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CN101612254A - A kind of pharmaceutical composition and preparation method thereof with resisting fatigue, immunoregulation effect - Google Patents

A kind of pharmaceutical composition and preparation method thereof with resisting fatigue, immunoregulation effect Download PDF

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Publication number
CN101612254A
CN101612254A CN200910059970A CN200910059970A CN101612254A CN 101612254 A CN101612254 A CN 101612254A CN 200910059970 A CN200910059970 A CN 200910059970A CN 200910059970 A CN200910059970 A CN 200910059970A CN 101612254 A CN101612254 A CN 101612254A
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echinacea
folium camelliae
camelliae sinensis
extractum
raw material
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刘晏平
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Abstract

The invention provides a kind of resisting fatigue that has, pharmaceutical composition of immunoregulation effect and preparation method thereof, it is by Echinacea, Folium Camelliae sinensis is the medicament that raw material is made, its weight proportion is: 1~5 part of Echinacea, 1~5 part of Folium Camelliae sinensis, it has phagocytic activity and the active remarkable efficacy of enhancing human body immunity that stimulates macrophage, the endurance of scalable enhancing body's immunological function and raising body fatigue resistance, it is simple and direct that the present invention has production technology, low cost of manufacture, select the materials safety environmental protection for use, no medication taboo, be suitable for the far-ranging advantage of crowd, splendid market prospect is arranged.

Description

A kind of pharmaceutical composition and preparation method thereof with resisting fatigue, immunoregulation effect
Technical field:
The present invention relates to a kind of medicine of regulating immune fatigue alleviating, belong to the technical field of Chinese patent medicine, specifically a kind of medicine with resisting fatigue, immunoregulation effect the invention still further relates to the Preparation method and use of this medicine.
Background technology:
Continuous quickening along with modern society's live and work rhythm need not to dare not or would not speak up, and has a large portion crowd's health always to be the sub-health state that is in fatigue.Modern medicine shows: overtiredly become a healthy stealthy killer of serious threat people.We know: the organism of the complexity that human body itself is made up of a plurality of physiological systems.In fact, people's in live and work, all be subjected at any time coming from the outside attack of various pathogenic bacterium and virus, people under normal circumstances can rely on the powerful immune system that self has resist various diseases and keep healthy animation fully.But, when human body undue tired or old weak the time immunologic function will significantly descend, influence life quality thereby just be easy to suffer from disease, in the time of seriously even go back the entail dangers to life security in this period.Up to now, medical circle is all being made great efforts the medicine that development can effectively be regulated body immunity, have fatigue alleviating building body effect always, though existing on the market a lot of antifatigue health foods and medicine listing, practical effect is mostly not ideal enough.Tell it like it is, and some Chinese medicine medicines of being developed according to China's Traditional Chinese medical theory are but being obtained comparatively satisfied curative effect aspect adjusting immunity and the fatigue alleviating recently.Chinese patent CN1251697C discloses " a kind of composition and method of making the same, purposes and method of quality control with immunomodulating and anti-fatigue effect ", it is to make flexible glue by Radix Panacis Quinquefolii Saponin extract and Echinacea ethanol extraction to assist for taking, it utilize Echinacea have immune stimulating activity, enhance immunity cell to the lethality of pathogen, suppress virus replication and antiphlogistic effect, improve the resistance of body fatigue resistance.But it but exists some defectives with Echinacea and Radix Panacis Quinquefolii material combination prescription, mainly shows as: first: traditional Chinese medical science pharmacology theory is thought cold in nature, the sweet and slightly bitter taste of Radix Panacis Quinquefolii, goes into the lung spleen channel.Effect with boosting qi and nourishing yin, nourishing the stomach to promote the production of body fluid.But it but has bigger taboo crowd: all stomaches have that cold-damp, middle-jiao yang, function of the spleen and stomach are on the decline, the damp and hot person of sense all should not take, and particularly cold, the many persons of dysmenorrhea amenorrhea band of impotence in male, woman's property avoid usefulness especially, otherwise further the damage yang-energy increase the weight of the state of an illness on the contrary.This has just greatly limited its suitable crowd's scope; Second: the American ginseng medicine price is expensive and technology Saponin extraction active component is comparatively complicated, causes market price more expensive owing to production cost is high, and numerous crowds of wage-earners also are difficult to accept for the moment.Could how on the basis that keeps the Echinacea special efficacy, create the drug matching prescription that makes new advances and new production technology? this the present invention just wants the problem researched and solved.
Summary of the invention:
Purpose of the present invention is intended to overcome defective and the deficiency that above-mentioned prior art exists, and propose a kind of select for use medical material rationally, the prescription compatibility is economical and practical, production cost is low, the crowd that is suitable for extensively need not to avoid and have pharmaceutical composition of remarkable resisting fatigue, immunomodulating effect and preparation method thereof.
The objective of the invention is to realize by following technical solution:
A kind of pharmaceutical composition with resisting fatigue, immunoregulation effect, said pharmaceutical composition is that component is formed or made on active component and the pharmaceutics acceptable auxiliary by the solvent extractable matter of following raw materials according and form: Echinacea, Folium Camelliae sinensis by following raw materials according, the weight part ratio of described raw material is: Echinacea 1 ∽ 5 weight portions, Folium Camelliae sinensis 1 ∽ 5 weight portions.
For further realizing purpose of the present invention, its optimizing materials weight part ratio is: Echinacea 1 ∽ 2 weight portions, Folium Camelliae sinensis 1 ∽ 2 weight portions.
Folium Camelliae sinensis in the above-mentioned said raw material components is meant a kind of, the perhaps wherein any two kinds mixture in black tea, LVHUA, the scented tea, or three kinds mixture, also can be other commercial local tea variety.
The solvent of above-mentioned said extraction raw material active component is a water, perhaps ethanol, perhaps aquiferous ethanol.
The said medicine of the present invention can be prepared into the various regular dosage forms that meet pharmaceutics, for example: dosage forms such as tablet, pill, granule, oral liquid.
A kind of preparation of drug combination method with resisting fatigue, immunoregulation effect, it is to carry out as follows:
(1) prepare the water extract extractum of Echinacea, Folium Camelliae sinensis respectively:
Put into separately container respectively than taking by weighing Echinacea, tea raw material by weight, extraordinarily going into clear water by 6 ∽ 10 of raw material weight respectively soaks, is heated to boil and decocted 20 ∽ 40 minutes, the leaching medicinal liquid promptly makes the aqueous extract of Echinacea and the aqueous extract of Folium Camelliae sinensis respectively, concentrates through the decompression heating respectively and can make the water extract extractum of Echinacea and the water extract extractum of Folium Camelliae sinensis respectively.
Behind the leaching medicinal liquid, can regather medicinal residues, Jia Shui and carry out secondary and decoct, the secondary raffinate of leaching is used in the lump, can improve medical material the extraction and application rate, save the medicinal raw material resource.
(2) prepare the ethanol extraction extractum of Echinacea, Folium Camelliae sinensis respectively:
Put into separately container respectively than taking by weighing Echinacea, tea raw material by weight, 6 ∽ 10 by raw material weight extraordinarily go into soak with ethanol, are heated to boil and decocted 20 ∽ 40 minutes respectively, the leaching medicinal liquid promptly makes the ethanol extract of Echinacea and the ethanol extract of Folium Camelliae sinensis respectively, concentrates through the decompression heating respectively and can make the ethanol extraction extractum of Echinacea and the ethanol extraction extractum of Folium Camelliae sinensis respectively.
Also can regather medicinal residues, add ethanol and carry out secondary and decoct, the secondary raffinate of leaching is used in the lump, can improve medical material the extraction and application rate, save the medicinal raw material resource.
(3) metering batch mixing:
Measure respectively according to weight part ratio: take by weighing ethanol extraction extractum 1 ∽, 5 weight portions of Echinacea or water extract extractum 1 ∽, 5 weight portions of Echinacea and ethanol extraction extractum 1 ∽, 5 weight portions of Folium Camelliae sinensis or the water extract of Folium Camelliae sinensis and get extractum 1 ∽ 5 weight portions, carry out the batch mixing operation, uniform compound obtains being mixed.
(4) add adjuvant:
Add adjuvant additives mix homogeneously, promptly can be made into the medicine of various pharmaceutical formulations.
It is to prepare the oral liquid formulation medicine like this:
After operating to the described mode of the step of (3) according to above-mentioned (1), said adding adjuvant additives are meant and add citric acid, potassium sorbate in (4) step, add the distilled water mixing again, through heating for dissolving, cold preservation, filtration, packing, sterilization treatment, promptly can be made into the medicine of oral liquid formulation.
It is to prepare the Tabules medicine like this:
After operating to the described mode of the step of (2) according to above-mentioned (1), in (3) step, also carry out following operation: with the ethanol extraction extractum of the Echinacea that taken by weighing, the water extract extractum of Echinacea, the ethanol extraction extractum of Folium Camelliae sinensis, after the water extract extractum of Folium Camelliae sinensis is made dry mash through spray drying respectively, take by weighing dry powder respectively according to weight part ratio again and carry out the batch mixing operation, uniform mixed powder material obtains being mixed, said adding adjuvant additives are meant and add medical disintegrating agent in above-mentioned (4) step, lubricant, with content is 85% alcohol granulation, tabletting promptly can be made into the medicine of Tabules.
A kind of preparation method with medicament composition granule agent dosage form of resisting fatigue, immunoregulation effect, it is to carry out as follows:
(1) metering is got the raw materials ready: measure respectively according to weight part ratio and take by weighing 5 parts of Echinacea 1 ∽, 5 parts of raw materials of Folium Camelliae sinensis 1 ∽.
(2) preparation powder: the Echinacea, the tea raw material that take by weighing are sent into pulverizer respectively carry out the grinding and processing operation and make Echinacea powder and Folium Camelliae sinensis powder.
(3) raw material that is mixed: the Echinacea powder of preparation and Folium Camelliae sinensis powder sent into carry out the batch mixing operation in the batch mixer, uniform mixed powder obtains being mixed.
(4) add adjuvant: machine is suppressed grain after adding adjuvant additives mixing according to conventional method, promptly can be made into the medicine of granule dosage form.
Said adding adjuvant additives are meant and add the Mel mixing in above-mentioned (4) step, promptly can be made into the medicine of pill dosage form.
The aforementioned pharmaceutical compositions that the present invention proposes can be widely used in producing the technical field that preparation has the health food and the medicine of resisting fatigue, immunological enhancement.
What the present invention proposed is primary raw material or makes the composition of prescription that the acceptable auxiliary additives are formed on active component and the pharmaceutics with the water of Echinacea, Folium Camelliae sinensis and/or the extract of organic solvent that with Echinacea, Folium Camelliae sinensis its pharmacological action is:
Echinacea (Echinacea): mean " bringing healthy SHENCAO ", it is a kind of herbaceos perennial that originates in America, the sweet light and delicate fragrance of distinguishing the flavor of, its flower, leaf, stem and root can be used as medicine, and all have a wide range of applications at aspects such as treatment and prevention bacterial infection, viral infection, fungal infection and human body immunity improving power.Show that through pharmacological research Echinacea can stimulate the phagocytic activity of macrophage, stimulate the T lymphopoiesis, significantly the enhancing human body immunity function.Toxicological study shows: toxicity is extremely low, and high safety is suitable for long-term or compatibility is used.In the European and American areas, people often take Echinacea and come the health invigorating prevent disease, and it is plant amedica and health product the longest on the western history, have been popular in the world immunostimulant.
Tea (Tea): the kind of plant that China finds the earliest, cultivates and utilizes.There is literature record to show, the drug effect that our ancestors' drought just began to plant Camellia sinensis and utilized tea before more than 3000 years.Put down in writing according to " legendary god of farming's book on Chinese herbal medicine ": " shennong went into the mountains collecting, tasting and testing different kinds of herbs to be used as medicine, day meets 72 poison, tea and separate it ".Effects such as Folium Camelliae sinensis has cholesterol and low density lipoprotein, LDL content in antioxidation, mutation, antitumor, the reduction blood, suppresses increased blood pressure, suppresses platelet aggregation, antibiotic, antiallergic, resisting fatigue.Nowadays drinking tea has become China common people other a kind of daily need and life style, have the good reputation of " the most cheap state's drink ", in China mass foundation is very widely arranged.Chinese tea and tea culture have spread all over all over the world, and the medical applications of Folium Camelliae sinensis has obtained global generally approval.
Distinguishing feature of the present invention and outstanding progressive being: it be based on China traditional tcm theory and medicine for treatment principle, with Echinacea and Folium Camelliae sinensis composition of prescription, give full play to the pharmacological effect that utilizes Echinacea and Folium Camelliae sinensis and form mutual supplement with each other's advantages.Prove by pharmacology test: it has resisting fatigue, regulate and the medicinal curative effect of raise immunity, has in the health food of resisting fatigue, immunological enhancement and the medicine in preparation to have a wide range of applications.Selected Echinacea and tea raw material all are avirulent pure natural plants, meet state food and the drug regulatory department prescription about health food and pharmaceutical raw material, and be without any side effects to human body.The present invention selects for use and is subjected to Folium Camelliae sinensis that the numerous common people of China have liked drink as raw material deeply, does not only have the taboo crowd, the also suitable especially popular common people's of China taste and living habit, and suitable colony is very extensive.Because tea raw material is cheap, can reduce manufacturing cost greatly, for people provide health promoting product inexpensive, of fine quality and that function is evident in efficacy.
The present invention has the advantage that following reality goes out:
1. the selected Chinese medicine medicinal raw material of the present invention meets the medicine for treatment principle of Traditional Chinese medical theory, the simple and direct compatibility science of component, particularly select for use Folium Camelliae sinensis as base stock, meet the traditional folk custom of China and common people's taste especially, almost do not have the taboo crowd, it has, and suitable crowd is in extensive range, the characteristics of obvious health-care efficacy.
2. preparation technology of the present invention is simple, manufacturing cost is low, taking convenience, and the utilization rate of active drug composition is high, and selected raw material is the medical material of pure natural, and life-time service is pollution-free, without any side effects, has high usage safety performance.
The specific embodiment:
The invention provides following embodiment, but these embodiment do not constitute the restriction to the claimed scope of the present invention.
[embodiment one]
A kind of preparation of drug combination method, it is to carry out as follows:
(1) metering is got the raw materials ready: get Echinacea 500g, Folium Camelliae sinensis 500g raw material than weighing balance respectively by weight.
(2) prepare powder: the Echinacea, the tea raw material that are taken by weighing are sent into respectively carried out the grinding and processing operation in the pulverizer, make Echinacea powder and Folium Camelliae sinensis powder, the fineness of control powder is 120 ∽, 150 orders.
(3) raw material that is mixed: the Echinacea powder of preparation and Folium Camelliae sinensis powder sent into carry out the batch mixing operation in the batch mixer, uniform mixed powder obtains being mixed.
(4) add adjuvant: send into machine compacting grain in the granulator after adding adjuvant additives mixing according to conventional method, the medicine that promptly can be made into the granule dosage form is for taking.
[embodiment two]
After carrying out (1) to (3) step according to embodiment one described mode, said adding adjuvant additives are to add the Mel raw material in (4) step, mix homogeneously, and the medicine that promptly can be made into the pill dosage form is for taking.
In medicine being carried out pharmacological effect test, will [embodiment one], in [embodiment two] the granule dosage form made of the Echinacea powder that adopts and Folium Camelliae sinensis powder mix, the drug labelling of pill dosage form be " pharmaceutical composition a ".
[embodiment three]
A kind of preparation of drug combination method, it is to carry out as follows:
(1) prepare the water extract extractum of Echinacea, Folium Camelliae sinensis respectively:
The raw material of getting Echinacea 500g, Folium Camelliae sinensis 500g than weighing balance is respectively put into container separately respectively by weight, extraordinarily go into the clear water immersion after 10 minutes by 10 of raw material weight respectively, being heated to boils decocted 35 minutes, the leaching medicinal liquid promptly makes the aqueous extract of Echinacea and the aqueous extract of Folium Camelliae sinensis respectively, regather medicinal residues and carry out the secondary decoction, the secondary raffinate of leaching is used in the lump, can make the water extract extractum of Echinacea and the water extract extractum of Folium Camelliae sinensis respectively through the decompression heating is concentrated respectively making the aqueous extract of Echinacea and the aqueous extract of Folium Camelliae sinensis.
(2) metering batch mixing:
The water extract extractum that takes by weighing the water extract extractum of the Echinacea that Echinacea 500g, Folium Camelliae sinensis 500g raw material made respectively and Folium Camelliae sinensis than metering is by weight put into batch mixer carry out the batch mixing operation, make the uniform extractum compound that is mixed.
(3) add adjuvant:
In the extractum compound that makes, add citric acid, potassium sorbate, add the distilled water mix homogeneously again after, through heating for dissolving, cold preservation, filtration, packing, sterilization treatment, can make the medicine of 1000mL oral liquid formulation.
[embodiment four]
According among the embodiment three (1), after the described mode of (2) step operates and make the extractum compound, carry out as follows again:
The extractum compound that makes is sent into drying machine carries out spray drying and make dry mash, add medical disintegrating agent, mix lubricant evenly after, be 85% alcohol granulation, tabletting with content, can make the medicine of 500 Tabuleses.
In medicine being carried out pharmacological effect test, will [embodiment three], the oral liquid formulation that the water extract extractum mix of the water extract extractum of the Echinacea that adopts and Folium Camelliae sinensis is made in [embodiment four], the drug labelling of Tabules be " pharmaceutical composition b ".
[embodiment five]
A kind of preparation of drug combination method, it is to carry out as follows:
(1) the water extract extractum of preparation Echinacea:
Operate by the described mode of (1) step among the embodiment three, make the water extract extractum of 500g Echinacea raw material.
(2) prepare the ethanol extraction extractum of Folium Camelliae sinensis, Echinacea respectively:
Put into separately container respectively than the raw material that takes by weighing Folium Camelliae sinensis 500g, Echinacea 500g by weight, extraordinarily go into soak with ethanol, be heated to the decoction 30 minutes of boiling by 10 of raw material weight respectively, the leaching medicinal liquid promptly makes the ethanol extract of Folium Camelliae sinensis and the ethanol extract of Echinacea respectively, regather medicinal residues and carry out the secondary decoction, the secondary raffinate of leaching is used in the lump, to make the ethanol extract of Folium Camelliae sinensis and the ethanol extract of Echinacea again and concentrate through the decompression heating respectively, promptly make the ethanol extraction extractum of Folium Camelliae sinensis and the ethanol extraction extractum of Echinacea respectively.
(3) metering batch mixing:
Carry out the batch mixing operation with putting into batch mixer than the ethanol extraction extractum of water extract extractum that takes by weighing the prepared Echinacea of 500g Echinacea raw material and the prepared Folium Camelliae sinensis of 500g tea raw material by weight, make the uniform extractum compound that is mixed.
(4) add adjuvant:
In the extractum compound that makes, add citric acid, potassium sorbate, add the distilled water mix homogeneously again after, through heating for dissolving, cold preservation, filtration, packing, sterilization treatment, can make the medicine of 1000mL oral liquid formulation.
[embodiment six]
Operate according to the described mode of (1) to (3) step among the embodiment five, after making the extractum compound, carry out as follows again:
The extractum compound that makes is sent into drying machine carries out spray drying and make dry mash, add medical disintegrating agent, mix lubricant evenly after, be 85% alcohol granulation, tabletting with content, can make the medicine of 500 Tabuleses.
In medicine being carried out pharmacological effect test, will [embodiment five], the oral liquid formulation that the ethanol extraction extractum mix of the water extract extractum of the Echinacea that adopts and Folium Camelliae sinensis is made in [embodiment six], the drug labelling of Tabules be " pharmaceutical composition c ".
[embodiment seven]
A kind of preparation of drug combination method, it is to carry out as follows:
(1) the ethanol extraction extractum of preparation Echinacea:
Operate according to the described mode of (2) step among the embodiment five, make the ethanol extraction extractum of 500g Echinacea raw material.
(2) the water extract extractum of preparation Folium Camelliae sinensis:
Operate according to the described mode of (1) step among the embodiment three, make the water extract extractum of 500g tea raw material.
(3) metering batch mixing:
Carry out the batch mixing operation with putting into batch mixer than the water extract extractum of ethanol extraction extractum that takes by weighing the prepared Echinacea of 500g Echinacea raw material and the prepared Folium Camelliae sinensis of 500g tea raw material by weight, make the uniform extractum compound that is mixed.
(4) add adjuvant:
In the extractum compound that makes, add citric acid, potassium sorbate, add the distilled water mix homogeneously again after, pass through heating for dissolving, cold preservation, filtration, packing, sterilization treatment again, can make the medicine of 1000mL oral liquid formulation.
[embodiment eight]
Operate according to the described mode of (1) to (3) step among the embodiment seven, after making the extractum compound, carry out as follows again:
The extractum compound that makes is sent into drying machine carry out spray drying and make dry mash, add medical disintegrating agent, mix lubricant is even, is 85% alcohol granulation, tabletting with content, can make the medicine of 500 Tabuleses.
In medicine being carried out pharmacological effect test, will [embodiment seven], the oral liquid formulation that the water extract extractum mix of the ethanol extraction extractum of the Echinacea that adopts and Folium Camelliae sinensis is made in [embodiment eight], the drug labelling of Tabules be " pharmaceutical composition d ".
[embodiment nine]
A kind of preparation of drug combination method, it is to carry out as follows:
(1) prepare the ethanol extraction extractum of Echinacea, Folium Camelliae sinensis respectively:
Operate according to the described mode of (2) step among the embodiment five, make the ethanol extraction extractum of 500g Echinacea raw material, the ethanol extraction extractum of 500g tea raw material respectively.
(2) metering batch mixing:
Carry out the batch mixing operation with putting into batch mixer than the ethanol extraction extractum of ethanol extraction extractum that takes by weighing the prepared Echinacea of 500g Echinacea raw material and the prepared Folium Camelliae sinensis of 500g tea raw material by weight, make the uniform extractum compound that is mixed.
(3) add adjuvant:
In the extractum compound that makes, add citric acid, potassium sorbate, add the distilled water mix homogeneously again after, through heating for dissolving, cold preservation, filtration, packing, sterilization treatment, can make the medicine of 1000mL oral liquid formulation.
[embodiment ten]
Operate according to the described mode of (1) to (2) step among the embodiment nine, after making the extractum compound, carry out as follows again:
The extractum compound that makes is sent into drying machine carries out spray drying and make dry mash, add medical disintegrating agent, mix lubricant evenly after, be 85% alcohol granulation, tabletting with content, can make 500 tablet medicines.
In medicine being carried out pharmacological effect test, will [embodiment nine], the oral liquid formulation that the ethanol extraction extractum mix of the ethanol extraction extractum of the Echinacea that adopts and Folium Camelliae sinensis is made in [embodiment ten], the drug labelling of Tabules be " pharmaceutical composition e ".
Carry out " pharmacology pharmacodynamic test " by following concrete experimental example and suffice to show that the beneficial effect that the present invention has.
[experimental example one]: Turnover of Mouse Peritoneal Macrophages phagocytic function experiment (half intracorporal method)
With 72 of the male mices of body weight 18 ∽ 20g, be divided into 6 groups at random, 12 every group.Each group # and corresponding administration are followed successively by:
1. matched group normal saline 2. pharmaceutical composition a 3. pharmaceutical composition b
4. pharmaceutical composition c 5. pharmaceutical composition d 6. pharmaceutical composition e
Pressing the formula material medical material calculates: mice dosage every day 3.5g/kg is equivalent to 10 times of clinical adult dose for oral use.
After 25 days, every mouse peritoneal is injected 20% chicken erythrocyte suspension 1mL, after 30 minutes at the continuous irrigation stomach, the cervical vertebra dislocation is put to death, and is fixed on the Mus plate, and abdominal skin is cut off in the center, inject normal saline 2mL through the abdominal cavity, rotated the Mus plate 1 minute, sucking-off abdominal cavity washing liquid 1mL, mean droplet is put 37 ℃ of insulations of wet box 30 minutes on 2 microscope slides, take out rinsing in normal saline, dry, fix, 4%GiemsaPBs dyeing 3 minutes, the distilled water rinsing is dried, microscopy.By formula calculate phagocytic percentage and phagocytic index, and carry out statistical procedures, result of the test as shown in Table 1:
Table one: the influence (X ± S) that Turnover of Mouse Peritoneal Macrophages is engulfed the chicken red blood cell ability
Annotate: compare with matched group, * represents P<0.01
Experimental result shows: pharmaceutical composition a provided by the invention, b, c, d, e all can significantly strengthen the ability that Turnover of Mouse Peritoneal Macrophages is engulfed chicken red blood cell.
[experimental example two]: mice swimming with a load attached to the body experiment
With 60 of the male mices of body weight 18 ∽ 20g, be divided into 6 groups at random, 10 every group.Each group # and corresponding administration are followed successively by:
1. matched group normal saline 2. pharmaceutical composition a 3. pharmaceutical composition b
4. pharmaceutical composition c 5. pharmaceutical composition d 6. pharmaceutical composition e
Pressing the formula material medical material calculates: mice dosage every day 3.5g/kg is equivalent to 10 times of clinical adult dose for oral use.
Successive administration 25 days is subjected to the reagent thing after 30 minutes at last, puts mice and swims in the case in swimming, the about 40cm of the depth of water, 25 ℃ of water temperatures, the load sheet lead of 5% body weight of Mus root of the tail portion.The record mice from swimming beginning to the dead time, as the mice swimming time (minute).The test statistics result is as shown in Table 2:
Table two: mice swimming with a load attached to the body experiment (X ± S)
Figure G2009100599708D00101
Annotate: compare with matched group, * represents P<0.05
Experimental result shows: pharmaceutical composition a provided by the present invention, b, e can significantly increase the mice swimming with a load attached to the body time and weightening finish not had influence.
Comprehensive conclusion:
The drug regimen of producing according to the technical scheme of the present invention's proposition has the phagocytic activity that stimulates macrophage and stimulates the active function of immunity of organism.Very obvious to the effect of regulating enhancing human body immunity ability and raising body fatigue resistance endurance.In the technical field of producing health food that preparation has resisting fatigue, immunological enhancement and medicine, has good development prospect.

Claims (10)

1. pharmaceutical composition with resisting fatigue, immunoregulation effect, it is characterized in that: said pharmaceutical composition is that component is formed or made on active component and the pharmaceutics acceptable auxiliary by the solvent extractable matter of following raw materials according and form: Echinacea, Folium Camelliae sinensis by following raw materials according, the weight part ratio of described raw material is: Echinacea 1 ∽ 5 weight portions, Folium Camelliae sinensis 1 ∽ 5 weight portions.
2. the pharmaceutical composition with resisting fatigue, immunoregulation effect according to claim 1 is characterized in that: the weight part ratio of said raw material is: Echinacea 1 ∽ 2 weight portions, Folium Camelliae sinensis 1 ∽ 2 weight portions.
3. the pharmaceutical composition with resisting fatigue, immunoregulation effect according to claim 1 and 2, it is characterized in that: the Folium Camelliae sinensis in the said raw material components is meant a kind of in black tea, LVHUA, the scented tea, perhaps wherein any two kinds mixture, or three kinds mixture.
4. the pharmaceutical composition with resisting fatigue, immunoregulation effect according to claim 1 and 2 is characterized in that: the solvent of said extraction raw material active component is a water, perhaps ethanol, perhaps aquiferous ethanol.
5. produce preparation of drug combination method as claimed in claim 1 for one kind, it is characterized in that: it carries out as follows:
(1) prepare the water extract extractum of Echinacea, Folium Camelliae sinensis respectively:
Put into separately container respectively than taking by weighing Echinacea, tea raw material by weight, adding the clear water post-heating decocts, the leaching medicinal liquid promptly makes the aqueous extract of Echinacea and the aqueous extract of Folium Camelliae sinensis respectively, concentrate through the decompression heating respectively again and can make the water extract extractum of Echinacea and the water extract extractum of Folium Camelliae sinensis respectively
(2) prepare the ethanol extraction extractum of Echinacea, Folium Camelliae sinensis respectively:
Put into separately container respectively than taking by weighing Echinacea, tea raw material by weight, adding the ethanol post-heating decocts, the leaching medicinal liquid promptly makes the ethanol extract of Echinacea and the ethanol extract of Folium Camelliae sinensis respectively, concentrate through the decompression heating respectively again and can make the ethanol extraction extractum of Echinacea and the ethanol extraction extractum of Folium Camelliae sinensis respectively
(3) metering batch mixing:
Measure respectively according to weight part ratio: take by weighing ethanol extraction extractum 1 ∽, 5 weight portions of Echinacea or water extract extractum 1 ∽, 5 weight portions and ethanol extraction extractum 1 ∽, 5 weight portions of Folium Camelliae sinensis or water extract extractum 1 ∽ 5 weight portions of Folium Camelliae sinensis of Echinacea, carry out the batch mixing operation, uniform compound obtains being mixed
(4) add adjuvant:
Add adjuvant additives mix homogeneously, promptly can be made into the medicine of various dosage forms.
6. preparation method according to claim 5, it is characterized in that: said adding adjuvant additives are meant and add citric acid, potassium sorbate in (4) step, add the distilled water mixing again, through heating for dissolving, cold preservation, filtration, packing, sterilization treatment, promptly make the medicine of oral liquid formulation.
7. preparation method according to claim 5, it is characterized in that: in (3) step, also carry out following operation: with the ethanol extraction extractum of the Echinacea that taken by weighing, the water extract extractum of Echinacea, the ethanol extraction extractum of Folium Camelliae sinensis, after the water extract extractum of Folium Camelliae sinensis is made dry mash through spray drying respectively, take by weighing dry powder respectively according to weight part ratio again and carry out the batch mixing operation, uniform mixed powder material obtains being mixed, said adding adjuvant additives are meant the adding disintegrating agent in (4) step, lubricant, with content is 85% alcohol granulation, tabletting is promptly made the medicine of Tabules.
8. produce preparation of drug combination method as claimed in claim 1 for one kind, it is characterized in that: it carries out as follows:
(1) metering is got the raw materials ready: measure respectively according to weight part ratio and take by weighing 5 parts of Echinacea 1 ∽, 5 parts of Folium Camelliae sinensis 1 ∽,
(2) preparation powder: the Echinacea, the Folium Camelliae sinensis that take by weighing are sent into pulverizer respectively carry out the grinding and processing operation and make Echinacea powder and Folium Camelliae sinensis powder,
(3) raw material that is mixed: the Echinacea powder of preparation and Folium Camelliae sinensis powder sent into carry out the batch mixing operation in the batch mixer, the uniform mixed powder that obtains being mixed,
(4) add adjuvant: add adjuvant additives mixing, granulation, promptly can be made into the medicine of granule dosage form.
9. preparation method according to claim 8 is characterized in that: in (4) step, said adding adjuvant additives are meant the adding Mel, promptly can be made into the medicine of pill dosage form.
10. a pharmaceutical composition as claimed in claim 1 has the health food of resisting fatigue, immunological enhancement and the application in the medicine in preparation.
CN200910059970A 2009-07-14 2009-07-14 A kind of pharmaceutical composition and preparation method thereof with resisting fatigue, immunoregulation effect Pending CN101612254A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102499413A (en) * 2011-11-03 2012-06-20 南昌大学 Recovering and nourishing beverage and preparation method thereof
CN103444960A (en) * 2013-09-11 2013-12-18 临沂大学 Hypsizygus mammoreus bigelow compound tea with anticancer and beautifying effects and preparation method thereof
CN104543130A (en) * 2014-12-30 2015-04-29 宁波戚家山茶叶有限公司 Preparation method of echinacea paradoxa black tea

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102499413A (en) * 2011-11-03 2012-06-20 南昌大学 Recovering and nourishing beverage and preparation method thereof
CN103444960A (en) * 2013-09-11 2013-12-18 临沂大学 Hypsizygus mammoreus bigelow compound tea with anticancer and beautifying effects and preparation method thereof
CN104543130A (en) * 2014-12-30 2015-04-29 宁波戚家山茶叶有限公司 Preparation method of echinacea paradoxa black tea

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