CN102125572A - Pharmaceutical composition and application thereof - Google Patents
Pharmaceutical composition and application thereof Download PDFInfo
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- CN102125572A CN102125572A CN2010106246219A CN201010624621A CN102125572A CN 102125572 A CN102125572 A CN 102125572A CN 2010106246219 A CN2010106246219 A CN 2010106246219A CN 201010624621 A CN201010624621 A CN 201010624621A CN 102125572 A CN102125572 A CN 102125572A
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Abstract
The invention relates to a pharmaceutical composition and a preparation method thereof. The pharmaceutical composition contains ginsenoside Rg1, ginsenoside Rb1 and ginsenoside Re, wherein the weight ratio of ginsenoside Rg1: ginsenoside Rb1: ginsenoside Re is 1:0.7:1.2. The composition provided by the invention has notable effects and high safety, can alleviate apoplexy symptoms, obviously shortens the course of disease, improves depression of patients with apoplexy sequelae, and the like.
Description
Technical field
The present invention relates to drug world, particularly relate to a kind of Pharmaceutical composition that is used for the treatment of hemorrhagic apoplexy or schizophrenia residual period.
Background technology
It is the disease of main clinical manifestation with brain ischemia and hemorrhagic damage symptom that apoplexy is one group, claims apoplexy or cerebrovascular accident again.Apoplexy morbidity is anxious, has high case fatality rate and disability rate, and the report of World Health Organization (WHO) shows, because of apoplexy death person is in second of global mortality rate, is only second to cancer, has 1/4 people to die from apoplexy in the annual death toll approximately.The kind of cancer has kind more than 10, if with the mortality rate of single kind, apoplexy can come first of mortality rate.In the U.S., the apoplexy mortality in said patients is about 7% for the first time, and the mortality rate of China is higher.
Apoplexy still is the primary factor that the adult is disabled, there is 1/2 apoplexy patient can cause in various degree deformity approximately, most patients are with sequela such as hemiplegia, dementia, tic of the limbs, inarticulateness, self care ability is limited, both increase patient's misery, and brought very big difficulty for again family and society.Especially exist evident difference between paralytic's mental status and the normal person, poor to epharmony, negative and positive coping style, effectively self regulation, bad phychology and pernicious stimulation can make the nervous function disorder, cause many organs, multi-functional imbalance and body is had a negative impact.Thereby most patients produce dysthymia owing to hold this decocting of daring not accept, even schizophrenia.The performance absentminded, symptom such as malaise, sad melancholy be kind cries, insomnia and dreamful sleep, cardiopalmus are timid.Thereby stroke patient is also usually taken antidepressants in the treatment sequela.But cardiac, old people should not use such medicine or careful usefulness.
Summary of the invention
The purpose of this invention is to provide a kind of compositions that is used for the treatment of hemorrhagic apoplexy and schizophrenia residual period, to overcome the above-mentioned defective that prior art exists.
Pharmaceutical composition provided by the invention contains ginsenoside Rg1, ginsenoside Rb1 and ginsenoside Re, and wherein, the ginsenoside Rg1: the weight ratio of ginsenoside Rb1 and ginsenoside Re's sum is 1: 0.7～1.2.
Preferably, ginsenoside Rg1: the weight ratio of ginsenoside Rb1 and ginsenoside Re's sum is 1: 0.8～1.1.
Preferred, the ginsenoside Rg1: the weight ratio of ginsenoside Rb1 and ginsenoside Re's sum is 1: 0.9～1.05.
Compositions of the present invention can also comprise arasaponin R1, and arasaponin R1 and ginsenoside Rg1's weight ratio is 0.15～0.55: 1.
Compositions of the present invention can also comprise the ginsenoside Rd, and ginsenoside Rd and ginsenoside Rg1's weight ratio is 0.15～0.55: 1.
Compositions of the present invention can also comprise ginsenoside Rd and arasaponin R1, and ginsenoside Rd, arasaponin R1 and ginsenoside Rg1's weight ratio is 0.15～0.55: 0.15～0.55: 1.
The present invention also provides the method for preparing above-mentioned composition, comprises the steps: the Radix Notoginseng appropriateness is pulverized, and adds the 70%-90% alcohol heat reflux and extracts, being concentrated into does not have the alcohol flavor, and thin up precipitation 12-24 hour is filtered, filtrate is through resin absorption, and the ethanol with the different volumes ratio carries out gradient elution successively.Eluent silica gel H thin-layer chromatographic analysis, developing solvent are " n-butyl alcohol-ethyl acetate-water " 5: 0.5: 4, and volume ratio is 10% ethanol solution of sulfuric acid colour developing.Merge chromatograph speckle same composition, decompression and solvent recovery.Last chromatography silicagel column is with " chloroform-methanol-water " mixed solvent eluting of different proportion.Merge chromatograph speckle same composition, decompression and solvent recovery, respectively highly purified arasaponin R1, ginsenoside Rg1, ginsenoside Rb1, ginsenoside Re and ginsenoside Rd.Be mixed in proportion and promptly get above-mentioned composition.
The present invention further provides and comprise the above-mentioned compositions and the preparation of available support pharmaceutically.
The present invention also provides described compositions in the application that is used for preparing the medicine for the treatment of hemorrhagic apoplexy.
The present invention further provides of the application of described compositions at the medicine that is used for preparing treatment schizophrenia residual period.
Chinese medicine composition of the present invention has following beneficial effect:
1) ginsenoside Rg1 can improve learning and memory, has stimulating central nervous system, suppresses the platelet aggregation effect.The ginsenoside Rb1 has the function that strengthens the choline system, increases the synthetic and release of acetylcholine and improves the memory effect.The ginsenoside Re has the inhibition nervus centralis, promotes DNA, and RNA is synthetic.The effect of rising plasma corticosterone, blood vessel dilating.
2) merge each component, the blood vessel dilating effect strengthens, can significantly suppress platelet aggregation, quick adjustment central nervous system.Thereby the hemorrhagic apoplexy disease had good curative effect, and can alleviate the apoplexy symptom fast, shorten the course of disease, and apoplexy sequela patient's depression, schizophrenia residual period is made moderate progress.
The specific embodiment
Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.
Embodiment 1
The extraction of component:
1000g is ground into coarse powder with the Radix Notoginseng raw medicinal herbs, adds 2.5 times of amount 90% ethanol, heating and refluxing extraction, and being evaporated to does not have the alcohol flavor.Thin up left standstill 24 hours to 0.25g (crude drug)/ml, filtered.Filtrate is used 20%, 40%, 60%, 80% and 90% (volume ratio) ethanol gradient elution successively by macroporous adsorptive resins, collects with every part of 500ml.Eluent silica gel H thin-layer chromatographic analysis, developing solvent are " n-butyl alcohol-ethyl acetate-water " 5: 0.5: 4 (upper strata), the colour developing of 10% (volume ratio) ethanol solution of sulfuric acid.Merge chromatograph speckle same composition, decompression and solvent recovery.Go up the chromatography silicagel column again, using " chloroform-methanol-water " successively is 80: 18: 2,75: 20: 5,65: 30: 5,60: 33: 7,54: 38: 8 solvent elution, collects with every part of 500ml.Eluent silica gel H thin-layer chromatographic analysis, developing solvent is the same.Merge chromatograph speckle same composition, decompression and solvent recovery, respectively highly purified above-mentioned each component.
With the acetonitrile-water gradient elution, acetonitrile: 0-20min, 18%-20% (volume ratio); 20-45min, 20-45% (volume ratio); 45-55min, 45-55% (volume ratio).Flow velocity 1.5ml/min detects wavelength 203nm, and sample size 10 μ l, column temperature are that 25 ℃ method detects above-mentioned each composition.
The separation and Extraction Panax Notoginseng saponin R
13.67g, Panax Notoginseng saponin R wherein
1Content be 96.8%.
Separation and Extraction ginsenoside Rg
114.25g, ginsenoside Rg wherein
1Content be 95.9%.
Separation and Extraction ginsenoside Re 1.45g, wherein ginsenoside Re's content is 96.1%.
Separation and Extraction ginsenoside Rb
113.4g, ginsenoside Rb wherein
1Content be 96.2%.
Separation and Extraction ginsenoside Rd 3.25g, wherein ginsenoside Rd's content is 95.6%.
Take by weighing each component (Zhi Bei basic pure component as stated above) of following weight: ginsenoside Rg1 30g, ginsenoside Rb1 28.5g and ginsenoside Re 3.0g.
Preparation method is as follows: above-mentioned each component mixed, dissolves in right amount, add the needle-use activated carbon decolouring, filter, add the injection water, regulate pH value to 6.8, filter to total amount with water for injection, and lyophilization, promptly.
Embodiment 2
The extraction of component is with embodiment 1.
Take by weighing each component (the same) of following weight: ginsenoside Rg1 30g, ginsenoside Rb1 28.5g, ginsenoside Re 3.0g, ginsenoside Rd 7.5g and arasaponin R1 7.8g.
Preparation method is as follows: above-mentioned each component mixed, dissolves in right amount, add the needle-use activated carbon decolouring, filter, add the injection water, regulate pH value to 6.7, filter to total amount with water for injection, and lyophilization, promptly.
Embodiment 3
Take by weighing each component of following weight: ginsenoside Rg1 45g, ginsenoside Rb1 29g and ginsenoside Re 2.5g.
Preparation method is as follows: above-mentioned each component mixed, dissolves in right amount, add the needle-use activated carbon decolouring, filter, add the injection water, regulate pH value to 6.0, filter to total amount with water for injection, and lyophilization, promptly.
Embodiment 4
Take by weighing each component of following weight: ginsenoside Rg1 33g, ginsenoside Rb1 26g and ginsenoside Re 3.7g.
Preparation method is as follows: above-mentioned each component mixed, dissolves in right amount, add the decolouring of 0.5% needle-use activated carbon, filter, add to the full amount of water for injection, transfer pH to 6.5, filter with water for injection, and fill, sterilization promptly gets small-volume injection.
Embodiment 5
Take by weighing each component of following weight: ginsenoside Rg1 30g, ginsenoside Rb1 28.5g and ginsenoside Re 3.0g.
Preparation method is as follows: above-mentioned each component mixed, dissolves in right amount, add the needle-use activated carbon decolouring, filter, add the injection water, regulate pH value to 6.8, filter to total amount with water for injection, and lyophilization, promptly.
Embodiment 6
Take by weighing each component of following weight: ginsenoside Rg1 40g, ginsenoside Rb1 27.3g and ginsenoside Re 4.7g.
Preparation method is as follows: above-mentioned each component is mixed, further be ground into fine powder, cross 300 mesh sieves, add composition weight 76% starch, mixing is made granule, adds to incapsulate after composition weight 4% Pulvis Talci mixes evenly, promptly gets capsule.
Embodiment 7
Take by weighing each component of following weight: ginsenoside Rg1 25g, ginsenoside Rb1 29.0g and ginsenoside Re 1.0g.
Preparation method is as follows: above-mentioned each component is mixed, further be ground into fine powder, add composition weight 70% dextrin, mixing is made granule, adds the mixed evenly back of composition weight 1% Pulvis Talci and composition weight 1% magnesium stearate and beats sheet, packing promptly gets tablet.
Embodiment 8
Take by weighing each component of following weight: ginsenoside Rg1 35g, ginsenoside Rb1 34.5g and ginsenoside Re 4.0g.
Preparation method is as follows: above-mentioned each component is mixed, further be ground into fine powder, add 2 times of sucrose of composition weight, mixing is made granule, packing, and packing promptly gets granule.
Embodiment 9
Take by weighing each component of following weight: ginsenoside Rg1 30g, ginsenoside Rb1 28.5g, ginsenoside Re 3.0g and ginsenoside Rd 5.5g.
Preparation method is as follows: above-mentioned each component mixed, dissolves in right amount, add the needle-use activated carbon decolouring, filter, add the injection water, regulate pH value to 6.6, filter to total amount with water for injection, and lyophilization, promptly.
Embodiment 10
Take by weighing each component of following weight: ginsenoside Rg1 30g, ginsenoside Rb1 28.5g, ginsenoside Re 3.0g and arasaponin R1 8.6g.
Preparation method is as follows: above-mentioned each component mixed, dissolves in right amount, add the needle-use activated carbon decolouring, filter, add the injection water, regulate pH value to 6.8, filter to total amount with water for injection, and lyophilization, promptly.
Embodiment 11
Take by weighing each component of following weight: ginsenoside Rg1 30g, ginsenoside Rb1 28.5g, ginsenoside Re 3.0g, ginsenoside Rd 7.5g and arasaponin R1 7.8g.
Preparation method is as follows: above-mentioned each component mixed, dissolves in right amount, add the needle-use activated carbon decolouring, filter, add the injection water, regulate pH value to 6.7, filter to total amount with water for injection, and lyophilization, promptly.
The influence of 1 pair of clotting time of experimental example
Get 50 of the rats of body weight 190-230g, be divided into 6 groups by the sex body weight, 10 every group, each 5 of male and female are respectively the blank group, 1 group of administration, 2 groups of administrations, 3 groups of administrations, 4 groups of administrations and positive controls.The equal tail intravenously administrable of each treated animal, the blank group gives sodium chloride injection; Administration gives embodiment 5 samples for 1 group; Administration gives embodiment 11 samples for 2 groups; Administration gives embodiment 1 sample for 3 groups; Administration gives commercially available product for 4 groups, ginsenoside Rg1 44.9%, ginsenoside Rb1 31.1%, ginsenoside Re 5.9%, ginsenoside Rd 3.0%, arasaponin R1 11.2%; Positive controls gives Defibrase.Dosage sees table 1 for details, and the administration volume is 0.2ml/100g, for three days on end.
Animal fasting 16h before the test, 5min after the last administration, each Mus intravenous injection sodium pentobarbital 40mg/kg anesthesia, heart extracting blood 4.5mL, add and be placed with in the centrifuge tube of 3.8% sodium citrate 0.5mL, the ratio strictness of arterial blood and anticoagulant is controlled to be 9: 1, with the centrifugal 10min of the speed of 3000r/min, obtains required plasma volume respectively with microsyringe behind the mixing, measure, record PT, TT, APTT, the significance of difference between each administration group and the blank group is compared in the t check, the results are shown in Table 1.
The influence of table 1 couple rat plasma TT, PT, APTT
The result shows, but each administration group is prolong rats thrombin time of blood plasma (TT) all, prothrombin time (PT), activated partial thromboplastin time (APTT), and 1 group of administration is suitable substantially with 3 groups, most pronounced effects, compare with the blank group, significant differences (P＜0.01) is arranged, and 4 groups of administrations and blank group relatively have significant difference (P＜0.05).
The influence of 2 pairs of rat plasma Fibrinogens of experimental example (Fib) content
Experimental example 1 is measured after testing rat collection blood plasma, record Fib content, and the significance of difference between each administration group and the blank group is compared in the t check, the results are shown in Table 2.
The influence of table 2 pair rat plasma Fib content
| Group | Dosage (mg/kg) | Number of animals (10) | Fib content (g/L) |
| The blank group | Deng capacity NS | 10 | 3.48±0.72 |
| 1 group of administration | 18.0 | 10 | 1.84±0.34 |
| 2 groups of administrations | 18.0 | 10 | 1.92±0.36 |
| 3 groups of administrations | 18.0 | 10 | 1.82±0.32 |
| 4 groups of administrations | 18.0 | 10 | 2.36±0.42 |
| Positive controls | 0.9U | 10 | 1.56±0.51 |
The result as seen, each administration group all can reduce rat plasma Fibrinogen (Fib) content, and 1 group of administration is suitable substantially with 3 groups, most pronounced effects, with the blank group relatively, significant difference (P＜0.05) is arranged.
The influence of 3 pairs of rabbit platelet aggregations of experimental example
Get 10 of the white big ear rabbits of body weight 1.95-2.75kg, the male and female dual-purpose, every intravenous injection pentobarbital sodium 40mg/kg anesthesia, the blood-letting of carotid artery intubate surpasses 22mL, be sub-packed in 6 test tubes that fill 0.4mL 3.8% sodium citrate anticoagulant, every pipe arterial blood 3.6mL, blood and the strictness of anticoagulant ratio are controlled to be 9: 1, centrifugal 10min takes out platelet rich plasma (PRP) 300 μ l, centrifugal again 10min, take out poor platelet blood plasma (PPP) 300 μ l, transfer transmittance with PPP300 μ l, respectively at Dropwise 50 μ l medicinal liquid among the 300 μ l LPRP that added magnetic bead, plasma specimen dosing situation sees Table 3.Behind the 37 ℃ of pre-temperature 1min in pre-temperature hole, put in people's measured hole, in each measuring tube, add platelet aggregation inducing agent ADP 10 μ l, start, the platelet 6min that traces the variable concentrations medicinal liquid assembles curve, assembles the gathering inhibition percentage rate that percentage rate calculates each medicine with maximum.T check each administration group of comparison and blank group are in the different time significance of difference.The results are shown in Table 3.
The influence of table 3 pair rabbit platelet aggregation
| 2 groups of administrations | 24 | 1.66 | 8.9±3.55 | 62.1±5.61 |
| 3 groups of administrations | 24 | 1.66 | 8.3±3.45 | 65.1±5.15 |
| 4 groups of administrations | 24 | 1.66 | 10.1±4.10 | 54.8±6.40 |
| Positive controls | 2.4U | 0.33U | 11.6±3.94 | 47.3±6.27 |
The result shows, each administration group has remarkable inhibitory action to the rabbit platelet aggregation, and significantly reduce the platelet maximum agglutination rate, 1 group of administration is suitable substantially with 3 groups, most pronounced effects compares with the blank group, and significant differences (P＜0.01) is arranged, 4 groups of administrations and blank group relatively have significant difference (P＜0.05).
The clinical comparison of experimental example 4 curative effects
Take the principle of random assortment that 90 routine patients are divided into treatment group 1, treatment group 2 and matched group, every group 30 example is the male, age, average course of disease, no significant difference.Require all to go into to organize psychosis kind that patient takes and dosage no change in 8 weeks before research, still keep former types of medicines during the research and dosage constant.Respectively do the inspection of a transcranial doppler excusing from death blood flow before and after the treatment.During the treatment, treatment group 1 adds 5 compositionss with embodiment, and treatment group 2 adds 1 compositions with embodiment, and per 2 weeks evaluate once patient, totally 5 times.The result, BPRS, SAPS after 1 medication organized in treatment, the fractional effective percentage of SANS is respectively 80%, 65%, 90%, obvious effective rate is respectively 30%, 20%, 35%, the treatment group has apoplexy patient 23 examples, treatment hindbrain improving blood flow reaches 100%, BPRS, SAPS after 2 medications organized in treatment, the fractional effective percentage of SANS is respectively 79%, 62%, 89%, obvious effective rate is respectively 29%, 18%, 34%, the treatment group has apoplexy patient 22 examples, treatment hindbrain improving blood flow reaches 100%, matched group has apoplexy patient 20 examples, therapeutic outcome no change.During treating, do not see that treatment group patient has untoward reaction.
Inspections such as experimental example 5 undue toxicitys, anaphylaxis, acute toxicity
Choose embodiment 5 and embodiment 1 carries out the following safety testing
1) acute toxicity test
Carry out with reference to " herbal pharmacology research methodology " acute toxicity test, adopt conventional prerun, measure the maximum lethal dose and the minimum lethal dose of product abdominal cavity and tail vein injection, get 130 mices and be divided into 13 groups at random, every group 10, male and female half and half are given the product solution of mouse tail vein and lumbar injection various dose, observe the poisoning symptom of mice, adopt the Sun Shi synthetic method to calculate the LD50 value.Found that after administration in the different time, free movable the minimizing appears in mice, when dying respiratory frequency speed, poisoning symptoms such as mouth breathing, flaring of alaenasi.The LD50 of embodiment 5 lumbar injections is 804.33mg/kg; The LD50 of tail vein injection is 520.62mg/kg.The LD50 of embodiment 1 lumbar injection is 780.26mg/kg; The LD50 of tail vein injection is 495.18mg/kg.
2) hypersensitive test
Is the solution that contains compositions 20mg among every 1ml with sodium chloride injection with the product dilution, gives guinea pig intraperitoneal injection.Each 0.5ml/ only, the next day once, totally three times.After the administration the 14th day and the 21st day respectively this solution of intravenous injection 1.0ml/ only, the result there is no Cavia porcellus anaphylaxis.The Cavia porcellus that gives 5% fresh albumen the 14th day and the 21st day after giving Ovum Gallus domesticus album anaphylaxis all occurring behind the intravenous injection Ovum Gallus domesticus album respectively, and all dead in 15min.These results show that the anaphylaxis of this product is checked up to specification.
3) haemolysis and agglutination test
With reference to " appendix related content of Chinese pharmacopoeia version in 2010 is tested, and the result shows that this product did not have haemolysis and red cell agglutination to tame rabbit erythrocyte in 3 hours.
4) vascular stimulation test
Test with reference to " specification requirement of study of tcm new drug " related content, adopt the ear contrast of the consubstantiality left and right sides, get 3 rabbit, left side ear is by auricular vein injection embodiment 5 (embodiment 1) 15.0ml (25mg)/only, auris dextra waits the sodium chloride injection of capacity, once a day, and continuous three days.The result shows that the perusal of rabbit auricular vein medicine-feeding part does not have significant change, and the pathological section microscope inspection shows, continuous, complete apart from injection site 1cm place blood vessel endothelium, do not see hypertrophy, swelling, the blood vessel surrounding tissue is not seen inflammatory cell infiltration and downright bad phenomenon, and no thrombosis forms in the tube chamber.These results show, embodiment 5 and all no blood vessel irritant reaction of embodiment 1 product.
5) abnormal toxicity test
With reference to " appendix related content of Chinese pharmacopoeia version in 2010 is tested, and mouse tail vein injection embodiment 5 (embodiment 1) solution 0.5ml (2.5mg)/only, the result shows that 5 mices all death and other exception table take place now.
Above-mentioned result of the test shows that the application safety of this product is up to specification.
Though above the present invention is described in detail with a general description of the specific embodiments, on basis of the present invention, can make some modifications or improvements it, this is to show and Yi Fengjian to those skilled in the art.Therefore, this modification of this that made or improvement without departing from theon the basis of the spirit of the present invention all belongs to the scope of protection of present invention.
Claims (9)
1. a Pharmaceutical composition is characterized in that, described compositions contains ginsenoside Rg1, ginsenoside Rb1 and ginsenoside Re, and wherein, the ginsenoside Rg1: the weight ratio of ginsenoside Rb1 and ginsenoside Re's sum is 1: 0.7～1.2.
2. compositions according to claim 1 is characterized in that the ginsenoside Rg1: the weight ratio of ginsenoside Rb1 and ginsenoside Re's sum is 1: 0.8～1.1.
3. compositions according to claim 2 is characterized in that the ginsenoside Rg1: the weight ratio of ginsenoside Rb1 and ginsenoside Re's sum is 1: 0.9～1.05.
4. according to each described compositions of claim 1-3, it is characterized in that, also comprise arasaponin R1, and arasaponin R1 and ginsenoside Rg1's weight ratio is 0.15～0.55: 1.
5. according to each described compositions of claim 1-3, it is characterized in that, also comprise the ginsenoside Rd, and ginsenoside Rd and ginsenoside Rg1's weight ratio is 0.15～0.55: 1.
6. according to each described compositions of claim 1-3, it is characterized in that, also comprise ginsenoside Rd and arasaponin R1, and ginsenoside Rd, arasaponin R1 and ginsenoside Rg1's weight ratio is 0.15～0.55: 0.15～0.55: 1.
7. comprise each the described compositions of claim 1-6 and the preparation of available support pharmaceutically.
8. each described compositions of claim 1-6 is in the application that is used for preparing the medicine for the treatment of hemorrhagic apoplexy.
9. each described compositions of claim 1-6 is in the application of the medicine that is used for preparing treatment schizophrenia residual period.
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| AU2016256704B2 (en) * | 2012-08-15 | 2018-08-02 | Chi, Yu Fen | Pharmaceutical composition increasing cyclic AMP content and availability in vivo, and preparation method thereof |
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Application publication date: 20110720 |