CN101703658B - Composition for treating hyperplasia of mammary glands and preparation method thereof - Google Patents
Composition for treating hyperplasia of mammary glands and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a composition for treating hyperplasia of mammary glands and a preparation method thereof. The composition is prepared from the following raw materials in part by weight: 5 to 10 parts of nutgrass galingale rhizome, 2 to 10 parts of white mustard seed, 5 to 15 parts of heroubill geranium, 3 to 6 parts of scorpion, 2 to 10 parts of common curculigo rhizome and 5 to 15 parts of glossy privet fruit. The composition has simple formula and definitely curative effect of treating the hyperplasia of mammary glands. The invention also relates to the preparation method of the composition, which comprises the following steps: uniformly mixing the nutgrass galingale rhizome with the white mustard seed, extracting essential oil through water vapor distillation until the essential oil is exhausted, taking the essential oil for later use, separating water liquid for later use; uniformly mixing the heroubill geranium, the scorpion, the common curculigo rhizome and the glossy privet fruit, adding water of which the adding amount is 10 times of the total weight of the medicinal materials into the medicaments, and decocting the mixture for two times for 2 hours each time; merging decoction for filtration; adding the aqueous liquid obtained after extracting essential oil, and concentrating the mixture to form thick paste; and adding the essential oil and auxiliary materials to prepare a pharmaceutically acceptable preparation. The preparation method can ensure that the composition has convenient use and controlled quality.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, especially a kind of composition and method of making the same of forming by Chinese medicine.
Background technology
Cyclomastopathy (Hyperplasia of Mammary Glands) is a kind of neither inflammation of mammary gland tissue, the proliferative disease of non-tumor again, and Clinical symptoms is mastalgia and lump in breast, and " nodules of the breast " of the symptom and the traditional Chinese medical science is quite similar.This disease is women's commonly encountered diseases, a frequently-occurring disease, and in recent years, this sick sickness rate increases year by year, and the women of child-bearing age's sickness rate is up to 28-40%.Primary disease has certain canceration rate.
The pathogenic factor of cyclomastopathy is still not fully aware of.It is generally acknowledged relevant with the ovary endocrine dysfunction.Lutein hyposecretion, estrogen relatively or too much absolute so that mammoplasia gets muddled with the restoration of old ways process in the menstrual cycle, makes breast duct or acinus epithelial proliferation, comedomastitis becomes cryptomere, the formation lump.The traditional Chinese medical science thinks, breast and Liver and kidney taste dash appoints etc. in close relationsly, and feelings will is not smooth, depression of liver-QI, and qi depression to blood stasis is pented up in newborn network, stagnation of QI and blood may bring about pain; Kidney unit loses empty, the mechanism of qi retardance, the stagnation of QI, blood stasis, expectorant coagulate etc. pathological product hinder in newborn network then mammary gland thicken block.Therefore, stagnation of liver-QI is suffered from a deficiency of the kidney and is the main pathogenesis of primary disease, and the stagnation of QI expectorant stasis of blood that generates therefrom is that the mark of primary disease is real.
About primary disease, doctor trained in Western medicine mainly adopts hormone therapy at present, but the hormone therapy cycle is long, and relapse rate is high, and side effect is big, and can further upset the balance of hormone in vivo.Domestic most employing Chinese medicine cyclomastopathy, but often prescription is huge, dosage form falls behind, and quality controllability is poor, is inconvenient to use.
Summary of the invention
Problem to be solved by this invention provides a kind of compositions of treating cyclomastopathy, and its prescription is simplified, and is safe and effective, quality controllable.
Another technical problem to be solved by this invention provides a kind of preparation of compositions method, is made into modern preparation, the convenient use.
In order to solve the problems of the technologies described above, the present invention proposes following technical proposals:
A kind of compositions of treating cyclomastopathy is characterized in that described compositions processed by the raw material of following parts by weight: Rhizoma Cyperi 5-10 part, Semen Sinapis Albae 2-10 part, Herba Erodii 5-15 part, Scorpio 3-6 part, Rhizoma Curculiginis 2-10 part, Fructus Ligustri Lucidi 5-15 part.
Prescription is preferably: 9 parts of Rhizoma Cyperis, 10 parts of Semen Sinapis Albaes, 12 parts of Herba Erodiis, 5 parts of Scorpios, 9 parts of Rhizoma Curculiginises, 10 parts of Fructus Ligustri Lucidi.
Rhizoma Cyperi is the dry rhizome of sedge dried tuber Cyperus rotundus L..
Semen Sinapis Albae is the seed of Cruciferae Caulis et Folium Sinapis albee Sinaps alba L..
Herba Erodii is the dry aerial parts of the plant Mang cattle Seedling Erodium stephanianum Willd. of Mang cattle Seedling section, Herba Erodii GeraniumWilfordii Maxim. or Carolina Cranesbill Herb Geranium carolinianum L..
Scorpio is the dry body of Buthidae animal Scorpio Buthus martensii Karsch.
Rhizoma Curculiginis is the dry rhizome of amrallid Rhizoma Curculiginis Curculigo orchioides Gaertn..
Fructus Ligustri Lucidi is the dry mature fruit of Oleaceae plant Fructus Ligustri Lucidi Ligustrum lucidum Ait..
Rhizoma Cyperi dispersing the stagnated live-QI to relieve the stagnation of QI in the side, promoting the circulation of QI to relieve pain; Semen Sinapis Albae reduces phlegm by drink, and the knot that disappears looses swollen; Herba Erodii, full scorpion obstruction removing pain relieving; The moon of Fructus Ligustri Lucidi nourishing the liver and kidney, the Rhizoma Curculiginis warming YANGization is cloudy, makes YIN and YANG promoting each other, dashes and appoints conditioning.All medicines share the merit of the circulation of qi promoting of common long memorial liver, dissipating phlegm and resolving masses, removing obstruction in the collateral to relieve pain, Chong and Ren Meridians regulating, can effectively prevent and treat cyclomastopathy.
The technique effect of traditional Chinese medicine composition for treating cyclomastopathy according to the invention can embody through following test.
Test Example 1, Chinese medicine composition of the present invention are to estradiol (E
2) the outgrowth influence of inductive rat mammary gland
1.1 test material
Animal: Wistar rat, China Medicine University's Experimental Animal Center.
Medicine and reagent: Chinese medicine composition of the present invention, press embodiment 13 self-controls; Tamoxifen Citrate, Suzhou the 1st pharmaceutical Co. Ltd; Estradiol benzoate (E
2), Zhejiang Province XianJu Pharmacy stock Co., Ltd; Estradiol radioimmunoassay, RIA medicine box, Beijing North technical research institute.
Instrument: GC-1500 γ radioimmunity enumerator, good branch company in the Keda Innovation Co., Ltd.
1.2 test method:
Get the Wistar rat, female, body weight 180-200g; Random packet; Every group 10: blank group, model group, positive controls (Tamoxifen Citrate, 4.0mg/kg), present composition high dose group, in, low dose group (8.8,4.4,2.2g crude drug/Kg).Except that the blank group, all the other organize intramuscular injection estradiol benzoate (E equal the next day
2) 0.5mg/kg, continuous 30 days, intramuscular injection began to irritate stomach and receives the reagent thing after two weeks, and every day 1 time, the blank group gives the normal saline of corresponding volume, intramuscular injection E
2Two weeks again after the end is got blood at last administration next day, and 3000rpm 10 minutes is centrifugal, gets serum, puts the method for exempting from and measures estradiol content in the serum.Change with second pair of breast diameter of vernier caliper measurement rat, every rat is chosen 2 of maximum mammary gland tissues, 10% formalin fixed; The routine paraffin wax embedding, section, HE dyeing; The professional reads sheet by pathology, and light microscopic is observed down and had or not tissue pathologies change and pathological changes light and heavy degree.
Mammary gland tissue is divided into I～IV level Four according to pathology hypertrophy situation, and scoring is 1 minute, 2 minutes, 3 minutes, 4 minutes respectively, and each grade standard is following:
The I level: (normal galactophore tissue), lobules of mammary gland is hypertrophy (-) not, and acinus quantity is few, and acinus and conduit are not expanded, and are in state resting stage.
The II level: slight hypertrophy (+), lobules of mammary gland does not have obvious hypertrophy, and indivedual acinuses and conduit have slight hypertrophy, do not have expansion.
The III level: moderate hypertrophy (++), the most of hypertrophy of lobules of mammary gland, part acinus and conduit are obviously expanded.
IV: obvious hypertrophy (+++), the obvious hypertrophy of lobules of mammary gland, acinus and conduit are in extremely expansion state, and glandular epithelium is flat, in the acinus and in the conduit a large amount of secretions is arranged.
The every treated animal mammary gland scoring of accumulative total; And calculate average ± standard deviation (
X ± SD), score value is high more to be carried---show that hyperplasia degree is heavy more.
Statistical analysis: test data adopts the t check between group.
1.3 experimental result:
Table 1 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Low dose group | 2.2 | 1.45±0.22* | 52.4±17.5* | 2.5±1.0* |
| Middle dose groups | 4.4 | 1.32±0.27** | 48.1±16.9** | 2.2±0.8** |
| High dose group | 8.8 | 1.15±0.30** | 44.5±20.0** | 1.7±0.7** |
Annotate: compare * p＜0.05, * * p＜0.01 with model group.
Can be known by table 1, compare with the blank group that it is big that the papilla diameter of model group rat obviously becomes, estradiol content obviously raises, and mammoplasia's scoring obviously raises, and all has highly significant property meaning (p＜0.01), shows the modeling success.Compare with model group, the papilla diameter of positive controls, each dose groups rat of the present composition obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05,0.01).
The above results shows that Chinese medicine composition of the present invention can effectively suppress E
2Inductive rat mammary gland hypertrophy.
The analgesic activity of Test Example 2, Chinese medicine composition of the present invention
2.1 test material
Animal: Kunming mouse, China Medicine University's Experimental Animal Center.
Medicine and reagent: Chinese medicine composition of the present invention, press embodiment 11 self-controls.Glacial acetic acid, Nanjing chemical reagent two factories.Pethidine, Qinghai Pharmaceutic Plant.
2.2 experimental technique
Writhing method
Get 60 of mices; Male and female half and half; Be divided into 5 groups at random; Every group 12: blank group (giving normal saline), positive controls (pethidine 0.013g/kg), present composition low dose group (4.4g crude drug/kg), middle dose groups (8.8g crude drug/kg), high dose group (17.6 crude drugs/kg); Blank group, each dose groups gastric infusion of the present composition be after 30 minutes (behind the positive controls lumbar injection 10min), and 0.2 milliliter in lumbar injection 0.6% glacial acetic acid/is only observed the number of times that writhing response appears in mice in 20 minutes.
2.3 experimental result
Table 2 analgesic activity (writhing method) (
x ± s, n=12)
| Group | Dosage (g/Kg) | Turn round body number of times (inferior) |
| The blank group | - | 26.9±6.7 |
| Positive controls | 1.3×10 -2 | 9.9±3.4** |
| Low dose group | 4.4 | 18.7±5.5** |
| Middle dose groups | 8.8 | 16.3±4.7** |
| High dose group | 17.6 | 14.7±5.2** |
Annotate: compare * p＜0.05, * * p＜0.01 with the blank group.
Can know by table 2, compare that what positive controls, each dose groups of the present invention can obviously reduce mice turns round the body number of times, and has highly significant property meaning (p＜0.01) with the blank group.The above results shows that Chinese medicine composition of the present invention has certain analgesic activity.
In sum, the present composition can effectively suppress E
2Inductive rat mammary gland hypertrophy, have a good analgesic activity simultaneously, above-mentioned effect is pharmacological basis of its treatment cyclomastopathy.
The method for preparing of the present composition is: get Rhizoma Cyperi, Semen Sinapis Albae 2 flavor medical materials, mixing, vapor distillation extract volatile oil to most, and volatile oil is subsequent use, divides dried up liquid, and is subsequent use; Get Herba Erodii, Scorpio, Rhizoma Curculiginis, Fructus Ligustri Lucidi 4 flavor medical materials, mixing, the decocting that adds 10 times of amounts of its gross weight volume boils each 2 hours 2 times; Merge decoction liquor, filter, add the above-mentioned water liquid behind the volatile oil of carrying, be concentrated into the thick paste shape; Add volatile oil, add adjuvant, process the acceptable preparation of pharmacy.
The dosage form of the present composition adopts peroral dosage form, is selected from a kind of in granule, sheet, capsule, drop pill, the soft capsule.
When Chinese medicine composition according to the invention is used to treat cyclomastopathy, different according to the state of an illness and occupation mode, daily crude drug amount is 10-100g.
For technical scheme of the present invention better is described, hereinafter will be done further statement to its specific embodiment, but the scope that the present invention requires to protect is not limited to following embodiment.
The specific embodiment
Embodiment 1
Prescription: Rhizoma Cyperi 683g, Semen Sinapis Albae 1366g, Herba Erodii 2049g, Scorpio 820g, Rhizoma Curculiginis 1366g, Fructus Ligustri Lucidi 2049g (being equivalent to 5: 10: 15: 6: 10: 15).
Method for making: get Rhizoma Cyperi, Semen Sinapis Albae 2 flavor medical materials, mixing, vapor distillation extract volatile oil to most, and volatile oil is subsequent use, divides dried up liquid, and is subsequent use; Get Herba Erodii, Scorpio, Rhizoma Curculiginis, Fructus Ligustri Lucidi 4 flavor medical materials, mixing, the decocting that adds 10 times of amounts of its gross weight volume boils each 2 hours 2 times; Merge decoction liquor, filter, add the above-mentioned water liquid behind the volatile oil of carrying; Be concentrated into the thick paste shape, add volatile oil, add starch, sodium carboxymethyl cellulose is an amount of; The system granule, the encapsulating capsule is processed 1000.
Usage: every day 3 times, each 2
Pharmacological testing: with reference to Test Example 1 method, present embodiment compositions dosage is 4.0g crude drug/kg, and result of the test sees the following form:
Table 3 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Implement 1 | 4.0 | 1.38±0.25** | 52.3±18.3* | 2.7±0.7* |
Result of the test shows that the papilla diameter of present embodiment compositions group rat obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05,0.01).
Embodiment 2
Prescription: Rhizoma Cyperi 1543g, Semen Sinapis Albae 309g, Herba Erodii 772g, Scorpio 463g, Rhizoma Curculiginis 309g, Fructus Ligustri Lucidi 772g (being equivalent to 10: 2: 5: 3: 2: 5).
Method for making: with embodiment 1.
Usage: every day 3 times, each 2
Pharmacological testing: with reference to Test Example 1 method, present embodiment compositions dosage is 2.0g crude drug/kg, and result of the test sees the following form:
Table 4 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Implement 2 | 2.0 | 1.46±0.18* | 54.6±15.6* | 2.6±0.8* |
Result of the test shows that the papilla diameter of present embodiment compositions group rat obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05).
Embodiment 3
Prescription: Rhizoma Cyperi 1293g, Semen Sinapis Albae 259g, Herba Erodii 1940g, Scorpio 776g, Rhizoma Curculiginis 1293g, Fructus Ligustri Lucidi 1940g (being equivalent to 10: 2: 15: 6: 10: 15).
Method for making: with embodiment 1.
Usage: every day 3 times, each 2
Pharmacological testing: with reference to Test Example 1 method, present embodiment compositions dosage is 3.6g crude drug/kg, and result of the test sees the following form:
Table 5 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Implement 3 | 3.6 | 1.44±0.22* | 55.3±17.3* | 2.6±1.0* |
Result of the test shows that the papilla diameter of present embodiment compositions group rat obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05).
Embodiment 4
Prescription: Rhizoma Cyperi 833g, Semen Sinapis Albae 1667g, Herba Erodii 833g, Scorpio 500g, Rhizoma Curculiginis 333g, Fructus Ligustri Lucidi 833g (being equivalent to 5: 10: 5: 3: 2: 5).
Method for making: with embodiment 1.
Usage: every day 3 times, each 2
Pharmacological testing: with reference to Test Example 1 method, present embodiment compositions dosage is 2.4g crude drug/kg, and result of the test sees the following form:
Table 6 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Implement 4 | 2.4 | 1.48±0.18* | 56.7±18.2* | 2.6±0.8* |
Result of the test shows that the papilla diameter of present embodiment compositions group rat obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05).
Embodiment 5
Prescription: Rhizoma Cyperi 1339g, Semen Sinapis Albae 1339g, Herba Erodii 670g, Scorpio 804g, Rhizoma Curculiginis 1339g, Fructus Ligustri Lucidi 2009g (being equivalent to 10: 10: 5: 6: 10: 15).
Method for making: with embodiment 1.
Usage: every day 3 times, each 2
Pharmacological testing: with reference to Test Example 1 method, present embodiment compositions dosage is 3.6g crude drug/kg, and result of the test sees the following form:
Table 7 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Implement 5 | 3.6 | 1.45±0.23* | 54.2±19.0* | 2.5±1.0* |
Result of the test shows that the papilla diameter of present embodiment compositions group rat obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05).
Embodiment 6
Prescription: Rhizoma Cyperi 781g, Semen Sinapis Albae 313g, Herba Erodii 2344g, Scorpio 469g, Rhizoma Curculiginis 313g, Fructus Ligustri Lucidi 781g (being equivalent to 5: 2: 15: 3: 2: 5).
Method for making: with embodiment 1.
Usage: every day 3 times, each 2.
Pharmacological testing: with reference to Test Example 1 method, present embodiment compositions dosage is 2.4g crude drug/kg, and result of the test sees the following form:
Table 8 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Implement 6 | 2.4 | 1.44±0.27* | 52.0±17.7* | 2.5±1.1* |
Result of the test shows that the papilla diameter of present embodiment compositions group rat obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05).
Embodiment 7
Prescription: Rhizoma Cyperi 1190g, Semen Sinapis Albae 1190g, Herba Erodii 1786g, Scorpio 357g, Rhizoma Curculiginis 1190g, Fructus Ligustri Lucidi 1786g (being equivalent to 10: 10: 15: 3: 10: 15).
Method for making: with embodiment 1.
Usage: every day 3 times, each 2
Pharmacological testing: with reference to Test Example 1 method, present embodiment compositions dosage is 3.6g crude drug/kg, and result of the test sees the following form:
Table 9 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Implement 7 | 3.6 | 1.49±0.16* | 56.1±18.4* | 2.6±1.0* |
Result of the test shows that the papilla diameter of present embodiment compositions group rat obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05).
Embodiment 8
Prescription: Rhizoma Cyperi 833g, Semen Sinapis Albae 333g, Herba Erodii 833g, Scorpio 1000g, Rhizoma Curculiginis 333g, Fructus Ligustri Lucidi 833g (being equivalent to 5: 2: 5: 6: 2: 5).
Method for making: with embodiment 1.
Usage: every day 3 times, each 2
Pharmacological testing: with reference to Test Example 1 method, present embodiment compositions dosage is 2.0g crude drug/kg, and result of the test sees the following form:
Table 10 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Implement 8 | 2.0 | 1.46±0.25* | 55.5±18.9* | 2.5±1.1* |
Result of the test shows that the papilla diameter of present embodiment compositions group rat obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05).
Embodiment 9
Prescription: Rhizoma Cyperi 1293g, Semen Sinapis Albae 1293g, Herba Erodii 1940g, Scorpio 776g, Rhizoma Curculiginis 259g, Fructus Ligustri Lucidi 1940g (being equivalent to 10: 10: 15: 6: 2: 15).
Method for making: with embodiment 1.
Usage: every day 3 times, each 2
Pharmacological testing: with reference to Test Example 1 method, present embodiment compositions dosage is 3.6g crude drug/kg, and result of the test sees the following form:
Table 11 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Implement 9 | 3.6 | 1.42±0.31* | 54.8±19.6* | 2.6±0.8* |
Result of the test shows that the papilla diameter of present embodiment compositions group rat obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05).
Embodiment 10
Prescription: Rhizoma Cyperi 833g, Semen Sinapis Albae 333g, Herba Erodii 833g, Scorpio 500g, Rhizoma Curculiginis 1667g, Fructus Ligustri Lucidi 833g (being equivalent to 5: 2: 5: 3: 10: 5).
Method for making: with embodiment 1.
Usage: every day 3 times, each 2
Pharmacological testing: with reference to Test Example 1 method, present embodiment compositions dosage is 2.4g crude drug/kg, and result of the test sees the following form:
Table 12 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Implement 10 | 2.4 | 1.44±0.28* | 53.9±17.8* | 2.7±0.8* |
Result of the test shows that the papilla diameter of present embodiment compositions group rat obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05).
Embodiment 11
Prescription: Rhizoma Cyperi 1339g, Semen Sinapis Albae 1339g, Herba Erodii 2009g, Scorpio 804g, Rhizoma Curculiginis 1339g, Fructus Ligustri Lucidi 670g (being equivalent to 10: 10: 15: 6: 10: 5).
Method for making: with embodiment 1.
Usage: every day 3 times, each 2
Pharmacological testing: with reference to Test Example 1 method, present embodiment compositions dosage is 3.6g crude drug/kg, and result of the test sees the following form:
Table 13 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Implement 11 | 3.6 | 1.46±0.26* | 53.7±19.0* | 2.6±1.1* |
Result of the test shows that the papilla diameter of present embodiment compositions group rat obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05).
Embodiment 12
Prescription: Rhizoma Cyperi 1042g, Semen Sinapis Albae 417g, Herba Erodii 1042g, Scorpio 625g, Rhizoma Curculiginis 417g, Fructus Ligustri Lucidi 3125g (being equivalent to 5: 2: 5: 3: 2: 15).
Method for making: with embodiment 1.
Usage: every day 3 times, each 2
Pharmacological testing: with reference to Test Example 1 method, present embodiment compositions dosage is 3.2g crude drug/kg, and result of the test sees the following form:
Table 14 couple E
2Induce rat mammary gland model of hyperplasia papilla diameter, serum E
2, mammoplasia influence (n=10,
X ± SD)
| Group | Dosage (g/Kg) | Papilla diameter (mm) | Estradiol (pg/ml) | Mammoplasia's scoring |
| The blank group | - | 0.89±0.19** | 34.8±12.6** | 1.0±0.0** |
| Model group | - | 1.69±0.21 | 76.3±21.5 | 3.5±0.7 |
| Positive controls | 4.0×10 -3 | 1.23±0.32** | 43.8±16.3** | 1.7±0.8** |
| Implement 12 | 3.2 | 1.45±0.20* | 54.1±20.5* | 2.5±1.0* |
Result of the test shows that the papilla diameter of present embodiment compositions group rat obviously diminishes, and serum estradiol content obviously reduces, mammoplasia's situation be clearly better (p＜0.05).
Embodiment 13
Prescription: Rhizoma Cyperi 1500g, Semen Sinapis Albae 1667g, Herba Erodii 2000g, Scorpio 833g, Rhizoma Curculiginis 1500g, Fructus Ligustri Lucidi 1667g (being equivalent to 9: 10: 12: 5: 9: 10).
Method for making: with embodiment 1.
Usage: every day 3 times, each 2.
Embodiment 14
Prescription: Rhizoma Cyperi 1500g, Semen Sinapis Albae 1667g, Herba Erodii 2000g, Scorpio 833g, Rhizoma Curculiginis 1500g, Fructus Ligustri Lucidi 1667g (being equivalent to 9: 10: 12: 5: 9: 10).
Method for making: get Rhizoma Cyperi, Semen Sinapis Albae 2 flavor medical materials, mixing, vapor distillation extract volatile oil to most, and volatile oil is subsequent use, divides dried up liquid, and is subsequent use; Get Herba Erodii, Scorpio, Rhizoma Curculiginis, Fructus Ligustri Lucidi 4 flavor medical materials, mixing, the decocting that adds 10 times of amounts of its gross weight volume boils each 2 hours 2 times; Merge decoction liquor, filter, add the above-mentioned water liquid behind the volatile oil of carrying; Be concentrated into the thick paste shape, add volatile oil, add starch, sodium carboxymethyl cellulose is an amount of; The system granule, tabletting is processed 1000.
Usage: every day 3 times, each 2.
Embodiment 15
Prescription: Rhizoma Cyperi 1500g, Semen Sinapis Albae 1667g, Herba Erodii 2000g, Scorpio 833g, Rhizoma Curculiginis 1500g, Fructus Ligustri Lucidi 1667g (being equivalent to 9: 10: 12: 5: 9: 10).
Method for making: get Rhizoma Cyperi, Semen Sinapis Albae 2 flavor medical materials, mixing, vapor distillation extract volatile oil to most, and volatile oil is subsequent use, divides dried up liquid, and is subsequent use; Get Herba Erodii, Scorpio, Rhizoma Curculiginis, Fructus Ligustri Lucidi 4 flavor medical materials, mixing, the decocting that adds 10 times of amounts of its gross weight volume boils each 2 hours 2 times; Merge decoction liquor, filter, add the above-mentioned water liquid behind the volatile oil of carrying, be concentrated into the thick paste shape; Add volatile oil, add starch, the system granule is processed 1000g.
Usage: every day 3 times, each 2g.
Embodiment 16
Prescription: Rhizoma Cyperi 1500g, Semen Sinapis Albae 1667g, Herba Erodii 2000g, Scorpio 833g, Rhizoma Curculiginis 1500g, Fructus Ligustri Lucidi 1667g (being equivalent to 9: 10: 12: 5: 9: 10).
Method for making: get Rhizoma Cyperi, Semen Sinapis Albae 2 flavor medical materials, mixing, vapor distillation extract volatile oil to most, and volatile oil is subsequent use, divides dried up liquid, and is subsequent use; Get Herba Erodii, Scorpio, Rhizoma Curculiginis, Fructus Ligustri Lucidi 4 flavor medical materials, mixing, the decocting that adds 10 times of amounts of its gross weight volume boils 2 times; Each 2 hours, merge decoction liquor, filter; Add the above-mentioned water liquid behind the volatile oil of carrying, be concentrated into the thick paste shape, add volatile oil; It is an amount of to add Polyethylene Glycol, and mixing drips the system drop pill and becomes 3000.
Usage: every day 3 times, each 6.
Embodiment 17
Prescription: Rhizoma Cyperi 1500g, Semen Sinapis Albae 1667g, Herba Erodii 2000g, Scorpio 833g, Rhizoma Curculiginis 1500g, Fructus Ligustri Lucidi 1667g (being equivalent to 9: 10: 12: 5: 9: 10).
Method for making: get Rhizoma Cyperi, Semen Sinapis Albae 2 flavor medical materials, mixing, vapor distillation extract volatile oil to most, and volatile oil is subsequent use, divides dried up liquid, and is subsequent use; Get Herba Erodii, Scorpio, Rhizoma Curculiginis, Fructus Ligustri Lucidi 4 flavor medical materials, mixing, the decocting that adds 10 times of amounts of its gross weight volume boils 2 times; Each 2 hours, merge decoction liquor, filter; Add the above-mentioned water liquid behind the volatile oil of carrying, be concentrated into the thick paste shape, add volatile oil; Add soybean oil, paraffin is an amount of, mixing, the compacting soft capsule becomes 1000.
Usage: every day 3 times, each 2.
Claims (4)
1. compositions of treating cyclomastopathy is characterized in that described compositions processed by the crude drug of following parts by weight: Rhizoma Cyperi 5-10 part, Semen Sinapis Albae 2-10 part, Herba Erodii 5-15 part, Scorpio 3-6 part, Rhizoma Curculiginis 2-10 part, Fructus Ligustri Lucidi 5-15 part; Method for preparing comprises the following steps: to get Rhizoma Cyperi, Semen Sinapis Albae 2 flavor medical materials, and mixing, vapor distillation extract volatile oil to most, and volatile oil is subsequent use, divides dried up liquid, and is subsequent use; Get Herba Erodii, Scorpio, Rhizoma Curculiginis, Fructus Ligustri Lucidi 4 flavor medical materials, mixing, the decocting that adds 10 times of amounts of its gross weight volume boils each 2 hours 2 times; Merge decoction liquor, filter, add the above-mentioned water liquid behind the volatile oil of carrying, be concentrated into the thick paste shape; Add volatile oil, add adjuvant, process the acceptable preparation of pharmacy.
2. according to the compositions of the said treatment cyclomastopathy of claim 1, it is characterized in that said composition processed by the crude drug of following parts by weight: 9 parts of Rhizoma Cyperis, 10 parts of Semen Sinapis Albaes, 12 parts of Herba Erodiis, 5 parts of Scorpios, 9 parts of Rhizoma Curculiginises, 10 parts of Fructus Ligustri Lucidi.
3. according to the compositions of the said treatment cyclomastopathy of claim 1, it is characterized in that the dosage form of described preparation adopts peroral dosage form.
4. according to the compositions of the said treatment cyclomastopathy of claim 3, it is characterized in that described peroral dosage form is selected from a kind of in granule, tablet, capsule, the drop pill.
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| CN101152360A (en) * | 2007-09-15 | 2008-04-02 | 尹克华 | Traditional Chinese medicine for treating adverse effect of mammary cancer endocrine |
| CN101244177A (en) * | 2008-03-21 | 2008-08-20 | 朱霞 | Rupisan and preparation thereof |
| CN101455809A (en) * | 2008-11-25 | 2009-06-17 | 王峰 | Traditional Chinese medicine composition for treating hyperplasia of mammary glands and preparation method thereof |
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2009
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1626219A (en) * | 2004-08-12 | 2005-06-15 | 汪金江 | 'Rukang' sticking piece prepared from cactus |
| CN101152360A (en) * | 2007-09-15 | 2008-04-02 | 尹克华 | Traditional Chinese medicine for treating adverse effect of mammary cancer endocrine |
| CN101244177A (en) * | 2008-03-21 | 2008-08-20 | 朱霞 | Rupisan and preparation thereof |
| CN101455809A (en) * | 2008-11-25 | 2009-06-17 | 王峰 | Traditional Chinese medicine composition for treating hyperplasia of mammary glands and preparation method thereof |
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| Title |
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| 孙继红.中药内服外敷治疗乳腺增生40例.《陕西中医》.2001,第22卷(第3期),第146页. * |
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