CN104324087A - Dragonwort pure powder ultramicro decoction piece and preparation method thereof - Google Patents

Dragonwort pure powder ultramicro decoction piece and preparation method thereof Download PDF

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CN104324087A
CN104324087A CN201410550660.7A CN201410550660A CN104324087A CN 104324087 A CN104324087 A CN 104324087A CN 201410550660 A CN201410550660 A CN 201410550660A CN 104324087 A CN104324087 A CN 104324087A
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preparation
rhizoma bistortae
decoction piece
pure powder
ultramicro decoction
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傅苗青
傅双英
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PAN'AN DAODI PANYAO CHINESE MEDICINE INSTITUTE
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PAN'AN DAODI PANYAO CHINESE MEDICINE INSTITUTE
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/70Polygonaceae (Buckwheat family), e.g. spineflower or dock
    • A61K36/704Polygonum, e.g. knotweed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089Processes

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  • Life Sciences & Earth Sciences (AREA)
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Abstract

The invention discloses a dragonwort pure powder ultramicro decoction piece preparation method and a prepared product. The preparation method is as follows: crushing dried dragonwort extracts to the particle size below 300 microns, performing ultramicro-crushing in an airflow crusher to prepare the dragonwort pure powder ultramicro decoction piece, and the ultramicro-crushing conditions are as follows: the crushing temperature is 15-22 DEG C, the pressure is 1-2MPa when entering the ultramicro-crusher, the crushing pressure is 2-6MPa, the air flow velocity is 200-285m / s, and the crushing time is 1-3H. The oral medicament prepared by the preparation method has good effect, good dissolution property, good stability and high bioavailability, and the smell and taste of the oral medicament are improved.

Description

Pure powder ultramicro decoction piece of Rhizoma Bistortae and preparation method thereof
Technical field
The present invention relates to field of traditional Chinese, particularly pure powder ultramicro decoction piece of Rhizoma Bistortae and preparation method thereof.
Background technology
Rhizoma Bistortae is come from " Bencao Tujing ": " Rhizoma Bistortae, raw Zi Zhou field.Leaf is as Radix Rumicis Japonici, and root is Penaeus seu panulirus seemingly, black.May adopts." " in Tang materia medica contained Herba Salviae Chinensis " and " Bencao Tujing " " Jinzhou Herba Salviae Chinensis ", for Rong belongs to Rhizoma Bistortae group plant.Therefore this product that is book on Chinese herbal medicine " one in Herba Salviae Chinensis.Rhizoma Bistortae perennial herb is high 50 ~ 90 centimetres.The plump distortion of rhizome, crust aubergine.Heat clearing away is relieving convulsion, the wet detumescence of reason.Control that calentura is frightened jerks, tetanus, bloody dysentery, carbuncle, scrofula.Clearing away heat-damp and promoting diuresis; Cooling blood for hemostasis; Detoxicating and resolving stagnation of pathogens.Main cough due to lung-heat; Calentura infantile convulsion; Bloody dysentery; Diarrhea of heat type; Spit blood; Epistaxis; Bleeding hemorrhoids; Carbuncle sore tumefacting virus.
The needs of modern healthy, in field of traditional Chinese in succession, revive and develop middle formation numerous Chinese medicine old established firm brand, as Tongrentang (1669), Hu Qingyu Pharmaceutical Workshop (1874), large life auspicious (1885), Han Xingtang (1901), Fu Tong (1644), Fructus Pruni and hall (1600), public good is large, Chen Zhi father-in-law, bosom moral crane (1948), old man and Tai, father-in-law Changchun (1699), Fu Jichun, refined vegetarian (between bright year in Wanli year), first-class and the Chinese medicine health-care tea old established firm brand of Lei Yun is as ten thousand safe units (1860), Zhu Qiansheng, roc red sun, universe Thailand is poly-, wherein ten thousand safe first tea No. win ten thousand state's World's Fair gold medals in 1915 especially, the first-class Grand Prix of nineteen twenty-six U.S. Philadelphia World's Fair and nineteen twenty-nine first West Lake Exposition gold medal.But Chinese medicine decoction pieces is concocted in a usual manner, medical material effective ingredient runs off or cannot fully discharge, and the sporoderm-broken rate of cell is extremely low, and its bioavailability is lower, and herb resource is wasted.Because its dissolution rate is low, therefore must be enough, and adhere to that the long period continues to take just meeting effectively, but this situation can cause drug cost high.Peroral dosage form mature preparation process in prior art, but its defect also can not be ignored.The preparation method of conventional peroral dosage form; usually can with problems such as the loss of medical material effective ingredient, degeneration or impurity increase; particularly for Rhizoma Bistortae be key agents active component preparation technology in; because the active constituents of medicine in Rhizoma Bistortae is comparatively responsive to preparation technology parameter; preparation technology is improper; make drug dissolution low, active constituent content reduces, and bioavailability is low.
Superfine communication technique developed a very fast new technique in recent years.Apply this technology, solid matter can be ground into the superfine powder that diameter is less than 10 microns, thus, the powder body through micronizing process often has good dissolubility, therefore can consider the preparation technology being applied to peroral dosage form.
But, in prior art, still superfine communication technique is not applied to the technique of preparation Rhizoma Bistortae decoction pieces, its reason is as previously mentioned: the active constituents of medicine in Rhizoma Bistortae is comparatively responsive for preparation technology, and the technological parameter of micronizing often causes the degeneration of active constituents of medicine, therefore, obtained peroral dosage form effective ingredient easily decomposes, impurity is many, and uniformity of dosage units is poor, poor stability.On this basis, seek one and can not cause active constituents of medicine degeneration, and obtained peroral dosage form has the micronizing technological parameter of more excellent properties, is a difficult problem urgently to be resolved hurrily in prior art.
Summary of the invention
It is low that main purpose of the present invention is to overcome Rhizoma Bistortae extract oral drug form dissolution in prior art, active constituent content reduces, bioavailability is low, and the process conditions of the superfine communication technique of routine are not suitable for the preparation of Rhizoma Bistortae peroral dosage form, in obtained peroral dosage form, effective ingredient easily decomposes, and impurity is many, and uniformity of dosage units is poor, the defect of poor stability etc., provides preparation technology of the pure powder ultramicro decoction piece of a kind of Rhizoma Bistortae and preparation method thereof.The peroral dosage form good drug efficacy that the preparation technology of the pure powder ultramicro decoction piece of Rhizoma Bistortae of the present invention obtains, stripping property is good, good stability, and bioavailability is high, and the abnormal smells from the patient of peroral dosage form and mouthfeel improve.
The present invention solves the problems of the technologies described above by the following technical programs:
An object of the present invention is, provide the preparation method of the pure powder ultramicro decoction piece of a kind of Rhizoma Bistortae, described preparation method comprises the following steps:
The Rhizoma Bistortae extract of drying is crushed to particle diameter less than 300 microns, micronizing in jet mill again, obtain the pure powder ultramicro decoction piece of Rhizoma Bistortae, the condition of described micronizing is: pulverize temperature 15-22 DEG C, pressure when entering super micron mill is 1-2Mpa, pulverize pressure 2-6Mpa, air velocity 200-285m/s, the time 1-3h of pulverizing.
Preferred further technical scheme below for above-mentioned steps does following explanation:
By obtained ultramicro decoction piece with meet the adjuvant that medicament requires, obtained tablet, capsule or other oral normal release dosage forms.
Described Rhizoma Bistortae extract is prepared by following method: the rhizome of Rhizoma Bistortae is crushed to 10-15 order, the water of 1: 1 and ethanol is used to extract, then the extracting solution obtained is concentrated, first use the washing decontamination of 5 column volumes, and then carry out eluting with eluant, collect eluent, dry, and described eluent is propanol, and the method wherein extracted is the extracting solution adding 5 times carries out extraction 4 times, then at room temperature flood 64 hours, and then the extracting solution of 15 volumes carries out percolation, flow velocity is 6mL/min.
Described adjuvant is the adjuvant of this area routine, preferably comprises one or more in disintegrating agent, lubricant, binding agent and filler.The addition of described adjuvant is preferably 10%-40%, and described percentage ratio is the mass percent accounting for described Rhizoma Bistortae extract.
Wherein, described disintegrating agent is the disintegrating agent of this area routine, is preferably one or more in starch, microcrystalline Cellulose, hydroxypropyl emthylcellulose, sodium alginate, crospolyvinylpyrrolidone and cross-linking sodium carboxymethyl cellulose.The addition of described disintegrating agent is the addition of this area routine, and be preferably 5%-15%, described percentage ratio is the mass percent accounting for described Rhizoma Bistortae extract.
Wherein, described lubricant is the lubricant of this area routine, is preferably one or more in magnesium stearate, sodium laurylsulfate and boric acid.The addition of described lubricant is the addition of this area routine, and be preferably 3%-9%, described percentage ratio is the mass percent accounting for described Rhizoma Bistortae extract.
Wherein, described binding agent is the binding agent of this area routine, is preferably Rhizoma Bistortae pure powder ultramicro decoction piece silica gel and/or Pulvis Talci.The addition of described binding agent is the addition of this area routine, and be preferably 1%-5%, described percentage ratio is the mass percent accounting for described Rhizoma Bistortae extract.
Wherein, described filler is the filler of this area routine, is preferably lactose and/or calcium sulfate.The addition of described filler is the addition of this area routine, and be preferably 1%-15%, described percentage ratio is the mass percent accounting for described Rhizoma Bistortae extract.
In step (1), the condition of described micronizing is preferably: pulverize temperature 20 DEG C, pressure when entering super micron mill is 1.5Mpa, pulverizes pressure 3-5Mpa, air velocity 220-260m/s, the time 1.5-2.5h of pulverizing.
In step (1), the method for described drying and condition are ability and conventional method and condition, and described drying is preferably carried out in vacuum drier.Described vacuum drying temperature is preferably 80-110 DEG C, and described vacuum drying pressure is preferably-0.1 ~ 0.2mpa.
In step (1), described is crushed to particle diameter less than 300 microns, then in jet mill before micronizing, preferably carries out sterilization treatment.The method of described sterilizing is the method for this area routine, is preferably one or more in ray sterilizing, microwave sterilizating, wet-hot steam sterilizing and ozone sterilization.
In step (1), described micronizing is preferably crushed to particle diameter 1-80 micron, and the particulate accumulation that particle diameter is less than 65 microns is no less than 90%.
Two of object of the present invention is, provides the pure powder ultramicro decoction piece of Rhizoma Bistortae that preparation method as above is obtained.
On the basis meeting this area general knowledge, above-mentioned each optimum condition, can combination in any, obtains the preferred embodiments of the invention.
Agents useful for same of the present invention and raw material are all commercially.
Positive progressive effect of the present invention is: the peroral dosage form good drug efficacy that the preparation technology of the pure powder ultramicro decoction piece of Rhizoma Bistortae of the present invention obtains, and stripping property is good, good stability, and bioavailability is high, and the abnormal smells from the patient of peroral dosage form and mouthfeel improve.
Detailed description of the invention
Mode below by embodiment further illustrates the present invention, but does not therefore limit the present invention among described scope of embodiments.
The raw material of the pure powder of the Rhizoma Bistortae in embodiment 1-6 ultramicro decoction piece is as shown in table 1.
The raw material of the pure powder ultramicro decoction piece of the Rhizoma Bistortae in table 1 embodiment 1-6
Note: in upper table, the addition of active constituents of medicine is weight portion; The addition of adjuvant is the mass percent accounting for active constituents of medicine.
In embodiment 1-3, the preparation method of Rhizoma Bistortae extract comprises the following steps:
The rhizome of Rhizoma Bistortae is crushed to 10-15 order, use the water of 1: 1 and ethanol to extract, then the extracting solution obtained is concentrated, first use the washing decontamination of 5 column volumes, and then carry out eluting with eluant, collect eluent, dry, and described eluent is propanol, and the method wherein extracted is the extracting solution adding 5 times carries out extraction 4 times, then at room temperature flood 64 hours, and then the extracting solution of 15 volumes carries out percolation, flow velocity is 6mL/min.By the Rhizoma Bistortae extract that the method prepares, the active component of Rhizoma Bistortae all can be extracted, and the loss rate of active component can drop to minimum.
After the rhizome of Rhizoma Bistortae is first pulverized, carry out the extraction of water and ethanol again, can by the gallic acid in the active component of Rhizoma Bistortae, benzoaric acid, dextrorotation catechol, left-handed table tea phenol, 6-Galloyl Glucose, 3, the isomer of 6-bis-gallic acid glucose, hydroxymethyl anthraquinone, vitamin, cupreol extracts, and can not lose, water can wash away impurity removing wherein simultaneously.
Adopt this put forward the methods, Organic substance wherein can be dissolved out, and the efficiency that puts forward of the method and composition best.
Embodiment 1
Preparation technology:
The Rhizoma Bistortae extract of drying is crushed to particle diameter less than 300 microns, ray sterilizing, then in jet mill micronizing to 40 micron, the particulate accumulation 90% that particle diameter is less than 65 microns, obtains the pure powder ultramicro decoction piece of Rhizoma Bistortae;
Wherein, vacuum drying temperature is 100 DEG C, and pressure is 0.1mpa; The condition surpassing Rhizoma Bistortae pure powder ultramicro decoction piece broken is: pulverize temperature 20 DEG C, pressure when entering super micron mill is 1.5Mpa, pulverizes pressure 3Mpa, air velocity 220m/s, the time 1.5h of pulverizing;
By obtained ultramicro decoction piece with meet the adjuvant that medicament requires, obtained tablet, capsule or other oral normal release dosage forms.
Embodiment 2
Preparation technology:
Rhizoma Bistortae extract described in drying is crushed to particle diameter less than 300 microns, microwave sterilizating, then ultra micro divides and is broken to 50 microns, the particulate accumulation 95% that particle diameter is less than 65 microns in jet mill, obtains the pure powder ultramicro decoction piece of Rhizoma Bistortae;
Wherein, vacuum drying temperature is 90 DEG C, and pressure is 0.2mpa; The condition that ultra micro is morcelled is: pulverize temperature 20 DEG C, pressure when entering super micron mill is 1.5Mpa, pulverizes pressure 5Mpa, air velocity 260m/s, the time 1.5h of pulverizing;
By obtained ultramicro decoction piece with meet the adjuvant that medicament requires, obtained tablet, capsule or other oral normal release dosage forms.
Embodiment 3
Preparation technology:
Rhizoma Bistortae extract described in drying is crushed to particle diameter less than 300 microns, ozone sterilization, then in jet mill micronizing to 35 micron, the particulate accumulation 93% that particle diameter is less than 65 microns, obtains the pure powder ultramicro decoction piece of Rhizoma Bistortae;
Wherein, vacuum drying temperature is 90 DEG C, and pressure is 0.1mpa; The condition of micronizing is: pulverize temperature 20 DEG C, pressure when entering super micron mill is 1.5Mpa, pulverizes pressure 5Mpa, air velocity 240m/s, the time 2.5h of pulverizing;
By obtained ultramicro decoction piece with meet the adjuvant that medicament requires, obtained tablet, capsule or other oral normal release dosage forms.
Embodiment 4
Preparation technology:
Rhizoma Bistortae extract described in drying is crushed to particle diameter less than 300 microns, then in jet mill micronizing to 80 micron, the particulate accumulation 90% that particle diameter is less than 65 microns, obtains the pure powder ultramicro decoction piece of Rhizoma Bistortae;
Wherein, vacuum drying temperature is 80 DEG C, and pressure is 0.2mpa; The broken condition of super Rhizoma Bistortae pure powder ultramicro decoction piece is: pulverize temperature 15 DEG C, and pressure when entering the broken machine of super Rhizoma Bistortae pure powder ultramicro decoction piece is 1Mpa, pulverizes pressure 6Mpa, air velocity 200m/s, the time 3h of pulverizing;
By obtained ultramicro decoction piece with meet the adjuvant that medicament requires, obtained tablet, capsule or other oral normal release dosage forms.
Embodiment 5
Preparation technology:
Rhizoma Bistortae extract described in drying is crushed to particle diameter less than 300 microns, wet-hot steam sterilizing, then in jet mill micronizing to 10 micron, the particulate accumulation 90% that particle diameter is less than 65 microns, obtains the pure powder ultramicro decoction piece of Rhizoma Bistortae;
Wherein, vacuum drying temperature is 80 DEG C, and pressure is-0.1mpa; Super broken condition is: pulverize temperature 22 DEG C, pressure when entering super micron mill is 2Mpa, pulverizes pressure 6Mpa, air velocity 285m/s, the time 1h of pulverizing;
By obtained ultramicro decoction piece with meet the adjuvant that medicament requires, obtained tablet, capsule or other oral normal release dosage forms.
Embodiment 6
Preparation technology:
Rhizoma Bistortae extract described in drying is crushed to particle diameter less than 300 microns, then in jet mill micronizing to 1 micron, the particulate accumulation 90% that particle diameter is less than 65 microns, obtains the pure powder ultramicro decoction piece of Rhizoma Bistortae;
Wherein, vacuum drying temperature is 80 DEG C, and pressure is 0.2mpa; The condition of micronizing is: pulverize temperature 22 DEG C, pressure when entering super micron mill is 2Mpa, pulverizes pressure 6Mpa, air velocity 285m/s, the time 3h of pulverizing;
By obtained ultramicro decoction piece with meet the adjuvant that medicament requires, obtained tablet, capsule or other oral normal release dosage forms.
Comparative example 1
Raw material and addition thereof are with embodiment 1;
Preparation technology: the condition of micronizing is: pulverizing temperature is 25 DEG C, and all the other step of preparation process and condition are with embodiment 1.
Comparative example 2
Raw material and addition thereof are with embodiment 2;
Preparation technology: the condition of micronizing is: pulverize pressure 8Mpa, all the other step of preparation process and condition are with embodiment 2.
Comparative example 3
Raw material and addition thereof are with embodiment 2;
Preparation technology: the condition of micronizing is: the time 4h of pulverizing, all the other step of preparation process and condition are with embodiment 3.
Effect example 1
Stability comparative experiments
1, sample acceleration environment: after sample being put high-density polyethylene bottle packaging, in temperature 40 ± 2 DEG C, place under the condition of relative humidity 75 ± 5%, after accelerated test March, inspection character, dissolution, content and related substance are carried out in sampling.
2, assay method:
1) dissolution method is according to dissolution method (Chinese Pharmacopoeia 2,010 two annex XC the 3rd methods), and with water 100ml for dissolution medium, rotating speed is 50 turns per minute, operates in accordance with the law, samples, get subsequent filtrate as need testing solution when 30 minutes; Every ml is prepared about containing the solution product solution in contrast of rasagiline 10 μ g, respectively injection liquid chromatography, by external standard method with calculated by peak area stripping quantity with reference substance.
2) content and related substance all adopt high performance liquid chromatography (Chinese Pharmacopoeia 2,010 two annex VD) to measure, and be filler with octadecylsilane silica gel, determined wavelength is 210nm, and record chromatogram, by external standard method with calculated by peak area.
3, stability data compares: in table 2.
Table 2 stability data compares
Effect example 3 uniformity of dosage units compares
According to Chinese Pharmacopoeia version annex XE Content uniformity test in 2010, adopt the content of the every sheet of high effective liquid chromatography for measuring, and calculate uniformity of dosage units (A+1.80S).The results are shown in Table 3.
Table 3 uniformity of dosage units tables of data
Group Average content Uniformity of dosage units
Embodiment 1 100.1 2.40
Embodiment 2 99.9 2.53
Embodiment 3 99.7 2.86
Embodiment 4 99.5 2.49
Embodiment 5 99.4 2.68
Embodiment 6 99.3 3.11
Comparative example 1 99.9 4.33
Comparative example 2 99.2 4.26
Comparative example 3 99.1 4.91
The above; be only preferred embodiment of the present invention; not to any formal and substantial restriction of the present invention; should be understood that; for those skilled in the art; under the prerequisite not departing from the inventive method, also can make some improvement and supplement, these improve and supplement and also should be considered as protection scope of the present invention.All those skilled in the art, without departing from the spirit and scope of the present invention, a little change made when utilizing disclosed above technology contents, the equivalent variations of modifying and developing, be Equivalent embodiments of the present invention; Meanwhile, all according to substantial technological of the present invention to the change of any equivalent variations that above-described embodiment is done, modify and differentiation, all still belong in the scope of technical scheme of the present invention.

Claims (9)

1. the preparation method of the pure powder ultramicro decoction piece of Rhizoma Bistortae, it is characterized in that: described preparation method comprises the following steps: the Rhizoma Bistortae extract of drying is crushed to particle diameter less than 300 microns, in jet mill, super Rhizoma Bistortae pure powder ultramicro decoction piece is broken again, obtain the pure powder ultramicro decoction piece of Rhizoma Bistortae, the condition that described super Rhizoma Bistortae pure powder ultramicro decoction piece is broken is: pulverize temperature 15-22 DEG C, pressure when entering the broken machine of super Rhizoma Bistortae pure powder ultramicro decoction piece is 1-2Mpa, pulverize pressure 2-6Mpa, air velocity 200-285m/s, the time 1-3h of pulverizing.
2. preparation method as claimed in claim 1, is characterized in that: by obtained ultramicro decoction piece and the adjuvant meeting medicament and require, obtained tablet, capsule or other oral normal release dosage forms.
3. preparation method as claimed in claim 2, it is characterized in that: described Rhizoma Bistortae extract is prepared by following method: the rhizome of Rhizoma Bistortae is crushed to 10-15 order, the water of 1: 1 and ethanol is used to extract, then the extracting solution obtained is concentrated, first use the washing decontamination of 5 column volumes, and then carry out eluting with eluant, collect eluent, dry, and described eluent is propanol, and the method wherein extracted is the extracting solution adding 5 times carries out extraction 4 times, then at room temperature flood 64 hours, and then 15 the extracting solution of volume carry out percolation, flow velocity is 6mL/min.
4. the preparation method according to any one of claim 1-3, is characterized in that: the pure powder ultramicro decoction piece of described Rhizoma Bistortae also comprises adjuvant, described adjuvant comprise in disintegrating agent, lubricant, binding agent and filler one or more; The addition of described adjuvant is 10%-40%, and described percentage ratio is the mass percent accounting for described Rhizoma Bistortae extract.
5. preparation method as claimed in claim 4, is characterized in that: described disintegrating agent is one or more in starch, microcrystalline Cellulose, hydroxypropyl emthylcellulose, sodium alginate, crospolyvinylpyrrolidone and cross-linking sodium carboxymethyl cellulose; The addition of described disintegrating agent is 5%-15%;
Described lubricant is one or more in magnesium stearate, sodium laurylsulfate and boric acid; The addition of described lubricant is 3%-9%;
Described binding agent is micropowder silica gel and/or Pulvis Talci; The addition of described binding agent is 1%-5%;
Described filler is for being lactose and/or calcium sulfate; The addition of described filler is 1%-15%;
Described percentage ratio is the mass percent accounting for described Rhizoma Bistortae extract.
6. the preparation method according to any one of claim 1-3, it is characterized in that: in step (1), the condition of described micronizing is: pulverize temperature 20 DEG C, pressure when entering super micron mill is 1.5Mpa, pulverize pressure 3-5Mpa, air velocity 220-260m/s, the time 1.5-2.5h of pulverizing.
7. the preparation method according to any one of claim 1-3, is characterized in that: in step (1), described drying is carried out in vacuum drier; Described vacuum drying temperature is 80-110 DEG C, and described vacuum drying pressure is-0.1 ~ 0.2mpa.
8. the preparation method according to any one of claim 1-3, is characterized in that: in step (1), and described is crushed to particle diameter less than 300 microns, then in jet mill before micronizing, carries out sterilization treatment; Described sterilizing is one or more in ray sterilizing, microwave sterilizating, wet-hot steam sterilizing and ozone sterilization;
Described micronizing is for being crushed to particle diameter 1-80 micron.
9. the pure powder ultramicro decoction piece of Rhizoma Bistortae that the preparation method according to any one of claim 1-8 is obtained.
CN201410550660.7A 2014-10-17 2014-10-17 Dragonwort pure powder ultramicro decoction piece and preparation method thereof Pending CN104324087A (en)

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Application publication date: 20150204