CN112807362B - Traditional Chinese medicine composition for treating subacute thyroiditis in acute stage and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating subacute thyroiditis in acute stage and preparation method and application thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/35—Caprifoliaceae (Honeysuckle family)
- A61K36/355—Lonicera (honeysuckle)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/30—Boraginaceae (Borage family), e.g. comfrey, lungwort or forget-me-not
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/346—Platycodon
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/536—Prunella or Brunella (selfheal)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/538—Schizonepeta
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
- A61K36/634—Forsythia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/87—Vitaceae or Ampelidaceae (Vine or Grape family), e.g. wine grapes, muscadine or peppervine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Abstract
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating subacute thyroiditis in an acute stage, and a preparation method and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 18 parts of honeysuckle, 12 parts of fructus forsythiae, 6 parts of great burdock achene, 6 parts of platycodon grandiflorum, 9 parts of herba schizonepetae, 9 parts of selfheal, 9 parts of lithospermum, 9 parts of uniflower swisscentaury root, 9 parts of Japanese ampelopsis root and 9 parts of rhizoma corydalis. The traditional Chinese medicine composition provided by the invention takes heat-clearing and detoxifying, goiter-eliminating and stagnation-dissipating as main treatment methods, has the effects of combining cold and warm, externally transmitting external pathogens, internally clearing heat and toxic materials, goiter-eliminating, carbuncle-dissipating and stagnation-dissipating, relieving urgency and pain, can quickly improve symptoms such as thyromegaly, fever, sore throat, hyperhidrosis and the like of patients with subacute thyroiditis, shortens the pain time, relieves the thyroid enlargement degree, improves the thyroid function and reduces the blood sedimentation. Has the advantages of definite curative effect, less adverse reaction, accurate and appropriate medication, suitability for industrial production, convenient taking and contribution to development and application, and can treat both symptoms and root causes.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating subacute thyroiditis in an acute stage and a preparation method and application thereof.
Background
Subacute thyroiditis (SAT), also known as giant cell thyroiditis and granulomatous thyroiditis. The incidence rate in thyroid diseases is 0.5 to 2.0 percent.
In recent years, the incidence of subacute thyroiditis has increased year by year, the cause of the disease has not been completely elucidated, and the disease is generally considered to be related to viral infection. Clinically, patients before onset often have a history of upper respiratory tract infection, and the onset often changes with seasons and has certain prevalence. The disease is considered to be autoimmune disease, because 35.1% -42.0% of patients reported can detect anti-thyroid antigen antibodies and anti-microsomal antibodies, but the titer is not high, the disease is probably caused by subacute thyroiditis injury, the cause of the disease cannot be determined, only temporary immune system dysfunction exists in subacute thyroiditis, and deep research is still needed.
Subacute thyroiditis is in mild cases or atypical cases, the thyroid is only slightly enlarged, pain and tenderness are slight, fever is avoided, general symptoms are slight, and hyperthyroidism or hypothyroidism is unlikely to appear clinically. The disease has different duration, can be from weeks to more than half a year, and is generally about 2-3 months, so the disease is called subacute thyroiditis. After the disease is relieved, the disease may recur.
At present, for the treatment of subacute thyroiditis, both domestic and foreign countries, western medicine treatment is mainly performed by hormone, such as oral prednisone or application of hydrocortisone intravenous drip, and fever and thyroid swelling and pain of patients can be quickly controlled after the medicine is taken. However, the disease is easily aggravated in the hormone reduction process, or goiter pain progresses from one side to the other side, resulting in a prolonged course of disease. The disease relapse after 20 to 30 percent of patients stop taking the medicine. Other side effects such as face full of moon, buffalo back, osteoporosis and the like can occur after long-term use of the hormone, and hypertension, diabetes, tuberculosis and peptic ulcer disease can be induced during the administration. The advantages of the traditional Chinese medicine in treating subacute thyroiditis are particularly remarkable, so that the development of a traditional Chinese medicine preparation with stable curative effect and low price is imperative.
The traditional Chinese medicine records are few, and researches suggest that the pathogenesis of subacute thyroiditis is mainly caused by exogenous wind-heat evil toxin, which is commonly seen in patients who suffer from short-term emotional disorder, improper diet, hypertrophic and greasy overfeeding or body deficiency, and finally caused by invasion of wind-heat evil toxin due to deficiency. The basic pathogenesis of the cervical spondylosis is that qi and blood in the neck are blocked by wind-heat evil toxin and then change to cause qi and blood disharmony of the whole body. Wherein, if wind-heat evil toxin is struggled at the neck and consumes local qi, blood and body fluid, the refined liquid is phlegm which obstructs qi movement, and blood stasis is formed for a long time, the thyroid gland local swelling and pain can be seen clinically; when wind-heat evil invades the defense-exterior, the disorder of the defense-exterior causes the disorder of the lung in dispersing, descending, and clinically, the symptoms of aversion to cold, fever, pharyngalgia, headache, hypodynamia and the like can be seen; if the disease lasts for a long time, heat toxin can damage yin, and yin deficiency and fire can be effulgent, palpitation, chest distress, insomnia and other symptoms can be seen; symptoms such as tremor of hands, irritability and the like can be seen when yin deficiency occurs for a long time and liver wind moves inwards; prolonged yin impairment affecting yang and yang deficiency failing to warm the whole body and limbs, aversion to cold and cold limbs, and qi deficiency driving weakness manifested as asthenia, anorexia, lethargy, etc. At present, some traditional Chinese medicine compositions are obtained by doctors according to the etiology and pathogenesis of the disease, but more or less defects exist (or the number of medicines in the formula is large, the curative effect is poor, or the recurrence rate is high, and the like).
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating subacute thyroiditis in the acute stage and a preparation method and application thereof, aiming at the defects of the prior art.
In order to achieve the purpose, the invention adopts the technical scheme that:
in a first aspect, the invention provides a traditional Chinese medicine composition for treating subacute thyroiditis, which comprises the following raw material medicines in parts by weight: 15-20 parts of honeysuckle, 10-15 parts of fructus forsythiae, 5-9 parts of burdock, 5-9 parts of platycodon grandiflorum, 5-12 parts of herba schizonepetae, 5-12 parts of selfheal, 5-12 parts of lithospermum, 5-12 parts of uniflower swisscentaury root, 5-12 parts of radix ampelopsis and 5-12 parts of rhizoma corydalis.
Preferably, the traditional Chinese medicine composition consists of the following raw material medicines in parts by weight: 16-19 parts of honeysuckle, 11-13 parts of fructus forsythiae, 5-8 parts of burdock, 5-8 parts of platycodon grandiflorum, 6-10 parts of herba schizonepetae, 6-10 parts of selfheal, 6-10 parts of lithospermum, 6-10 parts of uniflower swisscentaury root, 6-10 parts of radix ampelopsis and 6-10 parts of rhizoma corydalis.
Preferably, the traditional Chinese medicine composition consists of the following raw material medicines in parts by weight: 18 parts of honeysuckle, 12 parts of fructus forsythiae, 6 parts of great burdock achene, 6 parts of platycodon grandiflorum, 9 parts of herba schizonepetae, 9 parts of selfheal, 9 parts of lithospermum, 9 parts of uniflower swisscentaury root, 9 parts of Japanese ampelopsis root and 9 parts of rhizoma corydalis.
Further, the traditional Chinese medicine composition also comprises a pharmaceutically acceptable carrier.
Preferably, the dosage form of the traditional Chinese medicine composition is decoction, pills, tablets, mixture, capsules, granules and powder.
In a second aspect, the present invention provides a preparation method of the above-mentioned traditional Chinese medicine composition, comprising the step of weighing the raw materials according to the weight part ratio.
In a third aspect, the invention provides application of the traditional Chinese medicine composition in preparing a medicine for treating subacute thyroiditis.
Further, the invention provides application of the traditional Chinese medicine composition in preparing a medicine for treating subacute thyroiditis in an acute stage.
Furthermore, the invention provides application of the traditional Chinese medicine composition in preparing a medicine for treating the acute stage of subacute thyroiditis with syndrome of excessive toxic heat.
Furthermore, the invention provides application of the traditional Chinese medicine composition in preparing medicines for improving subacute thyropharyngalgia, fever, tenderness and hyperhidrosis symptoms, relieving subacute thyromegaly degree and reducing blood sedimentation.
Square solution:
in the formula, honeysuckle and forsythia are used as monarch drugs, and the drugs are pungent and cool to relieve exterior syndrome and clear away heat and toxic materials; fructus Arctii, radix Arnebiae, and radix Ampelopsis, with effects of dispelling pathogenic wind and heat, eliminating goiter, resolving hard mass, cooling blood, promoting blood circulation, removing toxic substance, and relieving sore throat; the schizonepeta has the effects of dispersing and relieving exterior syndrome, assisting monarch drugs in dispersing exterior pathogens, promoting heat and going out, and corydalis tuber in activating blood, promoting qi circulation and relieving pain, although the schizonepeta and the schizonepeta are pungent and warm products, the schizonepeta has the effects of pungent and mild effects and warm and mild effects, and can increase the efficacy of pungent and dispersing exterior syndrome when used in an adjuvant mode, and the five drugs are ministerial drugs. The selfheal strengthens the functions of clearing fire, dissipating stagnation and reducing swelling, the uniflower swisscentaury root clears away heat and toxic materials, eliminates goiter and promotes blood circulation, and the platycodon root can ventilate lung and relieve cough, regulate qi activity and guide medicines upwards, and the three are adjuvant medicines.
Term(s) for
As used herein, an ingredient of the term "pharmaceutically acceptable" is one that is suitable for use in humans and/or animals without undue adverse side effects (such as toxicity, irritation, and allergic response), i.e., at a reasonable benefit/risk ratio.
As used herein, the term "pharmaceutically acceptable carrier" refers to a carrier for administration of a therapeutic agent, including various excipients and diluents and the like. The term refers to such pharmaceutical carriers: they are not essential active ingredients per se and are not unduly toxic after administration. Suitable carriers are well known to those of ordinary skill in the art. A thorough discussion of pharmaceutically acceptable excipients can be found in Remington's Pharmaceutical Sciences (mackpub.co., n.j.1991). Pharmaceutically acceptable carriers in the compositions may comprise liquids such as water, saline, glycerol and ethanol. In addition, auxiliary substances such as emulsifiers, fillers, binders, wetting agents, disintegrants, absorption enhancers, flavoring agents, colorants, cosolvents and the like may also be present in these carriers. The emulsifier is selected from acetylated monoglyceride, acetylated diglyceride, sucrose ester, sorbitol ester, soybean phospholipid, lauric monoglyceride, propylene glycol fatty acid ester, calcium stearoyl lactylate, diacetyl tartaric acid, glyceryl monostearate, modified soybean phospholipid, etc. Such as magnesium stearate, microcrystalline cellulose, lactose, milk sugar, high molecular weight polyethylene glycols, and the like. Such as starch, mannitol, silicic acid, dextrin, calcium hydrogen phosphate, cellulose, etc. Such as carboxymethyl cellulose, alginates, gelatin, polyvinyl pyrrolidone, gum arabic, starch slurry, hydroxypropyl starch, modified starch, pregelatinized starch, dextrin, microcrystalline cellulose, polyvinyl pyrrolidone mucilage, gelatin mucilage. Such as glycerin and the like. The disintegrating agent is agar, calcium carbonate, potato starch, tapioca starch, alginic acid, hydroxypropyl starch, modified starch, sodium carboxymethyl starch, microcrystalline cellulose, guar gum, xanthan gum, etc. The absorption enhancer is such as quaternary ammonium compound, effervescent agent, cyclodextrin, vitamin D and its derivatives, piperine, etc. The flavoring agent can be sour agent, sweetener, such as phosphoric acid, lactic acid, tartaric acid, malic acid, fumaric acid, acetic acid, succinic acid, xylitol, steviosin, sodium cyclamate, aspartame, oleum Menthae Dementholatum, etc. The colorant may be a plant colorant, an animal colorant or a microbial colorant, such as beet red, turmeric, chlorophyll, shellac, cochineal, red yeast colorant, and the like. Such as beta-cyclodextrin, maltodextrin, tween, ethanol, span, sodium dodecyl sulfate, propylene glycol, polyethylene glycol, glycerol, etc. However, it will be appreciated by those skilled in the art that the pharmaceutically acceptable carriers useful in the present invention are not limited to the above-mentioned types.
As used herein, "parts by weight" can be any fixed weight expressed in milligrams, grams, or kilograms (e.g., 1mg, 1g, 2g, 5g, or 1kg, etc.). For example, a composition consisting of 1 part by weight of component a and 9 parts by weight of component b may be a composition consisting of 1g of component a +9 g of component b, or 10g of component a +90 g of component b. In the composition, the percentage content of a certain component is (parts by weight of the component/sum of parts by weight of all components) × 100%. Thus, in a composition consisting of 1 part by weight of component a and 9 parts by weight of component b, the content of component a is 10% and component b is 90%.
Dosage forms
The dosage form of the traditional Chinese medicine composition is not particularly limited, and can be any dosage form suitable for being taken by mammals; preferably, the dosage form may be selected from: decoction, pill, tablet, mixture, capsule, granule, powder or oral liquid. Preferred Chinese medicinal compositions are solid compositions, particularly tablets, granules and solid-filled or liquid-filled capsules, from the standpoint of ease of preparation, administration or ingestion. Oral administration is preferred.
The composition of the invention can be added with various conventional carriers or auxiliary materials required by preparing different dosage forms, such as filler (such as starch), flavoring agent (such as steviosin), antioxidant or coating material, and the like. Can be prepared into any common dosage form such as tablet, granule, capsule, pill, etc. by conventional Chinese medicinal preparation method.
Preparation method
After knowing the raw materials and their formulation used in the Chinese medicinal composition of the present invention, those skilled in the art can use various conventional methods to process the raw materials into drugs. Such processing includes, but is not limited to: pulverizing, extracting with water, extracting with organic solvent, etc. More specifically, the process comprises, for example, the steps of: weighing, pulverizing, decocting, etc.
The raw materials can be mixed and then the effective components are extracted by a proper method to prepare the traditional Chinese medicine composition; in addition, the effective components can also be extracted respectively (for example, the same or different extraction or processing methods are adopted respectively) and then combined to prepare the traditional Chinese medicine composition.
In addition, the technicians in the field can also directly adopt the effective parts of the raw material medicines for processing so as to prepare the traditional Chinese medicine composition. Furthermore, those skilled in the art can extract active ingredients from the raw materials, mix and process the active ingredients to prepare the traditional Chinese medicine composition.
Optionally, other pharmaceutically (or dietetically or nutraceutically) acceptable carriers can be added during the preparation process.
Use and method of use
The traditional Chinese medicine composition can be directly used for treating subacute thyroiditis. The traditional Chinese medicine composition can also contain other optional medicinal materials or medicinal material extracts.
The amount of the Chinese medicinal composition of the present invention to be used may vary depending on the mode of administration, the dosage form and the severity of the disease to be treated. For example, a single dose may be administered several times daily in divided doses, or the dose may be reduced proportionally as required by the condition being treated. Of course, the particular dosage will also take into account such factors as the mode of administration, the physical condition of the subject being administered, and the like, which are within the skill of the art.
The invention has the advantages that:
the traditional Chinese medicine composition provided by the invention takes heat-clearing and detoxifying, goiter-eliminating and stagnation-dissipating and pain-relieving as main treatment methods, the whole formula conforms to the compatibility of monarch, minister, assistant and guide, and honeysuckle and fructus forsythiae are used as monarch drugs in the formula, so that the traditional Chinese medicine composition is pungent and cool in property, and can clear heat and detoxify; great burdock achene, lithospermum and ampelopsis japonica,
dispelling wind and heat, eliminating goiter and resolving hard mass, cooling blood and promoting blood circulation, removing toxic substance and relieving sore throat; the schizonepeta has the effects of dispersing and relieving exterior syndrome, assisting monarch drugs in dispersing exterior pathogens, promoting heat and going out, and corydalis tuber in activating blood, promoting qi circulation and relieving pain, although the schizonepeta and the schizonepeta are pungent and warm products, the schizonepeta has the effects of pungent and mild effects and warm and mild effects, and can increase the efficacy of pungent and dispersing exterior syndrome when used in an adjuvant mode, and the five drugs are ministerial drugs. The selfheal strengthens the functions of clearing fire, dissipating stagnation and reducing swelling, the uniflower swisscentaury root clears away heat and toxic materials, eliminates goiter and promotes blood circulation, and the platycodon root can ventilate lung and relieve cough, regulate qi activity and guide medicines upwards, and the three are adjuvant medicines. The whole formula combines cold and warm, externally penetrates exterior evil, internally clears away heat toxin, eliminates goiter, disperses carbuncle nodes, relieves spasm and pain, can quickly improve symptoms of thyroid tenderness, fever, throat pain, hyperhidrosis and the like of patients with subacute thyroiditis, shortens pain time, relieves thyromegaly, improves thyroid function and reduces blood sedimentation. The traditional Chinese medicine compound has definite curative effect and less adverse reaction, can achieve the effect of treating both symptoms and root causes, has precise and appropriate medication, is suitable for industrial production, is convenient to take, and is beneficial to development and application.
Detailed Description
The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes and modifications can be made by those skilled in the art after reading the disclosure of the present invention, and equivalents fall within the scope of the appended claims.
EXAMPLE 1 Chinese medicinal composition 1
15 parts of honeysuckle, 10 parts of fructus forsythiae, 5 parts of great burdock achene, 5 parts of platycodon grandiflorum, 5 parts of herba schizonepetae, 5 parts of selfheal, 5 parts of lithospermum, 5 parts of uniflower swisscentaury root, 5 parts of Japanese ampelopsis root and 5 parts of rhizoma corydalis.
EXAMPLE 2 Chinese medicinal composition (II)
20 parts of honeysuckle, 15 parts of fructus forsythiae, 9 parts of great burdock achene, 9 parts of platycodon grandiflorum, 12 parts of herba schizonepetae, 12 parts of selfheal, 12 parts of lithospermum, 12 parts of uniflower swisscentaury root, 12 parts of Japanese ampelopsis root and 12 parts of rhizoma corydalis.
EXAMPLE 3 Chinese medicinal composition (III)
15 parts of honeysuckle, 15 parts of fructus forsythiae, 5 parts of great burdock achene, 9 parts of platycodon grandiflorum, 5 parts of herba schizonepetae, 12 parts of selfheal, 5 parts of lithospermum, 12 parts of uniflower swisscentaury root, 5 parts of Japanese ampelopsis root and 12 parts of rhizoma corydalis.
EXAMPLE 4 Chinese medicinal composition (IV)
20 parts of honeysuckle, 10 parts of fructus forsythiae, 9 parts of great burdock achene, 5 parts of platycodon grandiflorum, 12 parts of herba schizonepetae, 5 parts of selfheal, 12 parts of lithospermum, 5 parts of uniflower swisscentaury root, 12 parts of Japanese ampelopsis root and 5 parts of rhizoma corydalis.
EXAMPLE 5 Chinese medicinal composition (V)
16 parts of honeysuckle, 11 parts of fructus forsythiae, 5 parts of great burdock achene, 5 parts of platycodon grandiflorum, 6 parts of herba schizonepetae, 6 parts of selfheal, 6 parts of lithospermum, 6 parts of uniflower swisscentaury root, 6 parts of Japanese ampelopsis root and 6 parts of rhizoma corydalis.
EXAMPLE 6 Chinese medicinal composition (VI)
19 parts of honeysuckle, 13 parts of fructus forsythiae, 8 parts of great burdock achene, 8 parts of platycodon grandiflorum, 10 parts of herba schizonepetae, 10 parts of selfheal, 10 parts of lithospermum, 10 parts of uniflower swisscentaury root, 10 parts of Japanese ampelopsis root and 10 parts of rhizoma corydalis.
EXAMPLE 7 Chinese medicinal composition (seven)
16 parts of honeysuckle, 13 parts of fructus forsythiae, 5 parts of great burdock achene, 8 parts of platycodon grandiflorum, 6 parts of herba schizonepetae, 10 parts of selfheal, 6 parts of lithospermum, 10 parts of uniflower swisscentaury root, 6 parts of Japanese ampelopsis root and 10 parts of rhizoma corydalis.
EXAMPLE 8 Chinese medicinal composition (eight)
19 parts of honeysuckle, 11 parts of fructus forsythiae, 8 parts of great burdock achene, 5 parts of platycodon grandiflorum, 10 parts of herba schizonepetae, 6 parts of selfheal, 10 parts of lithospermum, 6 parts of uniflower swisscentaury root, 10 parts of Japanese ampelopsis root and 6 parts of rhizoma corydalis.
EXAMPLE 9 Chinese medicinal composition (nine)
18 parts of honeysuckle, 12 parts of fructus forsythiae, 6 parts of great burdock achene, 6 parts of platycodon grandiflorum, 9 parts of herba schizonepetae, 9 parts of selfheal, 9 parts of lithospermum, 9 parts of uniflower swisscentaury root, 9 parts of Japanese ampelopsis root and 9 parts of rhizoma corydalis.
Example 10 decoction
The raw materials are taken according to the weight parts of the raw materials in the embodiments 1-9 respectively, cleaned and decocted in water for 2 times, and each time lasts for 1 hour.
EXAMPLE 11 granules
The preparation method comprises the following steps of taking the raw materials according to the weight part ratio of the raw materials in the embodiments 1-9 respectively, cleaning the raw materials, adding 5 times of water, decocting for 2 times, 1 hour each time, filtering, combining the filtrates, concentrating to the relative density of 1.20(60-80 ℃), cooling, adding 2 times of ethanol, stirring, standing, taking the supernatant, filtering, steaming the filtrate without alcohol smell, standing, taking the supernatant, concentrating under reduced pressure to obtain an extract, drying the extract and crushing to particles.
EXAMPLE 12 pellets
The raw material medicines are respectively taken according to the weight parts of the embodiments 1-9, crushed into fine powder, sieved by a 80-mesh sieve for later use, a certain amount of honey is weighed, the honey is heated in an evaporation dish until boiling (if impurities can be filtered), the honey is continuously refined to the refined honey degree, and floating foams are fished out; mixing refined honey and the medicinal powder at a ratio of 1:1, and mixing thoroughly; placing the well-mixed dough-like soft material for a certain time; making into smooth and spherical pill by hand, and wrapping with wax paper.
Example 13 tablet/Capsule
The preparation method comprises the following steps of taking the raw materials according to the weight part ratio of the embodiment 1-9 respectively, cleaning the raw materials, adding 5 times of water, decocting for 2 times, 1 hour each time, filtering, combining the filtrates, concentrating to the relative density of 1.20(60-80 ℃), cooling, adding 2 times of ethanol, stirring, standing, taking the supernatant, filtering, steaming the filtrate without alcohol smell, standing, taking the supernatant, concentrating under reduced pressure to obtain an extract, adding pharmaceutical auxiliary materials, vacuum drying, crushing, granulating, and pressing into tablets or filling and packaging into capsules. The whole preparation process only needs to be decocted once.
EXAMPLE 14 clinical trial
1 data of
1.1 clinical data
100 patients with subacute thyroiditis with syndrome of heat-toxin congestion in outpatient service of hospital are selected, and are divided into an experimental group, a western medicine control group, a traditional Chinese medicine control group and a traditional Chinese medicine control group by adopting a random digital table method. Through statistical analysis, the patients in each group have no significant difference (P is more than 0.05) in age, disease course and the like, and have comparability.
1.2 diagnostic criteria
1.2.1 Western diagnostic standards
Based on the diagnosis standards carried in Chinese thyroid disease diagnosis and treatment guideline-thyroiditis in 2008 and in 8 th edition of internal medicine in 2013, the clinical practical situation is combined, and the grouped diagnosis standards are defined as follows: (1) prodrome of upper respiratory tract infection: acute inflammation general symptoms exist in the early stage of the disease, such as muscle pain, fatigue, lassitude, pharyngalgia, etc., and the body temperature is increased in different degrees and can be accompanied with neck lymph node swelling. (2) Pain characteristic of thyroid area: pain occurs gradually or suddenly, and varies in magnitude. The action of turning the neck and swallowing may worsen, and it is usually radiated to the ear and throat. (3) Goiter: diffuse or unsymmetrical light, moderate swelling, moderate hardness, obvious tenderness, no tremor and noise. (4) Firstly, the Erythrocyte Sedimentation Rate (ESR) is more than 50 mm/h; serum TT4, TT3, FT3 and FT4 are increased, and TSH is reduced or normal; ③ the intake rate of I131 is reduced (24h is less than 2 percent); thyroid color ultrasonography shows low echo, fuzzy boundary and irregular shape of a focus area; thyroid fine needle puncture or biopsy with granuloma change or multinucleated giant cells. Any 3 of the above-mentioned diagnoses (1), (2), (3) and (4) were confirmed to be subacute thyroiditis.
1.2.2 Chinese medicine diagnostic standards
The diagnosis standard of 2002 "guiding principles of clinical research on new Chinese medicines" is referred to, and the standard is formulated by combining the "diagnostics of traditional Chinese medicine", the "internal science of traditional Chinese medicine" and clinical experience as follows: (1) the main symptoms are: firstly, neck is swollen; ② pain in the anterior cervical region, pain when pressing, pressure or radiation pain; thirdly, heating; (2) secondary symptoms: firstly, palpitation; ② sore throat; ③ hyperhidrosis; fourthly, the patient is irritable; thirsty; sixthly, shaking; seventhly, eating too much; eighthly, emaciation; ninthly, hoarseness; (3) tongue pulse: a red tongue with a yellow and greasy coating and a slippery and rapid, wiry and rapid or rapid pulse. The syndrome diagnosis is performed by combining the tongue pulse, when the syndrome is satisfied with 2 items and 2 items of the main symptoms and has 3 items and 3 items of the secondary symptoms.
1.3 inclusion criteria
(1) Patients who meet the above diagnostic criteria;
(2) no other medicine related to the treatment of the disease is taken 3 months before the treatment.
(3) The patients voluntarily sign an informed consent, agree to use glucocorticoid for treatment, and can be matched with doctors to take medicine and check according to the agreement.
1.4 exclusion criteria
(1) Pregnant and lactating women;
(2) patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system diseases, mental diseases, etc.;
(3) patients with other types of thyroid disorders are pooled;
(4) allergic constitution and various herbs allergic.
1.5 rejection, shedding and termination of Observation criteria and related processing modes
(1) Serious adverse events or serious adverse reactions occur, and the research cannot be continued;
(2) those who developed allergic reactions during the study;
(3) the patient actively asked to withdraw from the investigator;
(4) other diseases appear and need to be treated in the research process, and the judgment of the curative effect is influenced by the evaluation of experts;
(5) in the research process, patients have the conditions of poor compliance, medicine taking refusal, non-timely visit and the like, and violate research schemes;
(6) in the process of data management, the curative effect judgment is affected by the incomplete record of clinical data.
The case data are properly stored, the patient should be contacted with the testee by communication modes such as telephone, short message and WeChat aiming at the active quit, the last time of taking medicine is recorded, the project to be evaluated is completed as far as possible, the reason for quitting is positively inquired, the record is faithfully recorded, and the curative effect statistics is not finally counted by the part of the testee.
2 method
2.1 methods of treatment
Experimental groups: the Chinese medicinal composition described in example 9 was administered.
And the western medicine control group comprises: prednisone is administered, initially orally, 10mg prednisone, 2 times daily, and is administered at a dose of 3mg weekly, with slow dose reduction based on patient symptoms, signs and blood sedimentation, and is discontinued after 6-8 weeks.
The traditional Chinese medicine is compared with a group of: administration of the Chinese medicinal composition: 10 parts of honeysuckle, 10 parts of fructus forsythiae, 10 parts of thunberg fritillary bulb, 15 parts of platycodon grandiflorum, 15 parts of herba schizonepetae, 10 parts of prepared pinellia ternate, 10 parts of lophatherum gracile, 10 parts of uniflower swisscentaury root, 15 parts of raw liquorice, 10 parts of mint and 10 parts of curcuma zedoary.
Two groups of traditional Chinese medicine contrast are as follows: administration of the Chinese medicinal composition: 10 parts of honeysuckle, 10 parts of fructus forsythiae, 2 parts of great burdock achene, 10 parts of platycodon grandiflorum, 3 parts of herba schizonepetae, 4 parts of selfheal, 15 parts of lithospermum, 15 parts of uniflower swisscentaury root, 15 parts of Japanese ampelopsis root and 15 parts of rhizoma corydalis.
The experimental group, the traditional Chinese medicine control group and the traditional Chinese medicine control group are decocted in water to obtain decoction, one dose is taken in the morning and at night for 2 times every day, 1 month is a treatment course, and each group is taken for 2 treatment courses continuously. And other hormones and immunosuppressants are prohibited during administration of each group of patients.
2.2 detection of indicators
2.2.1 general physical examination items: including body temperature, respiration, heart rate, blood pressure.
2.2.2 safety indices: three major diseases, liver and kidney function and electrocardiogram treatment are respectively treated once before and after the treatment.
2.2.3 possible adverse reactions
2.2.4 free triiodothyronine (FT3), serum free thyroxine (FT4), Thyroid Stimulating Hormone (TSH), blood routine, etc. once before and after treatment.
2.2.5 treatment of blood sedimentation was performed once each for 0, 2, 4, 8 weeks.
2.3 therapeutic efficacy criteria
And (3) healing: the thyroid gland returns to normal, all symptoms and physical signs disappear, and all detection indexes return to normal;
improvement: the pain of the thyroid disappears, the goiter is relieved by more than I degree, and FT3, FT4, TSH and blood sedimentation are improved by 30 percent;
and (4) invalidation: symptoms, signs and FT3, FT4, TSH, blood sedimentation did not improve significantly after treatment, or improved < 30% compared to before treatment.
3 results
3.1 the curative effects of each group are shown in Table 1.
TABLE 1 comparison of therapeutic effects of the groups
Note: p is less than 0.05 compared with western medicine control group
3.2 the change in blood sedimentation of each group is shown in Table 2.
TABLE 2 comparison of the sedimentation Change (mm/h) of each group
Note: p < 0.01 compared to this group before treatment
3.3 comparison of time to improvement in signs in each group of patients is shown in Table 3.
TABLE 3 comparison of time (days) of improvement for each group
Note: p is less than 0.05 compared with western medicine control group
3.4 the relapse rates of the patients in each group after drug withdrawal are shown in Table 4.
TABLE 4 comparison of relapse rates after drug withdrawal in groups of patients
Note: p is less than 0.05 compared with western medicine control group
3.5 the safety indexes of the patients in each group before and after treatment are normal, and the thyroid recovery cases have no significant difference in each group.
3.6 the adverse reactions after the administration of each group are compared in Table 5.
TABLE 5 comparison of adverse reactions after administration of each group
4 conclusion
The experimental results show that the effective rate of the experimental group is obviously superior to that of other groups, and the experimental group is also obviously superior to that of other groups in the aspects of recurrence rate, adverse reaction and the like. The traditional Chinese medicine composition has good application prospect in treating subacute thyroiditis, and provides a new treatment method for the disease.
Example 15 acute toxicity test
1 method of experiment
The traditional Chinese medicine composition described in the embodiment 9 is prepared into 0.1g/ml suspension according to a conventional preparation method. ICR mice, weight 18-22g, male and female half, Shanghai Si Laike laboratory animals, Inc. Fasting for 12h, intragastric administration of 0.4ml/10g body weight, repeated administration of the above dose once after 4h, and observation of animals for 7 consecutive days after administration.
2 results of the experiment
The results show that the mice in the experimental group have no abnormality in all aspects, no death and good weight gain, and the weight gain is increased from 20.5 +/-0.2 g before the administration to 24.3 +/-1.3 g. The medicine is administered at a dose of 8 g/kg/day, which is equivalent to 320 g/kg/day of crude drug, and animal has no serious toxic reaction. The dosage is more than 2000 times of the dosage for clinical use. The extract was proven safe.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and additions can be made without departing from the principle of the present invention, and these should also be considered as the protection scope of the present invention.
Claims (10)
1. The traditional Chinese medicine composition for treating subacute thyroiditis is characterized by comprising the following raw material medicines in parts by weight: 15-20 parts of honeysuckle, 10-15 parts of fructus forsythiae, 5-9 parts of burdock, 5-9 parts of platycodon grandiflorum, 5-12 parts of herba schizonepetae, 5-12 parts of selfheal, 5-12 parts of lithospermum, 5-12 parts of uniflower swisscentaury root, 5-12 parts of radix ampelopsis and 5-12 parts of rhizoma corydalis.
2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 16-19 parts of honeysuckle, 11-13 parts of fructus forsythiae, 5-8 parts of burdock, 5-8 parts of platycodon grandiflorum, 6-10 parts of herba schizonepetae, 6-10 parts of selfheal, 6-10 parts of lithospermum, 6-10 parts of uniflower swisscentaury root, 6-10 parts of radix ampelopsis and 6-10 parts of rhizoma corydalis.
3. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 18 parts of honeysuckle, 12 parts of fructus forsythiae, 6 parts of great burdock achene, 6 parts of platycodon grandiflorum, 9 parts of herba schizonepetae, 9 parts of selfheal, 9 parts of lithospermum, 9 parts of uniflower swisscentaury root, 9 parts of Japanese ampelopsis root and 9 parts of rhizoma corydalis.
4. The Chinese medicinal composition of any one of claims 1-3, wherein the Chinese medicinal composition further comprises a pharmaceutically acceptable carrier.
5. The traditional Chinese medicine composition according to any one of claims 1 to 3, wherein the dosage form of the traditional Chinese medicine composition is decoction, pill, tablet, mixture, capsule, granule or powder.
6. The preparation method of the traditional Chinese medicine composition as claimed in any one of claims 1 to 3, which is characterized by comprising the step of weighing the raw materials according to the weight part ratio.
7. Use of the Chinese medicinal composition of any one of claims 1-3 in the preparation of a medicament for the treatment of subacute thyroiditis.
8. Use of the Chinese medicinal composition of any one of claims 1-3 in the preparation of a medicament for treating the acute stage of subacute thyroiditis.
9. The use of the Chinese medicinal composition of any one of claims 1-3 in the preparation of a medicament for treating the acute stage of subacute thyroiditis with syndrome of excessive toxic heat.
10. Use of the Chinese medicinal composition of any one of claims 1-3 in the preparation of a medicament for ameliorating the symptoms of subacute thyropharyngeal pain, fever, hyperhidrosis, reducing the degree of subacute goiter, and reducing blood sedimentation.
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| CN109833417A (en) * | 2017-11-27 | 2019-06-04 | 田启旺 | The composition and preparation method thereof for treating thyroiditis |
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| CN102626484A (en) * | 2012-04-21 | 2012-08-08 | 济南康众医药科技开发有限公司 | Medicine compound for treating subacute thyroiditis |
| CN109833417A (en) * | 2017-11-27 | 2019-06-04 | 田启旺 | The composition and preparation method thereof for treating thyroiditis |
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