CN104840803A - Traditional Chinese medicine for treating thyroid adenoma due to qi depression and phlegm stagnation and preparation method thereof - Google Patents

Abstract

The invention provides a traditional Chinese medicine for treating thyroid adenoma due to qi depression and phlegm stagnation and a preparation method thereof. The traditional Chinese medicine comprises the following raw medicines: root of szechwan indigo, root of oval kumquat, perilla stem, flower of caudate sweetleaf, murdannia bracteata, loquat seed, bitter orange fruit, involucre of hairy chestnut, Japanese ardisia herb, herb of Chinese sprangletop, herb of three-leaved pronephrium, herb of red clover, seed of Chinese wampee and root of oblique rhychoglossum. The traditional Chinese medicine has definite curative effects on thyroid adenoma due to qi depression and phlegm stagnation and has small toxic and side effects.

Description

A kind ofly treat Chinese medicine of stagnation of QI phlegm retention thyroid adenoma and preparation method thereof

Technical field

The present invention relates to the medicinal preparation containing deriving from plant, animal or mineral component, particularly relating to and a kind ofly treating Chinese medicine of stagnation of QI phlegm retention thyroid adenoma and preparation method thereof.

Background technology

Thyroid adenoma is the benign tumor originating from thyroid follicular cells, is the modal benign tumor of thyroid.Be apt to occur in the active stage of thyroid function.Clinical point of filter blocking and adenoma papilliforum two kinds.Patient mostly is women, and the age is everlasting less than 40 years old, is generally the Solitary nodules in thyroid body.The course of disease is slow, most several months to the several years even the time longer, patient finds because of slightly uncomfortable or is found cervical region without any symptom to swell thing.Majority is single-shot, circular or oval, smooth surface, clear border, the tough reality of quality, with surrounding tissue without adhesion, without tenderness, can move up and down with swallowing.

Western medical treatment mainly based on operation and thyroxine therapy, but respectively has pluses and minuses.Have after total thyroidectomy up to 5% recurrence may, need postoperatively for a long time to take thyroxine even throughout one's life and recur to prevent it.And the full lobectomy of thyroid can cause the postoperative hypothyroidism of patient relatively thoroughly, the insufficiency of function also needing patient to take thyroxin tablet throughout one's life lowly to cause to make up hormonal readiness.And thyroxine therapy easily produces the untoward reaction such as nervous, irritated, arrhythmia, unstable blood pressure are fixed.

Thyroid adenoma belongs to Chinese medicine " goiter " category.Modern times, doctor thought that the pathogenic factor of primary disease was mainly feelings will internal injury, diet water and soil is inappropriate relevant with institutional factor.Long-term depression angry or strongly fragrant worry of being worried, i.e. feelings will internal injury, can make depression and stagnation of QI, irritability is lost and is reached in bar.And body fluid normally follow row and defeated cloth all need the operation of gas to promote, depression and stagnation of QI, then body fluid is easy to be condensed into expectorant.Stagnation of QI expectorant coagulates, and stops up knot throat, then forms goiter.

Summary of the invention

Technical problem to be solved by this invention is, provides a kind of Chinese medicine for the treatment of stagnation of QI phlegm retention thyroid adenoma, and Chinese medicine of the present invention has definite curative effect to stagnation of QI phlegm retention thyroid adenoma, and toxic and side effects is little.

In order to solve the problems of the technologies described above, the invention provides a kind of Chinese medicine for the treatment of stagnation of QI phlegm retention thyroid adenoma, its raw medicinal material comprises: Radix Indigoferae Szechuenensis, Radix Fortunellae Margaritae, Caulis Perillae, Flos Symplocoris Caudatae, phlegm-fire grass, Radix Eriobotryae, FRUCTUS CITRI AURANTII AMARAE, Involucrum Castaneae, Herba Ardisiae Japonicae, Herba Leptochloae Chinensis, Herba pronephrii triphylli, Herba Trifolii Pratentis, Semen clausenae lansii and Radix Rhynchoglossi Obliqui.

In described Chinese medicine, the ratio of weight and number of each raw medicinal material is as follows: Radix Indigoferae Szechuenensis 10 ~ 20 parts, Radix Fortunellae Margaritae 30 ~ 40 parts, Caulis Perillae 5 ~ 15 parts, Flos Symplocoris Caudatae 5 ~ 15 parts, phlegm-fire grass 20 ~ 30 parts, Radix Eriobotryae 30 ~ 40 parts, FRUCTUS CITRI AURANTII AMARAE 5 ~ 15 parts, Involucrum Castaneae 20 ~ 30 parts, Herba Ardisiae Japonicae 10 ~ 20 parts, Herba Leptochloae Chinensis 5 ~ 15 parts, Herba pronephrii triphylli 10 ~ 20 parts, Herba Trifolii Pratentis 10 ~ 20 parts, Semen clausenae lansii 40 ~ 50 parts and Radix Rhynchoglossi Obliqui 40 ~ 50 parts.

In described Chinese medicine, the ratio of weight and number of each raw medicinal material can be preferably: Radix Indigoferae Szechuenensis 10 ~ 15 parts, Radix Fortunellae Margaritae 30 ~ 35 parts, Caulis Perillae 5 ~ 10 parts, Flos Symplocoris Caudatae 5 ~ 10 parts, phlegm-fire grass 20 ~ 25 parts, Radix Eriobotryae 30 ~ 35 parts, FRUCTUS CITRI AURANTII AMARAE 5 ~ 10 parts, Involucrum Castaneae 20 ~ 25 parts, Herba Ardisiae Japonicae 10 ~ 15 parts, Herba Leptochloae Chinensis 5 ~ 10 parts, Herba pronephrii triphylli 10 ~ 15 parts, Herba Trifolii Pratentis 10 ~ 15 parts, Semen clausenae lansii 40 ~ 45 parts and Radix Rhynchoglossi Obliqui 40 ~ 45 parts.

In described Chinese medicine, the ratio of weight and number of each raw medicinal material also can be preferably: Radix Indigoferae Szechuenensis 11 parts, Radix Fortunellae Margaritae 33 parts, Caulis Perillae 6 parts, Flos Symplocoris Caudatae 8 parts, phlegm-fire grass 24 parts, Radix Eriobotryae 31 parts, FRUCTUS CITRI AURANTII AMARAE 7 parts, Involucrum Castaneae 22 parts, Herba Ardisiae Japonicae 14 parts, Herba Leptochloae Chinensis 9 parts, Herba pronephrii triphylli 12 parts, Herba Trifolii Pratentis 13 parts, Semen clausenae lansii 42 parts and Radix Rhynchoglossi Obliqui 44 parts.

Present invention also offers the preparation method of above-mentioned Chinese medicine, the dosage form of described Chinese medicine is capsule, and its preparation method comprises the following steps:

The first step, is mixed in proportion each for described Chinese medicine preparation raw medicinal material, and adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 75 ~ 85%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75 ~ 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 ~ 4 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;

Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 100 ~ 200 object micropowders;

3rd step, the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, the starch of 0.1 ~ 0.3 times, the magnesium stearate of 0.003 ~ 0.03 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.

Present invention also offers the preparation method of above-mentioned Chinese medicine, the dosage form of described Chinese medicine is granule, and its preparation method comprises the following steps:

The first step: described raw medicinal material is mixed in described ratio, adding relative to the determining alcohol of 3 ~ 5 times, mixture is the ethanol of 70 ~ 80%, be heated to boiling reflux 2 ~ 3 hours, filter, take backflow as solvent, take filtering residue as solute, adopt percolation with the speed of 1 ~ 2ml per minute slowly percolation, collect percolate, when being evaporated to 70 ~ 80 DEG C subsequently under vacuum 0.01 ~ 0.05Mpa, relative density is the mastic of 1.05 ~ 1.10, spraying dry, the inlet temperature of spray dryer 165 ~ 185 DEG C, leaving air temp 60 ~ 80 DEG C, be ground into powder subsequently, make dried cream powder,

Second step: the dextrin adding cane sugar powder relative to dried cream powder quality 0.4 ~ 0.6 times and 0.4 ~ 0.6 times in the dried cream powder obtained, makes granule, in 60 ~ 70 DEG C of dryings, obtains granule.

Beneficial effect of the present invention: Chinese medicine of the present invention has definite curative effect to stagnation of QI phlegm retention thyroid adenoma, and toxic and side effects is little.

Detailed description of the invention

The invention provides a kind of Chinese medicine for the treatment of stagnation of QI phlegm retention thyroid adenoma, its raw medicinal material comprises: Radix Indigoferae Szechuenensis, Radix Fortunellae Margaritae, Caulis Perillae, Flos Symplocoris Caudatae, phlegm-fire grass, Radix Eriobotryae, FRUCTUS CITRI AURANTII AMARAE, Involucrum Castaneae, Herba Ardisiae Japonicae, Herba Leptochloae Chinensis, Herba pronephrii triphylli, Herba Trifolii Pratentis, Semen clausenae lansii and Radix Rhynchoglossi Obliqui.

In described Chinese medicine, the pharmacology of each raw medicinal material is as follows:

Radix Indigoferae Szechuenensis: the root of [source] leguminous plant Sichuan Drymotaenium miyoshianum (Mak.) Mak. or aerial parts.[nature and flavor] are pungent, bitter, tepor.[return through] returns liver, stomach, lung meridian.[function cures mainly] regulating the flow of QI to ease the stomach, heat-clearing and toxic substances removing.Main gastric abscess, tripe abdomen cold type of pain, chest and diaphragm distension, pulmonary tuberculosis is generated heat, sore swollen toxin.

Radix Fortunellae Margaritae: [source] is rutaceae Fructus Fortunellae Margaritae, the root of golden bullet, Fortunella crassifolia Swingle.[nature and flavor] sour in the mouth is bitter, warm in nature.[return through] returns spleen, stomach, Liver Channel.[function cures mainly] promoting the circulation of QI to relieve pain, dissipating phlegm and resolving masses.Main epigastric distending pain, hernia, puerperal abdonimal pain, uterine prolapse, scrofula from the beginning of.

Caulis Perillae: the stem that [source] is labiate Folium Perillae or wild Folium Perillae.[nature and flavor] acrid in the mouth, warm in nature.[return through] returns spleen, stomach, lung meridian.[function cures mainly] regulating the flow of QI to ease the stomach, antiabortive and blood.Main stagnation of QI in spleen and stomach, gastral cavity abdomen feeling of fullness, nausea is got along well, edema beriberi, and spitting of blood tells nosebleed.

Flos Symplocoris Caudatae: [source] is the flower of Symplocaceae plant mountain vitriol.[nature and flavor] are bitter, pungent, and property is put down.[return through] returns lung meridian.[function cures mainly] eliminating phlegm and relaxing heart, promoting the production of body fluid to quench thirst.Main cough is uncomfortable in chest, and children's quenches one's thirst.

Phlegm-fire grass: [source] is the herb of Commelianaceae plant Murdannia bracteata (C. B. Clarke) O. UhtzeexJ. K. Mortoh.[nature and flavor] are sweet, light, cool.[function cures mainly] dissipating phlegm and resolving masses, clearing heat and freeing strangury.Main scrofula sucutaneous nodule, pyretic stranguria.

Radix Eriobotryae: [source] is the seed of rosaceous plant Chinese lute.[nature and flavor] are bitter, flat.[return through] returns kidney channel.[function cures mainly] preventing phlegm from forming and stopping coughing, soothing the liver circulation of qi promoting, inducing diuresis to remove edema.Main cough with copious phlegm, hernia, edema, scrofula.

FRUCTUS CITRI AURANTII AMARAE: the fruit of [source] rutaceae CitrusaurantiumL.Var.amara Engl..[nature and flavor] cold nature, bitter in the mouth, acid.[function cures mainly] promoting the circulation of QI to alleviate the stagnation in middle-JIAO, eliminates indigestion and phlegm.For the vexed distending pain of breast abdomen, accumulation of food in the stomach and intes tine due to indigestion, phlegm retention, proctoptosis.

Involucrum Castaneae: [source] is the involucre of Fagaceae chestnut.[nature and flavor] are sweet, puckery, and property is put down.[function cures mainly] heat clearing away eliminating stagnation, reduces phlegm, hemostasis.Main erysipelas, scrofula sucutaneous nodule, pertussis, aphasia due to apoplexy, has blood in stool, epistaxis.

Herba Ardisiae Japonicae: [source] is the herb of Myrsinacea plant Herba Ardisiae Japonicae.[nature and flavor] property is put down, acrid in the mouth, micro-hardship.[function cures mainly] preventing phlegm from forming and stopping coughing, dampness removing, invigorates blood circulation.For cough, sputum mixed with blood, chronic bronchitis, jaundice due to damp-heat, traumatic injury.

Herba Leptochloae Chinensis: [source] is the herb of grass Herba Leptochloae Chinensis.[nature and flavor] are light, flat, pungent.[function cures mainly] row water removing blood stasis, dissipating phlegm and resolving masses.Main lump in the abdomen, heat of a specified duration is not moved back.

Herba pronephrii triphylli: [source] is the herb of Thelypteridaceae plant three plumage crescent Herba pteridii latiusculi.[nature and flavor] are bitter, pungent, flat.[return through] GUIXIN, spleen channel.[function cures mainly] heat-clearing and toxic substances removing, dissipating blood stasis for subsidence of swelling, preventing phlegm from forming and stopping coughing.Main carbuncle furuncle swells, venom, traumatic injury, eczema, skin pruritus, acute and chronic tracheitis.

Herba Trifolii Pratentis: the inflorescence that [source] is leguminous plant Herba Trifolii Pratentis and wounded in the battle branch and leaf.[nature and flavor] sweet in the mouth, bitter, cold nature.[return through] returns lung meridian.[function cures mainly] clearing and antitussive, mass dissipating and swelling eliminating.Main flu, cough with asthma, firmly swollen, burn.

Semen clausenae lansii: [source] is the seed of rutaceae Clausena lansium (Lour.) Skeels.[nature and flavor] acrid in the mouth, micro-hardship, tepor.[return through] returns lung, stomach, Liver Channel.[function cures mainly] promoting the circulation of QI to relieve pain, detoxicating and resolving stagnation of pathogens.Staple food indigestion pain, stagnation of QI epigastric pain, colic, painful and swollen testis, dysmenorrhea, children's's head sore, centipete bite.

Radix Rhynchoglossi Obliqui: [source] is the whole herb with root of the askew hat Conandron ramondioides sieb. Et zuce of Gesneriaceae.[nature and flavor] salty in the mouth, property is put down.[function cures mainly] hard masses softening and resolving.Main thyromegaly.

In described Chinese medicine, the ratio of weight and number of each raw medicinal material is as follows: Radix Indigoferae Szechuenensis 10 ~ 20 parts, Radix Fortunellae Margaritae 30 ~ 40 parts, Caulis Perillae 5 ~ 15 parts, Flos Symplocoris Caudatae 5 ~ 15 parts, phlegm-fire grass 20 ~ 30 parts, Radix Eriobotryae 30 ~ 40 parts, FRUCTUS CITRI AURANTII AMARAE 5 ~ 15 parts, Involucrum Castaneae 20 ~ 30 parts, Herba Ardisiae Japonicae 10 ~ 20 parts, Herba Leptochloae Chinensis 5 ~ 15 parts, Herba pronephrii triphylli 10 ~ 20 parts, Herba Trifolii Pratentis 10 ~ 20 parts, Semen clausenae lansii 40 ~ 50 parts and Radix Rhynchoglossi Obliqui 40 ~ 50 parts.

In described Chinese medicine, the ratio of weight and number of each raw medicinal material can be preferably: Radix Indigoferae Szechuenensis 10 ~ 15 parts, Radix Fortunellae Margaritae 30 ~ 35 parts, Caulis Perillae 5 ~ 10 parts, Flos Symplocoris Caudatae 5 ~ 10 parts, phlegm-fire grass 20 ~ 25 parts, Radix Eriobotryae 30 ~ 35 parts, FRUCTUS CITRI AURANTII AMARAE 5 ~ 10 parts, Involucrum Castaneae 20 ~ 25 parts, Herba Ardisiae Japonicae 10 ~ 15 parts, Herba Leptochloae Chinensis 5 ~ 10 parts, Herba pronephrii triphylli 10 ~ 15 parts, Herba Trifolii Pratentis 10 ~ 15 parts, Semen clausenae lansii 40 ~ 45 parts and Radix Rhynchoglossi Obliqui 40 ~ 45 parts.

In described Chinese medicine, the ratio of weight and number of each raw medicinal material also can be preferably: Radix Indigoferae Szechuenensis 11 parts, Radix Fortunellae Margaritae 33 parts, Caulis Perillae 6 parts, Flos Symplocoris Caudatae 8 parts, phlegm-fire grass 24 parts, Radix Eriobotryae 31 parts, FRUCTUS CITRI AURANTII AMARAE 7 parts, Involucrum Castaneae 22 parts, Herba Ardisiae Japonicae 14 parts, Herba Leptochloae Chinensis 9 parts, Herba pronephrii triphylli 12 parts, Herba Trifolii Pratentis 13 parts, Semen clausenae lansii 42 parts and Radix Rhynchoglossi Obliqui 44 parts.

Present invention also offers the preparation method of above-mentioned Chinese medicine, the dosage form of described Chinese medicine is capsule, and its preparation method comprises the following steps:

The first step, is mixed in proportion each for described Chinese medicine preparation raw medicinal material, and adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 75 ~ 85%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75 ~ 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 ~ 4 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;

Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 100 ~ 200 object micropowders;

3rd step, the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, the starch of 0.1 ~ 0.3 times, the magnesium stearate of 0.003 ~ 0.03 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.

Present invention also offers the preparation method of above-mentioned Chinese medicine, the dosage form of described Chinese medicine is granule, and its preparation method comprises the following steps:

The first step: described raw medicinal material is mixed in described ratio, adding relative to the determining alcohol of 3 ~ 5 times, mixture is the ethanol of 70 ~ 80%, be heated to boiling reflux 2 ~ 3 hours, filter, take backflow as solvent, take filtering residue as solute, adopt percolation with the speed of 1 ~ 2ml per minute slowly percolation, collect percolate, when being evaporated to 70 ~ 80 DEG C subsequently under vacuum 0.01 ~ 0.05Mpa, relative density is the mastic of 1.05 ~ 1.10, spraying dry, the inlet temperature of spray dryer 165 ~ 185 DEG C, leaving air temp 60 ~ 80 DEG C, be ground into powder subsequently, make dried cream powder,

Second step: the dextrin adding cane sugar powder relative to dried cream powder quality 0.4 ~ 0.6 times and 0.4 ~ 0.6 times in the dried cream powder obtained, makes granule, in 60 ~ 70 DEG C of dryings, obtains granule.

Below adopt embodiment to describe embodiments of the present invention in detail, fully understand how application technology means solve technical problem in the present invention whereby, reach technique effect and implement according to this.

Embodiment 1 capsule

Get Radix Indigoferae Szechuenensis 110g, Radix Fortunellae Margaritae 330g, Caulis Perillae 60g, Flos Symplocoris Caudatae 80g, phlegm-fire grass 240g, Radix Eriobotryae 310g, FRUCTUS CITRI AURANTII AMARAE 70g, Involucrum Castaneae 220g, Herba Ardisiae Japonicae 140g, Herba Leptochloae Chinensis 90g, Herba pronephrii triphylli 120g, Herba Trifolii Pratentis 130g, Semen clausenae lansii 420g and Radix Rhynchoglossi Obliqui 440g;

Prepare according to the following steps:

The first step, is mixed in proportion each for described Chinese medicine preparation raw medicinal material, and adding relative to the determining alcohol of mixture quality 3 times is the ethanol of 85%, reflux 2 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 times again, reflux 1 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;

Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 2 hours, pulverize and sieve acquisition 100 object micropowders;

3rd step, the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.3 times, the starch of 0.3 times, the magnesium stearate of 0.03 times, carries out mixing process, namely obtains capsule 's content, described Capsule content is incapsulated in housing, namely obtains capsule finished product.

Embodiment 2 granule

Get Radix Indigoferae Szechuenensis 140g, Radix Fortunellae Margaritae 310g, Caulis Perillae 80g, Flos Symplocoris Caudatae 90g, phlegm-fire grass 220g, Radix Eriobotryae 340g, FRUCTUS CITRI AURANTII AMARAE 90g, Involucrum Castaneae 230g, Herba Ardisiae Japonicae 120g, Herba Leptochloae Chinensis 60g, Herba pronephrii triphylli 140g, Herba Trifolii Pratentis 110g, Semen clausenae lansii 450g and Radix Rhynchoglossi Obliqui 420g;

Prepare according to the following steps:

The first step: described raw medicinal material is mixed in described ratio, adding relative to the determining alcohol of 5 times, mixture is the ethanol of 80%, be heated to boiling reflux 2 hours, filter, take backflow as solvent, take filtering residue as solute, adopt percolation with the speed of 2ml per minute slowly percolation, collect percolate, when being evaporated to 80 DEG C subsequently under vacuum 0.01Mpa, relative density is the mastic of 1.05, spraying dry, the inlet temperature 185 DEG C of spray dryer, leaving air temp 80 DEG C, be ground into powder subsequently, make dried cream powder;

Second step: the dextrin adding cane sugar powder relative to dried cream powder quality 0.5 times and 0.4 times in the dried cream powder obtained, makes granule, in 70 DEG C of dryings, obtains granule.

Toxicity test:

Acute toxicity testing: application mice 60, male and female half and half, body weight 28 ~ 38g, carries out acute toxicity test.Mice is divided into two groups at random, i.e. matched group and administration group, before experiment, fasting 12 hours, is dissolved in water by Chinese medicine capsules prepared by embodiments of the invention 1, (concentration is 7.30g crude drug/ml, maximum concentration) gavage, gavage volume is 5ml/kg (namely unit dosage form is 36.5 crude drugs/kg), and matched group gives normal saline, administration in one day 2 times, delivery time 6 hours, Continuous Observation 14 days after administration, and record mice toxic reaction and death toll.Experimental result shows: compare with matched group, and after administration, mice has no notable difference, and experiment Continuous Observation 14 days, mouse systemic situation, diet, drinking-water, body weight increase all normal.Mouse oral gavage capsule LD50>36.5 crude drug/kg of the present invention, every day, maximum dosage-feeding was 73.0 crude drugs/kg/ day.Chinese medicine clinical application amount of the present invention be 6.4g crude drug/day/people, adult body weight in 60KG, average dosage is 0.107g crude drug/kg/ day.By weighing machine: the dosis tolerata of mice (average weight is in 33g) oral administration gavage Chinese medicine of the present invention is 682 times of quantity.Therefore Chinese medicine acute toxicity of the present invention is extremely low, clinical drug safety.

Long term toxicity test: Chinese medicine embodiment 1 capsule of the present invention presses 13.12,19.03 and 37.45g crude drug/kg continuous use 15 weeks (1.0ml/100g body weight to mice, every day 2 times) and drug withdrawal after 3 weeks, result shows: the index such as hair, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, blood fat of Chinese medicine of the present invention to mice all has no significant effect, internal organs naked eyes do not find that difference change and histological indications show, medication 15 weeks and drug withdrawal are after 3 weeks, and Organs of Mice is all without obviously changing.Illustrate that Chinese medicine of the present invention is little to toxicity after mice long-term prescription, also there is no difference reaction after drug withdrawal, application safety.

Clinical data:

Case selection: whole 115 routine cases are my Out-patient Department patient of in JIUYUE, 2010 ~ 2013 year December, and all patients are all diagnosed as thyroid adenoma, are divided into treatment group and matched group at random, wherein treatment group 65 people, male 15 people, women 50 people, 21 ~ 60 years old age, the course of disease 1 ~ 10 year.Filter blocking adenoma 55 example, adenoma papilliforum 10 example.Diseased region: right gland leaf 27 example, left gland leaf 33 example, two gland leaf 5 example; Symptom: Silent Neuritis tuberosity 55 serendipitous example, tracheal compression or swallow uncomfortable 7 examples, tuberosity unexpected enlargement companion pain 2 example, with hoarseness 1 example; Matched group 50 people, male 10 people, women 40 people, 20 ~ 58 years old age, the course of disease 1 ~ 10 year.Filter blocking adenoma 45 example, adenoma papilliforum 5 example.Diseased region: right gland leaf 23 example, left gland leaf 25 example, two gland leaf 2 example; Symptom: Silent Neuritis tuberosity 44 serendipitous example, tracheal compression or swallow uncomfortable 4 examples, tuberosity unexpected enlargement companion pain 1 example, with hoarseness 1 example.Two groups of ages, sex, the course of disease, diseased region, clinical manifestation and equal not statistically significants of coincident with severity degree of condition comparing difference (p>0.05).

Diagnostic criteria:

Western medicine diagnose standard: the diagnostic criteria with reference to the thyroid adenoma in " Clinics and Practices of thyroid disease " of Xue Yaoming chief editor: (1) clinical symptoms: region thyreoidea has limitation lump, mostly be Solitary nodules, circle or oval, differ in size, move 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; (2) auxiliary examination: ultrasound diagnosis: thyroid limitation enlargement, how 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.

Syndrome Differentiation of Traditional Chinese Medicine standard: stagnation of QI phlegm retention: throat wart swells, and can touch tuberosity, matter is soft not bitterly, sense that cervical region is swollen, does not uncomfortable in chestly relax, distention and pain of breast before menstruation, or companion's breast also nodosity lump, pale tongue, white and thin fur, stringy pulse.

Exclusion standard: 1, do not meet diagnostic criteria person; 2, severe primary disease and the psychotics such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system is associated with; 3, the age is below 20 years old or more than 50 years old person; 4, Hashimoto's disease patient, or with hyperthyroidism, trachea, esophagus, the obvious person of nerve compression symptom; 5, gestation or women breast-feeding their children; 6, not by regulation medication, curative effect cannot be judged, or the not congruent judgement person that affects the treatment of data.

Therapeutic Method:

Treatment group: give the embodiment of the present invention 1 capsule every day 3 times, each 4.1 month was 1 course for the treatment of, took 6 months continuously;

Matched group: oral thyroid element sheet first week 20 ~ 40 μ g/d, start for the 2nd week to be increased to 50 μ g/d, 1 month was 1 course for the treatment of, took 6 months continuously.

Curative effect judging standard: 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.

Therapeutic outcome: see the following form.

Two groups of comparitive study after 6 months treated by table 1:

Group	n	Cure	Effective	Effectively	Invalid	Effectively total
							Treatment group	65	30	21	10	4	61(93.85％)
Matched group	50	10	18	10	12	38(76.00％)

As known from Table 1, treatment group curative effect is better than matched group, and Different therapeutical effect has statistical significance (P<0.05).

Concrete case: late certain, women, 45 years old.Suffer from the thyroid adenoma course of disease 3 years, can touch tuberosity, matter is soft not bitterly, sense that cervical region is swollen, does not uncomfortable in chestly relax, distention and pain of breast before menstruation, pale tongue, white and thin fur, stringy pulse.Syndrome Types of TCM is stagnation of QI stagnation of phlegm.Give Chinese medicine embodiment 1 capsule of the present invention every day 3 times, each 4, treat after 5 months, recovery from illness, follows up a case by regular visits to and does not recur for 1 year.

The above is only preferred embodiment of the present invention, and be not restriction the present invention being made to other form, any those skilled in the art may utilize the technology contents of above-mentioned announcement to be changed or be modified as the Equivalent embodiments of equivalent variations.But everyly do not depart from technical solution of the present invention content, any simple modification, equivalent variations and the remodeling done above embodiment according to technical spirit of the present invention, still belong to the protection domain of technical solution of the present invention.

Claims (8)

1. treat a Chinese medicine for stagnation of QI phlegm retention thyroid adenoma, it is characterized in that, each raw medicinal material of described Chinese medicine comprises: Radix Indigoferae Szechuenensis, Radix Fortunellae Margaritae, Caulis Perillae, Flos Symplocoris Caudatae, phlegm-fire grass, Radix Eriobotryae, FRUCTUS CITRI AURANTII AMARAE, Involucrum Castaneae, Herba Ardisiae Japonicae, Herba Leptochloae Chinensis, Herba pronephrii triphylli, Herba Trifolii Pratentis, Semen clausenae lansii and Radix Rhynchoglossi Obliqui.

2. Chinese medicine as claimed in claim 1, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine is as follows: Radix Indigoferae Szechuenensis 10 ~ 20 parts, Radix Fortunellae Margaritae 30 ~ 40 parts, Caulis Perillae 5 ~ 15 parts, Flos Symplocoris Caudatae 5 ~ 15 parts, phlegm-fire grass 20 ~ 30 parts, Radix Eriobotryae 30 ~ 40 parts, FRUCTUS CITRI AURANTII AMARAE 5 ~ 15 parts, Involucrum Castaneae 20 ~ 30 parts, Herba Ardisiae Japonicae 10 ~ 20 parts, Herba Leptochloae Chinensis 5 ~ 15 parts, Herba pronephrii triphylli 10 ~ 20 parts, Herba Trifolii Pratentis 10 ~ 20 parts, Semen clausenae lansii 40 ~ 50 parts and Radix Rhynchoglossi Obliqui 40 ~ 50 parts.

3. Chinese medicine as claimed in claim 1 or 2, it is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine is as follows: Radix Indigoferae Szechuenensis 10 ~ 15 parts, Radix Fortunellae Margaritae 30 ~ 35 parts, Caulis Perillae 5 ~ 10 parts, Flos Symplocoris Caudatae 5 ~ 10 parts, phlegm-fire grass 20 ~ 25 parts, Radix Eriobotryae 30 ~ 35 parts, FRUCTUS CITRI AURANTII AMARAE 5 ~ 10 parts, Involucrum Castaneae 20 ~ 25 parts, Herba Ardisiae Japonicae 10 ~ 15 parts, Herba Leptochloae Chinensis 5 ~ 10 parts, Herba pronephrii triphylli 10 ~ 15 parts, Herba Trifolii Pratentis 10 ~ 15 parts, Semen clausenae lansii 40 ~ 45 parts and Radix Rhynchoglossi Obliqui 40 ~ 45 parts.

4. the Chinese medicine as described in claims 1 to 3, is characterized in that, the ratio of weight and number of each raw medicinal material of described Chinese medicine is as follows: Radix Indigoferae Szechuenensis 11 parts, Radix Fortunellae Margaritae 33 parts, Caulis Perillae 6 parts, Flos Symplocoris Caudatae 8 parts, phlegm-fire grass 24 parts, Radix Eriobotryae 31 parts, FRUCTUS CITRI AURANTII AMARAE 7 parts, Involucrum Castaneae 22 parts, Herba Ardisiae Japonicae 14 parts, Herba Leptochloae Chinensis 9 parts, Herba pronephrii triphylli 12 parts, Herba Trifolii Pratentis 13 parts, Semen clausenae lansii 42 parts and Radix Rhynchoglossi Obliqui 44 parts.

5. the Chinese medicine as described in Claims 1-4, is characterized in that, the dosage form of described Chinese medicine is capsule, and its preparation method comprises the following steps:

The first step, is mixed in proportion each for described Chinese medicine preparation raw medicinal material, and adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 75 ~ 85%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75 ~ 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 ~ 4 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;

Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 100 ~ 200 object micropowders;

3rd step, the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, the starch of 0.1 ~ 0.3 times, the magnesium stearate of 0.003 ~ 0.03 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.

6. the Chinese medicine as described in Claims 1-4, is characterized in that, the dosage form of described Chinese medicine is granule, and its preparation method comprises the following steps:

The first step: described raw medicinal material is mixed in described ratio, adding relative to the determining alcohol of 3 ~ 5 times, mixture is the ethanol of 70 ~ 80%, be heated to boiling reflux 2 ~ 3 hours, filter, take backflow as solvent, take filtering residue as solute, adopt percolation with the speed of 1 ~ 2ml per minute slowly percolation, collect percolate, when being evaporated to 70 ~ 80 DEG C subsequently under vacuum 0.01 ~ 0.05Mpa, relative density is the mastic of 1.05 ~ 1.10, spraying dry, the inlet temperature of spray dryer 165 ~ 185 DEG C, leaving air temp 60 ~ 80 DEG C, be ground into powder subsequently, make dried cream powder,

Second step: the dextrin adding cane sugar powder relative to dried cream powder quality 0.4 ~ 0.6 times and 0.4 ~ 0.6 times in the dried cream powder obtained, makes granule, in 60 ~ 70 DEG C of dryings, obtains granule.

7. a preparation method for Chinese medicine described in Claims 1-4, is characterized in that, the dosage form of described Chinese medicine is capsule, and its preparation method comprises the following steps:

The first step, is mixed in proportion each for described Chinese medicine preparation raw medicinal material, and adding relative to the determining alcohol of mixture quality 3 ~ 5 times is the ethanol of 75 ~ 85%, reflux 2 ~ 3 hours, extracts, and filters acquisition first extracting solution; It is the ethanol of 75 ~ 85% that the medicinal residues that filtration obtains add relative to the determining alcohol of medicinal residues quality 2 ~ 4 times again, reflux 1 ~ 2 hour, extracts, and filters acquisition second extracting solution; First extracting solution and the second extracting solution are merged, concentrating under reduced pressure removing alcohol solvent, dry, obtain and get dry extract;

Second step, is placed on the dry cream that the first step obtains in super micron mill and pulverizes 1 ~ 2 hour, pulverize and sieve acquisition 100 ~ 200 object micropowders;

3rd step, the micropowders obtained at second step adds relative to the microcrystalline Cellulose of its quality 0.1 ~ 0.3 times, the starch of 0.1 ~ 0.3 times, the magnesium stearate of 0.003 ~ 0.03 times, carry out mixing process, namely capsule 's content is obtained, described Capsule content is incapsulated in housing, namely obtains capsule finished product.

8. a preparation method for Chinese medicine described in Claims 1-4, is characterized in that, the dosage form of described Chinese medicine is granule, and its preparation method comprises the following steps:

The first step: described raw medicinal material is mixed in described ratio, adding relative to the determining alcohol of 3 ~ 5 times, mixture is the ethanol of 70 ~ 80%, be heated to boiling reflux 2 ~ 3 hours, filter, take backflow as solvent, take filtering residue as solute, adopt percolation with the speed of 1 ~ 2ml per minute slowly percolation, collect percolate, when being evaporated to 70 ~ 80 DEG C subsequently under vacuum 0.01 ~ 0.05Mpa, relative density is the mastic of 1.05 ~ 1.10, spraying dry, the inlet temperature of spray dryer 165 ~ 185 DEG C, leaving air temp 60 ~ 80 DEG C, be ground into powder subsequently, make dried cream powder,

Second step: the dextrin adding cane sugar powder relative to dried cream powder quality 0.4 ~ 0.6 times and 0.4 ~ 0.6 times in the dried cream powder obtained, makes granule, in 60 ~ 70 DEG C of dryings, obtains granule.