CN103006728A - Pharmaceutical composition for enhancing immunity as well as preparation method and application thereof - Google Patents
Pharmaceutical composition for enhancing immunity as well as preparation method and application thereof Download PDFInfo
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- CN103006728A CN103006728A CN2012105320365A CN201210532036A CN103006728A CN 103006728 A CN103006728 A CN 103006728A CN 2012105320365 A CN2012105320365 A CN 2012105320365A CN 201210532036 A CN201210532036 A CN 201210532036A CN 103006728 A CN103006728 A CN 103006728A
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Abstract
The invention provides a pharmaceutical composition for enhancing immunity, which is a preparation prepared from raw material medicines in parts by weight: 1-8 parts of acanthopanax root and 1-8 parts of ganoderma lucidum spore powder. The invention further provides a preparation method and an application of the pharmaceutical composition. The pharmaceutical composition provided by the invention has the health care effects of enhancing the immunity, improving sleeping and the like. The effect of the pharmaceutical composition is obviously better than the effect of single component of the medical composition. The pharmaceutical composition has obvious collaboration effect and synergism.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition of enhancing immunity, belong to drug world.
Background technology
According to World Health Organization's statistics, the whole world approximately has 35%～50% people to be in sub-health state, and subhealth state is the intermediateness of the dynamic change between Health and Disease.The performance of subhealth state is varied.Such as hypomnesis, inappetence, lassitude, dreaminess, weak, easy catching a cold, gastrointestinal function disorder etc., but no matter the subhealth state which kind of reason causes, its essential, the most most crucial problem is that the human body autoimmune function is low.
According to showing have 1 people to suffer from insomnia among approximately per 10～12 people in the whole world at the 3rd world Sleep association many parts of Epidemiological study statistics of conference that Germany holds in October, 1999.Global implication people are physically and mentally healthy, the first problem of quality of life and work efficiency is insomnia, surpass 700,000,000 insomniacs to the year two thousand twenty is nearly.Therefore, development raising immunity has widely social meaning with the product that improves sleep function.
Ganoderma begins to be stated from the Han dynasty Shennong's Herbal, and " tonifying liver QI invigorating " " the hard muscles and bones " that be considered to can " the beneficial motive " " to pacify smart soul " classified as top grade.Compendium of Material Medica thinks that Ganoderma has " strengthening by means of tonics " " life lengthening " " sharp joint " effects such as " controlling deafness ".Modern medicine study proves, the pharmacological action of Ganoderma spore powder mainly contains the hypoxia-bearing capability of immunity adjusting, blood sugar lowering, raising muscle power and nervous system is had regulating action.
Radix Et Caulis Acanthopanacis Senticosi is the dry root and rhizome of Araliaceae Radix Et Caulis Acanthopanacis Senticosi Acanthopanx Senticosus (RuPr.et Maxim) Harms, belong to Araliaceae together with Radix Ginseng, the effect that has " invigorating middle warmer benefit essence, hard muscles and bones, Qiang Zhiyi " for sibling species not, clothes " are made light of one's life by commiting suicide anti-old " for a long time, with his medicine compatibility, also can " advance diet, strong strength, not forget things ".The application of Radix Et Caulis Acanthopanacis Senticosi, in the existing long history of China, Li Shizhen (1518-1593 A.D.) is clearly record in Compendium of Material Medica one book: " peaceful one of slender acanthopanax, the not full car of gold and jade of getting ".Present pharmaceutical research, Radix Et Caulis Acanthopanacis Senticosi is all influential to body defensive enginery, central nervous system, cardiovascular system etc.
In the prior art, although the compound that comprises Ganoderma spore powder and Radix Et Caulis Acanthopanacis Senticosi composition is arranged, there is no at present the relevant report with Radix Et Caulis Acanthopanacis Senticosi and Ganoderma spore powder two flavor material combinations uses.Simultaneously, the existing compound recipe that has comprised Radix Et Caulis Acanthopanacis Senticosi and Ganoderma spore powder exists mostly that prescription is more, cost of material is high, compound recipe complicated process of preparation or production equipment required the shortcomings such as high.
Summary of the invention
Technical scheme of the present invention has provided a kind of pharmaceutical composition of enhancing immunity, and another technical scheme of the present invention has provided preparation method and the purposes of this pharmaceutical composition.
The invention provides a kind of pharmaceutical composition of enhancing immunity, it is the preparation that the crude drug by the following weight proportioning is prepared from:
Radix Et Caulis Acanthopanacis Senticosi 1-8 part, Ganoderma spore powder 1-8 part.
Further preferably, it is the preparation that the crude drug by the following weight proportioning is prepared from:
Radix Et Caulis Acanthopanacis Senticosi 1-6 part, Ganoderma spore powder 1-6 part.
Still more preferably, it is the preparation that the crude drug by the following weight proportioning is prepared from:
1 part of Radix Et Caulis Acanthopanacis Senticosi, 1 part of Ganoderma spore powder; Or 1 part of Radix Et Caulis Acanthopanacis Senticosi, 6 parts of Ganoderma spore powders; Or 6 parts of Radix Et Caulis Acanthopanacis Senticosis, 1 part of Ganoderma spore powder.
The Radix Et Caulis Acanthopanacis Senticosi component is preferably the former medicated powder of Radix Et Caulis Acanthopanacis Senticosi, alcohol extract or the water extract that the Radix Et Caulis Acanthopanacis Senticosi crude drug of above-mentioned weight proportion processes in the aforementioned pharmaceutical compositions, or the mixture of alcohol extract and water extract; Wall cell disruption powder, wall cell disruption powder alcohol extract or wall cell disruption powder water extract that above-mentioned Ganoderma spore powder component is preferably processed by the Ganoderma spore powder of above-mentioned weight proportion, or the mixture of wall cell disruption powder alcohol extract and wall cell disruption powder water extract.
Wherein, described preparation is tablet, capsule, granule, pill, oral liquid.
The present invention also provides a kind of method for preparing described pharmaceutical composition, and it comprises the steps:
A, take by weighing the crude drug of each weight proportion;
A-1, Radix Et Caulis Acanthopanacis Senticosi are former medicated powder, alcohol extract, water extract or the alcohol extract of Radix Et Caulis Acanthopanacis Senticosi and the mixture of water extract;
A-2, Ganoderma spore powder are wall cell disruption powder, wall cell disruption powder alcohol extract, wall cell disruption powder water extract or the wall cell disruption powder alcohol extract of Ganoderma spore powder and the mixture of wall cell disruption powder water extract;
B, with a-1, a-2 mixing of materials, add pharmaceutically acceptable adjuvant or complementary composition is prepared into preparation.
Above-mentioned pharmaceutically acceptable adjuvant comprises: diluent, wetting agent, binding agent, disintegrating agent, lubricant etc.
Above-mentioned diluent is one or more in starch, Icing Sugar, dextrin, lactose, calcium carbonate, microcrystalline Cellulose, the maltose alcohol.
Above-mentioned wetting agent is the ethanol of purified water or 30-90%.
Above-mentioned binding agent is one or more in starch slurry, gelatin, Polyethylene Glycol (PEG), hyprolose (HPC), hydroxypropyl emthylcellulose (HPMC), methylcellulose (MC), ethyl cellulose (EC), Cellulose Acetate Phthalate (CAP), the PVP K30.
Above-mentioned disintegrating agent is one or more in dried starch, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, the polyvinylpolypyrrolidone.
Above-mentioned lubricant is one or more in magnesium stearate, micropowder silica gel, the Pulvis Talci.
Further preferably, comprise the steps:
(1) get Ganoderma spore powder with cellular wall broken, Radix Et Caulis Acanthopanacis Senticosi water extract, its weight proportion is 8: 1, crosses 80 mesh sieves, mix homogeneously;
The extraction process of described Acanthopanacis is: get Radix Et Caulis Acanthopanacis Senticosi, add the water reflux, extract,, wherein Radix Et Caulis Acanthopanacis Senticosi: water=1:6-10(g:mL), each 1-3h filters merging filtrate; It is 1.15-1.2 that extracting solution is evaporated to 60 ℃ of lower relative densities, gets fluid extract; The fluid extract drying under reduced pressure is got the dried cream of Acanthopanacis;
(2) get maltodextrin, calcium phosphate, pregelatinized Starch, magnesium stearate, its weight proportion is: 9: 4: 3: 0.5, and even with above-mentioned steps (1) medicament mixed;
(3) capsule fill: filled capsules, the medicament composition capsule agent that gets enhancing immunity.
The present invention also provides the purposes of described pharmaceutical composition in the medicine of preparation enhancing immunity.
The present invention also provides the purposes of described pharmaceutical composition in the medicine of preparation improvement sleep.
Pharmaceutical composition of the present invention has the health-care effects such as enhancing immunity, improvement sleep, obviously is better than single component wherein, has significantly collaborative, potentiation.
The specific embodiment
The present invention is described in further detail below in conjunction with test example and the specific embodiment.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following embodiment, all technology that realizes based on content of the present invention all belong to scope of the present invention.
The preparation of the medicinal composition tablets of 1 one kinds of enhancing immunity of embodiment
1, takes by weighing Ganoderma spore powder with cellular wall broken water extract 50g, Radix Et Caulis Acanthopanacis Senticosi water extract 50g, dextrin 50g, cross-linking sodium carboxymethyl cellulose 40g mix homogeneously.
2, incite somebody to action the raw and auxiliary material of mix homogeneously, bonding with wetting agent, stir, make soft material.
3, with the soft material that makes, cross 20 eye mesh screens, get required granule.
4, with granulate behind the wet grain drying, add the 0.5g magnesium stearate as lubricant, carry out tabletting, coating, after the assay was approved packing behind the mix homogeneously.
The preparation method of this routine Ganoderma spore powder water extract is: take by weighing Ganoderma spore powder, add 5-15 times of weight water (Ganoderma spore powder: water=1:5-15(g:mL)), adopt circumfluence method to extract, remove by filter residue, precipitation adds water again and extracts twice with method, merges supernatant, drying under reduced pressure.
The preparation method of this routine Radix Et Caulis Acanthopanacis Senticosi water extract: Radix Et Caulis Acanthopanacis Senticosi adds 6-10 times of water gaging (Radix Et Caulis Acanthopanacis Senticosi: water=1:6-10(g:mL)) reflux, extract, 2 times, and each 1-3h filters merging filtrate; Extracting solution is evaporated to relative density and is about 1.15-1.2(60 ℃), get fluid extract; The fluid extract drying under reduced pressure is got dry extract; With broken mistake 80 mesh sieves of dried cream powder.
The pharmaceutical composition of 2 one kinds of enhancing immunity of embodiment is comprised of Ganoderma spore powder with cellular wall broken 200g and Radix Et Caulis Acanthopanacis Senticosi water extract 25g.
The preparation method of this routine pharmaceutical composition gets big or small approximate consistent attritive powder, mix homogeneously for component is crossed 80 mesh sieves.
The preparation method of this routine Acanthopanacis is with embodiment 1.
The preparation of the medicament composition capsule agent of 3 one kinds of enhancing immunity of embodiment
(1) gets maltodextrin 90g, calcium phosphate 40g, pregelatinized Starch 30g, magnesium stearate 5g, with embodiment 2 described pharmaceutical composition mix homogeneously;
(2) capsule fill: filled capsules gets finished product.
The preparation of the medicament composition capsule agent of 4 one kinds of enhancing immunity of embodiment
1, sieves: take by weighing wall cell disruption powder water extract and each 10g of wall cell disruption powder alcohol extract, the Radix Et Caulis Acanthopanacis Senticosi powder 160g of Ganoderma spore powder, cross 80 mesh sieves, get big or small approximate consistent attritive powder.
2, mix: take by weighing maltodextrin 80g, calcium phosphate 40g, pregelatinized Starch 40g, magnesium stearate 10g and Ganoderma spore powder with cellular wall broken, Radix Et Caulis Acanthopanacis Senticosi extract mix homogeneously.
3, capsule fill: filled capsules gets finished product.
The preparation method of the wall cell disruption powder water extract of this routine Ganoderma spore powder is: take by weighing Ganoderma spore powder, add 5-15 times of water gaging (Ganoderma spore powder: water=1:5-15(g:mL)), the employing circumfluence method is extracted, remove by filter residue, precipitation adds water again and extracts twice with method, merge supernatant, drying under reduced pressure.
The breaking cellular wall alcohol extract preparation method of this routine Ganoderma spore powder is: take by weighing Ganoderma spore powder, add 10-20 and doubly measure 95% ethanol (Ganoderma spore powder: ethanol=1:10-20(g:mL)), lixiviate is 3 times under 60-90 ℃ of condition, each 1-3h, merge 3 times extracting solution, filter merging filtrate, concentrating under reduced pressure, drying get breaking trachytectum of glossy ganoderma powder ethanol extract.
The preparation of embodiment 5 medicament composition granule agent of the present invention
1, takes by weighing Ganoderma spore powder with cellular wall broken water extract 25g, Radix Et Caulis Acanthopanacis Senticosi water extract 75, dextrin 45g, cross-linking sodium carboxymethyl cellulose 42g mix homogeneously.
2, incite somebody to action the raw and auxiliary material of mix homogeneously, add an amount of 80% ethanol and make soft material.
3, with the soft material that makes, cross 20 eye mesh screens, get required granule.
The preparation method of Radix Et Caulis Acanthopanacis Senticosi water extract: Radix Et Caulis Acanthopanacis Senticosi adds 6-10 times of water gaging (Radix Et Caulis Acanthopanacis Senticosi: water=1:6-10(g:mL)) reflux, extract, 2 times, and each 1-3h filters merging filtrate; Extracting solution is evaporated to relative density and is about 1.15-1.2(60 ℃), get fluid extract; The fluid extract drying under reduced pressure is got dry extract; With broken mistake 80 mesh sieves of dried cream powder.
The preparation method of this routine Ganoderma spore powder with cellular wall broken water extract: take by weighing Ganoderma spore powder, add 5-15 times of water gaging (Ganoderma spore powder: water=1:5-15(g:mL)), adopt circumfluence method to extract, remove by filter residue, precipitation adds water again and extracts twice with method, merges supernatant, drying under reduced pressure.
The pharmaceutical composition of 6 one kinds of enhancing immunity of embodiment
In weight portion, take by weighing 6 parts of former medicated powder of Ganoderma spore powder with cellular wall broken, 1 part of former medicated powder of Radix Et Caulis Acanthopanacis Senticosi, cross 80 mesh sieves, mix homogeneously; Add 2 parts of maltodextrins, 1 part in calcium phosphate, 1 part of pregelatinized Starch, 0.1 part of magnesium stearate and former medicated powder mix homogeneously.
The pharmaceutical composition of 7 one kinds of enhancing immunity of embodiment
In weight portion, take by weighing 3.5 parts of former medicated powder of Ganoderma spore powder with cellular wall broken, 3.5 parts of former medicated powder of Radix Et Caulis Acanthopanacis Senticosi, cross 80 mesh sieves, mix homogeneously; Add 2 parts of maltodextrins, 1 part in calcium phosphate, 1 part of pregelatinized Starch, 0.1 part of magnesium stearate and former medicated powder mix homogeneously.
The pharmaceutical composition of 8 one kinds of enhancing immunity of embodiment
In weight portion, take by weighing 1 part of former medicated powder of Ganoderma spore powder with cellular wall broken, 6 parts of former medicated powder of Radix Et Caulis Acanthopanacis Senticosi, cross 80 mesh sieves, mix homogeneously; Add 2 parts of maltodextrins, 1 part in calcium phosphate, 1 part of pregelatinized Starch, 0.1 part of magnesium stearate and former medicated powder mix homogeneously.
Below prove beneficial effect of the present invention by concrete pharmacodynamics test.
The experimental example 1 medicine enhancing immunity function test of pesticide effectiveness of the present invention
One, laboratory animal and grouping
Select 72 of healthy male mices, body weight 18-22g is divided into 6 groups, and 12 every group, as immune one group, the mensuration and the antibody-producting cell that carry out half hemolysis value (HC50) detect; Select 72 of healthy male mices, body weight 18-22g is divided into 6 groups, 12 every group, as immune two groups, carries out carbon and cleans up experiment; Select 72 of healthy male mices, body weight 18-22g is divided into 6 groups, 12 every group, as immune three groups, carries out the delayed allergy experiment; Select 72 of healthy male mices, body weight 18-22g is divided into 6 groups, 12 every group, as immune four groups, carries out Turnover of Mouse Peritoneal Macrophages and engulfs the chicken red blood cell experiment.
Two, experimental group setting and dosage
Ganoderma spore powder with cellular wall broken: Radix Et Caulis Acanthopanacis Senticosi is 6:1(embodiment 6), 1:1(embodiment 7), 1:6(embodiment 8) present composition of different proportion form.
Press 1.5g/kg BW dosage gavage, matched group is Ganoderma spore powder and the Radix Et Caulis Acanthopanacis Senticosi of equivalent, has carried out respectively the contrast experiment, and negative control group gives to wait the distilled water of capacity, and gavage is surveyed every immune indexes after 30 days continuously.
Three, experimental technique and result
1. delayed allergy (toes thicken method DTH)
Get Sanguis caprae seu ovis, normal saline washing 3 times, mice 2%(V/V) the SRBC peritoneal immunity, every Mus injection 0.2mL.In immunity rear 4 days, measure left back toes section thickness, then at measuring point injection 20%(V/V) SRBC, every Mus 20 μ L, 24h measures left back toes section thickness after the injection, and same position is measured three times, averages, and result of the test is as shown in table 1 below.
Table 1 is on the impact of Mouse Weight and delayed allergy (DTH)
| Group | Number of animals (only) | Starting weight | Continuous heavy | Weightening finish | Toes buildup thickness (mm) |
| Negative control | 12 | 18.7±0.7 | 36.2±1.0 | 17.3±0.9 | 0.54±0.07 |
| Ganoderma spore powder | 12 | 19.0±0.7 | 36.5±1.0 | 17.5±1.1 | 0.61±0.07* |
| Radix Et Caulis Acanthopanacis Senticosi extract | 12 | 19.1±0.8 | 36.7±1.4 | 17.6±1.1 | 0.60±0.06* |
| Embodiment 6 samples | 12 | 19.4±1.0 | 37.2±1.4 | 17.8±1.5 | 0.62±0.07** |
| Embodiment 7 samples | 12 | 19.2±0.9 | 36.9±1.1 | 17.7±1.2 | 0.63±0.08** |
| Embodiment 8 samples | 12 | 19.0±0.8 | 36.4±1.2 | 17.4±1.3 | 0.62±0.08** |
Compare with negative control group: *: P＜0.05, * *: P＜0.01
Result of the test shows: the toes buildup thickness of experimental group all is higher than matched group, all have and strengthen the allergic effect of mice Delayed onset that DNFB causes, but embodiment 6,7,8(Ganoderma spore powder: Radix Et Caulis Acanthopanacis Senticosi=6:1,1:1,1:6) on the impact of mice delayed allergy (DTH) Ganoderma spore powder and the Radix Et Caulis Acanthopanacis Senticosi greater than single component, illustrate that pharmaceutical composition of the present invention has obvious synergistic function.
Experimental example 2 medicines of the present invention are on the impact of humoral immunization
1 antibody-producting cell detects (Jerne improves slide method)
Hematocrit SRBC is made into 2%(V/V with normal saline) cell suspension, every Mus lumbar injection 0.2mL.To put to death with the mice cervical vertebra dislocation of SRBC immunity after 4-5 days, get spleen, put into the little plate that fills Hank ' s liquid, gently spleen is ground, make cell suspension, then through 4 filtered through gauze, use Hank ' s liquid to wash 2 times, each centrifugal 10min (1000r/min).Then with cell suspension in the 1mLRPMI640 culture fluid, counting cells, and cell concentration is adjusted into 5 * 10
6Individual/mL.
After the agarose heating for dissolving, put 45-50 ℃ of water bath heat preservations, mix with Hank ' the s liquid of equivalent PH7.2-7.42 times concentration, the packing small test tube, every pipe 0.5mL, in pipe, add 10%(V/V again, with the preparation of SA liquid) hematocrit SRBC 50 μ L, splenocyte suspension 20 μ L are rapidly behind the mixing, be poured on the slide of brushing the agarose thin layer, do parallel plate, after agar solidifies, the slide level buckled be placed on the horse, put into CO2 gas incubator incubation 1.5h, then the complement (1:8) with the dilution of SA buffer joins in the slide frame groove, continues incubation 1.5h, counting hemolysis plaque number.
The impact of table 2 antagonist cellulation number
| Group | Number of animals (only) | Hemolysis plaque number (* 10 3/ full spleen) |
| Negative control | 12 | 179.8±7.8 |
| Ganoderma spore powder | 12 | 186.2±8.9* |
| Radix Et Caulis Acanthopanacis Senticosi | 12 | 187.5±7.6* |
| Embodiment 6 samples | 12 | 189.0±6.9** |
| Embodiment 7 samples | 12 | 189.7±5.8** |
| Embodiment 8 samples | 12 | 188.5±6.2** |
Compare with negative control group: *: P＜0.05, * *: P＜0.01
By as seen from Table 2, per os gave embodiment 8 samples of each experimental group of mice after 0 day, learned by statistics and processed, and the Ganoderma spore powder group of single component, the antibody of Radix Et Caulis Acanthopanacis Senticosi group generate number and compares with negative control group, and significant difference (P＜0.05) is arranged; The antibody of the laboratory sample group of the present invention of two kinds of medicine different proportion forms (being embodiment 6 sample sets, embodiment 7 sample sets, embodiment 8 sample sets) generates number and compares with negative control group, and highly significant difference (P＜0.01) is arranged.Illustrate that embodiment 6 samples, embodiment 7 samples, embodiment 8 samples on the impact of mouse antibodies cellulation number Ganoderma spore powder and the Radix Et Caulis Acanthopanacis Senticosi greater than single component, illustrate that pharmaceutical composition of the present invention has obvious synergistic function.
2 mice half hemolysis value HC
50Mensuration
Get Sanguis caprae seu ovis, normal saline washing 3 times, each centrifugal (2000r/min) 10min, every Mus is prepared with normal saline through lumbar injection 2%(V/V) hematocrit SRBC 0.2mL carries out immunity.After 4 days, extract eyeball and get blood in centrifuge tube, place approximately 1h, solidification blood and tube wall are peeled off, serum composition is separated out, the centrifugal 10min of 2000r/min collects serum.With the SA buffer serum is diluted (400 times).Serum 1mL after the dilution is put in vitro, adds successively 10%(V/V) SRBC 0.5mL, complement 1mL(presses the 1:8 dilution with the SA buffer).Other establishes the not control tube of increase serum (replacing with the SA buffer).Put be incubated 15-30min in 37 ℃ of waters bath with thermostatic control after, the ice bath cessation reaction.The centrifugal 10min of 2000r/min gets supernatant 1mL, adds Dou Shi reagent 3mL.Get simultaneously 10%(V/V) SBRC 0.25mL, add Dou Shi reagent to 4mL, the composition mixing behind the placement 10min, is sentenced control tube with 540nm and is made blank, measures respectively and respectively manages optical density value.The amount of hemolysin is with half hemolysis value (HC
50) expression, be calculated as follows experimental result table following table 3.
Table 3 couple mice half hemolysis value HC
50Impact
| Group | Number of animals (only) | Sample HC 50 |
| Negative control | 12 | 165±7 |
| Ganoderma spore powder | 12 | 178±5 |
| Radix Et Caulis Acanthopanacis Senticosi | 12 | 180±6 |
| Embodiment 6 samples | 12 | 188±8* |
| Embodiment 7 samples | 12 | 193±7* |
| Embodiment 8 samples | 12 | 189±5* |
Compare with negative control group: *: P＜0.05
By as seen from Table 3, per os gave embodiment 8 samples of each experimental group of mice after 0 day, learned by statistics and processed, and the Ganoderma spore powder group of single component, the half hemolysis value of Radix Et Caulis Acanthopanacis Senticosi group are compared there was no significant difference (P〉0.05) with negative control group; The half hemolysis value of the laboratory sample group of the present invention of two kinds of medicine different proportion forms (being embodiment 6 sample sets, embodiment 7 sample sets, embodiment 8 sample sets) is compared with negative control group, and significant difference (P＜0.05) is arranged.Illustrate that embodiment 6 samples, embodiment 7 samples, embodiment 8 samples improve the mice half hemolysis value, and the Ganoderma spore powder of single component, Radix Et Caulis Acanthopanacis Senticosi act on without this.
3. mouse monokaryon-macrophage carbon is cleaned up the impact of function
The india ink that mouse tail vein injection 1:4 doubly dilutes treats that prepared Chinese ink injects immediately timing.Inject behind the prepared Chinese ink 2,10min, get blood 20 μ L from the angular vein clump respectively, and at once it be added to 2mL0.1%Na
2CO
3In the solution.With 722 spectrophotometers at 600nm wavelength place's photometry density value (OD), with Na
2CO
3Solution is made negative control.Mice is put to death, get liver and spleen, blot internal organs with filter paper and show blood stains, weigh respectively.Be calculated as follows phagocytic index a:
Table 4 is cleaned up the impact of function to mouse monokaryon-macrophage carbon
| Group | Number of animals (only) | Phagocytic index (a) |
| Negative control | 12 | 6.45±0.45 |
| Ganoderma spore powder | 12 | 6.73±0.41 |
| Radix Et Caulis Acanthopanacis Senticosi | 12 | 6.74±0.32 |
| Embodiment 6 samples | 12 | 6.86±0.35** |
| Embodiment 7 samples | 12 | 6.93±0.48** |
| Embodiment 8 samples | 12 | 6.95±0.53** |
Compare with negative control group: *: P＜0.05, * *: P＜0.01
By as seen from Table 4, per os gave embodiment 8 samples of each experimental group of mice after 0 day, learned by statistics and processed, and the Ganoderma spore powder of single component and the carbon of Radix Et Caulis Acanthopanacis Senticosi are cleaned up ability and compared there was no significant difference (P〉0.05) with negative control group; The carbon of the laboratory sample group of the present invention of two kinds of medicine different proportion forms (being embodiment 6 sample sets, embodiment 7 sample sets, embodiment 8 sample sets) is cleaned up ability and is compared with negative control group and significantly improve (P＜0.05).Illustrate that embodiment 6 samples, embodiment 7 samples, embodiment 8 samples improve mice carbon and clean up Ganoderma spore powder and the Radix Et Caulis Acanthopanacis Senticosi that the effect of ability all is better than single component, illustrate that pharmaceutical composition of the present invention has obvious synergistic function.
Experimental example 3 pharmaceutical compositions of the present invention improve the sleep function test of pesticide effectiveness
One, laboratory animal and grouping
Choose body weight and be 72 of the mices of 19.5-20.5g, be divided into 6 groups, 12 every group, prolong the pentobarbital sodium test length of one's sleep; Choose body weight and be 72 of the mices of 19.3-20.3g, be divided into 6 groups, 12 every group, carry out pentobarbital sodium sub-threshold dose hypnosis test.
Two, experimental group setting and dosage
Sample sets is Ganoderma spore powder with cellular wall broken: Radix Et Caulis Acanthopanacis Senticosi is 6:1(embodiment 6 samples), 1:1(embodiment 7 samples), 1:6(embodiment 8 samples) present composition of different proportion form, press 1.5g/kgBW dosage gavage, matched group is Ganoderma spore powder and the Radix Et Caulis Acanthopanacis Senticosi of equivalent, carried out respectively the contrast experiment, negative control group gives to wait the distilled water of capacity, and each organizes the continuous gavage of mice 30 days.
Three, experimental technique and result
1, prolongs the pentobarbital sodium test length of one's sleep
After the last gavage, the front 15min of peak effect occurs, give the pentobarbital sodium of each treated animal lumbar injection 45mg/kg BW, injection volume is 0.1mL/10g BW, take righting reflex loss as sleeping criterion, observe given the test agent and whether prolong pentobarbital sodium length of one's sleep.
Table 5 is on prolonging the pentobarbital sodium impact of the length of one's sleep
Compare with negative control group: *: P＜0.05, * *: P＜0.01
By as seen from Table 5, after the animal last gave distilled water and experimental group sample, 15min before the peak effect appearred, give each treated animal injection pentobarbital sodium, to carrying out one factor analysis of variance the length of one's sleep, the result shows, experimental group all has the effect of Sleeping Time Prolong Ed.The laboratory sample group of the present invention of two kinds of medicine different proportion forms is basic identical to the effect of Sleeping Time Prolong Ed, and embodiment 6 samples, embodiment 7 samples, embodiment 8 samples all are better than Ganoderma spore powder and the Radix Et Caulis Acanthopanacis Senticosi of single component on the impact that prolongs pentobarbital sodium length of one's sleep, illustrate that pharmaceutical composition of the present invention has obvious synergistic function.
2, pentobarbital sodium sub-threshold dose hypnosis test
After the last gavage, the front 10min of peak effect occurs, give each treated animal lumbar injection pentobarbital sodium maximum subthreshold hypnotic dosage (26mg/kg BW), injection volume is 0.1mL/10g BW, the number of animals (righting reflex reaches the above person of 1min) of falling asleep in the record 30min.Result of the test sees Table 6.
Table 6 is on the impact of pentobarbital sodium sub-threshold dose hypnosis test sleep incidence rate
P: each experimental group and negative control group are relatively
By as seen from Table 6, after the animal last gave distilled water and experimental group sample, effect front 10min in peak appearred, give maximal dose under each treated animal injection threshold, sleeping animal incidence rate is carried out X 2 test.The result shows, the sleep incidence rate has group difference, compare with negative control group, the laboratory sample group of the present invention of two kinds of medicine different proportion forms (is embodiment 6 sample sets, embodiment 7 sample sets, embodiment 8 sample sets) sleep incidence rate significantly improves (P＜0.01), the sleep incidence rate of Ganoderma spore powder group improves (P＜0.05), and the sleep incidence rate there was no significant difference (P＞0.05) of Radix Et Caulis Acanthopanacis Senticosi group, embodiment 6 samples are described, embodiment 7 samples, embodiment 8 samples all are better than Ganoderma spore powder and the Radix Et Caulis Acanthopanacis Senticosi of single component to the syngignoscism of mice pentobarbital sodium sub-threshold dose, illustrate that pharmaceutical composition of the present invention has obvious synergistic function.
Claims (10)
1. the pharmaceutical composition of an enhancing immunity is characterized in that: it is the preparation that the raw material of Chinese medicine by the following weight proportioning is prepared from:
Radix Et Caulis Acanthopanacis Senticosi 1-8 part, Ganoderma spore powder 1-8 part.
2. the pharmaceutical composition of enhancing immunity according to claim 1 is characterized in that: it is the preparation that the raw material of Chinese medicine by the following weight proportioning is prepared from:
Radix Et Caulis Acanthopanacis Senticosi 1-6 part, Ganoderma spore powder 1-6 part.
3. the pharmaceutical composition of enhancing immunity according to claim 2 is characterized in that: it is the preparation that the raw material of Chinese medicine by the following weight proportioning is prepared from:
1 part of Radix Et Caulis Acanthopanacis Senticosi, 1 part of Ganoderma spore powder; Or 1 part of Radix Et Caulis Acanthopanacis Senticosi, 6 parts of Ganoderma spore powders; Or 6 parts of Radix Et Caulis Acanthopanacis Senticosis, 1 part of Ganoderma spore powder.
4. the described pharmaceutical composition of any one according to claim 1-3, it is characterized in that: described Radix Et Caulis Acanthopanacis Senticosi component is the former medicated powder of Radix Et Caulis Acanthopanacis Senticosi, alcohol extract or the water extract that the Radix Et Caulis Acanthopanacis Senticosi Raw material processing by described weight proportion forms, or the mixture of alcohol extract and water extract; Described Ganoderma spore powder component is wall cell disruption powder, wall cell disruption powder alcohol extract or the wall cell disruption powder water extract that the Ganoderma spore powder by described weight proportion processes, or the mixture of wall cell disruption powder alcohol extract and wall cell disruption powder water extract.
5. described pharmaceutical composition according to claim 1-4, it is characterized in that: described preparation is tablet, capsule, granule, pill or oral liquid.
6. method for preparing the described pharmaceutical composition of claim 1-5 any one, it is characterized in that: it comprises the steps:
A, take by weighing the crude drug of each weight proportion;
A-1, Radix Et Caulis Acanthopanacis Senticosi are former medicated powder, alcohol extract or the water extract of Radix Et Caulis Acanthopanacis Senticosi, or the mixture of alcohol extract and water extract;
A-2, Ganoderma spore powder are wall cell disruption powder, wall cell disruption powder alcohol extract or the wall cell disruption powder water extract of Ganoderma spore powder, or the mixture of wall cell disruption powder alcohol extract and wall cell disruption powder water extract;
B, with a-1, a-2 mixing of materials, add pharmaceutically acceptable adjuvant or complementary composition is prepared into preparation.
7. preparation method according to claim 6, it is characterized in that: described pharmaceutically acceptable adjuvant comprises diluent, wetting agent, binding agent, disintegrating agent, lubricant; Described diluent is one or more in starch, Icing Sugar, dextrin, lactose, calcium carbonate, microcrystalline Cellulose, the maltose alcohol; Described wetting agent is the ethanol of purified water or 30-90%; Described binding agent is one or more in starch slurry, gelatin, Polyethylene Glycol, hyprolose, hydroxypropyl emthylcellulose, methylcellulose, ethyl cellulose, Cellulose Acetate Phthalate, the PVP K30; Described disintegrating agent is one or more in dried starch, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, the polyvinylpolypyrrolidone; Described lubricant is one or more in magnesium stearate, micropowder silica gel, the Pulvis Talci.
8. the preparation method of pharmaceutical composition according to claim 7 is characterized in that: comprise the steps:
(1) get Ganoderma spore powder with cellular wall broken, Radix Et Caulis Acanthopanacis Senticosi water extract, its weight proportion is 8: 1, crosses 80 mesh sieves, mix homogeneously;
The extraction process of described Acanthopanacis is: get Radix Et Caulis Acanthopanacis Senticosi, add the water reflux, extract,, wherein Radix Et Caulis Acanthopanacis Senticosi: water=1:6-10(g:mL), each 1-3h filters merging filtrate; It is 1.15-1.2 that extracting solution is evaporated to 60 ℃ of lower relative densities, gets fluid extract; The fluid extract drying under reduced pressure is got the dried cream of Acanthopanacis;
(2) get maltodextrin, calcium phosphate, pregelatinized Starch, magnesium stearate, its weight proportion is: 9: 4: 3: 0.5, and even with above-mentioned steps (1) medicament mixed;
(3) capsule fill: filled capsules, the medicament composition capsule agent that gets enhancing immunity.
The described pharmaceutical composition of claim 1-5 any one the preparation enhancing immunity medicine in purposes.
10. the described pharmaceutical composition of claim 1-5 any one is preparing the purposes of improving in the medicine of sleeping.
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| CN103948658A (en) * | 2014-04-15 | 2014-07-30 | 刘树成 | Preparation method for health medicinal wine |
| CN106361781A (en) * | 2016-10-28 | 2017-02-01 | 芜湖市诺康生物科技有限公司 | Composition for enhancing immunity and preparation method of composition |
| WO2018188409A1 (en) * | 2017-04-10 | 2018-10-18 | 浙江寿仙谷医药股份有限公司 | Shell-broken lingzhi spore powder, particulate, and method for preparation thereof |
| WO2018188408A1 (en) * | 2017-04-10 | 2018-10-18 | 浙江寿仙谷医药股份有限公司 | Sporoderm-removing ganoderma lucidum spore powder tablet and preparation method therefor |
| CN111632074A (en) * | 2020-07-27 | 2020-09-08 | 山东蓝康药业股份有限公司 | A Chinese and western medicinal composition for treating insomnia and preparation method thereof |
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| CN102151297A (en) * | 2011-04-19 | 2011-08-17 | 柳正良 | Compound ganoderma lucidum spore soft capsule and preparation method thereof |
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| CN101433630A (en) * | 2007-11-16 | 2009-05-20 | 北京因科瑞斯医药科技有限公司 | Antiradiation composition for improving immunity and preparation method thereof |
| CN102151297A (en) * | 2011-04-19 | 2011-08-17 | 柳正良 | Compound ganoderma lucidum spore soft capsule and preparation method thereof |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103948658A (en) * | 2014-04-15 | 2014-07-30 | 刘树成 | Preparation method for health medicinal wine |
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| CN106361781A (en) * | 2016-10-28 | 2017-02-01 | 芜湖市诺康生物科技有限公司 | Composition for enhancing immunity and preparation method of composition |
| WO2018188409A1 (en) * | 2017-04-10 | 2018-10-18 | 浙江寿仙谷医药股份有限公司 | Shell-broken lingzhi spore powder, particulate, and method for preparation thereof |
| WO2018188408A1 (en) * | 2017-04-10 | 2018-10-18 | 浙江寿仙谷医药股份有限公司 | Sporoderm-removing ganoderma lucidum spore powder tablet and preparation method therefor |
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| US11931389B2 (en) | 2017-04-10 | 2024-03-19 | Zhejiang Shouxiangu Pharmaceutical Company, Ltd. | Tablet of sporoderm-removed ganoderma lucidum spore and preparation method thereof |
| CN111632074A (en) * | 2020-07-27 | 2020-09-08 | 山东蓝康药业股份有限公司 | A Chinese and western medicinal composition for treating insomnia and preparation method thereof |
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Application publication date: 20130403 |