Traditional Chinese medicine composition and application thereof in preventing and treating recurrence and metastasis of thyroid cancer

Abstract

The invention discloses a traditional Chinese medicine composition and application thereof in preventing and treating recurrence and metastasis of thyroid cancer. The traditional Chinese medicine composition is prepared from the following raw material medicines: selfheal, sculellaria barbata, radix scrophulariae, thunberg fritillary bulb, platycodon grandiflorum, rhizoma cyperi, pericarpium citri reticulatae, ligusticum wallichii and angelica sinensis. The traditional Chinese medicine composition disclosed by the invention is exact in curative effect, has a good effect of preventing and treating recurrence and metastasis of thyroid cancer, is low in toxicity and high in safety, and can improve the treatment effect of the levothyroxine sodium tablets on thyroid cancer; the invention makes up the current situation of insufficient traditional Chinese medicine prescriptions for recurrence and metastasis of thyroid cancer, and has the characteristics of wide raw material sources, high safety coefficient, small dosage and clinical requirements of dosage forms.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition and its application, and specifically relates to a traditional Chinese medicine composition and its application in preventing and treating recurrence and metastasis of thyroid cancer or enhancing the therapeutic effect of levothyroxine sodium tablets on thyroid cancer. Background Art

[0002] Papillary thyroid carcinoma (PTC) is the most common endocrine malignancy, with an increasing incidence worldwide. PTC accounts for 85% to 90% of all thyroid cancers. Some PTC patients present with significant treatment difficulties, with extensive lymph node metastasis, distant metastases such as lung and bone, unresectable disease, 131I resistance, and resistance to targeted drugs. These phenomena can lead to recurrence, progression, and even death. Therefore, it is urgent to uncover the mechanisms of PTC invasion and metastasis and identify effective treatments.

[0003] Late-stage PTC accounts for nearly 20% of all cases and is characterized by poor differentiation, rapid progression, and high malignancy. The five-year survival rate for patients with lung metastases is only 77%, while the five-year survival rate drops to less than 20% for patients with bone and liver metastases. Late-stage PTC is insensitive to both radiotherapy and chemotherapy. Limitations such as resistance to radioiodine and resistance to existing targeted inhibitors and side effects reduce the therapeutic efficacy of late-stage PTC. The prevention and treatment of recurrence and metastasis of this disease has always been a clinical challenge, so the development of drugs to target PTC recurrence and metastasis is of great significance. Summary of the Invention

[0004] In order to make up for the deficiencies of the prior art, the purpose of the present invention is to provide a traditional Chinese medicine composition for preventing and treating recurrence and metastasis of thyroid cancer.

[0005] In order to achieve the above object, the present invention adopts the following technical solutions:

[0006] A first aspect of the present invention provides a traditional Chinese medicine composition.

[0007] Furthermore, the raw materials of the traditional Chinese medicine composition are: Prunella Vulgaris, Scutellaria barbata, Scrophularia ningpoensis, Fritillaria thunbergii, Platycodon grandiflorum, Cyperus rotundus, Tangerine peel, Ligusticum chuanxiong and Angelica sinensis.

[0008] Furthermore, by weight percentage, the ratio of Prunella Vulgaris: Scutellaria barbata: Scrophularia ningpoensis: Fritillaria thunbergii: Platycodon grandiflorum: Cyperus rotundus: Citrus reticulata: Ligusticum chuanxiong: Angelica sinensis is 3:3:1:1:1:0.6:0.6:0.6:0.6.

[0009] Furthermore, the traditional Chinese medicine composition is prepared from the following raw materials by weight: 30g of Prunella Vulgaris, 30g of Scutellaria barbata, 10g of Scrophularia ningpoensis, 10g of Fritillaria thunbergii, 10g of Platycodon grandiflorum, 6g of Cyperus rotundus, 6g of Citrus reticulatae, 6g of Ligusticum chuanxiong, and 6g of Angelica sinensis.

[0010] Furthermore, the types of the raw medicines include dry medicinal materials, fresh medicinal materials, raw medicinal materials, cooked medicinal materials, processed medicinal materials, the whole plant of the medicinal materials, the effective parts of the whole plant of the medicinal materials, or a combination thereof.

[0011] In the above compositions, the weight of the medicinal materials is calculated based on the crude drug, and the weight percentage is used as the proportion. This proportion can be increased or decreased during production. For example, large-scale production can use kilograms or tons as the unit, and small-scale production can use grams or milligrams as the unit. The weight can be increased or decreased, but the weight ratio of the crude drug materials in each component remains unchanged. The above weight ratios are obtained through scientific screening. For special patients, such as those with severe or mild symptoms, obese or thin patients, the quantitative ratio of the components can be adjusted accordingly, with an increase or decrease of no more than 100% without changing the efficacy.

[0012] In some embodiments, the traditional Chinese medicine composition further comprises active ingredients or pharmaceutically acceptable salts of active ingredients of Prunella Vulgaris, Scutellaria barbata, Scrophularia ningpoensis, Fritillaria thunbergii, Platycodon grandiflorum, Cyperus rotundus, Citrus reticulatae, Ligusticum chuanxiong and Angelica sinensis.

[0013] In some embodiments, the pharmaceutically acceptable salts include acid addition salts and base addition salts.

[0014] As used herein, the term "pharmaceutically acceptable salt" includes ammonium phosphates, metal salts, salts formed with amino acids, salts formed with amines, and salts formed with other bases such as piperidine or morpholine. The term "pharmaceutically acceptable salt" includes monosalts and disalts. Specific embodiments include ammonium, sodium, calcium, magnesium, cesium, lithium, potassium, barium, zinc, aluminum, lysine, arginine, histidine, methylamine, ethylamine, tert-butylamine, cyclohexylamine, N-methylglucamine, ethylenediamine, glycine, procaine, benzathene, diethanolamine, triethanolamine, piperidine, and morpholine.

[0015] In some embodiments, the term "pharmaceutically acceptable salt" may also include hydrates of pharmaceutically acceptable salts of the active ingredients of the present invention. Exemplary salts include, but are not limited to, sulfates, citrates, acetates, oxalates, chlorides, hydrochlorides, bromides, hydrobromides, iodides, nitrates, bisulfates, phosphates, acid phosphates, isonicotinates, lactates, salicylates, acid citrates, tartrates, oleates, tannates, pantothenates, bitartrates, ascorbates, gentisinates, gluconates, glucuronates, saccharates, formates, benzoates, glutamates, methanesulfonates, ethanesulfonates, benzenesulfonates, p-toluenesulfonates, camphorsulfonates, naphthylsulfonates, propionates, succinates, fumarates, maleates, malonates, mandelates, malates, palmitates, aspartates, phthalates, and pamoates.

[0016] As used herein, the term "pharmaceutically acceptable salt" also refers to a salt formed between the active ingredient of the Chinese medicinal material of the present invention having an acidic functional group, such as a carboxylic acid functional group, and a base. Examples of bases include, but are not limited to, alkali metal hydroxides including sodium, potassium, and lithium; alkaline earth metal hydroxides such as calcium and magnesium hydroxides; other metal hydroxides such as aluminum and zinc hydroxides; ammonia, organic amines such as unsubstituted or hydroxy-substituted mono-, di-, or trialkylamines, dicyclohexylamine; tributylamine; pyridine; N-methyl, N-ethylamine; diethylamine; triethylamine; mono-, di-, or tri-(2-OH-(C1-C6)-alkylamine), such as N, N-dimethyl-N-(2-hydroxyethyl)amine or tri-(2-hydroxyethyl)amine; N-methyl-D-glucamine; morpholine; thiomorpholine; piperidine; pyrrolidine; and amino acids such as arginine, lysine, and the like.

[0017] In some embodiments, when the Chinese medicine composition of the present invention is administered to a specific individual subject for treatment, the therapeutically effective amount and specific treatment plan for the individual subject may be affected by many factors, including the pharmacodynamic activity of the drug used, the age, weight, general condition, gender, diet, administration time, disease susceptibility, disease progression, and the judgment of the treating physician. In addition, those skilled in the art are aware that the mode of administration, dosage form, and dosage of the drug are affected by many factors such as the patient's age, weight, gender, morbidity, diet, administration time, excretion rate, and reaction sensitivity. Therefore, the dosage of the Chinese medicine composition described in the present invention is not limited to the dosage in the embodiments of the present invention, and the same applies to the mode of administration and dosage form.

[0018] Any Chinese medicine composition encompassed by the present invention can be delivered orally via any acceptable and suitable oral formulation. Exemplary oral formulations include, but are not limited to, tablets, lozenges, pastilles, aqueous and oily suspensions, dispersible powders or granules, emulsions, hard and soft capsules, liquid capsules, syrups, and elixirs.

[0019] In some embodiments, the Chinese medicine composition of the present invention further comprises a drug delivery system, specifically comprising biodegradable polymers, biodegradable implants, non-biodegradable implants, biodegradable microparticles such as biodegradable microspheres, nanoparticles, and the like.

[0020] As used herein, "raw material" is synonymous with "active pharmaceutical ingredient," and refers to the Chinese medicinal materials that are capable of exerting their active functions. These medicinal materials can exist in various forms, including, but not limited to, dried, fresh, raw, cooked, processed, whole plants, active parts of whole plants, or combinations thereof. In some embodiments, the raw materials also include major active ingredients extracted from the raw materials, which are all proven ingredients in the prior art.

[0021] A second aspect of the present invention provides a pharmaceutical preparation.

[0022] Furthermore, the active ingredient of the pharmaceutical preparation is the traditional Chinese medicine composition described in the first aspect of the present invention.

[0023] Furthermore, the pharmaceutical preparation further comprises a pharmaceutically acceptable buffer, carrier and / or excipient.

[0024] Furthermore, the buffer comprises phosphate, carbonate, acetate, citrate, glycolate, lactate, borate, tartrate or cacodylate.

[0025] Furthermore, the buffer also includes Trizma, Bicine, Tricine, MOPS, MOPSO, MOBS, Tris, Hepes, HEPBS, MES, ACES, ADA, AMP, AMPD, AMPSO, BES, CABS, CHES, DIPSO, EPPS, ethanolamine, glycine, HEPPSO, imidazole, imidazole lactate, PIPES, SSC, SSPE, POPSO, TAPS, TABS, TAPSO, and TES.

[0026] Furthermore, the carrier includes an isotonic agent, an antioxidant, a suspending agent, a dispersing agent, an emulsifier, a chelating agent, a thickener or a solubilizing agent.

[0027] Furthermore, the excipient includes carbohydrates, polymers, lipids or minerals.

[0028] Furthermore, the dosage form of the pharmaceutical preparation includes granules, tablets, pills, capsules, injections, oral liquids, tinctures, suppositories, mixtures, powders, lotions, films or pills.

[0029] Furthermore, the pharmaceutically acceptable buffer, carrier and / or excipient are described in detail in Remington's Pharmaceutical Sciences (19th ed., 1995). These substances are used to help stabilize the drug or to help improve the activity of the effective active ingredient in the drug as needed. The active ingredient that can be used in such a pharmaceutical composition can be in the form of its original compound itself, or optionally in other pharmaceutically acceptable forms. The pharmaceutical composition thus formulated can be administered in any appropriate manner known to those skilled in the art as needed.

[0030] Furthermore, pharmaceutically acceptable buffers, carriers and / or excipients may additionally contain liquids such as water, physiological saline, glycerol and ethanol. In addition, auxiliary substances such as wetting agents or emulsifiers or pH buffer substances may be present in the pharmaceutical composition. These carriers enable the pharmaceutical composition to be formulated into dosage forms such as granules, tablets, pills, capsules, injections, oral liquids, tinctures, mixtures, powders, lotions, films, dripping pills, etc. for patient ingestion.

[0031] A third aspect of the present invention provides a method for preparing a pharmaceutical preparation for preventing and treating recurrence and metastasis of thyroid cancer or enhancing the therapeutic effect of levothyroxine sodium tablets on thyroid cancer.

[0032] Furthermore, the method comprises extracting or processing the raw materials of the traditional Chinese medicine composition described in the first aspect of the present invention to obtain its effective ingredients, and then, using the effective ingredients as raw materials, adding pharmaceutically acceptable buffers, carriers and / or excipients as needed, and preparing the desired dosage form according to conventional pharmaceutical techniques.

[0033] The fourth aspect of the present invention provides use of the traditional Chinese medicine composition described in the first aspect of the present invention or the pharmaceutical preparation described in the second aspect of the present invention in the preparation of a drug for enhancing the therapeutic effect of levothyroxine sodium tablets on thyroid cancer.

[0034] Furthermore, the thyroid cancer includes papillary thyroid cancer, follicular thyroid cancer, medullary thyroid cancer or anaplastic thyroid cancer.

[0035] Furthermore, the thyroid cancer is papillary thyroid cancer.

[0036] The fifth aspect of the present invention provides use of the traditional Chinese medicine composition described in the first aspect of the present invention or the pharmaceutical preparation described in the second aspect of the present invention in the preparation of a drug for preventing and treating recurrence and metastasis of thyroid cancer.

[0037] Furthermore, the thyroid cancer includes papillary thyroid cancer, follicular thyroid cancer, medullary thyroid cancer or anaplastic thyroid cancer.

[0038] Furthermore, the thyroid cancer is papillary thyroid cancer.

[0039] Furthermore, the Chinese medicine composition described in the first aspect of the present invention or the pharmaceutical preparation described in the second aspect of the present invention can significantly reduce the thyroglobulin level in thyroid cancer patients and maintain the stability of the thyroid stimulating hormone level.

[0040] Furthermore, the Chinese medicine composition described in the first aspect of the present invention or the pharmaceutical preparation described in the second aspect of the present invention can also significantly inhibit the proliferation of thyroid cancer cells.

[0041] The term "patient" used in the present invention mainly refers to warm-blooded vertebrate mammals, including but not limited to cats, dogs, rabbits, bears, foxes, wolves, monkeys, deer, mice, pigs, cows, sheep, horses, humans, etc., preferably primates, and more preferably humans.

[0042] The term "and / or" used in the present invention includes any and all combinations of one or more of the associated listed items.

[0043] Advantages and beneficial effects of the present invention:

[0044] The traditional Chinese medicine composition of the present invention utilizes the inherent characteristics of each component raw material medicine, is rationally formulated, and scientifically proportioned to achieve optimal synergistic efficacy; the traditional Chinese medicine composition has definite efficacy, has a good effect of preventing and treating the recurrence and metastasis of thyroid cancer, has low toxicity, is highly safe, and can improve the therapeutic effect of levothyroxine sodium tablets on thyroid cancer; the present invention makes up for the current situation of insufficient traditional Chinese medicine prescriptions for the recurrence and metastasis of thyroid cancer, and has the characteristics of a wide source of raw materials, a high safety factor, a small dosage, and a dosage form that meets clinical needs. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 Shows the clinical cohort study flow chart;

[0046] Figure 2 The results show that the Chinese medicine composition of the present invention has an inhibitory effect on the proliferation of PTC cells; wherein, Figure 2 a is an EdU experiment, the results show the inhibitory effect of the Chinese herbal composition on the proliferation of thyroid cancer cell lines TPC-1, BCPAP, and K1; Figure 2 b is the proliferation rate of cells in each group at different concentrations of the Chinese medicine composition; Figure 2 c is a colony assay, the results of which show the inhibitory effect of the Chinese herbal composition on the thyroid cancer cell line TPC-1; Figure 2 d is the number of TPC-1 cells at different concentrations of the Chinese medicine composition. DETAILED DESCRIPTION

[0047] In order to make the purpose, technical scheme and beneficial effects of the embodiments of the present invention clearer, the technical scheme in the embodiments of the present invention will be clearly and completely described below. If specific conditions are not specified in the embodiments, they are carried out according to conventional conditions or conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased commercially. A Chinese medicine composition provided in the embodiments of the present invention and its application in preventing and treating recurrence and metastasis of thyroid cancer are specifically described below.

[0048] Unless otherwise indicated, all numbers used in this specification and claims to represent volume, weight, temperature, time, density, weight parts, technical effects, etc. should be understood as being modified by the term "about" or "approximately" under any circumstances. Therefore, unless otherwise indicated, the numerical parameters listed in the following specification and the appended claims are approximate values. Unless otherwise indicated, the terms used herein have the usual understanding meanings for those skilled in the art. For those skilled in the art, it can vary according to the desired properties and effects sought to be obtained through this disclosure, and each numerical parameter should be interpreted according to the number of significant digits and conventional rounding methods or in a manner understood by those skilled in the art.

[0049] Example 1 Clinical application study of a Chinese herbal medicine composition in preventing and treating high-risk PTC recurrence and metastasis

[0050] The traditional Chinese medicine composition of the present invention is composed of 30g of Prunella Vulgaris, 30g of Scutellaria barbata, 10g of Scrophularia ningpoensis, 10g of Fritillaria thunbergii, 10g of Platycodon grandiflorum, 6g of Cyperus rotundus, 6g of Tangerine peel, 6g of Ligusticum chuanxiong, and 6g of Angelica sinensis, and is named Xialian Jiaai Recipe. Prunella Vulgaris is the main ingredient; Scutellaria barbata, Scrophularia ningpoensis, Fritillaria thunbergii, and Platycodon grandiflorum are the auxiliary ingredients; and Cyperus rotundus, Tangerine peel, Angelica sinensis, and Ligusticum chuanxiong serve as adjuvant ingredients. The combined use of these ingredients can achieve the therapeutic effect of preventing and treating thyroid cancer recurrence and metastasis as described in the present invention.

[0051] Preparation and Administration of the Traditional Chinese Medicine Composition: Both the traditional Chinese medicine pieces and levothyroxine sodium tablets (Euthyrox®) were purchased from the 960th Hospital of the Joint Logistics Support Force of the People's Liberation Army (formerly the General Hospital of the Jinan Military Region). The quality standards for these traditional Chinese medicines complied with the 2020 edition of the Chinese Pharmacopoeia. After decoction, the components were identified using UHPLC-Q-Orbitrap HRMS. Patients in the experimental group took the traditional Chinese medicine composition once daily. According to the 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer: The American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated Thyroid Cancer and the Guidelines for the Diagnosis and Treatment of Thyroid Nodules and Differentiated Thyroid Cancer (Second Edition), combined with postoperative staging and recurrence risk stratification, both the experimental and control groups received TSH suppression therapy with oral levothyroxine sodium tablets once in the morning.

[0052] The flow chart of the clinical cohort study is as follows Figure 1 As shown, the present invention first included data on 154 PTC patients who completed total thyroidectomy in a single hospital center, excluding 6 cases of treatment interruption, 1 case of drug-induced liver injury, and 1 case of follow-up loss; a total of 68 patients in the experimental group were treated with the Chinese medicine composition of the present invention and levothyroxine sodium tablets, and a total of 78 patients in the control group were treated only with levothyroxine sodium tablets.

[0053] Tg is thyroglobulin, a major marker for assessing whether thyroid cancer will recur or metastasize. It is mainly used for follow-up observation after complete thyroidectomy. If Tg is elevated, it indicates the possibility of tumor recurrence. TSH is thyroid-stimulating hormone, and the level of the hormone mainly reflects the functional status of the patient's thyroid gland. Therefore, the applicant evaluated the effect of the Chinese medicine composition of the present invention on the recurrence and metastasis of thyroid cancer based on two key laboratory indicators, Tg and TSH. The results are shown in Table 1. The applicant found that the Tg value of high-risk patients who took the Chinese medicine composition of the present invention and levothyroxine sodium tablets after complete thyroidectomy was significantly lower than that of the control group treated with levothyroxine sodium tablets alone (Z=-2.270, P=0.023), and the TSH CV value of the group treated with the Chinese medicine composition and levothyroxine sodium tablets was also significantly lower than that of the control group (168.58% vs. 474.05%). This shows that the Chinese medicine composition of the present invention synergistically enhances the effect of levothyroxine sodium tablets on the recurrence of thyroid cancer and is more helpful in maintaining the stability of TSH levels. In addition, clinical cohort studies have shown that the Chinese medicine composition has a low incidence of adverse reactions, the Chinese medicine syndrome score of the Chinese medicine experimental group is better than that of the control group, and the Chinese medicine composition has good safety and effectiveness.

[0054] Table 1 Evaluation of the effects of Chinese herbal medicine compositions on TSH and Tg in patients

[0055] Table 2 Coefficient of variation of experimental groups

[0056] Table 3 Coefficient of variation of the control group

[0057] Example 2: Traditional Chinese medicine composition inhibits PTC cell proliferation

[0058] Furthermore, the applicant decocted the traditional Chinese medicine formula twice. The combined decoctions were filtered and concentrated to 400 mL. After storage at -80°C, the decoctions were freeze-dried to produce lyophilized powder using ultrapure water. The lyophilized powder stock solution was then prepared to a 500 mg / mL concentration using anhydrous ethanol, centrifuged, filtered, and allowed to stand. The pH was adjusted to neutral, concentrated using a rotary evaporator, and filtered. BCPAP, K1, and TPC-1 cells were seeded into 24-well plates at a density of 5 × 10³ / well. After cell attachment, the original culture medium was aspirated, and 100 μL of complete culture medium containing different concentrations of the traditional Chinese medicine formula (0, 100, 200, and 400 μg / mL) was added to each well. After 24 hours, 100 μL of EdU was added to each well, and the cells were incubated for 2 hours in the dark and then incubated with the Click reaction reagent for 0.5 hours. The Click reaction reagent was removed and washed three times. Cell nuclei were counterstained with 1× Hoechst 33342 and washed twice. EdU-positive cells (green fluorescence) and Hoechst 33342-positive cells (blue fluorescence) were observed and counted using a fluorescence microscope. Images were processed and data collected using ImageJ software. TPC-1 cells were seeded at a density of 1×103 cells per well in 6-well plates and cultured in complete medium containing different concentrations of the traditional Chinese medicine composition. Each group was replicated three times. After 9 days of culture, the cells were washed twice with PBS, fixed with 4% paraformaldehyde for 15 minutes, stained with crystal violet for 30 minutes, washed with PBS, air-dried, photographed, processed, and counted using ImageJ software. The EdU and colony assays described above revealed that treatment of PTC cell lines with different concentrations of the traditional Chinese medicine composition of the present invention inhibited PTC cell proliferation to varying degrees. Specifically, compared with the control group, the traditional Chinese medicine composition at concentrations of 100 μg / mL to 400 μg / mL inhibited PTC cell proliferation, with the inhibitory effect increasing with increasing concentration. This indicates that the traditional Chinese medicine composition of the present invention can inhibit the recurrence and metastasis of thyroid cancer by inhibiting the proliferation of PTC cells.

[0059] The above embodiments are only provided for understanding the method and core concept of the present invention. It should be noted that, without departing from the principles of the present invention, a number of improvements and modifications may be made to the present invention by a person skilled in the art, and such improvements and modifications shall fall within the scope of protection of the claims of the present invention.

Claims

1. A Chinese medicine composition, characterized in that The raw materials of the traditional Chinese medicine composition are: herba prunellae, herba barbata, herba scrophulariae, herba thunbergii, herba platycodonis, herba cyperi, herba tangerine peel, herba ligusticum and herba angelicae.

2. The Chinese medicine composition according to claim 1, characterized in that By weight percentage, the ratio of Prunella Vulgaris: Scutellaria barbata: Scrophularia ningpoensis: Fritillaria thunbergii: Platycodon grandiflorum: Cyperus rotundus: Citrus reticulata: Ligusticum chuanxiong: Angelica sinensis is 3:3:1:1:1:0.6:0.6:0.6:0.

6.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that The Chinese medicine composition is prepared from the following raw materials by weight: 30g of Prunella Vulgaris, 30g of Scutellaria barbata, 10g of Scrophularia ningpoensis, 10g of Fritillaria thunbergii, 10g of Platycodon grandiflorum, 6g of Cyperus rotundus, 6g of Citrus reticulatae, 6g of Ligusticum chuanxiong, and 6g of Angelica sinensis; Preferably, the types of the raw medicine include dried medicinal materials, fresh medicinal materials, raw medicinal materials, cooked medicinal materials, processed medicinal materials, the whole plant of medicinal materials, the effective parts of the whole plant of medicinal materials, or a combination thereof.

4. A pharmaceutical preparation, characterized in that The active ingredient of the pharmaceutical preparation is the traditional Chinese medicine composition according to any one of claims 1 to 3.

5. The pharmaceutical preparation according to claim 4, characterized in that The pharmaceutical preparation further comprises a pharmaceutically acceptable buffer, carrier and / or excipient; Preferably, the buffer comprises phosphate, carbonate, acetate, citrate, glycolate, lactate, borate, tartrate or cacodylate; Preferably, the carrier comprises an isotonic agent, an antioxidant, a suspending agent, a dispersing agent, an emulsifier, a chelating agent, a thickening agent or a solubilizing agent; Preferably, the excipient comprises a carbohydrate, a polymer, a lipid or a mineral.

6. The pharmaceutical preparation according to claim 4 or 5, characterized in that The dosage forms of the pharmaceutical preparation include granules, tablets, pills, capsules, injections, oral liquids, tinctures, suppositories, mixtures, powders, lotions, films or dripping pills.

7. A method for preparing a pharmaceutical preparation for preventing and treating recurrence and metastasis of thyroid cancer or enhancing the therapeutic effect of levothyroxine sodium tablets on thyroid cancer, characterized in that: The method comprises extracting or processing the raw materials of the traditional Chinese medicine composition according to any one of claims 1 to 3 to obtain its active ingredients, and then using the active ingredients as raw materials, adding pharmaceutically acceptable buffers, carriers and / or excipients as needed, and preparing the desired dosage form according to conventional pharmaceutical techniques.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the pharmaceutical preparation according to any one of claims 4 to 6 in the preparation of a medicament for enhancing the therapeutic effect of levothyroxine sodium tablets on thyroid cancer.

9. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the pharmaceutical preparation according to any one of claims 4 to 6 in the preparation of a medicament for preventing and treating recurrence and metastasis of thyroid cancer.

10. The use according to claim 8 or 9, characterized in that: The thyroid cancer includes papillary thyroid cancer, follicular thyroid cancer, medullary thyroid cancer or anaplastic thyroid cancer; Preferably, the thyroid cancer is papillary thyroid carcinoma.

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