CN103446500B - Traditional Chinese medicine composition for treating cyclomastopathy, mammary pain and postpartum milk obstruction - Google Patents
Traditional Chinese medicine composition for treating cyclomastopathy, mammary pain and postpartum milk obstruction Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine composition for treating cyclomastopathy, mammary pain and postpartum milk obstruction. The traditional Chinese medicine composition provided by the invention has the effects of tonifying kidney, soothing the liver, regulating the chong and ren meridians, invigorating blood circulation and removing stasis and is used for treating diseases such as the kidney-asthenia and liver depression type cyclomastopathy, the mammary pain and the postpartum milk obstruction. The traditional Chinese medicine composition is mainly prepared from the following medicinal raw materials in parts by weight: 9-15 parts of cornu cervi degelatinatum, 9-15 parts of cassia twig, 9-15 parts of radix bupleuri, 8-12 parts of snakegourd fruit, 8-12 parts of angelica, 8-12 parts of ligusticum wallichii, 5-9 parts of fructus liquidambaris, 9-15 parts of raw oyster shell, 5-9 parts of flos albiziae and 5-9 parts of raw malt.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, be particularly used for the treatment of cyclomastopathy, mastalgia and puerperal galactostasis Chinese medicine composition, relate to preparation method and the application of said composition simultaneously.
Background technology
Cyclomastopathy occupies first of cystic hyperplasia of breast morbidity, the women of 70% ~ 80% is about had to have cyclomastopathy in various degree according to investigations, developed country about 1/3 women suffers from this disease, and data confirms that primary disease is a kind of precancerous lesion, and its chance suffered from breast cancer is 3 ~ 5 times of general female.Its sickness rate is in ascendant trend year by year in recent years, and age of onset becomes younger gradually.
Cyclomastopathy is the modal cystic hyperplasia of breast of women, and its sickness rate accounts for the first place of mastopathy.Cyclomastopathy is mammary gland tissue conduit and lobule degeneration structurally and the growth of Progressive symmetric erythrokeratodermia connective tissue, can betide the women at postpubertal any age, common with the young women of 18 ~ 50 years old.Majority shows as breast lamellar and nodular hyperplasia enclosed mass clinically, or presents migrans distending pain, touches a tender spot, and premenstrual pain aggravates.Along with the development of social modernization's process, the update of electronic product, the cultural life of people also becomes and becomes increasingly abundant and anxiety, the sickness rate of mastalgia constantly raises, breast is the vitals of women, hypertrophy and pain annoying numerous women, current physician thinks relevant with endocrine disturbance and Nervous and Mental Factors, but because the cause of disease of cyclomastopathy and mastalgia thereof is still not very clear, most of patients is difficult to the treatment accepting doctor trained in Western medicine analgesic, and Chinese medicine market lacks this type of medicine, this is a difficult problem urgently to be resolved hurrily.
In addition, clinically early and effective treatment cyclomastopathy, the generation for Breast Cancer Prevention is significant.For many years, western medical treatment cyclomastopathy commonly uses androgens and other symptomatic treatment medicines.But there is certain side effect in the treatment of application androgen, if any some manlike performances, infringement liver etc.It is little that Chinese traditional treatment cyclomastopathy has toxic and side effects, the advantages such as expense is low, be the Main Means of domestic current treatment primary disease, it has feasibility delaying, block and reverse cyclomastopathy in breast cancer development, but existing Chinese medicine preparation curative effect is not very good.In addition, more than 60% is had to have mastalgia in cyclomastopathy, because doctor trained in Western medicine analgesic is to side effect such as the infringements of gastrointestinal tract and liver, make most of patients refuse the treatment of Western medicine, and Chinese medicine market lack the medicine that this type of fundamentally can treat mastalgia.
Hypogalactia, agalactia, galactostasis are also puerpera's commonly encountered diseases, one of frequently-occurring disease, and according to the statistics of World Health Organization, there is 47.6% puerpera's agalactia or hypogalactia in the whole world, and its popularity certainly will affect the growth promoter of baby, also causes extreme difficulties to suckling.As everyone knows, breast feeding is all helpful to mother and baby, wherein breast milk, especially the endocrine colostrum of 5d in puerperal to the growth promoter of baby, to resist disease significant.Colostrum also has the effect promoting lipid excretion, reduces the generation of jaundice.Meanwhile, suckling is also conducive to mother's health, and sucking milk by baby can stimulate mother's uterine contraction, reduces postpartum hemorrhage, also can reduce the morbidity of breast carcinoma and cervical cancer.Therefore, the patient of puerperal hypogalactia is treated timely and effectively, especially promote the increase of breast milk secretion in initial several days of puerperal, improve hypogalactia, agalactia, galactostasis, meet the needs that baby feeds nursing, have very important meaning.
Basic Theories of Chinese Medicine thinks that breast belongs to stomach, and nipple belongs to liver, puerperal milk very less or agalactia be called " hypogalactia ", also known as hypogalactia, because of stagnation of QI due to depression of the liver, milk run be obstructed caused by.Because of childbirth severe loss of blood, or ferritic is weak, deficiency of kidney-QI, the traditional Chinese medical science thinks the angry blood of essence and bloodization, and be above milk, lower is menses, consume impairment of QI blood puerperal, thus deficiency of vital energy insufficiency of blood, milk thus very less or completely without, in addition puerperal easy depressed emotion, irritability stasis, hinder caused by milk runs, should the kidney invigorating soothing liver-QI, QI invigorating nourishing the stomach, blood circulation promoting and blood stasis dispelling, dredging collateral for promoting lactation controls it.TCM Document is a lot of about the experience prescription of hypogalactia, agalactia, many employings are traditional in the past decoction, pill etc., and preparation is simple, and dosage is forbidden, and taste is uncomfortable, and mouthfeel is poor, swallows to carry inconvenience, is unfavorable for packed and transported and storage, easy moldy metamorphism.
But, can find from above-mentioned summary, the treatment cyclomastopathy provided at present, mastalgia, puerperal galactostasis Chinese traditional patent formulation be all treat for specific typing, after needing doctor to diagnose in Clinical practice, the state of an illness according to concrete patient carries out corresponding selection and adjustment, thus forms specific prescription.This and patient are desirably in pharmacy oneself and select the expectation of medicine not conform to according to symptom.At present, in Chinese traditional patent formulation, also its three diseases are not all had to the formula of special efficacy.
Chinese patent literature CN1509743A discloses a stimulating milk secretion oral liquid, adopt Radix Bupleuri, Fructus Gardeniae, Pericarpium Citri Reticulatae, Radix Angelicae Sinensis, the Radix Paeoniae Alba, Rhizoma Chuanxiong, Fructus Hordei Germinatus, Radix Rhapontici, Fructus Liquidambaris, Squama Manis, Wang Buliu, Radix Glycyrrhizae formulated, this prescription biases toward liver-smoothing, qi-regulating, promoting blood circulation to remove obstruction in the collateral, is only applicable to the cyclomastopathy caused by stagnation of QI due to depression of the liver blood stasis.
Chinese patent literature CN1857512A disclose a kind of treat puerperal breast less, the Chinese medicine of agalactia, galactostasis, by the Radix Paeoniae Alba of the Chinese crude drug Radix Astragali, Radix Rehmanniae Preparata, Medulla Tetrapanacis, Herba Dianthi, Radix Trichosanthis, Fructus Liquidambaris, Radix Rhapontici, Radix Codonopsis, Radix Angelicae Sinensis, Rhizoma Chuanxiong, wine parch, Semen Vaccariae, Radix Bupleuri, scald river Squama Manis, Cornu Cervi Degelatinatum ten five kinds of Chinese medicine of system, appropriate amount of auxiliary materials mixed preparing forms, and it is characterized in that this medicine is hard capsule or tablet.The kidney-reinforcing drug such as the medicine Radix Astragali, Radix Rehmanniae Preparata, Radix Codonopsis, Cornu Cervi of the existing the kidney invigorating of this prescription, also has the product Radix Angelicae Sinensis of the soothing liver-QI that nourishes blood, Rhizoma Chuanxiong, the Radix Paeoniae Alba, Radix Bupleuri.But breast belongs to stomach, nipple belongs to liver, and clinical milk reduces, obstructed, and how to digest relevant with taste, do not solve transporting and transforming function of the spleen and stomach problem, QI and blood is still without the source of vital function, what takes milk? said medicine can not effectively solve the problem, and clinical efficacy is not good.
Chinese patent literature CN101716299A discloses a kind of Chinese medicine composition for the treatment of cyclomastopathy, is made up of the crude drug of following weight: Concha Ostreae 30 grams, Thallus Laminariae (Thallus Eckloniae) 15 grams, Radix Bupleuri 15 grams, the Radix Astragali 15 grams, Radix Angelicae Sinensis 15 grams, Radix Salviae Miltiorrhizae 15 grams, Radix Paeoniae Rubra 15 grams, the Rhizoma Atractylodis Macrocephalae 15 grams, 10 grams, Poria, Semen Fructus Trichosanthis 10 grams, Rhizoma Chuanxiong 10 grams, Radix Asparagi 10 grams, Rhizoma Sparganii 10 grams, 10 grams, Pericarpium Citri Reticulatae Viride, Semen Citri Reticulatae 10 grams, but above-mentioned prescription drug is complicated, clinical practice shows, the party is only for particular patient, not good enough to most of patients curative effect.
Chinese medicine prevent and treat cystic hyperplasia of breast, mastalgia, puerperal the disease such as galactostasis there is unique advantage, but due to such disease pathogenesis indefinite, on market most Chinese patent medicine based on simple the kidney invigorating, send an expedition against, regulate the flow of vital energy, eliminating stagnation, late result is not good enough.
Summary of the invention
In order to solve the various problems existed in prior art, we sum up the pathogenic characteristic of cyclomastopathy for " suffer from a deficiency of the kidney, Chong and Ren channel disorder is this; the stagnation of QI, expectorant are solidifying, blood stasis is mark " by Study of Etiology, establish the kidney invigorating soothing liver-QI, the therapeutic rules of regulating qi-flowing for harmonizing stomach, hard masses softening and resolving, in conjunction with theoretical and modern pharmacological research achievement at all times, obtain Chinese medicine composition of the present invention, it melts adjusts benefits, stomach function regulating, is melt into one, for treat cyclomastopathy, mastalgia, puerperal the curative effect of disease such as galactostasis remarkable.
An object of the present invention, provide a kind of effective treatment cyclomastopathy, mastalgia, puerperal galactostasis and/or the method for relevant disease.
An object of the present invention, provide a kind of treat cyclomastopathy, mastalgia, puerperal galactostasis Chinese medicine composition.
An object of the present invention, provides a kind of method preparing described Chinese medicine composition.
An object of the present invention, provide a kind of described Chinese medicine composition prepare cyclomastopathy, mastalgia, puerperal galactostasis medicine in application.
Chinese medicine composition of the present invention is made primarily of following crude drug, based on parts by weight, and Cornu Cervi Degelatinatum 9-15 part, Ramulus Cinnamomi 9-15 part, Radix Bupleuri 9-15 part, Fructus Trichosanthis 8-12 part, Radix Angelicae Sinensis 8-12 part, Rhizoma Chuanxiong 8-12 part, Fructus Liquidambaris 5-9 part, Concha Ostreae 9-15 part, Flos Albiziae 5-9 part, Fructus Hordei Germinatus 5-9 part.
As one of preferred embodiment of the present invention, Chinese medicine composition of the present invention is made, based on parts by weight primarily of following crude drug, Cornu Cervi Degelatinatum 10-13 part, Ramulus Cinnamomi 10-13 part, Radix Bupleuri 10-13 part, Fructus Trichosanthis 9-11 part, Radix Angelicae Sinensis 9-11 part, Rhizoma Chuanxiong 9-11 part, Fructus Liquidambaris 6-8 part, Concha Ostreae 10-14 part, Flos Albiziae 6-8 part, Fructus Hordei Germinatus 6-8 part.
As one of preferred embodiment of the present invention, Chinese medicine composition of the present invention is made, based on parts by weight primarily of following crude drug, Cornu Cervi Degelatinatum 12 parts, Ramulus Cinnamomi 12 parts, Radix Bupleuri 12 parts, Fructus Trichosanthis 10 parts, Radix Angelicae Sinensis 10 parts, Rhizoma Chuanxiong 10 parts, Fructus Liquidambaris 7 parts, Concha Ostreae 12 parts, Flos Albiziae 7 parts, Fructus Hordei Germinatus 7 parts.
As one of preferred embodiment of the present invention, Chinese medicine composition of the present invention is made primarily of following crude drug, based on parts by weight, and Cornu Cervi Degelatinatum 12g, Ramulus Cinnamomi 12g, Radix Bupleuri 10g, Fructus Trichosanthis 12g, Radix Angelicae Sinensis 9g, Rhizoma Chuanxiong 9g, Fructus Liquidambaris 7g, Concha Ostreae 12g, Flos Albiziae 7g, Fructus Hordei Germinatus 6g.
The present invention with Cornu Cervi Degelatinatum, Ramulus Cinnamomi, Radix Bupleuri for monarch drug, warming and recuperating the kidney-YANG, promoting the circulation of blood subside a swelling, liver-smoothing, qi-regulating, kidney tonifying lactogenesis, be aided with Fructus Trichosanthis, Fructus Liquidambaris, Concha Ostreae reduce phlegm, hard masses softening and resolving is minister, assistant is with Radix Angelicae Sinensis, Rhizoma Chuanxiong, Flos Albiziae vital energy regualting and blood circulation-promoting, make with Fructus Hordei Germinatus dredging collateral for promoting lactation, the kidney invigorating soothing liver-QI is played, the effect of regulating qi-flowing for harmonizing stomach, hard masses softening and resolving altogether by full side, melt and adjust benefits, stomach function regulating, be melt into integrally, for cyclomastopathy, mastalgia, puerperal the disease such as galactostasis.
Monarch drug: Cornu Cervi Degelatinatum has effect of the kidney warming sun, bone and muscle strengthening, promoting the circulation of blood detumescence.There is antiinflammatory, analgesic activity, have and suppress the effect of cyclomastopathy, can the growth of Tumor suppression, promote anti-tumor immune response, activate immunity mechanism, killing tumor cell, is conducive to oncotherapy.Ramulus Cinnamomi has promoting the flow of QI-blood by warming the meridian, and effect of the positive pain of dehumidifying, all has obvious anti-pain effect to mice thermic pain and acetic acid induced pain, and analgesic effect and the rotundine group of the appearance of Ramulus Cinnamomi alcohol extract are close.Radix Bupleuri has soothing liver-QI for relieving depression, effect of elevate a turnable ladder yang-energy, and modern pharmacology research proves that Radix Bupleuri has the effects such as antiinflammatory, analgesia, antitumor, immunomodulating.Saikoside has antitumor cell molecular adhesion, and interference tumor cell s phase DNA synthesizes and protein metabolism, antiproliferative effect, the effect of cell death inducing.Radix Bupleuri has immunoregulation effect.
Ministerial drug: Fructus Trichosanthis has clearing away heat and eliminating phlegm, relieving stuffiness of the chest by dispersing aggregation of pathogens, moisturizes effect of laxation.Pharmacological research confirms, Fructus Trichosanthis has anti-inflammatory and antalgic, improves the multiple pharmacological effect such as autoimmune ability, Tumor suppression growth.Research finds, effect that Fructus Liquidambaris has dispelling, collateral-activating, diuretic stimulates the menstrual flow.Modern pharmacological research display Fructus Liquidambaris has antiinflammatory, analgesic activity, the acid of road road has certain anti-inflammatory activity for its known principle active component, the mice foot swelling that can obviously suppress carrageenin to cause, Dichlorodiphenyl Acetate induced mice abdominal cavity capillary permeability is hyperfunction demonstrates certain inhibitory action, and Dichlorodiphenyl Acetate causes mice pain to have certain analgesic activity.Concha Ostreae has effect of suppressing the hyperactive liver and subsiding YANG, hard masses softening and resolving.The effect such as Concha Ostreae has enhancing immunity, antitumor, slow down aging, protect the liver.Experimentation display oyster active peptides can the propagation of inhibition tumor cell, promotes apoptosis, and its mechanism may with apoptosis-induced gene expression to be in harmonious proportion Cycle Arrest relevant.
Adjuvant drug: effect of Radix Angelicae Sinensis is invigorated blood circulation for enriching blood, menstruction regulating and pain relieving, loosening bowel to relieve constipation, there is antiinflammatory, strengthen the effect such as immunization, antitumor, inhibited to the strain of kinds of tumors tumor, can obviously grow by Tumor suppression, increase macrophage numbers, strengthen its phagocytic function and splenocyte NK activity, obviously extend the animal survival phase.Rhizoma Chuanxiong has effect of blood-activating and qi-promoting wind-expelling pain-stopping.There is analgesia, the effect such as anticancer.Research shows, Rhizoma Chuanxiong has direct antitumor action, simultaneously the adhesive attraction of ligustrazine inhibition tumor cell and endotheliocyte, and the effect of anticoagulation and antiplatelet aggregation, decreases the transfer of tumor.The regulator solution of ligustrazine to immunocyte serves the effect of killing off tumor cells.Flos Albiziae has QI regulating by alleviation of mental depression, active effect of calming the nerves, there is the activity that body is widely interior, extracorporeal suppression tumor cell is bred, its main component Quercitroside has antidepressant effect, there is the effects such as antiinflammatory, antioxidation, tranquilizing soporific, immunity moderation system, significantly can suppress the activity of monoamine oxidase A, monoamine oxidase A too much accumulation in nervous tissue can produce excessive amine metabolite, causes the generation of all kinds of spirit depressing disease.
Make medicine: Fructus Hordei Germinatus has the effect of circulation of qi promoting removing food stagnancy, invigorating the spleen and regulating the stomach, stimulating milk secretion relieving distension.Modern pharmacology research shows, the Ergota compounds contained in Fructus Hordei Germinatus has the effect intending dopamine agonist sample.Dopamine, by acting on hypothalamus, makes prolactin releasing factor discharge and increases, suppress the secretion of prolactin antagonist, suppress the generation of cyclomastopathy to a certain extent.
Therefore, Chinese medicine composition of the present invention, has the kidney invigorating soothing the liver, Chong and Ren Meridians regulating, blood circulation promoting and dispersing pathogen accumulation.For liver energy stagnation type cyclomastopathy of suffering from a deficiency of the kidney, mastalgia, puerperal the disease such as galactostasis.
As one of specific embodiment of the invention scheme, Chinese medicine composition of the present invention is for the preparation of the application in treatment cyclomastopathy disease drug.
As one of specific embodiment of the invention scheme, Chinese medicine composition of the present invention is for the preparation of the application in treatment mastalgia medicine.
As one of specific embodiment of the invention scheme, Chinese medicine composition of the present invention is for the preparation of the application in treatment galactostasis medicine in puerperal.
An object of the present invention, provides a kind of method preparing described Chinese medicine composition, gets the traditional Chinese medicinal composition raw materials of the present invention by above-mentioned weight proportion, by pharmaceutics conventional method, adds customary adjuvant, is prepared into various clinical acceptable dosage form.
Further, dosage form and the exterior-applied formulation of described dosage form can be peroral dosage form also can be topical, include but not limited to the one in the middle of following dosage form: tablet, capsule, soft capsule, patch, gel, injection, pill, granule, suspensoid, drop pill or oral liquid etc.
As one of specific embodiment of the invention scheme, the preparation method of Chinese medicine composition of the present invention is preferably, the part or all of crude drug of solvent extraction, concentrated, remove impurity, after drying, again according to a conventional method, add customary adjuvant, be prepared into various clinical acceptable dosage form.Described solvent be preferably water, ethanol, acetone, chloroform, ethyl acetate, methanol one or more.
As one of specific embodiment of the invention scheme, the preparation method of Chinese medicine composition of the present invention preferably includes following steps:
1. above ten raw material of Chinese medicine medicines are got by above proportioning dosage;
2. get eight taste Chinese herbal medicine except Cornu Cervi Degelatinatum and Concha Ostreae, soak, heating extraction 3 times, each 1-3 hour, merge the decocting liquid of three times;
3. Cornu Cervi Degelatinatum and Concha Ostreae are smashed to sieve to put in extraction pot and decoct separately, add water heating extraction 0.2-2 hour, retains its medicinal liquid and medicinal residues in extraction pot;
4. step decocting liquid 3. and step medicinal liquid 4. and medicinal residues are mixed in the lump and place in vacuum concentration pot, room temperature to be chilled to, adds ethanol, stir evenly, cold preservation hour, get supernatant, filter, filtrate recycling ethanol, be concentrated into the extractum that 45-60 DEG C is surveyed relative density degree 1.25-1.28.
As one of specific embodiment of the invention scheme, the preparation method of Chinese medicine composition of the present invention preferably includes following steps:
1. above ten raw material of Chinese medicine medicines are got by above proportioning dosage;
2. get eight taste Chinese herbal medicine except Cornu Cervi Degelatinatum and Concha Ostreae, add 5-10 times amount water soaking, heating extraction 3 times, each 1-3 hour, merge the decocting liquid of three times;
3. Cornu Cervi Degelatinatum and Concha Ostreae are smashed to sieve to put in extraction pot and decoct separately, add 5-10 times amount, heating extraction 0.2-2 hour, retain its medicinal liquid and medicinal residues in extraction pot;
4. step decocting liquid 3. and step medicinal liquid 4. and medicinal residues being mixed in the lump places in vacuum concentration pot, room temperature to be chilled to, adding ethanol makes alcohol content be 50-70%, stir evenly, cold preservation 10-30 hour, gets supernatant, filters, filtrate recycling ethanol, is concentrated into the extractum that 45-60 DEG C is surveyed relative density degree 1.25-1.28.
As one of specific embodiment of the invention scheme; get the dry extract of Chinese medicine composition of the present invention; add customary adjuvant; preparation process or step routinely, make clinical acceptable tablet, capsule, soft capsule, injection, pill, granule, suspensoid, drop pill or oral liquid etc.
Detailed description of the invention
Following examples further illustrate of the present invention, but never limit the scope of the present invention.Elaborate the present invention further referring to embodiment, but it will be appreciated by those skilled in the art that the present invention is not limited to the preparation method of these embodiments and use.And those skilled in the art can carry out equivalent replacement, combination, improvement to the present invention according to description of the invention or modify, but these all will comprise within the scope of the invention.
embodiment 1
Get based on weight portion, Cornu Cervi Degelatinatum 9 parts, Ramulus Cinnamomi 9 parts, Radix Bupleuri 9 parts, Fructus Trichosanthis 9 parts, Radix Angelicae Sinensis 7 parts, Rhizoma Chuanxiong 7 parts, Fructus Liquidambaris 7 parts, Concha Ostreae 12 parts, Flos Albiziae 7 parts, Fructus Hordei Germinatus 5 parts.
Cornu Cervi Degelatinatum and Concha Ostreae are smashed to sieve to put in extraction pot and are decocted separately, add 10 times of water yields, heating extraction 0.5 hour, retain its medicinal liquid and medicinal residues in extraction pot; Remaining eight medicines add 10 times of water yields and soak 1 hour, heating extraction 3 times, each 1 hour, merge the decocting liquid of three times, filter, filtrate and said extracted thing mix to be placed in vacuum concentration pot, room temperature to be chilled to, adding ethanol makes alcohol content be 55%, stirs evenly, cold preservation 30 hours, get supernatant, filter, filtrate recycling ethanol, be concentrated into the extractum that 50 DEG C are surveyed relative density degree 1.25-1.28.
Get extractum again, directly or indirectly add pharmaceutically acceptable excipient through normal process steps and make capsule.
embodiment 2
Get based on weight portion, Cornu Cervi Degelatinatum 15 parts, Ramulus Cinnamomi 15 parts, Radix Bupleuri 15 parts, Fructus Trichosanthis 12 parts, Radix Angelicae Sinensis 12 parts, Rhizoma Chuanxiong 12 parts, Fructus Liquidambaris 9 parts, Concha Ostreae 9 parts, Flos Albiziae 9 parts, Fructus Hordei Germinatus 6 parts.
Cornu Cervi Degelatinatum and Concha Ostreae are smashed to sieve to put in extraction pot and are decocted separately, add 10 times of water yields, heating extraction 0.5 hour, retain its medicinal liquid and medicinal residues in extraction pot; Remaining eight medicines add 10 times of water yields and soak 1 hour, heating extraction 3 times, each 1 hour, merge the decocting liquid of three times, filter, filtrate and said extracted thing mix to be placed in vacuum concentration pot, room temperature to be chilled to, adding ethanol makes alcohol content be 60%, stirs evenly, cold preservation 25 hours, get supernatant, filter, filtrate recycling ethanol, be concentrated into the extractum that 50 DEG C are surveyed relative density degree 1.25-1.28.
Get extractum, directly or indirectly add pharmaceutically acceptable excipient through normal process steps and make oral liquid.
embodiment 3
Get based on weight portion, Cornu Cervi Degelatinatum 12 parts, Ramulus Cinnamomi 12 parts, Radix Bupleuri 12 parts, Fructus Trichosanthis 10 parts, Radix Angelicae Sinensis 10 parts, Rhizoma Chuanxiong 10 parts, Fructus Liquidambaris 7 parts, Concha Ostreae 12 parts, Flos Albiziae 7 parts, Fructus Hordei Germinatus 7 parts.
Cornu Cervi Degelatinatum and Concha Ostreae are smashed to sieve to put in extraction pot and are decocted separately, add 10 times of water yields, heating extraction 0.5 hour, retain its medicinal liquid and medicinal residues in extraction pot; Remaining eight medicines add 10 times of water yields and soak 1 hour, heating extraction 3 times, each 1 hour, merge the decocting liquid of three times, filter, filtrate and said extracted thing mix to be placed in vacuum concentration pot, room temperature to be chilled to, adding ethanol makes alcohol content be 65%, stirs evenly, cold preservation 25 hours, get supernatant, filter, filtrate recycling ethanol, be concentrated into the extractum that 50 DEG C are surveyed relative density degree 1.25-1.28.
Get extractum, directly or indirectly add pharmaceutically acceptable excipient through normal process steps and make granule.
embodiment 4
Get based on weight portion, Cornu Cervi Degelatinatum 12 parts, Ramulus Cinnamomi 12 parts, Radix Bupleuri 10 parts, Fructus Trichosanthis 12 parts, Radix Angelicae Sinensis 9 parts, Rhizoma Chuanxiong 9 parts, Fructus Liquidambaris 7 parts, Concha Ostreae 12 parts, Flos Albiziae 7 parts, Fructus Hordei Germinatus 7 parts.
Cornu Cervi Degelatinatum and Concha Ostreae are smashed to sieve and puts in extraction pot, then add residue eight Chinese medicines, add 10 times of water yields and soak 1 hour, heating extraction 3 times, each 1 hour, merges the decocting liquid of three times, filter, room temperature to be chilled to, adds ethanol and makes alcohol content be 65%, stir evenly, cold preservation 25 hours, gets supernatant, filters, filtrate recycling ethanol, is concentrated into the extractum that 50 DEG C are surveyed relative density degree 1.25-1.28.
embodiment 5
The dry extract of the Chinese medicine composition of Example 1 gained, adds customary adjuvant, and preparation process or step, make injection routinely.
embodiment 6
The dry extract of the Chinese medicine composition of Example 2 gained, adds customary adjuvant, and preparation process or step, make soft capsule routinely.
test example:
One, pharmacological evaluation basis
Test objective:
Evaluate this Chinese prescription by pharmacological evaluation and there is the kidney invigorating soothing liver-QI, regulating qi-flowing for harmonizing stomach, hard masses softening and resolving effect, integrate the dual function of prevention and therapy.
The preparation of zoopery medication:
Get the invention described above embodiment 3 traditional Chinese medicinal composition raw materials proportioning, add 10 times of water yields and soak 1 hour, preparation process is the same, adds water to make every 1ml to carry out test containing the solution being equivalent to 3g crude drug for subsequent use, for experimental rat gastric infusion.
The foundation of animal experimental model:
Experimental animal is chosen female sd inbred rats 150 ~ 200g conventional adaptation and is raised 3 ~ 5 days, adopts rat to press 0.5mg/kg estradiol benzoate lumbar injection, every day 1 time, continuous 4 weeks, sets up cyclomastopathy pathology model.
Zoopery is divided into groups:
By kg body weight random packet, respectively organize rat body weight, second pair of breast diameter there was no significant difference after testing.Rat is equally divided into 6 groups, often organizes 10.
Blank group (N): with normal saline 0.2mL lumbar injection, every day 1 time, continuous 4 weeks, from the 5th week, only gavage distilled water 2mL/, every day 1 time, last till end in the 8th week, all the other 5 groups all by 0.5mg/kg estradiol benzoate lumbar injection, every day 1 time, modeling in continuous 4 weeks.
Model group: start for after modeling the 5th week only to gavage distilled water 2mL/, every day 1 time;
The large small dose group of experimental drug: start to gavage experimental drug 3.6g/kg, 1.8g/kg every day 1 time for after modeling the 5th week;
Western medicine group: start for after modeling the 5th week to gavage tamoxifen tablet diluent 0.5mg/kg, every day 1 time;
Chinese medicine matched group: start for after modeling the 5th week to gavage RUZENGNING PIAN agent or RUKUAIXIAO PIAN dilution agent liquid 2.5g/kg, every day 1 time.Above gastric infusion all continues to end in the 8th week.
Within 1st week, start grouping in experiment to weigh, use vernier caliper measurement rat second pair of breast diameter average 1 time weekly;
The 4th week and the 8th week in experiment starts within continuous 5 days, to carry out rat vagina cell smear (pap staining), the ovarian function situation of test experience rat.
Results of animal:
1. this Chinese prescription is on the impact of hyperplasia of mammary gland model integrality and Serum Sex Hormones:
By detecting rat body weight, breast diameter, oestrous cycle and serum sex hormone level, observe the index such as rat mammary gland, uterus, ovary tissue change, disclose with this Treated with Chinese Decoction cyclomastopathy, mastalgia, puerperal galactostasis may be the integrally-regulated effect realization by Endocrine hormone.
Normal rats is along with the increase of the time of nursing, and breast diameter is without significant change, and Mus obviously increases model group rats modeling rear udder attachment diameter compared with normal, and along with the prolongation of time, breast diameter has no and reduces, and illustrates that the breast that animal pattern increases can not disappear voluntarily; This prescription rat breast diameter obviously reduces (P < 0.01), and close to normal range.We according to rat vaginal cell in rutting period based on table, middle layer cells, a small amount of bottom cell, rutting period, rat vagina cell was based on middle and bottom layers cell, the feature of a small amount of cells of superficial layer, calculate Rats During The Estrous Cycle vaginal cell index (P+E), the ovarian function situation of test experience rat.
Experiment is by the mensuration to each group of Rats During The Estrous Cycle index (P+E), and result shows: model group comparatively blank group Rats During The Estrous Cycle index (P+E) obviously reduces (P < 0.01); This prescription has clear improvement (P < 0.01) to rat model P+E, and close to normal range; Breast increasing is rather organized rat (P+E) and is had no significant change.
Experiment is by the mensuration to each group of hormone serum level, and result shows, the rat E after estrogen modeling
2, PRL level apparently higher than normal rat, P level obviously reduces, and this prescription can make the abnormal E raised of rat model
2, PRL reduce, reach normal range, P content can be made to raise, and the excessive secretion of PRL in serum can be blocked, suppress abnormal hormone to the pessimal stimulation of mammary gland tissue.
Experiment shows, a large amount of exogenous hormoneses can cause the diacrisis of rat model serum hormone, and the present composition has the effect regulating the disorder of the hormonal readiness such as blood serum E2, P, PRL.Point out the mechanism of action of this prescription may by regulating the function of laboratory animal hypothalamic-pituitary-ovarian gonad axis thus the abnormal secretion improving Serum Sex Hormones realizes, this be one of mechanism of action of this Treated with Chinese Decoction cyclomastopathy.
By detecting rat body weight, breast diameter, oestrous cycle (see table 1-3), disclosing with the kidney invigorating soothing the liver eliminating stagnation method prescription therapeutic cyclomastopathy that is principle may be integrally-regulated effect realization by Endocrine hormone.
Table 1 respectively group cyclomastopathy rat body weight change
Note: ratio before and after the treatment of this group,
*p < 0.05,
*p < 0.01.
Table 2 is the change of group cyclomastopathy rat breast diameter respectively
Note: ratio before and after the treatment of this group, * P < 0.05, * * P < 0.01.
Table 3 respectively group cyclomastopathy Rats During The Estrous Cycle index (P+E) change
Note: ratio before and after the treatment of this group, * P < 0.05, * * P < 0.01.
2. this Chinese prescription is on the Ultrastructural impact of hyperplasia of mammary gland model mammary gland
By Electronic Speculum and immunohistochemical analysis, this Chinese drug-treated group can make mammary gland prostate lumens areas, interstitial area and nuclear area obviously decline; And endometrial mucosa projection can be improved, Interstitial cell reduces, and nuclear division reduces mutually; Make folliculus ovarii film wrinkle wall mamillary decreased number, result shows this Chinese prescription has therapeutical effect (see table 4) to cyclomastopathy and endometrial hyperplasia.
Table 4 is group mammary gland pathological morphological image com-parison and analysis respectively
Note: with normal group ratio, △ P < 0.05, △ △ P < 0.01; With model group ratio, * P < 0.05, * * P < 0.01.
3. this Chinese prescription is on the impact of hyperplasia of mammary gland model neurotransmitter and gonadal hormone
By detecting the content of neurotransmitter (dopamine, 5-hydroxy tryptamine) and Serum Sex Hormones in rat gonad target organ-mammary gland tissue, serum, find rat model estradiol (E
2), lactotropin (PRL), 5-hydroxy tryptamine obviously raise, P (progesterone), dopamine obviously reduce, and this Chinese drug-treated group can make the abnormal E raised of rat model
2, PRL reduce, reach normal range, P content obviously raised; Also there is certain regulating action to the neurotransmitter in mammary gland tissue, while rising dopamine, reduce the content of 5-hydroxy tryptamine, blocked the excessive secretion of PRL in serum, inhibit abnormal hormone to the stimulation of mammary gland tissue.Point out the mechanism of action of this Chinese prescription may by regulating the neuroendocrine function of hypothalamic-pituitary-ovarian gonad axis thus the abnormal secretion improving some neurotransmitter and Serum Sex Hormones in mammary gland tissue realizes, this may be one of mechanism of action of this Treated with Chinese Decoction cyclomastopathy (see table 5).
Table 5 mammary gland tissue, serum dopamine, 5-hydroxy tryptamine and Serum PRL change
Note: compare with matched group, * P < 0.05, * * P < 0.01; Compare with model group, △ P < 0.01.
4. this Chinese prescription is on the impact of hyperplasia of mammary gland model proliferating cell nuclear antigen and hormone receptor
Find proliferating cell nuclear antigen (PCNA) and estrogen receptor (ER) in hyperplasia of mammary gland model animal's mammary gland tissue by light microscopic and immunohistochemical staining, the positive expression of progesterone receptor (PR) obviously strengthens, this Chinese drug-treated group can make ER, PR, PCNA positive staining intensity index be down to normal range (see table 6).
Table 6 is respectively organized ER, PR, PCNA staining power index and is compared
Note: compare △ P < 0.01 with normal group, compares * P < 0.01 with model group
This test discloses with " the kidney invigorating is soothing the liver eliminating stagnation " as the Chinese traditional compound medicine of method for the treatment of can regulate hormone serum level, reduce mammary gland tissue to the sensitivity of Estrogen and progestin, stop the overexpression of proliferating cell nuclear antigen, suppress further developing of cyclomastopathy, can play the dual function for the treatment of and prevention, theoretical basis has been established in the canceration for Chinese medicine preventing mammary gland hyperplasia.
Beneficial effect of the present invention
1. create cyclomastopathy " the kidney invigorating is soothing the liver eliminating stagnation " method
Investigation finds, in Patients of Mammary Gland Hyperplasia menophania early, menopause evening, do not give birth to, non-suckling, artificial abortion, happiness higher fatty acid factor proportion be high.More than 80% patient is because of psychentonia aggravation.Think that the factors such as the generation of primary disease and feelings will, diet, environment, heredity, relevant disease are relevant, Liver and kidney thin and weak with the menses of Chinese medicine loses supports, and the liver failing to maintain the normal flow of QI matches.The rule evolution of a blood stasis is coagulated in the change of disease according to the stagnation of QI one expectorant.Suffer from a deficiency of the kidney then through the overall process that the course of disease develops.Sum up the pathogenic characteristic of this disease with stagnation of liver-QI kidney asthenia as the principal aspect, the stagnation of QI, expectorant are solidifying, blood stasis is mark, found the therapeutic rules of " the kidney invigorating is soothing the liver eliminating stagnation ".
2. improve cyclomastopathy syndrome to objectify research
The performance of the B ultrasonic of Patients of Mammary Gland Hyperplasia and menstruation follicular phase, luteal phase, the onset of ovulation, the estrogen and progestogen level of premenstrua and the dependency of tcm syndrome are inquired into, find that these indexs and syndrome have certain dependency, sum up cyclomastopathy with kidney asthenia as the principal aspect, the stagnation of QI can be had again concurrently, expectorant coagulates, blood stasis three type, lobulus simplex Accretive Type, cystic cyclomastopathy type, the gland type cyclomastopathy type of corresponding B ultrasonic typing respectively; The change of menstrual cycle Estrogen and progestin level is closely related with the differentiation of symptoms and signs for classification of syndrome of cyclomastopathy, and the research that objectifies of the tcm syndrome for cyclomastopathy provides foundation.
3. set up cyclomastopathy Quantitative Diagnosis of TCM Syndrome standard and therapeutic efficacy assessment
Utilize the design of system, establish corresponding Quantitative Diagnosis of TCM Syndrome standard, cyclomastopathy Quantitative Diagnosis of TCM Syndrome table, cyclomastopathy case history observation table and objective scale point system are drafted, complete the transformation of Chinese traditional medical diagnose data by grade distinguishing vectorization standard, perfect corresponding syndrome quantized diagnosis standard and therapeutic efficacy assessment; Compare according to the Changing Pattern of Serum Sex Hormones and symptom integral value, for the improvement of the local sign and General Symptoms of passing judgment on cyclomastopathy, for the science demonstration of Chinese medicine primary disease provides thinking.
Claims (9)
1. treat cyclomastopathy, mastalgia, puerperal galactostasis and/or the Chinese medicine composition of relevant disease, it is characterized in that being made up, based on parts by weight of following crude drug, Cornu Cervi Degelatinatum 9-15 part, Ramulus Cinnamomi 9-15 part, Radix Bupleuri 9-15 part, Fructus Trichosanthis 8-12 part, Radix Angelicae Sinensis 8-12 part, Rhizoma Chuanxiong 8-12 part, Fructus Liquidambaris 5-9 part, Concha Ostreae 9-15 part, Flos Albiziae 5-9 part, Fructus Hordei Germinatus 5-9 part.
2. Chinese medicine composition according to claim 1, is characterized in that being made up, based on parts by weight of following crude drug, Cornu Cervi Degelatinatum 10-13 part, Ramulus Cinnamomi 10-13 part, Radix Bupleuri 10-13 part, Fructus Trichosanthis 9-11 part, Radix Angelicae Sinensis 9-11 part, Rhizoma Chuanxiong 9-11 part, Fructus Liquidambaris 6-8 part, Concha Ostreae 10-14 part, Flos Albiziae 6-8 part, Fructus Hordei Germinatus 6-8 part.
3. a preparation method for Chinese medicine composition according to claim 1, is characterized in that getting the crude drug by above-mentioned weight proportion, by pharmaceutics conventional method, adds customary adjuvant, is prepared into various clinical acceptable dosage form.
4. preparation method according to claim 3, is characterized in that described dosage form is selected from peroral dosage form or exterior-applied formulation.
5. preparation method according to claim 3, is characterized in that described dosage form is selected from the dosage form of topical.
6. preparation method according to claim 3, is characterized in that described dosage form is selected from tablet, capsule, patch, gel, injection, pill, granule, suspensoid.
7. preparation method according to claim 3, is characterized in that described dosage form is selected from soft capsule, drop pill.
8. preparation method according to claim 3, is characterized in that described dosage form is selected from oral liquid.
9. one kind according to claim 1 Chinese medicine composition prepare cyclomastopathy, mastalgia, puerperal galactostasis medicine in application.
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