CN104474113B - A kind of preparation method of bazhen yimu pills, bazhen yimu wan compositions - Google Patents
A kind of preparation method of bazhen yimu pills, bazhen yimu wan compositions Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/344—Codonopsis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K36/06—Fungi, e.g. yeasts
- A61K36/07—Basidiomycota, e.g. Cryptococcus
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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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/232—Angelica
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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)
- A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
- A61K36/236—Ligusticum (licorice-root)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
- A61K36/284—Atractylodes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/533—Leonurus (motherwort)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/65—Paeoniaceae (Peony family), e.g. Chinese peony
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/804—Rehmannia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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Abstract
The present invention relates to the preparation method of a kind of bazhen yimu pills, bazhen yimu wan compositions, particularly to Chinese medicine Herba Leonuri, Radix Codonopsis, Rhizoma Atractylodis Macrocephalae (parched), Poria, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Paeoniae Alba (parched with wine), Rhizoma Chuanxiong, Radix Rehmanniae Preparata is Chinese medicine preparation prepared by raw material, the preparation method of the present invention, and step is as follows: Radix Codonopsis 50g, Radix Glycyrrhizae 25g, Rhizoma Chuanxiong 50g, Radix Rehmanniae Preparata 100g are ground into medicated powder, remaining Herba Leonuri 200g, Rhizoma Atractylodis Macrocephalae (parched) 50g, Poria 50g, Radix Angelicae Sinensis 100g, Radix Paeoniae Alba (parched with wine) 50g ethanol extraction, extracting solution concentrates;Regulation pH value is 9, adds ethanol, places, and filters;Filtrate crosses D392 resin column, receives effluent, and adjusting pH value is 6.5~7.0, concentrates, and after obtaining extract, extract and the mixing of above-mentioned medicated powder, as active constituents of medicine, is prepared as pill.
Description
Technical field:
The present invention relates to the preparation method of a kind of bazhen yimu pills, bazhen yimu wan compositions, particularly to Chinese medicine Herba Leonuri, party
Ginseng, Rhizoma Atractylodis Macrocephalae (parched), Poria, Radix Glycyrrhizae, Radix Angelicae Sinensis, Radix Paeoniae Alba (parched with wine), Rhizoma Chuanxiong, Radix Rehmanniae Preparata is Chinese medicine pill prepared by raw material
Agent,
Background technology:
Bazhen yimu pills, bazhen yimu wan be a kind of will the Chinese patent medicine of listing, as follows in its description:
Adopted name: bazhen yimu pills, bazhen yimu wan
Composition: Herba Leonuri.Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae (fries), Poria, Radix Glycyrrhizae, Radix Angelicae Sinensis.The Radix Paeoniae Alba (wine stir-fry).Rhizoma Chuanxiong,
Radix Rehmanniae Preparata.Minor subject is excipient Mel.
Function cures mainly: this product benefiting QI and nourishing blood, promoting blood flow to regulate menstruation.The menstruation caused by blood stasis is had concurrently not for QI and blood deficiency
Adjust, after disease sees menstrual cycle mistake, row hypomenorrhea, lassitude, limbs weak.
Pharmacological action: fill blood, adjusts menstruation.
[storage] medicine cool place storage area (less than 20 DEG C)
[effect duration] 48 months
The preparation method of existing bazhen yimu pills, bazhen yimu wan is: Herba Leonuri, Radix Codonopsis, Rhizoma Atractylodis Macrocephalae (parched), Poria, Radix Glycyrrhizae, Radix Angelicae Sinensis,
Radix Paeoniae Alba (parched with wine), Rhizoma Chuanxiong, Radix Rehmanniae Preparata is ground into medicated powder, and honey 40-50g practiced by every 100g medicated powder, adds appropriate water
General ball, is dried and makes water-honeyed pill, or increasing is practiced honey consumption and is prepared as big honeyed pills or small honey pill.
Bazhen yimu pills, bazhen yimu wan dose prepared by existing method is relatively big, and mouthfeel is the best, easy moisture absorption, and the present invention is existing
On the basis of technology, the preparation method of bazhen yimu pills, bazhen yimu wan is improved, achieved good technique effect.
Summary of the invention:
The invention discloses the preparation method of a kind of bazhen yimu pills, bazhen yimu wan compositions.
Bazhen yimu pills, bazhen yimu wan, the proportioning of crude drug is:
The preparation method of bazhen yimu pills, bazhen yimu wan on the basis of existing technology, is improved, the present invention by the present invention
Preparation method as follows:
Step is as follows: step is as follows: Radix Codonopsis 50g, Radix Glycyrrhizae 25g, Rhizoma Chuanxiong 50g, and Radix Rehmanniae Preparata 100g is ground into
Medicated powder, remaining Herba Leonuri 200g, Rhizoma Atractylodis Macrocephalae (parched) 50g, Poria 50g, Radix Angelicae Sinensis 100g, Radix Paeoniae Alba (parched with wine) 50g second
Alcohol extraction, extracting solution concentrates;Regulation pH value is 9, adds ethanol, places, and filters;Filtrate crosses D392
Resin column, receives effluent, and adjusting pH value is 6.5~7.0, concentrates, obtains extract, extract and above-mentioned medicated powder
After mixing, as active constituents of medicine, it is prepared as pill.
In composition described above, weight calculates with crude drug, and composition described above can be made into pill 1000g.
Composition described above is by weight as proportioning, can increase according to corresponding proportion when producing or reduce, as greatly
Large-scale production can by kilogram in units of, or in units of ton, small-scale production can also in units of milligram,
Weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for special circumstances, such as serious symptom or mild,
Fat or modest, the proportioning of the amount of composition can be adjusted accordingly, be increased or decreased less than 100%, drug effect
Constant.
The active constituents of medicine of the present invention, its shared percentage by weight in pill can be 0.1-99.9%, its
Remaining is pharmaceutically acceptable carrier.
The pill of the present invention, optionally adds applicable pharmaceutically acceptable carrier when being prepared as medicament,
Adjunct ingredient as conventional: Mel, mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sulfur are for sulfur
Acid sodium, cysteine hydrochloride, TGA, methionine, injection Vitamin B_6 DTA disodium, Ethylenediaminetetraacetic Acid Calcium Salt,
The alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid,
Aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran,
Glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and its derivates, alginate,
Gelatin, polyvinylpyrrolidone, glycerol, POLYSORBATE 80, agar, calcium carbonate, calcium bicarbonate, surface activity
Agent, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate,
Magnesium stearate etc..
The pill of the present invention determines usage and dosage according to the state of an illness in use, can often taken three times per day, each 1-20g.
Preferably, the preparation method of bazhen yimu pills, bazhen yimu wan of the present invention, step is as follows:
Step 1, Radix Codonopsis 50g, Radix Glycyrrhizae 25g, Rhizoma Chuanxiong 50g, Radix Rehmanniae Preparata 100g are ground into medicated powder;
Step 2, Herba Leonuri 200g, Rhizoma Atractylodis Macrocephalae (parched) 50g, Poria 50g, Radix Angelicae Sinensis 100g, Radix Paeoniae Alba (parched with wine) 50g use
The ethanol extraction of the 90-100% (v/v) of 3-10 times of weight 1-3 time;Extracting solution merges concentration,
Step 3, the pH value of regulation concentrated solution is 9, adds ethanol, places, and filters;
Step 4, filtrate crosses D392 resin column, receives effluent, and adjusting pH value is 6.5~7.0, concentrates,
Extract,
After the medicated powder mixing that step 5, extract that step 4 obtains and step 1 obtain, become as pharmaceutically active
Point, add the adjuvants such as ethanol, starch, cane sugar powder, Mel, according to galenic pharmacy routine techniques, be prepared as pill.
Most preferably, the bazhen yimu pills, bazhen yimu wan preparation method of the present invention is as follows:
Step 1, Radix Codonopsis 50g, Radix Glycyrrhizae 25g, Rhizoma Chuanxiong 50g, Radix Rehmanniae Preparata 100g are ground into fine drug powder;
Step 2, Herba Leonuri 200g, Rhizoma Atractylodis Macrocephalae (parched) 50g, Poria 50g, Radix Angelicae Sinensis 100g, Radix Paeoniae Alba (parched with wine) 50g use
90% alcohol reflux three times, adds 90% ethanol and is respectively 8,6,6 times;It is respectively 3 first and second time little
Time, 2 hours for the third time, united extraction liquid, decompression recycling ethanol, to without alcohol taste, obtained concentrated solution;
Step, 3, it is 9 that concentrated solution adds 40% sodium hydroxide solution regulation pH value, and adding ethanol to alcohol content is
70%, stand overnight, filter;
Step 4, filtrate crosses D392 resin column with the speed of per hour 1.5~2 times of resin bed volume, its Chinese medicine
Material amount of resin ratio for 1:1, receives effluent, and adjusting pH value is 6.5~7.0, in 55~65 DEG C of decompression recycling ethanols
After continue to be concentrated into paste and carry out cold drying, obtain extract.
After extract that step 5, extract and step 4 obtain and the fine drug powder that step 1 obtains mixing, make
For active constituents of medicine, add the adjuvants such as water, starch, cane sugar powder, Mel, according to galenic pharmacy routine techniques,
It is prepared as water-honeyed pill.
Beneficial effects of the present invention is further illustrated below by way of test data:
The hygroscopic mensuration of eight delicacies with motherwort:
In the case of adjuvant is identical, prepare different eight delicacies with motherwort water-honeyed pills, the embodiment of the present invention 1 method system
Standby water-honeyed pill, and water-honeyed pill prepared by prior art.
Take a certain amount of water-honeyed pill, put constant weight 48 hours in 30 DEG C of baking ovens.Bottom is placed with NaCl saturated solution
Glass desicator in timing put into NaCl until forming NaCl supersaturated solution, now relative in exsiccator
Humidity is 75%.Putting into the water-honeyed pill of about 6g bottom the weighing botle of constant weight, correct amount is placed on above-mentioned
In exsiccator (weighing botle is opened).Weigh after 48 hours, calculate Moisture percentage.
Ball prepared by the embodiment of the present invention 1 method | Ball prepared by prior art | |
Before moisture absorption | 6.0652g | 6.0254g |
After moisture absorption | 6.0842g | 6.1222g |
Moisture percentage | 0.31% | 1.58% |
Result shows, ball Moisture percentage of the present invention is substantially less than prior art.
Eight delicacies with motherwort mouthfeel is tested
Experimental agents: ball prepared by the embodiment of the present invention 1 method, and ball prepared by prior art
Experimental technique: two kinds of balls are tasted by different personnel, tastes and pass judgment on according to following index:
"+" expression can accept, and " ++ " represents hardship, and " +++ " represents the most bitter, obtains according to the judge of majority
Result:
Experimental result:
Ball prepared by the embodiment of the present invention 1 method | Ball prepared by prior art | |
Taste | + | ++ |
"+", represents that can accept " ++ " represents that bitter " +++ " represents the most bitter
Result shows, the present invention can obtain satisfied mouthfeel effect.
Eight delicacies with motherwort stability contrast test data:
The medicine pill of the present invention, and pill prepared by prior art is according to quality standard, carries out stability test
Every performance assessment criteria that is defined as, use reserved sample observing under the conditions of constant temperature, constant humidity, product carried out six by a definite date
The study on the stability test of the moon, to observe its mass change.
Use constant temperature, constant humidity accelerated test.Pill is packed with medicinal composite plastic film, overcoat color printing carton.
Packing Intact.
Sample at regular time and quantity from the cabinet that keeps sample respectively, according to medicine by table designs 0,1,2,3,6 months time
Quality draft standard and the Pharmacopoeia of the People's Republic of China one requirement to pill of version in 2000 and regulation
Test.
Result see table:
Ball prepared by the embodiment of the present invention 1 method investigates result
Ball prepared by prior art investigates result
Bazhen yimu pills, bazhen yimu wan Evaluation of Synthetic Effect of Holistic:
Test group: the pill of the embodiment of the present invention 1;
Matched group: pill prepared by prior art
Method: use random blind, masculine parallel comparison.
Dosage regimen: (1) test group a: 6g, 3 times on the one;(2) matched group a: 6g, one day
3 times.
Result of the test is as follows:
QI and blood deficiency has the menoxenia Evaluation of Synthetic Effect of Holistic caused by blood stasis concurrently: test group (embodiment of the present invention 1)
Effective percentage 85.3%;Existing pill matched group effective percentage 80.6%.
Model case
Case one: Wang female's diagnosis in 25 years old: doctor trained in Western medicine: menoxenia, takes " pill of the present invention " 4 weeks,
Normally.
Case two: poplar women diagnosis in 30 years old: doctor trained in Western medicine: menoxenia, takes " pill of the present invention " 6
Week, normally.
Case three: female's Lee diagnosis in 35 years old: doctor trained in Western medicine: menoxenia, after taking " pill of the present invention " 2 weeks,
Normally.
Detailed description of the invention:
Embodiment 1:
Step 1, Radix Codonopsis 50g, Radix Glycyrrhizae 25g, Rhizoma Chuanxiong 50g, Radix Rehmanniae Preparata 100g are ground into fine drug powder;
Step 2, Herba Leonuri 200g, Rhizoma Atractylodis Macrocephalae (parched) 50g, Poria 50g, Radix Angelicae Sinensis 100g, Radix Paeoniae Alba (parched with wine) 50g use
90% alcohol reflux three times, adds 90% ethanol and is respectively 8,6,6 times;It is respectively 3 first and second time little
Time, 2 hours for the third time, united extraction liquid, decompression recycling ethanol, to without alcohol taste, obtained concentrated solution;
Step, 3, it is 9 that concentrated solution adds 40% sodium hydroxide solution regulation pH value, and adding ethanol to alcohol content is
70%, stand overnight, filter;
Step 4, filtrate crosses D392 resin column with the speed of per hour 1.5~2 times of resin bed volume, its Chinese medicine
Material amount of resin ratio for 1:1, receives effluent, and adjusting pH value is 6.5~7.0, in 55~65 DEG C of decompression recycling ethanols
After continue to be concentrated into paste and carry out cold drying, obtain extract.
After extract that step 5, extract and step 4 obtain and the medicated powder that step 1 obtains mixing, as medicine
Thing active component, adds the adjuvants such as ethanol, starch, cane sugar powder, Mel, according to galenic pharmacy routine techniques, system
Standby one-tenth water-honeyed pill.
Claims (1)
1. the preparation method of a bazhen yimu pills, bazhen yimu wan compositions, it is characterised in that step is as follows:
Step 1, Radix Codonopsis 50g, Radix Glycyrrhizae 25g, Rhizoma Chuanxiong 50g, Radix Rehmanniae Preparata 100g are ground into fine drug powder;
Step 2, Herba Leonuri 200g, Rhizoma Atractylodis Macrocephalae (parched) 50g, Poria 50g, Radix Angelicae Sinensis 100g, Radix Paeoniae Alba (parched with wine) 50g 90% alcohol reflux three times, add 90% ethanol and be respectively 8,6,6 times;Being respectively for first and second time 3 hours, 2 hours for the third time, united extraction liquid, decompression recycling ethanol, to without alcohol taste, obtained concentrated solution;
Step, 3, it is 9 that concentrated solution adds 40% sodium hydroxide solution regulation pH value, and adding ethanol is 70% to alcohol content, stands overnight, and filters;
Step 4, filtrate crosses D392 resin column with the speed of per hour 1.5~2 times of resin bed volume, and its Chinese crude drug amount of resin is than for 1:1, receive effluent, adjusting pH value is 6.5~7.0, continues to be concentrated into paste and carries out cold drying, obtain extract after 55~65 DEG C of decompression recycling ethanols;
After the medicated powder mixing that step 5, extract that step 4 obtains and step 1 obtain, as active constituents of medicine, add adjuvant ethanol, starch, cane sugar powder, dextrin, according to galenic pharmacy routine techniques, be prepared as pill.
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八珍益母丸剂型改革的探讨;王仁英等;《基层中药杂志》;20001231;第14卷(第3期);第33-35页 * |
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