CN104623152A - Traditional Chinese medicine composition for treating thyroid adenoma due to phlegm-damp stagnation and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating thyroid adenoma due to phlegm-damp stagnation and preparation method thereof Download PDF

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CN104623152A
CN104623152A CN201510024708.5A CN201510024708A CN104623152A CN 104623152 A CN104623152 A CN 104623152A CN 201510024708 A CN201510024708 A CN 201510024708A CN 104623152 A CN104623152 A CN 104623152A
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herba
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phlegm
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高雨
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Abstract

The invention provides a traditional Chinese medicine composition for treating thyroid adenoma due to phlegm-damp stagnation and a preparation method thereof, and belongs to the field of traditional Chinese medicines. The composition is prepared from pinellia ternata, semen brassicae, kamuning, pericarpium citri reticulatae, codonopsis pilosula, rhizoma atractylodis macrocephalae, divaricate knotweed herb, Chinese lobelia, artemisia anomala and licorice root. The composition has the effects of invigorating spleen, replenishing qi, regulating flow of qi and middle jiao, drying dampness, removing phlegm, promoting blood circulation to remove stasis and resolving hard lump, can be used for effectively reducing the size of adenoma, has a remarkable curative effect against the thyroid adenoma due to phlegm-damp stagnation and limited influence on functions of human thyroid, and has small side effect.

Description

A kind of Chinese medicine composition and preparation method for the treatment of phlegm-damp coagulation type thyroid adenoma
Technical field
The invention belongs to the field of Chinese medicines, be specifically related to a kind of Chinese medicine composition and preparation method for the treatment of phlegm-damp coagulation type thyroid adenoma.
Background technology
Thyroid adenoma is modal Treatment of Benign Tumor of Thyroid Gland, and general without general malaise symptom, can be sent out in any age, be apt to occur in young and middle-aged women, be the benign goitre originating from thyroid follicle tissue." toxic goiter " category of this Bing Shu motherland medical science.Modern Chinese medicine differentiation of symptoms and signs for classification of syndrome theory think the morbidity of thyroid adenoma patient many unsuitable with residence place, feelings will is smooth, just exogenous pathogen to have crouched close relationship.Under the effect of multiple unfavorable factor, cause the stagnation of QI, blood stasis, expectorant coagulates, and ends in neck, with the passing of time forms lump.
The traditional Chinese medical science thinks that diet is uncomfortable, insufficiency of the spleen resulting in production of dampness, or the prosperous insult soil of wood, and the dysfunction of the spleen is raw in phlegm-damp.Although expectorant all has relation with lung spleen kidney three is dirty, spleen is unequal to wet, transporting mistake department, is but the main cause of raw expectorant, i.e. so-called " the spleen being the source of producing phlegm ".Deficiency-weakness of spleen-QI, unable transmitting and distributing the fluids, wets poly-and is expectorant.Deficiency of spleen and stomach, transporting is too late, and warm unable, phlegm-damp is grown thickly.
Wet, expectorant goes out a source together, and name is different and in fact together, both are body fluid and lose the pathological product formed in positizing.Once after being formed, just become pathogenic turbid pathogen.Abundant expectoration stiff, after formation, can fall with gas lift, throughout whole body, the interior and vital organs of the human body, outward to skin muscles and bones, for disease nowhere less than.Damp pathogen being heavy and turbid in nature viscous, every many delay difficulties but.Expectorant is poly-by wetting, and its property is slitted greasy, and delay is difficult especially.Phlegm-damp condenses, and with the passing of time then likely follow meridians and tie and form primary disease in throat, phlegm-damp coagulation type thyroid adenoma disease is seen: uncomfortable in chest smooth, anorexia, limbs asthenia, thyroid node projection, matter is slightly hard.Tongue is greasy in vain, rolling pulse or moisten thin.
From patient clinical symptom, thyroid adenoma is confined to throat more, outer likeness in form Semen Juglandis, and quality is comparatively hard, can move up and down with the action such as swallowing.Thyroid adenoma patient is general non-evident sympton in the early stage, and generally need could be found by ultrasound diagnosis, patient is treated surgically more, or does not carry out any remedy measures.But compared with tcm therapy, operative treatment costly, and postoperatively very easily to recur.And take the prolongation of patient along with the course of disease not carrying out any treatment, very easily form the thyroid carcinoma healed compared with refractory.Therefore, there is very large demand to the Chinese medicine of effectively treating thyroid adenoma in people.
Summary of the invention
Inventor is according to take up a job as a doctor practical experience and the understanding to motherland's theory of medicine for many years, for the treatment of thyroid adenoma, define the theory of oneself uniqueness, on the basis of dialectical treatment, for the phlegm-damp cohesion disease type of thyroid adenoma, provide and a kind ofly treat the Chinese medicine composition of phlegm-damp coagulation type thyroid adenoma and the preparation method of this Chinese medicine composition; Selected by Chinese medicine composition of the present invention, medical material compatibility is suitable, meets Chinese medicine and pharmacy and modern medicine theory, and has invigorating the spleen and replenishing QI, regulating the flow of Qi and the middle Jiao, drying dampness to eliminate phlegm, promoting blood circulation to remove blood stasis, effect of hard masses softening and resolving, to treatment phlegm-damp coagulation type thyroid tumor, there is significant curative effect, and taking convenience, non-relapse after healing, safe without toxic side effect, can effectively alleviate patient's burden and misery, the object for the treatment of both the principal and secondary aspects of a disease can be reached, wide popularization and application on clinic.
For achieving the above object, technical scheme of the present invention is implemented as follows:
Treat a Chinese medicine composition for phlegm-damp coagulation type thyroid adenoma, it is characterized in that it is made up of the Rhizoma Pinelliae, Semen Sinapis Albae, Folium Et Cacumen Murrayae, Pericarpium Citri Reticulatae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba polygoni divaricati, Herba Lobeliae Chinensis, Herba Artemisiae Anomalae, Radix Glycyrrhizae.
According to we the therapeutic effect of phlegm-damp cohesion disease type patient is belonged to thyroid adenoma Syndrome Differentiation of Traditional Chinese Medicine and untoward reaction situation is optimum condition, preferably, the Chinese medicine composition for the treatment of phlegm-damp coagulation type thyroid adenoma described above, the raw material composition and the parts by weight that it is characterized in that making described effective ingredient are: Rhizoma Pinelliae 7-11 part, Semen Sinapis Albae 9-15 part, Folium Et Cacumen Murrayae 8-13 part, Pericarpium Citri Reticulatae 11-15 part, Radix Codonopsis 13-18 part, Rhizoma Atractylodis Macrocephalae 9-15 part, Herba polygoni divaricati 11-16 part, Herba Lobeliae Chinensis 16-21 part, Herba Artemisiae Anomalae 7-11 part, Radix Glycyrrhizae 6-9 part.
Further preferably, the Chinese medicine composition for the treatment of phlegm-damp coagulation type thyroid adenoma described above, the raw material composition and the parts by weight that it is characterized in that making described effective ingredient are: the Rhizoma Pinelliae 9 parts, Semen Sinapis Albae 11 parts, Folium Et Cacumen Murrayae 10 parts, Pericarpium Citri Reticulatae 13 parts, Radix Codonopsis 15 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, Herba polygoni divaricati 15 parts, Herba Lobeliae Chinensis 17 parts, Herba Artemisiae Anomalae 10 parts, 7 parts, Radix Glycyrrhizae.
Fang Zhong: the pungent loose temperature of the Rhizoma Pinelliae, merit is apt to drying dampness to eliminate phlegm, is the key medicine of drying dampness to eliminate phlegm, warming for resolving cold-phlegm, Semen Sinapis Albae promoting the circulation of QI eliminating phlegm, warming spleen and stomach for dispelling cold, and removing obstruction in the collateral to relieve pain is the key medicine of warming for resolving cold-phlegm, and it is strong that two medicines share temperatureization history expectorant cold-phlegm power, and can temperature three-way meridian; The pungent stagnant gas that can fall apart of Pericarpium Citri Reticulatae, diuretic paddy, the therapeutic method to keep the adverse QI flowing downwards, the capable then expectorant of gas is capable, and the sage of the past meeting " control expectorant and first control gas " is theoretical, and three medicines play drying dampness to eliminate phlegm altogether, warming spleen and stomach for dispelling cold, effect of regulating the flow of Qi and the middle Jiao, are monarch drug.Folium Et Cacumen Murrayae depressed liver-energy dispersing and QI regulating, promoting blood circulation to remove blood stasis, hard masses softening and resolving, Herba polygoni divaricati removing food stagnancy falls apart wart, and Herba Artemisiae Anomalae dissipating blood stasis to promote menstruationg can strengthen the merit of the hard masses softening and resolving of Herba polygoni divaricati and Folium Et Cacumen Murrayae, and in addition, primary disease with the passing of time must the stasis of blood, and also meeting the rule for the treatment of of its promoting blood circulation to remove blood stasis, is ministerial drug.Radix Codonopsis invigorating the spleen and replenishing QI, spleen invigorating lung benefiting, Rhizoma Atractylodis Macrocephalae invigorating the spleen and benefiting QI, dampness diuretic, it is good that two medicines share invigorating the spleen and benefiting QI power, and the strong then transporting of spleen is strong, hinders from its source, controls it at all, and in addition, the capable then blood of gas, strengthening the catharsis of phlegm-damp exopathogen, is adjuvant.Herba Lobeliae Chinensis inducing diuresis to remove edema, heat-clearing and toxic substances removing is adjuvant drug.Radix Glycyrrhizae coordinating the actions of various ingredients in a prescription, for making medicine.Full side combined into invigorating the spleen and replenishing QI, regulating the flow of Qi and the middle Jiao, drying dampness to eliminate phlegm, promoting blood circulation to remove blood stasis, hard masses softening and resolving, for phlegm-damp coagulation type thyroid adenoma treating both the principal and secondary aspects of a disease, clinical effectiveness is remarkable.
In side, the pharmaceutical research of each medical material component is discussed below:
The Rhizoma Pinelliae: pungent, temperature; Poisonous.Return spleen, stomach, lung meridian.Function cures mainly: drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass.For abundant expectoration cough with asthma, phlegm retention vertigo and palpitation, dizziness due to wind-phlegm, syncope due to accumulation of phlegm is had a headache, vomiting regurgitation, and breast gastral cavity painful abdominal mass is vexed, globus hystericus; Raw with external treatment carbuncle sucutaneous nodule.Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) is used for stopping nausea and vomiting by lowering the adverse flow of QI.
Semen Sinapis Albae: pungent, temperature.Enter lung, stomach warp.Function cures mainly: promoting the circulation of QI eliminating phlegm, warming spleen and stomach for dispelling cold, removing obstruction in the collateral to relieve pain.Control phlegm retention cough with asthma, fullness and distention in the chest and hypochondrium pain, regurgitation is vomitted, aphasia due to apoplexy, and limbs arthralgia pain is numb, beriberi, carbuncle of yin nature, toxic swelling, treating swelling and pain by traumatic injury.
Folium Et Cacumen Murrayae: pungent, micro-hardship, temperature; Slightly poisonous.Function cures mainly: promoting the circulation of QI to relieve pain, promoting blood circulation to remove blood stasis.For stomachache, rheumatic arthralgia; External treatment is had a toothache, tumbling and swelling, worm venom.
Pericarpium Citri Reticulatae: bitter, pungent, temperature.Return lung, spleen channel.Function cures mainly: regulating qi-flowing for strengthening spleen, drying dampness to eliminate phlegm.For fullness in the epigastrium and chest, lack of appetite and vomiting, cough with copious phlegm.
Radix Codonopsis: sweet is flat.Return spleen, lung meridian.Function cures mainly: invigorating the spleen and replenishing QI, spleen invigorating lung benefiting.For deficiency of the spleen and lung, cardiopalmus of breathing hard, anorexia and loose stool, dyspnea due to deficiency is coughed, and interior-heat is quenched one's thirst.
The Rhizoma Atractylodis Macrocephalae: bitter, sweet, temperature.Return spleen, stomach warp.Function cures mainly: invigorating the spleen and benefiting QI, dampness diuretic, and hidroschesis is antiabortive.For insufficiency of the spleen lack of appetite, abdominal distention is had loose bowels, phlegm retention vertigo and palpitation, edema, spontaneous perspiration, frequent fetal movement.Rhizoma Atractylodis Macrocephalae spleen invigorating, stomach function regulating, antiabortive.For insufficiency of the spleen lack of appetite, loose stool of having loose bowels, frequent fetal movement.
Herba polygoni divaricati: bitter is cool.Function cures mainly: heat clearing away, removing food stagnancy, loose wart, antidiarrheal.Control intestine and small intestine accumulated heat, goiter, diarrhea of heat type is suffered from abdominal pain.
Herba Lobeliae Chinensis: pungent, flat.GUIXIN, small intestinal, lung meridian.Function cures mainly: inducing diuresis to remove edema, heat-clearing and toxic substances removing.For extensive abdominal edema, face foot edema, carbuncle furuncle, snake bite and insect sting; Advanced schistosomiasis ascites.
Herba Dendrobii: sweet, is slightly cold.Return stomach, kidney channel.Function cures mainly: reinforcing stomach reg fluid, nourishing YIN and clearing away heat.Lose for cloudy impairment of body fluid, xerostomia excessive thirst, lack of appetite is retched, deficiency-heat after being ill, poor vision.
Herba Artemisiae Anomalae: acrid in the mouth; Micro-hardship; Warm in nature.GUIXIN; Liver; Spleen channel.Function cures mainly: dissipating blood stasis to promote menstruationg; Hemostasia and detumescence; Promoting digestion and removing stagnation.Main warp closes; Dysmenorrhea; The stagnant stomachache of the stasis of blood in puerperal; Lochiorrhea, lump in the abdomen; Traumatic injury; Incised wound is hemorrhage; Rheumatic arthralgia; Have blood in stool; Hematuria; Carbuncle pyogenic infections from tumour or sore; Scald; Abdominal pain due to retention of food; Dysentery.
Radix Glycyrrhizae: sweet, flat.GUIXIN, lung, spleen, stomach warp.Function cures mainly: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.For weakness of the spleen and stomach, fatigue and weakness, shortness of breath and palpitation, cough with copious phlegm, the anxious pain of gastral cavity abdomen, extremity contraction, carbuncle sore tumefacting virus, cushion toxicity, strong.
Another object of the present invention is to provide the preparation containing above-mentioned Chinese medicine composition.
Chinese medicine composition of the present invention can add one or more pharmaceutically acceptable carriers, is applied to the patient needing this treatment in the mode of oral administration.For time oral, conventional solid preparation can be made into, as tablet, capsule, soft capsule, dispersible tablet, oral liquid, granule, chewable tablet, oral cavity disintegration tablet, drop pill, slow releasing tablet, slow releasing capsule, controlled release tablet, controlled release capsule, make liquid preparation if water or oil-suspending agent or other liquid preparation are as syrup etc.
Chinese medicine composition of the present invention can adopt the conventional method in existing pharmaceutical field to produce, and adds various pharmaceutically acceptable carrier.Described carrier comprises the excipient, filler, binding agent, wetting agent, disintegrating agent, absorption enhancer, surfactant, absorption carrier, lubricant etc. of pharmaceutical field routine.
Chinese medicine composition of the present invention is when making oral formulations, and selectable filler has: starch, Icing Sugar, calcium phosphate, calcium sulfate two water thing, dextrin, microcrystalline Cellulose, lactose, pregelatinized Starch, mannitol etc.; Selectable binding agent has: sodium carboxymethyl cellulose, PVP-K30, hydroxypropyl cellulose, starch slurry, methylcellulose, ethyl cellulose, hypromellose, gelling starch etc.; Selectable disintegrating agent has: dried starch, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose etc.; Selectable lubricant has; Magnesium stearate, Pulvis Talci, sodium lauryl sulphate, micropowder silica gel etc.
Drug composition oral preparation of the present invention is preferably tablet, capsule or granule.
Another object of the present invention there is provided the preparation method of above-mentioned Chinese medicine composition.
Chinese medicine composition preparation method of the present invention comprises following steps: get the Semen Sinapis Albae of recipe quantity, Folium Et Cacumen Murrayae adds ethanol extraction secondary, each 1-2 hour, merge extractive liquid, filters, filtrate recycling ethanol, being evaporated to relative density is 1.03-1.10 (60 DEG C of surveys), get the Rhizoma Pinelliae of recipe quantity, Pericarpium Citri Reticulatae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba Lobeliae Chinensis, Herba polygoni divaricati, Herba Artemisiae Anomalae, Radix Glycyrrhizae, decoct with water twice, first time 5-8 times of the amount of water material total amount of getting it filled that is this step, decoct 2-3 hour, the 3-4 of the second time amount of water material total amount of getting it filled that is this step doubly decocts 1-2 hour, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 45-60%, place 12 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.01-1.10 (60 DEG C of surveys), merge above two kinds of thick pastes, add one or more pharmaceutically acceptable carriers, the conventional method manufacture in existing pharmaceutical field is adopted to obtain conventional Chinese medicine pharmaceutical dosage form clinically.
Visible by clinical observation test example 9: treatment group before the treatment rear FT3, FT4 and TSH there is no significant change, illustrates that Chinese medicine composition is very little for the function effect of thyroid gland hormone, so safer.Before the TSH of matched group is starkly lower than treatment after the treatment, T3, T4 are after the treatment before treatment, although also illustrate that ectogenic thyroxin is low dose of, the secretion of thyroxin also can be made to be affected, likely to have influence on the normal physiological function of human thyroglobulin, though illustrate that oral western medicine thyroid tablet can suppress the secretion of TSH feedback, impel atrophy of thyroid gland, tumor body reduces, but the course for the treatment of is longer, drug dose is difficult to grasp, and side effect is large.
To sum up, beneficial effect of the present invention is: the present invention selects all reasons of medical material all standby, and the property of medicine is suitable mutually auxiliary mutually, has invigorating the spleen and replenishing QI, regulating the flow of Qi and the middle Jiao, drying dampness to eliminate phlegm, promoting blood circulation to remove blood stasis, effect of hard masses softening and resolving, reduce adenoma volume, evident in efficacy for phlegm-damp coagulation type thyroid adenoma, limited to human thyroglobulin function effect, side effect is little.
Detailed description of the invention
Further describe the present invention below by way of specific embodiment, the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, the change carried out the present invention, combination or replacement, be apparent for a person skilled in the art, and be included within the scope of the present invention.
Embodiment 1
Prescription: Rhizoma Pinelliae 9g, Semen Sinapis Albae 11g, Folium Et Cacumen Murrayae 10g, Pericarpium Citri Reticulatae 13g, Radix Codonopsis 15g, Rhizoma Atractylodis Macrocephalae 12g, Herba polygoni divaricati 15g, Herba Lobeliae Chinensis 17g, Herba Artemisiae Anomalae 10g, Radix Glycyrrhizae 7g.
Preparation method: get the Semen Sinapis Albae of recipe quantity, Folium Et Cacumen Murrayae adds ethanol extraction secondary, each 1.5 hours, merge extractive liquid, filter, filtrate recycling ethanol, being evaporated to relative density is 1.06 (60 DEG C of surveys), get the Rhizoma Pinelliae of recipe quantity, Pericarpium Citri Reticulatae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba Lobeliae Chinensis, Herba polygoni divaricati, Herba Artemisiae Anomalae, Radix Glycyrrhizae, decoct with water twice, first time 6 times of the amount of water material total amount of getting it filled that is this step, decoct 2.5 hours, 3 times of decoctions of the second time amount of water material total amount of getting it filled that is this step 1.5 hours, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 50%, place 12 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.06 (60 DEG C of surveys), merge above two kinds of thick pastes, add starch, dextrin, the conventional method manufacture in existing pharmaceutical field is adopted to obtain capsule.
Embodiment 2
Prescription: Rhizoma Pinelliae 7g, Semen Sinapis Albae 9g, Folium Et Cacumen Murrayae 8g, Pericarpium Citri Reticulatae 11g, Radix Codonopsis 13g, Rhizoma Atractylodis Macrocephalae 9g, Herba polygoni divaricati 11g, Herba Lobeliae Chinensis 16g, Herba Artemisiae Anomalae 7g, Radix Glycyrrhizae 6g.
Preparation method: get the Semen Sinapis Albae of recipe quantity, Folium Et Cacumen Murrayae adds ethanol extraction secondary, each 1.5 hours, merge extractive liquid, filter, filtrate recycling ethanol, being evaporated to relative density is 1.05 (60 DEG C of surveys), get the Rhizoma Pinelliae of recipe quantity, Pericarpium Citri Reticulatae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba Lobeliae Chinensis, Herba polygoni divaricati, Herba Artemisiae Anomalae, Radix Glycyrrhizae, decoct with water twice, first time 6 times of the amount of water material total amount of getting it filled that is this step, decoct 3 hours, 4 times of decoctions of the second time amount of water material total amount of getting it filled that is this step 1.5 hours, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 55%, place 12 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.03 (60 DEG C of surveys), merge above two kinds of thick pastes, add micropowder silica gel, mannitol, the conventional method manufacture in existing pharmaceutical field is adopted to obtain capsule.
Embodiment 3
Prescription: Rhizoma Pinelliae 11g, Semen Sinapis Albae 15g, Folium Et Cacumen Murrayae 13g, Pericarpium Citri Reticulatae 15g, Radix Codonopsis 18g, Rhizoma Atractylodis Macrocephalae 15g, Herba polygoni divaricati 16g, Herba Lobeliae Chinensis 21g, Herba Artemisiae Anomalae 11g, Radix Glycyrrhizae 9g.
Preparation method: get the Semen Sinapis Albae of recipe quantity, Folium Et Cacumen Murrayae adds ethanol extraction secondary, each 2 hours, merge extractive liquid, filter, filtrate recycling ethanol, being evaporated to relative density is 1.10 (60 DEG C of surveys), get the Rhizoma Pinelliae of recipe quantity, Pericarpium Citri Reticulatae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba Lobeliae Chinensis, Herba polygoni divaricati, Herba Artemisiae Anomalae, Radix Glycyrrhizae, decoct with water twice, first time 8 times of the amount of water material total amount of getting it filled that is this step, decoct 3 hours, 4 times of decoctions of the second time amount of water material total amount of getting it filled that is this step 2 hours, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 60%, place 12 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.10 (60 DEG C of surveys), merge above two kinds of thick pastes, add one or more pharmaceutically acceptable carriers, the conventional method manufacture in existing pharmaceutical field is adopted to obtain capsule.
Embodiment 4
Prescription: Rhizoma Pinelliae 8g, Semen Sinapis Albae 14g, Folium Et Cacumen Murrayae 11g, Pericarpium Citri Reticulatae 13g, Radix Codonopsis 16g, Rhizoma Atractylodis Macrocephalae 12g, Herba polygoni divaricati 14g, Herba Lobeliae Chinensis 21g, Herba Artemisiae Anomalae 10g, Radix Glycyrrhizae 8g.
Preparation method: get the Semen Sinapis Albae of recipe quantity, Folium Et Cacumen Murrayae adds ethanol extraction secondary, each 1 hour, merge extractive liquid, filter, filtrate recycling ethanol, being evaporated to relative density is 1.03 (60 DEG C of surveys), get the Rhizoma Pinelliae of recipe quantity, Pericarpium Citri Reticulatae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba Lobeliae Chinensis, Herba polygoni divaricati, Herba Artemisiae Anomalae, Radix Glycyrrhizae, decoct with water twice, first time 7 times of the amount of water material total amount of getting it filled that is this step, decoct 2 hours, 3 times of decoctions of the second time amount of water material total amount of getting it filled that is this step 1.5 hours, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 45%, place 12 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.01 (60 DEG C of surveys), merge above two kinds of thick pastes, add one or more pharmaceutically acceptable carriers, the conventional method manufacture in existing pharmaceutical field is adopted to obtain capsule.
Embodiment 5
Prescription: Rhizoma Pinelliae 9g, Semen Sinapis Albae 11g, Folium Et Cacumen Murrayae 10g, Pericarpium Citri Reticulatae 13g, Radix Codonopsis 15g, Rhizoma Atractylodis Macrocephalae 9g, Herba polygoni divaricati 15g, Herba Lobeliae Chinensis 21g, Herba Artemisiae Anomalae 10g, Radix Glycyrrhizae 7g.
Preparation method: get the Semen Sinapis Albae of recipe quantity, Folium Et Cacumen Murrayae adds ethanol extraction secondary, each 2 hours, merge extractive liquid, filter, filtrate recycling ethanol, being evaporated to relative density is 1.07 (60 DEG C of surveys), get the Rhizoma Pinelliae of recipe quantity, Pericarpium Citri Reticulatae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba Lobeliae Chinensis, Herba polygoni divaricati, Herba Artemisiae Anomalae, Radix Glycyrrhizae, decoct with water twice, first time 8 times of the amount of water material total amount of getting it filled that is this step, decoct 2 hours, 3 times of decoctions of the second time amount of water material total amount of getting it filled that is this step 1.5 hours, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 50%, place 12 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.03 (60 DEG C of surveys), merge above two kinds of thick pastes, add one or more pharmaceutically acceptable carriers, the conventional method manufacture in existing pharmaceutical field is adopted to obtain tablet.
Embodiment 6
Prescription: Rhizoma Pinelliae 11g, Semen Sinapis Albae 15g, Folium Et Cacumen Murrayae 10g, Pericarpium Citri Reticulatae 15g, Radix Codonopsis 15g, Rhizoma Atractylodis Macrocephalae 12g, Herba polygoni divaricati 15g, Herba Lobeliae Chinensis 20g, Herba Artemisiae Anomalae 8g, Radix Glycyrrhizae 9g.
Preparation method: get the Semen Sinapis Albae of recipe quantity, Folium Et Cacumen Murrayae adds ethanol extraction secondary, each 1.5 hours, merge extractive liquid, filter, filtrate recycling ethanol, being evaporated to relative density is 1.03 (60 DEG C of surveys), get the Rhizoma Pinelliae of recipe quantity, Pericarpium Citri Reticulatae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba Lobeliae Chinensis, Herba polygoni divaricati, Herba Artemisiae Anomalae, Radix Glycyrrhizae, decoct with water twice, first time 6 times of the amount of water material total amount of getting it filled that is this step, decoct 2.5 hours, the 3-4 of the second time amount of water material total amount of getting it filled that is this step doubly decocts 1.5 hours, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 55%, place 12 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.01 (60 DEG C of surveys), merge above two kinds of thick pastes, add one or more pharmaceutically acceptable carriers, the conventional method manufacture in existing pharmaceutical field is adopted to obtain tablet.
Embodiment 7
Prescription: Rhizoma Pinelliae 10g, Semen Sinapis Albae 9g, Folium Et Cacumen Murrayae 12g, Pericarpium Citri Reticulatae 15g, Radix Codonopsis 13g, Rhizoma Atractylodis Macrocephalae 12g, Herba polygoni divaricati 11g, Herba Lobeliae Chinensis 20g, Herba Artemisiae Anomalae 10g, Radix Glycyrrhizae 8g.
Preparation method: get the Semen Sinapis Albae of recipe quantity, Folium Et Cacumen Murrayae adds ethanol extraction secondary, each 1 hour, merge extractive liquid, filter, filtrate recycling ethanol, being evaporated to relative density is 1.10 (60 DEG C of surveys), get the Rhizoma Pinelliae of recipe quantity, Pericarpium Citri Reticulatae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba Lobeliae Chinensis, Herba polygoni divaricati, Herba Artemisiae Anomalae, Radix Glycyrrhizae, decoct with water twice, first time 7 times of the amount of water material total amount of getting it filled that is this step, decoct 2 hours, 4 times of decoctions of the second time amount of water material total amount of getting it filled that is this step 1 hour, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 60%, place 12 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.10 (60 DEG C of surveys), merge above two kinds of thick pastes, add one or more pharmaceutically acceptable carrier and water, the conventional method manufacture in existing pharmaceutical field is adopted to obtain oral liquid.
Embodiment 8
Prescription: Rhizoma Pinelliae 11g, Semen Sinapis Albae 9g, Folium Et Cacumen Murrayae 13g, Pericarpium Citri Reticulatae 13g, Radix Codonopsis 18g, Rhizoma Atractylodis Macrocephalae 12g, Herba polygoni divaricati 13g, Herba Lobeliae Chinensis 21g, Herba Artemisiae Anomalae 9g, Radix Glycyrrhizae 8g.
Preparation method: get the Semen Sinapis Albae of recipe quantity, Folium Et Cacumen Murrayae adds ethanol extraction secondary, each 1.5 hours, merge extractive liquid, filter, filtrate recycling ethanol, being evaporated to relative density is 1.08 (60 DEG C of surveys), get the Rhizoma Pinelliae of recipe quantity, Pericarpium Citri Reticulatae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba Lobeliae Chinensis, Herba polygoni divaricati, Herba Artemisiae Anomalae, Radix Glycyrrhizae, decoct with water twice, first time 5 times of the amount of water material total amount of getting it filled that is this step, decoct 2 hours, 4 times of decoctions of the second time amount of water material total amount of getting it filled that is this step 2 hours, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 53%, place 12 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.07 (60 DEG C of surveys), merge above two kinds of thick pastes, add one or more pharmaceutically acceptable carriers, the conventional method manufacture in existing pharmaceutical field is adopted to obtain granule.
Embodiment 9 clinical observation is tested
1. clinical data: my institute accepts thyroid adenoma patient 68 example for medical treatment in April ,-2013 in May, 2011, and differential diagnosis in tcm disease belongs to phlegm-damp cohesion, is divided into two groups at random, often organizes 34 examples.In treatment group, man 5 example, female 29 example, 18 ~ 41 years old age, average (30.3 scholar 4.7) year, the course of disease: 1 month ~ 5 years, average (2.3 scholar 1.5) year.In matched group, male 6 example, women 28 example: 18 ~ 42 years old age, average (30.4 scholar 4.5) year.The course of disease: 1 month ~ 5 years, average (2.5 scholar 1.6) year.The each side there was no significant differences (P > 0.05) such as two groups of case ages, sex, the course of disease, symptom, tumor sizes, have comparability.
2. diagnostic criteria: diagnosis mark reference " practical internal medicine " (Chen Haozhu. Beijing: People's Health Publisher, 2005) customize, clinical symptoms: region thyreoidea has limitation lump, mostly be Solitary nodules, circle or oval, differing in size, moving up and down with swallowing, sometimes cervical region has constriction or hypopnea, can tracheas suppressed, esophagus and cause uncomfortable in chest, pharyngeal constriction, cough, swallow and be obstructed when lump is larger; Ultrasound diagnosis: thyroid limitation enlargement, many circular or oval, 50% periphery is sound dizzy, and the smooth of the edge, decomposes clear, has complete peplos, inner in even low echo, minority in strong or equal echo, echo rear without acoustic attenuation, partial liquefaction, stippled calcification; Radioisotope scan: radioisotope scanning can be " warm nodule ", cystic person is " cold nodule ", and thyroid absorbs 131 iodine rates normally; Determination of serum T3, T4 level increases, and increases comparatively obvious with T3.
TCM Syndrome Type: edit " disease of tcm conventional treatment " (Beijing: Chinese medicine Science and Technology City publishing house with reference to " new Chinese medicine guideline of clinical investigations (trying) 2002 " and Lu Yuantao, 2009) customize, phlegm-damp coagulation type: uncomfortable in chest not smooth, anorexia, limbs asthenia, thyroid node projection, matter is slightly hard.Tongue is greasy in vain, rolling pulse or moisten thin.
3. exclusion standard: do not meet diagnostic criteria person; Be associated with severe primary disease and the psychotics such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system; Hashimoto's disease patient, or with hyperthyroidism, trachea, esophagus, the obvious person of nerve compression symptom; Gestation or women breast-feeding their children; Not by regulation medication, cannot curative effect be judged, or the not congruent judgement person that affects the treatment of data.
4. Therapeutic Method: treatment group: give capsule prepared by the embodiment of the present invention 1, every 0.3g, is equivalent to crude drug 0.8g, every day 2 times, each 3-4 grain.Within 1 month, be 1 course for the treatment of, take 3 courses for the treatment of continuously; Matched group: oral thyroid element sheet first week 20 ~ 40 μ g/d, start to be increased to 50 μ g/d, 1 month be 1 course for the treatment of, take 3 courses for the treatment of continuously on the 2nd week; Two groups of patients are at the product of the pungent delicious food of period in a medicine fasting.
5. observation index: forward and backward at least each detection each course for the treatment of or record once following index: health check-up is or/and B ultrasonic detection thyroid or diagnosing cervical lump, tuberosity size and number; Related symptoms and sign; Blood test is conventional, the comparison checks such as Liver and kidney function, thyroid function (TSH, T3, T4, FT3, FT4), electrocardiogram.
6. curative effect judging standard: with reference to " new Chinese medicine guideline of clinical investigations (trying) 2002 " customization, cure: tumor disappearance, clinical symptom disappearance, serological index recovers normal; Effective: tumor mass reduction more than 1/2, clinical symptoms disappears substantially, and serological index 2/3 recovers normal; Effective: tumor mass reduction 1/3 ~ 1/2, clinical symptoms is clearly better, and serological index 1/3 ~ 2/3 recovers normal; Invalid: gross tumor volume has no and obviously reduces, clinical symptoms has no and is clearly better, and serological index is not improved.
7. date processing: adopt SPSS16.0 statistical software, measurement data adopts means standard deviation represent, compare between group with one factor analysis of variance and t inspection, enumeration data adopts χ 2inspection, with P < 0.05 for there being statistical significance.
8. result
8.1 clinical efficacies: after the clinical treatment of three courses for the treatment of, two groups through statistical procedures, treatment total effective rate treatment group is obviously better than matched group, and difference has statistical significance (P<0.05), in table 1.
Two groups of Clinical efficacy comparisons after three courses for the treatment of of table 1, example
8.2 thyroid function situations are in table 2.After treatment, two groups of TSH lower before all comparatively treating, no significant difference (P>0.05) before and after treatment group treatment, and before and after treatment of control group, difference has statistical significance (P<0.05); After treatment, two groups of T3, T4 raise before all comparatively treating, no significant difference (P>0.05) before and after treatment group treatment, and difference has statistical significance (P<0.05) before and after treatment of control group, compare after two groups of treatments, treatment group has statistical significance (P<0.05) lower than matched group difference.
Before and after table 2 liang group treatment, thyroid function compares (x ± s)
Note: compare with before treatment, * P<0.05, compares with matched group after treatment, #P<0.05
8.3 thyroid adenoma volume size cases: treatment group is by 8.21 ± 1.25cm before treating 3, reduce to 3.23 ± 2.07cm after treatment 3, matched group is by 8.37 ± 1.34cm before treating 3, reduce to 5.73 ± 2.25cm after treatment 3, before and after visible treatment, adenoma size has notable statistics difference (P<0.05).Compare difference after two groups of treatments and also have statistical significance (P<0.05).
Brief summary: by clinical observation, treatment group before the treatment rear FT3, FT4 and TSH there is no significant change, illustrates that Chinese medicine composition is very little for the function effect of thyroid gland hormone, so safer.Before the TSH of matched group is starkly lower than treatment after the treatment, T3, T4 are after the treatment before treatment, although also illustrate that ectogenic thyroxin is low dose of, the secretion of thyroxin also can be made to be affected, likely to have influence on the normal physiological function of human thyroglobulin, though illustrate that oral western medicine thyroid tablet can suppress the secretion of TSH feedback, impel atrophy of thyroid gland, tumor body reduces, but the course for the treatment of is longer, drug dose is difficult to grasp, and side effect is large.

Claims (7)

1. treat a Chinese medicine composition for phlegm-damp coagulation type thyroid adenoma, it is characterized in that it is made up of the Rhizoma Pinelliae, Semen Sinapis Albae, Folium Et Cacumen Murrayae, Pericarpium Citri Reticulatae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba polygoni divaricati, Herba Lobeliae Chinensis, Herba Artemisiae Anomalae, Radix Glycyrrhizae.
2. Chinese medicine composition as claimed in claim 1, the raw material composition and the parts by weight that it is characterized in that making its effective ingredient are: Rhizoma Pinelliae 7-11 part, Semen Sinapis Albae 9-15 part, Folium Et Cacumen Murrayae 8-13 part, Pericarpium Citri Reticulatae 11-15 part, Radix Codonopsis 13-18 part, Rhizoma Atractylodis Macrocephalae 9-15 part, Herba polygoni divaricati 11-16 part, Herba Lobeliae Chinensis 16-21 part, Herba Artemisiae Anomalae 7-11 part, Radix Glycyrrhizae 6-9 part.
3. Chinese medicine composition as claimed in claim 2, the raw material composition and the parts by weight that it is characterized in that making its effective ingredient are: the Rhizoma Pinelliae 9 parts, Semen Sinapis Albae 11 parts, Folium Et Cacumen Murrayae 10 parts, Pericarpium Citri Reticulatae 13 parts, Radix Codonopsis 15 parts, the Rhizoma Atractylodis Macrocephalae 12 parts, Herba polygoni divaricati 15 parts, Herba Lobeliae Chinensis 17 parts, Herba Artemisiae Anomalae 10 parts, 7 parts, Radix Glycyrrhizae.
4. the Chinese medicine composition as described in claim 1-3, is characterized in that described Chinese medicine composition is preferably oral formulations.
5. Chinese medicine composition as claimed in claim 4, is characterized in that described oral formulations is tablet, capsule, soft capsule, dispersible tablet, oral liquid, granule, chewable tablet, oral cavity disintegration tablet, drop pill, slow releasing tablet, slow releasing capsule, controlled release tablet, controlled release capsule.Make liquid preparation if water or oil-suspending agent or other liquid preparation are as syrup etc.
6. Chinese medicine composition as claimed in claim 5, is characterized in that described oral formulations is tablet, capsule or granule.
7. the Chinese medicine composition as described in claim 1-6, its preparation method comprises following steps: get the Semen Sinapis Albae of recipe quantity, Folium Et Cacumen Murrayae adds ethanol extraction secondary, each 1-2 hour, merge extractive liquid, filter, filtrate recycling ethanol, being evaporated to relative density is 1.03-1.10 (60 DEG C of surveys), get the Rhizoma Pinelliae of recipe quantity, Pericarpium Citri Reticulatae, Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, Herba Lobeliae Chinensis, Herba polygoni divaricati, Herba Artemisiae Anomalae, Radix Glycyrrhizae, decoct with water twice, first time 5-8 times of the amount of water material total amount of getting it filled that is this step, decoct 2-3 hour, the 3-4 of the second time amount of water material total amount of getting it filled that is this step doubly decocts 1-2 hour, collecting decoction, filter, filtrate reduced in volume, adding ethanol makes alcohol content be 45-60%, place 12 hours, filter, filtrate recycling ethanol, being concentrated into relative density is 1.01-1.10 (60 DEG C of surveys), merge above two kinds of thick pastes, add one or more pharmaceutically acceptable carriers, the conventional method manufacture in existing pharmaceutical field is adopted to obtain conventional Chinese medicine pharmaceutical dosage form clinically.
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CN105381133A (en) * 2015-12-26 2016-03-09 青岛昌安达药业有限公司 Traditional Chinese medicine used for treating thyroid tumor
CN105853638A (en) * 2016-05-09 2016-08-17 青岛辰达生物科技有限公司 Medicinal composition for treating thyroid adenomas and preparation method of medicinal composition

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105381133A (en) * 2015-12-26 2016-03-09 青岛昌安达药业有限公司 Traditional Chinese medicine used for treating thyroid tumor
CN105853638A (en) * 2016-05-09 2016-08-17 青岛辰达生物科技有限公司 Medicinal composition for treating thyroid adenomas and preparation method of medicinal composition

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