CN100393306C - Formulation for treating mammary gland proliferation - Google Patents

Formulation for treating mammary gland proliferation Download PDF

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Publication number
CN100393306C
CN100393306C CNB2005100352711A CN200510035271A CN100393306C CN 100393306 C CN100393306 C CN 100393306C CN B2005100352711 A CNB2005100352711 A CN B2005100352711A CN 200510035271 A CN200510035271 A CN 200510035271A CN 100393306 C CN100393306 C CN 100393306C
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thick paste
radix
olibanum
myrrha
extract
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CN1709373A (en
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叶耀良
廖志钟
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Abstract

The present invention relates to a 'rukang' preparation for treating mammary gland hyperplasia and a preparation method thereof. The preparation has the characteristics of good solubility and high biological availability of human bodies. Powdered extract and micro powder are prepared by extracting oyster shell, olibanum, snakegourd fruit, seaweed, milkvetch root, myrrh, radix asparagi, common selfheal fruit-spike, common prism tuber, figwort root, largehead atractylodes rhizome, thunberg fritillary bulb, zedoray rhizome, red sage root and stir-baked chicken's gizzard-membrane. Soft capsules are prepared from the powdered extract, the micro powder, dispersion media, suspending agents, antiseptics and emulsifying agents. Dispersible tablets, pellets, rapidly disintegrating tablets in the oral cavity or other oral preparations are prepared from the powdered extract, the micro powder, filling agents, disintegrating agents, wetting agents and lubricating agents.

Description

A kind of newborn health preparation for the treatment of cyclomastopathy
Technical field
The present invention relates to field of medicaments, be specifically related to a kind of newborn health preparation for the treatment of cyclomastopathy and preparation method thereof.
Background technology
Breast Kang Fang is a first side commonly used of treatment cyclomastopathy, has dispersing the stagnated live-QI to relieve the stagnation of QI, regulating QI to relieve pain, and promoting blood circulation and breaking stagnation, removing food stagnancy reduces phlegm, hard masses softening and resolving, the function of air making-up and spleen enlivening.RUKANG PIAN has been listed in the 12 of the Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ".This product treatment cyclomastopathy is evident in efficacy, has data to show that the therapeutic effect for cyclomastopathy is better than medicine treatment cyclomastopathy medicine tamoxifen commonly used.Former dosage form technical characterstic is that ten five tastes medicinal substances extracts add appropriate amount of auxiliary materials and make tablet.Along with the continuous variation of environment and human to the adaptive variation of medicine, people have had higher requirement for the bioavailability and the drug effect of Chinese medicine.
Summary of the invention
The present invention makes modern form of administration such as soft capsule, dispersible tablet, drop pill, capsule, oral cavity disintegration tablet, effervescent tablet, micropill by with adding appropriate amount of auxiliary materials in the newborn Kang Zufang Chinese crude drug extract.
Drug regimen of the present invention is: Concha Ostreae, Olibanum, Fructus Trichosanthis, Sargassum, the Radix Astragali, Myrrha, Radix Asparagi, Spica Prunellae, rhizoma sparganic, Radix Scrophulariae, the Rhizoma Atractylodis Macrocephalae, Bulbus Fritillariae Thunbergii, Rhizoma Curcumae, Radix Salviae Miltiorrhizae, the treated medicinal substances extract of making of Endothelium Corneum Gigeriae Galli (stir-fry), make soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or capsule or oral cavity disintegration tablet or effervescent tablet or micropill with pharmaceutically alleged adjuvant or substrate.
Or be preferably: the component weight proportion is preferably:
Concha Ostreae 60~90g Olibanum 20~40g Fructus Trichosanthis 60~90g Sargassum 45~75g
The Radix Astragali 100~140g Myrrha 20~40g Radix Asparagi 45~75g Spica Prunellae 60~90g
Rhizoma sparganic 20~40g Radix Scrophulariae 45~75g Rhizoma Atractylodis Macrocephalae 45~75g Bulbus Fritillariae Thunbergii 20~40g
Rhizoma Curcumae 20~40g Radix Salviae Miltiorrhizae 60~90g Endothelium Corneum Gigeriae Galli (stir-fry) 20~40g
Make soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or oral cavity disintegration tablet or effervescent tablet or micropill with pharmaceutically alleged adjuvant or substrate;
Or more preferably:
8 parts of 12 parts of Radixs Astragali of 5 portions of Sargassums of 2 parts of Fructus Trichosanthis of 5 parts of Olibanums of Concha Ostreae
4 parts of 2 portions of Radix Scrophulariaes of 5 parts of rhizoma sparganic of 4 parts of Spica Prunellaes of 2 parts of Radix Asparagis of Myrrha
2 parts of the Rhizoma Atractylodis Macrocephalae 4 parts of Bulbus Fritillariae Thunbergiis, 2 parts of Rhizoma Curcumae, 5 parts of Endothelium Corneum Gigeriae Galli of 2 parts of Radix Salviae Miltiorrhizaes (stir-fry)
Make soft capsule or pharmaceutical dosage forms such as dispersible tablet or drop pill or capsule or oral cavity disintegration tablet or effervescent tablet or micropill with pharmaceutically alleged adjuvant or substrate; Or more preferably:
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g Sargassum 60g Radix Astragali 120g
Radix Asparagi 60g Spica Prunellae 75g rhizoma sparganic 30g Radix Scrophulariae 60g Rhizoma Atractylodis Macrocephalae 60g
Bulbus Fritillariae Thunbergii 30g Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (stir-fry) 30g Myrrha 30g
Make 500 or 1000 slice, or its integral multiple.
The present invention is achieved in that
The preparation soft capsule:
1. get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary, each 1~3 hour simply, collecting decoction filters, and filtrate is concentrated into into 450-1100ml, add ethanol and make and contain alcohol amount and reach 40~95%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract;
2. modulate capsule liquid: get above-mentioned dried cream or thick paste, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
3. get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, additives etc., stir, after the degassing, insulation is left standstill, and makes the capsule material;
4. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
The disperse medium of making soft capsule is: olive oil or other crude vegetals; or triglyceride oils; or oleic acid sorbitol ester; or olein: propylene glycol is 90: 10 mixture by weight; or Oleum Cocois C8/C10 monoglyceride or dibasic acid esters; or Oleum Cocois C8/C10 propylene glycol ester; or Oleum Cocois triglyceride; or the acetylizad monoglyceride of purification; or olein; or glyceryl linoleate, or Polyethylene Glycol glyceryl laurate ester, or in the purification Oleum helianthi monoglyceride one or more.
The suspending agent of soft capsule is: can increase the solid matter of disperse medium viscosity, as Cera Flava, aluminum monostearate, ethyl cellulose, carbomer etc.
The antiseptic of soft capsule is: one or more in glycerol, propylene glycol, methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate, butyl p-hydroxybenzoate, benzyl p-hydroxybenzoate, the P-hydroxybenzoic acid phenyl ester.
Its adjuvant can preferably use by following proportioning:
A kind of newborn health extract 100g that treats cyclomastopathy with disperse medium 30~360g, suspending agent 0~55g, antiseptic 0~5.5g, is modulated into stable capsule liquid and makes soft capsule.
Its capsule material is: weight ratio is 1: 0.24: 0.76: 0.12: 1.42 gelatin: arabic gum: glycerol:
Syrup: distilled water etc. are mixed and made into.
The preparation dispersible tablet:
Get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary simply, and 1~3 hour for the first time, 1.0~2.0 hours for the second time, collecting decoction filters, and filtrate is concentrated into into 750-900ml, add ethanol and make and contain alcohol amount and reach 70~75%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract;
Get above-mentioned dried cream or thick paste, add adjuvant and granulate, drying adds adjuvants such as lubricant, mixing, and tabletting promptly gets dispersible tablet, or the coated coated dispersing tablet of making; Get 2 of this sheets, put jolting in the 100ml water, in 20 ℃ ± 1 ℃ water, the whole disintegrates of planted agent in 3 minutes are also passed through sieve No. 2.
Its The disintegrating agents of dispersible tablets is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, and low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.,
Binding agent in the dispersible tablet is: the alcoholic solution or the aqueous solution of 40% ethanol~95% alcoholic solution or starch slurry or polyvinylpyrrolidone;
Filler is in the dispersible tablet: starch, or lactose or microcrystalline Cellulose, or one or more of precoking starch etc.,
Lubricant in the dispersible tablet is a magnesium stearate, or micropowder silica gel, or one or more of Pulvis Talci etc.
Its adjuvant can preferably use by following proportioning:
A kind of newborn health extract 100g that treats cyclomastopathy is with filler 0~150g, disintegrating agent 3~85g, lubricant 0~25g proportioning;
The preparation drop pill:
Get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary, each 1~3 hour simply, collecting decoction filters, and filtrate is concentrated into into 450~1100ml, add ethanol and make and contain alcohol amount and reach 40~95%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract;
Get drop pill substrate heating and melting, other gets above-mentioned dried cream or thick paste and substrate mix homogeneously, splashes into coolant, makes drop pill;
Substrate in its drop pill is polyethylene glycol 6000, can also be: molecular weight be by cured etc. one or more of 2000~12000 Polyethylene Glycol, polyoxyethylene monostearate, sodium stearate or glycerin gelatine, poloxamer, stearic acid, glyceryl monostearate, polyvinylpyrrolidone, carboxymethyl cellulose, worm, or the best is a polyethylene glycol 6000: the mixture of poloxamer (10: 0.5).Coolant in its drop pill preparation is one or more of dimethicone or liquid paraffin or Oleum Camelliae or vegetable oil etc.
Its adjuvant can preferably use by following proportioning:
Extract 100g, with consumption be that the drop pill substrate of 120~460g is used, the best 210g that uses.
The preparation oral cavity disintegration tablet:
Oral cavity disintegration tablet of the present invention is made like this:
Get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary, each 1~3 hour simply, collecting decoction filters, and filtrate is concentrated into into 450-1100ml, add ethanol and make and contain alcohol amount and reach 40~95%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract;
Get above-mentioned dried cream or thick paste, with filler, disintegrating agent, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again; Or
Get above-mentioned dried cream or thick paste,, make granule, add adjuvant mix homogeneously such as fluidizer with one or more of adjuvants such as filler, disintegrating agent, tabletting, that is, or coating is made coated tablet again.
A kind of newborn health extract 100g, filler 0~120g, disintegrating agent 3~75g, correctives 0~25g, lubricant 0.01~20g that treats cyclomastopathy;
Described disintegrating agent is: crospolyvinylpyrrolidone, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, one or more of cross-linked carboxymethyl cellulose sodium etc.;
Described lubricant is: micropowder silica gel, or one or more of magnesium stearate etc.;
Described correctives is: A Basi is sweet, stevioside, sucrose, maltose alcohol, citric acid etc. are edible or one or more of medicinal correctives; Preferably use A Basi sweet with citric acid 1: 1.5.
The preparation effervescent tablet:
Get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary, each 1~3 hour simply, collecting decoction filters, and filtrate is concentrated into into 450-1100ml, add ethanol and make and contain alcohol amount and reach 40~95%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract;
Get above-mentioned dried cream or thick paste, with filler, disintegrating agent, effervescent acid-base pair, fluidizer, correctives mix homogeneously, direct compression promptly, or coating is made coated tablet again; Or
Get above-mentioned dried cream or thick paste,, make granule, add adjuvant mix homogeneously such as effervescent acid-base pair, fluidizer with one or more of adjuvants such as filler, disintegrating agent, tabletting, that is, or coating is made coated tablet again.
The effervescent acid-base pair is formed for two kinds of materials of bronsted lowry acids and bases bronsted lowry of meeting water and can produce gas, as the citric acid of sodium bicarbonate and equivalent or tartaric acid etc.;
Filler is a lactose, or starch, or pregelatinized Starch, or one or more of microcrystalline Cellulose etc., and the best is preferably lactose: mannitol: precoking starch: microcrystalline Cellulose 3: 5: 1: 1 mixture;
Disintegrating agent is: crospolyvinylpyrrolidone, or carboxymethyl starch sodium, or low-substituted hydroxypropyl cellulose, or one or more of cross-linked carboxymethyl cellulose sodium etc.; Or the best crospolyvinylpyrrolidone that uses: low-substituted hydroxypropyl cellulose: the mixture of carboxymethyl starch sodium=4: 1: 0.5.
Its supplementary product consumption proportioning is: a kind of newborn health extract 100g, filler 0~140g, disintegrating agent 3~50g, correctives 0~25g, effervescent acid-base pair 5~75g, lubricant 0~20g that treats cyclomastopathy.
The preparation granule:
Get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary, each 1~3 hour simply, collecting decoction filters, and filtrate is concentrated into into 450-1100ml, add ethanol and make and contain alcohol amount and reach 40~95%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract;
Get above-mentioned dried cream or thick paste, add adjuvant, make granule, drying;
The granule adjuvant be except that selecting for use the starch, can also be lactose, dextrin, starch, amylum pregelatinisatum, carboxymethyl starch, microcrystalline Cellulose, methylcellulose, hydroxy methocel, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, micropowder silica gel, xylitol etc. one or more.
The preparation capsule:
Get the alleged extract of the present invention; Add suitable adjuvant, granulate, drying, encapsulated, promptly.
Adjuvant be except that selecting for use the starch, can also be lactose, dextrin, starch, amylum pregelatinisatum, carboxymethyl starch, microcrystalline Cellulose, methylcellulose, hydroxy methocel, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, micropowder silica gel, xylitol, differential silica gel, Pulvis Talci etc. one or more.
Its adjuvant can preferably use by following proportioning:
Extract 100g of the present invention granulates with starch 0~60g, drying, and 5~25g mixes with differential silica gel, filled capsules.
Micropill of the present invention or pellet capsule are made like this:
(1) get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary, each 1~3 hour simply, collecting decoction filters, and filtrate is concentrated into into 450~1100ml, add ethanol and make and contain alcohol amount and reach 40~95%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract;
(2) preparation of micropill: get above-mentioned dried cream or thick paste,, make the micropill of diameter less than 2.0mm with the adjuvant mix homogeneously; With gained micropill drying, or the coating after drying, promptly.
100 parts of extracts of the present invention, 5~60 parts of carboxymethyl starch sodium, 2~40 parts of precoking starch, wetting agent are 60~95% alcoholic solution of 2~13% polyvinylpyrrolidones; Or be preferably: newborn health extract 100g, carboxymethyl starch sodium 45g, precoking starch 30g, wetting agent are 85% alcoholic solution of 11% polyvinylpyrrolidone.
The coating solution of making the various coated preparations of the present invention is a gastric solubility coating material, as Opadry, acrylic resin IV, hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl methylcellulose, polyvinyl alcohol, methylcellulose one or more, or the coating solution formula optimization is:
Polyvinylpyrrolidone 12g, hydroxypropyl methylcellulose 4~8g, 90% alcoholic solution 200ml, Pulvis Talci 4~8g, magnesium stearate 2g, titanium dioxide 4~6g, polyethylene glycol 6000 4g, pigment 1~2g.
Effect of the present invention:
The invention preparation is used for the treatment of the observation of curative effect of cyclomastopathy:
Cyclomastopathy is modal cystic hyperplasia of breast, and its sickness rate accounts for the first place of mastopathy, belongs to " nodules of the breast " category of the traditional Chinese medical science.According to the prescription characteristics, we use this medicine to control cyclomastopathy 210 examples in March, 2000~2004 year July. and obtain significant curative effect, now be described below.
Clinical data
1.1 diagnostic criteria: formulate with reference to " traditional Chinese medical science disease diagnosis criterion of therapeutical effect " (State Administration of Traditional Chinese Medicine issues) and " Surgery of Chinese Medicine ", " Gynecology of Chinese Medicine " (five editions teaching materials of national high traditional Chinese medical science universities and colleges).All possess following 5 persons and classify the object of observation as:
(1) there is the one or both sides breast single or multiple lumps to occur clinically, most with the periodicity mastalgia, and manyly obvious relation is arranged with emotion and menstrual cycle, general menstrual onset sx about the last week, back lump and the pain of passing through obviously alleviates, and continuous 3 months can not spontaneous remission.
(2) get rid of the physiological mastalgia, as reaching the mastalgia that only mastalgia is arranged and do not have lump through preceding slight distending pain of the breast, adolescence mastalgia.
(3) can touch the single or multiple irregular tuberositys that differ in size in the clinical health check-up breast, matter is tough, multidigit in outside go up quadrant, tuberosity and surrounding tissue do not have adhesion, can be pushed, and slight tenderness is often arranged, the axillary lymph knot not quite.
(4) utilize auxiliary detection means such as molybdenum target X line or xerography, B ultrasonic, thermal image figure, the lump pin of going is in case of necessity inhaled cytolgical examination and local living tissue pathologic finding, to get rid of other good, malignant galactophore diseases such as breast carcinoma, mammary gland fibroadenoma.
(5) Chinese medical discrimination has that irritability is smouldered, the syndrome of qi stagnation and blood stasis person.
Clinical manifestation: 1., depression of liver-QI: distending pain of the breast during menstruation, feeling of oppression over the chest and distention of hypochondrium or mammary swelling, vexed easy random, bitter taste red tongue, Tai Bai or BOHUANG, stringy pulse.
2., band of gas blood stasis: lump in breast touch a tender spot obvious dysmenorrhea, through dark clot, tongue is dark or ecchymosis, white, the stringy and hesitant pulse of tongue.
1.2 exclusion standard (comprising inadaptation or rejecting standard):
1. Chinese medical discrimination does not meet above-mentioned symptom person;
2. be diagnosed as tumor patient through the physics and chemistry inspection;
3. the age is under-18s or over-65s person;
4. merge to have the inclination, serious disease persons such as liver, kidney, hemopoietic system, gestation, women breast-feeding their children;
5. to this medicine allergy sufferers;
6. psychotic, and all standards of including in that do not meet, not medication in accordance with regulations can't be judged the not congruent person of affecting the treatment of curative effect or data.
1.3 physical data 210 examples are the women, are divided into two groups at random.
Treatment group (preparation of the present invention) 180 examples, 24~50 years old age, 37.5 years old mean age; Married 157 examples, unmarried 23 examples.The course of disease 4 months to 8 years, average 4.5 years.
Matched group (RUKANG PIAN) 30 examples, 25~50 years old age, average 37 years old; Married 24 examples, unmarried 6 examples.The course of disease 3 months to 7.5 years, average 4.3 years.Two groups of patient ages, courses of disease all do not have significant difference (P>0.05), and comparability is arranged.
2 Therapeutic Method:
2.1 treatment group: preparation of the present invention, each 4, every day 2 times.
Be divided into 6 groups at random, use soft capsule, drop pill, dispersible tablet, pellet capsule, oral cavity disintegration tablet, the capsule of preparation of the present invention respectively.(dose all is equivalent to the amount of 4.8g crude drug)
2.2 each 2~3 of matched group RUKANG PIAN (Ankang Chia Tai Pharmaceutical Co., Ltd.), every day 2 times.
It is 1 course of treatment that two groups of patients took medicine 20 days, judges curative effect after two courses of treatment of all taking medicine.
3 observation of curative effect:
3.1 curative effect determinate standard is pressed recovery from illness, produce effects, effective, invalid 4 grades of evaluations with reference to " the disease of tcm diagnoses and treatment standard " of State Administration of Traditional Chinese Medicine's promulgation:
Recovery from illness: mammary gland tumor and pain disappear;
Produce effects: mammary gland pain disappears and lump dwindles>and 1/2 and deliquescing;
Effectively: pain relief, lump dwindle<and 1/2 or deliquescing;
Invalid: pain and lump no change.
3.2 therapeutic outcome
3.2.1 two groups of clinical efficacies see Table 1,
Table 1 treatment group and matched group curative effect are relatively
Group The example number Recovery from illness Produce effects Effectively Invalid Total effective rate (%) Total obvious effective rate (%)
Treatment group 1 30 examples 12 13 4 1 96.7 83.3
Treatment group 2 30 examples 10 14 4 1 96.6 82.8
Treatment group 3 30 examples 11 14 3 2 93.3 83.3
Treatment group 4 30 examples 12 12 3 2 93.1 82.8
Treatment group 5 30 examples 11 13 5 1 96.7 80.0
Treatment group 6 30 examples 11 14 2 3 90.0 83.3
Matched group 30 examples 10 12 3 3 89.3 78.6
Adopt the T check, the total obvious effective rate of treatment group and matched group is P<0.05 relatively, has the significance meaning.
3.2.2 two groups of distending pain in the chest and hypochondrium, dysmenorrhea curative effects compare:
180 examples are organized in treatment, recovery from illness (distending pain in the chest and hypochondrium, dysmenorrhea) 61 examples, produce effects 86 examples, effective 23 examples. invalid 10 examples, total effective rate 94.4%.
Matched group 30 examples, recovery from illness (distending pain in the chest and hypochondrium, dysmenorrhea) 2 examples, produce effects 10 examples, effective 11 examples, invalid 7 examples, total effective rate 76.7%.Two groups of total effective rates compare P<0.01, have utmost point significance meaning.
3.2.3 two groups of red tongue, dark, the petechia ecchymosis, stringy pulse or heavy curative effect relatively treatment are organized 180 examples, recovery from illness (it is normal that the tongue arteries and veins recovers fully) 77 examples, produce effects 55 examples, effective 39 examples, invalid 9 examples, total effective rate is 95%.
Matched group 30 examples, 9 examples of fully recovering, produce effects 10 examples, effective 6 examples, invalid 5 examples, total effective rate is relatively P<0.05 of 83.3%, two group of total effective rate, and significant difference is arranged.
4. two groups of untoward reaction are relatively:
After treatment group 2:1 example is taken medicine drug withdrawal erythra appears and;
Treatment group 4:1 example breast lesion agglomerate is bigger and strong;
Matched group: occur erythra after 1 example is taken medicine and drug withdrawal; Nauseating, upper abdomen stomachache, hypocatharsis after taking medicine, 1 example are arranged and drug withdrawal.
5 model cases:
Open * *, the woman, 36 years old, married, the cadre.Main suit with " bilateral breast discontinuity pain 2 years " came to go to a doctor on March 18th, 2002.The bilateral mastalgia appearred in the patient before 2 years, be discontinuity stomachache, and to the radiation of bilateral shoulder, hot-tempered whenever anger and obviously increase the weight of through preceding, through after alleviate, influence work and sleep.Once obeyed multiple Drug therapys such as " RUPIXIAO ", " ease pill ", poor effect.Look into: the bilateral breast outside can touch flat lump, lay one's hand on the beans size arranged, matter is medium, and tenderness is arranged, obscure boundary does not have adhesion with surrounding tissue.Infrared ray galactophore scanning and the inspection of molybdenum target sheet all are diagnosed as " cyclomastopathy "
The soft capsule of medicinal preparation of the present invention, each 2, every day 3 times.After taking medicine 7 days, mastalgia obviously alleviates, and lump dwindles, and takes continuously that lump and pain disappear after 2 courses of treatment, and check near infrared ray galactophore scanning is no abnormal, and outpatient service is followed up a case by regular visits to does not have recurrence so far.
The specific embodiment:
Embodiment 1: a kind of newborn health preparation for the treatment of cyclomastopathy:
120 parts of 60 parts of Radixs Astragali of 75 portions of Sargassums of 30 parts of Fructus Trichosanthis of 75 parts of Olibanums of Concha Ostreae
60 parts of 60 parts of Rhizoma Atractylodis Macrocephalaes of 30 portions of Radix Scrophulariaes of 75 parts of rhizoma sparganic of 60 parts of Spica Prunellaes of Radix Asparagi
30 parts of 30 parts of Myrrhas of Bulbus Fritillariae Thunbergii 30 parts of Rhizoma Curcumae, 75 parts of Endothelium Corneum Gigeriae Galli of 30 parts of Radix Salviae Miltiorrhizaes (stir-fry)
Get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary simply, and 2 hours for the first time, 1 hour for the second time, collecting decoction filters, and filtrate is concentrated into into 450ml, adds ethanol and makes and contain the alcohol amount and reach 40%, stir, leave standstill, filter, filtrate recycling ethanol is to the thick paste shape, add above-mentioned medicated powder, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract, maybe can continue drying, are ground into fine powder.
Embodiment 2: a kind of newborn health preparation for the treatment of cyclomastopathy:
160 parts of 80 parts of Radixs Astragali of 100 portions of Sargassums of 40 parts of Fructus Trichosanthis of 100 parts of Olibanums of Concha Ostreae
80 parts of 80 parts of Rhizoma Atractylodis Macrocephalaes of 40 portions of Radix Scrophulariaes of 100 parts of rhizoma sparganic of 80 parts of Spica Prunellaes of Radix Asparagi
40 parts of 40 parts of Myrrhas of Bulbus Fritillariae Thunbergii 40 parts of Rhizoma Curcumae, 80 parts of Endothelium Corneum Gigeriae Galli of 40 parts of Radix Salviae Miltiorrhizaes (stir-fry)
Get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary simply, and 3 hours for the first time, 2 hours for the second time, collecting decoction filters, and filtrate is concentrated into into 750ml, adds ethanol and makes and contain the alcohol amount and reach 75%, stir, leave standstill, filter, filtrate recycling ethanol is to the thick paste shape, add above-mentioned medicated powder, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract, maybe can continue drying, are ground into fine powder.
Embodiment 3: a kind of newborn health preparation for the treatment of cyclomastopathy:
200 parts of 100 parts of Radixs Astragali of 125 portions of Sargassums of 50 parts of Fructus Trichosanthis of 125 parts of Olibanums of Concha Ostreae
100 parts of 100 parts of Rhizoma Atractylodis Macrocephalaes of 50 portions of Radix Scrophulariaes of 125 parts of rhizoma sparganic of 100 parts of Spica Prunellaes of Radix Asparagi
50 parts of 50 parts of Myrrhas of Bulbus Fritillariae Thunbergii 50 parts of Rhizoma Curcumae, 100 parts of Endothelium Corneum Gigeriae Galli of 50 parts of Radix Salviae Miltiorrhizaes (stir-fry)
Get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary simply, and 3.5 hours for the first time, 2.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into into 1100ml, adds ethanol and makes and contain the alcohol amount and reach 95%, stir, leave standstill, filter, filtrate recycling ethanol is to the thick paste shape, add above-mentioned medicated powder, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract, maybe can continue drying, are ground into fine powder.
Embodiment 4: a kind of newborn health preparation for the treatment of cyclomastopathy:
120 parts of 60 parts of Radixs Astragali of 75 portions of Sargassums of 30 parts of Fructus Trichosanthis of 75 parts of Olibanums of Concha Ostreae
60 parts of 60 parts of Rhizoma Atractylodis Macrocephalaes of 30 portions of Radix Scrophulariaes of 75 parts of rhizoma sparganic of 60 parts of Spica Prunellaes of Radix Asparagi
30 parts of 30 parts of Myrrhas of Bulbus Fritillariae Thunbergii 30 parts of Rhizoma Curcumae, 75 parts of Endothelium Corneum Gigeriae Galli of 30 parts of Radix Salviae Miltiorrhizaes (stir-fry)
Get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha is ground into impalpable powder or micropowder, rhizoma sparganic, Rhizoma Curcumae, Radix Salviae Miltiorrhizae reclaims ethanol and gets the alcohol extraction thick paste with 60% alcohol reflux 2.5 hours, measure to such an extent that doubly reach cyclodextrin inclusion compound with 5 times, all the other medical material eight flavors such as medicinal residues and Concha Ostreae decoct with water secondary, and 2 hours for the first time, 1 hour for the second time, collecting decoction, filter, filtrate is concentrated into into 800ml, adds ethanol and makes and contain the alcohol amount and reach 70~75%, stir, leave standstill, filter, filtrate recycling ethanol is to the thick paste shape, add the said medicine fine powder, mixing promptly gets thick paste, or dry, pulverize, above-mentioned alcohol extract doubly reaches cyclodextrin clathrate, medicated powder is medicinal substances extract.
Embodiment 5: a kind of newborn caring soft capsule preparation for the treatment of cyclomastopathy:
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g Sargassum 60g Radix Astragali 120g
Radix Asparagi 60g Spica Prunellae 75g rhizoma sparganic 30g Radix Scrophulariae 60g Rhizoma Atractylodis Macrocephalae 60g
Bulbus Fritillariae Thunbergii 30g Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (stir-fry) 30g Myrrha 30g
The about 200g of said extracted thing
Cera Flava 20g;
Olive oil 215g
Propylene glycol 2g
Soybean lecithin 8g
Make 1000
1. get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary, each 2 hours simply, collecting decoction filters, and filtrate is concentrated into into 750-900ml, add ethanol and make and contain alcohol amount and reach 70~75%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract.
2. modulate capsule liquid: get above-mentioned dried cream or thick paste, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
3. get gelatin, water mixing, in heating in water bath dissolving down, add glycerol, antiseptic, additives, stir, after the vacuumize degassing, insulation is left standstill, and it is standby to make the capsule material;
4. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
Embodiment 6: a kind of newborn caring soft capsule preparation for the treatment of cyclomastopathy:
Medicinal substances extract 100g
Peach kernel oil 15g
Soybean oil 90g
Cera Flava: 1.5: 3.5 12g of ethyl cellulose weight ratio
Ethylparaben 0.7g
Make 500
1. get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary, each 2 hours simply, collecting decoction filters, and filtrate is concentrated into into 800ml, add ethanol and make and contain alcohol amount and reach 70~75%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract.
2. modulate capsule liquid: get above-mentioned dried cream or thick paste, add one or more of disperse medium, antiseptic, suspending agent, emulsifying agent etc., stir, grind homogenizing, promptly get soft capsule liquid;
3. its capsule material formula is weight ratio 1: 0.23: 0.76: 0.12: 1.42 gelatin: arabic gum: glycerol: syrup: distilled water etc. are mixed and made into.Get gelatin, water in heating in water bath dissolving down, mix homogeneously adds glycerol, antiseptic, additives, stirs, and after the vacuumize degassing, insulation is left standstill, and makes capsule material glue;
4. make soft capsule: capsule liquid is encapsulated in the capsule material of compositions such as glycerol, gelatin, water with preparation soft capsule equipment.
Embodiment 7: a kind of newborn caring soft capsule preparation for the treatment of cyclomastopathy:
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g Sargassum 60g Radix Astragali 120g
Radix Asparagi 60g Spica Prunellae 75g rhizoma sparganic 30g Radix Scrophulariae 60g Rhizoma Atractylodis Macrocephalae 60g
Bulbus Fritillariae Thunbergii 30g Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (stir-fry) 30g Myrrha 30g
Medical material is made extract (thick paste) 200g by embodiment 1~4.
Peach kernel oil 25g
Soybean oil 100g:
Make 1000
Embodiment 8: a kind of preparation for the treatment of the mammary healthy dispersion tablet of cyclomastopathy:
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g Sargassum 60g Radix Astragali 120g
Radix Asparagi 60g Spica Prunellae 75g rhizoma sparganic 30g Radix Scrophulariae 60g art 60g
Bulbus Fritillariae Thunbergii 30g Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (stir-fry) 30g Myrrha 30g
Medical material is made extract (thick paste) 200g by embodiment 1~4.
Lactose: 100g
Microcrystalline Cellulose: 65g
Mannitol: 45g
Carboxymethyl starch sodium: 10g
Polyvinylpyrrolidone: 35g
Sodium lauryl sulphate: 2.5g
Magnesium stearate: 3.0g
Make extract by embodiment 1~4, use 75% alcohol granulation with lactose, carboxymethyl starch sodium, microcrystalline Cellulose, mannitol etc., drying adds polyvinylpyrrolidone, sodium lauryl sulphate, and the magnesium stearate mix homogeneously is pressed into 1000, promptly.
Embodiment 9: a kind of preparation for the treatment of the mammary healthy dispersion tablet of cyclomastopathy:
Medicinal substances extract (dried cream powder) 200g
Lactose: 30g
Hydroxypropyl emthylcellulose: 8g
Microcrystalline Cellulose: 25g
Crospolyvinylpyrrolidone: 12g
Micropowder silica gel: 2.3g
Make the extract thick paste by embodiment 1~4, with lactose, hydroxypropyl emthylcellulose, microcrystalline Cellulose, etc. granulate with the alcoholic solution moistening of 11% poly-second ketopyrrolidine, add volatile oil, dry, add polyvinylpyrrolidone, differential silica gel mix homogeneously, tabletting, coating is made 1000, and coating solution is:
Polyvinylpyrrolidone 12g
Hydroxypropyl methylcellulose 4~8g
90% alcoholic solution 200ml
Pulvis Talci 4~8g
Magnesium stearate 2g
Titanium dioxide 4~6g
Polyethylene glycol 6000 4g
Pigment 1~2g.
Embodiment 10: a kind of preparation for the treatment of the newborn disease treating drop pills of cyclomastopathy:
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g Sargassum 60g Radix Astragali 120g
Radix Asparagi 60g Spica Prunellae 75g rhizoma sparganic 30g Radix Scrophulariae 60g art 60g
Bulbus Fritillariae Thunbergii 30g Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (stir-fry) 30g Myrrha 30g
Medical material is made extract (thick paste) 200g by embodiment 1~4.
Polyethylene glycol 6000 235g
Macrogol 4000 15g
Poloxamer 10g
Make 5000.
Get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary, each 2 hours simply, collecting decoction filters, and filtrate is concentrated into into 800ml, add ethanol and make and contain alcohol amount and reach 70~75%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract.
Get drop pill substrate heating and melting, add medicinal substances extract dried cream powder, poloxamer mix homogeneously with it, be incubated under 95 ℃ of conditions, mix homogeneously splashes in the coolant and is shaped, and remove liquid coolant and promptly get drop pill, or coated again technology is made coated drop pill.
Keep 90 centimetres of cooling column effective column lengths when dripping system, 5 ℃ of liquid coolants are dripped 55 on every part of clock of speed, dropper mouth external diameter 2.5mm, and internal diameter 2.2mm, then dripping the drop pill of making does not have the tail of taking off, and outward appearance is bright and clean shaped.
Coating solution can be made by following proportioning:
Polyvinylpyrrolidone 30g
Hydroxypropyl methylcellulose 8g
95% alcoholic solution 200ml
Magnesium stearate 2g
Titanium dioxide 6g
Polyethylene glycol 6000 2g
Pigment 3g
Embodiment 11: a kind of preparation for the treatment of the newborn health oral cavity disintegration tablet of cyclomastopathy:
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g Sargassum 60g Radix Astragali 120g
Radix Asparagi 60g Spica Prunellae 75g rhizoma sparganic 30g Radix Scrophulariae 60g art 60g
Bulbus Fritillariae Thunbergii 30g Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (stir-fry) 30g Myrrha 30g
Get extract (thick paste) 210g that said ratio makes
Lactose: 40g
Microcrystalline Cellulose: 20g
Mannitol: 30g
Carboxymethyl starch sodium: 12g
Polyvinylpyrrolidone: 20g
The sweet 3.5g of A Basi
Citric acid 7.0g
Magnesium stearate: 7.0g
Get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary, each 2 hours simply, collecting decoction filters, and filtrate is concentrated into into 750-900ml, add ethanol and make and contain alcohol amount and reach 70~75%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract.
Get above-mentioned dried cream or thick paste, with 75% alcohol granulation, drying such as lactose, carboxymethyl starch sodium, microcrystalline Cellulose, mannitol, add volatile oil polyvinylpyrrolidone, sodium lauryl sulphate, A Basi is sweet, the magnesium stearate mix homogeneously, is pressed into 1000, promptly.
Embodiment 12: a kind of preparation for the treatment of the newborn health oral cavity disintegration tablet of cyclomastopathy:
The material extract 200g that gets it filled,
Carboxymethyl starch sodium: 17g
Polyvinylpyrrolidone: 22g
Magnesium stearate: 0.03g
Get said extracted thing and carboxymethyl starch sodium 75% alcohol granulation, drying adds polyvinylpyrrolidone, magnesium stearate mix homogeneously, is pressed into 1000, promptly.
Embodiment 13: a kind of preparation for the treatment of the newborn recovering particles of cyclomastopathy
The material extract 200g that gets it filled,
Lactose: 45g
Mannitol: 27g
Precoking starch: 17g
Crospolyvinylpyrrolidone: 7g
Low-substituted hydroxypropyl cellulose 17g
Sodium bicarbonate 12g
Citric acid 9g
Tartaric acid 17g
Make 250 bags.
Make extract and lactose, mannitol, precoking starch, sodium bicarbonate etc. by embodiment 1~4 and use 75% alcohol granulation, drying adds citric acid, tartaric acid etc., promptly.
Embodiment 14: a kind of preparation for the treatment of the newborn health micropill of cyclomastopathy
The material extract 200g that gets it filled,
Carboxymethyl starch sodium 20g
Precoking starch 12g
85% alcoholic solution, the 25~35ml of 11% polyvinylpyrrolidone
(1) gets above-mentioned dried cream or thick paste,, make the micropill of diameter less than 2.0mm with agitation procedure with mix homogeneously such as carboxymethyl starch sodium, precoking starch;
(2) with gained micropill drying, or the coating after drying, promptly.Or the micropill filled capsules made pellet capsule.
Embodiment 15: a kind of preparation for the treatment of the newborn recovering particles of cyclomastopathy
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g Sargassum 60g Radix Astragali 120g
Radix Asparagi 60g Spica Prunellae 75g rhizoma sparganic 30g Radix Scrophulariae 60g Rhizoma Atractylodis Macrocephalae 60g
Bulbus Fritillariae Thunbergii 30g Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (stir-fry) 30g Myrrha 30g
Dextrin: 12g
Starch: 25g
Microcrystalline Cellulose: 30g
Make 250 bags.
Above-mentioned medical material is made extract by embodiment 4, and dextrin, starch, microcrystalline Cellulose: granulate with 75% alcohol, drying, promptly.
Embodiment 16: a kind of preparation for the treatment of the newborn recovering capsule of cyclomastopathy:
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g Sargassum 60g Radix Astragali 120g
Radix Asparagi 60g Spica Prunellae 75g rhizoma sparganic 30g Radix Scrophulariae 60g art 60g
Bulbus Fritillariae Thunbergii 30g Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (stir-fry) 30g Myrrha 30g
Starch: 100g
Make 1000
Medical material is made the extract dried cream powder by embodiment 2, with starch mixing granulation, drying, fill capsule, promptly.
Embodiment 17: a kind of preparation for the treatment of the newborn recovering capsule of cyclomastopathy:
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g Sargassum 60g Radix Astragali 120g
Radix Asparagi 60g Spica Prunellae 75g rhizoma sparganic 30g Radix Scrophulariae 60g Rhizoma Atractylodis Macrocephalae 60g
Bulbus Fritillariae Thunbergii 30g Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (stir-fry) 30g Myrrha 30g
Starch 60g
Differential silica gel 22g
Medical material is made extract by embodiment 2,, add differential silica gel with starch mixing granulation, drying, the fill capsule, promptly.
Embodiment 18: a kind of preparation for the treatment of the newborn recovering capsule of cyclomastopathy:
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g Sargassum 60g Radix Astragali 120g
Radix Asparagi 60g Spica Prunellae 75g rhizoma sparganic 30g Radix Scrophulariae 60g Rhizoma Atractylodis Macrocephalae 60g
Bulbus Fritillariae Thunbergii 30g Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (stir-fry) 30g Myrrha 30g
Starch 80g
Doubly reach cyclodextrin 45g
Differential silica gel 22g
Make 1000.
Get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into micropowder, rhizoma sparganic, Rhizoma Curcumae, Radix Salviae Miltiorrhizae extracted 2.5 hours with 60% alcohol reflux, reclaimed ethanol and got the alcohol extraction thick paste, measured to such an extent that doubly to reach cyclodextrin inclusion compound standby with 5 times; All the other medical material eight flavors such as medicinal residues and Concha Ostreae decoct with water secondary, and 2 hours for the first time, 1 hour for the second time, collecting decoction, filter, filtrate is concentrated into into 800ml, adds ethanol and makes and contain the alcohol amount and reach 70~75%, stirs, leave standstill, filter, filtrate recycling ethanol is to the thick paste shape, add the said medicine fine powder, mixing promptly gets thick paste, or dry, pulverize, with starch mixing granulation, drying, add alcohol extract cyclodextrin clathrate, differential silica gel, the fill capsule, promptly.

Claims (2)

1. a newborn health micropill for the treatment of cyclomastopathy is characterized in that
1. used medical material is: Concha Ostreae, Olibanum, Fructus Trichosanthis, Sargassum, the Radix Astragali, Myrrha, Radix Asparagi, Spica Prunellae, rhizoma sparganic, Radix Scrophulariae, the Rhizoma Atractylodis Macrocephalae, Bulbus Fritillariae Thunbergii, Rhizoma Curcumae, Radix Salviae Miltiorrhizae, Endothelium Corneum Gigeriae Galli (parched);
2. used medical material proportioning is:
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g Sargassum 60g Radix Astragali 120g Myrrha 30g
Radix Asparagi 60g Spica Prunellae 75g rhizoma sparganic 30g Radix Scrophulariae 60g Rhizoma Atractylodis Macrocephalae 60g Bulbus Fritillariae Thunbergii 30g
Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (parched) 30g;
3. get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary, each 1~3 hour simply, collecting decoction filters, and filtrate is concentrated into into 450~1100ml, add ethanol and make and contain alcohol amount and reach 40~95%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract;
4. get above-mentioned dried cream or thick paste,, make the micropill of diameter less than 2.0mm with the adjuvant mix homogeneously; With gained micropill drying, or the coating after drying;
5. medicinal substances extract 100g, carboxymethyl starch sodium 5~60g, pregelatinized Starch 2~40g, wetting agent are 60~95% alcoholic solution of 2~13% polyvinylpyrrolidones.
2. a newborn health micropill for the treatment of cyclomastopathy is characterized in that
1. used medical material is: Concha Ostreae, Olibanum, Fructus Trichosanthis, Sargassum, the Radix Astragali, Myrrha, Radix Asparagi, Spica Prunellae, rhizoma sparganic, Radix Scrophulariae, the Rhizoma Atractylodis Macrocephalae, Bulbus Fritillariae Thunbergii, Rhizoma Curcumae, Radix Salviae Miltiorrhizae, Endothelium Corneum Gigeriae Galli (parched);
2. used medical material proportioning is:
Concha Ostreae 75g Olibanum 30g Fructus Trichosanthis 75g Sargassum 60g Radix Astragali 120g Myrrha 30g
Radix Asparagi 60g Spica Prunellae 75g rhizoma sparganic 30g Radix Scrophulariae 60g Rhizoma Atractylodis Macrocephalae 60g Bulbus Fritillariae Thunbergii 30g
Rhizoma Curcumae 30g Radix Salviae Miltiorrhizae 75g Endothelium Corneum Gigeriae Galli (parched) 30g;
3. get Endothelium Corneum Gigeriae Galli, Bulbus Fritillariae Thunbergii, Olibanum, Myrrha and be ground into fine powder, all the other Concha Ostreaes etc. ten decoct with water secondary, each 1~3 hour simply, collecting decoction filters, and filtrate is concentrated into into 450~1100ml, add ethanol and make and contain alcohol amount and reach 40~95%, stir, leave standstill, filter, filtrate recycling ethanol adds above-mentioned medicated powder to the thick paste shape, mixing promptly gets thick paste, or dry, be ground into fine powder, promptly get dry extract, above-mentioned dried cream or thick paste are medicinal substances extract;
4. get above-mentioned dried cream or thick paste,, make the micropill of diameter less than 2.0mm with the adjuvant mix homogeneously; With gained micropill drying, or the coating after drying;
5. medicinal substances extract 100g, carboxymethyl starch sodium 5~60g, pregelatinized Starch 2~40g, wetting agent are 60~95% alcoholic solution of 2~13% polyvinylpyrrolidones; The coating solution prescription is: polyvinylpyrrolidone 12g, hydroxypropyl methylcellulose 4~8g, 90% alcoholic solution 200ml, Pulvis Talci 4~8g, magnesium stearate 2g, titanium dioxide 4~6g, polyethylene glycol 6000 4g, pigment 1~2g.
CNB2005100352711A 2005-06-11 2005-06-11 Formulation for treating mammary gland proliferation Expired - Fee Related CN100393306C (en)

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CN103157061A (en) * 2011-12-14 2013-06-19 西安泰科迈医药科技有限公司 A pure traditional Chinese medicine combination used for mammary gland hyperplasia and a preparation method thereof
CN104547942B (en) * 2015-01-23 2015-09-30 西安新通药物研究有限公司 Rukang granules agent with slow releasing function and preparation method thereof

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Publication number Priority date Publication date Assignee Title
CN1593604A (en) * 2004-07-08 2005-03-16 谢子龙 Dispersible tablet for treating mammary glands hyperplasia and its preparing method

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1593604A (en) * 2004-07-08 2005-03-16 谢子龙 Dispersible tablet for treating mammary glands hyperplasia and its preparing method

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
乳康胶囊治疗气滞血瘀型乳腺增生病的临床研究. 冉淑萍,耿嘉.黑龙江中医药,第4期. 2002
乳康胶囊治疗气滞血瘀型乳腺增生病的临床研究. 冉淑萍,耿嘉.黑龙江中医药,第4期. 2002 *

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