Traditional Chinese medicine composition for improving thyroid nodule as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for improving thyroid nodules and a preparation method and application thereof. The invention provides a traditional Chinese medicine composition for improving thyroid nodules. The traditional Chinese medicine composition is prepared from the following components in parts by mass: 15-25 parts of exocarpium citri grandis, 15-25 parts of kelp, 15-25 parts of seaweed, 15-25 parts of fructus trichosanthis, 8-12 parts of bulbus fritillariae cirrhosae, 10-20 parts of selfheal, 10-20 parts of honeysuckle flower, 10-20 parts of dandelion, 10-20 parts of Chinese yam, 8-12 parts of codonopsis pilosula, 15-25 parts of Chinese dates, 8-12 parts of angelica sinensis and 8-12 parts of radix rehmanniae. The traditional Chinese medicine composition provided by the invention has the efficacy of tonifying the spleen and the kidney, is safe in formula and non-toxic, and can comprehensively improve body functions, improve thyroid tissues, relieve further damage and malignant transformation of the tissues and reduce thyroid nodules.

Description

Technical Field

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

[0002] TCM can be used to treat various thyroid diseases, but the effect is not good. For example, for the most common hyperthyroidism, Chinese medicine cannot reduce the secretion of thyroid hormones and cannot effectively suppress the symptoms of hyperthyroidism. Thyroid diseases also include subacute thyroiditis, which is related to autoimmune diseases. Chinese medicine cannot effectively suppress autoimmune factors, so the effect on subacute thyroiditis is poor. Thyroid diseases also include thyroid cancer. The treatment of thyroid cancer is mainly surgical resection, and Chinese medicine does not have a particularly good effect on thyroid cancer. Some Chinese medicines may have an effect on thyroid diseases, but they can only be used as auxiliary treatments and cannot achieve the purpose of effective treatment.

[0003] Thyroid nodules are the most common symptom of thyroid disease. Thyroid nodules are tissue masses that appear in the thyroid tissue after abnormal proliferation of thyroid cells. They may be single or multiple, and may be solid or cystic in texture. The causes of this disease are diverse, and may be due to iodine deficiency, excessive proliferation of normal thyroid tissue, degeneration, history of radiation exposure, genetics, thyroid inflammation, etc. The incidence of thyroid nodules is high, at more than 20%, of which malignant ones account for 7% to 15%, and can be found in routine physical examinations or imaging examinations. The treatment plan for thyroid nodules varies from person to person. In the medical system, asymptomatic benign nodules usually do not need to be treated, and only regular review and observation are required. Symptomatic benign or malignant nodules generally require surgical removal.

[0004] Therefore, how to provide a traditional Chinese medicine that can effectively improve or treat thyroid nodules is a problem that technical personnel in this field urgently need to solve. Summary of the invention

[0005] The purpose of the present invention is to provide a traditional Chinese medicine composition for improving thyroid nodules and a preparation method and application thereof.

[0006] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0007] The invention provides a traditional Chinese medicine composition for improving thyroid nodules. The composition comprises the following components in parts by weight: 15-25 parts of tangerine peel, 15-25 parts of kelp, 15-25 parts of seaweed, 15-25 parts of whole trichosanthes, 8-12 parts of fritillaria thunbergii, 10-20 parts of selfheal, 10-20 parts of honeysuckle, 10-20 parts of dandelions, 10-20 parts of yam, 8-12 parts of codonopsis pilosula, 15-25 parts of jujube, 8-12 parts of angelica sinensis, and 8-12 parts of rehmannia glutinosa.

[0008] The present invention also provides a method for preparing the Chinese medicine composition, comprising the following steps:

[0009] (1) Mixing tangerine peel, kelp, seaweed, whole trichosanthes, fritillaria thunbergii, selfheal, honeysuckle, dandelion, yam, codonopsis, jujube, angelica, and rehmannia to obtain material 1; mixing material 1 with water, soaking, decocting, and filtering to obtain a filtrate and a filter residue;

[0010] (2) mixing the filter residue obtained in step (1) with water and boiling, and filtering to obtain a decoction;

[0011] (3) Mixing the filtrate obtained in step (1) with the decoction obtained in step (2) to obtain a Chinese medicine composition.

[0012] Preferably, the mass ratio of the material 1 to water in step (1) is 1:3-4.

[0013] Preferably, the soaking time in step (1) is 25 to 35 minutes.

[0014] Preferably, the decocting time in step (1) is 15 to 25 minutes.

[0015] Preferably, the mass ratio of the filter residue to water in step (2) is 1:2-3.

[0016] Preferably, the cooking time in step (2) is 15 to 25 minutes.

[0017] The present invention also provides the use of the Chinese medicine composition or the Chinese medicine composition obtained by the preparation method in preparing a pharmaceutical preparation for treating thyroid nodules.

[0018] Preferably, the dosage form of the pharmaceutical preparation is a decoction, a fluid extract, a powder, a granule, a pill, a tablet or a capsule.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] The Chinese medicine composition provided by the present invention has the effect of invigorating the spleen and kidney, is safe and non-toxic, can improve body functions more comprehensively, improve thyroid tissue, slow down further tissue damage and malignant transformation, and reduce thyroid nodules. And the effect of the prescription is stable, without any damage to the human body, and can simultaneously improve the operating capacity of other internal organs. Among the components added to the Chinese medicine composition provided by the present invention, Huajuhong, Quangualou, Zhejiang Chuanbei can resolve phlegm and soften hard masses, and kelp and seaweed can soften hard masses with salty and cold properties, which are the main medicines; Prunella vulgaris, honeysuckle, and dandelion can clear away heat and detoxify, soften hard masses and disperse nodules, which are the ministerial medicines; Chinese yam, Codonopsis, jujube, Chinese angelica, and Radix Rehmanniae can invigorate the spleen and kidney qi and blood, which are the adjuvant medicines. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying creative work.

[0022] Figure 1 This is the diagnosis certificate result before treatment of Case 1 Duan*Ping.

[0023] Figure 2 This is the diagnosis certificate result after treatment of Case 1 Duan*Ping.

[0024] Figure 3 This is the diagnosis certificate result before treatment for Case 2 Lin * Fang.

[0025] Figure 4 This is the diagnosis certificate result after treatment for Case 2 Lin * Fang.

[0026] Figure 5 This is the diagnosis certificate result before treatment for Case 3 Luo*ying.

[0027] Figure 6 This is the diagnosis certificate result after treatment for Case 3 Luo*ying.

[0028] Figure 7 This is the diagnosis certificate result before treatment of Case 4 Si*Xia.

[0029] Figure 8 This is the diagnosis certificate result after treatment for Case 4 Si*Xia.

[0030] Fig. 9 This is the diagnosis certificate result before treatment of Case 5 Zhong*Hua.

[0031] Fig.10 This is the diagnosis certificate result after treatment for Case 5 Zhong*Hua.

[0032] Fig.11 This is the diagnosis certificate result before treatment of Case 6 Zou*Jin.

[0033] Fig.12 This is the diagnosis certificate result after treatment of Case 6 Zou*Jin. DETAILED DESCRIPTION

[0034] The invention provides a traditional Chinese medicine composition for improving thyroid nodules, comprising the following components in parts by weight: 15-25 parts of tangerine peel, 15-25 parts of kelp, 15-25 parts of seaweed, 15-25 parts of whole trichosanthes, 8-12 parts of fritillaria thunbergii, 10-20 parts of selfheal, 10-20 parts of honeysuckle, 10-20 parts of dandelion, 10-20 parts of yam, 8-12 parts of codonopsis pilosula, 15-25 parts of jujube, 8-12 parts of angelica, and 8-12 parts of raw rehmannia;

[0035] Preferably, 17-23 parts of Huajuhong, 17-23 parts of Kelp, 17-23 parts of Sargassum, 17-23 parts of Trichosanthes, 9-11 parts of Zhejiang Fritillaria, 12-18 parts of Prunella Vulgaris, 12-18 parts of Lonicera Japonica, 12-18 parts of Taraxacum Herba, 12-18 parts of Dioscorea Oppositae, 9-11 parts of Codonopsis Pilosula, 17-23 parts of Jujube, 9-11 parts of Angelica Sinensis, and 9-11 parts of Radix Rehmanniae;

[0036] More preferably, 19-21 parts of Huajuhong, 19-21 parts of Kelp, 19-21 parts of Sargassum, 19-21 parts of Trichosanthes, 10 parts of Zhejiang Fritillaria, 14-16 parts of Prunella Vulgaris, 14-16 parts of Lonicera japonica, 14-16 parts of Taraxacum, 14-16 parts of Dioscorea opposita, 10 parts of Codonopsis pilosula, 19-21 parts of jujube, 10 parts of Angelica sinensis, and 10 parts of Rehmannia glutinosa.

[0037] More preferably, be 20 parts of Huajuhong, 20 parts of Kelp, 20 parts of Sargassum, 20 parts of Fructus Trichosanthis, 10 parts of Fritillariae Zhechuan, 15 parts of Spica Prunellae, 15 parts of Flos Lonicerae, 15 parts of Herba Taraxacis, 15 parts of Rhizoma Dioscoreae, 10 parts of Codonopsis Pilosulae, 20 parts of Jujubes, 10 parts of Radix Angelicae Sinensis, and 10 parts of Radix Rehmanniae.

[0038] The present invention also provides a method for preparing the Chinese medicine composition, comprising the following steps:

[0039] (1) Mixing tangerine peel, kelp, seaweed, whole trichosanthes, fritillaria thunbergii, selfheal, honeysuckle, dandelion, yam, codonopsis, jujube, angelica, and rehmannia to obtain material 1; mixing material 1 with water, soaking, decocting, and filtering to obtain a filtrate and a filter residue;

[0040] (2) mixing the filter residue obtained in step (1) with water and boiling, and filtering to obtain a decoction;

[0041] (3) Mixing the filtrate obtained in step (1) with the decoction obtained in step (2) to obtain a Chinese medicine composition.

[0042] In the present invention, the mass ratio of the material 1 to water in step (1) is 1:3-4, preferably 1:3.

[0043] In the present invention, the soaking time in step (1) is 25 to 35 minutes, preferably 27 to 33 minutes, more preferably 29 to 31 minutes, and more preferably 30 minutes.

[0044] In the present invention, the decocting time in step (1) is 15 to 25 minutes, preferably 17 to 23 minutes, more preferably 19 to 21 minutes, and more preferably 20 minutes.

[0045] In the present invention, the mass ratio of the filter residue to water in step (2) is 1:2 to 3, preferably 1:2.

[0046] In the present invention, the cooking time in step (2) is 15 to 25 minutes, preferably 17 to 23 minutes, more preferably 19 to 21 minutes, and more preferably 20 minutes.

[0047] The present invention also provides the use of the Chinese medicine composition or the Chinese medicine composition obtained by the preparation method in preparing a pharmaceutical preparation for treating thyroid nodules.

[0048] In the present invention, the dosage form of the pharmaceutical preparation is a decoction, a fluid extract, a powder, a granule, a pill, a tablet or a capsule; preferably a decoction.

[0049] The technical solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be construed as limiting the protection scope of the present invention.

[0050] Example 1

[0051] A method for preparing a traditional Chinese medicine composition for improving thyroid nodules, comprising the following steps:

[0052] (1) Mix 15g of Citrus aurantium, 15g of Kelp, 15g of Sargassum, 15g of Trichosanthes, 8g of Fritillaria thunbergii, 10g of Prunella Vulgaris, 10g of Lonicera japonica, 10g of Taraxacum mongolicum, 10g of Dioscorea opposita, 8g of Codonopsis pilosula, 15g of Jujube, 8g of Angelica sinensis, and 8g of Rehmannia glutinosa to obtain material 1; mix the material 1 with water in a mass ratio of 1:4 and soak for 35 minutes, then decoct for 25 minutes, and filter to obtain a filtrate and a residue;

[0053] (2) mixing the filter residue obtained in step (1) with water in a mass ratio of 1:3 and boiling for 25 minutes, and filtering to obtain a decoction;

[0054] (3) Mixing the filtrate obtained in step (1) with the decoction obtained in step (2) to obtain a Chinese medicine composition.

[0055] Example 2

[0056] A method for preparing a traditional Chinese medicine composition for improving thyroid nodules, comprising the following steps:

[0057] (1) Mix 25 g of Citrus aurantium, 25 g of Kelp, 25 g of Sargassum, 25 g of Trichosanthes, 12 g of Fritillaria thunbergii, 20 g of Prunella Vulgaris, 20 g of Lonicera japonica, 20 g of Taraxacum mongolicum, 20 g of Dioscorea opposita, 12 g of Codonopsis pilosula, 25 g of Jujube, 12 g of Angelica sinensis, and 12 g of Rehmannia glutinosa to obtain material 1; mix the material 1 with water in a mass ratio of 1:3 and soak for 25 min, then decoct for 15 min, and filter to obtain a filtrate and a residue;

[0058] (2) mixing the filter residue obtained in step (1) with water in a mass ratio of 1:2 and boiling for 15 minutes, and filtering to obtain a decoction;

[0059] (3) Mixing the filtrate obtained in step (1) with the decoction obtained in step (2) to obtain a Chinese medicine composition.

[0060] Example 3

[0061] A method for preparing a traditional Chinese medicine composition for improving thyroid nodules, comprising the following steps:

[0062] (1) Mix 20 g of Citrus aurantium, 20 g of Kelp, 20 g of Sargassum, 20 g of Trichosanthes, 10 g of Fritillaria thunbergii, 15 g of Prunella vulgaris, 15 g of Lonicera japonica, 15 g of Taraxacum officinale, 15 g of Dioscorea opposita, 10 g of Codonopsis pilosula, 20 g of Jujube, 10 g of Angelica sinensis, and 10 g of Rehmannia glutinosa to obtain material 1; mix the material 1 with water in a mass ratio of 1:3 and soak for 30 min, then decoct for 20 min, and filter to obtain a filtrate and a residue;

[0063] (2) mixing the filter residue obtained in step (1) with water in a mass ratio of 1:2 and boiling for 20 minutes, and filtering to obtain a decoction;

[0064] (3) Mixing the filtrate obtained in step (1) with the decoction obtained in step (2) to obtain a Chinese medicine composition.

[0065] Experimental Example 1

[0066] Case 1

[0067] Duan * Ping, female, 42 years old, has a simple career that enriches her life, and her family life is stable and harmonious. Due to bad family genes, she has been weak since childhood and pays special attention to her health. In March 2020, she had a physical examination, in which thyroid B-ultrasound showed: a low-echo nodule was detected at the lower pole of the right thyroid gland, measuring 4*4*5mm, and no blood flow signal was found on CDFI. Systematic maintenance was started in March 2020, and the overall improvement was driven by nourishing the liver and kidneys. It lasted for two years. The patented prescription was taken intermittently for a total of 3 months (the product obtained in Example 3, once a day). In March 2022, the thyroid B-ultrasound was reviewed, showing a high-echo nodule in the lower part of the right lobe of the thyroid gland, measuring 2.4*2.2*3.3mm, and no blood flow signal was found on CDFI. It was 78.2% smaller than the thyroid nodule in March 2020. The changes after 15 months of maintenance show that this prescription is effective in improving thyroid nodules.

[0068] Case 2

[0069] Lin*, female, 52 years old, a staff member of the procuratorate, has a normal work rhythm, regular exercise and diet, good basic physical condition, is in menopause, and pays special attention to health. A comprehensive physical examination was performed in October 2022, in which thyroid B-ultrasound showed several liquid dark areas in the left lobe of the thyroid gland, the largest of which was about 5*3mm, with thin walls and good internal sound transmission, and was diagnosed as a thyroid cyst. Continuous system maintenance was started in January 2023. By nourishing the liver and kidneys to drive comprehensive improvement, it took a year and a half, and this patented prescription was taken intermittently for a total of 2 months (the product obtained in Example 3, once a day). A comprehensive physical examination was reviewed in September 2024, in which thyroid B-ultrasound showed: 2 anechoic nodules were visible in the lower pole of the left lobe of the thyroid gland, the largest of which was about 3*2mm, with thin walls and good internal sound transmission, and was diagnosed as a thyroid cyst. Compared with the thyroid cyst in October 2022, it was reduced by 60%. The changes after 13 months of maintenance show that this prescription is effective in improving thyroid cysts.

[0070] Case 3

[0071] Luo * Ying, female, 44 years old, entrepreneur, has a colorful work and life, and has a common family abnormal gene, with potential pressure on the lungs and stomach. She does not pay much attention to her health. The thyroid ultrasound during the physical examination in April 2021 showed a medium-grade, relatively strong echo nodule, about 0.54*0.67cm in size (TI-RADS IVa category), with an aspect ratio greater than 1, clear boundaries, and a few blood flow signals at the edge. She took care of it for one month in April 2021, and then stopped until she felt extremely uncomfortable in April 2022, when she resumed her care. Mainly for the symptoms of the lungs and stomach, taking into account the maintenance of the uterus and thyroid gland, taking this patented prescription (the product obtained in Example 3, once a day), 3 months later in July 2022, the review, the thyroid B-ultrasound showed: multiple echo nodules on the left side, a slightly higher echo nodule of about 0.53*0.58cm in the middle, with an aspect ratio greater than 1, TI-RADS 4a, clear boundaries, CDFI: blood flow signals around. Compared with the thyroid nodules in April 2021, the thyroid nodules were reduced by 15%. The changes after 3-4 months of maintenance show that this prescription is effective in improving thyroid nodules.

[0072] Case 4

[0073] Si * Xia, female, retired personnel, has regular physical examinations every year, and feels that her body needs systematic maintenance. Thyroid B-ultrasound in August 2020 showed: the left thyroid gland is of normal size, the basic echo is evenly distributed, and multiple nodules are seen inside, one of which is about 0.9*0.4cm in size, solid and cystic, with small light spots on the edge. The right thyroid gland is of normal size, the basic echo is evenly distributed, and multiple nodules are seen inside, one of which is about 0.8*0.5cm in size at the middle and lower poles, which is solid and cystic. CDFI: a small amount of blood flow signal is seen inside. Take this patented prescription (the product obtained in Example 3, once a day) for 4 months. After feeling that her body has improved, she stopped maintenance. In August 2021, the unit organized a comprehensive physical examination, in which thyroid B-ultrasound showed: the left thyroid gland is of normal size, the basic echo is evenly distributed, and multiple nodules are seen inside, one of which is about 0.5*0.3cm in size, solid and cystic, with small light spots on the edge. The right thyroid gland is of normal size, with evenly distributed basic echoes. Multiple nodules are seen inside, including one in the middle and lower pole, which is about 0.6*0.5cm in size and solid in appearance. CDFI: A small amount of blood flow signal is seen inside. Compared with the thyroid nodules in August 2020, according to general rules, when ultrasound doctors see multiple nodules, they will write down the size of relatively large nodules. There are multiple thyroid nodules on the left side, and the corresponding positions are not written. From the data comparison, the nodules on the left side have shrunk by 58%; both tests on the right side indicated that the nodule position was in the middle and lower pole, and the nodules were shrunk by 25%. The changes after 4 months of maintenance show that this prescription is effective in improving thyroid nodules.

[0074] Case 5

[0075] Zhong * Hua, male, 71 years old, has many physical injuries, lacks gallbladder and appendix, has a lot of work and social activities, and has a good alcohol tolerance. During the physical examination in August 2023, thyroid B-ultrasound showed multiple nodules in the left lobe, with a size of 12*12*11mm in the left middle position, and nodules of TI-RADS1 category. Maintenance for two months in August and September 2023 (taking the product obtained in Example 3, once a day), maintenance for 3 months in March, April and May 2024, and review of thyroid B-ultrasound in June 2024 showed: multiple nodules in the left lobe, with a size of 13*7mm in the left middle position. The measured dimensions are different, but compared with the thyroid nodules in August 2023, they have shrunk by at least 31%. The changes after 5 months of maintenance show that this prescription is effective in improving thyroid nodules.

[0076] Case 6

[0077] Zou * Jin, female, 37 years old, has been weak and sick since childhood. After cholecystectomy and bilateral breast nodule resection, the thyroid B-ultrasound in July 2023 showed scattered anechoic areas in both lobes of the thyroid gland, the largest of 1.2*3mm, aspect ratio of 0.4, clear boundaries, strong echo points inside, and no blood flow signals inside. The thyroid nodule problem was mild during the physical examination, and the main demand for her health was gastrointestinal maintenance. Maintenance was started in September 2023, and systematic maintenance lasted for 6 months. The intermittent use of this prescription (the product obtained in Example 3, once a day) took a total of 2 months and ended in March 2024. I felt that my body had improved significantly. Due to my congenital deficiency, I did not take this prescription for enough time. Although my gastrointestinal function had improved, it was not enough to fully repair the digestive system. The thyroid B-ultrasound reexamination in July 2024 showed: Several anechoic areas were seen in both lobes of the thyroid gland, the largest of 1*2mm, aspect ratio of 0.5, clear boundaries, regular morphology, strong echo points inside, and no blood flow signals inside. Compared with July 2023, the thyroid nodules have shrunk by 44%. The changes after 6 months of maintenance show that this prescription is effective in improving thyroid nodules.

[0078] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for improving thyroid nodules, characterized in that: The invention comprises the following components in parts by weight: 15-25 parts of dried tangerine peel, 15-25 parts of kelp, 15-25 parts of seaweed, 15-25 parts of whole trichosanthes, 8-12 parts of fritillaria thunbergii, 10-20 parts of selfheal, 10-20 parts of honeysuckle, 10-20 parts of dandelions, 10-20 parts of yam, 8-12 parts of codonopsis pilosula, 15-25 parts of jujube, 8-12 parts of angelica sinensis, and 8-12 parts of rehmannia glutinosa.

2. The method for preparing the Chinese medicine composition according to claim 1, characterized in that: The steps include: (1) Mixing tangerine peel, kelp, seaweed, whole trichosanthes, fritillaria thunbergii, selfheal, honeysuckle, dandelion, yam, codonopsis, jujube, angelica, and rehmannia to obtain material 1; mixing material 1 with water, soaking, decocting, and filtering to obtain a filtrate and a filter residue; (2) mixing the filter residue obtained in step (1) with water and boiling, and filtering to obtain a decoction; (3) Mixing the filtrate obtained in step (1) with the decoction obtained in step (2) to obtain a Chinese medicine composition.

3. The method for preparing the Chinese medicine composition according to claim 2, characterized in that: The mass ratio of the material 1 to water in step (1) is 1:3-4.

4. The method for preparing the Chinese medicine composition according to claim 2, characterized in that: The soaking time in step (1) is 25 to 35 minutes.

5. The method for preparing the Chinese medicine composition according to claim 2, characterized in that: The decocting time in step (1) is 15 to 25 minutes.

6. The method for preparing the Chinese medicine composition according to claim 2, characterized in that: The mass ratio of the filter residue to water in step (2) is 1:2-3.

7. The method for preparing the Chinese medicine composition according to claim 2, characterized in that: The cooking time in step (2) is 15 to 25 minutes.

8. Use of the Chinese medicine composition according to claim 1 or the Chinese medicine composition obtained by the preparation method according to any one of claims 2 to 7 in the preparation of a pharmaceutical preparation for treating thyroid nodules.

9. The use according to claim 8, characterized in that: The dosage form of the pharmaceutical preparation is decoction, fluid extract, powder, granule, pill, tablet or capsule.

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