CN101278949A - Composition and its preparation and application - Google Patents
Composition and its preparation and application Download PDFInfo
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- CN101278949A CN101278949A CNA2007100907339A CN200710090733A CN101278949A CN 101278949 A CN101278949 A CN 101278949A CN A2007100907339 A CNA2007100907339 A CN A2007100907339A CN 200710090733 A CN200710090733 A CN 200710090733A CN 101278949 A CN101278949 A CN 101278949A
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Abstract
The invention provides a composition comprising biologically active components as follows: 100 weight parts of pearl, 15 to 300 weight parts of gyrophora and 15 to 300 weight parts of ganoderma spore powder. A preparation method and application of the composition are provided by the invention.
Description
Technical field
The present invention relates to a kind of composition and method of making the same and purposes.Compositions of the present invention has enhancing immunity and improves the sleep effect, and has antitumor and/or antitumaous effect.
Background technology
From domestic and international statistics in recent years, tumor disease has become the second in the world number " killer " that is only second to cardiovascular disease.The annual tumour patient of newly making a definite diagnosis in the whole world is all more than 1,000 ten thousand since 1996, dead more than 700 ten thousand people.The tumor incidence of China is equally very surprising, increases tumour patient 2,000,000 people newly domestic every year in recent years, about dead more than 130 ten thousand people.A large amount of now medicine medical researches has been used for reducing and overcoming the cancer disaster, but do not find the method for radical cure so far as yet, can only adopt the method for chemicals in conjunction with operation, present stage to the operation of tumor, put, chemotherapy makes patient's deficient qi and blood, deficiency of both the liver and kidney, leukocyte reduces in a large number in the blood, immunologic hypofunction, cause treating difficulty and increase, patient suffering's aggravation.Recently, to trend towards for the control of tumor be not only to kill cancerous cell, surgical radical treatment in countries in the world, mainly must improve body's immunity of tumor patient, improve the quality of living, prolong life span from the immunology aspect, in this respect, motherland's medicine and pharmacology have its extensive studies prospect.Simultaneously, along with people's rhythm of life is more and more faster, improving sleep quality also is the important topic of pendulum in face of people.
Ganoderma was used nearly 2000 in China as the medical material of " strengthening the body resistance, nourishing the essence and strengthening QI, invigorating the spleen and regulating the stomach, mind tranquilizing and the heart calming ", and the medical the earliest monograph Shennong's Herbal of China is classified it as product on " it is not old to make light of one's life by commiting suicide ".And the content of effective of Ganoderma spore powder exceeds 75 times of Ganodermas.According to domestic many document announcements, Ganoderma spore powder has the tumor of inhibition, regulates immunity, regulates neural, regulative mechanism four big pharmacological actions.Modern scientific research proves that its anticancer effect is remarkable, and obviously anticancer produces, and prevents cancer cell metastasis, recurrence, and can strengthen immunity of human body itself that the ameliorate tumor patient is because of the toxic and side effects of performing the operation, putting, chemotherapy being brought.Margarita is traditional rare Chinese medicine, and Chinese medicine is thought: and Margarita " cold in nature, sweet-salty is gone into the conscience warp, can purge heat that it is cold to separate, the arresting convulsion of calming the nerves, clear nebula makes eye bright, convergence granulation promoting, relieving cough and resolving phlegm ".How have the Chinese crude drug that improves people quality of life and carry out prescription effectively, make and have the product that strengthens body immunity and improve sleep function, be still the present problem that needs further investigation existing.
The present invention passes through scientifically compatibility with Margarita, Ganoderma, Ganoderma spore powder, develop the compound that has enhancing immunity and improve sleeper effect, be used for tumor patient, can make patient's health invigorating with dosage form, prolong life span, appetite stimulator improves sleep, pain relieving, spirit takes a turn for the better, antisecosis improves whole life quality during one's sickness, has very wide prospect.Product of the present invention also can be used for common sub-health population and middle-aged and elderly people simultaneously, solves its healthy hidden danger.Another useful discovery be compositions of the present invention antitumor and/or anticancer in have useful effect.
Summary of the invention
The object of the present invention is to provide the preparation method and the purposes of a kind of compositions and said composition.Compositions of the present invention has enhancing immunity and improves the sleep effect, and has antitumor and/or antitumaous effect.
On the one hand, the invention provides a kind of compositions, its active component is prepared by following medical material: Margarita 100 weight portions, Ganoderma 15～300 weight portions and Ganoderma spore powder 15～300 weight portions.
Preferably, the active component of compositions of the present invention is prepared by following medical material: Margarita 100 weight portions, Ganoderma 60～100 weight portions and Ganoderma spore powder 40～100 weight portions.
In case of necessity, can also further contain the human body acceptable auxiliary in the compositions of the present invention.Described adjuvant can be the conventional adjuvant of pharmaceutical field, for example, and diluent such as starch, microcrystalline Cellulose, lactose etc.; Binding agent such as hydroxypropyl emthylcellulose, starch slurry, dextrin, sodium carboxymethyl cellulose etc.; Disintegrating agent such as carboxymethyl starch sodium, dried starch, low-substituted hydroxypropyl cellulose etc.; Lubricant or fluidizer such as stearic acid, magnesium stearate, Pulvis Talci, micropowder silica gel etc.In order to increase the human body acceptability, can also contain coloring agent, aromatic or correctives etc. in the compositions of the present invention.
Compositions provided by the invention is preferably peroral dosage form, for example capsule, tablet, granule or pill.
On the other hand, the present invention also provides the preparation method of above-mentioned composition, and in described preparation method, the preparation of active component may further comprise the steps:
I) crushing pearl is become nanoscale.
This step I) can preferably use the method for physical pulverization to prepare, not add any other organic chemistry composition, the Margarita powder mean diameter that can make acquisition is 40～800nm.Preferably, by this step I) mean diameter of the Margarita powder that obtains is 40～400nm.More preferably, by this step I) mean diameter of the Margarita powder that obtains is 40～100nm.
In this step I) in, the quality of raw material Margarita can be measured in advance by known method.As raw-material Margarita, its quality optimization ground reaches: calcium carbonate content＞90%, protein content＞2%.
Ii) with the Ganoderma spore powder rehydration, add cellulase and/or pectase and carry out enzymolysis, blunt enzyme is handled, and just enzymolysis solution carries out freezing and melt handling again, and drying dewaters, and obtains Ganoderma spore powder with cellular wall broken.
This step I i) can preferably operate according to the following steps: the liquid that Ganoderma spore powder is made into 5～10% concentration with pure water, under 40～80 ℃ through 0.5～3 hour rehydration, transfer pH to 4.0～6.0 with citric acid, follow amount by every gram spore powder, add cellulase (0.5～0.8 ten thousand U) and/or pectase (/ 0.6～0.9 ten thousand U), stirred 2～4 hours down at 35～55 ℃.After enzymolysis is finished, under 90～110 ℃, handle through blunt enzyme.Enzymolysis solution was put refrigerator and cooled but 2～4 hours, put again in-30～-15 ℃ of fridges freezing 10～15 hours.Take out, add water and melt, be melted up to the violent jolting of an about half 15～45 minutes, put back in the fridge freezing 10～15 hours again, repeats 2～4 times, filtration with the filtrate spray drying, promptly gets Ganoderma spore powder with cellular wall broken.By the effect that can reach sporoderm-broken rate＞98% after this step process.Described enzyme is preferably cellulase/pectase (0.6 ten thousand U/0.8, ten thousand U).
Iii), be ground into fine powder, add water and decoct in right amount, with the decoction liquor drying that dewaters the Ganoderma fragmentation.
This step I ii) can preferably be operated according to the following steps: with Ganoderma cleaning, drying, be broken into 0.5-1 centimetre of big fragment, adopt ultra micro comminution by gas stream equipment to carry out the Ganoderma powder that superfine powder is broken into about 4～6 μ m of medium particle diameter, add 8～16 times of deionized waters of Ganoderma powder weight, decoct each three hours three times, merge decoction liquor, leave standstill, filter, be concentrated into relative density and be 1.2～1.4 thick paste, vacuum drying becomes dry extract.This step is utilized the micropowder extractive technique, Ganoderma fine powder particle diameter after the micronizing is very little, the corresponding increase of surface area, cell wall major part when pulverizing is destroyed in addition, effective ingredient directly is exposed in the solvent, thereby the also corresponding increase with rate of release of the stripping that makes effective ingredient, extraction ratio of effective constituents improves, and improves the bioavailability of effective ingredient.
Iv) nanometer Margarita powder, spore powder with crushed sporoderm and the Ganoderma extractum of above acquisition are pressed formula proportion and mixed, pulverize, obtain mixture of active principles.The crushing operation of this step preferably adopts the ultra micro comminution by gas stream.
The mixture that above-mentioned steps is iv) made can not add adjuvant and directly make compositions of the present invention for particularly people's use of animal, also can add the human body acceptable auxiliary, makes desired composition then.
Compositions of the present invention is preferably peroral dosage form, as capsule, tablet, granule or pill etc.The preparation technology of described peroral dosage form is well known in the art, for example can find from " pharmaceutics " (Zou Lijia, chief editor, Beijing: Chinese Medicine science and technology publishing house, 1996).
Again on the one hand, the present invention also provides described compositions to be used for improving the purposes of the product of human health status in preparation.
Particularly, the described preferably enhancing immunity and/or improve sleeper effect of human health status that improves.
On the other hand, the present invention also provides the purposes of described compositions in preparation antitumor and/or anticancer medicine.
According to above-mentioned application, when being applied to the adult, the consumption of the present composition can be determined according to the human body situation.Preferably, the dosage that every adult takes the present composition every day is equivalent to contain in the said composition amount of Margarita 10mg～5000mg, preferred 50mg～2000mg, more preferably 100mg～1000mg.
In addition,, when being applied to human body, the day using dosage of described compositions can being divided into 1～10 time and taking, preferably be divided into 1～5 time and take, more preferably be divided into 1～3 time and take according to above-mentioned application.Like this, the compositions of above-mentioned oral form can be single dose or multiple-unit container, preferably unit dose package.When using unit dose package, can determine the concrete amount of each unit dose package according to preferred single dose.Advantage of the present invention is as follows: the first, enhancing immunity, to improve sleeper effect obvious, based on theory of Chinese medical science, and in conjunction with the modern pharmacological research gained.The second, the selected raw material of the present invention, Margarita powder is broken into nanoscale, and Ganoderma spore powder carries out cell wall breaking, and Ganoderma is adopted the micropowder extractive technique, significantly improves the bioavailability of effective ingredient, and drug effect is remarkable.
The present invention is safe, nontoxic through the toxicological test proof, and the result is as follows:
(1), 30 days every indexs of the high, medium and low three dosage groups of nursing of rat are not seen the overt toxicity reaction.
(2), rat oral administration acute toxicity belongs to actual non-toxic type.
(3), its mouse oral administration acute toxicity belongs to actual non-toxic type.
(4), the Salmonella reversion test result is negative.
(5), the mouse microkernel test result is negative.
(6), the mouse sperm deformity test is negative.
The specific embodiment
Below illustrate in greater detail the present invention by preparation example and test example respectively, but the present invention is not subjected to the restriction of these preparation examples and test example.
(1) preparation example
Preparation example1
The prescription of compositions is as follows:
Margarita 1500g Ganoderma 900g Ganoderma spore powder 600g
Starch is an amount of
Preparation method:
1, the 1500g Margarita powder is broken into the 1500g nanometer Margarita powder, mean diameter is 40nm
2, the 600g Ganoderma spore powder is made into 5% liquid with pure water, in 60 ℃ of hot water, keeps 1 hour water inlet rehydration, transfer pH to 4.5,, add cellulase 0.6 ten thousand U, 35 ℃ of constant temperature stirring actions 2 hours by the amount of every gram spore powder with citric acid.After enzymolysis is finished, handle by 100 ℃ of blunt enzymes.Enzymolysis solution was put 4 ℃ of fridge pre-freezes 2 hours, put again in-22 ℃ of fridges freezing 12 hours.Taking-up adds water melts, and is melted up to the violent jolting of a half 15 minutes, puts back in-22 ℃ of fridges freezing 10 hours again, repeats 2 filtrations, the filtrate spray drying is promptly got Ganoderma spore powder with cellular wall broken, sporoderm-broken rate＞98%.
3, with Ganoderma cleaning, drying, be broken into 0.5-1 centimetre of big fragment, adopt ultra micro comminution by gas stream equipment to carry out the Ganoderma powder that superfine powder is broken into medium particle diameter 4 μ m, add 8 times of deionized waters of Ganoderma weight, decoct each three hours three times, merge decoction liquor, static filtration, being concentrated into relative density is 1.30 thick pastes, vacuum drying (0.07～-0.08Mpa) to dry extract.
4, nanometer Margarita powder, Ganoderma extractum, the spore powder with crushed sporoderm mix homogeneously that will make according to above-mentioned technology, the ultra micro comminution by gas stream adds appropriate amount of starch (four total amounts are 3000g), and the Autocapsulefillingmachine fill makes 10000 seed lac wafers, every 0.3g.
Preparation example 2
The proportioning of compositions is as follows:
Margarita 1000g Ganoderma 1000g Ganoderma spore powder 1000g
Dextrin 2% carboxymethyl cellulose 1%
Preparation method:
1, the 1000g Margarita powder is broken into the 1000g nanometer Margarita powder, mean diameter is 100nm.
2, the 1000g Ganoderma spore powder is made into 8% dope with pure water and in 60 ℃ of hot water, keeps 1 hour water inlet rehydration, transfer PH to 5.0,, add pectase 0.8 ten thousand U, in 45 ℃ of constant temperature stirring actions 3 hours by the amount of every gram spore powder with citric acid.After enzymolysis is finished, handle by 100 ℃ of blunt enzymes.Enzymolysis solution was put 4 ℃ of fridge pre-freezes 3 hours, put again in-22 ℃ of fridges freezing 12 hours.Taking-up adds water melts, and is melted up to the violent jolting of a half 30 minutes, puts back in-22 ℃ of fridges freezing 12 hours again, repeats 3 filtrations, the filtrate spray drying is promptly got Ganoderma spore powder with cellular wall broken, sporoderm-broken rate＞98%.
3, with Ganoderma cleaning, drying, be broken into 0.5-1 centimetre of big fragment, adopt ultra micro comminution by gas stream equipment to carry out the Ganoderma powder that superfine powder is broken into medium particle diameter 5 μ m, add 12 times of deionized waters of Ganoderma weight, decoct each three hours three times, merge decoction liquor, static filtration, being concentrated into relative density is 1.33 thick pastes, vacuum drying (0.07～-0.08Mpa) to dry extract.
4, Ganoderma extractum, nanometer Margarita powder, spore powder with crushed sporoderm are pressed above-mentioned formula proportion mix homogeneously, pulverize, cross 80 mesh sieves, add the dextrin of former three gross weight 2% and 1% carboxymethyl cellulose, dry granulation, granulate, plastic-aluminum coating film bag packing makes granule.
Preparation example 3
The proportioning of compositions is as follows:
Margarita 700g Ganoderma 1500g Ganoderma spore powder 800g
Dextrin is an amount of
Production method:
1, the 700g Margarita powder is broken into the 700g nanometer Margarita powder, mean diameter is 400nm.
2, the 800g Ganoderma spore powder is made into 10% liquid with pure water, in 60 ℃ of hot water, keeps 1 hour water inlet rehydration, transfer pH to 5.0,, add pectase 0.8 ten thousand U, in 55 ℃ of constant temperature stirring actions 4 hours by the amount of every gram spore powder with citric acid.After enzymolysis is finished, handle by 100 ℃ of blunt enzymes.Enzymolysis solution was put 4 ℃ of fridge pre-freezes 4 hours, put again in-22 ℃ of fridges freezing 15 hours.Taking-up adds water melts, and is melted up to the violent jolting of a half 45 minutes, puts back in-22 ℃ of fridges freezing 12 hours again, repeats 4 filtrations, the filtrate spray drying is promptly got Ganoderma spore powder with cellular wall broken, sporoderm-broken rate＞98%.
3, with Ganoderma cleaning, drying, be broken into 0.5～1 centimetre of big fragment, adopt ultra micro comminution by gas stream equipment to carry out the Ganoderma powder that superfine powder is broken into medium particle diameter 6 μ m, add 16 times of deionized waters of Ganoderma weight, decoct each three hours three times, merge decoction liquor, static filtration, being concentrated into relative density is 1.35 thick pastes, vacuum drying (0.07～-0.08Mpa) to dry extract.
4, get the Ganoderma dry extract, cross 60～100 mesh sieves, add nanometer Margarita powder, spore powder with crushed sporoderm and the dextrin of recipe quantity, mixing adds 70% alcohol granulation, and drying, granulate, tabletting, packing promptly get tablet.
Preparation example 4
Margarita 1000g Ganoderma 150g Ganoderma spore powder 3000g
I) Margarita powder is broken into the nanoscale of the about 800nm of mean diameter with ball mill pulverizer.
Ii) Ganoderma spore powder is added water and be made into 8% liquid, 40 ℃ of rehydrations 0.5 hour, transfer pH to 4.0 with citric acid, amount by every gram spore powder, add cellulase and pectase (0.6 ten thousand U/0.8, ten thousand U) and carry out enzymolysis, 90 ℃ of blunt enzymes are handled, and enzymolysis solution are carried out-30 ℃ of freezing and thawing processing again, drying dewaters, and obtains Ganoderma spore powder with cellular wall broken.
Iii) with the Ganoderma fragmentation, be ground into the fine powder of the about 5 μ m of medium particle diameter with ball mill pulverizer, the decocting that adds 10 times of amounts boils 3 times, each 3 hours, decoction liquor is filtered, 60 ℃ of decompressions dewater to relative density be 1.20～1.25 thick pastes, vacuum drying gets extractum.
Iv) nanometer Margarita powder, spore powder with crushed sporoderm and the Ganoderma extractum of above acquisition are pressed formula proportion and mixed, the ultra micro comminution by gas stream obtains compositions of the present invention.
Preparation example 5
Margarita 1000g Ganoderma 3000g Ganoderma spore powder 150g
I) Margarita powder is broken into the nanoscale of the about 400nm of mean diameter with ball mill pulverizer.
Ii) Ganoderma spore powder is added water and be made into 8% liquid, 80 ℃ of rehydrations 3 hours, transfer pH to 6.0 with citric acid, amount by every gram spore powder, add cellulase and pectase (0.5 ten thousand U/0.6, ten thousand U) and carry out enzymolysis, 100 ℃ of blunt enzymes are handled, and enzymolysis solution are carried out-15 ℃ of freezing and thawing processing again, drying dewaters, and obtains Ganoderma spore powder with cellular wall broken.
Iii) with the Ganoderma fragmentation, be ground into the fine powder of the about 5 μ m of medium particle diameter with ball mill pulverizer, the decocting that adds 10 times of amounts boils 3 times, each 3 hours, decoction liquor is filtered, 60 ℃ of decompressions dewater to relative density be 1.30～1.35 thick pastes, vacuum drying gets extractum.
Iv) nanometer Margarita powder, spore powder with crushed sporoderm and the Ganoderma extractum of above acquisition are pressed formula proportion and mixed, the ultra micro comminution by gas stream obtains compositions of the present invention.
Preparation example 6
Margarita 1000g Ganoderma 600g Ganoderma spore powder 1000g
I) Margarita powder is broken into the nanoscale of the about 100nm of mean diameter with ball mill pulverizer.
Ii) Ganoderma spore powder is added water and be made into 8% liquid, 60 ℃ of rehydrations 1 hour, amount by every gram spore powder, add cellulase and pectase (0.8 ten thousand U/0.9, ten thousand U) and carry out enzymolysis, 110 ℃ of blunt enzymes are handled, enzymolysis solution is carried out-20 ℃ of freezing and thawing processing, drying dewaters, and obtains Ganoderma spore powder with cellular wall broken again.
Iii) with the Ganoderma fragmentation, be ground into the fine powder of the about 5 μ m of medium particle diameter with ball mill pulverizer, the decocting that adds 10 times of amounts boils 3 times, each 3 hours, decoction liquor is filtered, 60 ℃ of decompressions dewater to relative density be 1.30～1.35 thick pastes, vacuum drying gets extractum.
Iv) nanometer Margarita powder, spore powder with crushed sporoderm and the Ganoderma extractum of above acquisition are pressed formula proportion and mixed, the ultra micro comminution by gas stream obtains compositions of the present invention.
Preparation example 7
Margarita 1000g Ganoderma 1000g Ganoderma spore powder 600g
I) Margarita powder is broken into the nanoscale of the about 50nm of mean diameter with ball mill pulverizer.
Ii) Ganoderma spore powder is added water and be made into 8% liquid, 60 ℃ of rehydrations 1 hour, amount by every gram spore powder, add cellulase and pectase (0.6 ten thousand U/0.8, ten thousand U) and carry out enzymolysis, 100 ℃ of blunt enzymes are handled, enzymolysis solution is carried out-20 ℃ of freezing and thawing processing, drying dewaters, and obtains Ganoderma spore powder with cellular wall broken again.
Iii) with the Ganoderma fragmentation, be ground into the fine powder of the about 5 μ m of medium particle diameter with ball mill pulverizer, the decocting that adds 10 times of amounts boils 3 times, each 3 hours, decoction liquor is filtered, 60 ℃ of decompressions dewater to relative density be 1.35～1.40 thick pastes, vacuum drying gets extractum.
Iv) nanometer Margarita powder, spore powder with crushed sporoderm and the Ganoderma extractum of above acquisition are pressed formula proportion and mixed, the ultra micro comminution by gas stream obtains compositions of the present invention.
Above-mentioned composition is mixed with 1000g starch, and encapsulated, every loading amount is equivalent to contain the 100mg Margarita.Promptly get the compositions of Capsule form.
Preparation example 8
Margarita 1000g Ganoderma 600g Ganoderma spore powder 500g
I) crushing pearl is become nanoscale (the about 100nm of mean diameter).
Ii) with the Ganoderma spore powder rehydration, add cellulase/pectase (0.8 ten thousand U/0.8, ten thousand U) and carry out enzymolysis, blunt enzyme is handled, and enzymolysis solution is carried out freezing again and melt handling, and drying dewaters, and obtains Ganoderma spore powder with cellular wall broken.
Iii) with the Ganoderma fragmentation, be ground into fine powder, add water and decoct in right amount, decoction liquor is dewatered is dried to cream.
Iv) nanometer Margarita powder, spore powder with crushed sporoderm and the Ganoderma extractum of above acquisition are pressed formula proportion and mixed, pulverize, obtain compositions of the present invention.
Above-mentioned composition is mixed with the 2000g pregelatinized Starch, is wetting agent with 85% ethanol, granulate with High Speed Stirring Machine, and drying, tabletting is made every plain sheet that contains the 100mg Margarita, with plain sheet bag film-coat, promptly gets the compositions of tablet form.
(2) test example
The present invention has enhancing immunity and improves the effect of sleeping through effect experimentation proof, also has certain antitumor action simultaneously.Below test example can be used to the beneficial effect that illustrates that the present invention obtains.
Test example 1:
With A group (Margarita: Ganoderma: Ganoderma spore powder, weight ratio=100: 70: 50), B group (Margarita: Ganoderma: Ganoderma spore powder, weight ratio=100: 15: 300), C group (Margarita: Ganoderma: Ganoderma spore powder, weight ratio=100: 300: 15) compositions that ratio is mixed with is a test specimen, (animal and human is by the body weight conversion to be equivalent to the conventional intake of people respectively, be equivalent to Margarita 750mg/ day people) 10 times, establish negative control group (distilled water) simultaneously, gave this product of various dose to its mouse oral in continuous 30 days, 10 of every group of mices.The result shows: compare with negative control group, three dosage groups all can improve the inductive mice spleen lymphocytes proliferation ability of ConA, and difference all has significance; Low, middle dosage group all can increase the left back sufficient sole of the foot thickness difference 24h of the portion measured value of mice, and difference all has significance; Low dose group can improve mice serum hemolytic antibody product value, and difference has significance; Three dosage groups all can improve mice hemolysis plaque number, and difference all has significance; Low, high dose group all can improve the NK cells in mice activity, and difference all has significance.This shows that this product has the enhancing immunity function.Concrete result of the test sees Table 1.Three groups of test specimens of A, B and C, all be with reference to step 1～3 in preparation example 1 preparation method, make nanometer Margarita powder, Ganoderma spore powder with cellular wall broken and Ganoderma dry extract respectively, mix homogeneously then, the ultra micro comminution by gas stream obtains mixture, and this mixture is directly used in this test as compositions of the present invention.
Table 1, compositions strengthen the result of the test of mouse immune power
| Group | Spleen lymphocyte proliferation ability (optical density difference) | Increase the left back sufficient sole of the foot portion's thickness of mice (cm) | Serum hemolysin antibody product value | Hemolysis plaque number (individual/10 6Splenocyte) | NK cells in mice activity (%) |
| Matched group | 0.132±0.062 | 0.033±0.013 | 240.1±30.6 | 56±13 | 31.6±12.8 |
| The A group | 0.343±0.047 * | 0.034±0.004 | 248.4±27.3 | 102±16 * | 56.4±9.1 * |
| The B group | 0.340±0.049 * | 0.047±0.015 * | 242.3±34.4 | 98±22 * | 38.8±10.6 |
| The C group | 0.381±0.075 * | 0.051±0.012 * | 284.4±30.6 * | 122±20 * | 45.5±10.0 * |
The q check: compare with negative control group,
*P＜0.05
Test example 2:
With A group (Margarita: Ganoderma: Ganoderma spore powder, weight ratio=100: 70: 50), B group (Margarita: Ganoderma: Ganoderma spore powder, weight ratio=100: 15: 300), C group (Margarita: Ganoderma: Ganoderma spore powder, weight ratio=100: 300: 15) compositions that ratio is mixed with is a test specimen, (animal and human is by the body weight conversion to be equivalent to the conventional intake of people respectively, be equivalent to Margarita 750mg/ day people) 10 times, each mice was respectively with the dosage lumbar injection barbital sodium of 35mg/kg after its mouse oral gives in continuous 30 days.Simultaneously only do not inject barbital sodium and organize in contrast not give compositions.10 of every group of mices.The result shows: each dosage group does not have obvious influence to the mice body weight, each dosage group can obviously shorten the inductive mice sleep of barbital sodium incubation period (P＜0.01), can prolong the inductive mouse sleep time of pentobarbital sodium (P＜0.05), can increase the inductive mice sleep incidence rate of sub-threshold dose barbital sodium, this shows that this product and barbital sodium, pentobarbital sodium have collaborative sleep effect.Concrete result of the test sees Table 2.Three groups of test specimens of A, B and C are identical with the preparation method of A, B and C sample in the test example 1 respectively.
The result of the test of table 2, composition for improved sleep effect
| Group | Sleep incubation period (min) | The length of one's sleep (min) | Sleep incidence rate (%) |
| The barbital sodium group | 36.8±11.0 | 24.5±15.4 | 10 |
| A+ barbital sodium group | 20.3±3.2 * | 44.9±12.7 * | 70 |
| B+ barbital sodium group | 24.4±4.3 * | 38.3±9.7 * | 50 |
| C+ barbital sodium group | 23.2±3.5 * | 37.7±17.2 * | 40 |
The q check: compare with negative control group,
*P＜0.05
Test example 3:
With A group (Margarita: Ganoderma: Ganoderma spore powder, weight ratio=100: 70: 50), B group (Margarita: Ganoderma: Ganoderma spore powder, weight ratio=100: 15: 300), C group (Margarita: Ganoderma: Ganoderma spore powder, weight ratio=100: 300: 15) compositions that ratio is mixed with is a test specimen, (animal and human is by the body weight conversion to be equivalent to the conventional intake of people respectively, be equivalent to Margarita 750mg/ day people) 10 times, establish negative control group (distilled water) simultaneously, 10 of every group of mices.Give its mouse oral continuous irrigation stomach after 20 days in subcutaneous well-grown S-180, the EAC tumor liquid (1 * 10 inoculated respectively of the right fore armpit of every Mus
6Individual/ml) 0.2ml.Administration 9 days is continued in the inoculation back, and last administration 24h mice is weighed and the cervical vertebra mortar is put to death, and gets tumor and weighs.The result shows: each dosage group all can suppress growth of tumor.Concrete result of the test sees Table 3.Three groups of test specimens of A, B and C are identical with the preparation method of A, B and C sample in the test example 1 respectively.
The result of the test of table 3, compositions antitumor action
Compositions of the present invention effectively enhancing immunity, improve sleeper effect and have antitumor and/or antitumaous effect, do not see untoward reaction.
Claims (9)
1. compositions, its active component is prepared by following medical material: Margarita 100 weight portions, Ganoderma 15～300 weight portions and Ganoderma spore powder 15～300 weight portions.
2. compositions according to claim 1, wherein, Margarita is 100 weight portions, and Ganoderma is 60～100 weight portions, and Ganoderma spore powder is 40～100 weight portions.
3. compositions according to claim 1 and 2, wherein, described compositions is a peroral dosage form.
4. compositions according to claim 3, wherein, described compositions is capsule, tablet, granule or pill.
5. any described preparation of compositions method in the claim 1～4, the preparation of its active component may further comprise the steps:
I) Margarita powder is broken into nanoscale;
Ii) with the Ganoderma spore powder rehydration, add cellulase and/or pectase and carry out enzymolysis, blunt enzyme is handled, and just enzymolysis solution carries out freezing and melt handling again, and drying dewaters, and obtains Ganoderma spore powder with cellular wall broken;
Iii), be ground into fine powder, decoct with water,, obtain Ganoderma extractum the decoction liquor drying that dewaters with the Ganoderma fragmentation;
Iv) nanometer Margarita powder, spore powder with crushed sporoderm and the Ganoderma extractum of above acquisition are pressed formula proportion and mixed, obtain mixture of active principles.
6. preparation method according to claim 5, the preparation of its active component may further comprise the steps:
I) adopt the method for physical pulverization that crushing pearl is become nanoscale, mean diameter is 40～800nm;
Ii) Ganoderma spore powder is made into the liquid of 5～10% concentration with pure water, 40～80 ℃ down through rehydration, transfer pH to 4.0～6.0 with citric acid, then add cellulase and/or pectase, stir in good time down at 35～55 ℃.After enzymolysis is finished, under 90～110 ℃, handle through blunt enzyme.Enzymolysis solution was put refrigerator and cooled but 2～4 hours, put in the fridge freezing again.Add water and melt, be melted up to the violent jolting of an about half, put back in the fridge freezingly again, filter,, promptly get Ganoderma spore powder with cellular wall broken the filtrate spray drying;
Iii) with Ganoderma cleaning, drying, be broken into 0.5-1 centimetre of big fragment, adopt ultra micro comminution by gas stream equipment to carry out the Ganoderma powder that superfine powder is broken into about 4～6 μ m of medium particle diameter, add 8～16 times of deionized waters of Ganoderma powder weight, decoct three times, each three hours, merge decoction liquor, leave standstill, filter, being concentrated into relative density is 1.2～1.4 thick pastes, vacuum drying becomes dry extract, obtains Ganoderma extractum;
Iv) nanometer Margarita powder, spore powder with crushed sporoderm and the Ganoderma extractum of above acquisition are pressed formula proportion and mixed, the ultra micro comminution by gas stream obtains mixture of active principles.
7. any described compositions is used for improving the purposes of the product of human health status in the claim 1～4 in preparation.
8. according to the purposes of claim 7, wherein said to improve human health status be enhancing immunity and/or improve sleeper effect.
9. the purposes of any described compositions in preparation antitumor and/or anticancer medicine among the claim 1-4.
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|---|---|---|---|
| CNA2007100907339A CN101278949A (en) | 2007-04-05 | 2007-04-05 | Composition and its preparation and application |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2007100907339A CN101278949A (en) | 2007-04-05 | 2007-04-05 | Composition and its preparation and application |
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| CN101278949A true CN101278949A (en) | 2008-10-08 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101971975A (en) * | 2010-06-23 | 2011-02-16 | 安徽万山生物科技有限公司 | Low-temperature high-pressure sporoderm-broken ganoderma-spore and ganoderma freeze-dried powder capsule and production process thereof |
| CN102228107A (en) * | 2011-05-13 | 2011-11-02 | 宜兴市鸿润食用菌种植专业合作社 | Ganoderma lucidum tea and preparation method thereof |
| CN102813269A (en) * | 2012-09-21 | 2012-12-12 | 黄勇 | Edible fungus beverage and preparation method thereof |
| CN103054008A (en) * | 2013-02-04 | 2013-04-24 | 福建仙芝楼生物科技有限公司 | Lucid ganoderma sleep-aiding capsule and preparation method thereof |
| CN108079202A (en) * | 2017-01-25 | 2018-05-29 | 青海春天药用资源科技利用有限公司 | It sleeps with improving, enhances the pharmaceutical composition and preparation method of immunity of organisms effect |
-
2007
- 2007-04-05 CN CNA2007100907339A patent/CN101278949A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101971975A (en) * | 2010-06-23 | 2011-02-16 | 安徽万山生物科技有限公司 | Low-temperature high-pressure sporoderm-broken ganoderma-spore and ganoderma freeze-dried powder capsule and production process thereof |
| CN102228107A (en) * | 2011-05-13 | 2011-11-02 | 宜兴市鸿润食用菌种植专业合作社 | Ganoderma lucidum tea and preparation method thereof |
| CN102228107B (en) * | 2011-05-13 | 2013-05-08 | 宜兴市鸿润食用菌种植专业合作社 | Ganoderma lucidum tea and preparation method thereof |
| CN102813269A (en) * | 2012-09-21 | 2012-12-12 | 黄勇 | Edible fungus beverage and preparation method thereof |
| CN102813269B (en) * | 2012-09-21 | 2015-06-17 | 黄勇 | Edible fungus beverage and preparation method thereof |
| CN103054008A (en) * | 2013-02-04 | 2013-04-24 | 福建仙芝楼生物科技有限公司 | Lucid ganoderma sleep-aiding capsule and preparation method thereof |
| CN108079202A (en) * | 2017-01-25 | 2018-05-29 | 青海春天药用资源科技利用有限公司 | It sleeps with improving, enhances the pharmaceutical composition and preparation method of immunity of organisms effect |
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Open date: 20081008 |