CN107998157A - A kind of concocting method for improving ganoderma lucidum powder drug effect and its application - Google Patents
A kind of concocting method for improving ganoderma lucidum powder drug effect and its application Download PDFInfo
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Abstract
The invention discloses a kind of concocting method for improving ganoderma lucidum powder drug effect and products thereof and purposes, belong to field of medicinal materials processing.The present invention is directed to the deficiency of conventional concocting method, according to the biological characteristics of ganoderma lucidum, there is provided a kind of concocting method for the ganoderma lucidum powder for being used to prevent and treat diabetes and related hyperglycemic disorder.The concocting method of the present invention includes：Take fresh ganoderma lucidum → cleaning → chopping → plus Vc, Vc sodium, Vc phosphates, tea polyphenols make anti-oxidant protective agent → coarse crushing → enzymolysis → micronized pulverization → low-temperature microwave vacuum drying → fine crushing; this method is easy to operate, with short production cycle; the dissolution of active material can also be increased, reduce scattering and disappearing for active ingredient; improve the bioavilability of ganoderma lucidum; there is more preferable drug effect and curative effect to diabetes and related hyperglycemic disorder; uniform color at the same time; smell is good; and it is sterile, therefore will have broad application prospects in the processing field of ganoderma lucidum powder.
Description
Technical field
It is more particularly to a kind of to be used to prevent and treat diabetes and related hyperglycaemia disease the invention belongs to field of medicinal materials processing
The concocting method of the ganoderma lucidum powder of disease and its application in terms of the hyperglycemic disorders such as treatment diabetes.
Background technology
Ganoderma lucidum (Ganoderma Lucidum) is fungi Basidiomycotina, Hymenomycetes, Aphyllophorales, Polyporaceae, ganoderma lucidum
Belong to medicinal fungi.The mainly highest red sesame of medical value (Ganoderma Lucidum Karst) and the purple of general hyoscine
Sesame (Ganoderma sanensee Karst).Ganoderma lucidum is《Chinese Pharmacopoeia》A kind of Chinese medicine included, is eat medicine dual-purpose one
The component such as kind of fungi, triterpene, polysaccharide, nucleosides, alkaloid, amino acid polypeptide, trace element in ganoderma lucidum is its effective substance base
Plinth, wherein triterpene are one of most important active ingredients of ganoderma lucidum.Ganodenic acid has strong pharmacological activity, there is analgesic, calmness, solution
Poison, liver protection, kill tumour cell, the release of suppression cell tissue amine, enhancement digestive organs function and reduction blood cholesterol, be sweet
Oily three fat, the function of beta Lipoprotein, so as to suppress coagulating platelets, help blood circulation, eliminate thrombus, promote blood circulation,
Vascular pressure is adjusted, increase metabolism, makes body reach the situation of balance health.It can be also used for hypoglycemic, enhancing body
Adaptability has the function that to treat the hyperglycemic disorder such as diabetes.
Ganoderma lucidum is often processed to the very thin powder of particle as a kind of rare traditional Chinese medicine, not only easily turnover and preserves, and
And there is fabulous dispersibility, miscibility and absorbability.Conventional concocting method mainly takes dry glossy ganoderma directly fine ground
Powder processed.This method technique is simple, easily operated, but not gentle, be easy to cause the loss of active principle, and some harmful substances
Such as agriculture is residual and heavy metal harmful substance also easily remains, and has to human body potentially hazardous, while the production cycle is longer.
It is a kind of with targetedly ganoderma lucidum powder concocting method it is therefore desirable to develop, both retained all natural active products
Matter, and the residual of harmful substance can be reduced, so as to improve quality and efficiency.
The content of the invention
The present invention is directed to the deficiency of conventional concocting method, according to the biological characteristics of ganoderma lucidum, there is provided one kind can improve
Ganoderma lucidum powder prevents and treats the concocting method of diabetes and related hyperglycemic disorder drug effect and the powder is treating diabetes etc.
Application in terms of hyperglycemic disorder.
Present invention employs following technological means in order to achieve the above object：
A kind of concocting method of ganoderma lucidum powder of the present invention, comprises the following steps：
(1) clean：
The fresh glossy ganoderma that will be excavated, cleans and is shredded after draining；
(2) compound anti-oxidation protective agent is added：
The compound antioxygen being made of Vc, Vc sodium, Vc phosphates and tea polyphenols is added into the fresh ganoderma particles of chopping
Change protective agent；
(3) coarse crushing：
The protectant fresh ganoderma particles of compound anti-oxidation will be contained and remake coarse crushing processing with crusher, it is spare；
(4) digest：
According to solid-liquid ratio 1:Pure water is added in the fresh sesame coarse granule that the ratio of 10-25 is obtained to step (3), is then added
The complex enzyme of fresh sesame coarse granule weight 5%~10% is digested, and the complex enzyme is by cellulase, amylase and wooden
Plain enzyme composition；
(5) micronized pulverization：
Slurry after step (4) is digested, which is placed in broken microwave instrument, carries out micronized pulverization, and the slurry of 300-500 mesh is made
Material；
(6) low-temperature microwave is dried in vacuo：
Low-temperature microwave vacuum drying is carried out to the slurry after micronized pulverization in step (5), is made and dries ultra micro without Ganoderma
Powder, it is spare；
(7) crush：
Ganoderma lucidum drying Ultramicro-powder made from step (6) is made into further fine crushing processing, 600~800 mesh sieves is crossed, obtains clever
Sesame powder powder, it is spare.
In the present invention, it is preferred to, compound anti-oxidation protective agent described in step (2) by Vc, Vc sodium, Vc phosphates with
And tea polyphenols are 1~10 according to weight ratio：1~10：1~10：1~10 composition, it is preferred that Vc, Vc sodium, Vc phosphates and tea
The weight ratio of polyphenol is 1.5:2.5:3:3.
In the present invention, it is preferred to, the protectant amount of compound anti-oxidation added in step (2) is fresh ganoderma particles weight
The 0.5-1.2% of amount, it is preferred that the protectant amount of compound anti-oxidation added is the 0.9% of fresh sesame particle weight.
In the present invention, it is preferred to, the enzymolysis described in step (4) carries out in accordance with the following methods：According to solid-liquid ratio 1:20
Ratio add pure water into obtained fresh sesame coarse granule, then add the complex enzyme of fresh sesame coarse granule weight 8%, adjust
PH is 4.8~5.8, and 2.5~4.5h is digested in 45~65 DEG C of water-baths.
In the present invention, it is preferred to, the complex enzyme described in step (4) is by cellulase, amylase and lignin
Enzyme is 1~4 according to weight ratio：1~4：1~4 composition, it is preferred that cellulase, amylase and lignoenzyme are according to weight ratio
For 4:2:3.
In the present invention, it is preferred to, the micronized pulverization described in step (5) is that the slurry after step (4) is digested is placed in
In broken microwave instrument, in output frequency 2450MHz, 750~850W of power, pretreatment time 80s, after continue 250~350s's
Under the conditions of handle, the slurry of 300-500 mesh is made.
In the present invention, it is preferred to, the vacuum drying of low-temperature microwave described in step (6) be microwave power 0.6~
3.5kw, 100~150Pa of pressure, carry out low temperature under conditions of 60~80 DEG C of temperature to the slurry after micronized pulverization in step (5)
Micro-wave vacuum, is made and dries Ultramicro-powder without Ganoderma, spare.
In the present invention, it is preferred to, further include the ganoderma lucidum powder powder that will be obtained and be mixed and made into multiple powder with other powders, or
According to medication needs, solution is made and dissipates, decoction made from powder, dispel, oral medicine powde or external powder.
In order to illustrate the drug effect of the ganoderma lucidum powder of the present invention, the drug effect of ganoderma lucidum powder of the present invention to being prepared moves
Mechanics is studied：The present invention is successfully established mouse experiment mixed type hyperglycemia model, the ganoderma lucidum prepared to the present invention
The hypoglycemic drug effect of powder I and the ganoderma lucidum powder II prepared with conventional method have carried out system research.The result shows that both of which
Serum blood sugar level can be reduced, but ganoderma lucidum powder I high dose group effects are much better than ganoderma lucidum powder II high dose groups, show the present invention
Ganoderma lucidum powder I have the function that more significantly adjust blood glucose.
The present invention is successfully established pharmacokinetics in rats model, the ganoderma lucidum powder I and ganoderma lucidum powder II compared with systematic research
Effect to ganodenic acid physiological disposition.The Cmax C of ganoderma lucidum powder ImaxCompared with significantly increasing for ganoderma lucidum powder II；Dissipated with ganoderma lucidum
Agent II is compared, and the mean residence time (MRT) of ganoderma lucidum powder I active ingredients in vivo has a degree of increase, and blood concentration-
Time graph also embodies the rear shifting of peak time.The ganoderma lucidum powder I being prepared by the method for the present invention is prepared with conventional method
Ganoderma lucidum powder II is compared, and bioavilability significantly improves.
Clinical medicine verification is made to the effect of ganoderma lucidum powder, the results showed that, to the ganoderma lucidum powder I with comparability compared with ganoderma lucidum
Powder II is to more significant with the adjustment effect of the blood sugar concentration of 2h patient after meal on an empty stomach.Illustrate ganoderma lucidum powder prepared by the present invention
I is much better than the therapeutic effect of the hyperglycemic disorder patient such as diabetes the therapeutic effect of the ganoderma lucidum powder II of conventional method preparation,
And the probability that adverse reaction occurs is less.
Therefore, further, the invention also provides the spirit being prepared according to the concocting method described in any of the above item
Sesame powder.And purposes of the ganoderma lucidum powder in treatment diabetes and related hyperglycemic disorder medicine are prepared.
To sum up, the present invention innovates modern Chinese herbal medicine concocting method from traditional Chinese medical theory reality, to fresh sesame into
Row Processing methods, the main technique of processing are included after fresh glossy ganoderma is directly shredded, add protective agent to crush, digest, micronized pulverization,
The method crushed again after micro-wave vacuum.This method is easy to operate, with short production cycle, moreover it is possible to increase active material dissolution,
Scattering and disappearing for active ingredient is reduced, improves the bioavilability of ganoderma lucidum, is had to diabetes and related hyperglycemic disorder more preferable
Drug effect and curative effect, while uniform color, smell is good, and sterile.The present invention also uses modern pharmacology method, establishes medicine effect
Answer dynamics and pharmacokinetic mode, and verified in clinic, the pharmacodynamics hypoglycemic to ganoderma lucidum and metabolism into
Go compared with systematic research, it was demonstrated that the bioavilability higher of ganoderma lucidum powder I prepared by the method for the present invention, to the high blood such as diabetes
Sugared disease has more preferable drug effect and curative effect.
Compared to the prior art, the beneficial effects of the present invention are：
1st, it is processed using fresh glossy ganoderma, it is ensured that the ganoderma lucidum powder of preparation has good color and luster and smell, is in
Now authentic is isabelline, and uniform color, gas is special, and mildly bitter flavor is puckery.
2nd, Vc, Vc sodium, Vc phosphates, tea polyphenols are added as protective agent, can reduce in fresh sesame concocting process and oxygen occurs
Change reaction.
3rd, enzyme is selected to pre-process ganoderma lucidum substrate, the purpose is to realize that macromolecular cellulose, starch, lignin etc. are planted
Thing macromolecule enzymolysis improves efficiency dry in subsequent technique, and improve the biological utilisation of small molecule active component into small molecule
Degree.
Brief description of the drawings
Fig. 1 is the change of active constituent content in different time；
Fig. 2 is the blood concentration-time curve after rat intravenous injection ganodenic acid stoste；
Fig. 3 is the ganodenic acid blood concentration-time curve after rats gavaged ganoderma lucidum powder I or ganoderma lucidum powder II.
Specific implementation method
The invention will now be further described with reference to specific embodiments, the advantages and features of the present invention will be with description and
It is apparent.But these embodiments are only exemplary, do not form any restrictions to the scope of the present invention.People in the art
Member it should be understood that without departing from the spirit and scope of the invention can to the details of technical solution of the present invention and form into
Row modifications or substitutions, but these modifications and replacement are each fallen within protection scope of the present invention.
The processing of 1 ganoderma lucidum powder of embodiment
(1) clean：
The fresh glossy ganoderma root that will be excavated, cleans and is shredded after draining；
(2) compound anti-oxidation protective agent is added：
Added into the fresh ganoderma particles of chopping its weight 0.5% by Vc, Vc sodium, Vc phosphates and tea polyphenols institute group
Into compound anti-oxidation protective agent；The compound anti-oxidation protective agent is by Vc, Vc sodium, Vc phosphates and tea polyphenols according to weight
Amount is than being 1:1.5:2:1.5 composition；
(3) coarse crushing：
The protectant fresh ganoderma particles of compound anti-oxidation will be contained and remake coarse crushing processing with crusher, it is spare；
(4) digest：
According to solid-liquid ratio 1:Pure water is added in the fresh sesame coarse granule that 10 ratio is obtained to step (3), is then added fresh
The complex enzyme of ganoderma lucidum coarse granule weight 5% is digested, and the complex enzyme is by cellulase, amylase and lignoenzyme
It is 3 according to weight ratio：2：2 compositions, it is 5.0 to adjust pH, and 3h is digested in 50 DEG C of water-baths；
(5) micronized pulverization：
Slurry after step (4) is digested is placed in broken microwave instrument, at output frequency 2450MHz, power 750W, pre- place
Time 80s is managed, continues to carry out micronized pulverization processing under conditions of 300s afterwards, the slurry of 300 mesh is made；
(6) low-temperature microwave is dried in vacuo：
In microwave power 1kw, pressure 100Pa, under conditions of temperature 60 C to the slurry after micronized pulverization in step (5) into
Row low-temperature microwave is dried in vacuo, and is made and is dried Ultramicro-powder without Ganoderma, spare.
(7) crush：
Ganoderma lucidum drying Ultramicro-powder made from step (6) is made into further fine crushing processing, 600 mesh sieves is crossed, obtains ganoderma lucidum and dissipate
Agent powder, it is spare.
Also obtained ganoderma lucidum powder powder and other powders can be mixed and made into multiple powder, or according to medication needs, are made molten
Liquid dissipates, decoction made from powder, dispels, oral medicine powde or external powder.
The processing of 2 ganoderma lucidum powder of embodiment
(1) clean：
The fresh glossy ganoderma root that will be excavated, cleans and is shredded after draining；
(2) compound anti-oxidation protective agent is added：
Added into the fresh ganoderma particles of chopping its weight 0.9% by Vc, Vc sodium, Vc phosphates and tea polyphenols institute group
Into compound anti-oxidation protective agent；The compound anti-oxidation protective agent is by Vc, Vc sodium, Vc phosphates and tea polyphenols according to weight
Amount is than being 1.5:2.5:3:3 compositions；
(3) coarse crushing：
The protectant fresh ganoderma particles of compound anti-oxidation will be contained and remake coarse crushing processing with crusher, it is spare；
(4) digest：
According to solid-liquid ratio 1:Pure water is added in the fresh sesame coarse granule that 20 ratio is obtained to step (3), is then added fresh
The complex enzyme of ganoderma lucidum coarse granule weight 8% is digested, and the complex enzyme is by cellulase, amylase and lignoenzyme
It is 4 according to weight ratio:2:3 compositions, it is 5.0 to adjust pH, and 2.5h is digested in 55 DEG C of water-baths；
(5) micronized pulverization：
Slurry after step (4) is digested is placed in broken microwave instrument, at output frequency 2450MHz, power 800W, pre- place
Time 80s is managed, continues to carry out micronized pulverization processing under conditions of 250s afterwards, the slurry of 400 mesh is made；
(6) low-temperature microwave is dried in vacuo：
In microwave power 2.5kw, pressure 120Pa, to the slurry after micronized pulverization in step (5) under conditions of 65 DEG C of temperature
Low-temperature microwave vacuum drying is carried out, is made and dries Ultramicro-powder without Ganoderma, it is spare；
(7) crush：
Ganoderma lucidum drying Ultramicro-powder made from step (6) is made into further fine crushing processing, 700 mesh sieves is crossed, obtains ganoderma lucidum and dissipate
Agent powder, it is spare；
Also obtained ganoderma lucidum powder powder and other powders can be mixed and made into multiple powder, or according to medication needs, are made molten
Liquid dissipates, decoction made from powder, dispels, oral medicine powde or external powder.
The processing of 3 ganoderma lucidum powder of embodiment
(1) clean：
The fresh glossy ganoderma root that will be excavated, cleans and is shredded after draining；
(2) compound anti-oxidation protective agent is added：
Added into the fresh ganoderma particles of chopping its weight 1.0% by Vc, Vc sodium, Vc phosphates and tea polyphenols institute group
Into compound anti-oxidation protective agent；The compound anti-oxidation protective agent is by Vc, Vc sodium, Vc phosphates and tea polyphenols according to weight
Amount is than being 2:3:4:3 compositions；
(3) coarse crushing：
The protectant fresh ganoderma particles of compound anti-oxidation will be contained and remake coarse crushing processing with crusher, it is spare；
(4) digest：
According to solid-liquid ratio 1:Pure water is added in the fresh sesame coarse granule that 10 ratio is obtained to step (3), is then added fresh
The complex enzyme of ganoderma lucidum coarse granule weight 8% is digested, and the complex enzyme is by cellulase, amylase and lignoenzyme
It is 2 according to weight ratio:1:2 compositions, it is 5.0 to adjust pH, and 3h is digested in 65 DEG C of water-baths；
(5) micronized pulverization：
Slurry after step (4) is digested is placed in broken microwave instrument, at output frequency 2450MHz, power 850W, pre- place
Time 80s is managed, continues to carry out micronized pulverization processing under conditions of 350s afterwards, the slurry of 500 mesh is made；
(6) low-temperature microwave is dried in vacuo：
In microwave power 3.5kw, pressure 150Pa, to the slurry after micronized pulverization in step (5) under conditions of 75 DEG C of temperature
Low-temperature microwave vacuum drying is carried out, is made and dries Ultramicro-powder without Ganoderma, it is spare.
(7) crush：
Ganoderma lucidum drying Ultramicro-powder made from step (6) is made into further fine crushing processing, 800 mesh sieves is crossed, obtains ganoderma lucidum and dissipate
Agent powder, it is spare.
Also obtained ganoderma lucidum powder powder and other powders can be mixed and made into multiple powder, or according to medication needs, are made molten
Liquid dissipates, decoction made from powder, dispels, oral medicine powde or external powder.
The protecting effect of 1 anti-oxidant protective agent of experimental example
1st, method
Take cleaning, the fresh sesame fragment that finishes of chopping appropriate, be uniformly divided into two groups, experimental group and control group.To experimental group
Ganoderma lucidum fragment in add its weight 0.9% by Vc, Vc sodium, Vc phosphates, tea polyphenols according to weight ratio be 1.5:2.5:3:3
The compound anti-oxidation protective agent of composition, and it is uniformly mixed with ganoderma lucidum fragment；Control group is then not added with anti-oxidant protective agent.Every
5d is sampled observation to experimental group and control group, and measures ganodenic acid content.Ursolic acid (lot number：110742-201421),
It is used as ganodenic acid standard items, purchased from National Institute for Food and Drugs Control.
2nd, interpretation of result
It has been observed that starting stage, experimental group and control group, without significant difference, bitter and puckery flavor, surface brown, there is natural light
Pool, section part is white, there is slight wooden line；But after 10d is placed, there is mouldy sign in control group, and experimental group is unchanged；When
After placing 15d, control group has obvious mildew to occur, and with musty, though and experimental group has slight change, unobvious.
As shown in Figure 1, compared with control group, the ganodenic acid content of experimental group keeps basic smoothly horizontal, and right
Drastically reduced according to the ganodenic acid content of group, show that antioxidant has the ganodenic acid overflowed in fresh sesame certain protection to make
With, can make active ingredient keep compared with stable state.With the extension of time, may be influenced be subject to fresh sesame is mouldy, measure
The total ganodenic acid content of control group then persistently reduce to substantially scatter and disappear, it is consistent with sensory quality assessment result.And experimental group is total
Although the also decrease to some degree of ganodenic acid content, unobvious.It can be seen from the above result that the present invention is dissipated in preparation ganoderma lucidum
It is feasible that composite antioxidant is added during agent, and compared with not adding the control group of antioxidant, is had more preferable
Aesthetic quality and the protective effect of more obvious active ingredient.
The whole animal pharmacodynamics of the ganoderma lucidum powder of the present invention of experimental example 2
1st, experiment packet
Ganoderma lucidum powder I groups：The ganoderma lucidum prepared using 2 method of the embodiment of the present invention dries powder.
Ganoderma lucidum powder II groups：The ganoderma lucidum prepared using conventional method dries powder.
2nd, laboratory apparatus
1200 high performance liquid chromatograph of Agilent.
3rd, experimental method
The kunming mice 70 that weight is 18-22g is bought, adaptability is raised after a week, and 2 groups are randomly divided into by weight：Just
Normal control group (10), hyperglycemia model control group (60).Normal group is fed with normal diet, and the feeding of modeling group mouse is high
Fatty high-energy feed, after 10d, fasting for solids but not liquids, takes a blood sample and separates serum, measure serum blood sugar level as early as possible.Blood glucose is higher than
7.8mmol/L is that modeling successfully can be used for testing.Modeling group mouse is randomly divided into 6 groups according to blood sugar level and weight, i.e.,
Model control group, the low (5gkg of ganoderma lucidum powder I-1), height (10gkg-1) dosage group, the low (5gkg of ganoderma lucidum powder II-1), it is high
(10g·kg-1) dosage group and melbine group (0.75gkg-1), every group each 10.Administration group gives corresponding test sample
Product, 1 time a day, during the experiment each group freely ingest and drink water.
Last time is done after 30 days to be administered, and is taken a blood sample in next day mouse non-fasting, separates upper serum.By each group mouse blood
Operated according to the specification limit of every kind of kit clearly, detect blood sugar level in serum.
After modeling, compared with Normal group, the weight and blood glucose of modeling group mouse dramatically increase, and illustrate feeding
Higher fatty acid high-energy feed can cause mouse weight and blood glucose to dramatically increase.
4th, experimental result
Influence (mmolLs of the table 1 ganoderma lucidum powder I and ganoderma lucidum powder II to mouse blood sugar level-1, n=10,)
| Group | Dosage (g/kg) | Blood glucose before medication | Blood glucose after modeling | Blood glucose after medication |
| Normal group | - | 3.84±1.52 | 3.93±3.29 | 3.87±0.97 |
| Model control group | - | 3.91±0.85 | 18.26±3.48 | 26.38±1.21 |
| Ganoderma lucidum powder II is low | 5 | 4.13±0.97 | 17.54±2.91 | 15.34±0.87 |
| Ganoderma lucidum powder I is low | 10 | 3.97±1.03 | 19.23±2.64 | 12.65±1.42 |
| Ganoderma lucidum powder II high | 5 | 4.06±1.24 | 18.69±3.06 | 16.02±0.93 |
| Ganoderma lucidum powder I high | 10 | 4.02±1.76 | 20.12±3.81 | 9.14±1.24** |
| Melbine group | 0.75 | 4.10±1.57 | 17.98±2.67 | 8.13±2.06** |
Note：Compared with model control group,**P<0.01。
5th, interpretation of result
As shown in table 1, each group mice serum blood sugar level no significant difference before medication, is normal glycemic levels；And
After modeling compared with Normal group, the blood sugar level of model control group mice serum has notable rise, shows mouse experiment
Hyperglycemia model is successfully established；After administration, compared with model control group, ganoderma lucidum powder I is low, high dose group and ganoderma lucidum powder
II is low, the equal decrease to some degree of the blood glucose of high dose group and melbine group mouse.Compared with model control group, each group is small
The serum blood sugar level of mouse has a reduction, and the blood sugar level of ganoderma lucidum powder I high doses group and melbine group is dropped in pole conspicuousness
It is low.Compared with ganoderma lucidum powder II low dose groups, the blood sugar level of ganoderma lucidum powder I low dose groups is lower；With ganoderma lucidum powder II high agent
Amount group is compared, and the blood sugar level of ganoderma lucidum powder I high dose groups significantly reduces.It can be seen from the above result that prepared by the method for the present invention
Each dosage groups of ganoderma lucidum powder I act on more compared with each dosage groups of ganoderma lucidum powder II prepared by conventional method on serum blood sugar level is reduced
Substantially, the ganoderma lucidum powder I high dose group effects that prepared by the method for the present invention are much better than the ganoderma lucidum powder II high agent of conventional method preparation
Amount group.
The clinical verification of the ganoderma lucidum powder of the present invention of experimental example 3
1st, general information
Select be randomly divided into 64 diabetics for receiving treatment during in March, 2016 in certain institute in November, 2015
Two groups, experimental group and control group, every group of 32 people.Wherein experimental group patient (uses 2 side of the embodiment of the present invention with ganoderma lucidum powder I
Ganoderma lucidum drying powder prepared by method) treatment, control group patient is with ganoderma lucidum powder II (the ganoderma lucidum dryings prepared using conventional method
Powder) treatment.All patients meet diagnostic criteria of the World Health Organization for diabetes.Male patient 14 in experimental group
People, 18 people of female patient, 56~78 years old age, average age for (55.32 ± 10.61) year.12 people of male patient in control group,
20 people of female patient, 53~76 years old age, average age for (54.48 ± 13.64) year.Two groups are understood after statistical analysis
Treatment method corresponds to the general information such as age, gender, average course of disease and the lesion degree of patient and significant difference is not present
(P<0.05), it is believed that be comparable on two groups of case selection objects.
2nd, treatment method
Two kinds of ganoderma lucidum powders are given respectively for two groups of diabetics and carry out treatment observation, and experimental group gavages ganoderma lucidum every time
Powder I, control group then gavage ganoderma lucidum powder II；Two groups of each dosages are 3g, and 2 times a day, the course for the treatment of of two groups of patients is 4
A month.Blood routine, blood glucose inspection are done in 12h at pre-treatment and after treatment, and records adverse reaction performance.And record what is measured
Blood sugar concentration.
3rd, experimental result
With the observation after treatment before being treated to two groups of diabetes patients, the blood sugar concentration of two groups of patients is carried out pair
Than.
2 diabetes blood glucose level in patients of table contrasts
Note：Contrast before and after treatment,**P<0.01；Two groups of contrasts after treatment,##P<0.01。
4th, interpretation of result
From in table 2, the blood glucose after two groups of patients fasting state before the treatment and postprandial 2h is all remarkably higher than normally
Level, is hyperglycemic patients.After medication, the concentration of two groups of patient blood glucoses has reduction.Experimental group contrast before and after treatment, finds to control
Blood-sugar content changes extremely notable after treatment；Experimental group after treatment is compared with control group, finds the blood-sugar content of experimental group
There is also pole significant difference.Illustrate that ganoderma lucidum powder I prepared by the present invention is far good to the therapeutic effect of the hyperglycemic patients such as diabetes
In the therapeutic effect of ganoderma lucidum powder II prepared by conventional method.
5th, adverse reaction
After treatment, the blood routine and hepatic and renal function of two groups of patients do not have significant change.It is bad to occur enteron aisle in experimental group
Reaction 2, but without the normal administration of influence；There are different degrees of stomach and intestine portion malaise symptoms 5 in control group, but does not influence normal
Administration；Two groups do not occur other adverse reactions.After treatment end, two groups of patients do not occur obvious hypoglycemic reaction.It is real
The incidence for testing adverse reaction in group is 6.25%, and the incidence of adverse reactions of patients is 15.6% in control group, in two groups not
The incidence of good reaction is statistically significant.
The pharmacokinetic studies result of the ganoderma lucidum powder according to the present invention of experimental example 4：
1st, experimental method
The male rat 18 that weight is 240-270g is bought, divides 3 groups, gavages ganoderma lucidum powder I, II group and intravenous injection
Group, every group 6.Fasting 12h (free water) before experiment.Before administration 15 minutes in venous puncture blank blood sample 5mL, gavage into medicine
Group gavages ganoderma lucidum powder I (the ganoderma lucidum drying powder prepared using 2 method of the embodiment of the present invention) respectively and ganoderma lucidum powder II (is used
Ganoderma lucidum drying powder prepared by conventional method), gavage administration 1000mgkg-1；It is injected into the ganoderma lucidum three of medicine group vein note extraction
Terpene stoste, dosage 10mgkg-1.Intravenous injection administration is after 0.1,0.25,0.5,0.75,1.0,1.5,2.0,4.0,
6.0,8.0h blood drawing measure blood plasma in ganodenic acid concentration；Gavage administration after 0.5,1.0,1.5,2.0,2.5,3.0,3.5,
4.0th, ganodenic acid concentration in 6.0h, 8.0h blood drawing measure blood plasma.The unified feeds of 5h and drinking-water after administration.
2nd, detection method
According to Chinese Pharmacopoeia version one in 2015.
3rd, experimental result
The blood concentration of ganodenic acid and blood concentration-time curve difference after rat intravenous injection ganodenic acid stoste
As shown in table 3 and Fig. 2.
Blood concentration (the μ gmL of ganodenic acid after 3 rat intravenous injection ganodenic acid stoste of table-1,N=6)
1. rats gavaged ganoderma lucidum powder I or ganoderma lucidum powder II
The blood concentration of ganodenic acid and blood concentration-time are bent after rats gavaged ganoderma lucidum powder I or ganoderma lucidum powder II
Line is respectively as shown in table 4 and Fig. 3.
Blood concentration (the μ gmL of ganodenic acid after table 4 rats gavaged ganoderma lucidum powder I and ganoderma lucidum powder II-1,
N=6)
The measurement result of blood concentration after being administered according to rats gavaged, after dose modification, establishes pharmacokinetic model, counts
Pharmacokinetic parameters are calculated, obtain the AUC of ganodenic acid0-tData.The AUC of ganodenic acid after comprehensive rat intravenous injection administration0-t
With the AUC for gavaging the ganodenic acid after being administered0-t, the absolute bioavailability of ganodenic acid is calculated, the results are shown in Table 5.
5 pharmacokinetic parameters AUC of table0t(μg·mL-1·h)
2. the bioavilability of ganodenic acid in ganoderma lucidum powder I and ganoderma lucidum powder II
Bioavilability (bioavailability, F) is absorbed into whole body blood after referring to the outer approach administration of medicine intravascular
The relative quantity of liquid circulation.It is related with pharmaceutically-active intensity and speed, it is pharmaceutical preparation quality and evaluation preparation degree of absorption
Important indicator.
Absolute bioavailability F (%) calculation formula for gavaging preparation and injection is：
Wherein：AUC is lower area of blood concentration-time curve.
The absolute bioavailability result of calculation of ganodenic acid is as shown in table 6 in ganoderma lucidum powder I and ganoderma lucidum powder II.
The absolute bioavailability of ganodenic acid in table 6 ganoderma lucidum powder I and ganoderma lucidum powder II
| Group | Absolute bioavailability (%) |
| Powder I | 10.03 |
| Powder II | 5.69 |
4th, interpretation of result
The interior medicine dynamics process of ganodenic acid after this experimental study iv and po administration, and ganoderma lucidum powder I and
Effects of the ganoderma lucidum powder II to ganodenic acid physiological disposition.
After rat gavages ganoderma lucidum powder I and ganoderma lucidum powder II respectively, the Cmax C of ganoderma lucidum powder ImaxCompared with ganoderma lucidum powder II
Significantly increase, illustrate that two kinds of ganoderma lucidum powders contain effective ganodenic acid, compared with ganoderma lucidum powder II, ganoderma lucidum powder I is more
The absorption rate and uptake of ganodenic acid can be improved, illustrating to expose in ganoderma lucidum powder I more can be by the effective of body absorption
Component.
Compared with ganoderma lucidum powder II, the mean residence time (MRT) of each components of ganoderma lucidum powder I in vivo has in various degree
Increase, blood concentration-time curve also embodies the rear shifting of peak time, illustrates that the ganoderma lucidum powder I of ultra micro shape is more easy to and blood
Protein binding is starched, so as to promote medicine to be better absorbed in enteron aisle.
Ganoderma lucidum powder absolute bioavailability the result shows that, the ganoderma lucidum powder I that is prepared by the method for the present invention and tradition
Ganoderma lucidum powder II prepared by method is compared, and bioavilability improves 1.76 times.
Claims (10)
1. a kind of concocting method of ganoderma lucidum powder, it is characterised in that comprise the following steps：
(1) clean：
The fresh glossy ganoderma that will be excavated, cleans and is shredded after draining；
(2) compound anti-oxidation protective agent is added：
The compound anti-oxidation being made of Vc, Vc sodium, Vc phosphates and tea polyphenols is added into the fresh ganoderma particles of chopping to protect
Protect agent；
(3) coarse crushing：
The protectant fresh ganoderma particles of compound anti-oxidation will be contained and remake coarse crushing processing with crusher, it is spare；
(4) digest：
According to solid-liquid ratio 1:Pure water is added in the fresh sesame coarse granule that the ratio of 10-25 is obtained to step (3), is then added fresh
The complex enzyme of sesame coarse granule weight 5%~10% is digested, and the complex enzyme is by cellulase, amylase and lignoenzyme
Composition；
(5) micronized pulverization：
Slurry after step (4) is digested, which is placed in broken microwave instrument, carries out micronized pulverization, and the slurry of 300-500 mesh is made；
(6) low-temperature microwave is dried in vacuo：
Low-temperature microwave vacuum drying is carried out to the slurry after micronized pulverization in step (5), is made and dries Ultramicro-powder without Ganoderma, it is standby
With；
(7) crush：
Ganoderma lucidum drying Ultramicro-powder made from step (6) is made into further fine crushing processing, 600~800 mesh sieves is crossed, obtains ganoderma lucidum and dissipate
Agent powder, it is spare.
2. concocting method as claimed in claim 1, it is characterised in that compound anti-oxidation protective agent described in step (2) by
Vc, Vc sodium, Vc phosphates and tea polyphenols are 1~10 according to weight ratio：1~10：1~10：1~10 composition, it is preferred that Vc,
The weight ratio of Vc sodium, Vc phosphates and tea polyphenols is 1.5：2.5：3：3.
3. concocting method as claimed in claim 1, it is characterised in that the compound anti-oxidation added in step (2) is protectant
Measure as the 0.5-1.2% of fresh sesame particle weight, it is preferred that the protectant amount of compound anti-oxidation added is fresh ganoderma particles
The 0.9% of weight.
4. concocting method as claimed in claim 1, it is characterised in that enzymolysis described in step (4) in accordance with the following methods into
OK：According to solid-liquid ratio 1:20 ratio adds pure water into obtained fresh sesame coarse granule, then adds fresh sesame coarse granule weight
The complex enzyme of amount 8%, it is 4.8~5.8 to adjust pH, and 2.5~4.5h is digested in 45~65 DEG C of water-baths.
5. the concocting method as described in claim 1 or 4, it is characterised in that the complex enzyme described in step (4) is by cellulose
Enzyme, amylase and lignoenzyme are 1~4 according to weight ratio：1~4：1~4 composition, it is preferred that cellulase, amylase with
And lignoenzyme is 4 according to weight ratio:2:3.
6. concocting method as claimed in claim 1, it is characterised in that the micronized pulverization described in step (5) is by step (4)
Slurry after enzymolysis is placed in broken microwave instrument, in output frequency 2450MHz, 750~850W of power, pretreatment time 80s, after
Continue to handle under conditions of 250~350s, the slurry of 300-500 mesh is made.
7. concocting method as claimed in claim 1, it is characterised in that described in step (6) low-temperature microwave vacuum drying be
0.6~3.5kw of microwave power, 100~150Pa of pressure, under conditions of 60~80 DEG C of temperature to micronized pulverization in step (5) after
Slurry carries out low-temperature microwave vacuum drying, is made and dries Ultramicro-powder without Ganoderma, spare.
8. concocting method as claimed in claim 1, it is characterised in that further include the ganoderma lucidum powder powder and other powders that will be obtained
It is mixed and made into multiple powder, or according to medication needs, solution is made and dissipates, decoction made from powder, dispel, oral medicine powde or external powder.
9. the ganoderma lucidum powder being prepared according to claim 1-8 any one of them concocting methods.
10. purposes of the ganoderma lucidum powder in treatment diabetes and related hyperglycemic disorder medicine are prepared described in claim 9.
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| CN111540411A (en) * | 2019-03-28 | 2020-08-14 | 内蒙古自治区国际蒙医医院(内蒙古自治区蒙医药研究所) | Technology for quantitatively demonstrating accurate attenuation of myrobalan-processed kusnezoff monkshood root |
| CN111973498A (en) * | 2020-09-25 | 2020-11-24 | 广州环亚化妆品科技有限公司 | Ganoderma lucidum fermentation product and preparation method and application thereof |
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