-mentioned brain protein hydrolysate sodium chloride injection and preparation method thereof, described osmotic pressure regulator can be sodium chloride, glucose, mannitol, xylitol.
This technical scheme has following beneficial effect:
1. peptide concentration is less than the concentration of polypeptide in the Cerebrolysin Vial solution in the product of the present invention, thereby avoided brain protein hydrolysate sodium chloride injection micromolecule polypeptide in long-time preservation process that polymeric phenomenon easily takes place, make constant product quality, curative effect is reliable, reduces anaphylactoid incidence rate.
2. this product is Cerebrolysin Vial transfusion, has avoided the step of matching while using 5 in the clinical use, has not only improved medical personnel's work efficiency, and secondary pollution takes place when having reduced compatibility, for the patient provides safety guarantee.
3. technology of the present invention is simple, does not compared with prior art use extremely strong, the inflammable and explosive chemical solvents of volatility such as acetone, ether, production equipment is simple, detection, low production cost, and the chemical solvent degrease is used in existing Cerebrolysin Vial preparation, enzymolysis is refining again.
4. this product is used for craniocerebral trauma, apoplexy sequela are concentrated obstacle with hypomnesis and attention doing well,improving determined curative effect, safe in utilization, and carried out bacterial endotoxin test, hypersensitive test, haemolysis and agglutination test, muscular irritation test, blood vessel irritation test, result of the test is all good.Do not find persistent untoward reaction or life-threatening case after the medication so far as yet.
The present invention for the mammiferous cerebral tissue of health through extract, separate, the refining sterile preparation that gets.Include about 16 kinds of free amino acids, and contain a small amount of polypeptide.Character is light yellow or almost colourless clear liquid.It is 22～81mg/100ml that the present invention contains total nitrogen, contains osmotic pressure regulator 0.1～1.0g/100ml.
6. show that by table 1,2 data this product three batch samples are pressed commercially available back, placing 40 ℃ ± 2 ℃, relative humidity is under 75% ± 5% the strong condition, placed 6 months, every detection index of three batch samples is compared no significant change with 0 month sample, proves having good stability of this product.
7. Cerebrolysin Vial is to form through defat, enzyme hydrolysis, drying with the fresh brain of health mammal.Contain free amino acid and molecular weight mixture at small-molecular peptides below 10000 etc.Can act on nervus centralis in many ways; regulate and improve neuronic metabolism; promote the formation of synapse, induce neuronic differentiation, and further neuroprotective cell is in the infringement that is subjected to various ischemias and neurotoxin; can pass through blood brain barrier; promote the synthetic of brain internal protein, influence respiratory chain, have the protective capability of anti-hypoxia; improve the metabolism of brain self-energy, other hormone systems of activated adenyl cyclase and catalysis.Improve neurotransmitter, peptide hormone and coenzyme precursors.
8. Cerebrolysin Vial class medicine is to use one of maximum biochemical drug in recent years, occupies critical role on Related Research Domain and the market at home and abroad.It is reported that all a large amount of imports in China every year are applied to clinical, import value was 2,591 ten thousand dollars in 1992,1993 4768 ten thousand dollars, cumulative year after year.Scientist prophesy, 21 century whole world senile dementia, apoplexy, the cerebral infarction cerebrovascular disease sickness rate of waiting indefinitely will increase to present 3 times, and the ratio of the aging population of China is increasing year by year.Therefore, product of the present invention is to curing the sickness to save the patient and to improve the population quality of the Chinese nation all significant.
The specific embodiment of the present invention:
Embodiment 1:
A kind of brain protein hydrolysate sodium chloride injection, its composition comprises: aminoacid, osmotic pressure regulator, described amino acid whose parts by weight are 280.8～1262.5, and the parts by weight of described osmotic pressure regulator are 0.1～2500, and the parts by weight of total nitrogen are 55.0～202.5.
Embodiment 2:
The manufacture method of brain protein hydrolysate sodium chloride injection is: put into stainless steel cask after freezing health mammal brain is cleaned twice with purified water and thaw naturally, press 1:1 and add 5 minutes (min) of purified water stirring, twice of colloid mill homogenate, fineness 10 μ m for the first time, fineness 1 μ m for the second time, homogenate is put in the hydrolytic decomposition pot, transfers pH value 3.0 with HCl, is heated to 30 ℃, add 1% gastric enzyme enzymolysis by raw material weight, behind the enzymolysis 12 hours, be heated to 80 ℃ of 15min, cool to 30 ℃, with NaOH adjust pH 7.0, add 1% pancreatin by raw material weight, 30 ℃ of hydrolysis temperatures, 1 hour post-heating to 80 ℃ 15min of enzymolysis, filter cloth filters when cooling to 30 ℃, get coarse filtration liquid, take by weighing weight, calculated yield; Coarse filtration liquid is put in the jacketed pan by filtrate weight 0.1% and is added after medicinal carbon is heated to 80 ℃ of stirring and adsorbing 15min, when cooling to 25 ℃, with 0.45 μ m filtering with microporous membrane carbon removal, reuse 0.22 μ m filtering with microporous membrane, get fine straining liquid, take by weighing weight, calculated yield; Fine straining liquid adjust pH 6.0,20 ℃ of fluid temperature are with 3000 dalton's ultrafilter ultrafiltration, pressure 0.05MPa.Ultrafiltrate is packed in the pyrogen-free Plastic Drum, sampling censorship, refrigerated storage; Get the recipe quantity osmotic pressure regulator, after dissolving in the adding water for injection, add solution amount 0.01% needle-use activated carbon mixing, boiled 10 minutes, filtered while hot is to clarification, get recipe quantity Cerebrolysin Vial solution, mix with above-mentioned solution, transfer pH6.0, after-teeming is penetrated water to full dose, filtering with microporous membrane is measured content; After qualified, fill adds isolating membrane in vial, add plug, Zha Gai.
Embodiment 3:
The manufacture method of brain protein hydrolysate sodium chloride injection is: put into stainless steel cask after freezing health mammal brain is cleaned twice with purified water and thaw naturally, press 1:2 and add purified water stirring 15min, twice of colloid mill homogenate, fineness 15 μ m for the first time, fineness 5 μ m for the second time, homogenate is put in the hydrolytic decomposition pot, transfers pH value 4 with HCl, is heated to 40 ℃, add 4% gastric enzyme enzymolysis by raw material weight, behind the enzymolysis 14 hours, be heated to 90 ℃ of 20min, cool to 40 ℃, with NaOH adjust pH 8.0, add 5% pancreatin by raw material weight, 40 ℃ of hydrolysis temperatures, 3 hours post-heating to 90 ℃ 20min of enzymolysis, filter cloth filters when cooling to 40 ℃, get coarse filtration liquid, take by weighing weight, calculated yield; Coarse filtration liquid is put in the jacketed pan by filtrate weight 0.5% and is added after medicinal carbon is heated to 90 ℃ of stirring and adsorbing 20min, when cooling to 30 ℃, with 0.45 μ m filtering with microporous membrane carbon removal, reuse 0.22 μ m filtering with microporous membrane, get fine straining liquid, take by weighing weight, calculated yield; Fine straining liquid is transferred pH value 7.0, and 22 ℃ of fluid temperature are with 5000 dalton's ultrafilter ultrafiltration, pressure 0.06MPa.Ultrafiltrate is packed in the pyrogen-free Plastic Drum, sampling censorship, refrigerated storage; Get the recipe quantity osmotic pressure regulator, after dissolving in the adding water for injection, add solution amount 0.09% needle-use activated carbon mixing, boiled 25 minutes, filtered while hot is to clarification, get recipe quantity Cerebrolysin Vial solution, mix with above-mentioned solution, transfer pH7.0, after-teeming is penetrated water to full dose, filtering with microporous membrane is measured content; After qualified, fill adds isolating membrane in vial, add plug, Zha Gai.
Embodiment 4:
The manufacture method of brain protein hydrolysate sodium chloride injection is: put into stainless steel cask after freezing health mammal brain is cleaned twice with purified water and thaw naturally, press 1:3 and add purified water stirring 30min, twice of colloid mill homogenate, fineness 20 μ m for the first time, fineness 10 μ m for the second time, homogenate is put in the hydrolytic decomposition pot, transfers pH value 6.0 with HCl, is heated to 50 ℃, add 10% gastric enzyme enzymolysis by raw material weight, behind the enzymolysis 18 hours, be heated to 100 ℃ of 30min, cool to 50 ℃, transfer pH value 9.5 with NaOH, add 10% pancreatin by raw material weight, 50 ℃ of hydrolysis temperatures, 6 hours post-heating to 100 ℃ 30min of enzymolysis, filter cloth filters when cooling to 50 ℃, get coarse filtration liquid, take by weighing weight, calculated yield; Coarse filtration liquid is put in the jacketed pan by filtrate weight 1% and is added after medicinal carbon is heated to 100 ℃ of stirring and adsorbing 30min, when cooling to 35 ℃, with 0.45 μ m filtering with microporous membrane carbon removal, reuse 0.22 μ m filtering with microporous membrane, get fine straining liquid, take by weighing weight, calculated yield; Fine straining liquid is transferred pH value 8.0, and 25 ℃ of fluid temperature are with 10000 dalton's ultrafilter ultrafiltration, pressure 0.1MPa.Ultrafiltrate is packed in the pyrogen-free Plastic Drum, sampling censorship, refrigerated storage; Get the recipe quantity osmotic pressure regulator, after dissolving in the adding water for injection, add solution amount 2% needle-use activated carbon mixing, boiled 30 minutes, filtered while hot is to clarification, get recipe quantity Cerebrolysin Vial solution, mix with above-mentioned solution, transfer pH8.0, after-teeming is penetrated water to full dose, filtering with microporous membrane is measured content; After qualified, fill adds isolating membrane in vial, add plug, Zha Gai.
Embodiment 5:
The manufacture method of brain protein hydrolysate sodium chloride injection is: put into stainless steel cask after freezing health mammal brain is cleaned twice with purified water and thaw naturally; Press 1:1 and add purified water stirring 5min, colloid mill homogenate twice, fineness 20 μ m, fineness 10 μ m for the second time for the first time; Homogenate is put in the hydrolytic decomposition pot, transfers pH value 3.0 with HCl, is heated to 30 ℃, adds 1% gastric enzyme enzymolysis by raw material weight, and enzymolysis was heated to 80 ℃ of 30min after 12 hours, cooled to 30 ℃; Transfer pH value 7.0 with NaOH, add 1% pancreatin by raw material weight, 30 ℃ of hydrolysis temperatures, 1 hour post-heating to 80 ℃ 30min of enzymolysis, filter cloth filters when cooling to 30 ℃, gets coarse filtration liquid, takes by weighing weight, calculated yield; Coarse filtration liquid is put in the jacketed pan by filtrate weight 1% and is added after medicinal carbon is heated to 100 ℃ of stirring and adsorbing 15min, when cooling to 25 ℃, with 0.45 μ m filtering with microporous membrane carbon removal, reuse 0.22 μ m filtering with microporous membrane, get fine straining liquid, take by weighing weight, calculated yield; Fine straining liquid is transferred pH value 6.0, and 20 ℃ of fluid temperature are with 10000 dalton's ultrafilter ultrafiltration, pressure 0.1MPa.Ultrafiltrate is packed in the pyrogen-free Plastic Drum, sampling censorship, refrigerated storage.
Claims (1)
1. brain protein hydrolysate sodium chloride injection, its composition comprises: aminoacid, osmotic pressure regulator, described amino acid whose parts by weight are 1262.5, the parts by weight of described osmotic pressure regulator are 2500, the parts by weight of total nitrogen are 202.5, containing total nitrogen in the described injection is 81mg/100ml, contains osmotic pressure regulator 1.0g/100ml.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2007100726808A CN101371917B (en) | 2007-08-20 | 2007-08-20 | Brain protein hydrolysate sodium chloride injection |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2007100726808A CN101371917B (en) | 2007-08-20 | 2007-08-20 | Brain protein hydrolysate sodium chloride injection |
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| Publication Number | Publication Date |
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| CN101371917A CN101371917A (en) | 2009-02-25 |
| CN101371917B true CN101371917B (en) | 2011-08-24 |
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| CN2007100726808A Expired - Fee Related CN101371917B (en) | 2007-08-20 | 2007-08-20 | Brain protein hydrolysate sodium chloride injection |
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| CN102166200A (en) * | 2011-04-12 | 2011-08-31 | 罗诚 | Freeze-drying composition containing cerebroprotein hydrolysates and preparation method of freeze-drying composition |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1129451C (en) * | 2001-11-24 | 2003-12-03 | 海南斯达制药有限公司 | Process for preparing injection liquid of brain protein hydrolyzate |
| CN1939341A (en) * | 2006-10-13 | 2007-04-04 | 郭维城 | Brain protein hydrolyte freeze-drying preparation for injection and its making method |
| CN100998861A (en) * | 2006-01-09 | 2007-07-18 | 陈卓涛 | Cerebroprotein hydrolysate sodium chloride injection |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1129451C (en) * | 2001-11-24 | 2003-12-03 | 海南斯达制药有限公司 | Process for preparing injection liquid of brain protein hydrolyzate |
| CN100998861A (en) * | 2006-01-09 | 2007-07-18 | 陈卓涛 | Cerebroprotein hydrolysate sodium chloride injection |
| CN1939341A (en) * | 2006-10-13 | 2007-04-04 | 郭维城 | Brain protein hydrolyte freeze-drying preparation for injection and its making method |
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| CN101371917A (en) | 2009-02-25 |
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Granted publication date: 20110824 Termination date: 20170820 |