CN105816553A - Pharmaceutical composition for treating thyroid nodule and preparation method thereof - Google Patents
Pharmaceutical composition for treating thyroid nodule and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a pharmaceutical composition for treating a thyroid nodule and a preparation method thereof. The pharmaceutical composition is prepared through elaborate development by taking leaves of oval kumquat, whole plants of jasminum polyanthum Franch., herb of ammannia auriculata Willd., all-grass of winkled marshweed, radix angelicae sinensis, all-grass of canton speranskia, radix aucklandiae, radix pseudostellariae, rhizomes and roots of peliosanthes minor yamamoto, eucheuma gelatinae(Esp.)J.Ag. and white mustard seeds as medicinal materials, the pharmaceutical composition has the effects of soothing the liver, invigorating the spleen, promoting qi, removing stasis, resolving phlegm and dissipating blood stasis and has the effects of warming meridians, promoting qi and promoting blood circulation to remove meridian obstruction simultaneously, multi-system and multifunctional regulation is achieved for a syndrome of hepatic qi stagnation of a patient with the thyroid nodule, the traditional Chinese medicine symptoms can be significantly improved, the high risk factor score is lowered, the nodule is shrunk, and the curative effect is significant.
Description
Technical field
The invention belongs to tcm field, be specifically related to a kind of pharmaceutical composition treating thyroid nodule and preparation method thereof.
Background technology
The sickness rate of thyroid disease is in recent years in the trend of rising, and wherein thyroid nodule and hyperthyroidism are two kinds of thyroid diseases that sickness rate is the highest.Thyroid nodule refers to the lump in thyroid, can move up and down with thyroid with swallowing act, is clinical common disease, can be caused by Different types of etiopathogenises, and from nodositas qualitative classification, thyroid nodule includes benign protuberance and Malignant Nodules.The tuberosity of both character is extremely difficult from clinical symptoms to offer a clear explanation.In " Thyroid Diseases in China guideline of prevention and treatment ", the treatment of thyroid nodule there is no the medicine of definite curative effect at present.The most extensively growth of application L-T4 suppression thyroid nodule, but easily cause Patient drug's property hyperthyroidism, it is impossible to adapt to whole tuberosity patient.At present doctor trained in Western medicine there is no concrete curative effect to the treatment of thyroid nodule, and treatment means has some limitations and Operative risk, it is desirable to by Chinese traditional treatment permissible to more preferable curative effect.
Thyroid nodule belongs to " goiter " category in Chinese medicine.The etiology and pathogenesis of primary disease is the most inappropriate with diet water and soil, feelings will internal injury is relevant, additionally relevant to physical factors, " Shengji Zonglu goiter door " meaning goiter " married woman has it more; edge melancholy has more than that man is also ", the physiological characteristicies such as the warp of women, band, tire, product all QI and blood with Liver Channel have and contact closely, take good care of and accidentally can cause Liver Channel disorder of QI and blood, therefore the probability that women suffers from " goiter " is bigger.And along with the development of society, the quickening of rhythm of life, the increasing of life stress, be more easy to cause yin-Yang to lack of proper care, causing depression of liver-QI, lose in catharsis, take advantage of in taste, dysfunction of the spleen in transportation, body fluid not cloth, stagnation of QI expectorant coagulates, ties in throat, then cost disease.With the passing of time the stagnation of QI, can cause blood-vessel obstructive, or fire-transformation, the most then consume sad the moon, and have the deteriorated cases such as expectorant knot blood stasis, high liver fire, deficiency of YIN of both the heart and liver concurrently.The stagnation of QI, expectorant are turbid, blood stasis etc. be pathological product also be aggravation disease factor.
Modern medicine is a lot of about the Therapy study of thyroid nodule at present, diagnoses and treatment emerges in an endless stream, especially with carrying out of the interventional technique such as radio-frequency (RF) ablation, microwave ablation in recent years, more enrich the treatment means of thyroid nodule, but owing to operation and interventional therapy all also exist a certain proportion of side effect, so requiring that the patient of expectant treatment is the most in an endless stream clinically, and it is the most few in number about the research for the treatment of by Chinese herbs thyroid nodule, therefore, provide therapeutic choice the most necessary for clinical diagnosis and treatment primary disease.
Summary of the invention
The technical problem to be solved is, utilize the theory of Chinese medical science that China is traditional, the pharmaceutical composition of a kind of dialectical treatment thyroid nodule is provided, medicine composite for curing caused by hepatic stagnation qi stagnation thyroid nodule of the present invention, use safe and free of toxic and side effects, tcm symptom can be significantly improved, reduce high risk factor scoring well, evident in efficacy.
The present invention is achieved by the following technical solutions:
A kind of pharmaceutical composition treating thyroid nodule, it is characterised in that be that medicinal raw material develops meticulously by Folium Fortunellae Margarita, Flos jasmini, ear water Herba Amaranthi tricoloris, Herba Limnophilae rugosae, Radix Angelicae Sinensis, Herba speranskiae cantonensis, the Radix Aucklandiae, Radix Pseudostellariae, mountain centipede, Eucheuma gelatinosum, Semen Sinapis Albae.
Further, a kind of pharmaceutical composition treating thyroid nodule, it is characterised in that making with raw material by following weight: Folium Fortunellae Margarita 7-12 part, Flos jasmini 15-20 part, ear water Herba Amaranthi tricoloris 8-13 part, Herba Limnophilae rugosae 6-10 part, Radix Angelicae Sinensis 9-15 part, Herba speranskiae cantonensis 10-15 part, Radix Aucklandiae 2-4 part, Radix Pseudostellariae 10-15 part, mountain centipede 15-20 part, Eucheuma gelatinosum 8-13 part, Semen Sinapis Albae 5-8 part.
The preferred version further preferably gone out: a kind of pharmaceutical composition treating thyroid nodule, it is characterised in that making with raw material by following weight: Folium Fortunellae Margarita 9 parts, Flos jasmini 18 parts, ear water Herba Amaranthi tricoloris 10 parts, Herba Limnophilae rugosae 9 parts, Radix Angelicae Sinensis 10 parts, Herba speranskiae cantonensis 12 parts, the Radix Aucklandiae 2.5 parts, Radix Pseudostellariae 12 parts, mountain centipede 16 parts, Eucheuma gelatinosum 10 parts, Semen Sinapis Albae 6 parts.
Side of the present invention solves: Folium Fortunellae Margarita soothing liver-QI for relieving depression in Fang, eliminating stagnation of regulating the flow of vital energy；Flos jasmini promoting the circulation of QI to relieve pain, heat clearing away eliminating stagnation, the two soothing the liver circulation of qi promoting of medicine 5, removing obstruction for relieving pain is monarch drug.Ear water Herba Amaranthi tricoloris invigorating spleen to remove dampness, circulation of qi promoting dissipating blood stasis, Herba Limnophilae rugosae invigorating spleen to remove dampness, activating QI to eliminate phlegm, Chinese angelica blood supplementing invigorates blood circulation, and warming the meridian promoting the circulation of blood, three medicines 5 are regulated the flow of vital energy with spleen invigorating, enrich blood soothing the liver, and reduce phlegm dampness removing, and promoting blood circulation to remove blood stasis is ministerial drug.
Herba speranskiae cantonensis wind-damp dispelling, the meridian dredging, disappear hard block, promoting blood circulation and stopping pain；Radix Aucklandiae promoting the circulation of QI to relieve pain, spleen invigorating yang invigorating, dispersing stagnation and relieving accumulation of pathogens；Radix Pseudostellariae replenishing QI to invigorate the spleen, promoting the production of body fluid for nourishing the lung；Mountain centipede expelling phlegm for arresting cough, Shugan Zhitong；Eucheuma gelatinosum hard masses softening and resolving, removing toxic substances of reducing phlegm；Semen Sinapis Albae reduces phlegm by drink, and mass dissipating and swelling eliminating, for adjuvant.All medicines close 5, have the liver soothing and the spleen invigorating, promoting QI to circulate and dispersing the agglomeration of the pathogens, the merit of resolving phlegm and dissipating blood stasis, have warming the meridian circulation of qi promoting concurrently simultaneously, the effect of promoting blood circulation to remove obstruction in the collateral, for thyroid nodule patient's liver depression and qi stagnation, there are multisystem, multi-functional regulation, tcm symptom can be significantly improved, reduce high risk factor scoring well, evident in efficacy.
Meridian distribution of property and flavor and the primary efficacy of each medicinal raw material used by the present invention are as follows.
Folium Fortunellae Margarita: [nature and flavor] acrid in the mouth；Bitter；Cold nature.[return through] liver；Spleen；Lung meridian.[function cures mainly] soothing liver-QI for relieving depression；Regulate the flow of vital energy eliminating stagnation.Main dysphagic；Scrofula；Breast lumps；Mastitis.
Flos jasmini: [nature and flavor] are bitter is flat.[function cures mainly] circulation of qi promoting menstruction regulating and pain relieving, heat clearing away eliminating stagnation.For having a stomachache, hepatitis, menoxenia, dysmenorrhea, leukorrhagia, stomatitis, skin itching, orchitis, mastitis, tuberculous lymphadenitis.
Ear water Herba Amaranthi tricoloris: [nature and flavor] sweet in the mouth；Light；Property flat.[return through] returns spleen；Bladder warp.[function cures mainly] invigorating spleen to remove dampness；Circulation of qi promoting dissipating blood stasis.Main Spleen deficiency anorexia；Chest and diaphragm is full vexed；Acute and chronic cystitis；Women's leukorrhagia；Traumatic injury congestive edema is had a pain.
Herba speranskiae cantonensis: [nature and flavor] are bitter；Flat.[return through] lung；Liver；Large intestine channel.[function cures mainly] wind-damp dispelling；The meridian dredging；Removing blood stasis with potent drugs pain relieving.Main air pain of dampness syndrome；Lump in the abdomen；Scrofula；Furuncle swelling toxin；Traumatic injury.
The Radix Aucklandiae: [nature and flavor] are pungent, bitter, temperature.[return through] returns spleen, stomach, large intestine, three burnt, gallbladder meridians.[function cures mainly] promoting the circulation of QI to relieve pain, strengthening the spleen to promote digestion.For breast gastral cavity distending pain, weight after dysentery, food stagnation does not disappears, anorexia.Radix Aucklandiae (roasted) reality intestinal antidiarrheal.For stomachache of having loose bowels.
Herba Limnophilae rugosae: [nature and flavor] acrid in the mouth；Sweet；Warm in nature.[return through] returns lung；Spleen；Stomach warp.[function cures mainly] invigorating spleen to remove dampness；Activating QI to eliminate phlegm.Main edema；Stomachache；Distension and fullness of the chest and abdomen；Cough；Children's's infantile dyspepsia；Furuncle.
Radix Pseudostellariae: [nature and flavor] hardship sweet, micro-is flat.[return through] returns spleen, lung meridian.[function cures mainly] replenishing QI to invigorate the spleen, promoting the production of body fluid for nourishing the lung.Tired for insufficiency of the spleen body, inappetence, weak after being ill, deficiency of both vital energy and Yin, spontaneous perspiration is thirsty, dryness of the lung dry cough.[usage and dosage] 9～30g.
Radix Angelicae Sinensis: [nature and flavor] sweet in the mouth, pungent, bitter, warm in nature, [return through] enters liver, the heart, spleen channel, [function cures mainly] replenishing and activating blood, menstruction regulating and pain relieving, the effect of profit soup relieving constipation, demonstrate,prove for blood deficiency and yellow complexion, dizziness cardiopalmus, menoxenia, amenorrhea dysmenorrhea, asthenia cold abdominalgia, dryness of the intestine constipation, rheumatic arthralgia, injury from falling down, ulcer sores etc..
Mountain centipede: [nature and flavor] are sweet, light, flat, tepor.[function cures mainly] expelling phlegm for arresting cough, Shugan Zhitong.Cure mainly cough expectorant thick, chest pain, traumatic injury chest and hypochondrium.
Eucheuma gelatinosum: [return through] lung；Liver；Large intestine channel.[function cures mainly] removing heat from the lung and dissipating phlegm；Hard masses softening and resolving；Removing toxic substances.Main phlegm-heat cough；Gall subcutaneous nodule；Swelling and pain of hemorrhoid or hematochezia；Enteritis.
Semen Sinapis Albae: [nature and flavor] are pungent；Temperature.[return through] lung；Liver；Spleen；Stomach；Pericardium channel.[function cures mainly] reduces phlegm by drink；Mass dissipating and swelling eliminating.Main cough with asthma abundant expectoration；Fullness in the chest and hypochondriac pain；Numb limbs and tense tendons；Arthralgia；Multiple abscess caused by damp-phlegm；Carbuncle of yin nature toxic swelling.[usage and dosage] takes orally: decoct soup, 3-10g；Or enter ball, dissipate.
It is a further object to provide the preparation method of a kind of pharmaceutical composition treating thyroid nodule.
In order to preferably express the pharmaceutical composition of the present invention, pharmaceutical composition of the present invention can be active component by Folium Fortunellae Margarita, Flos jasmini, ear water Herba Amaranthi tricoloris, Herba Limnophilae rugosae, Radix Angelicae Sinensis, Herba speranskiae cantonensis, the Radix Aucklandiae, Radix Pseudostellariae, mountain centipede, Eucheuma gelatinosum, Semen Sinapis Albae or its water or its extractive with organic solvent, is prepared from according to routine techniques.Preferably, pharmaceutical composition of the present invention is made for peroral dosage form.
Pharmaceutical composition of the present invention can also optionally add applicable pharmaceutically acceptable carrier when being prepared as peroral dosage form medicament, described pharmaceutically acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, TGA, methionine, vitamin C, Ethylenediaminetetraacetic Acid Calcium Salt, acetate, phosphate, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and its derivates, alginate, gelatin, polyvinylpyrrolidone, glycerol, POLYSORBATE 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc..
Preferably, peroral dosage form of the present invention can be capsule, tablet, granule, pill, powder, sublimed preparation, unguentum, etc.；Further preferably tablet, capsule, granule, most preferably capsule.
Present invention also offers the preparation method of a kind of medicament composition capsule treating thyroid nodule, it comprises the steps:
(1) depletion Folium Citri tangerinae, Herba Limnophilae rugosae, the Radix Aucklandiae, Flos jasmini add after being ground into the granule that mean diameter is 10-60 μm 5-10 times amount 60% ethanol water, use ultrasonic extraction, ultrasonic extraction is complete, takes filtrate, and concentrating under reduced pressure becomes thick paste, obtain extract A, standby, wherein, extraction conditions includes: ultrasonic power is 130-160W, Extracting temperature is 30-50 DEG C, and extraction time is 10-50min；
(2) by ear water Herba Amaranthi tricoloris, Radix Angelicae Sinensis, Herba speranskiae cantonensis, Radix Pseudostellariae, mountain centipede, Eucheuma gelatinosum, Semen Sinapis Albae is pulverized, boiling twice, decoct 1.0-2.0 hour for the first time, amount of water is 6-10 times of medical material gross weight, second time decocts 1.0-1.5 hour, amount of water is 4-7 times of decocting herbs gross weight, collecting decoction, filter, filtrate reduced in volume to relative density is 1.05-1.10 (60 DEG C of survey), adding ethanol to determining alcohol is 30%, in-5～5 DEG C of cold preservations 12 hours, filter, filtrate recycling ethanol, it is condensed into thick paste, obtain extract B, mix homogeneously with extract A, it is dried, pulverize, load capsule shells and i.e. obtain medicament composition capsule of the present invention.
The medicament composition capsule of the present invention determines usage and dosage according to the situation of patient in use.The medicament composition capsule of the present invention 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 that protection aforementioned pharmaceutical compositions is preparing the purposes for thyroid nodule medicine, is especially used for the purposes of thyroid nodule Liver depression and Qi stagnation medicine in preparation.The embodiment of the present invention 9 medicine of the present invention clinical observation experiment to thyroid nodule patient, include 92 example patients altogether in, it is randomly divided into 2 groups, matched group takes Western medicine, medication therapy groups of the present invention takes the Chinese medicinal capsule of embodiment 1 preparation on the basis of matched group, Ureteral Calculus three months, result shows: the therapeutic effect for the treatment of group is substantially better than matched group, difference statistically significant (P ＜ 0.01)；Less with what matched group comparison therapy group disease total mark reduced, difference also has statistics meaning (P ＜ 0.05)；The scoring for the treatment of group tuberosity reduces, volume-diminished all reaches statistical significance (P ＜ 0.05, P ＜ 0.01), and Euthyrox matched 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 Chinese medical science, prescription is rigorous, monarch compatibility relationship is clear and definite, YAOJING is selected to work as, there is Mutiple Targets, too many levels, multi-level comprehensive regulation effect, for the stagnation of QI due to depression of the liver pattern of syndrome patient of thyroid nodule, the tcm clinical practice symptom of patient can be significantly improved, improve patients ' life quality.
(2) medicine of the present invention can reduce the high risk factor scoring of tuberosity, reduces tuberosity 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.Within the scope of the invention or without departing from present disclosure, spirit and scope, change that the present invention is carried out, combine or replace, will be apparent to the person skilled in the art, and be included within the scope of the present invention.
Embodiment 1 capsule
Prescription: Folium Fortunellae Margarita 9 parts, Flos jasmini 18 parts, ear water Herba Amaranthi tricoloris 10 parts, Herba Limnophilae rugosae 9 parts, Radix Angelicae Sinensis 10 parts, Herba speranskiae cantonensis 12 parts, the Radix Aucklandiae 2.5 parts, Radix Pseudostellariae 12 parts, mountain centipede 16 parts, Eucheuma gelatinosum 10 parts, Semen Sinapis Albae 6 parts.
Preparation method: (1) depletion Folium Citri tangerinae, Herba Limnophilae rugosae, the Radix Aucklandiae, Flos jasmini add the ethanol water of the 60% of 7 times amount after being ground into the granule that mean diameter is 30-40 μm, use ultrasonic extraction 2 times, ultrasonic extraction is complete, takes filtrate, and concentrating under reduced pressure becomes thick paste, obtain extract A, standby, wherein, extraction conditions includes: ultrasonic power is 130-140W, Extracting temperature is 30-50 DEG C, and extraction time is 40-50min；
(2) by ear water Herba Amaranthi tricoloris, Radix Angelicae Sinensis, Herba speranskiae cantonensis, Radix Pseudostellariae, mountain centipede, Eucheuma gelatinosum, Semen Sinapis Albae is pulverized, boiling twice, decoct 1.0-2.0 hour for the first time, amount of water is 8 times of medical material gross weight, second time decocts 1.0-1.5 hour, amount of water is 5 times of decocting herbs gross weight, collecting decoction, filter, filtrate reduced in volume to relative density is 1.08 (60 DEG C of surveys), adding ethanol to determining alcohol is 30%, in-5～5 DEG C of cold preservations 12 hours, filter, filtrate recycling ethanol, it is condensed into thick paste, obtain extract B, mix homogeneously with extract A, it is dried, pulverize, load capsule shells and i.e. obtain medicament composition capsule of the present invention.Capsule prepared by the present embodiment, every loading amount 0.34g, be equivalent to crude drug 1.14g.
Embodiment 2 capsule
Prescription: Folium Fortunellae Margarita 8 parts, Flos jasmini 18 parts, ear water Herba Amaranthi tricoloris 12 parts, Herba Limnophilae rugosae 6 parts, Radix Angelicae Sinensis 10 parts, Herba speranskiae cantonensis 15 parts, the Radix Aucklandiae 3 parts, Radix Pseudostellariae 15 parts, mountain centipede 15 parts, Eucheuma gelatinosum 8 parts, Semen Sinapis Albae 6 parts.
Preparation method: (1) depletion Folium Citri tangerinae, Herba Limnophilae rugosae, the Radix Aucklandiae, Flos jasmini add the ethanol water of the 60% of 8 times amount after being ground into the granule that mean diameter is 20-30 μm, use ultrasonic extraction 2 times, ultrasonic extraction is complete, takes filtrate, and concentrating under reduced pressure becomes thick paste, obtain extract A, standby, wherein, extraction conditions includes: ultrasonic power is 150-160W, Extracting temperature is 30-50 DEG C, and extraction time is 20-40min；
(2) by ear water Herba Amaranthi tricoloris, Radix Angelicae Sinensis, Herba speranskiae cantonensis, Radix Pseudostellariae, mountain centipede, Eucheuma gelatinosum, Semen Sinapis Albae is pulverized, boiling twice, decoct 1.0-2.0 hour for the first time, amount of water is 7 times of medical material gross weight, second time decocts 1.0-1.5 hour, amount of water is 6 times of decocting herbs gross weight, collecting decoction, filter, filtrate reduced in volume to relative density is 1.09 (60 DEG C of surveys), adding ethanol to determining alcohol is 30%, in-5～5 DEG C of cold preservations 12 hours, filter, filtrate recycling ethanol, it is condensed into thick paste, obtain extract B, mix homogeneously with extract A, it is dried, pulverize, load capsule shells and i.e. obtain medicament composition capsule of the present invention.Capsule prepared by the present embodiment, every loading amount 0.30g, be equivalent to crude drug 1.0g.
Embodiment 3 capsule
Prescription: Folium Fortunellae Margarita 12 parts, Flos jasmini 16 parts, ear water Herba Amaranthi tricoloris 12 parts, Herba Limnophilae rugosae 8 parts, Radix Angelicae Sinensis 13 parts, Herba speranskiae cantonensis 13 parts, the Radix Aucklandiae 2 parts, Radix Pseudostellariae 10 parts, mountain centipede 18 parts, Eucheuma gelatinosum 12 parts, Semen Sinapis Albae 5 parts.
Preparation method: (1) depletion Folium Citri tangerinae, Herba Limnophilae rugosae, the Radix Aucklandiae, Flos jasmini add the ethanol water of the 60% of 6 times amount after being ground into the granule that mean diameter is 40-50 μm, use ultrasonic extraction 2 times, ultrasonic extraction is complete, takes filtrate, and concentrating under reduced pressure becomes thick paste, obtain extract A, standby, wherein, extraction conditions includes: ultrasonic power is 150-160W, Extracting temperature is 30-50 DEG C, and extraction time is 30-40min；
(2) by ear water Herba Amaranthi tricoloris, Radix Angelicae Sinensis, Herba speranskiae cantonensis, Radix Pseudostellariae, mountain centipede, Eucheuma gelatinosum, Semen Sinapis Albae is pulverized, boiling twice, decoct 1.0-2.0 hour for the first time, amount of water is 6-10 times of medical material gross weight, second time decocts 1.0-1.5 hour, amount of water is 4-7 times of decocting herbs gross weight, collecting decoction, filter, filtrate reduced in volume to relative density is 1.07 (60 DEG C of surveys), adding ethanol to determining alcohol is 30%, in-5～5 DEG C of cold preservations 12 hours, filter, filtrate recycling ethanol, it is condensed into thick paste, obtain extract B, mix homogeneously with extract A, it is dried, pulverize, load capsule shells and i.e. obtain medicament composition capsule of the present invention.
Embodiment 4 capsule
Prescription: Folium Fortunellae Margarita 9 parts, Flos jasmini 15 parts, ear water Herba Amaranthi tricoloris 12 parts, Herba Limnophilae rugosae 10 parts, Radix Angelicae Sinensis 12 parts, Herba speranskiae cantonensis 10 parts, the Radix Aucklandiae 2.5 parts, Radix Pseudostellariae 14 parts, mountain centipede 16 parts, Eucheuma gelatinosum 8 parts, Semen Sinapis Albae 8 parts.
Preparation method: (1) depletion Folium Citri tangerinae, Herba Limnophilae rugosae, the Radix Aucklandiae, Flos jasmini add the ethanol water of the 60% of 6 times amount after being ground into the granule that mean diameter is 30-50 μm, use ultrasonic extraction 3 times, ultrasonic extraction is complete, takes filtrate, and concentrating under reduced pressure becomes thick paste, obtain extract A, standby, wherein, extraction conditions includes: ultrasonic power is 140-150W, Extracting temperature is 30-40 DEG C, and extraction time is 30-40min；
(2) by ear water Herba Amaranthi tricoloris, Radix Angelicae Sinensis, Herba speranskiae cantonensis, Radix Pseudostellariae, mountain centipede, Eucheuma gelatinosum, Semen Sinapis Albae is pulverized, boiling twice, decoct 1.0-2.0 hour for the first time, amount of water is 7 times of medical material gross weight, second time decocts 1.0-1.5 hour, amount of water is 5 times of decocting herbs gross weight, collecting decoction, filter, filtrate reduced in volume to relative density is 1.06 (60 DEG C of surveys), adding ethanol to determining alcohol is 30%, in-5～5 DEG C of cold preservations 12 hours, filter, filtrate recycling ethanol, it is condensed into thick paste, obtain extract B, mix homogeneously with extract A, it is dried, pulverize, load capsule shells and i.e. obtain medicament composition capsule of the present invention.
Embodiment 5 capsule
Prescription: Folium Fortunellae Margarita 9 parts, Flos jasmini 18 parts, ear water Herba Amaranthi tricoloris 10 parts, Herba Limnophilae rugosae 9 parts, Radix Angelicae Sinensis 10 parts, Herba speranskiae cantonensis 12 parts, the Radix Aucklandiae 2.5 parts, Radix Pseudostellariae 12 parts, mountain centipede 16 parts, Eucheuma gelatinosum 10 parts, Semen Sinapis Albae 6 parts.
Folium Fortunellae Margarita 7-12 part, Flos jasmini 15-20 part, ear water Herba Amaranthi tricoloris 8-13 part, Herba Limnophilae rugosae 6-10 part, Radix Angelicae Sinensis 9-15 part, Herba speranskiae cantonensis 10-15 part, Radix Aucklandiae 2-4 part, Radix Pseudostellariae 10-15 part, mountain centipede 15-20 part, Eucheuma gelatinosum 8-13 part, Semen Sinapis Albae 5-8 part.
Preparation method: the operation with reference to embodiment 1-4 is carried out.
Embodiment 6 capsule
Prescription: Folium Fortunellae Margarita 10 parts, Flos jasmini 20 parts, ear water Herba Amaranthi tricoloris 8 parts, Herba Limnophilae rugosae 8 parts, Radix Angelicae Sinensis 13 parts, Herba speranskiae cantonensis 10 parts, the Radix Aucklandiae 2 parts, Radix Pseudostellariae 15 parts, mountain centipede 15 parts, Eucheuma gelatinosum 12 parts, Semen Sinapis Albae 5 parts.
Preparation method: the operation with reference to embodiment 1-4 is carried out.
Embodiment 7 capsule
Prescription: Folium Fortunellae Margarita 8 parts, Flos jasmini 16 parts, ear water Herba Amaranthi tricoloris 13 parts, Herba Limnophilae rugosae 9 parts, Radix Angelicae Sinensis 12 parts, Herba speranskiae cantonensis 12 parts, the Radix Aucklandiae 4 parts, Radix Pseudostellariae 15 parts, mountain centipede 18 parts, Eucheuma gelatinosum 10 parts, Semen Sinapis Albae 5 parts.
Preparation method: the operation with reference to embodiment 1-4 is carried out.
Embodiment 8 capsule
Prescription: Folium Fortunellae Margarita 12 parts, Flos jasmini 15 parts, ear water Herba Amaranthi tricoloris 10 parts, Herba Limnophilae rugosae 9 parts, Radix Angelicae Sinensis 15 parts, Herba speranskiae cantonensis 12 parts, the Radix Aucklandiae 3.5 parts, Radix Pseudostellariae 15 parts, mountain centipede 16 parts, Eucheuma gelatinosum 8 parts, Semen Sinapis Albae 6 parts.
Preparation method: the operation with reference to embodiment 1-4 is carried out.
The embodiment 9 medicine of the present invention clinical observation experiment to thyroid nodule patient
1 data and method
1.1 physical data: choosing the 92 example thyroid nodule patients that in February, 2013 in February, 2014, my institute accepted for medical treatment, Chinese medical discrimination belongs to stagnation of QI due to depression of the liver.It is randomly divided into treatment group and matched group, often organizes each 46 examples.In treatment group, male 18 example, women 28 example；Age is (40.5 ± 6.4) year；In matched group, male 17 example, women 29 example；Age is (40.8 ± 6.7) year.Two groups of patients equal not statistically significant of difference (P ＞ 0.05) in terms of sex, age, disease time and tuberosity, has comparability.
1.2 diagnostic criteria
1.2.1 Western medicine diagnose: the diagnostic criteria of " thyroid nodule " in foundation " Thyroid Diseases in China diagnosis and treatment guide ": a variety of causes occurs, in causing thyroid, the agglomerate that one or more organizational structuries are abnormal, all patients all get rid of cell abnormal shape and (or) thyroid malignancy through thyroid needle.
1.2.2 Syndrome Differentiation of Traditional Chinese Medicine standard: with reference to " combination of Chinese and Western medicine oncology ", " tcm clinical practice diagnosis and treatment term syndrome part " and " new Chinese medicine guideline of clinical investigations " formulation Liver depression and Qi stagnation: discomfort of neck area, bitter taste in the mouth and dry throat, weak, depressed emotion uncomfortable in chest or being irritable and getting angry easily, cervical region twinge, the breast side of body or distending pain of the breast, have a dizzy spell, menoxenia, body of the tongue is light red, white and thin fur or micro-Huang, stringy pulse.
1.3 enter row's standard:
1.3.1 inclusive criteria: all patients all confirm through pathological examination, imaging examination: thyroid color ultrasound shows >=1 thyroid nodule；Palpation cervical region thyromegaly；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, tuberosity volume grows beyond 30% in a short time；Hyperthyroidism or hypothyroid；To treatment prescription drug allergy sufferers；Suffer from infectious disease, severe cardiac cerebrovascular disease, or serious hepatic and kidney function obstacle patient；Anemia of pregnant woman；The infull patient of collection of data.
1.4 Therapeutic Method: matched group 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 on the basis of matched group the embodiment of the present invention 1 preparation capsule for treating, twice on the one, each 4-6 grain.Within one month, it is a course for the treatment of, observes and judge curative effect after treating three courses for the treatment of.
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: discomfort of neck area or foreign body sensation in the throat, and bitter taste in the mouth and dry throat is uncomfortable in chest weak, depressed emotion or being irritable and getting angry easily, cervical region twinge, the breast side of body or distending pain of the breast, have a dizzy spell 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 tuberosity, have microcalciffcation meter 2 points；Sharpness of border degree: sharpness of border meter 1 point, obscure boundary meter 3 points, therebetween meter 2 points；Low echo nodules: equal echo or high 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 1 point of knuckle area, and internal flow signal distributions area accounts for knuckle area more than 1/3 or is almost covered with tuberosity meter 2 points；Scoring scope is divided between 4-9.
1.5.3 tuberosity 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: symptom is obviously improved, symptom integral reduces >=70%；Effective: symptom all take a favorable turn, symptom integral reduces >=30%；Invalid: symptom is 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 tuberosity volume efficacy evaluation: clinical recovery: tuberosity disappears；Effective: tuberosity volume reduces more than 2/3；Effective: tuberosity volume reduces more than 1/3；Invalid: tuberosity 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, and the comparison of enumeration data two sample rate uses χ2Inspection, measurement data withRepresenting, comparing before and after treatment with paired t-test, compare employing t inspection between group, P ＜ 0.05 represents that difference is statistically significant.
2 results
2.1 liang of group Clinical efficacy comparisons: treat treatment group clinical recovery 9 example after terminating, effective 20 examples, effective 12 examples, invalid 5 examples, total effective rate 89.1%；Matched group clinical recovery 2 example, effective 11 examples, effective 14 examples, invalid 19 examples, total effective rate 58.7%, the therapeutic effect for the treatment of group is substantially better than matched group, difference statistically significant (P ＜ 0.01).It is shown in Table 1.
Two groups of patient clinical comparitive study after table 1 treatment, example (%)
Note: compare with matched group, * P ＜ 0.01.
Before and after 2.2 liang of group treatments, syndrome total mark compares: after two groups of treatments, syndrome integral all significantly improves, and comparing difference front with treatment all has significant (P ＜ 0.05, P ＜ 0.01)；Comparing between two groups after treatment, it is less that treatment group disease total mark reduces, and difference also has statistics meaning (P ＜ 0.05).It is shown in Table 2.
Before and after the group treatment of 2 liang of table, disease total mark compares
Note: compare with before treatment,*P ＜ 0.05,**P ＜ 0.01；Compare between group,#P ＜ 0.05.
2.3 liang of groups high risk factor, tuberosity volume situations of change: after treatment, substantially reduce (P ＜ 0.01) before treatment group high risk factor scoring relatively treatment, tuberosity volume-diminished (P ＜ 0.05)；High risk factor scoring, tuberosity volume difference not statistically significant (P ＞ 0.05) before and after treatment of control group.It is shown in Table 3.
The group high risk factor scoring of 3 liang of table and tuberosity volume situation of change compare,
Note: compare with before treatment,*P ＜ 0.05,**P ＜ 0.01；Compare between group,#P ＜ 0.05.
2.4 untoward reaction: two groups of untoward reaction are compared, no significant difference.
This observed result shows, the therapeutic effect for the treatment of group is substantially better than matched group, difference statistically significant (P ＜ 0.01)；Less with what matched group comparison therapy group disease total mark reduced, difference also has statistics meaning (P ＜ 0.05)；The scoring for the treatment of group tuberosity reduces, volume-diminished all reaches statistical significance (P ＜ 0.05, P ＜ 0.01), and Euthyrox matched group improves inconspicuous.
Claims (10)
1. the pharmaceutical composition treating thyroid nodule, it is characterised in that be that medicinal raw material develops meticulously by Folium Fortunellae Margarita, Flos jasmini, ear water Herba Amaranthi tricoloris, Herba Limnophilae rugosae, Radix Angelicae Sinensis, Herba speranskiae cantonensis, the Radix Aucklandiae, Radix Pseudostellariae, mountain centipede, Eucheuma gelatinosum, Semen Sinapis Albae.
2. the pharmaceutical composition treating thyroid nodule as claimed in claim 1, it is characterised in that by making with raw material of following preferred weight part proportioning: Folium Fortunellae Margarita 7-12 part, Flos jasmini 15-20 part, ear water Herba Amaranthi tricoloris 8-13 part, Herba Limnophilae rugosae 6-10 part, Radix Angelicae Sinensis 9-15 part, Herba speranskiae cantonensis 10-15 part, Radix Aucklandiae 2-4 part, Radix Pseudostellariae 10-15 part, mountain centipede 15-20 part, Eucheuma gelatinosum 8-13 part, Semen Sinapis Albae 5-8 part.
3. the pharmaceutical composition treating thyroid nodule as claimed in claim 2, it is characterised in that by making with raw material of following preferred weight part proportioning: Folium Fortunellae Margarita 9 parts, Flos jasmini 18 parts, ear water Herba Amaranthi tricoloris 10 parts, Herba Limnophilae rugosae 9 parts, Radix Angelicae Sinensis 10 parts, Herba speranskiae cantonensis 12 parts, the Radix Aucklandiae 2.5 parts, Radix Pseudostellariae 12 parts, mountain centipede 16 parts, Eucheuma gelatinosum 10 parts, Semen Sinapis Albae 6 parts.
4. the pharmaceutical composition of the treatment thyroid nodule as described in claim 1-3 is arbitrary, it is characterized in that described pharmaceutical composition is is active component by Folium Fortunellae Margarita, Flos jasmini, ear water Herba Amaranthi tricoloris, Herba Limnophilae rugosae, Radix Angelicae Sinensis, Herba speranskiae cantonensis, the Radix Aucklandiae, Radix Pseudostellariae, mountain centipede, Eucheuma gelatinosum, Semen Sinapis Albae or its water or its extractive with organic solvent, makes according to routine techniques.
5. the pharmaceutical composition of the treatment thyroid nodule as described in claim 1-4 is arbitrary, it is characterised in that described pharmaceutical composition is preferably made as peroral dosage form.
6. the pharmaceutical composition treating thyroid nodule as claimed in claim 5, it is characterised in that described peroral dosage form is preferably capsule, tablet, granule, pill, powder, sublimed preparation, unguentum, etc..
7. the pharmaceutical composition treating thyroid nodule as claimed in claim 6, it is characterised in that described peroral dosage form is preferably capsule, tablet, granule.
8. the pharmaceutical composition treating thyroid nodule as claimed in claim 7, it is characterised in that described peroral dosage form is preferably capsule..
9. the pharmaceutical composition of the treatment thyroid nodule as described in claim 1-8 is arbitrary, it is characterised in that the preparation method of described capsule comprises the steps:
(1) depletion Folium Citri tangerinae, Herba Limnophilae rugosae, the Radix Aucklandiae, Flos jasmini add after being ground into the granule that mean diameter is 10-60 μm 5-10 times amount 60% ethanol water, use ultrasonic extraction, ultrasonic extraction is complete, takes filtrate, and concentrating under reduced pressure becomes thick paste, obtain extract A, standby, wherein, extraction conditions includes: ultrasonic power is 130-160W, Extracting temperature is 30-50 DEG C, and extraction time is 10-50min；
(2) by ear water Herba Amaranthi tricoloris, Radix Angelicae Sinensis, Herba speranskiae cantonensis, Radix Pseudostellariae, mountain centipede, Eucheuma gelatinosum, Semen Sinapis Albae is pulverized, boiling twice, decoct 1.0-2.0 hour for the first time, amount of water is 6-10 times of medical material gross weight, second time decocts 1.0-1.5 hour, amount of water is 4-7 times of decocting herbs gross weight, collecting decoction, filter, filtrate reduced in volume to relative density is 1.05-1.10 (60 DEG C of survey), adding ethanol to determining alcohol is 30%, in-5～5 DEG C of cold preservations 12 hours, filter, filtrate recycling ethanol, it is condensed into thick paste, obtain extract B, mix homogeneously with extract A, it is dried, pulverize, load capsule shells and i.e. obtain medicament composition capsule of the present invention.
10. claim 1-3 arbitrary described pharmaceutical composition purposes in preparation treatment thyroid nodule medicine.
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| KR20150051160A (en) * | 2013-10-29 | 2015-05-11 | 한국 한의학 연구원 | Composition for preventing or treating thyroid disorders comprising aloe extracts or fraction thereof |
| CN105250608A (en) * | 2015-11-05 | 2016-01-20 | 刘东滨 | Traditional Chinese medicine for treating thyroid nodule due to qi depression and phlegm stagnation and preparation method thereof |
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|---|---|---|---|---|
| KR20150051160A (en) * | 2013-10-29 | 2015-05-11 | 한국 한의학 연구원 | Composition for preventing or treating thyroid disorders comprising aloe extracts or fraction thereof |
| CN105250608A (en) * | 2015-11-05 | 2016-01-20 | 刘东滨 | Traditional Chinese medicine for treating thyroid nodule due to qi depression and phlegm stagnation and preparation method thereof |
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Application publication date: 20160803 |