CN104173910A - Traditional Chinese medicine compound capsule for treating gynecological diseases and preparation method thereof - Google Patents
Traditional Chinese medicine compound capsule for treating gynecological diseases and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Danefukang capsule and a preparation method thereof. The method includes the steps: mixing and crushing medicinal materials of radix salviae miltiorrhizae, rhizoma zedoariae, herba bupleuri marginati, pseudo-ginseng, radix paeoniae rubra, angelica sinensis, rhizoma sparganii, rhizoma cyperi, rhizoma corydalis and radix glycyrrhizae, adding ethanol, and extracting to obtain an aqueous solution and a water-insoluble part; taking the insoluble part, adding water with the same mass as the fed medicinal materials, and washing; merging the aqueous solution and the water washing solution, carrying out purification treatment by a macroporous adsorption resin column, carrying out reduced pressure concentration, drying, and thus obtaining an extract powder; and dissolving the water-insoluble matter with ethanol, granulating together with the extract powder, adding magnesium stearate, mixing evenly, and filling a capsule. Based on a Chinese patent medicine Danefukang decoction agent, through ethanol extraction, concentration, drying and other processes and with addition of pharmaceutically acceptable and proper auxiliary materials, the hard capsule preparation is prepared. The Danefukang capsule prepared by the method is small in dosage and convenient to take, effectively masks a decocted extract taken bitter taste, improves compliance of patients, and provides a great convenience for clinical use.
Description
Technical field
The extraction formulation art that the present invention relates to Chinese medicine, is specifically related to Dan e Fukang capsule and technology of preparing thereof.
Background technology
DANER FUKANG JIANGAO is Ministry of Public Health ministry standard (WS-10227(ZD-0227)-2002) record kind, formed by Radix Salviae Miltiorrhizae, Radix Notoginseng, HERBA BUPLEURI, Radix Paeoniae Rubra, Radix Angelicae Sinensis, Rhizoma Sparganii, Rhizoma Cyperi, Rhizoma Corydalis, Radix Glycyrrhizae etc.The preparation method of former soft extract is: above ten taste medical materials, Radix Salviae Miltiorrhizae, Rhizoma Curcumae, Radix Notoginseng, Radix Angelicae Sinensis, (annex I of Chinese Pharmacopoeia version in 2000 o) according to the percolation under fluid extract and extractum item for Rhizoma Corydalis, make solvent with 70% ethanol, flood and carry out percolation after 24 hours, the collection liquid of filtering, decompression recycling ethanol and to be concentrated into relative density be 1.30(50 DEG C) thick paste, the five tastes such as medicinal residues and all the other HERBA BUPLEURI decoct with water secondary, each 2 hours, collecting decoction, filter, it is 1.30(50 DEG C that filtrate is concentrated into relative density) thick paste, merge above-mentioned two kinds of thick pastes, add refined honey, sugar refinery, potassium sorbate, mix, obtain.
DANER FUKANG JIANGAO is the folk remedy that derives from the doctor of Yi nationality, and its function cures mainly, the doctor of Yi nationality: poor a word used in person's name and Keyes are many, the not assorted color soil in sea, graceful sieve color.The traditional Chinese medical science: blood circulation promoting and blood stasis dispelling, depressed liver-energy dispersing and QI regulating, menstruction regulating and pain relieving, softening the hard mass eliminate indigestion.For menoxenia due to women's stagnation of blood stasis, dysmenorrhea, menstrual period uncomfortable, lumps in the chest and abdomen, endometriosis of pelvis is shown in above-mentioned symptom person.
Endometriosis refers to that the endometrial tissue with growth function appears at other positions of health beyond cavity of uterus and the disease that causes, and its main clinical manifestation is the diseases such as the dysmenorrhea of carrying out property of Secondary cases aggravation and menoxenia, infertile, sexual anhedonia.The sickness rate of primary disease is in recent years and obviously increases trend, has become one of current common gynecological disease, difficult disease.Approximately have 5～15% women to get involved, wherein 80% patient has dysmenorrhea symptom, and 5% merging is infertile.Though gynecopathy is benign lesion but has similar malignant tumor metastasis and plantation energy for growth.In recent years and have an obvious ascendant trend.Its cardinal symptom shows as pelvic pain and sterile.The treatment of endometriosis is divided into two kinds of operative treatment and Drug therapys.Although operation be endometriosis first-selection be also best Therapeutic Method, operation can not be removed all focuses, can not dispel the focus being invisible to the naked eye, postoperative recurrence is often unavoidable, therefore, Drug therapy is occupied critical role at present.By clinical verification and gone through to produce or the chemicals of the treatment endometriosis of import listing has two large classes, i.e. androgens derivant and GuRH-A.Androgens derivant danazol is the traditional effective medicine for the treatment of gynecopathy, but because there being obvious androgen side reaction, developed country is few use at present.GuRH-A is the current generally acknowledged the most effective medicine for the treatment of gynecopathy, is the most frequently used medicine of developed country, in China's clinical practice showed increased in recent years.In addition, according to clinical experience, generally acknowledge that can alleviate the effective medicine of endometriosis pain symptom also has progestogens and Short-term effective oral contraceptives class.And the use of other drug, as arimedex, antagonists of gonadotropin-releasing hormone and containing birth control apparatus in medicine official etc. also in the discussion stage.Long-term medicine ovary suppresses the women who is unsuitable for not giving birth to, and after pseudo-fetus and pseudo menopause therapy drug withdrawal, relapse rate is high, and can not be pregnant during medication; The expense of GnRHa class Drug therapy is higher, and what cause encloses the side effect such as menopausal syndrome, osteoporosis, love life Quality Down; And oppositely the dosage of additive treatment is difficult for grasping.In uterus the drug treatment of endometriosis makes fast progress in recent years, and new drug is constantly employed, but clinical effectiveness is still unsatisfactory, how to alleviate drug side effect, improves pregnancy rate, reduces relapse rate, needs more, more deep research.
Through clinical verification, DANER FUKANG JIANGAO is the current effective Chinese medicine preparation of domestic unique treatment endometriosis.But backward coarse because of preparation, dose is large, and mouthfeel is poor, and compliance is poor, transport, storage is all inconvenient, has affected the use clinically of this medicine.Now macroporous adsorbent resin technology is applied to this compound recipe, can removes impurity a large amount of in former preparation, make former soft extracts into taking convenience, quality is easy to the capsule of control, high-efficiency low-toxicity, to improve the practical value of this prescription.So this kind is carried out to capsule exploitation, can create good Social benefit and economic benefit.
200410077402.8) and Chinese patent application " a kind of dan e women-healthcare granulae " (application number: 200910164817.1) be all prescription medical material and the extraction process that adopts DANER FUKANG JIANGAO, respectively DANER FUKANG JIANGAO prepared and become soft capsule and granule existing Chinese patent application " a kind of Dan e Fukang preparation and preparation method thereof " (application number:.Improve to a certain extent DANER FUKANG JIANGAO using dosage inaccurate, taken inconvenient shortcoming.But because these two patents are not done further optimization to the extraction process of DANER FUKANG JIANGAO, do not accomplish effective ingredient to carry out the effect of enrichment, although therefore these two patents are adjusted on preparation, but in technique, still apply mechanically the process route of former preparation, the dose of product is not still significantly reduced.Former DANER FUKANG JIANGAO agent is changed into after soft capsule preparation, and its soft capsule dose every day of taking is (the crude drug day dose of DANER FUKANG JIANGAO is 66g, and the drug loading of Dan e Fukang soft capsule is 2.2g/ grain) 30 left and right.
Summary of the invention
The object of the invention is to openly a kind of preparation method of red cowherb hard capsule, this method adopt ethanol extraction method extract formula medical material, by extracting solution according to the hydrotrope and water-insoluble differentiated treatment.Water dissolution composition, by macroporous adsorbent resin remove impurity processing, has effectively been reduced to saccharide wherein, inorganic salts, organic acid and part macromolecular components.By standby insoluble with water the water-soluble composition after removal of impurity composition combination system become capsule, fully ensure to have improved greatly on the basis of effective ingredient the drug loading of product to have reduced a day taking dose.Adopt technological means of the present invention can reach 5.5 g crude drug/capsules, there is clear superiority compared with the technology of preparing of existing Chinese patent (200410077402.8) " a kind of Dan e Fukang preparation and preparation method thereof " (drug loading is 2.2g/ grain), the granule drug loading of this product has improved 250%, with time dose drop to 12 by 30, reduce 60%.In the application, adopting advanced macroporous adsorbent resin technology to carry out independent purification process to the water soluble ingredient in alcohol extract greatly reduces the taking dose of medicine, adopt the hard capsule preparation of solid to overcome the content that Chinese medicinal soft capsule preparation content occurs in long-term put procedure and precipitate adherent drawbacks common, this product is owing to being solid preparation, long-term placement, physicochemical property is stable, not only promote the inherent quality of product, and easy to carry and transport, store.
Because hard capsule has effectively been covered the bitterness of product itself, overcome former soft extract and can not adhere to because of bitter in the mouth for a long time the shortcoming of use, greatly improve patient's compliance in clinical use.The application has obvious advantage compared with existing patented technology.A kind of dan e women-healthcare granulae of Chinese patent application (200910164817.1), this patent is mainly for how DANER FUKANG JIANGAO being prepared into granule.With above-mentioned patent comparison, the present invention is having obvious difference aspect the extracting method of medical material, and the application adopts the ethanol extraction of low concentration to all medical materials, reduced the poor problem of solution clarity that granular preparation brings because of water-insoluble.
Technical advantage of the present invention realizes by following scheme:
First the present invention provides a kind of preparation method of Dan e Fukang capsule, comprise the following steps: A. mixes medical material Radix Salviae Miltiorrhizae 1126 weight portions, Rhizoma Curcumae 625 weight portions, HERBA BUPLEURI 625 weight portions, Radix Notoginseng 375 weight portions, Radix Paeoniae Rubra 625 weight portions, Radix Angelicae Sinensis 625 weight portions, Rhizoma Sparganii 437 weight portions, Rhizoma Cyperi 375 weight portions, Rhizoma Corydalis 437 weight portions, Radix Glycyrrhizae 250 weight portions, pulverize, add ethanol extraction, decompression recycling ethanol extracting solution, to without alcohol taste, divides water intaking solution and water-insoluble fraction; B. get water-insoluble fraction and add after fully washing with the water of the quality such as medical material that feed intake and obtain water lotion, after insoluble matter indwelling, use; C. merge the water lotion that aqueous solution that above-mentioned steps A obtains and step B obtain, by processed good macroporous adsorptive resins, discard effluent, wash with water after macroporous adsorbent resin, use ethanolysis absorb-elute, collect ethanol elution, concentrating under reduced pressure, concentrated solution is dry, obtains extract powder; D. the insoluble matter dissolve with ethanol that above-mentioned steps B obtains, adds adjuvant and extract powder to granulate, and extract granule adds magnesium stearate, mixes filled capsules.
As further improvement, the ethanol extraction in described steps A adopts permeating extraction or ethanol reflux extraction.
The type of the macroporous adsorbent resin using in described step C is polystyrene type.
Concentrated solution drying mode in described step C for spraying is dry, vacuum drying or microwave drying.
Granulation in described step D adopts wet granulation or one-step palletizing.
The mass concentration of the ethanol in described steps A is 40-70%.
In described steps A the consumption of ethanol be medical material gross weight 6-18 doubly.
In described step C, macroporous adsorbent resin adopts macroporous adsorbent resin D101 type, D201 type, D301 type, D101B, AB-8 type or HP type.
In addition, the present invention also provides Dan e Fukang capsule prepared by said method.
Detailed description of the invention
Embodiment 1
The 10 taste medical materials such as medical material Radix Salviae Miltiorrhizae 1126 weight portions, Rhizoma Curcumae 625 weight portions, HERBA BUPLEURI 625 weight portions, Radix Notoginseng 375 weight portions, Radix Paeoniae Rubra 625 weight portions, Radix Angelicae Sinensis 625 weight portions, Rhizoma Sparganii 437 weight portions, Rhizoma Cyperi 375 weight portions, Rhizoma Corydalis 437 weight portions, Radix Glycyrrhizae 250 weight portions are mixed, pulverize, add 18 times of 40% ethanol percolate extraction of medical material gross weight, percolation extracts 10 hours, decompression recycling ethanol extracting solution, to without alcohol taste, divides water intaking solution and water-insoluble fraction; Water-insoluble fraction is added with the water of the quality such as medical material that feed intake and fully washs to obtain water lotion, after insoluble matter indwelling, use.Merge aqueous solution and water lotion, by processed good D101 type (styrene type) macroporous adsorptive resins, discard effluent, after water washing macroporous adsorbent resin by 2 times of medical material weight, with 40% ethanolysis absorb-elute of 3 times of medical material weight, collect ethanol elution, concentrating under reduced pressure, concentrated solution vacuum decompression is dry, obtains extract powder.Above-mentioned insoluble matter 50% dissolve with ethanol, adds proper starch and extract powder to carry out one-step palletizing, and the granule making adds appropriate magnesium stearate, mixes filled capsules.
Embodiment 2
Take 10 taste medical materials according to the formulation ratio in embodiment 1 and mix, pulverize, add 12 times of 70% ethanol percolate extraction of medical material gross weight, percolation extracts 24 hours, and decompression recycling ethanol extracting solution, to without alcohol taste, divides water intaking solution and water-insoluble fraction; Water-insoluble fraction is added with the water of the quality such as medical material that feed intake and fully washs to obtain water lotion, after insoluble matter indwelling, use.Merge aqueous solution and water lotion, by processed good D201 type (styrene type) macroporous adsorptive resins, discard effluent, after water washing macroporous adsorbent resin by 6 times of medical material weight, with 80% ethanolysis absorb-elute of 8 times of medical material weight, collect ethanol elution, concentrating under reduced pressure, concentrated solution microwave drying, obtains extract powder.Above-mentioned insoluble matter 70% dissolve with ethanol, adds suitable dextrin and extract powder to carry out wet granulation, and the granule making adds appropriate magnesium stearate, mixes filled capsules.
Embodiment 3
Take 10 taste medical materials according to the formulation ratio in embodiment 1 and mix, pulverize, add 6 times of 50% ethanol percolate extraction of medical material gross weight, percolation extracts 48 hours, and decompression recycling ethanol extracting solution, to without alcohol taste, divides water intaking solution and water-insoluble fraction; Water-insoluble fraction is added with the water of the quality such as medical material that feed intake and fully washs to obtain water lotion, after insoluble matter indwelling, use.Merge aqueous solution and water lotion, by processed good D301 type (styrene type) macroporous adsorptive resins, discard effluent, after water washing macroporous adsorbent resin by 4 times of medical material weight, with 70% ethanolysis absorb-elute of 6 times of medical material weight, collect ethanol elution, concentrating under reduced pressure, concentrated solution spraying is dry, obtains extract powder.Above-mentioned insoluble matter 70% dissolve with ethanol, adds suitable sucrose and extract powder to carry out one-step palletizing, and the granule making adds appropriate magnesium stearate, mixes filled capsules.
Embodiment 4
Take 10 taste medical materials according to the formulation ratio in embodiment 1 and mix, pulverize, add 12 times of 60% ethanol percolate extraction of medical material gross weight, percolation extracts 36 hours, and decompression recycling ethanol extracting solution, to without alcohol taste, divides water intaking solution and water-insoluble fraction; Water-insoluble fraction is added with the water of the quality such as medical material that feed intake and fully washs to obtain water lotion, after insoluble matter indwelling, use.Merge aqueous solution and water lotion, by processed good AB-8 type (styrene type) macroporous adsorptive resins, discard effluent, after water washing macroporous adsorbent resin by 5 times of medical material weight, with 60% ethanolysis absorb-elute of 5 times of medical material weight, collect ethanol elution, concentrating under reduced pressure, concentrated solution vacuum decompression is dry, obtains extract powder.Above-mentioned insoluble matter 70% dissolve with ethanol, adds suitable sucrose and extract powder to carry out wet granulation, and the granule making adds appropriate magnesium stearate, mixes filled capsules.
Embodiment 5
Take 10 taste medical materials according to the formulation ratio in embodiment 1 and mix, pulverize, add 10 times of 50% ethanol percolate extraction of medical material gross weight, percolation extracts 18 hours, and decompression recycling ethanol extracting solution, to without alcohol taste, divides water intaking solution and water-insoluble fraction; Water-insoluble fraction is added with the water of the quality such as medical material that feed intake and fully washs to obtain water lotion, after insoluble matter indwelling, use.Merge aqueous solution and water lotion, by processed good HP type (styrene type) macroporous adsorptive resins, discard effluent, after water washing macroporous adsorbent resin by 3 times of medical material weight, with 50% ethanolysis absorb-elute of 3 times of medical material weight, collect ethanol elution, concentrating under reduced pressure, concentrated solution spraying is dry, obtains extract powder.Above-mentioned insoluble matter 50% dissolve with ethanol, adds suitable lactose and extract powder to carry out one-step palletizing, and the granule making adds appropriate magnesium stearate, mixes filled capsules.
Embodiment 6
Take 10 taste medical materials according to the formulation ratio in embodiment 1 and mix, pulverize, add 18 times of 70% alcohol reflux of medical material gross weight 1 time, extract 1 time, extract 2 hours, decompression recycling ethanol extracting solution, to without alcohol taste, divides water intaking solution and water-insoluble fraction; Water-insoluble fraction is added with the water of the quality such as medical material that feed intake and fully washs to obtain water lotion, after insoluble matter indwelling, use.Merge aqueous solution and water lotion, by processed good D101 type (styrene type) macroporous adsorptive resins, discard effluent, after water washing macroporous adsorbent resin by 2 times of medical material weight, with 40% ethanolysis absorb-elute of 3 times of medical material weight, collect ethanol elution, concentrating under reduced pressure, concentrated solution vacuum decompression is dry, obtains extract powder.Above-mentioned insoluble matter 50% dissolve with ethanol, adds proper starch and extract powder to carry out one-step palletizing, and the granule making adds appropriate magnesium stearate, mixes filled capsules.
Embodiment 7
Take 10 taste medical materials according to the formulation ratio in embodiment 1 and mix, pulverize, add 12 times of 60% alcohol reflux of medical material gross weight 2 times, extract 2 hours/time, decompression recycling ethanol extracting solution, to without alcohol taste, divides water intaking solution and water-insoluble fraction; Water-insoluble fraction is added with the water of the quality such as medical material that feed intake and fully washs to obtain water lotion, after insoluble matter indwelling, use.Merge aqueous solution and water lotion, by processed good D201 type (styrene type) macroporous adsorptive resins, discard effluent, after water washing macroporous adsorbent resin by 6 times of medical material weight, with 80% ethanolysis absorb-elute of 8 times of medical material weight, collect ethanol elution, concentrating under reduced pressure, concentrated solution microwave drying, obtains extract powder.Above-mentioned insoluble matter 70% dissolve with ethanol, adds suitable dextrin and extract powder to carry out wet granulation, and the granule making adds appropriate magnesium stearate, mixes filled capsules.
Embodiment 8
Take 10 taste medical materials according to the formulation ratio in embodiment 1 and mix, pulverize, add 8 times of 50% alcohol reflux of medical material gross weight 3 times, extract 1.5 hours/time, decompression recycling ethanol extracting solution, to without alcohol taste, divides water intaking solution and water-insoluble fraction; Water-insoluble fraction is added with the water of the quality such as medical material that feed intake and fully washs to obtain water lotion, after insoluble matter indwelling, use.Merge aqueous solution and water lotion, by processed good D301 type (styrene type) macroporous adsorptive resins, discard effluent, after water washing macroporous adsorbent resin by 4 times of medical material weight, with 70% ethanolysis absorb-elute of 6 times of medical material weight, collect ethanol elution, concentrating under reduced pressure, concentrated solution spraying is dry, obtains extract powder.Above-mentioned insoluble matter 70% dissolve with ethanol, adds suitable sucrose and extract powder to carry out one-step palletizing, and the granule making adds appropriate magnesium stearate, mixes filled capsules.
Embodiment 9
Take 10 taste medical materials according to the formulation ratio in embodiment 1 and mix, pulverize, add 10 times of 40% alcohol reflux of medical material gross weight 2 times, extract 1.5 hours/time, decompression recycling ethanol extracting solution, to without alcohol taste, divides water intaking solution and water-insoluble fraction; Water-insoluble fraction is added with the water of the quality such as medical material that feed intake and fully washs to obtain water lotion, after insoluble matter indwelling, use.Merge aqueous solution and water lotion, by processed good AB-8 type (styrene type) macroporous adsorptive resins, discard effluent, after water washing macroporous adsorbent resin by 5 times of medical material weight, with 60% ethanolysis absorb-elute of 5 times of medical material weight, collect ethanol elution, concentrating under reduced pressure, concentrated solution vacuum decompression is dry, obtains extract powder.Above-mentioned insoluble matter 70% dissolve with ethanol, adds suitable sucrose and extract powder to carry out wet granulation, and the granule making adds appropriate magnesium stearate, mixes filled capsules.
Embodiment 10
Take 10 taste medical materials according to the formulation ratio in embodiment 1 and mix, pulverize, add 15 times of 70% alcohol reflux of medical material gross weight 1 time, extract 1 hour/time, decompression recycling ethanol extracting solution, to without alcohol taste, divides water intaking solution and water-insoluble fraction; Water-insoluble fraction is added with the water of the quality such as medical material that feed intake and fully washs to obtain water lotion, after insoluble matter indwelling, use.Merge aqueous solution and water lotion, by processed good HP type (styrene type) macroporous adsorptive resins, discard effluent, after water washing macroporous adsorbent resin by 3 times of medical material weight, with 50% ethanolysis absorb-elute of 3 times of medical material weight, collect ethanol elution, concentrating under reduced pressure, concentrated solution spraying is dry, obtains extract powder.Above-mentioned insoluble matter 50% dissolve with ethanol, adds suitable lactose and extract powder to carry out one-step palletizing, and the granule making adds appropriate magnesium stearate, mixes filled capsules.
Dan e Fukang capsule prepared by the present invention and DANER FUKANG JIANGAO and Chinese patent application 200410077402.8(soft capsule) capsule for preparing compares, and day dose contrast is as shown in table 1 below:
The dose impact of table 1 different technologies route on Dan e Fukang
The curative effect of Dan e Fukang capsule of the present invention is achieved through the following technical solutions
1, the impact of Dan e Fukang Capsule in Rats endometriosis
Animal Model: 54 of Healthy female SD rats, body weight 180-220 g.With 3% pentobarbital sodium 30 mg/kg intraperitoneal anesthesia animals, hypogastric region is shaved after hair sterilization, median incision approximately 2 cm, expose uterus, the uterus section that left side cornua uteri far-end is about to 1 cm is put into the culture dish that fills physiological saline solution, is cut into the uterine cancer cell (comprising flesh layer) of 3 mm × 3 mm, uses 6-0 not damaged silk suture on ileocecus mesentery, in art, keep abdominal cavity moistening with physiological saline solution, whole operation process keeps aseptic condition.The capable same operation process of normal control treated animal, but only expose uterus.Art finishes, and closes abdominal cavity, puts back under old terms and continues to raise.
Experiment grouping: 54 rats are divided into 6 groups at random, see the following form 2:
54 rat random experiments groupings of table 2
Respectively organize all with 20 ml/kg gastric infusions above, once a day, continuous 45 days.When experiment finishes, de-neck is put to death animal, and femoral artery is got blood, and the centrifugal 10 min separation of serum of 3000 rpm, put-20 DEG C of Refrigerator stores, standby estradiol and the cytokine IL-8 of surveying; Cut open the belly and expose uterus or focus region, measure focus film recording.
Estradiol and IL-8 measure: press the operation of test kit description, the detection of estradiol adopts to put exempts from method mensuration, and IL-8 carries out with ELASA.
Result shows, postoperative 60 days, the endometrium survival of transplanting, along mesentery growth, forms little cyst, graft area increases, the focus area of the each group of administration all dwindles in various degree, and with model control group comparison, difference has significance, Dan e Fukang capsule also presents dose-effect relationship, the results are shown in Table 3, table 4.
The impact of table 3 Dan e Fukang capsule gastric infusion on rat endometrium dystopy growing state
X ± s.
*p < 0.05,
*p < 0.01 and model group comparison (t-test).
The impact of table 4 Dan e Fukang capsule gastric infusion antithetical phrase endometriosis in rats estradiol and IL-8
X ± s.
*p < 0.05,
*p < 0.01 and model group comparison,
▲p < 0.05,
▲ ▲p < 0.01 DANER FUKANG JIANGAO comparison (t-inspection between group)
As seen from the above table, the high, medium and low dosage group of Dan e Fukang capsule and DANER FUKANG JIANGAO have the trend that reduces estradiol on the impact of uterus Endometriosis rat blood serum estradiol, but do not reach statistically significant meaning; Dan e Fukang capsule in high dose group (2.0 g/kg) and DANER FUKANG JIANGAO obviously reduce the level of cytokine IL-8 in metrecotpia disease rat blood serum, relatively have significant difference with model group.
2, the impact of Dan e Fukang capsule on unpregnancy isolated rat
10 of Healthy female SD rats, body weight 220 ± 20 g.Reference literature method is to rat skin lower injection diethylstilbestrol 0.1 mg/kg.d, once a day, and totally 2 times.Rat is put to death in cervical vertebra dislocation in the 3rd day, cuts open the belly and takes out uterus, is placed in oxygen-saturated krebs solution (krebs solution composition: NaCl 7.5, KCl 0.35, CaCl
20.12, MgCl
20.05, NaH
2pO
40.1, NaHCO
31.0, glucose 0.5 g/L).By the ligation of cornua uteri two ends, be placed in the Maxwell pipe of 10 mL krebs solutions, one end is fixed on the metal hook of isolated organ bath lower curtate, and the other end is connected with tonotransducer.1 g that loads, 37 ± 0.5 DEG C of operating temperatures, logical oxygen, balance 1 h, every 20 min change liquid once.Tonotransducer is connected to PowerLab data collecting system, uses Chart software records uterine smooth muscle curve movement.
Record after one section of normal uterus shrinkage curve, (final concentration is 5 × 10 to add neurohypophyseal hormone
-4u/mL), observe shrink tension and frequency.Change for three times after liquid recovery, then record one section of normalized curve, add DANER FUKANG JIANGAO or Dan e Fukang capsule medicinal liquid, observe the impact of matched doses pituitrin effect, be calculated as follows suppression ratio:
Suppression ratio %=(administration after-contraction amplitude-hypophysis shrinkage amplitude) ÷ hypophysis shrinkage amplitude × 100 %
T-inspection between statistical method employing group.
Result of the test demonstration Dan e Fukang capsule and DANER FUKANG JIANGAO all can significantly be resisted the isolated uterine contraction that neurohypophyseal hormone causes, show as tension force and decline, and present concentration effect dependency, half-inhibition concentration (IC
50) be respectively 0.24 ± 0.11 mg/ml (being equivalent to crude drug amount 4.01 ± 1.84 mg/ml) and 3.50 ± 0.87 mg/ml (being equivalent to crude drug amount 10.5 ± 2.61 mg/ml), waiting under crude drug amount, the inhibitory action of Dan e Fukang capsule is than DANER FUKANG JIANGAO strong (P < 0.01), compare by crude drug amount, Dan e Fukang capsule is tired and has been improved approximately 2.6 times (table 5).In addition, Dan e Fukang capsule and DANER FUKANG JIANGAO all can reduce the isolated uterine contraction frequency due to pituitrin, and present concentration dependent (table 6).
Table 5 Dan e Fukang Capsule in Rats isolated uterine smooth muscle maximum shrinkage amplitude (tension force, impact g)
X ± s, n=10,
*p < 0.01, and etc. the DANER FUKANG JIANGAO comparison (between group t-inspection) of crude drug amount
The impact of table 6 DANER FUKANG JIANGAO and Capsule in Rats isolated uterine smooth muscle contraction frequency
X ± s, n=10,
*p < 0.01, and etc. the DANER FUKANG JIANGAO comparison (between group t-inspection) of crude drug amount,
▲p<0.01, with (the pairing t-inspection) of hypophysis frequency ratio
Prove the enclosed mass of the endometriosis that Dan e Fukang capsule of the present invention effectively Reduction surgery the same as former dosage form forms, the content of IL-8 in increase body by pharmacodynamics test; The isolated uterine contraction that antagonism neurohypophyseal hormone causes, shows as tension force and declines, and present concentration effect dependency.Apply pharmaceutical preparation of the present invention easy to use, quick.In the process using, patient's acceptance is good, compliance is high, in use procedure, without any misery, feels comfortable, is easy to carry and preserves.It is simple that this product has preparation section, low cost and other advantages.
Above scheme proof Dan e Fukang capsule of the present invention was taken in crude drug amount situation and can reduced greatly preparation content dose from 30g/ day dropping to 4.8g/ day in equal maximum day, minimizing amplitude reaches 83%, drops to 12 falls and reaches 60% from the volume of taking of preparation compared with existing patented technology by 30; Adopt the technology of the present invention to make the drug loading of product rise to 5.5 g crude drug/capsules by original 2.2g/g soft extracts or 2.2 g crude drug/soft capsules from the drug loading analysis of product, the amplitude that improves drug loading reaches 150%, therefore the present invention has promoted the taking convenience of product and patient's compliance greatly, strong lifting product quality.
The above; it is only preferred embodiment of the present invention; not the present invention is done to any pro forma restriction, those skilled in the art utilize the technology contents of above-mentioned announcement to make a little simple modification, equivalent variations or modification, all drop in protection scope of the present invention.
Claims (9)
1. a preparation method for Dan e Fukang capsule, comprises the following steps:
A. medical material Radix Salviae Miltiorrhizae 1126 weight portions, Rhizoma Curcumae 625 weight portions, HERBA BUPLEURI 625 weight portions, Radix Notoginseng 375 weight portions, Radix Paeoniae Rubra 625 weight portions, Radix Angelicae Sinensis 625 weight portions, Rhizoma Sparganii 437 weight portions, Rhizoma Cyperi 375 weight portions, Rhizoma Corydalis 437 weight portions, Radix Glycyrrhizae 250 weight portions are mixed, pulverized, add ethanol extraction, decompression recycling ethanol extracting solution, to without alcohol taste, divides water intaking solution part and water-insoluble part;
B. get water-insoluble fraction and add with the water of the quality such as medical material that feed intake and fully wash and obtain water lotion, after insoluble matter indwelling, use;
C. merge the water lotion that aqueous solution that above-mentioned steps A obtains and step B obtain, by processed good macroporous adsorptive resins, discard effluent, wash with water after macroporous adsorbent resin, use ethanolysis absorb-elute, collect ethanol elution, concentrating under reduced pressure, concentrated solution is dry, obtains extract powder;
D. the insoluble matter dissolve with ethanol that above-mentioned steps B obtains, adds adjuvant and extract powder to granulate, and extract granule adds magnesium stearate, mixes filled capsules.
2. preparation method according to claim 1, is characterized in that: the ethanol extraction in described steps A adopts permeating extraction or reflux extraction.
3. preparation method according to claim 1, is characterized in that: the type of the macroporous adsorbent resin using in described step C is polystyrene type.
4. preparation method according to claim 1, is characterized in that: the concentrated solution drying mode in described step C for spraying is dry, vacuum drying or microwave drying.
5. preparation method according to claim 1, is characterized in that the granulation in described step D adopts wet granulation or one-step palletizing.
6. preparation method according to claim 1, the mass concentration that it is characterized in that the ethanol in described steps A is 40-70%.
7. preparation method according to claim 1, the consumption that it is characterized in that ethanol in described steps A is 6-18 times of medical material gross weight.
8. preparation method according to claim 1, is characterized in that in described step C, macroporous adsorbent resin adopts macroporous adsorbent resin D101 type, D201 type, D301 type, D101B, AB-8 type or HP type.
9. the Dan e Fukang capsule of preparing according to method described in any one in claim 1-8.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104547905A (en) * | 2014-12-26 | 2015-04-29 | 浙江大学 | Traditional Chinese medicine composite for preventing postoperative recurrence of endometriosis, and application |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104547905A (en) * | 2014-12-26 | 2015-04-29 | 浙江大学 | Traditional Chinese medicine composite for preventing postoperative recurrence of endometriosis, and application |
| CN104547905B (en) * | 2014-12-26 | 2017-11-17 | 浙江大学 | Prevent Chinese medicine composition and the application of postoperative recurrence of endometriosis |
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Application publication date: 20141203 |