CN105343022B - A kind of roxburgh anoectochilus terminal bud tablet and preparation method thereof - Google Patents
A kind of roxburgh anoectochilus terminal bud tablet and preparation method thereof Download PDFInfo
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- CN105343022B CN105343022B CN201510808016.XA CN201510808016A CN105343022B CN 105343022 B CN105343022 B CN 105343022B CN 201510808016 A CN201510808016 A CN 201510808016A CN 105343022 B CN105343022 B CN 105343022B
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
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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)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/898—Orchidaceae (Orchid family)
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Abstract
The invention discloses a kind of roxburgh anoectochilus terminal bud tablets and preparation method thereof.Step is respectively to crush dry jewel orchid and xylitol with high speed disintegrator, sieving；Roxburgh anoectochilus terminal bud powder and xylosic alcohol powder are poured into the valve bag of PE materials and are sieved after shaking mixing, continued shaking into uniform powder, uniformly mixed powder is poured into dry granulating machine and is directly pelletized；Hydrophobic lubricant MS is added, the valve bag of PE materials is packed into, is uniformly mixed；Adjust rotating speed and pressure, tabletting.
Description
Technical field
The present invention relates to formulation arts more particularly to a kind of roxburgh anoectochilus terminal bud tablet and preparation method thereof.
Background technology
Roxburgh anoectochilus terminal bud is orchid Anoectochilus Roxburghii Anoectochilus roxburghii (Wall) Lindl, alias gold
Line orchid, rough melic herb are known as the laudatory titles such as " king of medicine ", " gold grass ", " god's medicine ", " black ginseng ",《Fujian Province's prepared slices of Chinese crude drugs concocted specification》
(version in 2012) is recorded, and roxburgh anoectochilus terminal bud has clearing heat and cooling blood, expelling wind and removing dampness, removing toxic substances.Cough with lung heat is cured mainly, is spat blood, hematuria, acute infantile convulsion
Wind, jaundice, oedema, stranguria are quenched one's thirst, arthralgia pain due to rheumatism, traumatic injury, venomous snake bite.Modern times are used for hepatitis, ephritis, cystitis, sugar
Urine disease, bronchitis, the diseases such as rheumatic arthritis.Roxburgh anoectochilus terminal bud is Fujian platform characteristic Chinese herbal medicine, the civil title for being known as " king of medicine ".
The generation of Chinese medicinal tablet is the improvement to conventional dosage forms such as decoction, pills.The dissolution rate and bioavilability of tablet
It is good compared with pill；Dosage is accurate, and medicament contg difference is smaller in tablet；Stable quality；It takes, carry, transport and stores etc. and all compare
It is more convenient；Mechanization production, yield is big, at low cost.Currently, Chinese medicinal tablet has become, wide in variety, yield is big, purposes is wide, takes
With the main dosage form of Chinese medicine for storing and transporting convenient, stable quality.It is computed, 1 roxburgh anoectochilus terminal bud original powder tablet dose is equivalent to about 4.2g
Fresh roxburgh anoectochilus terminal bud.
It is mainly being sold currently on the market with fresh roxburgh anoectochilus terminal bud, drying roxburgh anoectochilus terminal bud and roxburgh anoectochilus terminal bud tea；In addition there is few portion
Point roxburgh anoectochilus terminal bud compound oral liquid and spray are cured the disease use as hospital preparation to patient；The instant powder of also related roxburgh anoectochilus terminal bud surpasses
Micro mist, granule patent solve the problems, such as that roxburgh anoectochilus terminal bud is taken, is inconvenient to carry, but hospital preparation is controlled just for patient in hospital
Disease uses, and is not suitable for the daily health caring of ruck；But regardless of the product for being the instant powder of roxburgh anoectochilus terminal bud, Ultramicro-powder or granule
It is designed as the type for needing to be brewed with water, it is inconvenient directly oral.
Invention content
Accurate, easy storage that the purpose of the present invention is to provide a kind of dosage carries simple and convenient to take (can directly use
Water delivery service) roxburgh anoectochilus terminal bud tablet.
To achieve the above object, the present invention provides a kind of preparation method of roxburgh anoectochilus terminal bud tablet, which is characterized in that and step is,
It crushes：Dry jewel orchid and xylitol are crushed with high speed disintegrator respectively, are sieved；
Mixing granulation：Roxburgh anoectochilus terminal bud powder and xylosic alcohol powder are poured into the valve bag of PE materials and are sieved after shaking mixing, continued
Uniform powder is shaken into, uniformly mixed powder is poured into dry granulating machine and is directly pelletized；
Tabletting：Hydrophobic lubricant MS is added, the valve bag of PE materials is packed into, is uniformly mixed；Adjust rotating speed and pressure, pressure
Piece.
Further, in the pulverising step, the wet weight of dry jewel orchid is 6-12%.
Further, in the pulverising step, roxburgh anoectochilus terminal bud powder crosses 200 mesh sieve；Xylitol crosses 120 mesh sieve.
Further, in the mixing granulation step, roxburgh anoectochilus terminal bud powder and xylosic alcohol powder are poured into the valve bag of PE materials and is shaken
It is sieved with 100 mesh sieve after shaking 90s, continues to shake 60s or more.
Further, in the mixing granulation step, the weight ratio of roxburgh anoectochilus terminal bud and xylitol is 80-110:90-120；It is preferred that
80:120 or 90:110、100:100、110:90.
Further, in the whole grain step, be sieved for No. 1 pharmacopeia sieve.
Further, in the mixing granulation step, dry granulating machine used is 10 mesh screens.
Further, in the tableting step, the hydrophobic lubricant MS of 0.8% weight is added.
Further, in the tableting step, rotary tablet machine pressure 26kN, 28kN or 30kN.
The present invention also provides the roxburgh anoectochilus terminal bud tablets that the preparation method of the roxburgh anoectochilus terminal bud tablet is prepared.
The dry granulation procedure removes bulky grain using 10 mesh screens, because dry granulating machine is raw material in pelletization
It is packed into hopper, material extruding flakiness is made up using granulating system by the broken granulation of thin slice of smooth extruding roller
Particle is irregular little particle, by 10 mesh screens, removes bulky grain, ensures even particle size.
In prepared by tablet, the purpose of granulation is not just to improve the mobility of material, dustability, adhesion and advantageous
In accurate measurement, protection production environment etc., it is necessary to ensure uniform, good appearance of shape size of particle etc..Method of granulating has
It is a variety of.Method of granulating is different, even same prescription, the shape, size, the intensity that obtain granulation object are also different, and
Disintegration, dissolubility are also different, to generate different drug effects.After roxburgh anoectochilus terminal bud original powder tablet mainly uses dry jewel orchid to crush
The powder of auxiliary material is uniformly mixed, after being compressed into big sheet or plate, then the method that is ground into required size particles, belong to dry method system
The tablet manufacturing technique of grain, the method are added without binder, only make intermolecular generation binding force by compressing force, it is desirable that drug and auxiliary material
Property want close, in this way can to avoid mix it is uneven.Because when the physical properties such as the heap density of material, size distribution are close
Mixed uniformity is better.
In preparation method of the present invention, the selection of the shaking time in softwood step processed, applicant examines according to appearance uniform degree
It looks into determine best mixed method.It is specifically shown in Tables 1 and 2.
Inventor screens roxburgh anoectochilus terminal bud powder and xylosic alcohol powder hybrid mode and incorporation time, powder after being mixed by comparison
The appearance uniform degree at end, filters out best hybrid mode and incorporation time.
By roxburgh anoectochilus terminal bud powder and xylosic alcohol powder (weight 1:1) it pours into the valve bag of PE materials, the upper and lower shaking 30s of difference,
60s, 90s, 120s, 150s, 170s, 190s do appearance uniform degree inspection, take mixed-powder appropriate, set in glossy paper, tiling
5cm2, its surface is flattened with glass plate, is observed at light, uniform color and luster, no decorative pattern, color spot is presented.It the results are shown in Table 1.
The mixed-powder appearance contrast table of the different shaking times of table 1
| Shake duration (s) | Appearance |
| 30 | There is apparent white decorative pattern |
| 60 | There are apparent white decorative pattern or color spot |
| 90 | There are apparent white decorative pattern or color spot |
| 120 | There are white decorative pattern or color spot |
| 150 | There are white decorative pattern or color spot |
| 170 | There are white decorative pattern or color spot |
| 190 | There are white decorative pattern or color spot |
As can be seen from Table 1,30-60s is shaken, as the shaking time increases, mixed-powder decorative pattern or color spot are reduced, 90s
Afterwards, as the shaking time increases, the mixed-powder uniformity does not increase, still there is white decorative pattern or color spot.So method can mix
Powder, but checked by appearance uniform degree, is unable to that appearance luster is uniform, no decorative pattern, color spot mixed-powder, be only used as powder
The premixing step at end.Appearance uniform degree inspection is carried out after shaking, decorative pattern or color spot are no longer reduced after 90s, therefore are pre-mixed most
The good time is 90s.
By roxburgh anoectochilus terminal bud powder and xylosic alcohol powder (weight ratio 1:1) it pours into the valve bag of PE materials, after shaking 90s, pours out, mistake
(fine powder is easy to form small agglomerate because electrostatic generates polymerization No. 6 pharmacopeia sieves (100 mesh), and sieving contributes to the dispersion of agglomerate in fine powder
And with the mixing of other powder) after, pour into PE materials valve bag respectively up and down shaking mixing 30s, 60s, 90s, 120s,
150s does appearance uniform degree inspection, the results are shown in Table 2.30s appearance uniforms are shaken, there is white color spot once in a while, shake 60s-150s,
Uniform color, no decorative pattern, color spot.Therefore No. 6 pharmacopeia sieves are crossed after mixed-powder shaking 90s, then it is best hybrid mode to shake 60s.
The mixed-powder appearance contrast table of the different shaking times after being sieved of table 2
| Shake duration (s) | Appearance |
| 30 | Appearance uniform has white color spot once in a while |
| 60 | Uniform color, no decorative pattern, color spot. |
| 90 | Uniform color, no decorative pattern, color spot. |
| 120 | Uniform color, no decorative pattern, color spot. |
| 150 | Uniform color, no decorative pattern, color spot. |
Inventor's manufactured particle effect under differential roller wheel pressure the ratio of roxburgh anoectochilus terminal bud powder and xylosic alcohol powder, to gold
Line lotus powder and xylosic alcohol powder and roller pressure carry out comparison screening.
The different roxburgh anoectochilus terminal bud powder of table 3, particle effect contrast table is made in xylosic alcohol powder ratio and differential roller wheel pressure
It according to table 3, can be obtained from particle appearance, roxburgh anoectochilus terminal bud powder is 80 with xylosic alcohol powder weight ratio:120、90:110、
100:100 and 110:90, in the case of roller pressure is 3MPa, because roller pressure is less than normal, it is complete to make particle, but holds and embrace
Group, partial particulate bulk ingredient, such granule fines are more, and tabletting is also easy to produce loose pieces；Roxburgh anoectochilus terminal bud powder and xylosic alcohol powder weight
Ratio is 80:120、90:110、100:100 and 110:90, in the case of roller pressure is 6MPa, because roller pressure is excessive, system
At particle, particle is complete, hard, and holding is not united, and such particle is hard, is not easy to be pressed into the smooth tablet in surface, and easily production
Raw sliver；Roxburgh anoectochilus terminal bud powder is 120 with xylosic alcohol powder weight ratio:80 and 130:70, since roxburgh anoectochilus terminal bud powder proportions are higher, gold thread
Fibre-bearing is more in lotus powder, keeps fiber content in mixed-powder higher, lacks viscosity, causes particle loose, in different pressures
Under it is all different degrees of loose with powder or the particle made, be not suitable for tabletting；And in roxburgh anoectochilus terminal bud powder and xylosic alcohol powder weight
Ratio is 80-110:90-120；Especially 80:120、90:110、100:100 and 110:90, roller pressure is 4MPa, 5MPa feelings
Under condition, the particle made is complete, and holding is united.
The angle of repose contrast table for the particle that 4 complete appearance of table, holding are united
For the angle of repose that measures particle, (angle of repose is smaller, and the mobility of particle is better, in tableting processes, contributes to
Grain is filled into punch die, reduces weight differential between tablet), funnel is fixed on horizontal positioned shelf by inventor, mouth under funnel
It is H away from horizontal position height, carefully pours into dry particl in funnel, until the nib contacts of the cone formed under funnel
Until the lower mouth of funnel, a diameter of 2R of cone, then tg α=H/R, the angles α are angle of repose.(when angle of repose is more than 45 °,
There is grain loose sense, poor fluidity often to make particle filling die hole amount insufficient and generate loose pieces).
It can be obtained from the angle of repose of particle, be 110 in roxburgh anoectochilus terminal bud powder and xylosic alcohol powder:Under 90 weight ratio, particle
Angle of repose is 47 °, is more than 45 °, mobility is poor；It is 80 in roxburgh anoectochilus terminal bud powder and xylosic alcohol powder:120、90:110、100:100 weights
Under amount ratio, roller pressure is 4MPa or 5MPa, and in roxburgh anoectochilus terminal bud powder and xylosic alcohol powder is 110:Under 90 weight ratio, roller
Pressure is 5MPa, and particle angle of repose is respectively less than 45 °, it is optimal to make particle.
Carrying out tabletting after obtained particle is mixed with hydrophobic lubricant MS again in 5min, general dosage is 0.25~
1 weight %, the present invention have investigated the ratio of 0.4 weight %, 0.6 weight %, 0.8 weight %, 1 weight % to ensure piece after tabletting
The bright and clean beauty in face, and it is ultimately determined to 0.8%.
After tablet is made, inventor also visits tablet appearance, disintegration time limited and hardness tablet press machine different pressures
Study carefully, is shown in Table 5.
The different tablet press machine pressure of table 5 to tablet appearance, disintegration time limited, hardness, weight differential influence table
Inventor checks tablet appearance, extracts 20, sample and is laid on white background plate, is placed in 60cm under 75W light sources
Place, to visually observe 30 seconds, is checking whether complete bright and clean, the uniform color of tablet at tablet 30cm, and whether there is or not serious piebalds
Or foreign matter.First under tablet press machine 20Kn, 22Kn pressure, due to insufficient pressure, tablet portion is loosely imperfect, 24Kn,
Under 26Kn, 28Kn, 30Kn, 32Kn pressure, tablet is completely bright and clean, no piebald；
Inventor again probes into the disintegration of tablet time limit, first checks for lift disintegration tester, and hanging basket is passed through upper end
Stainless steel shaft is hung on metallic support, is immersed in 1000ml beakers, and the thermostatted water that temperature is 37 DEG C ± 1 DEG C is filled in cup, is adjusted
When section height of water level is that hanging basket rises, sieve is at the 15mm of underwater, and when decline, sieve is away from beaker bottom 25mm, above and below holder
Displacement distance is 55mm ± 2mm, and roundtrip frequency is 30~32 times per minute.Roxburgh anoectochilus terminal bud original powder piece 6 is taken, the glass of hanging basket is placed in
Guan Zhong is often managed and is respectively added 1, adds baffle, is started disintegration tester and is checked, calculates the average value of 6 disintegration time limiteds.As a result exist
Under 20Kn, 22kN, 24Kn, 26Kn, 28Kn, 30Kn pressure, disintegration time limited of tablet be respectively 4min, 8min, 20min,
23min, 24min, 26min, and under 32Kn pressure, disintegration time limited 38min, disintegration time it is long (《Chinese Pharmacopoeia》2015
Four 0921 regulations of version, each of the full powder piece of Chinese medicine should all be all disintegrated in 30min.), therefore 20Kn, 22kN, 24Kn, 26Kn,
The disintegration of tablet time limit made under 28Kn, 30Kn pressure meets the requirements.
The inspection of tablet hardness, with Monsanto durometer, between tablet is stood on two pressing plates, along tablet diameters side
To pressurizeing slowly, until broken, measuring makes to be crushed required power.Wherein under 20Kn, 22kN, 24Kn pressure, tablet hardness point
Not Wei 1.7Kg, 1.8Kg, 1.8Kg, hardness is less than normal, is easy to break up in transportational process, it cannot be guaranteed that the integrality of tablet, generally
Chinese medicinal tablet hardness is in 2-3Kg：Under 26Kn, 28Kn, 30Kn, 32Kn pressure, tablet hardness be respectively 2.3Kg, 2.6Kg,
2.9Kg, 3.2Kg, hardness meet the requirements.
In conclusion tablet press machine is best under 26Kn, 28Kn, 30Kn pressure, tablet is completely bright and clean, no piebald, when disintegration
Limit and tablet hardness meet the requirements.
Specific implementation mode
The embodiment of the present invention is described below in detail, the examples of the embodiments are intended to be used to explain the present invention, and cannot
It is interpreted as limitation of the present invention.In the examples where no specific technique or condition is specified, according to described by document in the art
Technology or condition or carried out according to product description.Reagents or instruments used without specified manufacturer is that can lead to
Cross the conventional products of acquisition purchased in market.
Embodiment 1：The preparation of roxburgh anoectochilus terminal bud tablet
1, the selection of mode is shaken：
By roxburgh anoectochilus terminal bud powder and xylosic alcohol powder (weight 1:1) it pours into the valve bag of PE materials, the upper and lower shaking 30s of difference,
60s, 90s, 120s, 150s, 170s, 190s do appearance uniform degree inspection, take mixed-powder appropriate, set in glossy paper, tiling
5cm2, its surface is flattened with glass plate, is observed at light, uniform color and luster, no decorative pattern, color spot is presented.It the results are shown in Table 1.
The mixed-powder appearance contrast table of the different shaking times of table 1
| Shake duration (s) | Appearance |
| 30 | There is apparent white decorative pattern |
| 60 | There are apparent white decorative pattern or color spot |
| 90 | There are apparent white decorative pattern or color spot |
| 120 | There are white decorative pattern or color spot |
| 150 | There are white decorative pattern or color spot |
| 170 | There are white decorative pattern or color spot |
| 190 | There are white decorative pattern or color spot |
As can be seen from Table 1,30-60s is shaken, as the shaking time increases, mixed-powder decorative pattern or color spot are reduced, 90s
Afterwards, as the shaking time increases, the mixed-powder uniformity does not increase, still there is white decorative pattern or color spot.So method can mix
Powder, but checked by appearance uniform degree, cannot obtain that appearance luster is uniform, no decorative pattern, color spot mixed-powder, only make
For the premixing step of powder.Appearance uniform degree inspection is carried out after shaking, decorative pattern or color spot are no longer reduced after 90s, therefore are pre-mixed
Best Times be 90s.
By roxburgh anoectochilus terminal bud powder and xylosic alcohol powder (weight ratio 1:1) valve bag of PE materials is poured into, after shaking 90s, is poured out, crosses 6
(fine powder is easy to form small agglomerate because electrostatic generates polymerization number pharmacopeia sieve (100 mesh), and sieving contributes to the dispersion of agglomerate in fine powder simultaneously
With the mixing of other powder) after, the valve bag for pouring into PE materials shakes mixing 30s, 60s, 90s, 120s, 150s up and down respectively,
Appearance uniform degree inspection is done, the results are shown in Table 2.
The mixed-powder appearance contrast table of the different shaking times after being sieved of table 2
| Shake duration (s) | Appearance |
| 30 | Appearance uniform has white color spot once in a while |
| 60 | Uniform color, no decorative pattern, color spot. |
| 90 | Uniform color, no decorative pattern, color spot. |
| 120 | Uniform color, no decorative pattern, color spot. |
| 150 | Uniform color, no decorative pattern, color spot. |
From table 2 it can be seen that shaking 30s appearance uniforms, there is white color spot once in a while, 60s-150s, uniform color, nothing are shaken
Decorative pattern, color spot.Therefore No. 6 pharmacopeia sieves are crossed after mixed-powder shaking 90s, then it is best hybrid mode to shake at least 60s.
2, the ratio of different raw material and the selection of roller pressure in pelletization
Inventor's manufactured particle effect under differential roller wheel pressure the ratio of roxburgh anoectochilus terminal bud powder and xylosic alcohol powder, to gold
Line lotus powder and xylosic alcohol powder and roller pressure carry out comparison screening.
The different roxburgh anoectochilus terminal bud powder of table 3, particle effect contrast table is made in xylosic alcohol powder weight ratio and differential roller wheel pressure
It according to table 3, can be obtained from particle appearance, roxburgh anoectochilus terminal bud powder is 80 with xylosic alcohol powder weight ratio:120、90:110、
100:100 and 110:90, in the case of roller pressure is 3MPa, because roller pressure is less than normal, it is complete to make particle, but holds and embrace
Group, partial particulate bulk ingredient, such granule fines are more, and tabletting is also easy to produce loose pieces；Roxburgh anoectochilus terminal bud powder and xylosic alcohol powder weight
Ratio is 80:120、90:110、100:100 and 110:90, in the case of roller pressure is 6MPa, because roller pressure is excessive, system
At particle, particle is complete, hard, and holding is not united, and such particle is hard, is not easy to be pressed into the smooth tablet in surface, and easily production
Raw sliver；Roxburgh anoectochilus terminal bud powder is 120 with xylosic alcohol powder weight ratio:80 and 130:70, since roxburgh anoectochilus terminal bud powder proportions are higher, gold thread
Fibre-bearing is more in lotus powder, keeps fiber content in mixed-powder higher, lacks viscosity, causes particle loose, in different pressures
Under it is all different degrees of loose with powder or the particle made, be not suitable for tabletting；And in roxburgh anoectochilus terminal bud powder and xylosic alcohol powder weight
Ratio is 80:120、90:110、100:100 and 110:90, roller pressure be 4MPa, 5MPa in the case of, the particle made is complete,
Holding is united.
The angle of repose contrast table for the particle that 4 complete appearance of table, holding are united
For the angle of repose that measures particle, (angle of repose is smaller, and the mobility of particle is better, in tableting processes, contributes to
Grain is filled into punch die, reduces weight differential between tablet), funnel is fixed on horizontal positioned shelf by inventor, mouth under funnel
It is H away from horizontal position height, carefully pours into dry particl in funnel, until the nib contacts of the cone formed under funnel
Until the lower mouth of funnel, a diameter of 2R of cone, then tg α=H/R, the angles α are angle of repose.(when angle of repose is more than 45 °,
There is grain loose sense, poor fluidity often to make particle filling die hole amount insufficient and generate loose pieces).
The angle of repose of particle can obtain from table 4, be 110 in roxburgh anoectochilus terminal bud powder and xylosic alcohol powder:Under 90 weight ratio,
The angle of repose of grain is 47 °, is more than 45 °, mobility is poor；It is 80 in roxburgh anoectochilus terminal bud powder and xylosic alcohol powder weight ratio:120、90:
110、100:Under 100 weight ratio, roller pressure is 4MPa or 5MPa, and in roxburgh anoectochilus terminal bud powder and xylosic alcohol powder is 110:90 weights
Under amount ratio, roller pressure is 5MPa, and particle angle of repose is respectively less than 45 °, it is optimal to make particle.
3. the experiment of hydrophobic lubricant MS difference dosages
Carrying out tabletting after obtained particle is mixed with hydrophobic lubricant MS again in 5min, general dosage is 0.25~
1 weight %, respectively by particle and 0.4 weight %, 0.6 weight %, 0.8 weight %, the MS of 1 weight % are uniformly mixed, and 24,
It is tested under 28,32Kn pressure.
As a result it obtains：0.4 weight %, the tablet appearance of 0.6 weight % ratios is rough, 0.8 weight %, 1 weight %
The tablet appearance of ratio is smooth, but finds that the disintegration time limited of 1 weight % ratios is more than 30min, and 0.8 weight through disintegration experiment
The disintegration time limited of % ratios is measured in 25min or so, each of the full powder piece of Chinese medicine should all be all disintegrated in 30min, therefore be chosen to be
0.8% ratio.
4, the selection of tablet press machine pressure
After tablet is made, inventor also visits tablet appearance, disintegration time limited and hardness tablet press machine different pressures
Study carefully, is shown in Table 5.
The different tablet press machine pressure of table 5 to tablet appearance, disintegration time limited, hardness, weight differential influence table
Inventor checks tablet appearance, extracts 20, sample and is laid on white background plate, is placed in 60cm under 75W light sources
Place, to visually observe 30 seconds, is checking whether complete bright and clean, the uniform color of tablet at tablet 30cm, and whether there is or not serious piebalds
Or foreign matter.First under tablet press machine 20Kn, 22Kn pressure, due to insufficient pressure, tablet portion is loosely imperfect, 24Kn,
Under 26Kn, 28Kn, 30Kn, 32Kn pressure, tablet is completely bright and clean, no piebald；
Inventor again probes into the disintegration of tablet time limit, first checks for lift disintegration tester, and hanging basket is passed through upper end
Stainless steel shaft is hung on metallic support, is immersed in 1000ml beakers, and the thermostatted water that temperature is 37 DEG C ± 1 DEG C is filled in cup, is adjusted
When section height of water level is that hanging basket rises, sieve is at the 15mm of underwater, and when decline, sieve is away from beaker bottom 25mm, above and below holder
Displacement distance is 55mm ± 2mm, and roundtrip frequency is 30-2 times per minute.Roxburgh anoectochilus terminal bud original powder piece 6 is taken, the glass tube of hanging basket is placed in
In, it often manages and respectively adds 1, add baffle, start disintegration tester and checked, calculate the average value of 6 disintegration time limiteds.As a result 20Kn,
Under 22kN, 24Kn, 26Kn, 28Kn, 30Kn pressure, disintegration time limited of tablet be respectively 4min, 8min, 20min, 23min,
24min, 26min, and under 32Kn pressure, disintegration time limited 38min, disintegration time it is long (《Chinese Pharmacopoeia》2015 editions four
0921 regulation, each of the full powder piece of Chinese medicine should all in 30min all be disintegrated), therefore 20Kn, 22kN, 24Kn, 26Kn, 28Kn,
The disintegration of tablet time limit made under 30Kn pressure meets the requirements.
The inspection of tablet hardness, with Monsanto durometer, between tablet is stood on two pressing plates, along tablet diameters side
To pressurizeing slowly, until broken, measuring makes to be crushed required power.Wherein under 20Kn, 22kN, 24Kn pressure, tablet hardness point
Not Wei 1.7Kg, 1.8Kg, 1.8Kg, hardness is less than normal, is easy to break up in transportational process, it cannot be guaranteed that the integrality of tablet, generally
Chinese medicinal tablet hardness is in 2-3Kg：Under 26Kn, 28Kn, 30Kn, 32Kn pressure, tablet hardness be respectively 2.3Kg, 2.6Kg,
2.9Kg, 3.2Kg, hardness meet the requirements.
Therefore tablet press machine is best under 26Kn, 28Kn, 30Kn pressure, tablet is completely bright and clean, no piebald, disintegration time limited and tablet
Hardness meets the requirements.
In conclusion obtaining in preparation method of the invention：
In the softwood step processed, mixed-powder crosses No. 6 pharmacopeia sieve after shaking 90s, then to shake at least 60s effects preferable；
It is 80 in roxburgh anoectochilus terminal bud powder and xylosic alcohol powder:120、90:110、100:Under 100 weight ratio, roller pressure is 4MPa
Or 5MPa, and in roxburgh anoectochilus terminal bud powder and xylosic alcohol powder be 110:Under 90 weight ratio, roller pressure is 5MPa, and particle angle of repose is equal
Less than 45 °, and particle is complete, and holding is united, and it is optimal to make particle.
Tablet press machine is best under 26Kn, 28Kn, 30Kn pressure, and tablet is completely bright and clean, no piebald, and disintegration time limited and tablet are hard
Degree meets the requirements.
Although the embodiments of the present invention has been shown and described above, it is to be understood that above-described embodiment is example
Property, it is not considered as limiting the invention, those skilled in the art are not departing from the principle of the present invention and objective
In the case of can make changes, modifications, alterations, and variations to the above described embodiments within the scope of the invention.
Claims (9)
1. a kind of preparation method of roxburgh anoectochilus terminal bud tablet, which is characterized in that step is,
It crushes：Dry jewel orchid and xylitol are crushed with high speed disintegrator respectively, are sieved；
Mixing granulation：Roxburgh anoectochilus terminal bud powder and xylosic alcohol powder are poured into the valve bag of PE materials after shaking 90s mixing and are sieved with 100 mesh sieve,
The weight ratio of roxburgh anoectochilus terminal bud and xylitol is 80-110:90-120 continues to shake 60s or more, uniformly mixed powder is poured into dry
Method granulator is directly pelletized；
Tabletting：Hydrophobic lubricant MS is added, the valve bag of PE materials is packed into, is uniformly mixed；Adjust rotating speed and pressure, tabletting.
2. the preparation method of roxburgh anoectochilus terminal bud tablet described in claim 1, which is characterized in that in the pulverising step, dry jewel orchid
Wet weight be 6-12%.
3. the preparation method of roxburgh anoectochilus terminal bud tablet described in claim 1, which is characterized in that in the pulverising step, roxburgh anoectochilus terminal bud powder mistake
200 mesh sieve；Xylitol crosses 120 mesh sieve.
4. the preparation method of roxburgh anoectochilus terminal bud tablet described in claim 1, which is characterized in that in the mixing granulation step, roxburgh anoectochilus terminal bud
Weight ratio with xylitol is 80:120 or 90:110、100:100、110:90.
5. the preparation method of roxburgh anoectochilus terminal bud tablet described in claim 1, which is characterized in that in the whole grain step, be sieved for No. 1
Pharmacopeia is sieved.
6. the preparation method of roxburgh anoectochilus terminal bud tablet described in claim 1, which is characterized in that in the mixing granulation step, dry method system
Grain machine used is 10 mesh screens.
7. the preparation method of roxburgh anoectochilus terminal bud tablet described in claim 1, which is characterized in that in the tableting step, add 0.8% weight
The hydrophobic lubricant MS of amount.
8. the preparation method of roxburgh anoectochilus terminal bud tablet described in claim 1, which is characterized in that in the tableting step, rotary tabletting
Machine pressure 26kN, 28kN or 30kN.
9. the roxburgh anoectochilus terminal bud tablet that the preparation method of any one of the claim 1-8 roxburgh anoectochilus terminal bud tablets is prepared.
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Citations (2)
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|---|---|---|---|---|
| CN102697748A (en) * | 2012-06-21 | 2012-10-03 | 厦门加晟生物科技有限公司 | Roxburgh anoectochilus terminal bud buccal tablet and preparation method thereof |
| CN104622946A (en) * | 2015-01-12 | 2015-05-20 | 福建农林大学 | Gynura bicolor heat-clearing buccal tablet and preparation method thereof |
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2015
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102697748A (en) * | 2012-06-21 | 2012-10-03 | 厦门加晟生物科技有限公司 | Roxburgh anoectochilus terminal bud buccal tablet and preparation method thereof |
| CN104622946A (en) * | 2015-01-12 | 2015-05-20 | 福建农林大学 | Gynura bicolor heat-clearing buccal tablet and preparation method thereof |
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