CN108310119A - A kind of Herba Cistanches chewable tablets and preparation method thereof - Google Patents
A kind of Herba Cistanches chewable tablets and preparation method thereof Download PDFInfo
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- CN108310119A CN108310119A CN201810377587.6A CN201810377587A CN108310119A CN 108310119 A CN108310119 A CN 108310119A CN 201810377587 A CN201810377587 A CN 201810377587A CN 108310119 A CN108310119 A CN 108310119A
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- herba cistanches
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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)
- A61K36/64—Orobanchaceae (Broom-rape family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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)
- A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
- A61K36/605—Morus (mulberry)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
- A61K36/815—Lycium (desert-thorn)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/2022—Organic macromolecular compounds
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- 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
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- 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
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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Abstract
The invention discloses a kind of Herba Cistanches chewable tablets and preparation method thereof.The present invention will concentrate after ethyl alcohol recycling in extracting solution by extracting 250~350 mass parts fruits of Chinese wolfberry, the ethyl alcohol that 100~200 mass parts mulberries mass fractions are 20%, obtain thick paste；1~3 mass parts Aspartame is added in absolute ethyl alcohol and is suspended uniformly, suspension is obtained；110~120 mass parts casein sodiums, 650~750 mass parts Herba Cistanches powder and the thick paste, suspension are mixed evenly, granulation softwood is obtained, by the closed preservation of the softwood 1~3 hour；By after preservation softwood extrusion granulator, drying, after whole grain, obtain dry particl, by the dry particl and 8~12 mass parts Macrogol 6000 powder mixings, tabletting, obtain Herba Cistanches chewable tablets.Effective component higher contained by chewable tablets of the present invention, and each ingredient is not conflicted with each other, is influenced, and can more fully be absorbed by human body；Under the premise of equivalent effect, dosage smaller that needed by human body is taken；And be more easy to it is moulding, can be effectively moisture-proof, stability is high.
Description
Technical field
The invention belongs to traditional Chinese medicine health care product fields more particularly to a kind of Herba Cistanches chewable tablets and preparation method thereof.
Background technology
Herba Cistanches are a kind of parasitic plants colonizing in desert trees sacsaoul root, and nutrient and water are drawn from sacsaoul host
Point.It is known as the good reputation of " desert ginseng ", there is high medical value, be the rare traditional Chinese medicine of Chinese tradition.With China pair
The continuous expansion of the artificial growth scale of Herba Cistanches, the effective exploitation of the later application chewable tablets of Herba Cistanches will high degrees
The plantation income for expanding local farmer, improves economic well-being of workers and staff, while locals can also be excited to participate in the positive of desertification treatment
Property.
Herba Cistanches mouthfeel is more bitter, and the mouthfeel of chewable tablets determines that the compliance of user, the bad raw material of mouthfeel are difficult
It is taken by the way of chewing.Therefore, in the development process of existing Herba Cistanches invention chewable tablets, chewable tablets will not all be made
Form, it will usually use processing method：
(1) Herba Cistanches are directly extracted；
(2) by modes such as the taste conditioning agents of the various drug components stackings of heterozygosis, large dosage, oral solution, mouth are fabricated to
Take other preparations such as piece.
For the first above-mentioned processing method, removed containing benzyl carbinol glycoside, iridoid and its glycoside, polysaccharide in Herba Cistanches
Outside class main component, also contain lignanoids and its glycoside, trace element, alkaloids, phytosterol, organic acid and amino
The health-care effect of a variety of chemical compositions such as acids, Herba Cistanches is the coefficient result of these ingredients.It is molten due to each constituents
It is larger to solve behavioral difference, if using a certain solvent extraction Herba Cistanches, it is difficult to its functional component be extracted complete.If adopted
It finds to extract through preliminary experiment although than its functional component is preferably extracted with first ethyl alcohol extraction double formulations that water extracts again
Object yield is up to 76%, does not achieve the purpose that effectively reduce taking dose while increasing manufacturing cost.
For above-mentioned second of processing method, from the point of view of presentation, various very effective drug ingedients, mouthfeel are contained
Preferably.But the physicochemical property difference of ingredient is larger in Herba Cistanches, and under the premise of considering mouthfeel, the preparation of invention chewable tablets
The proportioning etc. of type, size, the stack manner of drug ingedient, drug ingedient, for example, oral tablet etc. is due to needing in a timing
Interior disintegration needs that more disintegrant is added, and may result in solution rate speed of the invention chewable tablets in gastro-intestinal Fluid and molten
Solution degree difference in size is larger, and the optimal site absorbed in the gastrointestinal tract is also not quite similar.
Existing Herba Cistanches product has ignored these factors, as a result causes many ingredients in Herba Cistanches that can not obtain really
It is effective to absorb.This is not only the waste of valuable ingredient of traditional Chinese medicine, but also consumer can not obtain practical curative effect.
Invention content
The purpose of the present invention is to provide a kind of Herba Cistanches chewable tablets, it is desirable to provide it is a kind of can be by the abundant efficient absorption of human body
The Herba Cistanches invention chewable tablets utilized.
It is still another object of the present invention to provide the preparation methods of above-mentioned Herba Cistanches chewable tablets.
The invention is realized in this way a kind of Herba Cistanches chewable tablets, which includes each component in parts by mass：
650~750 portions of Herba Cistanches, 250~350 portions of fruits of Chinese wolfberry, 100~200 portions of mulberry fruits, 110~120 parts of casein sodiums, 1~3 part
Aspartame and 8~12 parts of PEG6000.
Preferably, which includes each component in parts by mass：700 portions of Herba Cistanches, 300 portions of fruits of Chinese wolfberry, 150 parts
Mulberry fruit, 116 parts of casein sodiums, 2 parts of Aspartames and 10 parts of PEG6000.
The present invention further discloses the preparation methods of above-mentioned Herba Cistanches chewable tablets, and this approach includes the following steps：
(1) 250~350 mass parts fruits of Chinese wolfberry, 100~200 mass parts mulberries are carried with the ethyl alcohol that mass fraction is 20%
It takes, will be concentrated after ethyl alcohol recycling in extracting solution, obtain thick paste；1~3 mass parts Aspartame is added in absolute ethyl alcohol and is mixed
It is outstanding uniform, obtain suspension；
(2) by 110~120 mass parts casein sodiums, 650~750 mass parts Herba Cistanches powder and the thick paste, suspension
Liquid was mixed evenly, and obtains granulation softwood, by the closed preservation of the softwood 1~3 hour；
(3) by after preservation softwood extrusion granulator, drying, after whole grain, dry particl is obtained, by the dry particl and 8~12
Mass parts Macrogol 6000 powder mixing, tabletting, obtain Herba Cistanches chewable tablets.
In the present invention, the mouthfeel of chewable tablets determines that the compliance of user, the bad raw material of mouthfeel are difficult to adopt chewing
Mode take.Chewable tablets of the present invention is made of three kinds of Herba Cistanches, the fruit of Chinese wolfberry, mulberry fruit raw materials, except the mouthfeel of Herba Cistanches medicinal material is micro-
Puckery outer, two kinds of fruit of Chinese wolfberry, mulberry fruit medicinal materials are good in taste, and flavoring difficulty is little, can be made into mouthfeel not through a small amount of corrigent is added
Wrong preparation.
Furthermore chewable tablets is a kind of preparation taken by chewing, and preparation is after oral cavity is swallowed by chewing with fluid shape
Formula enters stomach and intestine, not the disintegrating procedue of oral tablet, and dissolution and the absorption stage of functional component, effect are directly entered in stomach
Ingredient rate of release is fast, and bioavilability is high.Chewable tablets of the present invention is made of three kinds of Herba Cistanches, the fruit of Chinese wolfberry, mulberry fruit raw materials, meat desert
In Rong except mainly containing benzyl carbinol glycosides, iridoid, lignanoid and their glycoside in addition to, also contain volatile ingredient, alkaloid, list
Terpene glycosides, polysaccharide, amino acid, inorganic microelement etc. still have the ingredients such as flavones, anthocyanidin in the fruit of Chinese wolfberry, mulberry fruit in addition to polysaccharide.This
The physicochemical property difference of a little ingredients is larger, and the solution rate speed and solubility difference in size in gastro-intestinal Fluid are larger, in stomach and intestine
The optimal site absorbed in road is also not quite similar.Chewable tablets can discharge rapidly functional component immediately under one's belt without disintegration,
Feature effect ingredient that physicochemical property difference can be made larger digestion different in absorption function during gastrointestinal peristalsis empties
Each section of road is fully absorbed.
In addition, oral tablet is disintegrated within a certain period of time due to needing, need that more disintegrant is added, and in the present invention
In, chewable tablets is taken by chewing, and without disintegrating procedue in stomach and intestine, disintegrant need not be added, although the dosage form needs to add
Enter a certain amount of corrigent, but corrigent dosage is much smaller than disintegrant dosage, thus this product select chewable tablets dosage form each taking
With both effectiveness object amount it is certain in the case of, be conducive to reduce taking dose.
Finally, chewable tablets of the present invention is taken by chewing, does not have to consider internal disintegration time, therefore use in the preparation
The pressure tabletting of bigger, surface soundness higher of the gained tablet than general oral tablet, interior porosity smaller, equal conditions
Under can improve the moisture absorption of tablet to a certain extent, be conducive to improve preparation stability.
Preferably, in step (1), the ethyl alcohol extraction is specially：It is 20% to use the fruit of Chinese wolfberry, mulberries with mass fraction
Ethyl alcohol extract 2 times, every time extraction 1.5 hours；Wherein, 8 times that ethyl alcohol used is the fruit of Chinese wolfberry and mulberries quality are extracted for the first time,
Second of extraction ethyl alcohol used is 6 times of the fruit of Chinese wolfberry and mulberries quality.
Preferably, in step (1), the concentration is specially：Two effect vacuum concentration equipments of extracting solution are recycled into ethyl alcohol
And concentrate, relative degree of vacuum 0.008Mp when concentration, extracting solution is reduced to D1.30/25 DEG C.
Preferably, in step (2), the Herba Cistanches powder is 120 mesh fine powders.
Preferably, in step (2), after obtaining granulation softwood, 1~2h is beaten after the granulation softwood is freezed, it will
After softwood after beating is warming up to room temperature, by the closed preservation of the softwood 1~3 hour.
Preferably, in step (3), the drying is specially：Wet granular is set into heated-air circulation oven, 40 DEG C of dryings
15min is warming up to 60 DEG C of dry 15min, then is warming up to 80 DEG C of dry 120min.
Preferably, the whole grain is specially：Dry particle is crossed into 20 mesh and 60 mesh sieve.
Preferably, the piece weight of the chewable tablets is 1g.The raw material dose of the present invention is set to takes Herba Cistanches 2.1 daily
Gram, fruit of Chinese wolfberry 0.9g, mulberry fruit 0.45g should be raw material 1.15g, wherein, Herba Cistanches each taking dosage to take daily 3 times
0.7g, fruit of Chinese wolfberry 0.3g, mulberry fruit 0.15g.In terms of each taking 1, since Herba Cistanches use crushing for the technique of fine powder, every
The 0.7g of fine powder containing Herba Cistanches, the fruit of Chinese wolfberry, mulberry fruit use extraction process, the extraction through determined extraction process as a result, it has been found that, prescription
Measure the fruit of Chinese wolfberry, mulberry fruit extract be no more than 0.2g, per tablet raw material be no more than 0.9g, if tablet format is set to every 1g,
Still there is certain auxiliary material addition space, therefore the specification of the chewable tablets is determined as 1g/ pieces.
The present invention overcomes the deficiencies of the prior art and provide a kind of Herba Cistanches chewable tablets and preparation method thereof.The present invention chews
Piece is made of three kinds of Herba Cistanches, the fruit of Chinese wolfberry, mulberry fruit raw materials, in addition to the mouthfeel micro-puckery of Herba Cistanches medicinal material, two kinds of fruit of Chinese wolfberry, mulberry fruit medicines
Material is good in taste, and flavoring difficulty is little, can be made into the pretty good preparation of mouthfeel through a small amount of corrigent is added, the chewable tablets is as chewing
The preparation taken enters stomach and intestine, not the disintegrating procedue of oral tablet, in stomach after oral cavity is swallowed by chewing with fluid form
In can discharge rapidly functional component immediately, be directly entered dissolution and the absorption stage of functional component, gastrointestinal peristalsis emptying mistake
Cheng Zhong, effect ingredient which can make physicochemical property difference larger are fully inhaled for each section in the different alimentary canal of absorption function
It receives, bioavilability is high.
The present invention carries out refluxing extraction by the fruit of Chinese wolfberry close with the ingredient solubility behavior of Herba Cistanches, mulberry fruit, not only exists
It is also advantageous to extract adhesive effect of the thick paste of gained in granulation, tabletting for the taking dose that chewable tablets can be reduced to a certain extent
In preparations shaping；Also, since viscosity is very big after concentration for the fruit of Chinese wolfberry, mulberry, rate of drying is slow, and material is heated
Time is longer, can not only shorten material heated time, but also can shorten process cycle.
In addition, chewable tablets of the present invention is taken by chewing, without disintegrating procedue in stomach and intestine, disintegrant need not be added,
Although the dosage form needs that a certain amount of corrigent is added, corrigent dosage is much smaller than disintegrant dosage, therefore chewable tablets of the present invention
In the case of certain each taking both effectiveness object amount, be conducive to reduce taking dose.
Finally, chewable tablets of the present invention is taken by chewing, does not have to consider internal disintegration time, therefore use in the preparation
The pressure tabletting of bigger, surface soundness higher of the gained tablet than general oral tablet, interior porosity smaller, equal conditions
Under can improve the moisture absorption of tablet to a certain extent, be conducive to improve preparation stability.
Compared with the prior art the shortcomings that and deficiency, the invention has the advantages that：
(1) the effective component higher contained by chewable tablets of the present invention, and each ingredient is not conflicted with each other, is influenced, and can more be filled
That divides is absorbed by human body；
(2) chewable tablets of the present invention is under the premise of equivalent effect, the dosage smaller that needed by human body is taken；
(3) chewable tablets of the present invention is more easy to moulding, can be effectively moisture-proof, and stability is high；
(4) present invention, which need not largely add flavoring agent and can reach, overcomes the problems, such as that Herba Cistanches mouthfeel is bad, and flavoring is held
Easily, good in taste, the preparation process period is shorter.
Description of the drawings
The effect of Fig. 1 is different grain size Herba Cistanches powder in embodiment of the present invention ingredient dissolves out variation diagram；
Fig. 2 is the standard curve of glucose in the embodiment of the present invention；
Fig. 3 is the standard curve of rutin in the embodiment of the present invention；
Fig. 4 is the Moisture percentage of particle under different relative humidity in the embodiment of the present invention；
Specific implementation mode
In order to make the purpose , technical scheme and advantage of the present invention be clearer, with reference to the accompanying drawings and embodiments, right
The present invention is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, and
It is not used in the restriction present invention.
One, instrument
UV Blue Star B ultraviolet specrophotometers (the safe Science and Technology Ltd. of Beijing Lay one hundred)；HH-S type electric heating constant temperature water
Bath (Zhejiang Province's Yuyao City detects instrucment and meter plant)；DD-5M centrifuges (Xiang Yi centrifuges Instrument Ltd.)；SB-5200DTR is super
Sound wave cleaning machine (NingBo XinZhi Biology Science Co., Ltd)；(Huangshi is permanent for YLD-2000 electric heating air blast thermostatic drying chamber
Rich Medical Devices Co., Ltd.)；AKRY-UP-1816 ultrapureization water dispenser (Chengdu Tangshi Kangning Science and Technology Development Co., Ltd)；
BS124S a ten thousandths electronic balance (German Sai Duolisi scientific instrument Co., Ltd)；Ten a ten thousandth electronic analysis of BT125D
Balance (German Sai Duolisi scientific instrument Co., Ltd)；(glad scientific instrument are limited together in Shanghai for DZF-6090 types vacuum drying chamber
Company)；WK types granulator (absolute sincerity Machinery Co., Ltd. of city of Qingzhou in Shandong province)；ZP types rotary tablet machine (all medicine mechanism in Shanghai day
Make factory)；CSD-2 type friabilities detector (Tianjin bass spy scientific ＆ technical corporation)；(Tianjin is rich blue for YD-I tablet hardnesses tester
This electronics scientific ＆ trading Co., Ltd.)；RC-8 dissolution rates instrument (Tianjin richness Lance's electronics scientific ＆ trading Co., Ltd.).
Two, reagent
Herba Cistanches are that product are planted by the Gansu bio tech ltd Rong Bao, are identified as Cistanche deserticoLa
The fleshy stem of the drying Dai Scales leaves of Y.C.Ma；The fruit of Chinese wolfberry, mulberry fruit are that the Gansu bio tech ltd Rong Bao chooses, identified Chinese holly
Matrimony vine is the fruit of Lycium barbarum L.；Mulberry fruit is the drying fruit ear of Morus alba L..
D-941 macroporous absorbent resins (Shandong Lukang Record Pharmaceuticals Co., Ltd.)；The polyamide of 80~100 mesh
(Sinopharm Chemical Reagent Co., Ltd., lot number：F20100120)；Phenol (Laiyang City Co., Ltd in pairs, lot number：
20090701)；Glucose (National Institute for Food and Drugs Control, lot number：110833~200503)；Rutin (Chinese food medicine
Research institute, lot number are determined in product examine：100080201209), Aspartame (Distributions in Liaocheng of Shandong Province An Xin pharmaceutic adjuvants Co., Ltd, lot number：
20150412)；Casein sodium (Gansu Huaan biotechnology group, lot number：20150704)；PEG6000 (Beijing Haidian meetings
Friendly Fine Chemical Works, lot number：20150811)；Absolute ethyl alcohol, sodium hydroxide, concentrated hydrochloric acid, glacial acetic acid (being that analysis is pure), dense sulphur
Sour (top pure grade).
Three, research and development of the invention
(1) Herba Cistanches disintegrating process is studied
To enable effect ingredient in Herba Cistanches fine powder to dissolve out well, the molten of functional component in Herba Cistanches powder should be investigated
Relationship between output and granularity.The Herba Cistanches powder granule (60 mesh, 80 mesh, 120 mesh, 200 mesh) of 4 kinds of different sizes is respectively sampled
3 parts, sampling amount 10g, the dissolution situation of functional component when investigating dissolution 60min.Process in leaching uses《People's Republic of China's medicine
Allusion quotation》2015 editions four 0,931 second methods, dissolution medium are water, dissolution medium addition 500mL.Functional component echinacoside and hair
Stamen spends the assay method of glucosides to use《Pharmacopoeia of People's Republic of China》2015 editions methods, the result is shown in Figure 1.
The solable matters such as the benzyl carbinol glycoside in Herba Cistanches are typically found in into the cell, the diffusion generated due to cell wall
Resistance can cause the dissolution rate of its principle active component to slow down.Along with diffusion area is smaller when granularity is larger, it is less useful for
Ingredient dissolves out.From figure 1 it appears that the reduction echinacoside and acteoside stripping quantity with medicinal material granularity also gradually increase
Add, but after granularity reaches 120 mesh, stripping quantity reaches maximum value, and the stripping quantity of 200 mesh medicinal powder is declined slightly instead, the phenomenon
May be caused by the suction-operated generated after medicinal powder specific surface area extremely increases.Therefore, in the present invention, determine Herba Cistanches powder
It is broken (all to lead to and sieve with 100 mesh sieve, no less than 95% powder is sieved by 120 mesh) for most fine powder.
(2), the fruit of Chinese wolfberry, mulberry fruit Study on extraction
1, the study on determination method of technology assessment index
According to the main chemical compositions that the fruit of Chinese wolfberry, mulberry fruit contain in prescription, in conjunction with the document report of antifatigue effect ingredient
Research, determine using the extracted amount of total starches and general flavone as evaluation index, optimization the fruit of Chinese wolfberry, mulberry fruit extraction process.
1.1, the research of total starches content assaying method
1.1.1, the preparation research of polysaccharide sample
Due to containing more colored component in the fruit of Chinese wolfberry, mulberry fruit, with the total starches of the extracting solution preparation of the fruit of Chinese wolfberry, mulberry fruit
Sample liquid color is deeper, seriously affects the accuracy of assay result.Access through documents and materials selects D-941 macropores to inhale
Attached decolorizing resin carries out decolorization to polysaccharide sample.
(1) macropore decolorizing resin pre-processes
A certain amount of macropore decolorizing resin (D-941) is weighed, is washed with deionized water to liquid and clarifies.A certain amount of go is added
Ionized water impregnates 8h, wet method dress post.The 4%HCL solution dynamic desorptions processing of 2.5BV, flow velocity 1BVh is added-1, Zhi Houyong
A large amount of deionized waters are washed till neutrality；Again plus the 5%NaOH solution dynamic desorptions of 2.5BV are handled, flow velocity 1BVh-1, Zhi Houyong
A large amount of deionized waters are washed till neutrality；12h or more is impregnated with 95% ethyl alcohol of 2BV, no alcohol taste is washed till with a large amount of deionized waters, it is standby
With.
(2) preparation of total starches test sample liquid
Precision pipettes the fruit of Chinese wolfberry, mulberry fruit extraction concentrate 10ml (0.6g crude drugs/ml) in 25ml volumetric flasks, adds water fixed
Hold, shakes up.Precision pipettes 10ml constant volume liquid and is placed in centrifugation (3500rmin in centrifuge tube again-1, 10min), take supernatant
2.5ml fills into 40mL absolute ethyl alcohols, concentration of alcohol is made to reach 80%, shake up in another centrifuge tube, and refrigeration centrifuges afterwards for 24 hours
(3500r·min-1, 10min), supernatant is abandoned, the Thick many candies in centrifuge tube are dissolved in water, is quantitatively transferred to 25mL volumetric flasks
Constant volume obtains Thick many candies solution.Precision pipettes Thick many candies solution 12.5ml, upper D-941 large pore resin absorption columns (resin volume：D15
× H90mm), Static Adsorption 4h.It is eluant, eluent with 2BVh using deionized water-1Flow velocity elutes, collect eluent and constant volume in
It in 100ml volumetric flasks, is measured respectively using 3.1.1.2 methods, investigates influence of the elution volume to result, the results are shown in Table 1.
Eluting agent investigates result when 1 total starches sample of table decolourizes
As seen from the results in Table 1, each sample 75ml deionized waters can elute completely.It finally determines with flow velocity and is
2BV·h-1, collect eluent 75ml, then with deionized water constant volume in 100ml volumetric flasks to get total starches test solution.
1.1.2 the foundation of total starches sample size assay method
(1) preparation of sulfuric acid
By the concentrated sulfuric acid and pure water with 7：1 ratio is prepared, and is cooled to room temperature, matching while using.
(2) preparation of phenol liquid
0.6g phenol crystals are weighed, add 15ml pure water to dissolve, matching while using.
(3) assay method of polysaccharide sample liquid
Precision measures each 1ml of total starches test solution in two tool plug test tubes, and one group first adds the oscillation of 1ml phenol liquid mixed
Conjunction is uniform, is rapidly added the sulfuric acid oscillation that 5ml volume fractions are 87.5% and is uniformly mixed, sets and heat 15min in boiling water bath, taking-up
It is cooled to room temperature, adds 1ml pure water, its absorbance value A is measured at 485nm after mixing1；Another group of addition 1ml pure water oscillation
Uniformly, the sulfuric acid solution that 5ml volume fractions are 87.5% is added, 15min is heated in boiling water bath, takes out, is cooled to room temperature, adds
Enter 40mgmL-1Phenol solution 1ml, measure absorbance value A immediately after mixing2, equally operated with pure water as blank control, meter
Calculate corresponding absorbance value △ A (A1-A2)。
(4) preparation of reference substance stock solution
Accurately weighed glucose control product (the vacuum drying chamber drying 12h or more for setting P2O5) 15.30mg, is placed in 25ml appearances
Measuring bottle simultaneously plus water constant volume, shake up to get.
(5) methodological study
1. linear relationship is investigated
Precision pipettes glucose control product stock solution 0.5,1.0,2.0,2.5,3.0,4.0mL respectively, is respectively placed in 10mL
Volumetric flask in, add distilled water dilution and constant volume, pipette respectively various concentration glucose control solution 1mL set tool plug scale examination
Guan Zhong is measured according to (3) method, calculates Δ A (A1- A2), linear regression is carried out to Δ A by mass concentration C, obtains regression equation
For：Δ A=0.0049C+0.0389, r=0.9991, glucose is 15.30~244.80 μ gmL in quality-1In range and inhale
Luminosity difference DELTA A is in good linear relationship, as a result sees Fig. 2.
2. precision test
Glucose control product solution is taken, is operated by the assay method of above-mentioned polysaccharide sample liquid, replication 5 times is surveyed respectively
Each group absorbance value Δ A, calculate Δ A RSD be 0.61%, illustrate that the precision of instrument is good.
3. stability test
It takes with a collection of 1 part of total starches test solution, operates, measured respectively simultaneously by the assay method of above-mentioned polysaccharide sample liquid
Calculate test solution 0,20,40,60,80,100,120min absorbance value Δ A, calculate RSD be 1.72%, explanation
Stablize in 2.0h after test solution colour developing.
4. repetitive test
It takes with a collection of 5 parts of total starches test solution, is operated by the assay method of above-mentioned polysaccharide sample liquid, measure inhale respectively
Shading value, it is 1.83% to calculate RSD.
5. being loaded recovery test
Take the above-mentioned total starches test sample liquid of the fruit of Chinese wolfberry, mulberry of known total starches content to prepare Thick many candies molten
Liquid, then it is separately added into the glucose control product solution of a concentration of 0.816mg/ml of certain volume, addition is equivalent to sample polysaccharide
80%, 100%, the 120% of content.It is settled to 100ml respectively after upper prop decolorization.By the measurement of above-mentioned polysaccharide sample liquid
Method measures, and the results are shown in Table 2.
2 total starches assay of table is loaded recovery test result
Through methodological study, the total starches content assaying method established can be used for total more in the fruit of Chinese wolfberry, mulberry
Sugared extracted amount measures.
(3) research of Determination Method of Flavone Content
1, the preparation of Determination of Total Flavonoids sample
Containing other a large amount of substances in the fruit of Chinese wolfberry, mulberry, to improve the accurate of Determination Method of Flavone Content
Property, Determination of Total Flavonoids sample is prepared using the method that polyamide adsorbs.It is as follows that method establishes process：
(1) polyamide pre-processes
A certain amount of polyamide (crossing 80 mesh sieve) is taken, is dried at 50 DEG C after being impregnated 24 hours with 95% ethyl alcohol of volume fraction,
4.5g polyamides are weighed in 100mL beakers, 95% ethyl alcohol of 45mL volume fractions is added and is sufficiently stirred rear wet method dress post, waits for
It is washed till eluent clarification for 95% ethyl alcohol with 3BV volume fractions after stabilization, then is rinsed with the NaOH solution of 2.5BV5%, flow velocity
1.5BV·h-1, later neutrality is washed till with pure water.2.5BV5% acetic acid solutions are used to rinse again, flow velocity 1.5BVh-1, later with pure
It is washed to neutrality, it is spare.
(2) preparation of general flavone test solution
Distilled water is added to be packed into the glass column of internal diameter 15mm the polyamide that 9mL has been pre-processed.The precision shifting fruit of Chinese wolfberry,
Mulberry fruit takes extracting solution (0.6gmL-1) in 10mL to 25mL volumetric flasks, with water constant volume, mixing.It is transferred in centrifuge tube and centrifuges
(3500r·min-1, 10min).Precision pipettes supernatant sample 2mL to the polyamide chromatographic column pre-processed, and Static Adsorption 4h is used
Pure water is washed till eluent clarification.Use anhydrous ethanol elution, elution speed 1BVh again afterwards-1, collect eluent, and constant volume in
100mL volumetric flasks.The method that linear relationship in being studied with above-mentioned Determination Method of Flavone Content is investigated measures, and eluent is used
Amount is investigated and the results are shown in Table 3.
It is prepared by 3 general flavone test solution of table
As seen from the results in Table 3, each sample can be eluted completely substantially with 50ml absolute ethyl alcohols.It finally determines with flow velocity and is
1BV·h-1, collect eluent 50ml, then with absolute ethyl alcohol constant volume in 100ml volumetric flasks to get general flavone test solution.
2, Determination Method of Flavone Content is studied
(1) preparation of control substance of Rutin stock solution
Precision weighs control substance of Rutin (vacuum drying 12h or more) 5.61mg, is placed in dry 50mL volumetric flasks, with nothing
Water-ethanol dissolves and is diluted to scale to get spare.
(2) investigation of linear relationship
Precision draws control substance of Rutin stock solution 0.50,2.50,4.50,6.50,8.50,10.50,12.50mL, respectively
It sets in 25mL volumetric flasks, absolute ethyl alcohol is added and is diluted to scale, shakes up.Using absolute ethyl alcohol as blank, it is taken at wavelength 258nm and surveys
Determine absorbance.With concentration (the μ gmL of control substance of Rutin-1) it is abscissa, absorbance value is mapped for ordinate, as a result such as Fig. 3 institutes
Show.
Absorbance and mass concentration regression equation Y=0.0370X+0.0179, r=0.9998 can be obtained by Fig. 3.The result shows that
Rutin concentration is in 2.24~56.10 μ gmL-1Good linear relationship is presented with absorbance in range.
(3) precision test
Pipette 11.22 μ gmL-1Control substance of Rutin solution by above-mentioned Determination Method of Flavone Content study in line
Sexual intercourse investigate method operation, parallel determination 5 times, record absorbance, and calculate RSD be 0.11%, show the instrument essence
Density is good.
(4) stability test
It takes with 1 part of the batch of fruit of Chinese wolfberry, mulberry, sample is prepared by the preparation method of above-mentioned general flavone test solution
Product liquid, then by with the method for the linear relationship investigation in the research of above-mentioned Determination Method of Flavone Content respectively 1,4,8,12,
16, absorbance is measured respectively for 24 hours.It is 1.01% to calculate RSD, shows that the absorption angle value variation of the flavones within 24 hours is not shown
It writes.
(5) repetitive test
It takes with 5 parts of the batch of fruit of Chinese wolfberry, mulberry, prepared by the preparation method for pressing above-mentioned Determination of Total Flavonoids sample successively
Sample liquid, then absorbance is measured by the method that the linear relationship in the research of above-mentioned Determination Method of Flavone Content is investigated, it calculates
It is 0.89% to obtain RSD.
(6) it is loaded recovery test
Precision pipettes the flavones sample liquid fruit of Chinese wolfberry, the mulberry of known content, is separately added into and is equivalent to sample size
80%, 100%, 120% control substance of Rutin solution (each sample-adding level does 3 Duplicate Samples) is pressed above-mentioned general flavone and is surveyed successively
The preparation method of random sample product prepares sample liquid, then investigated by the linear relationship in the research of above-mentioned Determination Method of Flavone Content
Method measures absorbance, and sample recovery rate is calculated by measured amount, and it is 102.01%, RSD 2.45% to obtain average recovery rate.
Through methodological study, the Determination of Total Flavonoids method established can be used for general flavone in the fruit of Chinese wolfberry, mulberry and carry
Taken amount measures.
(4) fruit of Chinese wolfberry, mulberry fruit optimal extraction technology
1, the establishment of factor level table
General flavone and total starches extracted amount be as index in selective extraction liquid, concentration of alcohol, solvent dosage, extraction time,
Extraction time takes 6 levels, extraction time, extraction time two as investigation factor, wherein two concentration of alcohol, solvent dosage factors
A factor takes 3 levels, factor level table to be shown in Table 4.
4 uniform design factor level table of table
Note：A：Concentration of alcohol；B：The total dosage of solvent；C：Total extraction time；D：Extraction time.
2, Uniform Design arrangement and interpretation of result
Totally 6 parts of the fruit of Chinese wolfberry, mulberry fruit are weighed in prescription ratio, every part of 150g is extracted.By uniform design U6(62×32) side
Case carries out heating and refluxing extraction, merges extracting solution (crossing 300 mesh medicines sieve), water-bath concentration, and constant volume is in 250mL volumetric flasks.
Even test arranges and the results are shown in Table 5.
5 uniform experiments arrangement of table and result
Using Polyose extraction amount as dependent variable Y, concentration of alcohol (A), solvent dosage (B), total extraction time (C), extraction time
(D) it is independent variable, uses spss17.0 softwares to carry out multiple linear regression in a manner of backword, obtain regression equation Y=
46.107~0.188A (R=0.964, P<0.05).By regression equation it is found that concentration of alcohol has a significant impact experimental result,
The extracted amount that polysaccharide is improved with concentration of alcohol declines.Solvent dosage, extraction time and extraction time do not have Polyose extraction result
It influences.The Polyose extraction amount water known to experimental result is ideal solvent, and when concentration of alcohol is incremented to 30% by 20%, polysaccharide carries
Taken amount has larger fall.
Using general flavone extracted amount as dependent variable Y, concentration of alcohol (A), solvent dosage (B), total extraction time (C), extraction time
Number (D) is independent variable, and spss17.0 softwares is used to carry out multiple linear regression in a manner of backword, and it is Y to obtain regression equation
=1.490+0.004A+0.001C (R=0.983, P<0.05), by regression equation it is found that the extracted amount of general flavone and ethyl alcohol are dense
Degree, extraction time are proportionate.
Since concentration of alcohol raising is unfavorable for Polyose extraction, balancedly to extract general flavone and two substance of total starches, knot
Actual conditions are produced in symphysis, intend selecting 20% ethanol solution heating and refluxing extraction, twice, solvent dosage is medicinal material total amount for extraction
14 times of amounts (8 times of amounts for the first time are measured for 6 times for the first time), the process conditions of each 1.5h.
3, extraction process is checked
Totally 3 parts, every part of 150g of the fruit of Chinese wolfberry, mulberry fruit are weighed in prescription ratio, is extracted by technique obtained by 4.2.2.As a result
It is shown in Table 6.
6 fruit of Chinese wolfberry of table, mulberry fruit extraction process check result
Have technique review result it is visible select 20% ethanol solution heating and refluxing extraction, extraction twice, solvent dosage is
14 times of amounts (8 times of amounts for the first time are measured for 6 times for the first time) of medicinal material total amount, the extracting factor of each 1.5h is stable, feasible, will
Gained extracting solution is spare after merging.
(5) the concentration technology research of the fruit of Chinese wolfberry, mulberry
Since the fruit of Chinese wolfberry, mulberry need and Herba Cistanches fine powder mixing granulation, concentrate in the moulding process stage
Character change with concentrating degree difference, and the character of concentrate is related to the effect of pelletizing forming.Therefore Chinese holly need to be investigated
The relationship of matrimony vine, mulberry difference concentrating degree and character variation.
The fruit of Chinese wolfberry, mulberry are filtered to remove insoluble matter with 300 mesh screens, concentrated using vacuum concentration equipment.Subtract
Pressure concentration condition is 95 DEG C of water bath heating temperature, relative degree of vacuum 0.08MP.By measuring the opposite of concentrating degree different liquids
Density, water content and character, determine striking point.It the results are shown in Table 7.
Result is concentrated under reduced pressure in 7 fruit of Chinese wolfberry of table, mulberry
By experimental result it is found that when the fruit of Chinese wolfberry, mulberry are concentrated under reduced pressure into relative density 1.35, mobility is bright
It is aobvious to decline, for ease of mixing granulation, do not concentrate further.
(6) chewable tablet forming process is studied
Due to containing a large amount of monosaccharide, oligosaccharide and pectic substance in the fruit of Chinese wolfberry, mulberry, extracting solution is condensed into thick
Find that rate of drying is very slow through vacuum decompression drying experiment after cream, material heated time is too long, therefore determines to use wet granulation
Tablet forming technique.The route Preliminary design of moulding process is：The fruit of Chinese wolfberry, mulberry fruit concentrate are uniformly mixed with Herba Cistanches powder, auxiliary material
Afterwards, add a certain concentration ethyl alcohol softwood, granulation, then by wet granular drying, whole grain, the tabletting added with primary medicinal powder, auxiliary material.
1, the concentrating degree selection of extracting solution
Due to the fruit of Chinese wolfberry, mulberry fruit concentration fluid viscosity is big, poor fluidity, it is therefore desirable to investigate the concentrate of different concentrating degrees
The concentrating degree of extracting solution is determined with the Combination of Herba Cistanches powder.The different concentrate of concentrating degree is added in prescription ratio
It is added in multifunctional mini-mixer and is stirred in Herba Cistanches powder.Mixing resultant is shown in Table 8.
The mixing resultant of table 8 different concentrating degree concentrates and Herba Cistanches fine powder
It can be seen from the experiment that the fruit of Chinese wolfberry, mulberry fruit concentrate in relative density (25 DEG C) although can be mixed with medicinal powder when 1.20,1.25
It closes uniformly, but obtained sticky dough is difficult to be adjusted to satisfactory softwood in wet granulation, when concentrate is relatively close
Since cohesive force is too big when spending 1.35 (25 DEG C), can not be uniformly mixed.It is thus determined that selecting the dense of relative density 1.30 (25 DEG C)
Contracting liquid.
2, the selection of auxiliary material
2.1, casein sodium
Due to containing a large amount of Herba Cistanches fine powders in chewable tablets, tablet hardness and finish are influenced, to improve product appearance, is needed
A certain amount of auxiliary material is added.Casein sodium is the sodium salt of main protein casein in cow's milk, is a kind of safe and harmless increasing
Thick dose, there are good improvement dry materials adhesiveness feature, and a variety of amino acid containing needed by human body.The increasing of casein sodium
Thick effect can also be passivated taste bud feeling, be conducive to flavoring.Therefore it is the shaping auxiliary materials of chewable tablets to select casein sodium.According to setting
Fixed edible dosage, the addition of casein sodium is between 11~12%.
2.2, the selection of corrigent
Chewable tablets makes moderate progress to the bitter taste of Herba Cistanches due to there is the presence of the fruit of Chinese wolfberry, Fructus Mori extract, is further
Improve chewable tablets mouthfeel, selects Aspartame as corrigent.Aspartame is a kind of non-carbohydrate sweetener, sugariness
About 200 times of sucrose widely as the substitute of sucrose, are selected Aspartame as corrigent, few in addition
In the case of can be effectively improved chewable tablets mouthfeel, be conducive to control chewable tablets piece weight, also make diabetic using this product
When it is unrestricted.It is determined by experiment the addition of Aspartame, the results are shown in Table 9.
9 corrigent dosage of table investigates result
Shown when addition of the corrigent Aspartame with 2 ‰ by 9 test result of table, lozenge it is good in taste.Work as addition
When amount reaches 3%, start taste very sweet tea, but rear taste shows certain astringent taste instead, it is thus determined that using 2 ‰ Aspartames as lozenge
Corrigent.
2.3, the screening of wetting agent
Since the low-concentration ethanol containing fruit crude drugs in chewable tablets piece extracts thick paste, there is stronger viscosity, to be made
The swing available softwood of extrusion granulator machine, wetting agent is made using the ethyl alcohol of high concentration.Take Herba Cistanches most fine powder, fruit of Chinese wolfberry mulberry fruit
3 parts of the material (every part of 200g) that concentrate, the sour sodium of junket member mix in proportion, respectively with 92%, 95%, absolute ethyl alcohol softwood,
Oscillating granulator is pelletized, 80 DEG C of dryings, and whole grain is sieved with 16 mesh and 60 mesh medicines, and to pelletizing the case where is observed, and the results are shown in Table
10。
10 wetting agent the selection result of table
Shown that under the premise of thick paste is relatively viscous, wetting agent, the character of softwood are done using absolute ethyl alcohol by 10 test result of table
Well, the yield of particle is higher, and dry particl hardness is moderate to be conducive to follow-up tabletting.Therefore final choice absolute ethyl alcohol is as wetting
Agent, amount of alcohol added are the 32% of quality of material.
2.4, the determination of lubricant quantity
To keep tableting processes more smooth, reduces tablet weight variation, need that glidant and lubrication are added in manufactured particle
Agent.PEG-6000 is tasteless water-soluble substances, while having and helping stream and lubricating action.Select PEG-6000 as this chewable tablets
Lubricant, can fully be dissolved in saliva, not change the chewable tablets mouthfeel mixed up.By PEG-6000 fine powders (120 mesh) with
Dry particl is uniformly mixed, and using angle of repose and tablet weight variation as index, determines its dosage.It the results are shown in Table 11.
11 lubricant quantity of table investigates result
It can be seen from the experiment that when the addition of PEG-6000 obtains 1.0%, you can achieve the goal, it is not necessary that be further added by use
Amount.
2.5, the composition of tablet recipe is chewed
According to result of study, by the composition of Rong's treasured board chewable tablets primarily determine for：Herba Cistanches 700g, fruit of Chinese wolfberry 300g, mulberry
Mulberry 150g, Aspartame 2g, PEG60001g, 110~120g of casein sodium.
3, influence of the drying process to particle is investigated
Due to chewable tablets pelletize material water content it is higher, moisture in thick paste and medicinal material total material 14~16% it
Between, material viscosity is larger, therefore could reduce its viscosity using absolute ethyl alcohol, smoothly pelletizes.It heats up in wet granular drying process
Speed is different, can influence particle yield.Wet granular is set in stainless steel disc, thickness 3cm, hot air circulation drying.The result is shown in tables
12。
12 drying process temperature change of table is to particles effect result
It finally determines wet granular first in 40 DEG C of dry 15min, then is warming up to 60 DEG C of dry 15min, finally done at 80 DEG C
Dry 60min.Dry particl water content is 5.66% after measured.
4, influence of the pelletization to microorganism particle index is investigated
Since Herba Cistanches are to crush to be used as medicine in prescription, be easy to causeing product microorganism transfinites, therefore in tablet formative stage
In addition to the cleanliness factor for considering production space, sterilizing problem need to be also considered in technical process.It is wet since this product is solid pharmaceutical preparation
Heat disinfection is less suitable for, and temperature is too high again for hot air sterilization.When in view of the product wet granulation material moisture 13~
Between 15%, between the equilibrium concentration of ethyl alcohol is 72~76% in material after addition absolute ethyl alcohol.To kill in material as far as possible
Microorganism wetting agent absolute ethyl alcohol and after mixing is being added, streams closed is preserved into certain time according to consulting literatures
The effect of sterilizing can be played, therefore is determined after softwood is made in absolute ethyl alcohol addition material, streams closed is preserved into certain time
Extrusion granulator again.80 DEG C of drying times are appropriately extended simultaneously, to further increase sterilization effect.By the dry particle finished 80
DEG C sampling sealing immediately, carries out microorganism limit detection, experimental result is shown in Table 13.
Influence of 13 pelletization of table to microorganism particle index is investigated
From the experimental results, it is preserving softwood is closed 1 hour, and after 80 DEG C of drying times are extended 60min, gained
The microbiological indicator of dry particl is qualified through examining.For the sake of assurance, it determines pelletization being determined as that the closed preservation 2 of softwood is small
Shi Houzai pelletizes, and 80 DEG C of drying times are extended 60min to 120min.
5, the hygroscopicity of chewable tablets granular material is investigated
7 parts of the dry particl particle prepared by above-mentioned technique is taken, each every part about 1g is accurately weighed, sets dry flat to constant weight
It in shape measuring cup, is placed in the drier added with 7 kinds of different saturated salt solutions of relative humidity, weigh the cap is opened, in 25 DEG C
It is placed 1 day in constant incubator, takes out measuring cup, it is accurately weighed after capping, hydroscopicity is calculated, using relative humidity as abscissa,
Hydroscopicity is ordinate, draws sucting wet curve, the results are shown in Table 14 and Fig. 4.
Particle Moisture percentage result table under the different relative humidity of table 14
As seen from Figure 4, Particles at Critical relative humidity is 42%, and particle is easy the moisture absorption before illustrating tabletting, should be opposite
Tabletting, packing in environment of the humidity less than 42%.
6, the research of tablet forming technique parameter
Tabletting speed (material is filled and pressing times) and punch pressure and tablet weight variation and tablet hardness in tableting processes
Closely related, tablet forming technique should determine two parameters of tabletting speed and punch pressure.By first selecting tableting pressure, then determining pressure
The mode of piece speed determines two parameters.Particle made of above-mentioned method of granulating is taken, tabletting on rotary tablet machine is rushed 5, is adjusted
Nodal plate weight 1.0g (piece diameter 16mm), investigates relationship of the piece thick (distance between upper and lower punching) between hardness, and related experiment the results are shown in Table
15。
15 tableting pressure of table investigates result
It is final to determine that tablet hardness and friability are relatively suitble to by when distance is adjusted to 2mm between upper and lower punching.It is basic herein
Seamless piece speed is raised, the Reasonable Speed of tabletting is investigated.Experimental result is shown in Table 16.
16 tabletting speed of table investigates result
From the experimental results, with 1 speed tabletting each second, the quality of gained chewable tablets is relatively good.
In conclusion present invention offer optimum embodiment is as follows：
Embodiment 1
(1) the 250g fruits of Chinese wolfberry, 200g mulberries are put into multi-function extractor, the ethyl alcohol for being 20% using mass fraction is solvent
Extraction 2 times, extraction 1.5 hours every time, the total dosage of solvent be the fruit of Chinese wolfberry and mulberries quality sum 14 times (8 times for the first time, second
Secondary 6 times), obtain extracting solution；
Two effect vacuum concentration equipments recycling of extracting solution and are concentrated ethyl alcohol, relative degree of vacuum 0.008Mp when concentration, feed liquid
It is concentrated into D1.30 (25 DEG C), obtains thick paste；
Material-compound tank is added in 1g Aspartames, absolute ethyl alcohol, is dispersed with stirring 30min, is suspended uniform, obtains suspension；
(2) it is 120 mesh (most fine powder) by Herba Cistanches pulverizing medicinal materials with Universalpulverizer；Groove profile is added in above-mentioned thick paste to mix
Machine adds 110g casein sodiums, 750g Herba Cistanches powder and above-mentioned suspension, is stirred, and is uniformly mixed and is pelletized
Softwood；The softwood that will pelletize is closed to be preserved 3 hours；
(3) oscillating granulator is added in the softwood after preservation, wet-method extrusion granulation obtains wet granular；Wet granular is set
40 DEG C of dry 15min, heated-air circulation oven is warming up to 60 DEG C of dry 15min, is warming up to 80 DEG C of dry 120min again, being done
Particle；Dry particl is crossed into 60 mesh sieve, takes 60 mesh particles；
(4) by above-mentioned particle, 8g Macrogol 6000s powder (120 mesh) input V-type blender, 10min is mixed, it is ensured that
It is evenly affixed to particle surface；Chewable tablets, every weight 1g, 1/min of tabletting speed, upper and lower punching are suppressed with rotary tablet machine
Spacing 2mm obtains chewable tablets 1.
Embodiment 2
(1) the 350g fruits of Chinese wolfberry, 100g mulberries are put into multi-function extractor, the ethyl alcohol for being 20% using mass fraction is solvent
Extraction 2 times, extraction 1.5 hours every time, the total dosage of solvent be the fruit of Chinese wolfberry and mulberries quality sum 14 times (8 times for the first time, second
Secondary 6 times), obtain extracting solution；
Two effect vacuum concentration equipments recycling of extracting solution and are concentrated ethyl alcohol, relative degree of vacuum 0.008Mp when concentration, feed liquid
It is concentrated into D1.30 (25 DEG C), obtains thick paste；
Material-compound tank is added in 1~3g Aspartames, absolute ethyl alcohol, is dispersed with stirring 30min, is suspended uniform, obtains suspension；
(2) it is 120 mesh (most fine powder) by Herba Cistanches pulverizing medicinal materials with Universalpulverizer；Groove profile is added in above-mentioned thick paste to mix
Machine adds 120g casein sodiums, 650g Herba Cistanches powder and above-mentioned suspension, is stirred, and is uniformly mixed and is pelletized
Softwood；The softwood that will pelletize is closed to be preserved 3 hours；
(3) oscillating granulator is added in the softwood after preservation, wet-method extrusion granulation obtains wet granular；Wet granular is set
40 DEG C of dry 15min, heated-air circulation oven is warming up to 60 DEG C of dry 15min, is warming up to 80 DEG C of dry 120min again, being done
Particle；Dry particl is crossed into 20 mesh sieve, takes 20 mesh particles；
(4) by above-mentioned particle, 12g Macrogol 6000s powder (120 mesh) input V-type blender, 10min is mixed, really
Guarantor is evenly affixed to particle surface；Chewable tablets is suppressed with rotary tablet machine, every weighs 1g, 1/min of tabletting speed, above and below
Spacing 2mm is rushed, chewable tablets 2 is obtained.
Embodiment 3
(1) the 300g fruits of Chinese wolfberry, 150g mulberries are put into multi-function extractor, the ethyl alcohol for being 20% using mass fraction is solvent
Extraction 2 times, extraction 1.5 hours every time, the total dosage of solvent be the fruit of Chinese wolfberry and mulberries quality sum 14 times (8 times for the first time, second
Secondary 6 times), obtain extracting solution；
Two effect vacuum concentration equipments recycling of extracting solution and are concentrated ethyl alcohol, relative degree of vacuum 0.008Mp when concentration, feed liquid
It is concentrated into D1.30 (25 DEG C), obtains thick paste；
Material-compound tank is added in 2g Aspartames, absolute ethyl alcohol, is dispersed with stirring 30min, is suspended uniform, obtains suspension；
(2) it is 120 mesh (most fine powder) by Herba Cistanches pulverizing medicinal materials with Universalpulverizer；Groove profile is added in above-mentioned thick paste to mix
Machine adds 115g casein sodiums, 700g Herba Cistanches powder and above-mentioned suspension, is stirred, and is uniformly mixed and is pelletized
Softwood；The softwood that will pelletize is closed to be preserved 2 hours；
(3) oscillating granulator is added in the softwood after preservation, wet-method extrusion granulation obtains wet granular；Wet granular is set
40 DEG C of dry 15min, heated-air circulation oven is warming up to 60 DEG C of dry 15min, is warming up to 80 DEG C of dry 120min again, being done
Particle；Dry particl is crossed into 20~60 mesh sieve, takes the particle between 20~60 mesh；
(4) by above-mentioned particle, 10g Macrogol 6000s powder (120 mesh) input V-type blender, 10min is mixed, really
Guarantor is evenly affixed to particle surface；Chewable tablets is suppressed with rotary tablet machine, every weighs 1g, 1/min of tabletting speed, above and below
Spacing 2mm is rushed, chewable tablets 3 is obtained.
The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all essences in the present invention
All any modification, equivalent and improvement etc., should all be included in the protection scope of the present invention made by within refreshing and principle.
Claims (9)
1. a kind of Herba Cistanches chewable tablets, which is characterized in that the chewable tablets includes each component in parts by mass：650~750 parts
Herba Cistanches, 250~350 portions of fruits of Chinese wolfberry, 100~200 portions of mulberry fruits, 110~120 parts of casein sodiums, 1~3 part of Aspartame with
And 8~12 parts of PEG6000.
2. Herba Cistanches chewable tablets as described in claim 1, which is characterized in that the chewable tablets includes each group in parts by mass
Point：700 portions of Herba Cistanches, 300 portions of fruits of Chinese wolfberry, 150 portions of mulberry fruits, 116 parts of casein sodiums, 2 parts of Aspartames and 10 parts
PEG6000。
3. a kind of preparation method of Herba Cistanches chewable tablets, which is characterized in that this approach includes the following steps：
(1) 250~350 mass parts fruits of Chinese wolfberry, the ethyl alcohol that 100~200 mass parts mulberries mass fractions are 20% are extracted, it will
It is concentrated after ethyl alcohol recycling in extracting solution, obtains thick paste；1~3 mass parts Aspartame is added in absolute ethyl alcohol and is suspended
It is even, obtain suspension；
(2) 110~120 mass parts casein sodiums, 650~750 mass parts Herba Cistanches powder and the thick paste, suspension are mixed
Conjunction stirred evenly, and obtains granulation softwood, by the closed preservation of the softwood 1~3 hour；
(3) by after preservation softwood extrusion granulator, drying, after whole grain, dry particl is obtained, by the dry particl and 8~12 mass
Part Macrogol 6000 powder mixing, tabletting, obtain Herba Cistanches chewable tablets.
4. the preparation method of Herba Cistanches chewable tablets as claimed in claim 3, which is characterized in that in step (1), the ethyl alcohol
Extraction is specially：The ethyl alcohol for being 20% with mass fraction is used to extract 2 times the fruit of Chinese wolfberry, mulberries, every time extraction 1.5 hours；Wherein,
8 times that ethyl alcohol used is the fruit of Chinese wolfberry and mulberries quality are extracted for the first time, and it is the fruit of Chinese wolfberry and mulberries matter that second, which is extracted ethyl alcohol used,
6 times of amount.
5. the preparation method of Herba Cistanches chewable tablets as claimed in claim 3, which is characterized in that in step (1), the concentration
Specially：Two effect vacuum concentration equipments recycling of extracting solution and are concentrated ethyl alcohol, relative degree of vacuum 0.008Mp when concentration, extraction
Liquid is reduced to D1.30/25 DEG C.
6. the preparation method of Herba Cistanches chewable tablets as claimed in claim 3, which is characterized in that in step (2), the meat desert
Rong's powder is 120 mesh fine powders；
After obtaining granulation softwood, 1~2h is beaten after the granulation softwood is freezed, the softwood after beating is warming up to room temperature
Afterwards, by the closed preservation of the softwood 1~3 hour.
7. the preparation method of Herba Cistanches chewable tablets as claimed in claim 4, which is characterized in that in step (3), the drying
Specially：Wet granular is set into heated-air circulation oven, 40 DEG C of dry 15min are warming up to 60 DEG C of dry 15min, then are warming up to 80 DEG C
Dry 120min.
8. the preparation method of Herba Cistanches chewable tablets as claimed in claim 4, which is characterized in that the whole grain is specially：It will do
Dry particle crosses 20 mesh and 60 mesh sieve.
9. the preparation method of Herba Cistanches chewable tablets as claimed in claim 4, which is characterized in that the piece weight of the chewable tablets is
1g。
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| CN110004015A (en) * | 2019-03-22 | 2019-07-12 | 广西圣特记科技有限公司 | A kind of strong king's health preserving wine |
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