CN104095944B - A kind of Chinese medicine composition for the treatment of cyclomastopathy and preparation method thereof - Google Patents
A kind of Chinese medicine composition for the treatment of cyclomastopathy and preparation method thereof Download PDFInfo
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- CN104095944B CN104095944B CN201410336188.7A CN201410336188A CN104095944B CN 104095944 B CN104095944 B CN 104095944B CN 201410336188 A CN201410336188 A CN 201410336188A CN 104095944 B CN104095944 B CN 104095944B
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Abstract
The invention provides a kind of Chinese medicine composition for the treatment of cyclomastopathy, it is made up of the crude drug of following weight portion: Radix Codonopsis 1 ~ 5 part, the Radix Astragali 3 ~ 8 parts, 1 ~ 5 part, Poria, the Radix Paeoniae Alba 1 ~ 5 part, Radix Platycodonis 1 ~ 5 part, 0.5 ~ 3 part, Radix Glycyrrhizae.Chinese medicine composition of the present invention obviously can reduce E2 and P level in rat model serum, E2/P ratio is raised, reduce rat model height of nipples, alleviate mammary gland tissue congestion and edema, reduce the acinus quantity of lobules of mammary gland, alleviate acinar epithelia hypertrophy, suppress acinus secreting phenomenon, improve Epithelial hyperplasia degree, there is the effect for the treatment of cyclomastopathy.The present invention also provides the method for the Chinese medicine composition described in preparation.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, be specifically related to a kind of Chinese medicine composition for the treatment of cyclomastopathy.
Background technology
Cyclomastopathy refers to breast epithelium and proliferation of fibrous tissue, mammary gland tissue conduit and newborn lobule degeneration structurally and the growth of Progressive symmetric erythrokeratodermia connective tissue, is the modal cystic hyperplasia of breast of women.The reason that cyclomastopathy occurs mainly estrogen definitely or relatively increases, and the bad Nervous and Mental Factors such as spiritual hypertonicity or emotion be too exciting.Cyclomastopathy is women of child-bearing age's commonly encountered diseases and frequently-occurring disease, accounts for breast disease 75%, wherein has the patient of 2%-5% that canceration occurs.Cyclomastopathy belongs to Chinese medicine " nodules of the breast " category, and think that Chong and Ren channel disorder is the basic reason that cyclomastopathy occurs, its pathogenesis mostly is caused by depression of liver-QI, stagnation of QI blood stasis, hyperactive liver-QI attacking the spleen, the dysfunction of the spleen, stagnation of Qi and phelgm etc.Clinically there are distending pain of the breast, pain, caking etc., except above-mentioned symptom, mainly in lobule and tip conduit performance epithelial hyperplasia and acinus expansion and hypertrophy.Its key is E2, P off-leveling in hypothalamic-pituitary-ovary gonad axis endocrine disturbance and body.Galactophore epithelial cell and interstitial cell hyperplasia after long term, PRL increases, and increases the storage of connective tissue water sodium and stays, cause edema between lobule.
Adopt operation or hormone and receptor blocking agent etc. to this disease more at present, though effective in cure, hormone metabolism often can be caused to be more afterwards tending towards disorderly.Some oral medicine then effect is obvious not, and treatment time is long, and onset is slow.Therefore, be necessary to provide a kind of Chinese medicine composition for the treatment of cyclomastopathy, can drug side effect be reduced while raising drug effect.
Summary of the invention
The object of the invention is to: a kind of Chinese medicine composition for the treatment of cyclomastopathy is provided, not only there is significant endocrine regulation effect, and toxic and side effects is not had to human body.
The technical scheme that the present invention realizes above-mentioned purpose is:
There is provided a kind of Chinese medicine composition for the treatment of cyclomastopathy, it is made up of the crude drug of following weight portion: Radix Codonopsis 1 ~ 5 part, the Radix Astragali 3 ~ 8 parts, 1 ~ 5 part, Poria, the Radix Paeoniae Alba 1 ~ 5 part, Radix Platycodonis 1 ~ 5 part, 0.5 ~ 3 part, Radix Glycyrrhizae.
In the preferred technical scheme of the present invention, described Chinese medicine composition is made up of the crude drug of following weight portion: Radix Codonopsis 2 ~ 4 parts, the Radix Astragali 4 ~ 6 parts, 1 ~ 3 part, Poria, the Radix Paeoniae Alba 1 ~ 3 part, Radix Platycodonis 1 ~ 3 part, 0.5 ~ 2 part, Radix Glycyrrhizae.
In the most preferred technical scheme of the present invention, described Chinese medicine composition is made up of the crude drug of following weight portion: Radix Codonopsis 3 parts, the Radix Astragali 5 parts, 2 parts, Poria, the Radix Paeoniae Alba 2 parts, Radix Platycodonis 2 parts, 1 part, Radix Glycyrrhizae.
The present invention also provides the method for the Chinese medicine composition of the treatment cyclomastopathy described in preparation, comprise the following steps: through decoction and alcohol sedimentation technique process after crude drug mixes according to described ratio, the filtrate obtained makes dry extract, and dry extract is broken to fine powder and namely obtains Chinese medicine composition of the present invention.
The method of the Chinese medicine composition of the treatment cyclomastopathy described in preparation of the present invention, preferably specifically comprises the following steps:
1) water extraction 2 times of 2 ~ 3 times of volumes is added after being mixed by the crude drug of described weight portion, each 0.5 ~ 2h, extracting solution merges, filter, and it is after 1.1 ~ 1.3 that filtrate is concentrated into relative density, add ethanol to make alcohol content reach 60 ~ 75% to precipitate, and hold over night;
2) step 1) ethanol that obtains reclaims ethanol after filtering, and be concentrated into thick paste, then vacuum drying becomes dry extract;
3) by step 2) dry extract that obtains is broken into fine powder, obtains Chinese medicine composition of the present invention.
In the preferred preparation method of the present invention, further the fine-powdered Chinese medicine composition obtained can also be conventionally prepared into capsule, tablet, powder, pill or granule.
The usage of Chinese medicine composition of the present invention and consumption: oral, be grown up and recommend a consumption 48g in.
In Chinese medicine composition of the present invention, [Radix Codonopsis] property is sweet, flat, return spleen, lung meridian, have spleen invigorating lung benefiting, nourishing blood to promote the production of body fluid function, interior-heat thirsty for deficiency of both the splenic and pulmonary QI, lack of appetite asthenia, cough dyspnea due to deficiency, insufficiency of vital energy and blood, shallow complexion, shortness of breath and palpitation, Tianjin wound is quenched one's thirst; [Radix Astragali] property is sweet, tepor, return lung, spleen channel, have tonifying Qi and lifting yang, strengthening superficial resistance to stop perspiration, inducing diuresis to remove edema, promote the production of body fluid nourish blood, the stagnant blood stasis dispelling of row, expelling pus and toxin by strengthening QI, expelling pus and promoting granulation function, anorexia and loose stool, sinking of QI of middle-JIAO, chronic diarrhea proctoptosis weak for the deficiency of vital energy, metrorrhagia of having blood in stool, exterior deficiency spontaneous perspiration, deficiency of vital energy edema, interior-heat is quenched one's thirst, blood deficiency and yellow complexion, hemiplegia, arthralgia pain are numb, carbuncle is difficultly burst, burst for a long time and do not hold back; [Poria] property is sweet, light, flat, and GUIXIN, lung, spleen, kidney channel have the function of promoting diuresis to eliminate damp pathogen, spleen invigorating, mind calming, have loose bowels for edema oliguria, phlegm retention vertigo and palpitation, insufficiency of the spleen lack of appetite, loose stool, irritability, palpitation with fear insomnia; [Radix Paeoniae Alba] property is bitter, acid, be slightly cold, and returns liver, spleen channel, has the function of nourishing blood for regulating menstruation, astringing YIN to stop sweating, easing the affected liver to relieve pain, suppressing liver-YANG, dizzy for blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat, hypochondriac pain, stomachache, limb pain twin, headache; [Radix Platycodonis] property is bitter, pungent, flat, returns lung meridian, has lung qi dispersing, sore-throat relieving, eliminates the phlegm, the function of evacuation of pus, for cough with copious phlegm, smooth, pharyngalgia hoarseness, lung abscess vomiting pus uncomfortable in chest; [Radix Glycyrrhizae] property is sweet, flat, GUIXIN, lung, spleen, stomach warp, there is the function of invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription, for weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, gastral cavity abdomen, the twin anxious pain of extremity, carbuncle sore tumefacting virus, cushion toxicity, strong.
In Chinese medicine composition of the present invention, Radix Codonopsis and the Radix Astragali play main effect as principal agent to adjustment endocrine regulation, hard masses softening and resolving, and Poria, the Radix Paeoniae Alba, Radix Platycodonis and Radix Glycyrrhizae play auxiliary regulating action as accessory drugs.Extract through preparation method of the present invention between the effective ingredient obtained can complement each other under specific ratio, synergism, make Chinese medicine composition of the present invention have effect of the disorder of significant endocrine regulation, hard masses softening and resolving, depressed liver-energy dispersing and QI regulating on the whole, cyclomastopathy tool is had significant therapeutic effect.
The usage of Chinese medicine composition of the present invention and consumption: oral, be grown up and recommend a consumption 48g in.
Chinese medicine composition of the present invention can with reference to the following zoopery for cyclomastopathy rat model for the therapeutic effect of cyclomastopathy:
1 material
1.1 medicines:
By reagent: three kinds of Chinese medicine compositions prepared by the embodiment of the present invention 1,2 and 3; Rat clinical equivalent dosage: be grown up a consumption per day 48g × 0.09g/kg=4.32g/kg.
Contrast medicine: tamoxifen (Yangzijiang Pharmaceutical Group Co., Ltd, lot number 13060701), drafts dosage 7.0mg/kg; BUPIXIAO PIAN (Shenyang Chinese Medicine Pharmaceutical Co., Ltd, lot number: 130102098): draft dosage 1.0g/kg.
1.2 animals: female unpregnancy Wistar rat 70,70-80 age in days, body weight 200 ± 20g, Lukang Medical Co., Ltd., Shandong provides, the quality certification number: SCXK (Shandong) 20130001, buys rear adaptability breeding observing one day.
1.3 environment and feedstuff: Shandong Province's Experimental Animal Center barrier environment Laboratory Animal Facility, credit number: SYXK (Shandong) 20090014.Full nutrition Mus feedstuff, Jinan Kang great feed corporation,Ltd provides, credit number: SCXK (Shandong) 20090014.
2. method and result
2.1 animal groupings: after rat adaptability raises one week, are divided into blank group, model group, tamoxifen group, RUPIXIAO matched group, experiment A group, experiment B group, experiment C group at random according to body weight equilibrium, amount to seven groups, often organize 10.
2.2 modelings: adopt exogenous estrogen long-time stimulus to set up cyclomastopathy pathology model, blank group intramuscular injection every day normal saline 0.2ml, all the other respectively organize equal intramuscular injection estradiol benzoate (0.5mg/kg), 1 times/day.Continuous 25 days, intramuscular injection Progesterone (4mg/kg) subsequently, continuous 5 days, caused hyperplasia of mammary gland model by one times/day.
2.3 administrations: after modeling success, blank group and model group gavage give normal saline 10ml/kg, and tamoxifen matched group, according to 7.0mg/kg, is mixed with respective concentration with 10ml/kg gastric infusion, RUPIXIAO matched group, according to 1.0g/kg, is mixed with 0.1g/ml with 10ml/kg gastric infusion; The Chinese medicine composition fine powder of embodiment 1,2 and 3 is mixed with 10ml/kg gastric infusion after 0.36g/ml by experimental group A, B, C group respectively, once a day, and continuous 30 days.
Before grouping modeling, after modeling, after administration, measure second pair of height of nipples; 1h after last administration, gets blood examination and looks into E2, P, PRL concentration, and clip second pair of teat tissue, fixes with 10% formaldehyde, do histopathologic examination, compare between organizing.
2.4 result
2.4.1 the Chinese medicine composition of embodiment 1,2,3 is on the impact of rat model serum estrogen levels
Gather each group of rat blood serum, measured by radioimmunoassay respectively organizes rat blood serum estrogen level, result is as shown in table 1, each experimental group medication all can E2 and P level in reduction serum in various degree, compare with model group, there is notable statistics difference, point out Chinese medicine composition of the present invention to have the effect regulating estrogen, progestogen out of proportion.
Rat blood serum E2, P, PRL level of respectively organizing table 1 compares (
n=10)
Note: compare " * " P<0.05 with model group; " * * " P<0.01.
2.4.2 the middle compositions of embodiment 1,2,3 is on the impact of rat model height of nipples
Before grouping modeling, three time points after modeling and after administration, measure each group of rat second pair of height of nipples, after the visible modeling of result, each group height of nipples more all has significant difference (P<0.01) with normal group, the feasibility that model is set up is described, successive administration is after 30 days, add up each group of rat second pair of height of nipples, visible each experimental group medication alleviates the red and swollen phenomenon of nipple in various degree, there is the pharmacodynamic action significantly reducing height of nipples, comparing with model group according to there being significant difference (P<0.01).
Table 2 Chinese medicine of the present invention on each group of rat second on the impact of height of nipples (
n=10, mm)
Note: compare " * " P<0.05 with model group; " * * " P<0.01.
2.4.3 the Chinese medicine composition of embodiment 1,2,3 is on the pathological impact of rat model teat tissue
Extract second pair of nipple, 10% formaldehyde is fixed, and carries out histopathologic examination, and all mammary gland tissues of visible Normal group are all in normal morphology.Lobules of mammary gland is dispersed in distribution, increase without acinus, the increase of glandular epithelium level, acinus expansion, the cyclomastopathy phenomenon such as secretion; Also the pathological change such as duct free epithelial proliferation, tissue degeneratiaon's necrosis, cell infiltration.The all mammary gland tissues of model group are all in severe cyclomastopathy.Acinus showed increased.Partial leaflet boundary is unclear, and acinus height is expanded, and secretes vigorous.Ductal epithelium is that moderate is to severe hypertrophy.But tissue is without the pathological change such as degeneration necrosis, cell infiltration.The all mammary gland tissues of each experimental group are the cyclomastopathy of light to moderate not grade.Obviously comparatively model combination matched group is light for overall lesion degree.Wherein light to moderately account for 8/10, moderate 2/10.Also the pathological change such as duct free epithelial proliferation, tissue degeneratiaon's necrosis, cell infiltration.Show: cyclomastopathy model is successfully established, each experimental group obviously can reduce acinus and be formed, and suppresses the expansion of acinar epithelia hypertrophy, acinus and secretes and big-and-middle Epithelial hyperplasia, prompting: Chinese medicine of the present invention has the effect delaying cyclomastopathy and formed.
Table 3 Chinese medicine of the present invention on the impact of the sick type classification of rat model (
n=10)
More than experiment adopts Chinese medicine composition of the present invention to act on hyperplasia of mammary gland model rat, result shows that Chinese medicine composition of the present invention can obviously reduce E2 and P level in serum, E2/P ratio is raised, reduce rat model height of nipples, alleviate mammary gland tissue congestion and edema, reduce the acinus quantity of lobules of mammary gland, alleviate acinar epithelia hypertrophy, suppress acinus secreting phenomenon, improve Epithelial hyperplasia degree, there is the effect for the treatment of cyclomastopathy.
In addition, Chinese medicine composition of the present invention proves safe without toxic side effect through animal model acute toxicity test and long term toxicity test.
Detailed description of the invention
Embodiment 1.
Treat a Chinese medicine granules for cyclomastopathy, it is prepared by the crude drug of following weight portion: Radix Codonopsis 3 parts, the Radix Astragali 5 parts, 2 parts, Poria, the Radix Paeoniae Alba 2 parts, Radix Platycodonis 2 parts, 1 part, Radix Glycyrrhizae.
Preparation method is as follows:
1) water extraction 2 times of 2 times of volumes is added after being mixed by the crude drug of described part by weight, first time 1.5h, second time 0.5h, extracting solution merges, filtration, it is after 1.1 ~ 1.3 that filtrate is concentrated into relative density, adds ethanol and makes alcohol content reach 65% to precipitate, and hold over night;
2) step 1) ethanol that obtains reclaims ethanol after filtering, and be concentrated into thick paste, then vacuum drying becomes dry extract;
3) by step 2) dry extract that obtains is broken into fine powder;
4) by step 3) fine powder that obtains adds appropriate Icing Sugar and dextrin, is conventionally prepared into granule.Embodiment 2.
Treat a medicine pill for cyclomastopathy, it is prepared by the crude drug of following weight portion: Radix Codonopsis 1 part, the Radix Astragali 8 parts, 1 part, Poria, the Radix Paeoniae Alba 5 parts, Radix Platycodonis 1 part, 3 parts, Radix Glycyrrhizae.
Preparation method is as follows:
1) water extraction 2 times of 3 times of volumes is added after being mixed by the crude drug of described part by weight, first time 2h, second time 1h, extracting solution merges, filtration, it is after 1.1 ~ 1.3 that filtrate is concentrated into relative density, adds ethanol and makes alcohol content reach 75% to precipitate, and hold over night;
2) step 1) ethanol that obtains reclaims ethanol after filtering, and be concentrated into thick paste, then vacuum drying becomes dry extract;
3) by step 2) dry extract that obtains is broken into fine powder;
4) by step 3) fine powder that obtains adds proper honey and conventionally makes honeyed pill.
Embodiment 3.
Treat a Chinese medicinal capsule for cyclomastopathy, it is prepared by the crude drug of following weight portion: Radix Codonopsis 5 parts, the Radix Astragali 3 parts, 5 parts, Poria, the Radix Paeoniae Alba 1 part, Radix Platycodonis 5 parts, 0.5 part, Radix Glycyrrhizae.
Preparation method is as follows:
1) water extraction 2 times of 2.5 times of volumes is added after being mixed by the crude drug of described part by weight, first time 1.5h, second time 0.5h, extracting solution merges, filtration, it is after 1.1 ~ 1.3 that filtrate is concentrated into relative density, adds ethanol and makes alcohol content reach 60% to precipitate, and hold over night;
2) step 1) ethanol that obtains reclaims ethanol after filtering, and be concentrated into thick paste, then vacuum drying becomes dry extract;
3) by step 2) dry extract that obtains is broken into fine powder;
4) by step 3) fine powder that obtains adds appropriate dextrin, and be distributed into capsule shells, conventionally make hard capsule.
Claims (5)
1. treat a Chinese medicine composition for cyclomastopathy, it is characterized in that, it is made up of the crude drug of following weight portion: Radix Codonopsis 1 ~ 5 part, the Radix Astragali 3 ~ 8 parts, 1 ~ 5 part, Poria, the Radix Paeoniae Alba 1 ~ 5 part, Radix Platycodonis 1 ~ 5 part, 0.5 ~ 3 part, Radix Glycyrrhizae;
Through decoction and alcohol sedimentation technique process after crude drug mixes according to described ratio, the filtrate obtained makes dry extract, and dry extract is broken to fine powder and namely obtains described Chinese medicine composition.
2. Chinese medicine composition according to claim 1, is characterized in that, it is made up of the crude drug of following weight portion: Radix Codonopsis 2 ~ 4 parts, the Radix Astragali 4 ~ 6 parts, 1 ~ 3 part, Poria, the Radix Paeoniae Alba 1 ~ 3 part, Radix Platycodonis 1 ~ 3 part, 0.5 ~ 2 part, Radix Glycyrrhizae.
3. Chinese medicine composition according to claim 1, is characterized in that, it is made up of the crude drug of following weight portion: Radix Codonopsis 3 parts, the Radix Astragali 5 parts, 2 parts, Poria, the Radix Paeoniae Alba 2 parts, Radix Platycodonis 2 parts, 1 part, Radix Glycyrrhizae.
4. the preparation method of Chinese medicine composition according to claim 1, is characterized in that, specifically comprises the following steps:
1) by weight, the water extraction 2 times of 2 ~ 3 times of volumes will be added after Radix Codonopsis 1 ~ 5 part, the Radix Astragali 3 ~ 8 parts, 1 ~ 5 part, Poria, the Radix Paeoniae Alba 1 ~ 5 part, Radix Platycodonis 1 ~ 5 part and the mixing of 0.5 ~ 3 part, Radix Glycyrrhizae, each 0.5 ~ 2h, extracting solution merges, filtration, it is after 1.1 ~ 1.3 that filtrate is concentrated into relative density, add ethanol to make alcohol content reach 60 ~ 75% to precipitate, and hold over night;
2) step 1) ethanol that obtains reclaims ethanol after filtering, and be concentrated into thick paste, then vacuum drying becomes dry extract;
3) by step 2) dry extract that obtains is broken into fine powder, obtains described Chinese medicine composition.
5. method according to claim 4, is characterized in that, further the fine-powdered Chinese medicine composition obtained conventionally is prepared into capsule, tablet, powder, pill or granule.
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