Traditional Chinese medicine composition for treating thyroid nodule and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating thyroid nodules and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine compositions. The Uygur medicine honey ointment aims at solving the problem that safe and effective Uygur medicine honey ointment for treating thyroid nodules is lacked in the prior art. The traditional Chinese medicine composition comprises the following components in parts by weight: 5-15 parts of bungarus parvus, 5-15 parts of peganum harmala, 5-15 parts of capparis spinosa root bark, 10-20 parts of galangal, 10-20 parts of dried ginger, 5-15 parts of fructus piperis longi and 5-15 parts of cinnamon. The traditional Chinese medicine composition is prepared into the Uygur medicine honey ointment, and natural medicinal materials with homology of medicine and food are selected and are safe and free of toxic and side effects; through reasonable compatibility and synergistic interaction of a plurality of medicinal materials, the traditional Chinese medicine composition has remarkable effects of removing abnormal spleen fluid and qi, eliminating stagnation, expelling wind and removing cold, and resisting tumors; the traditional Chinese medicine composition not only can be used for treating thyroid nodules, but also can be used for treating gland nodular diseases caused by dry cold such as breast nodules and benign prostatic hyperplasia, and can effectively relieve clinical symptoms of patients; the preparation method is simple and convenient to operate, easy to popularize, suitable for industrial production and worthy of popularization and application.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine compositions, and in particular to a traditional Chinese medicine composition for treating thyroid nodules and a preparation method thereof. Background Art

[0002] Thyroid nodules are a common clinical condition, yet their etiology and pathogenesis remain unclear. Thyroid nodules can develop due to inflammation, tumors, degenerative changes, and immune dysfunction, and are primarily characterized by the presence of one or more structurally abnormal tissue masses within the thyroid gland. Benign thyroid nodules include multinodular goiter, Hashimoto's thyroiditis, cysts, follicular adenomas, and Hurthle cell adenomas. The vast majority of malignant nodules are thyroid cancer, with a minority representing primary thyroid lymphoma or metastatic thyroid cancer (breast cancer, kidney cancer, etc.). Modern medicine generally treats benign thyroid nodules with regular follow-up, without requiring specific treatment. Surgical treatment may be appropriate for certain specific cases of benign nodules (such as severe compression, malignant potential, tumor location, and concurrent hyperthyroidism that is refractory to medical treatment). Conservative treatments, such as thyroid-stimulating hormone suppression, 131I, percutaneous anhydrous ethanol injection, percutaneous laser ablation, and radiofrequency ablation, have demonstrated some clinical efficacy but have numerous limitations and adverse reactions, and are not recommended for routine use in international and domestic guidelines.

[0003] Traditional Chinese Medicine considers thyroid nodules to be "goiters" or "tumors." Their primary causes are congenital deficiency, emotional imbalance, and an unhealthy diet, leading to sluggish Qi flow, phlegm retention, and blood stasis, which accumulate in the anterior neck. Liver Qi stagnation and spleen deficiency are the primary pathogenesis. Uyghur medicine considers thyroid nodules to be "goiters." While ancient texts do not mention thyroid nodules as a disease, similar clinical symptoms are found in numerous medical texts. Thyroid nodules are caused by various internal and external factors, leading to thyroid temperament and fluid imbalance. Clinically, they present as diffuse swelling or nodules in the anterior neck, often accompanied by a mass, neck discomfort, hoarseness, or a feeling of pharyngeal obstruction. Most physicians believe that genetic factors, combined with dietary and environmental factors, lead to thyroid temperament and fluid imbalance, affecting the "inhibitory drive, stimulating drive, and growth drive," resulting in diffuse thyroid swelling or nodules. The treatment is guided by dialectical treatment, with the principles of regulating temperament, balancing body fluids, dispersing qi and restraining, and inhibiting nodule hyperplasia, combining internal and external treatments.

[0004] Currently, there are no patent reports on Uighur medical honey paste for treating thyroid nodules and its preparation method. Therefore, developing a safe, effective and easy-to-use Uighur medical honey paste for treating thyroid nodules has important clinical significance and market value. Summary of the Invention

[0005] In response to the above-mentioned problems, the present invention is guided by Uyghur medical theory and combined with modern pharmaceutical technology to prepare an oral honey paste with the effects of clearing abnormal spleen fluid, expelling qi, dispersing nodules, dispelling wind and cold, and anti-tumor, which is used to treat thyroid nodules to solve the problem of large side effects in the existing technology.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0007] A traditional Chinese medicine composition for treating thyroid nodules, comprising the following components: Agkistrodon halys, camel thorn fruit, Capparis spinulosa root bark, galangal, dried ginger, Piper longum, and cinnamon bark;

[0008] The weight proportions of different components are as follows: 5-15 parts of Agkistrodon halys, 5-15 parts of Camel Peaches, 10-20 parts of Alpinia officinalis, 5-15 parts of Capparis spinosa root bark, 10-20 parts of dried ginger, 5-15 parts of Piper longum and 5-15 parts of cinnamon bark.

[0009] Preferably, the weight parts of different components are: 6 parts of Agkistrodon halys, 5 parts of camel thorn fruit, 5 parts of caper root bark, 10 parts of galangal, 10 parts of dried ginger, 5 parts of piper longum, 5 parts of cinnamon bark, etc.

[0010] Preferably, the weight parts of different components are: 7 parts of Agkistrodon hawthorne, 10 parts of camel thorn fruit, 10 parts of caper root bark, 15 parts of galangal, 15 parts of dried ginger, 10 parts of longan, 10 parts of cinnamon bark, etc.

[0011] Preferably, the weight proportions of the different components are: 8 parts of Agkistrodon halys, 15 parts of camel thorn fruit, 15 parts of caper root bark, 20 parts of galangal, 20 parts of dried ginger, 15 parts of long piper longum, and 15 parts of cinnamon bark.

[0012] The pharmacology of each component is as follows:

[0013] White Snake: Dry and heaty, dissipates Qi and softens hard masses, reduces inflammation and swelling, purifies blood and removes toxins, removes dampness and strengthens muscles, and restores skin color. It is mainly used to treat damp-cold or mucus-based diseases, such as various benign and malignant tumors, lymph node tuberculosis, various stubborn skin diseases, ulcers, eczema, leprosy and rheumatoid arthritis, numbness of hands and feet, vitiligo, etc.

[0014] Camel pistachio: This product has a second-degree dryness and third-degree heat, and a bitter taste. Its functions include: dispelling wind and relieving pain, strengthening the body and enhancing yang, strengthening tendons and invigorating the mind, relieving cough and asthma, and warming the body and opening the orifices. It is primarily used to treat damp-cold or mucus-based conditions, such as joint pain, sciatica, emaciation and impotence, paralysis, facial paralysis, cough and asthma, depression, and forgetfulness.

[0015] Capparis spinosa root bark: This product has a secondary dry-heat property and a pungent flavor. It functions to invigorate dryness and heat, dissipate qi and relieve pain, clear obstructions and strengthen tendons, clear abnormal mucus, soften hard masses and reduce inflammation, promote diuresis and reduce swelling, and eliminate dampness and freckles. It is primarily used to treat damp-cold or mucus-based diseases.

[0016] Alpinia officinalis: It can disperse Qi and relieve pain, open up blockages, and is mainly used to treat various diseases caused by cold body fluids such as abnormal spleen fluid and abnormal mucus.

[0017] Dried ginger: This product has a secondary dry-heat property and a pungent taste. It has the functions of generating heat, warming the stomach and promoting digestion, drying dampness and stopping diarrhea, dispersing wind and cold, warming the body and strengthening yang, dispelling cold and stopping leukorrhea, etc. It is mainly used to treat damp-cold or mucus-based diseases.

[0018] Piper longum: This product has a dry and hot nature and a pungent flavor. It has the functions of promoting dryness and heat, nourishing the stomach and aiding digestion, promoting ventilation and relieving bloating, replenishing essence and strengthening yang, promoting urination and menstruation, relieving cough and phlegm, and dispelling cold and relieving pain. It is mainly used to treat damp-cold or mucus-based diseases.

[0019] Cinnamon: This product has a secondary dry-heat property, a fragrant aroma, and a pungent flavor. It functions to generate heat and dryness, regulate abnormal mucus, dispel cold and nourish the heart, warm the middle and stimulate the appetite, dry dampness and stop diarrhea, and promote urination and menstruation. It is primarily used to treat damp-cold or mucus-based conditions.

[0020] On the other hand, the present invention also provides a traditional Chinese medicine preparation, comprising the traditional Chinese medicine composition as described above.

[0021] Preferably, the traditional Chinese medicine preparation is Uyghur medical honey paste.

[0022] In another aspect, the present invention also provides a method for preparing the aforementioned traditional Chinese medicine preparation.

[0023] The following steps are involved:

[0024] S1: Dry the formulated amounts of Agkistrodon halys, Camel thorn fruit, Capparis spinosa root bark, Alpinia officinalis, Dried ginger, Piper longum and Cinnamomum cassia bark;

[0025] S2: Stir-fry the camel pectin seeds over light heat, then mix and grind all the drugs together, grind the prescribed herbs into fine powder, and pass through an 80-mesh sieve;

[0026] S3: Add three times the amount of honey to all the other ingredients in the prescription and mix well to make a dense paste.

[0027] The beneficial effects of the present invention are as follows: compared with the prior art, the improvement of the present invention is that:

[0028] 1. The Chinese medicine composition provided by the present invention is made of natural medicinal materials that are both medicinal and edible, and is safe and has no toxic side effects;

[0029] 2. The Chinese medicine composition provided by the present invention, through the rational combination of multiple medicinal materials and synergistic synergy, has significant effects in clearing abnormal spleen fluid, dispelling qi, dispersing nodules, dispelling wind and cold, and resisting tumors. It is used for glandular nodular diseases caused by dryness and cold, such as thyroid nodules, breast nodules, and prostate hyperplasia. Clinical trials in our hospital have shown that it can effectively alleviate patients' clinical symptoms.

[0030] 3. The preparation method of the Chinese medicine composition provided by the present invention is simple to operate, easy to promote, suitable for industrial production, and worthy of promotion and application. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 This is a photo of the Chinese medicine composition of the present invention being sieved during the production process;

[0032] Figure 2 This is a photo of adding honey to the prescription during the preparation process of the Chinese medicine composition of the present invention;

[0033] Figure 3 This is a photo of the Chinese medicine composition of the present invention being stirred to obtain a honey paste during the production process;

[0034] Figure 4 This is a photo of the Chinese medicine composition of the present invention after being bottled after production.

[0035] Figure 5 This is a single photo of the thyroid ultrasound examination of Pa in Case 1 of the present invention before treatment;

[0036] Figure 6 This is a single photo of the thyroid ultrasound examination of Pa Mou after treatment in Case 1 of the present invention;

[0037] Figure 7 This is a single photo of the thyroid ultrasound examination of Tu Mou before treatment in Case 2 of the present invention;

[0038] Figure 8 This is a single photo of the thyroid ultrasound examination of Tu Mou before treatment in Case 2 of the present invention;

[0039] Figure 9 This is a single photo of the thyroid ultrasound examination of Tu Mou after treatment in Case 2 of the present invention;

[0040] Figure 10 This is a single photo of bilateral breast ultrasound examination after treatment of Tu Mou in Case 2 of the present invention; DETAILED DESCRIPTION

[0041] In order to enable those skilled in the art to better understand the technical solution of the present invention, the technical solution of the present invention is further described below in conjunction with the accompanying drawings and embodiments. 1. Specific embodiments

[0043] Example 1:

[0044] A traditional Chinese medicine composition for treating thyroid nodules comprises the following components: galangal, capparis spinosa root bark, dried ginger, longan, cinnamon bark, scutellaria baicalensis, and camel thorn fruit.

[0045] The weight proportions of the different components are as follows: 6 parts of Agkistrodon halys, 5 parts of camel thorn fruit, 5 parts of caper root bark, 10 parts of galangal, 10 parts of dried ginger, 5 parts of piper longum and 5 parts of cinnamon bark.

[0046] All raw materials in this application are common commercial products, so there is no need to specifically limit their sources.

[0047] The traditional Chinese medicine of the present invention uses Agkistrodon halys and Camel pampas grass as main drugs, and the two drugs synergistically exert the effects of dispersing qi, softening hard masses, relieving inflammation and reducing swelling, purifying blood and removing toxins, and removing dampness and strengthening muscles; the thyroid temperament is imbalanced and the balance of body fluids is disordered, which affects "inhibiting drive, stimulating drive, and growing drive" and causes diffuse swelling or agglomeration of the thyroid gland, and the root of the disease is treated by regulating the temperament, balancing the body fluids, dispersing qi and restraining, and inhibiting nodule hyperplasia; the root bark of Capparis spinosa, Piper longum and cinnamon bark are auxiliary drugs, which help the main drug to disperse qi, relieve pain, reduce inflammation and reduce swelling, and clear abnormal mucus, thereby enhancing the softening and relieving inflammation; Alpinia officinarum is a corrective drug, which assists the main drug and the auxiliary drug in enhancing the function of dispersing qi and softening hard masses with its effect of opening and blocking; and dried ginger is a regulating drug, which harmonizes the warming and coldness of the whole prescription with its effect of generating dryness and heat, maintains the balance of body fluids, and prevents other drugs from being too pungent and dispersing and consuming qi. The entire formula adheres to the principle of "dispelling Qi to fight tumors, dispelling wind and dispersing cold," dispersing Qi to soften and resolve nodules, balance body fluids and regulate Qi, and achieve the effects of reducing swelling, dispersing nodules, dispelling Qi and relieving inflammation. The functions of each ingredient are as follows:

[0048] White-flowered Snake: This product has a Class III dry heat property, a salty flavor, and is toxic. Functions: It clears dryness and generates heat, disperses qi and softens hard masses, reduces inflammation and swelling, purifies blood and removes toxins, removes dampness and strengthens muscles, and restores complexion. It is primarily used to treat damp-cold or mucus-based diseases, such as various benign and malignant tumors, lymph node tuberculosis, various stubborn skin diseases, ulcers, eczema, leprosy and rheumatoid arthritis, numbness of the hands and feet, and vitiligo. Experimental studies have shown that it primarily contains protein, fat, and guanosine. The venom glands in its head contain a potent neurotoxin, composed of small molecule proteins or polysaccharides, and also contain hemolytic and hemagglutinating components.

[0049] Camel pistachio: This product has a second-degree dryness and third-degree heat, and a bitter taste. Its functions include: dispelling wind and relieving pain, strengthening the body and enhancing yang, strengthening tendons and invigorating the mind, relieving cough and asthma, and warming the body and opening the orifices. It is primarily used to treat damp-cold or mucus-based conditions, such as joint pain, sciatica, emaciation and impotence, paralysis, facial paralysis, cough and asthma, depression, and forgetfulness.

[0050] Capparis spinosa root bark: This product has a secondary dry-heat property and a pungent flavor. It functions to invigorate dryness and heat, dissipate qi and relieve pain, clear obstructions and strengthen tendons, clear abnormal mucus, soften hard masses and reduce inflammation, promote diuresis and reduce swelling, and eliminate dampness and freckles. It is primarily used to treat damp-cold or mucus-based diseases.

[0051] Galangal: It disperses qi and relieves pain, clears blockages, and is primarily used to treat various conditions caused by cold constitutions, such as abnormal spleen fluid and excessive mucus. Galangin inhibits tumor angiogenesis both in vivo and in vitro. Galangin has a certain degree of inhibitory effect on various tumor cell types, and its mechanisms of antioxidant free radicals, anti-inflammatory effects, and analgesic effects are becoming increasingly clear.

[0052] Dried ginger: This product has a secondary dry-heat property and a pungent flavor. It generates heat, warms the stomach and aids digestion, expels dampness and stops diarrhea, dispels wind and cold, warms the body and strengthens yang, dispels cold and stops leukorrhea. It is primarily used to treat damp-cold or mucous-based conditions. Dried ginger contains volatile oils and a pungent component (gingerol), which has antipyretic, analgesic, anti-inflammatory, and antibacterial properties.

[0053] Piper longum: This product has a dry and hot nature and a pungent flavor. It promotes digestion and generates heat, nourishes the stomach and aids digestion, relieves bloating, replenishes essence and strengthens yang, promotes urination and menstruation, relieves cough and phlegm, dispels cold and relieves pain. It is primarily used to treat damp-cold or mucus-based conditions, such as a weak stomach with poor appetite, abdominal distension and pain, low sperm count and impotence, urinary obstruction, irregular menstruation, cough with excessive phlegm, and joint pain.

[0054] Cinnamon: This product has a secondary dry-heat property, a fragrant aroma, and a pungent flavor. It functions to generate heat and dryness, regulate abnormal mucus, dispel cold and nourish the heart, warm the middle and stimulate the appetite, dry dampness and stop diarrhea, and promote urination and menstruation. It is primarily used to treat damp-cold or mucus-based conditions.

[0055] Furthermore, in this embodiment, the Chinese medicine composition is prepared into a Uyghur medical honey paste for patients to take. The specific preparation method of the Uyghur medical honey paste comprises the following steps:

[0056] S1: Dry the formulated amounts of Agkistrodon halys, Camel thorn fruit, Capparis spinosa root bark, Alpinia officinalis, Dried ginger, Piper longum and Cinnamomum cassia bark;

[0057] S2: Stir-fry the camel thorn fruit on a light fire, then mix and crush all the medicines, and crush the prescribed herbs into fine powder. Figure 1 , pass through 80 mesh sieve;

[0058] S3: Add three times the amount of honey to the whole prescription and mix well to make a dense paste. Figure 2 and 3 After the production is completed, it is bottled, as shown in the attached Figure 4 shown.

[0059] Example 2

[0060] Example 2 provides a Chinese medicine composition for treating thyroid nodules, and the specific scheme is as follows:

[0061] 7 parts of Agkistrodon halys, 10 parts of camel thorn fruits, 10 parts of capparis spinulosa root barks, 15 parts of galangal, 15 parts of dried ginger, 10 parts of piper longum, 10 parts of cinnamon barks.

[0062] The preparation method of the Chinese medicine composition is the same as that in Example 1 and will not be described again here.

[0063] Example 3

[0064] Example 3 provides a Chinese medicine composition for treating thyroid nodules, the specific scheme is as follows:

[0065] 8 parts of Agkistrodon halys, 15 parts of camel thorn fruits, 15 parts of capparis spinulosa root barks, 20 parts of galangal, 20 parts of dried ginger, 15 parts of piper longum, 15 parts of cinnamon barks.

[0066] The preparation method of the Chinese medicine composition is the same as that in Example 1 and will not be described again here.

[0067] 2. Clinical Report

[0068] The Chinese medicine composition of the present invention is used to treat thyroid nodules with good clinical effect. The specific clinical experiment report is as follows.

[0069] 2.1 General Information

[0070] Ten patients with thyroid nodules who visited the outpatient department and ward of our hospital from March 2023 to February 2024 were selected for treatment, and the treatment effects were statistically analyzed.

[0071] 2.2 Diagnostic criteria

[0072] 2.2.1 Western medicine diagnostic criteria: The patient must be diagnosed during outpatient consultation or hospitalization in our hospital and meet the following criteria: Refer to the "Guidelines for the Diagnosis and Treatment of Thyroid Nodules and Differentiated Thyroid Cancer (Second Edition)".

[0073] (1) Symptoms: Neck swelling, nodules with swallowing, local neck compression symptoms and neck discomfort, but the swelling is not red, swollen, hot or painful.

[0074] (2) Physical signs: One or more nodules can be palpated, which can move up and down with swallowing, have clear boundaries, smooth surface, no tenderness, no tremor, and no vascular murmur.

[0075] (3) Imaging examination: Color Doppler ultrasound of the thyroid gland may reveal one or more nodules, excluding the possibility of malignant tumors and compression of surrounding organs. Fine needle aspiration biopsy (FNAB) may be performed to confirm the diagnosis if necessary.

[0076] (4) Laboratory tests: Thyroid stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) were all within normal range.

[0077] 2.2.2 Uyghur medicine symptom classification: abnormal mucus type,

[0078] (1) Main symptoms: Swelling of the neck or palpable nodules, which move up and down with swallowing, heaviness of the limbs, and paleness of the body.

[0079] (2) Secondary symptoms: foreign body sensation in the throat, distension of the neck, broad and thick tongue with many teeth marks on the edges, pale tongue coating, astringent taste, damp and cold skin, dull skin, dizziness, pale face, fatigue and laziness, insomnia and dreaminess, rough and slow pulse, frequent urination, small amount of urination, and transparent color.

[0080] Anyone who meets the main symptoms, two or more secondary symptoms, and tongue and pulse criteria is considered to be within the diagnostic criteria of Uyghur medicine.

[0081] 2.2.3 Inclusion criteria

[0082] (1) Patients with thyroid nodules that meet the diagnostic criteria of Western medicine;

[0083] (2) patients who meet the criteria for abnormal mucinous syndrome;

[0084] (3) Aged 18 to 65 years, regardless of gender;

[0085] (4) thyroid ultrasound TI-RADS grade ≤3, nodule diameter <2.5 cm;

[0086] (5) thyroid function is within normal range;

[0087] 2.3 Exit and Removal Criteria

[0088] Potential subjects who meet the inclusion criteria will be withdrawn or excluded if they meet any of the following:

[0089] Exit (dropout) criteria: (1) Patients withdraw on their own; (2) Lost to follow-up; (3) Investigators persuade them to withdraw (poor compliance, serious comorbidities or complications, serious adverse events); (4) Although the trial is completed, the dosage is not within the range of 80%-120% of the required dosage; (5) Blind breach or emergency unblinding.

[0090] Exclusion criteria: (1) Failure to take the trial drug as required; (2) Patients were found to not meet the inclusion or exclusion criteria after treatment began; (3) Compliance <80% or >120%; (4) Taking prohibited drugs specified in the protocol during the observation period.

[0091] 2.4 Methods

[0092] All patients were advised to follow a low-iodine diet, supplement adequate calories and nutrition, exercise appropriately, avoid irritability, and avoid spicy and stimulating foods.

[0093] Patients were given the inventive "Quqi Jinqian Baihua Shemi Paste" (the prescription name of the Chinese herbal preparation used in our hospital, consisting of: 8 stalks of Jinqian Baihua Shemi, 8 parts of Camel Peaches, 9 parts of Capparis Spinosa root bark, 10 parts of Alpinia officinarum, 10 parts of Dried Ginger, 10 parts of Piper Longum, 10 parts of Cinnamon Bark, and 160 parts of Honey). The bottle size was 200 portions / bottle (20-day supply). Dosage and administration: Take 5-10 portions orally three times daily. A four-week course of treatment was considered one course, and observation and evaluation were performed for three courses.

[0094] 2.5 Observation indicators

[0095] 2.5.1 Evaluation of Western medicine efficacy

[0096] Color Doppler blood flow imaging data of thyroid nodules: blood flow was classified using the semiquantitative Alder classification method: grade 0: no blood flow signal in the nodule; grade 1: 1-2 dot-like or short-line blood flow signals were visible in the nodule; grade 2: 3-4 dot-like blood flow signals or a blood vessel with a clear wall were visible in the nodule; grade 3: multiple colored blood flows were visible in the nodule, in a reticular or sheet-like manner, or two blood vessels with clear walls.

[0097] (2) Criteria for evaluating the efficacy of nodule size reduction: Refer to the "Diagnosis and Efficacy Criteria for Surgical Diseases". Cured: All thyroid nodules disappear on ultrasound examination. Markedly effective: The thyroid nodules shrink by more than 2 / 3 on ultrasound examination. Effective: The thyroid nodules shrink by more than 1 / 3 on ultrasound examination. Ineffective: No significant improvement in thyroid nodules on ultrasound examination.

[0098] 2.5.2 Statistical methods

[0099] The data were processed using SPSS 23.0 statistical software. Chi-square and rank sum tests were used for enumeration data. Normality was tested for measurement data. Homogeneity of variance was tested using the t-test. Data were expressed as mean ± standard deviation (x ± s). Inconsistent variance was tested using a nonparametric test. P < 0.05 indicated statistical significance.

[0100] 2.6 Results

[0101] Comparison of the effectiveness of nodule size reduction: After 12 weeks of treatment, the total effectiveness rate was 90%, the marked effectiveness rate was 40%, and the effective rate was 30% (P<0.05), see Table 1 below.

[0102] Table 1 Effectiveness of patients after treatment [cases (%)]

[0103] Group Number of cases Clinical recovery Significantly effective efficient invalid Total efficiency Treatment group 10 2 4 3 1 90％

[0104] 2.7 Discussion

[0105] 2.7.1 Pharmacological effects

[0106] White-flowered Snake: This product has a Class III dry heat property, a salty flavor, and is toxic. Functions: It clears dryness and generates heat, disperses qi and softens hard masses, reduces inflammation and swelling, purifies blood and removes toxins, removes dampness and strengthens muscles, and restores complexion. It is primarily used to treat damp-cold or mucus-based diseases, such as various benign and malignant tumors, lymph node tuberculosis, various stubborn skin diseases, ulcers, eczema, leprosy and rheumatoid arthritis, numbness of the hands and feet, and vitiligo. Experimental studies have shown that it primarily contains protein, fat, and guanosine. The venom glands in its head contain a potent neurotoxin, composed of small molecule proteins or polysaccharides, and also contain hemolytic and hemagglutinating components.

[0107] Camel pistachio: This product has a second-degree dryness and third-degree heat, and a bitter taste. Its functions include: dispelling wind and relieving pain, strengthening the body and enhancing yang, strengthening tendons and invigorating the mind, relieving cough and asthma, and warming the body and opening the orifices. It is primarily used to treat damp-cold or mucus-based conditions, such as joint pain, sciatica, emaciation and impotence, paralysis, facial paralysis, cough and asthma, depression, and forgetfulness.

[0108] Capparis spinosa root bark: This product has a secondary dry-heat property and a pungent flavor. It functions to invigorate dryness and heat, dissipate qi and relieve pain, clear obstructions and strengthen tendons, clear abnormal mucus, soften hard masses and reduce inflammation, promote diuresis and reduce swelling, and eliminate dampness and freckles. It is primarily used to treat damp-cold or mucus-based diseases.

[0109] Galangal: It disperses qi and relieves pain, clears blockages, and is primarily used to treat various conditions caused by cold constitutions, such as abnormal spleen fluid and excessive mucus. Galangin inhibits tumor angiogenesis both in vivo and in vitro. Galangin has a certain degree of inhibitory effect on various tumor cell types, and its mechanisms of antioxidant free radicals, anti-inflammatory effects, and analgesic effects are becoming increasingly clear.

[0110] Dried ginger: This product has a secondary dry-heat property and a pungent flavor. It generates heat, warms the stomach and aids digestion, expels dampness and stops diarrhea, dispels wind and cold, warms the body and strengthens yang, dispels cold and stops leukorrhea. It is primarily used to treat damp-cold or mucous-based conditions. Dried ginger contains volatile oils and a pungent component (gingerol), which has antipyretic, analgesic, anti-inflammatory, and antibacterial properties.

[0111] Piper longum: This product has a dry and hot nature and a pungent flavor. It promotes digestion and generates heat, nourishes the stomach and aids digestion, relieves bloating, replenishes essence and strengthens yang, promotes urination and menstruation, relieves cough and phlegm, dispels cold and relieves pain. It is primarily used to treat damp-cold or mucus-based conditions, such as a weak stomach with poor appetite, abdominal distension and pain, low sperm count and impotence, urinary obstruction, irregular menstruation, cough with excessive phlegm, and joint pain.

[0112] Cinnamon: This product has a secondary dry-heat property, a fragrant aroma, and a pungent flavor. It functions to generate heat and dryness, regulate abnormal mucus, dispel cold and nourish the heart, warm the middle and stimulate the appetite, dry dampness and stop diarrhea, and promote urination and menstruation. It is primarily used to treat damp-cold or mucus-based conditions.

[0113] 2.7.2 Pharmacological Analysis

[0114] Uyghur medicine considers thyroid nodules to be classified as "goiters." While there's no mention of a specific disease name for thyroid nodules in ancient texts, similar clinical symptoms are found in numerous medical texts. Thyroid nodules are caused by various internal and external factors, leading to imbalances in thyroid temperament and fluid balance. Clinically, they present as diffuse swelling or nodules in the anterior neck, often accompanied by a mass in the anterior neck, discomfort and fullness in the neck, hoarseness, or a feeling of pharyngeal obstruction. Most physicians believe that genetic factors, combined with dietary and environmental factors, lead to imbalances in thyroid temperament and fluid balance, affecting the "inhibitory drive, stimulating drive, and growth drive," resulting in diffuse thyroid swelling or nodules. Treatment is guided by a dialectical approach, focusing on regulating the thyroid temperament, balancing fluids, dispersing and astringing qi, and inhibiting nodule proliferation. Internal and external therapies are combined.

[0115] Pharmacological studies have shown that the snake contains anti-cancer active ingredients that have a direct inhibitory effect on cancer cells. The snake's body contains protein, fat, amino acids, and 21 elements, including calcium, phosphorus, magnesium, iron, aluminum, zinc, strontium, titanium, manganese, vanadium, and copper, which have anti-inflammatory and analgesic effects.

[0116] The main categories of active ingredients isolated from galangal are volatile oils, flavonoids, and diarylheptanes. The main anti-tumor pharmacological components in galangal are galangin and its derivatives. Galangin can inhibit tumor cell proliferation by interfering with the expression of cyclins and cyclin-dependent kinases. It can also induce tumor cell apoptosis through mitochondrial and endoplasmic reticulum apoptosis pathways, and inhibit the expression of focal adhesion kinase and epithelial-mesenchymal transition, thereby inhibiting tumor cell invasion and metastasis. Furthermore, galangin can downregulate the expression of anti-apoptotic proteins, thereby increasing the chemotherapy sensitivity of drug-resistant tumors. Galangin has the effect of inhibiting tumor angiogenesis both in vitro and in vivo. Galangin has a certain degree of inhibitory effect on various different types of tumor cells, and its mechanisms of antioxidant free radicals and anti-inflammatory and analgesic effects are gradually becoming clear. Studies have found that dried ginger contains volatile oils and pungent components (gingerols), which have antipyretic, analgesic, anti-inflammatory, and antibacterial effects.

[0117] The present invention combines the aforementioned drugs to achieve synergistic efficacy. This Uyghur medicinal composition for treating thyroid nodules offers advantages such as rapid effectiveness, a short treatment course, simple treatment methods, and no side effects. This formula has been used to treat over 10 patients, achieving excellent results with an efficacy rate exceeding 90%.

[0118] 2.8 Typical Cases

[0119] Case 1: Patient Pa, female, 39 years old, Uyghur, was first diagnosed on July 13, 2024, mainly due to "discomfort on both sides of the neck for 1 month, aggravated for 1 week". The patient had discomfort on both sides of the neck 1 month ago and went to the Xinjiang Uyghur Autonomous Region Hospital of Traditional Chinese Medicine for thyroid color Doppler ultrasound on July 12, 2024. The results are as follows: Figure 5 As shown, it indicates nodular goiter. The patient did not receive treatment and took medicine on his own to relieve the symptoms (the details are unknown). In the past week, the above symptoms have worsened due to emotional stimulation, so he came to our outpatient clinic for further diagnosis and treatment. There is discomfort on both sides of the neck, intermittent foreign body sensation in the throat, irritability, dry mouth and bitter taste, no symptoms such as palpitations and hand tremors. The appetite is okay, sleep is poor, bowel movements are occasionally constipated (1-2 times a day), urination is normal, the tongue is red, the tongue coating is light blue, there are teeth marks on the sides of the tongue, and the pulse is coarse, slow and deep. He is in good health and has no significant changes in weight recently. Physical examination: T: 36.2℃, P: 87 times / min, R: 21 times / min, BP: 123 / 80mmHg, bilateral thyroid enlargement, multiple nodules are palpable, not exceeding the sternocleidomastoid muscle, it is grade II thyroid enlargement, soft texture, good mobility, and no tenderness. Ancillary examinations: Thyroid ultrasound performed on July 12, 2024, revealed: right lobe: 15×14mm; left lobe: 16×14mm; isthmus: 2mm. A hypoechoic mass approximately 4×3mm was visible in the central portion of the left lobe, with well-defined, regular, and uneven echogenicity. CDFI revealed blood flow signals around and within the periphery. The remaining thyroid parenchyma was homogeneous. CDFI revealed no significant abnormal blood flow signals. A solid nodule (2×2mm) in the left lobe was TI-RADS category 4a, suggesting: 1. Localized inflammation 2. Other conditions to be excluded. A reexamination of the solid nodule (4×3mm) in the left lobe was TI-RADS category 3, suggesting: nodular goiter. Western medicine diagnosis: thyroid nodule. Uyghur medicine diagnosis: goiter, astringent, mucous type. The patient experienced discomfort in both sides of the neck, intermittent foreign body sensation in the throat, irritability, dry mouth, bitter taste, and poor sleep. Treatment: Burning and dispelling qi. Prescription: Administer the aforementioned Qi-dispelling Jinqianbaihua Shemi Paste, 5g orally twice daily. Instruct the patient to regulate their mood and reduce their intake of strong tea, coffee, dried foods, seafood, and condiments such as black and white pepper.

[0120] Follow-up on July 24, 2024: The patient reported that his symptoms were relieved after taking the medicine, the discomfort on both sides of his neck was relieved, his sleep was better than before, his tongue coating became lighter, and his pulse was mild. He also presented the results of the color Doppler ultrasound examination conducted at the local Xinjiang Uyghur Autonomous Region Traditional Chinese Medicine Hospital on July 23, 2024 (see attached). Figure 6Repeat color Doppler ultrasound revealed a hypoechoic mass approximately 2 × 2 mm in the central left thyroid lobe, with poorly defined, irregular, and uneven echoes. CDFI revealed no significant blood flow. The solid nodule in the left thyroid lobe, combined with contrast-enhanced ultrasound, was TI-RADS category 3, suggesting localized inflammation. The patient's symptoms improved after medication, and the left thyroid nodule also decreased in size. The patient was then prescribed the aforementioned Quqi Jinqian Baihua Shemi ointment, 5g orally twice daily. Precautions remain the same.

[0121] Case Summary: This patient, a middle-aged woman, initially presented with a feeling of tightness and discomfort in her neck following emotional stimulation. It is suspected that this emotional impact, coupled with a predominance of dryness and coldness in her body, heightened nerve sensitivity, disrupted the coordination between drive and vital energy, and led to endocrine imbalance, resulting in this condition. On follow-up, her symptoms improved, so the prescription remained unchanged, and she continued taking the same medications and lifestyle interventions.

[0122] Case 2: Patient Tu, female, 54 years old, first visited the hospital on September 7, 2024, with the chief complaint of "discovering breast nodules and thyroid nodules for more than a month". One month ago, the patient experienced discomfort, lumps, and swelling in the neck and chest. Two weeks ago, the lumps and swelling did not subside, so she visited the local hospital (the First Affiliated Hospital of Xinjiang Medical University) for outpatient treatment and completed breast and thyroid ultrasound examinations. The results are as follows: Figure 7 As shown, the results suggest that: a low-echo nodule of approximately 0.70cm×0.42cm×0.56cm can be seen in the middle and upper part of the right lobe, with clear boundaries, regular shape, and uneven internal echoes. The solid nodule in the middle and upper part of the right thyroid lobe, combined with ultrasound contrast imaging, is considered: TI-RADS-4b category: moderately suspected malignancy, and ultrasound-guided puncture biopsy is recommended. No abnormal lymph nodes were found beside the thyroid spleen on both sides. Multiple cystic nodules in the right breast. A week ago, the patient developed abdominal pain and underwent thyroid contrast examination. The results are shown in the attached Figure 8As shown, the results suggest a solid nodule in the upper middle portion of the right thyroid lobe. Combined ultrasound imaging revealed a TI-RADS category 4b, indicating moderate suspicion of malignancy. Ultrasound-guided biopsy was recommended. The patient declined biopsy and sought further conservative treatment at our outpatient clinic. During the course of the illness, she presented with neck discomfort, a foreign body sensation, phlegm in the throat, mild dysphagia, and dry and astringent mouth. She did not experience palpitations or hand tremors. Her appetite was poor, but her bowel movements and urination were normal. Her tongue was red with a pale yellow coating, and her pulse was strong, slow, and deep. There was no recent weight fluctuation. Physical examination revealed a temperature of 36.4°C, a pulse of 65 beats / min, a pulse of 22 beats / min, and a blood pressure of 134 / 68 mmHg. The right thyroid was enlarged, with a palpable nodule that did not extend beyond the sternocleidomastoid muscle. This was grade II thyroid enlargement, soft in texture, well-mobilized, and nontender. The Western medical diagnosis was thyroid nodule. The Uyghur medical diagnosis was goiter, astringent and mucous type. Treatment: Focus on regulating the Qi, balancing body fluids, dispersing Qi and constricting Qi, and inhibiting nodular hyperplasia. Prescription: Administer 5g of the aforementioned Qi-removing Jinqian Baihua Shemi Paste orally twice daily. Instruct the patient to regulate their mood and reduce their intake of strong tea, coffee, dried foods, seafood, and condiments such as black and white pepper.

[0123] Follow-up visit on January 5, 2025: The patient reported less neck discomfort, but no improvement in dry mouth or astringency. Therefore, the patient was given our in-house Yanxiao Dinal Syrup, 30 ml orally twice daily, for the purpose of clearing heat and promoting diuresis. This was followed by the aforementioned Quqi Jinqian Baihua Shemi Paste, 5 g orally twice daily. Precautions remain the same.

[0124] On February 24, 2025, the patient felt that the above symptoms had improved, the tongue coating had become lighter, and the pulse was mild. Our hospital re-examined the thyroid color Doppler ultrasound (the results are as attached). Figure 9 As shown) and breast ultrasound (results as shown in the attached Figure 10 (As shown in the figure), a very hypoechoic nodule measuring approximately 6.5 x 4.7 mm was observed in the middle and lower pole of the right lobe. Its boundaries were unclear, its shape was irregular, and its internal echoes were uneven. CDFI revealed no significant blood flow. The solid nodule in the right lobe was graded 4a by TI-RADSUS. Regular follow-up is recommended. A follow-up thyroid ultrasound revealed a reduction in the nodule's size, and the patient continued to take the aforementioned Quqi Jinqian Baihua Shemi ointment.

[0125] Case Summary: This patient was diagnosed with thyroid nodules, and the Uyghur doctor diagnosed them as astringent mucous goiter. Therefore, treatment should be used to disperse qi, dissipate qi, and inhibit nodule growth. Thyroid temperament imbalance and fluid imbalance affect the "suppressive drive, stimulating drive, and growth drive," causing diffuse thyroid swelling or nodules. At the follow-up visit, the patient's primary symptoms had improved, but dry mouth and astringency persisted. Therefore, Yanxiao Dinal Syrup was administered for heat-clearing and diuretic purposes. The combination of these two drugs softens and dissipates nodules, clearing heat. At the third visit, the patient's nodules had decreased in size, and regular follow-up visits were recommended.

[0126] The basic principles, main features, and advantages of the present invention are shown and described above. Those skilled in the art should understand that the present invention is not limited to the foregoing embodiments. The foregoing embodiments and descriptions are merely illustrative of the principles of the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Such changes and modifications are intended to fall within the scope of the present invention. The scope of protection claimed in the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating thyroid nodules, characterized in that: The ingredients include: white snake, camel thorn fruit, caper root bark, galangal, dried ginger, long pipe, cinnamon bark; The weight proportions of different components are as follows: 5-15 parts of Agkistrodon halys, 5-15 parts of camel thorn fruit, 5-15 parts of caper root bark, 10-20 parts of galangal, 10-20 parts of dried ginger, 5-15 parts of long piper longum and 5-15 parts of cinnamon bark.

2. A Chinese medicine composition for treating thyroid nodules according to claim 1, characterized in that, The weight proportions of the different components are as follows: 6 parts of Agkistrodon halys, 5 parts of camel thorn fruit, 5 parts of caper root bark, 10 parts of galangal, 10 parts of dried ginger, 5 parts of piper longum and 5 parts of cinnamon bark.

3. A Chinese medicine composition for treating thyroid nodules according to claim 1, characterized in that, The weight proportions of the different components are respectively: 7 parts of Agkistrodon halys, 10 parts of camel thorn fruit, 10 parts of caperca root bark, 15 parts of galangal, 15 parts of dried ginger, 10 parts of piper longum and 10 parts of cinnamon bark.

4. A Chinese medicine composition for treating thyroid nodules according to claim 1, characterized in that, The weight proportions of the different components are as follows: 8 parts of Agkistrodon halys, 15 parts of camel thorn fruit, 15 parts of caperca root bark, 20 parts of galangal, 20 parts of dried ginger, 15 parts of piper longum and 15 parts of cinnamon bark.

5. A Chinese medicine preparation, characterized in that The invention comprises the Chinese medicine composition according to any one of claims 1 to 4.

6. A Chinese medicine preparation according to claim 5, characterized in that, The traditional Chinese medicine preparation is a Uighur medical honey paste.

7. The method for preparing a traditional Chinese medicine preparation according to claim 6, wherein: The preparation method of the Uighur medical honey paste comprises the following steps: S1: Dry the formulated amounts of Agkistrodon halys, Camel thorn fruit, Capparis spinosa root bark, Alpinia officinalis, Dried ginger, Piper longum and Cinnamomum cassia bark; S2: Stir-fry the camel pectin seeds over light heat, then mix and grind all the drugs together, grind the prescribed herbs into fine powder, and pass through an 80-mesh sieve; S3: Add three times the amount of honey to all the other ingredients in the prescription and mix well to make a dense paste.

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