CN103356967A - Chinese herbal compound extract with effect of resisting proliferation of mammary gland, and preparation method thereof - Google Patents
Chinese herbal compound extract with effect of resisting proliferation of mammary gland, and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese herbal compound extract with an effect of resisting proliferation of mammary gland, and a preparation method thereof. The Chinese herbal compound extract is prepared by the following raw materials by weight: 10-20 parts of radix bupleuri, 10-20 parts of rhizoma cyperi, 5-15 parts of rheum officinale, 5-15 parts of pericarpium citri reticulatae viride, 5-15 parts of rhizoma chuanxiong, 5-15 parts of rhizoma curcumae, 5-15 parts of fritillary bulb, 10-20 parts of angelica sinensis, 10-20 parts of white peony root, 5-15 parts of ground beetle and 5-15 parts of cowherb seed. The Chinese herbal compound extract is prepared by a scientific formula, treats based on syndrome differentiation according to the theory of traditional Chinese medicine. Active components and an optimum preparation process are screened out by adopting a modern chemical component extraction separation and a pharmacological experiment tracking method. Pharmacological experiments show that the Chinese herbal compound extract provided by the invention has very good effect for treating the proliferation of the mammary gland, and has no toxic and side effect. The preparation method provided by the invention is stable in process and good in repeatability. The prepared extract is stable in quality. A plurality of oral drug preparations can be prepared and the oral drug preparations are convenient for clinic use.
Description
Technical field
The present invention relates to a kind of Chinese medicine compound, specifically relate to a kind of Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect and preparation method thereof.
Background technology
Cyclomastopathy is common women's surgical diseases, its sickness rate accounts for 75% of whole cystic hyperplasia of breast, accounts for the women of child-bearing age's 40%, has a strong impact on numerous women's physical and mental health, be that more this disease has the danger of the breast carcinoma of developing into, cause that the probability of canceration accounts for 2～4%.Thereby the active treatment cyclomastopathy, improve the WomanHealth level, reduce canceration rate and have very great significance.
Modern medicine thinks, cyclomastopathy be because of endocrine dysfunction, ovarian dysfunction, cause body inner estrogen level to increase or increased activity, due to progesterone level descends.Obvious for the heavier or local tuberosity of cyclomastopathy pain, the obvious patient of tenderness, clinical versatility hormonotherapy and incretotherapy.Such as Progesterone, danazol, tamoxifen, bromocriptine etc.With the said method treatment, though curative effect is good, side effect is larger, and drug price is expensive, can not adhere to for a long time treatment, and recurrent pain after the drug withdrawal, lump increases, and finally still needs continual cure-excision.Especially may further disturb the balance between the human hormone after gonadal hormone is used, increase the probability of canceration.In sum, modern medicine is treated this disease at present take operation as main, and medicine is auxiliary.No matter be excision, Drug therapy, have all that expense is high, side effect is obvious, wound face is large, a shortcoming such as easy recurrence after operation or the drug withdrawal.Therefore doctor trained in Western medicine there is no desirable solution route and Therapeutic Method to this disease.
Motherland's medicine just has a deep understanding since ancient times to cyclomastopathy, belongs to the category of " nodules of the breast ", " newborn painful abdominal mass ", " nodule in the breast ", and the syndrome of relevant " nodules of the breast " is discussed from " Huatuo's Zhongzang classic " of Han dynasty and all is documented to the Qing Dynasty " surgeon is complete works of ".Think that this is sick relevant with Nervous and Mental Factors, mainly and the internal organs such as liver,kidney,spleen dirty in close relations.The cause of disease, pathogenesis are due to feelings will internal injury, qi depression to blood stasis, Chong and Ren channel disorder, the expectorant stasis of blood are condensed, newborn network is obstructed.Liver controlling conveyance and dispersion should be transferred to reach, the Liver Channel stagnation of QI, QI and blood week loss degree, coagulation of QI-blood; Worry impairing spleen, spleen fortune mistake department, the turbid interior life of expectorant; Turbid and the blood stasis of expectorant is tied mutually to hinder in newborn network and is formed nodules of the breast.Adopt Chinese medicine that cyclomastopathy is treated, have the advantages such as curative effect is reliable, side effect is little.
Summary of the invention
Goal of the invention: the objective of the invention is to solve the deficiencies in the prior art, provide a kind of curative effect reliable, security performance is high, and untoward reaction is low, and price is easy to Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect of vast sufferer acceptance and preparation method thereof.
Technical scheme: in order to realize above purpose, the technical scheme that the present invention takes is:
A kind of Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect, it is made by the raw material of following parts by weight:
10～20 parts of Radix Bupleuri, 10～20 parts of Rhizoma Cyperis, 5～15 parts of Radix Et Rhizoma Rhei, 5～15 parts on Pericarpium Citri Reticulatae Viride, 5～15 parts of Rhizoma Chuanxiongs, 5～15 parts of Rhizoma Curcumae, 5～15 parts of Bulbus Fritillariae Thunbergiis, 10～20 parts of Radix Angelicae Sinensis, 10～20 parts of the Radix Paeoniae Albas, 5～15 parts of Eupolyphaga Seu Steleophagas, Semen Vaccariae 5-15 part.
As preferred version, the Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect of the present invention, it is prepared by following method:
A, get 10～20 parts of Radix Bupleuri, 5～15 parts of Radix et Rhizoma Rhei (processed with wine), 5～15 parts of Bulbus Fritillariae Thunbergiis, 10～20 parts of the Radix Paeoniae Albas, Semen Vaccariae (parched) and add water or C
1～3Alcohol extraction, extracting liquid filtering, filtrate is concentrated into 0.25g to 4g crude drug/mL medicinal liquid;
B, get 5～15 parts of 5～15 parts of Rhizoma Chuanxiongs, 5～15 parts of Rhizoma Curcumae, 10～20 parts of Radix Angelicae Sinensis, parch skin and adopt extraction by steam distillation, the volatile oil of acquisition adopts cyclodextrin inclusion compound; Extracting liquid filtering, it is 60%～80% alcohol that adding ethanol makes the concentration of ethanol, places precipitation, filters, and filtrate is concentrated into without the ethanol flavor, and thin up is to 0.25g to 4g crude drug/mL medicinal liquid again;
C, get the medicinal liquid that medicinal liquid that step a prepares and step b prepare, upper macroporous adsorbent resin after mixing, after the standing adsorption, being eluted to the stream eluent with deionized water is light color, discards eluent, then is 5%～20% C with concentration
1～3It is light color that alcohol is eluted to eluent as eluant, discards eluent, is 40%～90% C again with concentration
1～3The alcohol eluting is collected eluent, and the eluent reclaim under reduced pressure is removed C
1～3Alcohol is concentrated into 0.5g～2g crude drug/1ml medicinal liquid;
D, get 5～15 parts of Eupolyphaga Seu Steleophagas, add water or C
1～3Alcohol extraction, extracting liquid filtering, filtrate is concentrated into 0.5g～2g crude drug/1ml;
E, get the Eupolyphaga Seu Steleophaga that medicinal liquid that step c prepares and steps d prepare and extract the medicinal liquid mix homogeneously, concentrate drying is pulverized, the cyclodextrin of volatile oil clathrate mix homogeneously that gained extract powder and step b prepare, and get final product.The present invention screens by experiment and shows, the volatile oil component of Rhizoma Chuanxiong, Rhizoma Curcumae, Radix Angelicae Sinensis and Pericarpium Citri Reticulatae Viride has the effect of good resisting hyperplasia of mammary glands in the Chinese herbal compounds, and prior art is when preparing, do not keep the volatility active component, so the extract that the present invention prepares has the effect of better resisting hyperplasia of mammary glands.
As preferred version, above-described Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect, step a, c, the described C of d
1～3Alcohol is methanol, ethanol or propanol.
As preferred version, above-described Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect, the described cyclodextrin inclusion method of step b is: every milliliter of volatile oil is dissolved in 80 to the 100ml water with 8g to 10g beta-schardinger dextrin-, under 60 ℃ to 80 ℃ condition, stir 1 to 3 hour enclose.As preferred method, the described cyclodextrin inclusion method of step b is: every milliliter of volatile oil 8g beta-schardinger dextrin-, be dissolved in the 80ml water, and under 60 ℃ condition, stir 1 hour enclose.
As preferred version, above-described Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect, described macroporous adsorbent resin are D101(Cangzhou precious grace chemical industry company limited), HPD100(Cangzhou precious grace chemical industry company limited), X-5(Cangzhou precious grace chemical industry company limited) or AB-8(Cangzhou precious grace chemical industry company limited) macroporous adsorbent resin.
As preferred version, above-described Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect is got 5～15 parts of Eupolyphaga Seu Steleophagas, water or the C of 10 to 12 times of amounts
1～3Alcohol extraction 1 to 3 time, each 1 to 3 hour, extracting liquid filtering, filtrate is concentrated into 0.5g～2g crude drug/1ml.
Preparation method with Chinese medicinal compound extract of resisting hyperplasia of mammary glands effect provided by the invention, it may further comprise the steps:
A, get 5～15 parts of 10～20 parts of Radix Bupleuri, 5～15 parts of Radix et Rhizoma Rhei (processed with wine), 5～15 parts of Bulbus Fritillariae Thunbergiis, 10～20 parts of the Radix Paeoniae Albas, Semen Vaccariae (parched) and add water or C
1～3Alcohol extraction, extracting liquid filtering, filtrate is concentrated into 0.25g to 4g crude drug/mL medicinal liquid;
B, get 5～15 parts of 5～15 parts of Rhizoma Chuanxiongs, 5～15 parts of Rhizoma Curcumae, 10～20 parts of Radix Angelicae Sinensis, parch skin and adopt extraction by steam distillation, the volatile oil of acquisition adopts cyclodextrin inclusion compound; Extracting liquid filtering, it is 60%～80% alcohol that adding ethanol makes the concentration of ethanol, places precipitation, filters, and filtrate is concentrated into without the ethanol flavor, and thin up is to 0.25g to 4g crude drug/mL medicinal liquid again;
C, get the medicinal liquid that medicinal liquid that step a prepares and step b prepare, upper macroporous adsorbent resin after mixing, after the standing adsorption, being eluted to the stream eluent with deionized water is light color, discards eluent, then is 5%～20% C with concentration
1～3It is light color that alcohol is eluted to eluent as eluant, discards eluent, is 40%～90% C again with concentration
1～3The alcohol eluting is collected eluent, and the eluent reclaim under reduced pressure is removed C
1～3Alcohol is concentrated into 0.5g～2g crude drug/1ml medicinal liquid;
D, get 5～15 parts of Eupolyphaga Seu Steleophagas, add water or C
1～3Alcohol extraction, extracting liquid filtering, filtrate is concentrated into 0.5g～2g crude drug/1ml;
E, get the Eupolyphaga Seu Steleophaga that medicinal liquid that step c prepares and steps d prepare and extract the medicinal liquid mix homogeneously, concentrate drying is pulverized, the cyclodextrin of volatile oil clathrate mix homogeneously that gained extract powder and step b prepare, and get final product.The present invention screens by experiment and shows, the volatile oil component of Rhizoma Chuanxiong, Rhizoma Curcumae, Radix Angelicae Sinensis and parch skin has the effect of good resisting hyperplasia of mammary glands in the Chinese herbal compounds, and prior art is when preparing, do not keep the volatility active component, so the extract that the present invention prepares has the effect of better resisting hyperplasia of mammary glands.
As preferred version, above-described preparation method with Chinese medicinal compound extract of resisting hyperplasia of mammary glands effect, wherein step a, c, the described C of d
1～3Alcohol is methanol, ethanol or propanol.
As preferred version, above-described preparation method with Chinese medicinal compound extract of resisting hyperplasia of mammary glands effect, the described cyclodextrin inclusion method of step b is: every milliliter of volatile oil is with 8g to 10g beta-schardinger dextrin-, be dissolved in 80 to the 100ml water, under 60 ℃ to 80 ℃ condition, stir 1 to 3 hour enclose.As preferred method, the described cyclodextrin inclusion method of step b is: every milliliter of volatile oil 8g beta-schardinger dextrin-, be dissolved in the 80ml water, and under 60 ℃ condition, stir 1 hour enclose.
The application of Chinese medicinal compound extract in preparation resisting hyperplasia of mammary glands medicine with resisting hyperplasia of mammary glands effect provided by the invention.
The above-described application of Chinese medicinal compound extract in preparation resisting hyperplasia of mammary glands medicine with resisting hyperplasia of mammary glands effect, Chinese medicinal compound extract and pharmaceutically acceptable carrier are prepared into oral liquid, granule, capsule, tablet, drop pill, the soft capsule medicine.
When the Chinese medicinal compound extract of resisting hyperplasia of mammary glands effect provided by the invention is made tablet, the extract of each raw material and lactose or corn starch, add magnesium stearate lubricant when needing, mix homogeneously, granulate, then tabletting is made tablet.
When the Chinese medicinal compound extract of resisting hyperplasia of mammary glands effect provided by the invention is made capsule the extract of each raw material and carrier lactose or corn starch mix homogeneously, granulate, the then encapsulated capsule of making.
During the Chinese medicinal compound extract granulation agent of resisting hyperplasia of mammary glands effect provided by the invention, the extract of each raw material and diluent lactose or corn starch mix homogeneously, granulate, drying, granulation agent.
When the Chinese medicinal compound extract of resisting hyperplasia of mammary glands effect provided by the invention is made oral liquid, the extract of each raw material is added the purified water dissolving, add syrup, regulate pH, make oral liquid.
Beneficial effect: the Chinese medicinal compound extract of resisting hyperplasia of mammary glands effect provided by the invention has the following advantages:
The present invention is according to Chinese medical theory, and determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs is formulated the present invention through scientific composition, and adopts modern chemistry component extraction separation and pharmacological evaluation tracking, filters out active component and best preparation technology thereof.
And preparation method provided by the invention, process stabilizing, favorable reproducibility, the extract for preparing, steady quality, easy to use, can prepare multiple oral drug preparation, convenient clinical taking.And pharmacological evaluation shows that Chinese medicinal compound extract provided by the invention has the effect of good treatment cyclomastopathy, has no side effect.
The specific embodiment
Further illustrate the present invention below in conjunction with specific embodiment, should understand these embodiment only is used for explanation the present invention and is not used in and limits the scope of the invention, after having read the present invention, those skilled in the art all fall within the application's claims limited range to the modification of the various equivalent form of values of the present invention.
Embodiment 1
A kind of preparation method with Chinese medicinal compound extract of resisting hyperplasia of mammary glands effect, it may further comprise the steps:
A, the powder mixing of getting 12.5 parts of Radix Bupleuri, 8.34 parts of Radix et Rhizoma Rhei (processed with wine), 8.34 parts of Bulbus Fritillariae Thunbergiis, 12.5 parts of the Radix Paeoniae Albas, 8.34 parts of mistake 60 mesh sieves of Semen Vaccariae (parched), add 70% alcohol reflux 3 times, each 3h filters, filtrate is concentrated into without the alcohol flavor, and thin up is to 0.25g to 4g crude drug/mL medicinal liquid again;
B, get 8.34 parts of 12.5 parts of Rhizoma Cyperis, 8.34 parts of Rhizoma Chuanxiongs, 8.34 parts of Rhizoma Curcumae, 12.5 parts of Radix Angelicae Sinensis, Pericarpium Citri Reticulatae Viride and be mixed in proportion, add the water of 12 times of medical material gross weights, adopt extraction by steam distillation, get volatile oil component; It is 0.75g/ml that extracting liquid filtering, filtrate are concentrated into the crude drug amount, and then adding ethanol to determining alcohol is 70%, staticly settles 24h, filters, and filtrate decompression concentrates to get medicinal liquid;
Every milliliter of use of volatile oil part 8g beta-schardinger dextrin-is dissolved in the 80ml water, and inclusion, stirring are 1 hour under 60 ℃ condition, and volatile oil inclusion rate reaches 82.5%.；
C, Radix Bupleuri, Radix et Rhizoma Rhei (processed with wine), Bulbus Fritillariae Thunbergii, the Radix Paeoniae Alba, the extracting solution of Semen Vaccariae (parched)-1 and Rhizoma Cyperi, Rhizoma Chuanxiong, Rhizoma Curcumae, Radix Angelicae Sinensis, the refined liquid of Pericarpium Citri Reticulatae Viride-2 is mixed, thin up to crude drug amount is 0.5g/ml, upper AB-8 macroporous adsorbent resin, after the standing adsorption 12, being eluted to the stream eluent with deionized water is light color, discard eluent, then being eluted to eluent with 20% ethanol as eluant is light color, discard eluent, use 80% ethanol elution of 12 times of loading volumes again, collect eluent, the eluent reclaim under reduced pressure is removed ethanol, be concentrated into the 1ml concentrated solution and be equivalent to the 1.5g crude drug, cooling;
D, get 8.34 parts of Eupolyphaga Seu Steleophagas, add 12 times of medical material weight water extraction 2 times, each 2h filters, merging filtrate is concentrated into the 1ml concentrated solution and is equivalent to the 1.5g crude drug, cooling;
E, get the Eupolyphaga Seu Steleophaga that medicinal liquid that step c prepares and steps d prepare and extract the medicinal liquid mix homogeneously, concentrate drying is pulverized, the cyclodextrin of volatile oil clathrate mix homogeneously that gained extract powder and step b prepare, and get final product.
F, get step e extract and add lactose, add magnesium stearate lubricant, mix homogeneously, granulate, then tabletting is made tablet.
Embodiment 2
Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect of the present invention, it is prepared by following method:
A, get 20 parts of Radix Bupleuri, 15 parts of Radix et Rhizoma Rhei (processed with wine), 15 parts of Bulbus Fritillariae Thunbergiis, 20 parts of the Radix Paeoniae Albas, 15 parts of Semen Vaccariae (parched)s, add respectively the water extraction 3 times of 8,10 and 12 times of amounts, each 2 hours, extracting liquid filtering, filtrate is concentrated into 0.25g to 4g crude drug/mL medicinal liquid;
B, get 15 parts of 15 parts of Rhizoma Chuanxiongs, 15 parts of Rhizoma Curcumae, 20 parts of Radix Angelicae Sinensis, parch skin and adopt extraction by steam distillation, the volatile oil of acquisition, every milliliter of volatile oil 8g beta-schardinger dextrin-is dissolved in the 80ml water, under 60 ℃ condition, stirs 1 hour enclose; Extracting liquid filtering, it is 80% alcohol that adding ethanol makes the concentration of ethanol, places precipitation, filters, and filtrate is concentrated into without the ethanol flavor, and thin up is to 0.25g to 4g crude drug/mL medicinal liquid again;
C, get the medicinal liquid that medicinal liquid that step a prepares and step b prepare, upper D101 macroporous adsorbent resin after mixing, after the standing adsorption, being eluted to the stream eluent with deionized water is light color, discards eluent, then be that to be eluted to eluent as eluant be light color for 5%～20% ethanol with concentration, discarding eluent, is 40%～90% ethanol elution again with concentration, collects eluent, the eluent reclaim under reduced pressure is removed ethanol, is concentrated into 0.5g～2g crude drug/1ml medicinal liquid;
D, get 15 parts of Eupolyphaga Seu Steleophagas, add the water extraction 2 times of 12 times of amounts, each 2 hours, extracting liquid filtering, filtrate is concentrated into 0.5g～2g crude drug/1ml;
E, get the Eupolyphaga Seu Steleophaga that medicinal liquid that step c prepares and steps d prepare and extract the medicinal liquid mix homogeneously, 60 ℃ of drying under reduced pressure are pulverized, the cyclodextrin of volatile oil clathrate mix homogeneously that gained extract powder and step b prepare, and get final product.
F, get step e extract and add appropriate amount of starch or cyclodextrin, granulate the encapsulated capsule of making.
Embodiment 3
Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect of the present invention, it is prepared by following method:
A, get 10 parts of Radix Bupleuri, 5 parts of Radix et Rhizoma Rhei (processed with wine), 5 parts of Bulbus Fritillariae Thunbergiis, 10 parts of the Radix Paeoniae Albas, 5 parts of Semen Vaccariae (parched)s, add 10 times of amounts, concentration is 70% ethanol extraction 3 times, each 2 hours, and extracting liquid filtering, filtrate is concentrated into 0.25g to 4g crude drug/mL medicinal liquid;
B, get 5 parts of 5 parts of Rhizoma Chuanxiongs, 5 parts of Rhizoma Curcumae, 10 parts of Radix Angelicae Sinensis, parch skin and adopt extraction by steam distillation, the volatile oil of acquisition, every milliliter of volatile oil 8g beta-schardinger dextrin-is dissolved in the 80ml water, under 60 ℃ condition, stirs 1 hour enclose; Extracting liquid filtering, it is 60% alcohol that adding ethanol makes the concentration of ethanol, places precipitation, filters, and filtrate is concentrated into without the ethanol flavor, and thin up is to 0.25g to 4g crude drug/mL medicinal liquid again;
C, get the medicinal liquid that medicinal liquid that step a prepares and step b prepare, upper HPD100 macroporous adsorbent resin after mixing, after the standing adsorption, being eluted to the stream eluent with deionized water is light color, discards eluent, then be that to be eluted to eluent as eluant be light color for 5%～20% ethanol with concentration, discarding eluent, is 40%～90% ethanol elution again with concentration, collects eluent, the eluent reclaim under reduced pressure is removed ethanol, is concentrated into 0.5g～2g crude drug/1ml medicinal liquid;
D, get 5 parts of Eupolyphaga Seu Steleophagas, the concentration that adds 10 times of amounts is 75% ethanol extraction 2 times, each 3 hours, and extracting liquid filtering, filtrate is concentrated into 0.5g～2g crude drug/1ml;
E, get the Eupolyphaga Seu Steleophaga that medicinal liquid that step c prepares and steps d prepare and extract the medicinal liquid mix homogeneously, 60 ℃ of drying under reduced pressure are pulverized, the cyclodextrin of volatile oil clathrate mix homogeneously that gained extract powder and step b prepare, and get final product.
F, get step e extract and add the purified water dissolving, add syrup, regulate pH, make oral liquid.
Embodiment 4 Chinese medicinal compound extracts are on the impact research of rat mammary gland cyclomastopathy effect
1, laboratory animal modeling: getting body weight is 120 of the female not pregnant rats of 170～200g cleaning level SD, form hyperplasia of mammary gland model with estradiol and Progesterone combined induction, method is: except blank group intramuscular injection normal saline 0.25ml/kg, 1 times/day, injection 25 beyond the highest heavens continuously, all the other respectively organize equal intramuscular injection estradiol 0.5mg/kg, 1 times/day, continuous 20 days, then use intramuscular injection Progesterone 5mg/kg, 1 times/day, continuous 5 days instead.
2, experiment grouping: the modeling rat is pressed cyclomastopathy situation random packet and administration, the administration component is the newborn eliminating stagnation Capsules group (0.9g/kg) that disappears, the Chinese medicinal compound extract low dose group that the embodiment of the invention 1 prepares (2.7g crude drug amount/kg) and Chinese medicinal compound extract high dose group (8.1g/ crude drug amount kg), and the Chinese medicinal compound extract low dose group that the embodiment of the invention 2 prepares (2.7g crude drug amount/kg) and Chinese medicinal compound extract high dose group (8.1g crude drug amount/kg).Other establishes model group and blank group.Model group and blank group give corresponding normal saline, all the other each groups are by above-mentioned dosage gastric infusion, every day 1 time, continuous 20 days, and carry out following index determining: the breast height: after the experiment beginning, survey the 3rd pair of breast height of 1 rat with digital display calliper weekly.The mammary gland tissue pathology check: rat is got its mammary gland tissue after putting to death, be fixed in 10% formalin, and the routine paraffin wax embedding, slice thick 5 μ m, histopathologic examination is carried out in HE dyeing.
3, experimental result is as follows:
3.1 the impact on the rat breast height
After the beginning administration, survey weekly the breast height 1 time.The result shows: model group rat breast height and blank group relatively have notable difference (P ﹤ 0.05,0.01).Chinese medicinal compound extract high and low dose group and the model group that newborn eliminating stagnation Capsules group, the embodiment of the invention 1 and embodiment 2 prepare that disappear more all has the effect that reduces the breast height, with obvious (the P ﹤ 0.05 of model group comparing difference, 0.01), and prolong with administration time, effect is better, and concrete experimental result as shown in Table 1 and Table 2.
Each group of table 1 is on the impact of rats with left breast height
#P ﹤ 0.05, ##P ﹤ 0.01 compares with the blank group; * P ﹤ 0.05, and * * P ﹤ 0.01 compares with model group
Each group of table 2 is on the impact of rat right breast height
#P ﹤ 0.05, ##P ﹤ 0.01 compares with the blank group; * P ﹤ 0.05, and * * P ﹤ 0.01 compares with model group
3.2 the impact on the variation of rat mammary gland histopathology
Mammary gland is carried out semi-quantitative analysis, analyze content and comprise: the hyperplasia degree of the acinus par of each lobules of mammary gland, acinus secreting phenomenon, acinus and ductal epithelium.According to pathological changes by gently being designated as 0 minute (normal) to heavy degree, 1 minute (slightly), 2 minutes (moderate), 3 minutes (severe), 4 minutes (utmost point severe).
The result shows: blank group rat acinous cell is without hypertrophy, and conduit diameter is normal, sees a small amount of in the conduit or without secretions, epithelium is without hypertrophy.Model group rat mammary gland lobule acinus number increases, and the acinus volume increases, and with the blank group notable difference (P ﹤ 0.01) is arranged relatively.And the Chinese medicinal compound extract high and low dose group that disappear newborn eliminating stagnation group, the embodiment of the invention 1 and embodiment 2 prepare and model group are relatively, all can reduce the cyclomastopathy degree, with model group comparing difference obvious (P ﹤ 0.05,0.01), concrete experimental result sees Table 3.
Each group of table 3 is on the impact of rat mammary gland hyperplasia degree
| Group | Dosage (g/kg) | Number of animals (only) | Pathological score |
| Blank | - | 9 | 0.00±0.00 |
| Model | - | 10 | 1.00±0.76## |
| Newborn eliminating stagnation disappears | 0.9 | 9 | 0.57±0.98 |
| Embodiment 1 low dose group | 2.7 | 10 | 0.00±0.00** |
| Embodiment 1 high dose group | 8.1 | 9 | 0.11±0.33* |
| Embodiment 2 low dose group | 2.7 | 8 | 0.38±0.52 |
| Embodiment 2 high dose group | 8.1 | 9 | 0.00±0.00** |
##P ﹤ 0.01 compares * P ﹤ 0.05 with the blank group, and * * P ﹤ 0.01 compares with model group
Compare with the blank group, model group rat breast height increases, and lobules of mammary gland acinus number increases, and the acinus volume increases; The Chinese medicinal compound extract high and low dose group that the embodiment of the invention 1 and embodiment 2 prepare all can reduce the breast height, alleviates breast lesion; Demonstrated the effect of good resisting hyperplasia of mammary glands, and pathology detection to other internal organs without obvious damage, have safely and effectively and have a few, be expected to be developed to the medicine of new resisting hyperplasia of mammary glands.
The above only is preferred implementation of the present invention; should be pointed out that for those skilled in the art, under the prerequisite that does not break away from the principle of the invention; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.
Claims (9)
1. the Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect is characterized in that, it is made by the raw material of following parts by weight:
10 ~ 20 parts of Radix Bupleuri, 10 ~ 20 parts of Rhizoma Cyperis, 5 ~ 15 parts of Radix Et Rhizoma Rhei, 5 ~ 15 parts on Pericarpium Citri Reticulatae Viride, 5 ~ 15 parts of Rhizoma Chuanxiongs, 5 ~ 15 parts of Rhizoma Curcumae, 5 ~ 15 parts of Bulbus Fritillariae Thunbergiis, 10 ~ 20 parts of Radix Angelicae Sinensis, 10 ~ 20 parts of the Radix Paeoniae Albas, 5 ~ 15 parts of Eupolyphaga Seu Steleophagas, Semen Vaccariae 5-15 part.
2. the Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect according to claim 1 is characterized in that, it is prepared by following method:
A, get 10 ~ 20 parts of Radix Bupleuri, 5 ~ 15 parts of Radix Et Rhizoma Rhei, 5 ~ 15 parts of Bulbus Fritillariae Thunbergiis, 10 ~ 20 parts of the Radix Paeoniae Albas, Semen Vaccariae 5-15 part and add water or C
1 ~ 3Alcohol extraction, extracting liquid filtering, filtrate is concentrated into 0.25g to 4g crude drug/mL medicinal liquid;
B, get 5 ~ 15 parts of 5 ~ 15 parts of Rhizoma Chuanxiongs, 5 ~ 15 parts of Rhizoma Curcumae, 10 ~ 20 parts of Radix Angelicae Sinensis, Pericarpium Citri Reticulatae Viride and adopt extraction by steam distillation, the volatile oil of acquisition adopts cyclodextrin inclusion compound; Extracting liquid filtering, it is 60% ~ 80% alcohol that adding ethanol makes the concentration of ethanol, places precipitation, filters, and filtrate is concentrated into without the ethanol flavor, and thin up is to 0.25g to 4g crude drug/mL medicinal liquid again;
C, get the medicinal liquid that medicinal liquid that step a prepares and step b prepare, upper macroporous adsorbent resin after mixing, after the standing adsorption, being eluted to the stream eluent with deionized water is light color, discards eluent, then is 5% ~ 20% C with concentration
1 ~ 3It is light color that alcohol is eluted to eluent as eluant, discards eluent, is 40% ~ 90% C again with concentration
1 ~ 3The alcohol eluting is collected eluent, and the eluent reclaim under reduced pressure is removed C
1 ~ 3Alcohol is concentrated into 0.5g ~ 2g crude drug/1ml medicinal liquid;
D, get 5 ~ 15 parts of Eupolyphaga Seu Steleophagas, add water or C
1 ~ 3Alcohol extraction, extracting liquid filtering, filtrate is concentrated into 0.5g ~ 2g crude drug/1ml;
E, get the Eupolyphaga Seu Steleophaga that medicinal liquid that step c prepares and steps d prepare and extract the medicinal liquid mix homogeneously, concentrate drying is pulverized, and gets the cyclodextrin of volatile oil clathrate mix homogeneously that extract powder and step b prepare, and get final product.
3. the Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect according to claim 1 is characterized in that, step a, c, the described C of d
1 ~ 3Alcohol is methanol, ethanol or propanol.
4. the Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect according to claim 1, it is characterized in that, the described cyclodextrin inclusion method of step b is: every milliliter of volatile oil is with 8g to 10g beta-schardinger dextrin-, be dissolved in 80 to the 100ml water, under 60 ℃ to 80 ℃ condition, stir 1 to 3 hour enclose.
5. the Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect according to claim 1 is characterized in that, described macroporous adsorbent resin is D101, HPD100, X-5 or AB-8 macroporous adsorbent resin.
6. the Chinese medicinal compound extract with resisting hyperplasia of mammary glands effect according to claim 1 is characterized in that, gets 5 ~ 15 parts of Eupolyphaga Seu Steleophagas, the water of 10 to 12 times of amounts or C1 ~ 3 alcohol extractions 1 to 3 time, each 1 to 3 hour, extracting liquid filtering, filtrate is concentrated into 0.5g ~ 2g crude drug/1ml.
7. the preparation method with Chinese medicinal compound extract of resisting hyperplasia of mammary glands effect claimed in claim 2 is characterized in that may further comprise the steps:
A, get 10 ~ 20 parts of Radix Bupleuri, 5 ~ 15 parts of Radix Et Rhizoma Rhei, 5 ~ 15 parts of Bulbus Fritillariae Thunbergiis, 10 ~ 20 parts of the Radix Paeoniae Albas, Semen Vaccariae and add water or C
1 ~ 3Alcohol extraction, extracting liquid filtering, filtrate is concentrated into 0.25g to 4g crude drug/mL medicinal liquid;
B, get 5 ~ 15 parts of 5 ~ 15 parts of Rhizoma Chuanxiongs, 5 ~ 15 parts of Rhizoma Curcumae, 10 ~ 20 parts of Radix Angelicae Sinensis, Pericarpium Citri Reticulatae Viride and adopt extraction by steam distillation, the volatile oil of acquisition adopts cyclodextrin inclusion compound; Extracting liquid filtering, it is 60% ~ 80% alcohol that adding ethanol makes the concentration of ethanol, places precipitation, filters, and filtrate is concentrated into without the ethanol flavor, and thin up is to 0.25g to 4g crude drug/mL medicinal liquid again;
C, get the medicinal liquid that medicinal liquid that step a prepares and step b prepare, upper macroporous adsorbent resin after mixing, after the standing adsorption, being eluted to the stream eluent with deionized water is light color, discards eluent, then is 5% ~ 20% C with concentration
1 ~ 3It is light color that alcohol is eluted to eluent as eluant, discards eluent, is 40% ~ 90% C again with concentration
1 ~ 3The alcohol eluting is collected eluent, and the eluent reclaim under reduced pressure is removed C
1 ~ 3Alcohol is concentrated into 0.5g ~ 2g crude drug/1ml medicinal liquid;
D, get 5 ~ 15 parts of Eupolyphaga Seu Steleophagas, add water or C
1 ~ 3Alcohol extraction, extracting liquid filtering, filtrate is concentrated into 0.5g ~ 2g crude drug/1ml;
E, get the Eupolyphaga Seu Steleophaga that medicinal liquid that step c prepares and steps d prepare and extract the medicinal liquid mix homogeneously, concentrate drying is pulverized, the cyclodextrin of volatile oil clathrate mix homogeneously that gained extract powder and step b prepare, and get final product.
8. the described application of Chinese medicinal compound extract in preparation resisting hyperplasia of mammary glands medicine with resisting hyperplasia of mammary glands effect of claim 1 to 6.
9. the application of Chinese medicinal compound extract in preparation resisting hyperplasia of mammary glands medicine with resisting hyperplasia of mammary glands effect according to claim 7, it is characterized in that, Chinese medicinal compound extract and pharmaceutically acceptable carrier are prepared into oral liquid, granule, capsule, tablet, drop pill, the soft capsule medicine.
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| CN2013103261564A CN103356967A (en) | 2013-07-30 | 2013-07-30 | Chinese herbal compound extract with effect of resisting proliferation of mammary gland, and preparation method thereof |
| CN201410122333.1A CN103908631A (en) | 2013-07-30 | 2014-03-28 | Traditional Chinese medicinal compound extract with anti-breast hyperplasia effect and preparation method thereof |
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| CN105327069A (en) * | 2015-12-15 | 2016-02-17 | 无限极（中国）有限公司 | Formulation, preparation method and application of liver soothing traditional Chinese herbal medicine composition |
| CN110141634B (en) * | 2018-04-09 | 2021-10-26 | 达州市中西医结合医院 | Granule for regulating qi and eliminating stagnation and preparation method thereof |
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| CN102120020B (en) * | 2011-03-10 | 2012-04-18 | 雷允上药业有限公司 | Medicinal composition for treating hyperplastic diseases of breast and hysteromyoma and preparation method thereof |
| CN102120021B (en) * | 2011-03-11 | 2012-05-02 | 雷允上药业有限公司 | Detection method of concentrated pills for treating hyperplastic disease of breast |
| CN103356967A (en) * | 2013-07-30 | 2013-10-23 | 雷允上药业有限公司 | Chinese herbal compound extract with effect of resisting proliferation of mammary gland, and preparation method thereof |
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Application publication date: 20131023 |