A traditional Chinese medicine composition for treating thyroid solid and cystic nodules of liver stagnation and spleen deficiency, traditional Chinese medicine preparation and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition, its preparation, and its application for treating solid and cystic thyroid nodules caused by liver stagnation and spleen deficiency. The traditional Chinese medicine composition of this invention, by weight, comprises the following raw materials: 20-30 parts of Prunella vulgaris, 20-30 parts of Taraxacum mongolicum, 10-15 parts of Salvia miltiorrhiza, 6-9 parts of Bupleurum chinense (processed with vinegar), 9-10 parts of Citrus aurantium (fried), 9-12 parts of Paeonia lactiflora, 10-15 parts of Cyperus rotundus, 20-30 parts of Coix lacryma-jobi, 15-20 parts of Fritillaria thunbergii, 20-30 parts of pearl powder, and 20-30 parts of oyster shell. This invention also discloses the preparation of this traditional Chinese medicine composition. The traditional Chinese medicine composition and its preparation of this invention can effectively shrink thyroid nodules and improve symptoms such as neck fullness, pulling sensation, foreign body sensation in the throat, occasional stabbing pain in the front of the neck, irritability or depression, fatigue, loose stools, and poor sleep in patients with nodules caused by liver stagnation and spleen deficiency, without affecting thyroid function.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology. More specifically, it relates to a traditional Chinese medicine composition for treating solid and cystic nodules of the thyroid gland with liver stagnation and spleen deficiency syndrome, as well as its preparation and application. Background Technology

[0002] The incidence of thyroid nodules has shown a significant upward trend in recent years. The primary purpose of examination for thyroid nodules is to differentiate between benign and malignant nodules. Malignant nodules, such as papillary thyroid carcinoma, are mainly treated surgically. Benign nodules larger than 4 cm with compressive symptoms can also be treated surgically. However, there are currently a lack of medical treatment options for nodules smaller than 4 cm, goiter, nodules with certain risks, and nodules with neck fullness or discomfort. Every treatment method has its advantages and disadvantages. Surgical treatment often leads to irreversible hypothyroidism, and ablation therapy also has problems such as poor absorption and adhesions. Traditional Chinese medicine has advantages in internal medicine treatment, but current clinical treatment methods and plans for thyroid nodules still mainly rely on regular observation and surgery; no specific therapeutic drugs have been found. Summary of the Invention

[0003] To address the aforementioned technical problems, one objective of this invention is to provide a novel traditional Chinese medicine composition that can effectively shrink thyroid nodules and improve symptoms such as neck fullness, pulling sensation, foreign body sensation in the throat, occasional stabbing pain in the front of the neck, irritability or depression, fatigue, loose stools, and poor sleep in patients with liver stagnation and spleen deficiency syndrome, without affecting thyroid function.

[0004] Another object of the present invention is to provide various traditional Chinese medicine preparations made using the above-mentioned traditional Chinese medicine composition.

[0005] Another objective of this invention is to provide the application of the above-mentioned traditional Chinese medicine composition and preparation in the preparation of drugs for treating solid and cystic nodules of the thyroid gland with liver stagnation and spleen deficiency syndrome.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating solid and cystic nodules of the thyroid gland with liver stagnation and spleen deficiency syndrome. The raw materials of the traditional Chinese medicine composition include, by weight, 20-30 parts of Prunella vulgaris, 20-30 parts of Taraxacum mongolicum, 10-15 parts of Salvia miltiorrhiza, 6-9 parts of Bupleurum chinense (processed with vinegar), 9-10 parts of Citrus aurantium (fried), 9-12 parts of Paeonia lactiflora (red), 10-15 parts of Cyperus rotundus, 20-30 parts of Coix lacryma-jobi, 15-20 parts of Fritillaria thunbergii, 20-30 parts of pearl powder, and 20-30 parts of oyster shell.

[0008] The herbal composition of this invention soothes the liver and strengthens the spleen, detoxifies and dissipates nodules. It is mainly used to treat thyroid nodules or cervical lymphadenopathy of the liver stagnation and spleen deficiency type, accompanied by symptoms such as irritability or depression, fullness and stabbing pain in the front of the neck, foreign body sensation in the throat, fatigue, and poor sleep.

[0009] In this invention's prescription, *Prunella vulgaris* is used in large quantities to clear liver heat, reduce swelling, and dissipate nodules; dandelion clears heat, detoxifies, and reduces swelling and nodules. Together, they clear heat, detoxify, dissipate nodules, and reduce swelling, thus clearing heat stagnation, making them the principal herbs. *Bupleurum chinense* relieves liver stagnation; *Cyperus rotundus* is a key herb for qi stagnation, assisting *Bupleurum chinense* in relieving liver stagnation; *Citrus aurantium* regulates qi, promotes circulation, relieves bloating, and alleviates qi stagnation, serving as the assistant herbs. *Fritillaria thunbergii* strengthens the spleen, resolves phlegm, dissipates nodules, and eliminates carbuncles; *Coix lacryma-jobi* strengthens the spleen, drains dampness, dissipates nodules, drains pus, and resolves phlegm stagnation, achieving the combined effect of strengthening the spleen, removing dampness, resolving phlegm, and dissipating nodules. *Salvia miltiorrhiza* invigorates blood, removes blood stasis, cools the blood, and eliminates carbuncles; *Paeonia lactiflora* clears liver and spleen heat, dissipates blood stasis, and eliminates carbuncles, resolving blood stasis. *Pterocarpus tinctoria* calms the liver, subdues yang, soothes the mind, and calms the nerves; *Ostrea gigas* resolves phlegm and softens hardness, serving as adjuvant herbs. All these herbs together achieve the effects of soothing the liver, strengthening the spleen, detoxifying, and dissipating nodules. Clinically, this disease is often seen as liver dysfunction combined with liver fire rising, spleen deficiency and phlegm stagnation, resulting in stagnation and obstruction, which over time forms a mass in the front of the neck. This formula works by soothing the liver, clearing the liver, and calming the liver to relieve qi stagnation, clear liver fire, and clear fire stagnation; strengthen the spleen and resolve dampness, eliminate phlegm and dissipate nodules, resolve phlegm stagnation and dampness stagnation; disperse blood stasis and eliminate carbuncles, and relieve blood stagnation; thus achieving the effect of relieving the five stagnations.

[0010] In this invention, by way of example, the traditional Chinese medicine composition for treating solid and cystic nodules of the thyroid gland with liver stagnation and spleen deficiency syndrome comprises, by weight, the raw materials of the traditional Chinese medicine composition including: 20 parts of Prunella vulgaris, 30 parts of Taraxacum mongolicum, 10 parts of Salvia miltiorrhiza, 9 parts of Bupleurum chinense (processed with vinegar), 10 parts of Citrus aurantium (fried), 10 parts of Paeonia lactiflora (red), 15 parts of Cyperus rotundus, 30 parts of Coix lacryma-jobi, 15 parts of Fritillaria thunbergii (Zhejiang fritillary bulb), 30 parts of pearl powder, and 30 parts of oyster shell.

[0011] For example, the traditional Chinese medicine composition for treating solid and cystic nodules of the thyroid gland with liver stagnation and spleen deficiency syndrome comprises, by weight, the raw materials of the traditional Chinese medicine composition including: 20 parts of Prunella vulgaris, 20 parts of Taraxacum mongolicum, 10 parts of Salvia miltiorrhiza, 6 parts of Bupleurum chinense (processed with vinegar), 10 parts of Citrus aurantium (fried), 10 parts of Paeonia lactiflora (red), 10 parts of Cyperus rotundus, 30 parts of Coix lacryma-jobi, 20 parts of Fritillaria thunbergii (Zhejiang fritillary bulb), 20 parts of pearl powder, and 30 parts of oyster shell.

[0012] For example, the traditional Chinese medicine composition for treating solid and cystic nodules of the thyroid gland with liver stagnation and spleen deficiency syndrome comprises, by weight, the raw materials of the traditional Chinese medicine composition including: 20 parts of Prunella vulgaris, 30 parts of Taraxacum mongolicum, 10 parts of Salvia miltiorrhiza, 6 parts of Bupleurum chinense (processed with vinegar), 10 parts of Citrus aurantium (fried), 10 parts of Paeonia lactiflora (red), 15 parts of Cyperus rotundus, 20 parts of Coix lacryma-jobi, 15 parts of Fritillaria thunbergii (Zhejiang fritillary bulb), 30 parts of pearl powder, and 20 parts of oyster shell.

[0013] The basic formula of the above-mentioned traditional Chinese medicine composition of the present invention can be adjusted according to clinical symptoms to reduce thyroid nodules, improve symptoms such as neck distension and stabbing pain, pulling sensation, foreign body sensation, irritability or depression, loose stools, fatigue, and poor sleep in patients with liver stagnation and spleen deficiency syndrome, and improve certain specific clinical symptoms, thereby further enhancing the adaptability of the composition of the present invention and improving the therapeutic effect. These adjustments made based on the basic formula of the present invention are also within the scope of protection of this application.

[0014] For example, for those with sore throat, add one or more of honeysuckle, scrophularia, and platycodon. The recommended dosage is 8-10 parts of honeysuckle, 10-15 parts of scrophularia, and 9-10 parts of platycodon.

[0015] For example, for those with severe depression, add one or more of turmeric and albizia bark. The recommended dosage of turmeric is 10-12 parts and the dosage of albizia bark is 10-15 parts.

[0016] For example, for those with severe fatigue, add one or more of Astragalus membranaceus and Codonopsis pilosula. The recommended dosage of Astragalus membranaceus is 10-15 parts and the dosage of Codonopsis pilosula is 10-20 parts.

[0017] For example, for those with severe sleep problems, add one or more of magnetite and polygala tenuifolia. The recommended dosage of magnetite is 20-30 parts and the dosage of polygala tenuifolia is 6-9 parts.

[0018] For example, for those with severe phlegm and qi stagnation, add one or more of turmeric and soapberry thorns. The recommended dosage of turmeric is 10-20 parts and soapberry thorns is 6-10 parts.

[0019] For example, for those with obvious teeth marks and severe loose stools, add stir-fried Atractylodes macrocephala; for those with severe constipation, add raw Atractylodes macrocephala. The recommended dosage of raw or stir-fried Atractylodes macrocephala is 10-20 parts.

[0020] Secondly, the present invention provides a traditional Chinese medicine preparation for treating solid and cystic nodules of the thyroid gland with liver stagnation and spleen deficiency syndrome, wherein the raw materials of the traditional Chinese medicine preparation include the above-mentioned traditional Chinese medicine composition.

[0021] Depending on actual needs, the traditional Chinese medicine preparations may also include pharmaceutically acceptable excipients. Various dosage forms, such as decoctions, tablets, granules, pills, powders, capsules, or granules, are prepared according to conventional pharmaceutical processes.

[0022] Thirdly, the present invention also provides the application of the above-mentioned traditional Chinese medicine composition and traditional Chinese medicine preparation in the preparation of any of the following drugs:

[0023] 1) Control the growth of thyroid nodules, shrink thyroid nodules, and promote the absorption of the cystic portion of nodules;

[0024] 2) Treatment of cervical lymphadenopathy;

[0025] 3) Improves symptoms such as irritability or depression, fullness and stabbing pain in the front of the neck, foreign body sensation in the throat, fatigue, loose stools, and poor sleep.

[0026] 4) Treatment of solid and cystic nodules of the thyroid gland with liver stagnation and spleen deficiency syndrome.

[0027] In addition, unless otherwise specified, all raw materials of the traditional Chinese medicine composition of the present invention can be obtained commercially available. Any range of traditional Chinese medicine composition described in the present invention, including any value between the endpoints and any sub-ranges formed by the endpoints or any value between the endpoints, can achieve the effect of treating solid and cystic nodules of the thyroid gland with liver stagnation and spleen deficiency syndrome.

[0028] The beneficial effects of this invention are as follows:

[0029] The herbal composition of this invention has been clinically verified to effectively shrink thyroid nodules, control nodule growth, and improve symptoms such as neck fullness and stabbing pain, pulling sensation, foreign body sensation, irritability or depression, loose stools, fatigue, and poor sleep in patients with liver stagnation and spleen deficiency syndrome. It does not affect thyroid function. Detailed Implementation

[0030] To more clearly illustrate the present invention, the following description, in conjunction with preferred embodiments, further clarifies the invention. Those skilled in the art should understand that the specific descriptions below are illustrative rather than restrictive, and should not be construed as limiting the scope of protection of the present invention.

[0031] Example 1

[0032] A traditional Chinese medicine composition for treating solid and cystic nodules of the thyroid gland due to liver stagnation and spleen deficiency:

[0033] Raw material formula: Prunella vulgaris 20g, Taraxacum mongolicum 30g, Salvia miltiorrhiza 10g, Bupleurum chinense (vinegar-processed) 9g, Citrus aurantium (fried) 10g, Paeonia lactiflora 10g, Cyperus rotundus 15g, Coix lacryma-jobi (raw) 30g, Fritillaria thunbergii 15g, pearl powder 30g, Ostrea gigas 30g.

[0034] Take the above-mentioned raw materials according to the formula, add water and decoct, heat to boiling, maintain a gentle boil for 1 hour, and filter (200 mesh); continue to add water to the dregs and decoct, heat to boiling, maintain a gentle boil for 0.5 to 1 hour, filter (200 mesh), and combine the filtrates. Then concentrate the filtrate under reduced pressure to a clear extract with a certain specific gravity.

[0035] Example 2

[0036] A traditional Chinese medicine preparation for treating solid and cystic nodules of the thyroid gland due to liver stagnation and spleen deficiency:

[0037] Raw material formula: Prunella vulgaris 20g, Taraxacum mongolicum 20g, Salvia miltiorrhiza 10g, Bupleurum chinense (processed with vinegar) 6g, Citrus aurantium (fried) 10g, Paeonia lactiflora 10g, Cyperus rotundus 10g, Coix lacryma-jobi (raw) 30g, Fritillaria thunbergii 20g, pearl powder 20g, Ostrea gigas 30g.

[0038] Take the above-mentioned raw materials according to the formula, add water and decoct, heat to boiling, maintain a gentle boil for 1 hour, and filter (200 mesh); add water to the dregs and decoct, heat to boiling, maintain a gentle boil for 0.5 to 1 hour, filter (200 mesh), and combine the filtrates; then concentrate the filtrate under reduced pressure to a clear paste of a certain specific gravity, spray dry; sieve to obtain dry paste powder; granulate by dry method to make 12-40 mesh granules, and thus obtain the product.

[0039] Example 3: Clinical observation of the efficacy of the traditional Chinese medicine composition of the present invention in treating solid and cystic-solid thyroid nodules with liver stagnation and spleen deficiency syndrome.

[0040] Study Protocol: A prospective, randomized controlled clinical trial was conducted to observe the clinical efficacy in 130 patients with thyroid nodules. Trial Groups: Patients with thyroid nodules meeting the inclusion criteria were randomly assigned in a 1:1 ratio to either a control group (n=65) or an experimental group (n=65). Medication Administration: Control group: Prunella vulgaris tablets, 6 tablets orally twice daily. Experimental group: Liver-Soothing and Spleen-Strengthening Formula granules (a traditional Chinese medicine preparation from Example 2 of this invention), orally twice daily.

[0041] Treatment duration: 3 months. Visits: Patients will undergo thyroid color Doppler ultrasound examination and symptom scoring every 3 months; safety laboratory tests will be performed once after the 3-month treatment period ends.

[0042] Inclusion criteria for study participants:

[0043] ① Age 18-75 years old;

[0044] ② Meets the criteria for ultrasound diagnosis of thyroid nodules, including solid, cystic-solid, and cystic nodules, and the long diameter of the thyroid nodule is ≥0.5cm and <5.0cm;

[0045] ③ Observe for ≤4 nodules in both thyroid lobes;

[0046] ④ High-risk nodules that undergo fine-needle aspiration biopsy (FNAB) and cytopathology indicate non-malignant lesions;

[0047] ⑤ Meets the diagnostic criteria for goiter with liver stagnation and spleen deficiency in Traditional Chinese Medicine;

[0048] ⑥ Those who sign the informed consent form.

[0049] Research findings:

[0050] The Liver-Soothing and Spleen-Strengthening Formula group (141 lesions): After 3 months of intervention, 7.8% of lesions completely disappeared; 27.66% shrank by <25%; 26.24% shrank by 25-49%; 11.35% shrank by >50%; 19.86% showed no significant change in nodules; and 7.09% increased in size. 73.05% of nodules shrank after 3 months of intervention. Among them, 17 lesions showed no risk of grade 4 nodules disappearing. Of the 37 high-risk nodules in this group, 45.94% showed no risk disappearance. 16 high-risk nodules shrank, accounting for 43.24%.

[0051] In the control group (89 lesions) of Prunella vulgaris tablets: after intervention, 3.37% of lesions disappeared; 15.73% lesions shrank by <25%; 21.35% lesions shrank by 25-49%; 10.11% lesions shrank by >50%; 25.84% of nodules showed no significant change; and 23.59% of nodules increased in size compared to before. A total of 50.56% of nodules shrank compared to before. In this group, there were 13 high-risk nodules; 4 nodules (30.77%) showed no risk disappearance, and 5 high-risk nodules (38.46%) shrank.

[0052] Currently, the main clinical preparations of Prunella vulgaris include granules, injections, oral liquids, and ointments, which are widely used in clinical practice. A consensus on the clinical application of Prunella vulgaris oral liquid in the treatment of goiter, thyroid nodules, and other thyroid diseases has been published.

[0053] After 3 months of intervention with the Liver-Soothing and Spleen-Strengthening Formula, 45.39% of the nodules shrank by more than 25% (based on the total number of nodules), the overall nodule shrinkage rate was 73.05%, the control rate was 92.91%, and the risk disappearance rate was 45.94%. The risk nodule shrinkage rate was 43.24%. The therapeutic effect was superior to that of the control group.

[0054] After 3 months of intervention with Prunella vulgaris tablets, 34.83% of the nodules shrank by more than 25% based on the total number of nodules, the total nodule shrinkage rate was 50.56%, and the control rate was 76.41%.

[0055] After 3 months of intervention with the Liver-Soothing and Spleen-Strengthening Formula, the relief rate of symptoms such as neck distension and stabbing pain, foreign body sensation in the throat, depression or irritability, fatigue, loose stools, and poor sleep was 92.2%, while the symptom improvement rate of the Prunella vulgaris tablets was approximately 75.8%.

[0056] Experimental Example 4: Typical Case

[0057] Case 1: Mr. Di, male, 61 years old. In December 2023, an examination revealed a cystic-solid mass in the left lobe of his thyroid gland, approximately 3.7 × 2.8 cm in size, predominantly cystic, grade 3. He visited the outpatient clinic and was prescribed this formula (Prunella vulgaris 20g, Taraxacum mongolicum 30g, Bupleurum chinense (processed with vinegar) 9g, Citrus aurantium (fried) 10g, Paeonia lactiflora 10g, Salvia miltiorrhiza 10g, Coix lacryma-jobi 30g, Fritillaria thunbergii 15g, Cyperus rotundus 15g, Curcuma longa 10g, Margarita 30g, Ostrea gigas 30g). After 3 months of treatment, a follow-up ultrasound showed: a cystic-solid nodule in the left lobe, 3.4 × 2.4 cm, grade 3. The cystic-solid mass had shrunk by 21.24% compared to the previous examination.

[0058] Case 2: Ms. Han, female, 60 years old. A thyroid ultrasound on September 8, 2023, showed multiple cystic-solid nodules in the right lobe of the thyroid gland, the largest measuring 4.3×2.6×1.9cm, grade 3. She sought outpatient treatment and was prescribed this formula (Prunella vulgaris 20g, Taraxacum mongolicum 30g, Bupleurum chinense (vinegar-processed) 6g, Citrus aurantium (fried) 10g, Paeonia lactiflora 10g, Coix lacryma-jobi 20g, Fritillaria thunbergii 15g, Cyperus rotundus 15g, Salvia miltiorrhiza 10g, Margarita 30g, Ostrea gigas 20g, Curcuma zedoaria 12g, Magnetite 20g, Polygala tenuifolia 9g). After 3 months of treatment, a follow-up thyroid ultrasound on December 20 showed multiple isoechoic, hypoechoic, and mixed echogenic nodules in the right lobe of the thyroid gland, the largest measuring 2.8×1.3cm, grade 3. The nodules had shrunk by 55.45% compared to the previous reading.

[0059] Case 3: Ms. Lu, female, 76 years old. A thyroid ultrasound on June 6, 2023, showed: a 3.2×2.3×2.1cm isoechoic lesion in the left lobe of the thyroid gland, with blood flow signals in the periphery and internal area; and a 0.7×0.5×0.4cm nodule in the right lobe, grade 3. She sought outpatient treatment and was prescribed this formula (Prunella vulgaris 20g, Taraxacum mongolicum 30g, Bupleurum chinense (vinegar-processed) 9g, Citrus aurantium (fried) 10g, Paeonia lactiflora 10g, Salvia miltiorrhiza 10g, Fritillaria thunbergii 15g, Cyperus rotundus 15g, Coix lacryma-jobi 30g, Pearl powder 30g, Ostrea gigas 30g). After 3 months of intervention, a follow-up ultrasound on September 13, 2023, showed: a 2.7×1.9cm isoechoic lesion in the left lobe of the thyroid gland, with blood flow signals in the periphery and internal area; and a 0.4×0.3cm hypoechoic lesion in the right lobe, grade 3. Both nodules in the left and right lobes have shrunk compared to before. The isoechoic mass in the left lobe has shrunk by 23.67% compared to 3 months ago, and the nodule in the right lobe has shrunk by 57.15% compared to before.

[0060] Case 4: Ms. Xu, female, 23 years old, visited the outpatient clinic on September 14, 2023. Recent thyroid ultrasound showed an isoechoic mass in the left lobe of the thyroid gland, approximately 3.1 × 1.6 cm in size, with peripheral and internal blood flow signals, grade 3. She was treated with this formula (Prunella vulgaris 20g, Taraxacum mongolicum 30g, Bupleurum chinense (vinegar-processed) 6g, Citrus aurantium (fried) 10g, Salvia miltiorrhiza 10g, Paeonia lactiflora 10g, Coix lacryma-jobi 20g, Fritillaria thunbergii 15g, Cyperus rotundus 15g, Curcuma longa 10g, Gleditsia sinensis 10g, pearl powder 30g, oyster shell 20g) for 4 months. Follow-up ultrasound showed a hypoechoic mass in the left lobe of the thyroid gland, approximately 1.7 × 1.0 cm in size, with heterogeneous internal echoes and a few blood flow signals. After medication intervention, the nodule shrank by 65.73% compared to before, and her fatigue and insomnia significantly improved.

[0061] Case 5: Ms. Zhao, female, 30 years old. In February 2024, a thyroid ultrasound showed a mixed echogenic lesion in the lower pole of the right lobe, approximately 2.1 × 1.6 cm in size, predominantly cystic, with peripheral blood flow signal (grade 3). She consulted an outpatient and was treated with this formula (Prunella vulgaris 20g, Taraxacum mongolicum 20g, Bupleurum chinense (vinegar-processed) 6g, Citrus aurantium (fried) 10g, Paeonia lactiflora 10g, Salvia miltiorrhiza 10g, Fritillaria thunbergii 20g, Coix lacryma-jobi 30g, Cyperus rotundus 10g, Margarita 20g, Ostrea gigas 30g, Lonicera japonica 10g, Codonopsis pilosula 15g). After only 3 weeks of treatment, a follow-up thyroid ultrasound showed a cystic-solid nodule in the right lobe, approximately 1.3 × 0.9 cm in size, with the cystic portion partially absorbed (grade 3). After one month of intervention with this formula, the nodule shrank by 65.18%. Within one month of intervention, most of the cystic portion of the cystic-solid nodule was absorbed, and the nodule rapidly shrank.

[0062] Case 6: Ms. Yu, female, 58 years old. In November 2023, a thyroid ultrasound showed a hypoechoic nodule in the right lobe, approximately 0.5×0.2×0.3cm in size, with indistinct borders and irregular shape, TI-RADS 4C grade. She presented with a foreign body sensation when swallowing and was prescribed this formula (Prunella vulgaris 20g, Taraxacum mongolicum 20g, Bupleurum chinense (processed with vinegar) 6g, Citrus aurantium (fried) 10g, Paeonia lactiflora 10g, Salvia miltiorrhiza 10g, Cyperus rotundus 10g, Coix lacryma-jobi 30g, Fritillaria thunbergii 20g, Pearl powder 20g, Ostrea gigas 30g). After 3 months of treatment, a follow-up thyroid ultrasound showed a hypoechoic nodule in the right lobe, 0.34×0.25cm in size, with regular shape, grade 3. The results showed that after 3 months of intervention with this formula, the risk nodule shrank and the risk disappeared, with a shrinkage rate of 43.33%.

[0063] Case 7: Mr. Xu, male, 72 years old, presented in November 2023 with multiple thyroid nodules. The right lobe nodule measured 1.0×0.7cm, and the left lobe nodule measured 0.7×0.4cm, grade 3. He reported that the nodules had increased in size compared to before, accompanied by a foreign body sensation in his neck and emotional instability. He was prescribed this formula at the outpatient clinic (Prunella vulgaris 20g, Taraxacum mongolicum 20g, Bupleurum chinense (vinegar-processed) 6g, Citrus aurantium (fried) 10g, Paeonia lactiflora 10g, Salvia miltiorrhiza 10g, Cyperus rotundus 10g, Coix lacryma-jobi 30g, Fritillaria thunbergii 20g, Margarita 20g, Ostrea gigas 30g). A follow-up examination 3 months later showed the right lobe nodule measuring 0.6×0.5cm and the left lobe nodule measuring 0.5×0.3cm, grade 3, representing a reduction in size of 57.15% and 46.43% respectively compared to before. His symptoms were significantly relieved.

[0064] Case 8: Ms. Huang, female, 56 years old. In December 2023, an examination revealed multiple cystic-solid nodules in her thyroid gland. The right lobe measured 2.7 × 1.7 cm, and the left lobe showed a mixed echogenic nodule measuring 2.1 × 1.2 cm (grade 3), which was larger than before. She visited the outpatient clinic and was treated with this formula (Prunella vulgaris 20g, Taraxacum mongolicum 30g, Salvia miltiorrhiza 10g, Bupleurum chinense (processed with vinegar) 9g, Citrus aurantium (fried) 10g, Paeonia lactiflora 10g, Cyperus rotundus 15g, Coix lacryma-jobi 30g, Fritillaria thunbergii 15g, pearl powder 30g, oyster shell 30g) for 2 months. A follow-up ultrasound showed a mixed echogenic nodule of 1.2 × 0.9 cm in the right lobe and 1.9 × 1.2 cm in the left lobe (grade 3). The right lobe nodule had significantly shrunk, and the nodules on both sides had shrunk by 76.47% and 9.53% respectively compared to before.

[0065] Case 9: Mr. Jin, male, 44 years old, presented with a significantly enlarged thyroid nodule in November 2023, as observed during a follow-up examination. Thyroid ultrasound showed a mixed echogenic lesion in the left lobe of the thyroid gland, approximately 3.0 × 2.4 cm in size, with visible blood flow signal (grade 3). He was treated with this formula (Prunella vulgaris 20g, Taraxacum mongolicum 30g, Salvia miltiorrhiza 10g, Paeonia lactiflora 10g, Bupleurum chinense (vinegar-processed) 6g, Citrus aurantium (fried) 10g, Gleditsia sinensis 10g, Fritillaria thunbergii 15g, Coix lacryma-jobi 20g, Cyperus rotundus 15g, Curcuma longa 10g, Albizia julibrissin bark 15g, Margarita 30g, Ostrea gigas 20g, Curcuma zedoaria 10g, Lonicera japonica 10g). After one month of treatment, a follow-up thyroid ultrasound showed a mixed echogenic lesion in the left lobe of the thyroid gland measuring 2.7 × 2.1 cm (grade 3). After one month of intervention with this formula, the nodule significantly shrank, with a reduction rate of 21.25%. This short-term intervention achieved a nodule reduction of more than 20%.

[0066] Case 10: Mr. Zhou, male, 46 years old, underwent lobectomy for micropapillary carcinoma in 2014. A follow-up thyroid ultrasound in October 2023 showed a hypoechoic nodule measuring 0.3 × 0.4 cm in the residual thyroid lobe of his left thyroid gland. The 301 Hospital indicated a TI-RADS category 5, suggesting high risk. He then sought outpatient treatment and was prescribed this formula (Prunella vulgaris 20g, Taraxacum mongolicum 30g, Salvia miltiorrhiza 10g, Bupleurum chinense (processed with vinegar) 6g, Citrus aurantium (fried) 10g, Paeonia lactiflora 10g, Cyperus rotundus 15g, Gleditsia sinensis 10g, Coix lacryma-jobi 20g, Fritillaria thunbergii 15g, Margarita 30g, Ostrea gigas 20g, Curcuma zedoaria 15g) for two months. A follow-up thyroid ultrasound in January 2024 showed no trace of the hypoechoic nodule in the residual left thyroid lobe. The high-risk nodule disappeared, avoiding further biopsy.

[0067] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. For those skilled in the art, other variations or modifications can be made based on the above description. It is impossible to exhaustively list all the implementation methods here. All obvious variations or modifications derived from the technical solutions of the present invention are still within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating solid and cystic-solid thyroid nodules due to liver stagnation and spleen deficiency, characterized in that, The raw materials of the traditional Chinese medicine composition, by weight, include: 20-30 parts of Prunella vulgaris, 20-30 parts of Taraxacum mongolicum, 10-15 parts of Salvia miltiorrhiza, 6-9 parts of Bupleurum chinense (processed with vinegar), 9-10 parts of Citrus aurantium (fried), 9-12 parts of Paeonia lactiflora (red peony root), 10-15 parts of Cyperus rotundus, 20-30 parts of Coix lacryma-jobi, 15-20 parts of Fritillaria thunbergii, 20-30 parts of pearl powder, and 20-30 parts of oyster shell.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials of the Chinese herbal composition, by weight, include: 20 parts of Prunella vulgaris, 30 parts of Taraxacum mongolicum, 10 parts of Salvia miltiorrhiza, 9 parts of Bupleurum chinense (processed with vinegar), 10 parts of Citrus aurantium (fried), 10 parts of Paeonia lactiflora (red), 15 parts of Cyperus rotundus, 30 parts of Coix lacryma-jobi, 15 parts of Fritillaria thunbergii (Zhejiang fritillary bulb), 30 parts of pearl powder, and 30 parts of oyster shell. or, The raw materials of the traditional Chinese medicine composition, by weight, include: 20 parts of Prunella vulgaris, 20 parts of Taraxacum mongolicum, 10 parts of Salvia miltiorrhiza, 6 parts of Bupleurum chinense (processed with vinegar), 10 parts of Citrus aurantium (fried), 10 parts of Paeonia lactiflora (red), 10 parts of Cyperus rotundus (fragrant), 30 parts of Coix lacryma-jobi (coix seed), 20 parts of Fritillaria thunbergii (Zhejiang fritillary bulb), 20 parts of pearl powder, and 30 parts of oyster shell. or, The raw materials of the traditional Chinese medicine composition, by weight, include: 20 parts of Prunella vulgaris, 30 parts of Taraxacum mongolicum, 10 parts of Salvia miltiorrhiza, 6 parts of Bupleurum chinense (processed with vinegar), 10 parts of Citrus aurantium (fried), 10 parts of Paeonia lactiflora (red), 15 parts of Cyperus rotundus, 20 parts of Coix lacryma-jobi, 15 parts of Fritillaria thunbergii (Zhejiang fritillary bulb), 30 parts of pearl powder, and 20 parts of oyster shell.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, By weight, the raw materials of the traditional Chinese medicine composition also include one or more of the following: 8-10 parts of honeysuckle, 10-15 parts of scrophularia, and 9-10 parts of platycodon.

4. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, By weight, the raw materials of the traditional Chinese medicine composition also include one or more of the following: 10-12 parts of turmeric and 10-15 parts of Albizia bark.

5. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, By weight, the raw materials of the traditional Chinese medicine composition also include one or more of the following: 10-15 parts of Astragalus membranaceus and 10-20 parts of Codonopsis pilosula.

6. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, By weight, the raw materials of the traditional Chinese medicine composition also include one or more of the following: 20-30 parts of magnetite and 6-9 parts of Polygala tenuifolia.

7. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, By weight, the raw materials of the traditional Chinese medicine composition also include one or more of the following: 10-20 parts of Curcuma zedoaria and 6-10 parts of Gleditsia sinensis thorns.

8. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The raw materials of the traditional Chinese medicine composition also include, by weight, 10-20 parts of Atractylodes macrocephala.

9. A traditional Chinese medicine preparation for treating solid and cystic-solid thyroid nodules due to liver stagnation and spleen deficiency, characterized in that, The raw materials for the traditional Chinese medicine preparation include the traditional Chinese medicine composition according to any one of claims 1-8.

10. The traditional Chinese medicine preparation according to claim 9, characterized in that, The raw materials for the traditional Chinese medicine preparations also include pharmaceutically acceptable excipients.

11. The traditional Chinese medicine preparation according to claim 9, characterized in that, The dosage forms of the traditional Chinese medicine preparations are decoctions, tablets, granules, pills, powders, capsules, or powders.

12. The use of the traditional Chinese medicine composition according to any one of claims 1-8 or the traditional Chinese medicine preparation according to any one of claims 9-11 in the preparation of a medicament for treating solid and cystic nodules of the thyroid gland with liver stagnation and spleen deficiency syndrome.