CN105943740A - Pharmaceutical composition for treating thyroid nodule with hyperplasia of mammary glands - Google Patents
Pharmaceutical composition for treating thyroid nodule with hyperplasia of mammary glands Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
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Abstract
The invention belongs to the field of traditional Chinese medicine, and particularly relates to a pharmaceutical composition for treating thyroid nodule with hyperplasia of mammary glands and a preparation method thereof. The pharmaceutical composition is prepared from calamondin orange leaves, fruits of thatch screwpine, bark of Franxinus pistacifolia Feng. miss., common hawksbeard, Chinese holly leaves, herb of Onanthe rosthornii Diels, Japanese violet herb or roots, ficus lyrata, silvery aleuritopteris, all-grass of Nakedcaule Groundsel, Frangrant daphne flowers and spina date seeds. All the medicine materials achieve the effects of promoting qi circulation and removing obstruction in collaterals, nourishing and soothing the liver, strengthening the spleen and stomach, resolving dampness and eliminating phlegm, removing stasis and eliminating swelling and promoting blood circulation to remove blood stasis, both the symptoms and root causes are treated according to the etiology and pathogenesis of thyroid nodule with hyperplasia of mammary glands, the thyroid nodule and breast lumps can be remarkably reduced, pain of a patient is relieved, and a good comprehensive treatment effect is achieved during clinical use.
Description
Technical field
The invention belongs to tcm field, be specifically related to a kind of pharmaceutical composition treating thyroid nodule companion's cyclomastopathy and system thereof
Preparation Method.
Background technology
Thyroid nodule is the commonly encountered diseases in endocrine field, and its prevalence increased in increasing trend with the age, was mainly in women.Closely
Nian Lai, the sickness rate of cyclomastopathy presents ascendant trend, studies have reported that, its prevalence reaches more than 22%.Thyroid nodule, breast
The physical and mental health of the numerous women of gland hypertrophy serious harm.Normal two diseases of clinical discovery most of patients are also suffered from.
Modern medicine is the most inconsistent to cyclomastopathy and thyroid nodule pathogenic factor and pathology understanding, and most scholars think mammary gland
Hypertrophy, thyroid nodule are incretion diseases, and modern medicine study also confirms that, cyclomastopathy and the cause of disease of thyroid nodule
Contact in many aspects deposited by pathogenesis, and both morbidities mainly endocrine disturbance and Nervous and Mental Factors cause.The generation of cyclomastopathy
More than hypothalamic-pituitary-ovarian axis, endocrine disturbance is relevant, and estrogen and progestogen ratio are not normal, and lutein secretion reduces, female
Hormone, prolactin secretion increase, and cause mammoplasia and subinvolution, cause breast duct epithelium, glandular epithelium and interstitial
Fibrous tissue hypertrophy in various degree.The generation of thyroid nodule is relevant more than hypothalamic-pituitary-thyroid axis endocrine disturbance.
Thyroxin is direct on the impact of thyroid nodule, and the impact on development of breast is indirectly.
The site of pathological change of thyroid nodule and cyclomastopathy is respectively at cervical region and mammary gland, but both pathogenic factors are all lost with endocrine
Adjust closely related.Though Chinese medicine think both sick positions at table, blood stasis solidifying with the stagnation of QI, expectorant is for mark, and right liver,spleen,kidney is appointed with punching
Not enough is this.Modern women or because life stress is big, feelings will is not relaxed, stagnation of QI due to depression of the liver, wood Yu Ke soil, dysfunction of the spleen in transportation, water liquid is transported
Changing not normal, the most poly-liquid becomes expectorant, phlegm and qi stasis, and phlegm and blood stasis forms；Or because of improper diet, the product of surfeit delicious food, insufficiency of the spleen fortune
Changing mistake department, the most poly-liquid becomes expectorant；Or because natural endowment is not enough, deficiency of kidney-essence, the liver failing to be nourished, Chong and Ren channel disorder, qi depression to blood stasis,
Phlegm and blood stasis, before knot and throat larynx, caused by breast network.The traditional Chinese medical science payes attention to determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, and according to the principle of determination for the treatment of based on pathogenesis obtained through differentiation of symptoms and signs, card is ruled together mutually
Treat also the most identical, though thus thyroid nodule and cyclomastopathy are two kinds of diseases, but there is identical etiology and pathogenesis in it, can different disease
Ruling together, " treating different diseases with the same therapeutic principle " embodies the characteristic of differentiation of tcm, the most fully application " treating different diseases with the same therapeutic principle " jointly
This rule, can obtain preferable curative effect, and illustrate the development prospect that Chinese medicine is good.
Summary of the invention
The technical problem to be solved is, utilizes the theory of Chinese medical science that China is traditional, it is provided that a kind of dialectical treatment first shape
The pharmaceutical composition of gland tuberosity companion's cyclomastopathy, pharmaceutical composition of the present invention is dialectical imposes on thyroid nodule companion's cyclomastopathy stagnation of liver-QI
Syndrome of stagnation of QI, it is possible to significantly improve tcm symptom, alleviates distending pain of the breast, hypertrophy, reduces thyroid nodule, use safety, nothing
Toxic and side effects, evident in efficacy.
The present invention is achieved by the following technical solutions:
A kind of pharmaceutical composition treating thyroid nodule companion's cyclomastopathy, it is disappeared by Folium Fortunellae Margarita, Fructus Pandani tectorii, great Pi, Crepis crocea Babc.(C.turczaninowii C.A.Mey.),
Folium Mahoniae, Flos Rosae Rugosae, ovum leaf Herba Oenanthes Javanicae, Herba Violae mundae, Radix fici panduratae, Aleuritopteris argentea (Gmel.) Fee, Radix Semiaquilegiae, Flos daphnes odorae, Semen Ziziphi Spinosae are made.
Further, a kind of pharmaceutical composition treating thyroid nodule companion's cyclomastopathy, it is used by following weight
Raw material is made: Folium Fortunellae Margarita 8-13 part, Fructus Pandani tectorii 13-18 part, great Pi disappear 10-15 part, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 18-23 part, Folium Mahoniae 8-13 part,
Flos Rosae Rugosae 6-11 part, ovum leaf Herba Oenanthes Javanicae 8-13 part, Herba Violae mundae 5-8 part, Radix fici panduratae 15-20 part, Aleuritopteris argentea (Gmel.) Fee 10-15 part, Radix Semiaquilegiae 11-16
Part, Flos daphnes odorae 6-9 part, Semen Ziziphi Spinosae 6-9 part.
It is further preferred that a kind of pharmaceutical composition treating thyroid nodule companion's cyclomastopathy, it is by following weight
Make with raw material: Folium Fortunellae Margarita 10 parts, Fructus Pandani tectorii 15 parts, great Pi disappear 10 parts, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 20 parts, Folium Mahoniae 10 parts, Flos Rosae Rugosae 8
Part, ovum leaf Herba Oenanthes Javanicae 8 parts, Herba Violae mundae 6 parts, Radix fici panduratae 16 parts, Aleuritopteris argentea (Gmel.) Fee 12 parts, Radix Semiaquilegiae 15 parts, Flos daphnes odorae 8 parts, Semen Ziziphi Spinosae
6 parts；Or Folium Fortunellae Margarita 12 parts, Fructus Pandani tectorii 18 parts, great Pi disappear 15 parts, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 20 parts, Folium Mahoniae 12 parts, Flos Rosae Rugosae 10 parts, ovum
Leaf Herba Oenanthes Javanicae 12 parts, Herba Violae mundae 6 parts, Radix fici panduratae 18 parts, Aleuritopteris argentea (Gmel.) Fee 15 parts, Radix Semiaquilegiae 12 parts, Flos daphnes odorae 8 parts, Semen Ziziphi Spinosae 8 parts.
Side of the present invention solves, Folium Fortunellae Margarita soothing liver-QI for relieving depression in side, eliminating stagnation of regulating the flow of vital energy；Fructus Pandani tectorii spleen reinforcing benefit blood, promoting the circulation of QI to relieve pain, reduce phlegm dampness removing,
Two medicine 5 promoting QI circulation for relieving depression, soothing the liver and spleen, removing obstruction for relieving pain is monarch drug.The great Pi invigorating spleen and reinforcing stomach that disappears disappears, circulation of qi promoting treating blood disorders；Crepis crocea Babc.(C.turczaninowii C.A.Mey.) is mended
Liver and kidney tonifying, invigorating spleen to remove dampness；Folium Mahoniae boosting qi and nourishing yin, heat clearing away suppressing the hyperactive liver；Flos Rosae Rugosae promoting QI circulation for relieving depression, and blood dissipating blood stasis, pain relieving, four medicines
5 use tonifying liver body, row irritability nourishing the liver blood, solve stagnation of liver-QI, have invigorating the spleen and regulating the stomach concurrently, make the water defeated cloth of liquid transporting normal, and expectorant is difficult raw, gas
Machine and be freely ministerial drug.Herba Violae mundae dispelling the stagnated QI blood, heat clearing away is soothing the liver, Radix fici panduratae expelling wind and removing dampness, removing toxic substances and promoting subsidence of swelling, promoting blood circulation to restore menstrual flow；Aleuritopteris argentea (Gmel.) Fee
Eliminate the phlegm dampness removing, promoting blood circulation to restore menstrual flow；Removing toxic substances and promoting subsidence of swelling；Radix Semiaquilegiae heat-clearing and toxic substances removing, dispersing swelling and dissipating binds；Flos daphnes odorae promoting blood circulation and stopping pain, detoxicating and resolving stagnation of pathogens,
Five medicine compatibility dissipating phlegm and resolving masses, blood stasis dispersing and deswelling, pain relieving of detoxifying, for adjuvant.Semen Ziziphi Spinosae suppressing the hyperactive liver is regulated the flow of vital energy, nourishing lung-YIN, warming middle-JIAO profit
Wet, astringing QI hidroschesis；Ovum leaf Herba Oenanthes Javanicae invigorating qi and benefiting blood, dampness removing is let out turbid, is also adjuvant.
In side, all medicines make a concerted effort to play promoting QI circulation for relieving depression altogether, nourishing the liver soothing liver-QI, invigorating the spleen and regulating the stomach, removing dampness expectorant, mass dissipating and swelling eliminating, blood circulation promoting and blood stasis dispelling,
For the etiology and pathogenesis of thyroid nodule companion's cyclomastopathy Liver depression and Qi stagnation, treating both the principal and secondary aspects of a disease, Clinical practice obtains good treatment
Effect,
Meridian distribution of property and flavor and the primary efficacy of each medicinal raw material used by the present invention are as follows.
Folium Fortunellae Margarita: [nature and flavor] acrid in the mouth；Bitter；Cold nature.[return through] liver；Spleen；Lung meridian.[function cures mainly] soothing liver-QI solution
Strongly fragrant；Regulate the flow of vital energy eliminating stagnation.Main dysphagic；Scrofula；Breast lumps；Mastitis.
Fructus Pandani tectorii: [source] medical material Ji Yuan: for the drupe of Pandanaceae plant Pandanus tectorius.[nature and flavor] acrid in the mouth；Light；Cool in nature.
[return through] kidney；Spleen；Liver；Stomach warp.[function cures mainly] spleen reinforcing benefit blood；Promoting the circulation of QI to relieve pain；Reduce phlegm dampness removing；Improving eyesight.Main dysentery；
Stomachache；Cough；Hernia；Orchitis；Hemorrhoid dysuria；The raw cataracta of mesh.
Great Pi disappears: [nature and flavor] micro-hardship, flat.[function cures mainly] invigorating the stomach and promoting digestion, circulation of qi promoting treating blood disorders.Cure mainly food stagnation stomachache, chronic
Gastritis, qi-stagnating amenorrhea, migraine.Area, Red River with controlling tertian malaria, subtertian malaria；Root is used for driving pinworm.
Crepis crocea Babc.(C.turczaninowii C.A.Mey.): [source] is root [nature and flavor] bitter in the mouth of feverfew Crepis phoenix Dunn；Sweet；Warm in nature.[function cures mainly] mends
Liver and kidney tonifying；Invigorating spleen to remove dampness.Master has a dizzy spell；Soreness of the waist and knees；Edema；Leukorrhagia infantile malnutrition；Hypogalactia.
Folium Mahoniae: [nature and flavor] are bitter；Cool.[return through] liver；Kidney channel.[function cures mainly] clearind deficient heat；Liver and kidney tonifying；Dispel
Rheumatism.Main hectic fever due to deficiency of YIN；Cough spitting of blood；Have a dizzy spell；Soreness of the waist and knees；Rheumatic arthralgia；Vitiligo.
Flos Rosae Rugosae: [nature and flavor] hardship sweet, micro-, temperature.[return through] returns liver, spleen channel.[function cures mainly] regulates the flow of vital energy resolving depression, and blood
Dissipating blood stasis.Treating the liver peratodynia, new lingering pathogenic wind numbness, spitting of blood of spitting blood, menoxenia, leucorrhea with red and white discharge, dysentery, acute mastitis, toxic swelling.
Herba Violae mundae: [source] is the herb of Violaceae plant Herba Violae mundae.[nature and flavor] are slightly cold, octanoic acid.[function cures mainly] dissipates
Wind, heat clearing away, soothing the liver, detumescence.Controlling wind-fire acute conjunctivitis, corneal nebula hides eyeball, acute mastitis, scrofula, and furuncle swells.
Radix fici panduratae: [nature and flavor] sweet in the mouth, micro-pungent, property are put down.[function cures mainly] expelling wind and removing dampness；Removing toxic substances and promoting subsidence of swelling；Promoting blood circulation to restore menstrual flow.
Main air pain of dampness syndrome；Yellow cellulitis；Malaria；Pertussis；Galactostasis；Acute mastitis；Dysmenorrhea；Amenorrhea；Carbuncle furuncle and phyma pain；Traumatic injury；
Venom.
Aleuritopteris argentea (Gmel.) Fee: [nature and flavor] are pungent；Sweet；Flat.[return through] lung；Liver Channel.[function cures mainly] expelling phlegm for arresting cough；Promoting blood circulation to restore menstrual flow；
Dampness removing；Removing toxic substances and promoting subsidence of swelling.Main cough；Menoxenia；Amenorrhea is suffered from abdominal pain；Leucorrhea with red and white discharge；Pulmonary tuberculosis hemoptysis；Loose stool and diarrhea；Urine is puckery
Bitterly；Lung abscess；Acute mastitis；Rheumatic arthritis；Traumatic injury；Intercostal neuralgia；Epidemic hemorrhagic conjunctivitis；Skin ulcer swells.
Radix Semiaquilegiae: [nature and flavor] are sweet, bitter, cold.[return through] returns liver, stomach warp.[function cures mainly]: heat-clearing and toxic substances removing, detumescence
Eliminating stagnation.For carbuncle furuncle, acute mastitis, scrofula, venom.
Flos daphnes odorae: [source] is the flower of Isolated From Thymelaeaceae Species winter daphne.Taste: sweet；Pungent；Property flat.Gui Jing: lung；Stomach；Liver
Warp.Promoting blood circulation and stopping pain；Detoxicating and resolving stagnation of pathogens.Main headache；Toothache；Laryngopharynx swelling and pain；Rheumatalgia；Breast is swollen hard；Rheumatalgia.
Semen Ziziphi Spinosae: [nature and flavor] are sweet, sour is flat.[return through] returns liver, gallbladder, heart channel.[function cures mainly] tonifying liver, mind calming,
Arresting sweating, promotes the production of body fluid.For restlessness of asrhenia type and insomnia, dreaminess of palpitating with fear, body void hyperhidrosis, Tianjin wound is thirsty.[usage and dosage] 9～15g.
Ovum leaf Herba Oenanthes Javanicae: [source] medical material Ji Yuan: for the herb of samphire ovum leaf Herba Oenanthes Javanicae.[function cures mainly] invigorating qi and benefiting blood；
Hemostasis；Diuresis.Main Qi and blood deficiency；The vertigo；Edema；Traumatic hemorrhage.
It is a further object to provide the preparation method of a kind of pharmaceutical composition treating thyroid nodule companion's cyclomastopathy.
A kind of preparation method of pharmaceutical composition treating thyroid nodule companion's cyclomastopathy that the present invention provides, its mainly include as
Lower step:
(1) depletion Folium Citri tangerinae, Herba Violae mundae, Radix Semiaquilegiae, Flos Rosae Rugosae, Flos daphnes odorae are ground into the granule that mean diameter is 10-60 μm
The ethanol water of the 50% of rear addition 5-10 times amount, uses ultrasonic extraction 2-3 time, and ultrasonic extraction is complete, takes filtrate,
Concentrating under reduced pressure becomes thick paste, obtains extract A, standby, and wherein, extraction conditions includes: ultrasonic power is 130-160W, extracts
Temperature is 30-50 DEG C, and extraction time is 10-50min；
(2) Fructus Pandani tectorii, great Pi disappeared, Crepis crocea Babc.(C.turczaninowii C.A.Mey.), Folium Mahoniae, ovum leaf Herba Oenanthes Javanicae, Radix fici panduratae, Aleuritopteris argentea (Gmel.) Fee, Semen Ziziphi Spinosae are pulverized,
Boiling twice, decocts 1.0-2.0 hour for the first time, and amount of water is 6-10 times of medical material gross weight, and second time decocts 1.0-1.5
Hour, amount of water is 4-7 times of decocting herbs gross weight, collecting decoction, filters, and filtrate reduced in volume to relative density is
1.05-1.10 (60 DEG C of surveys), adding ethanol to determining alcohol is 30%, in-5～5 DEG C of cold preservations 12 hours, filters, and filtrate reclaims second
Alcohol, is condensed into thick paste, obtains extract B, mixs homogeneously with extract A, to obtain final product.Those skilled in the art can be in this, as pharmaceutically active
Composition, prepares suitable dosage form according to Chinese medicine preparation common process.
Further, the present invention can also add pharmaceutically acceptable carrier or complementary composition, as starch, Icing Sugar, dextrin,
Microcrystalline cellulose, amylum pregelatinisatum, magnesium stearate, micropowder silica gel, fructose, carboxymethyl starch sodium, sodium carboxymethyl cellulose, hydroxyl
Propyl methocel, vegetable oil, lecithin, Polyethylene Glycol, propylene glycol, ethyl hydroxybenzoate etc..
Preferably, pharmaceutical composition of the present invention is made for peroral dosage form, such as, and tablet, film coated tablet, enteric coating
Tablet, capsule, hard capsule, soft capsule, oral liquid, granule, honey pill agent, powder, sublimed preparation, solution or hard
Unguentum etc., further, the dosage form of described pharmaceutical composition is tablet, capsule, oral liquid or granule, most preferably
For capsule.
The preparation of the present invention determines usage and dosage according to the situation of patient in use.The preparation of the present invention is in use according to patient
Situation determine usage and dosage, can take 1-3 time every day, each 1-20 agent, such as: 1-20 bag or grain or sheet etc..
Another object of the present invention is that protection aforementioned pharmaceutical compositions is preparing the purposes for thyroid nodule medicine, especially
The purposes of cyclomastopathy patient's Liver depression and Qi stagnation medicine is accompanied for thyroid nodule in preparation.The embodiment of the present invention 9 medicine pair of the present invention
The clinical observation experiment of thyroid nodule companion cyclomastopathy patient, result shows, the comprehensive therapeutic effect for the treatment of group is substantially better than matched group
(total effective rate is respectively 87.0%, 56.5%), difference statistically significant (P ＜ 0.01)；With matched group comparison therapy group disease
It is less that total mark reduces, and difference also has statistics meaning (P ＜ 0.05)；Treatment group lump in breast, thyroid nodule are relatively treated
Before be obviously reduced and all reach statistical significance (P ＜ 0.05, P ＜ 0.01), and matched group improves inconspicuous；With matched group comparison therapy
Group pain integration is obviously reduced, and the remission time of pain is substantially very fast, difference statistically significant (P ＜ 0.05).Therefore this
Bright medicine is to treatment thyroid nodule companion's cyclomastopathy, and Chinese medical discrimination belongs to Liver depression and Qi stagnation patient and has preferable clinical efficacy, value
Obtain further genralrlization to use.
In a word, compared with prior art, the present invention has a following beneficial features:
(1) present invention is based on theory of Chinese medical science, and prescription is rigorous, and monarch compatibility relationship is clear and definite, selects YAOJING to work as, has
Mutiple Targets, too many levels, multi-level comprehensive regulation effect, for the stagnation of QI due to depression of the liver pattern of syndrome patient of thyroid nodule companion's cyclomastopathy,
The tcm clinical practice symptom of patient can be significantly improved, improve patients ' life quality.
(2) medicine of the present invention can significantly alleviate mastalgia, reduces the volume of lump in breast and thyroid nodule.
(3) present invention can be prepared as capsule, it is to avoid takes inconvenience, the shortcoming of patient compliance difference.
Detailed description of the invention
Further describing the present invention below by way of specific embodiment, the present invention is not limited only to following example.Model in the present invention
Enclose interior or without departing from present disclosure, spirit and scope, change that the present invention is carried out, combine or replace, for
It is apparent from for those skilled in the art, and is included within the scope of the present invention.
Embodiment 1 capsule
Prescription: Folium Fortunellae Margarita 10 parts, Fructus Pandani tectorii 15 parts, great Pi disappear 10 parts, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 20 parts, Folium Mahoniae 10 parts, Flos Rosae Rugosae 8 parts,
Ovum leaf Herba Oenanthes Javanicae 8 parts, Herba Violae mundae 6 parts, Radix fici panduratae 16 parts, Aleuritopteris argentea (Gmel.) Fee 12 parts, Radix Semiaquilegiae 15 parts, Flos daphnes odorae 8 parts, Semen Ziziphi Spinosae 6 parts.
Preparation method: it is 30-40 μm that (1) depletion Folium Citri tangerinae, Herba Violae mundae, Radix Semiaquilegiae, Flos Rosae Rugosae, Flos daphnes odorae are ground into mean diameter
Granule after add 7 times amount 50% ethanol water, use ultrasonic extraction 2 times, ultrasonic extraction is complete, takes filter
Liquid, concentrating under reduced pressure becomes thick paste, obtains extract A, standby, and wherein, extraction conditions includes: ultrasonic power is 140-150W,
Extracting temperature is 30-50 DEG C, and extraction time is 30-40min；
(2) Fructus Pandani tectorii, great Pi disappeared, Crepis crocea Babc.(C.turczaninowii C.A.Mey.), Folium Mahoniae, ovum leaf Herba Oenanthes Javanicae, Radix fici panduratae, Aleuritopteris argentea (Gmel.) Fee, Semen Ziziphi Spinosae are pulverized,
Boiling twice, decocts 1.0-2.0 hour for the first time, and amount of water is 8 times of medical material gross weight, and second time decocts 1.0-1.5 hour,
Amount of water is 5 times of decocting herbs gross weight, collecting decoction, filters, and filtrate reduced in volume to relative density is 1.07 (60 DEG C of surveys),
Adding ethanol to determining alcohol is 30%, in-5～5 DEG C of cold preservations 12 hours, filters, filtrate recycling ethanol, is condensed into thick paste, must carry
Take thing B, mix homogeneously with extract A, load capsule shells and get final product.Capsule prepared by the present embodiment, every loading amount 0.34g, phase
When in crude drug 1.08g.
Embodiment 2 capsule
Prescription: Folium Fortunellae Margarita 12 parts, Fructus Pandani tectorii 18 parts, great Pi disappear 15 parts, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 20 parts, Folium Mahoniae 12 parts, Flos Rosae Rugosae 10 parts,
Ovum leaf Herba Oenanthes Javanicae 12 parts, Herba Violae mundae 6 parts, Radix fici panduratae 18 parts, Aleuritopteris argentea (Gmel.) Fee 15 parts, Radix Semiaquilegiae 12 parts, Flos daphnes odorae 8 parts, Semen Ziziphi Spinosae 8
Part.
Preparation method: it is 20-40 μm that (1) depletion Folium Citri tangerinae, Herba Violae mundae, Radix Semiaquilegiae, Flos Rosae Rugosae, Flos daphnes odorae are ground into mean diameter
Granule after add 6 times amount 50% ethanol water, use ultrasonic extraction 2 times, ultrasonic extraction is complete, takes filter
Liquid, concentrating under reduced pressure becomes thick paste, obtains extract A, standby, and wherein, extraction conditions includes: ultrasonic power is 150-160W,
Extracting temperature is 40-50 DEG C, and extraction time is 30-40min；
(2) Fructus Pandani tectorii, great Pi disappeared, Crepis crocea Babc.(C.turczaninowii C.A.Mey.), Folium Mahoniae, ovum leaf Herba Oenanthes Javanicae, Radix fici panduratae, Aleuritopteris argentea (Gmel.) Fee, Semen Ziziphi Spinosae are pulverized,
Boiling twice, decocts 1.0-2.0 hour for the first time, and amount of water is 8 times of medical material gross weight, and second time decocts 1.0-1.5 hour,
Amount of water is 6 times of decocting herbs gross weight, collecting decoction, filters, and filtrate reduced in volume to relative density is 1.06 (60 DEG C of surveys),
Adding ethanol to determining alcohol is 30%, in-5～5 DEG C of cold preservations 12 hours, filters, filtrate recycling ethanol, is condensed into thick paste, must carry
Take thing B, mix homogeneously with extract A, load capsule shells and get final product.Capsule prepared by the present embodiment, every loading amount 0.32g, quite
In crude drug 1.06g.
Embodiment 3 capsule
Prescription: Folium Fortunellae Margarita 10 parts, Fructus Pandani tectorii 15 parts, great Pi disappear 10 parts, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 23 parts, Folium Mahoniae 10 parts, Flos Rosae Rugosae 6 parts,
Ovum leaf Herba Oenanthes Javanicae 8 parts, Herba Violae mundae 6 parts, Radix fici panduratae 16 parts, Aleuritopteris argentea (Gmel.) Fee 10 parts, Radix Semiaquilegiae 12 parts, Flos daphnes odorae 8 parts, Semen Ziziphi Spinosae 6 parts.
Preparation method: it is 10-20 μm that (1) depletion Folium Citri tangerinae, Herba Violae mundae, Radix Semiaquilegiae, Flos Rosae Rugosae, Flos daphnes odorae are ground into mean diameter
Granule after add 5 times amount 50% ethanol water, use ultrasonic extraction 3 times, ultrasonic extraction is complete, takes filter
Liquid, concentrating under reduced pressure becomes thick paste, obtains extract A, standby, and wherein, extraction conditions includes: ultrasonic power is 130-140W,
Extracting temperature is 35-50 DEG C, and extraction time is 15-25min；
(2) Fructus Pandani tectorii, great Pi disappeared, Crepis crocea Babc.(C.turczaninowii C.A.Mey.), Folium Mahoniae, ovum leaf Herba Oenanthes Javanicae, Radix fici panduratae, Aleuritopteris argentea (Gmel.) Fee, Semen Ziziphi Spinosae are pulverized,
Boiling twice, decocts 1.0-2.0 hour for the first time, and amount of water is 6 times of medical material gross weight, and second time decocts 1.0-1.5 hour,
Amount of water is 6 times of decocting herbs gross weight, collecting decoction, filters, and filtrate reduced in volume to relative density is 1.08 (60 DEG C of surveys),
Adding ethanol to determining alcohol is 30%, in-5～5 DEG C of cold preservations 12 hours, filters, filtrate recycling ethanol, is condensed into thick paste, must carry
Take thing B, mix homogeneously with extract A, to obtain final product.Those skilled in the art can be normal according to Chinese medicine preparation in this, as active constituents of medicine
Rule technique prepares suitable dosage form.Capsule prepared by the present embodiment, every loading amount 0.34g, be equivalent to crude drug 1.08g.
Embodiment 4 capsule
Prescription: Folium Fortunellae Margarita 8 parts, Fructus Pandani tectorii 18 parts, great Pi disappear 12 parts, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 18 parts, Folium Mahoniae 10 parts, Flos Rosae Rugosae 9 parts,
Ovum leaf Herba Oenanthes Javanicae 12 parts, Herba Violae mundae 5 parts, Radix fici panduratae 15 parts, Aleuritopteris argentea (Gmel.) Fee 12 parts, Radix Semiaquilegiae 11 parts, Flos daphnes odorae 7 parts, Semen Ziziphi Spinosae 6
Part.
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 5 capsule
Prescription: Folium Fortunellae Margarita 12 parts, Fructus Pandani tectorii 16 parts, great Pi disappear 15 parts, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 20 parts, Folium Mahoniae 8 parts, Flos Rosae Rugosae 10 parts,
Ovum leaf Herba Oenanthes Javanicae 13 parts, Herba Violae mundae 6 parts, Radix fici panduratae 18 parts, Aleuritopteris argentea (Gmel.) Fee 10 parts, Radix Semiaquilegiae 15 parts, Flos daphnes odorae 6 parts, Semen Ziziphi Spinosae 9
Part.
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 6 capsule
Prescription: Folium Fortunellae Margarita 9 parts, Fructus Pandani tectorii 16 parts, great Pi disappear 10 parts, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 20 parts, Folium Mahoniae 10 parts, Flos Rosae Rugosae 8 parts,
Ovum leaf Herba Oenanthes Javanicae 9 parts, Herba Violae mundae 6 parts, Radix fici panduratae 18 parts, Aleuritopteris argentea (Gmel.) Fee 15 parts, Radix Semiaquilegiae 12 parts, Flos daphnes odorae 8 parts, Semen Ziziphi Spinosae 7 parts.
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 7 capsule
Prescription: Folium Fortunellae Margarita 12 parts, Fructus Pandani tectorii 16 parts, great Pi disappear 12 parts, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 22 parts, Folium Mahoniae 10 parts, Flos Rosae Rugosae 7 parts,
Ovum leaf Herba Oenanthes Javanicae 10 parts, Herba Violae mundae 5 parts, Radix fici panduratae 16 parts, Aleuritopteris argentea (Gmel.) Fee 10 parts, Radix Semiaquilegiae 13 parts, Flos daphnes odorae 6 parts, Semen Ziziphi Spinosae 7
Part.
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 8 capsule
Prescription: Folium Fortunellae Margarita 9 parts, Fructus Pandani tectorii 15 parts, great Pi disappear 15 parts, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 18 parts, Folium Mahoniae 12 parts, Flos Rosae Rugosae 6 parts,
Ovum leaf Herba Oenanthes Javanicae 8 parts, Herba Violae mundae 6 parts, Radix fici panduratae 16 parts, Aleuritopteris argentea (Gmel.) Fee 10 parts, Radix Semiaquilegiae 16 parts, Flos daphnes odorae 8 parts, Semen Ziziphi Spinosae 6 parts.
Preparation method: the operation with reference to embodiment 1-3 is carried out.
The clinical observation test to thyroid nodule companion cyclomastopathy patient of embodiment 9 medicine of the present invention
1 data and method
1.1 physical data: choose 92 example thyroid nodule companion's cyclomastopathy that in February, 2013 in February, 2014, my institute accepted for medical treatment and suffer from
Person, Chinese medical discrimination belongs to Liver depression and Qi stagnation.It is randomly divided into treatment group and matched group, often organizes each 46 examples.The treatment group mean age be (36.5 ±
6.6) year, individual month of average course of disease (13.9 ± 2.4), unilateral ill 20 examples of breast, ill 26 examples of bilateral breast；Matched group is put down
All the age be (35.8 ± 6.4) year, individual month of average course of disease (14.2 ± 2.5), one side ill 19 examples of breast, bilateral breast ill 27
Example.Two groups of patients are at the equal not statistically significant of difference of the aspects such as sex, age, disease time, pain degree, tuberosity size
(P ＞ 0.05), has comparability.
1.2 diagnostic criteria
1.2.1 Diagnosis of Thyroid: according to the diagnostic criteria of " thyroid nodule " in " Thyroid Diseases in China diagnosis and treatment guide ":
There is, in causing thyroid, the agglomerate that one or more organizational structuries are abnormal in a variety of causes, and all patients all get rid of through thyroid needle
Cell abnormal shape and (or) thyroid malignancy.
1.2.2 cyclomastopathy diagnostic criteria: with reference to the 8th meeting of breast disease Professional Committee of Chinese surgery of Chinese medicine association in 2002
The Diagnosis of Cyclomastopathy criterion of therapeutical effect passed through.Symptom and sign: breast has distending pain in various degree, twinge, dull pain, can put
It is incident upon oxter, shoulder back, can have a dependency with menstruation, emotion changes, continuous 3 months or be interrupted pain 3～can not delay for 6 months
Solve；There is single or multiple differing in size, the lump of form of diverse in one or both sides breast, lump is dispersed among whole breast,
Unclear with surrounding tissue boundary, with skin or deep tissue adhesion, push away movable, can have tenderness, can be with emotion and menstruation week
Phase changes and growth and decline, and some patients nipple can be with discharge or pruritus.Auxiliary examination: mammography, B ultrasonic, infrared light scanning,
Mammary gland fiber duct mirror, puncture cell or tissue check.
1.2.3 Syndrome Differentiation of Traditional Chinese Medicine standard: with reference to " combination of Chinese and Western medicine oncology ", " tcm clinical practice diagnosis and treatment term syndrome part "
And " new Chinese medicine guideline of clinical investigations " formulation Liver depression and Qi stagnation: primary symptom: distending pain of the breast companion's caking, side or bilateral
The accessible tuberosity of lobus glandulae thyroideae；Secondary disease: discomfort of neck area or cervical region twinge, pharyngalgia, weak, depressed emotion uncomfortable in chest or being irritable and getting angry easily, breast
Side of body distension, has a dizzy spell, and menoxenia, body of the tongue is light red, white and thin fur or micro-Huang, stringy pulse.
1.3 include in and exclusion standard:
1.3.1 inclusive criteria: all patients all confirm through pathological examination, and meeting above-mentioned diagnostic criteria, patient is in the research
Hold and therapeutic scheme is known the inside story, signed letter of consent.
1.3.2 exclusion standard: the person that turns out to be Malignant Nodules, tuberosity volume grows beyond 30% in a short time；Hyperthyroidism or
Hypothyroid；Breast innocent and malignant tumour person, to treatment prescription drug allergy sufferers；Suffer from infectious disease, severe cardiac
Cerebrovascular disease, or serious hepatic and kidney function obstacle patient；Anemia of pregnant woman；The infull patient of collection of data.
1.4 Therapeutic Method: matched group: application levothyroxine sodium treatment, levothyroxine sodium tables (trade name Euthyrox,
Shenzhen China Associated Pharmaceutical Co., Ltd. produces), 50～100 μ g/ time, 1 time/d, to play warm water and take morning, be administered orally BUPIXIAO PIAN in the evening
(Liaoning good nurse Pharmaceutical Co., Ltd, specification: 0.32g/ sheet), 5～6 pieces/times, 1 time/d.Treatment group: take this
The capsule for treating of inventive embodiments 1 preparation, twice on the one, each 4-6 grain.One month is a course for the treatment of, within before and after menstrual period 2 days, can subtract clothes
Or withdraw, observe and judge curative effect after treating three courses for the treatment of.
1.5 observation index:
1.5.1 draft according to relevant curative effect determinate standard in " new Chinese medicine clinical research guide ".Disease is marked, each disease
Shape according to without, light, in, weigh four grades and count 0,1,2,3 points respectively.
1.5.2 tuberosity calculation method of physical volume: V (cm3)=π/6 × major diameter (cm) × transverse diameter (cm) × wide footpath (cm)；Lump in breast calculates: B
The super lower lump in breast 2 of maximum of measuring is as vertical major diameter, and two footpaths are multiplied and are Tumor size.
1.5.3 mastalgia scoring: without spontaneous pain, without note 0 point of touching a tender spot；Spontaneous dull pain, nothing are touched a tender spot and are remembered 1 point；Idiopathic pain is brighter
Show, have tenderness note 2 points；Idiopathic pain and substantially note 3 points of touching a tender spot；Idiopathic pain is serious, can not touch and affect activity remembers 4 points.
1.6 comprehensive therapeutic effects evaluations: clinical recovery: transference cure or substantially disappear, symptom integral reduces >=95%；Effective: symptom
Being obviously improved, tuberosity volume or lump in breast reduce more than 2/3, and symptom integral reduces >=70%；It is effective: symptom all take a favorable turn,
Tuberosity volume or lump in breast reduce by more than 1/3 symptom integral and reduce >=30%；Invalid: symptom is all without taking a turn for the better and improving, even add
Weight, tuberosity volume or lump in breast reduce less than 1/3, and symptom integral reduces less than 30%.
1.7 statistical analysis: statistical analysis uses spss16.0 statistical software to be analyzed, the comparison of enumeration data two sample rate
Use χ2Inspection, measurement data withRepresent, compare before and after treatment with paired t-test, between group, compare employing t inspection, P ＜ 0.05
Represent that difference is statistically significant.
2 results
2.1 liang of group Comprehensive Clinical comparitive study: treat treatment group clinical recovery 9 example after terminating, effective 19 examples, effective 12 examples, nothing
Imitate 6 examples, total effective rate 87.0%；Matched group clinical recovery 2 example, effective 9 examples, effective 15 examples, invalid 20 examples, total effective rate 56.5%,
The therapeutic effect for the treatment of group is substantially better than matched group, difference statistically significant (P ＜ 0.01).It is shown in Table 1.
After table 1 treatment, two groups of patient clinical comprehensive therapeutic effects compare, example (%)
Note: compare with matched group, * P ＜ 0.01.
Before and after 2.2 liang of group treatments, syndrome total mark compares: after two groups of treatments, syndrome integral all significantly improves, front with treatment poor
Different all have significant (P ＜ 0.05, P ＜ 0.01)；Comparing between two groups after treatment, it is less that treatment group disease total mark reduces,
Difference also has statistics meaning (P ＜ 0.05).It is shown in Table 2.
Before and after the group treatment of 2 liang of table, disease total mark compares
Note: compare with before treatment, * P ＜ 0.05, * * P ＜ 0.01；Compare between group,#P ＜ 0.05.
2.3 liang of groups lump in breast, thyroid nodule situations of change: after treatment, treatment group lump in breast, thyroid nodule are relatively controlled
(P ＜ 0.01) it is obviously reduced before treatment；Treatment of control group rear udder attachment lump, thyroid nodule have the trend of reducing before relatively treating, but poor
Different not statistically significant (P ＞ 0.05).It is shown in Table 3.
3 liang of table group lump in breast size and tuberosity volume situation of change compare,
Note: compare with before treatment, * P ＜ 0.05, * * P ＜ 0.01；Compare between group,#P ＜ 0.05.
2.4 liang of group mastalgia scorings, pain relieving times compare: after treatment, treatment group pain integration is obviously reduced, with treatment
Front comparing difference statistically significant (P ＜ 0.01)；After treatment of control group, pain integration is obviously reduced, comparing difference front with treatment
Statistically significant (P ＜ 0.05), compares between two groups, and it is more that treatment group pain integration reduces, the statistically significant (P of difference
＜ 0.05).The remission time of the pain for the treatment of group simultaneously is significantly shorter than matched group, difference statistically significant (P ＜ 0.01).See
Table 4.
The group mastalgia scoring of 4 liang of table, pain relieving time compare,
Note: compare with before treatment, * P ＜ 0.05, * * P ＜ 0.01；Compare between group,#P ＜ 0.05,##P ＜ 0.01.
2.5 untoward reaction: treatment group during observing patient without any subjective uncomfortable, blood, urine, stool routine examination and the heart, liver,
Renal functioies etc. check exception all do not occur.
This observed result shows, the comprehensive therapeutic effect for the treatment of group is substantially better than matched group, difference statistically significant (P ＜ 0.01)；With
It is less that matched group comparison therapy group disease total mark reduces, and difference also has statistics meaning (P ＜ 0.05)；Treatment group breast swells
Block, thyroid nodule are obviously reduced before relatively treating and all reach statistical significance (P ＜ 0.05, P ＜ 0.01), and matched group improves not clear
Aobvious；Being obviously reduced with matched group comparison therapy group pain integration, the remission time of pain is substantially very fast, and difference is statistically significant
(P ＜ 0.05).Medicine the most of the present invention is to treatment thyroid nodule companion's cyclomastopathy, and Chinese medical discrimination belongs to Liver depression and Qi stagnation patient tool
There is preferable clinical efficacy, be worth further genralrlization to use.
Claims (10)
1. the pharmaceutical composition treating thyroid nodule companion's cyclomastopathy, it is characterised in that by Folium Fortunellae Margarita, Fructus Pandani tectorii, great Pi
Disappear, Crepis crocea Babc.(C.turczaninowii C.A.Mey.), Folium Mahoniae, Flos Rosae Rugosae, ovum leaf Herba Oenanthes Javanicae, Herba Violae mundae, Radix fici panduratae, Aleuritopteris argentea (Gmel.) Fee, Radix Semiaquilegiae, Flos daphnes odorae, acid
Semen Ziziphi Spinosae is made.
2. the pharmaceutical composition for the treatment of thyroid nodule companion's cyclomastopathy as claimed in claim 1, it is characterised in that by weighing as follows
The medicinal raw material of amount part proportioning is made: Folium Fortunellae Margarita 8-13 part, Fructus Pandani tectorii 13-18 part, great Pi disappear 10-15 part, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 18-23 part,
Folium Mahoniae 8-13 part, Flos Rosae Rugosae 6-11 part, ovum leaf Herba Oenanthes Javanicae 8-13 part, Herba Violae mundae 5-8 part, Radix fici panduratae 15-20 part, Aleuritopteris argentea (Gmel.) Fee 10-15
Part, Radix Semiaquilegiae 11-16 part, Flos daphnes odorae 6-9 part, Semen Ziziphi Spinosae 6-9 part.
3. the pharmaceutical composition for the treatment of thyroid nodule companion's cyclomastopathy as claimed in claim 2, it is characterised in that by weighing as follows
Amount part proportioning medicinal raw material make: Folium Fortunellae Margarita 10 parts, Fructus Pandani tectorii 15 parts, great Pi disappear 10 parts, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 20 parts, Folium Mahoniae 10
Part, Flos Rosae Rugosae 8 parts, ovum leaf Herba Oenanthes Javanicae 8 parts, Herba Violae mundae 6 parts, Radix fici panduratae 16 parts, Aleuritopteris argentea (Gmel.) Fee 12 parts, Radix Semiaquilegiae 15 parts, Flos daphnes odorae
8 parts, Semen Ziziphi Spinosae 6 parts.
4. the pharmaceutical composition for the treatment of thyroid nodule companion's cyclomastopathy as claimed in claim 2, it is characterised in that by weighing as follows
Amount part proportioning medicinal raw material make: Folium Fortunellae Margarita 12 parts, Fructus Pandani tectorii 18 parts, great Pi disappear 15 parts, Crepis crocea Babc.(C.turczaninowii C.A.Mey.) 20 parts, Folium Mahoniae 12
Part, Flos Rosae Rugosae 10 parts, ovum leaf Herba Oenanthes Javanicae 12 parts, Herba Violae mundae 6 parts, Radix fici panduratae 18 parts, Aleuritopteris argentea (Gmel.) Fee 15 parts, Radix Semiaquilegiae 12 parts, winter daphne
Spend 8 parts, Semen Ziziphi Spinosae 8 parts.
5. the pharmaceutical composition of the treatment thyroid nodule companion's cyclomastopathy as described in claim 1-4 is arbitrary, it is characterised in that described
The preparation method of pharmaceutical composition comprises the steps:
(1) depletion Folium Citri tangerinae, Herba Violae mundae, Radix Semiaquilegiae, Flos Rosae Rugosae, Flos daphnes odorae are ground into the granule that mean diameter is 10-60 μm
The ethanol water of the 50% of rear addition 5-10 times amount, uses ultrasonic extraction 2-3 time, and ultrasonic extraction is complete, takes filtrate,
Concentrating under reduced pressure becomes thick paste, obtains extract A, standby, and wherein, extraction conditions includes: ultrasonic power is 130-160W, extracts
Temperature is 30-50 DEG C, and extraction time is 10-50min；
(2) Fructus Pandani tectorii, great Pi disappeared, Crepis crocea Babc.(C.turczaninowii C.A.Mey.), Folium Mahoniae, ovum leaf Herba Oenanthes Javanicae, Radix fici panduratae, Aleuritopteris argentea (Gmel.) Fee, Semen Ziziphi Spinosae are pulverized,
Boiling twice, decocts 1.0-2.0 hour for the first time, and amount of water is 6-10 times of medical material gross weight, and second time decocts 1.0-1.5
Hour, amount of water is 4-7 times of decocting herbs gross weight, collecting decoction, filters, and filtrate reduced in volume to relative density is
1.05-1.10 (60 DEG C of surveys), adding ethanol to determining alcohol is 30%, in-5～5 DEG C of cold preservations 12 hours, filters, and filtrate reclaims second
Alcohol, is condensed into thick paste, obtains extract B, mixs homogeneously with extract A, to obtain final product, and those skilled in the art can be in this, as pharmaceutically active
Composition, prepares suitable dosage form according to Chinese medicine preparation common process.
6. the pharmaceutical composition of the treatment thyroid nodule companion's cyclomastopathy as described in claim 1-5 is arbitrary, it is characterised in that described
Pharmaceutical composition is preferably made as peroral dosage form.
7. the pharmaceutical composition for the treatment of thyroid nodule companion's cyclomastopathy as claimed in claim 6, it is characterised in that described oral
Dosage form is preferably tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, granule
Agent, honey pill agent, powder, sublimed preparation, solution or plaster etc..
8. the pharmaceutical composition for the treatment of thyroid nodule companion's cyclomastopathy as claimed in claim 7, it is characterised in that described oral agents
Type is preferably tablet tablet, capsule, oral liquid or granule.
9. the pharmaceutical composition for the treatment of thyroid nodule companion's cyclomastopathy as claimed in claim 8, it is characterised in that described oral
Dosage form is preferably capsule.
10. claim 1-4 arbitrary described pharmaceutical composition use in preparation treatment thyroid nodule companion's cyclomastopathy medicine
On the way.
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| CN105327269A (en) * | 2015-10-21 | 2016-02-17 | 苏静 | Chinese medicine external application for treating hyperplasia of mammary glands |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105327269A (en) * | 2015-10-21 | 2016-02-17 | 苏静 | Chinese medicine external application for treating hyperplasia of mammary glands |
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Application publication date: 20160921 |