CN105362851A - Method for preparing traditional Chinese medicine composition for treating hyperplasia of mammary glands - Google Patents
Method for preparing traditional Chinese medicine composition for treating hyperplasia of mammary glands Download PDFInfo
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Abstract
The invention discloses a method for preparing a traditional Chinese medicine composition for treating hyperplasia of mammary glands, and belongs to the technical field of traditional Chinese medicine. The preparation method comprises the following steps: respectively weighing radix clematidis, lychee seeds, radix salviae miltiorrhizae, uniflower swisscentaury root, rhizoma sparganii, semen cuscutae, herba abri, rhizoma cyperi, pericarpium citri reticulatae and mastic, drying, and smashing; uniformly mixing the smashed radix salviae miltiorrhizae, rhizoma cyperi, pericarpium citri reticulatae and mastic, and carrying out alcohol extraction concentration to obtain thick paste; uniformly mixing the smashed radix clematidis, lychee seeds, radix rhapontici, rhizoma sparganii, semen cuscutae and herba abri, and carrying out water extraction concentration to obtain thick paste; combining the two kinds of thick paste, drying and smashing to obtain the traditional Chinese medicine composition. Compared with the prior art, the traditional Chinese medicine composition prepared through the method has the advantages of simple formula, good curative effect and high efficiency, and deserves popularization and application.
Description
Technical field
The invention belongs to technical field of Chinese medicines, relate to a kind of method preparing the Chinese medicine composition for the treatment of cyclomastopathy.
Background technology
Cyclomastopathy is a kind of cystic hyperplasia of breast that women often sends out, and in the cystic hyperplasia of breast of women, sickness rate is higher.The clinical symptoms of usual performance is: mastalgia, and normally side or both sides breast twinge or distending pain, can feed through to costa sternales time serious, the positions such as axillary fossa, and impact normally works.This pain appears at after menstrual phase or time listless usually; In bilateral or one-sided breast, have lump to be also the main clinic symptoms of cyclomastopathy, mostly wherein be lamellar, lump in breast boundary line is not obvious, varies in size; Nipple discharge, small part cyclomastopathy patient also there will be the symptom of nipple overflowing liquid, and liquid mostly is brown or olive drab(O．D).
Doctor trained in Western medicine thinks that the generation of cyclomastopathy is closely related with human internal environment; mammary gland belongs to the target organ of gonadal hormone; gonadal hormone can stimulate the generation of cyclomastopathy, and progestogen can shield, and just may cause the generation of cyclomastopathy when the ratio of gonadal hormone and progestogen is disorderly.
The traditional Chinese medical science thinks that cyclomastopathy is due to the physiological hypertrophy of lobules of mammary gland and subinvolution, the race conditio that its normal configuration occurs, breast epithelium and fibrous tissue increase, and belong to a kind of pathologic proliferative disease, do not belong to inflammation and also do not belong to tumor.Cyclomastopathy is because caused by depression of liver-QI mostly viewed from traditional Chinese medical science angle.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of Chinese medicine composition for the treatment of cyclomastopathy and preparation method thereof.
The Chinese medicine composition that the present invention treats cyclomastopathy is achieved through the following technical solutions:
Treat a Chinese medicine composition for cyclomastopathy, be prepared from by following Chinese crude drug: Radix Clematidis, Semen Litchi, Radix Salviae Miltiorrhizae, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae, Herba Abri, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum.
Particularly, treat a Chinese medicine composition for cyclomastopathy, be prepared from by the Chinese crude drug of following weight portion: Radix Clematidis 7-19 part, Semen Litchi 5-16 part, Radix Salviae Miltiorrhizae 5-16 part, Radix Rhapontici 3-12 part, Rhizoma Sparganii 3-9 part, Semen Cuscutae 5-16 part, Herba Abri 5-16 part, Rhizoma Cyperi 12-24 part, Pericarpium Citri Reticulatae 3-12 part, Olibanum 5-16 part.
Preferably, treat a Chinese medicine composition for cyclomastopathy, be prepared from by the Chinese crude drug of following weight portion: Radix Clematidis 12 parts, Semen Litchi 6 parts, Radix Salviae Miltiorrhizae 6 parts, Radix Rhapontici 9 parts, Rhizoma Sparganii 6 parts, Semen Cuscutae 9 parts, Herba Abri 12 parts, Rhizoma Cyperi 18 parts, Pericarpium Citri Reticulatae 6 parts, Olibanum 6 parts.
Preferably, treat a Chinese medicine composition for cyclomastopathy, be prepared from by the Chinese crude drug of following weight portion: Radix Clematidis 15 parts, Semen Litchi 10 parts, Radix Salviae Miltiorrhizae 9 parts, Radix Rhapontici 5 parts, Rhizoma Sparganii 5 parts, Semen Cuscutae 7 parts, Herba Abri 7 parts, Rhizoma Cyperi 15 parts, Pericarpium Citri Reticulatae 8 parts, Olibanum 10 parts.
Another object of the present invention is to provide a kind of preparation method for the treatment of the Chinese medicine composition of cyclomastopathy, particularly, comprises following preparation process:
(1) Radix Clematidis, Semen Litchi, Radix Salviae Miltiorrhizae, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae, Herba Abri, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum is taken, respectively, drying and crushing, for subsequent use;
(2), get the Radix Salviae Miltiorrhizae after pulverizing, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum mixing, add the ethanol of the concentration 80%-90% of 6-12 times of weight, soak 1-6 hour, reflux, extract, 2 times, each 1-2 hour, filters, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(3), get the Radix Clematidis after pulverizing, Semen Litchi, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae and Herba Abri mixing, add the water of 6-12 times of weight, soak 1-12 hour, backflow decoction 3 times, each 1-2 hour, filters, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(4), the thick paste of combining step (2) and (3) gained, drying and crushing, is prepared into tablet, capsule, granule or oral liquid with pharmaceutically acceptable carrier.
The meridian distribution of property and flavor of the present invention recorded in documents and materials all tastes medical material, function to cure mainly etc. as follows:
Radix Clematidis: pungent, salty, temperature.Return urinary bladder channel.Wind-damp dispelling, removing obstruction in the collateral to relieve pain, disappear a fishbone or other bone caught in the throat.Be mainly used in rheumatism arthromyodynia, fishbone caught in throat, traumatic pain, headache, toothache, gastric abscess, and phlegm retention, dysphagic, Fu Nv mass in the abdomen amass block, lump in breast etc.Doctor trained in Western medicine is examined as hysteromyoma, cyclomastopathy, breast carcinoma belong to phlegm-damp stagnation, qi depression to blood stasis person.The pungent loose temperature general character of Radix Clematidis is violent, and be apt to away not keep, a surname for wind medicine leads kind passerby, master enters urinary bladder channel, and can pass through the twelve regular channels, therefore can drive away the wind at table, can change again inner wet, sensible meridians, can lead and can declare, can hard masses softening and resolving, Keization mass in the abdomen again, eliminate a fishbone or other bone caught in the throat, conventional control a fishbone or other bone caught in the throat and Fu Nv mass in the abdomen amasss block, breast caking etc.
Semen Litchi: pungent, micro-hardship, temperature.Return liver, stomach warp.Promoting QI to circulate and dispersing the agglomeration of the pathogens, dispersing cold for relieving pain.Be mainly used in the colicky of QI stagnated by cold, painful and swollen testis, the gastric abscess of incoordination between the liver and stomach, the dysmenorrhea of stagnation of QI due to depression of the liver blood stasis and puerperal abdonimal pain etc.Doctor trained in Western medicine is examined as chronic gastritis, chronic hepatitis belong to irritability stasis or incoordination between the liver and stomach person, and chronic adnexitis, ovarian cyst, hysteromyoma, cyclomastopathy, dysmenorrhea belong to irritability stasis person.Semen Litchi is worked hard catharsis, has depressed liver-energy dispersing and QI regulating, promoting QI to circulate and dispersing the agglomeration of the pathogens, the merit of dispersing cold for relieving pain.Control the gastral cavilty pain of a specified duration of depression of liver-QI, incoordination between the liver and stomach; The dysmenorrhea of stagnation of QI due to depression of the liver blood stasis and puerperal abdonimal pain.
Radix Salviae Miltiorrhizae: bitter, is slightly cold.GUIXIN, pericardium, Liver Channel.Promoting blood flow to regulate menstruation, stasis-dispelling and pain-killing, removing heat from blood eliminating carbuncle, relieving restlessness is calmed the nerves.Be mainly used in menoxenia caused by stagnation of blood stasis, dysmenorrhea, amenorrhea, postpartum stagnation is suffered from abdominal pain, blood stasis is pained, epigastric pain, lumps in the chest and abdomen, rheumatic arthralgia, traumatic injury.The drop-down of Radix Salviae Miltiorrhizae bitter in the mouth, be slightly cold heat clearing away, main enter blood system, merit is arrogated to oneself blood circulation promoting and blood stasis dispelling and is stimulated the menstrual flow, can promoting tissue regeneration by removing blood stasis and just not hindering.Radix Salviae Miltiorrhizae kind energy blood circulation promoting and blood stasis dispelling, inducing menstruation to relieve menalgia, Xiao Chu mass in the abdomen is Fuke Tiaojing common medicine.Can removing heat from blood and promoting blood circulation, again can heat clearing away eliminating carbuncle.
Radix Rhapontici: bitter, cold.Return stomach warp.Heat-clearing and toxic substances removing, eliminating carbuncle eliminating stagnation, stimulating milk secretion of stimulating the menstrual flow, relaxing muscles and tendons is promoted blood circulation.Be mainly used in that treatment acute mastitis swells and ache, scrofula sore, agalactia, arthralgia chiefly caused by damp pathogen contracture etc.Doctor trained in Western medicine is examined as acute mastitis, cyclomastopathy, mammary neoplasms, herpes simplex, pyogenic infection, Neck lymphatic tuberculosis, rheumatoid arthritis, rheumatic arthritis etc. belong to the pyretic toxicity person of penting up.Radix Rhapontici bitter cold is fallen and is let out, and has the merit of heat-clearing and toxic substances removing, eliminating carbuncle eliminating stagnation, particularly controls the good medicine of acute mastitis.Therefore conventional control carbuncle sore tumefacting virus, acute mastitis swells and ache.Radix Rhapontici bitter in the mouth falls to be let out, and has the effect of stimulating milk secretion of stimulating the menstrual flow, therefore can be used for newborn network and stop up stagnant, agalactia and distending pain of the breast etc.
Rhizoma Sparganii: pungent, bitter is flat.Return liver, spleen channel.Removing blood stasis circulation of qi promoting, removing food stagnancy pain relieving.Be mainly used in caused by energy stagnation and blood stasis lumps in the chest and abdomen, amenorrhea, trusted subordinate's stasis of blood pain, stagnation of QI due to dyspepsia, abdominal distention, traumatic injury, pain caused by ecchymoma etc.Doctor trained in Western medicine is examined as hepatosplenomegaly, liver cirrhosis, hepatocarcinoma, gastric cancer, esophageal carcinoma, breast carcinoma, cervical cancer, ovarian cyst, hysteromyoma etc. belong to syndrome of qi stagnation and blood stasis person, and soft tissue injury, wound swell and ache and belong to blood-stasis syndrome person.Rhizoma Sparganii acrid in the mouth is capable loose, bitter in the mouth drop-down, and both entered blood system and to have fallen apart Yu Xiao Disorder with removing blood stasis, entering again edema caused by disorder of QI with the pain relieving of circulation of qi promoting removing food stagnancy, is the key medicine of removing mass of assaulting fortified position.Commonly use and control caused by energy stagnation and blood stasis lumps in the chest and abdomen, amenorrhea, trusted subordinate's stasis of blood pain, and traumatic injury, pain caused by ecchymoma.
Semen Cuscutae: sweet, temperature.Return liver,kidney,spleen warp.YANG invigorating tonifying YIN, controlling nocturnal emission with astringent drugs reducing urination, improving eyesight antidiarrheal.Be mainly used in soreness of waist and knee joint, impotence and seminal emission, enuresis frequent micturition, deficiency of the liver and kindey, poor vision, deficiency of spleen-YANG and kidneyYANG, have loose bowels in loose stool, frequent fetal movement, blood leaking in gestation etc.Doctor trained in Western medicine is examined as chronic nephritis, diabetes, aldosteronism, hypothyroidism, sexual neurasthenie, hypoadrenocorticism, the climacteric syndrome person that belongs to insufficiency of kidney-YANG, hypertension, interior Ménière belong to deficiency of the liver and kindey person, central serous chorioretinopathy, optic neuritis, vitreous opacity belong to deficiency of the liver and kindey.The sweet temperature of Semen Cuscutae, energy invigorating the liver and kidney, Gu Chong appoints and antiabortive hemostasis, again the frequent fetal movement of available treating the liver kidney deficiency, vaginal bleeding during pregnancy hematochezia.
Herba Abri: sweet, micro-hardship is cool.Return liver, stomach warp.Dampness removing jaundice eliminating, heat-clearing and toxic substances removing, dispersing the depressed liver-QI for alleviating pain.Be mainly used in that jaundice, acute mastitis, side of body rib do not relax, epigastric distending pain etc.Doctor trained in Western medicine is examined as icterohepatitis, infectious hepatitis belong to damp and hot person, and mastitis, stomachache, cyclomastopathy, hysteria belong to irritability stasis person.The micro-hardship of Herba Abri property, has the merit of heat-clearing and toxic substances removing, treatment acute mastitis.Herba Abri enters liver, stomach two warp, tool dispersing the depressed liver-QI for alleviating pain effect, and the side of body rib controlling depression of liver-QI does not relax, gastralgia.
Rhizoma Cyperi: pungent, micro-hardship, micro-sweet, flat.Return liver, spleen, tri-jiao channel.Dispersing the stagnated live-QI to relieve the stagnation of QI, menstruction regulating and pain relieving, regulates the flow of vital energy in adjusting.Be mainly used in stagnation of QI due to depression of the liver hypochondriac pain, stomachache, menoxenia, dysmenorrhea, distending pain of the breast, abdominal pain due to stagnation of QI etc.Doctor trained in Western medicine is examined as chronic gastritis, gastroduodenal ulcer, cholecystitis, chronic hepatitis, liver cirrhosis, cholelithiasis, chronic pancreatitis, simple goiter, cyclomastopathy, primary dysmenorrhea, secondary dysmenorrhea, menoxenia, ovarian cyst, pelvic inflammatory disease etc. belong to stagnation of QI due to depression of the liver person.Rhizoma Cyperi acrid in the mouth, micro-hardship, micro-sweet and property are put down, and enter Liver Channel, and pungent energy passes through, the pent-up of kind loose irritability, bitter can catharsis, with the perverse and unreasonable manner of suppressing the hyperactive liver gas, micro-sweet emergency is the key medicine of dispersing the stagnated live-QI to relieve the stagnation of QI, promoting the circulation of QI to relieve pain.Rhizoma Cyperi is longer than dispersing the stagnated live-QI to relieve the stagnation of QI, the capable then blood of gas, QI and blood tonneau, and catharsis is adjusted and reached, then menstruation self-regulated, and pain, from only, is again the key medicine of Fuke Tiaojing pain relieving, for stagnation of QI due to depression of the liver, and menoxenia, dysmenorrhea, distending pain of the breast etc.
Pericarpium Citri Reticulatae: pungent, bitter, temperature.Return spleen, lung meridian.Regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.Be mainly used in stagnation of QI in spleen and stomach card, vomiting, singultus, damp-phlegm, cold-phlegm cough, the thoracic obstruction etc.Doctor trained in Western medicine is examined as gastritis, gastric and duodenal ulcers, colitis, chronic hepatitis, pancreatitis, cholelithiasis, dysentery etc. belong to stagnation of QI in spleen and stomach person, and bronchitis, pneumosilicosis, hypertension, coronary heart disease, hyperlipemia, Simple Obesity etc. belong to the turbid inner stopper of expectorant.The pungent row temperature of Pericarpium Citri Reticulatae is led to, and fragrance is amusing, main enter spleen channel and the stagnant gas of row, therefore can promoting the circulation of QI to relieve pain, spleen invigorating and in, control the abdominal distention of stagnation of QI in spleen and stomach, belch acid regurgitation, nausea and vomiting, constipation or diarrhoea etc.
Olibanum: pungent, bitter, temperature.GUIXIN, liver, spleen channel.Blood-activating and qi-promoting pain relieving, detumescence and promoting granulation.Be mainly used in all pain cards of stagnation of blood stasis, as trusted subordinate's pain, dysmenorrhea, postpartum stagnation stomachache, rheumatic arthralgia, lumps in the chest and abdomen, traumatic injury, skin infection carbuncle etc.Doctor trained in Western medicine is examined as coronary heart disease, stomachache, dysmenorrhea, rheumatic arthritis, cancer pain etc. belong to syndrome of blood stasis and stagnant qi person, fracture, soft tissue injury, acute appendicitis etc. belong to blood-stasis syndrome person.Pungent loose, hardship is fallen, temperature the is logical property of Olibanum, fragrance is walked to alter, can blood circulation promoting and blood stasis dispelling, and can circulation of qi promoting fall apart stagnant again, relieving pain, be the common medicine that stagnation of QI and blood pain is demonstrate,proved.Therefore chest pain, hypochondriac pain, cardiac and abdominal pain, dysmenorrhea, puerperal abdonimal pain, rheumatic arthralgia etc. caused by all stagnation of QI and blood all available it.
The Chinese medicine composition that the present invention treats cyclomastopathy has following advantage:
1. in prescription of the present invention, all medicines share, can depressed liver-energy dispersing and QI regulating, dissipating phlegm and resolving masses, resolving depression pain relieving, promoting flow of QI and blood, dredge newborn network, significantly can reduce body of gland thickness, hypertrophy lump maximum gauge and conduit diameter, it reduces amplitude and have significant difference compared with existing medicine;
2. flavour of a drug are easy to get, and formula is simple, and average daily dosage is few, and safety is high;
3. good effect, effective percentage is high, without obvious side effect.
Therefore, the present invention's also application of claimed above-mentioned Chinese medicine composition in the medicine of preparation treatment cyclomastopathy.
Detailed description of the invention
Further illustrate the present invention below by embodiment, it should be understood that embodiments of the invention are for illustration of the present invention instead of limitation of the present invention.Essence according to the present invention all belongs to the scope of protection of present invention to the simple modifications that the present invention carries out.
Embodiment 1
Component (weight portion): Radix Clematidis 12 parts, Semen Litchi 6 parts, Radix Salviae Miltiorrhizae 6 parts, Radix Rhapontici 9 parts, Rhizoma Sparganii 6 parts, Semen Cuscutae 9 parts, Herba Abri 12 parts, Rhizoma Cyperi 18 parts, Pericarpium Citri Reticulatae 6 parts, Olibanum 6 parts.
Preparation method:
(1) Radix Clematidis, Semen Litchi, Radix Salviae Miltiorrhizae, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae, Herba Abri, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum is taken, respectively, drying and crushing, for subsequent use;
(2), get the Radix Salviae Miltiorrhizae after pulverizing, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum mixing, add the ethanol of the concentration 90% of 10 times of weight, soaks 2 hours, reflux, extract, 2 times, each 1 hour, filtration, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(3), get the Radix Clematidis after pulverizing, Semen Litchi, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae and Herba Abri mixing, add the water of 10 times of weight, soak 6 hours, backflow decoction 3 times, each 1 hour, filters, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(4), the thick paste of combining step (2) and (3) gained, drying and crushing, adds the adjuvant such as sweeting agent, dextrin, mixing, granulates, dry, granulate, and subpackage, obtains granule, and pack, every bag of 3.0g, containing crude drug 1.0g.
Embodiment 2
Component (weight portion): Radix Clematidis 15 parts, Semen Litchi 10 parts, Radix Salviae Miltiorrhizae 9 parts, Radix Rhapontici 5 parts, Rhizoma Sparganii 5 parts, Semen Cuscutae 7 parts, Herba Abri 7 parts, Rhizoma Cyperi 15 parts, Pericarpium Citri Reticulatae 8 parts, Olibanum 10 parts.
Preparation method is with embodiment 1.
Embodiment 3
Component (weight portion): Radix Clematidis 7 parts, Semen Litchi 5 parts, Radix Salviae Miltiorrhizae 5 parts, Radix Rhapontici 3 parts, Rhizoma Sparganii 3 parts, Semen Cuscutae 5 parts, Herba Abri 5 parts, Rhizoma Cyperi 12 parts, Pericarpium Citri Reticulatae 3 parts, Olibanum 5 parts.
Preparation method:
(1) Radix Clematidis, Semen Litchi, Radix Salviae Miltiorrhizae, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae, Herba Abri, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum is taken, respectively, drying and crushing, for subsequent use;
(2), get the Radix Salviae Miltiorrhizae after pulverizing, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum mixing, add the ethanol of the concentration 80% of 10 times of weight, soaks 2 hours, reflux, extract, 2 times, each 1 hour, filtration, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(3), get the Radix Clematidis after pulverizing, Semen Litchi, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae and Herba Abri mixing, add the water of 10 times of weight, soak 4 hours, backflow decoction 3 times, each 1 hour, filters, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(4), the thick paste of combining step (2) and (3) gained, drying and crushing, filling capsule, obtains capsule, and every containing crude drug 0.25g.
Embodiment 4
Component (weight portion): Radix Clematidis 19 parts, Semen Litchi 16 parts, Radix Salviae Miltiorrhizae 16 parts, Radix Rhapontici 12 parts, Rhizoma Sparganii 9 parts, Semen Cuscutae 16 parts, Herba Abri 16 parts, Rhizoma Cyperi 24 parts, Pericarpium Citri Reticulatae 12 parts, Olibanum 16 parts.
Preparation method:
(1) Radix Clematidis, Semen Litchi, Radix Salviae Miltiorrhizae, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae, Herba Abri, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum is taken, respectively, drying and crushing, for subsequent use;
(2), get the Radix Salviae Miltiorrhizae after pulverizing, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum mixing, add the ethanol of the concentration 90% of 10 times of weight, soaks 2 hours, reflux, extract, 2 times, each 1 hour, filtration, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(3), get the Radix Clematidis after pulverizing, Semen Litchi, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae and Herba Abri mixing, add the water of 10 times of weight, soak 6 hours, backflow decoction 3 times, each 1 hour, filters, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(4), the thick paste of combining step (2) and (3) gained, drying and crushing, every 100g powder adds refined honey 80-90g and makes concentrated honeyed pill, obtains big honeyed pills, and every containing crude drug 1g.
Embodiment 5
Component (weight portion): Radix Clematidis 8 parts, Semen Litchi 15 parts, Radix Salviae Miltiorrhizae 6 parts, Radix Rhapontici 11 parts, Rhizoma Sparganii 4 parts, Semen Cuscutae 15 parts, Herba Abri 6 parts, Rhizoma Cyperi 22 parts, Pericarpium Citri Reticulatae 4 parts, Olibanum 15 parts.
(1) Radix Clematidis, Semen Litchi, Radix Salviae Miltiorrhizae, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae, Herba Abri, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum is taken, respectively, drying and crushing, for subsequent use;
(2), get the Radix Salviae Miltiorrhizae after pulverizing, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum mixing, add the ethanol of the concentration 85% of 8 times of weight, soaks 2 hours, reflux, extract, 2 times, each 1 hour, filtration, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(3), get the Radix Clematidis after pulverizing, Semen Litchi, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae and Herba Abri mixing, add the water of 10 times of weight, soak 6 hours, backflow decoction 3 times, each 1 hour, filters, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(4), the thick paste of combining step (2) and (3) gained, drying and crushing, adds appropriate hydroxypropyl methylcellulose, alcohol granulation, tabletting, obtains Tablets, and every sheet is containing crude drug 0.25g.
clinical trial:
1. physical data
Choose cyclomastopathy patient 192 example of accepting for medical treatment in October ,-2015 in January, 2014 as object of study, be divided into matched group at random, observe 1 group and observe 2 groups, each 64 examples.Matched group age 20-49 year, 40.21 years old mean age, the course of disease 7 days-5 years, average course of disease 4.24 years; Observe 1 group of age 23-50 year, 39.89 years old mean age, the course of disease 10 days-5 years, average course of disease 4.56 years; Observe 2 groups of age 25-52 years, 40.89 years old mean age, the course of disease 12 days-6 years, average course of disease 4.38 years.Above three groups of patients are all diagnosed as cyclomastopathy through color Doppler ultrasonography, get rid of symptoms such as having the change of nipple discharge, nipple and skin change simultaneously.Three groups are compared no difference of science of statistics (P > 0.05) and have comparability in age, the scoring of mammary gland tumor size, pain scores, TCM syndrome evaluation etc.
2. diagnose inclusive criteria:
1) mammary gland pain: mostly be bilateral, also can be one-sided, and characteristic of pain is that dull pain is touched a tender spot or distending pain, alters pain, or twinge, burning pain, can increase the weight of during the moon premenstrual or anxious state of mind;
2) mammary gland tumor: mostly be bilateral or for one-sided, lump form irregular (Tumor size not etc., form is not lamellar, plate-like, graininess, streak etc.), quality is soft tough or firmly tough, obscure boundary, has tenderness, with skin without adhesion;
3) auxiliary examination: the disorderly or Echoenhance of glandular tissue echo in the visible mammary gland of mammary gland color doppler flow imaging inspection, to owe all, visible irregular shape echo subtracts dark space.Breast molybdenum target X takes the photograph the visible mammary gland of sheet and presents comparatively uniform density and increase shade, can occur at a quadrant or multiple quadrant.The visible breast duct of pathological examination, acinus increase in various degree, expand, interstitial fibers hamartoplasia.
Above 1), 2) item is indispensable, and meet 3) any one person is namely diagnosable in item.
Exclusion standard: breast carcinoma; Merge small cyst or mammary gland fibroma; Gestation or age of sucking; Severe cardiac, lung, kidney, hemopoietic system and disease of immune system; To this institute drug allergy.
3. Therapeutic Method:
Observe 1 group: take granule prepared by the embodiment of the present invention 1, each 1 bag, one after each meal, 3 times/day.7 days 1 courses for the treatment of, serve on for 2 courses for the treatment of.
Observe 2 groups: take granule prepared by the embodiment of the present invention 2, each 1 bag, one after each meal, 3 times/day.7 days 1 courses for the treatment of, serve on for 2 courses for the treatment of.
Matched group: take RUPIXIAO capsule (specification is every 0.32g), each 5-6 grain, 3 times/day.Take 14 days continuously.
4. evaluation of clinical curative effect standard:
Recovery from illness: for mastalgia and mammary gland tumor disappear completely, and nothing recurrence in 3 months after drug withdrawal;
Effective: for mastalgia disappear but the maximum gauge of mammary gland tumor reduces more than 1/2;
Effective: for mastalgia symptom alleviates, mass reduction 1/2 or more;
Invalid: for mastalgia is without alleviating or increasing the weight of on the contrary, mammary gland tumor without reducing or increasing on the contrary, or simple mastalgia alleviate but lump without reducing.
Former three adds up to effectively total.
Relatively before and after patient treatment, body of gland thickness, hypertrophy lump maximum gauge, conduit diameter change situation, and clinical manifestation, the hematuria of treatments period close observation three groups of patients are conventional, hepatic and renal function, and a situation arises in record untoward reaction, if any abnormal timely drug withdrawal.
5. statistical procedures
Application SPSS18.0 statistical software, measurement data represents with (x ± s), adopts t inspection and X
2inspection.
6. experimental result:
6.1 3 groups of Clinical efficacy comparisons, three groups of patients treat through adopting diverse ways, and the treatment cure rate observing 1 group of patient is 43.8%, and the treatment cure rate observing 2 groups of patients is 39.1%, all apparently higher than 9.4% of matched group; The treatment total effective rate simultaneously observing 1 group of patient can reach 98.4%, and apparently higher than 78.1% of matched group, difference all has statistical significance (P<0.05).In table 1.
Table 1 three groups of Clinical efficacy comparison n(%)
Compare with matched group,
*p<0.05.
6.2 color Doppler ultrasonography results.
Body of gland thickness, hypertrophy lump maximum gauge, conduit diameter change situation in table 2
Table 2 three groups of patient's body of gland thickness, hypertrophy lump maximum gauge, conduit diameter compare (x ± s, mm)
Note: with organize treat before compared with
*p < 0.05, compared with after matched group patient treatment
#p < 0.05.
6.3 untoward reaction:
Three groups of patients check blood, routine urinalysis and renal function after the treatment and are showed no obvious abnormalities change; Observation group has no adverse reaction patient.
There are 5 routine untoward reaction in matched group, a routine menstruation shifts to an earlier date, 2 routine blood pressures reduce, 2 example diarrhoea, but symptom is all comparatively slight, does not affect treatment.
Claims (4)
1. prepare a method for the Chinese medicine composition for the treatment of cyclomastopathy, it is characterized in that, described preparation method comprises the following steps:
(1) Radix Clematidis, Semen Litchi, Radix Salviae Miltiorrhizae, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae, Herba Abri, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum is taken, respectively, drying and crushing, for subsequent use;
(2), get the Radix Salviae Miltiorrhizae after pulverizing, Rhizoma Cyperi, Pericarpium Citri Reticulatae and Olibanum mixing, add the ethanol of the concentration 80%-90% of 6-12 times of weight, soak 1-6 hour, reflux, extract, 2 times, each 1-2 hour, filters, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(3), get the Radix Clematidis after pulverizing, Semen Litchi, Radix Rhapontici, Rhizoma Sparganii, Semen Cuscutae and Herba Abri mixing, add the water of 6-12 times of weight, soak 1-12 hour, backflow decoction 3 times, each 1-2 hour, filters, merging filtrate, filtrate being concentrated into 60 DEG C of relative densities is the thick paste of 1.15-1.25;
(4), the thick paste of combining step (2) and (3) gained, drying and crushing, to obtain final product.
2. the method for the Chinese medicine composition of preparation treatment cyclomastopathy as claimed in claim 1, it is characterized in that, the weight portion of described traditional Chinese medicinal material raw materials is: Radix Clematidis 7-19 part, Semen Litchi 5-16 part, Radix Salviae Miltiorrhizae 5-16 part, Radix Rhapontici 3-12 part, Rhizoma Sparganii 3-9 part, Semen Cuscutae 5-16 part, Herba Abri 5-16 part, Rhizoma Cyperi 12-24 part, Pericarpium Citri Reticulatae 3-12 part, Olibanum 5-16 part.
3. the method for the Chinese medicine composition of preparation treatment cyclomastopathy as claimed in claim 2, it is characterized in that, the weight portion of described traditional Chinese medicinal material raw materials is: Radix Clematidis 12 parts, Semen Litchi 6 parts, Radix Salviae Miltiorrhizae 6 parts, Radix Rhapontici 9 parts, Rhizoma Sparganii 6 parts, Semen Cuscutae 9 parts, Herba Abri 12 parts, Rhizoma Cyperi 18 parts, Pericarpium Citri Reticulatae 6 parts, Olibanum 6 parts.
4. the method for the Chinese medicine composition of preparation treatment cyclomastopathy as claimed in claim 2, it is characterized in that, the weight portion of described traditional Chinese medicinal material raw materials is: Radix Clematidis 15 parts, Semen Litchi 10 parts, Radix Salviae Miltiorrhizae 9 parts, Radix Rhapontici 5 parts, Rhizoma Sparganii 5 parts, Semen Cuscutae 7 parts, Herba Abri 7 parts, Rhizoma Cyperi 15 parts, Pericarpium Citri Reticulatae 8 parts, Olibanum 10 parts.
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