CN103948782A - Pharmaceutical composition for treating hyperplasia of mammary glands due to stagnation of liver qi as well as preparation method and application of pharmaceutical composition - Google Patents
Pharmaceutical composition for treating hyperplasia of mammary glands due to stagnation of liver qi as well as preparation method and application of pharmaceutical composition Download PDFInfo
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Abstract
The invention provides a pharmaceutical composition for treating hyperplasia of mammary glands due to stagnation of liver qi. The pharmaceutical composition is a preparation prepared from the following bulk pharmaceuticals in parts by weight: 10-25 parts of Chinese thorowax root, 15-25 parts of baikal skullcap root, 10-20 parts of rhizoma pinellinae praeparata, 25-40 parts of tangerine seed, 23-35 parts of lychee seed, 5-15 parts of dried orange peel, 8-20 parts of green tangerine peel, 15-30 parts of tangerine pith, 10-25 parts of folium citri reticulatae, 10-20 parts of thunberg fritillary bulb, 10-20 parts of common selfheal fruit-spike and 3-10 parts of liquoric root. The invention further provides a preparation method and application of the pharmaceutical composition. By adopting the medicinal composition, breast pain can be relieved effectively, breast lumps are reduced, the number of lumps is reduced, and a new option is provided for the administration of hyperplasia of mammary glands due to stagnation of liver qi in clinical treatment. The medicinal composition has a good treatment effect on hyperplasia of mammary glands.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of caused by hepatic stagnation qi stagnation cyclomastopathy.
Background technology
Cyclomastopathy is western medicine name of disease, is the benign proliferative disease of a kind of non-inflammation, Non-cancerous mammary gland tissue.Primary disease is taking mastalgia and lump as main clinical manifestation, and approximately 2/3 patient's symptom presents cyclically-varying with menstrual cycle and anxious state of mind.Primary disease is the common disease of Women of Childbearing Age, clinically changes into main clinical manifestation with mastalgia, lump in breast, nipple discharge, menoxenia and feelings will.Epidemiological study shows that primary disease sickness rate accounts for the women of child-bearing age's 40% left and right, accounts for 75% of whole cystic hyperplasia of breast, is one of modal cystic hyperplasia of breast, and has certain canceration risk, and China has been classified as one of precancerous lesion now.This disease belongs to the traditional Chinese medical science " nodules of the breast " and " nodule in the breast " category, comprises pure cyclomastopathy, gland cyclomastopathy, capsule cyclomastopathy, body of gland fibroplasia and sclerosing adenosis etc. on Western medicine diagnose.Clinical discovery, it is one of Important cause of disease of cyclomastopathy that feelings will changes, feelings will is caused a disease inseparable with the function of liver controlling conveyance and dispersion.
The mechanism and the cause of disease that at present cyclomastopathy are occurred there is no definite understanding, for cyclomastopathy patient, how to alleviate patient's pain, eliminate lump in breast and prevent that recurrence from being fundamentally to realize treatment and successfully crucial, but cyclomastopathy is cause of disease complexity often, in treatment, be symptomatic treatment substantially.The clinical polytype that is divided into of cyclomastopathy, physiological cyclomastopathy, as Simple proliferation of mammary gland, does not need special handling, can disappear voluntarily.Because the cyclomastopathy that spirit, emotion and anthropic factor cause, by adjustment (other organ disease as relevant to mastopathy generation in timely diagnosis and treatment of self, regulate emotion, alleviate stress, change unsound dietary habit, discontinue the habit of smoking and drinking etc.) also can disappear or alleviate.Pathologic cyclomastopathy, needs active treatment, and especially cystic hyperplasia type, owing to there is the possibility of canceration, tends to aggravate outpatients mental state burden, further increases the weight of the state of an illness.At present western medical treatment pathologic cyclomastopathy often adopts hormonotherapy and operative therapy, but that hormone therapy may further aggravate between human hormone is unbalance, brings other adverse effect and complication to patient.There is great risk in operative treatment, patient can produce psychology fear simultaneously, increases patient's misery and financial burden.Western medicine, for the research and the result that treatment does not allow people convince of cyclomastopathy, also can not be obtained substantive breakthroughs afterwards in a period of time in a word.
Chinese medicine claims that cyclomastopathy is " nodules of the breast "." nodules of the breast " this call is proposed in " Huatuo's Zhongzang classic " that Huatuo shows the earliest.In " Required Readings for Medical Professionals ", point out: " addiction person, also out-of-the-way, inside tie in hidden addiction, outer also invisible ".In " the sick nobility's addiction of General Treatise on the Cause and Symptoms of Diseases addiction marquis " that Chao Yuanfang (550-630 A.D.) is write, say: " addiction person, meaning addiction side is between two sides of body, is also sometimes and bitterly." Wu Qian " Yizong Jinjian surgery heart method gist " volume 66: " addiction person, addiction also, is inside tied in hidden out-of-the-way, outer also invisible." explain the origin of nodules of the breast name of disease." Yangke Xinde Ji, Experience Gained in Treating External Diseases " said clearly: " breast belongs to the stomach channel of foot-Yang-ming, and nipple belongs to liver channel of foot-Jueyin.Anger is suffered from man's exhaustion due to sexual indulgence, hinders in Liver and kidney; Madam ponders over melancholy, damages in liver spleen, all can cause infections.So breast has difference for infections.Have nodule in the breast, shape is as ball ovum, and not pain, does not have a fever, and color of the leather is constant, and its core is with susceptible to anger growth and decline, this nodules of the breast ".Its etiology and pathogenesis is excessive anger impairing the liver, depressed emotion, and catharsis dereliction of duty, stagnation of QI due to depression of the liver, qi stagnation hemagglutination, newborn network is obstructed, sends out distending pain of the breast, coagulation of QI-blood, lump formation due to accumulation of pathogens and form nodule in the breast; Worry impairing spleen, or stagnation of liver-QI perverse and unreasonable manner insult spleen, liver spleen two is hindered, and fortune is received dereliction of duty, gives birth to humidogene expectorant, and phlegm stagnancy is tied mutually, hinders in newborn network, also can form addiction core.Rush wantonly two arteries and veins and arise from born of the same parents, the upper breast that connects, variable effect breast and uterus physiological change are appointed in punching.CHONG meridian being the blood pool, is subordinate in Liver and kidney, deficiency of kidney-QI, and sea of blood inanition, Chong and Ren channel disorder, blood network is tired stagnant, and functional activity of QI being not smooth can cause stagnation of QI blood tired, and expectorant agglutinates in breast, and knot is polymerized to core.Version association standard in 2002 is by cyclomastopathy and be dialectically divided into that stagnation of QI due to depression of the liver, accumulation of phlegm in the hypochondrium are tied mutually, Chong and Ren channel disorder three types.Famous TCM Gynecology expert doctor Li Jimin also thinks that depression of liver-QI is its main pathogenesis, but there is again direct relation in Chong and Ren channel disorder, the ratio that has statistical confirmation caused by hepatic stagnation qi stagnation cyclomastopathy card to account for cyclomastopathy is 44.38%, in a word, and the pathogenic characteristic that depression of liver-QI, Chong and Ren channel disorder are primary disease.Through the constantly accumulation of development and experience, more perfect complete theoretical system and the prescription system of Chinese traditional treatment hyperplasia of mammary glands, in addition after Chinese medicine reasonable compatibility, its toxic and side effects is little, therefore,, at present by Chinese traditional treatment hyperplasia of mammary glands, there is significant advantage, not only can improve the short term effect of cyclomastopathy, can also in the prevention of breast carcinoma, play positive role.
Summary of the invention
Technical scheme of the present invention has been to provide the pharmaceutical composition of the good caused by hepatic stagnation qi stagnation cyclomastopathy of a kind of drug effect, and another technical scheme of the present invention has been to provide preparation method and the purposes of this pharmaceutical composition.
The invention provides a kind of pharmaceutical composition for the treatment of caused by hepatic stagnation qi stagnation cyclomastopathy, it is the preparation being prepared from by the crude drug that contains following weight proportion:
Radix Bupleuri 10-25 part, Radix Scutellariae 15-25 part, Rhizoma Pinelliae Preparatum 10-20 part, Semen Citri Reticulatae 25-40 part, Semen Litchi 23-35 part, Pericarpium Citri Reticulatae 5-15 part, Pericarpium Citri Reticulatae Viride 8-20 part, Vascular aurantii 15-30 part, Folium Citri tangerinae 10-25 part, Bulbus Fritillariae Thunbergii 10-20 part, Spica Prunellae 10-20 part, Radix Glycyrrhizae 3-10 part.
Further preferably, it is the preparation being prepared from by the crude drug of following weight proportioning:
Radix Bupleuri 10-25 part, Radix Scutellariae 15-25 part, Rhizoma Pinelliae Preparatum 10-20 part, Semen Citri Reticulatae 25-40 part, Semen Litchi 23-35 part, Pericarpium Citri Reticulatae 5-15 part, Pericarpium Citri Reticulatae Viride 8-20 part, Vascular aurantii 15-30 part, Folium Citri tangerinae 10-25 part, Bulbus Fritillariae Thunbergii 10-20 part, Spica Prunellae 10-20 part, Radix Glycyrrhizae 3-10 part.
Still more preferably, it is the preparation being prepared from by the crude drug of following weight proportioning:
Radix Bupleuri 12-20 part, Radix Scutellariae 18-23 part, Rhizoma Pinelliae Preparatum 12-18 part, Semen Citri Reticulatae 28-35 part, Semen Litchi 28-35 part, Pericarpium Citri Reticulatae 8-15 part, Pericarpium Citri Reticulatae Viride 10-18 part, Vascular aurantii 18-25 part, Folium Citri tangerinae 13-23 part, Bulbus Fritillariae Thunbergii 12-18 part, Spica Prunellae 12-18 part, Radix Glycyrrhizae 5-8 part.
Still more preferably, it is the preparation being prepared from by the raw material of following weight proportioning:
15 parts of Radix Bupleuri, 20 parts of Radix Scutellariaes, 15 parts of Rhizoma Pinelliae Preparatum, 30 parts of Semen Citri Reticulataes, 30 parts of Semen Litchis, 10 parts of Pericarpium Citri Reticulataes, 15 parts, Pericarpium Citri Reticulatae Viride, 20 parts of Vascular aurantiis, 15 parts of Folium Citri tangerinae, 15 parts of Bulbus Fritillariae Thunbergiis, 15 parts of Spica Prunellaes, 6 parts, Radix Glycyrrhizae.
Wherein, described Radix Bupleuri is made a living Radix Bupleuri or/and Radix Bupleuri (processed with vinegar); Described Radix Scutellariae is made a living Radix Scutellariae or/and Radix Scutellariae (parched); Described Pericarpium Citri Reticulatae Viride is made a living Pericarpium Citri Reticulatae Viride or/and processed with vinegar Pericarpium Citri Reticulatae Viride.
Pharmaceutical composition of the present invention is the protogenic medicinal powder by Radix Bupleuri, Radix Scutellariae, Rhizoma Pinelliae Preparatum, Semen Citri Reticulatae, Semen Litchi, Pericarpium Citri Reticulatae, Pericarpium Citri Reticulatae Viride, Vascular aurantii, Folium Citri tangerinae, Bulbus Fritillariae Thunbergii, Spica Prunellae, Radix Glycyrrhizae, water or extractive with organic solvent are active component, add pharmaceutically acceptable adjuvant or complementary composition to be prepared into pharmaceutically conventional oral formulations.
Wherein, described oral formulations is granule, powder, pill, capsule, soft capsule, drop pill, tablet or oral liquid.
The present invention also provides a kind of method of preparing described pharmaceutical composition, and it comprises the steps:
A, take the crude drug of each weight proportion;
B, beat powder; Or decoct with water, or add organic solvent extraction, and to filter, filtrate is concentrated, adds pharmaceutically acceptable adjuvant or complementary composition to be prepared into pharmaceutically conventional preparation.
The present invention also provides the purposes in the medicine of this pharmaceutical composition in preparation treatment caused by hepatic stagnation qi stagnation cyclomastopathy.
Wherein, described medicine is to have dispersing the stagnated live-QI to relieve the stagnation of QI, active eliminating stagnation, effect of reducing swelling and alleviating pain; There is the mastalgia of alleviating, dwindle lump in breast, reduce the medicine of lump number curative effect.
Oneself generally acknowledges that " organic conception ", " determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs ", " compound recipe use ", " compound compatibility medication is as used military forces " are the most scientific the most several large advantages of the traditional Chinese medical science at present, and wherein " compound compatibility medication is as used military forces " is the original theory of Chinese medicine of very science.In traditional Chinese medical science prescription and medicine tight compatibility all linked with one another as arrayed troops for battle. be its section of being effective in that is better than Western medicine formula.Tcm prescription theory is thought, each prescription, not only need to select the appropriate compatibility of suitable medicine according to etiology and pathogenesis, also should meet the basic structure of prescription simultaneously, the i.e. prescription compatibility of " monarch, minister, help, make ", slide the prescription compatibility of " monarch, minister, help, make ", be exactly that it is based upon the scientific matching on the comprehensive judgement basis of disease pathogenesis.In medical square tube cross too many levels, many target spots and integrate the biological mechanism regulating, to the so machine-processed complicated difficult of cyclomastopathy look into, doctor trained in Western medicine curative effect, the very difficult illness for the treatment of or symptom are withered control, can obtain, more thoroughly therapeutic effect better than Western medicine, and this curative effect is to be based upon on the definite guidance of the original theory of above-mentioned traditional Chinese medical science tradition, prescription of the present invention has been followed this principle.
At all times doctor mostly think the generation of this disease and the traditional Chinese medical science " seven emotions " in close relations.In the traditional Chinese medical science, say " seven emotions " refer to happiness, anger, melancholy, think of, compassion, probably, the people's such as frightened basic emotion.Emotion plays harmonious protection effect to human physiological functions, is the normal physiological activity form of people." liver controlling conveyance and dispersion, property happiness bar reaches and dislikes depression ", this is the most basic function of liver, and it should be the spring of 4 o'clock, and property belongs to the five elements' wood, and main liter initiatively, has bar to reach, smooth and easy, the characteristic of unfolding.Liver being bold and firm viscera, its basic function and emotion are closely related, and people's emotion is happy, and feelings will bar reaches, and liver could be adjusted smooth whole body mechanism of qi, and mechanism of qi is unobstructed, and qi-blood-body fluid is able to normally move defeated cloth, and the each function of human body is able to normal operation.It is upper every, cloth costa sternales that liver channel of foot-Jueyin follows row, through breast area " danxi's experiential therapy " meaning: " the bright institute of breast sun warp, nipple faint cloudy under ", nipple belongs to liver, breast belongs to stomach, with regard to meridians, Liver Channel and breast have close physiological and pathological relations.Woman is taking blood as use, and taking blood as this, the performance of breast physiological function also needs the keeping of blood; Woman is taking liver as congenital, blood stored in the liver, and main catharsis, the storage operation and regulation of blood all depends on liver.The physiological and pathological closely bound up " Waike Zhengzong, Orthodox Manual of External Diseases " that liver and breast are described is pointed out: " melancholy impairing the liver, worry impairing spleen long-pending think intentionally, institute is willing to unappreciated, causes meridians painful abdominal mass puckery, coalescent nucleation ", the impairing the liver of pointing out to be worried is the key factor that nodules of the breast is fallen ill.Hyperplasia of mammary glands is due to liver physiology functional disorder, depression and stagnation of QI, and disorder of QI and blood week loss degree, strongly fragrant fire-transformation of a specified duration, solidifying the penting up in breast of stagnation of QI expectorant fallen ill.Above theory has been established dialectical opinion for we's treatment caused by hepatic stagnation qi stagnation cyclomastopathy and has been controlled foundation.
Medicine of the present invention is made up of Radix Bupleuri, Radix Scutellariae, Rhizoma Pinelliae Preparatum, Semen Citri Reticulatae, Semen Litchi, Pericarpium Citri Reticulatae, Pericarpium Citri Reticulatae Viride, Vascular aurantii, Folium Citri tangerinae, Bulbus Fritillariae Thunbergii, Spica Prunellae, Radix Glycyrrhizae, Radix Bupleuri dispersing the stagnated live-QI to relieve the stagnation of QI in side, and regulating functional activities of qi is principal agent; Pericarpium Citri Reticulatae Viride is soothing the liver dispelling the stagnated QI, eliminating stagnation removing food stagnancy, Folium Citri tangerinae depressed liver-energy dispersing and QI regulating, dissipating phlegm and resolving masses, during Pericarpium Citri Reticulatae circulation of qi promoting is adjusted, drying dampness to eliminate phlegm, above three taste medicines are accessory drugs, principal drug assistance dispersing the stagnated live-QI to relieve the stagnation of QI, harmonizing emotions; Bulbus Fritillariae Thunbergii, Spica Prunellae vital energy regualting and blood circulation-promoting, resolving mass and removing the obstruction of the collateral, Semen Litchi, promoting QI to circulate and dispersing the agglomeration of the pathogens, the pain relieving of dispeling cold; Vascular aurantii promoting of the circulation of QI and removing the obstruction in the collaterals, resolving phlegm and softening hard masses; With the passing of time, phlegm-damp is assembled heat-transformation to the stagnation of QI, therefore with Semen Citri Reticulatae, Radix Scutellariae, Rhizoma Pinelliae Preparatum heat clearing and damp drying, eliminating fire and detoxication; Several tastes adjuvant drug in the side of being altogether above.Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, for making medicine.All medicines share, and play altogether mildly regulating cold and heat, soothing the liver circulation of qi promoting, drying dampness to eliminate phlegm, the merit of removing obstruction in the collateral to relieve pain, treating both the principal and secondary aspects of a disease, determined curative effect.
Pharmaceutical composition of the present invention can effectively alleviate mastalgia, dwindles lump in breast, reduces lump number, has the effect of good treatment cyclomastopathy, for the medication of clinical treatment caused by hepatic stagnation qi stagnation cyclomastopathy provides a kind of new selection.
Detailed description of the invention
The preparation of embodiment 1 medicine of the present invention
Get Radix Bupleuri 15g, Radix Scutellariae 20g, Rhizoma Pinelliae Preparatum 15g, Semen Citri Reticulatae 30g, Semen Litchi 30g, Pericarpium Citri Reticulatae 10g, Pericarpium Citri Reticulatae Viride 15g, Vascular aurantii 20g, Folium Citri tangerinae 15g, Bulbus Fritillariae Thunbergii 15g, Spica Prunellae 15g, Radix Glycyrrhizae 6g.
Each flavour of a drug take according to quantity, mix and enough water purification, and slow fire boiling is more than 30 minutes.Collect decocting liquid; Medicinal residues decoct with water 2 times again, merge decocting liquid each time, obtain decoction.
In we, Semen Litchi, Semen Citri Reticulatae large usage quantity, the merit of getting its activating collaterals and eliminating stagnation.
The preparation of embodiment 2 medicines of the present invention
Get decoction prepared by embodiment 1, concentrated after, add proper starch, dextrin mixes rear granulation, is prepared into granule.
The preparation of embodiment 3 pharmaceutical compositions of the present invention
Get Radix Bupleuri 15g, Radix Scutellariae 20g, Rhizoma Pinelliae Preparatum 15g, Semen Citri Reticulatae 30g, Semen Litchi 30g, Pericarpium Citri Reticulatae 10g, Pericarpium Citri Reticulatae Viride 15g, Vascular aurantii 20g, Folium Citri tangerinae 15g, Bulbus Fritillariae Thunbergii 15g, Spica Prunellae 15g, Radix Glycyrrhizae 6g.Each flavour of a drug take according to quantity, mix and enough water purification, and slow fire boiling is more than 30 minutes.Collect decocting liquid; Medicinal residues decoct with water 2 times again, merge decocting liquid each time, after concentrating, dry, and after adding appropriate dextrin, soluble starch to granulate, tabletting, obtains tablet.
The preparation of embodiment 4 pharmaceutical compositions of the present invention
Get Radix Bupleuri 15g, Radix Scutellariae 20g, Rhizoma Pinelliae Preparatum 15g, Semen Citri Reticulatae 30g, Semen Litchi 30g, Pericarpium Citri Reticulatae 10g, Pericarpium Citri Reticulatae Viride 15g, Vascular aurantii 20g, Folium Citri tangerinae 15g, Bulbus Fritillariae Thunbergii 15g, Spica Prunellae 15g, Radix Glycyrrhizae 6g.Each flavour of a drug take according to quantity, mix and enough water purification, and slow fire boiling is more than 30 minutes.Collect decocting liquid; Medicinal residues decoct with water 2 times again, merge decocting liquid each time, after concentrating, after being dried, add appropriate microcrystalline Cellulose, after mixing, encapsulated, obtain capsule.
The preparation of embodiment 5 medicines of the present invention
Get Radix Bupleuri 10g, Radix Scutellariae 15g, Rhizoma Pinelliae Preparatum 10g, Semen Citri Reticulatae 25g, Semen Litchi 23g, Pericarpium Citri Reticulatae 5g, Pericarpium Citri Reticulatae Viride 8g, Vascular aurantii 15g, Folium Citri tangerinae 10g, Bulbus Fritillariae Thunbergii 10g, Spica Prunellae 10g, Radix Glycyrrhizae 3g, directly beat powder, make the watered pill.
The preparation of embodiment 6 medicines of the present invention
Get Radix Bupleuri 25g, Radix Scutellariae 25g, Rhizoma Pinelliae Preparatum 20g, Semen Citri Reticulatae 40g, Semen Litchi 35g, Pericarpium Citri Reticulatae 15g, Pericarpium Citri Reticulatae Viride 20g, Vascular aurantii 30g, Folium Citri tangerinae 25g, Bulbus Fritillariae Thunbergii 20g, Spica Prunellae 20g, Radix Glycyrrhizae 10g, be prepared into decoction by the method for embodiment 1.
The preparation of embodiment 7 medicines of the present invention
Get Radix Bupleuri 12g, Radix Scutellariae 18g, Rhizoma Pinelliae Preparatum 12g, Semen Citri Reticulatae 28g, Semen Litchi 28g, Pericarpium Citri Reticulatae 8g, Pericarpium Citri Reticulatae Viride 10g, Vascular aurantii 18g, Folium Citri tangerinae 13g, Bulbus Fritillariae Thunbergii 12g, Spica Prunellae 12g, Radix Glycyrrhizae 5g; Be prepared into capsule by the method described in embodiment 4.
The preparation of embodiment 8 medicines of the present invention
Get Radix Bupleuri 20g, Radix Scutellariae 23g, Rhizoma Pinelliae Preparatum 18g, Semen Citri Reticulatae 35g, Semen Litchi 35g, Pericarpium Citri Reticulatae 15g, Pericarpium Citri Reticulatae Viride 18g, Vascular aurantii 25g, Folium Citri tangerinae 23g, Bulbus Fritillariae Thunbergii 18g, Spica Prunellae 18g, Radix Glycyrrhizae 8g, add 70% ethanol extraction, filter, concentrated, be prepared into oral liquid.
Prove beneficial effect of the present invention by concrete clinical trial below.
Experimental example 1 clinical drug of the present invention (outpatient service) treatment situation.
(1) accept patient's situation for medical treatment
Gender, the range of age, marital status, the course of disease: selected 185 examples are my Out-patient Department cyclomastopathy patient, married 108 examples, unmarried 77 examples; 20～25 years old age, 90 examples, 25～45 years old 95 example; 1 year 44 example of the course of disease, 2～4 years 74 examples, >4 67 examples; One-sided cyclomastopathy 99 examples, bilateral breast hypertrophy 86 examples.Card belongs to caused by hepatic stagnation qi stagnation.
(2) diagnostic criteria: the diagnostic criteria with reference to breast disease Professional Committee of Society of Surgery of China Association of Traditional Chinese Medicine in 2002 is formulated, and standard is as follows:
1. symptom and sign: breast has distending pain, twinge and dull pain in various degree, can have dependency with menstruation, emotion changes, continuous 3 months or be interrupted pain within 3～6 months, do not alleviate; There are single or multiple lumps in breast, lump dispersibles in whole breast, unclear with surrounding tissue boundary, pushes away movably, may touch a tender spot, can the growth and decline with the variation of emotion and menstrual cycle, and some patients were can have nipple discharge or rash to itch.
2. auxiliary examination: all cases are all taken the photograph sheet or the inspection of breast high-frequency color doppler ultrasound through mammary gland platinum target, are diagnosed as cyclomastopathy.
(3) inclusive criteria:
1. meet the diagnostic criteria of cyclomastopathy and the female patient of caused by hepatic stagnation qi stagnation differentiation of symptoms and signs for classification of syndrome;
2. course of disease >3 month;
3. the women of age between 20 years old one 45 years old;
4. voluntary participation test, signature Informed Consent Form also can be adhered to treatment.
(4) exclusion standard
1. do not meet the diagnostic criteria of cyclomastopathy and the female patient of caused by hepatic stagnation qi stagnation differentiation of symptoms and signs for classification of syndrome;
2. be associated with other mastopathy such as mammary gland fibroma, mastitis, duct papilloma, breast carcinoma
Patient;
3. the course of disease " 3 months;
The women in year in 4. age <20 year, or >45;
5. suffer from acute and chronic diseases and the organic illness of body such as the heart, brain, kidney, liver;
6. be associated with the serious mental disease such as depression, anxiety neurosis, schizophrenia;
7. the person that can not coordinate with completed treatment;
8. pregnancy period, women breast-feeding their children;
9. allergic constitution.
(5) Therapeutic Method and nursing:
1. Therapeutic Method is from intending pharmaceutical composition of the present invention.Basic composition: Radix Bupleuri 15g, Radix Scutellariae 20g, Rhizoma Pinelliae Preparatum 15g, Semen Citri Reticulatae 30g, Semen Litchi 30g, Pericarpium Citri Reticulatae 10g, Pericarpium Citri Reticulatae Viride 15g, Vascular aurantii 20g, Folium Citri tangerinae 15g, Bulbus Fritillariae Thunbergii 15g, Spica Prunellae 15g, Radix Glycyrrhizae 6g.Usage: 1 dose of every day, decocting divides to be taken for 3 times, and generally taking 20 doses was 1 course for the treatment of, was used in conjunction 3 courses for the treatment of.
2. care method should be carried out patient's ideological work before taking medicine, and patient advantage from Chinese medicine to patient and the effect thereof of explaining, makes patient have correct understanding to Chinese medicine psychologically, actively coordinates.Emphasize Chinese medicine instructions of taking and points for attention to patient: (1) medicine time: the morning, noon and afternoon take after meal half an hour simultaneously.(2) medicining times: take medicine every day 3 times.(3) method of administration: be taken cold.Generally take with boiled water, because of the vomiting difficult person that takes medicine, can drink Sucus Zingberis, in medicinal liquid, add white sugar or correctives.(4) diet compatibility and incompatibility of drugs: marine product and the irritable food etc. such as stodgy food and fish and shrimp such as generally avoid eating anything raw or cold at period in a medicine, greasy, pungent.(5) special circumstances processing: stop using if there is irritated or other malaise symptoms in patient's drug administration process, and take the circumstances into consideration to take further treatment; As there is vomiter, and after taking medicine, can advise patient to chew a slice Rhizoma Zingiberis Recens or Pericarpium Citri Reticulatae, seriously can ask for instructions after doctor and further process; Women's menstrual phase should be withdrawn Chinese medicine.
(6) observation of curative effect:
1. criterion of therapeutical effect:
" the cyclomastopathy the standard of curative effect evaluation " passing through with reference to the 8th meeting of Chinese surgery of Chinese medicine breast disease Professional Committee of association in 2002.Calculate treatment front and back symptom integral (comprising pain scores, lump scoring, simultaneous phenomenon scoring) improvement rate.Improvement rate=[integration before (the rear total mark of total mark one treatment before treatment)/treatment] x100%.Cure: improvement rate >=90%; Effective: improvement rate 70%～89%; Effective: improvement rate 30%～69%; Invalid: improvement rate <30%.
2. therapeutic outcome is controlled 185 examples altogether, cures 58 examples, effective 60 examples, effective 50 examples, invalid 17 examples, total effective rate 90.8%.
3. cure patient's the situation of following up a case by regular visits to
From the scoring of lump size, pain scores and this three aspects: of tcm syndrome total score, 68 of clinical cure patients are followed up a case by regular visits to, each group data show: treatment finished after one month, when treatment finishes, each symptom and sign, without increasing the weight of, illustrates that the state of an illness is without recurrence, and curative effect is determined.
According to clinical trial, the present invention can also carry out prescription plus-minus according to clinical being suitable for, for example, add taste method: relatively blood addiction person adds Radix Salviae Miltiorrhizae, Herba Leonuri; The breast obvious person of luming adds Squama Manis, Pseudobulbus Cremastrae Seu Pleiones; Libido is indifferent, and soreness of the waist and knees person adds Herba Epimedii, Semen Cuscutae etc.
Model case:
Gong patient, female, 35 years old, tell bilateral mastalgia 4 years, light when heavy when distending pain of the breast, month premenstrual and obviously increase the weight of while being in a very depressed state, after menstruation, symptom can alleviate, and companion's susceptible to lose temper due to restlessness, asks easily and wakes up, dimly red tongue yellow and thin fur, rolling pulse night.Bilateral breast can touch and differ in size, and form is each one, is streak, nodositas lump, owe clearly on border, mobility can, have tenderness, bilateral axillary lymph is tied without enlargement, color ultrasound shows: two corpus mamma structure disturbances, increase thick, enhancing, Diagnosis of Breast cyclomastopathy, dialectical is stagnation of QI due to depression of the liver, the heat-transformation of phlegm-damp resistance network, control with the heat clearing away of holding concurrently of depressed liver-energy dispersing and QI regulating, activating collaterals and eliminating stagnation, with medicine decoction plus-minus of the present invention treatment.Prescription: Radix Bupleuri 15g, Semen Citri Reticulatae 30g, Vascular aurantii 20g, Folium Citri tangerinae 15g, Semen Litchi 30g, Pericarpium Citri Reticulatae 10g, Pericarpium Citri Reticulatae Viride 15g, Bulbus Fritillariae Thunbergii 15g, Rhizoma Pinelliae Preparatum 15g, Fructus Gardeniae 10g, Radix Scutellariae 20g, Spica Prunellae 15g, Radix Glycyrrhizae 6g.Further consultation after 1 menstrual cycle, telling distending pain of the breast alleviates, two swelling of the breast pieces obviously dwindle, and companion's dizziness and blurred vision, severe palpitation, go Pericarpium Citri Reticulatae Viride to add Radix Paeoniae Alba 15g, Radix Angelicae Sinensis lOg, treat after 3 menstrual cycle, above-mentioned symptom and sign are all eliminated, color ultrasound examination: cyclomastopathy lump disappears, follow up a case by regular visits to, do not recur again so far.
In sum: pharmaceutical composition of the present invention can effectively alleviate mastalgia, dwindles lump in breast, reduce lump number, there is the effect of good treatment cyclomastopathy, for the medication of clinical treatment caused by hepatic stagnation qi stagnation cyclomastopathy provides a kind of new selection.
Claims (10)
1. a pharmaceutical composition for the treatment of caused by hepatic stagnation qi stagnation cyclomastopathy, is characterized in that: it is the preparation being prepared from by the crude drug that contains following weight proportion:
Radix Bupleuri 10-25 part, Radix Scutellariae 15-25 part, Rhizoma Pinelliae Preparatum 10-20 part, Semen Citri Reticulatae 25-40 part, Semen Litchi 23-35 part, Pericarpium Citri Reticulatae 5-15 part, Pericarpium Citri Reticulatae Viride 8-20 part, Vascular aurantii 15-30 part, Folium Citri tangerinae 10-25 part, Bulbus Fritillariae Thunbergii 10-20 part, Spica Prunellae 10-20 part, Radix Glycyrrhizae 3-10 part.
2. pharmaceutical composition according to claim 1, is characterized in that: it is the preparation being prepared from by the crude drug of following weight proportioning:
Radix Bupleuri 10-25 part, Radix Scutellariae 15-25 part, Rhizoma Pinelliae Preparatum 10-20 part, Semen Citri Reticulatae 25-40 part, Semen Litchi 23-35 part, Pericarpium Citri Reticulatae 5-15 part, Pericarpium Citri Reticulatae Viride 8-20 part, Vascular aurantii 15-30 part, Folium Citri tangerinae 10-25 part, Bulbus Fritillariae Thunbergii 10-20 part, Spica Prunellae 10-20 part, Radix Glycyrrhizae 3-10 part.
3. pharmaceutical composition according to claim 2, is characterized in that: it is the preparation being prepared from by the crude drug of following weight proportioning:
Radix Bupleuri 12-20 part, Radix Scutellariae 18-23 part, Rhizoma Pinelliae Preparatum 12-18 part, Semen Citri Reticulatae 28-35 part, Semen Litchi 28-35 part, Pericarpium Citri Reticulatae 8-15 part, Pericarpium Citri Reticulatae Viride 10-18 part, Vascular aurantii 18-25 part, Folium Citri tangerinae 13-23 part, Bulbus Fritillariae Thunbergii 12-18 part, Spica Prunellae 12-18 part, Radix Glycyrrhizae 5-8 part.
4. pharmaceutical composition according to claim 3, is characterized in that: it is the preparation being prepared from by the raw material of following weight proportioning:
15 parts of Radix Bupleuri, 20 parts of Radix Scutellariaes, 15 parts of Rhizoma Pinelliae Preparatum, 30 parts of Semen Citri Reticulataes, 30 parts of Semen Litchis, 10 parts of Pericarpium Citri Reticulataes, 15 parts, Pericarpium Citri Reticulatae Viride, 20 parts of Vascular aurantiis, 15 parts of Folium Citri tangerinae, 15 parts of Bulbus Fritillariae Thunbergiis, 15 parts of Spica Prunellaes, 6 parts, Radix Glycyrrhizae.
5. according to the pharmaceutical composition described in claim 1-4 any one, it is characterized in that: described Radix Bupleuri is made a living Radix Bupleuri or/and Radix Bupleuri (processed with vinegar); Described Radix Scutellariae is made a living Radix Scutellariae or/and Radix Scutellariae (parched); Described Pericarpium Citri Reticulatae Viride is made a living Pericarpium Citri Reticulatae Viride or/and processed with vinegar Pericarpium Citri Reticulatae Viride.
6. according to the pharmaceutical composition described in claim 1-4 any one, it is characterized in that: it is the protogenic medicinal powder by Radix Bupleuri, Radix Scutellariae, Rhizoma Pinelliae Preparatum, Semen Citri Reticulatae, Semen Litchi, Pericarpium Citri Reticulatae, Pericarpium Citri Reticulatae Viride, Vascular aurantii, Folium Citri tangerinae, Bulbus Fritillariae Thunbergii, Spica Prunellae, Radix Glycyrrhizae, water or extractive with organic solvent are active component, add pharmaceutically acceptable adjuvant or complementary composition to be prepared into pharmaceutically conventional oral formulations.
7. pharmaceutical composition according to claim 6, is characterized in that: described oral formulations is granule, powder, pill, capsule, soft capsule, drop pill, tablet or oral liquid.
8. a method of preparing the pharmaceutical composition described in claim 1-7 any one, it comprises the steps:
A, take the crude drug of each weight proportion;
B, beat powder; Or decoct with water, or add organic solvent extraction, and to filter, filtrate is concentrated, adds pharmaceutically acceptable adjuvant or complementary composition to be prepared into pharmaceutically conventional preparation.
9. the purposes in the medicine of the pharmaceutical composition described in claim 1-7 any one in preparation treatment caused by hepatic stagnation qi stagnation cyclomastopathy.
10. purposes according to claim 9, is characterized in that: described medicine is to have dispersing the stagnated live-QI to relieve the stagnation of QI, active eliminating stagnation, effect of reducing swelling and alleviating pain; There is the mastalgia of alleviating, dwindle lump in breast, reduce the medicine of lump number curative effect.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105920545A (en) * | 2016-06-29 | 2016-09-07 | 唐会杰 | Chinese medicinal composition for treating breast hyperplasia and preparation method thereof |
| CN106074963A (en) * | 2016-08-08 | 2016-11-09 | 蓝国希 | A kind of Chinese medicine composition treating cyclomastopathy |
| CN110302296A (en) * | 2019-05-30 | 2019-10-08 | 成都中医药大学附属医院 | A kind of Chinese medicine composition and its preparation method and application for treating liver-stomach disharmony or/and pharyngeal discomfort |
| CN111759997A (en) * | 2020-08-27 | 2020-10-13 | 段素社 | Traditional Chinese medicine decoction for treating hyperplasia of mammary glands |
-
2014
- 2014-04-28 CN CN201410176154.6A patent/CN103948782B/en not_active Expired - Fee Related
Non-Patent Citations (1)
| Title |
|---|
| 安泽余: "中医药治疗乳腺增生病临床研究进展", 《河北中医》 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105920545A (en) * | 2016-06-29 | 2016-09-07 | 唐会杰 | Chinese medicinal composition for treating breast hyperplasia and preparation method thereof |
| CN106074963A (en) * | 2016-08-08 | 2016-11-09 | 蓝国希 | A kind of Chinese medicine composition treating cyclomastopathy |
| CN110302296A (en) * | 2019-05-30 | 2019-10-08 | 成都中医药大学附属医院 | A kind of Chinese medicine composition and its preparation method and application for treating liver-stomach disharmony or/and pharyngeal discomfort |
| CN111759997A (en) * | 2020-08-27 | 2020-10-13 | 段素社 | Traditional Chinese medicine decoction for treating hyperplasia of mammary glands |
| CN111759997B (en) * | 2020-08-27 | 2021-08-10 | 段素社 | Traditional Chinese medicine decoction for treating hyperplasia of mammary glands |
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| CN103948782B (en) | 2017-04-26 |
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