CN105920343A - Traditional Chinese medicine composition for treating thyroid nodule - Google Patents
Traditional Chinese medicine composition for treating thyroid nodule Download PDFInfo
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- CN105920343A CN105920343A CN201610408876.9A CN201610408876A CN105920343A CN 105920343 A CN105920343 A CN 105920343A CN 201610408876 A CN201610408876 A CN 201610408876A CN 105920343 A CN105920343 A CN 105920343A
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Abstract
The invention belongs to the field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating thyroid nodule, and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition is finely developed and prepared from medicinal raw materials including fiveleaf akebia fruit, oval kumquat seed, asarum, merremia yunnanensis, huechys, radix tetrastigme, styrax, oyster, pseudostellaria maximowicziana, gymnadenia conopsea and dried radix rehmanniae. With the combination of the medicines, effects of soothing the liver to regulate qi, reducing phlegm and resolving hard lump as well as nourishing and activating blood, tonifying spleen and nourishing qi can be achieved, and regulation functions of multiple targets and systems can be brought into play for patients suffering from stagnant qi and phlegm cohere caused by thyroid nodule. The clinical test shows that the traditional Chinese medicine clinical symptoms of patients can be remarkably relieved, and the living quality of the patients can be improved, the high-risk factor score of nodule can be reduced, the size of nodule can be reduced, and the traditional Chinese medicine composition is worthy of clinical popularization and application.
Description
Technical field
The invention belongs to tcm field, be specifically related to a kind of Chinese medicine composition treating thyroid nodule and preparation method thereof.
Background technology
Thyroid nodule refers to the lump in thyroid gland, can move up and down with thyroid gland with swallowing act, is clinical common
Illness, can be caused by Different types of etiopathogenises, and from nodositas qualitative classification, thyroid nodule includes benign protuberance and Malignant Nodules.Doctor trained in Western medicine exists
Follow-up observation, thyroid hormone suppression therapy, operative treatment etc. are mainly had in the method for the treatment of benign thyroid nodules.There is scholar
Think that the effect of thyroxine therapy thyroid nodule is the most relevant to the iodine deficiency of the TSH level of patient and location, and far
Phase curative effect is undesirable, and long-term taking exists bone loss, and thyroid function changes and the side effect of cardiovascular aspect.Therefore use
Thyroid hormone suppression therapy benign thyroid nodules remains in certain dispute.Operative treatment is widely used the most clinically, but
It is to exist to treat excessively or the shortcoming of postoperative recurrence.And thyroid gland normal function may be caused to go down or lose, postoperative need hormone to replace
In generation, also can aggravate patient anxiety's fear and affect its quality of life.
Thyroid disease belongs to goiter category at Ancient Times in China document.Thyroid nodule is equivalent to the diseases such as the meat goitre of the traditional Chinese medical science, goiter and tumor.
Feelings will internal injury is the internal cause that this disease is main." the Three Kingdoms book Wei " draws " Wei is slightly " the record of " raw goitre of making a determined effort ", and prompting is worked as
Time have realized that the generation of this disease is relevant with emotional factors.In " Prescriptions for Succouring the Sick goiter and tumor opinion is controlled " " husband goiter and tumor person, how by liking
Anger does not saves, and is worried excessively, here forms this disease.On the whole the qi and blood of people, circulation the whole body, the trouble of Chang Yuwu delay, take good care of oneself inappropriate,
Stagnation of the circulation of vital energy stasis, is knurl for goitre " also illustrate the emotional factors that goiter is fallen ill.The traditional Chinese medical science thinks liver controlling conveyance and dispersion, as angry worried and indigant then liver is lost
Catharsis, dysfunction of acting as a pivot, then depression and stagnation of QI.Functional activity of QI being not smooth, the unable promotion of blood, and the existing stasis of blood as；Disorder of qi, Lung Qi obstraction,
Thus raw phlegm, blood is unfavorable again be then water, and water liquid loses fortune and is phlegm, gradually develops into the stagnation of the circulation of vital energy, phlegm solidifying.Therefore within the morbidity of meat goitre
Gene basis is that temperament and interest is hindered.Gas, stagnant, phlegm, the stasis of blood are its pathogenesis.The treatment of thyroid nodule be there is no specifically by doctor trained in Western medicine at present
Curative effect, and treatment means have some limitations and Operative risk, it is desirable to by Chinese traditional treatment permissible to more preferable curative effect.
Summary of the invention
For the deficiencies in the prior art, inventor explores the medicine effectively treating thyroid nodule repeatedly, is becoming sick and dialectical treatment
On the basis of, it was found that a kind of Chinese medicine composition effectively controlling thyroid nodule, the solidifying card of diagnosis and treatment based on an overall analysis of the illness and the patient's condition Thyreoidine tubercle stagnation of the circulation of vital energy phlegm
Type patient has significant effect.
Specifically, the present invention is realized in.
A kind of Chinese medicine composition treating thyroid nodule, it is characterised in that by fiveleaf akebia fruit, oval kumquat seed, the root of Chinese wild ginger, white clouds melon, red
Wife, radix tetrastigme, storax, oyster, stick grass, conic gymnadenia tuber, dried rehamnnia root are that medicinal raw material develops meticulously.
Each medicinal raw material consumption of Chinese medicine composition of the present invention all has preferable curative effect in the range of the weight portion of the present invention, described
The weight of each medicinal raw material is as follows: fiveleaf akebia fruit 8-13 part, oval kumquat seed 6-11 part, root of Chinese wild ginger 4-7 part, white clouds melon 15-20 part,
Huechys 2-4 part, radix tetrastigme 11-16 part, storax 0.5-1.0 part, oyster 12-17 part, stick grass 10-15 part, conic gymnadenia tuber 15-20
Part, dried rehamnnia root 8-13 part.
It is further preferred that a kind of Chinese medicine composition treating thyroid nodule, it is characterised in that wanting by following weight
Make with raw material: fiveleaf akebia fruit 8 parts, oval kumquat seed 8 parts, the root of Chinese wild ginger 4 parts, 18 parts of white clouds melon, huechys 3 parts, radix tetrastigme 12 parts, Soviet Union
Blending 0.6 part, oyster 13 parts, stick grass 12 parts, conic gymnadenia tuber 15 parts, dried rehamnnia root 10 parts；
Or fiveleaf akebia fruit 10 parts, oval kumquat seed 8 parts, the root of Chinese wild ginger 5 parts, 18 parts of white clouds melon, huechys 2.5 parts, radix tetrastigme 15 parts, storax
0.6 part, oyster 12 parts, stick grass 15 parts, conic gymnadenia tuber 18 parts, dried rehamnnia root 12 parts；
Or fiveleaf akebia fruit 12 parts, oval kumquat seed 9 parts, the root of Chinese wild ginger 4 parts, 16 parts of white clouds melon, huechys 3 parts, radix tetrastigme 12 parts, storax 0.8
Part, oyster 15 parts, stick grass 14 parts, conic gymnadenia tuber 16 parts, dried rehamnnia root 10 parts.
Prescription compatibility relationship of the present invention and side solve as follows:
Fiveleaf akebia fruit merit is apt to soothing liver and harmonizing stomach, softening and resolving hard mass, promoting blood circulation and stopping pain, and dampness removing is let out turbid；Oval kumquat seed is apt to reducing phlegm and resolving masses, regulating qi-flowing for relieving pain,
Two medicines 5 are soothing the liver with promoting the circulation of qi, and softening and resolving hard mass is monarch.
Root of Chinese wild ginger temperature lungization is drunk, expelling wind and clearing away cold, sensible pain relieving；White clouds melon eleminating phlegm and freeing channels；Huechys drastically removing blood stasis and resolving static blood, three medicine 5 useization
Phlegm dissipating bind, stimulating the menstrual flow by the stasis of blood is ministerial drug.
Radix tetrastigme is clearing heat and detoxicating, dispelling pathogenic wind and eliminating phlegm, promoting blood circulation and stopping pain；Storax is regulated the flow of vital energy and is opened surreptitiously, wards off dirty pain relieving, oyster resolving phlegm and softening hard masses,
Removing damp-heat, principal drug assistance ministerial drug promoting the circulation of qi disappears stagnant, reducing phlegm and resolving masses, for adjuvant.Stick grass tonifying lung invigorating the spleen；Nourishing Yin and promoting production of body fluid；Palm
Ginseng tonifying spleen moistening lung, calms the nerves relieving convulsion, benefit gas and blood；Dried rehamnnia root is nourishing Yin and clearing heat, and cool blood is enriched blood, four medicine 5 nourshing blood and promoting blood circulation, invigorating the spleen
Benefit gas, causes the pathological change of deficiecny of liver-YIN, the source that dissolving phlegm simultaneously is wet, the road that dredging is eliminated the phlegm for a long time, is also for this disease stagnation of liver qi
Assistant is allowed to use.All medicines close 5 dispersing stagnated hepatoqis, resolving phlegm and softening hard masses dissipating bind, hold concurrently with nourshing blood and promoting blood circulation, strengthening the spleen and replenishing qi, for thyroid nodule
Stagnation of the circulation of vital energy phlegm coagulate card type patient, play Mutiple Targets, the regulation effect of multisystem, evident in efficacy.
Meridian distribution of property and flavor and the pharmacological action of medicinal raw material of the present invention are as follows.
Fiveleaf akebia fruit: [nature and flavor] hide micro-hardship, property is put down.Return liver, stomach, bladder warp.[return through] liver；Stomach warp.[function cures mainly] dredges
Liver and stomach, promoting blood circulation and stopping pain, softening and resolving hard mass, diuresis.Main stagnation of liver-QI and stomach-QI, gastral cavity abdomen, the side of body help distending pain, diet not to disappear, diarrhea is just
Let out, hernia pain, pain in the back, through closing dysmenorrhoea, goiter and tumor scrofula, malignant tumour.
Oval kumquat seed: [nature and flavor] are sour, pungent, flat.[return through] liver；Spleen；Stomach；Lung channel.[function cures mainly] reducing phlegm and resolving masses, regulates the flow of vital energy
Pain relieving.Main larynx numbness；Scrofula tuberculosis；Hernia；Testiclar gall；Breast lumps；Mastitis.
Storax: [nature and flavor] are pungent, temperature.[return through] thoughts of returning home, the spleen channel.[function cures mainly] opens surreptitiously, wards off dirty, pain relieving.In for
Wind coma due to blocking of the respiratory system, suddenly faints, chest and abdomen crymodynia, frightened epilepsy.
The root of Chinese wild ginger: [nature and flavor] are pungent, temperature.[return through] thoughts of returning home, lung, kidney channel.[function cures mainly] expelling wind and clearing away cold, sensible pain relieving, temperature
Lungization is drunk.For anemofrigid cold, headache, toothache, nasosinusitis of having a stuffy nose, arthralgia due to wind-dampness, phlegm and retained fluid is breathed with cough.[usage and dosage] 1～3g；
Suitable amount used externally.
White clouds melon: [another name] chervil.[source] medicinal material Ji Yuan: spend the block root of soil melon for convolvulaceous plant indigo plant.[nature and flavor] are sweet；
Micro-pungent；Flat.[function cures mainly] eleminating phlegm and freeing channels.Main aphasia from apoplexy；Sputum is jammed；Hemiplegia.[extracts] " China's book on Chinese herbal medicine "
Stick grass [source] medicinal material Ji Yuan: for the dried root of the short and small caryophyllaceous ginseng of pinkwort.[nature and flavor] are sweet；Bitter；Tepor.
[function cures mainly] tonifying lung；Invigorating the spleen；Nourishing Yin and promoting production of body fluid.Main cough due to deficiency of the lung；Insufficiency of the spleen food is few；Palpitaition spontaneous perspiration；Tired out weak；Dry.
Radix tetrastigme: [nature and flavor] micro-hardship, flat.[function cures mainly] is clearing heat and detoxicating, dispelling pathogenic wind and eliminating phlegm, promoting blood circulation and stopping pain.Cure mainly: diphtheria,
Children with high fever induced convulsions, dysentery, hepatitis.Venomous snake bite, tonsillitis, scrofula, cervicitis are controlled in external application, and honeycomb is knitted
Inflammation, traumatic injury.
Huechys: [nature and flavor] bitter；Pungent；Property flat.[return through] heart；Liver；Gallbladder channel.[function cures mainly] breaks the stasis of blood；Dissipating bind；Rose
Poison.Main blood stasis is through closing；Pain in the back；Infertile；Scrofula；Tinea sore；Lyssodexis.
Conic gymnadenia tuber: [nature and flavor] are sweet；Flat.[return through] lung；Spleen；Stomach warp.[function cures mainly] is relieving cough and asthma；Yishen Jianpi；Reason
Gas and blood；Pain relieving.The main deficiency syndrome of the lung is coughed and is breathed heavily；Consumptive disease is become thin；Neurasthenia；Suffer from a deficiency of the kidney lassitude in loin and legs；Impotence；Involuntary emission；Frequent micturition；Slowly
Property hepatitis；Rush down for a long time；Lose blood；Under band；Breast is few；Traumatic injury.
Dried rehamnnia root: [nature and flavor] taste is sweet；Bitter；It is slightly cold.[return through] thoughts of returning home；Liver；Kidney channel.[function cures mainly] is nourishing Yin and clearing heat；Cool
Blood is enriched blood.Main pyreticosis polydipsia；Interior heat is quenched one's thirst；Hectic fever due to yin labor heat；Warm disease sends out spot；Haematemesis caused by blood-head；Uterine bleeding；Hematuria；Just
Blood；The deficiency of blood is sallow；Dizziness palpitaition；Blood is few through closing.
Oyster: [nature and flavor] are salty, are slightly cold.[return through] returns liver, courage, kidney channel.[function cures mainly] is transquilization with heavy material, checking exuberance of yang tonifying yin,
Softening and resolving hard mass.For insomnia of palpitating with fear, dizziness tinnitus, scrofula subcutaneous nodule, abdominal mass lump in the abdomen.Calcined oyster shell convergence is astringent or styptic treatment for spontaneous sweating.Steal for spontaneous perspiration
Sweat, band, stomachache acid regurgitation are collapsed in seminal emission.
In order to preferably express the Chinese medicine composition of the present invention, the Chinese medicine composition of the present invention can by fiveleaf akebia fruit, oval kumquat seed, the root of Chinese wild ginger,
White clouds melon, huechys, radix tetrastigme, storax, oyster, stick grass, conic gymnadenia tuber, dried rehamnnia root or its water or its organic solvent carry
Taking thing is active component, makes various formulation according to galenic pharmacy routine techniques.
The Chinese medicine composition described above of the present invention can add various customary adjuvant required when preparing different dosage form or complementary one-tenth
Point, be prepared as any conventional oral formulations with conventional method of Chinese medicinal, can be such as tablet, sugar coated tablet,
Film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, granule, electuary, pill,
Powder, supensoid agent, pulvis.
Preferably, peroral dosage form described above is capsule, tablet, oral liquid, granule or pill.
Most preferably, peroral dosage form described above is capsule.
Customary adjuvant described above or complementary composition can be: mannitol, sorbierite, sodium pyrosulfite, sodium hydrogensulfite,
Sodium thiosulfate, cysteine hydrochloride, TGA, methionine, injection Vitamin B_6 DTA disodium, Ethylenediaminetetraacetic Acid Calcium Salt, monovalence
Alkali-metal carbonate, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acid, sodium chloride,
Potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose,
Mannitol, silicon derivative, cellulose and its derivates, alginates, gelatin, polyvinylpyrrolidone, glycerine, POLYSORBATE 80,
Agar, calcium carbonate, calcium bicarbonate, surfactant, polyethylene glycol, cyclodextrin, beta-schardinger dextrin, phospholipid material, kaolinite
Soil, talcum powder, calcium stearate, magnesium stearate etc..
The preparation method of a kind of Chinese medicinal composition capsules treating thyroid nodule that the present invention also provides for, it is characterised in that include
Following steps:
(1) taking the dilute hydrochloric acid solution of add 3-5 times amount after ostreae testa pulverata is broken into 1%, use ultrasonic wave to extract, ultrasonic wave carries
Taking complete, take filtrate, reduced pressure concentration crushed after being dried, obtain extract A, standby, wherein, extraction conditions includes: ultrasonic
Power is 130-160W, and Extracting temperature is 30-40 DEG C, and extraction time is 10-20min；
(2) by fiveleaf akebia fruit, oval kumquat seed, the root of Chinese wild ginger, white clouds melon, huechys, radix tetrastigme, stick grass, conic gymnadenia tuber, dried rehamnnia root
Boiling twice, decocts 1.5-2.0 hour for the first time, and amount of water is 6-10 times of decocting herbs gross weight, and second time decocts
1.0-1.5 hour, amount of water was 4-7 times of decocting herbs gross weight, collecting decoction, filtered, filtrate reduced in volume, added
Ethanol to concentration is 30%, refrigerates 12 hours in-5～5 DEG C, filters, filtrate recycling ethanol, is condensed into thick paste, obtains extraction
Thing B；
(3) storax is ground into the fine powder of 200-300 mesh, mixes with extract A, extract B, fill after sterilizing
Enter capsule shells and i.e. obtain Chinese medicinal composition capsules of the present invention.
The Chinese medicinal composition capsules of the present invention determines usage and dosage according to the situation of patient in use.The Chinese traditional medicine composition of the present invention
Composite capsule determines usage and dosage according to the situation of patient in use, can take 1-3 time every day, each 1-20 grain.
Another object of the present invention is to protect above-mentioned Chinese medicine composition preparing the purposes for thyroid nodule medicine, especially
The purposes of card medicine is coagulated for thyroid nodule stagnation of the circulation of vital energy phlegm in preparation.Thyroid nodule is suffered from by the embodiment of the present invention 10 medicine of the present invention
The clinical observation experiment of person, includes 78 example patients altogether in, is randomly divided into 2 groups, and control group takes Western medicine, and medication therapy groups of the present invention takes
With the Chinese medicinal capsule of embodiment 1 preparation, Ureteral Calculus three months, result shows: the result for the treatment of of treatment group is substantially better than control group,
Total effective rate is respectively 87.2% and 59.0%, two groups of total effective rate comparing differences statistically significant (P ＜ 0.01)；With control group ratio
It is less that relatively treatment group disease total mark reduces, and difference also has statistics meaning (P ＜ 0.05)；The scoring reduction for the treatment of group tubercle,
Volume-diminished all reaches statistical significance (P ＜ 0.05, P ＜ 0.01), and Euthyrox control group improves inconspicuous.
In a word, compared with prior art, the present invention has a following beneficial features:
(1) present invention is based on theory of traditional Chinese medical science, and prescription is rigorous, and monarch compatibility relationship is clear and definite, selects medicine precise and appropriate, has
Mutiple Targets, too many levels, multi-level comprehensive regulation effect, the stagnation of the circulation of vital energy phlegm for thyroid nodule coagulates card type patient, can significantly change
The tcm clinical practice symptom of kind patient, improves patients ' life quality.
(2) medicine of the present invention can reduce the high risk factor scoring of tubercle, reduces tubercle volume.
(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: fiveleaf akebia fruit 8 parts, oval kumquat seed 8 parts, the root of Chinese wild ginger 4 parts, 18 parts of white clouds melon, huechys 3 parts, radix tetrastigme 12 parts, Su He
Perfume 0.6 part, oyster 13 parts, stick grass 12 parts, conic gymnadenia tuber 15 parts, dried rehamnnia root 10 parts；
Preparation method: (1) takes the diluted hydrochloric acid aqueous solution of add 4 times of weight portions after oyster is pulverized 1%, uses ultrasonic wave to extract
2 times, ultrasonic wave extracts complete, takes filtrate, reduced pressure concentration crushed after being dried, obtains extract A, standby, wherein, extracts bar
Part includes: ultrasonic power is 130-160W, and Extracting temperature is 30-40 DEG C, and extraction time is 10-20min；
(2) by fiveleaf akebia fruit, oval kumquat seed, the root of Chinese wild ginger, white clouds melon, huechys, radix tetrastigme, stick grass, conic gymnadenia tuber, dried rehamnnia root
Boiling twice, decocts 1.5-2.0 hour for the first time, and amount of water is 8 times of decocting herbs total weight parts, and second time decocts
1.0-1.5 hour, amount of water was 5 times of decocting herbs total weight parts, collecting decoction, filtered, filtrate reduced in volume, added
Ethanol to concentration is 30%, refrigerates 12 hours in-5～5 DEG C, filters, filtrate recycling ethanol, is condensed into thick paste, after drying,
Pulverize to obtain extract B；
(3) storax is ground into the fine powder of 200-300 mesh, mixes with extract A, extract B, after sterilizing, load glue
Softgel shell i.e. obtains Chinese medicinal composition capsules of the present invention.Capsule prepared by the present embodiment, every loading amount 0.30g, be equivalent to crude drug 1.04g.
Embodiment 2 capsule
Prescription: fiveleaf akebia fruit 10 parts, oval kumquat seed 8 parts, the root of Chinese wild ginger 5 parts, 18 parts of white clouds melon, huechys 2.5 parts, radix tetrastigme 15 parts, Soviet Union
Blending 0.6 part, oyster 12 parts, stick grass 15 parts, conic gymnadenia tuber 18 parts, dried rehamnnia root 12 parts；
Preparation method: (1) takes the diluted hydrochloric acid aqueous solution of add 3 times of weight portions after oyster is pulverized 1%, uses ultrasonic wave to extract
2 times, ultrasonic wave extracts complete, takes filtrate, reduced pressure concentration crushed after being dried, obtains extract A, standby, wherein, extracts bar
Part includes: ultrasonic power is 130-160W, and Extracting temperature is 30-40 DEG C, and extraction time is 10-20min；
(2) by fiveleaf akebia fruit, oval kumquat seed, the root of Chinese wild ginger, white clouds melon, huechys, radix tetrastigme, stick grass, conic gymnadenia tuber, dried rehamnnia root
Boiling twice, decocts 1.5-2.0 hour for the first time, and amount of water is 7 times of decocting herbs total weight parts, and second time decocts
1.0-1.5 hour, amount of water was 5 times of decocting herbs total weight parts, collecting decoction, filtered, filtrate reduced in volume, added
Ethanol to concentration is 30%, refrigerates 12 hours in-5～5 DEG C, filters, filtrate recycling ethanol, is condensed into thick paste, after drying,
Pulverize to obtain extract B；
(3) storax is ground into the fine powder of 200-300 mesh, mixes with extract A, extract B, after sterilizing, load glue
Softgel shell i.e. obtains Chinese medicinal composition capsules of the present invention.Capsule prepared by the present embodiment, every loading amount 0.34g, be equivalent to crude drug 1.12g.
Embodiment 3 capsule
Prescription: fiveleaf akebia fruit 12 parts, oval kumquat seed 9 parts, the root of Chinese wild ginger 4 parts, 16 parts of white clouds melon, huechys 3 parts, radix tetrastigme 12 parts, Su He
Perfume 0.8 part, oyster 15 parts, stick grass 14 parts, conic gymnadenia tuber 16 parts, dried rehamnnia root 10 parts.
Preparation method: (1) takes the diluted hydrochloric acid aqueous solution of add 4 times of weight portions after oyster is pulverized 1%, uses ultrasonic wave to extract
2 times, ultrasonic wave extracts complete, takes filtrate, reduced pressure concentration crushed after being dried, obtains extract A, standby, wherein, extracts bar
Part includes: ultrasonic power is 130-160W, and Extracting temperature is 30-40 DEG C, and extraction time is 10-20min；
(2) by fiveleaf akebia fruit, oval kumquat seed, the root of Chinese wild ginger, white clouds melon, huechys, radix tetrastigme, stick grass, conic gymnadenia tuber, dried rehamnnia root
Boiling twice, decocts 1.5-2.0 hour for the first time, and amount of water is 9 times of decocting herbs total weight parts, and second time decocts
1.0-1.5 hour, amount of water was 4 times of decocting herbs total weight parts, collecting decoction, filtered, filtrate reduced in volume, added
Ethanol to concentration is 30%, refrigerates 12 hours in-5～5 DEG C, filters, filtrate recycling ethanol, is condensed into thick paste, after drying,
Pulverize to obtain extract B；
(3) storax is ground into the fine powder of 200-300 mesh, mixes with extract A, extract B, after sterilizing, load glue
Softgel shell i.e. obtains Chinese medicinal composition capsules of the present invention.Capsule prepared by the present embodiment, every loading amount 0.33g, be equivalent to crude drug 1.12g.
Embodiment 4 capsule
Prescription: fiveleaf akebia fruit 8 parts, oval kumquat seed 6 parts, the root of Chinese wild ginger 5 parts, 15 parts of white clouds melon, huechys 4 parts, radix tetrastigme 15 parts, Su He
Perfume 0.7 part, oyster 15 parts, stick grass 10 parts, conic gymnadenia tuber 15 parts, dried rehamnnia root 10 parts；
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 5 capsule
Prescription: fiveleaf akebia fruit 12 parts, oval kumquat seed 8 parts, the root of Chinese wild ginger 4.5 parts, 15 parts of white clouds melon, huechys 2.5 parts, radix tetrastigme 15 parts,
Storax 0.5 part, oyster 16 parts, stick grass 10 parts, conic gymnadenia tuber 20 parts, dried rehamnnia root 10 parts；
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 6 capsule
Prescription: fiveleaf akebia fruit 8 parts, oval kumquat seed 8 parts, the root of Chinese wild ginger 5 parts, 18 parts of white clouds melon, huechys 2.5 parts, radix tetrastigme 12 parts, Soviet Union
Blending 0.8 part, oyster 15 parts, stick grass 14 parts, conic gymnadenia tuber 16 parts, dried rehamnnia root 12 parts.
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 7 capsule
Prescription: fiveleaf akebia fruit 10 parts, oval kumquat seed 8 parts, the root of Chinese wild ginger 4.5 parts, 18 parts of white clouds melon, huechys 2 parts, radix tetrastigme 11 parts, Soviet Union
Blending 0.8 part, oyster 17 parts, stick grass 13 parts, conic gymnadenia tuber 18 parts, dried rehamnnia root 10 parts.
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 8 capsule
Prescription: fiveleaf akebia fruit 10 parts, oval kumquat seed 7 parts, the root of Chinese wild ginger 7 parts, 15 parts of white clouds melon, huechys 2.5 parts, radix tetrastigme 12 parts, Soviet Union
Blending 0.6 part, oyster 16 parts, stick grass 15 parts, conic gymnadenia tuber 15 parts, dried rehamnnia root 10 parts；
Preparation method: the operation with reference to embodiment 1-3 is carried out.
Embodiment 9 toxicological experiment
(1) acute toxicity testing: choose kunming mice 60, male and female half and half, body weight 28～38g, be randomly divided into four groups,
I.e. control group and administration group, before experiment, fasting 12 hours, is dissolved in Chinese medicine capsules prepared by embodiments of the invention 1-3
Making suspension (concentration is 6.6g-6.8g crude drug/ml, maximum concentration) gavage in water, gavage volume is 5ml/kg, comparison
Group gives normal saline, within one day, is administered 2 times, delivery time 6 hours, Continuous Observation 14 days after administration, and
Record mouse toxic reaction and death toll.
Test result indicate that: compare with control group, after administration, each group mouse has no notable difference, tests Continuous Observation 14 days,
Mouse systemic situation, diet, drinking-water, body weight increase the most normal.The capsule i.e. LD50 ＞ of the Mouse oral gavage present invention
33.0-34.0g crude drug/kg, every day, maximum dosage-feeding was 68.0g crude drug/kg/ day.Therefore the Chinese medicine acute toxicity of the present invention is extremely low,
Clinical drug safety.
(2) long term toxicity test: mouse is pressed 1.04,2.08 and 5.2g crude drugs/kg by Chinese medicine embodiment 1 capsule of the present invention
After 15 weeks (1.0ml/100g body weight, every day 2 times) of continuous use and drug withdrawal 3 weeks, result shows: Chinese medicine pair of the present invention
The equal nothings of index such as the hair of mouse, behavior, stool and urine, body weight, organ weights, blood picture, hepatic and renal function, blood sugar, blood fat
Significantly affecting, internal organs naked eyes do not find that difference change and histological indications show, after medication 15 weeks and drug withdrawal 3 weeks,
Organs of Mice is all without substantially changing.Illustrate that Chinese medicine of the present invention is little to toxicity after mouse long-term prescription, after drug withdrawal, also there is no difference
Reaction, application safety.
The embodiment 10 medicine of the present invention clinical observation experiment to thyroid nodule patient
1 data and method
1.1 physical data: choose the 78 example thyroid nodule patients that in February, 2014 in February, 2015, my institute accepted for medical treatment, Syndrome Differentiation of Chinese Medicine
Card belongs to stagnation of the circulation of vital energy phlegm and coagulates disease.It is randomly divided into treatment group and control group, often organizes each 39 examples.In treatment group, the male sex 15 example, women 24 example；
Age is (40.6 ± 8.4) year；In control group, the male sex 14 example, women 25 example；Age is (40.8 ± 8.7) year.Two groups of patients
The equal not statistically significant of difference (P ＞ 0.05) in terms of sex, age, disease time and tubercle, has comparativity.
1.2 diagnostic criteria
1.2.1 doctor trained in Western medicine diagnosis: according to reference to the diagnosis mark in " surgery conventional treatment " and " Thyroid Diseases in China diagnosis and treatment guide "
Accurate: 1. symptom: neck tubercle, without red and swollen heat pain, when tubercle is bigger, can there be the symptoms such as discomfort of neck area sense, dysphagia.2. body
Lattice check: can lay one's hand on and unilateral or one, bilateral thyroid gland and with superior thyroid tubercle, quality is medium, clear border, without tenderness, and can be with gulping down
Swallow up and down.3. ultrasound diagnosis can find single or multiple tubercle, can be that capsule, capsule reality, adenoma sample or Combination swell thing.
4. askiatic has the situation of calcification in checking display swollen thing tracheas suppressed displacement or lump.
1.2.2 Syndrome Differentiation of Traditional Chinese Medicine standard: with reference to " combination of Chinese tradiational and Western medicine oncology ", " tcm clinical practice diagnosis and treatment term syndrome part "
It is and " new Chinese medicine guideline of clinical investigations " is formulated, and stagnation of the circulation of vital energy phlegm is solidifying to be demonstrate,proved: main symptom: neck region lump, up and down with swallowing,
The reddest, the hottest, the most bitterly.Secondary card: neck turgor is uncomfortable, dysphagia is in a very depressed state, irritated, weak, chest side of body gastral cavity abdominal distension
Vexed alter pain, cough up white phlegm, the white greasy wiry and rolling pulse of tongue.
1.3 enter row's standard:
1.3.1 inclusive criteria: all patients all confirm through pathological examination, imaging examination: thyroid gland color ultrasound shows >=1 first shape
Gland tubercle；Palpation neck Thyroid Gland Swell；The research content and therapeutic scheme are known the inside story by patient, signed letter of consent.
1.3.2 exclusion standard: the person that turns out to be Malignant Nodules, tubercle volume grows beyond 30% in a short time；Hyperthyroidism or
Hypothyroid；To treatment prescription drug allergy sufferers；Suffer from infectious diseases, severe cardiac cranial vascular disease, or seriously
Hepatic and kidney function obstacle patient；Pregnant woman；The infull patient of Data acquisition,.
1.4 methods of treatments: control group patient applies levothyroxine sodium to treat, levothyroxine sodium tables (trade name Euthyrox,
Shenzhen China Associated Pharmaceutical Co., Ltd. produces), 50～100 μ g/ time, 1 time/d, play warm water and take morning.Treatment group: take this
The capsule for treating of bright embodiment 1 preparation, twice on the one, each 4-6 grain.Within one month, it is a course for the treatment of, observes after treating three courses for the treatment of
Judge curative effect.
1.5 observation index:
1.5.1 draft according to thyroid disease curative effect determinate standard in " new Chinese medicine clinical research guide ".Disease is marked: neck
Turgor is uncomfortable, dysphagia, is in a very depressed state or irritated, weak, and chest side of body gastral cavity abdominal distension is vexed alters pain, cough up white phlegm totally 6 represent symptom,
Each symptom according to without, light, in, weigh four grades and count 0,1,2,3 points respectively.
1.5.2 high risk factor scoring: microcalciffcation: without microcalciffcation meter 1 point in tubercle, have microcalciffcation meter 2 points；Border is clear
Clear degree: sharpness of border meter 1 point, obscure boundary meter 3 points, therebetween meter 2 points；Low echo nodules: equal echo or height
Echo meter 1 point, low echo meter 2 points；Internal flow signal: internal no blood signal or blood flow signal account for 1/3 meter of knuckle area
1 point, internal flow signal distributions area accounts for knuckle area more than 1/3 or is almost covered with tubercle meter 2 points；Scoring scope is divided between 4-9.
1.5.3 tubercle calculation method of physical volume: V (cm3)=π/6 × major diameter (cm) × transverse diameter (cm) × wide footpath (cm).
Integration × 100% before the deduction rate of the 1.6 each integrations of efficacy evaluation method=(integration after integration-treatment before treatment)/treatment.
1.6.1 symptom efficacy evaluation: clinical recovery: transference cure or substantially disappear, symptom integral reduces >=95%；Effective: disease
Shape is obviously improved, and symptom integral reduces >=70%；Effective: symptom all take a favorable turn, symptom integral reduces >=30%；Invalid: symptom
All without taking a turn for the better and improving, even increase the weight of, symptom integral reduces less than 30%.
1.6.2 high risk factor efficacy evaluation: integral contrast before and after treatment.
1.6.3 tubercle volume efficacy evaluation: clinical recovery: tubercle disappears；Effective: tubercle volume reduces more than 2/3；Effective:
Tubercle volume reduces more than 1/3；Invalid: tubercle volume minimizing less than 1/3 or unchanged or volume increase.
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 group Clinical efficacy comparisons: treatment terminate after treatment group clinical recovery 7 example, effective 18 examples, effective 9 examples, invalid 5 examples,
Total effective rate 87.2%；Control group clinical recovery 2 example, effective 8 examples, effective 13 examples, invalid 16 examples, total effective rate 59.0%, control
The result for the treatment of of treatment group is substantially better than control group, difference statistically significant (P ＜ 0.01).It is shown in Table 1.
Two groups of patient clinical comparitive study after table 1 treatment, example (%)
Note: compare with control group, * P ＜ 0.01.
Before and after 2.2 liang of group treatments, syndrome total mark compares: after treatment, two groups of syndrome integral all significantly improve, 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.
2 liang of table group treatment before and after disease total mark compare (Point)
Note: compare with before treatment, * P ＜ 0.05, * * P ＜ 0.01；Compare between group,#P ＜ 0.05.
2.3 liang of groups high risk factor, tubercle volume situations of change: after treatment, obvious fall before treatment group high risk factor scoring relatively treatment
Low (P ＜ 0.01), tubercle volume-diminished (P ＜ 0.05)；Before and after treatment of control group high risk factor scoring, tubercle volume difference without
Statistical significance (P ＞ 0.05).It is shown in Table 3.
The group high risk factor scoring of 3 liang of table and tubercle volume situation of change compare,
Note: compare with before treatment, * P ＜ 0.05, * * P ＜ 0.01；Compare between group,#P ＜ 0.05.
2.4 bad reactions: treatment group during observing patient without any subjective uncomfortable, blood, urine, stool routine examination and the heart, liver,
Renal functions etc. check exception all do not occur.
This observed result shows, the result for the treatment of of treatment group is substantially better than control group, difference statistically significant (P ＜ 0.01)；With
It is less that control group comparison therapy group disease total mark reduces, and difference also has statistics meaning (P ＜ 0.05)；Treatment group tubercle is commented
Divide reduction, volume-diminished all to reach statistical significance (P ＜ 0.05, P ＜ 0.01), and Euthyrox control group improves inconspicuous.
Claims (10)
1. the Chinese medicine composition treating thyroid nodule, it is characterised in that by fiveleaf akebia fruit, oval kumquat seed, the root of Chinese wild ginger, white clouds melon,
Huechys, radix tetrastigme, storax, oyster, stick grass, conic gymnadenia tuber, dried rehamnnia root are that medicinal raw material develops meticulously.
2. the Chinese medicine composition treating thyroid nodule as claimed in claim 1, it is characterised in that by the medicine of following weight
Make with raw material: fiveleaf akebia fruit 8-13 part, oval kumquat seed 6-11 part, root of Chinese wild ginger 4-7 part, white clouds melon 15-20 part, huechys 2-4 part, three leaves
Blue or green 11-16 part, storax 0.5-1.0 part, oyster 12-17 part, stick grass 10-15 part, conic gymnadenia tuber 15-20 part, dried rehamnnia root 8-13 part.
3. the Chinese medicine composition treating thyroid nodule as claimed in claim 2, it is characterised in that by following weight
Make with raw material: fiveleaf akebia fruit 8 parts, oval kumquat seed 8 parts, the root of Chinese wild ginger 4 parts, 18 parts of white clouds melon, huechys 3 parts, radix tetrastigme 12 parts,
Storax 0.6 part, oyster 13 parts, stick grass 12 parts, conic gymnadenia tuber 15 parts, dried rehamnnia root 10 parts.
4. the Chinese medicine composition treating thyroid nodule as claimed in claim 2, it is characterised in that by following weight
Make with raw material: fiveleaf akebia fruit 10 parts, oval kumquat seed 8 parts, the root of Chinese wild ginger 5 parts, 18 parts of white clouds melon, huechys 2.5 parts, radix tetrastigme 15 parts,
Storax 0.6 part, oyster 12 parts, stick grass 15 parts, conic gymnadenia tuber 18 parts, dried rehamnnia root 12 parts；Or fiveleaf akebia fruit 12 parts, oval kumquat seed 9
Part, the root of Chinese wild ginger 4 parts, 16 parts of white clouds melon, huechys 3 parts, radix tetrastigme 12 parts, storax 0.8 part, oyster 15 parts, stick grass 14 parts,
Conic gymnadenia tuber 16 parts, dried rehamnnia root 10 parts.
5. the Chinese medicine composition of the treatment thyroid nodule as described in claim 1-4 is arbitrary, it is characterised in that described Chinese medicine composition
Be by fiveleaf akebia fruit, oval kumquat seed, the root of Chinese wild ginger, white clouds melon, huechys, radix tetrastigme, storax, oyster, stick grass, conic gymnadenia tuber,
Dried rehamnnia root or its water or its extractive with organic solvent are that active component is made for peroral dosage form.
6. the Chinese medicine composition of the treatment thyroid nodule as described in claim 1-5 is arbitrary, it is characterised in that described peroral dosage form can
For tablet, enteric coated tablet, capsule, oral liquid, granule, electuary, pill, powder, supensoid agent, pulvis.
7. the Chinese medicine composition treating thyroid nodule as claimed in claim 6, it is characterised in that described peroral dosage form is preferably
Capsule, tablet, oral liquid, granule or pill.
8. the Chinese medicine composition treating thyroid nodule as claimed in claim 7, it is characterised in that described peroral dosage form is preferably
Capsule.
9. the Chinese medicine composition of the treatment thyroid nodule as described in claim 1-8 is arbitrary, it is characterised in that described capsule
Preparation method comprise the following steps:
(1) take the diluted hydrochloric acid aqueous solution of add 3-5 times of weight portion after oyster is pulverized 1%, use ultrasonic wave to extract, ultrasonic
Ripple extracts complete, takes filtrate, reduced pressure concentration crushed after being dried, obtains extract A, and standby, wherein, extraction conditions includes:
Ultrasonic power is 130-160W, and Extracting temperature is 30-40 DEG C, and extraction time is 10-20min；
(2) by fiveleaf akebia fruit, oval kumquat seed, the root of Chinese wild ginger, white clouds melon, huechys, radix tetrastigme, stick grass, conic gymnadenia tuber, dried rehamnnia root
Boiling twice, decocts 1.5-2.0 hour for the first time, and amount of water is 6-10 times of decocting herbs total weight parts, and second time is decocted
Boiling 1.0-1.5 hour, amount of water is 4-7 times of decocting herbs total weight parts, collecting decoction, filters, filtrate reduced in volume,
Adding ethanol to concentration is 30%, refrigerates 12 hours in-5～5 DEG C, filters, filtrate recycling ethanol, is condensed into thick paste, dry
After dry, pulverize to obtain extract B；
(3) storax is ground into the fine powder of 200-300 mesh, mixes with extract A, extract B, fill after sterilizing
Enter capsule shells and i.e. obtain Chinese medicinal composition capsules of the present invention.
10. claim 1-4 arbitrary described Chinese medicine composition purposes in preparation treatment thyroid nodule medicine.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201610408876.9A CN105920343A (en) | 2016-06-11 | 2016-06-11 | Traditional Chinese medicine composition for treating thyroid nodule |
Applications Claiming Priority (1)
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