A traditional Chinese medicine composition for treating hashimoto's thyroiditis with depressive symptoms

Abstract

A traditional Chinese medicine composition for treating Hashimoto's thyroiditis comprises the following raw materials in the indicated weight ratios: 50-200 parts Rehmannia glutinosa (processed), 10-60 parts Cinnamomum cassia, 30-100 parts Ephedra sinica, 10-60 parts Cervi cornu slices, 10-60 parts Zingiber officinale (dried), 30-80 parts Glycyrrhiza uralensis (processed), 50-200 parts Paeonia lactiflora (white), 50-200 parts Paeonia veitchii (red), 30-100 parts Paeonia suffruticosa (moutan bark), 50-200 parts Codonopsis pilosula, 50-200 parts Angelica sinensis, 50-200 parts Prunus persica, and 30-100 parts Carthamus tinctorius. The preparation method is as follows: Place Rehmannia glutinosa, Cinnamomum cassia, Ephedra sinica, deer antler slices, dried ginger, prepared licorice root, white peony root, red peony root, peony bark, Codonopsis pilosula, Angelica sinensis, peach kernel, and safflower in a container, add 8 times the total weight of the herbs in cold water, soak for 30 minutes to fully moisten the herbs, bring to a boil over high heat, then simmer over low heat for another 30 minutes; for the second decoction, filter out the liquid from the first decoction, add the remaining herbs and 6 times the total weight of the herbs in warm water, just enough to cover the herbs; soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for another 20 minutes; after the decoction is completed, combine the two decoctions, filter out the dregs, and obtain the traditional Chinese medicine decoction.

Description

Technical Field

[0001] This invention relates to the application of traditional Chinese medicine compositions in the treatment of thyroid diseases, particularly in the treatment of Hashimoto's thyroiditis accompanied by depressive symptoms. Background Technology

[0002] Hashimoto's thyroiditis (HT) is an organ-specific autoimmune disease characterized by lymphocytic infiltration in the thyroid gland, elevated levels of specific autoantibodies (TPOAb, TgAb), and progressive thyroid dysfunction. Current modern medical treatment strategies primarily focus on symptomatic relief and disease modification; there is no universally accepted cure. Specific treatment options are as follows: 1. Levothyroxine replacement therapy, the most common treatment for HT. When patients present with clinical or subclinical hypothyroidism (especially TSH > 10 mIU / L, or with symptoms, pregnancy plans, etc.), oral levothyroxine sodium tablets are administered to supplement insufficient thyroid hormone and control TSH within the target range (usually 0.5-2.5 mIU / L). Advantages: Effective, effectively corrects hypothyroidism symptoms, improves lipid metabolism, and enhances quality of life. The medication is inexpensive and convenient to take. Disadvantages: It is a "replacement" rather than "causal" treatment; it cannot block the autoimmune process, reduce thyroid autoantibody titers, or reverse thyroid lymphocytic infiltration. 1. Lifelong medication is required, and the dosage needs to be adjusted individually according to TSH levels. There is a possibility of overdose leading to subclinical hyperthyroidism, increased osteoporosis, and cardiovascular risk. 2. Selenium yeast supplementation: Selenium yeast supplementation (usually 100-200 μg daily) is used as an adjunct therapy. Advantages: Selenium is an important component of the thyroid antioxidant system (such as glutathione peroxidase). Some studies have shown that selenium supplementation may help reduce TPOAb titers and improve immune disorders and inflammatory states in some patients, especially in selenium-deficient areas. Disadvantages: The efficacy is controversial, and not all studies show its benefits. Excessive selenium has toxicity (brittle nails, hair loss, gastrointestinal symptoms, and even neurotoxicity), and the risks of long-term high-dose use have not been fully clarified. Currently, it is only recommended as a possible adjunct for specific populations (such as high antibody titers, pregnancy), rather than routine treatment. 3. Glucocorticoids and other immunosuppressants: Short-term use of glucocorticoids in the acute progression of HT (such as painful Hashimoto's thyroiditis) or in the presence of other autoimmune diseases. Other immunosuppressants (such as mycophenolate mofetil and rituximab) are only used for exploratory treatment in a very small number of severe, refractory cases. Advantages: They can rapidly suppress inflammation and immune responses, relieving acute symptoms. Disadvantages: Long-term use of glucocorticoids and potent immunosuppressants carries significant risks such as osteoporosis, infection, and metabolic abnormalities, and antibody rebound often occurs after discontinuation; current guidelines do not recommend them as a routine treatment strategy for Hashimoto's thyroiditis. 4. Surgical treatment: Total or near-total thyroidectomy. Advantages: Suitable for patients with large goiters causing significant compressive symptoms, suspected malignant nodules, or progressively enlarging goiters despite drug treatment. It can rapidly relieve compression and eliminate the target organ of the local immune response. Disadvantages: Surgical trauma and risks (recurrent laryngeal nerve injury, hypoparathyroidism), and permanent hypothyroidism is inevitable post-surgery, requiring lifelong adequate thyroid hormone replacement.Surgery itself does not treat systemic immune abnormalities. 5. Cutting-edge research and comprehensive management, including biologics targeting specific cytokines or immune pathways (such as CD20, IL-17), vitamin D supplementation, probiotic regulation of gut microbiota, gluten-free diets, etc. Current status: Most are in the basic research or small-scale clinical trial stage, lacking high-level evidence-based medicine to support their universality. This highlights the limitations of current treatments in the core aspect of "regulating immune imbalance." Currently, the "hard core" evidence for Hashimoto's thyroiditis is still mainly based on L-T4 replacement to correct hypothyroidism. Selenium supplementation, vitamin D, inositol, and traditional Chinese medicine have shown some potential in improving antibodies, inflammation, and symptoms, but they are mostly "disease-modifying or auxiliary means," and the evidence is insufficient to replace or weaken the core position of L-T4. Summary of the Invention

[0003] Technical problems to be solved How to truly "regulate immunity, reduce fibrosis, and improve oxidative stress" through comprehensive treatment is a crucial issue in the current management of Hashimoto's thyroiditis, and precisely the entry point where traditional Chinese medicine (TCM) can leverage its advantages. This invention constructs a new strategy for treating Hashimoto's thyroiditis centered on "warming and unblocking," breaking through the conventional methods of simply "resolving phlegm and dissipating nodules" or "soothing the liver and regulating qi." It provides a profound theoretical framework and a distinctive example for TCM intervention in autoimmune thyroid diseases. This clinical application strictly adheres to TCM syndrome differentiation, using symptoms such as "aversion to cold and cold limbs, fatigue, hardened thyroid gland, pale and dark tongue with ecchymosis, and deep, thready, and hesitant pulse," indicating spleen and kidney yang deficiency and cold stagnation.

[0004] Technical solution A traditional Chinese medicine composition for treating Hashimoto's thyroiditis comprises the following raw materials in the indicated weight ratios: 50-200 parts Rehmannia glutinosa (processed), 10-60 parts Cinnamomum cassia, 30-100 parts Ephedra sinica, 10-60 parts Cervi cornu slices, 10-60 parts Zingiber officinale (dried), 30-80 parts Glycyrrhiza uralensis (processed), 50-200 parts Paeonia lactiflora (white), 50-200 parts Paeonia veitchii (red), 30-100 parts Paeonia suffruticosa (moutan bark), 50-200 parts Codonopsis pilosula, 50-200 parts Angelica sinensis, 50-200 parts Prunus persica, and 30-100 parts Carthamus tinctorius. Further, the formula includes: 80-150 parts Rehmannia glutinosa, 20-50 parts Cinnamomum cassia, 40-80 parts Ephedra sinica, 20-50 parts Cervi cornu slices, 20-50 parts Dried ginger, 40-70 parts Glycyrrhiza uralensis (processed), 90-120 parts Paeonia lactiflora (white peony root), 90-120 parts Paeonia veitchii (red peony root), 50-80 parts Paeonia suffruticosa root bark, 80-150 parts Codonopsis pilosula, 80-150 parts Angelica sinensis, 80-150 parts Prunus persica kernel, and 50-80 parts Carthamus tinctorius. Even further, the formula includes: 100 parts Rehmannia glutinosa, 30 parts Cinnamomum cassia, 60 parts Ephedra sinica, 30 parts Cervi cornu slices, 30 parts Dried ginger, 50 parts Glycyrrhiza uralensis (processed), 100 parts Paeonia lactiflora, 100 parts Paeonia veitchii, 60 parts Paeonia suffruticosa root bark, 100 parts Codonopsis pilosula, 100 parts Angelica sinensis, 100 parts Prunus persica kernel, and 60 parts Carthamus tinctorius.

[0005] The preparation method of this traditional Chinese medicine composition is as follows: Place Rehmannia glutinosa, Cinnamomum cassia, Ephedra sinica, deer antler slices, dried ginger, prepared licorice root, white peony root, red peony root, peony bark, Codonopsis pilosula, Angelica sinensis, peach kernel, and safflower in a container, add 8 times the total weight of the herbs in cold water, ensuring the water level is 2-3 cm above the herbs; soak for 30 minutes to fully moisten the herbs; bring to a boil over high heat, then simmer over low heat for 30 minutes; for the second decoction, filter out the liquid from the first decoction, add the remaining herbs and 6 times the total weight of the herbs in warm water, just enough to cover the herbs; soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 20 minutes; after decoction, combine the two decoctions, filter out the dregs, and obtain the traditional Chinese medicine decoction.

[0006] Beneficial effects A new theoretical framework based on the pathogenesis of "spleen and kidney yang deficiency, cold coagulation, blood stasis, and toxin accumulation" and an analysis of the rationale behind prescriptions. 1. Theoretical Explanation: Hashimoto's thyroiditis has a long course. Initially, it may be asymptomatic, gradually developing symptoms such as fatigue, cold intolerance, edema, low mood, and menstrual irregularities. The thyroid gland is enlarged and firm, often accompanied by nodules. Traditional Chinese medicine believes that "prolonged illness enters the collaterals," and treatment often focuses on "liver stagnation" and "phlegm accumulation." This theory posits that its core lies in the deficiency of spleen and kidney yang. Kidney yang is the root of all yang energy in the body, and spleen yang is the source of qi and blood production. Deficiency of spleen and kidney yang leads to impaired warming and qi transformation, resulting in: Cold coagulation—yang deficiency generates internal cold, which constricts and stagnates, hindering the flow of qi, blood, and body fluids. Blood stasis—"blood flows when warm and congeals when cold," cold coagulation inevitably leads to blood stasis. Collateral toxins—blood stasis and phlegm-dampness generated by yang deficiency combine and accumulate in the neck collaterals (thyroid gland), eventually becoming toxins that damage the glandular collateral structure. This "toxin" corresponds to "autoimmune inflammatory damage" in modern medicine. Therefore, lymphocytic infiltration, fibrosis, and hypothyroidism of the thyroid gland can be considered pathological products of "cold, blood stasis, and toxins" accumulating in the neck meridians. Treatment should focus on "warming and tonifying the spleen and kidneys, dispelling cold and unblocking the meridians, and resolving blood stasis and detoxifying."

[0007] 2. Analysis of the prescription's rationale: This prescription uses Rehmannia glutinosa and other herbs to enhance the warming and tonifying effects, forming a well-defined, multi-layered treatment plan. The principal herb: warms Yang and dispels cold, strongly tonifying the spleen and kidneys—directly targeting the root cause of the disease; Deer antler slices, cinnamon, and dried ginger: Deer antler slices, being a substance rich in blood and flesh, warm and tonify kidney Yang, nourish essence and blood, and unblock the meridians; cinnamon tonifies the fire of the gate of life and warms and unblocks the blood vessels; dried ginger warms the middle and restores Yang, strengthening the spleen. The three herbs combined powerfully restore the original Yang of the spleen and kidneys, dispelling internal and external cold, forming the core of treating the root cause of "Yang deficiency and cold stagnation." Rehmannia glutinosa and Angelica sinensis: greatly tonify Yin, blood, and essence. Taking the principle of "seeking Yang within Yin" and "those who are good at tonifying Yang must seek Yang within Yin," this allows Yang Qi to be nourished by Yin blood, generating endless vitality, while simultaneously nourishing the thyroid Yin depleted due to long-term accumulation of stagnant toxins. The primary herbs: Promote blood circulation, remove blood stasis, cool the blood, and detoxify—effectively addressing the symptoms; Peach kernel, safflower, and red peony root: focused on promoting blood circulation, removing blood stasis, clearing the channels, and dispersing nodules. They powerfully break down existing blood stasis and obstruction in the thyroid area, improving microcirculation and addressing pathological fibrosis and tissue hypoxia. Peony bark: uniquely possesses the function of clearing liver fire, cooling the blood, and dispersing blood stasis within the warming and blood-activating formula. Its "cooling blood" property can clear away the "channel toxins" (immune inflammation) formed by long-term blood stasis, restrain the dryness of warming herbs, prevent bleeding, and embody the principle of "combining clearing and tonifying, and using both warming and cooling herbs." The adjuvant herbs: Tonify qi and nourish blood, harmonize the body's defenses—strengthening the middle jiao; Codonopsis and prepared licorice root: tonify qi and strengthen the spleen, working together with dried ginger to warm and invigorate the middle yang. The spleen and stomach are the foundation of acquired constitution and the source of qi and blood production; a healthy spleen can nourish the innate kidney yang, and also resolve phlegm and dampness, and enhance the efficacy of other herbs. White peony root: used together with red peony root, one astringent and the other dispersing. White peony root nourishes blood, softens the liver, relieves spasms and pain. Combined with licorice root, its sour and sweet properties nourish yin, alleviating potential neck stiffness and discomfort, and harmonizing the body's vital energy. The guiding herb is pungent and warm, dispersing and penetrating, directing the medicine to the collaterals—opening and unblocking the orifices. Ephedra is crucial in this formula. Used in small doses, its effect is to open the pores, penetrate the pores, and unblock the meridians, rather than to induce sweating. It guides the warming and blood-activating properties of the other herbs, penetrating the thyroid collaterals where cold stagnation and toxin accumulation have formed, like "thawing ice," opening a key channel for the medicine to act on its target.

[0008] 3. The significance of comprehensive formula compatibility and its potential implications for modern medicine. This formula fundamentally tonifies the Yang of the spleen and kidneys, focuses on promoting blood circulation, removing blood stasis, cooling the blood, and detoxifying, supports the treatment with Qi-tonifying and blood-nourishing methods, and guides the application of pungent and warm herbs. These four methods are interconnected and work together to address the core pathogenesis of "spleen and kidney Yang deficiency, cold-induced blood stasis, and toxin accumulation." From a modern medical perspective, this formula works through multiple targets: Immunoregulation: Warming and tonifying kidney herbs (such as deer antler slices and cinnamon) influence immune homeostasis by regulating the hypothalamus-pituitary-adrenal / thyroid axis; blood-activating and cooling herbs (such as peony bark and red peony root) inhibit local inflammatory cytokine storms. Improved microcirculation and anti-fibrosis: Blood-activating and stasis-removing herbs improve thyroid blood supply, inhibit tissue fibrosis, and delay glandular destruction. Regulated cell function: Qi-tonifying and blood-nourishing herbs support the recovery of function of remaining thyroid cells. Attached Figure Description

[0009] Figure 1 A schematic diagram for creating an animal model.

[0010] Figure 2 This study compares the efficacy of forced swimming stillness time in six groups (blank group, model group, selenium yeast group, high-dose traditional Chinese medicine, medium-dose traditional Chinese medicine, and low-dose traditional Chinese medicine).

[0011] Figure 3 This study compares the efficacy of saccharide preference among six groups (blank group, model group, selenium yeast group, high-dose traditional Chinese medicine, medium-dose traditional Chinese medicine, and low-dose traditional Chinese medicine). Specific Implementation

[0012] 1. Diagnostic criteria for Hashimoto's thyroiditis 1.1 Western Medicine Diagnostic Criteria: Referencing the "Guidelines for the Diagnosis and Treatment of Thyroid Diseases in China" published by the Chinese Society of Endocrinology in 2008: ① Diffuse thyroid enlargement, with a coarse texture, especially enlargement of the isthmus; ② Positive serum antibodies TPOAb and TgAb can confirm the diagnosis. Fine-needle aspiration of the thyroid gland can serve as a diagnostic indicator.

[0013] 1.2 Traditional Chinese Medicine Diagnostic Criteria: Referring to the "Guidelines for the Diagnosis and Treatment of Hashimoto's Thyroiditis" published in 2024 by the Endocrinology and Metabolic Diseases Committee of the Chinese Medical Association's Branch of Integrative Medicine, and combining the characteristics of the disease and clinical practice, as well as the classification of HT in monographs such as "Internal Medicine of Traditional Chinese Medicine," HT can be divided into the following types: ① Liver Qi stagnation syndrome, clinical manifestations: There is usually no obvious swelling in the neck, but there may be a feeling of swelling in the neck, or a foreign body sensation in the throat, emotional distress, or irritability, or depression, accompanied by chest tightness, frequent sighing, abdominal distension and constipation; pale red tongue, thin white coating, and wiry pulse.

[0014] ② Liver Qi Stagnation Transforming into Fire Syndrome, clinical manifestations include: diffuse swelling of the neck, possibly accompanied by neck distension and pain, or a foreign body sensation in the throat, irritability, hypochondriac pain, bitter taste in the mouth, dry throat, and palpitations. The tongue is red with little coating, and the pulse is rapid.

[0015] ③ Spleen Qi Deficiency Syndrome, clinical manifestations include: diffuse swelling of the neck, fatigue, lethargy, shortness of breath, reluctance to speak, poor appetite, abdominal distension, and loose stools. The tongue is large and swollen with teeth marks on the edges, pale in color, with a thin white coating, and the pulse is weak.

[0016] ④ Qi and Yin deficiency syndrome, clinical manifestations include: diffuse swelling of the neck, fatigue, shortness of breath, reluctance to speak, dry mouth and throat, spontaneous sweating and night sweats, palpitations and restlessness. The tongue is red with a thin white coating, and the pulse is thready and weak or thready and rapid.

[0017] ⑤ Yang deficiency with phlegm stagnation syndrome, clinical manifestations include: diffuse swelling of the neck, sallow complexion, soreness and weakness of the lower back and knees, aversion to cold and cold limbs, abdominal distension and poor appetite, loose stools and edema of the limbs, frequent urination at night, forgetfulness and hair loss. The tongue is swollen with a white and slippery coating, and the pulse is deep and thready.

[0018] 2. Diagnostic criteria for depression 2.1 Western Medicine Diagnostic Criteria: This document is formulated with reference to the relevant content of the single depressive episode and generalized anxiety disorder in the third edition of the Chinese Classification and Diagnostic Criteria for Mental Disorders (CCMD-3).

[0019] 2.2 Typical symptoms of depression: ① depressed mood; ② loss of interest or pleasure; ③ decreased energy or fatigue.

[0020] 2.3 Other common symptoms are: ① Reduced ability to concentrate and pay attention; ② Decreased self-esteem and self-confidence; ③ Feelings of guilt and worthlessness (even in mild episodes); ④ Believes the future is bleak and pessimistic; ⑤ Thoughts or behaviors of self-harm or suicide; ⑥ Sleep disorders; ⑦ Decreased appetite.

[0021] 3. Diagnostic criteria for a depressive episode: at least one typical symptom, two other symptoms, and a duration of ≥2 weeks.

[0022] 4. Standards for Depression ① Mild depressive episode The patient presents with typical depressive symptoms, all of which are present but not severe. The entire episode lasts at least two weeks. Patients with mild depressive episodes are usually troubled by the symptoms and have some difficulty continuing their daily work and social activities, but their social functioning is unlikely to be impaired.

[0023] ② Moderate depressive episode The entire episode lasts at least two weeks. Patients with moderate depression typically have considerable difficulty continuing their work, social, or household activities.

[0024] 4.1 Traditional Chinese Medicine Diagnostic Criteria

[0025] The diagnostic criteria for depression were mainly formulated with reference to the diagnostic and therapeutic standards for diseases and syndromes in traditional Chinese medicine (ZY / T001.1-94) issued by the State Administration of Traditional Chinese Medicine of the People's Republic of China. The specific content is as follows:

[0026] ① Symptoms include depression, low spirits, chest tightness and rib distension, frequent sighing, loss of appetite, insomnia and dreaminess, irritability and crying. ② History of emotional distress such as anger, anxiety, sadness, and worry; ③ Organic diseases can be ruled out through examination of various systems and laboratory tests; ④ It should be differentiated from epilepsy and mania.

[0027] 4.2 Inclusion Criteria

[0028] ① Meets the Western medicine diagnostic criteria for HT;

[0029] ②Those who meet the Western medical diagnostic criteria for mild to moderate depressive episodes; ③ Age 18-65, gender not limited; ④ Agree to participate in this research and sign the informed consent form, and possess good language communication skills; ⑤ The patient is conscious, has self-awareness, and can accurately express their feelings. The patient voluntarily participates in the study after giving informed consent.

[0030] 4.3 Exclusion Criteria

[0031] ① Patients who do not meet the inclusion criteria;

[0032] ②Pregnant or expectant women, and breastfeeding women; ③Severe complications affecting the heart, liver, kidneys, brain, and blood system; ④ Patients suffering from other serious primary diseases or severe mental illness who have lost their ability to perform their own actions; ⑤ Those who cannot cooperate in completing laboratory tests and questionnaires during the trial period; ⑥ Patients with allergies; ⑦ I have not participated in other research projects or taken other medications in the past three months.

[0033] 4.4 Case dropout and exclusion criteria

[0034] ① Patients who cannot independently complete the follow-up examination and fill out the scoring scale; ②Those whose condition worsens and requires other treatment methods; ③ Follow up with patients who have lost contact.

[0035] 4.5 Treatment Plan

[0036] (1) Sample size estimation: This study is a randomized controlled trial. The efficacy rates of the treatment group and the control group are 80% and 50%, respectively. α is set to 0.05 and β=0.1. According to the following formula, the required sample size of the case group and the control group is calculated using PASS 2025 software as N1=N2=45, so the required sample size is 90 cases.

[0037]

[0038] (2) Grouping: Ninety patients were collected from Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine according to the inclusion and exclusion criteria. They were randomly assigned to two groups using a random number table: a treatment group (using the herbal composition of this invention plus lifestyle intervention) and a control group (using lifestyle intervention), with approximately 45 patients in each group. All patients were selected for HT depression and met the inclusion criteria.

[0039] (3) Intervention methods: In the control group, lifestyle interventions were based on the "Guidelines for Primary Care Diagnosis and Treatment of Depression (2021)" compiled by the Chinese Medical Association and related dissertations: patients were treated with verbal understanding, empathy, and care; patients were listened to in a timely manner; psychological counseling was provided; dietary guidance was given, with a diet that was light, easily digestible, and nutritious; patients were guided to exercise moderately, with some traditional exercises that combined movement and stillness to promote physical and mental well-being, such as jogging, Tai Chi, and Baduanjin; and patients were guided to maintain regular routines and have good sleep.

[0040] Treatment group: In addition to the treatment given to the control group, the patient received the herbal composition of this invention. Basic formula: Rehmannia glutinosa (processed) 10g, Cinnamomum cassia 3g, Ephedra sinica 6g, Cervi cornu slices 3g, Zingiber officinale (dried) 3g, Glycyrrhiza uralensis (processed) 5g, Paeonia lactiflora (white) 10g, Paeonia veitchii (red) 10g, Paeonia suffruticosa (moutan bark) 6g, Codonopsis pilosula 10g, Angelica sinensis 10g, Prunus persica (peach kernel) 10g, Carthamus tinctorius 6g. One dose daily.

[0041] Preparation method: Place 10g of Rehmannia glutinosa (processed), 3g of Cinnamomum cassia, 6g of Ephedra sinica, 3g of deer antler slices, 3g of dried ginger, 5g of prepared licorice root, 10g of Paeonia lactiflora (white), 10g of Paeonia suffruticosa (red), 6g of Paeonia suffruticosa root bark, 10g of Codonopsis pilosula, 10g of Angelica sinensis, 10g of Prunus persica kernel, and 6g of Carthamus tinctorius in a container. Add 8 times the total weight of the herbs in cold water, ensuring the water level is 2-3 cm above the herbs; soak for 30 minutes to fully moisten the herbs. Bring to a boil over high heat, then simmer over low heat for 30 minutes. For the second decoction, filter the liquid from the first decoction, add the remaining herbs and 6 times the total weight of the herbs in warm water, ensuring the water level just covers the herbs; soak for 30 minutes, then bring to a boil over high heat, and simmer over low heat for 20 minutes. After decoction, combine the two decoctions, filter out the dregs, and obtain a traditional Chinese medicine decoction. Divide the decoction into two equal portions, one for morning and one for evening.

[0042] The treatment course for both groups was 3 months.

[0043] 2. Animal experiments 2.1 Experimental Materials 2.1.1 Laboratory animals Thirty-six 8-week-old SPF-grade C57 female mice were housed in the animal room of our experimental animal center. The room temperature was 25±2℃, the relative humidity was 55-60%, the light was circadian, the ventilation was regular, and the mice were fed a sufficient amount of ordinary feed and tap water.

[0044] 2.1.2 Model Preparation: See Figure 1 Model establishment: Mouse models were established by subcutaneous immunization with porcine thyroglobulin (pTg) and Freund's adjuvant (FA). The specific model establishment procedure is as follows: Dissolve PTg in sterile PBS, then mix with an equal volume of complete Freund's adjuvant to prepare PTg (concentration 8 mg / mL). Shake thoroughly to prepare a water-in-oil emulsion (complete emulsification means it does not dissolve when dropped into water). Mix the PTg solution with incomplete Freund's adjuvant (IFA) at a 1:1 ratio to prepare PTg injection solution. Inject the pegs, back, and abdominal cavity of mice in the model group subcutaneously at multiple points, twice, with a 2-day interval, for primary immunization. After primary immunization, inject once every week for 6 consecutive weeks for booster immunization. At the end of week 6, a significant increase in serum TPOAb and TgAb, and the presence of lymphocyte infiltration in the thyroid tissue, indicate successful model establishment. Except for the normal group, mice in other groups received 5% Lugol's iodine solution during the modeling period.

[0045] Grouping: All mice underwent emotional and behavioral assessments before and after modeling. Thirty-six 8-week-old SPF-grade female mice were randomly divided into six groups: a control group, a model group, a selenium-enriched yeast group, and low, medium, and high doses of Yanghe Huoxue Shunqi Decoction. The mice were administered Yanghe Huoxue Shunqi Decoction via gavage. After the experiment, all mice underwent emotional, behavioral, and biochemical parameter assessments.

[0046] 2.1.3 Emotional and behavioral detection: (1) Forced swimming test (FST) The forced swimming test is used to assess despair behavior in laboratory animals. The procedure involves filling a transparent cylindrical glass container (30cm*30cm*15cm) with approximately 20cm of water at a temperature of 24±1℃. The water depth is adjusted so that the animal's tail is a certain distance from the bottom of the test chamber. A backlight is placed behind the swimming container to prevent light reflection from affecting the experimental results. Mice are placed in the swimming container for 5 minutes, and their activity is recorded by a camera throughout. The final evaluation metric is the time spent immobile.

[0047] (2) Sugar water preference test Mice were housed individually in cages and trained to drink sucrose water. For the first 24 hours, they were given two bottles of 1% to 2% sucrose water; for the next 24 hours, one bottle contained 1% to 2% sucrose water, and the other contained regular drinking water (the positions of the two bottles were switched during this period). The sucrose preference index was determined after 24 hours of fasting and water restriction. The amount of water consumed by the rats from both bottles was recorded within one hour. The formula for calculating the sucrose preference index is: Sucrose preference (%) = (Sucrose water consumption / (Sucrose water consumption + Regular drinking water consumption)) × 100%.

[0048] 2.1.4 Experimental Results: Forced swimming is a commonly used method for evaluating depressive-like behavior in mice. The immobility pattern in mice reflects a state of behavioral despair, a manifestation of depressive behavior in animals. This study found that the model group exhibited a significantly longer period of immobility compared to the control group. Compared to the control group, both Yanghe Huoxue Shunqi Decoction and selenium yeast improved the immobility time in mice, with statistically significant differences. However, the middle dose of Yanghe Huoxue Shunqi Decoction showed better efficacy (see...). Figure 2 ).

[0049] Compared with the control group, the model group rats showed a significantly reduced preference for sucrose, indicating a lack of pleasure and exhibiting depressive-like behavior. Compared with the model group, the herbal composition of this invention can improve the anhedonia in the model mice and effectively antagonize depressive abnormal behavior, with statistically significant differences (see...). Figure 3 ).

[0050] In summary, the traditional Chinese medicine composition of the present invention can indeed improve anhedonia in model mice and effectively antagonize depressive abnormal behavior in the treatment of Hashimoto's thyroiditis with depressive symptoms, demonstrating significant efficacy.

Claims

1. A traditional Chinese medicine composition for treating Hashimoto's thyroiditis with depressive symptoms, characterized in that... It is composed of the following raw materials in the following weight ratios: 50-200 parts Rehmannia glutinosa, 10-60 parts Cinnamomum cassia, 30-100 parts Ephedra sinica, 10-60 parts Cervi cornu slices, 10-60 parts Zingiber officinale, 30-80 parts Glycyrrhiza uralensis (processed), 50-200 parts Paeonia lactiflora (white peony root), 50-200 parts Paeonia veitchii (red peony root), 30-100 parts Paeonia suffruticosa root bark, 50-200 parts Codonopsis pilosula, 50-200 parts Angelica sinensis, 50-200 parts Prunus persica kernel, and 30-100 parts Carthamus tinctorius.

2. The traditional Chinese medicine composition for treating Hashimoto's thyroiditis with depressive symptoms as described in claim 1, characterized in that... Prepared Rehmannia Root 80-150 parts, Cinnamon 20-50 parts, Ephedra 40-80 parts, Deer Antler Slices 20-50 parts, Dried Ginger 20-50 parts, Prepared Licorice Root 40-70 parts, White Peony Root 90-120 parts, Red Peony Root 90-120 parts, Moutan Bark 50-80 parts, Codonopsis Root 80-150 parts, Angelica Root 80-150 parts, Peach Kernel 80-150 parts, Safflower 50-80 parts.

3. The traditional Chinese medicine composition for treating Hashimoto's thyroiditis with depressive symptoms as described in claim 2, characterized in that... Prepared Rehmannia Root 100 parts, Cinnamon 30 parts, Ephedra 60 parts, Deer Antler Slices 30 parts, Dried Ginger 30 parts, Prepared Licorice Root 50 parts, White Peony Root 100 parts, Red Peony Root 100 parts, Moutan Bark 60 parts, Codonopsis Root 100 parts, Angelica Root 100 parts, Peach Kernel 100 parts, Safflower 60 parts.

4. A traditional Chinese medicine composition for treating Hashimoto's thyroiditis with depressive symptoms as described in any one of claims 1-3, characterized in that... The preparation method is as follows: Place Rehmannia glutinosa, cinnamon, ephedra, deer antler slices, dried ginger, prepared licorice root, white peony root, red peony root, peony bark, codonopsis root, angelica root, peach kernel, and safflower in a container, add 8 times the total weight of the herbs in cold water, with the water level 2-3 cm above the herbs; soak for 30 minutes to fully moisten the herbs, bring to a boil over high heat, then simmer over low heat for another 30 minutes; for the second decoction, filter out the liquid from the first decoction, add the remaining herbs and 6 times the total weight of the herbs in warm water, just enough to cover the herbs; soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for another 20 minutes; after the decoction is complete, combine the two decoctions, filter out the dregs, and obtain the traditional Chinese medicine decoction.

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