Traditional chinese medicine composition, method for preparing same, and use thereof in preparing medicament for preventing and treating thyroid disease

Abstract

The present application relates to the technical field of traditional Chinese medicine, and in particular, to a traditional Chinese medicine composition, a method for preparing same, and use thereof in preparing a medicament for preventing and treating a thyroid disease. The traditional Chinese medicine composition consists of Ranunculi Ternati radix, Taraxaci herba, Cyperi rhizoma, and Semiaquilegiae radix. The method comprises: mixing and crushing formulation amounts of Ranunculi Ternati radix, Taraxaci herba, Cyperi rhizoma, and Semiaquilegiae radix; or extracting formulation amounts of Ranunculi Ternati radix, Taraxaci herba, Cyperi rhizoma, and Semiaquilegiae radix. The compounding of the four traditional Chinese medicines, Ranunculi Ternati radix, Taraxaci herba, Cyperi rhizoma, and Semiaquilegiae radix, can significantly treat hypothyroidism, thyroid nodules, and the like caused by insufficient thyroid hormones. Compared with the prior art, the traditional Chinese medicine composition features clear ingredients, good safety, and better therapeutic effects, providing technical support for the treatment of thyroid diseases with traditional Chinese medicines.

Description

A traditional Chinese medicine composition, a preparation method thereof and application thereof in preparing a medicine for preventing and treating thyroid diseases

[0001] Related applications

[0002] This application is a PCT application based on and claiming priority to Chinese patent application No. 2024108833680 filed on July 03, 2024. The patent application is incorporated herein in its entirety as if fully set forth. TECHNICAL FIELD

[0003] The present application belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition, a preparation method thereof and application thereof in preparing a medicine for preventing and treating thyroid diseases. BACKGROUND

[0004] Thyroid nodule is a common disease of the endocrine system, including nodular goiter, thyroid adenoma, acute thyroiditis, hyperthyroidism and thyroid micro-papillary carcinoma. Thyroid nodule is a global public health problem, and the probability of people suffering from thyroid nodule is increasing year by year with the acceleration of modern life rhythm.

[0005] The most common treatment methods for thyroid nodules include radioactive iodine therapy, anti-thyroid drug therapy, hormone replacement therapy and surgical treatment, which are still controversial. Graves' disease patients with smaller age, larger thyroid nodules or larger thyroid volume have a higher risk of recurrence after stopping anti-thyroid drug therapy. Surgery can treat thyroid nodules, however, total thyroidectomy will cause permanent hypothyroidism, which needs to be supplemented with thyroid stimulating hormone for a lifetime, and subtotal thyroidectomy will cause recurrence. When radioactive iodine therapy is performed on thyroid nodules, THs level should be monitored regularly because hypothyroidism will occur within 2-3 years after treatment. Therefore, it is necessary to find a safer and more effective method for treating thyroid nodules.

[0006] CN109568477A discloses a pharmaceutical composition for treating thyroid nodules, which is prepared from raw materials in the following proportions by weight: Rhizoma Cyperi 9-15 parts, Radix Paeoniae Alba 9-15 parts, Sargassum 16-24 parts, Radix Bupleuri 8-12 parts, Laminaria japonica 12-18 parts, Fritillaria 30-45 parts, Rhizoma Pinelliae 8-12 parts, Pericarpium Citri Reticulatae Viride 5-7 parts, Pericarpium Citri Reticulatae 8-12 parts, Radix Angelicae Sinensis 12-18 parts, Rhizoma Chuanxiong 8-12 parts, Forsythia 8-12 parts, Ostrea 12-18 parts, Prunella vulgaris 7-11 parts. The invention can significantly relieve the clinical symptoms of patients with thyroid nodules and effectively treat thyroid nodules.

[0007] CN113209208A discloses a traditional Chinese medicine composition for treating thyroid nodules and a preparation method thereof. The preparation raw materials of the traditional Chinese medicine composition include Radix Bupleuri, Fructus Aurantii, Rhizoma Cyperi, Ranunculus japonicus, Cornu Cervi, Ostreae, Rhizoma Chuanxiong, Radix Paeoniae Rubra, Pericarpium Citri Reticulatae, Rhizoma Pinelliae, and Radix Glycyrrhizae. The application can effectively improve the clinical symptoms of thyroid nodule patients, regulate thyroid hormone levels, control and delay the development of thyroid nodule disease, improve nodule size, regulate the overall function of patients, and change the constitution problem of easy thyroid nodules, and fundamentally intervene.

[0008] CN110393781A discloses a pure traditional Chinese medicine preparation for treating thyroid nodules, which includes the following components by weight: Herba Prunellae 15-30 parts, Herba Taraxaci 15-30 parts, Fructus Forsythiae 10-20 parts, Bulbus Allii Macrostemonis 10-20 parts, Concha Arcae 30-60 parts, Ranunculus japonicus 10-20 parts, Radix Sophorae Tonkinensis 15-20 parts, Radix Curcumae 10-20 parts, Carapax Trionycis 20-30 parts, Herba Monotropaei 5-10 parts, and Herba Euphorbiae 10-15 parts. The application can significantly reduce the size of thyroid nodules, eliminate the clinical symptoms of patients, and reduce pain.

[0009] Traditional Chinese medicine has obvious advantages in treating thyroid nodules compared with Western medicine. It is safe and can largely avoid drug dependence and thyroid function changes caused by long-term oral administration of hormone drugs, lifelong thyroid hormone drug dependence and nodule recurrence caused by thyroid nodule resection surgery, and other risks. However, the current traditional Chinese medicine formula for treating thyroid diseases still has problems such as complex components, unknown side effects, and long treatment time.

[0010] SUMMARY

[0011] To solve the above technical problems, the present application provides a traditional Chinese medicine composition, a preparation method thereof, and an application thereof in preparing a medicine for preventing and treating thyroid diseases.

[0012] To achieve the above-mentioned purposes, the technical solutions adopted by the present application are as follows:

[0013] In a first aspect, the present application provides a traditional Chinese medicine composition composed of Ranunculus japonicus, Herba Taraxaci, Rhizoma Cyperi, and Herba Euphorbiae.

[0014] In the present application, catpaw grass (Ranunculus ternatus Thunb.) is a perennial herb of Ranunculus of Ranunculaceae, and its tuber can be used as medicine with sweet and pungent flavor and warm nature, which has the effects of resolving masses and dissipating swelling. It is used for treating unbroken scrofula and lymph node tuberculosis. Dandelion is a commonly used traditional Chinese medicine, and its whole grass is used as medicine, containing dandelion sterol, dandelion sesquiterpene alcohol, dandelion bitter, coffee acid, choline, inulin and other components, which can clear heat and resolve toxicity, dissipate swelling and resolve masses. Radix Euphorbiae Humifusae can also clear heat and resolve toxicity, dissipate swelling and resolve masses, and is mainly used for treating scrofula. Rhizoma Zedoariae can resist bacteria and relieve pain, and has the effects of regulating qi and resolving stagnation. The present application uses the combination of the four traditional Chinese medicines, which has clear components and good safety, and can significantly treat thyroid nodules caused by insufficient thyroid hormone.

[0015] In some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials by weight: catpaw grass 1-120 parts, dandelion 1-30 parts, Rhizoma Zedoariae 1-20 parts, and Radix Euphorbiae Humifusae 1-20 parts.

[0016] In some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials by weight: catpaw grass 1-100 parts, dandelion 1-25 parts, Rhizoma Zedoariae 1-18 parts, and Radix Euphorbiae Humifusae 1-18 parts.

[0017] In some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials by weight: catpaw grass 1-80 parts, dandelion 1-20 parts, Rhizoma Zedoariae 1-15 parts, and Radix Euphorbiae Humifusae 1-15 parts.

[0018] In some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials by weight: catpaw grass 1-50 parts, dandelion 1-18 parts, Rhizoma Zedoariae 1-12 parts, and Radix Euphorbiae Humifusae 1-12 parts.

[0019] In some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials by weight: catpaw grass 1-20 parts, dandelion 1-15 parts, Rhizoma Zedoariae 1-10 parts, and Radix Euphorbiae Humifusae 1-10 parts.

[0020] In some preferred embodiments, the traditional Chinese medicine composition is composed of the following raw materials by weight: catpaw grass 1-15 parts, dandelion 1-10 parts, Rhizoma Zedoariae 1-8 parts, and Radix Euphorbiae Humifusae 1-8 parts.

[0021] In some preferred embodiments, the mass ratio of catpaw grass, dandelion, Rhizoma Zedoariae and Radix Euphorbiae Humifusae is 5-6:1-4:2-8:2-6; further preferably 5-6:3-4:2-3:2-3, and most preferably 5:3:2:2.

[0022] In the second aspect, the present application provides a preparation method of the above-mentioned traditional Chinese medicine composition, which comprises the following steps: mixing and crushing catpaw grass, dandelion, Rhizoma Zedoariae and Radix Euphorbiae Humifusae in formula amount; or

[0023] The prescription amount of cat's claw, dandelion, cyperus rotundus and ephedra sinica is extracted, purified and enriched to obtain the traditional Chinese medicine composition.

[0024] In the present application, the extraction can be carried out after each medicine is extracted separately and then mixed, or after each medicine is mixed and then extracted together.

[0025] In some embodiments, the extraction further comprises a pulverization process, in which the prescription amount of cat's claw, dandelion, cyperus rotundus and ephedra sinica is pulverized before extraction.

[0026] In some embodiments, the extraction is water extraction and / or alcohol extraction.

[0027] In some embodiments, the extraction is water extraction, which comprises the following steps:

[0028] The prescription amount of cat's claw, dandelion, cyperus rotundus and ephedra sinica is mixed and extracted with water, and the filtrates are combined to obtain the traditional Chinese medicine composition.

[0029] Preferably, the amount of water is 5-20 times, preferably 8-12 times, and further preferably 10-11 times, of the total amount of the extracted raw materials.

[0030] Preferably, the water extraction is carried out at least once, preferably 1-3 times, and further preferably 2-3 times, with each extraction time being 0.5-3 h, preferably 1-2.5 h, and further preferably 1-2 h.

[0031] In some embodiments, after the combined filtrates, concentration and / or drying are further included.

[0032] In a third aspect, the present application provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for the treatment of a disease caused by an increase in thyroid hormone.

[0033] In some embodiments, the disease includes hypothyroidism and / or thyroid nodules.

[0034] In some embodiments, the thyroid nodules include at least one of nodular goiter, thyroid adenoma, acute thyroiditis, chronic thyroiditis and thyroid micro-papillary carcinoma.

[0035] In a fourth aspect, the present application provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for the treatment of a disease caused by a decrease in THs level.

[0036] In some embodiments, the THs include at least one of T4, T3 and TSH.

[0037] In some embodiments, the disease includes hypothyroidism and / or thyroid nodules.

[0038] In some embodiments, the thyroid nodule comprises at least one of nodular goiter, thyroid adenoma, acute thyroiditis, chronic thyroiditis, and thyroid micro-papillary carcinoma.

[0039] In a fifth aspect, the present application provides use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating hypothyroidism.

[0040] In a sixth aspect, the present application provides use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating thyroid nodule.

[0041] In some embodiments, the thyroid nodule comprises at least one of nodular goiter, thyroid adenoma, acute thyroiditis, chronic thyroiditis, and thyroid micro-papillary carcinoma.

[0042] The traditional Chinese medicine composition of the present application can reduce the expression of thyroid function level and / or inflammatory factors in serum to achieve the auxiliary treatment of thyroid disease.

[0043] In some embodiments, the thyroid function level comprises at least one of tetraiodothyronine level, triiodothyronine level, and thyroid-stimulating hormone level.

[0044] In some embodiments, the inflammatory factor comprises IL-6 and / or TNF-α.

[0045] In a seventh aspect, the present application provides a pharmaceutical composition for treating thyroid disease, comprising the aforementioned traditional Chinese medicine composition and a pharmaceutically acceptable excipient.

[0046] In some embodiments, the dosage form of the pharmaceutical composition is tablet, pill, drop pill, capsule, granule, powder, suppository, powder, paste, patch, injection, oral solution, suspension, spray, lotion, drop, rub or emulsion; preferably tablet, capsule, granule, powder or solution.

[0047] Compared with the prior art, the present application has the following beneficial effects:

[0048] (1) The present application uses the combination of cat's claw, dandelion, cyperus rotundus and ephedra, which can significantly treat thyroid nodules caused by insufficient thyroid hormone. Compared with the prior art, the composition of the present application is clear, safe, and has better treatment effect.

[0049] (2) The mechanism of the traditional Chinese medicine composition for treating thyroid nodule is studied, which provides technical support for the treatment of thyroid disease by traditional Chinese medicine. BRIEF DESCRIPTION OF DRAWINGS

[0050] Figure 1 is a SD rat thyroid nodule model.

[0051] Figure 2. Thyroid tissue of SD rats;

[0052] Figure 3 shows the trends of AST, ALT and BUN levels in the serum of SD rats. Detailed Implementation

[0053] The present invention will be described below through specific embodiments to make the technical solution of the present invention easier to understand and master. However, the present invention is not limited thereto. The described embodiments are only some embodiments of the present invention, and not all embodiments.

[0054] The endpoints and any values ​​of the ranges disclosed herein are not limited to the precise ranges or values, which should be understood to include values ​​close to them. For numerical ranges, one or more new numerical ranges can be obtained by combining the endpoint values ​​of the ranges, the endpoint values ​​of the ranges with individual point values, and individual point values ​​with each other, and these numerical ranges should be considered as specifically disclosed herein. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein include both singular and plural indicators. Numerical ranges expressed by endpoints include all numerical values ​​and fractions within the corresponding range, as well as the expressed endpoints.

[0055] the term

[0056] In this article, THs represents thyroid function levels, T4 represents tetraiodothyronine, T3 represents triiodothyronine, TSH represents thyroid-stimulating hormone, IL-6 represents interleukin-6, and TNF-α represents tumor necrosis factor.

[0057] The “medicine” described in this invention includes the aforementioned traditional Chinese medicine composition or pharmaceutical composition and acceptable excipients. In specific embodiments, the traditional Chinese medicine composition or pharmaceutical composition described in this invention is provided in the medicine in an effective amount (e.g., a therapeutically effective amount).

[0058] The "pharmaceuticalally acceptable excipients" described in this invention include inert diluents, dispersants and / or granulators, surfactants and / or emulsifiers, disintegrants, binders, preservatives, buffers, lubricants and / or oils. The pharmaceutical compositions may also contain excipients (e.g., cocoa butter and suppository waxes), colorants, coating agents, sweeteners, flavoring agents, and aroma agents.

[0059] The "medicine" described in this invention can be prepared by any method known in pharmaceutical science. Generally, these preparation methods involve associating the aforementioned traditional Chinese medicine composition (i.e., the first active ingredient) with a carrier or excipient and / or one or more other auxiliary ingredients, and then, if desired and / or expected, shaping and / or packaging the product into desired single-dose or multi-dose units.

[0060] The "medicament" of the present application can be prepared according to known methods, for example, the methods set forth in the general rules for preparation of the Chinese Pharmacopoeia (2020 edition), Japanese Pharmacopoeia (16th edition), United States Pharmacopoeia, and European Pharmacopoeia (9th edition). The specific preparation method depends on the dosage form.

[0061] The first active ingredient, pharmaceutically acceptable excipient in the "medicament" described in the present application will vary depending on the attributes, size and / or condition of the subject being treated and further depending on the route of administration of the composition. The medicament can comprise between 0.1% and 100% (w / w) of the first active ingredient.

[0062] "Treatment" as described in the present application means, unless otherwise indicated, reversing, alleviating, lessening, inhibiting progression of, or preventing the disorder or condition to which such term applies, or one or more symptoms of such disorder or condition, as the case can be. The term "treatment" as used in the application refers to therapeutic action, as "treatment" is defined immediately above.

[0063] "Effective amount" as described in the present application means an amount sufficient to elicit the desired biological response. The effective amount of an active ingredient of the present application can vary depending on such factors as the desired biological endpoint, the pharmacokinetics of the compound, the disorder being treated, the mode of administration, and the age and health of the subject. In certain embodiments, the effective amount is a therapeutically effective amount. An effective amount is the amount of the first active ingredient described in the present application in a single dose. In certain embodiments, an effective amount is the combined amount of the active ingredients described in the present application in multiple doses.

[0064] A "therapeutically effective amount" as described in the present application is an amount sufficient to provide a therapeutic benefit in the treatment of a disorder or to delay or minimize one or more symptoms associated with the disorder. A therapeutically effective amount of a traditional Chinese medicine composition or traditional Chinese medicine extract means an amount of a therapeutic agent alone or in combination with other therapies that provides a therapeutic benefit in the treatment of a disorder. The term "therapeutically effective amount" can encompass an amount that improves overall therapy, reduces or avoids symptoms, signs, or causes of a disorder, and / or enhances the therapeutic efficacy of another therapeutic agent. In certain embodiments, a therapeutically effective amount is an amount sufficient to treat any of the diseases or disorders described.

[0065] The term "subject" or "patient" as used herein is well understood in the art and is used interchangeably herein to refer to a mammal, including a dog, cat, rat, mouse, monkey, cow, horse, goat, sheep, pig, camel, and most preferably a human. The term does not connote a particular age or gender. Thus, adult and neonatal subjects, whether male or female, are encompassed.

[0066] The traditional Chinese medicine composition or the pharmaceutical composition described in the present application can also be used as one of the raw materials contained in a drug, a functional food or a health product.

[0067] Based on the examples in the present application, all other examples obtained by a person of ordinary skill in the art without making creative efforts shall fall within the scope of protection of the present application. The experimental methods described in the following examples are all conventional methods unless otherwise specified; and the reagents and materials described are all commercially available unless otherwise specified.

[0068] The cat's claw, dandelion, cyperus rotundus and ephedra sinica in the present application are conventional traditional Chinese medicine decoction pieces, which are purchased from the traditional Chinese medicine decoction piece factory of Guangdong Pharmaceutical Material Company.

[0069] Traditional Chinese medicine composition of example 1-2 and comparative example 1-2

[0070] [Preparation method]

[0071] According to the traditional Chinese medicine composition formula in table 1, the cat's claw, dandelion, cyperus rotundus and ephedra sinica of the formula amount are mixed, 10 times the amount of water is added, reflux extraction is carried out twice, each for 1.5 hours, the filtrate is combined, and concentrated to a relative density of 1.512 g / ml (50℃), which is ready.

[0072] Table 1 formula of traditional Chinese medicine composition of examples and comparative examples (unit: weight part)

[0073] * indicates that spirea prunifolia is used instead of cyperus rotundus.

[0074] [Efficacy verification]

[0075] The present application induces hypothyroidism and thyroid nodule model by propylthiouracil (PTU) induction, and explores the therapeutic protection of traditional Chinese medicine composition on thyroid.

[0076] 1、Experimental materials

[0077] 1.1 Drugs and reagents

[0078] Euthyrox 50 μg / tablet was purchased from Merck Pharmaceutical, Darmstadt, Germany; PTU (propylthiouracil) was purchased from Solarbio Technology Co., Ltd. Beijing; AST (glutamic-oxalacetic transaminase) test kit, ALT (glutamic-pyruvic transaminase) test kit, BUN (urea nitrogen) test kit were purchased from Nanjing Jiancheng Biological Engineering Institute.

[0079] 1.2 Experimental animals

[0080] Seventy male SD rats (180-200 g) were purchased from Guangdong Experimental Animal Center. The experimental animals were bred in a SPF barrier animal room environment with fixed temperature (22±2℃), stable humidity (50±10%) and 12-hour light / dark cycle.

[0081] 2, Animal grouping and drug administration

[0082] After 3 days of adaptive feeding, the rats were randomly divided into 6 groups, namely the blank control group (CON), the model group (MOD), the positive drug group (Euthyrox), the traditional Chinese medicine example 1 group (ZY1), the traditional Chinese medicine example 2 group (ZY2), the traditional Chinese medicine comparative example 1 group (DB1), and the traditional Chinese medicine comparative example 2 group (DB1). There were 9 rats in the blank control group, 11 rats in the model group, and 10 rats in each of the other groups.

[0083] The blank control group was not treated, and physiological saline was injected daily according to the body weight. The remaining rats in each group were subcutaneously injected with 1 mg / 100 g / d of PTU solution according to the body weight, for 28 days, to induce thyroid nodules and develop a thyroid nodule model. In addition, the positive drug group was given Euthyrox 2 μg / 100 g / d by gavage, and the operation was performed for 28 days. The traditional Chinese medicine group was given the traditional Chinese medicine composition liquid 0.378 g / 100 g / d by gavage, and the operation was performed for 28 days.

[0084] 3, Blood and tissue collection

[0085] After 4 weeks of drug intervention, all rats were anesthetized with isoflurane. Blood was collected from the abdominal aorta, placed at 4℃ for 1 h, and centrifuged at 3500 r / min for 15 min. The supernatant was collected and stored at -80℃ for subsequent use. After blood collection, the neck skin was incised to expose the thyroid tissue and lymphoid tissue, which was completely removed and weighed, and the relative thyroid weight [thyroid weight (mg) / rat weight (g)] was calculated. The liver, kidney, lung, spleen, intestinal tract and their contents were quickly stripped, and part of the thyroid, liver and kidney tissues were fixed in 4% paraformaldehyde for immunohistochemical staining, while the other part was frozen in liquid nitrogen and stored at -80℃; the lung, spleen, intestinal tract and their contents were stored in a -80℃ refrigerator after quenching in liquid nitrogen.

[0086] 4. Histopathological examination

[0087] The embedded thyroid tissue was cut into 1 mm, 2 blocks were fixed, then dehydrated, infiltrated, and embedded blocks. After being prepared into paraffin blocks, cut into 4 μm thickness sections and deparaffinized. Then stained with hematoxylin-eosin, dehydrated with ethanol and xylene, and made the sections transparent. Then sealed with neutral glue, and observed the pathological changes of thyroid under light microscope (thyroid follicle morphology, colloid cell distribution, fibroblast and epithelial cell morphology for evaluation of thyroid nodules).

[0088] 5. Biochemical analysis

[0089] The enzyme-linked immunosorbent assay (ELISA) was used to detect the contents of serum T3, T4, TSH hormones to evaluate the anti-hypothyroidism effect of the traditional Chinese medicine compound. And detect interleukin 6 (IL-6), tumor necrosis factor alpha (TNF-α) in serum to evaluate the anti-inflammatory efficacy of the traditional Chinese medicine compound. At the same time, detect the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and urea nitrogen (BUN) in serum to evaluate the liver and kidney function.

[0090] 6. Experimental results

[0091] 6.1 PTU constructs rat thyroid nodule model

[0092] After PTU gavage for 4 weeks, compared with the blank control group, the thyroid of the model group appeared obvious redness and swelling, and the volume became larger, indicating that the thyroid nodule model was successfully constructed, as shown in Figure 1.

[0093] 6.2 General observation

[0094] PTU is an antithyroid drug, which inhibits the synthesis of THs by inhibiting the iodination catalyzed by thyroid peroxidase and the coupling of tyrosine residues on thyroglobulin, thereby inducing the generation of thyroid nodule model. Systematic evaluation of the effect of traditional Chinese medicine composition on rat thyroid can be reflected from the observation of the general signs and body weight changes of rats.

[0095] The results are shown in Table 2.

[0096] After modeling for 4 weeks, the model group rats showed rough hair, slow movement, pale skin, apathy, lethargy and other performances, suggesting that the rats were in a low metabolic state caused by PTU, and the body weight of the model group rats was lower than that of the blank control group (P<0.05), indicating that PTU induced hypothyroidism in rats, which reduced the metabolic level of rats and reduced appetite.

[0097] After treatment, compared with the model group, the symptoms of all treatment groups were improved except for the traditional Chinese medicine comparative examples 1 and 2 groups. Compared with the model group, the body weight of the positive drug group was significantly increased (P<0.05), while the body weight of the other treatment groups had no significant change (P>0.05), but compared with the traditional Chinese medicine comparative examples 1 and 2 groups, the body weight of the SD rats in the traditional Chinese medicine examples 1 and 2 groups showed an increasing trend, as shown in Table 2.

[0098] Table 2 Effects of traditional Chinese medicine compositions on the body weight of rats

[0099] Note: Different letters in the table indicate significant differences between groups (P<0.05).

[0100] 6.3 Reducing the volume of thyroid gland

[0101] Figure 2 shows the size of the thyroid gland after treatment. Compared with the blank control group, the volume of the thyroid gland of the model group was significantly increased (P<0.05), and the average body weight of the model group was 100g lighter than that of the blank control group, indicating that the drug PTU successfully caused the enlargement of the thyroid tissue of the rats.

[0102] After four weeks of treatment, compared with the model group, the volume of the thyroid gland of the positive drug group, the traditional Chinese medicine examples 1 and 2 groups was reduced, among which the treatment effect of the traditional Chinese medicine example 1 group was the best, similar to the positive drug group, and the enlargement of the thyroid tissue was significantly improved (P<0.05).

[0103] 6.4 Improving the function of the thyroid gland of rats

[0104] After treatment with the traditional Chinese medicine composition, the serum THs level of the rats in each group was detected to verify whether the traditional Chinese medicine composition regulates the function of the thyroid gland.

[0105] The results are shown in Table 3.

[0106] Table 3 Effects of traditional Chinese medicine compositions on the serum THs of rats

[0107] Note: Different letters in the table indicate significant differences between groups (P<0.05).

[0108] The results show that the PTU drug induces the abnormal function of the thyroid gland of the model group of rats, resulting in the increase of TSH, T3 and T4 compared with the blank control group (P<0.05). The above dysfunction of the positive drug group, the traditional Chinese medicine examples 1 and 2 groups is improved (P<0.05), indicating that the traditional Chinese medicine compositions provided by the examples 1 and 2 of the present application have good regulation ability on THs.

[0109] Meanwhile, compared with the model group, the TSH content in the serum of the traditional Chinese medicine comparative example 1 group and the traditional Chinese medicine comparative example 2 group has no significant difference (P>0.05), the T3 and T4 contents in the serum are significantly reduced (P>0.05), but compared with the traditional Chinese medicine example 1 group and the traditional Chinese medicine example 2 group, the TSH levels in the serum of the rats have significant differences (P<0.05), indicating that the traditional Chinese medicine composition provided by the example 1 and the example 2 of the present application has a better effect of improving the thyroid function of rats than the traditional Chinese medicine composition provided by the comparative example 1 and the comparative example 2.

[0110] 6.5 Improvement of inflammation caused by thyroid nodules in rats

[0111] After the treatment of the traditional Chinese medicine composition, the expression levels of inflammatory factors IL-6 and TNF-α in the serum of rats in each group are detected to verify whether the traditional Chinese medicine composition has the effects of anti-inflammation, detumescence and knot-dissolving.

[0112] The results are shown in Table 4.

[0113] Table 4 Influence of the traditional Chinese medicine composition on inflammatory factors in rats

[0114] Note: Different letters in the table indicate significant differences between groups (P<0.05).

[0115] The results show that the expression levels of inflammatory factors in the serum of the model group of rats are significantly higher than those of the blank control group (P<0.05).

[0116] Compared with the model group, the expression levels of inflammatory factors in each administration group are effectively reduced (P<0.05). Meanwhile, compared with the traditional Chinese medicine comparative example 1 group and the traditional Chinese medicine comparative example 2 group, the expression levels of inflammatory factors in the serum of the rats in the traditional Chinese medicine example 1 group and the traditional Chinese medicine example 2 group are significantly reduced, indicating that compared with the traditional Chinese medicine composition provided by the comparative example 1 and the comparative example 2, the traditional Chinese medicine composition provided by the example 1 and the example 2 of the present application shows better regulation ability to IL-6 and TNF-α and plays a better anti-inflammatory effect.

[0117] 6.6 Influence on liver and kidney coefficients

[0118] The present medicine formula contains 4 kinds of traditional Chinese medicines, and according to the guidance of the theory of traditional Chinese medicine, the compatibility of the traditional Chinese medicines may cause potential side effects or adverse reactions. Therefore, the inventors also pay attention to the changes of serum liver and kidney injury markers to ensure the safety of the medicine.

[0119] As shown in FIG. 3, compared with the blank control group, the differences in the levels of ALT, AST and BUN in the serum of rats between groups have no statistical significance (P>0.05), indicating that the traditional Chinese medicine composition provided by the present application does not produce toxic side effects on the liver and kidney, and is in line with the safety standard of medicine and can be applied to subsequent human experiments.

[0120] Finally, it should be noted that the above is only to illustrate the technical solutions of the present application, and is not a limitation on the scope of protection of the present application, and simple modifications or equivalent replacements of the technical solutions of the present application by those skilled in the art do not deviate from the essence and scope of the technical solutions of the present application.

Claims

1. A traditional Chinese medicine composition, characterized in that, The cat's paw grass, dandelion, cyperus rotundus and euphorbia anserina are composed of the following raw materials by weight: cat's paw grass 1-120 parts, dandelion 1-30 parts, cyperus rotundus 1-20 parts and euphorbia anserina 1-20 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The mass ratio of the cat's paw grass, dandelion, cyperus rotundus and euphorbia anserina is 5-6:1-4:2-8:2-6.

3. The preparation method of the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The method comprises the following steps: mixing and crushing the cat's paw grass, dandelion, cyperus rotundus and euphorbia anserina in the formula amount; or The cat's paw grass, dandelion, cyperus rotundus and euphorbia anserina in the formula amount are extracted, purified and enriched to obtain the traditional Chinese medicine composition.

4. The use of the traditional Chinese medicine composition of claim 1 in the preparation of a drug for the treatment of diseases caused by the increase of thyroid hormone.

5. The use of the traditional Chinese medicine composition of claim 1 in the preparation of a drug for the treatment of diseases caused by the decrease of THs level.

6. The use of the traditional Chinese medicine composition of claim 1 in the preparation of a drug for the treatment of hypothyroidism or thyroid nodule.

7. Use according to claim 4 or 5, characterized in that, The diseases include hypothyroidism and / or thyroid nodule.

8. Use according to claim 7, characterized in that, The thyroid nodule includes at least one of nodular goiter, thyroid adenoma, acute thyroiditis, chronic thyroiditis and thyroid micro-papillary carcinoma.

9. A pharmaceutical composition for treating thyroid disease, comprising, The pharmaceutical composition comprises the traditional Chinese medicine composition of claim 1 or 2 and a medically acceptable adjuvant.

10. The pharmaceutical composition of claim 9, wherein, The dosage form of the pharmaceutical composition is tablet, pill, dripping pill, capsule, granule, powder, suppository, powder, paste, patch, injection, oral solution, suspension, spray, lotion, drop, rub or emulsion. The diseases include hypothyroidism and / or thyroid nodule. The thyroid nodule includes at least one of nodular goiter, thyroid adenoma, acute thyroiditis, chronic thyroiditis and thyroid micro-papillary carcinoma. The pharmaceutical composition comprises the traditional Chinese medicine composition of claim 1 or 2 and a medically acceptable adjuvant. The dosage form of the pharmaceutical composition is tablet, pill, dripping pill, capsule, granule, powder, suppository, powder, paste, patch, injection, oral solution, suspension, spray, lotion, drop, rub or emulsion.

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