CN105832791B - A kind of ginseng under forest pure powder tablet and preparation method thereof - Google Patents

A kind of ginseng under forest pure powder tablet and preparation method thereof Download PDF

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CN105832791B
CN105832791B CN201610345302.1A CN201610345302A CN105832791B CN 105832791 B CN105832791 B CN 105832791B CN 201610345302 A CN201610345302 A CN 201610345302A CN 105832791 B CN105832791 B CN 105832791B
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tablet
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tabletting
ginseng under
ginseng
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CN105832791A (en
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李桂生
解飞霞
潘丽丽
初红梅
修丽杰
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Jilin Xuanshang Changbai Ginseng Industry Co ltd
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JILIN CHANGBAI LVYE GINSENG INDUSTRY Co Ltd
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
    • A61K36/258—Panax (ginseng)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/15—Preparation or pretreatment of starting material involving mechanical treatment, e.g. chopping up, cutting or grinding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/10—Preparation or pretreatment of starting material
    • A61K2236/17—Preparation or pretreatment of starting material involving drying, e.g. sun-drying or wilting

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Abstract

The invention discloses a kind of ginseng under forest pure powder tablets and preparation method thereof, are made of ginseng under forest micro mist, preparation method are as follows: removal surface soil, it is dry sliced, continuing drying to water content is 3-5%, is ground into coarse powder, then is ground into tabletting after the ginseng under forest micro mist that partial size is≤75 μm.Ginseng under forest pure powder tablet of the invention does not add any auxiliary material, tabletted；Its dissolution rate is very high, and dissolution time is fast, can guarantee within the shortest time, and active pharmaceutical ingredient reaches the blood concentration for the treatment of disease.The pure powder tablet piece type appearance extruded with the method for the present invention is good, and pitted skin rate and sliver rate are low, and tablet hardness and disintegration meet tablet quality requirement.

Description

A kind of ginseng under forest pure powder tablet and preparation method thereof
Technical field
The present invention relates to medicine and health product technology fields, more particularly to a kind of ginseng under forest pure powder tablet and its preparation side Method.
Background technique
Ginseng is the drying root and rhizome of Araliaceae ginseng (Panax ginseng C.A.Meyer).According to ginseng Growth pattern difference can be divided into wild ginseng, ginseng under forest, garden ginsent etc..Due to the widespread demand in market and being on the verge of for wild ginseng Extinction, ginseng under forest and garden ginsent are the main sources of ginseng crude drug in the market at present.Ginseng under forest is by the kind Ziren of wild ginseng Work sowing is in virgin forest, without any Human disturbance, gives free rein to grow 15-20, goods is made in excavation, and ginseng under forest is raw The long time limit is higher, and nutritive value is higher, can match in excellence or beauty with wild ginseng.The growth conditions of ginseng under forest is extremely harsh, to the strongly fragrant of forest The gradient of degree of closing and soil quality and forest, direction etc. have strict requirements；With the development of ginseng under forest industry, to forest The consumption of resource is very huge, and the area of woods for ginseng under forest retention is fewer and fewer at present, joins hayashishita of the age at 15 years or more Wild ginseng quantity is even more rareness, and it is even more rare that 20 years seeds broadcast ginseng under forest.
With the acceleration of people's life rhythm, the preservation of fresh ginseng and conventional use (as decocted) are unable to satisfy current consumption Processing of Panax ginseng is ginseng product, had not only facilitated storage, transport and use, but also can improve the utilization rate of ginseng by the demand of person.It is existing Ginseng product be mainly drying whole ginseng, slice ginseng, Panax Capsule or tablet etc., wherein the use of ginseng tablet is most extensive.It is logical In normal situation, the auxiliary material that be first suitable for according to the property of drug and clinical application requirement selection when preparing tablet adds by mixing Work makes it have good mobility and compressibility.Filler and adhesive are the key that tablettings when direct tablet compressing, determine piece Can agent qualified.Filler and adhesive are then even more important as excipient when wet granule compression tablet.
It is typically necessary in the preparation process of ginseng tablet after other auxiliary material figurations are added at present, then carries out tabletting.No matter It is Ginseng Root Powder or Radix Ginseng extractum, Radix Ginseng extractum's powder etc., it all can be by addition auxiliary material to improve powder, medicinal extract or extract powder Certain performances, so that the tablet extruded meets correlated quality requirement.
With special favor of the consumer to pure natural and no added product in recent years, exploitation 100% is pure natural not to be added The preparation of any auxiliary material becomes the new hot spot of drug and health care product.
However, in the pure powder tableting processes made of ginseng under forest, show as that powder diameter is smaller, and dissolution time is faster, But powder diameter is smaller, and surface tension is bigger, between gap it is bigger, can not directly use the pure powder tabletting of ginseng under forest or granulation, Needing to add auxiliary material improves its mobility and compressibility.And the volatilization in the granulating process of Conventional fluidization bed, in ginseng under forest Property lost at branch, it is also desirable to be added auxiliary material carry out figuration, to improve mobility, the water content of particle, to guarantee tabletting matter Amount.Therefore up to the present, it yet there are no the report that tablet is directly prepared with the pure powder of ginseng under forest.
Summary of the invention
The purpose of the present invention is be directed to technological deficiency existing in the prior art, on the one hand, provide one kind be not added with it is any The ginseng under forest pure powder tablet of auxiliary material is formed by ginseng under forest micro mist tabletting.
The water content of the ginseng under forest micro mist is 3-5wt%, preferably 4.5wt%.
The partial size of the ginseng under forest micro mist is≤75 μm, preferably average grain diameter D90For 10 μm of < D9020 μm of <, more preferably D90It is 12-18 μm, most preferably D90It is 15 μm.
Second aspect, the present invention provides a kind of methods for preparing above-mentioned ginseng under forest pure powder tablet, remove ginseng under forest table After the soil of face, 60 DEG C are sliced after drying 48 hours, and then proceeding to 60 DEG C of dryings to water content is 3-5wt%, preferably 4.5wt%, Ginseng under forest slice after drying is ground into coarse powder, then coarse powder is ground into≤75 μm of partial size (preferably D90It is 20 μm of <, more excellent Select average grain diameter D90It is 12-18 μm, most preferably average grain diameter D90Be 15 μm) ginseng under forest micro mist after tabletting to get to described Ginseng under forest pure powder tablet.
Ozone sterilization is also used after compression.
Direct tablet compressing technique can be used in the tabletting, can also be using secondary or multiple tablet forming technique, can also be using dry Method is granulated tablet forming technique or wet granulation tablet forming technique；It is preferred that first carrying out precompressed before tabletting.
The direct tablet compressing technique are as follows: ginseng under forest micro mist is directly pressed into piece with tablet press machine, wherein preload pressure is 0.5-2.0kN, principal pressure 35-55kN；The preferred 1.2kN of preload pressure, the preferred 45kN of principal pressure.
Described secondary or multiple tablet forming technique are as follows: after ginseng under forest micro mist is directly pressed into piece with tablet press machine, be crushed to energy 50-100 mesh is crossed, again tabletting, as secondary tabletting；Be repeated several times tabletting-crushing-again tabletting the step of, as repeatedly Tabletting；Precompressed can be all carried out before each tabletting, and precompressed, preload pressure 10- can also be only carried out before first time tabletting 18kN, principal pressure 15-28kN；The preferred 17kN of preload pressure, the preferred 20kN of principal pressure.
The dry granule tabletting technique are as follows: ginseng under forest micro mist is first pressed into embryo piece, 50- can be crossed by being then crushed to 100 meshes, then tabletting, the embryo piece or the pressure of tabletting of being pressed into is 15-28kN (the preferred 20kN of pressure)；
Precompressed can be carried out before tabletting and/or before being pressed into embryo piece, preload pressure is that (preload pressure is preferred by 10-18kN 17kN)。
The wet granulation tablet forming technique are as follows: by ginseng under forest micro mist with volumn concentration be 0-40% alcohol it is (excellent 20-35% is selected, after most preferably 30%) being granulated, crosses 50-80 mesh, 60-80 DEG C of dry 1-1.5h to water content is 8-12wt%, Tabletting again；Precompressed, preload pressure 10-18kN, principal pressure 15-28kN can be carried out before tabletting；The preferred 17kN of preload pressure, The preferred 20kN of principal pressure.
Compared with prior art, the beneficial effects of the present invention are:
Ginseng under forest pure powder tablet of the invention is suppressed by pure ginseng under forest micro mist, does not add any auxiliary material；Its Taste is slightly sweet, without bitter taste, and dissolution rate is high, and dissolution time is fast, can guarantee within the shortest time, and active pharmaceutical ingredient reaches similar The blood concentration that product can reach.The pure powder tablet piece type appearance extruded with the method for the present invention is good, and pitted skin rate and sliver rate are low, piece Agent hardness and disintegration meet tablet quality requirement.The present invention is with the tabletting of ginseng under forest micro mist compared with ginseng under forest extract tabletting Preparation cost it is low, but also effective component is lost when can prevent from extracting, and preparation process is simpler.Ginseng under forest of the invention Pure powder tablet taste is slightly sweet, returns flavor sweet, with fresh ginseng, can be used as lozenge and takes, passes through oral mucosa combination gastrointestinal tract Approach absorb, quickly enter the effective component in ginseng under forest micro mist in vivo, can overcome the first pass effect of liver, improve treatment Effect, and dose can be made to reduce, the meaning of clinical meaning and the utilization of resources is very great.
Specific embodiment
There is the report (Publication No. 104257710A) of preparation pure wild ginseng powder piece method at present, will be freeze-dried to aqueous It is 5-20 μm (average grain diameter is 10 μm) that the wild ginseng that amount is 5.5wt% or more, which is crushed to partial size, then through dry granulation tabletting work Pure powder tablet is made in skill.But inventor study discovery the wild ginseng in the document is substituted for ginseng under forest after, with its technique without Method obtains ginseng under forest pure powder tablet.Because of the ginseng under forest micro mist surface that average grain diameter is 10 μm, water content is 5.5wt% or more Tension is very big, and gap is very big between powder, therefore, can not be by its direct tablet compressing with existing method, and needing to add auxiliary material improves its stream Dynamic property and compressibility；When being pelletized with Conventional fluidization bed, it is also desirable to auxiliary material be added and carry out figuration to it, improve mobility of particle, contain Water, just can be reduced the loss of the volatile component in ginseng under forest, while guarantee tablet quality.But after being added to auxiliary material, meeting There is drug and mix unevenness with auxiliary material, the defect of the content inaccuracy of tablet Chinese traditional medicine effective component can also be forced to take when taking Under do not play the auxiliary material of drug effect, increase the burden of the organs such as liver, kidney, diabetic may be will limit, hepatic and kidney function obstacle is suffered from The use of person.In addition, the wild ginseng micro mist is to crush to obtain after being freeze-dried by wild ginseng, the production of the pure wild ginseng powder piece, It is required to cryogenic freezing (room temperature is all not all right) in the overall processes such as transport, storage, otherwise the serious bitter taste of product, influences to take.So And be freeze-dried and need special equipment, it involves great expense, equipment operation is maintained to need special refrigerant, increase cost, and is dry Time is long, and production efficiency is low；The low temperature environment of production, transport and storage process also increases the cost of product, is not easy to make With.
Inventor gropes to obtain a kind of method for preparing ginseng under forest pure powder tablet by many experiments, and this method is to grow year It is raw material, full of nutrition, rare preciousness that the seed for being limited to 15-20, which broadcasts ginseng under forest,.This method specifically: pick good hayashishita Wild ginseng removes surface soil, is put into drying in 60 DEG C of air dry ovens and is sliced after 48 hours, 60 DEG C of forced air dryings are put back to after slice Continuing drying to water content in case is 3-5wt%, the ginseng under forest slice after drying is then ground into coarse powder, then coarse powder is passed through Pulverizing into partial size is≤75 μm of (preferably 10 μm of < D9020 μm of <, more preferable average grain diameter D90It is 12-18 μm, it is most preferably flat Equal partial size D90Be 15 μm) ginseng under forest micro mist after tabletting, finally by tablet ozone sterilization to get arrive hayashishita mountain of the invention Join pure powder tablet.It is not added with the auxiliary materials such as any lubricant, disintegrating agent in the preparation process in accordance with the present invention, ginseng under forest micro mist is gained The sole component of tablet.
Ginseng under forest pure powder tablet proposed by the present invention is to use water content for 3-5wt%, and partial size is≤75 μm (preferably 10 μm < D9020 μm of <, more preferable average grain diameter D90It is 12-18 μm, most preferably average grain diameter D90Be 15 μm) ginseng under forest micro mist can , can also be by secondary or multiple tablet forming technique by direct tablet compressing technique, it can also be by dry granule tabletting technique or wet Method is granulated tablet forming technique tabletting and obtains, and pressing step can also be used before tabletting, is conducive to exclude the air in powder, reduce Sliver increases the hardness of tablet.
Wherein, above four kinds of methods specifically includes the following steps:
Method one: direct tablet compressing technique, i.e. direct power compressing method obtain ginseng under forest micro mist direct tablet compressing.
Method two: secondary or multiple tablet forming technique, i.e., after ginseng under forest micro mist being pressed direct power compressing method tabletting, then powder It is broken to after capable of crossing the powder of 50-100 mesh, tabletting again, as secondary tabletting；If tablet quality does not reach requirement, or in order to Tablet hardness is further adjusted, the step is repeated several times in tabletting again after can crushing the micropowder tablet after secondary tabletting, until producing Product conform to quality requirements, as multiple tabletting；Under normal circumstances, secondary tabletting can just make the yield rate, hardness, pitted skin of tablet The indexs such as rate, sliver rate reach requirement.
Method three: dry granule tabletting technique after ginseng under forest micro mist is pressed into big sheet or plate embryo piece, crushes Tabletting again after to the powder that can cross 50-100 mesh；If tablet quality does not reach requirement, the step is repeated several times, until tablet Quality reaches requirement.
Method four: wet granulation tablet forming technique, i.e., the alcohol for being 0-40% with volumn concentration by ginseng under forest micro mist (0% refer to be granulated with water) is granulated (alcohol of 1kg ginseng under forest micro mist 80-200ml is granulated), crosses 50-80 mesh, 60-80 DEG C of dry 1-1.5h, after drying to water content is 8-12wt%, tabletting to obtain the final product；It is preferred that with 20-35% (v/v), most preferably It is granulated with the alcohol of 30% (v/v).
In order to exclude the air in micro mist in tabletting, reduces sliver, increases hardness, precompressed step can be increased before tabletting Suddenly.It is different and different that preload pressure and principal pressure (pressure when tabletting) regard specific tablet forming technique.For the direct pressure of method one Blade technolgy, preload pressure is between 0.5-2.0kN, and principal pressure is between 35-55kN；It is preferred that preload pressure is 1.2kN, principal pressure For 45kN.For the secondary or multiple tablet forming technique of method two, pressing step can be used before each tabletting, can also only be existed Pressing step is used when first time tabletting；Preload pressure between 10-18kN, principal pressure is between 15-25kN；It is preferred that precompressed pressure Power is 17kN, principal pressure 20kN.For the dry granule tabletting technique of method three, before big sheet or plate embryo piece and/or press Can exclude the air in micro mist before piece by precompressed, preload pressure between 10-18kN, principal pressure is between 15-25kN；It is excellent To select preload pressure be 17kN, principal pressure 20kN.Compacting is directed to the wet granulation tablet forming technique of method four, can also lead to before tabletting Cross precompressed and exclude air in micro mist, preload pressure between 10-18kN, principal pressure is between 15-25kN；It is preferred that preload pressure For 17kN, principal pressure 20kN.
Below in conjunction with specific embodiment, the content of the present invention will be explained in more detail, and the present invention is further elaborated, but These embodiments limit the invention absolutely not.
Ginseng under forest pure powder tablet of the invention is prepared by above four kinds of methods, tablet format 0.35g/ piece, 100, Then the mass parameter for the ginseng under forest pure powder tablet tested, the mass parameter of the technological parameter of method and obtained tablet See 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 average grain diameter D90It is 5 μm, water content is that the ginseng under forest micro mist of 5.5wt% is suppressed obtained tablet by method two；Comparative example 2 is with average grain Diameter D90It is 10 μm, water content is that the ginseng under forest micro mist of 5.5wt% is suppressed obtained tablet by method three；Comparative example 3 is with public affairs The number of opening is the wild ginseng submicron powder sheet that method obtains in the patent document of CN102783642A.
The technological parameter of 1 the method for the present invention of table and obtain the mass parameter of tablet
The technological parameter of 2 the method for the present invention four of table and obtain the mass parameter of tablet
One, the screening of ginseng under forest pure powder tablet preparation process
Example one, direct tablet compressing technique:
1. raw material: ginseng under forest micro mist, average grain diameter D90It is 15 μm；Water content is 4.5wt%.
2. tablet press machine preload pressure 1.2kN, principal pressure 45kN.
3. micro mist is sent into tablet press machine, using pole type impeller blanking device, to increase the mobility of medicinal powder.
Ginseng under forest micro mist is directly compressed into tablet under above-mentioned process conditions, tablet format 0.35g/ piece, 100.
Example two, secondary tablet forming technique:
1. raw material: ginseng under forest micro mist, average grain diameter D90It is 15 μm；Water content is 4.5wt%.
2. first time tabletting preload pressure 17kN, principal pressure 20kN；Second of tabletting preload pressure 17kN, principal pressure 20kN。
3. micro mist is sent into tablet press machine, using pole type impeller blanking device, to increase the mobility of medicinal powder.
Under above-mentioned process conditions, the first piece that average hardness is 2.57Kg is made in tabletting for the first time, and (first piece specification is about 0.35g/ piece), then the powder crushed as that can sieve with 100 mesh sieve, tabletted using above-mentioned process conditions again, tablet format 0.35g/ piece, 100.
Example three, dry granulation tablet forming technique:
1. raw material: ginseng under forest micro mist, average grain diameter D90It is 15 μm；Water content is 4.5wt%.
2. tablet press machine suppresses big sheet or plate embryo piece, preload pressure 17kN, principal pressure 20kN；It is pre- when tabletting after crushing Pressure pressure 17kN, principal pressure 20kN.
3. micro mist is sent into tablet press machine, using pole type impeller blanking device, to increase the mobility of medicinal powder.
Under above-mentioned process conditions, after ginseng under forest micro mist is compressed into big sheet or plate embryo piece first, crush, whole grain To 50 meshes can be crossed, use above-mentioned process conditions tabletted again, tablet format 0.35g/ piece, 100.(big sheet embryo piece Heavy-duty tabletting press can be used, ginseng under forest micro mist is pressed into the embryo piece that diameter is about 20-25mm；Rolling can be used in plate embryo piece Method preparation.)
Example four, wet granule compression tablet technique:
1. raw material: ginseng under forest micro mist, average grain diameter D90It is 15 μm；Water content is 4.5wt%.
2. preload pressure 17kN when tabletting machine, principal pressure 20kN.
3. micro mist is sent into tablet press machine, using pole type impeller blanking device, to increase the mobility of medicinal powder.
Under above-mentioned process conditions, ginseng under forest micro mist is granulated first with the alcohol of 30% (v/v), crosses 70 mesh Sieve, at 60-80 DEG C dry 1-1.5h to water content be 10%, tablet format tabletted using above-mentioned process conditions 0.35g/ piece, 100.
Ginseng under forest pure powder tablet of the invention is prepared by the method for example one to four, the hayashishita mountain then tested Join the mass parameter of pure powder tablet, technological parameter and mass parameter are shown in Table 3.
The four kinds of tablet forming technique parameters and mass parameter of 3 example one to four of table (in terms of 100 tablets)
Four kinds of methods of application example one to four, which can be made, it can be seen from the data of table 3 meets the quality standard Ginseng under forest pure powder tablet, but the resulting tablet of these four tablet forming techniques is in quality or distinct: direct tablet compressing work The tablet yield rate that skill obtains is relatively low, and it is small etc. that discrete piece, shedding, chip off-falling, sliver, loose pieces, hardness easily occurs in obtained tablet Problem.Compared with direct tablet compressing technique, what secondary tablet forming technique, dry granule tabletting technique and wet granulation tablet forming technique obtained Tablet is significantly better than the tablet that example one obtains, the piece that these three techniques obtain in terms of appearance in terms of hardness, sliver rate Agent pitted skin and sliver degree are considerably less than the resulting tablet of direct tablet compressing technique.Three kinds of techniques in comparative example two to four, can Know that secondary tablet forming technique and the resulting tablet quality of wet granulation tablet forming technique are better than the tablet that dry granule tabletting technique obtains, Especially in terms of yield rate, pitted skin rate and sliver rate, it is superior to the tablet that example three obtains.
To sum up, preparation method is simple by the present invention, and site technique workflow reengineering is convenient, and feasibility is strong, and application prospect is wide It is wealthy.
Two, the determination of ginseng under forest micro mist water content
Influence of the water content to tabletting is very big in conventional micro mist tabletting: the excessively high easy sticking of water content cannot continuously give birth to It produces, numb piece rate is high, and chip off-falling is unable to get the complete tablet of shape；And water content it is low easily occur discrete piece, shedding, sliver, loose pieces, The problems such as hardness is small, thus water content it is low or it is high usually be all not easy it is tabletted.
The water content of wild ginseng micro mist is higher in existing document, when being used for ginseng under forest micro mist, due to raw material difference, property Shape and the effective component contained are different, need to be adjusted.
For present invention ginseng under forest pure powder tablet to be provided, inventor is in the screening process of tablet forming technique, discovery The moisture content of ginseng under forest micro mist is to influence tablet quality very important parameter.The control of ginseng under forest micro mist moisture is bad, Finished product rate is low, hardness, and pitted skin rate, sliver rate is unqualified, can not industrially apply.
In the present invention, the water content of ginseng under forest micro mist is more suitable for compressed tablets in 3-5wt%.If moisture content is low It will appear the situations such as sliver, disintegrating tablet when 3wt%, after tabletting, if moisture content is higher than 5wt%, piece embryo is easy to change after tabletting, face Color is deepened, and is in yellowish-brown, there is point and blackspot, and tarnish reasons are that effective component is precipitated, and cannot reach the appearance requirement of tablet, and And also have an impact to subsequent packages, be unfavorable for industrial operation, thus need to control the water content of ginseng under forest micro mist 3-5wt% it Between, it can just obtain qualified pure powder tablet.
It is obtained in test of the ginseng under forest micro mist water content to the influence of tablet quality according to inventor, works as ginseng under forest When powder moisture is about 4.5%, tablet yield rate obtained by compacting is high, and quality is stablized, and complies with standard, also reaches subsequent packages Etc. the quality requirements such as product hardness, disintegration needed for processing modes.
Three, the screening of ginseng under forest grain size of micropowder
Below by way of active principle the amount of dissolution experiment screening hayashishita mountain in the ginseng under forest micro mists for measuring different crushing ranks Join the particle size distribution range of micro mist.By ginseng under forest by size reduction to five ranks: I grades are 150 μm≤D90≤ 350 μm, II Grade is 80 μm≤D90≤ 100 μm, III level is 38 μm≤D90≤ 58 μm, IV grades are 12 μm≤D90≤ 18 μm, V grades of D90≤6.5μm。 Measure respectively this five crushing rank ginseng under forest micro mist in effective component dissolution rate (effective component be mainly total saposins and Thick many candies).Difference crushes the dissolution rate of effective component at any time in the ginseng under forest micro mist of rank and is shown in Table 4 and table 5.
1, the measurement of total saposins
Precision weighs each 5g of ginseng under forest micro mist that crushing rank is I, II, III, IV, V grades, and (every group sets Duplicate Samples, makes even Mean value), it adds diethyl ether after flowing back degreasing, discards ether solution, residue volatilizes ether, sets in triangular flask, add distilled water 100ml, It is placed in refluxing extraction in boiling water bath, respectively in 1,5,10,30,60,90,120min sampling, 50ml extracting solution is taken, is saturated with water Extracting n-butyl alcohol saponin(e, is dissolved after being evaporated with methanol, and ginsenoside can develop the color with sulfuric acid-vanillic aldehyde, is measured in 544nm wavelength Absorption value, difference crush the amount of dissolution (g) of total saposins at any time in the ginseng under forest micro mist of rank, the results are shown in Table 4.
The amount of dissolution (g) of total saposins at any time in the different ginseng under forest micro mists for crushing rank of table 4
The result of table 4 is but different it is found that the total saposins dissolution rate for respectively crushing rank is stepped up with the extension of dissolution time The amount of dissolution for crushing total saposins in the ginseng under forest micro mist of rank is different.Wherein, ginseng under forest V grades of micro mists are in instantaneous dissolution rate Than the other groups dissolutions of (when 1min) and later each time point are rapid, and compared to other in the dissolution time section of 1-90min Group is always maintained at highest the amount of dissolution.The amount of dissolution of each group tends towards stability after 90min.
2, the measurement of Thick many candies
With the dry molecular weight to constant weight for 5 × 105Glucan be control, precision weigh crush rank be I, II, III, IV, V grades of each 3.0g of ginseng under forest micro mist, with (60 DEG C) extraction Thick many candies of water extraction and alcohol precipitation method, respectively 1min, 10min, 30min and 60min sampling, sets constant volume in 50ml volumetric flask, shakes up.Different crushing ranks are measured using phenolsulfuric acid method The dissolution rate (%) of Thick many candies, the results are shown in Table 5 in ginseng under forest micro mist.
The dissolution rate (%) of Thick many candies at any time in the different ginseng under forest micro mists for crushing rank of table 5
Table 5 the result shows that, each Thick many candies dissolution rate for crushing rank is stepped up with the extension of dissolution time, and difference crushes The dissolution rate of Thick many candies is different in the ginseng under forest micro mist of rank, wherein V grades of ginseng under forest micro mists dissolution rate in 1min is just 1.55%, quickly, in 30min, dissolution rate is 18.74%, and I grades of ginseng under forest micro mists dissolution rate in 30min is then for dissolution 10.26%, II grades are 13.46%, and III level 16.72% is significantly lower than V grades of ginseng under forest micro mists, dissolution when 60min Degree still keeps this rule, but V grades equal in the entire experiment process with the Thick many candies dissolution rate difference of IV grades of ginseng under forest micro mists Very little, and difference is not significant.
From in table 4 and table 5 as can be seen that crush rank be I grades, II grades, have in III level and IV grades of ginseng under forest micro mist The dissolution rate significant difference of ingredient is imitated, is presented crush rank higher, the amount of dissolution or the higher trend of dissolution rate, however this trend Terminate to V grades, in V grades of ginseng under forest micro mist the dissolution rate of effective component with IV grades there was no significant difference, it is contemplated that Cheng Benyuan Ginseng under forest is crushed to IV grades in practical operation by cause.
The result of table 4 and table 5 is also shown that dissolution rate is very when the crushing rank of ginseng under forest micro mist is IV grades Rapidly, in the case where the dissolution of the ingredients such as the Thick many candies of I grades and II grades groups is less, IV grades of groups can also have the molten of mass efficient ingredient Out.From whole comparison, IV grades of ginseng under forest micro mist group ratio I, II, III level groups are higher by 2-3 times substantially in the amount of dissolution.Due to micro- Powder has extremely strong dissolution permeance property, and dissolution rate is improved largely in other coarse powder of 60min internal ratio, especially 1min- It is significantly improved in 30min, therefore ginseng under forest pure powder tablet of the invention both can also pass through oral cavity with traditional oral with oral cavity is buccal Mucosa absorption effective component, make the effective component of ginseng under forest discharged rapidly in limited digestion time and enter in vivo, from And curative effect is improved, and dose can be made to reduce at double due to not adding any auxiliary material.
Four, screening of the ginseng under forest grain size of micropowder in preparation process
Below by way of the different ginseng under forest micro mists for crushing rank are measured in preparation process to the influence of tablet quality, sieve Select the particle size distribution range of ginseng under forest micro mist.Not due to I grades and II grades of ginseng under forest micro mist effective component result of extraction It is good, therefore select in the screening of tablet technique the ginseng under forest micro mist for crushing that rank is III level, IV grades and V grades: III level is 38μm≤D90≤ 58 μm, IV grades are 12 μm≤D90≤ 18 μm, V grades of D90≤6.5μm.Embodiment two and embodiment three is respectively adopted Tablet forming technique these three ginseng under forest micro mists for crushing ranks are pressed into tablet, and measure and obtain the quality of tablet.Using reality The tablet forming technique for applying example two obtains the quality results of tablet and is shown in Table 6, obtains the quality of tablet using the tablet forming technique of embodiment three It the results are 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 same process parameter, IV grades of ginseng under forest micro mists yield rate, It is significantly better than III level ginseng under forest micro mist in terms of hardness, pitted skin rate and sliver rate, but not bright with V grades of ginseng under forest micro mists Aobvious difference, or even in terms of pitted skin rate, IV grades are also significantly better than V grades, therefore, select IV grades of ginseng under forest micro- in tableting processes Powder.
Table 7 obtains the quality of tablet according to the tablet forming technique of embodiment three
As shown in Table 7, using same process parameter, IV grades of ginseng under forest micro mists yield rate, It is significantly better than III level ginseng under forest micro mist in terms of hardness, pitted skin rate and sliver rate, but not bright with V grades of ginseng under forest micro mists Aobvious difference, therefore, under the pressing process parameter that this experiment is selected, IV grades can be very with thinner V grade ginseng under forest micro mist It is good tabletted, in view of crushing cost in production, IV grades of ginseng under forest micro mists can be selected in tableting processes.
It is 3-5wt% that the present invention, which selects water content, partial size is≤75 μm, preferably 10 μm of < D90It is 20 μm of <, more preferably average Partial size D90It is 12-18 μm, most preferably average grain diameter D90Ginseng under forest micro mist for 15 μm is the micro mist powder due to the particle size range Broken even particle size distribution, also without fibre composition.Grain size analysis report shows that ginseng under forest has reached cell grade powder under the partial size It is broken, and research shows that respectively crush the dissolution rate of effective components and the crushing grains of ginseng under forest such as total saposins, the Thick many candies of rank Spend related, grinding particle size is smaller, and dissolution time is faster, i.e., dissolution rate (rate) is bigger.The instantaneously experimental result of (1min) dissolution rate Compare display, the effective component dissolution rate of IV grades of powder of ginseng under forest is very rapid, dissolution may be implemented fastly, quickly effective mesh 's.In actual production, the partial size of ginseng under forest powder is controlled in 10 μm of < D9020 μm of <, average grain diameter D90Preferably 15 μm (i.e. IV grades of powder of ginseng under forest) just fully achieve two-win in terms of drug effect and cost control.
The above is only a preferred embodiment of the present invention, it is noted that for the common skill of the art For art personnel, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications Also the contents of the present invention be should be regarded as.

Claims (17)

1. a kind of ginseng under forest pure powder tablet, which is characterized in that formed by ginseng under forest micro mist tabletting；The ginseng under forest micro mist Water content is 3-5wt%, the average grain diameter D of the ginseng under forest micro mist90It is 12-18 μm.
2. ginseng under forest pure powder tablet according to claim 1, which is characterized in that the water content of the ginseng under forest micro mist is 4.5wt%.
3. ginseng under forest pure powder tablet according to claim 1 or claim 2, which is characterized in that the average grain of the ginseng under forest micro mist Diameter D90It is 15 μm.
4. a kind of method for preparing any ginseng under forest pure powder tablet of claim 1-3, which is characterized in that removal ginseng under forest After the soil of surface, 60 DEG C are sliced after drying 48 hours, and then proceeding to 60 DEG C of dryings to water content is 3-5wt%, after drying Ginseng under forest slice is ground into coarse powder, then coarse powder is ground into average grain diameter D90For tabletting after 12-18 μm of ginseng under forest micro mist, Obtain the ginseng under forest pure powder tablet.
5. method according to claim 4, which is characterized in that also use ozone sterilization after compression.
6. method according to claim 4 or 5, which is characterized in that the tabletting uses direct tablet compressing technique, or using secondary Or multiple tablet forming technique, or use dry granule tabletting technique or wet granulation tablet forming technique.
7. method according to claim 6, which is characterized in that first carry out precompressed before tabletting.
8. method according to claim 7, which is characterized in that the direct tablet compressing technique are as follows: with tablet press machine directly by hayashishita Wild ginseng micro mist is pressed into piece, wherein preload pressure 0.5-2.0kN, principal pressure 35-55kN.
9. method according to claim 8, which is characterized in that preload pressure 1.2kN, principal pressure 45kN.
10. method according to claim 7, which is characterized in that described secondary or multiple tablet forming technique are as follows: with tablet press machine by woods After lower wild ginseng micro mist is directly pressed into piece, 50-100 mesh, again tabletting, as secondary tabletting can be crossed by being crushed to；Pressure is repeated several times Piece-crushing-again tabletting the step of, as multiple tabletting；Precompressed is all carried out before each tabletting, or only before first time tabletting Carry out precompressed, preload pressure 10-18kN, principal pressure 15-28kN.
11. method according to claim 10, which is characterized in that preload pressure 17kN, principal pressure 20kN.
12. method according to claim 7, which is characterized in that the dry granule tabletting technique are as follows: by ginseng under forest micro mist It is first pressed into embryo piece, 50-100 mesh, then tabletting can be crossed by being then crushed to, and the embryo piece or the pressure of tabletting of being pressed into is 15- 28kN；Precompressed, preload pressure 10-18kN are carried out before tabletting and/or before being pressed into embryo piece.
13. method according to claim 12, which is characterized in that pressure 20kN, preload pressure 17kN.
14. method according to claim 7, which is characterized in that the wet granulation tablet forming technique are as follows: by ginseng under forest micro mist After being granulated with the alcohol that volumn concentration is 0-40%, 50-80 mesh is crossed, 60-80 DEG C of dry 1-1.5h to water content is 8- 12wt%, then tabletting；Precompressed, preload pressure 10-18kN, principal pressure 15-28kN are carried out before tabletting.
15. 4 the method according to claim 1, which is characterized in that preload pressure 17kN, principal pressure 20kN.
16. 4 the method according to claim 1, which is characterized in that the volumn concentration of alcohol is 20-35%.
17. 6 the method according to claim 1, which is characterized in that the volumn concentration of alcohol is 30%.
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