CN100486596C - Chinese medicine preparation with organism immunity increasing function - Google Patents
Chinese medicine preparation with organism immunity increasing function Download PDFInfo
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Abstract
The present invention relates to compound oral preparation with function of raising immunity, and the compound oral preparation contains glossy ganoderma polysaccharide and ash tree flower polysaccharide. The compound oral preparation can reverse the leucopenia, thymic index lowering and spleen index lowering caused by cytotoxic chemotherapeutic medicine.
Description
Technical field
The present invention relates to health product or oral preparation of Chinese traditional medicinal, particularly a kind of health product with enhancing human body immunity power or oral preparation of Chinese traditional medicinal and preparation method thereof.
Background technology
Immunologic function is not only the first line of defence that body is defendd external source of disease invasion, also be that self or the kind mutant that produced by environmental stimuli are discerned and killed, eliminate in the body " impurity ", guarantee " bodyguard " of the normal and balance and stability of body cell function.Immunologic function that a variety of causes causes reduces and is common in not only that the resistance to antibacterial and viral infection descends under the sub-health state, also is the major reason that causes cancer and some chronic disease accompanying infection diseases.Therefore, correct the immunologic function of imbalance, for diseases prevention, cure the disease, improve people and be significant quality of life.
Immunostimulant such as bacillus calmette-guerin vaccine, levamisole and interleukin-2, interferon and thymosin etc. commonly used at present, or use inconvenience, or untoward reaction is serious, has all limited their application.
Chinese medicine is accumulating rich experience aspect the adjusting human body self function, and finds that plurality of Chinese has stronger immunomodulating and immune enhancing function in the Chinese medicine practice, as Ganoderma, Radix Ginseng, the Radix Astragali etc.Modern pharmacology studies have shown that polysaccharide is to regulate immunity of organism balance, the main functional component of performance immunoregulation effect in the above-mentioned Chinese medicine.Active polysaccharide can be by activated lymphocyte and macrophage, the various cytokines of promotion (interferon, interleukin, tumor necrosis factor) generation, the approach such as activity that activate reticuloendothelial system and strengthen natural killer cell regulate body's immunological function.And toxicologic study shows that the natural polysaccharide composition does not have toxicity, and is safe in utilization, is that the prepared health promoting product of raw material can be taken for a long time for general crowd with it.
Ganoderma, broadly comprise any among the polypor Ganoderma of kind surplus in the of known 180, be meant Ganoderma lucidum (Leyss. Ex Fr.) Karst. Ganoderma Lucidum (the Leyss ex Fr.) Karst. or the Ganoderma Ganoderma sinensiZhao that are recorded for Pharmacopoeia of People's Republic of China (version was two ones in 2005) narrowly, the dry sporophore of Xu et Zhang.Contained according to pharmacopeia, the Ganoderma nature and flavor are sweet, and are flat; Invigorating QI and tranquilization is arranged, and the effect of relieving cough and asthma can be controlled dizzy sleeplessness, shortness of breath and palpitation, asthenia cough with asthma.Ganoderma is listed in top grade in China's pharmacy works Shennong's Herbal the earliest, and it also is one of U.S.'s " medical herbs pharmacopeia " 10 kinds of Chinese herbal medicine of only including.Modern scientific research shows that Ganoderma contains multiple bioactive substances such as polysaccharide, several amino acids, steroid class, triterpenes, alkaloid, organic acid, mannitol, and contains various trace elements.Its contained ganoderan is considered to the main component of its pharmacologically active, and the Pharmacopoeia of the People's Republic of China (version was an one in 2005) is with the control criterion of ganoderan as the Ganoderma quality.At present with the pharmacology activity research of the ganoderan that from Ganoderma lucidum (Leyss. Ex Fr.) Karst., obtains at most, the most deep, find that ganoderan has effects such as antitumor, human body immunity improving power and hypoxia-bearing capability (referring to World Science technology-Chinese medicine modernization 6 (2): 57-62; 2004), the polysaccharide that derives from other kinds of Ganoderma has similar pharmacologically active to Ganoderma lucidum (Leyss. Ex Fr.) Karst..Ganoderan does not have direct kill capability to tumor cell, its antitumor action is relevant with its adjusting body power, find that it is mainly by promoting the T lymphopoiesis, the B cell that improves mice produces the ability of specific antibody, promote the generation of the factors such as interleukin, interferon and TNF-α, and enhancing human body immunity functions such as the phagocytic function of enhancing mouse macrophage and raising NKT (NK) cytoactive.
The production of ganoderan is outside the raw material divided by wild or tame Ganoderma sporophore, also can extract from the mycelium of Ganderma lucidum submerged fermentation or fermentation liquid.By studies show that ganoderan is formed by glucose, fructose in Ganoderma sporophore, the mycelium, and these two kinds of monosaccharide are identical with mol ratio in the mycelium polysaccharides at sporophore, provide molecular basis for the ganoderan in different genera source has similar biologic activity.Long because of the artificial culture sporophore production cycle, cost is high, the much more existing deep fermentation methods that adopt are produced ganoderans (referring to the research of Ganoderma intracellular polysaccharide superior strain G7 deep layer fermenting process, edible fungi of china 23 (6): 36-39; 2004).The ganoderan molecular weight except that the sub-fraction micromolecular polysaccharide, scarcely is dissolved in alcohol in high concentration, and is dissolved in hot water from hundreds of to hundreds thousand of, therefore is applicable to water extraction-alcohol precipitation technology extraction.
The Grifola frondosa (Grif ola f rondosa (Dicks, ex Fr) S.F.Gray) that the present invention uses has another name called hen of the woods, thousand Buddhist bacterium, Semen Castaneae mushroom, YUNTAN, Flos Nelumbinis bacterium etc. for Polyporaceae tree flower Pseudomonas fungus.Its sporophore fragrant odour, delicious in taste, and be rich in multivitamin, mineral and bioactive substance, be the dual-purpose dual-purpose fungus of a kind of food, medicine of preciousness.Modern pharmacology studies have shown that its contained polysaccharide component has antitumor, regulates multiple pharmacological activities such as immunity and antiviral (referring to research and development of natural products 15 (4): 364-368; 2003).The production of grifolan is outside the raw material divided by tame sporophore, also can extract from the mycelium of Grifolas frondosa germ submerged fermentation or fermentation liquid.
This patent invention is discovered, with Ganoderma and Grifola frondosa is raw material, the extract that is rich in ganoderan and is rich in grifolan that obtains all has the effect of numeration of leukocyte of the mice of the injection cyclophosphamide that raises, and it is oral by the compound preparation that above-mentioned two kinds of polysaccharide components are formed, under the prerequisite that reduces the total polysaccharides consumption, can not only increase the numeration of leukocyte level of the mice of injection cyclophosphamide, and can reverse the reduction of injecting cyclophosphamide mouse thymus exponential sum spleen index, and can increase the phagocytic function of normal mouse macrophage.Safety testing studies show that the above compound preparation of the present invention of mice oral 20g/kg every day does not have any untoward reaction, and compound preparation promptly of the present invention belongs to innocuous substance, is fit to general crowd and takes in a large number for a long time.
Summary of the invention
The purpose of this invention is to provide a kind of oral formulations and preparation method thereof with the effect of enhancing human body immunity power.
The present inventor discovers that the Ganoderma that the employing Pharmacopoeia of the People's Republic of China is used as medicine and the fungus Grifola frondosa of food and medicament dual-purpose are raw material, and the ganoderan of extraction and grifolan all have the effect of enhancing human body immunity power.And the compound preparation that above-mentioned two kinds of polysaccharide components are formed is oral, under the prerequisite that reduces the total consumption of polysaccharide, can significantly reverse the reduction of mice blood leukocytes counting, thymus index and spleen index that the cytotoxicity chemotherapeutics causes, increase the phagocytic function of normal mouse reticuloendothelial system.Safety testing studies show that, the above no any untoward reaction of mice oral 20g/kg every day, and compound preparation promptly of the present invention belongs to innocuous substance, is fit to general crowd and takes in a large number for a long time.
The invention provides a kind of oral formulations, wherein contain the ganoderan of effective dose with the effect of enhancing human body immunity power, and optionally pharmaceutically acceptable carrier.Accordingly, the present invention also provides ganoderan to be used to the purposes for preparing treatment or prevent to have the medicine of enhancing human body immunity power.
On the other hand, the invention provides a kind of oral formulations, wherein contain the grifolan of effective dose with the effect of enhancing human body immunity power, and optionally pharmaceutically acceptable carrier.Accordingly, the present invention also provides grifolan to be used to the purposes for preparing treatment or prevent to have the medicine of enhancing human body immunity power.
In optimized technical scheme, the invention provides a kind of compound oral administration preparation with enhancing human body immunity power, wherein contain the ganoderan and the grifolan of effective dose, and optionally pharmaceutically acceptable carrier.In preferred technical scheme, contain in polysaccharide weight in the oral formulations of the present invention: ganoderan 10%～95%, grifolan 5%～90%, preferred ganoderan 20%～90%, grifolan 10%～80%, more preferably ganoderan 70～85%, grifolan 15～30%.
Being used for ganoderan of the present invention and grifolan can prepare according to the preparation method that the embodiment of the invention provides, and also can obtain according to the disclosed known method of prior art, also can obtain by commercially available approach.
All can obtain to be applicable to polyoses extract of the present invention according to different extracting method.For example water extraction-pure sedimentation method, membrane filter method and alkali liquor extraction-salt precipitation method technology etc.
According to optimized technical scheme of the present invention, can be with the mycelium water extraction of Ganoderma or Grifola frondosa fermentation, perhaps medicinal lucid ganoderma or Grifola frondosa raw material (are preferably adopted water-boiling method with water extraction, or water reflux extraction, 80 ℃-100 ℃ of control temperature, 1 hour-4 hours time), (preferably use ethanol, preferred alcohols concentration is 65%-95% with the alcohol precipitation, 4 ℃-30 ℃ of temperature, 3 hours-12 hours time), can obtain to be rich in the crude extract of ganoderan or grifolan thus, the crude extract that obtains is dissolved with suitable quantity of water, reuse alcohol precipitation (is preferably used ethanol, preferred alcohols concentration is 65%-95%, 4 ℃-30 ℃ of temperature, 3 hours-12 hours time) refining, spray-dried separately or drying under reduced pressure then, make powder, crushing screening is used to prepare described preparation.
In preferred embodiments, with the Ganoderma raw material hot water backflow lixiviate after pulverizing 1-3 time, filtering residue is brought up again 1-3 time, merging filtrate, and concentrating under reduced pressure, ethanol precipitation, precipitation is with the deionized water dilution, and spray drying or drying under reduced pressure become extract powder.Grifola frondosa raw material hot water backflow lixiviate 1-3 time, filtering residue is brought up again 1-3 time, merging filtrate, concentrating under reduced pressure, ethanol precipitation, precipitation is with the deionized water dilution, and spray drying or drying under reduced pressure become extract powder.
The main functional component of product of the present invention is ganoderan and grifolan, and therefore the detection with polyoses content is the controllable quality method.Content Determination of Polysaccharide can adopt sulphuric acid-anthrone method, phenolsulfuric acid method etc. in the extract, the present invention is with reference under one one 130 pages Ganoderma assay items of Pharmacopoeia of the People's Republic of China version in 2005, adopt sulphuric acid-anthrone method, be applicable to that preferably polyoses content is 10～90% in Ganoderma of the present invention and the Grifola frondosa extract.
The present invention also provides the preparation method of above-mentioned compound preparation, described method comprises described ganoderan and grifolan extract or its powder by required mixed, can directly be mixed with preparation, also can optionally add pharmaceutically acceptable carrier, mix homogeneously, be processed into oral formulations, for example capsule, tablet, granule or oral liquid.
Preparation of the present invention is main component with the polysaccharide, and the scalable immunity of organisms is with health role to human body, particularly enhancing immunity effect.In polysaccharide weight, contain in the compound oral administration preparation of the present invention: ganoderan 10%～95%, grifolan 5%～90%, preferred ganoderan 20%～90%, grifolan 10%～80%, more preferably ganoderan 70～85%, grifolan 15～30%.According to a conventional method can be directly or selectivity add suitable pharmaceutical carrier and make capsule, tablet, granule or oral liquid, promptly can be used as the health product of general sub-health population, can be used as the control medicine after the treatment of cytotoxicity chemotherapeutics again.For the adult of body weight 60kg, as single with ganoderan or single with the grifolan using dosage for being not less than 0.2g/ time, preferably be not less than 0.8g/ time, most preferably 2g/ time-10g/ time, 1-4 time/day, preferred 2 times or 3 times; Taking in proportion the ganoderan formed and the compound preparation using dosage of grifolan is that polysaccharide total amount meter is not less than 0.03g/ time, preferably be not less than 0.05g/ time, and most preferably 0.1g/ time-0.5g/ time, 1-4 time/day, preferred every day 2 times or 3 times.
Oral formulations can solve by the preparation of following feature among the present invention, and promptly said preparation contains ganoderan and grifolan as principal agent, and additional pharmaceutically acceptable carrier (being additive) is as adjuvant.Additive is selected from one or more mixing in disintegrating agent, binding agent, lubricant, the filler.
Formulation additives can be combination in any in disintegrating agent, binding agent, lubricant, the filler according to the present invention.Wherein filler is preferably one or more mixing in pregelatinized Starch, starch, dextrin, mannitol, microcrystalline Cellulose, calcium sulfate, calcium carbonate, the light magnesium oxide; Lubricant is preferably one or more mixing in calcium stearate, magnesium stearate, the Pulvis Talci; Disintegrating agent is preferably one or more mixing in cross-linking sodium carboxymethyl cellulose, microcrystalline Cellulose, dried starch, the polyvinylpolypyrrolidone; Binding agent is preferably one or more mixing of starch slurry, dextrin, cellulose and derivant thereof.
Preferred principal agent polysaccharide total amount is 10-100%, and more preferably 20-90% most preferably is 30-75%.
The preferable additives consumption is 0-80%.Preferred disintegrating agent consumption is 0.5%-5%, and more preferably 0.8%-2% is preferably 1.0%-1.5% especially.The preferred emollient consumption is 0.3%-1.0%, more preferably 0.5%-0.9%.Filler loading is decided on the preparation specification, and binder dosage is decided on particulate flowability in the concrete production and disintegrate situation.
The invention still further relates to the purposes of the medicine of ganoderan and the grifolan compound oral administration preparation that is used to prepare the enhancing immunity effect linked together, wherein said medicine can be used for the auxiliary treatment because of the immunologic hypofunction symptom that the leukocyte number that uses the cytotoxicity cancer therapy drug to occur reduces, central immune organ (as thymus) and peripheral immune organ (as spleen) atrophy cause, and also can be used for the general crowd of the immunologic hypofunction that other reason causes.In polysaccharide weight, contain in the described medicine: ganoderan 10%～95%, grifolan 5%～90%, preferred ganoderan 20%～90%, grifolan 10%～80%, more preferably ganoderan 70～85%, grifolan 15～30%.
Description of drawings
Fig. 1 has shown the influence that the independent thymus index that causes with ganoderan and grifolan pair cell toxicity chemotherapeutics descends.
Fig. 2 has shown the influence that the independent spleen index that pair cell toxicity chemotherapeutics is caused with ganoderan and grifolan descends.
Fig. 3 has shown the influence of the blood leukocytes counting decline that Ganoderma extract and Grifola frondosa extractive compound preparation pair cell toxicity chemotherapeutics cause.
Fig. 4 has shown Ganoderma extract and Grifola frondosa extract list usefulness, and the blood leukocytes that the two associating pair cell toxicity chemotherapeutics causes is counted the influence that descends.
Fig. 5 has shown the influence of the blood leukocytes counting decline that Ganoderma extract and Grifola frondosa extract formula I pair cell toxicity chemotherapeutics cause.
Fig. 6 has shown the influence of the thymus index decline that the prescription I pair cell toxicity chemotherapeutics among the biological activity embodiment 4 causes.
Fig. 7 has shown the influence of the spleen index decline that the prescription I pair cell toxicity chemotherapeutics among the biological activity embodiment 5 causes.
Fig. 8 has shown that prescription I among the biological activity embodiment 6 is to the influence of normal mouse phagocytic index K.
Fig. 9 has shown that prescription I among the biological activity embodiment 6 is to the influence of normal mouse activate the phagocytic capacity α.
In the accompanying drawing data presented, n=10, * P＜0.05, * * P＜0.01 is compared with the normal control group; #＜0.05 is compared with the cyclophosphamide group.
The specific embodiment
Embodiment 1
Get Ganoderma 8kg, pulverize, add 10 times of calorimetric water backflow lixiviates 2 hours, filter, filtering residue is brought up again 1 time with the same manner, merging filtrate, control temperature concentrating under reduced pressure under 50 ℃ condition, concentrated solution adds 95% ethanol precipitation and spends the night, with deionized water dissolution precipitation again, added 95% ethanol precipitation 12 hours, drying under reduced pressure gets the Ganoderma extractum powder, pulverizes, cross 100 mesh sieves, get Ganoderma extract.Detect through sulphuric acid-anthrone method, ganoderma polyoses content is 35% in the extract.
Get Grifola frondosa 3kg, pulverize, add 10 times of water gaging hot water backflow lixiviates and filtered in 2 hours, filtering residue is brought up again 1 time with the same manner, merging filtrate, concentrating under reduced pressure under the condition that the control temperature is 50 ℃, concentrated solution adds 95% ethanol precipitation and spends the night, deionized water is dissolution precipitation again, adds 95% ethanol precipitation 12 hours, drying under reduced pressure, get the Grifola frondosa extract powder, pulverize, cross 100 mesh sieves, get the Grifola frondosa extract.Detect through sulphuric acid-anthrone method, the Grifola frondosa polyoses content is 20% in the extract.
Prepare 1000 herbal mixture capsules: Ganoderma extract 229 grams that the method as embodiment 1 of getting respectively makes and as the Grifola frondosa extract 100 that makes of the method for embodiment 2 restrain, gross weight 329 grams, (in the ratio of ganoderan in the compound recipe 80%, grifolan 20%) mix homogeneously, filling becomes 1000 capsules.
Embodiment 4
The preparation of electuary: Ganoderma extract 214 grams that the method as embodiment 1 of getting respectively makes and as the Grifola frondosa extract 125 that makes of the method for embodiment 2 restrain (in the ratio of ganoderan in the compound recipe 75%, grifolan 25%), mix homogeneously, granulate, packing promptly.
Embodiment 5
Ganoderma extract 243 grams that the method as embodiment 1 of getting respectively makes and as the Grifola frondosa extract 75 that makes of the method for embodiment 2 restrain (in the ratio of ganoderan in the compound recipe 85%, grifolan 15%), with suitable adjuvant mix homogeneously, make powder, add the deionized water dilution, packing, sterilization, promptly.
Biological activity embodiment 1
Kunming mice, ♂, body weight 18-22g are adopted in experiment.Experiment component is the blank group, cyclophosphamide group and medication therapy groups.After mice conformed 3 hours, the drug treating group gave Ganoderma extract or Grifola frondosa extract to irritate the stomach mode, and normal and cyclophosphamide group is given the normal saline of respective amount, administration 2 times/day.After 2 hours, except that the normal control group, all the other respectively organize intraperitoneal injection of cyclophosphamide 50mg/kg once in last administration administration in the morning in preceding 1 day, the normal saline of normal control group injection respective amount; Normal administration in afternoon.Weigh before the last administration, administration is after 1 hour, the numeration of leukocyte to be measured of taking a blood sample; Put to death animal, get spleen and thymus rapidly, filter paper is weighed after wiping away and doing.
The result judges: can reverse being reduced to effectively of mice blood leukocytes counting, thymus index and spleen index due to the cyclophosphamide injection.
Discover that mice gives cytotoxic drug cyclophosphamide 50mg/kg injection, its thymus index and spleen index reduce by 28.4% and 24.2% respectively; When the dosage of counting 400mg/kg with ganoderma polyoses content gives Ganoderma extract, can make thymus index and the spleen index of the mice that gives the cyclophosphamide injection rise 13.6% and 14.2% respectively; When the dosage of counting 400mg/kg with grifolan content gives the Grifola frondosa extract, can make the spleen index of the mice that gives the cyclophosphamide injection rise 18.0%, cyclophosphamide injection group is more remarkable than difference with giving merely, shown in Fig. 1-2.
Conclusion: Ganoderma extract can reverse the reduction of cyclophosphamide injection mouse thymus exponential sum spleen index, can obviously the raise spleen index of cyclophosphamide injection mice of Grifola frondosa extract.
According to the uniform Design principle Grifola frondosa extract of the Ganoderma extract of embodiment 1 and embodiment 2 is calculated with polyoses content that to press the different proportion prescription as follows:
Prescription I ganoderan: grifolan=4:1;
Prescription II ganoderan: grifolan=2:1;
Prescription III ganoderan: grifolan=1:1;
Prescription IV ganoderan: grifolan=1:2;
Prescription V ganoderan: grifolan=1:4;
Adopt the research method of biological Examples 1, discover that mice gives cytotoxic drug cyclophosphamide 50mg/kg injection, its numeration of leukocyte reduces by 25.6%; The compound preparation that Ganoderma extract and Grifola frondosa extract are formed all has the effect of leukocyte increasing in various degree when total polysaccharides content is 80mg/kg.Prescription I, prescription II, prescription III, prescription IV and prescription V 2 times/day, after 8 administrations, can make the murine interleukin counting raise 44.3%, 19.7%, 23.0%, 16.4% and 11.5% respectively, as shown in Figure 3.
Conclusion: the compound preparation that Ganoderma extract and Grifola frondosa extract are formed is 20%-80% at ganoderma polyoses content particularly, when grifolan content is 20%-80%, can reverse the numeration of leukocyte that mice reduces after the chemotherapy.
According to the uniform Design principle Grifola frondosa extract of the Ganoderma extract of embodiment 1 and embodiment 2 is calculated with polyoses content that to press the different proportion prescription as follows:
Prescription XI ganoderan: grifolan=8:1;
Prescription I ganoderan: grifolan=4:1;
Prescription III ganoderan: grifolan=1:1;
Prescription V ganoderan: grifolan=1:4;
Prescription XII ganoderan: grifolan=1:8;
Adopt the research method of biological Examples 1, compare test with independent employing ganoderan or grifolan.
Found that mice gives cytotoxic drug cyclophosphamide 50mg/kg injection, its numeration of leukocyte has reduced by 31.6% with normal control group ratio.
Use Ganoderma extract or Grifola frondosa extract separately, when ganoderma polyoses content is 80mg/kg, can make murine interleukin counting raise 1.4% through the cyclophosphamide injection; Grifolan content can make the numeration of leukocyte rising 10.5% through the mice of cyclophosphamide injection when 80mg/kg.
Under same experimental conditions, the compound preparation that Ganoderma extract and Grifola frondosa extract are formed is when total polysaccharides content is 80mg/kg, prescription XI, prescription I, prescription III, prescription V and prescription XII with give cytotoxicity chemotherapeutics cyclophosphamide group mice ratio separately, can make numeration of leukocyte raise 42.7%, 36.4%, 11.2%, 20.3% and 11.6% respectively, as shown in Figure 4.
Conclusion: the compound preparation that Ganoderma extract and Grifola frondosa extract are formed, it reverses the effect that effect that murine interleukin counting that cytotoxicity chemotherapeutics causes reduces is better than using separately the extract of Ganoderma or Grifola frondosa.
Biological activity embodiment 4
According to the screening study result of this Chinese medicine compound, selected ganoderan is further made pharmacodynamic study with grifolan content ratio for the prescription I of 4:1.The result is as follows:
Mice gives cyclophosphamide 50mg/kg lumbar injection, descends 31.0% with the normal control group than its blood leukocytes counting.Under similarity condition, prescription I is when concentration 20mg/kg, 80mg/kg, 200mg/kg and 400mg/kg, make leucocyte level rise 4.1%, 18.3%, 21.3% and 27.8% respectively, be the dose dependent effect, wherein prescription I80mg/kg, 200mg/kg and 400mg/kg group murine interleukin level is more remarkable than difference with cyclophosphamide 50mg/kg group mice; Give ZHENQI FUZHENG JIAONANG 485mg/kg (lot number: 20051201, Gansu Lanyao Pharmaceutical Industry Group Co., Ltd. produces) group mice blood leukocytes and raise 16.0%, see Fig. 5.
Conclusion: the reduction of the blood leukocytes counting that prescription I pair cell toxicity chemotherapeutics causes has reverse effect.
Biological activity embodiment 5
Use the method for biological activity embodiment 1, discover that mice gives cyclophosphamide 50mg/kg lumbar injection, reduce by 36.5% than its thymus index with the normal control group.Under similarity condition, prescription I can make thymus index rise 16.3%, 10.9%, 21.9% and 10.0% respectively when concentration 20mg/kg, 80mg/kg, 200mg/kg and 400mg/kg; Give ZHENQI FUZHENG JIAONANG 485mg/kg (lot number: 20051201, Gansu Lanyao Pharmaceutical Industry Group Co., Ltd. produces) group mouse thymus index and raise 7.0%, see Fig. 6.
Conclusion: the atrophy of thymus gland of prescription I pair cell toxicity caused by chemotherapeutic medicines has reverse effect.
Mice gives cyclophosphamide 50mg/kg lumbar injection, reduces by 30.5% with the normal control group than its spleen index.Under similarity condition, prescription I makes spleen index increase by 9.4%, 5.1%, 23.1% and 12.4% respectively when concentration 20mg/kg, 80mg/kg, 200mg/kg and 400mg/kg; Give ZHENQI FUZHENG JIAONANG 485mg/kg (lot number: 20051201, Gansu Lanyao Pharmaceutical Industry Group Co., Ltd. produces) mouse spleen index and raise 23.2%, see Fig. 7.
Conclusion: the spleen atrophy of prescription I pair cell toxicity caused by chemotherapeutic medicines has reverse effect.
Biological activity embodiment 7
Test method: kunming mice is used in test, ♂, and body weight 18-22g is divided into the drug treating group of normal control group and various dose at random.In the last administration after 30 minutes, tail vein injection india ink 0.1ml/10g body weight, blood 20 μ l are got from the vena orbitalis posterior clump respectively at 3min and 20min respectively with pipettor (use in advance heparin solution moistening) in the injection back, are dissolved in 2ml 0.1% Na
2CO
3Shake up in the solution, use visible-ultraviolet spectrophotometer, in wavelength 600nm place's colorimetric determination optical density.
Found that normal mouse is irritated stomach and given natural drug prescription I 20mg/kg, its macrophage phagocytic function increases by 53.09% with the normal control group than phagocytic index K, and activate the phagocytic capacity increases by 23.26%, and is more remarkable than difference with the normal control group; When its dosage is 80mg/kg and 400mg/kg, can make phagocytic index K increase by 27.0% and 11.0% respectively, activate the phagocytic capacity increases by 11.7% and 12.3%, sees Fig. 8-9.
Conclusion: prescription I can strengthen the innate immunity function of normal mouse.
Claims (10)
1. compound oral administration preparation with enhancing immunity effect, wherein active component is made up of ganoderan and grifolan, in polyoses content, ganoderan accounts for 10%～95%, grifolan accounts for 5%～90%, and described compound oral administration preparation also contains selectively pharmaceutically acceptable carrier.
2. according to the compound oral administration preparation of claim 1, wherein in polyoses content, ganoderan accounts for 20%～90%, and grifolan accounts for 10%～80%.
3. according to the compound oral administration preparation of claim 2, wherein in polyoses content, ganoderan accounts for 70～85%, and grifolan accounts for 15～30%.
4. preparation is according to each the method for compound oral administration preparation of claim 1-3, described method comprises: with ganoderan and grifolan extract or its powder by required mixed, directly be mixed with preparation, also can optionally add pharmaceutically acceptable carrier, mix homogeneously is processed into oral formulations.
5. ganoderan and the grifolan purposes that is used to prepare the medicine of enhancing immunity linked together, the active component of wherein said medicine is made up of ganoderan and grifolan, in polyoses content, ganoderan accounts for 10%～95%, grifolan accounts for 5%～90%.
6. according to the purposes of claim 5, in polyoses content, ganoderan accounts for 20%～90% in the wherein said medicine, and grifolan accounts for 10%～80%.
7. according to the purposes of claim 6, in polyoses content, ganoderan accounts for 70～85% in the wherein said medicine, and grifolan accounts for 15～30%.
8. according to each purposes of claim 5-7, wherein said medicine can be used for the treatment of immunologic hypofunction behind the cancer chemotherapy, the atrophy of maincenter behind the cancer chemotherapy and peripheral immune organ is had reverse effect, strengthens the innate immunity function.
9. according to each purposes of claim 5-7, wherein said medicine is an oral formulations.
10. according to the purposes of claim 9, wherein said preparation is capsule, tablet, granule or oral liquid.
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| CN103652839A (en) * | 2012-08-31 | 2014-03-26 | 江苏益加生物有限公司 | Health-care capsules for enhancing human immunity and production process thereof |
| CN103564424A (en) * | 2013-11-17 | 2014-02-12 | 哈尔滨艾克尔食品科技有限公司 | Method for preparing grifola frondosa chewable tablet |
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