CN103800400A - Ganoderma lucidum/Balanophoora involucrate Hook.f pharmaceutical composition, and preparation method, preparation and application thereof - Google Patents
Ganoderma lucidum/Balanophoora involucrate Hook.f pharmaceutical composition, and preparation method, preparation and application thereof Download PDFInfo
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Abstract
The invention discloses a ganoderma lucidum/Balanophoora involucrate Hook.f pharmaceutical composition, and a preparation method, preparation and application thereof, belonging to the technical field of preparation of medicines. The pharmaceutical composition comprises 45-55 parts by weight of ganoderma lucidum ultrafine powder and 45-55 parts by weight of Balanophoora involucrate Hook.f ultrafine powder. The preparation method comprises the following steps: removing impurities from ganoderma lucidum and Balanophoora involucrate Hook.f, selecting, cleaning, airing, and drying until the water content is at most 3%; respectively pulverizing the ganoderma lucidum and Balanophoora involucrate Hook.f with a coarse pulverizer, and passing through an 80-140-mesh screen; pulverizing the ganoderma lucidum coarse powder by a vibromill to obtain the ultrafine powder with the particle size of 6-12 mu m, and pulverizing the Balanophoora involucrate Hook.f coarse powder by a jet mill to obtain the ultrafine powder with the particle size of 10-20 mu m; and evenly mixing the 45-55 parts by weight of ganoderma lucidum ultrafine powder and the 45-55 parts by weight of Balanophoora involucrate Hook.f ultrafine powder. The preparation is prepared by adding pharmaceutically acceptable auxiliary materials into the pharmaceutical composition. The pharmaceutical composition can be used for preparing medicines for tranquilizing the mind, promoting sleeping, invigorating qi and soothing the nerves, and has the characteristics of high bioavailability, high active component leaching speed and favorable drug absorption effect.
Description
Technical field
The invention belongs to field of medicine preparing technology, be specifically related to a kind of Ganoderma, Balanophora dioica R Br ex Royle pharmaceutical composition and preparation method thereof, preparation and application.
Background technology
Ganoderma claims again Ganoderma, Herba mesonae chinensis, it is Polyporaceae Ganoderma plant, contain 150 various active materials, wherein triterpenes, polysaccharide and protein are to study at present more health care, medicinal ingredient, there is calmness, pain relieving, relieving asthma, regulate or strengthen body immunity, antioxidation and antidotal effect, be used to clinically prevention and the existing more report for the treatment of of the diseases such as asthma, hypertension, angina pectoris.Balanophora dioica R Br ex Royle (
balanophora Simoensiss.Y.Chang et Tam) be Balanophoraceae Balanophora plant, contain abundant triterpenes, Phenylpropanoid Glycosides class, sterols, tannin class and flavonoid bioactive ingredients, there is effect of the liver and the kidney tonifying, regulating menstruation and activating blood, heat-clearing and toxic substances removing, the treatment that is usually used in sexual impotence, dysmenorrhea, cirrhotic ascites etc. among the people.
According to Chinese prescription theory, Ganoderma and Balanophora dioica R Br ex Royle mixture are had to the curative effect of getting twice the result with half the effort for the treatment of the diseases such as cranial nerve function imbalance, irritated insomnia, night sweat dreaminess.But traditional prepared slices of Chinese crude drugs not only decoct trouble, use inconvenience, and quality stability is poor, be difficult for storing and keeping, because bioavailability is low, cause the use amount of former medicine higher, these defects become the major obstacle of restriction prepared slices of Chinese crude drugs development already.Therefore, develop that a kind of bioavailability is high, active constituents of medicine stripping is fast, drug absorption is effective, and former survival dose is little, and stay-in-grade glossy ganoderma, Balanophora dioica R Br ex Royle pharmaceutical composition and preparation method thereof are necessary with preparation.
Summary of the invention
The first object of the present invention is to provide a kind of Ganoderma, Balanophora dioica R Br ex Royle pharmaceutical composition; The second object is to provide the preparation method of described pharmaceutical composition; The preparation that provides described pharmaceutical composition to make is provided the 3rd object; The 4th object is to provide the application of described pharmaceutical composition in the calm sleeping of preparation, benefiting vital QI for tranquillizing medicine.
The first object of the present invention is achieved in that described pharmaceutical composition comprises 45 ~ 55 parts of 45 ~ 55 parts of Ganoderma micropowders by weight and Balanophora dioica R Br ex Royle micropowders.
The second object of the present invention is achieved in that and comprises pretreatment, coarse pulverization, micronizing and mixture operation, specifically comprises:
A, pretreatment: foreign material in Ganoderma, Balanophora dioica R Br ex Royle are rejected, through cleaning, cleaning, dry in the sun, to be dried to moisture content≤3% for subsequent use;
B, coarse pulverization: Ganoderma, Balanophora dioica R Br ex Royle are pulverized with Roughpulverizer respectively, crossed 80 ~ 140 mesh sieves for subsequent use;
C, micronizing: Ganoderma coarse powder is ground into the micropowders of particle diameter 6 ~ 12 μ m with vibromill, Balanophora dioica R Br ex Royle coarse powder is ground into the micropowders of particle diameter 10 ~ 20 μ m with jet mill;
D, mixture: by 45 ~ 55 parts of Ganoderma micropowders by weight and 45 ~ 55 parts of mixtures of Balanophora dioica R Br ex Royle micropowders evenly.
The 3rd object of the present invention is achieved in that described preparation adds pharmaceutically acceptable adjuvant to make powder, tablet, granule, capsule, pill, membranous patch, Foradil Aerolizer formoterol fumarate, oral controlled-release sheet or injection by Ganoderma, Balanophora dioica R Br ex Royle pharmaceutical composition.
The 4th object of the present invention is achieved in that the application of described pharmaceutical composition in the calm sleeping of preparation, benefiting vital QI for tranquillizing medicine.
Ganoderma of the present invention, Balanophora dioica R Br ex Royle pharmaceutical composition are made up according to the prescription mixture of accurate setting of the micropowders of Ganoderma and Balanophora dioica R Br ex Royle.According to the diversity of former medicine reason, chemical property and contained active component, preparation method of the present invention has been selected different superfine grinding methods to the former medicine of difference.
Ganoderma is carried out to routine and pulverize and easily form fibrous and block, affect absorbing of effective ingredient, and dissolution rate and the temperature of ganoderan isoreactivity material are closely related, the body temperature of absorption object is also unfavorable for the efficient stripping of polysaccharose substance.Preparation method of the present invention adopts vibromill to pulverize it, and the process combination setting has effectively improved cell wall breaking rate, and the bioavailability of the medicinal component low-molecular-weight polysaccharide that especially biological activity is stronger in Ganoderma is obviously improved.In addition, because polysaccharose substance is the macromolecular compound being linked into by multiple monosaccharide groups, the disintegrating process that the present invention adopts also helps the disintegration of accelerating polysaccharose substance polycrystalline state structure, and the dissolubility of the amorphous polysaccharide forming is better, has improved the assimilation effect of medicine.
Balanophora dioica R Br ex Royle is perennial meat herbaceous plant, contains the cell that more wall is thin, matter is soft, contains a large amount of fatty elaioleucites in cell, adopts jet mill to carry out micronizing and has good crushing effect, and cell separation rate is high, the feature that destructive rate is low.The disintegrating process that preparation method of the present invention is set only forms abundant damage and parietal layer is produced to appropriate skiving on cell wall surface, but not cell wall is destroyed completely, be conducive on the one hand improve rate of release and the burst size of the rear active component of medicine absorption, corresponding drug absorption rate and bioavailability also improve thereupon, reduce on the other hand the volatilization of effective ingredient, particularly fatty elaioleucite in the medicine cell of crushing process Central Plains.
In addition, because the content of its medicinal ingredient of Ganoderma different parts is not identical, antioxidant activity also has larger difference, especially the non-oxidizability of spore powder polysaccharide is not good, the present invention selects the stem of Ganoderma and cap as former medicine targetedly according to the target purposes of medicine, selective use has further improved the bioavailability of medicine, has saved Chinese material medicine resource.Owing to being processed into micropowders, pharmaceutical composition of the present invention is at mixing uniformity, all there is larger improvement the aspects such as divided dose accuracy, compressibility and quality stability, be conducive to be processed into different dosage forms, thereby accurately control the infiltration rate of medicine, the retention times of drug effect etc., meet different patients' health care, Treatment need.
The specific embodiment
The present invention is further illustrated below, but never in any form the present invention is limited, and any conversion or the replacement done based on training centre of the present invention, all belong to protection scope of the present invention.
Ganoderma of the present invention, Balanophora dioica R Br ex Royle pharmaceutical composition comprise 45 ~ 55 parts of 45 ~ 55 parts of Ganoderma micropowders by weight and Balanophora dioica R Br ex Royle micropowders.
Described pharmaceutical composition preferably includes 50 parts of 50 parts of Ganoderma micropowders by weight and Balanophora dioica R Br ex Royle micropowders.
The particle diameter of described Ganoderma micropowders is 6 ~ 12 μ m, and the particle diameter of described Balanophora dioica R Br ex Royle micropowders is 10 ~ 20 μ m.
In described Ganoderma micropowders, particle diameter is that the ratio of the fine powder of 6 ~ 12 μ m is 90 ~ 95%, and in described Balanophora dioica R Br ex Royle micropowders, particle diameter is that the ratio of the fine powder of 10 ~ 20 μ m is 90 ~ 95%.
Described pharmaceutical composition is prepared by the following method:
A, pretreatment: foreign material in Ganoderma, Balanophora dioica R Br ex Royle are rejected, through cleaning, cleaning, dry in the sun, to be dried to moisture content≤3% for subsequent use;
B, coarse pulverization: Ganoderma, Balanophora dioica R Br ex Royle are pulverized with Roughpulverizer respectively, crossed 80 ~ 140 mesh sieves for subsequent use;
C, micronizing: Ganoderma coarse powder is ground into the micropowders of particle diameter 6 ~ 12 μ m with vibromill, Balanophora dioica R Br ex Royle coarse powder is ground into the micropowders of particle diameter 10 ~ 20 μ m with jet mill;
D, mixture: by 45 ~ 55 parts of Ganoderma micropowders by weight and 45 ~ 55 parts of mixtures of Balanophora dioica R Br ex Royle micropowders evenly.
The preparation method of Ganoderma of the present invention, Balanophora dioica R Br ex Royle pharmaceutical composition, comprises pretreatment, coarse pulverization, micronizing and mixture operation, specifically comprises:
A, pretreatment: foreign material in Ganoderma, Balanophora dioica R Br ex Royle are rejected, through cleaning, cleaning, dry in the sun, to be dried to moisture content≤3% for subsequent use;
B, coarse pulverization: Ganoderma, Balanophora dioica R Br ex Royle are pulverized with Roughpulverizer respectively, crossed 80 ~ 140 mesh sieves for subsequent use;
C, micronizing: Ganoderma coarse powder is ground into the micropowders of particle diameter 6 ~ 12 μ m with vibromill, Balanophora dioica R Br ex Royle coarse powder is ground into the micropowders of particle diameter 10 ~ 20 μ m with jet mill;
D, mixture: by 45 ~ 55 parts of Ganoderma micropowders by weight and 45 ~ 55 parts of mixtures of Balanophora dioica R Br ex Royle micropowders evenly.
Described preparation method can also comprise sterilization steps, and uniform mixture pharmaceutical composition is carried out to sterilization treatment.
Described sterilization treatment can be any in dry heat sterilization, microwave sterilizating, heat-wind circulate drying sterilizing, far-infrared disinfecting and ozone sterilization.
Cleaning described in steps A refers to and uses flowing water rinsing.
Dry in the sun described in steps A refers to and is placed under natural sunlight, allows Ganoderma and Balanophora dioica R Br ex Royle nature air dry.
Being dried described in steps A can be any in microwave drying, far-infrared ray drying, heat-wind circulate drying, vacuum lyophilization or solar energy drying.
Described Ganoderma can be Ganoderma (
ganoderma lucidum), Ganoderma (
ganoderma sinense), Ganoderma tsugae (
ganoderma tsugae), yellow limit Ganoderma (
ganoderma luteomarginatum) or Ganaderma capense (
ganoderma capense) in any.
Described Ganoderma be preferably Ganoderma (
ganoderma sinense).
Described Ganoderma refers to stem and the cap of Ganoderma.
Roughpulverizer described in step B is preferably Circoplex classified grinding machine.
Ganoderma, Balanophora dioica R Br ex Royle are pulverized with Roughpulverizer respectively described in step B, it is for subsequent use that Ganoderma coarse powder is preferably crossed 100 ~ 140 mesh sieves, and it is for subsequent use that Balanophora dioica R Br ex Royle coarse powder is preferably crossed 80 ~ 100 mesh sieves.
Ganoderma coarse powder is pulverized with vibromill described in step C, vibromill is ZM-2 type high-frequency vibration mill, working condition is set: grinding media is bar-shaped or spherical, grinding media diameter is 0.3 ~ 0.5mm, grinding media pack completeness is 45 ~ 55%, and grinding media material ratio is 4 ~ 5, and grinding time is 1.5 ~ 2.0h; Balanophora dioica R Br ex Royle coarse powder is pulverized with jet mill, and jet mill is TC-20 type fluid bed supersonic jet mill, and working condition is set: inlet amount is 0.8 ~ 1.5kg, and air consumption is 0.8 ~ 1.0m
3/ min, admission pressure is 0.7 ~ 0.9MPa, grader rotating speed is reversion 2400 ~ 2800r/min.
Described grinding media is preferably bar-shaped.
Mixture described in step D preferably by 50 parts of Ganoderma micropowders by weight and 50 parts of mixtures of Balanophora dioica R Br ex Royle micropowders evenly.
Mixture described in step D is placed in medium stirring mill mix and blend 1.5 ~ 2.5min after evenly referring to Ganoderma micropowders and Balanophora dioica R Br ex Royle micropowders being mixed by formula proportion.
Mixture described in step D is evenly preferably pressed Ganoderma micropowders and Balanophora dioica R Br ex Royle micropowders after formula proportion mixing, be placed in KDL-SPECIAL type medium stirring mill mix and blend, working condition is set: grinding media is bar-shaped or spherical, grinding media diameter is 0.5 ~ 1.0mm, grinding media pack completeness is 70 ~ 80%, grinding media material ratio is 4 ~ 5, and stirring disc rotation speed is 1800 ~ 2200r/min, and mixing time is 1.5 ~ 2.5min.
Described grinding media is preferably bar-shaped.
Mixture described in step D evenly after, the particle diameter of pharmaceutical composition is 4 ~ 14 μ m.
Mixture described in step D evenly after, in pharmaceutical composition, particle diameter is that the ratio of the fine powder of 4 ~ 14 μ m is 90 ~ 95%.
The preparation of pharmaceutical composition of the present invention adds pharmaceutically acceptable adjuvant to make powder, tablet, granule, capsule, pill, membranous patch, Foradil Aerolizer formoterol fumarate, oral controlled-release sheet or injection by Ganoderma, Balanophora dioica R Br ex Royle pharmaceutical composition.
Described pharmaceutical composition can be used for preparing the medicine of calm sleeping, benefiting vital QI for tranquillizing.
embodiment 1
---the preparation of described pharmaceutical composition
A, pretreatment: get Ganoderma (
ganoderma sinense) 10kg, Balanophora dioica R Br ex Royle 10kg, foreign material are wherein rejected, after cleaning, use flowing water rinsing, be placed in again dry in the sun under sunlight, nature air dry to moisture content no longer changes, and then Ganoderma and Balanophora dioica R Br ex Royle is placed in to RXH type hot air circular drying machine, is dried to moisture content≤3% for subsequent use.
B, coarse pulverization: Ganoderma, Balanophora dioica R Br ex Royle are pulverized with Circoplex classified grinding machine respectively, and it is for subsequent use that Ganoderma coarse powder is crossed 120 mesh sieves, and it is for subsequent use that Balanophora dioica R Br ex Royle coarse powder is crossed 100 mesh sieves.
C, micronizing: Ganoderma coarse powder is pulverized with ZM-2 type high-frequency vibration mill, working condition is set as: grinding media is bar-shaped, grinding media diameter is 0.3mm, grinding media pack completeness is 50%, grinding media material ratio is 4.5, grinding time is 1.7h, and in the rear Ganoderma micropowders of pulverizing, particle diameter is that the ratio of the fine powder of 6 ~ 12 μ m is 93%..
Balanophora dioica R Br ex Royle coarse powder is pulverized with TC-20 type fluid bed supersonic jet mill, and working condition is set: inlet amount is 1.2kg, and air consumption is 0.9m
3/ min, admission pressure is 0.8MPa, and grader rotating speed is reversion 2600r/min, and in the rear Balanophora dioica R Br ex Royle micropowders of pulverizing, particle diameter is that the ratio of the fine powder of 10 ~ 20 μ m is 92%.
D, mixture: 50 parts of Ganoderma micropowders are by weight mixed with 50 parts of Balanophora dioica R Br ex Royle micropowders, be placed in KDL-SPECIAL type medium stirring mill mix and blend, working condition is set: grinding media is spherical, grinding media diameter is 1.0mm, grinding media pack completeness is 75%, grinding media material ratio is 4.5, and stirring disc rotation speed is 2000r/min, and mixing time is 2min.After mixture is even, in pharmaceutical composition, particle diameter is that the ratio of the fine powder of 4 ~ 14 μ m is 92%.
embodiment 2
---sedative-hypnotic effect pharmacological evaluation
Experiment material:
(1) pharmaceutical composition of the present invention prepared by experimental drug: embodiment 1, Ganoderma powder, Balanophora dioica R Br ex Royle powder, the Ganoderma powder forming by weight 1:2,1:3,3:1,2:1 mixture: Balanophora dioica R Br ex Royle powder medicine compounds, stable, Colophonium, aseptic sodium chloride-peptone buffer agent, sodium phenobarbital.Wherein, Ganoderma powder and Balanophora dioica R Br ex Royle powder are to be prepared with quality inspection according to the quality standard of " Yunnan Province's prepared slices of Chinese crude drugs standard " (cloud YPBZ-0194-2013 cloud YPBZ-0197-2013) defined.Stable purchased from Plain, Shandong Province pharmaceutical factory, Colophonium purchased from Guangxi Wuzhou Jinyuan Resin Co., Ltd., aseptic sodium chloride-peptone buffer agent purchased from the good Medical Devices Co., Ltd. of Shanghai luck tendency, sodium phenobarbital is purchased from Shanghai Xinya Pharmaceutical Industry Co. Ltd..
(2) experimental subject: the male white mouse of Kunming kind, body weight 20 ± 2g, is provided by Test Animal Centre, Academy of Military Medical Sciences, P.L.A, quality certification SCXK(army) 2007-004.
(3) experimental facilities: aluminum pot, Stainless steel basin, electric furnace, water-bath, electronic balance, baking oven, analytical balance, zip lock bag, weighing botle, sieve, white mouse inspection box and active box, stopwatch, disposable syringe, beaker, triangular flask.Above-mentioned experimental facilities is laboratory apparatus & equipment in common use.
Experimental technique:
(1) collaborative hypnosis experiment
Adopt sodium phenobarbital sub-threshold dose 65mg/kg and each tested combination use, whether the observation white mouse number of falling asleep increases; With the above index of sleeping of behaving of righting reflex loss 1min of white mouse.Get 80 male white mouse of body weight 20 ± 2g, be divided at random 10 groups: i.e. Ganoderma powder group, Balanophora dioica R Br ex Royle powder group, pharmaceutical composition group of the present invention, the Ganoderma powder of Different Weight ratio: Balanophora dioica R Br ex Royle powder medicine compounds (1:2,1:3,3:1,2:1) group, stable group, Colophonium group and matched group, every group all has 8 white mouse.Adopt the administration of gavage mode, Ganoderma powder group, Balanophora dioica R Br ex Royle powder group, pharmaceutical composition group of the present invention, the Ganoderma powder of Different Weight ratio: the dosage of Balanophora dioica R Br ex Royle powder medicine compounds (1:2,1:3,3:1,2:1) group and stable group is 7g/kg, the dosage of Colophonium group is 0.25g/kg, and matched group gives the normal saline of equivalent (7g/kg).Gavage 60min pneumoretroperitoneum benzene injection barbital sodium 65mg/kg, relatively under sodium phenobarbital sub-threshold dose condition, the number of falling asleep of the white mouse in administration group and matched group 30min.Adopt G check to carry out data statistic analysis, experimental result is in table 1.
(2) suppress the experiment of white mouse autonomic activities
Autonomic activities experiment adopts white mouse to walk about and lifts number of times on time and two forelimbs is laboratory observation index.Get 80 male white mouse of body weight 20 ± 2g, be divided at random 10 groups: i.e. Ganoderma powder group, Balanophora dioica R Br ex Royle powder group, pharmaceutical composition group of the present invention, the Ganoderma powder of Different Weight ratio: Balanophora dioica R Br ex Royle powder medicine compounds (1:2,1:3,3:1,2:1) group, stable group, Colophonium group and matched group, every group all has 8 white mouse.Adopt the administration of gavage mode, Ganoderma powder group, Balanophora dioica R Br ex Royle powder group, pharmaceutical composition group of the present invention, the Ganoderma powder of Different Weight ratio: the dosage of Balanophora dioica R Br ex Royle powder medicine compounds (1:2,1:3,3:1,2:1) group and stable group is 7g/kg, the dosage of Colophonium group is 0.25g/kg, and matched group gives the normal saline of equivalent (7g/kg).Upwards praise number of times as observation index take walk about time and two forelimb of white mouse in 2min, before administration, white mouse is dropped in inspection box and adapted to after 5min, record the movable numerical value of white mouse in 2min as normal value, after gastric infusion 60rain, measure walk about time and two forelimb of white mouse by same method and upwards praise number of times, later every 30min measures 1 time, measures altogether 5 times.Adopt t check to carry out data statistic analysis, experimental result is in table 2.
(3) toxicological experiment
1. median lethal dose(LD 50) is measured
Adopt Sun Shi synthetic method (" China kill mouse plant and research method thereof "), prerun experiment, get 30 body weight 20 ± 2g white mouse, be divided at random 10 groups, group asks that dosage is 20g/kg, 18g/kg, 16g/kg, 14g/kg, 12g/kg, 10g/kg, 8g/kg, 6g/kg, 4g/kg, 2g/kg, every white mouse dosage 0.2mL10
-1g
-1, observe the white mouse phenomena of mortality.
2. maximum tolerance determination
Get 66 body weight 20 ± 2g white mouse, be divided at random 11 groups, male and female half and half.Every group of administration concentration is respectively lg/mL, 0.7g/mL, 0.4g/mL, 0.1g/mL, and every 0.5mL observes the toxic reaction of white mouse in 7d.
Experimental result:
(1) collaborative hypnosis experiment
Adopt G check to carry out data statistic analysis, experimental result is in table 1.
Table 1 is worked in coordination with hypnosis experimental result
| Group | White mouse number | Dosage (g/kg) | The number of falling asleep in 30min | Number/experiment number of falling asleep |
| Contrast | 8 | - | 0 | 0 |
| Pharmaceutical composition of the present invention | 8 | 7 | 8 | 8/8 |
| Pharmaceutical composition (1:2) | 8 | 7 | 5 | 5/8 |
| Pharmaceutical composition (1:3) | 8 | 7 | 3 | 3/8 |
| Pharmaceutical composition (3:1) | 8 | 7 | 6 | 6/8 |
| Pharmaceutical composition (2:1) | 8 | 7 | 6 | 6/8 |
| Ganoderma powder | 8 | 7 | 4 | 4/8 |
| Balanophora dioica R Br ex Royle powder | 8 | 7 | 3 | 3/8 |
| Stable | 8 | 7 | 7 | 7/8 |
| Colophonium | 8 | 0.25 | 7 | 7/8 |
Experimental result shows: except matched group, other administration groups all can have collaborative syngignoscism that white mouse is fallen asleep with sodium phenobarbital.By each administration group, to recently seeing, the pharmaceutical composition that adopts the method for the invention to prepare has larger difference compared with other group, and inhibitory action and hypnotic effect to nervus centralis are the most obvious.
(2) suppress the experiment of white mouse autonomic activities
Adopt t check to carry out data statistic analysis, experimental result is in table 2.
Table 2 suppresses white mouse autonomic activities experimental result (X ± SD represents with average)
Note: * represents compared with matched group significant difference; * represents extremely remarkable compared with matched group difference; * * represents extremely remarkable compared with Colophonium group difference.
Experimental result shows: each group does not all have significant difference before administration, matched group does not have significant difference before and after administration yet, and there is the utmost point significant difference pharmaceutical composition of the present invention white mouse after administration time of walking about compared with matched group, there were significant differences on forelimb, to lift number of times.The white mouse of the pharmaceutical composition group of the present invention time of walking about also has notable difference compared with Colophonium matched group.Illustrate that the pharmaceutical composition that adopts the method for the invention to prepare has good tranquilizing effect, can obviously improve sleep quality.
(3) toxicological experiment
Median lethal dose(LD 50) is measured, and in prerun experiment, under maximal dose, the phenomena of mortality do not appear in white mouse, do not find out 100% dead dosage, cannot formally test.And carry out maximum tolerance determination, result is that toxic reaction does not all appear in 11 groups of white mouse.Pharmaceutical composition avirulence of the present invention and untoward reaction are described, use safety.
Claims (9)
1. Ganoderma, a Balanophora dioica R Br ex Royle pharmaceutical composition, is characterized in that described pharmaceutical composition comprises 45 ~ 55 parts of 45 ~ 55 parts of Ganoderma micropowders by weight and Balanophora dioica R Br ex Royle micropowders.
2. Ganoderma according to claim 1, Balanophora dioica R Br ex Royle pharmaceutical composition, the particle diameter that it is characterized in that described Ganoderma micropowders is 6 ~ 12 μ m, the particle diameter of described Balanophora dioica R Br ex Royle micropowders is 10 ~ 20 μ m.
3. a preparation method for the Ganoderma described in claim 1 or 2, Balanophora dioica R Br ex Royle pharmaceutical composition, is characterized in that comprising pretreatment, coarse pulverization, micronizing and mixture operation, specifically comprises:
A, pretreatment: foreign material in Ganoderma, Balanophora dioica R Br ex Royle are rejected, through cleaning, cleaning, dry in the sun, to be dried to moisture content≤3% for subsequent use;
B, coarse pulverization: Ganoderma, Balanophora dioica R Br ex Royle are pulverized with Roughpulverizer respectively, crossed 80 ~ 140 mesh sieves for subsequent use;
C, micronizing: Ganoderma coarse powder is ground into the micropowders of particle diameter 6 ~ 12 μ m with vibromill, Balanophora dioica R Br ex Royle coarse powder is ground into the micropowders of particle diameter 10 ~ 20 μ m with jet mill;
D, mixture: by 45 ~ 55 parts of Ganoderma micropowders by weight and 45 ~ 55 parts of mixtures of Balanophora dioica R Br ex Royle micropowders evenly.
4. preparation method according to claim 3, it is characterized in that described Ganoderma can for Ganoderma (
ganoderma lucidum), Ganoderma (
ganoderma sinense), Ganoderma tsugae (
ganoderma tsugae), yellow limit Ganoderma (
ganoderma luteomarginatum) or Ganaderma capense (
ganodermacapense) in any.
5. preparation method according to claim 3, is characterized in that Ganoderma, Balanophora dioica R Br ex Royle are pulverized with Roughpulverizer respectively described in step B, and it is for subsequent use that Ganoderma coarse powder is crossed 100 ~ 140 mesh sieves, and it is for subsequent use that Balanophora dioica R Br ex Royle coarse powder is crossed 80 ~ 100 mesh sieves.
6. preparation method according to claim 3, it is characterized in that Ganoderma coarse powder vibromill is pulverized described in step C, vibromill is ZM-2 type high-frequency vibration mill, working condition is set: grinding media is bar-shaped or spherical, grinding media diameter is 0.3 ~ 0.5mm, grinding media pack completeness is 45 ~ 55%, and grinding media material ratio is 4 ~ 5, and grinding time is 1.5 ~ 2.0h; Balanophora dioica R Br ex Royle coarse powder is pulverized with jet mill, and jet mill is TC-20 type fluid bed supersonic jet mill, and working condition is set: inlet amount is 0.8 ~ 1.5kg, and air consumption is 0.8 ~ 1.0m
3/ min, admission pressure is 0.7 ~ 0.9MPa, grader rotating speed is reversion 2400 ~ 2800r/min.
7. preparation method according to claim 3, after it is characterized in that mixture described in step D evenly refers to Ganoderma micropowders and Balanophora dioica R Br ex Royle micropowders are mixed by formula proportion, is placed in medium stirring mill mix and blend 1.5 ~ 2.5min.
8. a preparation for the pharmaceutical composition described in claim 1 or 2, is characterized in that described preparation adds pharmaceutically acceptable adjuvant to make powder, tablet, granule, capsule, pill, membranous patch, Foradil Aerolizer formoterol fumarate, oral controlled-release sheet or injection by Ganoderma, Balanophora dioica R Br ex Royle pharmaceutical composition.
9. the application of the pharmaceutical composition described in a claim 1 or 2 in the calm sleeping of preparation, benefiting vital QI for tranquillizing medicine.
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| CN103250827A (en) * | 2013-06-05 | 2013-08-21 | 楊光雲 | Alcoholism prevention and liver protection pu'er tea powder and preparation technology thereof |
| CN103316054A (en) * | 2013-06-01 | 2013-09-25 | 普洱淞茂制药股份有限公司 | Balanophora involucrata superfine pure powder, preparation method therefor and preparations thereof |
| CN103550263A (en) * | 2013-06-01 | 2014-02-05 | 普洱淞茂制药股份有限公司 | Mythic fungus superfine pure powder, preparation method and preparations thereof |
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2014
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103316054A (en) * | 2013-06-01 | 2013-09-25 | 普洱淞茂制药股份有限公司 | Balanophora involucrata superfine pure powder, preparation method therefor and preparations thereof |
| CN103550263A (en) * | 2013-06-01 | 2014-02-05 | 普洱淞茂制药股份有限公司 | Mythic fungus superfine pure powder, preparation method and preparations thereof |
| CN103250827A (en) * | 2013-06-05 | 2013-08-21 | 楊光雲 | Alcoholism prevention and liver protection pu'er tea powder and preparation technology thereof |
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| 吕光荣: "论脑与衰老――兼述补脑安神的方法", 《云南中医学院学报》, vol. 08, no. 02, 2 July 1985 (1985-07-02) * |
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