A traditional Chinese medicine compound for treating hashimoto's thyroiditis

Abstract

The application provides a traditional Chinese medicine compound for treating Hashimoto's thyroiditis, and relates to the technical field of traditional Chinese medicine pharmacy.The traditional Chinese medicine compound is composed of traditional Chinese medicinal materials of mountain yam, Humulus scandens, catechu, Sabina tibetica, bitter ground ivy, crossandra infundibuliformis, Usnea, luffa, bergamot, oleander, rootless incense, gardenia leaf, eucommia, mulberry ear, has the effects of resolving phlegm and removing nodules, promoting blood circulation to remove stasis, regulating qi to relieve depression, and clearing heat and resolving toxins, is suitable for treating Hashimoto's thyroiditis.The traditional Chinese medicine compound can effectively regulate the levels of TPOAb, TgAb and thyroid hormone, and has a good anti-inflammatory effect, so that excellent treatment of Hashimoto's thyroiditis is realized.The traditional Chinese medicine compound can be further popularized and applied as a medicine for treating Hashimoto's thyroiditis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine manufacturing technology, specifically to a traditional Chinese medicine compound for treating Hashimoto's thyroiditis. Background Technology

[0002] Hashimoto's thyroiditis (HT), also known as chronic lymphocytic thyroiditis, is an autoimmune disease and a common aseptic inflammation of the thyroid gland. Clinically, it is characterized by diffuse thyroid enlargement, lymphocytic infiltration within the gland, and elevated levels of thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TGAb) in the serum. HT is the most common thyroid disease, and its incidence is increasing year by year. Recent studies have found a positive correlation between HT and the incidence of papillary thyroid carcinoma (PTC), suggesting that HT may be a precancerous lesion. Therefore, HT has received increasing attention, but there is currently no cure. Western medicine currently mainly uses thyroid hormone (L-T4) replacement therapy, surgical treatment, and selenium-based adjuvant therapy, but all of these have certain limitations.

[0003] Hashimoto's thyroiditis is a modern medical term, but based on its clinical symptoms, ancient medical texts categorize it under the traditional Chinese medicine concept of "goiter." Traditional Chinese medicine, guided by a holistic approach and syndrome differentiation, has significant advantages in treating Hashimoto's thyroiditis. Throughout history, traditional Chinese medicine has provided valuable insights into this condition, resulting in numerous advancements in its understanding. Summary of the Invention

[0004] (a) Technical problems to be solved

[0005] In view of the shortcomings of the existing technology, the present invention provides a traditional Chinese medicine compound for the treatment of Hashimoto's thyroiditis.

[0006] (II) Technical Solution

[0007] To achieve the above objectives, the present invention provides the following technical solution:

[0008] In a first aspect, the present invention provides a traditional Chinese medicine compound for treating Hashimoto's thyroiditis, the traditional Chinese medicine compound being composed of the following traditional Chinese medicinal materials in parts by weight: 5-20 parts of Cremastra appendiculata, 5-20 parts of Homponia spp., 5-20 parts of Catechu, 10-25 parts of Juniperus chinensis var. spp., 5-20 parts of Viola yedoensis, 5-20 parts of Physalis alkekengi, 10-25 parts of Usnea indica, 5-20 parts of Luffa cylindrica, 5-20 parts of Morus alba var. spinosa, 5-20 parts of Citrus medica var. sarcodactylis, 1-10 parts of Daphne odora, 1-10 parts of Aquilaria sinensis, 10-25 parts of Gardenia jasminoides, and 5-20 parts of Eucommia ulmoides.

[0009] Preferably, the above-mentioned traditional Chinese medicine compound for treating Hashimoto's thyroiditis is composed of the following parts by weight of Chinese medicinal materials: 5-15 parts of Cremastra appendiculata, 10-20 parts of Hops tectorum, 10-20 parts of Catechu, 10-20 parts of Platycladus orientalis leaves, 5-15 parts of Viola yedoensis, 10-20 parts of Physalis alkekengi, 10-20 parts of Usnea indica, 5-15 parts of Luffa cylindrica, 5-15 parts of Morus alba, 10-20 parts of Citrus medica, 3-8 parts of Daphne odora, 3-8 parts of Aquilaria sinensis, 10-20 parts of Gardenia jasminoides leaves, and 10-20 parts of Eucommia ulmoides.

[0010] Preferably, the above-mentioned traditional Chinese medicine compound for treating Hashimoto's thyroiditis is composed of the following parts by weight of Chinese medicinal materials: 9 parts of Cremastra appendiculata, 12 parts of Homponia spp., 12 parts of Catechu, 12 parts of Juniperus chinensis var. spp., 15 parts of Viola yedoensis, 15 parts of Physalis alkekengi, 15 parts of Usnea indica, 9 parts of Luffa cylindrica, 12 parts of Morus alba, 15 parts of Citrus medica, 6 parts of Daphne odora, 6 parts of Aquilaria sinensis, 15 parts of Gardenia jasminoides, and 15 parts of Eucommia ulmoides.

[0011] Secondly, the present invention provides the application of the above-mentioned traditional Chinese medicine compound in the preparation of a drug for treating Hashimoto's thyroiditis. The drug is made from the traditional Chinese medicinal materials in the specified weight proportions, supplemented with pharmaceutically acceptable excipients, and prepared into an oral dosage form. The dosage form is any one of pills, oral liquids, decoctions, granules, powders, capsules, and tablets.

[0012] The pharmacological effects of each herb in the traditional Chinese medicine compound of this invention are described in detail below:

[0013] *Cremastra appendiculata*: The dried pseudobulb of *Cremastra appendiculata*, *Cremastra yunnanensis*, or *Cremastra yunnanensis* (orchid family). It has a sweet and slightly pungent taste and is cool in nature; it enters the liver and spleen meridians. Its functions and indications include clearing heat and detoxifying, resolving phlegm and dissipating nodules, and eliminating goiter and masses. It is used for carbuncles, boils, scrofula, snake and insect bites, and abdominal masses.

[0014] Humulus scandens: The whole herb of Humulus scandens, a plant of the Moraceae family. It is sweet and bitter in taste and cold in nature. Traditional medicine believes that it has the effects of clearing heat and detoxifying, promoting diuresis and relieving strangury, reducing swelling and dissipating nodules. It is often used to treat sores caused by heat toxins, difficulty in urination, and damp-heat jaundice.

[0015] Catechu: A decoction of the peeled and dried branches of *Acacia catechu* (Lf) Willd., a plant belonging to the genus *Acacia* of the legume family. It has a bitter and astringent taste, and is slightly cold in nature; it enters the lung and heart meridians. Its functions and indications include: promoting blood circulation and relieving pain, stopping bleeding and promoting tissue regeneration, astringing dampness and healing sores, clearing the lungs and resolving phlegm. It is used for injuries from falls and blows, external bleeding, hematemesis, epistaxis, non-healing sores, eczema, damp sores, and cough due to lung heat.

[0016] Ground cypress leaves: The whole herb of *Hydrangea macrophylla*, a plant in the family Acernaceae. It tastes sweet and slightly bitter, and is cool in nature; it enters the lung and liver meridians. Functions and indications: Clears heat and detoxifies, relieves cough and soothes the throat, promotes diuresis and reduces swelling, stops bleeding and relieves pain. Used for influenza, common cold, cough, tonsillitis, mumps, red and swollen eyes, enteritis, dysentery, and insufficient lactation; externally used to treat boils, carbuncles, traumatic injuries, eczema, burns, and bleeding from cuts.

[0017] Bitter violet: The dried whole herb of *Corydalis bungeana* Turcz., a plant belonging to the genus *Corydalis* in the Papaveraceae family. It has a bitter taste and cold properties; it enters the heart, liver, and large intestine meridians. Its functions and indications include clearing heat and detoxifying, dispersing nodules and reducing swelling. It is used for epidemic colds, sore throat, boils and carbuncles, mumps, erysipelas, and damp-heat diarrhea.

[0018] Physalis alkekengi L. var. franchetii (Mast.) Makino, a plant in the Solanaceae family. It has a bitter taste and cold properties; it enters the Lung meridian. Its functions and indications include clearing heat and detoxifying, relieving sore throat and resolving phlegm, and promoting urination. It is used for sore throat and hoarseness, cough with phlegm and heat, difficulty urinating, and painful urination due to heat; externally, it is used to treat pemphigus, eczema, etc.

[0019] Usnea: The dried lichen thallus of *Usnea longissima* Ach. and *Usnea diffracta* Vain., belonging to the Usneaceae family. It has a sweet and bitter taste, and is neutral in nature; it enters the heart, lung, and liver meridians. Its functions and indications include clearing heat and detoxifying, resolving phlegm and unblocking the meridians, cooling the blood and stopping bleeding. It is used for exogenous fever, cough due to lung heat, phlegm and asthma, malaria, scrofula, mastitis, burns, snake bites, hematemesis, epistaxis, and hematochezia.

[0020] Luffa sponge: The vascular bundles of the dried, mature fruit of *Luffa cylindrica* (L.) Roem., a plant in the Cucurbitaceae family. It has a sweet taste and neutral properties; it enters the lung, stomach, and liver meridians. Its functions and indications include: dispelling wind, clearing the meridians, promoting blood circulation, and promoting lactation. It is used for conditions such as arthralgia, chest and rib pain, insufficient lactation, and mastitis.

[0021] Mulberry ear fungus: The fruiting body of edible fungi belonging to the genus *Tremella* in the family Tremellaceae and the genus *Auricularia* in the family Auriculariaceae. It has a sweet taste and neutral properties; it enters the liver and spleen meridians. Its functions and indications include: cooling the blood and stopping bleeding, promoting blood circulation and resolving stagnation, strengthening the spleen and aiding digestion. It is used for epistaxis, hematuria, hematochezia, hemorrhoidal bleeding, metrorrhagia, sore throat, abdominal masses, and poor appetite due to spleen deficiency.

[0022] Buddha's Hand: The dried fruit of *Citrus medica* L. var. *sarcodactylis* Swingle, a plant belonging to the Rutaceae family and the *Citrus* genus. It has a pungent, bitter, and sour taste, and is warm in nature; it enters the liver, spleen, stomach, and lung meridians. Its functions and indications include: soothing the liver and regulating qi, harmonizing the stomach and relieving pain, drying dampness and resolving phlegm. It is used for liver and stomach qi stagnation, chest and rib distension and pain, epigastric fullness, poor appetite and vomiting, cough with excessive phlegm, etc.

[0023] Daphne odora flower: The dried flower buds of *Edgeworthia chrysantha* Lindl., a plant belonging to the genus *Edgeworthia* in the family Thymelaeaceae. It has a sweet taste and neutral properties; it enters the liver meridian. Its functions and indications include nourishing yin and calming the mind, improving eyesight, and removing blemishes. It is used for night blindness, pterygium, excessive tearing, nocturnal emission, urinary tract infections, and aphonia.

[0024] Calogyne pilosa R.Br., a plant in the Calogyneceraceae family. It has a pungent taste and warm properties; it enters the liver and spleen meridians. Its functions and indications include dispelling wind and cold, promoting qi and blood circulation, and detoxifying snake venom. It is used for wind-cold arthralgia, stomachache, abdominal pain, traumatic injuries, and snake bites.

[0025] Gardenia Leaf: Source: Dried leaves of *Gardenia jasminoides* Ellis, a plant in the Rubiaceae family. It has a bitter taste and cold properties; it enters the heart, lung, and liver meridians. Functions and Indications: Clears heat and detoxifies, cools the blood and stops bleeding, reduces swelling and relieves pain. Used for colds with fever, cough due to lung heat, sore throat, epistaxis, hematemesis, hematochezia, carbuncles and boils, traumatic injuries, insect and snake bites, etc.

[0026] Eucommia: The dried bark of Eucommia ulmoides Oliv., a plant in the Eucommiaceae family. It has a sweet taste and warm properties; it enters the liver and kidney meridians. Its functions and indications include: tonifying the liver and kidneys, strengthening tendons and bones, and calming the fetus. It is used for liver and kidney deficiency, lower back and knee pain, weakness of tendons and bones, dizziness, threatened miscarriage, and fetal restlessness.

[0027] (III) Beneficial Effects

[0028] Traditional Chinese medicine (TCM) believes that Hashimoto's thyroiditis is primarily caused by phlegm-toxin accumulation and blood stasis, as well as liver qi stagnation. Based on this, this invention employs a core treatment principle of clearing heat and detoxifying, resolving phlegm and dissipating nodules, promoting blood circulation and eliminating masses, and soothing the liver and regulating qi. A TCM compound formula for treating Hashimoto's thyroiditis is rationally formulated, consisting of *Cremastra appendiculata*, *Humulus scandens*, *Caterpillar fungus*, *Platycladus orientalis*, *Viola yedoensis*, *Physalis alkekengi*, *Usnea indica*, *Luffa cylindrica*, *Auricularia auricula-judae*, *Citrus medica*, *Daphne odora*, *Aristolochia debilis*, *Gardenia jasminoides*, and *Eucommia ulmoides*. Each herb in the formula works synergistically, each fulfilling its specific function. *Cremastra appendiculata* and *Humulus scandens* clear heat, resolve phlegm, dissipate nodules, and eliminate blood stasis, primarily targeting phlegm-toxin; *Caterpillar fungus* and *Auricularia auricula-judae* promote blood circulation, eliminate blood stasis, dissipate nodules, and resolve phlegm, specifically targeting blood stasis; the four herbs together form the principal herb, focusing on eliminating pathogenic factors, targeting the three major pathological products of phlegm, toxins, and blood stasis, directly attacking the masses in the neck. Buddha's Hand and Ligeng are used to soothe the liver and relieve depression, regulate qi, and promote qi circulation. Their main function is to regulate qi and blood, ensuring smooth blood flow and clearing stagnation. Kudi Ding and Physalis alkekengi are used to clear heat, detoxify, reduce swelling, and resolve phlegm, assisting the principal herbs in enhancing their ability to attack pathogens. These four herbs are the assistant herbs. Dihuangye and Gardenia are used to clear heat, cool the blood, and guide heat downwards; Usnea and Luffa are used to clear heat, resolve phlegm, and promote blood circulation; and Daphne odora relieves depression and calms the mind. These five herbs are the adjuvant herbs, assisting the principal and assistant herbs in enhancing the overall effect of clearing heat and toxins, dispersing stagnation, and soothing the liver. Eucommia ulmoides is sweet and warm, tonifying the liver and kidneys, strengthening tendons and bones, and supporting the body's vital energy. It is an adjuvant herb, preventing the overall cold and cooling herbs from being too strong and ensuring that the attack on pathogens does not harm the body's vital energy. The herbal compound of this invention, composed of the above-mentioned Chinese medicinal materials, has the effects of resolving phlegm and dispersing nodules, promoting blood circulation and eliminating masses, regulating qi and relieving depression, and clearing heat and detoxifying. It is suitable for the treatment of Hashimoto's thyroiditis.

[0029] Based on traditional Chinese medicine theory, this invention further verifies the therapeutic effect of this herbal compound on Hashimoto's thyroiditis. Using HT model rats as the research subject, the herbal compound of this invention can effectively reduce the serum TPOAb and TgAb levels in HT model rats, and simultaneously reverse the changes in serum TSH, FT3, and FT4 levels in HT model rats. Furthermore, the herbal compound of this invention can significantly improve the serum inflammatory factor levels in HT model rats, effectively alleviating the inflammatory response. Based on the above results, the herbal compound of this invention can effectively inhibit TPOAb and TgAb levels, improve thyroid hormone levels, and exhibit good anti-inflammatory effects, demonstrating excellent therapeutic efficacy in Hashimoto's thyroiditis model rats. This herbal compound of this invention holds promise for further promotion and application as a drug for treating Hashimoto's thyroiditis. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0031] Example 1

[0032] A traditional Chinese medicine compound for treating Hashimoto's thyroiditis, comprising the following ingredients in parts by weight: 9 parts of Cremastra appendiculata, 12 parts of Homponia spp., 12 parts of Catechu, 12 parts of Juniperus chinensis var. spp., 15 parts of Viola yedoensis, 15 parts of Physalis alkekengi, 15 parts of Usnea indica, 9 parts of Luffa cylindrica, 12 parts of Morus alba, 15 parts of Citrus medica, 6 parts of Daphne odora, 6 parts of Aristolochia debilis, 15 parts of Gardenia jasminoides, and 15 parts of Eucommia ulmoides.

[0033] The above-mentioned traditional Chinese medicine compound is used to prepare a drug for treating Hashimoto's thyroiditis. The drug is made from the traditional Chinese medicinal materials in the specified weight proportions, supplemented with pharmaceutically acceptable excipients, and prepared into an oral dosage form. The dosage form is any one of pills, oral liquids, decoctions, granules, powders, capsules, and tablets.

[0034] Example 2

[0035] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of Chinese medicinal materials: 5 parts of Cremastra appendiculata, 5 parts of Homponia spp., 5 parts of Catechu, 10 parts of Juniperus chinensis leaves, 5 parts of Viola yedoensis, 5 parts of Physalis alkekengi, 10 parts of Usnea indica, 5 parts of Luffa cylindrica, 5 parts of Morus alba, 5 parts of Citrus medica, 1 part of Daphne odora, 1 part of Aquilaria sinensis, 10 parts of Gardenia jasminoides leaves, and 5 parts of Eucommia ulmoides.

[0036] Example 3

[0037] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of Chinese medicinal materials: 20 parts of Cremastra appendiculata, 20 parts of Homponia spp., 20 parts of Catechu, 25 parts of Juniperus chinensis var. spp., 20 parts of Viola yedoensis, 20 parts of Physalis alkekengi, 25 parts of Usnea indica, 20 parts of Luffa cylindrica, 20 parts of Morus alba var. mongolica, 20 parts of Citrus medica var. sarcodactylis, 10 parts of Daphne odora, 10 parts of Aquilaria sinensis var. sarcodactylis, 25 parts of Gardenia jasminoides var. jasminoides, and 20 parts of Eucommia ulmoides.

[0038] Example 4

[0039] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of Chinese medicinal materials: 16 parts of Cremastra appendiculata, 18 parts of Humulus scandens, 18 parts of Catechu, 22 parts of Platycladus orientalis leaves, 16 parts of Viola yedoensis, 18 parts of Physalis alkekengi, 22 parts of Usnea indica, 16 parts of Luffa cylindrica, 16 parts of Morus alba, 18 parts of Citrus medica, 9 parts of Daphne odora, 9 parts of Aquilaria sinensis, 22 parts of Gardenia jasminoides leaves, and 18 parts of Eucommia ulmoides.

[0040] Example 5

[0041] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of Chinese medicinal materials: 5 parts of Cremastra appendiculata, 10 parts of Homponia spp., 10 parts of Catechu, 10 parts of Juniperus chinensis var. spp., 5 parts of Viola yedoensis, 10 parts of Physalis alkekengi, 10 parts of Usnea indica, 5 parts of Luffa cylindrica, 5 parts of Morus alba var. mongolica, 10 parts of Citrus medica var. sarcodactylis, 3 parts of Daphne odora, 3 parts of Aquilaria sinensis, 10 parts of Gardenia jasminoides var. jasminoides, and 10 parts of Eucommia ulmoides.

[0042] Example 6

[0043] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of Chinese medicinal materials: 15 parts of Cremastra appendiculata, 20 parts of Homponia spp., 20 parts of Catechu, 20 parts of Juniperus chinensis var. spp., 15 parts of Viola yedoensis, 20 parts of Phyllanthus urinaria, 20 parts of Usnea indica, 15 parts of Luffa cylindrica, 15 parts of Morus alba, 20 parts of Citrus medica, 8 parts of Daphne odora, 8 parts of Aquilaria sinensis, 20 parts of Gardenia jasminoides, and 20 parts of Eucommia ulmoides.

[0044] Example 7

[0045] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine compound is composed of the following parts by weight of Chinese medicinal materials: 12 parts of Cremastra appendiculata, 15 parts of Homponia spp., 15 parts of Catechu, 18 parts of Platycladus orientalis leaves, 12 parts of Viola yedoensis, 18 parts of Physalis alkekengi, 18 parts of Usnea indica, 9 parts of Luffa cylindrica, 9 parts of Morus alba, 12 parts of Citrus medica, 6 parts of Daphne odora, 5 parts of Aquilaria sinensis, 16 parts of Gardenia jasminoides leaves, and 16 parts of Eucommia ulmoides.

[0046] Test case

[0047] Effects of the traditional Chinese medicine compound of this invention on a rat model of Hashimoto's thyroiditis

[0048] 1. Materials

[0049] 1.1 Laboratory Animals

[0050] Seventy SPF-grade female SD rats, aged 6-8 weeks and weighing 120-140g, were housed in an SPF-grade animal laboratory and were acclimatized for one week before the experiment.

[0051] 1.2 Experimental Drugs

[0052] Traditional Chinese medicine compound liquid: 9g of Pseudobulbus Cremastrae, 12g of Humulus scandens, 12g of Catechu, 12g of Juniperus chinensis leaves, 15g of Viola yedoensis, 15g of Phyllanthus urinaria, 15g of Usnea indica, 9g of Luffa cylindrica, 12g of Morus alba, 15g of Citrus medica, 6g of Daphne odora, 6g of Aristolochia debilis, 15g of Gardenia jasminoides leaves, and 15g of Eucommia ulmoides. Weigh each ingredient according to the above weights, add water and decoct 3 times, then concentrate to a liquid containing 1g / mL of raw herbs, and refrigerate for later use.

[0053] Positive control drug: Tripterygium wilfordii polyglycosides tablets, 10mg / tablet.

[0054] 2 methods

[0055] 2.1 Modeling

[0056] Ten rats were randomly selected as the control group, while the remaining rats were used to establish a Hashimoto's thyroiditis model. Specifically, the model group (n=60) was given 0.64 g / L high-iodine water for drinking. In week 4, thyroglobulin was dissolved in phosphate buffer to prepare a 1 mg / mL solution, which was then mixed with an equal volume of complete Freund's adjuvant and thoroughly emulsified into a white suspension. 0.2 mL of this suspension was injected subcutaneously into the paw pads of the rats twice a week for primary immunization. From week 5 to 8, an equal dose of porcine thyroglobulin emulsified with incomplete Freund's adjuvant was injected once a week for booster immunization. Blood was collected from the tail vein of the rats, and serum TPOAb and TGAb levels were measured using enzyme-linked immunosorbent assay (ELISA). A result indicating successful model establishment was that the antibody level in the model group was more than twice the mean of the control group.

[0057] 2.2 Grouping and Administration

[0058] Fifty rats that successfully established the model were randomly divided into five groups: model group, positive control group, low-dose traditional Chinese medicine group, medium-dose traditional Chinese medicine group, and high-dose traditional Chinese medicine group, with ten rats in each group. The positive control group was given Tripterygium wilfordii polyglycoside tablets at 9.3 mg / kg, while the low-, medium-, and high-dose traditional Chinese medicine groups were given the compound traditional Chinese medicine solution of this invention at 7.3 g / kg, 14.5 g / kg, and 29.0 g / kg, respectively. The blank group and the model group were given the same dose of physiological saline by gavage. Drug administration began after the modeling process and was administered once daily for eight weeks. The general condition of the rats in each group was observed during the experiment.

[0059] 2.3 Detection Indicators

[0060] After administration, the rats were anesthetized, and blood was collected from the eyes of each group of rats. Serum was separated, and the levels of TPOAb, TgAb, TSH, FT3, FT4, IL-17, IL-10, and TNF-α in the serum were detected by ELISA.

[0061] 2.4 Statistical Analysis

[0062] SPSS 20.0 statistical analysis software was used for experimental data processing. Quantitative data were expressed as mean ± standard deviation. One-way ANOVA was used for comparisons between groups, and the LSD test was used for multiple comparisons; p < 0.05 was considered statistically significant.

[0063] 3 Results

[0064] 3.1 General Case

[0065] During the experiment, no rats in any group died, indicating that the herbal compound of this invention has good safety. The rats in the control group had normal, glossy fur, and their activity levels, diet, and water intake remained normal. Compared to the control group, the rats in the model group had rough fur or hair loss, reduced activity levels, and exhibited agitation, irritability, and restlessness. Compared to the model group, the above symptoms gradually improved in all treatment groups during the treatment period.

[0066] 3.2 Effects of the herbal compound of this invention on thyroid function and thyroid antibody levels in HT model rats

[0067] As shown in Table 1, compared with the control group, the levels of thyroid antibodies TPOAb and TgAb in the model group rats were significantly increased (P<0.05), indicating successful model establishment. Compared with the control group, the TSH level in the model group rats was significantly increased (P<0.05), and the FT3 and FT4 levels were significantly decreased (P<0.05), indicating significant hypothyroidism in the model group rats. Compared with the model group, the levels of thyroid antibodies TPOAb and TgAb in each treatment group rats were significantly decreased (P<0.05), the TSH level was significantly decreased (P<0.05), and the FT3 and FT4 levels were significantly increased (P<0.05). The TPOAb, TgAb, and TSH levels in the low, medium, and high dose groups of traditional Chinese medicine were lower than those in the positive control group, while the FT3 and FT4 levels were significantly higher than those in the positive control group; among them, the above indicators in the high dose group of traditional Chinese medicine were significantly different from those in the positive control group (P<0.05).

[0068] Table 1. Serum levels of TPOAb, TgAb, TSH, FT3, and FT4 in rats of each group.

[0069] Note that in the same column of data, the same lowercase letter indicates no significant difference between groups (P>0.05), while different lowercase letters indicate significant differences between groups (P<0.05).

[0070] 3.3 Effects of the herbal compound of this invention on serum inflammatory factor levels in HT model rats

[0071] As shown in Table 2, compared with the blank group, the serum levels of inflammatory factors IL-17 and TNF-α in the model group rats were significantly increased (P<0.05), while IL-10 was significantly decreased (P<0.05). Compared with the model group, the serum levels of inflammatory factors IL-17 and TNF-α in each treatment group rats were significantly decreased (P<0.05), while IL-10 was significantly increased (P<0.05). The levels of IL-17 and TNF-α in the low, medium, and high dose groups of traditional Chinese medicine were lower than those in the positive control group, while the level of IL-10 was significantly higher than that in the positive control group; among them, the above indicators in the medium and high dose groups of traditional Chinese medicine were significantly different from those in the positive control group (P<0.05).

[0072] Table 2. Serum levels of IL-17, IL-10, and TNF-α in rats of each group.

[0073]

[0074] Note that in the same column of data, the same lowercase letter indicates no significant difference between groups (P>0.05), while different lowercase letters indicate significant differences between groups (P<0.05).

[0075] 4. Conclusion

[0076] HT is a highly prevalent autoimmune disease characterized by anti-thyroglobulin and anti-thyroid peroxidase antibodies. Most HT patients are positive for serum TPOAb and TgAb. TPOAb and TgAb not only serve as diagnostic markers for HT but also as important indicators for clinical treatment and prognosis. TPOAb and TgAb can cause thyroid cell damage through antibody-complement system-mediated T cell activation; therefore, reducing TPOAb and TgAb levels is a key goal of HT treatment. Based on the above experimental results, the traditional Chinese medicine compound of this invention can effectively reduce serum TPOAb and TgAb levels in HT model rats and reverse changes in serum TSH, FT3, and FT4 levels in HT model rats. HT is a chronic aseptic inflammation. In HT model rats, the levels of pro-inflammatory factors IL-17 and TNF-α are significantly increased, while the level of anti-inflammatory factor IL-10 is significantly decreased. After administration of the traditional Chinese medicine compound of this invention, the levels of inflammatory factors in the serum of HT model rats were significantly improved, effectively alleviating the inflammatory response in HT model rats. In summary, the traditional Chinese medicine compound of this invention can effectively inhibit TPOAb and TgAb levels, improve thyroid hormone levels, and exhibit good anti-inflammatory effects, demonstrating excellent therapeutic efficacy in Hashimoto's thyroiditis model rats. This traditional Chinese medicine compound is expected to be further promoted and applied as a drug for treating Hashimoto's thyroiditis.

[0077] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine compound for treating Hashimoto's thyroiditis, characterized in that, The traditional Chinese medicine compound is composed of the following medicinal materials in parts by weight: 5-20 parts of Cremastra appendiculata, 5-20 parts of Homponia spp., 5-20 parts of Catechu, 10-25 parts of Juniperus chinensis var. spp., 5-20 parts of Viola yedoensis, 5-20 parts of Physalis alkekengi, 10-25 parts of Usnea indica, 5-20 parts of Luffa cylindrica, 5-20 parts of Morus alba var. mongolica, 5-20 parts of Citrus medica, 1-10 parts of Daphne odora, 1-10 parts of Aquilaria sinensis, 10-25 parts of Gardenia jasminoides var. jasminoides, and 5-20 parts of Eucommia ulmoides.

2. The traditional Chinese medicine compound for treating Hashimoto's thyroiditis as described in claim 1, characterized in that, The traditional Chinese medicine compound is composed of the following medicinal materials in parts by weight: 5-15 parts of Cremastra appendiculata, 10-20 parts of Hops tectorum, 10-20 parts of Catechu, 10-20 parts of Platycladus orientalis leaves, 5-15 parts of Viola yedoensis, 10-20 parts of Physalis alkekengi, 10-20 parts of Usnea indica, 5-15 parts of Luffa cylindrica, 5-15 parts of Morus alba, 10-20 parts of Citrus medica, 3-8 parts of Daphne odora, 3-8 parts of Aquilaria sinensis, 10-20 parts of Gardenia jasminoides leaves, and 10-20 parts of Eucommia ulmoides.

3. The traditional Chinese medicine compound for treating Hashimoto's thyroiditis as described in claim 1, characterized in that, The traditional Chinese medicine compound is composed of the following medicinal materials in parts by weight: 9 parts of Cremastra appendiculata, 12 parts of Homponia spp., 12 parts of Catechu, 12 parts of Juniperus chinensis leaves, 15 parts of Viola yedoensis, 15 parts of Phyllanthus urinaria, 15 parts of Usnea indica, 9 parts of Luffa cylindrica, 12 parts of Morus alba, 15 parts of Citrus medica, 6 parts of Daphne odora, 6 parts of Aquilaria sinensis, 15 parts of Gardenia jasminoides leaves, and 15 parts of Eucommia ulmoides.

4. The use of the traditional Chinese medicine compound according to any one of claims 1 to 3 in the preparation of a drug for treating Hashimoto's thyroiditis, characterized in that, The drug is made from the Chinese medicinal materials in the specified weight proportions, supplemented with pharmaceutically acceptable excipients, and prepared into an oral dosage form, wherein the dosage form is any one of pills, oral liquids, decoctions, granules, powders, capsules, and tablets.

Images