CN108175825A - For tonifying Qi of the kidney, pharmaceutical composition of invigorating the spleen moistening lung and preparation method thereof - Google Patents
For tonifying Qi of the kidney, pharmaceutical composition of invigorating the spleen moistening lung and preparation method thereof Download PDFInfo
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- CN108175825A CN108175825A CN201810059545.8A CN201810059545A CN108175825A CN 108175825 A CN108175825 A CN 108175825A CN 201810059545 A CN201810059545 A CN 201810059545A CN 108175825 A CN108175825 A CN 108175825A
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Abstract
The invention belongs to medicine or field of health care products, and in particular to for tonifying Qi of the kidney, pharmaceutical composition of invigorating the spleen moistening lung and preparation method thereof especially alleviates the organism fatigue caused by various consumptive diseases and the Chinese medicine composition for improving male's sexual and preparation method thereof.Pharmaceutical composition of the present invention is using cordyceps sinensis, ginseng, pilose antler, sealwort, vinegar tortoise plastron as bulk pharmaceutical chemicals, and weight proportion is as follows：1 12 parts of cordyceps sinensis, 5 40 parts of ginseng, 2 20 parts of pilose antler, 15 45 parts of sealwort, 15 45 parts of vinegar CARAPAX ET PIASTRUM TESTUDINIS PREPARATA.Clinic trial improves male's sexual, and pharmacological property is mild, and a kind of completely new selection is provided for the public the results show that the substantially reduced organism fatigue degree of present composition energy.
Description
Technical field
The invention belongs to medicine or field of health care products, and in particular to for tonifying Qi of the kidney, the pharmaceutical composition of invigorating the spleen moistening lung
And preparation method thereof, in particular for alleviating the organism fatigue caused by various consumptive diseases and improving male's sexual.
Background technology
Modern medicine thinks that fatigue is that function caused by body crosses use reduces and the state of body discomfort occurs, main table
It is now sleepy for fatigue, it may occur in which the simultaneous phenomenons such as dizzy, forgetful, sleep quality decline.
The traditional Chinese medical science thinks that fatigue is mainly that a variety of causes leads to spleen, liver, three dirty dysfunction of kidney, and the heart, lung are involved qi and blood the moon
Sun imbalance and caused by.It is clinically common with asthenic symptoms and syndrome of intermingled deficiency and excess.Void is mainly based on yin, yang, gas, blood deficiency；Actually
Mainly by visceral dysfunction, the invasion of diseases caused by external factors perverse trend, the obstruction of the circulation of vital energy and evil stop up such as phlegm wet, damp and hot is caused to hinder.
Fatigue is broadly divided into two major class of physiological and pathologic.Physiologic fatigability includes physical fatigue, mental fatigue, the heart again
Manage 4 kinds of (spirit) fatigue and mixing fatigue etc..Physical fatigue is called exercise induced fatigue, refers to caused in itself by body movement
" organism physiology process cannot continue its function on specified level and (or) cannot maintain scheduled exercise intensity " body
The phenomenon that locomitivity declines；And male's over fatigue, such as because melancholy, anxiety, it is nervous caused by mental fatigue, can inhibit with
The relevant nervous centralis of physiological function, reduces the promoting sexual gland hormone of hypophysis and the secretory volume of male sex hormone, causes man in the course of time
The pathological lesion of property physiological system, eventually leads to the generation of physiological dysfunctions.Mental fatigue be in the modern life longest see and
A kind of more complicated fatigue is generated due to the anxiety and pressure of duration.Fatigue is frequently not caused by the modern life
Caused by single reason, its existing muscle power, it is mental the reason of, also have the reason of psychology, social, it is also possible to also be mingled with disease
Reason, " symptom " for making various single fatigues is not bery prominent and typical, and fatigue is known as " comprehensive caused by this non-single factors
Fatigue ".
Chemicals with antifatigue effect are mostly cerebral cortex analeptic drug such as caffeine, amphetamine etc., but are mostly
Central excitation class, have it is additive, side effect is bigger, and modafinil is that the good one kind of tolerance acts on central nervous system
It unites, refresh the mind the newtype drug to work well.In terms of male's sexual is improved, mainly there are silaenafil, Ai Lili etc., but
The only effect of short time can not fundamentally improve.
Traditional Chinese medicine has great advantage, such as American Ginseng, rhodiola root, Herba Epimedii, pilose antler, Radix Codonopsis in terms of dispelling fatigue
There is certain curative effect to antifatigue.In the national OTC of present approved, the product of function of physical fatigue alleviation has more than 900
A, import health food more than 20, probably in 13,000,000,000 RMB or so, overall last year increases health liquor industry market capacity at present
Long rate 5%~10%.
Invention content
Technical problem solved by the invention is to provide a kind of completely new pharmaceutical composition for tonifying Qi of the kidney, invigorating the spleen profit
Lung, in particular for alleviating the organism fatigue caused by various consumptive diseases and improving male's sexual.
The present invention provides for tonifying Qi of the kidney, the pharmaceutical composition of invigorating the spleen moistening lung, bulk pharmaceutical chemicals weight proportion is as follows：
1-12 parts of cordyceps sinensis, 5-40 parts of ginseng, 2-20 parts of pilose antler, 15-45 parts of sealwort, 15-45 parts of vinegar CARAPAX ET PIASTRUM TESTUDINIS PREPARATA.
Further, bulk pharmaceutical chemicals weight proportion is as follows：2-10 parts of cordyceps sinensis, 10-30 parts of ginseng, 4-15 parts of pilose antler, Huang
20-40 parts smart, 20-40 parts of vinegar CARAPAX ET PIASTRUM TESTUDINIS PREPARATA.
Further preferred bulk pharmaceutical chemicals weight proportion is as follows：4-8 parts of cordyceps sinensis, 15-25 parts of ginseng, 5-15 parts of pilose antler, Huang
25-35 parts smart, 25-35 parts of vinegar CARAPAX ET PIASTRUM TESTUDINIS PREPARATA.
Most preferred weight proportion is as follows：6 parts of cordyceps sinensis, 20 parts of ginseng, 10 parts of pilose antler, 30 parts of sealwort, vinegar CARAPAX ET PIASTRUM TESTUDINIS PREPARATA
30 parts.
Wherein, the pilose antler is preferably sika deer velvet antler.
The 2015 editions contents recorded in the source of above-mentioned raw materials medicine and Chinese Pharmacopoeia are consistent.
Above-mentioned raw materials medicine dry product and fresh goods can be used, it is preferable to use dry product, the preparation method of dry product：Impurity is removed, is washed
Only, dry to get.Wherein, the parts by weight are in terms of dry product.
Further, described for tonifying Qi of the kidney, the pharmaceutical composition of invigorating the spleen moistening lung is to take each bulk pharmaceutical chemicals, according to pharmacy
Oral preparation is made in conventional method；Or it adds in pharmaceutically acceptable auxiliary material and common oral preparation is made.
Further, the common oral preparation is powder, capsule, tablet, granule, pill, oral liquid or vina.
The present invention provides described for tonifying Qi of the kidney, the preparation method of the pharmaceutical composition of invigorating the spleen moistening lung, including such as
Lower step：The bulk pharmaceutical chemicals of each weight proportion are taken, beat powder or add in water or organic solvent extraction, are added pharmaceutically or health products
In acceptable auxiliary material or complementary ingredient to get.
The present invention provides described for tonifying Qi of the kidney, the preparation method of the pharmaceutical composition of invigorating the spleen moistening lung, including：
Method one：Each bulk pharmaceutical chemicals are ground into fine powder, mixing powder；
Method two：Each bulk pharmaceutical chemicals are ground into fine powder, encapsulated capsule；
Method three：Each bulk pharmaceutical chemicals are ground into fine powder, tabletting, that is, piece agent；
Method four：By each bulk pharmaceutical chemicals using after conventional method water boiling and extraction, particle is made in concentrated extracting solution,
Granula；
Method five：By each bulk pharmaceutical chemicals using after conventional method water boiling and extraction, particle is made in concentrated extracting solution, encapsulated
Capsule；
Method six：By each bulk pharmaceutical chemicals using after conventional method water boiling and extraction, particle is made in concentrated extracting solution, and tabletting is
Piece agent；
Method seven：By each bulk pharmaceutical chemicals using after conventional method water boiling and extraction, oral liquid is made；
Method eight：After each bulk pharmaceutical chemicals are extracted using conventional method with ethyl alcohol, oral liquid is made；
Method nine：After each bulk pharmaceutical chemicals are extracted with water using conventional method, vina is made；
Method ten：After each bulk pharmaceutical chemicals are impregnated using conventional method with ethyl alcohol, vina is made.
The present invention provides described for tonifying Qi of the kidney, the preparation method of the pharmaceutical composition of invigorating the spleen moistening lung：Take each original
Material medicine is prepared as vina, includes the following steps：
A, cordyceps sinensis adds base liquor to impregnate to obtain extracting solution I；
B, ginseng, sika deer velvet antler, sealwort and vinegar tortoise plastron add base liquor to impregnate to obtain extracting solution II；
C, the dregs of a decoction obtained by step B add base liquor to impregnate at least 2 times again, and merging filtrate obtains extracting solution III；
D, merge extracting solution I, extracting solution II, extracting solution III, obtain mixed liquor；Mixed liquor adds in the color of certain formula rate
Element, stirring are uniformly mixed it, and adjustment alcoholic strength adds to allotment volume to 35 ± 1 degree；
E. it refrigerates：0 DEG C~4 DEG C refrigerations of amalgamation liquid obtained by step D are placed, are filtered to obtain the final product.
Further, soaking conditions described in step A are：The base liquor addition is measured for 8-12 times；It is preferred that 10 times of amounts.
Further, soaking conditions described in step A are：The base liquor is 35-50 ° of base liquor；It is preferred that 42 ° of base liquors.
Further, soaking conditions described in step A are：The soaking time is 14-40 days；It is preferred that soaking time is 30
My god；
Further, soaking conditions described in step A are：Extracting solution I is filtered to obtain after immersion；Wherein, filter condition 100-
300 mesh sievings；It is preferred that filter condition is 200 mesh sievings.
Further, step B, the soaking conditions of extracting solution II are described in C：The base liquor addition is measured for 2-6 times；It is preferred that
6 times of amounts.
Further, step B, the soaking conditions of extracting solution II are described in C：The base liquor is 35-50 ° of base liquor；It is preferred that 42 °
Base liquor.
Further, step B, the soaking conditions of extracting solution II are described in C：The soaking time is 4-10 days；It is preferred that it soaks
It is 7 days to steep the time.
Further, step B, the soaking conditions of extracting solution II are described in C：Extracting solution II is filtered to obtain after immersion；Wherein, mistake
Filter condition is 100-300 mesh sievings；It is preferred that filter condition is 200 mesh sievings.
Further, step B, the soaking conditions of extracting solution III are described in C：It is 1-3 times that the medicinal material, which impregnates number,；It is preferred that
2 times；Merging filtrate obtains extracting solution III.
Further, step D amalgamation liquids can also add in toner.
Further, step D amalgamation liquids adjust alcoholic strength to 30-38 degree；Preferably ethanol degree is to 34-36 degree.
Further, refrigerated condition described in step E is：Refrigerated storage temperature is -4-4 DEG C~0-8 DEG C；It is preferred that refrigerated storage temperature is 0
DEG C~4 DEG C；Cold preservation time is places at least 24 hours；It is preferred that it places 48 hours.
Further, it is filtered into described in step E using 0.45 μm of plate-frame filtering.
In the above-mentioned technical solutions, when filling, whole cordyceps sinensis after being impregnated step A is put into every bottle.
The present invention provides the pharmaceutical composition prepare for alleviate organism fatigue caused by various consumptive diseases and
Improve the application in the drug or health products of male's sexual.
The present invention provides a kind of completely new for tonifying Qi of the kidney, invigorating the spleen moistening lung, for alleviating the machine caused by various consumptive diseases
Chinese medicine composition of body fatigue and raising male's sexual and preparation method thereof.Animal experiment study proves that the present invention combines
Object can significantly reduce tired mice serum urea content, extend mouse blood lactase acid song after mice burden swimming time, reduction swimming
Area under line shows that it can play the significant effect for alleviating organism fatigue.Clinic trial result further proves, of the invention
The substantially reduced organism fatigue degree of composition energy, improves male's sexual, and pharmacological property is mild, is provided for the public a kind of completely new
Selection.
Specific embodiment
The raw material that is used in the specific embodiment of the invention, equipment are known product, are obtained by buying commercial product.
" cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine " as described below vina i.e. of the present invention.
The present invention is provided using cordyceps sinensis, ginseng, sika deer velvet antler, sealwort and vinegar tortoise plastron as bulk pharmaceutical chemicals with kidney tonifying benefit
The composition of the effect of gas, invigorating the spleen moistening lung, for alleviating the organism fatigue caused by various consumptive diseases and improving male's sexual, effect
Fruit is very notable.
Pharmaceutical composition ginseng and pilose antler of the present invention are altogether monarch drug in a prescription, have blood-nourishing of promoting the production of body fluid, tonify Qi of the kidney, the effect of qualcomm meridian.
The effect of sealwort, cordyceps sinensis are altogether for ministerial drug, principal drug assistance tonifying kidney and strengthening yang, hemostasis and phlegm, tonifying Qi enriching yin, invigorating the spleen moistening lung strong kidney.Tortoise
First is adjutant, auxiliary air compensating yin-nourishing, moreover it is possible to all pharmacological property overheats in the side of neutralization.Therefore the intelligence development that can take shelter on we, to help cardiopulmonary；Middle energy
Tonifying Qi enriching yin, the nourishing the liver with strengthening the spleen and stomach；It is lower can QI invigorating strengthening the essence and kidney tonifying, alleviate the organism fatigue caused by various consumptive diseases and raising
Male's sexual has the advantages of curative effect is clear and definite, quality controllable.
Inventor has carried out Dismemberment study to the present composition.Clinical trial results show that the present composition can be bright
It is aobvious to mitigate organism fatigue degree, with taking the monarch drug in a prescription (ginseng+pilose antler) of same dose or minister adjutant (sealwort+cordyceps sinensis+tortoise
First) it compares, curative effect is more notable.In terms of function of male is improved, morning vigorous frequency, sexual desire and the frequency that erects naturally can be significantly improved
Rate increases the hardness in sexual life and maintains the time of erecing, shortens refractory period, make sexual intercourse more satisfied, with obvious effects to be higher than minister
Adjutant group, it is substantially suitable with monarch drug in a prescription group, but monarch drug in a prescription group has the uncomfortable people felt more, it is mainly shown as swelling and aching of gum, dry, on
Fire etc..It can be seen that the present composition is on the basis of playing monarch drug in a prescription and tonifying Qi of the kidney, moreover it is possible to neutralize pharmacological property, avoid pharmacological property mistake
Heat.
Inventor in use, in the range of following weight proportion adjust bulk pharmaceutical chemicals dosage, can realize kidney tonifying benefit
Gas, invigorating the spleen moistening lung, for alleviating the organism fatigue caused by various consumptive diseases and improving the purpose of male's sexual：Cordyceps sinensis 1-
12 parts, 5-40 parts of ginseng, 2-20 parts of pilose antler, 15-45 parts of sealwort, 15-45 parts of tortoise plastron (vinegar system).
It is summarized by Long-term clinical or experimental applications, pharmaceutical composition bulk pharmaceutical chemicals of the present invention, preferred weight proportioning is as follows：Winter
Grass 2-10 parts of worm summer, 10-30 parts of ginseng, 4-15 parts of pilose antler, 20-40 parts of sealwort, 20-40 parts of tortoise plastron (vinegar system).
Further preferred weight proportion is as follows：4-8 parts of cordyceps sinensis, 15-25 parts of ginseng, 5-15 parts of pilose antler, sealwort 25-35
25-35 parts of part, tortoise plastron (vinegar system).
Most preferred weight proportion is as follows：6 parts of cordyceps sinensis, 20 parts of ginseng, 10 parts of pilose antler, 30 parts of sealwort, tortoise plastron (vinegar
System) 30 parts；The pharmaceutical composition curative effect being made of above-mentioned consumption proportion relationship is more stable, controllably.
Further, the present invention also provides the preparation methods of described pharmaceutical composition.
Pharmaceutical composition primary raw material of the present invention is cordyceps sinensis, ginseng, sika deer velvet antler, sealwort, vinegar tortoise plastron, with reference to vina
Common process, the preparation method that vina is determined according to actual production conditions is made in pharmaceutical composition of the present invention, including impregnating, mixing
Close, allocate, refrigerating and etc., process route is easy to operate, is suitable for practical big production.
The preparation process of 1 vina of the present invention of embodiment
1st, the selection of wine base
This product formula using cordyceps sinensis, ginseng, sika deer velvet antler, sealwort, vinegar tortoise plastron as primary raw material, select total saposins (with
Ginsenoside Re counts) extracted amount for inspection target, 42 ° of base liquors and 50 ° of base liquors are screened, specific method is as follows：
2 parts of pharmaceutical decocting piece is weighed, every part of ginseng 20g, sika deer velvet antler 10g, sealwort 30g, vinegar tortoise plastron 30g add up to 90g, point
Not Jia Ru 42 ° of 6 times of amounts and 50 ° of base liquors impregnate 7 days, filtering measures the content of total saposins (in terms of ginsenoside Re) in filtrate, ties
Fruit is shown in Table 1：
1 wine base of table is investigated
The result shows that 42 ° of base liquors and 50 ° of base liquor extraction total saposins (in terms of ginsenoside Re) content differences are smaller, 42 ° of bases
Wine alcohol content is moderate, and health care vina requirement determining alcohol is no more than 38 °, and this product determining alcohol is set to 35 ° ± 1, is made using 42 ° of base liquors
For Extraction solvent, facility is also provided, therefore select 42 ° of base liquors for subsequent allotment.
2nd, the investigation of ginseng, sika deer velvet antler, sealwort, vinegar tortoise plastron extracting mode
Using the extracted amount, color and luster, mouthfeel of total saposins (being counted using ginsenoside Re) as inspection target, to extracting, being percolated and soak
Three kinds of extracting modes of bubble are investigated, and concrete operations are as follows：
Refluxing extraction：Pharmaceutical decocting piece ginseng 20g, sika deer velvet antler 10g, sealwort 30g, vinegar tortoise plastron 30g are weighed, adds up to 90g, is used
8 times of 42 ° of base liquor refluxing extractions 2 hours, filtration, let cool, and adjustment alcoholic strength to 35 ° ± 1 and adds to 1000ml.
Diacolation：Pharmaceutical decocting piece ginseng 20g, sika deer velvet antler 10g, sealwort 30g, vinegar tortoise plastron 30g are weighed, adds up to 90g, adds 2 times
42 ° of base liquors of amount infiltrate 2 hours, and upper diacolation bucket adds in 42 ° of base liquors, and diacolation after impregnating 24 hours collects 8 times of volume percolates, adjusts
Whole alcoholic strength is to 35 ° ± 1 and adds to 1000ml.
It impregnates：Pharmaceutical decocting piece ginseng 20g, sika deer velvet antler 10g, sealwort 30g, vinegar tortoise plastron 30g are weighed, adds up to 90g, with 8 times
42 ° of base liquors are impregnated 7 days, filtering, and adjustment alcoholic strength to 35 ° ± 1 and adds to 1000ml.
Respectively measure 3 kinds of Different Extraction Method seasoning liquids in total saposins (in terms of ginsenoside Re) total amount, and with content,
Color and luster, mouthfeel are evaluated for index, the results are shown in Table 2：
2 extracting mode of table is investigated
The color and luster that wine is made in extraction is dense, and saponin content is low, and mouthfeel is general；The color and luster that wine is made in seepage pressure effects is pure, contains
Measure it is relatively low, it is in good taste；Although the soak extraction production cycle is relatively long, the color and luster that wine is made is pure, and content is high, in good taste, therefore
Select soak extraction.
3rd, the selection of ginseng, sika deer velvet antler, sealwort, vinegar tortoise plastron feeding mode
Weighing 2 parts of pharmaceutical decocting piece, every part of ginseng 20g, sika deer velvet antler 10g, sealwort 30g, vinegar tortoise plastron 30g add up to 90g, and one
Part is directly fed intake in a manner of medicine materical crude slice, another coarse powder for being broken into 10 mesh or so feeds intake, and is separately added into the base liquors leaching of 6 times of 42 ° of amounts
Bubble 7 days, filtering measure the content of total saposins (in terms of ginsenoside Re) in filtrate, the results are shown in Table 3：
3 medicinal material feeding mode of table selects
The result shows that two kinds of feeding modes have no significant effect the extraction of total saposins (in terms of ginsenoside Re), therefore determine
Direct medicine materical crude slice feeds intake, and to reduce process, reduces production cost.
4th, ginseng, sika deer velvet antler, sealwort, vinegar tortoise plastron technological parameter are preferred
Extracted amount (is counted) using ginsenoside Re as inspection target using total saposins, designs Three factors-levels orthogonal test, because
Plain level is shown in Table 4, table 5, table 6.
4 factor level table of table
9 parts of pharmaceutical decocting piece is weighed, every part of ginseng 20g, sika deer velvet antler 10g, sealwort 30g, vinegar tortoise plastron 30g add up to 90g, press
According to (L934) table arrangement experiment, it filters, merging filtrate, measures the content of total saposins (in terms of ginsenoside Re) in filtrate, as a result see
Table 5.
5 orthogonal experiment of table and result table (L934)
6 variance analysis of table
| Error source | Sum of squares of deviations | Degree of freedom | It is square | F values | P values | Conspicuousness |
| A | 59960.09 | 2 | 29980.04 | 76.19 | P ＜ 0.05 | * |
| B | 8317.15 | 2 | 4158.57 | 10.57 | P ＞ 0.05 | |
| C | 4803.71 | 2 | 2401.85 | 6.10 | P ＞ 0.05 | |
| Error (D) | 787.02 | 2 | 393.51 | —— | —— | —— |
F0.05(2,2)=19.00F0.01(2,2)=99.00
Knowing from variance analysis, factor A impregnates number and the extraction of total saposins (in terms of ginsenoside Re) is had a significant impact, because
Plain B soaking times and factor C base liquor multiples extract it and do not make significant difference, by intuitively analyze preferably condition be A3B3C3, but from
It is not very big that orthogonal experiment, which can be seen that immersion 2 times and impregnate 3 result difference,；It impregnates 7 days and 10 days difference of immersion is little；
To save solvent and saving the time, it is thus determined that preferably extraction conditions are combined as A2B2C3, i.e., 6/4 times amount, 42 ° of base liquors immersions 2
It is secondary, 7 days every time.
5th, ginseng, sika deer velvet antler, sealwort, vinegar tortoise plastron verification test
3 parts of pharmaceutical decocting piece is weighed, every part of ginseng 200g, sika deer velvet antler 100g, sealwort 300g, vinegar tortoise plastron 300g add up to
900g, the base liquor for adding in 6 times of 42 ° of amounts for the first time are impregnated 7 days, and filtering, the base liquor that the dregs of a decoction add 4 times of 42 ° of amounts is impregnated 7 days, filter
It crosses, merges liquid, measure the content of total saposins (in terms of ginsenoside Re) in filtrate, the results are shown in Table 7：
7 soaking technology of table is verified
It can be seen that total saposins (are counted) content using ginsenoside Re and are averaged extracted amount as 5.251g by three batches of verification tests, demonstrate,prove
Bright extraction process is stablized, feasible.
6th, the selection of wine base odor type
This product is Chinese medicine through base liquor soak extraction, and to increase the adaptability of vina and covering other smells, we investigate
The wine base of delicate fragrance type and Luzhou-flavor, specific method are as follows：
2 parts of pharmaceutical decocting piece is weighed, every part of ginseng 200g, sika deer velvet antler 100g, sealwort 300g, vinegar tortoise plastron 300g add up to
900g, is separately added into fen-flavor type white spirit and aromatic Chinese spirit, adds in 6 times of amounts for the first time and impregnates 7 days, filtering, the dregs of a decoction add 4 times
Amount is impregnated 7 days, filtration, merges liquid, and adjustment alcoholic strength to 35 ° ± 1 and adds to 10000ml.Respective mouthfeel is tasted, observes wine
Character, the results are shown in Table 8：
The screening of 8 wine base odor type of table
| Odor type | Character | Mouthfeel |
| Delicate fragrance type | Light brown is pure transparent | Faint scent is agreeable to the taste, and rear lightly seasoned flavour of a drug are apparent |
| Luzhou-flavor | Light brown is pure transparent | Smell giving off a strong fragrance, mellowness are strong |
Experiments have shown that Luzhou-flavor can make wine liquid smell giving off a strong fragrance, mellowness is strong, and wine liquid color and luster is pure transparent.Therefore this product
Use Luzhou-flavor wine base.
7th, refrigerated condition is investigated
To reduce influence of the impurity to final product quality, wine liquid need to be refrigerated, it is made to be filtered after fully precipitating, with total soap
The content of glycosides (being counted using ginsenoside Re) is inspection target, to 4 DEG C~8 DEG C, 0 DEG C~4 DEG C and -4 DEG C~0 DEG C three temperature conditions
It is investigated, specific method is as follows：
Take 3.6 lower seasoning liquids, every part of 300ml, respectively in 4 DEG C~8 DEG C, 0 DEG C~4 DEG C and -4 DEG C~0 DEG C three temperature
Lower refrigeration 48 hours, filtration measure the content of total saposins (in terms of ginsenoside Re) in respective filtrate, and observe clarity, tie
Fruit is shown in Table 9.
9 refrigerated storage temperature of table is investigated
The result shows that：Refrigerated storage temperature can achieve the effect that remove out precipitation for 0 DEG C~4 DEG C, therefore determine that refrigerated storage temperature is 0 DEG C
~4 DEG C.
After determining refrigerated storage temperature, cold preservation time is investigated, specific method is as follows：
3.9 lower seasoning liquids are taken, it is small to store 24 hours, 48 hours and 72 under the conditions of 0 DEG C~4 DEG C respectively by every part of 300ml
When, filtration measures the content of total saposins (in terms of ginsenoside Re) in respective filtrate, the results are shown in Table 10：
10 cold preservation time of table is investigated
The result shows that as cold preservation time extends, precipitation capacity is increasing, but place 72 hours and 48 hours two test
Situation difference is little, and to shorten working hour, it is 48 hours to determine the refrigeration resting period.
8th, cordyceps sinensis soaking technology choice of parameters
The cordyceps sinensis 3g of complete strips is weighed, in the soak for putting 3.9 lower 500ml35 ° of seasoning liquids, 4 parts are prepared with method.
14d, 21d, 28d, 35d are impregnated respectively, are then measured adenosine content, be the results are shown in Table 11：
The selection of 11 soaking time of table
| Time | Adenosine content (mg/100ml) |
| 14d | 1.312 |
| 21d | 1.691 |
| 28d | 1.804 |
| 35d | 1.810 |
As can be seen from the above table, influence of the soaking time to ingredient be than more significant, the content of adenosine with soaking time increasing
Add and gradually rise, adenosine tends towards stability after 28d is impregnated, and the extraction efficiency of comprehensive analysis adenosine selects the immersion of cordyceps sinensis
Time is 30 days.
Cordyceps sinensis adds in 10 times of amounts, 42 ° of base liquors and impregnates 30 days, and 200 mesh sievings obtain extracting solution I；
Finally determine that technique is：Ginseng, sika deer velvet antler, sealwort and vinegar tortoise plastron add in 6 times of amounts, 42 ° of base liquors and impregnate 7 days, and 200
Mesh sieving obtains extracting solution II；The dregs of a decoction add 4 times of amounts, 42 ° of base liquors and impregnate 7 days, and the filtration of 200 mesh screens merges filtrate twice,
Obtain extracting solution III；Extracting solution I, extracting solution II, extracting solution III are uniformly mixed；Mixed liquor adds in formula rate chrysanthemum tertiary colour
Plain solution (taking the compound pigment of chrysanthemum of formula rate, add in the solution that 42 ° of base liquors are configured to 1%), burnt sugar coloring, stirring make it
It is uniformly mixed, adjustment alcoholic strength adds to allotment volume to 35 ± 1 degree.Seasoning liquid is placed 48 hours in 0 DEG C~4 DEG C refrigerations,
It filters (0.45 μm), obtains filtrate, it is spare；It is filling, it is put in storage, detection.
3rd, the preferred and foundation of production environment
Foundation《Health food Good Manufacture Practice》The middle relevant requirement of administration of health, the production environment of this product are strictly pressed
It is designed according to the relevant regulations of health food GMP, it is stringent to control key link in production process to ensure product quality.Into clean
The material in net area is 100,000 grades of purifications between allotment, refrigeration, filling, material stock.
Supplementary material ingredient in this product formula is non-easy microbiological contamination ingredient, and each health cup in stringent control production
Section, it is ensured that the quality of product.
4th, three batches of pilot scale verification data
With this technique by 3 batch scale up test, theoretical yield has been investigated respectively, practical must measured and the pilot scales such as yield rate are given birth to
Produce technical data, the results showed that Product Process is stablized, feasible.Pilot scale data are shown in Table 12.
12 pilot scale tables of data of table
5th, the source of supplementary material and execution standard in product
6th, Detection of Stability result
The vina of pharmaceutical composition of the present invention is in the content of shady and cool, closed lower different time detection ginsenoside, adenosine, inspection
Survey project, foundation are that result is as follows：
Inspection project and foundation：Ginsenoside --- health food is examined and technology value disciplines (2003)
Adenosine --- health food is examined and technology value disciplines (2003)
Sample places condition：38 DEG C of constant temperature, relative humidity 75%.
The 13 zero moon of table result
14 first month result of table
15 second month result of table
Table 16 third month result
2 pharmaceutical composition of the present invention of embodiment takes daily the verification of dosage
Pharmaceutical composition of the present invention day taking dose and Pharmacopoeial Reference take daily dosage such as table 17：
Day taking dose of the invention of table 17 and Pharmacopoeial Reference take daily dosage
| Raw material | Consumption per day of the present invention | Medicinal material refers to consumption per day |
| Cordyceps sinensis | 0.6g | 3-9g |
| Ginseng | 2g | 3-9g |
| Sika deer velvet antler | 1g | 1-2g |
| Sealwort | 3g | 9-15g |
| Vinegar tortoise plastron | 3g | 9-24g |
Therefore using the pharmaceutical composition of the present invention of above-mentioned formula, cordyceps sinensis, ginseng, sealwort, vinegar tortoise plastron are aobvious
It writes and takes daily dosage less than Pharmacopoeial Reference.Therefore, recommended dose is not up in order to avoid querying, inventor's especially just following four groups of agent
Amount has done mice burden swimming test, and the comparison of consumption per day is shown in Table 18：
18 consumption per day of table
The medicinal material of four groups of phase application amounts more than taking, cordyceps sinensis add in 10 times of amounts, 42 ° of base liquors and impregnate 30 days, 200 mesh sievings
It crosses, obtains extracting solution I；Ginseng, sika deer velvet antler, sealwort and vinegar tortoise plastron add in 6 times of amounts, 42 ° of base liquors and impregnate 7 days, and 200 mesh sievings obtain
Extracting solution II；The dregs of a decoction add 4 times of amounts, 42 ° of base liquors and impregnate 7 days, and the filtration of 200 mesh screens merges filtrate twice, obtains extracting solution III；
Extracting solution I, extracting solution II, extracting solution III are uniformly mixed；Mixed liquor adds in the compound pigment solution of formula rate chrysanthemum and (takes and match
The compound pigment of chrysanthemum of square ratio, add in 42 ° of base liquors be configured to 1% solution), burnt sugar coloring, stirring make its be uniformly mixed, adjust
Whole alcoholic strength adds to allotment volume to 35 ± 1 degree；Seasoning liquid in 0 DEG C~4 DEG C refrigerations is placed 48 hours, filters (0.45 μ
M), filtrate is obtained.Filtrate is condensed into the suitable concentration of suitable gavage before use.
1st, test method
Mice burden swimming is tested：Once a day, the above-mentioned each group solution of orally administration mouse and blank control group solution 31d
Afterwards, after 30min after the last administration, by the mouse of 5% weight galvanized wire of root of the tail portion load as swimming trunk went swimming.The depth of water
30cm, 25 ± 1.0 DEG C of water temperature, record mouse from swim to death time, as the mice burden swimming time.During swimming
Between as measurement data, tested group of swimming time is considerably longer than blank control group and significant difference, can determine that tested material
Play the role of extending the mice burden swimming time.
2nd, result of the test
Influence comparison of the table 19 to the mice burden swimming time
Compared with blank control group：*P<0.05
3rd, conclusion (of pressure testing)
Table 19 compared with blank control group, can significantly prolong as it can be seen that after this product 31d of orally administration mouse different formulations
Long mice burden swimming time (P<0.05).I.e. inventive formulation has the function of to alleviate physical fatigue.
3 pharmaceutical composition of the present invention of embodiment alleviates the zoopery of physical fatigue
According to《Health food is examined and assessment technique specification》" alleviate body in (2003 editions) function assessment evaluation test method
The power fatigue function method of inspection " is tested：
1 material and method
1.1 sample：It is provided by Qinghai Spring Medicinal Resources Sci-tech Utilization Co., Ltd., Beijing Hai Derun pharmaceutical Co. Ltds
The cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine of production, character be rufous liquid, sample specification：50mL/ bottles, lot number：20150901, it keeps away
Light, sealing are put and are preserved at dry, 24 months shelf-lifves.Human body recommended dose is daily 100mL/60kgBW.Enterprise provides sample
23.8 times of concentrate 1.5L (being substantially free of alcoholic strength), recommended dose is daily 4.2mL/60kgBW, and provides 42 degree of wine base 3L.
Tested material 23.8 times of concentrates of sample, 42 degree of wine bases and sterile water co-formulation, for experiment.
1.2 experimental animal：Select Beijing HFK Bio-Technology Co., Ltd.'s [credit number：SCXK- (capital)
2014-0004] breeding 16g~20g Kunming kind cleaning grade male mice 204, be divided into four batches and tested, every batch of is random
It is divided into 4 groups, experiment a batch every group 15, excess-three criticizes every group 12.Experiment a batch carry out Loaned swimming test, experiment two batches into
The measure of row serum urea tests the measure of three batches of progress hepatic glycogen, tests the measure of four batches of progress blood lactase acids.Experimental animal is raised
It supports in Health Food Function Detection Center, Applied Literature and Science College, B SPF grades of animal housing's [credit number：SYXK (capital)
2012-0031].Feed is maintained to be pulled together feed corporation,Ltd's [credit number by Beijing Australia of section：SCXK (capital) 2014-0010] it is raw
Production.
1.3 dosage：The recommended dose of cordyceps sinensis ginseng and pilose antler tortoise plastron 23.8 times of concentrates of sealwort wine is adult (pressing 60kg batheroom scales)
Daily 4.2mL is equivalent to 5 times, 10 times, 30 times that 0.07mL/kgBW/d o experiments set human body recommended amounts, i.e., daily 0.35mL/
KgBW, 0.70mL/kgBW, 2.10mL/kgBW are basic, normal, high dosage group.High dose tested material：Measure 23.8 times of concentrations of sample
Liquid 21.0mL, 42 degree of wine base 35.7mL, add sterile water to 100.0mL；Middle dosage tested material：Measure 23.8 times of concentrates of sample
7.0mL.42 degree wine base 35.7mL, add sterile water to 100.0mL；Low dosage tested material：Measure 23.8 times of concentrates of sample
3.5mL.42 degree of wine base 35.7mL, add sterile water to 100.0mL.Orally administration once a day, continuous gavage 31d survey items and refer to
Mark.Intragastric administration on mice volume is 10mL/kgBW.A blank control group (0mL/kgBW) is set simultaneously, tested material is replaced with 15 degree of wine bases.
15 degree of wine bases：42 degree of wine base 35.7mL that enterprise provides are measured, add sterile water to l00.0mL.Daily gavage volume with it is each tested
Object group is identical.Each dosage group gives maintenance feed.
1.4 instruments and reagent
1.4.1 instrument：UV2600 ultraviolet-uisible spectrophotometers (2015003), VITALAB SELECTRA-E types are biochemical
Analyzer (2005001), HZF-B3000 electronic balances (2013002), BS2202S electronic balances (2014008), BS223S electricity
Sub- balance (2008007), centrifuge, oscillator, swimming trunk, galvanized wire, sample injector, homogenizer, test tube, tool plug test tube.
1.4.2 reagent：Urea kit (Zhongsheng Beikong Biological Science ＆ Technology Co., Ltd., lot number：151331).Three chloroethenes
Acid (Tianjin recovery fine chemistry industry research institute, lot number：2013.4.7), glucose .H2O (Amresco, lot number：2734B53)、
Sulfuric acid (Beijing Chemical Plant, lot number：20150730), anthrone (Solution on Chemical Reagents in Shanghai company of Chinese Medicine group, lot number：
20031203), thiocarbamide (Sinopharm Chemical Reagent Co., Ltd., lot number：20140424), (Beijing Chemical Plant criticizes copper sulphate
Number：20120826), sodium fluoride (Beijing Chemical Plant, lot number：20100312), sodium tungstate (criticize by Tianjin good fortune morning chemical reagent factory
Number：20110527), parazon (Sinopharm Chemical Reagent Co., Ltd., lot number：20130620), sodium hydroxide (Beijing
Chemical plant, lot number：20130520), calcium lactate (Tianjin recovery fine chemistry industry research institute, lot number：2013.1.23).
1.5 experimental method：
1.5.1 swimming with a load attached to the body is tested
After last is to mouse tested material 30min, the mouse of 5% weight galvanized wire of root of the tail portion load is placed in swimming trunk middle reaches
Swimming.Depth of water 30cm, 25.0 DEG C ± 1.0 DEG C of water temperature, record mouse from swim to death time, as mice burden swimming
Time.
Swimming time is measurement data, if tested material group swimming time is considerably longer than blank control group swimming time, and poor
Different significant (P<0.05) it, can determine that the tested material plays the role of extending the mice burden swimming time.
1,5.2 serum ureas measure
After last is to mouse tested material 30min, pulled out immediately after temperature is 30 DEG C of water went swimming 90min, rest 60min
Eyeball blood sampling 0.5mL.4 DEG C of refrigerator about 3h are put, 3000r/min centrifuges 15min after blood clotting, takes serum.In VITALAB
It is measured on SELECTRA-E type Biochemical Analyzers.
The data obtained is measurement data, if tested material group serum urea content is significantly lower than blank control group, and difference has
Conspicuousness (P<0.05) it, can determine that the tested material is reduced the effect of tired mouse urea content.
1.5.3 hepatic glycogen measures：Anthrone method
It after last is to mouse tested material 30min, puts to death immediately, liver is taken to be blotted after physiological saline rinses with filter paper, essence
Liver 100mg is really weighed, adds in 4.0mLTCA, 1min is homogenized, homogenate is poured into centrifuge tube, is centrifuged with 3000r/min
15min takes supernatant 0.5mL, adds 95% ethyl alcohol 2mL, abundant mixing between two kinds of liquid not there are interface, with clean plug plug
On, it erects stand overnight at room temperature.Next day centrifuges 15min with 3000r/min.It is careful to outwell supernatant and place test tube handstand
10min.It is to be measured with 2.00mL distilled water dissolving glycogen.0.25mL prepare liquids and 0.25mL distilled water is taken to be put into test tube, mixing.
Reagent blank pipe：0.5mL distilled water is inhaled to clean tube.Standard pipe：Inhale 0.125mL glucose standards (50mg/dL) and
0.375mL distilled water is put into test tube, mixing.
2.5mL anthrone reagents are firmly added in into each pipe, 15min is boiled, then moves on to ice-water bath, in 620nm waves after cooling
Under length, absorbance is measured after being returned to zero with reagent blank pipe.Calculate hepatic glycogen content.
The data obtained is measurement data, if tested material group hepatic glycogen content is apparently higher than blank control group, and difference have it is aobvious
Work property (P<0.05) it, can determine that the tested material plays the role of promoting mouse liver glycogen reserves.
1.5.4 blood lactase acid measures
It is prepared by the making of high blood lactase acid model and blood specimen：After last gives tested material 30min, before swimming, by mouse
Intraocular corner of the eyes veniplex takes 20 μ L of blood to add in 0.48mL l0%NaF solution, adds 15mL protein precipitants, vibrates mixing；So
It does not bear a heavy burden and stops after 30 DEG C of water went swimming 10min afterwards, the 20 μ L that take a blood sample immediately are added in 0.48mL 1%NaF solution, then are added
Enter 1.5mL protein precipitants, vibrate mixing；The 20 μ L that take a blood sample immediately after rest 20min are added in 0.48mL l0%NaF solution, then
1.5mL protein precipitants are added in, vibrate mixing.10min is centrifuged in 3000r/min, supernatant is taken, presses table handling.
20 sample blood lactase acid of table measures
It after the completion of above-mentioned steps, shakes up, puts 30 DEG C of water-bath 30min (primary every 10min shakings).Boiling water is put into after taking-up
90s is heated in bath, taking-up is cooled to room temperature, the colorimetric at wavelength 560nm, blank tube zeroing.Calculate Serum lactic acid content and blood breast
Sour area under the curve：
The data obtained is measurement data, if tested material group blood lactase acid area under the curve is significantly lower than blank control group, and poor
Different significant (P<0.05) it, can determine that the tested material is reduced the effect of blood lactase acid area under the curve after mouse swimming.
1.6 test datas count
Data processing is carried out with SPSS softwares.Using variance analysis, but it is neat first to carry out variance by the program of variance analysis
Property examine, variance is neat, calculate F values, F values<F0.05, conclusion：No significant difference between each group mean；F values>F0.05,P<0.05, it uses
The comparative approach two-by-two of mean is counted between multiple experimental groups and a control group：To the data of abnormal or heterogeneity of variance into
The appropriate variable conversion of row, after normal state or the neat requirement of variance is met, is counted with transformed data；If after variable conversion
Normal state or the neat purpose of variance are still not up to, rank sum test is used instead and is counted.
1.7 result judgement
If swimming with a load attached to the body experimental result is positive, and binomial is appointed to refer in three blood lactase acid, serum urea, hepatic glycogen biochemical indicators
Mark is positive, you can judges that the tested material has function of relieving physical fatigue.
2 results
Influence of the 2.1 cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wines to mouse weight
The original body mass of mouse is in four batches of each dosage groups of experimental animal and 0mL/kgBW comparison among groups, and there are no significant for difference
(P>0.05).I.e. the original body mass of mouse is more balanced between each group.
After the cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine 31d of orally administration mouse various dose, mouse weight is in four batches of experimental animals
Each dosage group and 0mL/kgBW comparison among groups, difference there are no significant (P>0.05), that is, cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine is to mouse
Weight has no adverse effects.
Influence of the 2.2 cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wines to the mice burden swimming time
Influence of the 21 cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine of table to the mice burden swimming time
*：With the more significant difference of 0mL/kgBW groups
As it can be seen that after the cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine 31d of orally administration mouse various dose, compared with 0mL/kgBW groups,
2.10mL/kgBW group mice burden swimming time lengthenings, significant difference (P<0.05) o, that is, cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine exists
High dose group can extend the walking weight load of mouse.
The influence of serum urea level after 2.3 cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wines swim to mouse
The influence of serum urea level after 22 cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine of table swims to mouse
*：With the more significant difference of 0mL/kgBW groups
As it can be seen that after the cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine 3ld of orally administration mouse various dose, compared with 0mL/kgBW groups,
Mice serum urea content reduces after the swimming of 0.70mL/kgBW groups, significant difference (P<0.05)：2.10mL/kgBW group trip
Mice serum urea content reduces after swimming, significant difference (P<0.01).That is cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine is in high dose group
Tired mice serum urea content can be reduced.
The influence of blood lactase acid value after 2.5 cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wines swim to mouse
The influence of blood lactase acid value after 23 cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine of table swims to mouse
*：With the more significant difference of 0mL/kgBW groups
3 brief summaries
After the cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine 31d of orally administration mouse various dose, with 0mL/kgBW groups (15 degree of wine bases)
Compare, which can reduce tired mice serum urea content (P in 0.70mL/kgBW groups<0.05)：In 2.10mL/kgBW
Group can extend the walking weight load (P of mouse<0.05) tired mice serum urea content (P can, be reduced<0.01) it, can reduce
Mouse blood lactase acid area under the curve (P after swimming<0.05).Tested material has no adverse effects to mouse weight growth.According to《Health care is eaten
Product examine is tested and assessment technique specification》(2003 editions) are to alleviating the criterion of physical fatigue health food it is found that cordyceps sinensis ginseng and pilose antler tortoise
Methyl yellow essence wine has function of relieving physical fatigue.
The Toxicological evaluation of 4 pharmaceutical composition of the present invention of embodiment
Cordyceps sinensis ginseng and pilose antler tortoise plastron sealwort wine is all higher than 15g/ to the maximum tolerated dose (MTD) of the mouse oral of two kinds of genders
KgBW belongs to nontoxic grade by acute toxicity classification.Through Salmonella reversion test, mice bone marrow micronucleus, mouse sperm
Deformity experiment, result is feminine gender, and Mutagenicity is had no in the range of study dosage.30 days feeding trials of rat, rat body
Weight, weightening, food ration, food utilization, internal organs inspection, organ weights, dirty/body ratio, hematology and blood biochemical analysis inspection
The result shows that blank control group respectively examines project without significant difference (P with wine base control group>0.05)：Blank control group
It is each to examine project without significant difference (P compared with each dosage group>0.05).Histopathologic examination the result shows that, blank control
Group, wine base control group and high dose group is female, male rat liver, kidney, stomach, intestines, spleen, ovary and testis do not find it is apparent damaging
Pathological change.30 days feeding trials do not find that this sample has apparent toxic effect.
5 pharmaceutical composition of the present invention of embodiment alleviates physical fatigue, the clinical efficacy for improving male's sexual
In order to verify clinical efficacy of the pharmaceutical composition of the present invention in terms of alleviating physical fatigue, improving male's sexual, and
According to compatibility, formula is split as monarch drug in a prescription group (ginseng+pilose antler), minister adjutant group (sealwort+cordyceps sinensis+tortoise plastron), with the present invention
Formula carries out paired observation.Selection includes office work white collar, the retired, business people, man of the age at 35-70 Sui
Property, there are the personnel totally 180 situations such as the organism fatigue caused by various consumptive diseases and male's sexual decline, are randomly divided into 3
Group is evaluated according to " Fatigue Self-assessment Scale ", " function of male evaluation charter ".Specific method is as follows：
1st, sample preparation：According to the formula ratio of following table, three groups of vina are prepared respectively：
24 formula table of table
2nd, Fatigue Self-assessment Scale (in nearest January)
25 fatigue symptom Self-assessment Scale of table
3rd, function of male marking scales (in nearest January)
26 function of male marking scales of table
4th, test-meal scheme
180 subjects are randomly divided into 3 groups, every group 60, take formula A, B, C respectively.It continuously takes 30 days, point
Not before test-meal, after test-meal 30 days, scalar quantization scoring record is carried out to fatigue symptom, function of male, statistical data simultaneously carries out
Symptom and efficacy analysis.
Fatigue symptom self-appraisal integrates evaluation criteria：
Total mark × 100% before integration reduced rate=(total mark after total mark-treatment before treatment)/treatment
Highly significant：Clinical symptoms, sign disappear or mostly disappear, integration reduce >=95%
Significantly：Clinical symptoms, sign are obviously improved, and integration reduces >=70%
Effectively：Clinical symptoms, sign take a favorable turn, and integration reduces >=30%
In vain：Clinical symptoms, sign are not improved, and integration reduces≤30%
Male's sexual evaluation takes individual event comparison to be made a concrete analysis of.
5th, result
5.1 alleviate physical fatigue curative effect statistics
Table 27 alleviates physical fatigue curative effect statistical result
| Curative effect/formula | It is formulated A | It is formulated B | It is formulated C |
| Highly significant number of cases | 16 | 6 | 6 |
| Notable number of cases | 20 | 10 | 12 |
| Effective number of cases | 16 | 32 | 22 |
| Invalid number of cases | 8 | 12 | 20 |
| Total effective rate | 86.7% | 80% | 66.7% |
| There is uncomfortable reaction number of cases * | 1 | 10 | 1 |
* uncomfortable reaction includes：Dry, slight to get angry, gum is red and swollen.
(the main single item evaluation having clear improvement before and after examination clothes tries scoring after taking and is less than examination 5.2 function of male curative effects statistics
Before clothes)
28 function of male curative effect statistical result of table
More than result of the test can be seen that：After taking the present composition 30 days, the substantially reduced organism fatigue degree of energy, always
Effective percentage reaches 86.7%, is compared with monarch drug in a prescription group, the minister adjutant group behind the side of tearing open, number of cases significant in efficacy is apparently higher than two groups latter；
In terms of function of male is improved, morning vigorous frequency, sexual desire and natural erection frequency can be significantly improved, increase hardness in sexual life and
The time of erecing is maintained, shortens refractory period, makes sexual intercourse more satisfied, it is with obvious effects higher than minister adjutant group, it is substantially suitable with monarch drug in a prescription group,
But monarch drug in a prescription group has the uncomfortable people felt more (10 people), is mainly shown as swelling and aching of gum, dry, excessive internal heat etc..It can be seen that this hair
Bright composition is on the basis of playing monarch drug in a prescription and tonifying Qi of the kidney, moreover it is possible to neutralize pharmacological property, pharmacological property is avoided to overheat.
Claims (9)
1. for tonifying Qi of the kidney, the pharmaceutical composition of invigorating the spleen moistening lung, it is characterised in that：Bulk pharmaceutical chemicals weight proportion is as follows：
1-12 parts of cordyceps sinensis, 5-40 parts of ginseng, 2-20 parts of pilose antler, 15-45 parts of sealwort, 15-45 parts of vinegar CARAPAX ET PIASTRUM TESTUDINIS PREPARATA.
2. according to claim 1 for tonifying Qi of the kidney, the pharmaceutical composition of invigorating the spleen moistening lung, it is characterised in that：Bulk pharmaceutical chemicals
Weight proportion is as follows：2-10 parts of cordyceps sinensis, 10-30 parts of ginseng, 4-15 parts of pilose antler, 20-40 parts of sealwort, vinegar CARAPAX ET PIASTRUM TESTUDINIS PREPARATA 20-40
Part；
Further preferred bulk pharmaceutical chemicals weight proportion is as follows：4-8 parts of cordyceps sinensis, 15-25 parts of ginseng, 5-15 parts of pilose antler, sealwort 25-
35 parts, 25-35 parts of vinegar CARAPAX ET PIASTRUM TESTUDINIS PREPARATA；
Most preferred weight proportion is as follows：6 parts of cordyceps sinensis, 20 parts of ginseng, 10 parts of pilose antler, 30 parts of sealwort, 30 parts of vinegar CARAPAX ET PIASTRUM TESTUDINIS PREPARATA；
Wherein, the pilose antler is preferably sika deer velvet antler.
3. according to claim 1 or 2 for tonifying Qi of the kidney, the pharmaceutical composition of invigorating the spleen moistening lung, it is characterised in that：It takes each
Oral preparation is made according to pharmacy conventional method in bulk pharmaceutical chemicals；Or it adds in pharmaceutically acceptable auxiliary material and common oral preparation is made.
4. according to claim 3 for tonifying Qi of the kidney, the pharmaceutical composition of invigorating the spleen moistening lung, it is characterised in that：It is described normal
It is powder, capsule, tablet, granule, pill, oral liquid or vina with oral preparation.
5. it is used to tonify Qi of the kidney described in Claims 1 to 4 any one, the preparation method of the pharmaceutical composition of invigorating the spleen moistening lung,
It is characterized in that：Include the following steps：The bulk pharmaceutical chemicals of each weight proportion are taken, beat powder or add in water or organic solvent extraction, are added
Pharmaceutically or in health products acceptable auxiliary material or complementary ingredient to get.
6. claim 1-4 any one of them is for tonifying Qi of the kidney, the preparation method of the pharmaceutical composition of invigorating the spleen moistening lung, special
Sign is：Including：
Method one：Each bulk pharmaceutical chemicals are ground into fine powder, mixing powder；
Method two：Each bulk pharmaceutical chemicals are ground into fine powder, encapsulated capsule；
Method three：Each bulk pharmaceutical chemicals are ground into fine powder, tabletting, that is, piece agent；
Method four：By each bulk pharmaceutical chemicals using after conventional method water boiling and extraction, particle is made in concentrated extracting solution, particle
Agent；
Method five：By each bulk pharmaceutical chemicals using after conventional method water boiling and extraction, concentrated extracting solution is made particle, encapsulated
Capsule；
Method six：By each bulk pharmaceutical chemicals using after conventional method water boiling and extraction, particle, tabletting, that is, in blocks is made in concentrated extracting solution
Agent；
Method seven：By each bulk pharmaceutical chemicals using after conventional method water boiling and extraction, oral liquid is made；
Method eight：After each bulk pharmaceutical chemicals are extracted using conventional method with ethyl alcohol, oral liquid is made；
Method nine：After each bulk pharmaceutical chemicals are extracted with water using conventional method, vina is made；
Method ten：After each bulk pharmaceutical chemicals are impregnated using conventional method with ethyl alcohol, vina is made.
7. claim 1-4 any one of them is for tonifying Qi of the kidney, the preparation method of the pharmaceutical composition of invigorating the spleen moistening lung, special
Sign is：Each bulk pharmaceutical chemicals is taken to be prepared as vina, are included the following steps：
A, cordyceps sinensis adds base liquor to impregnate to obtain extracting solution I；
B, ginseng, sika deer velvet antler, sealwort and vinegar tortoise plastron add base liquor to impregnate to obtain extracting solution II；
C, the dregs of a decoction obtained by step B add base liquor to impregnate at least 2 times again, and merging filtrate obtains extracting solution III；
D, merge extracting solution I, extracting solution II, extracting solution III, obtain mixed liquor；Mixed liquor adds in the pigment of certain formula rate, stirs
Mixing is uniformly mixed it, and adjustment alcoholic strength adds to allotment volume to 35 ± 1 degree；
E. it refrigerates：0 DEG C~4 DEG C refrigerations of amalgamation liquid obtained by step D are placed, are filtered to obtain the final product.
8. according to claim 7 for tonifying Qi of the kidney, the preparation method of the pharmaceutical composition of invigorating the spleen moistening lung, feature exists
In：At least meet any one of following：
Soaking conditions described in step A are：The base liquor addition is measured for 8-12 times, preferably 10 times amounts；
Soaking conditions described in step A are：The base liquor is 35-50 ° of base liquor；It is preferred that 42 ° of base liquors；
Soaking conditions described in step A are：The soaking time is 14-40 days, and preferably soaking time is 30 days；
Soaking conditions described in step A are：Extracting solution I is filtered to obtain after immersion；Wherein, filter condition is 100-300 mesh sievings；It is excellent
It is 200 mesh sievings to select filter condition；
Step B, the soaking conditions of extracting solution II are described in C：The base liquor addition is measured for 2-6 times, preferably 6 times amounts；
Step B, the soaking conditions of extracting solution II are described in C：The base liquor is 35-50 ° of base liquor；It is preferred that 42 ° of base liquors；
Step B, the soaking conditions of extracting solution II are described in C：The soaking time is 4-10 days, and preferably soaking time is 7 days；
Step B, the soaking conditions of extracting solution II are described in C：Extracting solution II is filtered to obtain after immersion；Wherein, filter condition 100-
300 mesh sievings；It is preferred that filter condition is 200 mesh sievings；
Step B, the soaking conditions of extracting solution III are described in C：It is 1-3 times, preferably 2 times that the medicinal material, which impregnates number,；Merging filtrate
Obtain extracting solution III；
Step D amalgamation liquids can also add in toner；
Step D amalgamation liquids adjust alcoholic strength to 30-38 degree；Preferably ethanol degree is to 34-36 degree；
Refrigerated condition described in step E is：Refrigerated storage temperature is -4-4 DEG C~0-8 DEG C, and preferably refrigerated storage temperature is 0 DEG C~4 DEG C；During refrigeration
Between for place at least 24 hours, preferably place 48 hours；
It is filtered into described in step E using 0.45 μm of plate-frame filtering；
In the above-mentioned technical solutions, when filling, whole cordyceps sinensis after being impregnated step A is put into every bottle.
9. claim 1-4 any one of them pharmaceutical composition prepare for alleviate the organism fatigue caused by various consumptive diseases with
And the application in the drug or health products of raising male's sexual.
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| CN114832694A (en) * | 2022-03-22 | 2022-08-02 | 天马（安徽）国药科技股份有限公司 | Preparation process and preparation device of medicinal liquor for health preserving and health care |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111264862A (en) * | 2020-02-10 | 2020-06-12 | 云南中科本草科技有限公司 | Anti-fatigue composition, preparation method thereof and anti-fatigue medicine or health food |
| CN114832694A (en) * | 2022-03-22 | 2022-08-02 | 天马（安徽）国药科技股份有限公司 | Preparation process and preparation device of medicinal liquor for health preserving and health care |
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