CN109288854A - Baicalin composition, baicalin capsule and preparation method thereof - Google Patents
Baicalin composition, baicalin capsule and preparation method thereof Download PDFInfo
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- CN109288854A CN109288854A CN201811425066.XA CN201811425066A CN109288854A CN 109288854 A CN109288854 A CN 109288854A CN 201811425066 A CN201811425066 A CN 201811425066A CN 109288854 A CN109288854 A CN 109288854A
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- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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Abstract
本发明提供了一种黄芩苷组合物、黄芩苷胶囊及其制备方法，所述组合物按重量份计包括黄芩苷180～280份，崩解剂40～80份，粘合剂1.1～10.8份，滑石粉1～5份，溶剂53.9～97.2份；本发明提供的黄芩苷组合物，通过各物料的合理搭配，使得制粒得到的颗粒性能稳定，混合均匀，质量优良；尤其是选用了适宜的粘合剂，使得胶囊具有非常优良的均匀度和稳定性，并且进一步通过适宜的制粒参数，保证了产品质量稳定，具有良好的应用前景。
The invention provides a baicalin composition, a baicalin capsule and a preparation method thereof. The composition comprises, by weight, 180 to 280 parts of baicalin, 40 to 80 parts of a disintegrant, 1.1 to 10.8 parts of a binder, 1 to 5 parts of talcum powder and 53.9 to 97.2 parts of a solvent. The baicalin composition provided by the invention has stable performance, uniform mixing and excellent quality of granules obtained by granulation through reasonable matching of various materials. In particular, a suitable binder is selected so that the capsule has very good uniformity and stability, and further through suitable granulation parameters, stable product quality is guaranteed, and the composition has good application prospects.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, it is related to a kind of secretion in HepG 2.2.2.15, baicalin capsules and preparation method thereof.
Background technique
Scutelloside is that a kind of flavonoid separated is extracted from the dry root of dicotyledonous Lamiaceae plant radix scutellariae
Object is pale yellow powder, bitter under room temperature.Scutelloside is insoluble in water, readily soluble in organic solvent.It is living with significant biology
Property, there is antibacterial, diuresis, anti-inflammatory, norcholesterol, antithrombus formation, alleviate asthma, purging fire for removing toxin, hemostasis, miscarriage prevention, resistance state
Reaction and spasmolysis, are also the specific inhibitor of mammalian liver sialidase, have the function of adjusting certain diseases, also have
There is stronger antitumor response physiological potency.Baicalin capsules are a kind of Anaphylactic mediator resistance drug releases, for acute hepatitis, chronic hepatitis, delay
The adjuvant treatment of property hepatitis.Practical study the result shows that, have to hepatitis B surface antibody, e antigen, core antigen more significant
Inhibiting effect also has inhibiting effect to hepatitis B virus DNA duplication；Glutamic-pyruvic transaminase can be substantially reduced after medication, to liver
There is preferable protective effect.
CN106943374A discloses a kind of baicalin capsules formula and its production technology, mainly includes scutelloside, dissolution
Agent, diluent, emulsification solubilising and antioxidative stabilizer and opacifier, wherein scutelloside dosage is the 32%-78% of recipe quantity, molten
It solves agent and diluent is mainly animals and plants oils, by increasing solubility of the scutelloside in vegetable and animals oils, can effectively be promoted
The stability of scutelloside；Antioxidative stabilizer is vitamin E and ascorbic acid brown eleostearic acid ester, to improve the inoxidizability of product
Can, soft capsule shell is made using gelatin, glycerol, sorbierite, and is added opacifier；By flying water, agitating and heating keeps material molten
Solution is uniformly mixed, then by pressurization sizing, drying is made；This baicalin capsules overcomes the stability of scutelloside oral liquid formulations
Difference, the problems such as bioavilability is low, but it does not have good mobility.
CN106176935A discloses a kind of baicalein aluminium glue capsule, and preparation method takes radix scutellariae coarse powder 1000g, dosing material as follows
The water of 10 times of weight impregnates 0.5h, decocts 1 hour, and filtering, the dregs of a decoction add the water of 8 times of weight of medicinal material, decocts 1 hour, medical fluid
It filters out, merges decoction liquor twice, being concentrated into 60 DEG C of relative densities is 1.05, and the percent by volume for adding ethyl alcohol to make alcohol content reaches
75%, stir, stand, filtering, relative density is 1.25 when filtrate is concentrated into 65 DEG C, and recycle ethyl alcohol, obtain concentrate, slowly plus
Enter to be saturated alum solution, make into precipitating, filter, until precipitating is washed with water to sulfate radical-free, dry, pulverize, pelletize, fills glue
Cream is to get baicalein aluminium glue capsule, and content of baicalin is high in the baicalein aluminium glue capsule that is prepared, but the method can not be controlled well
The uniformity of granulation and the mobility of dry materials.
Currently, existing baicalin capsules formula and preparation process, since the selection such as auxiliary material is improper, and there are dryings
Mode is coarse, and drying effect is unstable, the poor defect of material fluidity, so that final product quality is not sufficiently stable, how
A kind of new formula and excellent preparation process are developed, it is most important for finally obtained capsule effect and quality control.
Summary of the invention
In view of the deficiencies of the prior art, the purpose of the present invention is to provide a kind of secretion in HepG 2.2.2.15, baicalin capsules and
Preparation method.
In order to achieve that object of the invention, the invention adopts the following technical scheme:
In a first aspect, the composition includes scutelloside by weight the present invention provides a kind of secretion in HepG 2.2.2.15
180~280 parts, 40~80 parts of disintegrating agent, 1.1~10.8 parts of adhesive, 1~5 part of talcum powder, 53.9~97.2 parts of solvent.
Secretion in HepG 2.2.2.15 provided by the invention, by the reasonably combined of each material, so that the particulates' properties that granulation obtains
Stablize, is uniformly mixed, it is superior in quality.Suitable adhesive is especially selected, so that capsule has the very good uniformity
And stability.
The parts by weight of scutelloside be 180~280 parts, such as can be 180 parts, 185 parts, 190 parts, 210 parts, 220 parts,
230 parts, 240 parts, 250 parts, 260 parts, 270 parts or 280 parts etc..
The parts by weight of disintegrating agent are 40~80 parts, such as can be 40 parts, 45 parts, 50 parts, 55 parts, 60 parts, 65 parts, 70
Part, 75 parts or 80 parts etc..
Preferably, the disintegrating agent includes that microcrystalline cellulose, sodium carboxymethyl starch, polyvinylpyrrolidone or low substitution are fine
Dimension element in any one or at least two combination.
Preferably, the disintegrating agent is the composition of microcrystalline cellulose and sodium carboxymethyl starch.
Preferably, the mass ratio of the microcrystalline cellulose and sodium carboxymethyl starch is 1:1.
The parts by weight of adhesive are 1.1~10.8 parts, such as can be 1.1 parts, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8
Part, 9 parts or 10.8 parts etc..
Preferably, described adhesive includes appointing in starch, dextrin, polyvinyl alcohol, carboxymethyl cellulose or PVP K30
It anticipates a kind of or at least two combinations.
Preferably, described adhesive is PVP K30.
Scutelloside is insoluble in water, readily soluble in organic solvent, and water-soluble adhesive is i.e. enabled to be made particle, dissolves out
It spends also poor.Therefore adhesive is made with 50% ethanol solution of PVP K30 in capsule, using wet granulation mode, made
By the wet dissolution of ethyl alcohol when grain, partial size is caused to reduce, is equivalent to the process that adhesive has carried out scutelloside the dispersion of solid,
So that disintegration or dissolving out faster and better, scutelloside can be allowed to be easier to be uniformly mixed with unclassified stores in pelletization, guarantee product
The uniformity.The quality of PVP K30 accounts for the 2%~10% of composition gross mass, most preferably 3.5%.
The parts by weight of talcum powder are 1~5 part, such as can be 1 part, 2 parts, 3 parts, 4 parts or 5 parts etc..
The parts by weight of solvent are 53.9~97.2 parts, such as can be 53.9 parts, 60 parts, 70 parts, 80 parts, 90 parts, 97.2
Part etc..
Preferably, the solvent includes any one in methanol, ethyl alcohol or water.
Preferably, the solvent is the combination of second alcohol and water.
Preferably, the mass ratio of the second alcohol and water is 1:1.
The concentration control of ethyl alcohol is best in 50% or so effect, and excessive concentration particle stickiness is poor, particle easily quilt when dry
It destroys, causes fine powder excessive, be unfavorable for filling.
Preferably, the concentration of the ethyl alcohol is 95%.
As optimal technical scheme, secretion in HepG 2.2.2.15 provided by the invention includes scutelloside 180~280 by weight
Part, 20~40 parts of microcrystalline cellulose, 20~40 parts of sodium carboxymethyl starch, 1.1~10.8 parts of PVP K30, talcum powder 1~5
Part, 95% 26~48.6 parts of ethyl alcohol, 26~48.6 parts of water, the mass ratio of the microcrystalline cellulose and sodium carboxymethyl starch is 1:1,
The mass ratio of the second alcohol and water is 1:1, and mass percent of the PVP K30 in binder solution is 2%~10%.
Binder solution of the present invention refers to adhesive and solvent being individually configured to solution, the quality of addition, with Huang
The quality of a kind of reed mentioned in ancient books glycosides and disintegrating agent is to add referring to dosage form.The quality of general binder solution be scutelloside and disintegrating agent quality it
The 25%~33.3% of sum, further, you can get it for the adhesive mass fraction in binder solution.
Second aspect, the present invention provides a kind of baicalin capsules, the baicalin capsules include gelatin empty hard capsule
Secretion in HepG 2.2.2.15 as described in relation to the first aspect.
The third aspect, the present invention provides the preparation method of the baicalin capsules as described in second aspect, the preparation side
Method includes the following steps:
(1) by vacuum feeding, first a part of scutelloside is first sucked in wet granulation pot, then a part of disintegrating agent is inhaled
Enter into wet granulation pot, a part of scutelloside is drawn into wet granulation pot, adds second part disintegrating agent, finally inhale
Enter remaining scutelloside, is stirred to obtain mixture；
(2) it passes sequentially through in the mixture that a, b, c three phases are obtained to step (1) and adhesive is added:
A is directly added into first part's adhesive；
Second part adhesive is added under peristaltic pump, cutter, the equal open state of agitating paddle in b；
Part III adhesive is added under peristaltic pump, cutter, the equal open state of agitating paddle in c；
(3) cutter and agitating paddle speed are adjusted, is pelletized；
(4) it is dried the particle that step (3) obtains to obtain dry particle using fluidized bed；
(5) talcum powder is added into particle obtained in step (4), is mixed to get total mix particle, and backward gelatin is hollow
Total mix particle is filled in hard capsule, wherein filling total mix particle 250mg in each hard capsule to get baicalin capsules are arrived.
During step of the present invention (1) premixes, since scutelloside is main ingredient, amount is bigger, so first plus a part of
Scutelloside, then plus unclassified stores, then plus remaining scutelloside, be easier to be uniformly mixed in this way.
Preferably, the time of vacuum feeding described in step (1) be 5~10min, such as can be 5min, 6min,
7min, 8min, 9min or 10min etc..
Preferably, the revolving speed of stirring described in step (1) be 60~100rpm, such as can be 60rpm, 65rpm,
70rpm, 75rpm, 80rpm, 85rpm, 90rpm, 95rpm or 100rpm etc..
Preferably, the time of stirring described in step (1) be 2~8min, such as can be 2min, 3min, 4min,
5min, 6min, 7min or 8min etc..
Preferably, adhesive described in step (2) is 50% ethanol solution of PVP K30.
Preferably, the speed of b-stage peristaltic pump is 0~180rpm in step (2), and the revolving speed of agitating paddle is 0~80rpm,
The speed of cutter is 0~1500rpm.
Preferably, the speed of c stage peristaltic pump is 0~110rpm in step (2), and the revolving speed of agitating paddle is 0~80rpm,
The speed of cutter is 0~1500rpm.
Preferably, in step (2) first part's adhesive, second part adhesive and Part III adhesive mass ratio
For 1:(3~4): (0.1~1), such as can be 1:3:0.1,1:2.5:0.5,1:4:1 etc..
In the present invention, adhesive is added three times when being added, and it is viscous that the relatively primary amount of gradation dosage is easier control
The amount of mixture.After in granulation, mixing time extends, the dissolution rate of product than the time it is short than get well.It is generally preferred to for the first time
15% (being manually added) that amount of binder is about total amount is added, stirring is not turned on cutter when addition.Make adhesive and object
Material obtains permeating wet process.Second of additional amount is about 70%, this time be added be is added with gun spraying, addition the time be
4.5min, stirring is opened with cutter at this time, and it is more evenly abundant that spraying addition can be such that adhesive mixes with material.Third time is added
About 15%, time about 2min.
Preferably, in step (3) agitating paddle revolving speed be 80~150rpm, such as can be 80rpm, 90rpm,
100rpm, 110rpm, 120rpm, 130rpm, 140rpm or 150rpm etc..
Preferably, the time of stirring paddle stirring is 2~6min in step (3), for example, can be 2min, 3min, 4min,
5min or 6min etc..
Preferably, in step (3) cutter speed be 2000~3000rpm, such as can be 2000rpm,
2200rpm, 2500rpm, 2700rpm, 2900rpm or 3000rpm etc..
Preferably, in step (3) cutter clipping time be 2~6min, such as can be 2min, 3min, 4min,
5min or 6min etc..
Preferably, the intake of fluidized bed described in step (4) is 800~2500m3/ h, such as can be 800m3/h、
900m3/h、1000m3/h、1100m3/h、1500m3/h、1800m3/h、2000m3/h、2100m3/h、2300m3/ h or 2500m3/h
Deng.
Preferably, in step (4), when the moisture of particle is≤3.0%, such as can be 0,0.5%, 0.8%,
1.0%, 1.2%, 1.5%, 2.3%, 2.8% or 3.0% etc., stop drying.
" moisture " of the present invention refers to water shared mass percent in the grain.
Wherein, the mesh size of fluidized bed is 10.0 × 9.5mm, intake 800-2500m in step (3)3/h.Feeding
After stage, into drying stage, inlet air temperature is set as 40-60 DEG C, when moisture≤3.0%, stops drying.After dry
Particle cross 2.0 (A) mm sieves, be 300-800rpm whole grain in convolution swivel speed, whole grain waits for next step total mix.
In the present invention, material is added in fluidized bed dryer by feeder, by rousing after filtered pure air heating
Blower is sent into fluidized-bed bottom and is contacted through distribution grid with solid material, and the caloic exchange that fluidisation state reaches gas-solid is formed.Material is dry
It is discharged after dry by discharge gate, exhaust gas is by discharge at the top of ebullated bed after cyclone dust collectors group and bag filter recycling solid powder
Emptying.
In step (4), when wet granular uses fluidized bed drying, hot-air passes through material bed (stratum granulosum) from bottom to top, makes
Particle forms suspension fluidization (i.e. boiling-like), the drying mode that hot-air takes away the moisture in wet granular.Since particle suspends
When be zeiosis state so that hot-air penetrability is good, easily pass through inside particle, so that the moisture in particle is able to quilt rapidly
Hot-air is taken away.Compared with traditional oven drying, drying efficiency several times higher than baking oven, particles by heat is equal when dry
It is even and stable, the agglomerating and particle that agglomerates is not likely to produce because the even particle of uneven heating has situations such as piebald.
Preferably, the time of mixing described in step (5) be 10~30min, such as can be 10min, 15min,
20min, 25min or 30min etc..
Preferably, the speed of agitator of mixing described in step (5) be 10~20rpm, such as can be 10rpm, 12rpm,
15rpm, 17rpm, 18rpm, 19rpm or 20rpm etc..
Preferably, the speed filled in step (5) is 60~80 turns/min, for example, can be 60 turns/min, 65 turns/min,
70 turns/min, 75 turns/min or 80 turn/min etc..
It preferably, further include after baicalin capsules to be carried out to aluminum-plastic packaged and outer packing, obtaining Huang after step (5)
A kind of reed mentioned in ancient books glycosides capsule product.
Wherein aluminum-plastic packaged process is as follows: blanking system, aluminum-plastic packaged mold and corresponding lot number are got between mold
Character, interior packaging material working area get polyvinyl chloride solid medicinal stiff sheet, blank aluminium foil, the qualification of respective batch are got from intermediate station
Baicalin capsules 250mg capsule is added in Aluminium-coating Packer lower hopper, aluminium foil and polychlorostyrene by baicalin capsules 250mg capsule
Ethylene solid medicinal stiff sheet is mounted on Aluminium-coating Packer, and temperature carries out empty machine operating after reaching, check plastic-aluminum heat-sealing, cutting,
Lot number prints situation, and cloth situation, heat seal quality, cutting situation, lot number are kept a close eye in packaging process and prints situation.Aluminium-plastic panel
Must not there are scarce grain, leakage grain, a fine powder, foreign matter, fold etc., aluminium-plastic panel neat in edge, without skirt, crimping, cracking, lot number, effect phase beat
Print is clear correct.
The process of outer packing are as follows: the qualified outsourcing material and product to be packaged for getting outer packing needs, getting outer packing needs
The product to be packaged baicalin capsules 250mg capsule aluminium-plastic panel quantity wanted, first the rolling well on one side by capsule of outer packing personnel, by 2
Plate baicalin capsules 250mg capsule aluminium-plastic panel and 1 specification are packed into a carton, then roll another side well.
Compared with the existing technology, the invention has the following advantages:
Secretion in HepG 2.2.2.15 provided by the invention, by the reasonably combined of each material, so that the particulates' properties that granulation obtains
Stablize, is uniformly mixed, it is superior in quality.Suitable adhesive is especially selected, so that capsule has the very good uniformity
And stability.
The preparation method of baicalin capsules provided by the invention reaches fine by suitable adhesive and grain made parameter
Granulating efficiency, good evenness, quality stablize；Using fluidized bed drying mode, rate of drying is high, and the thermal efficiency is high, and temperature is uniform,
Good fluidity after dry materials；Pot, fluidized bed, pelletizing machine pelletize by pipeline disjunctor, Automation of Manufacturing Process degree is high；It keeps away
Manpower-free's operation causes to pollute, and uses manpower and material resources sparingly simultaneously.Using efficient hybrid mode, material is uniformly mixed, and product quality is steady
It is fixed.
Detailed description of the invention
Fig. 1 is the preparation technology flow chart for the baicalin capsules that the embodiment of the present invention 1 provides.
Specific embodiment
The technical scheme of the invention is further explained by means of specific implementation.Those skilled in the art should be bright
, the described embodiments are merely helpful in understanding the present invention, should not be regarded as a specific limitation of the invention.
Embodiment 1
The present embodiment provides a kind of secretion in HepG 2.2.2.15
200 parts of scutelloside, 20 parts of microcrystalline cellulose, 20 parts of sodium carboxymethyl starch, 3.6 parts of PVP K30, talcum powder 3
Part, 95% 34.2 parts of ethyl alcohol, 34.2 parts of water.
Baicalin capsules are prepared by following below scheme, flow chart is shown in Fig. 1:
Premix: opening feeding port, first sucks a part of scutelloside in wet granulation pot, then microcrystalline cellulose is added to
In wet granulation pot；A part of scutelloside is drawn into wet granulation pot again, adds second part carboxyrnethyl starch sodium, finally
It sucks remaining scutelloside, after feeding, starts rotating speed of agitator 80rpm.Mixing 5 minutes.
During above-mentioned premix, since scutelloside is main ingredient, amount is bigger, so first add a part of scutelloside, then
Add unclassified stores, then plus remaining scutelloside, be easier to be uniformly mixed in this way.
Wet granulation: entering plus the 50% ethanol solution stage of adhesive PVP K30, and three phases are obtained to step (1)
To mixture in adhesive is added:
A is directly added into first part's adhesive, and stirring and cutter are not turned on, and accounts for the 15% of adhesive total amount；
It is viscous that second part is added in the case where wriggling pump speed is 150rpm, cutter 1200rpm, agitating paddle 60rpm state in b
Mixture accounts for the 70% of adhesive total amount, time 4.5min；
It is viscous that Part III is added in the case where wriggling pump speed is 100rpm, cutter 1000rpm, agitating paddle 40rpm state in c
Mixture accounts for the 15% of adhesive total amount, time 2min；
Add the adhesive stage to terminate, enter granulating stage, adjustment mixing speed is 120rpm, stirs 4min, cutter
Speed 2500rpm cuts 4min.
Wet whole grain and particle drying: wet granular by whole grain and sucks fluidized bed after wet granulation.
The mesh size of fluidized bed is 10.0 × 9.5mm, intake 2000m3/h.Wet process whole grain and fluidized bed feeding rank
Section terminates, and is adjusted into drying stage according to goods fluid state, and inlet air temperature is set as 40~60 DEG C, when moisture≤3.0%, stops
Only drying.
Dry whole grain: dry particl is crossed into 2.0 (A) mm sieves with dry method pelletizing machine, swivel speed 600rpm whole grain of circling round, by whole grain
Particle afterwards is in mixed-hopper.
Total mix: talcum powder is added into baicalin capsules 250mg dry particle, mixed-hopper cover board is covered, will be mixed
Bucket is fixed on mixing machine, revolving speed 15rpm, mixes 20min.
Capsule filling: from capsule die is got between mold, correctly installing capsule die and part of appliance, after weighing temporarily
Gelatin empty hard capsule, baicalin capsules 250mg total mix particle are got between depositing, and baicalin capsules 250mg total mix particle will be housed
Mixed-hopper hopper elevator be promoted to above capsule filling machine, connect mixed-hopper and lower hopper, setting capsule is filled out
Filling speed is 60~80 revs/min, crawl blanking agitating paddle, makes to adjust in powder disk full of baicalin capsules 250mg total mix particle
The compression depth of good each medicine-feeding station, is automatic mode by machine set after regulating capsule pad parameter, carries out capsule and fill out
It fills.
Aluminum-plastic packaged: from blanking system, aluminum-plastic packaged mold and corresponding lot number character is got between mold, interior packaging material is temporary
Polyvinyl chloride solid medicinal stiff sheet, blank aluminium foil are got by area, and the qualified baicalin capsules 250mg of respective batch is got from intermediate station
Baicalin capsules 250mg capsule is added in Aluminium-coating Packer lower hopper by capsule, aluminium foil and polyvinyl chloride solid medicinal stiff sheet
It is mounted on Aluminium-coating Packer, temperature carries out empty machine operating after reaching, check that plastic-aluminum heat-sealing, cutting, lot number print situation, packaging
Cloth situation, heat seal quality, cutting situation, lot number are kept a close eye in the process prints situation.Aluminium-plastic panel must not have scarce grain, leakage grain,
Fine powder, foreign matter, fold etc., aluminium-plastic panel neat in edge, without skirt, crimping, cracking, lot number, the printing of effect phase are clear correct.
Wherein, the speed of service be 150 plates/minute, forming temperature be 120 DEG C, 220 DEG C of heat-sealing temperature, briquetting pressure 7bar.
Outer packing: the outer packaging material of qualification and product to be packaged of outer packing needs are got, the to be packaged of outer packing needs is got
Product baicalin capsules 250mg capsule aluminium-plastic panel quantity, first the rolling well on one side by capsule of outer packing personnel, by 2 plate scutelloside glue
Capsule 250mg capsule aluminium-plastic panel and 1 specification are packed into a carton, then roll another side well.
Embodiment 2
The present embodiment provides a kind of secretion in HepG 2.2.2.15
280 parts of scutelloside, 40 parts of microcrystalline cellulose, 40 parts of sodium carboxymethyl starch, 9 parts of PVP K30,5 parts of talcum powder,
95% 44.5 parts of ethyl alcohol, 44.5 parts of water.
Preparation method and embodiment 1 with it is identical.
Embodiment 3
The present embodiment provides a kind of secretion in HepG 2.2.2.15
180 parts of scutelloside, 20 parts of microcrystalline cellulose, 20 parts of polyvinylpyrrolidone, 3.63 parts of PVP K30, talcum powder
1 part, 95% 26 parts of ethyl alcohol, 26 parts of water.
Preparation method and embodiment 1 with it is identical.
Embodiment 4
The present embodiment provides a kind of secretion in HepG 2.2.2.15
190 parts of scutelloside, 25 parts of microcrystalline cellulose, 30 parts of sodium carboxymethyl starch, 8.1 parts of starch, 2 parts of talcum powder, 95%
48.6 parts of ethyl alcohol, 48.6 parts of water.
Preparation method and embodiment 1 with it is identical.
Embodiment 5
The present embodiment provides a kind of secretion in HepG 2.2.2.15
200 parts of scutelloside, 20 parts of microcrystalline cellulose, 20 parts of sodium carboxymethyl starch, 1.58 parts of PVP K30, talcum powder 3
Part, 95% 34.5 parts of ethyl alcohol, 36.5 parts of water.
Preparation method and embodiment 1 with it is identical.
Embodiment 6
The present embodiment provides a kind of secretion in HepG 2.2.2.15
200 parts of scutelloside, 20 parts of microcrystalline cellulose, 20 parts of sodium carboxymethyl starch, 6 parts of starch, 3 parts of talcum powder, 95% second
45 parts of alcohol, 45 parts of water.
Preparation method and embodiment 1 with it is identical.
Comparative example 1
The difference of this comparative example and embodiment 1 is only that, in this comparative example wet-granulation process, adhesive is added and is not divided into
Three phases, but be added by a step.Remaining process is same as Example 1.
Comparative example 2
The difference of this comparative example and embodiment 1 is only that this comparative example drying mode does not use fluidized bed, and uses hot wind
Oven drying is recycled, i.e. material is placed in dry pallet, is placed on the fixation bracket in baking oven or cart bracket, hot wind is heated
Enter drier, the method that then material is dried by particle layer surface with horizontal direction after device heating.Remaining process
It is same as Example 1.
There are biggish defects for heated-air circulation oven seasoning: (1) because particle has certain thickness (about 2-3cm) and locates
In stationary state, cause baking oven hot wind penetration power not strong, drying time is longer, easily causes particle because uneven heating is even, particle is easy
Generate piebald or the different situation of color；(2) in the drying process, uniformity of dosage units may be will cause because water translocation is uneven
Variant situation；(3) in operation, material or particle large labor intensity are loaded and unloaded, condition is poor, is also easy to produce dust and causes dirt
Dye etc..
Comparative example 3
The difference of this comparative example and embodiment 1 is only that, in this comparative example capsule composition, the quality of ethyl alcohol is 40 parts,
The quality of water is 30 parts.Remaining is same as Example 1.
The above-mentioned capsule being prepared is subjected to quality testing, the test uniformity is (after granulation, in specified position point
Do not sample, carry out assay, compare the content and relative standard deviation (RSD) of each point, the method is most reliable method) and
Stability (dissolution rate), the result of test are as shown in table 1 below:
Table 1
| Sample | Uniformity of dosage units (RSD) | Stability (dissolution rate) |
| Embodiment 1 | ≤ 5% | 85~95% |
| Embodiment 2 | ≤ 5% | 90~98% |
| Embodiment 3 | 5~10% | 90~100% |
| Embodiment 4 (adhesive is starch) | 5~10% | 50~70% |
| Embodiment 5 | ≤ 5% | 95~100% |
| Embodiment 6 (adhesive is starch) | 5~10% | 50~70% |
| Comparative example 1 | 5~10% | 80~95% |
| Comparative example 2 | 5~10% | 85~95% |
| Comparative example 3 | ≤ 5% | 95~100% |
Adhesive uses starch in embodiment 4 and embodiment 6, and dissolution rate is poor.Ethyl alcohol can not mix completely with starch slurry
It closes uniformly, also reduction starch slurry adhesive viscosity, is not easy to pelletize in granulation, fine powder is more.
It is to be added at one time to be added without being divided into three phases that it is because of adhesive that 1 dissolution rate of comparative example is relatively poor,
It is shorter because the time may be stirred when being added at one time because of ethyl alcohol and the scutelloside in adhesive, fail to fill scutelloside
Divide wet dissolution, partial size, which fails to become smaller, achievees the effect that solid redisperse or effect are slightly worse, and it is poor to may result in dissolution.
Comparative example 2 is dry using heated-air circulation oven, therefore method has an inevitable defect, and thickness is not in pallet for particle
It is even, when failing timing stirring during the drying process, it may result in granule content distribution and have an impact.
Comparative example 3 and embodiment 1 are distinguished only adhesive amount of alcohol and are improved, and water reduces, because scutelloside dissolves in ethanol,
Therefore in granulation, scutelloside dissolution is more preferable, and the uniformity is compared with stability with embodiment, is not much different substantially, difference be exactly because
Water reduces, and will lead to that material fine powder is more, may will affect the mobility of filling.
The Applicant declares that the present invention is explained by the above embodiments secretion in HepG 2.2.2.15 of the invention, baicalin capsules
And preparation method thereof, but the invention is not limited to above-mentioned processing steps, that is, do not mean that the present invention must rely on above-mentioned technique
Step could be implemented.It should be clear to those skilled in the art, any improvement in the present invention, to selected by the present invention
The equivalence replacement of raw material and addition, the selection of concrete mode of auxiliary element etc. all fall within protection scope of the present invention and openly
Within the scope of.
Claims (10)
1. a kind of secretion in HepG 2.2.2.15, which is characterized in that the composition includes 180~280 parts of scutelloside by weight, is collapsed
40~80 parts of agent, 1.1~10.8 parts of adhesive, 1~5 part of talcum powder, 53.9~97.2 parts of solvent of solution.
2. composition according to claim 1, which is characterized in that the disintegrating agent includes microcrystalline cellulose, carboxymethyl shallow lake
In powder sodium, polyvinylpyrrolidone or low substituted cellulose any one or at least two combination；
Preferably, the disintegrating agent is the composition of microcrystalline cellulose and sodium carboxymethyl starch；
Preferably, the mass ratio of the microcrystalline cellulose and sodium carboxymethyl starch is 1:1.
3. composition according to claim 1 or 2, which is characterized in that described adhesive includes starch, dextrin, polyethylene
In alcohol, carboxymethyl cellulose or PVP K30 any one or at least two combination；
Preferably, described adhesive is PVP K30.
4. composition according to any one of claim 1-3, which is characterized in that the solvent include methanol, ethyl alcohol or
Any one in water；
Preferably, the solvent is the combination of second alcohol and water；
Preferably, the mass ratio of the second alcohol and water is 1:1；
Preferably, the concentration of the ethyl alcohol is 95%.
5. composition described in any one of -4 according to claim 1, which is characterized in that the composition includes by weight
180~280 parts of scutelloside, 20~40 parts of microcrystalline cellulose, 20~40 parts of sodium carboxymethyl starch, PVP K30 1.1~10.8
Part, 1~5 part of talcum powder, 95% 26~48.6 parts of ethyl alcohol, 26~48.6 parts of water, the microcrystalline cellulose and sodium carboxymethyl starch
Mass ratio be 1:1, the mass ratio of the second alcohol and water is 1:1, quality percentage of the PVP K30 in binder solution
Than being 2%~10%.
6. a kind of baicalin capsules, which is characterized in that the baicalin capsules include gelatin empty hard capsule and such as claim
Secretion in HepG 2.2.2.15 described in any one of 1-5.
7. the preparation method of baicalin capsules according to claim 6, which is characterized in that the preparation method includes as follows
Step:
(1) by vacuum feeding, first a part of scutelloside is first sucked in wet granulation pot, then a part of disintegrating agent is drawn into
In wet granulation pot, then a part of scutelloside is drawn into wet granulation pot, adds second part disintegrating agent, finally suck
Remaining scutelloside is stirred to obtain mixture；
(2) it passes sequentially through in the mixture that a, b, c three phases are obtained to step (1) and adhesive is added:
A is directly added into first part's adhesive；
Second part adhesive is added under peristaltic pump, cutter, the equal open state of agitating paddle in b；
Part III adhesive is added under peristaltic pump, cutter, the equal open state of agitating paddle in c；
(3) cutter and agitating paddle speed are adjusted, is pelletized；
(4) it is dried the particle that step (3) obtains to obtain dry particle using fluidized bed；
(5) talcum powder is added into particle obtained in step (4), is mixed to get total mix particle, and backward gelatin empty hard
Total mix particle is filled in capsule, wherein filling total mix particle 250mg in each hard capsule to get baicalin capsules are arrived.
8. preparation method according to claim 7, which is characterized in that the time of vacuum feeding described in step (1) be 5~
10min；
Preferably, the revolving speed of stirring described in step (1) is 60~100rpm；
Preferably, the time of stirring described in step (1) is 2~8min；
Preferably, adhesive described in step (2) is 50% ethanol solution of PVP K30；
Preferably, the speed of b-stage peristaltic pump is 0~180rpm in step (2), and the revolving speed of agitating paddle is 0~80rpm, cutting
The speed of knife is 0~1500rpm；
Preferably, the speed of c stage peristaltic pump is 0~110rpm in step (2), and the revolving speed of agitating paddle is 0~80rpm, cutting
The speed of knife is 0~1500rpm；
Preferably, the mass ratio of first part's adhesive, second part adhesive and Part III adhesive is 1 in step (2):
(3~4): (0.1~1).
9. preparation method according to claim 7 or 8, which is characterized in that in step (3) revolving speed of agitating paddle be 80~
150rpm；
Preferably, the time of stirring paddle stirring is 2~6min in step (3)；
Preferably, the speed of cutter is 2000~3000rpm in step (3)；
Preferably, the clipping time of cutter is 2~6min in step (3)；
Preferably, the intake of fluidized bed described in step (4) is 800~2500m3/h；
Preferably, in step (4), when the moisture of particle is≤3.0%, stop drying.
10. the preparation method according to any one of claim 7-9, which is characterized in that mixing described in step (5) when
Between be 10~30min；
Preferably, the speed of agitator of mixing described in step (5) is 10~20rpm；
Preferably, the speed filled in step (5) is 60~80 turns/min.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1481805A (en) * | 2003-07-14 | 2004-03-17 | 军 王 | Medication for hepatitis and its preparation method |
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2018
- 2018-11-27 CN CN201811425066.XA patent/CN109288854A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1481805A (en) * | 2003-07-14 | 2004-03-17 | 军 王 | Medication for hepatitis and its preparation method |
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Application publication date: 20190201 |