CN108186806A - With anti-oxidant, immunoregulation effect pharmaceutical composition and preparation method thereof - Google Patents

With anti-oxidant, immunoregulation effect pharmaceutical composition and preparation method thereof Download PDF

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Publication number
CN108186806A
CN108186806A CN201810226931.1A CN201810226931A CN108186806A CN 108186806 A CN108186806 A CN 108186806A CN 201810226931 A CN201810226931 A CN 201810226931A CN 108186806 A CN108186806 A CN 108186806A
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parts
pharmaceutical composition
auxiliary material
oxidant
green tea
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闫玉森
闫蔚
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Zhuhai Special Economic Zone Natural Medicine Research Institute Co Ltd
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Zhuhai Special Economic Zone Natural Medicine Research Institute Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/82Theaceae (Tea family), e.g. camellia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/42Cucurbitaceae (Cucumber family)
    • A61K36/424Gynostemma
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/734Crataegus (hawthorn)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Medicinal Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

There is anti-oxidant, immunoregulation effect pharmaceutical composition and preparation method thereof the invention discloses a kind of, belong to technical field of traditional Chinese medicines.The pharmaceutical composition includes following raw material by weight:15~30 parts of green tea, 35~55 parts of gynostemma pentaphylla, 15~25 parts of hawthorn, 5~15 parts of auxiliary material;Preparation method is as follows:By in whole raw materials input extractor other than auxiliary material, refluxing extraction, and extracting solution is concentrated under reduced pressure twice is carried out using ethanol extraction process, auxiliary material stirring is added in and softwood or mixed liquor is made, be processed into clinically-acceptable dosage form.For the pharmaceutical composition using green tea, hawthorn, gynostemma pentaphylla as primary raw material, active component content is higher, take it is more convenient, have good immunological regulation and antioxidation.

Description

With anti-oxidant, immunoregulation effect pharmaceutical composition and preparation method thereof
Technical field
The present invention relates to technical field of traditional Chinese medicines, and in particular to a kind of to have anti-oxidant, immunoregulation effect pharmaceutical composition Object and preparation method thereof.
Background technology
Oxidative stress is when body is by external source or endogenous stimulation, and active bioactive molecule such as oxygen radical and nitrogen are free Base content increases, and accelerates oxidation reaction, once beyond body to oxidation product Scavenging activity, each system operation load of body adds Weight leads to the generation that eubolism is disorderly, a variety of diseases occur, induce for inflammatory reaction, such as:Neurodegenerative disease, glycosuria Disease, hypertension, atherosclerosis etc., therefore it is the necessary means for protecting body normal function to resist oxidative stress.In antioxygen Change stress research in, many naturals can effectively reduce monoamine oxidase (MAO) and malonaldehyde (MDA) content etc. Index rises, and prevents these oxidizing ferment or oxidation product excessively caused cell ageing or necrosis, cell dysfunction, cell Proliferative capacity declines, and protease activity reduces, and then entire organism aging process, immunity degradation, leads to the various diseases occurred.Clear During except free radical, many antioxidases play an important role, such as relevant superoxide dismutase (SOD), peroxide Change hydrogen enzyme (CAT) etc., these antioxidases damage caused by can reducing free radical, protect body from caused by oxidative stress Injury.Immune system plays the function of response, defence and monitoring in vivo, in this process, not only mononuclear macrophage pair Respiratory burst can be generated by swallowing to antigen digestion, form a large amount of active oxygens, and the lymphocyte and NK cells and target activated When cell works, reactive oxygen metabolite is equally also quickly generated, therefore, immune system is more easy to than other systems in a kind of slow Property oxidative stress stimulation, active oxygen be likely in the atrophy of immune organ and functional deterioration process play start or promote Effect.
In existing natural, teas (catechin, green tea, black tea and oolong tea) antioxidation is most strong, and And find that catechin and cloves also have certain immanoprotection action, but its immanoprotection action is relatively limited.In view of this, The drug or pharmaceutical composition that it is necessary to find and find more effectively to have both anti-oxidant and immunological regulation, protect.
Invention content
For overcome the deficiencies in the prior art, the purpose of the present invention is to provide one kind, and there is anti-oxidant, immunological regulation to make Pharmaceutical composition and preparation method thereof, the pharmaceutical composition is using green tea, hawthorn, gynostemma pentaphylla as primary raw material, active constituent Content is higher, take it is more convenient, have good immunological regulation and antioxidation.
To solve the above problems, the technical solution adopted in the present invention is as follows:
With anti-oxidant, immunoregulation effect pharmaceutical composition, including following raw material by weight:Green tea 15 ~30 parts, 35~55 parts of gynostemma pentaphylla, 15~25 parts of hawthorn, 5~15 parts of auxiliary material.
As the preferred embodiment of the present invention, pharmaceutical composition of the present invention includes following original by weight Material:20~30 parts of green tea, 40~55 parts of gynostemma pentaphylla, 18~25 parts of hawthorn, 8~12 parts of auxiliary material.
As further preferred embodiment of the present invention, pharmaceutical composition of the present invention include it is following by weight The raw material of meter:25 parts of green tea, 45 parts of gynostemma pentaphylla, 20 parts of hawthorn, 10 parts of auxiliary material.
As the preferred embodiment of the present invention, the green tea is green tea dry tea or dark brownish green.
As the preferred embodiment of the present invention, the auxiliary material is by the adjuvant that receives on drug.
As the preferred embodiment of the present invention, described pharmaceutical composition is tablet, granule, capsule or soft capsule Agent.
In the formula of the present invention, separation and Extraction obtains in green tea polyphenols EGCG be it is a kind of it is natural it is harmful from By base scavenger, isolated Flavonoid substances are can to improve microcirculation, reduce blood viscosity prevention cardiovascular and cerebrovascular in hawthorn Disease and promote digestive function, the ginsenoside that separation and Extraction obtains in gynostemma pentaphylla has the function of adjusting human immune system.Cause This pharmaceutical composition of the present invention is with well with immunological regulation and antioxidation.
The present invention also provides a kind of preparation methods of pharmaceutical composition as described above, include the following steps:
1) each raw material is weighed by formula ratio, whole raw materials other than auxiliary material is put into extractor successively, add in 70% Ethyl alcohol infiltrates, and extraction twice, merges extracting solution and is concentrated under reduced pressure and recycles ethyl alcohol, and it is 1.25~1.30 to obtain relative density Concentrate, shady place are kept in spare;
2) auxiliary material is sieved or filtered, be added in mixing machine, then add in concentrate made from step 1) in auxiliary material Softwood or mixed liquor is made in stirring, is subsequently processed into clinically-acceptable dosage form.
Preferably, the concrete operations of step 1) are as follows:70% ethyl alcohol of 6 times of amounts of medicinal material amount is added in, infiltrates 15~30min, The heating of oil heater oil supply is opened, when oil temperature is up to when spending 130 DEG C, open the circulation pump carries out oil bath heating;When leach cooking liquid starts to boil First time refluxing extraction is carried out after rising, extracting solution is filtered, filtrate is pumped into inspissator concentrates;The remaining dregs of a decoction add in 70% ethyl alcohol of 5 times of amounts of medicinal material amount carries out second of refluxing extraction, and filtrate is pumped into inspissator and first time extracting solution by filtering Continue to be concentrated under reduced pressure, obtain 25~30L of concentrate that relative density is 1.25~1.30, weigh, after cooling under shady place It is temporary spare.
Preferably, in step 1) extraction time of first time refluxing extraction for 1.5h, during the extraction of second refluxing extraction Between be 1h.
Preferably, the concentration condition in step 1) is:Vacuum degree is -0.03~-0.06Mpa, and thickening temperature is 60~95 ℃。
Compared with prior art, the beneficial effects of the present invention are:
Pharmaceutical composition of the present invention has carried out extraction purification to medicinal materials such as natural plants green tea, gynostemma pentaphylla, hawthorn, Obtained active skull cap components polyphenols EGCG, Flavonoid substances and content of ginsenoside is higher, passes through experimental verification sheet The pharmaceutical composition of invention has stronger Scavenging ability, and antioxidant effect is good, can not only inhibit tumour growth, and And the mouse NK activity as caused by tumour can be fought and declined, there is immunoregulatory effect.
The present invention pharmaceutical composition active component content it is higher, take it is more convenient, have good immunological regulation and Antioxidation.
Description of the drawings
Fig. 1 is the process flow chart that tablet is made in pharmaceutical composition of the present invention.
Specific embodiment
The present invention is described in further detail with reference to the accompanying drawings and detailed description.
Embodiment 1:
With anti-oxidant, immunoregulation effect pharmaceutical composition, including following raw material by weight:Green tea 25 Part, 45 parts of gynostemma pentaphylla, 20 parts of hawthorn, 10 parts of auxiliary material.
In the present embodiment, green tea is dark brownish green, and auxiliary material is starch, and above pharmaceutical composition is made tablet, such as Fig. 1 institutes Show, specific preparation method step is as follows:
1) each raw material is weighed by formula ratio, whole raw materials other than auxiliary material is put into extractor successively, add in medicinal material 6 times of 70% ethyl alcohol measured are measured, infiltrate 20min, open the heating of oil heater oil supply, when oil temperature, which reaches, spends 130 DEG C, open the circulation pump Carry out oil bath heating;First time refluxing extraction is carried out after leach cooking liquid comes to life, refluxing extraction 1.5h takes out extracting solution Filter, is pumped into inspissator by filtrate and concentrates;70% ethyl alcohol progress, second of reflux that the remaining dregs of a decoction add in 5 times of amounts of medicinal material amount carries Take, refluxing extraction 1h, filter, filtrate is pumped into inspissator and continues to be concentrated under reduced pressure with first time extracting solution, concentration it is true Reciprocal of duty cycle be -0.03~-0.06Mpa, thickening temperature be 60~95 DEG C, obtain relative density be 1.25~1.30 concentrate 25~ 30L is weighed, temporary spare under shady place after cooling.
2) starch is sieved, be added in mixing machine, then added in stir in starch by concentrate made from step 1) and make Into softwood, after 10 mesh screens are loaded onto on oscillating granulator, manufactured softwood is added in into swing particle, particle, granulation knot is made The particle made is transferred to clean stainless steel disc in heat-circulation oven to dry, whole grain, total mixed, tabletting after beam, it is aluminum-plastic packaged.
Embodiment 2:
With anti-oxidant, immunoregulation effect pharmaceutical composition, including following raw material by weight:Green tea 15 Part, 55 parts of gynostemma pentaphylla, 15 parts of hawthorn, 15 parts of auxiliary material.
In the present embodiment, green tea is dark brownish green, and auxiliary material is the capsules such as microcrystalline cellulose, magnesium stearate, talcum powder, sodium starch Auxiliary material is commonly used in agent, above pharmaceutical composition is made capsule, specific preparation method step is as follows:
1) each raw material is weighed by formula ratio, whole raw materials other than auxiliary material is put into extractor successively, add in medicinal material 6 times of 70% ethyl alcohol measured are measured, infiltrate 30min, open the heating of oil heater oil supply, when oil temperature, which reaches, spends 130 DEG C, open the circulation pump Carry out oil bath heating;First time refluxing extraction is carried out after leach cooking liquid comes to life, refluxing extraction 1.5h takes out extracting solution Filter, is pumped into inspissator by filtrate and concentrates;70% ethyl alcohol progress, second of reflux that the remaining dregs of a decoction add in 5 times of amounts of medicinal material amount carries Take, refluxing extraction 1h, filter, filtrate is pumped into inspissator and continues to be concentrated under reduced pressure with first time extracting solution, concentration it is true Reciprocal of duty cycle be -0.03~-0.06Mpa, thickening temperature be 60~95 DEG C, obtain relative density be 1.25~1.30 concentrate 25~ 30L is weighed, temporary spare under shady place after cooling.
2) auxiliary materials such as microcrystalline cellulose, magnesium stearate, talcum powder, sodium starch are sieved, be added in mixing machine, then will Concentrate made from step 1) adds in stirring in auxiliary material and softwood is made, and after 10 mesh screens are loaded onto on oscillating granulator, will be made Softwood add in swing particle particle be made, the particle made is transferred to thermal cycle baking with clean stainless steel disc after granulation Dry in case, capsule is filling, aluminum-plastic packaged.
Embodiment 3:
With anti-oxidant, immunoregulation effect pharmaceutical composition, including following raw material by weight:Green tea 35 Part, 35 parts of gynostemma pentaphylla, 25 parts of hawthorn, 5 parts of auxiliary material.
In the present embodiment, green tea is dark brownish green, and auxiliary material is Icing Sugar and dextrin, and above pharmaceutical composition is made particle Agent, specific preparation method step are as follows:
1) each raw material is weighed by formula ratio, whole raw materials other than auxiliary material is put into extractor successively, add in medicinal material 6 times of 70% ethyl alcohol measured are measured, infiltrate 25min, open the heating of oil heater oil supply, when oil temperature, which reaches, spends 130 DEG C, open the circulation pump Carry out oil bath heating;First time refluxing extraction is carried out after leach cooking liquid comes to life, refluxing extraction 1.5h takes out extracting solution Filter, is pumped into inspissator by filtrate and concentrates;70% ethyl alcohol progress, second of reflux that the remaining dregs of a decoction add in 5 times of amounts of medicinal material amount carries Take, refluxing extraction 1h, filter, filtrate is pumped into inspissator and continues to be concentrated under reduced pressure with first time extracting solution, concentration it is true Reciprocal of duty cycle be -0.03~-0.06Mpa, thickening temperature be 60~95 DEG C, obtain relative density be 1.25~1.30 concentrate 25~ 30L is weighed, temporary spare under shady place after cooling.
2) Icing Sugar and dextrin are sieved, are added in mixing machine, then add in concentrate made from step 1) in auxiliary material Softwood is made in stirring, after 10 mesh screens are loaded onto on oscillating granulator, manufactured softwood is added in swing particle, particle is made, The particle made is transferred in heat-circulation oven dry, packaging with clean stainless steel disc after granulation.
First, animal safety evaluation test
1st, acute toxicity test in mice
20 intragastric administration on mice is taken to give the suspension of the 0.3g/mL aforementioned pharmaceutical compositions of 0.25mL/10g, twice in succession Daily, it is spaced 6 hours, is observed continuously 7 days, animal ingests daily, drink water and defecation is normal, none animal dead is converted into Intragastric administration on mice maximal tolerance dose>15g/kg illustrates toxicity very little.
2nd, rat chronic toxicity test
60 rats are divided into two groups, continuously feed the pharmaceutical composition (low dose group of the present invention:2.5g/kg and high agent Amount group:10g/kg), gavage is after three months, as shown in table 1~3, does not find various caused by the pharmaceutical composition of the present invention Pathologic changes, and shows that the pharmaceutical composition of the present invention is suitble to take for a long time, will not generate overt toxicity to animal body.
The influence increased to rat body weight in 3 months of 1 continuous gavage of the present invention of table
The 2 continuous gavage of the present invention influence to rat blood index in 3 months of table
The 3 continuous gavage of the present invention influence to rat blood index in 3 months of table
2nd, compliance test result
1st, influence of the present invention to mice transplanted tumor
The pharmaceutical composition of the present invention is divided into three concentration (0.2g, 0.6g, 1.2g) and is injected in three groups of transplanted tumors Mouse:Sarcoma 180 (S180), ehrlich carcinoma solid type (EC) and liver cancer entity (HEPS), injection is found after 14 days, the results are shown in Table 4, Tumor size is reduced in three groups of mouse, and tumor control rate is up to 26~66%.It is noted by the pharmaceutical composition of the present invention Penetrated in mouse, average viability also increases.In addition, in another experiment, mouse is divided into two groups:Prevention group and Treatment group.The results are shown in Table 5, and prevention group gavage before S180 tumour cells are inoculated with takes the pharmaceutical composition of the present invention, and The pharmaceutical composition of the present invention is then taken after S180 cells are inoculated with by treatment group, as a result, it was confirmed that the pharmaceutical composition of the present invention can Effectively improve average Survival number of days and tumor control rate.
Table 4 gives difference and is put to the test after Rat 24 h that NPRO is horizontal in urine
Influence of 5 present invention of table to S180 Bearing Mice Life Prolongations
2nd, influence of the present invention to immune function of mice
NK cells are that a kind of antibody that do not need to participates in and the multi-functional cell mass with natural killer effect, research shows that, There is proportional relation between external high NK is active and antitumor in vivo.9 mouse are divided into three groups and are inoculated with Emhorn ascites by this experiment Cancer after giving within continuous 10 days pharmaceutical composition dosage 0.3g/kg, 0.6g/kg, 0.9g/kg of the present invention, the results are shown in Table 6 and table 7, As a result confirm that taking pharmaceutical composition of the present invention can make to take a group NK increased activities, wherein 0.9g/kg groups effect is most strong, takes Pharmaceutical composition mouse lymphocyte conversion ratio of the present invention can go up 64.3%, with the increasing of pharmaceutical composition dosage of the present invention Adding, NK cells and T lymphocytes have pull(ing) effect, illustrate that pharmaceutical composition of the present invention can not only inhibit tumour growth, and The mouse NK activity as caused by tumour can be fought to decline, there is immunoregulatory effect.
Influence of 6 present invention of table to Ehrlich ascites carcinoma Splenic vein hemodynamics
Influence of 7 present invention of table to Ehrlich ascites carcinoma NK cell activity
3rd, the present invention tests inferior ammonium nitrate synthesis blocking effect (Ames)
In an aseptic environment, five kinds of reaction systems are distributed:(1) sodium nitrite and aminopyrine;(2) sodium nitrite, amino Than woods plus the present invention;(3) sodium nitrite, aminopyrine add vitamin c;(4) sodium nitrite;(5) aminopyrine.Five kinds of samples are pressed Ames methods detect mutagenicity.Experiment confirms:The pharmaceutical composition of the present invention can block the synthesis of N-nitrosodimethylamine, with It does not add in of the present invention group to compare, difference has significant property, and synthesizes nitrosamine with concentrations of vitamin C solution and block efficiency significantly low In of the present invention group.
4th, the present invention blocks the experiment of N ﹣ nitrite synthesis in rat body
N- nitroso compounds have carcinogenesis, a large amount of during the marinated of food, frying to generate, and human body is caused Injury.Experiment in vitro proves that the pharmaceutical composition of the present invention can significantly block the synthesis of N-nitrosomorpholine, blocking rate It is 94%, this experiment further confirms the protective effect on cancer risk of the present invention in animal body:Take 13 healthy rats, using itself as pair According to, different foods are given by stages, the first phase is no process phase, and the second phase gives L-PROLINE, and the third phase gives sodium nitrite, the The fourth phase gives L-PROLINE and adds sodium nitrite, and the fifth phase gives L-PROLINE and sodium nitrite is added to add ascorbic acid, and the 6th phase was given L-PROLINE adds sodium nitrite to add medicinal composition solution of the invention.By surveying NPRO contents in urine, rat L- dried meat ammonia is given Acid and sodium nitrite, NPRO contents are 64.64mol in twenty-four-hour urine, 40 times higher than background level, and feed the rat of the present invention NPRO in twenty-four-hour urine is only 2.18mol, and blocking rate is up to 97%, and difference has significant meaning (P<0.01).
Table 8 gives difference and is put to the test after Rat 24 h that NPRO is horizontal in urine
Note:Proline, sodium nitrite dosage are 40umol, 0.5ml gavages, ascorbic acid 36umol, 1.2ml gavage, 0.9g/kg of the present invention, 1.2ml gavage.
5th, the present invention removes the experiment in vitro of harmful free radicals
Using thymidylic acid (TMP), directly irradiated 46 minutes with ten thousand rad of 60Co100, utilize electron spin resonance Spectrometer detection ESR obtains number of free radical after being computed, and pharmaceutical composition using the present invention is as free radical scavenger, And are found by the pharmaceutical composition of the present invention has and significantly removes 60Co irradiations as control for haw thorn extract, green tea polyphenols Caused harmful free radicals, Scavenging activity reach 63% and are compared with control group, have significant statistical significance.
Scavenging effect of 9 present invention of table to harmful free radicals
By being tested above it is found that the pharmaceutical composition of the present invention contains the higher active skull cap components polyphenols of content EGCG, Flavonoid substances and ginsenoside, pharmaceutical composition of the invention have stronger Scavenging ability, anti-oxidant effect Fruit is good, can not only inhibit tumour growth, and can fight the mouse NK activity as caused by tumour and decline, and has immunological regulation Effect.
The above embodiment is only the preferred embodiment of the present invention, it is impossible to the scope of protection of the invention is limited with this, The variation and replacement for any unsubstantiality that those skilled in the art is done on the basis of the present invention belong to institute of the present invention Claimed range.

Claims (10)

1. with anti-oxidant, immunoregulation effect pharmaceutical composition, it is characterised in that:Including following original by weight Material:15~30 parts of green tea, 35~55 parts of gynostemma pentaphylla, 15~25 parts of hawthorn, 5~15 parts of auxiliary material.
2. according to claim 1 have anti-oxidant, immunoregulation effect pharmaceutical composition, it is characterised in that:Including Raw material by weight below:20~30 parts of green tea, 40~55 parts of gynostemma pentaphylla, 18~25 parts of hawthorn, 8~12 parts of auxiliary material.
3. according to claim 1 have anti-oxidant, immunoregulation effect pharmaceutical composition, it is characterised in that:Including Raw material by weight below:25 parts of green tea, 45 parts of gynostemma pentaphylla, 20 parts of hawthorn, 10 parts of auxiliary material.
4. according to claim 1 have anti-oxidant, immunoregulation effect pharmaceutical composition, it is characterised in that:It is described Green tea is green tea dry tea or dark brownish green.
5. according to claim 1 have anti-oxidant, immunoregulation effect pharmaceutical composition, it is characterised in that:It is described Auxiliary material is by the adjuvant that receives on drug.
6. according to claim 1 have anti-oxidant, immunoregulation effect pharmaceutical composition, it is characterised in that:It is described Pharmaceutical composition is tablet, granule, capsule or soft capsule.
7. a kind of preparation method of pharmaceutical composition as described in claim 1, it is characterised in that:Include the following steps:
1) each raw material is weighed by formula ratio, whole raw materials other than auxiliary material is put into extractor successively, add in 70% ethyl alcohol Infiltration, extraction twice, merge extracting solution and are concentrated under reduced pressure and recycle ethyl alcohol, obtain the concentration that relative density is 1.25~1.30 Liquid, shady place are kept in spare;
2) auxiliary material is sieved or filtered, be added in mixing machine, then concentrate made from step 1) is added in auxiliary material and is stirred Softwood or mixed liquor is made, is subsequently processed into clinically-acceptable dosage form.
8. preparation method as claimed in claim 7, it is characterised in that:The concrete operations of step 1) are as follows:Add in 6 times of medicinal material amount 70% ethyl alcohol measured infiltrates 15~30min, opens the heating of oil heater oil supply, when oil temperature, which reaches, spends 130 DEG C, open the circulation pump Carry out oil bath heating;First time refluxing extraction is carried out after leach cooking liquid comes to life, extracting solution is filtered, filtrate is pumped into Inspissator is concentrated;70% ethyl alcohol that the remaining dregs of a decoction add in 5 times of amounts of medicinal material amount carries out second of refluxing extraction, and filtering will filter Liquid pump enters in inspissator to be continued to be concentrated under reduced pressure with first time extracting solution, obtains the concentrate that relative density is 1.25~1.30 25~30L is weighed, temporary spare under shady place after cooling.
9. preparation method as claimed in claim 8, it is characterised in that:The extraction time of first time refluxing extraction is in step 1) 1.5h, the extraction time of second of refluxing extraction is 1h.
10. preparation method as claimed in claim 8, it is characterised in that:Concentration condition in step 1) is:Vacuum degree for- 0.03~-0.06Mpa, thickening temperature are 60~95 DEG C.
CN201810226931.1A 2018-03-14 2018-03-14 With anti-oxidant, immunoregulation effect pharmaceutical composition and preparation method thereof Pending CN108186806A (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104666618A (en) * 2013-12-03 2015-06-03 天津尖峰弗兰德医药科技发展有限公司 Traditional Chinese medicine composition with anti-aging effect

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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Application publication date: 20180622