CN109620867A - A kind of green blood buccal tablet in good taste and its preparation method and application - Google Patents
A kind of green blood buccal tablet in good taste and its preparation method and application Download PDFInfo
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Abstract
The present invention discloses a kind of green blood buccal tablet and its preparation method and application in good taste, the green blood buccal tablet is on the basis of existing hematopoietic Chinese medicinal composition is formulated, by prepared fleece flower root, the fruit of glossy privet, mulberry fruit, eclipta, Radix Paeoniae Alba, Radix Astragali, seven taste Chinese medicine of rhizoma cibotii passes through pre-treatment, freeze-drying, it pulverizes, raw material mixing, auxiliary material mixing, the granulation of supplementary material total mix, tabletting obtains the green blood buccal tablet, meeting safety, stability, under the premise of validity, substantially it has no toxic side effect, it is in good taste, it works rapid, green blood is enriched blood, it is nourishing liver and kidney, tranquilization and refreshment, there is good relaxation effect to oligoleukocythemia symptom caused by tumor chemoradiotherapy, significantly increase the immunocompetence of patient.
Description
Technical field
The present invention relates to Shengxue technical fields, and in particular to a kind of green blood buccal tablet and preparation method thereof in good taste
And application.
Background technique
The method that existing tumor therapeuticing method mostly uses greatly chemotherapy and radiation, chemotherapy and radiation be using chemicals or
Ray prevents the proliferation of cancer cell, infiltration, transfer, until a kind of final therapeutic modality for killing cancer cell.Due to treatment method
Selectivity is not strong, inevitably damages a large amount of human normal cells while killing cancer cell, and especially damage proliferation is prosperous
The stem cell of Sheng causes the whole blood cells quantity such as peripheral leukocytes of patient to decline, the decline of marrow hemopoiesis green blood ability, into
One step leads to the deficiency of vital energy deficiency of blood, immunity degradation, the decline of viral infection resisting ability.
For the symptom of the quantity of leucocyte decline, the deficiency of vital energy deficiency of blood that are generated after oncotherapy, researches and develops and sold in the market
Sell some blood-enriching and blood-promoting circulations, nourishing liver and kidney form of Chinese drug.The patent of application number 201310373355.0 is disclosed by Hunan Kang Shou
A kind of hematopoietic Chinese medicinal composition of pharmaceutical Co. Ltd's research and development, which is by eclipta, Radix Paeoniae Alba, the fruit of glossy privet, mulberries
The granule that son, rhizoma cibotii, prepared fleece flower root and seven taste bulk pharmaceutical chemicals of Radix Astragali are mentioned through Dynamic Water, filter, are concentrated and obtain after being spray-dried,
The composition bioactive substance increases, and good fluidity, heated time is short, more significant compared to existing Shengxuebao-medicine for improving hematopoitic function curative effect.
Above-mentioned hematopoietic Chinese medicinal composition be granule, be to be administered orally after being brewed by boiled water, into gastrointestinal tract after through stomach
Intestinal mucosa, which absorbs, plays drug effect.Oral administration methods are simple, but destroy vulnerable to gastrointestinal tract and reduce what drug effect even failed
Drug cannot take orally.Buccal tablet refers generally to contained in the compressed tablets being slowly dissolved in oral cavity, has that simple process, stability be good, medicine
Effect rapidly, absorb fast and high bioavilability advantage, preparation process generally comprises raw material mixing, softwood processed, granulating and drying, whole
Grain, tabletting, sterilizing, packaging.It if hematopoietic Chinese medicinal composition is applied in buccal tablet dosage form, can have the following problems: 1, make
A few taste medicinal material tastes of the fleece-flower root, the fruit of glossy privet, Radix Astragali, rhizoma cibotii are bitter, and taste is difficult to cover after lozenge is made, and mouthfeel is poor, influence
Patient medication effect;2, the anthraquinones that prepared fleece flower root contains have certain toxicity, and rhizoma cibotii pharmacological property partial heat easily causes mouth
Chamber is got angry and mucous membrane blistering, generates toxic side effect;3, seven taste Chinese medicines are included into liver and kidney channel mostly, it is not easy to be inhaled by mucous membrane of mouth
It receives and reaches active component.
Summary of the invention
In order to overcome above-mentioned technical problem, the purpose of the present invention is to provide a kind of green blood buccal tablet in good taste and its
Preparation method and application, on the basis of existing hematopoietic Chinese medicinal composition formula, by prepared fleece flower root, the fruit of glossy privet, mulberry fruit, ink drought
Lotus, Radix Paeoniae Alba, Radix Astragali, seven taste Chinese medicine of rhizoma cibotii are by pre-treatment, freeze-drying, ultramicro grinding, raw material mixing, auxiliary material mixing, original
The granulation of auxiliary material total mix, tabletting obtain the green blood buccal tablet, substantially nontoxic under the premise of meeting safety, stability, validity
Side effect, it is in good taste, it works rapidly, green blood is enriched blood, and nourishing liver and kidney, tranquilization and refreshment subtracts leucocyte caused by tumor chemoradiotherapy
Few symptom has good relaxation effect, significantly increases the immunocompetence of patient.
The purpose of the present invention can be achieved through the following technical solutions:
The present invention provides a kind of green blood buccal tablet in good taste, the raw material including following parts by weight: prepared fleece flower root 11~
15 parts, 14~18 parts of the fruit of glossy privet, 14~18 parts of mulberry fruit, 14~18 parts of eclipta, 11~15 parts of Radix Paeoniae Alba, 11~15 parts of Radix Astragali, dog
11~14 parts of ridge;
The preparation method of the green blood buccal tablet the following steps are included:
(1) pre-treatment: the fleece-flower root and decoction of black soybean are mixed according to the ratio of mass ratio 10:1, the stifling fleece-flower root is in inside and outside
It is spare to be ground into soya bean size for sepia after drying;The fruit of glossy privet, mulberry fruit, Radix Astragali, Radix Paeoniae Alba, eclipta are robbed water and cleaned, is dried standby
With;Rhizoma cibotii is fried to the golden villus of crisp yellow and unilateral edge noresidue, it is spare;
(2) it is freeze-dried: by prepared fleece flower root, the fruit of glossy privet, mulberry fruit, eclipta, Radix Paeoniae Alba, Radix Astragali, seven taste Chinese medicine of rhizoma cibotii point
It Song Ru not be passed through 120 ± 2 DEG C of hot steam, action time 40-60s guarantees the center of Chinese medicine in steam rotary dryer
Temperature is cooled to room temperature between 80 ± 5 DEG C;It being then fed into freeze drier, medicinal material spacing is maintained between 1-3cm ,-
25 DEG C~-20 DEG C freeze-drying 30-40min;
(3) it pulverizes: by seven taste Chinese medicine precomminution after step (2) freeze-drying at graininess, crossing 20-40 mesh
Sieve is put into freezing charging basket, and -5 DEG C of freezing 10min are then fed into closed loop airflow milling, in motor speed 4000-5000r/
Min, air compressor machine pressure >=0.75MPa, air compressor machine tolerance > 10m3Seven taste traditional Chinese medicine powders are broken into partial size 6-8 under conditions of/min
μm fine powder;
(4) raw material mixes: seven taste Chinese medicine fine powders prepared by step (3), and 10-20min is mixed and obtains bulk pharmaceutical chemicals
Powder;
(5) auxiliary material mixes: in parts by weight, taking 60-90 parts of reduced isomaltooligosaccharide, 6-12 parts of microcrystalline cellulose, wood
0.2-0.6 parts of sugar alcohol, 10-16 parts of Macrogol 6000,0.3-0.6 parts of Flos Albiziae extract obtain after 3-6min is mixed
To auxiliary material mixture;
(6) supplementary material total mix, granulation: the total powder of raw material of whipping step (4) preparation is slowly added to the auxiliary of step (5) preparation
Expect in mixture, after addition, 10-15min is mixed, puts into granulator and pelletizes, and obtaining partial size is 400-600 μm
Mixing particle;
(7) tabletting: mixing particle prepared by step (6) carries out tabletting using rotary tablet machine, and obtaining slice weight is
The green blood buccal tablet of 1g/ piece.
The meridian distribution of property and flavor and major function for the Chinese medicine selected in raw material and auxiliary material of the present invention are as follows:
Prepared fleece flower root: [nature and flavor] are bitter, sweet, puckery, temperature.[channel tropism] returns liver, the heart, kidney channel.[major function] nourishing liver and kidney, strengthening the essence
Blood, black beard and hair, strengthening the bones and muscles.For blood deficiency chlorosis, dizziness and tinnitus, poliosis, soreness and weakness of waist and knees, extremity numbness, metrorrhagia and metrostaxis leukorrhagia, long
Malaria is physically weak;Hyperlipidemia.
The concocting method of prepared fleece flower root is as follows: taking fleece-flower root piece or block, is mixed thoroughly according to stewed method with decoction of black soybean, sets non-ferrous fit
In suitable container, stewes to juice and exhaust;Or shine steaming method, steam in clear soup or steamed after being mixed thoroughly with decoction of black soybean, it steams to inside and outside in sepia, or shine
It is dry to half-dried, slice.Every 100kg fleece-flower root piece (block) uses semen sojae atricolor 10kg.Decoction of black soybean preparation method is to take semen sojae atricolor 10kg, adds water
In right amount, it boils about 4 hours, extractive about 15kg, bean dregs, which add water, to be boiled about 3 hours, extractive about 10kg, and decoction of black soybean about 25kg is merged to obtain.
The fruit of glossy privet: [nature and flavor] sweet, bitter, cold.[channel tropism] returns liver and kidney channel.[major function] is nourishing liver and kidney, improving eyesight black hair.With
In dizziness and tinnitus, soreness and weakness of waist and knees, poliosis, mesh is secretly unknown.
Mulberry fruit: [nature and flavor] are sweet, tremble with fear.[channel tropism] returns liver and kidney channel.[major function] tonifying liver, kidney-nourishing relieve dizziness, high fever, infantile convulsions, epilepsy, etc., and grow liquid.Control liver kidney
Yin deficiency is quenched one's thirst, and constipation, mesh is dark, tinnitus, scrofula, articular instability.
Eclipta: [nature and flavor] are sweet, sour, cool.[channel tropism] returns liver and kidney channel.[major function] tonifies the liver and kidney, cooling blood and hemostasis.It is main
Kidney deficiency and liver is had a dizzy spell, poliosis, is spitted blood, hemoptysis, bleeding from five sense organs or subcutaneous tissue, hematochezia, and bloody flux collapses, and is leaked, traumatic hemorrhage.
Radix Paeoniae Alba: [nature and flavor] are bitter, sour, slightly cold.[channel tropism] returns liver, the spleen channel.[major function] calming the liver and relieving pain, nourishing blood for regulating menstruation are held back
Negative hidroschesis.For headache and dizziness, hypochondriac pain, abdominal pain, four limbs contraction pain, blood deficiency chlorosis, irregular menstruation, spontaneous perspiration, night sweat.
Radix Astragali: [nature and flavor] are sweet, warm.[channel tropism] return lung, the spleen channel.[major function] invigorating qi, consolidating exterior, promoting urination and detoxification, apocenosis are held back
Sore myogenic.For deficiency of vital energy and acking in strength, anorexia and loose stool, the sinking of qi of middle-jiao, rush down prolapse of the anus for a long time, uterine bleeding of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy and edema, carbuncle
Subcutaneous ulcer difficulty is burst, burst for a long time and does not holds back, flaccidity of limbs due to deficiency of blood is yellow, Heat Diabetes;Chronic rephrilis protinuria, diabetes.
Rhizoma cibotii: [nature and flavor] hardship, sweet, warm.[channel tropism] returns liver, kidney, the heart, bladder meridian.[major function] curing rheumatism is good for waist foot,
Sharp joint.Main lumbago due to the kidney deficiency ridge is strong, and sufficient knee is weak and feeble, rheumatic arthralgia, frequent micturition, spermatorrhea, leukorrhea.
Flos Albiziae: [nature and flavor] are sweet, flat.[channel tropism] return heart, the spleen channel.[major function] Shu Yu, qi-regulating are calmed the nerves, active.It controls strongly fragrant
Accumulation of pathogens in chest is bored, insomnia, amnesia, acute conjunctivitis disease, blurring of vision, pharyngalgia, carbuncle swells, traumatic injury pain.
Green blood buccal tablet of the invention does not carry out after preceding processing compared with the preparation method of hematopoietic Chinese medicinal composition
The decocting and concentrating technique of Chinese medicine, but will first be passed through again in closed loop airflow milling and pulverize after the freeze-drying of seven taste Chinese medicines.
Specifically, Chinese medicine is first passed through drying in steam rotary dryer in freezing dry process, the action time of 40-60s will not
Make the excessive thermal expansion pore of Chinese medicine, heat-sensitive substance, protein, vitamin are also unlikely to heated denaturalization, reduce remaining moisture content
Content, being cooled to room temperature rear active constituent will not inactivate;- 25 DEG C~-20 DEG C of freeze-drying can cool down Chinese medicine in advance
It is frozen into solid, then comes out steam sublimation under vacuum conditions, and heat-sensitive substance, protein, vitamin isoreactivity
Substance can be left in the ice shelf freezed, it is dry after medicinal material constancy of volume and loose porous structure is presented, oxygen under low temperature
Air exhaustion is few, be easy the anthraquinones being oxidized by oxygen, Flavonoid substances will not be oxidized inactivation, remains to the maximum extent
The activity of medicinal material.
Low temperature closed loop Gas grinding is used during pulverizing, Chinese medicine materials can be under blower draft effect with upper
Air motion is risen to graded region, under the powerful centrifugal force effect that high-speed rotating stage turbine generates, thickness feed separation, slightly
Material is constantly crushed, until forming the fine powder of uniform particle size.Cryogenic ultramicro pulverization will not make medicinal material become fragile, and will not generate
Thermal phenomenon, and crushing speed is fast, retains the bioactive ingredients such as the flavonoids, glycoside, carbohydrate of non-refractory and vitamin, ammonia
The nutritional ingredients such as base acid promote the release and dissolution of Multiple components, and the high revolving speed pressurization broken wall of 4000-5000r/min can be right
The cell pulverization broken wall of Chinese medicine, specific surface area increase, and increase the contact area with blood, improve bioavilability.
The present invention is in the selection of auxiliary material, and by largely screening and testing, reduced isomaltooligosaccharide conduct is chosen in discovery
Sweetener, microcrystalline cellulose, xylitol are as filler, and Macrogol 6000 is as wetting agent and viscosity modifier, Flos Albiziae
Medicated premix of the extract as tranquilization and refreshment, so that the buccal tablet that tabletting is formed strengthens tranquilizing the mind, qi-regulating, analgesic function
Effect, it is good in taste, there is good relaxation effect to oligoleukocythemia symptom caused by concurrent chemoradiotherapy of malignant tumor after taking, significantly
Enhance the immunocompetence for taking rear patient.
As a further solution of the present invention, the Flos Albiziae extract preparation method the following steps are included:
1) alcohol extracting: 10-20g Flos Albiziae is put into extraction tank, and the ethyl alcohol of the 8-10 times of volume fraction 70-80% measured is added
Solution, refluxing extraction 3 times, each 2h, combined extract, concentration and recovery ethyl alcohol;
2) macroporous resin adsorption: the large pore resin absorption column that extracting solution is passed through after activation is adsorbed, is measured using 3-5 times
The ethanol solution that the volume fraction of column volume is 30-40% elutes impurity, reuses the 2-4 times of volume fraction 70- for measuring column volume
80% ethanol solution elutes target substance, collects eluent;Eluent is concentrated to get 60 DEG C of heat and surveys relative density 1.1-1.3g/
The concentrate of mL;
3) crystallize: after the concentrate of step 2) preparation is cooled to room temperature, a para-crystal is obtained by filtration in 5-8 DEG C of crystallization 12-16h
Body;Filtrate is added the 3-5 times of mixed solution measured and secondary crystal is obtained by filtration in 3-5 DEG C of recrystallization 20-24h;Crystal with
After secondary crystal mixing, the Flos Albiziae extract of high-purity is arrived in 65 DEG C of dryings to water capacity less than 5%.
The preparation method of Flos Albiziae extract of the invention has obtained high-purity by alcohol extracting, macroporous resin adsorption, crystallization
Flos Albiziae extract quercitin.Wherein, quercitin category flavonols glycosides compound, with good relieve stagnation, tranquilizing the mind, qi-regulating
Effect, but dissolubility is poor in conventional reagent, there are the hangovers of conventional normal-phase chromatography seriously, and disengaging time is longer, and is difficult
The problem of obtaining its high-purity monomer.After extracting the Alcohol soluble composition in Flos Albiziae by ethanol solution, first using volume
Low-concentration ethanol elution removes small polar impurity, then the eluent of high concentration is collected using a small amount of high concentration ethanol.Pass through
Under the paying of a large amount of screening experiment of inventor and creative work, discovery concentrate crystallization rate at 5-8 DEG C is higher, filters out
The mixed solution that is formed with small polar solvent of ethyl acetate it is good to the dissolubility of quercitin, the crystal purity warp after crystallizing twice
HPLC measurement has reached 99.5% or more, and cost is relatively low, easy to industrialized production.
As a further solution of the present invention, the mixed solution is pressed by ethyl acetate and n-hexane, hexamethylene, petroleum ether
It is mixed according to volume ratio 1:3-5.
As a further solution of the present invention, the decoction of black soybean preparation method is to take semen sojae atricolor 10kg, is pulverized into partial size 20-40
μm powder, add 6 times of amount water, filter within infusion 4 hours, retain filtrate, filter residue adds 4 times of amount water again, infusion 3 hours, filters, twice
Filtered filtrate merges.
The present invention also provides a kind of preparation methods of green blood buccal tablet in good taste, comprising the following steps:
(1) pre-treatment: the fleece-flower root and decoction of black soybean are mixed according to the ratio of mass ratio 10:1, the stifling fleece-flower root is in inside and outside
It is spare to be ground into soya bean size for sepia after drying;The fruit of glossy privet, mulberry fruit, Radix Astragali, Radix Paeoniae Alba, eclipta are robbed water and cleaned, is dried standby
With;Rhizoma cibotii is fried to the golden villus of crisp yellow and unilateral edge noresidue, it is spare;
(2) it is freeze-dried: by prepared fleece flower root, the fruit of glossy privet, mulberry fruit, eclipta, Radix Paeoniae Alba, Radix Astragali, seven taste Chinese medicine of rhizoma cibotii point
It Song Ru not be passed through 120 ± 2 DEG C of hot steam, action time 40-60s guarantees the center of Chinese medicine in steam rotary dryer
Temperature is cooled to room temperature between 80 ± 5 DEG C;It being then fed into freeze drier, medicinal material spacing is maintained between 1-3cm ,-
25 DEG C~-20 DEG C freeze-drying 30-40min;
(3) it pulverizes: by seven taste Chinese medicine precomminution after step (2) freeze-drying at graininess, crossing 20-40 mesh
Sieve is put into freezing charging basket, and -5 DEG C of freezing 10min are then fed into closed loop airflow milling, in motor speed 4000-5000r/
Min, air compressor machine pressure >=0.75MPa, air compressor machine tolerance > 10m3Seven taste traditional Chinese medicine powders are broken into partial size 6-8 under conditions of/min
μm fine powder;
(4) raw material mixes: seven taste Chinese medicine fine powders prepared by step (3), and 10-20min is mixed and obtains bulk pharmaceutical chemicals
Powder;
(5) auxiliary material mixes: in parts by weight, taking 60-90 parts of reduced isomaltooligosaccharide, 6-12 parts of microcrystalline cellulose, wood
0.2-0.6 parts of sugar alcohol, 10-16 parts of Macrogol 6000,0.3-0.6 parts of Flos Albiziae extract obtain after 3-6min is mixed
To auxiliary material mixture;
(6) supplementary material total mix, granulation: the total powder of raw material of whipping step (4) preparation is slowly added to the auxiliary of step (5) preparation
Expect in mixture, after addition, 10-15min is mixed, puts into granulator and pelletizes, and obtaining partial size is 400-600 μm
Mixing particle;
(7) tabletting: mixing particle prepared by step (6) carries out tabletting using rotary tablet machine, and obtaining slice weight is
The green blood buccal tablet of 1g/ piece.
The present invention also provides a kind of applications of green blood buccal tablet in good taste, and the green blood buccal tablet is in treatment malignant tumour
Application in the oligoleukocythemia of caused by radiotherapy and chemotherapy.
Beneficial effects of the present invention:
1, green blood buccal tablet in good taste of the invention will be made on the basis of existing hematopoietic Chinese medicinal composition formula
The fleece-flower root, the fruit of glossy privet, mulberry fruit, eclipta, Radix Paeoniae Alba, Radix Astragali, seven taste Chinese medicine of rhizoma cibotii pass through pre-treatment, freeze-drying, Ultramicro-powder
Broken, raw material mixing, auxiliary material mixing, the granulation of supplementary material total mix, tabletting obtain, and are meeting safety, stability, the premise of validity
Under, it has no toxic side effect substantially, it is in good taste, it works rapidly, green blood is enriched blood, and nourishing liver and kidney, malignant tumour is put in tranquilization and refreshment analgesia
Oligoleukocythemia symptom caused by chemotherapy and chemicotherapy position pain symptom have good relaxation effect, significantly increase patient's
Immunocompetence.
2, Chinese medicine is first passed through drying in steam rotary dryer in freezing dry process, the action time of 40-60s is not
It can make the excessive thermal expansion pore of Chinese medicine, heat-sensitive substance, protein, vitamin are also unlikely to heated denaturalization, reduce residual water
Part content, being cooled to room temperature rear active constituent will not inactivate;- 25 DEG C~-20 DEG C of freeze-drying can drop Chinese medicine in advance
Temperature is frozen into solid, then comes out steam sublimation under vacuum conditions, and heat-sensitive substance, protein, vitamin etc. are living
Property substance can be left in the ice shelf freezed, it is dry after medicinal material constancy of volume and loose porous structure is presented, under low temperature
Oxygen is few, is easy the anthraquinones being oxidized by oxygen, Flavonoid substances will not be oxidized inactivation, remains to the maximum extent
The activity of Chinese medicine.
3, the preparation method of Flos Albiziae extract has obtained the silk tree of high-purity by alcohol extracting, macroporous resin adsorption, crystallization
Flower extract quercitin.Wherein, quercitin category flavonols glycosides compound has effects that good relieve stagnation, tranquilizing the mind, qi-regulating,
But dissolubility is poor in conventional reagent, there are the hangovers of conventional normal-phase chromatography seriously, and disengaging time is longer, and is difficult to obtain it
The problem of high-purity monomer.After extracting the Alcohol soluble composition in Flos Albiziae by ethanol solution, the low concentration of volume is first used
Ethanol elution removes small polar impurity, then the eluent of high concentration is collected using a small amount of high concentration ethanol.Pass through inventor
Under the paying of a large amount of screening experiment and creative work, discovery concentrate crystallization rate at 5-8 DEG C is higher, the acetic acid filtered out
The mixed solution that ethyl ester is formed with small polar solvent is good to the dissolubility of quercitin, and the crystal purity after crystallizing twice is surveyed through HPLC
Surely reached 99.5% or more, cost is relatively low, easy to industrialized production.
Specific embodiment
Below in conjunction with the embodiment of the present invention, technical scheme in the embodiment of the invention is clearly and completely described,
Obviously, described embodiments are only a part of the embodiments of the present invention, instead of all the embodiments.Based in the present invention
Embodiment, all other embodiment obtained by those of ordinary skill in the art without making creative efforts, all
Belong to the scope of protection of the invention.
Embodiment 1
A kind of green blood buccal tablet in good taste, the raw material including following parts by weight: 13 parts of prepared fleece flower root, 16 parts of the fruit of glossy privet,
17 parts of mulberry fruit, 16 parts of eclipta, 13 parts of Radix Paeoniae Alba, 14 parts of Radix Astragali, 13 parts of rhizoma cibotii.
The preparation method of the green blood buccal tablet the following steps are included:
(1) pre-treatment: the fleece-flower root and decoction of black soybean are mixed according to the ratio of mass ratio 10:1, the stifling fleece-flower root is in inside and outside
It is spare to be ground into soya bean size for sepia after drying;The fruit of glossy privet, mulberry fruit, Radix Astragali, Radix Paeoniae Alba, eclipta are robbed water and cleaned, is dried standby
With;Rhizoma cibotii is fried to the golden villus of crisp yellow and unilateral edge noresidue, it is spare;Wherein, decoction of black soybean preparation method is to take semen sojae atricolor 10kg,
The powder for pulverizing into 20-40 μm of partial size adds 6 times of amount water, filters within infusion 4 hours, retains filtrate, and filter residue adds 4 times of amount water again,
Infusion 3 hours, filtering, filtered filtrate merged twice.
(2) it is freeze-dried: by prepared fleece flower root, the fruit of glossy privet, mulberry fruit, eclipta, Radix Paeoniae Alba, Radix Astragali, seven taste Chinese medicine of rhizoma cibotii point
It Song Ru not be passed through 120 ± 2 DEG C of hot steam, action time 55s guarantees the center temperature of Chinese medicine in steam rotary dryer
Degree is cooled to room temperature between 80 ± 5 DEG C;It is then fed into freeze drier, medicinal material spacing is maintained between 1-3cm, -22
DEG C freeze-drying 35min;
(3) it pulverizes: by seven taste Chinese medicine precomminution after step (2) freeze-drying at graininess, crossing 20-40 mesh
Sieve is put into freezing charging basket, and -5 DEG C of freezing 10min are then fed into closed loop airflow milling, in motor speed 4000-5000r/
Min, air compressor machine pressure >=0.75MPa, air compressor machine tolerance > 10m3Seven taste traditional Chinese medicine powders are broken into partial size 6-8 under conditions of/min
μm fine powder;
(4) raw material mixes: seven taste Chinese medicine fine powders prepared by step (3), and 16min is mixed and obtains raw material medicinal powder;
(5) auxiliary material mixes: in parts by weight, taking 78 parts of reduced isomaltooligosaccharide, 10 parts of microcrystalline cellulose, xylitol
0.4 part, 14 parts of Macrogol 6000,0.5 part of Flos Albiziae extract obtain auxiliary material mixture after 5min is mixed;
(6) supplementary material total mix, granulation: the total powder of raw material of whipping step (4) preparation is slowly added to the auxiliary of step (5) preparation
Expect in mixture, after addition, 10-15min is mixed, puts into granulator and pelletizes, and obtaining partial size is 400-600 μm
Mixing particle;
(7) tabletting: mixing particle prepared by step (6) carries out tabletting using rotary tablet machine, and obtaining slice weight is
The green blood buccal tablet of 1g/ piece.
Wherein, Flos Albiziae extract preparation method the following steps are included:
1) alcohol extracting: 10-20g Flos Albiziae is put into extraction tank, and the ethyl alcohol of the 8-10 times of volume fraction 70-80% measured is added
Solution, refluxing extraction 3 times, each 2h, combined extract, concentration and recovery ethyl alcohol;
2) macroporous resin adsorption: the large pore resin absorption column that extracting solution is passed through after activation is adsorbed, is measured using 3-5 times
The ethanol solution that the volume fraction of column volume is 30-40% elutes impurity, reuses the 2-4 times of volume fraction 70- for measuring column volume
80% ethanol solution elutes target substance, collects eluent;Eluent is concentrated to get 60 DEG C of heat and surveys relative density 1.1-1.3g/
The concentrate of mL;Wherein, mixed solution mixed with n-hexane, hexamethylene, petroleum ether according to volume ratio 1:3-5 by ethyl acetate and
At.
3) crystallize: after the concentrate of step 2) preparation is cooled to room temperature, a para-crystal is obtained by filtration in 5-8 DEG C of crystallization 12-16h
Body;Filtrate is added the 3-5 times of mixed solution measured and secondary crystal is obtained by filtration in 3-5 DEG C of recrystallization 20-24h;Crystal with
After secondary crystal mixing, the Flos Albiziae extract of high-purity is arrived in 65 DEG C of dryings to water capacity less than 5%.
The green blood buccal tablet of the present embodiment is treating the application in oligoleukocythemia caused by concurrent chemoradiotherapy of malignant tumor.
Embodiment 2
A kind of green blood buccal tablet in good taste, the raw material including following parts by weight: 15 parts of prepared fleece flower root, 17 parts of the fruit of glossy privet,
17 parts of mulberry fruit, 15 parts of eclipta, 15 parts of Radix Paeoniae Alba, 14 parts of Radix Astragali, 14 parts of rhizoma cibotii;
The preparation method of the green blood buccal tablet the following steps are included:
(1) pre-treatment: the fleece-flower root and decoction of black soybean are mixed according to the ratio of mass ratio 10:1, the stifling fleece-flower root is in inside and outside
It is spare to be ground into soya bean size for sepia after drying;The fruit of glossy privet, mulberry fruit, Radix Astragali, Radix Paeoniae Alba, eclipta are robbed water and cleaned, is dried standby
With;Rhizoma cibotii is fried to the golden villus of crisp yellow and unilateral edge noresidue, it is spare;Wherein, decoction of black soybean preparation method is to take semen sojae atricolor 10kg,
The powder for pulverizing into 20-40 μm of partial size adds 6 times of amount water, filters within infusion 4 hours, retains filtrate, and filter residue adds 4 times of amount water again,
Infusion 3 hours, filtering, filtered filtrate merged twice.
(2) it is freeze-dried: by prepared fleece flower root, the fruit of glossy privet, mulberry fruit, eclipta, Radix Paeoniae Alba, Radix Astragali, seven taste Chinese medicine of rhizoma cibotii point
It Song Ru not be passed through 120 ± 2 DEG C of hot steam, action time 40-60s guarantees the center of Chinese medicine in steam rotary dryer
Temperature is cooled to room temperature between 80 ± 5 DEG C;It being then fed into freeze drier, medicinal material spacing is maintained between 1-3cm ,-
23 DEG C of freeze-drying 35min;
(3) it pulverizes: by seven taste Chinese medicine precomminution after step (2) freeze-drying at graininess, crossing 20-40 mesh
Sieve is put into freezing charging basket, and -5 DEG C of freezing 10min are then fed into closed loop airflow milling, in motor speed 4000-5000r/
Min, air compressor machine pressure >=0.75MPa, air compressor machine tolerance > 10m3Seven taste traditional Chinese medicine powders are broken into partial size 6-8 under conditions of/min
μm fine powder;
(4) raw material mixes: seven taste Chinese medicine fine powders prepared by step (3), and 18min is mixed and obtains raw material medicinal powder;
(5) auxiliary material mixes: in parts by weight, taking 85 parts of reduced isomaltooligosaccharide, 7 parts of microcrystalline cellulose, xylitol 0.5
Part, 14 parts of Macrogol 6000,0.6 part of Flos Albiziae extract obtain auxiliary material mixture after 5min is mixed;Wherein, it closes
The preparation method of joyous flower extract is same as Example 1.
(6) supplementary material total mix, granulation: the total powder of raw material of whipping step (4) preparation is slowly added to the auxiliary of step (5) preparation
Expect in mixture, after addition, 15min is mixed, puts into granulator and pelletizes, obtaining partial size is 400-600 μm mixed
Expect particle;
(7) tabletting: mixing particle prepared by step (6) carries out tabletting using rotary tablet machine, and obtaining slice weight is
The green blood buccal tablet of 1g/ piece.
The green blood buccal tablet of the present embodiment is treating the application in oligoleukocythemia caused by concurrent chemoradiotherapy of malignant tumor.
Embodiment 3
A kind of green blood buccal tablet in good taste, the raw material including following parts by weight: 15 parts of prepared fleece flower root, 17 parts of the fruit of glossy privet,
16 parts of mulberry fruit, 16 parts of eclipta, 14 parts of Radix Paeoniae Alba, 15 parts of Radix Astragali, 13 parts of rhizoma cibotii;
The preparation method of the green blood buccal tablet the following steps are included:
(1) pre-treatment: the fleece-flower root and decoction of black soybean are mixed according to the ratio of mass ratio 10:1, the stifling fleece-flower root is in inside and outside
It is spare to be ground into soya bean size for sepia after drying;The fruit of glossy privet, mulberry fruit, Radix Astragali, Radix Paeoniae Alba, eclipta are robbed water and cleaned, is dried standby
With;Rhizoma cibotii is fried to the golden villus of crisp yellow and unilateral edge noresidue, it is spare;Wherein, decoction of black soybean preparation method is to take semen sojae atricolor 10kg,
The powder for pulverizing into 20-40 μm of partial size adds 6 times of amount water, filters within infusion 4 hours, retains filtrate, and filter residue adds 4 times of amount water again,
Infusion 3 hours, filtering, filtered filtrate merged twice.
(2) it is freeze-dried: by prepared fleece flower root, the fruit of glossy privet, mulberry fruit, eclipta, Radix Paeoniae Alba, Radix Astragali, seven taste Chinese medicine of rhizoma cibotii point
It Song Ru not be passed through 120 ± 2 DEG C of hot steam, action time 40-60s guarantees the center of Chinese medicine in steam rotary dryer
Temperature is cooled to room temperature between 80 ± 5 DEG C;It being then fed into freeze drier, medicinal material spacing is maintained between 1-3cm ,-
25 DEG C of freeze-drying 32min;
(3) it pulverizes: by seven taste Chinese medicine precomminution after step (2) freeze-drying at graininess, crossing 20-40 mesh
Sieve is put into freezing charging basket, and -5 DEG C of freezing 10min are then fed into closed loop airflow milling, in motor speed 4000-5000r/
Min, air compressor machine pressure >=0.75MPa, air compressor machine tolerance > 10m3Seven taste traditional Chinese medicine powders are broken into partial size 6-8 under conditions of/min
μm fine powder;
(4) raw material mixes: seven taste Chinese medicine fine powders prepared by step (3), and 20min is mixed and obtains raw material medicinal powder;
(5) auxiliary material mixes: in parts by weight, taking 85 parts of reduced isomaltooligosaccharide, 11 parts of microcrystalline cellulose, xylitol
0.5 part, 15 parts of Macrogol 6000,0.4 part of Flos Albiziae extract obtain auxiliary material mixture after 6min is mixed;
Wherein, the preparation method of Flos Albiziae extract is same as Example 1.
(6) supplementary material total mix, granulation: the total powder of raw material of whipping step (4) preparation is slowly added to the auxiliary of step (5) preparation
Expect in mixture, after addition, 10-15min is mixed, puts into granulator and pelletizes, and obtaining partial size is 400-600 μm
Mixing particle;
(7) tabletting: mixing particle prepared by step (6) carries out tabletting using rotary tablet machine, and obtaining slice weight is
The green blood buccal tablet of 1g/ piece.
The green blood buccal tablet of the present embodiment is treating the application in oligoleukocythemia caused by concurrent chemoradiotherapy of malignant tumor.
Comparative example 1
The difference from embodiment 1 is that lacking step (2) freeze-drying.
Comparative example 2
The difference from embodiment 1 is that step (3) be by step (2) freeze-drying after seven taste Chinese medicine precomminution at
Graininess crosses 20-40 mesh.
Comparative example 3
The difference from embodiment 1 is that being not added with reduced isomaltooligosaccharide in auxiliary material.
Green blood buccal tablet sensory test
30 patients for suffering from leukopenia after chemoradiotherapy are chosen, are divided into 6 groups, every group of 5 people take embodiment respectively
The green blood buccal tablet of 1-3, comparative example 1-3, number 1,2,3,4 respectively represent mouthfeel satisfaction, and number is bigger, and mouthfeel is more satisfied,
Mouthfeel index has sugariness, sophistication, hardness, counts the total value of each mouthfeel index, and concrete outcome is shown in Table 1:
1. green blood buccal tablet sensory test result of table
Group | Sugariness | Sophistication | Hardness |
Example 1 group | 16 | 18 | 16 |
2 groups of embodiment | 15 | 17 | 16 |
3 groups of embodiment | 15 | 16 | 15 |
1 group of comparative example | 13 | 12 | 12 |
2 groups of comparative example | 12 | 7 | 9 |
3 groups of comparative example | 8 | 14 | 13 |
As can be seen from the above table, the green blood buccal tablet of the embodiment of the present invention is on sugariness, sophistication, hardness number, mouthfeel
Well, it is high to take rear satisfaction by patient.1 group of comparative example lacks freeze-drying step, and the more moisture content of meeting remaining, yellow in Chinese medicine
Substance is oxidized easily and inactivates in ketone, anthraquinone, and bitter taste is caused to increase, taste bad, and 2 groups of comparative example lack ultramicro grinding, leads
Cause the granularity of Chinese medicine larger, specific surface area is small, and hardness increases, taste bad.3 groups of comparative example oligomeric different due to lacking sweetener
Maltitol, sugariness reduce, and bitterness sense increases, taste bad.
Human trial
Subjects and method
Oligoleukocythemia, pain is obvious, clouded in mind trial volunteer 60, are divided into implementation after selection tumor chemoradiotherapy
Example 1-3 group, reference examples 1-3 group, every group of 10 people.Embodiment 1-3 group, reference examples 1-3 group take embodiment 1-3, comparative example respectively
The green blood buccal tablet of 1-3 preparation, 3 times a day, 1 tablet once, and the observation period is 40 days, life and drink during taking to study subject
Intervention is not added in food, but avoids using other containing iron preparation.
Before the test and after test, through arm venous blood collection 6mL (3mL is not anticoagulant, and 3mL is anticoagulant), examined respectively in designated hospital
It tests section to be detected, main indicator includes subjective sensation index, physical examination index, hematological indices, biochemical indicator, blood red egg
White (Hb) measurement, leucocyte (WBC) measurement, Erythrocyte chemokine recepter (FEP) measurement and serum ferritin (SF) measurement.
Criterion
1. effective: clinical symptoms, sign disappear or are clearly better, and Hemoglobin Value rises 10g/L or more, white blood cell concentration
Rise 2000/L or more, the index observed by remaining has improvement;2. effectively: clinical symptoms, sign have improvement, hemoglobin liter
High 5g/L~10g/L, white blood cell concentration rise 1000-2000/L, and other observed indexs are without adverse changes;3. invalid: its
Remaining is invalid.
Specific test result is shown in Table 2:
2. green blood buccal tablet human test results of table
As can be seen from the above table, the total effective rate of embodiment 1-3 group is higher than reference examples 1-3 group, illustrates green blood of the invention
Buccal tablet can be improved the hemoglobin concentration and white blood cell concentration of patient, to oligoleukocythemia symptom caused by tumor chemoradiotherapy
With good relaxation effect, and tranquilization and refreshment, it is nourishing liver and kidney.
In the description of this specification, the description of reference term " one embodiment ", " example ", " specific example " etc. means
Particular features, structures, materials, or characteristics described in conjunction with this embodiment or example are contained at least one implementation of the invention
In example or example.In the present specification, schematic expression of the above terms may not refer to the same embodiment or example.
Moreover, particular features, structures, materials, or characteristics described can be in any one or more of the embodiments or examples to close
Suitable mode combines.
Above content is only citing made for the present invention and explanation, affiliated those skilled in the art are to being retouched
The specific embodiment stated does various modifications or additions or is substituted in a similar manner, and without departing from invention or surpasses
More range defined in the claims, is within the scope of protection of the invention.
Claims (6)
1. a kind of green blood buccal tablet in good taste, which is characterized in that the raw material including following parts by weight: prepared fleece flower root 11~15
Part, 14~18 parts of the fruit of glossy privet, 14~18 parts of mulberry fruit, 14~18 parts of eclipta, 11~15 parts of Radix Paeoniae Alba, 11~15 parts of Radix Astragali, rhizoma cibotii
11~14 parts;
The preparation method of the green blood buccal tablet the following steps are included:
(1) pre-treatment: the fleece-flower root and decoction of black soybean are mixed according to the ratio of mass ratio 10:1, fumigate the fleece-flower root to inside and outside in brown
It is spare to be ground into soya bean size for color after drying;The fruit of glossy privet, mulberry fruit, Radix Astragali, Radix Paeoniae Alba, eclipta are robbed water and cleaned, is dried for standby;
Rhizoma cibotii is fried to the golden villus of crisp yellow and unilateral edge noresidue, it is spare;
(2) it is freeze-dried: prepared fleece flower root, the fruit of glossy privet, mulberry fruit, eclipta, Radix Paeoniae Alba, Radix Astragali, seven taste Chinese medicine of rhizoma cibotii is sent respectively
Enter in steam rotary dryer, be passed through 120 ± 2 DEG C of hot steam, action time 40-60s guarantees the central temperature of Chinese medicine
Between 80 ± 5 DEG C, it is cooled to room temperature;It is then fed into freeze drier, medicinal material spacing is maintained between 1-3cm, at -25 DEG C
~-20 DEG C of freeze-drying 30-40min;
(3) it pulverizes: by seven taste Chinese medicine precomminution after step (2) freeze-drying at graininess, crossing 20-40 mesh, put
Enter to freeze in charging basket, -5 DEG C of freezing 10min are then fed into closed loop airflow milling, in motor speed 4000-5000r/min, pneumatics
Machine pressure >=0.75MPa, air compressor machine tolerance > 10m3Seven taste traditional Chinese medicine powders are broken into 6-8 μm of partial size thin under conditions of/min
Powder;
(4) raw material mixes: seven taste Chinese medicine fine powders prepared by step (3), and 10-20min is mixed and obtains raw material medicinal powder;
(5) auxiliary material mixes: in parts by weight, taking 60-90 parts of reduced isomaltooligosaccharide, 6-12 parts of microcrystalline cellulose, xylitol
0.2-0.6 parts, 10-16 parts of Macrogol 6000,0.3-0.6 parts of Flos Albiziae extract obtain auxiliary after 3-6min is mixed
Expect mixture;
(6) supplementary material total mix, granulation: the total powder of raw material of whipping step (4) preparation, the auxiliary material for being slowly added to step (5) preparation are mixed
It closes in object, after addition, 10-15min is mixed, puts into granulator and pelletizes, obtain the mixing that partial size is 400-600 μm
Particle;
(7) tabletting: mixing particle prepared by step (6) carries out tabletting using rotary tablet machine, and obtaining slice weight is 1g/ piece
Green blood buccal tablet.
2. green blood buccal tablet in good taste according to claim 1, which is characterized in that the preparation of the Flos Albiziae extract
Method the following steps are included:
(1) alcohol extracting: 10-20g Flos Albiziae is put into extraction tank, and the ethyl alcohol that the 8-10 times of volume fraction 70-80% measured is added is molten
Liquid, refluxing extraction 3 times, each 2h, combined extract, concentration and recovery ethyl alcohol;
(2) macroporous resin adsorption: the large pore resin absorption column that extracting solution is passed through after activation is adsorbed, measures column using 3-5 times
The ethanol solution that the volume fraction of volume is 30-40% elutes impurity, reuses the 2-4 times of volume fraction 70- for measuring column volume
80% ethanol solution elutes target substance, collects eluent;Eluent is concentrated to get 60 DEG C of heat and surveys relative density 1.1-1.3g/
The concentrate of mL;
(3) crystallize: after the concentrate of step 2) preparation is cooled to room temperature, a crystal is obtained by filtration in 5-8 DEG C of crystallization 12-16h;
Filtrate is added the 3-5 times of mixed solution measured and secondary crystal is obtained by filtration in 3-5 DEG C of recrystallization 20-24h;Crystal with it is secondary
After crystal mixing, the Flos Albiziae extract of high-purity is arrived in 65 DEG C of dryings to water capacity less than 5%.
3. green blood buccal tablet in good taste according to claim 2, which is characterized in that the mixed solution is by ethyl acetate
It is mixed with n-hexane, hexamethylene, petroleum ether according to volume ratio 1:3-5.
4. green blood buccal tablet in good taste according to claim 1, which is characterized in that the decoction of black soybean preparation method is to take semen sojae atricolor
10kg pulverizes the powder at 20-40 μm of partial size, adds 6 times of amount water, filters within infusion 4 hours, retains filtrate, filter residue adds 4 times again
Water is measured, infusion 3 hours, filtering, filtered filtrate merged twice.
5. a kind of preparation method of green blood buccal tablet in good taste, which comprises the following steps:
(1) pre-treatment: the fleece-flower root and decoction of black soybean are mixed according to the ratio of mass ratio 10:1, fumigate the fleece-flower root to inside and outside in brown
It is spare to be ground into soya bean size for color after drying;The fruit of glossy privet, mulberry fruit, Radix Astragali, Radix Paeoniae Alba, eclipta are robbed water and cleaned, is dried for standby;
Rhizoma cibotii is fried to the golden villus of crisp yellow and unilateral edge noresidue, it is spare;
(2) it is freeze-dried: prepared fleece flower root, the fruit of glossy privet, mulberry fruit, eclipta, Radix Paeoniae Alba, Radix Astragali, seven taste Chinese medicine of rhizoma cibotii is sent respectively
Enter in steam rotary dryer, be passed through 120 ± 2 DEG C of hot steam, action time 40-60s guarantees the central temperature of Chinese medicine
Between 80 ± 5 DEG C, it is cooled to room temperature;It is then fed into freeze drier, medicinal material spacing is maintained between 1-3cm, at -25 DEG C
~-20 DEG C of freeze-drying 30-40min;
(3) it pulverizes: by seven taste Chinese medicine precomminution after step (2) freeze-drying at graininess, crossing 20-40 mesh, put
Enter to freeze in charging basket, -5 DEG C of freezing 10min are then fed into closed loop airflow milling, in motor speed 4000-5000r/min, pneumatics
Machine pressure >=0.75MPa, air compressor machine tolerance > 10m3Seven taste traditional Chinese medicine powders are broken into 6-8 μm of partial size thin under conditions of/min
Powder;
(4) raw material mixes: seven taste Chinese medicine fine powders prepared by step (3), and 10-20min is mixed and obtains raw material medicinal powder;
(5) auxiliary material mixes: in parts by weight, taking 60-90 parts of reduced isomaltooligosaccharide, 6-12 parts of microcrystalline cellulose, xylitol
0.2-0.6 parts, 10-16 parts of Macrogol 6000,0.3-0.6 parts of Flos Albiziae extract obtain auxiliary after 3-6min is mixed
Expect mixture;
(6) supplementary material total mix, granulation: the total powder of raw material of whipping step (4) preparation, the auxiliary material for being slowly added to step (5) preparation are mixed
It closes in object, after addition, 10-15min is mixed, puts into granulator and pelletizes, obtain the mixing that partial size is 400-600 μm
Particle;
(7) tabletting: mixing particle prepared by step (6) carries out tabletting using rotary tablet machine, and obtaining slice weight is 1g/ piece
Green blood buccal tablet.
6. a kind of application of green blood buccal tablet in good taste, which is characterized in that the green blood buccal tablet is in treatment putting of malignant tumour
The application in oligoleukocythemia caused by treating.
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Citations (3)
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CN1313096A (en) * | 2000-03-09 | 2001-09-19 | 马术村 | Health-care tonic buccal lozenge |
CN101804103A (en) * | 2009-02-17 | 2010-08-18 | 清华德人西安幸福制药有限公司 | Drug for treating leukopenia caused by concurrent chemoradiotherapy of malignant tumor and preparation method thereof |
CN102503998A (en) * | 2011-12-15 | 2012-06-20 | 成都普思生物科技有限公司 | Method for rapidly separating quercetin from flos albiziae |
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2019
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CN1313096A (en) * | 2000-03-09 | 2001-09-19 | 马术村 | Health-care tonic buccal lozenge |
CN101804103A (en) * | 2009-02-17 | 2010-08-18 | 清华德人西安幸福制药有限公司 | Drug for treating leukopenia caused by concurrent chemoradiotherapy of malignant tumor and preparation method thereof |
CN102503998A (en) * | 2011-12-15 | 2012-06-20 | 成都普思生物科技有限公司 | Method for rapidly separating quercetin from flos albiziae |
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SUK-KYUN YANG ET AL.: "A common missense variant in NUDT15 confers susceptibility to thiopurine-induced leukopenia", 《NAT GENET》 * |
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Application publication date: 20190416 |