CN104888184A - A pharmaceutical composition of cerebroprotein hydrolysate and applications thereof - Google Patents
A pharmaceutical composition of cerebroprotein hydrolysate and applications thereof Download PDFInfo
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- CN104888184A CN104888184A CN201510254965.8A CN201510254965A CN104888184A CN 104888184 A CN104888184 A CN 104888184A CN 201510254965 A CN201510254965 A CN 201510254965A CN 104888184 A CN104888184 A CN 104888184A
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Abstract
A pharmaceutical composition of cerebroprotein hydrolysate and applications thereof are disclosed. The composition comprises 15-60 parts by weight of the cerebroprotein hydrolysate, 50-200 parts by weight of ligustrazine hydrochloride, 1-4 parts by weight of sodium DL-beta-(3,4-dihydroxyphenyl)lactate and 100-400 parts by weight of troxerutin. The ligustrazine hydrochloride, the sodium DL-beta-(3,4-dihydroxyphenyl)lactate, the troxerutin and the cerebroprotein hydrolysate are combined for the first time and blended through a proper ratio. The composition has good effects of improving disordered brain functions and preventing cerebral infarction, and can be prepared into any clinically or pharmaceutically acceptable preparation form, preferentially an injection. The composition is definite in effective components and definite in contents, and is mainly used for preparing medicines improving brain functions. A preparing process is simple, convenient and feasible. A preparation is high and stable in quality. The composition is suitable for large-scale industrial production.
Description
Technical field
The present invention relates to new drug development technical field, be specifically related to a kind of pharmaceutical composition and application thereof of Cerebrolysin Vial.
Background technology
Disordered brain function comprises brain tissue ischemia anoxia-induced apoptosis, the cranial nerve function obstacle that a variety of causes such as acute and chronic cerebrovascular, cerebral trauma, various toxic encephalopthys cause and hypomnesis, Congenital maldevelopment of brain, child intelligence hypoevolutism, alzheimer disease etc.Cerebral tissue is very responsive to ischemia, anoxia.Along with social senescence trend and the prolongation of the average life span, the sickness rate of hypoxic ischemic cerebrovascular disease obviously rises, serious harm human health, brings heavy burden to society and family.The cognitive dysfunction that Cerebral ischemia and reperfusion causes also is subject to people's attention day by day.Dementia is common senile disease, is also the difficult treatment that current the world of medicine generally acknowledges.According to World Health Organization, in the old people of over-65s, have people's intelligence of 10% to occur obstacle, and wherein dementia occurs the people of 60%, and with advancing age, dementia incidence rate is in the trend significantly risen.Senile dementia can be divided into chronic and acute two large classes according to the speed of symptom development, and wherein chronic dementia accounts for about 80%, comprises alzheimer disease, vascular dementia and both simultaneous Mixed dementias.Cause the dull-witted cause of disease to have a lot, wherein most importantly Alzheimer (AD) and vascular dementia (VD), vascular dementia is mainly by caused by cerebrovascular disease.Dull-witted is modal performance with memory disorder.At present, more for the medicine improving brain function, but general formula is more single, be difficult to have many-sided synergism, and accumulate poisoning and side effect easily occurs life-time service.
Neurotrophic agents (Nerve nutritional amgents) refers to a series of promotion nervous system development, maintain the protein of nervous function, early stage neurotrophic agents is neurotrophic factor (Nerve MGrowth Factor, NMGF).The object that application neurotrophic agents carries out neuroprotective is the pathological biochemistry cascade reaction of intervening Penumbra zone generation; prevent or postpone cell death; it is it is emphasised that " in early days " and " protection ", and neurotrophy medicine is usually used in treatment cerebral ischemia, brain injury, Alzheimer, parkinson disease etc. in clinical common cerebrovascular.
Cerebrolysin Vial represents medicine cerebrolysin, Cerebrolysin, brain polypeptide etc., containing several amino acids and cephalin, lecithin, peptide class nerve growth factor, improve with the symptom of hypomnesis and visual cognitive ability obstacle for craniocerebral trauma, apoplexy sequela.It is mainly formed through enzyme hydrolysis by healthy Medulla sus domestica, containing 16 free seed amino acids and a small amount of micromolecule polypeptide, not containing protein.Current commercially available pharmaceutics of hydrolysate of brain protein is divided into tablet and injection.
Described in existing market and patent, Cerebrolysin Vial and formulation content thereof are all based on free amino acid, comprising import brain protein hydrolysate injection (Cerebrolysin) is also for predominant amount with 16 kinds of free amino acids, all below 30% (patent and import), total free amino acid content is more than 60% for content of peptides described in each family.In actual applications, brain Proteolytic enzyme injection is in the storage of product, transport and sell links and all require that environment storage temperature can not freeze within the scope of 0-20 DEG C.And brain protein hydrolysate injection liquid drugs injection dosage form will solve the problem of insulation when transporting and sell, thus make this link become complicated, and add cost.In addition, the injection of Cerebrolysin Vial to photaesthesia, thus makes unstable product quality in preservation and use procedure.For improving above-mentioned situation, prior art changes the liquid drugs injection dosage form of above-mentioned brain protein hydrolysate injection into injectable powder, thus improves the stability of Cerebrolysin Vial.But the problems such as it is long that the preparation method of these brain protein hydrolysate injection injectable powder of the prior art exists the production cycle, yields poorly, operating procedure complicated, the requirement of technology total nitrogen content is high.Therefore, the exploitation being applicable to the Pharmaceutical composition of the brain protein hydrolysate for injection of suitability for industrialized production is very necessary.
The good originator of cerebral infarction is the crowd of more than 50 ~ 60 years old, often has atherosclerosis, hypertension, rheumatic heart disease, coronary heart disease or diabetes, and smoking, the bad habit such as to drink patient.Transient ischemic attack medical history is had before the disease of about 25%.There is prodrome before onset more, show as headache, dizziness, dizzy, transience numb limbs and tense tendons, unable.Onset is general comparatively slow, patient many in quiet and sleep onset.Most of patients symptom through several hours even 1 ~ 3 day state of an illness peak.
Most of patients Consciousness after Cerebral Infarction, minority can have the disturbance of consciousness that degree is different, and general vital sign is without obvious change.If cerebral hemisphere larger area infarction, ischemia, edema, can affect the function of diencephalon and brain stem, rise and occur disturbance of consciousness soon after being ill, even cerebral hernia, death.If namely unclear consciously after morbidity, Vertebro-basilar System cerebral infarction be considered.
Improving human-subject test is that the mankind constantly pursue, especially in modern society, along with sharply increase and the renewal of various information, no matter be that student or adult need constantly to grasp increasing knowledge and skill, therefore, the product that exploitation effectively improves brain function is very important, and has wide market prospect.
At present, there is not yet and ligustrazine hydrochloride, danshensu sodium, troxerutin are used for the research that disordered brain function prevents cerebral infarction medicine aspect, be also used for there are no by ligustrazine hydrochloride, danshensu sodium, troxerutin collocation Cerebrolysin Vial the relevant report improving disordered brain function prevention cerebral infarction medicine aspect.
Summary of the invention
The object of this invention is to provide a kind of pharmaceutical composition improving the Cerebrolysin Vial of disordered brain function prevention cerebral infarction.Another object of the present invention is to provide above-mentioned composition preparing antithrombotic, improving microcirculation, protecting vascular endothelial cell, cerebral ischemia cell, memory reinforcing, not only improves disordered brain function situation, and effectively prevents the application in the medicine of cerebral infarction.
Above-mentioned purpose of the present invention is achieved by following scheme: a kind of pharmaceutical composition of Cerebrolysin Vial, and said composition is made up of each component of following parts by weight: Cerebrolysin Vial 15-60 part; Ligustrazine hydrochloride 50-200 part; Danshensu sodium 1-4 part; Troxerutin 100-400 part.The preferred version of above-mentioned composition is as follows:
Cerebrolysin Vial 30 parts, ligustrazine hydrochloride 100 parts, danshensu sodium 2 parts, troxerutin 200 parts are or/and Cerebrolysin Vial 60 parts, ligustrazine hydrochloride 200 parts, danshensu sodium 4 parts, troxerutin 400 parts.. the pharmaceutical composition of above-mentioned Cerebrolysin Vial can make various dosage form with pharmaceutically acceptable carrier or excipient, as tablet, granule, capsule or injection etc.Compared with prior art, the present invention has following beneficial effect: 1. the pharmaceutical composition of Cerebrolysin Vial of the present invention, first ligustrazine hydrochloride, danshensu sodium, troxerutin are introduced and improved in the drug research of brain function, by these three kinds of material collocation Cerebrolysin Vials, allocated by suitable ratio, serve and improve disordered brain function situation well, effectively effect of prevention cerebral infarction; 2. the pharmaceutical composition of Cerebrolysin Vial of the present invention, in its formula, each composition is all that basic research and clinical practice confirm do not have obvious toxic-side effects, and does not have the taboo of compatibility between each composition, without mutual ill effect, therefore has safety.
detailed description of the inventionbelow in conjunction with specific embodiment the present invention done and describe further, but specific embodiment does not do any restriction to the present invention.Embodiment 1
By ligustrazine hydrochloride 50-200 part, danshensu sodium 1-4 part, trehalose 100-300 part is dissolved in the water for injection of 40 ~ 50 DEG C that account for medicinal liquid total amount 40 ~ 50%, limit edged stirs, until completely dissolved, add the water for injection of 50 ~ 70 DEG C to medicinal liquid total amount 80 ~ 90%, Cerebrolysin Vial 15-60 part is added again one by one when stirring, troxerutin 100-400 part, sodium sulfite 1-5 part, until completely dissolved, and with sodium hydrogen phosphate buffer adjust pH to 5.5 ~ 6.5, benefit adds to the full amount of water for injection, again through the membrane filtration mistake of 0.22 μm, sterile filling is in ampoule, 121 DEG C of steam sterilizations 30 minutes, obtained small-volume injection.
Embodiment 2 is by ligustrazine hydrochloride 100 parts, danshensu sodium 2 parts, trehalose 150 parts is dissolved in the water for injection of 40 ~ 50 DEG C that account for medicinal liquid total amount 40 ~ 50%, limit edged stirs, until completely dissolved, add the water for injection of 50 ~ 70 DEG C to medicinal liquid total amount 80 ~ 90%, Cerebrolysin Vial 30 parts is added again one by one when stirring, troxerutin 200 parts, sodium sulfite 2.5 parts, until completely dissolved, and with sodium hydrogen phosphate buffer adjust pH to 5.5 ~ 6.5, benefit adds to the full amount of water for injection, again through the membrane filtration mistake of 0.22 μm, sterile filling is in ampoule, often prop up dress 5ml, 121 DEG C of steam sterilizations 30 minutes, obtained 5ml small-volume injection.
Embodiment 3 is by ligustrazine hydrochloride 200 parts, danshensu sodium 4 parts, trehalose 300 parts is dissolved in the water for injection of 40 ~ 50 DEG C that account for medicinal liquid total amount 40 ~ 50%, limit edged stirs, until completely dissolved, add the water for injection of 50 ~ 70 DEG C to medicinal liquid total amount 80 ~ 90%, Cerebrolysin Vial 60 parts is added again one by one when stirring, troxerutin 400 parts, sodium sulfite 5 parts, until completely dissolved, and with sodium hydrogen phosphate buffer adjust pH to 5.5 ~ 6.5, benefit adds to the full amount of water for injection, again through the membrane filtration mistake of 0.22 μm, sterile filling is in ampoule, often prop up dress 10ml, 121 DEG C of steam sterilizations 30 minutes, obtained 10ml small-volume injection.
Embodiment 4 is by ligustrazine hydrochloride 100 parts, danshensu sodium 2 parts, trehalose 150 parts is dissolved in the water for injection of 40 ~ 50 DEG C that account for medicinal liquid total amount 40 ~ 50%, limit edged stirs, until completely dissolved, add the water for injection of 50 ~ 70 DEG C to medicinal liquid total amount 80 ~ 90%, Cerebrolysin Vial 30 parts is added again one by one when stirring, troxerutin 200 parts, sodium sulfite 2.5 parts, 300 parts, mannitol, until completely dissolved, and with sodium hydrogen phosphate buffer adjust pH to 5.5 ~ 6.5, benefit adds to the full amount of water for injection, again through the membrane filtration mistake of 0.22 μm, aseptic subpackaged in cillin bottle, every bottled 2ml, partly jump a queue, lyophilization about 36 hours, evacuation tamponade, roll lid, obtained lyophilized injectable powder.
Embodiment 5 is by ligustrazine hydrochloride 200 parts, danshensu sodium 4 parts, trehalose 300 parts is dissolved in the water for injection of 40 ~ 50 DEG C that account for medicinal liquid total amount 40 ~ 50%, limit edged stirs, until completely dissolved, add the water for injection of 50 ~ 70 DEG C to medicinal liquid total amount 80 ~ 90%, Cerebrolysin Vial 60 parts is added again one by one when stirring, troxerutin 400 parts, sodium sulfite 5 parts, 600 parts, mannitol, until completely dissolved, and with sodium hydrogen phosphate buffer adjust pH to 5.5 ~ 6.5, benefit adds to the full amount of water for injection, again through the membrane filtration mistake of 0.22 μm, aseptic subpackaged in cillin bottle, every bottled 4ml, partly jump a queue, lyophilization about 52 hours, evacuation tamponade, roll lid, obtained lyophilized injectable powder.
Claims (5)
1. a pharmaceutical composition for Cerebrolysin Vial, is characterized in that said composition is made up of each component of following parts by weight: Cerebrolysin Vial 15-60 part; Ligustrazine hydrochloride 50-200 part; Danshensu sodium 1-4 part; Troxerutin 100-400 part.
2. the pharmaceutical composition of Cerebrolysin Vial according to claim 1, is characterized in that described compositions is made up of each component of following parts by weight: Cerebrolysin Vial 30 parts; Ligustrazine hydrochloride 100 parts; Danshensu sodium 2 parts; Troxerutin 200 parts.
3. the pharmaceutical composition of Cerebrolysin Vial according to claim 1, is characterized in that described compositions is made up of each component of following parts by weight: Cerebrolysin Vial 60 parts; Ligustrazine hydrochloride 200 parts; Danshensu sodium 4 parts; Troxerutin 400 parts.
4. the pharmaceutical composition of the Cerebrolysin Vial of any one according to claim 1 or 2 or 3, this pharmaceutical composition of its feature can make clinically arbitrary or pharmaceutically acceptable dosage form as tablet, granule, capsule, injection etc. with pharmaceutically acceptable adjuvant hybrid process.
5. the pharmaceutical composition of the Cerebrolysin Vial of any one described in claim 1 or 2 or 3 is being prepared antithrombotic, is improving microcirculation, is being protected vascular endothelial cell, cerebral ischemia cell, memory reinforcing; not only improve disordered brain function situation, and effectively prevent the application in the medicine of cerebral infarction.
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| CN201510254965.8A CN104888184A (en) | 2015-05-19 | 2015-05-19 | A pharmaceutical composition of cerebroprotein hydrolysate and applications thereof |
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| CN201510254965.8A CN104888184A (en) | 2015-05-19 | 2015-05-19 | A pharmaceutical composition of cerebroprotein hydrolysate and applications thereof |
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| CN104888184A true CN104888184A (en) | 2015-09-09 |
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| CN201510254965.8A Pending CN104888184A (en) | 2015-05-19 | 2015-05-19 | A pharmaceutical composition of cerebroprotein hydrolysate and applications thereof |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1736475A (en) * | 2005-08-26 | 2006-02-22 | 李志林 | Troxerutin brain protein hydrolysate for injection and preparation process thereof |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1736475A (en) * | 2005-08-26 | 2006-02-22 | 李志林 | Troxerutin brain protein hydrolysate for injection and preparation process thereof |
Non-Patent Citations (3)
| Title |
|---|
| 杨正宇等: "丹参川芎嗪联合脑蛋白水解物治疗急性脑梗死31例疗效观察", 《云南中医中药杂志》 * |
| 耿国民等: "丹参川芎嗪联合曲克芦丁脑蛋白水解物治疗急性脑梗死38例", 《中国药业》 * |
| 路维君等: "曲克芦丁脑蛋白水解物注射液联合丹参川芎嗪注射液对急性脑梗死患者神经功能及血液流变学的影响", 《实用心脑肺血管病杂志》 * |
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