CN1857678A - Mastoproliferation treating medicine and its preparing method - Google Patents
Mastoproliferation treating medicine and its preparing method Download PDFInfo
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- CN1857678A CN1857678A CNA2006100444065A CN200610044406A CN1857678A CN 1857678 A CN1857678 A CN 1857678A CN A2006100444065 A CNA2006100444065 A CN A2006100444065A CN 200610044406 A CN200610044406 A CN 200610044406A CN 1857678 A CN1857678 A CN 1857678A
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Abstract
The present invention discloses a kind of mastoproliferation treating medicine and its preparation process. The medicine is prepared with red peony root, bupleurum root, angelica, nutagrass flatsedge rhizome, curcuma root and other nine kinds of Chinese medicinal materials in certain weight proportion. The preparation process includes the steps of: supercritical CO2 fluid extraction of the effective components in five kinds of Chinese medicinal materials; dilute alcohol solution extraction of the effective components in other three kinds of Chinese medicinal materials; water extraction of the effective components in rest six kinds of Chinese medicinal materials; and final including with cyclodextrin to obtain the product.
Description
Technical field
The present invention relates to a kind of medicine for the treatment of cyclomastopathy, is to be the medicine of feedstock production with the Chinese herbal medicine concretely, the invention still further relates to the preparation method of this medicine.
Background technology
Lump is one of common clinical manifestation of surgical diseases, divides optimum and pernicious two big classes, is commonly encountered diseases, the frequently-occurring disease of harm humans health.For the lump treatment of diseases, effectively patent medicine treatment for want of generally based on excision, has increased patient's misery at present.And in motherland's medical science, the lump disease not only belongs to surgery, in the classes such as being stated from interior, woman, department of eye of also loosing.About treatment, total rule of treatment is just proposed as far back as " interior warp ".Modern Chinese medicine is from integral body, and determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs obtains good effect in the part class.And relate to the medicine that adopts Chinese medicine preparation treatment cyclomastopathy, not seeing as yet so far has report.
Summary of the invention
One of purpose of the present invention provides a kind of evident in efficacy, the medicine of the treatment cyclomastopathy that has no side effect.It is simple that two of purpose provides a kind of technology that one of achieves the goal, the preparation method of this medicine of easy operating.
One of purpose of the present invention can realize by following technical measures:
Medicine of the present invention is the medicament of being made by the following weight parts proportion raw material
Radix Paeoniae Rubra 12～24 Radix Bupleuri 12～24 Radix Angelicae Sinensis 12～24
Rhizoma Cyperi 6～15 Radix Curcumaes 6～15 Pericarpium Citri Reticulatae Virides 6～15
Spica Prunellae 12～24 Radix Ranunculi Ternatis 12～24 Pseudobulbus cremastrae seu pleiones 6～15
Spina Gleditsiae 6～15 Bombyx Batryticatus 6～15 Scorpios 6～15
Radix Scrophulariae 6～15 Rhizoma Bolbostematiss 12～24.
Optimum weight part proportioning of preparation medicine of the present invention is
Radix Paeoniae Rubra 18 Radix Bupleuri 18 Radix Angelicae Sinensis 18
Rhizoma Cyperi 9 Radix Curcumaes 9 Pericarpium Citri Reticulatae Virides 9
Spica Prunellae 18 Radix Ranunculi Ternatis 18 Pseudobulbus cremastrae seu pleiones 10
Spina Gleditsiae 9 Bombyx Batryticatus 9 Scorpios 9
Radix Scrophulariae 15 Rhizoma Bolbostematiss 18.
The said dosage form of the present invention is a said dosage form on any pharmaceutics; Said pharmaceutical formulation can be powder, powder, tablet, pill, granule or capsule, serves as preferred with granule or capsule wherein.
Two of purpose of the present invention can realize by following technical measures:
Above-mentioned each component is made medicine production method of the present invention is:
A, get the Radix Bupleuri powder and add in the extraction kettle supercritical CO
2Fluid extraction gets saikoside or Radix Bupleuri volatile oil;
B, with a operation, different is replaces the Radix Bupleuri powder with Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Curcumae, Pericarpium Citri Reticulatae Viride mixed powder, volatile oil;
C, get Bombyx Batryticatus, Scorpio with Diluted Alcohol solution reflux, extract,, the elimination residue merges ethanol extract, and decompression recycling ethanol also is condensed into alcohol extraction cream;
D, with the c operation, different is to replace Bombyx Batryticatus, Scorpio with Radix Paeoniae Rubra, alcohol extraction cream;
E, get Spica Prunellae, Radix Ranunculi Ternati, Radix Scrophulariae, Rhizoma Bolbostematis, Pseudobulbus cremastrae seu pleiones, Spina Gleditsiae earlier, decoct with decocting method, decocting liquid naturally cools to room temperature after concentrating, and slowly adds Diluted Alcohol solution down in stirring then, through precipitation, filtration, decompression recycling ethanol also is condensed into the water decoction-alcohol sedimentation condensed cream;
F, the alcohol extraction cream of c, d operation preparation and the water decoction-alcohol sedimentation condensed cream of e operation preparation are mixed, add the dextrin of 200～800 weight portions and the stevioside of 5～30 weight portions, mixing again in 40～90 ℃ of spray dryinges, is pulverized the powder that gets dry extract;
G, get the beta-schardinger dextrin-of 1～12 weight portion, add the distilled water of 15～35 times of weight portions, the ultrasonic beta-schardinger dextrin-solution that is mixed into; Other gets the saikoside or the Radix Bupleuri volatile oil of the preparation of a operation, dehydrated alcohol dilution with 3～8 times of weight portions, under 20～60 ℃, in ultrasonic procedure, slowly add in the beta-schardinger dextrin-solution, through cold preservation, sucking filtration, filtering layer is used distilled water and absolute ethanol washing respectively, 30～70 ℃ of dry down saikoside Benexate Hydrochloride powder that get;
H, with the g operation, different is replaces the saikoside or the Radix Bupleuri volatile oil of the preparation of a operation with the volatile oil of b operation preparation, the volatile oil beta cyclodextrin inclusion complex powder;
M, with dried cream powder and volatile oil beta cyclodextrin inclusion complex, saikoside Benexate Hydrochloride mixing powder, powder is made powder or tablet or pill, add an amount of pharmaceutical purpose starch routinely and make granule, granule is incapsulated make capsule.
Two of purpose of the present invention also can realize by following technical measures:
Supercritical CO described in a, the b operation
2Fluid extraction is that extraction kettle, extraction-container are heated respectively or be cooled to 30～60 ℃, adds CO then in system
2Gas when pressure is 20～50MPa, extracted under constant temperature, the constant voltage 1.0～3.0 hours;
Diluted Alcohol solution reflux, extract, described in c, the d operation is 50～80% the ethanol liquid that adds 6～15 times of weight portions of Bombyx Batryticatus, Scorpio, soaks 0.5～1 hour, 50～100 ℃ of backflows 2～3 times down, each 1～3 hour; The relative density of described alcohol extraction cream is 1.10～1.50;
It is the water that adds Spica Prunellae, Radix Ranunculi Ternati, Radix Scrophulariae, Rhizoma Bolbostematis, Pseudobulbus cremastrae seu pleiones and 6～15 times of weight portions of Spina Gleditsiae that decocting method described in the e operation decocts, soaking the back decocts 2～3 times, each 1～3 hour, merging decocting liquid and being concentrated into relative density was 1.03～1.50 water drug-decocting concentrating liquid; Be cooled to room temperature then, under agitation slowly add 60～95% ethanol of 1～3 times of weight portion of concentrated solution, continue to stir 10～40 minutes, staticly settled 24～72 hours under 0～8 ℃, filter, water decoction-alcohol sedimentation condensed cream relative density is 1.10～1.50;
Cold preservation time described in the g operation is 10～30 hours.
The cystic hyperplasia of breast traditional Chinese medical science claims nodules of the breast, thinks that morbidity is relevant with feelings will, diet, overstrain, internal injury, and most doctors are tame from integral body, dialectically combine with differential diagnosis of diseases, reach with endocrine regulation with it, enhancing human body immunity power is treated this disease, the dialectical treatment of cystic hyperplasia of breast at present, mainly be divided into stagnation of QI due to depression of the liver according to different phase and syndrome, phlegm and blood stasis and Chong and Ren channel disorder type adopt depressed liver-energy dispersing and QI regulating respectively, dissipating phlegm and resolving masses, blood circulation promoting and blood stasis dispelling, warming the kidney to activate YANG, method of treatment such as regulating thoroughfare and controlling vessel.The present invention sums up based on dispersing liver and promoting blood circulation treating for many years on this disease basis, and assistant is with dissipating phlegm and resolving masses, regulating thoroughfare and controlling vessel, and promptly on the basis of dialectical and differential diagnosis of diseases, the side's of choosing medication in conjunction with modern medicine understanding and Chinese medicine modern pharmacological research.The present invention defers to broken hard the loosing and " Medicine Comprehended " the scrofula ball that disappears of Golden Mirror of Medicine Haizao Yuhu Tang and " miscellaneous diseases source and course rhinoceros candle ", in conjunction with the clinical practice sanction, and function hard masses softening and resolving, promoting blood circulation to remove obstruction in the collateral, reducing swelling and alleviating pain.Be used to cure mainly various mammary gland tumor diseases, see diseases such as tumor, chronic inflammation piece, all can effectively treat.We reuse Radix Paeoniae Rubra, Spica Prunellae, are monarch drug altogether, with hard masses softening and resolving, easing the affected liver yin nourishing.Clear old scholar's tongued bell is pointed out in " the soft method of treatment of the secret record in stone chamber ": " disease has hard strength and the person that be unwilling to loose easily, when controlling with soft ... of a specified duration and hard from soft, gentlely can control firm excellent method also." compatibility Pseudobulbus Cremastrae Seu Pleiones, Rhizoma Bolbostematis, Radix Ranunculi Ternati, Pericarpium Citri Reticulatae Viride dispelling phlegm and eliminating dampness, detoxicating and resolving stagnation of pathogens, wherein Pericarpium Citri Reticulatae Viride has the merit of invigorating the spleen and regulating the stomach concurrently, more can control the source of expectorant, is ministerial drug; Compatibility blood circulation promoting and blood stasis dispelling, reducing swelling and alleviating pain are with eliminating stagnation, to strengthen the power of monarch drug eliminating stagnation, Radix Bupleuri, the pain relieving of Rhizoma Cyperi depressed liver-energy dispersing and QI regulating, Bombyx Batryticatus, Scorpio, Spina Gleditsiae hard masses softening and resolving, detumescence poison holding, both can strengthen the power of the eliminating stagnation of Spica Prunellae, Pseudobulbus Cremastrae Seu Pleiones, Radix Ranunculi Ternati, Pericarpium Citri Reticulatae Viride, also bootable all medicines sick institute that goes directly to reach the purpose of lump dissipation, is an adjuvant drug altogether, the circulation of qi promoting of enriching blood of Radix Angelicae Sinensis, Radix Curcumae, Radix Scrophulariae, heat clearing away Yu Zuowei messenger drug.Take a broad view of full side, totally ten four Chinese medicines complement each other, and prescription is compact, to attack, in attacking benefit is arranged, and plays the effect of hard masses softening and resolving, promoting the circulation of QI and reducing phlegm, promoting blood circulation to remove obstruction in the collateral, reducing swelling and alleviating pain altogether.
Medicine of the present invention is an example with the granule, fill in Drug Manufacturing Room, every bag 3～10 grams.For oral administration, obey 6～40 grams at every turn, every day 2～3 times, 10～30 days is a course of treatment, generally takes 2～6 courses of treatment.
Medicine of the present invention has the effect of blood circulation promoting and blood stasis dispelling, soothing the liver dissipating phlegm and resolving masses, reducing swelling and alleviating pain.Be used for the treatment of cyclomastopathy, have the good effect of efficient, long-acting, quick-acting low toxicity, few side effects.Medicine of the present invention is example with the decoction, has carried out clinical use, proves to have hard masses softening and resolving, promoting the circulation of QI and reducing phlegm, and promoting blood circulation to remove obstruction in the collateral, the effect of reducing swelling and alleviating pain is used for the treatment of various mammary gland tumor diseases, as tumor, chronic inflammation piece etc., has obtained remarkable result.The present invention adopts supercritical CO
2Fluid extraction technology and cyclodextrin inclusion technique, as be prepared into granule, make more stable quality controlled, be convenient to take and improve curative effect.
The pharmacodynamics test of medicine of the present invention:
1, antiinflammatory action:
The reaction that can obviously reduce inflammation of the scorching method of white mice caused by dimethylbenzene xylene, the high, medium and low dosage group of medicine of the present invention relatively has significant difference with matched group, and dose-effect relationship is arranged.Rat foot formaldehyde causes scorching method, obviously inflammation-inhibiting reaction of medicine of the present invention.Medicine of the present invention is best in 0.3～4.0h effect, no dose-effect relationship.Medicine of the present invention can reduce the permeability of mouse peritoneal blood capillary.
2, bacteriostasis
Medicine of the present invention has in various degree bacteriostasis to staphylococcus aureus, Escherichia coli, salmonella typhi, Diplococcus pneumoniae.Bacillus pyocyaneus there is not effect.
3, analgesic activity
Medicine of the present invention can make the mouse writhing number of times obviously reduce, and significant difference is arranged compared with the control, and dose-effect relationship is arranged.
4, immunologic function test
The high, medium and low dosage group of medicine of the present invention has remarkable potentiation to the humoral immunization with serum agglutinin index.No dose-effect relationship.
5, medicine of the present invention is to the influence of rabbit clotting time
Medicine of the present invention has the effect (P＜0.05) of obvious prolongation clotting time.
The toxicology test of medicine of the present invention:
Medicine of the present invention was given mouse stomach (20～60) g/kg/d[people's consumption (0.1～1.0) g/kg/d in one day], to observe continuously seven days, none death is equivalent to more than 120 times of clinical consumption, shows nontoxic, the safety of this medicine.The Coming-of-Age Day of clinical recommendation is used dosage 6～40g, 10～30 days is a course of treatment, do not measure this medicine LD50 in the acute toxicity testing, its maximum tolerated dose is that clinical consumption is more than 100 times, so select for use clinical (people presses 60kg and calculates) consumption to be high dose for 60 times, 30 times is that low dosage is given the rat medication respectively, according to growing the poison time is clinical course of treatment 2-4 principle doubly, determine that the long malicious successive administration time is 45 days, in view of overt toxicity is not made in this experiment, and medicine such as no eighteen incompatible medicaments nineteen medicaments of mutual restraint in the side is so exempt to do the long term toxicity test of Canis familiaris L..In a word, clinical drug of the present invention is drafted dosage and medication cycle safety, nontoxic.
The clinical data of medicine of the present invention:
Before and after the Drug therapy of the present invention, patient's chest distending pain doing well,improving and breast nodositas lump change in conjunction with the computer infrared light checking, the variation of color ultrasound examination, observe medicine of the present invention to therapeutical effect, untoward reaction and the medicine of the present invention of cyclomastopathy to effects such as experimental animal, antiinflammatory, analgesias.Relatively to fully understand the therapeutical effect of this medicine to cystic hyperplasia of breast.In order well to finish this research contents, the present invention is by (" disease of tcm diagnosis criterion of therapeutical effect " ZY/T001.2-94 of State Administration of Traditional Chinese Medicine's promulgation) and diagnose reference standard (the 8th meeting of Chinese surgery of Chinese medicine breast disease Professional Committee of association in 2002 passed through) as this important function for of research diagnostic criteria, formulated the case history system of selection, all selected patient all meets above-mentioned standard, and in conjunction with computer infrared mammary gland somascope, color ultrasound or pathology auxiliary diagnosis eliminating breast carcinoma, mammary gland fibroma or other mastopathy person.Observe in detail, curative effect is judged in symptom and sign variation before and after the record patient, with the clinical definite curative effect of further observation medicine of the present invention.Whole process is elaborately planned, and careful tissue is coordinated strict standard mutually, clinical observation case 79 examples, wherein 45 examples are organized in treatment, take medicine of the present invention every day three times, each 10g, 10 days is a course of treatment, and generally with can obviously taking effect 2～3 courses of treatment, can fully recover 5～6 courses of treatment.29 examples of wherein fully recovering account for 64.4%; Effective 12 examples account for 26.6%; Total effective rate is 91.1%; Matched group 34 examples, with the RUKANG PIAN treatment, every day three times, each 2, the course of treatment, 17 examples of wherein fully recovering accounted for 50% with the treatment group, and effective 12 examples account for 35%; Total effective rate is that 85%, two group of total effective rate relatively has significant difference, P＜0.05, and medication effect of the present invention obviously is better than the RUKANG PIAN group.Two groups of treatment back symptom and sign curative effects compare: the treatment group obviously is better than matched group.Treatment group treatment back hemorheology index: whole blood viscosity, packed cell volume, Fibrinogen all have obvious decline before the treatment.
The specific embodiment
Embodiment 1:
Take by weighing raw material (kilogram) by following proportioning:
Radix Paeoniae Rubra 16 Radix Bupleuri 20 Radix Angelicae Sinensis 18
Rhizoma Cyperi 8 Radix Curcumaes 8 Pericarpium Citri Reticulatae Virides 10
Spica Prunellae 18 Radix Ranunculi Ternatis 16 Pseudobulbus cremastrae seu pleiones 10
Spina Gleditsiae 8 Bombyx Batryticatus 10 Scorpios 12
Radix Scrophulariae 12 Rhizoma Bolbostematiss 18.
Production method is as follows:
Supercritical CO
2Fluid extraction: adopt supercritical CO
2Fluid (SFE-CO
2) main effective ingredient saikoside and Radix Bupleuri volatile oil in the extraction Radix Bupleuri.Radix Bupleuri dry powder is dropped in the extraction kettle, to extraction kettle, extraction-container I, extraction-container II, basin heats respectively or cool off.When reaching 30 ℃ of chosen temperature, open CO
2Gas cylinder pressurizes to system, when reaching selected pressure 50MPa, closes gas cylinder, cycling extraction, and keep constant temperature, constant voltage.1.0h after reaching selected extraction time, from extraction-container I, extraction-container II discharge hole for discharge, saikoside or Radix Bupleuri volatile oil.
With 60% ethanol is entrainer, uses CO
2Volatile oil in supercritical extraction Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Curcumae, the Pericarpium Citri Reticulatae Viride medical material.A certain amount of Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Curcumae, Pericarpium Citri Reticulatae Viride mixed powder are dropped in the extraction kettle, to extraction kettle, extraction-container I, extraction-container II, basin heats respectively or cool off.When reaching chosen temperature 30 ℃, open CO
2Gas cylinder pressurizes to system, when reaching selected pressure 50MPa, closes gas cylinder, cycling extraction, and keep constant temperature, constant voltage.1.0h after reaching selected extraction time, from extraction-container I, extraction-container II discharge hole for discharge, volatile oil.By " 41 page of first method of 2000 editions appendix of Chinese pharmacopoeia, recording its relative density is 1.0.
The extraction of alcohol extraction medicine: take by weighing recipe quantity Bombyx Batryticatus, Scorpio add 80% ethanol of 7 times of weight portions, soak about 0.5h, 50 ℃ of following heating and refluxing extraction 3 times, each 1.h, the elimination residue merges ethanol extract, decompression recycling ethanol and to be condensed into relative density be 1.5 alcohol extraction cream.
The extraction of Radix Paeoniae Rubra: take by weighing recipe quantity Radix Paeoniae Rubra, add the ethanol of 7 times of weight portions 80%, soak about 0.5h, 50 ℃ of following heating and refluxing extraction 3 times, each 1h, elimination residue, merge ethanol extract, decompression recycling ethanol and to be condensed into relative density be 1.5 alcohol extraction cream.
The extraction of water decoction-alcohol sedimentation medicine: take by weighing recipe quantity Spica Prunellae, Radix Ranunculi Ternati, Radix Scrophulariae, Rhizoma Bolbostematis, Pseudobulbus cremastrae seu pleiones, Spina Gleditsiae, the water that adds 7 times of weight portions, soaking the back decocts 3 times with decocting method, each 1h, merge decocting liquid, be condensed into relative density and be 1.1 water drug-decocting concentrating liquid, water drug-decocting concentrating liquid is naturally cooled to room temperature, 90% the ethanol that under agitation slowly adds 1 times of weight portion of water drug-decocting concentrating liquid, continue to stir 10min, under 1 ℃ of temperature conditions, staticly settle 70h, filter the water decoction-alcohol sedimentation condensed cream, decocting liquid naturally cools to room temperature after concentrating, descend slowly to add 50% Diluted Alcohol solution in stirring then, through precipitation, filter decompression recycling ethanol and to be condensed into relative density be 1.10 water decoction-alcohol sedimentation condensed cream.
The mixing of alcohol extraction cream and the preparation of dried cream powder: above-mentioned alcohol extraction cream and water decoction-alcohol sedimentation condensed cream are mixed, add the dextrin of 800 weight portions, the stevioside of 5 weight portions, mix homogeneously in 85 ℃ of spray dryinges, is pulverized, and powder gets dry extract.
The preparation of volatile oil beta-cyclodextrin inclusion complex: take by weighing the beta-schardinger dextrin-of 1 weight portion, add the distilled water of 15 weight portions, the ultrasonic beta-schardinger dextrin-solution that is mixed into; Other gets the saikoside or the Radix Bupleuri volatile oil of the preparation of a operation, dehydrated alcohol dilution with 3 weight portions, under 60 ℃, in ultrasonic procedure, dropwise go in the beta-schardinger dextrin-solution, take out, through 2 ℃ of following cold preservations 30 hours, sucking filtration, filtering layer is used distilled water and absolute ethanol washing respectively, filtering layer is taken out 30 ℃ of dry down volatile oil beta cyclodextrin inclusion complex powder that get;
The preparation of saikoside beta-cyclo dextrin included compound: take by weighing the beta-schardinger dextrin-of 1 weight portion, add the distilled water of 15 weight portions, the ultrasonic mix homogeneously that makes.Other gets the saikoside or the Radix Bupleuri volatile oil of the preparation of a operation, dehydrated alcohol dilution with 4 weight portions, under 60 ℃, in ultrasonic procedure, dropwise go in the beta-schardinger dextrin-solution, take out, through 8 ℃ of following cold preservations 10 hours, sucking filtration, filtering layer is used distilled water and absolute ethanol washing respectively, filtering layer is taken out 30 ℃ of dry white loose shape clathrate powder, i.e. saikoside beta-cyclo dextrin included compound powder of getting.
The mixing of medicated powder and particulate preparation: with above-mentioned dried cream powder and volatile oil beta-cyclodextrin inclusion complex powder, saikoside beta-cyclo dextrin included compound powder mixes even powder, powder made powder or tablet or pill routinely or add an amount of pharmaceutical purpose starch make granule, granule is incapsulated make capsule.
Embodiment 2:
Take by weighing raw material (kilogram) by following proportioning:
Radix Paeoniae Rubra 20 Radix Bupleuri 18 Radix Angelicae Sinensis 18
Rhizoma Cyperi 12 Radix Curcumaes 8 Pericarpium Citri Reticulatae Virides 12
Spica Prunellae 20 Radix Ranunculi Ternatis 18 Pseudobulbus cremastrae seu pleiones 10
Spina Gleditsiae 10 Bombyx Batryticatus 12 Scorpios 10
Radix Scrophulariae 10 Rhizoma Bolbostematiss 20.
Production method is as follows:
Supercritical CO
2Fluid extraction: adopt supercritical CO
2Fluid (SFE-CO
2) main effective ingredient saikoside and Radix Bupleuri volatile oil in the extraction Radix Bupleuri.Radix Bupleuri dry powder is dropped in the extraction kettle, to extraction kettle, extraction-container I, extraction-container II, basin heats respectively or cool off, when reaching 60 ℃ of chosen temperature, unlatching CO
2Gas cylinder pressurizes to system, when reaching selected pressure 20MPa, closes gas cylinder, cycling extraction, and keep constant temperature, constant voltage.3.0h after reaching selected extraction time, from extraction-container I, extraction-container II discharge hole for discharge, saikoside or Radix Bupleuri volatile oil.
With 50% ethanol is entrainer, uses CO
2Volatile oil in supercritical extraction Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Curcumae, the Pericarpium Citri Reticulatae Viride medical material.A certain amount of Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Curcumae, Pericarpium Citri Reticulatae Viride mixed powder are dropped in the extraction kettle, to extraction kettle, extraction-container I, extraction-container II, basin heats respectively or cool off, when reaching chosen temperature 55 ℃, unlatching CO
2Gas cylinder pressurizes to system, when reaching selected pressure 20MPa, closes gas cylinder, cycling extraction, and keep constant temperature, constant voltage.3.0h after reaching selected extraction time, from extraction-container I, extraction-container II discharge hole for discharge, volatile oil, by " 41 page of first method of 2000 editions appendix of Chinese pharmacopoeia, recording its relative density is 0.70.
The extraction of alcohol extraction medicine: take by weighing recipe quantity Bombyx Batryticatus, Scorpio add 50% ethanol of 14 times of amounts, soak about 1h, 100 ℃ of following reflux 2 times, each 3h, the elimination residue merges ethanol extract, decompression recycling ethanol and to be condensed into relative density be 1.15 alcohol extraction cream.
The extraction of Radix Paeoniae Rubra: take by weighing recipe quantity Radix Paeoniae Rubra, add 14 times of amount ethanol of 50%, soaks about 1h, 100 ℃ of following heating and refluxing extraction 2 times, 3h at every turn, elimination residue, merging ethanol extract, decompression recycling ethanol and to be condensed into relative density be 1.10 alcohol extraction cream.
The extraction of water decoction-alcohol sedimentation medicine: take by weighing recipe quantity Spica Prunellae, Radix Ranunculi Ternati, Radix Scrophulariae, Rhizoma Bolbostematis, Pseudobulbus cremastrae seu pleiones, Spina Gleditsiae, the water that adds 7 times of weight portions, soaking the back decocts 2 times with decocting method, each 3h, merge decocting liquid, be condensed into relative density and be 1.5 water drug-decocting concentrating liquid, water drug-decocting concentrating liquid is naturally cooled to room temperature, 60% the ethanol that under agitation slowly adds 3 times of weight portions of water drug-decocting concentrating liquid, continue to stir 40min, under 8 ℃ of temperature conditions, staticly settle 24h, filter the water decoction-alcohol sedimentation condensed cream, decocting liquid naturally cools to room temperature after concentrating, descend slowly to add 80% Diluted Alcohol solution in stirring then, through precipitation, filter decompression recycling ethanol and to be condensed into relative density be 1.50 water decoction-alcohol sedimentation condensed cream.
The mixing of alcohol extraction cream and the preparation of dried cream powder: above-mentioned alcohol extraction cream and water decoction-alcohol sedimentation condensed cream are mixed, add the dextrin of 250 weight portions, the stevioside of 25 weight portions, mix homogeneously in 45 ℃ of spray dryinges, is pulverized, and powder gets dry extract.
The preparation of volatile oil beta-cyclodextrin inclusion complex: take by weighing the beta-schardinger dextrin-of 11 weight portions, add the distilled water of 30 times of weight portions, the ultrasonic beta-schardinger dextrin-solution that is mixed into; Other gets the saikoside or the Radix Bupleuri volatile oil of the preparation of a operation, with the dehydrated alcohol dilution of 8 times of weight portions, under the temperature of regulation, in ultransonic process, dropwise go in the solution of beta-schardinger dextrin-, under 30 ℃, in ultrasonic procedure, dropwise go in the beta-schardinger dextrin-solution, take out, through 12 ℃ of cold preservation 12h, sucking filtration, filtering layer are used distilled water and absolute ethanol washing respectively, and filtering layer is taken out, 65 ℃ of dry down white loose shape clathrate powder, i.e. volatile oil beta-cyclodextrin inclusion complex powder of getting.
The preparation of saikoside beta-cyclo dextrin included compound: take by weighing the beta-schardinger dextrin-of 10 weight portions, add the distilled water of 35 weight portions, the ultrasonic mix homogeneously that makes.Other gets the saikoside or the Radix Bupleuri volatile oil of the preparation of a operation, dehydrated alcohol dilution with 7 times of amounts, under 25 ℃, in ultrasonic procedure, dropwise go in the solution of beta-schardinger dextrin-, take out, through 3 ℃ of following cold preservations 28 hours, sucking filtration, filtering layer is used distilled water and absolute ethanol washing respectively, filtering layer is taken out 60 ℃ of dry white loose shape clathrate powder, i.e. saikoside beta-cyclo dextrin included compound powder of getting.
The mixing of medicated powder and particulate preparation: with above-mentioned dried cream powder and volatile oil beta-cyclodextrin inclusion complex powder, saikoside beta-cyclo dextrin included compound powder mixes even powder, powder made powder or tablet or pill routinely or add an amount of pharmaceutical purpose starch make granule, granule is incapsulated make capsule.
Claims (6)
1, a kind of medicine for the treatment of cyclomastopathy is characterized in that it is the medicament of being made by the following weight parts proportion raw material
Radix Paeoniae Rubra 12～24 Radix Bupleuri 12～24 Radix Angelicae Sinensis 12～24
Rhizoma Cyperi 6～15 Radix Curcumaes 6～15 Pericarpium Citri Reticulatae Virides 6～15
Spica Prunellae 12～24 Radix Ranunculi Ternatis 12～24 Pseudobulbus cremastrae seu pleiones 6～15
Spina Gleditsiae 6～15 Bombyx Batryticatus 6～15 Scorpios 6～15
Radix Scrophulariae 6～15 Rhizoma Bolbostematiss 12～24.
2, the medicine of treatment cyclomastopathy according to claim 1, wherein the weight portion proportioning of each raw material is
Radix Paeoniae Rubra 18 Radix Bupleuri 18 Radix Angelicae Sinensis 18
Rhizoma Cyperi 9 Radix Curcumaes 9 Pericarpium Citri Reticulatae Virides 9
Spica Prunellae 18 Radix Ranunculi Ternatis 18 Pseudobulbus cremastrae seu pleiones 9
Spina Gleditsiae 9 Bombyx Batryticatus 9 Scorpios 9
Radix Scrophulariae 15 Rhizoma Bolbostematiss 18.
3, the medicine of treatment cyclomastopathy according to claim 1 and 2 is characterized in that said medicament is a said dosage form on any pharmaceutics.
4, the medicine of treatment cyclomastopathy according to claim 3 is characterized in that said medicament is powder, tablet, pill, granule or capsule.
5, the preparation method of the medicine of the described treatment cyclomastopathy of claim 1 is characterized in that
A, get the Radix Bupleuri powder and add in the extraction kettle supercritical CO
2Fluid extraction gets saikoside or Radix Bupleuri volatile oil;
B, with a operation, different is replaces the Radix Bupleuri powder with Rhizoma Cyperi, Radix Angelicae Sinensis, Radix Curcumae, Pericarpium Citri Reticulatae Viride mixed powder, volatile oil component;
C, get Bombyx Batryticatus, Scorpio with Diluted Alcohol solution reflux, extract,, the elimination residue merges ethanol extract, and decompression recycling ethanol also is condensed into alcohol extraction cream;
D, with the c operation, different is to replace Bombyx Batryticatus, Scorpio with Radix Paeoniae Rubra, alcohol extraction cream;
E, get Spica Prunellae, Radix Ranunculi Ternati, Radix Scrophulariae, Rhizoma Bolbostematis, Pseudobulbus cremastrae seu pleiones, Spina Gleditsiae earlier, decoct with decocting method, decocting liquid naturally cools to room temperature after concentrating, and slowly adds Diluted Alcohol solution down in stirring then, through precipitation, filtration, decompression recycling ethanol also is condensed into the water decoction-alcohol sedimentation condensed cream;
F, the alcohol extraction cream of c, d operation preparation and the water decoction-alcohol sedimentation condensed cream of e operation preparation are mixed, add the dextrin of 200～800 weight portions and the stevioside of 5～30 weight portions, mixing again in 40～90 ℃ of spray dryinges, is pulverized the powder that gets dry extract;
G, get the beta-schardinger dextrin-of 1～12 weight portion, add the distilled water of 15～35 times of weight portions, the ultrasonic beta-schardinger dextrin-solution that is mixed into; Other gets the saikoside or the Radix Bupleuri volatile oil of the preparation of a operation, dehydrated alcohol dilution with 3～8 times of weight portions, under 20～60 ℃, in ultrasonic procedure, slowly add in the beta-schardinger dextrin-solution, through cold preservation, sucking filtration, filtering layer is used distilled water and absolute ethanol washing respectively, 30～70 ℃ of dry down saikoside Benexate Hydrochloride powder that get;
H, with the g operation, different is replaces the saikoside or the Radix Bupleuri volatile oil of the preparation of a operation with the volatile oil of b operation preparation, the volatile oil beta cyclodextrin inclusion complex powder;
M, with dried cream powder and volatile oil beta cyclodextrin inclusion complex, saikoside Benexate Hydrochloride mixing.
6, according to the preparation method of the medicine of the described treatment cyclomastopathy of claim 5, it is characterized in that
Supercritical CO described in a, the b operation
2Fluid extraction is that extraction kettle, extraction-container are heated respectively or be cooled to 30～60 ℃, adds CO then in system
2Gas when pressure is 20～50MPa, extracted under constant temperature, the constant voltage 1.0～3.0 hours;
Diluted Alcohol solution reflux, extract, described in c, the d operation is 50～80% the ethanol liquid that adds 6～15 times of weight portions of Bombyx Batryticatus, Scorpio, soaks 0.5～1 hour, 50～100 ℃ of backflows 2～3 times down, each 1～3 hour; The relative density of described alcohol extraction cream is 1.10～1.50;
It is the water that adds Spica Prunellae, Radix Ranunculi Ternati, Radix Scrophulariae, Rhizoma Bolbostematis, Pseudobulbus cremastrae seu pleiones and 6～15 times of weight portions of Spina Gleditsiae that decocting method described in the e operation decocts, soaking the back decocts 2～3 times, each 1～3 hour, merging decocting liquid and being concentrated into relative density was 1.03～1.50 water drug-decocting concentrating liquid; Be cooled to room temperature then, under agitation slowly add 60～95% ethanol of 1～3 times of weight portion of water drug-decocting concentrating liquid, continue to stir 10～40 minutes, staticly settled 24～72 hours under 0～8 ℃, filter, water decoction-alcohol sedimentation condensed cream relative density is 1.10～1.50;
Cold preservation time described in the g operation is 10～30 hours.
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Cited By (7)
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| WO2008119130A1 (en) * | 2007-04-02 | 2008-10-09 | Medcina Group Pty Ltd | Herbal compositions and methods for treating premenstrual syndrome |
| CN101214365B (en) * | 2008-01-14 | 2010-06-09 | 李仕金 | Chinese medicine composing prescription for treating mastoproliferation |
| CN101337048B (en) * | 2008-08-19 | 2010-12-08 | 姜雅平 | Medicine for treating hyperplasia of mammary glands |
| CN103536745A (en) * | 2012-07-12 | 2014-01-29 | 马建民 | Traditional Chinese medicinal watered pills for treating hyperplasia of mammary glands |
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| CN108721574A (en) * | 2018-08-23 | 2018-11-02 | 盐城刘氏健康咨询有限公司 | A kind of medicine for removing tumour object and preparation method thereof |
| CN109078154A (en) * | 2018-10-31 | 2018-12-25 | 中山市六安堂健康管理有限公司 | A kind of pharmaceutical composition and its preparation method and application for treating the proliferation of mammary gland |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1201782C (en) * | 2002-11-29 | 2005-05-18 | 咸阳步长制药有限公司 | Medicine composition for treating mammary gland proliferation, and its prepn. method |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008119130A1 (en) * | 2007-04-02 | 2008-10-09 | Medcina Group Pty Ltd | Herbal compositions and methods for treating premenstrual syndrome |
| CN101214365B (en) * | 2008-01-14 | 2010-06-09 | 李仕金 | Chinese medicine composing prescription for treating mastoproliferation |
| CN101337048B (en) * | 2008-08-19 | 2010-12-08 | 姜雅平 | Medicine for treating hyperplasia of mammary glands |
| CN103536745A (en) * | 2012-07-12 | 2014-01-29 | 马建民 | Traditional Chinese medicinal watered pills for treating hyperplasia of mammary glands |
| CN103536745B (en) * | 2012-07-12 | 2016-02-24 | 马建民 | A kind of Chinese kmedicine bolus for the treatment of cyclomastopathy |
| CN104474279A (en) * | 2014-12-05 | 2015-04-01 | 青岛祥翔生物医药科技有限公司 | Traditional Chinese medicine for treating stasis-phlegm type breast nodules |
| CN108721574A (en) * | 2018-08-23 | 2018-11-02 | 盐城刘氏健康咨询有限公司 | A kind of medicine for removing tumour object and preparation method thereof |
| CN109078154A (en) * | 2018-10-31 | 2018-12-25 | 中山市六安堂健康管理有限公司 | A kind of pharmaceutical composition and its preparation method and application for treating the proliferation of mammary gland |
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