CN105816643A - Application of traditional Chinese medicine composition for preventing and treating thyroid nodules - Google Patents

Application of traditional Chinese medicine composition for preventing and treating thyroid nodules Download PDF

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Publication number
CN105816643A
CN105816643A CN201510005300.3A CN201510005300A CN105816643A CN 105816643 A CN105816643 A CN 105816643A CN 201510005300 A CN201510005300 A CN 201510005300A CN 105816643 A CN105816643 A CN 105816643A
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olibanum
preparation
pericarpium citri
citri reticulatae
reticulatae viride
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郑璐
吴斌
范明松
盛卫国
丛海建
朱汀滢
刘文刚
韩翠翠
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Shanghai Haini Pharm Co Ltd Yangzijiang Pharm Group
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Shanghai Haini Pharm Co Ltd Yangzijiang Pharm Group
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Abstract

The invention relates to a traditional Chinese medicine composition. The traditional Chinese medicine composition comprises the following components in parts by weight: 150-299 parts of green tangerine peel, 150-299 parts of frankincense, 200-399 parts of laminaria japonica, 200-399 parts of prunella vulgaris, and 150-299 parts of fritillaria. The traditional Chinese medicine composition has efficacy for softening hardness and dissipating binds, coursing liver and rectifying qi, and activating blood to remove stasis, and can be used for preparing medicines for preventing and treating thyroid nodules.

Description

Chinese medicine composition application in preventing and treating thyroid nodule
Technical field
The compositions that the present invention relates to a kind of be processed plant and make, particularly relates to a kind of Chinese medicine composition with Pericarpium Citri Reticulatae Viride as monarch drug and preparation thereof, for prevention and the treatment of thyroid nodule.
Background technology
Thyroid nodule is a kind of common thyropathy, has Various Thyroid disease clinically, such as: thyroid degeneration, inflammation, autoimmune and neoplasm etc. may appear as tuberosity.Tuberosity on thyroid is probably thyroid carcinoma, it is also possible to thyroid tumor, and other causes of disease such as nodular goiter, is referred to as thyroid nodule before its character the clearest and the most definite.Thyroid nodule can be with single-shot, it is also possible to multiple, and multiple nodules is higher than the sickness rate of Solitary nodules, but the incidence rate of Solitary nodules thyroid carcinoma is higher.Thyroid nodule has optimum Yu pernicious point, optimum in mainly include the nodositas change etc. that nodular goiter, thyroid adenoma and thyroiditis cause;Pernicious thyroid nodule, then based on thyroid carcinoma, additionally includes thyroid lymphoma and metastatic tumor etc..
Since modern age, due to people's work and many pressure in life, the sickness rate of thyroid nodule is more and more higher, especially common in female middle-aged, the harm that it brings also is the most serious, may produce disease of the liver, renal tubular acidosis, impact are social, impact work and the efficiency of work, cause diabetes and cause cardiovascular diseases etc., cause fertility and the harm of sexual function and the infringement etc. of motor system, and consequence is extremely serious.
Epidemiological study shows, has the adult of 5%~10% to be diagnosed as thyroid nodule by physical palpation in non-iodine deficient area, be may be up to the thyroid nodule patient of 17%~67% by B ultrasonic detection.It is pernicious for having 5%~15% in all thyroid nodule patients, and sufferer ratio is the highest.
Thyroid nodule can have Different types of etiopathogenises to cause, such as: (1) Hypertrophic nodular goiter, and Iodine intake is too high or too low, eat goitrogenic material, take cause goiter medicine or thyroxin synzyme defect etc.;(2) tumprigenicity tuberosity, the thyroid follicular cells such as Treatment of Benign Tumor of Thyroid Gland, papillary thyroid tumours, follicular cells cancer, medullary thyroid carcinoma, undifferentiated carcinoma, lymphatic cancer and non-follicular cells malignant tumor and metastatic carcinoma;(3) cyst, the cyst that nodular goiter, adenoma degeneration and remote hemorrhage speckle cystis degeneration, thyroid carcinoma cystis degeneration, inborn cyst thyroglossal and the 4th gill slit remnants cause;(4) struvite tuberosity, acute suppurative thyroiditis, subacute suppurative thyroiditis, chronic lymphocytic thyroiditis all can occur with nodule form.Rare occasion thyroid tuberosity is caused by tuberculosis or syphilis.
Nodular goiter is modal a kind of thyroid nodules diseases.Its cause of disease is not fully aware of, may be relevant with endocrine regulation, high iodine diet, environmental factors, inherited genetic factors and radiation contacts history etc..Nodular goiter patient is typically all and is found by health check-up or oneself find that neck region lump is gone to a doctor.Having a medical check-up and can touch 1cm with superior thyroid tubercle, many matter are soft or tough, smooth surface, clear border, can be up and down with swallowing.Thyroid function Index for examination is all within normal range.Ultrasound diagnosis prompting thyroid morphology is normal or enlargement, side or bilateral thyroid can have single or multiple tuberosity.These tuberositys can be capsule, Combination or substance, ovalize.The periphery of tuberosity can sound be swooned, form or can be irregular, and border maybe can be unclear, and blood supply maybe can be enriched, and solid nodule may occur in which the thick calcification of rear accompanying sound shadow, but general without microcalciffcation.
The pathological change of thyroid disease is with gas as elder generation, namely, blood stasis, liver-fire solidifying by the stagnation of QI, expectorant and until the deficiency of YIN, and this pathological change further relates to the internal organs such as liver, the heart, kidney and spleen, in treatment while dispersing the stagnated live-QI to relieve the stagnation of QI, activating QI to eliminate phlegm and blood circulation promoting and blood stasis dispelling, focus on nourishing YIN and benefiting blood and tonification vigour, adjust the function of body, recover the normal function of each system of body, especially recover the immunologic function of body, only in this way could consolidate curative effect, treating both the principal and secondary aspects of a disease.Chinese medicine composition effectively can be treated in terms of hard masses softening and resolving, depressed liver-energy dispersing and QI regulating, blood stasis dispelling are invigorated blood circulation etc. for the old complaint of thyroid disease, to reach treating both the principal and secondary aspects of a disease, can also effectively overcome simultaneously Anti-thyroid Medicine a series of toxic and side effects extremely and malaise symptoms.
"Nei Jing" proposes the method for the treatment of of " heavily fortified point person disappears it ... disease caused by accumulations of pathogen should be treated with therapy of dispersion " very early, gradually forms the method for hard masses softening and resolving later.Hard masses softening and resolving medicine can make lump first soften, and dribbles later.This type of medicine typically belongs to saline taste medicine, therefore the traditional Chinese medical science claims " salty energy softening the hard mass ".Conventional prescription has Thallus Laminariae (Thallus Eckloniae), Carapax Trionycis, Carapax et Plastrum Testudinis, Concha Ostreae, Squama Manis, Bombyx Batryticatus, Sargassum, Rhizoma Curcumae and Spica Prunellae, Concha Arcae etc..Clinical observation with experimental studies have found that, a part of hard masses softening and resolving medicine has direct antitumaous effect, and can adjust immune function of human body.Hard masses softening and resolving medicine is the most less to be used alone, so compatibility is particularly important.It is typically based on and produces the reason of lump to select the medicine of compatibility.Such as: Yin Re and knot person, compatibility antipyretic, with heat clearing away eliminating stagnation;Because trembling with fear and knot person, adapted warming YANG medicine, with warming YANG eliminating stagnation;Because poison causes knot person, adapted antidote, with detoxicating and resolving stagnation of pathogens;The knot person because of expectorant, is equipped with apophlegmatisant, with dissipating phlegm and resolving masses;The knot person because of the stagnation of QI, is equipped with QI regulating medicine, with eliminating stagnation of regulating the flow of vital energy;The knot person because of the stasis of blood, joins blood stasis dispelling medicine with blood stasis-eliminating and stagnation-dissipating, and the knot person because of dyspepsia, and compatibility is with food stagnation removing eliminating stagnation.
" the method for dissipating hard mass " i.e. belongs to one of traditional Chinese medical science " disappear knot ".Chinese medicine is all can make lump softening, the medicine of dissipation be referred to as hard masses softening and resolving medicine.Tcm clinical practice experience, the Chinese medicine of all salty in the mouth can hard masses softening and resolving, have saline taste such as Sal Ammoniacus, Borax, Concha Ostreae, Carapax Trionycis, Eupolyphaga Seu Steleophaga, Concha Arcae, Sargassum, Thallus Laminariae (Thallus Eckloniae), Pumex, Indigo Naturalis, Pheretima, Galla Chinensis etc., also have softening the hard mass effect.As for " eliminating stagnation ", typically the cause of disease of the turbid coalescence of expectorant is occurred to reach the purpose of " eliminating stagnation " usually through treatment.Heat and toxic materials clearing away medicine is such as: Herba Solani Nigri, Herba Houttuyniae, Herba Taraxaci, Herba Solani Lyrati, Herba Salviae Chinensis, Radix Sophorae Tonkinensis, Rhizoma Paridis, Indigo Naturalis and Herba Salviae Chinensis etc. can control accumulation of heat.Detoxicating and resolving stagnation of pathogens medicine is such as: Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae and Rhizoma Dioscoreae Bulbiferae etc. can treat poison knot.Dissipating phlegm and resolving masses medicine is such as: Pumex, Fructus Trichosanthis, Sargassum, Fructus Aristolochiae, Concha Arcae, Rhizoma Arisaematis and Semen Hyoscyami etc. control expectorant knot.Eliminating stagnation of regulating the flow of vital energy medicine is such as: the treatment such as Fructus Toosendan, Fructus Akebiae, Radix Et Rhizoma Nardostachyos and CitrusaurantiumL.Var.amara Engl. is depressed.Change the treatment blood agglomeration such as silt medicine Rhizoma Curcumae, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Semen Vaccariae, Ophicalcitum, Pyritum, Flos Campsis and Lignum Sappan.Chinese digestant drugs for removing food accumulation are such as: the treatment food knot such as Resina Ferulae.
Chinese invention patent application 200810157698.2 discloses a kind of endo-medicine treating human thyroid tuberosity, and it is formulated by Radix Bupleuri, Pseudobulbus cremastrae seu pleiones, Spica Prunellae, Pericarpium Citri Reticulatae, Ramulus Euonymi, the Rhizoma Pinelliae, Rhizoma Bolbostematis, Sargassum and Thallus Laminariae (Thallus Eckloniae),.
Chinese invention patent application ZL201310118565.5 discloses a kind of external traditional Chinese medicinal application treating thyroid nodule, Herba seu Radix Calanthes, Radix Capparis Membranaceae, Radix securidacae, Botrypus virginianus(L.)Holub[Osmunda virginiana L,Botrychium virginianum(L.) Sw., Fructus Ponciri Trifoliatae (Fructus Ponciri Trifoliatae Immaturus), Carapax Bellamyae quadratae, Pumex and Rhizoma soulieae vaginatae multi-flavor medical material are selected, grind as powder, add appropriate Sucus Zingberis and make pasty state unguentum, it is externally applied to affected part, through clinical trial, total effective rate 93.3%, achieve more significantly effect.
Chinese invention patent application 201410179645.6 discloses a kind of thyroid nodule softening hardness and disperse swelling preparation, mainly it is prepared from by the crude drug of the first component and second component, by weight, first component includes Radix Bupleuri 3~6 parts, Radix Aristolochiae 3~9 parts, Spica Prunellae 2~6 parts, Folium Mahoniae 8~15 parts, the Rhizoma Atractylodis Macrocephalae 6~12 parts;And second component includes Thallus Laminariae (Thallus Eckloniae) 6~12 parts, Sargassum 6~10 parts, Rhizoma Cyperi (processed) 6~15 parts, Fructus Aurantii 3~12 parts, Carnis Rapanae thomasianae Octopus ocellatus Gray 5~10 parts, Concha Ostreae 15~35 parts, Semen Canavaliae 4~12 parts, Rhizoma Sparganii 4~12 parts and Fructus Forsythiae 6~15 parts.
Summary of the invention
It is an object of the present invention to provide a kind of Chinese crude drug compositions, for prevention and the treatment of thyroid nodule.
A kind of compositions being made up of several kinds of Chinese medicinal materials of offer is provided, or with it as active component, coordinates and add other adjuvant, for preparing prevention and the preparation for the treatment of thyroid nodule.
It is yet a further object of the present invention to provide a kind of method producing preparation for medicine portion with several kinds of Chinese medicinal materials, it is simple to the prevention of thyroid nodule and treatment use.
" prevention " alleged by the present invention refers to before the disease do not assert by clinical criteria, various for preventing disease from occurring or the means of development or measure, including medical science, method physically or chemically, to stop and to reduce generation or the development of the various symptom of disease.
" treatment " alleged by the present invention refers to stop and reduce generation or the development of disease, make the development of disease course or increase the weight of to be suppressed, contain, alleviate, improve, slow down, stop, postponing or invert, disease when described holding or medication, disorderly or pathologic state various indexs include alleviating or reducing symptom or complication, or cure or eliminate a disease, disorder or situation.
" preparation " alleged by the present invention refers to that the various plants provided containing the present invention and extract thereof and active site are conducive to the dosage form being administered, as: but be not limited only to, aqueous solution injection, injectable powder, pill, powder, tablet, patch, suppository, Emulsion, cream, gel, granule, capsule, aerosol, spray, powder spray, slow releasing agent and controlled release agent etc..These pharmaceutic adjuvants both can be conventional use of in various preparation, such as: but be not limited only to, isotonic agent, buffer, correctives, excipient, filler, binding agent, disintegrating agent and lubricant etc.;Can also select to adapt with described material to use, as: emulsifying agent, solubilizing agent, antibacterial, analgesic and antioxidant etc., this kind of adjuvant can be effectively improved the stability of compound contained by compositions and dissolubility or the rate of release changing compound and absorption rate etc., thus improve the compounds of this invention metabolism in vivo, and then strengthen administering effect.In addition, can also be for realizing specific administration purpose or mode, as: sustained-release administration, controlled release drug administration and pulsatile administration etc., and the adjuvant used, as: but be not limited only to, gelatin, albumin, chitosan, polyethers and polyesters macromolecular material, such as: but be not limited only to, Polyethylene Glycol, polyurethane, Merlon and copolymer thereof etc..Mainly being presented with of alleged " being beneficially administered ": but be not limited only to improve therapeutic effect, improve bioavailability, reduction toxic and side effects and improve patient's compliance etc..
" Pericarpium Citri Reticulatae Viride " alleged by the present invention is rutaceae orange (CitrusreticulataBlanco) and the dry young fruit of variety thereof or the peel of immature fruit.5~be collected from the young fruit fallen June, dry, practise and claim " FTUCTUS CITRI IMMATURI ";7~green fruit of gathering August, on peel, vertical profile becomes pintongs to base portion, eliminates flesh lobe, dries, and practises and claims " Sihuaqingpi ".Nature and flavor toil, tepor.Return liver, gallbladder, stomach warp.It is mainly composed of volatile oil, flavone, flavonoid glycoside etc..It is used as medicine and can be used for soothing the liver dispelling the stagnated QI, and removing food stagnancyization is stagnant.For distending pain in the chest and hypochondrium, hernia pain, tuberosity, tuberculosis, stagnation of QI due to dyspepsia, abdominal distention.Can use it is monarch drug, and consumption is 150 weight portions~299 weight portions, especially 200 weight portions~280 weight portions, such as: but it is not limited only to 200 weight portions, 220 weight portions, 240 weight portions, 250 weight portions, 260 weight portions and 280 weight portions.
The present invention alleged " Spica Prunellae " is the dry fruit ear of labiate Spica Prunellae (PrunellavulgarisL.).Nature and flavor are pungent, bitter, cold.Return liver, gallbladder meridian.Purging liver-fire, improving eyesight, mass dissipating and swelling eliminating.For conjunctival congestion and swelling pain, mesh pearl nyctalgia, dizziness of having a headache, scrofula, goiter.It is mainly composed of the triterpene saponin with oleanolic acid as aglycon, the glycoside material such as rutin, hyperin. also contain the organic acid such as rosmarinic acid, ursolic acid, caffeic acid and free oleanolic acid. still containing inorganic salts such as vitamin B1, vitamin C, vitamin K, carotene, resin, amaroid, tannin, volatile oil, alkaloid and potassium chloride.Can use it is ministerial drug, consumption is 200 weight portions~399 weight portions, especially 250 weight portions~350 weight portions, such as: but it is not limited only to 250 weight portions, 260 weight portions, 280 weight portions, 300 weight portions, 320 weight portions, 330 weight portions, 350 weight portions and 380 weight portions.
The present invention is alleged " Bulbus Fritillariae Uninbracteatae ", practises and claims " Bulbus Fritillariae Thunbergii sheet ", for the dry bulb of liliaceous plant Bulbus Fritillariae Uninbracteatae (FritillariathunbergiiMiq.).Early summer, plant was excavated when withering, and cleaned.Separately, big person removes core bud to size, practises and claims " Bulbus Fritillariae Thunbergii ";Little person not coring bud, practises and claims " pearl shellfish ".Hit wiping respectively, remove crust, mix the conch meal forged, suck the juice clashed, be dried;Or taking bulb, size separately, is cleaned, and removes core bud, takes advantage of fresh-cut and become sheet, cleans and is dried.Nature and flavor are bitter, cold.Return lung, heart channel.Clearing heat, eliminating phlegm, relieving cough, detoxicating and resolving stagnation of pathogens disappears knot.For cough due to pathogenic wind-heat, phlegm-fire cough, lung abscess, scrofula, sore.It is mainly composed of the first-class alkaloid of peimisine and glycol and glycoside thereof.Can use it is ministerial drug, and consumption is 150 weight portions~299 weight portions, especially 180 weight portions~280 weight portions, such as: but it is not limited only to 180 weight portions, 200 weight portions, 210 weight portions, 225 weight portions, 240 weight portions, 250 weight portions and 280 weight portions.
The present invention alleged " Thallus Laminariae (Thallus Eckloniae) " be this product be Laminariaceae plant Thallus Laminariae (Thallus Eckloniae) (LaminariajaponicaAresch.) or the dry thallus of Alariaceae plant Thallus Laminariae (Thallus Eckloniae) (EckloniakuromeOkam.).Nature and flavor are salty, cold.Return liver, stomach, kidney channel.Eliminating phlegm and softening indurated mass eliminating stagnation, inducing diuresis to remove edema.For goiter, scrofula, painful and swollen testis, phlegm retention edema.Chemical composition is algin element, mannitol, galactan, aminoacid, vitamin, iodine and potassium etc..Can use it is adjuvant drug, consumption is 200 weight portions~399 weight portions, especially 250 weight portions~350 weight portions, such as: but it is not limited only to 250 weight portions, 260 weight portions, 280 weight portions, 300 weight portions, 320 weight portions, 330 weight portions, 350 weight portions and 380 weight portions.
The present invention alleged " Olibanum " is the resin that this product is olive subject plant Boswellia carterii (BoswelliacarteriiBirdw.) and congener Boswelliabhaw-dajianaBirdw. bark oozes out.It is divided into Somalia's Olibanum and Gum Olibanum Ethiopia, every kind of Olibanum to be divided into again Olibanum pearl and former Olibanum.Cold in nature pungent, bitter, temperature.GUIXIN, liver, spleen channel.Invigorate blood circulation analgesic therapy, detumescence and promoting granulation.For obstruction of qi in the chest and cardialgia, gastralgia, dysmenorrhea amenorrhea, postpartum stagnation, abdominal mass stomachache, rheumatic arthralgia, muscle arteries and veins contracture, traumatic injury and carbuncle skin infection.Can use it is adjuvant drug, and consumption is 150 weight portions~299 weight portions, especially 180 weight portions~250 weight portions, such as: but it is not limited only to 180 weight portions, 200 weight portions, 210 weight portions, 225 weight portions, 240 weight portions, 250 weight portions and 280 weight portions.
The traditional Chinese medical science is thought, the main pathogenesis of thyroid nodule is raw, stagnation of QI-blood and phlegm-damp condensation throat in stagnation of QI due to depression of the liver, dysfunction of the spleen in transportation, phlegm-damp, with the passing of time causes blood-vessel obstructive, with expectorant, gas, stasis of blood three combined into trouble.Primary disease is in healthy energy virtual loss, on the basis of visceral dysfunction, expectorant is solidifying in addition, the stagnation of QI, blood stasis and be disease.Its main pathological product and paathogenic factor are that expectorant is solidifying, the stagnation of QI, blood stasis.Showing and be tuberosity in disease, therapeutic scheme should be software eliminating stagnation, depressed liver-energy dispersing and QI regulating and blood stasis dispelling mutually and invigorates blood circulation.
Hard masses softening and resolving is that the knots such as treatment phlegm-turbidity and blood stasis blood gather and form the method for the treatment of of all cards that lumps, and has the effect making caking dribble from hard to soft.The method of dissipating hard mass is applicable to thyroid nodule, lymph tuberosity, scrofula, goiter and various long-pending blocks etc..The traditional Chinese medical science is thought, lump can cause by the many reasons such as, the stagnation of QI solidifying by expectorant, so this kind of medicine includes very wide, clinical according to card feelings, often combines the same use of other drug, such as: reduces phlegm, regulate the flow of vital energy, detoxify, invigorate blood circulation and the multiple rule for the treatment of such as counteracting toxic substances.Hard masses softening and resolving type Chinese medicine is all can promote tumor bag to soften soon, the medicine of dissipation tuberosity, claims hard masses softening and resolving medicine.The medicine that hard masses softening and resolving is conventional has Bulbus Fritillariae Uninbracteatae, Concha Ostreae, Spica Prunellae, Fructus Forsythiae, Sargassum, Thallus Laminariae (Thallus Eckloniae), Radix Trichosanthis, Radix Ranunculi Ternati, Bombyx Batryticatus, the Rhizoma Pinelliae, Rhizoma Cyperi, Fructus Toosendan, Semen Persicae, Radix Paeoniae Rubra and Radix Scrophulariae etc..It addition, the medicine of some blood circulation promoting and blood stasis dispelling also has the effect of hard masses softening and resolving, such as Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, Flos Carthami etc..
The solution of the present invention is based on motherland's medical science understanding pathogenetic to thyroid nodule and Therapeutic Principle, with reference to modern pharmacology achievement in research, on the basis of using " herbal " single Pericarpium Citri Reticulatae Viride soup, with Pericarpium Citri Reticulatae Viride as monarch drug, minister is with tonic blood vessels, the Spica Prunellae of hard masses softening and resolving and heat radiation are except dry, the Bulbus Fritillariae Uninbracteatae of dissipating phlegm and resolving masses, assistant is with hard masses softening and resolving and drug for invigorating blood circulation and eliminating stasis Olibanum, all formulas are matched, knot is caused to remove, pain solves, gas is suitable, expectorant disappears, blood is lived and is played hard masses softening and resolving, depressed liver-energy dispersing and QI regulating, the effect of blood circulation promoting and blood stasis dispelling, pathogenic factor and various symptom for thyroid nodule, for preventing the various diseases relevant with treating thyroid nodule: thyroid nodule, thyromegaly, pain, tenderness, irritable, thyromegaly hoarseness together, dyspnea, dysphagia and other relevant patients.
A kind of compositions that the present invention provides, for Chinese crude drug compositions, by weight, including
Pericarpium Citri Reticulatae Viride 150~299, Olibanum 150~299, Thallus Laminariae (Thallus Eckloniae) 200~399, Spica Prunellae 200~399 and Bulbus Fritillariae Uninbracteatae 150~299.
The another kind of compositions that the present invention provides, for Chinese crude drug compositions, by weight, including
Stir-baked PERICARPIUM CITRI RETICULATAE VIRIDE with vinegar 150~299, Olibanum (processed with vinegar) 150~299, Thallus Laminariae (Thallus Eckloniae) 200~399, Spica Prunellae 200~399 and Bulbus Fritillariae Uninbracteatae 150~299.
The another kind of compositions that the present invention provides, for Chinese crude drug compositions, by weight, including
Stir-baked PERICARPIUM CITRI RETICULATAE VIRIDE with vinegar is 250, Olibanum (processed with vinegar) is 225, Thallus Laminariae (Thallus Eckloniae) 300, Spica Prunellae 300 and Bulbus Fritillariae Uninbracteatae 250.
The various compositionss that the present invention provides, have hard masses softening and resolving, blood circulation promoting and blood stasis dispelling and tonic blood vessels, are suitable for thyroid nodule and treat and prevent.
The various compositionss that the present invention provides, make various preparation by the common concocting method of Chinese medicine, such as: but it is not limited only to decoction, powder, unguentum and patch etc..
For ease of using, prioritizing selection tablet of the present invention, and the adjuvant pharmaceutically accepted jointly concoct and form, accepted adjuvant such as: but be not limited only to sucrose, dextrin, beta-schardinger dextrin-and steviosin etc..Its preparation method is as follows:
Weighing combinations of the above thing all tastes medical material, Pericarpium Citri Reticulatae Viride and Olibanum and add soak by water, extract volatile oil, gained volatile oil is standby with (in right amount) adjuvant inclusion, and decoction liquor filters standby.Pericarpium Citri Reticulatae Viride, Olibanum medicinal residues add all taste medical materials such as Spica Prunellae, Bulbus Fritillariae Uninbracteatae and Thallus Laminariae (Thallus Eckloniae), boiling 2 times, decocting liquid filters, merge aforementioned decoction liquor, it is concentrated into the extractum that relative density is 1.05~1.10 (60 DEG C~65 DEG C), add ethanol, make alcohol content reach 50v/v%, stand overnight, extraction supernatant, reclaim ethanol and be concentrated into the extractum than 1.15~1.25 (60 DEG C~65 DEG C) that weigh, be dried, pulverize, add the adjuvants such as suitable amount of sucrose, dextrin and steviosin, and volatile oil clathrate compound, mix homogeneously, tabletting, make tablet.
The another kind of preparation method that the present invention provides, by weight, weighs Pericarpium Citri Reticulatae Viride 150~299, Olibanum 150~299, Thallus Laminariae (Thallus Eckloniae) 200~399, Spica Prunellae 200~399 and Bulbus Fritillariae Uninbracteatae 150~299 respectively, Pericarpium Citri Reticulatae Viride and Olibanum add soak by water, extract volatile oil, standby, decoction liquor filters, standby.Medicinal residues add Spica Prunellae, Bulbus Fritillariae Uninbracteatae and Thallus Laminariae (Thallus Eckloniae), the ethanol adding 50v/v%~95v/v% decocts three times, decocting liquid filters, integrate with Pericarpium Citri Reticulatae Viride Olibanum decoction liquor, it is concentrated into 60 DEG C~concentrated solution that 65 DEG C of relative densities are 1.15~1.25, add volatile oil and appropriate amount of auxiliary materials, stir, make the dosage forms such as oral liquid, mixture, drop pill.
The beneficial effect that technical solution of the present invention realizes:
The various compositionss that the present invention provides, with Pericarpium Citri Reticulatae Viride as monarch drug, minister with Thallus Laminariae (Thallus Eckloniae) and Olibanum, has hard masses softening and resolving, blood circulation promoting and blood stasis dispelling, depressed liver-energy dispersing and QI regulating and effect of tonic blood vessels with Spica Prunellae and Bulbus Fritillariae Uninbracteatae, assistant.
The various compositionss that the present invention provides, use natural plant material to be used for preventing and treating thyroid nodule as medicine portion.It is evident in efficacy, and without obvious ill effect, safety is gentle, has no side effect, and clear curative effect is easy to use, is suitable to large-scale promotion clinically.
Detailed description of the invention
Technical scheme described in detail below.The embodiment of the present invention is only in order to illustrate technical scheme and unrestricted, although the present invention being described in detail with reference to preferred embodiment, it will be understood by those within the art that, the technical scheme of invention can be modified or equivalent, without deviating from the spirit and scope of technical solution of the present invention, it all should be contained in scope of the presently claimed invention.
The preparation of the Chinese medicine composition that following example of the present invention are produced and verified, weighs each component medical material or decoction pieces by following weight proportion: Pericarpium Citri Reticulatae Viride: 250;Spica Prunellae: 300;Bulbus Fritillariae Uninbracteatae: 250;Thallus Laminariae (Thallus Eckloniae): 300;Olibanum (processed with vinegar): 225.
Embodiment 1
Weigh all taste medical materials in combinations of the above thing, described stir-baked PERICARPIUM CITRI RETICULATAE VIRIDE with vinegar, Olibanum (processed with vinegar), add soak by water, extract volatile oil, gained volatile oil is standby with appropriate amount of auxiliary materials inclusion, and decoction liquor filters standby.Spica Prunellae, described Bulbus Fritillariae Uninbracteatae and described Thallus Laminariae (Thallus Eckloniae) all tastes medical material described in the addition of above-mentioned stir-baked PERICARPIUM CITRI RETICULATAE VIRIDE with vinegar, Olibanum (processed with vinegar) medicinal residues, add soak by water 2 times, decocting liquid filters, merge aforementioned decoction liquor, it is concentrated into the extractum that relative density is 1.05~1.10, adds ethanol, make alcohol content reach 50%, stand overnight, extraction supernatant, reclaims ethanol and is concentrated into the extractum than 1.15~1.25 (60 DEG C~65 DEG C) that weigh, be dried, pulverize, add adjuvant and the volatile oil clathrate compounds such as suitable amount of sucrose, dextrin, steviosin, mix homogeneously, tabletting, fill, makes tablet.
Embodiment 2
By weight, weighing Pericarpium Citri Reticulatae Viride 150~299, Olibanum 150~299, Thallus Laminariae (Thallus Eckloniae) 200~399, Spica Prunellae 200~399 and Bulbus Fritillariae Uninbracteatae 150~299, Pericarpium Citri Reticulatae Viride and Olibanum respectively and add soak by water, extract volatile oil, standby, water cooking liquid filters, standby.Medicinal residues add Spica Prunellae, Bulbus Fritillariae Uninbracteatae and Thallus Laminariae (Thallus Eckloniae), the ethanol adding 50v/v%~95v/v% decocts three times, decocting liquid filters, integrate with Pericarpium Citri Reticulatae Viride Olibanum decoction liquor, it is concentrated into 60 DEG C~concentrated solution that 65 DEG C of relative densities are 1.15~1.25, add volatile oil and appropriate amount of auxiliary materials, stir, make the dosage forms such as oral liquid, mixture, drop pill.
Embodiment 3: animal acute toxicity test
The purebred kunming mice of experimental animal 22, male and female half and half, gavage 185g/kg//day, being administered (calculating by crude drug, be equivalent to 209.5 times of quantity) in three times, before and after administration, there is not obvious toxicity in animal, Continuous Observation 7 days, animal without death, performance the most without exception.
Test shows: compositions extract dry extract is to laboratory animal without overt toxicity, and it is safe for pointing out this medicine clinical practice.
Embodiment 4: long term toxicity test
Select healthy white rat 172, be randomly divided into 4 groups, often group 40~44, male and female half and half.The capacity gavages such as matched group distilled water;Rat gavage gives the dry extract (being configured to certain density solution) of the present composition for continuous 180 days, and heavy dose of group, with 88g/kg gavage (calculating by crude drug), is approximately equivalent to clinical adult and intends 100 times of consumption every day;Small dose group, with 22g/kg gavage (calculating by crude drug), is approximately equivalent to clinical adult and intends 25 times of consumption every day.
Every day, gastric infusion 1 time, consistent with clinical administration approach.Observe the general status of rat during experiment, before being administered and after drug withdrawal 24 hours, survey body weight and defecation, take blood examination survey SGPT, BUN and routine blood test.Often organize execution 2/3rds animal (about 29) after being administered 6 months, core, liver, spleen, lung, kidney, adrenal gland, brain, stomach, large intestine, small intestinal, mesentery, lymph node, testis and ovary send disease to examine.All put to death after drug withdrawal surrounding, as above send disease to examine.
1. general status and body weight change: observe the expression of each group of rat, activity, secretions, diet, feces, hair, skin etc. day by day, show no obvious abnormalities change, be shown in Table 1.
The table 1 impact (g) on rat body weight
2. hematological examination: each dosage group HB, RBC and WBC medication before and after look, has no significant change, and each administration group compares no significant difference (P < 0.05) with matched group, is shown in Table 2.
3. the impact on rat WBC classification: each dosage group medication before and after look, has no significant change, and each administration group compares no significant difference (P < 0.05) with matched group, is shown in Table 3.
4.BUM checks result: each dosage group and matched group no significant difference (P < 0.05), is shown in Table 4.
5. it is administered 6 months and after drug withdrawal surrounding, the rat perusal of each dosage group, no abnormality seen, the sick inspection internal organs of each dosage group compare without obvious pathological change (P < 0.05) with matched group, and organ coefficient result of calculation shows that each dosage group Rats Organs and Tissues coefficient compares no significant difference (P < 0.05) with matched group.
Result above shows, present composition extract clinical practice is safe.
The table 2 impact (X ± SD) on rat blood
The table 3 impact (X ± SD) on rat WBC
The table 4 impact (mmol/L, X ± SD, n=20) on rat BUM
Shown by the test of above-mentioned every pharmacological effect, the long term toxicity test of continuous 180 days shows, experimental group and matched group there was no significant difference in the indexs such as rat body weight, HB, RBC, WBC, BUM and organ coefficient, it was demonstrated that said composition life-time service is without overt toxicity, and clinical practice is safe.
Embodiment 5
Take Wistar rat 36, be randomly divided into 6 groups, often organize each 6, be i.e. normal group, model group, L-T4 (levothyrocine sheet, lower same) group, low dose of administration group, middle dosed administration group and heavy dose of administration group.Be made into the PTU solution of 0.11% with normal saline, every rat is gavaged 8 weeks continuously by 100mg/kg weight every day, sets up nodular goiter model.Normal group gavages normal saline, remaining 5 groups, i.e. model group, L-T4 group, low dose of administration group, middle dosed administration group and heavy dose of administration group is processed by modeling.L-T4 group rat gavages L-T4 by 100mg/kg weight every day simultaneously.Low dose of administration group, middle dosed administration group, heavy dose of administration group rat press 0.44g/kg weight, 0.88g/kg weight and 1.76g/kg weight administration group every day respectively.Put to death rat after 8 weeks, take rats with bilateral thyroid and adrenal gland, be stored in-20 DEG C of refrigerators.
1. use flow cytometer AnnexinV/PI double-staining detection rat thyroid to swell the Level of Apoptosis in tissue.Result shows, in experimental rat goiter model, apoptosis compared with normal matched group is compared, ratio is remarkably reinforced, L-T4 group, low dose of administration group, middle dosed administration group and heavy dose of administration group all significantly reduce apoptosis ratio, invention formulation three groups and model group are than all there being significant difference (P < 0.05), and present dose dependent feature.The results are shown in Table 5.
Thyroid apoptosis rate (X ± SD) respectively organized by table 5
The Chinese medicine composition the most of the present invention impact on rat (Wistar series is male) body weight change
After modeling 30 days, comparing with blank group, each group body weight significantly reduces (equal P < 0.05).
After treating 30 days, comparing with model group, each group body weight dramatically increases (equal P < 0.05).Meanwhile, it is administered each group and is better than L-T4 treatment group.The results are shown in Table 6.
Body weight determination result (g, X ± SD) before and after rat modeling respectively organized by table 6
3. the compositions extract impact on rat (Wistar series is male) parathyroid tissue organ coefficient
From table 7, and model group compares, and respectively organizes rat thyroid, adrenal tissue's organ coefficient significantly reduces (equal P < 0.05).
Table 7 is to rat thyroid tissue organ coefficient measurement result (mg, X ± S)
Embodiment 6
The invention formulation impact on rat (Wistar series is male) choleretic effect, duodenum gives invention formulation 4.42g crude drug/more than kg (being equivalent to clinical application amount more than 5 times) and rat bile secretion is obviously promoted effect, a certain amount of effect relationship, 8.84g crude drug/more than kg is had to organize sustainable 150 minutes between each dosage group.Show that this compositions has the pharmacological action of depressed liver-energy dispersing and QI regulating and resolving depression.
Embodiment 7
Kunming mouse, gives invention formulation extractum 4.42g, 8.84g and 17.68g crude drug/kg body weight (quite clinic day dosing 5,10 and 20 times);The mice induced pain writhing method number of times of Dichlorodiphenyl Acetate abdomen note induction, significantly reduces (P < 0.05) in 8.84g crude drug/more than kg group, and compared with waiting, test multiple L-T4 group analgesic activity is obvious.Show that this medicine has analgesia drug action, and in a certain amount of effect relationship.
Invention formulation has obvious inhibiting effect to PTU induced rat nodular goiter, can significantly reduce rat thyroid organ coefficient, increases glandular cell apoptosis ratio, increases rat body weight.Additionally, invention formulation is obvious to the analgesic activity (writhing method) of mice, there is the pharmacological action of depressed liver-energy dispersing and QI regulating, resolving depression.

Claims (10)

1. a compositions, is characterised by, by weight, including
Pericarpium Citri Reticulatae Viride 150~299, Olibanum 150~299, Thallus Laminariae (Thallus Eckloniae) 200~399, Spica Prunellae 200~399 and Bulbus Fritillariae Uninbracteatae 150~299.
Compositions the most according to claim 1, it is characterised in that by weight, including
Stir-baked PERICARPIUM CITRI RETICULATAE VIRIDE with vinegar 150~299, Olibanum (processed with vinegar) 150~299, Thallus Laminariae (Thallus Eckloniae) 200~399, Spica Prunellae 200~399 and Bulbus Fritillariae Uninbracteatae 150~299.
Compositions the most according to claim 1, it is characterised in that by weight, including
Stir-baked PERICARPIUM CITRI RETICULATAE VIRIDE with vinegar is 250, Olibanum (processed with vinegar) is 225, Thallus Laminariae (Thallus Eckloniae) 300, Spica Prunellae 300 and Bulbus Fritillariae Uninbracteatae 250.
4. the application preventing according to the compositions one of claim 1-3 Suo Shu in preparation and treating in thyroid nodule medicine.
5. a preparation, with the compositions one of claim 1-3 Suo Shu as active component.
Preparation the most according to claim 5, it is characterised in that described preparation is solid preparation or liquid preparation.
Preparation the most according to claim 5, it is characterised in that described preparation is tablet, capsule, granule, oral liquid, drop pill or mixture.
Preparation the most according to claim 5, it is characterised in that produce as follows:
By weight, weighing Pericarpium Citri Reticulatae Viride 150~299, Olibanum 150~299, Thallus Laminariae (Thallus Eckloniae) 200~399, Spica Prunellae 200~399 and Bulbus Fritillariae Uninbracteatae 150~299, Pericarpium Citri Reticulatae Viride and Olibanum respectively and add soak by water, extract volatile oil, gained volatile oil is standby with adjuvant inclusion, and decoction liquor filters standby;After above-mentioned Pericarpium Citri Reticulatae Viride and Olibanum medicinal residues add Spica Prunellae, Bulbus Fritillariae Uninbracteatae and Thallus Laminariae (Thallus Eckloniae), boiling 2 times, decocting liquid filters, and merges, under the conditions of being concentrated into 60 DEG C~65 DEG C, relative density is 1.05~1.10 extractum, ethanol precipitate with ethanol, stands overnight, and extracts supernatant, under the conditions of reclaiming ethanol and being concentrated into 60 DEG C~65 DEG C, relative density is the extractum of 1.15-1.25, it is dried, pulverizes, add adjuvant and volatile oil clathrate compound, stir.
Preparation the most according to claim 8, it is characterised in that described adjuvant is selected from one or more of sucrose, dextrin, beta-schardinger dextrin-and steviosin.
Preparation the most according to claim 5, it is characterised in that as follows:
By weight, weighing Pericarpium Citri Reticulatae Viride 150~299, Olibanum 150~299, Thallus Laminariae (Thallus Eckloniae) 200~399, Spica Prunellae 200~399 and Bulbus Fritillariae Uninbracteatae 150~299, Pericarpium Citri Reticulatae Viride and Olibanum respectively and add soak by water, extract volatile oil, standby, decoction liquor filters, standby.Medicinal residues add Spica Prunellae, Bulbus Fritillariae Uninbracteatae and Thallus Laminariae (Thallus Eckloniae), the ethanol adding 50v/v%~95v/v% decocts three times, decocting liquid filters, integrate with Pericarpium Citri Reticulatae Viride and Olibanum decoction liquor, it is concentrated into 60 DEG C~concentrated solution that 65 DEG C of relative densities are 1.15~1.25, add volatile oil and appropriate amount of auxiliary materials, stir, make oral liquid, mixture or drop pill.
CN201510005300.3A 2015-01-04 2015-01-04 Application of traditional Chinese medicine composition for preventing and treating thyroid nodules Pending CN105816643A (en)

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CN112076250A (en) * 2020-09-28 2020-12-15 南方医科大学 Prunella vulgaris extract and preparation method and application thereof
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