CN104491765B - A kind of medical composition and its use for the treatment of nodules of the breast - Google Patents

Abstract

The invention belongs to medical art, be specifically related to a kind of pharmaceutical composition and purposes for the treatment of nodules of the breast.Described pharmaceutical composition comprises following component: Radix Bupleuri, Radix Curcumae, the Radix Paeoniae Alba, Fructus Liquidambaris, Olibanum, Thallus Laminariae (Thallus Eckloniae), Squama Manis, Bulbus Fritillariae Thunbergii, Pericarpium Citri Reticulatae, Semen Sinapis Albae, Fructus Trichosanthis, Ramulus Cinnamomi.The present invention is pure Traditional Chinese medicine composition, reasonable recipe, dialectical administration, has good curative effect for nodules of the breast especially liver energy depression and phlegm stagnation type nodules of the breast.

Description

A kind of medical composition and its use for the treatment of nodules of the breast

Technical field

The invention belongs to medical art, be specifically related to a kind of medical composition and its use for the treatment of nodules of the breast.

Background technology

Nodules of the breast refers to the chronic good victory lump that female breast portion is common, with lump in breast and distending pain for primary symptom, is common in young women.Often be called mastalgia (Mastodynia) abroad.Nodules of the breast is by feelings will internal injury, Chong and Ren channel disorder, and the condensation of the expectorant stasis of blood forms.Lump in breast is relevant to menstrual cycle with pain, be equivalent to cyclomastopathy, Chinese medicine is thought, the generation of primary disease is relevant with many factors such as feelings will, diet, overstrains, depression of liver-QI, the expectorant blood coagulation stasis of blood, Chong and Ren channel disorder are its basic pathogenesis, and disorder of emotion plays vital effect in morbidity.Modern Western medicine treatment is rapid-action, but effect is difficult to continue, and side effect is obvious, and relapse rate is high, mostly can not receive good therapeutic effect clinically.Use Chinese traditional treatment, determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, effectively can overcome the untoward reaction that western medicine causes, have good researching value and practical significance.

Summary of the invention

The invention provides a kind of new pharmaceutical composition for the treatment of nodules of the breast, overcome the deficiency of Chinese and western medicine preparation in the past, have good curative effect to liver energy depression and phlegm stagnation type nodules of the breast, and have no side effect.Described pharmaceutical composition is obtained by following raw material: Radix Bupleuri, Radix Curcumae, the Radix Paeoniae Alba, Fructus Liquidambaris, Olibanum, Thallus Laminariae (Thallus Eckloniae), Squama Manis, Bulbus Fritillariae Thunbergii, Fructus Trichosanthis, Ramulus Cinnamomi.

Preferably, described pharmaceutical composition also comprises Pericarpium Citri Reticulatae and Semen Sinapis Albae.

The technical scheme adopted for solving its technical problem is the pharmaceutical composition of described treatment nodules of the breast, be made up of the medicine of following weight: Radix Bupleuri 15-20 part, Radix Curcumae 10-20 part, Radix Paeoniae Alba 10-20 part, Fructus Liquidambaris 5-15 part, Olibanum 15-25 part, Thallus Laminariae (Thallus Eckloniae) 1-6 part, Squama Manis 1-8 part, Bulbus Fritillariae Thunbergii 15-20 part, Fructus Trichosanthis 5-10 part, Ramulus Cinnamomi 10-16 part.

Preferably, described pharmaceutical composition also comprises the medicine of following weight: Pericarpium Citri Reticulatae 15-20 part and Semen Sinapis Albae 5-15 part.

Most preferred technique scheme of the present invention is, described pharmaceutical composition of the present invention, is obtained by the raw material of following weight portion: Radix Bupleuri 18 parts, Radix Curcumae 15 parts, the Radix Paeoniae Alba 15 parts, Fructus Liquidambaris 10 parts, Olibanum 20 parts, Thallus Laminariae (Thallus Eckloniae) 3 parts, Squama Manis 4 parts, Bulbus Fritillariae Thunbergii 18 parts, Pericarpium Citri Reticulatae 18 parts, Semen Sinapis Albae 10 parts, Fructus Trichosanthis 8 parts, Ramulus Cinnamomi 13 parts.

Present invention also offers the preparation method of described pharmaceutical composition, after specifically comprising the steps: the raw material Radix Bupleuri of above-mentioned weight portion, Radix Curcumae, the Radix Paeoniae Alba, Fructus Liquidambaris, Olibanum, Thallus Laminariae (Thallus Eckloniae), Squama Manis, Bulbus Fritillariae Thunbergii, Pericarpium Citri Reticulatae, Semen Sinapis Albae, Fructus Trichosanthis, Ramulus Cinnamomi to pulverize respectively, add the water of 6 times amount of medical material gross weight, decoct after 2 hours and filter, filtrate is concentrated into thick paste, crushed after being dried.

Those skilled in the art directly can be used as medicine on obtained active constituents of medicine basis of the present invention to use or add on pharmaceutics acceptable adjuvant routinely technique be prepared into required preparation.Preferably, pharmaceutical composition of the present invention conveniently preparation technology be prepared into tablet or capsule.Described tablet, is after being pulverized by active component and microcrystalline Cellulose, hydroxypropyl cellulose mix, and add 2% polyvidone alcoholic solution soft material, cross 20 mesh sieves and granulate, dry, add magnesium stearate, 20 mesh sieve granulate, mixing, tabletting, to obtain final product.

The present invention also asks to protect aforementioned pharmaceutical compositions in the purposes of preparation treatment nodules of the breast particularly in preparation treatment liver energy depression and phlegm stagnation type nodules of the breast medicine.In clinical observation process, treatment group comes off 3 routine cases, and matched group comes off 2 routine cases, and this 5 routine patient is all improvement backed off after randoms, and effectively to add up curative effect, all the other all complete clinical observation.Treatment group efficacy result is as follows: clinical cure 29 example (52.7%), effective 20 examples (36.4%), effective 5 examples (9.1%), invalid 1 example (1.8%), total effective rate 98.2%; Matched group clinical cure 4 example (7.3%), effective 21 examples (38.2%), effective 24 examples (43.6%), invalid 6 examples (10.9%), total effective rate 89.1%.Between two groups, total effective rate compares, and treatment group is apparently higher than matched group.In treatment group therapeutic process, vital sign steadily and without serious adverse reactions such as allergy, treatment terminates rear lab index routine blood test, routine urinalysis etc. to the routine patient for the treatment of group 55 and carries out statistical procedures, shows no obvious abnormalities.Result shows that the clinical application of we is safely and effectively, can effectively eliminate cyclomastopathy lump, alleviating pain, is worth studying and applying further.

Further, pharmaceutical composition of the present invention, described Radix Bupleuri, bitter, be slightly cold.Return liver, gallbladder meridian.Reconciling superficies and interior, soothing the liver, yang invigorating.For cold, fever, alternate attack of chill and fever, distending pain in the chest and hypochondrium, menoxenia, uterine prolapse, proctoptosis.

Radix Curcumae, pungent, bitter, cold.Return liver, the heart, lung meridian.Regulating qi to disperse stagnation, heart fire-clearing upset-relieving, promoting the function of the gallbladder to alleviate jaundice.For amenorrhea dysmenorrhea, chest and abdomen swelling and pain, twinge, calentura coma, epilepsy is gone mad, jaundice dark coloured urine.

The Radix Paeoniae Alba, bitter, sour, be slightly cold.Return liver, spleen channel.Suppressing the hyperactive liver pain relieving, nourishing blood for regulating menstruation, astringing YIN to stop sweating.Dizzy for having a headache, hypochondriac pain, stomachache, limb pain twin, blood deficiency and yellow complexion, menoxenia, spontaneous perspiration, night sweat.

Fructus Liquidambaris is bitter, flat.Return liver, kidney channel.Dispelling, collateral-activating, diuretic stimulates the menstrual flow.For arthralgia, numbness contracture, edema distension, the few amenorrhea of breast.

Olibanum, pungent, bitter, temperature.Promoting blood circulation and stopping pain.For all pains of trusted subordinate, the contracture of muscle arteries and veins, traumatic injury, sore, carbuncle and painful swelling; Externally used detumescence granulation promoting.

Thallus Laminariae (Thallus Eckloniae) is salty, cold.Return liver, stomach, kidney channel.Hard masses softening and resolving, expectorant, diuretic.For goiter, scrofula, painful and swollen testis, phlegm retention edema.

Squama Manis, salty, be slightly cold.Return liver, stomach warp.To stimulate the menstrual flow stimulating milk secretion, detumescence and apocenosis, expel wind to dredge collateral.For Jing Bi WEIJIA, galactostasis, carbuncle sore tumefacting virus, arthralgia, numbness contracture.

Bulbus Fritillariae Thunbergii is bitter, cold.Return lung, heart channel.Heat clearing away eliminating stagnation, preventing phlegm from forming and stopping coughing, for wind-heat invading the lung, phlegm-fire cough, lung abscess, acute mastitis, scrofula, sore.

Fructus Trichosanthis, sweet, micro-hardship, cold.Return lung, stomach, large intestine channel.Clearing away heat and eliminating phlegm, relieving stuffiness of the chest by dispersing aggregation of pathogens, moisturizes laxation.For cough due to lung-heat, the turbid Huang of expectorant is thick, obstruction of qi in the chest and cardialgia, blocked-up chest feeling of fullness, acute mastitis, lung abscess, and acute appendicitis swells and ache, constipation.

Ramulus Cinnamomi, acrid, sweet, warm.GUIXIN, lung, urinary bladder channel.Diaphoresis expelling pathogenic factors from muscles, promoting the flow of QI-blood by warming the meridian, supporing yang activating QI, the flat gas that spins.For anemofrigid cold, coldness and pain in the epigastrium, cold in blood amenorrhea, arthralgia, phlegm retention, edema, cardiopalmus, renal mass.

Pericarpium Citri Reticulatae, bitter, pungent, temperature.Return lung, spleen channel.Regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.

Semen Sinapis Albae, pungent; Temperature.Lung; Liver; Spleen; Stomach; Pericardium channel.Reduce phlegm by drink; Mass dissipating and swelling eliminating.Main cough with asthma abundant expectoration; Fullness in the chest and hypochondriac pain; Numb limbs and tense tendons; Arthralgia; Multiple abscess caused by damp-phlegm; Carbuncle of yin nature toxic swelling.

In side of the present invention, Radix Curcumae, Radix Bupleuri, the Radix Paeoniae Alba, Pericarpium Citri Reticulatae dispersing the stagnated live-QI to relieve the stagnation of QI, circulation of qi promoting are alleviated pain; Thallus Laminariae (Thallus Eckloniae), Fructus Trichosanthis, Semen Sinapis Albae invigorating the spleen for dissipating phlegm, hard masses softening and resolving; Bulbus Fritillariae Thunbergii removing heat-phlegm; Ramulus Cinnamomi, Squama Manis, Fructus Liquidambaris, Olibanum blood circulation promoting and blood stasis dispelling, inducing menstruation to relieve menalgia.Pharmaceutical composition reasonable recipe of the present invention, all medicines share, can dispersing the stagnated live-QI to relieve the stagnation of QI, inducing menstruation to relieve menalgia, dissipating phlegm and resolving masses, effectively can cure nodules of the breast particularly liver energy depression and phlegm stagnation type nodules of the breast disease.Through clinical practice checking, its determined curative effect, mild in medicine property and, do not occur toxic and side effects and untoward reaction, safety coefficient is high, and relapse rate is low, and clinical observation total effective rate reaches more than 95%.

Detailed description of the invention

Further describe the present invention below by way of specific embodiment, but the present invention is not limited only to following specific embodiment.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.

Embodiment 1

The each raw material of the present invention is taken: Radix Bupleuri 18 parts, Radix Curcumae 15 parts, the Radix Paeoniae Alba 15 parts, Fructus Liquidambaris 10 parts, Olibanum 20 parts, Thallus Laminariae (Thallus Eckloniae) 3 parts, Squama Manis 4 parts, Bulbus Fritillariae Thunbergii 18 parts, Pericarpium Citri Reticulatae 18 parts, Semen Sinapis Albae 10 parts, Fructus Trichosanthis 8 parts, Ramulus Cinnamomi 13 parts by following weight portion.

Preparation technology is as follows:

After the raw material Radix Bupleuri of above-mentioned weight portion, Radix Curcumae, the Radix Paeoniae Alba, Fructus Liquidambaris, Olibanum, Thallus Laminariae (Thallus Eckloniae), Squama Manis, Bulbus Fritillariae Thunbergii, Pericarpium Citri Reticulatae, Semen Sinapis Albae, Fructus Trichosanthis, Ramulus Cinnamomi are pulverized respectively, add the water of 6 times amount of medical material gross weight, decoct after 2 hours and filter, filtrate is concentrated into thick paste, crushed after being dried.Those skilled in the art directly can be used as medicine and be used or mix with appropriate microcrystalline Cellulose, hydroxypropyl cellulose on this basis, add 2% polyvidone alcoholic solution soft material, cross 20 mesh sieves and granulate, drying, adds magnesium stearate, 20 mesh sieve granulate, mixing, tabletting, to obtain final product.

When using medicine composite for curing nodules of the breast disease of the present invention, take prepared tablet, every sheet, containing crude drug amount 0.2g, every day 3 times, each 3, is taken after meal half an hour.

Embodiment 2

The each raw material of the present invention is taken: Radix Bupleuri 15 parts, Radix Curcumae 10 parts, the Radix Paeoniae Alba 10 parts, Fructus Liquidambaris 5 parts, Olibanum 15 parts, Thallus Laminariae (Thallus Eckloniae) 1 part, Squama Manis 1 part, Bulbus Fritillariae Thunbergii 15 parts, Pericarpium Citri Reticulatae 15 parts, Semen Sinapis Albae 5 parts, Fructus Trichosanthis 5 parts, Ramulus Cinnamomi 10 parts by following weight portion.

Preparation technology is with embodiment 1.

Embodiment 3

The each raw material of the present invention is taken: Radix Bupleuri 20 parts, Radix Curcumae 20 parts, the Radix Paeoniae Alba 20 parts, Fructus Liquidambaris 15 parts, Olibanum 25 parts, Thallus Laminariae (Thallus Eckloniae) 6 parts, Squama Manis 8 parts, Bulbus Fritillariae Thunbergii 20 parts, Pericarpium Citri Reticulatae 20 parts, Semen Sinapis Albae 15 parts, Fructus Trichosanthis 10 parts, Ramulus Cinnamomi 16 parts by following weight portion.

Preparation technology is with embodiment 1.

Embodiment 4

The each raw material of the present invention is taken: Radix Bupleuri 15 parts, Radix Curcumae 10 parts, the Radix Paeoniae Alba 20 parts, Fructus Liquidambaris 15 parts, Olibanum 15 parts, Thallus Laminariae (Thallus Eckloniae) 6 parts, Squama Manis 8 parts, Bulbus Fritillariae Thunbergii 20 parts, Pericarpium Citri Reticulatae 15 parts, Semen Sinapis Albae 5 parts, Fructus Trichosanthis 10 parts, Ramulus Cinnamomi 16 parts by following weight portion.

Preparation technology is with embodiment 1.

Embodiment 5

The each raw material of the present invention is taken: Radix Bupleuri 20 parts, Radix Curcumae 20 parts, the Radix Paeoniae Alba 10 parts, Fructus Liquidambaris 5 parts, Olibanum 25 parts, Thallus Laminariae (Thallus Eckloniae) 1 part, Squama Manis 1 part, Bulbus Fritillariae Thunbergii 15 parts, Pericarpium Citri Reticulatae 20 parts, Semen Sinapis Albae 15 parts, Fructus Trichosanthis 5 parts, Ramulus Cinnamomi 10 parts by following weight portion.

Preparation technology is with embodiment 1.

The clinical observation of embodiment 6 medicine composite for curing nodules of the breast of the present invention

1, case-data: that selects hospital ward and outpatient clinic meets liver energy depression and phlegm stagnation type nodules of the breast patient 110 example, is divided into treatment group, matched group at random.

Wherein, treatment group: in 55 routine patients, married 39 examples, unmarried 16 examples; The oldest 39 years old, minimum 25 years old, 29 years old mean age; The course of disease 6 months-4 years; Bilateral breast hypertrophy 35 example, one-sided cyclomastopathy 20 example; Gestation one tire person 47 example, above person 8 example of two tires; More than post-secondary education 40 examples, following 15 examples.

Matched group: in 55 routine patients, married 37 examples, unmarried 18 examples; The oldest 40 years old, minimum 26 years old, 30 years old mean age; The course of disease 5 months-3.5 years; Bilateral breast hypertrophy 32 example, one-sided cyclomastopathy 23 example; Gestation one tire person 48 example, above person 7 example of two tires; More than post-secondary education 39 examples, following 16 examples.

The physical data there was no significant differences such as two groups of Genders, age, courses of disease, have comparability.

2, diagnosis basis:

(1) tcm diagnosis standard:

1) most have a flat lump at the outside upper quadrant of breast, and that lays one's hand on has the tough hard tubercle of beans size, can have tenderness.Lump border owes clear, with surrounding tissue adhesion.;

2) breast can have distending pain, the often growth and decline with susceptible to anger, and the moon of being everlasting is premenstrual to be increased the weight of, and alleviates after menstruation;

3) primary disease is more common in 20-40 year women;

4) molybdenum palladium x-ray breast is taken the photograph sheet, cold light source strong illumination, liquid crystal thermography picture etc. inspections and is helped diagnosis.Make histopathological examination if desired.

(2) liver energy depression and phlegm stagnation disease CM syndrome differentiation criterion: be more common between twenty and fifty women.Lump in breast, with susceptible to anger growth and decline, with feeling of oppression over the chest and distention of hypochondrium, is apt to strongly fragrant irritability, insomnia and dreamful sleep, vexed bitter taste.Tongue fur BOHUANG, stringy and rolling pulse.

3, case standard is included in:

(1) age 20-45 year, women;

(2) tcm diagnosis standard and syndrome CM syndrome differentiation criterion is met;

The medicine on hepatic and renal function impact was not used in (3) 3 months;

(4) not yet in effect or postoperative recurrence person half a year more than is treated through Chinese and western drugs;

(5) clinical observation " Informed Consent Form " is signed.

4, Excluded cases standard:

(1) clinical observation " Informed Consent Form " is not signed;

(2) gestation or women breast-feeding their children;

(3) drug allergy or can not resistance to receptor is used to this research;

(4) the severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system are associated with, psychotic;

(5) breast tumor is merged, mastitis or other mastopathy person;

(6) age is below 20 years old or more than 45 years old person.

5, case standard is rejected:

(1) rear discovery is included in exclusion standard disease patient;

(2) case of medication is not specified by testing program;

(3) drug administration process data logging is incomplete, cannot judge curative effect person.

6, to come off and termination criteria:

(1) observe in patient exit voluntarily, person lost to follow-up;

(2) there is the person that should not continue reception test such as complication or special physiological change in experimenter;

(3) serious adverse reaction occurs person in test, should stop clinical trial in time.

Come off and answer itemized record reason with the case stopped, and the switching of its last curative effect testing result is added up for final result.

7, usage and dosage:

Treatment group: take medicine composite for curing of the present invention, tablet prepared by Example 1, every sheet containing crude drug amount 0.2g, every day 3 times, each 3, after meal half an hour warm water delivery service.

Matched group: BUPIXIAO PIAN (traditional Chinese medicines accurate word Z21021822) is oral, one time 3,3 times on the one.

Two groups are taken 1 menstrual cycle is continuously 1 course for the treatment of, observe the curative effect after 3 courses for the treatment of.

8, curative effect determinate standard:

(1) cure: mastalgia is eliminated, lump in breast disappears;

(2) effective: mastalgia disappears, lump in breast disappearance > 1/2;

(3) effective: mastalgia alleviates, mass reduction > 1/3;

(4) invalid: mastalgia does not alleviate, lump in breast is unchanged or increase.

9, therapeutic effect:

In clinical observation process, treatment group comes off 3 routine cases, and matched group comes off 2 routine cases, and this 5 routine patient is all improvement backed off after randoms, and effectively to add up curative effect, all the other all complete clinical observation.Treatment group efficacy result is as follows: clinical cure 29 example (52.7%), effective 20 examples (36.4%), effective 5 examples (9.1%), invalid 1 example (1.8%), total effective rate 98.2%; Matched group clinical cure 4 example (7.3%), effective 21 examples (38.2%), effective 24 examples (43.6%), invalid 6 examples (10.9%), total effective rate 89.1%.Between two groups, total effective rate compares, and treatment group is apparently higher than matched group.

In treatment group therapeutic process, vital sign steadily and without serious adverse reactions such as allergy, treatment terminates rear lab index routine blood test, routine urinalysis etc. to the routine patient for the treatment of group 55 and carries out statistical procedures, shows no obvious abnormalities.Result shows that the clinical application of we is safely and effectively, can effectively eliminate cyclomastopathy lump, alleviating pain, is worth studying and applying further.

Claims (6)

1. treat the pharmaceutical composition of nodules of the breast for one kind, it is characterized in that, it is obtained by the raw material of following weight portion: Radix Bupleuri 15-20 part, Radix Curcumae 10-20 part, Radix Paeoniae Alba 10-20 part, Fructus Liquidambaris 5-15 part, Olibanum 15-25 part, Thallus Laminariae (Thallus Eckloniae) 1-6 part, Squama Manis 1-8 part, Bulbus Fritillariae Thunbergii 15-20 part, Fructus Trichosanthis 5-10 part, Ramulus Cinnamomi 10-16 part.

2. pharmaceutical composition as claimed in claim 1, it is characterized in that, described pharmaceutical composition also comprises Pericarpium Citri Reticulatae 15-20 part and Semen Sinapis Albae 5-15 part.

3. pharmaceutical composition as claimed in claim 2, it is characterized in that, it is obtained by the raw material of following weight portion: Radix Bupleuri 18 parts, Radix Curcumae 15 parts, the Radix Paeoniae Alba 15 parts, Fructus Liquidambaris 10 parts, Olibanum 20 parts, Thallus Laminariae (Thallus Eckloniae) 3 parts, Squama Manis 4 parts, Bulbus Fritillariae Thunbergii 18 parts, Pericarpium Citri Reticulatae 18 parts, Semen Sinapis Albae 10 parts, Fructus Trichosanthis 8 parts, Ramulus Cinnamomi 13 parts.

4. the pharmaceutical composition as described in as arbitrary in claim 1-3, it is characterized in that, described pharmaceutical composition is oral formulations.

5. pharmaceutical composition as claimed in claim 4, it is characterized in that, described oral formulations is tablet or capsule.

6. the purposes of the pharmaceutical composition as described in as arbitrary in claim 1-3 in preparation treatment liver energy depression and phlegm stagnation type nodules of the breast medicine.