CN105832791A - Pure under-forest ginseng powder tablet and preparation method thereof - Google Patents
Pure under-forest ginseng powder tablet and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a pure under-forest ginseng powder tablet and a preparation method thereof. The pure under-forest ginseng powder tablet consists of under-forest ginseng micro-powder. The preparation method comprises the following steps: removing surface earth, performing drying and slicing, continuing drying until the water content is 3 to 5 percent, performing crushing to obtain coarse powder, performing crushing to obtain under-forest ginseng micro-powder with particle sizes of less than or equal to 75 [mu]m, and performing tabletting. The pure under-forest ginseng powder tablet is pressed without any accessories, is high in dissolution rate and short in dissolution time, and active pharmaceutical ingredients can reach a blood drug concentration capable of treating diseases within the shortest time. The pure powder tablet obtained by the method is attractive in appearance and low in surface pitting rate and breaking rate, and the hardness and disintegration degree of the tablet meet tablet quality requirements.
Description
Technical field
The present invention relates to medicine and health product technology field, particularly relate to a kind of ginseng under forest pure powder tablet and preparation side thereof
Method.
Background technology
Radix Ginseng is the dry root and rhizome of Araliaceae Radix Ginseng (Panax ginseng C.A.Meyer).According to people
The growth pattern difference of ginseng can be divided into wild ginseng, ginseng under forest, Park Ginseng etc..Widespread demand and Ye Shan due to market
That joins is endangered, and current ginseng under forest and Park Ginseng are the main sources of ginseng crude drug on market.Ginseng under forest is by open country
The seed artificial seeding of SHANSHEN is at virgin forest, without any Human disturbance, gives free rein to grow 15-20,
Excavating and make goods, ginseng under forest growth year is the highest, and nutritive value is the highest, can match in excellence or beauty with wild ginseng.The life of ginseng under forest
Elongate member is the harshest, to the canopy density of forest and soil quality and the gradient of forest, towards etc. have strict requirements；
Along with the development of ginseng under forest industry, the consumption to the forest reserves is the hugest, the forest retained for ginseng under forest at present
Area is fewer and feweri, and ginseng age, the ginseng under forest quantity more than 15 years was the most rare, and the seed of 20 years broadcasts ginseng under forest more
It is rare.
Disappear now along with the quickening of people's rhythm of life, the preservation of fresh ginseng and conventional use (as decocted) cannot meet
The demand of the person of expense, is ginseng product by processing of Panax ginseng, both facilitates storage, transports and use, can improve again the profit of Radix Ginseng
By rate.Existing ginseng product is mainly drying whole ginseng, section ginseng, Panax Capsule or tablet etc., wherein, Radix Ginseng slice
The use of agent is the most extensive.Under normal circumstances, the first character according to medicine and clinical application is wanted to require to select when preparing tablet
Suitable adjuvant, through hybrid process so that it is have good mobility and compressibility.During direct compression filler and
Binding agent is the key of tabletting, and can determine tablet qualified.During wet granule compression tablet, filler and binding agent are as tax
Shape agent is the most even more important.
After at present the preparation technology of Radix Ginseng tablet being typically necessary other adjuvant figuration of addition, then carry out tabletting.No matter
It is Radix Ginseng powder or Radix Ginseng extractum, Radix Ginseng extractum powder etc., all can be by adding adjuvant to improve powder, extractum or leaching
Some performance of cream powder so that the tablet of extrusion meets correlated quality requirement.
Along with consumer, to pure natural with without adding the special favor of product, develops 100% pure natural without appointing in recent years
The preparation of what adjuvant becomes the new focus of medicine and health product.
But, in the pure powder tableting processes made with ginseng under forest, showing as powder diameter the least, dissolution time is the fastest,
But powder diameter is the least, surface tension is the biggest, between space the biggest, it is impossible to directly with ginseng under forest pure powder tabletting or
Pelletize, need to add adjuvant and improve its mobility and compressibility.And in the granulating process of Conventional fluidization bed, sylvan life mountain
Volatile ingredient in ginseng can lose, it is also desirable to adds adjuvant and carries out figuration, to improve the mobility of granule, water content,
Thus ensure tablet quality.The most up to the present, yet there are no and directly prepare the report of tablet with the pure powder of ginseng under forest.
Summary of the invention
It is an object of the invention to for technological deficiency present in prior art, on the one hand, provide one to be not added with any
The ginseng under forest pure powder tablet of adjuvant, is formed by ginseng under forest micropowder tabletting.
The water content of described ginseng under forest micropowder is 3-5wt%, preferably 4.5wt%.
The particle diameter of described ginseng under forest micropowder is≤75 μm, preferably mean diameter D90It is 10 μm ＜ D90＜ 20 μm, more excellent
Select D90For 12-18 μm, most preferably D90It is 15 μm.
Second aspect, the invention provides a kind of method preparing above-mentioned ginseng under forest pure powder tablet, removes ginseng under forest table
After the earth of face, 60 DEG C are dried after 48 hours and cut into slices, then proceed to 60 DEG C be dried to water content be 3-5wt%, preferably
4.5wt%, is ground into coarse powder by the section of dried ginseng under forest, then coarse powder is ground into≤particle diameter of 75 μm is (excellent
Select D90＜ 20 μm, more preferably mean diameter D90For 12-18 μm, most preferably mean diameter D90Be 15 μm) sylvan life mountain
Tabletting after ginseng micropowder, i.e. obtains described ginseng under forest pure powder tablet.
The most also use ozone sterilization.
Described tabletting can use direct compression technique, it would however also be possible to employ secondary or repeatedly tablet forming technique, it is also possible to uses dry
Method pelletize tablet forming technique or wet granulation tablet forming technique；Preferably first carry out precompressed before tabletting.
Described direct compression technique is: directly ginseng under forest micropowder is pressed into sheet with tablet machine, and wherein, preload pressure is
0.5-2.0kN, principal pressure is 35-55kN；The preferred 1.2kN of preload pressure, the preferred 45kN of principal pressure.
Described secondary or repeatedly tablet forming technique be: after directly ginseng under forest micropowder being pressed into sheet with tablet machine, is crushed to energy
Cross 50-100 mesh sieve, again tabletting, be secondary tabletting；The step of tabletting-pulverizing-again tabletting is repeated several times, i.e.
For repeatedly tabletting；Precompressed can be all carried out, it is also possible to only before first time tabletting, carry out precompressed, in advance before each tabletting
Pressure pressure is 10-18kN, principal pressure is 15-28kN；The preferred 17kN of preload pressure, the preferred 20kN of principal pressure.
Described dry granule tabletting technique is: ginseng under forest micropowder is first pressed into embryo sheet, and being then crushed to can mistake
50-100 mesh sieve, then tabletting, described in be pressed into the pressure of embryo sheet or tabletting be 15-28kN (the preferred 20kN of pressure)；
Can carry out precompressed before tabletting and/or before being pressed into embryo sheet, preload pressure is that (preload pressure is preferred for 10-18kN
17kN)。
Described wet granulation tablet forming technique is: by (excellent for ethanol that ginseng under forest micropowder volumn concentration is 0-40%
Select 20-35%, most preferably 30%) after pelletize, crossing 50-80 mesh sieve, 60-80 DEG C of dry 1-1.5h is 8-12 to water content
Wt%, then tabletting；Can carry out precompressed before tabletting, preload pressure is 10-18kN, principal pressure is 15-28kN；Precompressed
The preferred 17kN of pressure, the preferred 20kN of principal pressure.
Compared with prior art, the invention has the beneficial effects as follows:
The ginseng under forest pure powder tablet of the present invention is formed, without any adjuvant by pure ginseng under forest micropowder compacting；Its
Taste micro-sweet, without bitterness, dissolution rate is high, and dissolution time is fast, can guarantee that within the shortest time, active constituents of medicine
Reach the blood drug level that like product can reach.The pure powder tablet flap-type outward appearance extruded by the inventive method is good, pitted skin rate
Low with sliver rate, tablet hardness and disintegration all meet tablet quality requirement.The present invention is with ginseng under forest micropowder tabletting relatively
The preparation cost of ginseng under forest extract tabletting is low, but also when being possible to prevent to extract, effective ingredient runs off, preparation technology
Simpler.The ginseng under forest pure powder tablet taste of the present invention micro-sweet, return the local flavor sweet, there is fresh ginseng, can be as containing
Sheet is taken, and combines gastrointestinal approach by oral mucosa and absorbs, makes the effective ingredient in ginseng under forest micropowder enter rapidly
Enter internal, the first pass effect of liver can be overcome, improve curative effect, and dose can be made to reduce, its clinical meaning and resource
The meaning utilized is the most great.
Detailed description of the invention
There is the report (Publication No. 104257710A) of preparation pure wild ginseng powder sheet method at present, by lyophilization to containing
The water yield is that to be crushed to particle diameter be 5-20 μm (mean diameter is 10 μm) for the wild ginseng of more than 5.5wt%, then through dry method system
Grain tablet forming technique makes pure powder tablet.But inventor studies after finding the wild ginseng in the document is replaced to ginseng under forest,
Ginseng under forest pure powder tablet cannot be obtained by its technique.Because mean diameter is 10 μm, water content is more than 5.5wt%'s
Ginseng under forest micropowder surface tension is very big, and between powder, space is very big, therefore, with existing method cannot by its direct compression,
Need to add adjuvant and improve its mobility and compressibility；When pelletizing with Conventional fluidization bed, it is also desirable to add adjuvant and it is entered
Row figuration, improves mobility of particle, water content, could reduce the loss of volatile ingredient in ginseng under forest, simultaneously
Ensure tablet quality.But after with the addition of adjuvant, it may appear that medicine mixes inequality, tablet Chinese traditional medicine effective ingredient with adjuvant
The inaccurate defect of content, also can be forced when taking under clothes not play the adjuvant of drug effect, increase the organ such as liver, kidney
Burden, may limit diabetics, the use of hepatic and kidney function obstacle patient.Additionally, this wild ginseng micropowder be by
Pulverize after wild ginseng lyophilization and obtain, the production of this pure wild ginseng powder sheet, transport, the overall process such as storage is required to
Freezing (room temperature is the most not all right), the otherwise serious bitter taste of product, impact is taken.But lyophilization needs to set specially
Standby, involve great expense, maintaining equipment to run needs special cold-producing medium, increases cost, and drying time is long, produces effect
Rate is low；The low temperature environment producing, transport and store process too increases the cost of product, is not convenient to use.
Inventor gropes to obtain a kind of method preparing ginseng under forest pure powder tablet through many experiments, and the method is to grow year
Being limited to the seed of 15-20 and broadcasting ginseng under forest is raw material, preciousness nutritious, rare.The method is particularly as follows: pluck excellent
The ginseng under forest of matter, removes surface earth, puts into after 60 DEG C of air dry ovens are dried 48 hours and cuts into slices, after section
Continue in putting back to 60 DEG C of air dry ovens to be dried to water content be 3-5wt%, powder of then dried ginseng under forest being cut into slices
It is broken into coarse powder, then becomes particle diameter to be≤75 μm (preferably 10 μm ＜ D through micronizing coarse powder90＜ 20 μm, the most flat
All particle diameter D90For 12-18 μm, most preferably mean diameter D90Be 15 μm) ginseng under forest micropowder after tabletting, finally will
Tablet ozone sterilization, i.e. obtains the ginseng under forest pure powder tablet of the present invention.It is not added with in the preparation process in accordance with the present invention appointing
What adjuvant such as lubricant, disintegrating agent, ginseng under forest micropowder is the sole component of gained tablet.
The present invention propose ginseng under forest pure powder tablet be use water content be 3-5wt%, particle diameter is≤75 μm (preferably 10 μm
＜ D90＜ 20 μm, more preferably mean diameter D90For 12-18 μm, most preferably mean diameter D90Be 15 μm) sylvan life mountain
Ginseng micropowder can pass through direct compression technique, it is also possible to by secondary or repeatedly tablet forming technique, it is also possible to pass through non-slurry pelletizing
Tablet forming technique or wet granulation tablet forming technique tabletting obtain, and can also use pressing step before tabletting, are conducive to getting rid of
Air in powder, reduces sliver, increases the hardness of tablet.
Wherein, above four kinds of methods specifically include following steps:
Method one: direct compression technique, i.e. direct power compressing method, obtains ginseng under forest micropowder direct compression.
Method two: secondary or repeatedly tablet forming technique, will after ginseng under forest micropowder presses direct power compressing method tabletting, then
Be crushed to can cross 50-100 mesh sieve powder after, tabletting again, be secondary tabletting；If tablet quality does not reaches requirement,
Or in order to adjust tablet hardness further, tabletting again after the micropowder tablet after secondary tabletting can being pulverized, this is repeated several times
Step, until product conforms to quality requirements, is repeatedly tabletting；Generally, secondary tabletting just can make tablet
Yield rate, hardness, pitted skin rate, the index such as sliver rate reach requirement.
Method three: dry granule tabletting technique, will be after ginseng under forest micropowder be pressed into big lamellar or tabular embryo sheet, powder
It is broken to cross tabletting again after the powder of 50-100 mesh sieve；If tablet quality does not reaches requirement, this step is repeated several times,
Until tablet quality reaches requirement.
Method four: wet granulation tablet forming technique, will ginseng under forest micropowder volumn concentration be the ethanol of 0-40%
(0% refers to use water pelletize) carries out pelletize (the ethanol pelletize of 1kg ginseng under forest micropowder 80-200ml), crosses 50-80
Mesh sieve, 60-80 DEG C of dry 1-1.5h, it is dried after being 8-12wt% to water content, tabletting and get final product；Preferably use 20-35%
(v/v), most preferably with the ethanol pelletize of 30% (v/v).
In order to get rid of the air in micropowder when tabletting, reduce sliver, increase hardness, precompressed can be increased before tabletting
Step.It is different and different that preload pressure and principal pressure (pressure during tabletting) regard concrete tablet forming technique.For method one
Direct compression technique, preload pressure is between 0.5-2.0kN, and principal pressure is between 35-55kN；Preferably precompressed pressure
Power is 1.2kN, principal pressure is 45kN.For secondary or the repeatedly tablet forming technique of method two, can before each tabletting
Use pressing step, it is also possible to only use pressing step when first time tabletting；Preload pressure between 10-18kN,
Principal pressure is between 15-25kN；Preferably preload pressure be 17kN, principal pressure be 20kN.Dry method for method three is made
Grain tablet forming technique, can get rid of the air in micropowder, precompressed by precompressed before big lamellar or tabular embryo sheet and/or before tabletting
Pressure between 10-18kN, principal pressure is between 15-25kN；Preferably preload pressure be 17kN, principal pressure be 20kN.
Suppress the wet granulation tablet forming technique for method four, before tabletting, the air in micropowder can also be got rid of by precompressed, in advance
Pressure pressure between 10-18kN, principal pressure is between 15-25kN；Preferably preload pressure be 17kN, principal pressure be 20kN.
Below in conjunction with specific embodiment, further illustrate present disclosure, and the present invention is further elaborated,
But these embodiments limit the invention absolutely not.
The ginseng under forest pure powder tablet of the present invention is prepared by above four kinds of methods, tablet format 0.35g/ sheet, 100,
Then the quality of the mass parameter of the ginseng under forest pure powder tablet obtained, the technological parameter of its method and the tablet obtained is tested
Parameter is shown in that Tables 1 and 2 (is method one, method two and method three in table 1；Table 2 is method four).Comparative example
1 is to use mean diameter D90Being 5 μm, water content is the sheet that the ginseng under forest micropowder of 5.5wt% is obtained by method two compacting
Agent；Comparative example 2 is to use mean diameter D90Being 10 μm, water content is that the ginseng under forest micropowder of 5.5wt% is by method three pressure
The tablet prepared；Comparative example 3 is the wild ginseng obtained by method in the patent documentation of Publication No. CN102783642A
Submicron powder sheet.
The technological parameter of table 1 the inventive method and obtain the mass parameter of tablet
The technological parameter of table 2 the inventive method four and obtain the mass parameter of tablet
One, the screening of ginseng under forest pure powder tablet preparation technology
Example one, direct compression technique:
1. raw material: ginseng under forest micropowder, mean diameter D90It is 15 μm；Water content is 4.5wt%.
2. tablet machine preload pressure 1.2kN, principal pressure 45kN.
3., when micropowder being sent into tablet machine, use pole type impeller blanking device, to increase the mobility of medicated powder.
By ginseng under forest micropowder direct pressing piece agent under above-mentioned process conditions, tablet format 0.35g/ sheet, 100.
Example two, secondary tablet forming technique:
1. raw material: ginseng under forest micropowder, mean diameter D90It is 15 μm；Water content is 4.5wt%.
2. first time tabletting preload pressure 17kN, principal pressure 20kN；Tabletting preload pressure 17kN, principal pressure for the second time
20kN。
3., when micropowder being sent into tablet machine, use pole type impeller blanking device, to increase the mobility of medicated powder.
Under above-mentioned process conditions, tabletting is made first sheet that average hardness is 2.57Kg (first sheet specification is about first
0.35g/ sheet), then pulverize the powder for 100 mesh sieves can be crossed, it being again with above-mentioned process conditions tabletted, tablet is advised
Lattice 0.35g/ sheet, 100.
Example three, dry granulation tablet forming technique:
1. raw material: ginseng under forest micropowder, mean diameter D90It is 15 μm；Water content is 4.5wt%.
2. when tablet machine suppresses big lamellar or tabular embryo sheet, preload pressure 17kN, principal pressure 20kN；After pulverizing during tabletting
Preload pressure 17kN, principal pressure 20kN.
3., when micropowder being sent into tablet machine, use pole type impeller blanking device, to increase the mobility of medicated powder.
Under above-mentioned process conditions, after first ginseng under forest micropowder being compressed into big lamellar or tabular embryo sheet, pulverize, whole
Grain to can mistake 50 mesh sieves, be again with above-mentioned process conditions tabletted, tablet format 0.35g/ sheet, 100.(big
Lamellar embryo sheet can use heavy-duty tabletting press that ginseng under forest micropowder is pressed into the embryo sheet that diameter is about 20-25mm；Tabular embryo
Sheet can use rolling process to prepare.)
Example four, wet granule compression tablet technique:
1. raw material: ginseng under forest micropowder, mean diameter D90It is 15 μm；Water content is 4.5wt%.
2. preload pressure 17kN during tabletting machine, principal pressure 20kN.
3., when micropowder being sent into tablet machine, use pole type impeller blanking device, to increase the mobility of medicated powder.
Under above-mentioned process conditions, first the ginseng under forest micropowder ethanol of 30% (v/v) is carried out pelletize, cross 70
Mesh sieve, being dried 1-1.5h at 60-80 DEG C is 10% to water content, uses above-mentioned process conditions tabletted, tablet
Specification 0.35g/ sheet, 100.
Prepare the ginseng under forest pure powder tablet of the present invention by the method for example one to four, then test the sylvan life mountain obtained
The mass parameter of ginseng pure powder tablet, its technological parameter and mass parameter are shown in Table 3.
Four kinds of tablet forming technique parameters of table 3 example one to four and mass parameter (in terms of 100 tablets)
By the data of table 3 it can be seen that four kinds of methods of application example one to four all can prepare and meet quality standard
Ginseng under forest pure powder tablet, but the tablet of these four tablet forming technique gained is the most distinct in quality: directly press
The tablet yield rate that blade technolgy obtains is relatively low, and the tablet obtained discrete piece, shedding easily occurs, falls block, sliver, pine
The problems such as sheet, hardness are little.Compared with direct compression technique, secondary tablet forming technique, dry granule tabletting technique and wet method
The tablet that pelletize tablet forming technique obtains all is significantly better than the tablet that example one obtains, in outward appearance in terms of hardness, sliver rate
Tablet pitted skin that aspect these three technique obtains and sliver degree are considerably less than the tablet of direct compression technique gained.Relatively
Three kinds of techniques in example two to four, it is known that the tablet quality of secondary tablet forming technique and wet granulation tablet forming technique gained is excellent
In the tablet that dry granule tabletting technique obtains, especially in terms of yield rate, pitted skin rate and sliver rate, it is superior to example
Three tablets obtained.
To sum up, preparation method of the present invention is simple, and site technique workflow reengineering is convenient, and feasibility is strong, application prospect
Wide.
Two, the determination of ginseng under forest micropowder water content
In conventional micropowder tabletting, water content is the biggest on the impact of tabletting: the too high easy sticking of water content, it is impossible to give birth to continuously
Producing, fiber crops sheet rate is high, falls block, it is impossible to obtain the tablet that shape is complete；And low easily there is discrete piece, shedding, splits in water content
The problems such as sheet, loose pieces, hardness are little, therefore water content is low or high is generally all difficult to tabletted.
In existing document, the water content of wild ginseng micropowder is higher, when ginseng under forest micropowder, owing to raw material is different, its
Character and the effective ingredient contained are different, need to be adjusted.
For present invention ginseng under forest to be provided pure powder tablet, inventor, in the screening process of tablet forming technique, finds
The moisture of ginseng under forest micropowder is to affect tablet quality very important parameter.Ginseng under forest micropowder moisture Control is not
Good, finished product rate is low, hardness, pitted skin rate, and sliver rate is defective, industrial cannot apply.
In the present invention, the water content of ginseng under forest micropowder is more suitable for compressed tablets when 3-5wt%.If moisture is low
When 3wt%, there will be the situation such as sliver, disintegrating tablet after tabletting, if moisture is higher than 5wt%, tabletting rear panel embryo is variable
Color, color burn, in yellowish-brown, there are pit and black speck, tarnish reasons is that effective ingredient separates out, it is impossible to reach tablet
Appearance requirement, and subsequent packages is also had an impact, is unfavorable for industrial operation, therefore needs to control ginseng under forest micropowder
Water content between 3-5wt%, just can obtain qualified pure powder tablet.
Draw in ginseng under forest micropowder water content is on the test of the impact of tablet quality according to inventor, work as ginseng under forest
When powder moisture is about 4.5%, tablet yield rate obtained by compacting is high, and steady quality, conformance with standard, after also reaching
Continue the prescriptions such as the product hardness needed for the processing modes such as packaging, disintegration.
Three, the screening of ginseng under forest grain size of micropowder
Below by way of measuring active substance stripping quantity experiment screening ginseng under forest in the different ginseng under forest micropowder pulverizing rank
The particle size distribution range of micropowder.By ginseng under forest by size reduction to five rank: I level is 150 μm≤D90≤ 350 μm,
II level is 80 μm≤D90≤ 100 μm, III level is 38 μm≤D90≤ 58 μm, IV level is 12 μm≤D90≤ 18 μm, V level
D90≤6.5μm.Measure the dissolution (effective ingredient of effective ingredient in these five the ginseng under forest micropowders pulverizing rank respectively
Predominantly total saponins and crude polysaccharides).In the different ginseng under forest micropowders pulverizing rank, effective ingredient dissolution in time is shown in
Table 4 and table 5.
1, the mensuration of total saponins
Precision weigh pulverize rank be I, II, III, IV, V level each 5g of ginseng under forest micropowder (often group sets Duplicate Samples,
Average), add diethyl ether after backflow defat, discard ether solution, residue volatilizes ether, puts in tool plug triangular flask, adds steaming
Distilled water 100ml, is placed in reflux, extract, in boiling water bath, and respectively 1,5,10,30,60,90,120min take
Sample, takes 50ml extracting solution, extracts saponin with water-saturated n-butanol, dissolves with methanol after being evaporated, and ginsenoside can be with
Sulphuric acid-vanillin colour developing, measures absorption value, total saponins in the different ginseng under forest micropowders pulverizing rank at 544nm wavelength
Stripping quantity (g) in time, the results are shown in Table 4.
Total saponins stripping quantity (g) in time in the different ginseng under forest micropowder pulverizing rank of table 4
The result of table 4 understands, and each total saponins dissolution pulverizing rank is stepped up with the prolongation of dissolution time, but not
Different with the stripping quantity of total saponins in the ginseng under forest micropowder of pulverizing rank.Wherein, ginseng under forest V level micropowder is instantaneous
Dissolution (during 1min) and later each time point are all rapid than other group dissolution, and in the dissolution time section of 1-90min
Inside compare other group and be always maintained at the highest stripping quantity.The stripping quantity of each group all tends towards stability after 90min.
2, the mensuration of crude polysaccharides
With the molecular weight that is dried to constant weight for 5 × 105Glucosan for comparison, precision weigh pulverizing rank be I, II,
The each 3.0g of ginseng under forest micropowder of III, IV, V level, with decoction and alcohol sedimentation technique (60 DEG C) extract crude polysaccharides, respectively 1min,
10min, 30min and 60min sample, and put constant volume in 50ml volumetric flask, shake up.Phenolsulfuric acid method is used to measure
In the different ginseng under forest micropowders pulverizing rank, the dissolution (%) of crude polysaccharides, the results are shown in Table 5.
Crude polysaccharides dissolution (%) in time in the different ginseng under forest micropowder pulverizing rank of table 5
Table 5 result shows, each crude polysaccharides dissolution pulverizing rank is stepped up with the prolongation of dissolution time, different powder
In the ginseng under forest micropowder of broken rank, the dissolution of crude polysaccharides is different, and wherein, V level ginseng under forest micropowder is molten when 1min
Out-degree is just 1.55%, and quickly, when 30min, dissolution is 18.74%, and I level ginseng under forest micropowder is at 30min in dissolution
Time dissolution be then 10.26%, II level is 13.46%, and III level is 16.72%, all significantly lower than V level ginseng under forest
Micropowder, dissolution during 60min still keeps this rule, but the crude polysaccharides of V level and IV level ginseng under forest micropowder is molten
Out-degree difference is the least in whole experimentation, and difference is the most notable.
It can be seen that the ginseng under forest that pulverizing rank is I level, II level, III level and IV level is micro-from table 4 and table 5
The dissolution significant difference of effective ingredient in powder, presents pulverizing rank the highest, stripping quantity or the highest trend of dissolution,
But this trend terminates to V level, in the ginseng under forest micropowder of V level, the dissolution of effective ingredient and IV level are without significance
Difference, it is contemplated that cost reason, is crushed to IV level by ginseng under forest in practical operation.
The result of table 4 and table 5 it is also shown that when the pulverizing rank of ginseng under forest micropowder is IV level, its dissolution rate ten
Point rapidly, in the case of the composition dissolution such as crude polysaccharides of I level and II level group is less, IV level group also can have and have in a large number
The dissolution of effect composition.Comparing from entirety, IV level ginseng under forest micropowder group is than I, II, III level group base on stripping quantity
Originally 2-3 times is exceeded.Owing to micropowder has extremely strong dissolution permeance property, its dissolution is at other coarse powder of 60min internal ratio
It is improved largely, significantly improves in especially 1min-30min, therefore the ginseng under forest pure powder tablet of the present invention both can be normal
Rule are oral, it is also possible to oral cavity buccal passes through oral mucosal absorption active ingredient, makes the effective ingredient of ginseng under forest limited
Digestion time in discharge rapidly and enter internal, thus improve curative effect, and can make owing to not adding any adjuvant
Dose reduces at double.
Four, ginseng under forest grain size of micropowder screening in preparation technology
The impact on tablet quality in preparation technology of the ginseng under forest micropowder of rank, sieve is pulverized below by way of measuring difference
Select the particle size distribution range of ginseng under forest micropowder.Owing to the ginseng under forest micropowder effective ingredient dissolution of I level and II level is imitated
The most bad, the ginseng under forest therefore selecting pulverizing rank to be III level, IV level and V level in the screening of tablet technique is micro-
Powder: III level is 38 μm≤D90≤ 58 μm, IV level is 12 μm≤D90≤ 18 μm, V level D90≤6.5μm.It is respectively adopted
These three is pulverized the ginseng under forest micropowder of rank and is pressed into tablet by the tablet forming technique of embodiment two and embodiment three, and measures
Obtain the quality of tablet.The tablet forming technique using embodiment two obtains the quality results of tablet and is shown in Table 6, uses embodiment
The tablet forming technique of three obtains the quality results of tablet and is shown in Table 7.
Table 6 obtains the quality of tablet according to the tablet forming technique of embodiment two
As shown in Table 6, using in the case of same process parameter, IV level ginseng under forest micropowder yield rate,
Hardness, pitted skin rate and sliver rate aspect are all significantly better than III level ginseng under forest micropowder, but and V level ginseng under forest micropowder
Not being clearly distinguished from, even in terms of pitted skin rate, IV level is also significantly better than V level, therefore, selects in tableting processes
IV level ginseng under forest micropowder.
Table 7 obtains the quality of tablet according to the tablet forming technique of embodiment three
As shown in Table 7, using in the case of same process parameter, IV level ginseng under forest micropowder yield rate,
Hardness, pitted skin rate and sliver rate aspect are all significantly better than III level ginseng under forest micropowder, but and V level ginseng under forest micropowder
It is not clearly distinguished from, therefore, under the pressing process parameter that this experiment is selected, IV level and thinner V level ginseng under forest
Micropowder all can tabletted very well, in view of pulverizing cost in production, IV level sylvan life can be selected in tableting processes
SHANSHEN micropowder.
The present invention selects water content to be 3-5wt%, particle diameter is≤75 μm, preferably 10 μm ＜ D90＜ 20 μm, the most flat
All particle diameter D90For 12-18 μm, most preferably mean diameter D90Be the ginseng under forest micropowder of 15 μm be due to this particle size range
Micropowder grinding particle size be evenly distributed, also without fibre composition.Grain size analysis report shows that under this particle diameter, ginseng under forest is
Reach Cellular Level Pulverizing, and study the dissolution showing the effective ingredient such as the total saponins of each pulverizing rank, crude polysaccharides with
The grinding particle size of ginseng under forest is relevant, and grinding particle size is the least, and dissolution time is the fastest, i.e. dissolution (rate) is the biggest.Instantaneous
(1min) Comparison of experiment results of dissolution shows, the effective ingredient dissolution rate of ginseng under forest IV level powder is very rapid,
Dissolution can be realized fast, effective fast purpose.In actual production, control the particle diameter of ginseng under forest powder at 10 μm ＜ D90
＜ 20 μm, mean diameter D90Preferably 15 μm (i.e. ginseng under forest IV level powder) just fully achieve drug effect and cost
Doulbe-sides' victory in terms of control.
The above is only the preferred embodiment of the present invention, it is noted that for the common skill of the art
For art personnel, under the premise without departing from the principles of the invention, it is also possible to make some improvements and modifications, these improve
Also present disclosure is should be regarded as with retouching.
Claims (10)
1. a ginseng under forest pure powder tablet, it is characterised in that formed by ginseng under forest micropowder tabletting.
Ginseng under forest pure powder tablet the most according to claim 1, it is characterised in that described ginseng under forest micropowder aqueous
Amount is 3-5wt%, preferably 4.5wt%.
Ginseng under forest pure powder tablet the most according to claim 1 or claim 2, it is characterised in that described ginseng under forest micropowder
Particle diameter is≤75 μm, preferably mean diameter D90It is 10 μm ＜ D90＜ 20 μm, more preferably D90For 12-18 μm, optimum
Select D90It is 15 μm.
4. the method preparing the arbitrary described ginseng under forest pure powder tablet of claim 1-3, it is characterised in that remove woods
After the earth of lower SHANSHEN surface, 60 DEG C are dried after 48 hours and cut into slices, then proceed to 60 DEG C be dried to water content be 3-5wt%,
Preferably 4.5wt%, is ground into coarse powder by the section of dried ginseng under forest, and coarse powder then is ground into≤the particle diameter of 75 μm
(preferably D90＜ 20 μm, more preferably mean diameter D90For 12-18 μm, most preferably mean diameter D90Be 15 μm) woods
Tabletting after lower SHANSHEN micropowder, i.e. obtains described ginseng under forest pure powder tablet.
Method the most according to claim 4, it is characterised in that the most also use ozone sterilization.
6. according to method described in claim 4 or 5, it is characterised in that described tabletting can use direct compression technique,
Secondary or repeatedly tablet forming technique can also be used, it is also possible to use dry granule tabletting technique or wet granulation tablet forming technique；
Preferably first carry out precompressed before tabletting.
Method the most according to claim 6, it is characterised in that described direct compression technique is: direct with tablet machine
Ginseng under forest micropowder is pressed into sheet, and wherein, preload pressure is 0.5-2.0kN, and principal pressure is 35-55kN；Preload pressure
The preferred 45kN of preferably 1.2kN, principal pressure.
Method the most according to claim 6, it is characterised in that described secondary or repeatedly tablet forming technique be: use tabletting
After ginseng under forest micropowder is directly pressed into sheet by machine, it is crushed to cross 50-100 mesh sieve, again tabletting, is secondary tabletting；
The step of tabletting-pulverizing-again tabletting is repeated several times, is repeatedly tabletting；Precompressed can be all carried out before each tabletting,
Only can also carry out precompressed before first time tabletting, preload pressure is 10-18kN, principal pressure is 15-28kN；Precompressed pressure
The preferred 17kN of power, the preferred 20kN of principal pressure.
Method the most according to claim 6, it is characterised in that described dry granule tabletting technique is: by sylvan life mountain
Ginseng micropowder is first pressed into embryo sheet, be then crushed to can mistake 50-100 mesh sieve, then tabletting, described in be pressed into embryo sheet or tabletting
Pressure be 15-28kN (the preferred 20kN of pressure)；
Can carry out precompressed before tabletting and/or before being pressed into embryo sheet, preload pressure is that (preload pressure is preferred for 10-18kN
17kN)。
Method the most according to claim 6, it is characterised in that described wet granulation tablet forming technique is: by sylvan life
After SHANSHEN micropowder volumn concentration is ethanol (preferably 20-35%, the most preferably 30%) pelletize of 0-40%, cross 50-80
Mesh sieve, 60-80 DEG C of dry 1-1.5h is 8-12wt% to water content, then tabletting；Precompressed can be carried out, in advance before tabletting
Pressure pressure is 10-18kN, principal pressure is 15-28kN；The preferred 17kN of preload pressure, the preferred 20kN of principal pressure.
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| CN102805345A (en) * | 2012-08-13 | 2012-12-05 | 吉林省和升圆生物科技有限公司 | Ginseng oral tablet and production process thereof |
| CN103463151A (en) * | 2013-08-15 | 2013-12-25 | 吉林省和升圆生物科技有限公司 | Method for producing pure mountain ginseng lozenge |
| CN103784487A (en) * | 2014-03-07 | 2014-05-14 | 山东东阿阿胶股份有限公司 | Ginseng micro-powder tablet and preparation method thereof |
| KR20140087657A (en) * | 2012-12-31 | 2014-07-09 | 주식회사 풀무원 | Composition for improving hepatic function comprising powder of Panax ginseng cultured by hydroponics |
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Patent Citations (4)
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|---|---|---|---|---|
| CN102805345A (en) * | 2012-08-13 | 2012-12-05 | 吉林省和升圆生物科技有限公司 | Ginseng oral tablet and production process thereof |
| KR20140087657A (en) * | 2012-12-31 | 2014-07-09 | 주식회사 풀무원 | Composition for improving hepatic function comprising powder of Panax ginseng cultured by hydroponics |
| CN103463151A (en) * | 2013-08-15 | 2013-12-25 | 吉林省和升圆生物科技有限公司 | Method for producing pure mountain ginseng lozenge |
| CN103784487A (en) * | 2014-03-07 | 2014-05-14 | 山东东阿阿胶股份有限公司 | Ginseng micro-powder tablet and preparation method thereof |
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| CN109662990A (en) * | 2019-01-29 | 2019-04-23 | 韩佳妹 | A kind of Dong ling cao tablet process of preparing |
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Address after: 134400 No.22 Changbai street, Changbai Town, Changshan City, Jilin Province Patentee after: Jilin xuanshang Changbai ginseng industry Co.,Ltd. Address before: 264670 No. 39 Science and Technology Avenue, Yantai High-tech Zone, Shandong Province Patentee before: Jilin Linxia Caotang ginseng industry Co.,Ltd. |