A traditional Chinese medicine composition, its preparation method, and its application in the preparation of drugs for the prevention and treatment of thyroid diseases.

Abstract

This invention discloses a traditional Chinese medicine composition, its preparation method, and its application in the preparation of drugs for the prevention and treatment of thyroid diseases, belonging to the field of traditional Chinese medicine technology. The traditional Chinese medicine composition comprises *Uncaria rhynchophylla*, *Taraxacum mongolicum*, *Cyperus rotundus*, and *Semiaquilegia adoxoides*. The preparation method includes the following steps: mixing and pulverizing the prescribed amounts of *Uncaria rhynchophylla*, *Taraxacum mongolicum*, *Cyperus rotundus*, and *Semiaquilegia adoxoides*; or extracting the prescribed amounts of *Uncaria rhynchophylla*, *Taraxacum mongolicum*, *Cyperus rotundus*, and *Semiaquilegia adoxoides*. This invention utilizes the compound combination of four traditional Chinese medicines—*Uncaria rhynchophylla*, *Taraxacum mongolicum*, *Cyperus rotundus*, and *Semiaquilegia adoxoides*—to significantly treat hypothyroidism and thyroid nodules caused by insufficient thyroid hormones. Compared with existing technologies, this invention has clearly defined components, good safety, and better therapeutic effects, providing technical support for the treatment of thyroid diseases with traditional Chinese medicine.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and relates to a traditional Chinese medicine composition, its preparation method, and its application in the preparation of drugs for the prevention and treatment of thyroid diseases. Background Technology

[0002] Thyroid nodules are a common endocrine disorder, including nodular goiter, thyroid adenoma, acute thyroiditis, hyperthyroidism, and papillary thyroid microcarcinoma. Thyroid nodules are a global public health issue, and with the fast pace of modern life, the incidence of thyroid nodules is increasing year by year.

[0003] The most common treatments for thyroid nodules include radioactive iodine therapy, antithyroid drug therapy, hormone replacement therapy, and surgery, though the treatment remains controversial. Younger patients, those with large thyroid nodules, or those with a large thyroid volume are at higher risk of recurrence after discontinuing antithyroid drug therapy. Surgery can treat thyroid nodules; however, total thyroidectomy leads to permanent hypothyroidism requiring lifelong thyroid-stimulating hormone (TSH) supplementation, while subtotal thyroidectomy can lead to recurrence. During radioactive iodine therapy for thyroid nodules, thyroid hormone (TH) levels should be monitored regularly, as hypothyroidism can occur within 2-3 years post-treatment. Therefore, it is necessary to find a safer and more effective treatment for thyroid nodules.

[0004] CN109568477A discloses a pharmaceutical composition for treating thyroid nodules, prepared from the following raw materials in the indicated weight ratios: Cyperus rotundus 9-15 parts, Paeonia lactiflora 9-15 parts, Sargassum fusiforme 16-24 parts, Bupleurum chinense 8-12 parts, Laminaria japonica 12-18 parts, Fritillaria cirrhosa 30-45 parts, Pinellia ternata 8-12 parts, Citrus reticulata peel 5-7 parts, Citrus aurantium peel 8-12 parts, Angelica sinensis 12-18 parts, Ligusticum chuanxiong 8-12 parts, Forsythia suspensa 8-12 parts, Ostrea gigas 12-18 parts, and Prunella vulgaris 7-11 parts. This invention can significantly alleviate the clinical symptoms of patients with thyroid nodules and effectively treat thyroid nodules.

[0005] CN113209208A discloses a traditional Chinese medicine composition and its preparation method for treating thyroid nodules. The raw materials for this composition include Bupleurum chinense, Citrus aurantium, Cyperus rotundus, Uncaria rhynchophylla, fossilized bone, oyster shell, Ligusticum chuanxiong, Paeonia lactiflora, Citrus reticulata peel, Pinellia ternata, and Glycyrrhiza uralensis. This invention can effectively improve the clinical symptoms of patients with thyroid nodules, regulate thyroid hormone levels, control and delay the progression of thyroid nodules, improve nodule size, regulate the patient's overall function, and change the constitution that predisposes them to thyroid nodules, thus providing fundamental intervention.

[0006] CN110393781A discloses a pure traditional Chinese medicine preparation for treating thyroid nodules, comprising the following ingredients by weight-volume ratio: 15-30 parts of Prunella vulgaris, 15-30 parts of Taraxacum mongolicum, 10-20 parts of Forsythia suspensa, 10-20 parts of Fritillaria cirrhosa, 30-60 parts of raw oyster shell, 10-20 parts of Uncaria rhynchophylla, 15-20 parts of Gleditsia sinensis thorns, 10-20 parts of Curcuma longa, 20-30 parts of raw turtle shell, 5-10 parts of Cremastra appendiculata, and 10-15 parts of Semiaquilegia adoxoides. This invention can significantly reduce the size of thyroid nodules, eliminate clinical symptoms, and alleviate pain in patients.

[0007] Traditional Chinese medicine (TCM) treatment for thyroid nodules has significant advantages over Western medicine, including better safety and a greater avoidance of the risks associated with long-term oral hormone therapy, such as drug dependence and thyroid function changes, as well as the risks of lifelong thyroid hormone dependence and nodule recurrence after surgical removal of thyroid nodules. However, current TCM formulas for treating thyroid diseases still have issues such as complex ingredients, unclear side effects, and long treatment durations. Summary of the Invention

[0008] To address the above-mentioned technical problems, this invention provides a traditional Chinese medicine composition, its preparation method, and its application in the preparation of drugs for the prevention and treatment of thyroid diseases.

[0009] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0010] In a first aspect, the present invention provides a traditional Chinese medicine composition composed of cat's claw grass, dandelion, cyperus rhizome and safflower seed.

[0011] In this invention, *Ranunculus ternatus* Thunb., a perennial herb belonging to the genus *Ranunculus* of the family Ranunculaceae, is used medicinally. Its tuberous root is sweet and pungent in taste, warm in nature, and has the effects of dispersing nodules and reducing swelling. It is used for scrofula before ulceration and lymph node tuberculosis. Dandelion is a commonly used traditional Chinese medicine; the whole plant is used medicinally. It contains taraxasterol, taraxerol, taraxacin, caffeic acid, choline, inulin, and other components, and can clear heat and detoxify, reduce swelling and disperse nodules. *Smilax glabra* seeds also have the effects of clearing heat and detoxifying, reducing swelling and dispersing nodules, and are mainly used to treat scrofula. *Cyperus rotundus* has antibacterial and analgesic effects, and can promote qi circulation and relieve depression. This invention utilizes a compound of four traditional Chinese medicines with clearly defined components and good safety, and can significantly treat thyroid nodules caused by insufficient thyroid hormone.

[0012] In some preferred embodiments, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 1-120 parts of cat's claw herb, 1-30 parts of dandelion, 1-20 parts of cyperus rhizome, and 1-20 parts of safflower seed.

[0013] In some preferred embodiments, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 1-100 parts of cat's claw herb, 1-25 parts of dandelion, 1-18 parts of cyperus rhizome, and 1-18 parts of safflower seed.

[0014] In some preferred embodiments, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 1-80 parts of cat's claw herb, 1-20 parts of dandelion, 1-15 parts of cyperus rhizome, and 1-15 parts of safflower seed.

[0015] In some preferred embodiments, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 1-50 parts of cat's claw herb, 1-18 parts of dandelion, 1-12 parts of cyperus rhizome, and 1-12 parts of safflower seed.

[0016] In some preferred embodiments, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 1-20 parts of cat's claw herb, 1-15 parts of dandelion, 1-10 parts of cyperus rhizome, and 1-10 parts of safflower seed.

[0017] In some preferred embodiments, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 1-15 parts of cat's claw herb, 1-10 parts of dandelion, 1-8 parts of cyperus rhizome, and 1-8 parts of safflower seed.

[0018] In some preferred embodiments, the mass ratio of cat's claw grass, dandelion, cyperus rhizome and safflower seed is 5-6:1-4:2-8:2-6; more preferably 5-6:3-4:2-3:2-3; and most preferably 5:3:2:2.

[0019] Secondly, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: mixing and pulverizing the prescribed amounts of cat's claw herb, dandelion, cyperus rhizome, and safflower seed; or

[0020] The prescribed amounts of cat's claw herb, dandelion, cyperus rhizome, and safflower seed were extracted, purified, and enriched to obtain the aforementioned traditional Chinese medicine composition.

[0021] The extraction described in this invention can be performed by extracting each herb separately and then mixing them together, or by mixing each herb and then extracting them together.

[0022] In some implementations, the extraction process further includes a crushing treatment, in which the prescribed amounts of cat's claw grass, dandelion, cyperus rhizome, and safflower seed are crushed before extraction.

[0023] In some embodiments, the extraction is a water extraction and / or an alcohol extraction.

[0024] In some implementations, the extraction is a water extraction, comprising the following steps:

[0025] The prescribed amounts of cat's claw grass, dandelion, cyperus rhizome, and safflower seed were mixed and extracted with water. The filtrates were combined to obtain the Chinese herbal composition.

[0026] Preferably, the amount of water used is 5-20 times the total amount of the extracted raw materials, more preferably 8-12 times; and even more preferably 10-11 times.

[0027] Preferably, the water extraction is performed at least once, preferably 1-3 times, and more preferably 2-3 times; the extraction time for each extraction is 0.5-3 hours, preferably 1-2.5 hours, and more preferably 1-2 hours.

[0028] In some embodiments, the combined filtrate is further concentrated and / or dried.

[0029] Thirdly, the present invention provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating diseases by increasing thyroid hormone levels.

[0030] In some implementations, the disease includes hypothyroidism and / or thyroid nodules.

[0031] In some embodiments, the thyroid nodule includes at least one of nodular goiter, thyroid adenoma, acute thyroiditis, chronic thyroiditis, and papillary thyroid microcarcinoma.

[0032] Fourthly, the present invention provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating diseases by lowering TH levels.

[0033] In some implementations, the THs include at least one of T4, T3, and TSH.

[0034] In some implementations, the disease includes hypothyroidism and / or thyroid nodules.

[0035] In some embodiments, the thyroid nodule includes at least one of nodular goiter, thyroid adenoma, acute thyroiditis, chronic thyroiditis, and papillary thyroid microcarcinoma.

[0036] Fifthly, the present invention provides the application of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating hypothyroidism.

[0037] Sixthly, the present invention provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating thyroid nodules.

[0038] In some embodiments, the thyroid nodule includes at least one of nodular goiter, thyroid adenoma, acute thyroiditis, chronic thyroiditis, and papillary thyroid microcarcinoma.

[0039] The traditional Chinese medicine composition of the present invention can achieve adjunctive treatment of thyroid diseases by reducing the level of thyroid function and / or the expression of inflammatory factors in serum.

[0040] In some embodiments, the thyroid function level includes at least one of tetraiodothyronine level, triiodothyronine level, and thyroid-stimulating hormone level.

[0041] In some implementations, the inflammatory factors include IL-6 and / or TNF-α.

[0042] In a seventh aspect, the present invention provides a pharmaceutical composition for treating thyroid diseases, comprising the aforementioned traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0043] In some embodiments, the dosage form of the pharmaceutical composition is tablets, pills, drops, capsules, granules, powders, suppositories, powders, ointments, patches, injections, oral solutions, suspensions, sprays, lotions, drops, liniments, or emulsions; preferably tablets, capsules, granules, powders, or solutions.

[0044] Compared with the prior art, the present invention has the following beneficial effects:

[0045] (1) This invention utilizes a combination of four Chinese medicinal herbs: cat's claw grass, dandelion, cyperus rhizome, and safflower seed, which can significantly treat thyroid nodules caused by insufficient thyroid hormones. Compared with the prior art, the components of this invention are clearly defined, the safety is good, and the therapeutic effect is better.

[0046] (2) This invention studies the mechanism of traditional Chinese medicine components in treating thyroid nodules, providing technical support for the treatment of thyroid diseases with traditional Chinese medicine. Attached Figure Description

[0047] Figure 1 SD rat thyroid nodule model;

[0048] Figure 2 SD rat thyroid tissue;

[0049] Figure 3 The trends of changes in serum AST, ALT, and BUN levels in SD rats are shown. Detailed Implementation

[0050] 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.

[0051] 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.

[0052] the term

[0053] 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.

[0054] 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).

[0055] 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.

[0056] 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.

[0057] The "medicine" of this invention can be prepared according to known methods, such as those described in the general rules for preparation in the Chinese Pharmacopoeia (2020 edition), the 16th edition of the Japanese Pharmacopoeia, the United States Pharmacopoeia, and the 9th edition of the European Pharmacopoeia. The specific preparation method depends on the dosage form.

[0058] The first active ingredient and pharmaceutically acceptable excipients in the "medicine" described in this invention will vary depending on the attributes, body type, and / or condition of the treated subject and further on the route of administration of the composition. The medicine may contain between 0.1% and 100% (w / w) of the first active ingredient.

[0059] As used herein, “treatment” means, unless otherwise stated, reversing or alleviating the condition or disease to which the term applies, or one or more symptoms of such condition or disease, inhibiting the progression of said condition or disease or one or more symptoms thereof, or preventing said condition or disease or one or more symptoms thereof. As used in this invention, the term “treatment” refers to a therapeutic act, as defined above.

[0060] The term "effective amount" as used in this invention refers to an amount sufficient to elicit the desired biological response. The effective amount of the active ingredient of this invention may vary depending on factors such as the desired biological endpoint, the pharmacokinetics of the compound, the condition being treated, the administration pattern, and the age and health status of the subject. In some embodiments, the effective amount is a therapeutically effective amount. The effective amount is the amount of the first active ingredient described in this invention in a single dose. In some embodiments, the effective amount is a combined amount of the active ingredient described in this invention in multiple doses.

[0061] The term "therapeuticly effective amount" as used in this invention refers to an amount sufficient to provide therapeutic benefit in the treatment of a condition or sufficient to delay or minimize one or more symptoms associated with that condition. For traditional Chinese medicine compositions or extracts, a therapeutically effective amount means an amount that provides therapeutic benefit in the treatment of a condition, alone or in combination with other therapies. The term "therapeuticly effective amount" may encompass amounts that improve overall therapy, reduce or avoid symptoms, signs, or causes of a condition, and / or enhance the therapeutic efficacy of another therapeutic agent. In some embodiments, a therapeutically effective amount is an amount sufficient to treat any of the diseases or conditions described.

[0062] As used herein, the terms "subject" or "patient" are well known in the art and are used interchangeably to refer to mammals, including dogs, cats, rats, mice, monkeys, cows, horses, goats, sheep, pigs, camels, and most preferably humans. This term does not imply a specific age or sex. Therefore, adult and neonatal subjects, whether male or female, are included.

[0063] The traditional Chinese medicine composition or pharmaceutical composition described in this invention can also be used as one of the raw materials in pharmaceuticals, functional foods or health products.

[0064] Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without inventive effort should fall within the scope of protection of this invention. Unless otherwise specified, the experimental methods described in the following embodiments are conventional methods; the reagents and materials described, unless otherwise specified, are commercially available.

[0065] The cat's claw herb, dandelion, cyperus rhizome, and safflower seed used in this invention are conventional Chinese medicinal herbs, purchased from the Chinese medicinal herb processing plant of Guangdong Pharmaceutical Company.

[0066] Traditional Chinese medicine compositions of Examples 1-2 and Comparative Examples 1-2

[0067] [Preparation Method]

[0068] According to the herbal composition formula in Table 1, take the prescribed amounts of cat's claw grass, dandelion, cyperus rhizome and safflower seed, mix them together, add 10 times the amount of water and reflux extract twice, 1.5 hours each time, combine the filtrates, and concentrate to a relative density of 1.512 g / ml (50℃).

[0069] Table 1. Formulations of the traditional Chinese medicine compositions in the examples and comparative examples (unit: parts by weight)

[0070] Cat's Claw Dandelion Cyperus rotundus Tiankuizi Example 1 5 3 2 2 Example 2 5 1 8 6 Comparative Example 1 1 1 1 1 Comparative Example 2 5 3 2* 2

[0071] * indicates that Prunella vulgaris was used instead of Cyperus rotundus.

[0072] [Efficacy Verification]

[0073] This invention investigates the therapeutic and protective effects of a traditional Chinese medicine composition on the thyroid gland by inducing hypothyroidism and thyroid nodules using a propylthiouracil (PTU)-induced hypothyroidism model.

[0074] 1. Experimental Materials

[0075] 1.1 Drugs and Reagents

[0076] Levothyroxine sodium tablets (Euthyroxine 50μg / tablet) were purchased from Merck Pharmaceutical (Darmstadt, Germany); PTU (propylthiouracil) was purchased from Beijing Solarbio Technology Co., Ltd.; Aspartate aminotransferase (AST / GOT) test kits, alanine aminotransferase (ALT / GPT) test kits, and blood urea nitrogen (BUN) test kits were all purchased from Nanjing Jiancheng Bioengineering Institute.

[0077] 1.2 Laboratory Animals

[0078] Seventy male SD rats (180-200g) were purchased from the Guangdong Provincial Experimental Animal Center. All experimental animals were housed in an SPF-grade barrier animal room with a fixed temperature (22±2℃), stable humidity (50±10%), and a 12-hour light / dark cycle.

[0079] 2. Animal grouping and administration

[0080] After 3 days of acclimatization, the rats were randomly divided into 6 groups: blank control group (CON), model group (MOD), positive drug group (Euthyrox), traditional Chinese medicine example 1 group (ZY1), traditional Chinese medicine example 2 group (ZY2), traditional Chinese medicine comparison group 1 (DB1), and traditional Chinese medicine comparison group 2 (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.

[0081] The blank control group received no treatment and was injected daily with a dose of physiological saline corresponding to the drug volume based on body weight. The remaining rats in each group were subcutaneously injected daily with 1 mg / 100 g / d of PTU solution based on body weight for 28 days to induce thyroid nodules and develop a thyroid nodule model. In addition, the positive control group was administered 2 μg / 100 g / d of levothyroxine via gavage for 28 days. The traditional Chinese medicine group was administered 0.378 g / 100 g / d of a traditional Chinese medicine composition via gavage for 28 days.

[0082] 3. Blood and tissue collection

[0083] Four weeks after drug intervention, all rats were anesthetized with isoflurane. Blood was collected from the abdominal aorta, incubated at 4°C for 1 hour, and centrifuged at 3500 rpm for 15 minutes. The supernatant was collected and stored at -80°C for later use. After blood collection, the neck skin was incised to expose the thyroid and lymphoid tissues, which were completely removed and weighed to calculate the relative thyroid mass [thyroid mass (mg) / rat body weight (g)]. The liver, kidneys, lungs, spleen, intestines, and their contents were quickly dissected. Parts of the thyroid, liver, and kidney tissues were fixed in 4% paraformaldehyde for immunohistochemical staining, while other parts were frozen in liquid nitrogen and stored at -80°C. The lungs, spleen, intestines, and their contents were quenched in liquid nitrogen and stored at -80°C.

[0084] 4. Histopathological examination

[0085] The embedded thyroid tissue was cut into 1 mm pieces, fixed in two sections, and then dehydrated, infiltrated, and embedded again. After preparing paraffin blocks, these were cut into 4 μm thick sections and dewaxed. The sections were then stained with hematoxylin and eosin, and dehydrated using ethanol and xylene to make them clear. They were then sealed with neutral glue and observed under a light microscope (thyroid follicle morphology, glial cell distribution, fibroblast and epithelial cell morphology were used to assess thyroid nodules).

[0086] 5. Biochemical analysis

[0087] Serum T3, T4, and TSH levels were measured using enzyme-linked immunosorbent assay (ELISA) to evaluate the anti-hypothyroidism effect of a traditional Chinese medicine compound. Serum interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels were also measured to assess the anti-inflammatory efficacy of the compound. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and blood urea nitrogen (BUN) levels were simultaneously measured to assess liver and kidney function.

[0088] 6. Experimental Results

[0089] 6.1 PTU-based model of rat thyroid nodules

[0090] Four weeks after PTU gavage, compared with the blank control group, the thyroid gland in the model group showed significant redness and swelling, and its volume increased, indicating that the thyroid nodule model was successfully established. Figure 1 As shown.

[0091] 6.2 General Observation

[0092] PTU is an antithyroid drug that inhibits the synthesis of thyroid hormones (THs) by suppressing iodination catalyzed by thyroid peroxidase and the coupling of tyrosine residues on thyroglobulin, thereby inducing the formation of a thyroid nodule model. A systematic review of the effects of traditional Chinese medicine compositions on the thyroid gland in rats can be conducted by observing changes in the rats' general physical signs and body weight.

[0093] The results are shown in Table 2.

[0094] Four weeks after modeling, the rats in the model group showed signs such as rough hair, slow movement, pale skin, apathy, and lethargy, indicating that the rats were in a low metabolic state induced by PTU. The body weight of the rats in the model group was lower than that of the blank control group (P<0.05), indicating that PTU induced hypothyroidism in rats, which reduced the metabolic level and appetite in the rats.

[0095] After treatment, compared with the model group, all treatment groups except for the Chinese medicine control groups 1 and 2 showed improvement in symptoms. Compared with the model group, the physical condition of rats in the positive drug group was significantly increased (P < 0.05), while the body weight of other treatment groups did not change significantly (P > 0.05). However, compared with the Chinese medicine control groups 1 and 2, the physical condition of SD rats in the Chinese medicine example groups 1 and 2 showed an increasing trend, as shown in Table 2.

[0096] Table 2 Results of the effect of traditional Chinese medicine composition on rat body weight

[0097]

[0098] Note: Different letters in the table indicate significant differences between groups (P < 0.05).

[0099] 6.3 Reduce thyroid volume

[0100] Figure 2 The size of the thyroid gland after treatment. Compared with the blank control group, the thyroid gland volume of rats in the model group was significantly increased (P<0.05), and the average weight of rats in the model group was 100g lighter than that in the blank control group, indicating that the drug PTU successfully induced thyroid tissue enlargement in rats.

[0101] After four weeks of treatment, compared with the model group, the thyroid volume of the positive drug group, the traditional Chinese medicine example 1 group and the 2 group decreased. Among them, the traditional Chinese medicine example 1 group had the best treatment effect, and similar to the positive drug group, the thyroid tissue enlargement was significantly improved (P<0.05).

[0102] 6.4 Improvement of thyroid function in rats

[0103] After treatment with the traditional Chinese medicine composition, the serum THs levels of rats in each group were measured to verify whether the traditional Chinese medicine composition could regulate thyroid function.

[0104] The results are shown in Table 3.

[0105] Table 3. Effects of traditional Chinese medicine composition on serum THs in rats

[0106]

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

[0108] The results showed that the PTU-induced model group rats had abnormal thyroid function, resulting in elevated levels of TSH, T3, and T4 compared to the blank control group (P<0.05). The above-mentioned functional disorders in the positive drug group, the traditional Chinese medicine Example 1 group, and the second group were all improved (P<0.05), indicating that the traditional Chinese medicine compositions provided in Examples 1 and 2 of this invention have good regulatory ability on THs.

[0109] Meanwhile, compared with the model group, there was no significant difference in the TSH content in the serum of rats in the Chinese medicine comparative groups 1 and 2 (P>0.05), and the content of T3 and T4 in the serum was significantly reduced (P>0.05). However, compared with the Chinese medicine examples 1 and 2, the THs levels in the rat serum were significantly different (P<0.05), indicating that the Chinese medicine compositions provided in Examples 1 and 2 of this invention have a better effect on improving thyroid function in rats than the Chinese medicine compositions provided in comparative groups 1 and 2.

[0110] 6.5 Improves inflammation induced by thyroid nodules in rats

[0111] After treatment with the traditional Chinese medicine composition, the expression levels of inflammatory factors IL-6 and TNF-α in the serum of rats in each group were detected to verify whether the traditional Chinese medicine composition has anti-inflammatory, swelling-reducing and nodule-dispersing effects.

[0112] The results are shown in Table 4.

[0113] Table 4. Effects of traditional Chinese medicine composition on inflammatory factors in rats.

[0114]

[0115] Note: Different letters in the table indicate significant differences between groups (P < 0.05).

[0116] The results showed that the expression levels of inflammatory factors in the serum of rats in the model group were significantly higher than those in the blank control group (P<0.05).

[0117] Compared with the model group, the expression levels of inflammatory factors in each treatment group were effectively reduced (P<0.05). Meanwhile, compared with the comparative groups 1 and 2 of the traditional Chinese medicine, the expression levels of inflammatory factors in the serum of rats in the traditional Chinese medicine examples 1 and 2 were significantly reduced, indicating that compared with the traditional Chinese medicine compositions provided in comparative groups 1 and 2, the traditional Chinese medicine compositions provided in examples 1 and 2 of this invention exhibit better regulatory ability on IL-6 and TNF-α, and exert a superior anti-inflammatory effect.

[0118] 6.6 Effects on liver and kidney coefficients

[0119] This prescription contains four traditional Chinese medicines. According to the principles of traditional Chinese medicine, their combination may cause potential side effects or adverse reactions. Therefore, the inventors also paid attention to changes in serum liver and kidney damage markers to ensure the safety of the drug.

[0120] Depend on Figure 3 It can be seen that, compared with the blank control group, there were no statistically significant differences in the levels of ALT, AST and BUN in the serum of rats among the groups (P>0.05), indicating that the traditional Chinese medicine composition provided by the present invention will not produce toxic side effects on the liver and kidneys, meets the standards for safe drug use, and can be applied in subsequent human experiments.

[0121] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for treating thyroid nodules, characterized in that, It is composed of the following ingredients in parts by weight: 5 parts cat's claw grass, 3 parts dandelion, 2 parts cyperus rhizome and 2 parts safflower seed, or 5 parts cat's claw grass, 1 part dandelion, 8 parts cyperus rhizome and 6 parts safflower seed. The preparation method of the traditional Chinese medicine composition is as follows: take the prescribed amount of cat's claw grass, dandelion, cyperus rhizome and safflower seed, mix them, add 8-12 times the amount of water and reflux extract 1-3 times, each time for 1-2.5 hours, combine the filtrates, and it is ready.

2. The method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, The process includes the following steps: Take the prescribed amounts of cat's claw grass, dandelion, cyperus rhizome, and safflower seed, mix them together, add 8-12 times the amount of water, and reflux extract 1-3 times, each time for 1-2.5 hours. Combine the filtrates, and it is ready.

3. The preparation method according to claim 2, characterized in that, The process includes the following steps: Take the prescribed amounts of cat's claw grass, dandelion, cyperus rhizome, and safflower seed, mix them together, add 10 times the amount of water, and reflux extract twice, 1.5 hours each time. Combine the filtrates, and the extract is ready.

4. The use of the traditional Chinese medicine composition of claim 1 in the preparation of a medicament for treating thyroid nodules.

5. A pharmaceutical composition for treating thyroid nodules, characterized in that, It is made from the traditional Chinese medicine composition as described in claim 1 and medically acceptable excipients.

6. The pharmaceutical composition according to claim 5, characterized in that, The dosage form of the pharmaceutical composition is tablet, pill, capsule, granule, powder, suppository, powder, ointment, patch, injection, oral solution, suspension, spray, lotion, drops, liniment or emulsion.

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