CN101850093B

CN101850093B - Medicinal composition for treating hyperplasia of mammary glands

Info

Publication number: CN101850093B
Application number: CN2010102097677A
Authority: CN
Inventors: 陈国水
Original assignee: Individual
Current assignee: Individual
Priority date: 2010-06-25
Filing date: 2010-06-25
Publication date: 2011-10-12
Anticipated expiration: 2030-06-25
Also published as: CN101850093A

Abstract

The invention relates to the field of medicinal preparations, in particular to a medicinal composition for treating hyperplasia of mammary glands and a preparation method thereof. The medicinal composition is prepared by processing Chinese medicinal plants of herb of common christia, paris polyphylla, chaff flower root, Siberia cocklebur whole herb, dotomitum, catechu, dragon's blood, scorpion, centipede, frankincense, myrrh, radix rehmanniae, Japanese ampelopsis root, bletilla hyacinthina reichb, weeping forsythia, raw common monkshood mother root, raw kusnezoff monkshood root, cassia bark, angelica dahurlica, red peony root, lightyellow sophora root, cochinchina momordica seed, blister beetle, hair, camphor, Chinese eaglewood, semen gleditsiae, fructus gardeniae, medlar, raw pinellia tuber, curcuma longa, peach twig, willow twig, sophora twig, minium, ephedra, oleum sesame and the like.

Description

A kind of pharmaceutical composition for the treatment of cyclomastopathy

Technical field

The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of pharmaceutical composition for the treatment of cyclomastopathy and preparation method thereof.

Background technology

Cyclomastopathy is the modal cystic hyperplasia of breast of women, and its sickness rate accounts for the first place of mastopathy.Should be the trend that rises year by year by the disease sickness rate in the last few years, the age also more and more becomes younger.Cyclomastopathy is meant breast epithelium and proliferation of fibrous tissue, mammary gland tissue conduit and the newborn lobule degeneration structurally and the growth of carrying out property connective tissue, and its pathogenic factor mainly is because the endocrine hormone imbalance.

There is 70%～80% women that in various degree cyclomastopathy is all arranged according to investigations approximately, is more common in 25～45 years old women.

The symptom of hyperplasia of mammary glands is a feature with breast periodicity pain mainly.Originally overflow the property distending pain for trip, touch a tender spot for the outer upside of breast and middle and upper part for obviously, the pain increased before the menstruation in every month, the back pain of passing through goes down or disappears.Severe patient through preceding through after all be rest pain.Sometimes pain is located radiation to armpit, shoulder back, upper limb etc.

Cyclomastopathy, traditional good traditional Chinese medical science on-line expert think that it is because depressed rage impairing the liver, worry impairing spleen, qi stagnation blood stasis, expectorant congeal into due to the nuclear, and Chinese medicine is referred to as " nodules of the breast ".Modern medicine is then thought, its generation develops and lapses to, and is because the intravital hormone cyclically-varying of women causes fully.Too high when the estrogen level of ovarian secretion, the corpus luteum progestogen are very few, and perhaps the two secretion is inharmonious, just can cause breast duct epithelial cell and proliferation of fibrous tissue in the breast.Under the normal condition, the acinus of the women's that each adolesces breast, glandular tube and fibrous tissue in each menstrual cycle, all will experience hypertrophy and restorative change in organization process.Because this change, each women the light or heavy distending pain of one or both sides breast might occur before menstruation each time, menstruation distending pain Lock-out again later, and this does not hinder life fully, and study and work is normal physiological phenomenon.But, (too nervous under the effect of body as work in some stressors, emotion is too exciting, advanced age is unmarried, not suckling in puerperal and suffer from some chronic disease etc.), just might cause breast should restorative cyclomastopathy tissue can not get restoring or meromorphosis, in the course of time, just form cyclomastopathy, show as the newborn leaf and the nodositas granule that thicken, three big sings and symptomses such as distending pain of the breast and nipple galactorrhea.

The medicine of the treatment cyclomastopathy of Xiao Shouing is more numerous and diverse in the market, and we find that by visiting patient and scientific research its therapeutic effect is not fine.

For this reason, we have invented a kind of pharmaceutical composition for the treatment of cyclomastopathy by constantly research and test.

Pharmaceutical composition of the present invention is by Herba Christiae, Rhizoma Paridis, Radix Achyranthis Bidentatae, Herba Xanthii herb, dotomitum, catechu, Sanguis Draxonis, Scorpio, Scolopendra, Olibanum, Myrrha, the Radix Rehmanniae, Radix Ampelopsis, the Pseudobulbus Bletillae (Rhizoma Bletillae) connects and calls Radix Aconiti, Radix Aconiti Kusnezoffii, Cortex Cinnamomi, the Radix Angelicae Dahuricae together, Radix Paeoniae Rubra, Radix Sophorae Flavescentis, Semen Momordicae, Mylabris, Crinis Carbonisatus, Camphora, Lignum Aquilariae Resinatum, Semen Gleditsiae, Fructus Gardeniae, Fructus Lycii, Rhizoma Pinelliae, Rhizoma Curcumae Longae, Ramulus Persicae, Ramulus Salicis Babylonicae, Rumalus sophorae, the Plumbum preparatium, Herba Ephedrae, Chinese crude drugs such as Oleum Sesami are through being processed into.

Wherein, Herba Christiae, another name: must ginseng, tylophora florlbunda, TUXIXIN, see perfume (or spice), source: asclepiadaceae Tylophora plant Herba Christiae.

Rhizoma Paridis, the Liliaceae herbaceos perennial.Yin Qiye mostly is 7 wheels and is born in the stem item, singly is born on the verticillate blade and gains the name and spend.Another name Rhizoma Paridis, Rhizoma Paridis, golden pan arrest Fructus Litchi, Rhizoma Paridis, Radix Schefflerae Arboricolae (Caulis et Folium Schefflerae Arboricolae), Shuan Tai, Herba Hemipiliae Flabellatae.Latin name Paris polyphylla var.chinensis.

Radix Achyranthis Bidentatae is the root of amaranthaceous plant Radix Achyranthis Bidentatae, Latin literary fame Radix Achyranthis Bidentatae.

Herba Xanthii is the fruit of the drying and ripening band involucre of feverfew Herba Xanthii, Xanthium sibiricum Patr.

Catechu is the peeling branch of pulse family albizzia plant catechu tree Acacia catechu (L.f.) Willd., dried dry soft extracts.Gather winter branch, do, remove crust, be chopped to bulk, decoct with water, concentrate drying

Sanguis Draxonis is the resin in babassu Sanguis Draxonis fruit and the trunk.

Scorpio has another name called Scorpio, Scorpio, Scorpio, reaches tens provinces in China place of production, have 15 surplus kind, the general designation Scorpio.

The Plumbum preparatium has another name called Plumbum preparatium, red powder, Zhu's powder, lead powder used in cosmetics.System closes refining with lead, sulfur, Sal Nitri etc. and forms.The Plumbum preparatium is plumbous oxide Pb304.

Oleum Sesami is Oleum sesami, and general Semen Sesami Nigrum is taken, the Semen sesami Albae oil expression, and it is the fatty oil that squeezes from Hu section plant sesame seed, also claims " siritch " " sesame oil " " Wang's oil " " Oleum sesami " etc.

The raw material that the present invention selects for use is the conventional Chinese medicine material, can buy in the market.

Plaster belongs to a kind of of external treatment of tcm, utilizes plaster to paste and controls disease, and in the history in existing over thousands of year of China, the theory and the oral medicine of its treatment disease are not different from, nothing but the approach difference of administration, " reason of external treatment, the i.e. reason of treatment by oral administration of medicines; The medicine of external treatment, that is the medicine of treatment by oral administration of medicines; The medical knowledge pharmacology does not have two, different person's method ear ".Simultaneously, plaster also have " letter, just, test, honest and clean ".The little oral medicine characteristics can't be obtained that wait of side effect are done in the proper way with it, and it imitates upright answering.Plaster is wonderful work in the Chinese medicine garden, be handed down from age to age over over thousands of year, flourishing long time, but since old times the closure of society and the conservative of traditional Chinese medical science idea handed down from one's ancestors, the progress of plaster is unhappy, most of so far plaster producers still stick to the established practice, still following ancestor's a cover, many drawbacks of its existence fail to overcome, and can not adapt to modern human needs, have also hindered the paces of plaster development.I constantly sums up on the basis of plaster, research, and improved formulations incorporates the modern medicine high-tech, strengthens drug level, innovates preparation process, improves the therapeutic domain and the therapeutic effect of plaster.

Summary of the invention

The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of cyclomastopathy.

Pharmaceutical composition of the present invention, specifically be processed into by following raw material process:

Herba Christiae 7.5-30g Rhizoma Paridis 10-30g Radix Achyranthis Bidentatae 7.5-30g Herba Xanthii 15-60g

Dotomitum 5-20g catechu 5-20g Sanguis Draxonis 5-20g Scorpio 7.5-30g

Scolopendra 5-15 bar Olibanum 7.5-30g Myrrha 7.5-30g Radix Rehmanniae 7.5-30g

Radix Ampelopsis 7.5-30g Pseudobulbus Bletillae (Rhizoma Bletillae) 7.5-30g Fructus Forsythiae 5-20g Radix Aconiti 5-20g

Radix Aconiti Kusnezoffii 5-20g Cortex Cinnamomi 5-20g Radix Angelicae Dahuricae 5-20g Radix Paeoniae Rubra 5-20g

Radix Sophorae Flavescentis 5-20g Semen Momordicae 5-20g Mylabris 5-20g Crinis Carbonisatus 15-60g

Camphora 5-20g Lignum Aquilariae Resinatum 7.5-30g Semen Gleditsiae 5-20g Fructus Gardeniae 5-20g

Fructus Lycii 5-20g Rhizoma Pinelliae 7.5-30g Rhizoma Curcumae Longae 5-20g Ramulus Persicae 5-20g

Ramulus Salicis Babylonicae 5-20g Rumalus sophorae 5-20g Plumbum preparatium 500-2000g Herba Ephedrae 5-20g

Oleum Sesami 1000-4000g.

Preferably, drug regimen of the present invention is:

Herba Christiae 15g Rhizoma Paridis 20g Radix Achyranthis Bidentatae 15g Herba Xanthii 30g

Dotomitum 10g catechu 10g Sanguis Draxonis 10g Scorpio 15g

10 Olibanum 15g of Scolopendra Myrrha 15g Radix Rehmanniae 15g

Radix Ampelopsis 15g Pseudobulbus Bletillae (Rhizoma Bletillae) 15g Fructus Forsythiae 10g Radix Aconiti 10g

Radix Aconiti Kusnezoffii 10g Cortex Cinnamomi 10g Radix Angelicae Dahuricae 10g Radix Paeoniae Rubra 10g

Radix Sophorae Flavescentis 10g Semen Momordicae 10g Mylabris 10g Crinis Carbonisatus 30g

Camphora 10g Lignum Aquilariae Resinatum 15g Semen Gleditsiae 10g Fructus Gardeniae 10g

Fructus Lycii 10g Rhizoma Pinelliae 15g Rhizoma Curcumae Longae 10g Ramulus Persicae 10g

Ramulus Salicis Babylonicae 10g Rumalus sophorae 10g Plumbum preparatium 1000g Herba Ephedrae 10g

Oleum Sesami 2000g.

More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.

The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of the amount of can corresponding adjustment forming increases or reduces being no more than 100%, and drug effect is constant.

Raw material of Chinese medicine, especially adjuvant drug in more than forming can be replaced with the suitable Chinese medicine with identical property of medicine with messenger drug, and its drug effect of the Chinese medicine preparation after the replacement is constant.

Chinese medicine preparation of the present invention is to process through extraction or other modes by the raw material of Chinese medicine that above-mentioned prescription is formed, and makes pharmaceutically active substance, subsequently, with this material is raw material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by the co-extracted raw material of Chinese medicine, also can obtain by other modes, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain, these active substances can be the material of extractum form, can be that dry extract also can be a fluid extract, make different concentration according to the different needs decision of preparation.

Pharmaceutical composition of the present invention, its pharmaceutically active substance makes through extracting processing, and processing can be adopted any combination in the said method.

Preferred preparation method of the present invention may further comprise the steps:

Except that Plumbum preparatium, Myrrha, Olibanum, Crinis Carbonisatus list are put, all the other medicines are cataclasm together, put into iron pan after cataclasm, soak medicine with Oleum Sesami; set fire subsequently and temper on the stove, stir until fried the picking up with the fingers of medicine floated, after the truce; pull medicinal residues out, get oil and filter, obtain medicine oil; add Crinis Carbonisatus again, after waiting to dissolve, add the Plumbum preparatium; heating is stirred, and Olibanum and Myrrha is joined in the medicine oil again; stir evenly, stop heating, get final product.

Further preferred, preparation method of the present invention is:

Except that Plumbum preparatium, Myrrha, Olibanum, Crinis Carbonisatus list were put, all the other medicines were cataclasm together, put into iron pan after cataclasm; soak medicine with Oleum Sesami; set fire subsequently and temper on the stove, stir back and forth until fried the picking up with the fingers of medicine floated with peach willow chopsticks, after the truce; pull medicinal residues out; get oil and filter, obtain medicine oil, add Crinis Carbonisatus again; after treating that it dissolves; add the Plumbum preparatium again, heating is with stirring towards a direction that peach willow chopsticks do not stop; make and emit blue or green cigarette in the pot; after become cloud and mist when overlapping, again Olibanum and Myrrha are joined in the medicine oil, stir evenly; can stop heating, obtain plaster.

Other preferred manufacturing procedure of the present invention in an embodiment.

Compositions of the present invention optionally adds suitable medicine acceptable carrier when being prepared into medicament.Compositions of the present invention active component wherein, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are the medicine acceptable carrier.

Compositions of the present invention obtains by above-mentioned active component and medicine acceptable carrier are mixed with.

Compositions of the present invention, its pharmaceutical dosage forms can be any pharmaceutically useful dosage forms, and composition medicine preparation of the present invention is unguentum preferably.

Described unguentum of the present invention is the externally applied ointment agent, determines usage and dosage according to patient's situation in use,

Usage and dosage: plaster, is affixed on the affected part at every day 1 time.30 days is 1 course of treatment.

Below further specify beneficial effect of the present invention by test data.

1, physical data

200 routine cyclomastopathy patients are as object of study.Patient age 20-50 year, 35 years old mean age, wherein unmarried 30 examples, married 170 examples, bilateral hyperplasia 120 examples, unilateral hyperplasia 80 examples.Be divided into treatment group (100 example) and matched group (100 example) at random, between 2 groups on age, the course of disease, site of pathological change and marital status distribute difference not statistically significant (p＞0.05).

2, diagnostic criteria

Diagnosis basis by relevant milk nodules of the breast in " traditional Chinese medical science disease diagnosis criterion of therapeutical effect " of State Administration of Traditional Chinese Medicine's promulgation in 1994: (1) majority quadrant outside breast has flat lump, that lays one's hand on has a tough hard tubercle of beans size, can be by tenderness, owe clearly on the lump border, with the surrounding tissue adhesion; (2) breast possibility distending pain, the growth and decline with susceptible to anger whenever increase the weight of before the menstruation of being everlasting, and alleviate after the menstruation; (3) be more common in 20-40 year women; (4) the nearly outside line surface sweeping of mammary gland helps diagnosis

3, Therapeutic Method

3.1, the outer affected part that is affixed on of experimental group (selecting the plaster of the embodiment of the invention 1 preparation for use), from menstrual onset the 14th day, end to next menstrual onset, 1 time/day, 30 days is 1 course of treatment, observes 2 courses of treatment;

3.2, matched group adopts BUPIXIAO PIAN (Shenyang Chinese Medicine Pharmaceutical Co., Ltd) oral, 5 slices/time, 2 times/day, from menstrual onset the 14th day, end to next menstrual onset, 30 days is 1 course of treatment, observes 2 courses of treatment.

4, criterion of therapeutical effect

According to " traditional Chinese medical science disease diagnosis criterion of therapeutical effect ", lump in breast and mastalgia disappear, for curing;

Lump in breast dwindles, and swells and ache to alleviate or disappear, and is to take a turn for the better;

Lump in breast and pain no change be not for healing.

5, therapeutic outcome

Group

The example number

Cure

Take a turn for the better

Do not heal

Cure rate

Total effective rate

Experimental group

100

77

20

3

77％

97％

Matched group

100

54

28

18

54％

82％

Experimental result shows that experimental group obviously is better than matched group on every index, and therapeutic effect is remarkable.

The major function of pharmaceutical composition of the present invention is: blood circulation promoting and blood stasis dispelling, remove the rotten and let fresh grow, and dispelling wind and removing obstruction in the collateral, hard eliminating stagnation disappears.

Pharmaceutical composition of the present invention be mainly used in treatment: cyclomastopathy, all treat malicious obstinate pyogenic sore of the skin, having burst does not burst can paste usefulness, the person that burst has the corruption putrefaction removing of drawing out pus by applying a plaster to the affected part, no necrotic tissue and promoting muscle growing is put on flesh, and the person that do not burst can subside a swelling, the contractile root foot can loose, draw out pus by applying a plaster to the affected part and carry pus, to all carbuncle, toxic swelling, sucutaneous nodule, multiple abscess, traumatic injury, bones and muscles pain, lump in breast, the inclined to one side boil on the nape opposite the mouth of furuncle and phyma, numb limbs and tense tendons, lumbago and skelalgia, ecthyma, suppurative osteomyelitis, vasculitis, back pad all can paste usefulness.

The specific embodiment

The invention will be further described by following specific embodiment, but not as limitation of the present invention.

Embodiment 1, unguentum

Dotomitum 10g catechu 10g Sanguis Draxonis 10g Scorpio 15g

10 Olibanum 15g of Scolopendra Myrrha 15g Radix Rehmanniae 15g

Oleum Sesami 2000g.

Embodiment 2, unguentum of the present invention

Herba Christiae 7.5g Rhizoma Paridis 10g Radix Achyranthis Bidentatae 7.5g Herba Xanthii 15g dotomitum 5g

5 Olibanum 7.5g of catechu 5g Sanguis Draxonis 5g Scorpio 7.5g Scolopendra

Myrrha 7.5g Radix Rehmanniae 7.5g Radix Ampelopsis 7.5g Pseudobulbus Bletillae (Rhizoma Bletillae) 7.5g Fructus Forsythiae 5g

Radix Aconiti 5g Radix Aconiti Kusnezoffii 5g Cortex Cinnamomi 5g Radix Angelicae Dahuricae 5g Radix Paeoniae Rubra 5g

Radix Sophorae Flavescentis 5g Semen Momordicae 5g Mylabris 5g Crinis Carbonisatus 15g Camphora 5g

Lignum Aquilariae Resinatum 7.5g Semen Gleditsiae 5g Fructus Gardeniae 5g Fructus Lycii 5g Rhizoma Pinelliae 7.5g

Rhizoma Curcumae Longae 5g Ramulus Persicae 5g Ramulus Salicis Babylonicae 5g Rumalus sophorae 5g Plumbum preparatium 500g

Herba Ephedrae 5g Oleum Sesami 1000g.

Embodiment 3, unguentum of the present invention

Herba Christiae 30g Rhizoma Paridis 30g Radix Achyranthis Bidentatae 30g herb 60g dotomitum 20g

15 Olibanum 30g of catechu 20g Sanguis Draxonis 20g Scorpio 30g Scolopendra

Myrrha 30g Radix Rehmanniae 30g Radix Ampelopsis 30g Pseudobulbus Bletillae (Rhizoma Bletillae) 30g Fructus Forsythiae 20g

Radix Aconiti 20g Radix Aconiti Kusnezoffii 20g Cortex Cinnamomi 20g Radix Angelicae Dahuricae 20g Radix Paeoniae Rubra 20g

Radix Sophorae Flavescentis 20g Semen Momordicae 20g Mylabris 20g Crinis Carbonisatus 60g Camphora 20g

Lignum Aquilariae Resinatum 30g Semen Gleditsiae 20g Fructus Gardeniae 20g Fructus Lycii 20g Rhizoma Pinelliae 30g

Rhizoma Curcumae Longae 20g Ramulus Persicae 20g Ramulus Salicis Babylonicae 20g Rumalus sophorae 20g Plumbum preparatium 2000g

Herba Ephedrae 20g Oleum Sesami 4000g.

The preparation method of embodiment 4, unguentum of the present invention

According to embodiment 1-4 any 1 assembly side preparation.

Claims

1. an externally-applied medicinal composition that is used for the treatment of cyclomastopathy is characterized in that, is processed into by following medical material process

2. pharmaceutical composition according to claim 1 is characterized in that, is processed into by following medical material process

3. pharmaceutical composition according to claim 1 and 2 wherein contains the medicine acceptable carrier.

4. pharmaceutical composition according to claim 1 and 2 is a unguentum.

5. a method for preparing claim 1 or 2 described pharmaceutical compositions is characterized in that, the raw material of Chinese medicine that prescription is formed is processed through extraction or other modes, making pharmaceutically active substance, subsequently, is raw material with this material, add the medicine acceptable carrier when needing, be mixed and made into.

6. the described method of claim 5 is characterized in that, may further comprise the steps:

7. the described method of claim 5 is characterized in that, may further comprise the steps:

8. claim 1 or the 2 described pharmaceutical compositions application in the medicine of preparation treatment cyclomastopathy.