CN109394921A - Clearing heat and detoxicating cool blood is treating stranguria Chinese medicine composition and its method of granulating - Google Patents
Clearing heat and detoxicating cool blood is treating stranguria Chinese medicine composition and its method of granulating Download PDFInfo
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- 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)
- A61K36/35—Caprifoliaceae (Honeysuckle family)
- A61K36/355—Lonicera (honeysuckle)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/68—Plantaginaceae (Plantain Family)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
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- A61K36/74—Rubiaceae (Madder family)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/884—Alismataceae (Water-plantain family)
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- 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
- A61K9/1605—Excipients; Inactive ingredients
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- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
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- A61K9/2022—Organic macromolecular compounds
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- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
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- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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Abstract
The present invention relates to pharmaceutical production fields, specifically, providing a kind for the treatment of stranguria Chinese medicine composition of clearing heat and detoxicating cool blood and its method of granulating.The method of granulating of the treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood provided by the invention; including by the prefabricated powder of raw material in fluid bed granulator with solvent mixing boiling granulating; the step of obtaining particle; wherein; the inlet air temperature of fluid bed granulator is 65-95 DEG C; blower frequency is 20-55Hz, while the temperature before the prefabricated powder addition fluid bed granulator of raw material is 30-70 DEG C.This method is able to solve the treating stranguria Chinese medicine composition disintegration time limited longer quality problems of clearing heat and detoxicating cool blood, and the clearing heat and detoxicating cool blood being prepared is treating stranguria, and Chinese medicine composition disintegration time limited is reduced to 28-35min, improves product curative effect, improves bioavilability.Reach time saving, the purpose of plant and equipment is saved in energy conservation.Improve that product homogeneity is poor simultaneously, the low quality problems for easily causing sliver of hardness.
Description
Technical field
The present invention relates to pharmaceutical production field, in particular to a kind for the treatment of stranguria Chinese medicine composition of clearing heat and detoxicating cool blood and
Its method of granulating.
Background technique
Infirmity clear piece is a kind of presently commercially available Chinese medicine, and major function is used for damp-heat in lower-JIAO institute for clearing heat and detoxicating, cool blood is treating stranguria
Heat gonorrhea symptoms include frequent micturition, urgent urination, urodynia, pain in the loins, the underbelly falling inflation of cause；Also it is used for chronic prostatitis damp-heat accumulation and blood stasis symptom,
Symptoms include urine frequency is anxious, not to the utmost, urethra scorching hot, perineum lacks abdomen lumbus sacrum pain or discomfort etc. to dribble of urine.Clinical pharrnacokinetics experiment is ground
Study carefully proof, infirmity clear piece truly has apparent anti-inflammatory, analgesic activity, be for controlling especially suitable in treatment the elderly's urinary system infection contamination
The effective Chinese patent drug for treating urinary system infection contamination, especially suitable for preventing and treating old prostatic disorders.
Infirmity clear tablet recipe and preparation method are as follows: Cortex Phellodendri, honeysuckle, coptis root, field pennycress, oldenlandia diffusa, radix paeoniae rubra, cortex moutan, celestial being
Crane grass, semen plantaginis, rhizoma alismatis.Above ten taste, honeysuckle, field pennycress, oldenlandia diffusa, hairyvein agrimony boiling twice, 1 hour every time,
Water cooking liquid filtration, filtrate are condensed into thick paste；The coptis, Cortex Phellodendri, radix paeoniae rubra, cortex moutan, semen plantaginis are extracted three times with 60% alcohol reflux,
Filtration, filtrate are condensed into cream and merge with water cooking liquid condensed cream, and the rhizoma alismatis fine powder of crushing is added, and mix, low-temperature vacuum drying, powder
It is broken, starch is added, pelletizes, it is dry, be pressed into 1000 to get.
Using the method for the wet granulation and dry rolling granulating of ethyl alcohol, this method material flow in infirmity clear piece pelletization
Property it is poor, easily cause raw material mixing uneven, the dust pollution in production process is also more serious, and production process is relatively complicated, uses
Mechanical equipment it is more, production efficiency is low, while the infirmity clear piece disintegration time limited being prepared is longer, and the compliance rate of product cannot obtain
To being effectively ensured.
In view of this, the present invention is specifically proposed.
Summary of the invention
The first object of the present invention is to provide a kind of method of granulating for the treatment of stranguria Chinese medicine composition of clearing heat and detoxicating cool blood, with slow
Solve that preparation method in the prior art is cumbersome, and dust pollution is serious, the degree of automation is low and product disintegration time limited is longer and matter
Measure poor technical problem.
The second object of the present invention is to provide the treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood that the above method is prepared.
In order to realize above-mentioned purpose of the invention, the following technical scheme is adopted:
A kind of method of granulating of the treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood, including by the prefabricated powder of raw material in fluid bed granulator
In with solvent mixing boiling granulating, the step of obtaining particle；
The parameter of the fluid bed granulator includes: that inlet air temperature is 65-95 DEG C and blower frequency is 20-55Hz；
Temperature when fluid bed granulator is added in the prefabricated powder of raw material is 30-70 DEG C.
Further, the prefabricated powder of raw material is put into fluid bed granulator, is added by peristaltic pump into the prefabricated powder of raw material molten
Matchmaker, the prefabricated powder of raw material and solvent mixing boiling granulating；
Preferably, the wriggling revolution speed is 100-260rpm/min.
Further, the solvent includes ethanol solution, preferably the ethanol solution of volume fraction 10-20%.
Further, the water content of the particle is 3-8%.
Further, the grain diameter was 40-80 mesh.
Further, the method also includes carrying out tabletting and coating for the particle.
Further, the mass volume ratio of the prefabricated powder of the raw material and the solvent is 1.27-1.76.
Further, the prefabricated powder of the raw material includes the combination drying powder that water mentions cream, alcohol extracting cream and figuration powder；
The water mentions the water extract that cream includes honeysuckle, field pennycress, oldenlandia diffusa and hairyvein agrimony；
The alcohol extracting cream includes the alcohol extracting thing of semen plantaginis, the coptis, Cortex Phellodendri, radix paeoniae rubra and cortex moutan；
The figuration powder includes rhizoma alismatis powder；
Preferably, the prefabricated powder of the raw material further includes pharmaceutically acceptable auxiliary material；
Preferably, the auxiliary material includes starch, microcrystalline cellulose, sucrose, Aspartame, dextrin, lactose, Icing Sugar, grape
Sugar, sodium chloride, sodium carboxymethylcellulose, crosslinked polyvinylpyrrolidone, magnesium stearate, superfine silica gel powder, vitamin C, half Guang ammonia
At least one of acid, citric acid or sodium sulfite；
Preferably, water proposes the relative density of cream and alcohol extracting cream at 50-60 DEG C and independently is 1.05-1.15；
Preferably, figuration powder crosses 80-120 mesh.
Further, the combination drying powder is mentioned after cream, alcohol extracting cream and figuration powder mix by water by being spray-dried
It arrives.
The treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood that above-mentioned method of granulating is prepared；
Preferably, the dosage form of the treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood is peroral dosage form, preferably includes tablet, glue
Capsule or granule.
Compared with prior art, the invention has the benefit that
The treating stranguria Chinese medicine composition method of granulating of clearing heat and detoxicating cool blood provided by the invention, including the prefabricated powder of raw material is being boiled
With solvent mixing boiling granulating in granulator, the step of obtaining particle, wherein the inlet air temperature of fluid bed granulator is 65-95 DEG C,
Blower frequency is 20-55Hz, while the temperature before the prefabricated powder addition fluid bed granulator of raw material is 30-70 DEG C.This method makes original
Expect that prefabricated powder is mixed with solvent, boil after a period of time, be sampled by sampler, lower road work can be transferred to after total mix is qualified
Sequence.This method is able to solve the treating stranguria Chinese medicine composition disintegration time limited longer quality problems of clearing heat and detoxicating cool blood, is prepared
Clearing heat and detoxicating cool blood treating stranguria Chinese medicine composition disintegration time limited is reduced to 28-35min, and then improves the clearing heat and detoxicating treating stranguria Chinese medicine of cool blood
The pharmaceutical effectiveness of composition, increases bioavilability.Reach time saving, the purpose of plant and equipment is saved in energy conservation.The prefabricated powder of raw material
By boiling granulating, dust from flying is avoided, fluid bed granulator is set instead of a variety of machinery such as mixing machine, granulator and drying machine
It is standby, it by mixing, spraying, granulation and drying while carrying out, simplifies production process.This method reduces production cost, develops skill
Safety reduces human injury.Boiling granulating can not only carry out continuous production, high degree of automation, and granulating is fast, production
Favorable reproducibility, obtained even particle size, shape rounding, good fluidity, compressibility are good, and intensity is high, can also greatly reduce auxiliary
Doses greatlys improve production efficiency.Simultaneously because pelletization is completed in closed granulator, product is not easy to be contaminated,
Quality can be ensured preferably.The preparation method can be effectively improved the mobility of the prefabricated powder of raw material, and grain diameter is uniform, produce
The weight differential of product is small, uniform component, and it is not in the quality problems of sliver that hardness is high.
The treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood provided by the invention is prepared using the above method, clearing heat and detoxicating cool
The disintegration time limited of blood is treating stranguria Chinese medicine composition significantly reduces, not exceeded risk.Between tablet significant difference reduce, product at
Divide more uniform.
Specific embodiment
Embodiment of the present invention is described in detail below in conjunction with embodiment, but those skilled in the art will
Understand, the following example is merely to illustrate the present invention, and is not construed as limiting the scope of the invention.It is not specified in embodiment specific
Condition person carries out according to conventional conditions or manufacturer's recommended conditions.
A kind of method of granulating of the treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood, including by the prefabricated powder of raw material in fluid bed granulator
In with solvent mixing boiling granulating, the step of obtaining particle, wherein the parameter of fluid bed granulator includes: that inlet air temperature is 65-95
DEG C and blower frequency be 20-55Hz, temperature when fluid bed granulator is added in the prefabricated powder of raw material is 30-70 DEG C.
Fluidized drying granulation is boiled after a period of time, is taken by sampler so that the prefabricated powder of raw material is mixed with solvent
Sample can be transferred to next procedure after total mix is qualified.When this method is able to solve the treating stranguria Chinese medicine composition disintegration of clearing heat and detoxicating cool blood
Longer quality problems are limited, the clearing heat and detoxicating cool blood being prepared is treating stranguria, and Chinese medicine composition disintegration time limited is reduced to 28-35min,
And then improve the pharmaceutical effectiveness of the treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood, increase bioavilability.Reach time saving, energy conservation,
Save the purpose of plant and equipment.The prefabricated powder of raw material avoids dust from flying, fluid bed granulator is instead of mixing by boiling granulating
A variety of mechanical equipments such as machine, granulator and drying machine by mixing, spraying, granulation and drying while carrying out, simplify production work
Sequence.This method reduces production cost, and develop skill safety, reduces human injury.Boiling granulating not only can continuously be given birth to
Produce, high degree of automation, and granulating is fast, produce favorable reproducibility, obtained even particle size, shape rounding, good fluidity,
Compressibility is good, and intensity is high, can also greatly reduce auxiliary material amount, greatly improve production efficiency.Simultaneously because pelletization is closed
Granulator in complete, product is not easy to be contaminated, and quality can be ensured preferably.The preparation method can be effectively improved raw material
The mobility of prefabricated powder, grain diameter is uniform, and the weight differential of product is small, uniform component, and it is not in the matter of sliver that hardness is high
Amount problem.
It should be noted that inlet air temperature is typical but non-limiting is 65 DEG C, 68 DEG C, 70 DEG C, 72 DEG C, 75 DEG C, 78 DEG C,
80 DEG C, 83 DEG C, 85 DEG C, 87 DEG C, 90 DEG C, 93 DEG C or 95 DEG C；Blower frequency it is typical but non-limiting for 20Hz, 23Hz, 25Hz,
27Hz, 30Hz, 33Hz, 35Hz, 37Hz, 40Hz, 43Hz, 45Hz, 48Hz, 50Hz, 53Hz or 55Hz；Boiling is added in the prefabricated powder of raw material
Temperature when rising granulator is 30 DEG C, 32 DEG C, 35 DEG C, 38 DEG C, 40 DEG C, 42 DEG C, 45 DEG C, 47 DEG C, 50 DEG C, 52 DEG C, 54 DEG C, 55
DEG C, 57 DEG C, 60 DEG C, 62 DEG C, 65 DEG C, 68 DEG C or 70 DEG C.
In an embodiment of the invention, the prefabricated powder of raw material is put into fluid bed granulator, by peristaltic pump to original
Expect that solvent is added in prefabricated powder, the prefabricated powder of raw material and solvent mixing boiling granulating.Boiling granulating is added in solvent by peristaltic pump
It in machine, carries out mixing boiling granulating with the prefabricated powder of raw material, solvent can be made adequately to mix with the prefabricated powder of raw material, with production
Progress, solvent is constantly added, and solvent comes into full contact with the prefabricated powder of raw material, and each position synchronizes to be formed in fluid bed granulator
Particle, intergranular ingredient is uniform, uniform particle diameter, can produce a large amount of particles with a step.
In the present invention, one is preferably carried out in mode, wriggling revolution speed 100-260rpm/min.The revolving speed of peristaltic pump
Solvent is controlled to be added, so that the prefabricated powder of raw material and solvent are sufficiently mixed uniformly, it is synchronous in fluid bed granulator to form a large amount of, ingredient
The identical particle of uniform and partial size.Wriggling revolution speed it is typical but non-limiting for 100rpm/min, 110rpm/min,
120rpm/min、130rpm/min、140rpm/min、150rpm/min、160rpm/min、170rpm/min、180rpm/min、
190rpm/min、200rpm/min、210rpm/min、220rpm/min、230rpm/min、240rpm/min、250rpm/min
Or 260rpm/min.
In one embodiment of the present invention, solvent includes ethanol solution, and the ethyl alcohol of preferably volume fraction 10-20% is molten
Liquid.Particle is formed by the prefabricated powder of raw material by solvent, ethanol solution is chosen as solvent, on the one hand can guarantee the prefabricated powder of raw material
Particle is formed, the water content of particle on the other hand can be reduced.The volume fraction of ethanol solution is typical but non-limiting to be
10%, 13%, 15%, 17% or 20%.
In the present invention, one is preferably carried out in mode, and the water content of particle is 3-8%.The water content of particle is typical but non-
Restrictive is 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, 7%, 7.5% or 8%.Water content it is too low or
Excessively high poor to will lead to mobility of particle, grain graininess is uneven, and mixed fine powder is more, and then causes tablet weight variation big, tablet
Hardness not enough causes sliver.Water content can effectively solve that above-mentioned tablet weight variation is big, hardness is low and sliver in the range of 3-8%
Quality problems, product composition is uniform, high-quality.
In the present invention, one is preferably carried out in mode, and grain diameter was 40-80 mesh.Grain diameter was 40-80
The case where mesh, size is more uniform, while being conducive to compression molding under the partial size, and hardness is not in well sliver is reduced
The usage amount of auxiliary material, the disintegration time limited of tablet is also more unified and is shortened, and the qualification rate of product is improved.
In some embodiments of the present invention, method further includes the steps that particle carrying out tabletting and coating.
In the present invention, one is preferably carried out in mode, and the mass volume ratio of the prefabricated powder of raw material and solvent is 1.27-1.76.
In one embodiment of the present invention, the prefabricated powder of raw material includes the combination drying that water mentions cream, alcohol extracting cream and figuration powder
Powder, wherein water mentions the water extract that cream includes honeysuckle, field pennycress, oldenlandia diffusa and hairyvein agrimony, and alcohol extracting cream includes Chinese herbaceous peony
Son, the coptis, Cortex Phellodendri, radix paeoniae rubra and cortex moutan alcohol extracting thing, figuration powder includes rhizoma alismatis powder.
In the present invention, one is preferably carried out in mode, and honeysuckle, field pennycress, oldenlandia diffusa and hairyvein agrimony are with 6-12 times
The water of weight extracts 2 times, and boiling keeps 0.8-1.2h every time, and combined extract crosses the filtering of 100 mesh filters, and concentrated filtrate is extremely
Relative density is 1.25-1.30 under the conditions of 45-55 DEG C, obtains water and mentions cream.
In the present invention, one is preferably carried out in mode, 1-5 times of weight of the coptis, Cortex Phellodendri, radix paeoniae rubra, cortex moutan and semen plantaginis
Concentration of volume percent be 60% ethyl alcohol extract 3 times, boiling keeps 1-3h every time, and combined extract crosses 100 mesh filters
Filtering, concentrated filtrate to relative density under the conditions of 45-55 DEG C are 1.25-1.30, obtain alcohol extracting cream.
In the present invention, one is preferably carried out in mode, and figuration powder crosses 80-120 mesh.
The present invention one be preferably carried out in mode, relative density independently is 1.12-1.30 water mention cream and
Relative density is 1.05-1.15 when alcohol extracting cream is diluted with water to 50-60 DEG C, and figuration powder is added and is uniformly mixed, is dried to obtain mixing
Xeraphium.
In the present invention, one is preferably carried out in mode, and the prefabricated powder of raw material further includes pharmaceutically acceptable auxiliary material.Auxiliary material
For starch, microcrystalline cellulose, sucrose, Aspartame, dextrin, lactose, Icing Sugar, glucose, sodium chloride, sodium carboxymethylcellulose,
In crosslinked polyvinylpyrrolidone, magnesium stearate, superfine silica gel powder, vitamin C, cysteine, citric acid or sodium sulfite extremely
Few one kind.
In the present invention, one is preferably carried out in mode, and combination drying powder mentions cream, alcohol extracting cream and figuration powder by water and mixes
It is obtained afterwards by spray drying.Powder is dried to using the mixed liquor that spray drying can directly make water mention cream, alcohol extracting cream and figuration powder
Shape product can save the processes such as devaporation, crushing.
The treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood that above-mentioned method of granulating is prepared.
In certain embodiments of the present invention, the dosage form of the treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood is peroral dosage form,
Preferably include tablet, capsule or granule.The disintegration time limited of the clearing heat and detoxicating treating stranguria Chinese medicine composition of cool blood significantly reduces, and does not have
Exceeded risk.Significant difference reduces between tablet, and the ingredient of product is more uniform.
Present invention will be further explained by specific examples below, it should be understood, however, that, these embodiments are only
It is used, is but should not be understood as present invention is limited in any form for being described in more detail.
Embodiment 1
The present embodiment provides a kind of prefabricated powder producing methods of raw material of clearing heat and detoxicating treating stranguria Chinese medicine composition of cool blood, including with
Lower step:
A) water extracts: according to parts by weight, 174 portions of honeysuckles, 348 parts of field pennycress, 348 parts of oldenlandia diffusas and 174 parts
Hairyvein agrimony is placed in extract equipment, boiling 2 times, by 10 times of Chinese medicine weight, adds first time extraction water, and heating is boiled to boiling,
1h is kept, extracting solution is sent to receiver through 100 mesh filters by pipeline, stands 1h and add and mention for the second time by 8 times of Chinese medicine weight
Water is taken, heating is boiled to boiling, and 1h is kept, and extracting solution is sent through 100 mesh filters to receiver by pipeline, stands 1h.Water is mentioned
Liquid is concentrated into relative density 1.25-1.30 (50 DEG C).
B) alcohol extracting: according to parts by weight, 35 portions of semen plantaginis, 174 portions of coptiss, 174 portions of Cortex Phellodendris, 174 parts of radix paeoniae rubras and 174 parts
Cortex moutan is placed in extract equipment, by 3.5 times of Chinese medicine weight, is added and is extracted 60% ethyl alcohol for the first time, and heating is boiled to boiling, is kept
3h.Extracting solution is sent through 100 mesh filters to receiver by pipeline, is stood 1h by 2.5 times of Chinese medicine weight and is added second of extraction
60% ethyl alcohol, heating are boiled to boiling, and 2h is kept.Extracting solution is sent through 100 mesh filters to receiver by pipeline, stand 1h, is pressed
2 times of medicine weight add third time to extract 60% ethyl alcohol, and heating is boiled to boiling, keep 1h, extracting solution is filtered by pipeline through 100 mesh
Device is sent to receiver, stands 1h.Alcohol extract is concentrated into relative density 1.25-1.30 (50 DEG C).
C) figuration powder: 174 parts of rhizoma alismatis crushing sieve with 100 mesh sieve according to parts by weight.
D) add purified water to dilute concentrated liquid, alcohol extracting concentrate, add about 2 times of condensed cream weight of purified water, be diluted to
Relative density 1.05-1.15 (55 DEG C), medical fluid is put into storage tank.Partial concentration liquid is sucked in premixing tank, it is thin that rhizoma alismatis is added
Powder stirs evenly, and sucks in blend tank, remaining concentrate is added and continues to stir, is spray-dried mixed concentrated liquid after stirring evenly,
Obtain combination drying powder.
E the raw material that) combination drying powder and starch, dextrin and microcrystalline cellulose are mixed to get in fluid bed granulator to be added is pre-
Powder processed.
Embodiment 2
The present embodiment provides a kind of method of granulating of clearing heat and detoxicating treating stranguria Chinese medicine composition of cool blood, comprising the following steps:
A) the prefabricated powder of raw material that temperature in embodiment 1 is 30 DEG C is added in fluid bed granulator, the air inlet of fluid bed granulator
Temperature is 95 DEG C, and blower frequency is 20Hz.
B) 10% ethanol solution is added with the revolving speed of 260rpm/min into fluid bed granulator for peristaltic pump, keeps raw material prefabricated
Powder boils completely, ethanol solution is uniformly mixed with the prefabricated powder of raw material, boiling granulating.Wherein, the prefabricated powder of raw material and ethanol solution
Mass volume ratio example be 1.27.
C) control water content is 3%, and when the particle that the prefabricated powder of raw material is formed reaches 80 mesh, boiling granulating is completed.
D it) by the magnesium stearate mixed pressuring plate 0.6g/ piece of particle and 80 meshes excessively in step C), obtains clearing heat and detoxicating cool
Blood is treating stranguria Chinese medicine composition.
Embodiment 3
The present embodiment provides a kind of method of granulating of clearing heat and detoxicating treating stranguria Chinese medicine composition of cool blood, comprising the following steps:
A) the prefabricated powder of raw material that temperature in embodiment 1 is 70 DEG C is added in fluid bed granulator, the air inlet of fluid bed granulator
Temperature is 65 DEG C, and blower frequency is 55Hz.
B) 20% ethanol solution is added with the revolving speed of 100rpm/min into fluid bed granulator for peristaltic pump, keeps raw material prefabricated
Powder boils completely, ethanol solution is uniformly mixed with the prefabricated powder of raw material, boiling granulating.Wherein, the prefabricated powder of raw material and ethanol solution
Mass volume ratio example be 1.76.
C) control water content is 8%, and when the particle that the prefabricated powder of raw material is formed reaches 40 mesh, boiling granulating is completed.
D it) by the magnesium stearate mixed pressuring plate 0.6g/ piece of particle and 80 meshes excessively in step C), obtains clearing heat and detoxicating cool
Blood is treating stranguria Chinese medicine composition.
Embodiment 4
The present embodiment provides a kind of method of granulating of clearing heat and detoxicating treating stranguria Chinese medicine composition of cool blood, comprising the following steps:
A) the prefabricated powder of raw material that temperature in embodiment 1 is 50 DEG C is added in fluid bed granulator, the air inlet of fluid bed granulator
Temperature is 80 DEG C, and blower frequency is 37Hz.
B) 15% ethanol solution is added with the revolving speed of 160rpm/min into fluid bed granulator for peristaltic pump, keeps raw material prefabricated
Powder boils completely, ethanol solution is uniformly mixed with the prefabricated powder of raw material, boiling granulating.Wherein, the prefabricated powder of raw material and ethanol solution
Mass volume ratio example be 1.50.
C) control water content is 5%, and when the particle that the prefabricated powder of raw material is formed reaches 60 mesh, boiling granulating is completed.
D it) by the magnesium stearate mixed pressuring plate 0.6g/ piece of particle and 80 meshes excessively in step C), obtains clearing heat and detoxicating cool
Blood is treating stranguria Chinese medicine composition.
Comparative example
This comparative example provides a kind of dry rolling granulating method for the treatment of stranguria Chinese medicine composition of clearing heat and detoxicating cool blood, including following step
It is rapid:
A) the prefabricated powder of raw material in embodiment 1 is added in dry-pressing granulator and is pelletized.
B it is 60-65rpm/min, barrel velocity 14rpm/ that) process conditions of dry-pressing granulator, which include: screw feeding,
Min, shear velocity 15rpm/min.
C 80 meshes are crossed after particle) is made.
D it) by the magnesium stearate mixed pressuring plate 0.6g/ piece of particle and 80 meshes excessively in step C), obtains clearing heat and detoxicating cool
Blood is treating stranguria Chinese medicine composition.
Test example
The disintegration time limited of detection embodiment 2-4 and the treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood in comparative example, each group
Middle detection 10, statistical result is as shown in the table:
When can be seen that the disintegration of the treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood in embodiment 2-4 from result in upper table
Limit is significantly less than the treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood in comparative example, generally between 28-35min.Meanwhile the present invention
The treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood disintegration time limited it is also more uniform than comparative example, illustrate that method of the invention is prepared into
The treating stranguria pharmaceutical compositions of clearing heat and detoxicating cool blood arrived are more uniform, product with stable quality.In industrial standard, it is not coated
Tabletting disintegration time limited be no more than 50min, from the above results, the heat-clearing that method of granulating through the invention is prepared
The removing toxic substances treating stranguria Chinese medicine composition of cool blood significantly reduces the treating stranguria Chinese medicine group of clearing heat and detoxicating cool blood in original production process (comparative example)
The exceeded risk of object is closed, favorable reproducibility, stable product quality are produced, this method high degree of automation is effectively reduced and is produced into
This, improves the quality of product, is conducive to large-scale industrial production.
The particle water content that method of granulating provided by the invention obtains be 3-8%, be conducive within this range tablet at
Type, tablet hardness is good, is not susceptible to sliver；And the water content difference between batch of particle is larger in the preparation method of comparative example, is difficult to control
Make uniform, the tablet hardness of preparation is low, and sliver phenomenon has occurred, and influences the quality of product.The product homogeneity that the present invention obtains
More preferably, pharmaceutical effectiveness is also more preferable, improves bioavailability.
Although illustrate and describing the present invention with specific embodiment, it will be appreciated that without departing substantially from of the invention
Many other change and modification can be made in the case where spirit and scope.It is, therefore, intended that in the following claims
Including belonging to all such changes and modifications in the scope of the invention.
Claims (10)
1. a kind of method of granulating of the treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood, which is characterized in that including the prefabricated powder of raw material exists
With solvent mixing boiling granulating in fluid bed granulator, the step of obtaining particle；
The parameter of the fluid bed granulator includes: that inlet air temperature is 65-95 DEG C and blower frequency is 20-55Hz；
Temperature when fluid bed granulator is added in the prefabricated powder of raw material is 30-70 DEG C.
2. method of granulating according to claim 1, which is characterized in that the prefabricated powder of raw material is put into fluid bed granulator, is led to
It crosses peristaltic pump and is added solvent into the prefabricated powder of raw material, the prefabricated powder of raw material and solvent mixing boiling granulating；
Preferably, the wriggling revolution speed is 100-260rpm/min.
3. method of granulating according to claim 1, which is characterized in that the solvent includes ethanol solution, preferably volume
The ethanol solution of score 10-20%.
4. method of granulating according to claim 1, which is characterized in that the water content of the particle is 3-8%.
5. method of granulating according to claim 1, which is characterized in that the grain diameter was 40-80 mesh.
6. method of granulating according to claim 1, which is characterized in that the method also includes the particle is carried out tabletting
The step of with coating.
7. method of granulating according to claim 1, which is characterized in that the matter of the raw material prefabricated powder kg and the solvent L
Amount volume ratio is 1.27-1.76.
8. method of granulating according to claim 1-7, which is characterized in that the prefabricated powder of raw material includes that water mentions
The combination drying powder of cream, alcohol extracting cream and figuration powder；
The water mentions the water extract that cream includes honeysuckle, field pennycress, oldenlandia diffusa and hairyvein agrimony；
The alcohol extracting cream includes the alcohol extracting thing of semen plantaginis, the coptis, Cortex Phellodendri, radix paeoniae rubra and cortex moutan；
The figuration powder includes rhizoma alismatis powder；
Preferably, the prefabricated powder of the raw material further includes pharmaceutically acceptable auxiliary material；
Preferably, the auxiliary material includes starch, microcrystalline cellulose, sucrose, Aspartame, dextrin, lactose, Icing Sugar, glucose, chlorine
Change sodium, sodium carboxymethylcellulose, crosslinked polyvinylpyrrolidone, magnesium stearate, superfine silica gel powder, vitamin C, cysteine, lemon
At least one of lemon acid or sodium sulfite；
Preferably, water proposes the relative density of cream and alcohol extracting cream at 50-60 DEG C and independently is 1.05-1.15；
Preferably, figuration powder crosses 80-120 mesh.
9. method of granulating according to claim 8, which is characterized in that the combination drying powder mentions cream, alcohol extracting cream by water
It is obtained with being spray-dried after the mixing of figuration powder.
10. the treating stranguria Chinese traditional medicine composition of clearing heat and detoxicating cool blood that -9 described in any item method of granulating are prepared according to claim 1
Object；
Preferably, the dosage form of the treating stranguria Chinese medicine composition of clearing heat and detoxicating cool blood be peroral dosage form, preferably include tablet, capsule or
Granule.
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| CN114907513A (en) * | 2022-06-28 | 2022-08-16 | 广东石油化工学院 | Preparation method of spherical high-performance water-absorbing microspheres and product thereof |
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| CN105548405A (en) * | 2016-01-19 | 2016-05-04 | 李兴惠 | Method for detecting traditional Chinese medicinal composition and preparation |
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| CN114907513A (en) * | 2022-06-28 | 2022-08-16 | 广东石油化工学院 | Preparation method of spherical high-performance water-absorbing microspheres and product thereof |
| CN114907513B (en) * | 2022-06-28 | 2024-04-02 | 广东石油化工学院 | Preparation method of spherical high-performance water-absorbing microsphere and product thereof |
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