A traditional Chinese medicine composition for treating hashimoto's thyroiditis, and a decoction and a powder thereof

Abstract

The application provides a traditional Chinese medicine composition for treating Hashimoto's thyroiditis and a decoction and a powder thereof, and belongs to the technical field of traditional Chinese medicine.The traditional Chinese medicine composition comprises the following components: radix codonopsis, fried atractylodes, poria cocos, dried tangerine or orange peel, salted eucommia ulmoides, huaiyin achyranthes, taxillus, radix rubrascenii, calcined oyster shell, poria cum zygomycetes, albizzia julibrissin bark, fried bitter orange fruit, fried white peony root, radix scrophulariae, zedoary, cassia, licorice root.The various medicines have their own functions, but are interwoven with each other;they not only consider various aspects, but also have certain emphases, so that the whole prescription can jointly play the functions of invigorating the spleen, benefiting the kidney, soothing the liver and tranquilizing the mind.The use of the traditional Chinese medicine composition can significantly inhibit the increase of thyroid-related antibodies of experimental autoimmune thyroiditis (EAT) rats, reduce the degree of hypothyroidism, inhibit the increase of thyroid organ index, reduce the destruction of thyroid follicles and the infiltration of inflammatory cells, and has a good effect on EAT rats.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating Hashimoto's thyroiditis and a decoction and a powder thereof. BACKGROUND

[0002] Hashimoto's thyroiditis is one of the most common organ-specific autoimmune diseases. The etiology and pathogenesis of the disease have not been fully understood, and it is currently believed that under the joint action of genetic factors and environmental factors, the body's immune system is disordered, the immune tolerance to the self thyroid antigen is damaged, and eventually the disease is caused. The main clinical features of Hashimoto's thyroiditis are diffuse enlargement of the thyroid gland, significant increase of anti-thyroid peroxidase antibodies and anti-thyroglobulin antibodies in serum, and a large number of lymphocytes infiltrating the thyroid tissue. With the progression of the disease, hypothyroidism can gradually appear, and then affect various systems of the body, greatly reducing the quality of life of patients. The incidence of Hashimoto's thyroiditis is increasing year by year, and studies have reported that Hashimoto's thyroiditis is also a high-risk factor for the onset of thyroid cancer. As for the treatment of Hashimoto's thyroiditis, Western medicine generally believes that when Hashimoto's thyroiditis progresses to the hypothyroidism stage, oral administration of levothyroxine can be used for supplementation or replacement therapy. However, when Hashimoto's thyroiditis does not appear hypothyroidism, there is no specific intervention means. Therefore, it is urgent to actively seek effective and specific prevention and treatment means. SUMMARY

[0003] In view of this, the present application aims to provide a traditional Chinese medicine composition for treating Hashimoto's thyroiditis and a decoction and a powder thereof, which can achieve the therapeutic effect on patients in the early and middle stages of Hashimoto's thyroiditis by invigorating the spleen and kidney, soothing the liver and calming the mind.

[0004] In order to achieve the above-mentioned application purpose, the present application provides the following technical scheme:

[0005] The present application provides a traditional Chinese medicine composition for treating Hashimoto's thyroiditis, which comprises the following components in mass parts: Radix Codonopsis 9-30 parts, fried Atractylodes 6-20 parts, Poria cocos 10-20 parts, dried tangerine or orange peel 3-10 parts, salted Eucommia ulmoides 6-20 parts, Radix Hedysari 6-20 parts, Taxillus 9-20 parts, Dipsacus asper 9-20 parts, calcined oyster shell 9-30 parts, Sclerotium 9-20 parts, Albizia julibrissin 6-20 parts, fried bitter orange 3-10 parts, fried Paeonia suffruticosa 6-17 parts, Scutellaria 3-10 parts, Curcuma longa 1-8 parts, Cinnamomum cassia 1-8 parts, and Glycyrrhiza 1-10 parts.

[0006] As preferred, the components include the following mass parts: Dangshen 12-20 parts, Fried Baizhu 10-18 parts, Fuling 12-17 parts, Chenpi 5-8 parts, Salt Duzhong 10-18 parts, Huai Niuxi 10-18 parts, Suanzaoren 12-18 parts, Chuanxuduan 11-15 parts, Chunaomuqi 12-20 parts, Fushen 12-18 parts, Hehuanpi 10-18 parts, Fried Jiaoshou 5-8 parts, Fried Baishao 10-15 parts, Huangqi 5-8 parts, Jianghuanglian 2-5 parts, Rougui 2-5 parts, Gancao 2-5 parts.

[0007] As preferred, the components include the following mass parts: Dangshen 15 parts, Fried Baizhu 15 parts, Fuling 15 parts, Chenpi 6 parts, Salt Duzhong 15 parts, Huai Niuxi 15 parts, Suanzaoren 15 parts, Chuanxuduan 12 parts, Chunaomuqi 15 parts, Fushen 15 parts, Hehuanpi 15 parts, Fried Jiaoshou 6 parts, Fried Baishao 12 parts, Huangqi 6 parts, Jianghuanglian 3 parts, Rougui 3 parts, Gancao 3 parts.

[0008] The application also provides the use of the traditional Chinese medicine composition in the preparation of a drug for treating Hashimoto's thyroiditis.

[0009] As preferred, the dosage form of the drug is a decoction or a powder.

[0010] The application also provides a decoction for treating Hashimoto's thyroiditis, and the preparation method of the decoction is as follows:

[0011] (6.1) Taking the traditional Chinese medicine components in the traditional Chinese medicine composition, mixing other components except Chunaomuqi and Rougui, and soaking to obtain traditional Chinese medicine component A;

[0012] (6.2) Separately decocting Chunaomuqi;

[0013] (6.3) Mixing traditional Chinese medicine component A and separately decocted Chunaomuqi, continuing to decoct for 15-35 min, adding Rougui to continue decocting, filtering, and taking the filtrate to obtain the decoction.

[0014] As preferred, the mass ratio of Chunaomuqi to water in the separately decocted Chunaomuqi in step (6.2) is 1:8-12, and the separately decocting time of Chunaomuqi is 20-40 min.

[0015] The application also provides a powder for treating Hashimoto's thyroiditis, and the preparation method of the powder is as follows:

[0016] (8.1) Taking the traditional Chinese medicine components in the traditional Chinese medicine composition, mixing other components except Rougui, crushing, sieving, and taking the undersize components;

[0017] (8.2) Soaking, decocting, filtering, and concentrating the undersize components to obtain an extract;

[0018] (8.3) Crushing Rougui, soaking, and extracting volatile oil;

[0019] (8.4) Mix the volatile oil with the extract, dry, and obtain the powder.

[0020] As preferred, the soaking time in step (8.2) is 40-80 min; the decocting time is 30-120 min; and the concentration is under reduced pressure.

[0021] As preferred, the soaking time in step (8.3) is 60-180 min; and the extraction is by steam distillation.

[0022] Compared with the prior art, the present application has the following beneficial effects: The traditional Chinese medicine composition in the present application achieves the therapeutic effect on the patients in the pre- and middle- stage of Hashimoto's thyroiditis by invigorating the spleen, tonifying the kidney, soothing the liver, and tranquilizing the mind. The radix codonopsis is used as the monarch drug for invigorating the spleen, the fried atractylodes rhizome and the poria cocos are used as the ministerial drugs for invigorating the spleen, the dried tangerine or orange peel is used as the auxiliary drug for invigorating the spleen; the salt of eucommia ulmoides is used as the monarch drug for tonifying the kidney, the radix astragali complanati is used as the ministerial drug for tonifying the kidney, the euonymus alatus is used as the auxiliary drug for tonifying the kidney, the radix curdlans is used as the auxiliary drug for tonifying the kidney; the fried radix paeoniae alba is used as the monarch drug for soothing the liver, the fried fructus aurantii is used as the ministerial drug for soothing the liver; the calcined concha murex is used as the monarch drug for tranquilizing the mind, the poria cocos is used as the ministerial drug for tranquilizing the mind, the cortex albicinis is used as the ministerial drug for tranquilizing the mind. The curcuma zedoary is used as the monarch drug for clearing away heat and purging fire (clearing away heart fire), the cortex cinnamomi is used as the monarch drug for warming and tonifying yang (tonifying kidney essence), and the radix bupleuri is used as the ministerial drug for clearing away heat. The radix glycyrrhizae is used as the assistant drug for invigorating the spleen and tonifying qi, clearing away heat and relieving urgency, and regulating all drugs. The poria cocos is used as the auxiliary drug for tranquilizing the mind, the radix astragali complanati is used as the auxiliary drug for guiding heat downward, the calcined concha murex is used as the auxiliary drug for soothing the liver, and the fried fructus aurantii is used as the auxiliary drug for invigorating the spleen. All the drugs have their own functions, but they are interwoven with each other, and they have multiple functions and some special functions, so that the whole prescription has the functions of invigorating the spleen, tonifying the kidney, soothing the liver, and tranquilizing the mind. The traditional Chinese medicine composition in the present application can significantly inhibit the increase of thyroid-related antibodies of experimental autoimmune thyroiditis (EAT) rats, reduce the degree of hypothyroidism, inhibit the increase of thyroid organ index, reduce the destruction of thyroid follicles and the infiltration of inflammatory cells, and has a good effect on EAT rats. BRIEF DESCRIPTION OF DRAWINGS

[0023] Figure 1 The thyroid organ index of each group of rats after 8 weeks of administration, wherein ** indicates a very significant difference compared with the control group, P<0.01, and # indicates a significant difference compared with the model group, P<0.05;

[0024] Figure 2HE staining of thyroid tissue of rats in each group after 8 weeks of administration (×200). DETAILED DESCRIPTION

[0025] The application provides a traditional Chinese medicine composition for treating Hashimoto's thyroiditis, and contains the following components in mass parts:

[0026] Radix Codonopsis 9-30 parts, preferably 12-20 parts, and further preferably 15 parts;

[0027] Fried Atractylodes Rhizome 6-20 parts, preferably 10-18 parts, and further preferably 15 parts;

[0028] Poria cocos 10-20 parts, preferably 12-17 parts, and further preferably 15 parts;

[0029] Pericarpium Citri Reticulatae Viride 3-10 parts, preferably 5-8 parts, and further preferably 6 parts;

[0030] Salted Eucommia Ulmoides 6-20 parts, preferably 10-18 parts, and further preferably 15 parts;

[0031] Hairy Knotweed Root 6-20 parts, preferably 10-18 parts, and further preferably 15 parts;

[0032] Viscum Album 9-20 parts, preferably 12-18 parts, and further preferably 15 parts;

[0033] Radix Sophorae Tonkinensis 9-20 parts, preferably 11-15 parts, and further preferably 12 parts;

[0034] Calcined Oyster Shell 9-30 parts, preferably 12-20 parts, and further preferably 15 parts;

[0035] Fuling 9-20 parts, preferably 12-18 parts, and further preferably 15 parts;

[0036] Albizia Julibrissin 6-20 parts, preferably 10-18 parts, and further preferably 15 parts;

[0037] Fried Aurantii Fructus Immaturus 3-10 parts, preferably 5-8 parts, and further preferably 6 parts;

[0038] Fried Paeoniae Radix Alba 6-17 parts, preferably 10-15 parts, and further preferably 12 parts;

[0039] Scrophularia Ningpoensis 3-10 parts, preferably 5-8 parts, and further preferably 6 parts;

[0040] Curcuma Longa 1-8 parts, preferably 2-5 parts, and further preferably 3 parts;

[0041] Cinnamomum Cassia 1-8 parts, preferably 2-5 parts, and further preferably 3 parts;

[0042] Gancao 1-10 parts, preferably 2-5 parts, further preferably 3 parts.

[0043] In the present application, the treatment effect on the patients in the early and middle stages of Hashimoto's thyroiditis is achieved by invigorating the spleen, tonifying the kidney, soothing the liver and tranquilizing the mind.

[0044] The spleen-invigorating formula comprises Radix Codonopsis, which is sweet and neutral, and is distributed in the spleen and lung channels, and can invigorate the spleen and boost qi, and is the monarch of the spleen-invigorating formula; roasted Atractylodes Rhizome, which is bitter, sweet and warm, and is distributed in the spleen and stomach channels, and can invigorate the spleen, boost qi, benefit water and is the minister of the spleen-invigorating formula; Poria, which is sweet, bland and neutral, and is distributed in the spleen, lung, heart and kidney channels, and can dampen the spleen, calm the heart and is the assistant of the spleen-invigorating formula; and Pericarpium Citri Reticulatae, which is bitter, pungent and warm, and is distributed in the lung and spleen channels, and can regulate qi and invigorate the spleen, and is the assistant of the spleen-invigorating formula.

[0045] The kidney-tonifying formula comprises Salt Eucommia, which is sweet and warm, and is distributed in the kidney and liver channels, and can tonify the liver and kidney and strengthen the tendons and bones, and is the monarch of the kidney-tonifying formula; Radix Cyathulae, which is bitter, sweet, sour and neutral, and is distributed in the liver and kidney channels, and can remove blood stasis, tonify the liver and kidney, strengthen the tendons and bones and lead heat downward, and is the minister of the kidney-tonifying formula; Euonymus, which is bitter and neutral, and is distributed in the liver and kidney channels, and can dispel wind and dampness, tonify the liver and kidney and strengthen the tendons and bones, and is the assistant of the kidney-tonifying formula; and Radix Dipsaci, which is bitter, pungent and slightly warm, and is distributed in the liver and kidney channels, and can tonify the liver and kidney, strengthen the tendons and bones and continue the broken, and is the assistant of the kidney-tonifying formula.

[0046] The liver-soothing formula comprises roasted Paeonia, which is bitter, sour and slightly cold, and is distributed in the liver and spleen channels, and can soothe the liver and astringe the yin, and suppress the yang of the liver, and is the monarch of the liver-soothing formula; and roasted Fructus Aurantii, which is bitter, pungent, sour and slightly cold, and is distributed in the spleen and stomach channels, and can regulate qi, expand the middle and remove stagnation, and is the minister of the liver-soothing formula.

[0047] The mind-tranquilizing formula comprises calcined Concha Molluscorum, which is salty and slightly cold, and is distributed in the liver, gallbladder and kidney channels, and can calm the mind, tranquilize the mind, suppress the yang and tonify the yin, and is the monarch of the mind-tranquilizing formula; Poria, which is sweet and neutral, and is distributed in the heart and spleen channels, and can calm the heart and tranquilize the mind, and is the minister of the mind-tranquilizing formula; and Cortex Albiziae, which is sweet and neutral, and is distributed in the heart, liver and lung channels, and can relieve depression, tranquilize the mind and activate blood, and is the assistant of the mind-tranquilizing formula.

[0048] The formula for clearing the upper and warming the lower and leading the fire back to the origin comprises Rhizoma Curcumae, which is bitter and cold, and is distributed in the heart, spleen, stomach, liver, gallbladder and large intestine channels, and can clear heat and purge fire (clear the heart fire), and is the monarch of the upper-clearing formula; Cinnamomum Cassia, which is pungent, sweet and extremely hot, and is distributed in the kidney, spleen, heart and liver channels, and can tonify the fire and assist the yang (tonify the kidney origin), and lead the fire back to the origin, and is the monarch of the lower-warming formula; and Radix Scrophulariae, which is bitter and cold, and is distributed in the lung, gallbladder, spleen, large intestine and small intestine channels, and can clear heat and purge fire, and is the minister of the upper-clearing formula.

[0049] The formula for regulating the various herbs comprises Radix Glycyrrhizae, which is sweet and neutral, and is distributed in the heart, lung, spleen and stomach channels, and can invigorate the spleen, boost qi, clear heat and relieve urgency, and regulate the various herbs, and is the assistant of the entire formula.

[0050] Poria can calm the heart, and is the assistant of the mind-tranquilizing formula; Radix Cyathulae can lead the heat downward, and is the assistant of the formula for leading the fire back to the origin; calcined Concha Molluscorum can suppress the yang and tonify the yin, and is the assistant of the liver-soothing formula; and roasted Fructus Aurantii can regulate qi, and is the assistant of the spleen-invigorating formula. The various herbs have their own functions, but they are interwoven with each other; they take into account multiple aspects, but they have their own emphasis, so that the entire formula can invigorate the spleen, tonify the kidney, soothe the liver and tranquilize the mind.

[0051] The application also provides the use of the traditional Chinese medicine composition in the preparation of a drug for treating Hashimoto's thyroiditis.

[0052] In the application, the dosage form of the drug is decoction or powder.

[0053] The application also provides a decoction for treating Hashimoto's thyroiditis, and the preparation method of the decoction is as follows:

[0054] (6.1) taking the traditional Chinese medicine components in the traditional Chinese medicine composition, mixing other components except calcined oyster shell and cassia to obtain traditional Chinese medicine component A after soaking;

[0055] (6.2) separately decocting the calcined oyster shell;

[0056] (6.3) mixing the traditional Chinese medicine component A and the separately decocted calcined oyster shell, continuing to decoct for 15-35 min, adding cassia to continue decocting, filtering, and taking the filtrate to obtain the decoction.

[0057] In the application, there is no special limitation on the source of raw materials, and conventional commercially available products can be used. In the application, other components except calcined oyster shell and cassia are mixed and soaked to obtain traditional Chinese medicine component A. The soaking time is 20-40 min, preferably 25-35 min, and further preferably 30 min; the traditional Chinese medicine component A comprises traditional Chinese medicine components and water, and the mass ratio of the traditional Chinese medicine components to water is 1:2-5, preferably 1:2.5-4, and further preferably 1:3.

[0058] In the application, the mass ratio of calcined oyster shell to water in the separately decocted calcined oyster shell is 1:8-12, preferably 1:9-11, and further preferably 1:10; and the separately decocted calcined oyster shell is decocted for 20-40 min, preferably 25-35 min, and further preferably 30 min.

[0059] In the application, the traditional Chinese medicine component A and the separately decocted calcined oyster shell are mixed, and after continuing to decoct for 15-35 min, cassia is added to continue decocting, filtering, and taking the filtrate to obtain the decoction. The time for continuing to decoct is 15-35 min, preferably 20-30 min, and further preferably 25 min; the time for adding cassia to continue decocting is 1-10 min, preferably 3-8 min, and further preferably 5 min; and the filtering can be performed by using a 60-mesh filter screen, gauze, non-woven fabric, or a combination of two of them.

[0060] The application also provides a powder for treating Hashimoto's thyroiditis, and the preparation method of the powder is as follows:

[0061] (8.1) Take the Chinese medicine components in the Chinese medicine composition, mix other components except cinnamon, crush, sieve, take the sieve under component;

[0062] (8.2) Soak, decoct, filter, concentrate the sieve under component to obtain extract;

[0063] (8.3) Crush cinnamon, soak, extract volatile oil;

[0064] (8.4) Mix volatile oil and extract, dry, obtain powder.

[0065] In the application, take the Chinese medicine components in the Chinese medicine composition, mix other components except cinnamon, crush, sieve, take the sieve under component. The crushing can adopt conventional method, and the crushing degree is appropriate to pass 10 mesh sieve. The sieve mesh number is 10 mesh.

[0066] In the application, soak, decoct, filter, concentrate the sieve under component to obtain extract. The mass ratio of sieve under component and water is 1:8-12, preferably 1:9-11, further preferably 1:10. The soaking time is 40-80 min, preferably 50-70 min, further preferably 60 min. The decocting times is 1-3 times, and the decocting time is 30-120 min / time, preferably 50-100 min / time, further preferably 60 min / time. The filter mesh number is 100-200 mesh, preferably 140-180 mesh, further preferably 160 mesh. The concentration is reduced pressure concentration, and the concentration temperature is 60-90℃, preferably 70-80℃, further preferably 75℃. The concentration time is 8-12 h, preferably 9-11 h, further preferably 10 h.

[0067] In the application, crush cinnamon, soak, extract volatile oil. The crushing can adopt conventional method, and the crushing degree is appropriate to pass 10 mesh sieve. In the application, the cinnamon is soaked with water after crushing, and the mass ratio of cinnamon and water is 1:10-14, preferably 1:11-13, further preferably 1:12. The soaking time is 60-180 min, preferably 100-150 min, further preferably 120 min. The extraction adopts water vapor distillation method, and the distillation time is 6-10 h, preferably 7-9 h, further preferably 8 h. The volatile oil can be separated and recovered from the distillate by oil-water separator. And the initial separation distillate can enter the distillation-separation process again to increase the volatile oil extraction rate.

[0068] In this invention, volatile oil and extract are mixed and dried to obtain powder. The mixing can be done using conventional methods, and the drying is done using centrifugal spray drying. The process parameters for centrifugal spray drying are as follows: material relative density is 1.10, feed rate is 12 mL / min, drying tower inlet air temperature is 180℃, outlet air temperature is 80℃, and atomizer speed is 19000 r / min.

[0069] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0070] Example 1

[0071] Weigh out 105g of Codonopsis pilosula, 105g of stir-fried Atractylodes macrocephala, 105g of Poria cocos, 42g of Citrus reticulata peel, 105g of salt-processed Eucommia ulmoides, 105g of Achyranthes bidentata, 105g of Loranthus parasiticus, 84g of Dipsacus asper, 105g of calcined Ostrea gigas, 105g of Poria cocos, 105g of Albizia julibrissin bark, 42g of stir-fried Citrus aurantium, 84g of stir-fried Paeonia lactiflora, 42g of Scutellaria baicalensis, 21g of Curcuma longa, 21g of Cinnamomum cassia, and 21g of Glycyrrhiza uralensis. Place all the herbs except calcined Ostrea gigas and Cinnamomum cassia into a non-woven fabric decoction bag, seal the bag, and place it in a decoction bucket with 5kg of water to soak for 30 minutes. Place the weighed calcined Ostrea gigas into a separate non-woven fabric decoction bag, seal it, and place it in a decoction bucket with an inner filter. Add 1kg of water and decoct for 30 minutes. Place the water from the soaking tub and the soaked components into the decoction tub. Bring to a boil over high heat, then simmer over low heat for 25 minutes. Add cinnamon and continue simmering for 5 minutes. After simmering, lift the filter screen of the decoction machine, and remove the non-woven decoction bag and dregs. Divide the decoction obtained from the decoction tub into sealed plastic bags to obtain the decoction.

[0072] Example 2

[0073] Weigh out 105g of Codonopsis pilosula, 105g of stir-fried Atractylodes macrocephala, 105g of Poria cocos, 42g of Citrus reticulata peel, 105g of salt-processed Eucommia ulmoides, 105g of Achyranthes bidentata, 105g of Loranthus parasiticus, 84g of Dipsacus asper, 105g of calcined Ostrea gigas, 105g of Poria cocos, 105g of Albizia julibrissin bark, 42g of stir-fried Citrus aurantium, 84g of stir-fried Paeonia lactiflora, 42g of Scutellaria baicalensis, 21g of Curcuma longa, 21g of Cinnamomum cassia, and 21g of Glycyrrhiza uralensis. Mix all components except Cinnamomum cassia and pulverize them using a grinder until they just pass through a 10-mesh sieve. Place the sieved components in 12.81kg of water and soak for 1 hour. Bring to a boil over high heat, then simmer over low heat for 1 hour. Collect the decoction to obtain the first decoction. Add another 12.81kg of water to the remaining herb residue, bring to a boil over high heat, then simmer over low heat for 1 hour. Collect the decoction to obtain the second decoction. The two decoctions were combined, filtered, and the filtrate was collected. The filtrate was placed in a vacuum concentration apparatus, the temperature was set to 75℃, and concentration was carried out for 10 hours to obtain an extract. Cinnamon was pulverized to pass through a 10-mesh sieve to obtain coarse cinnamon powder. 252g of water was added to the coarse cinnamon powder, and the mixture was soaked for 2 hours. Then, steam distillation was performed for 8 hours to obtain volatile oil. The volatile oil was mixed with the extract, and spray-dried to obtain a powder.

[0074] Example 3

[0075] Weigh out 63g of Codonopsis pilosula, 42g of stir-fried Atractylodes macrocephala, 70g of Poria cocos, 21g of Citrus reticulata peel, 42g of salt-processed Eucommia ulmoides, 42g of Achyranthes bidentata, 63g of Loranthus parasiticus, 63g of Dipsacus asper, 63g of calcined Ostrea gigas, 63g of Poria cocos, 42g of Albizia julibrissin bark, 21g of stir-fried Citrus aurantium, 42g of stir-fried Paeonia lactiflora, 21g of Scutellaria baicalensis, 7g of Curcuma longa, 7g of Cinnamomum cassia, and 7g of Glycyrrhiza uralensis. Place all the herbs except calcined Ostrea gigas and Cinnamomum cassia into a non-woven fabric decoction bag, seal the bag, and place it in a decoction bucket with 3kg of water to soak for 40 minutes. Place the weighed calcined Ostrea gigas into a separate non-woven fabric decoction bag, seal it, and place it in a decoction bucket with an inner filter. Add 0.8kg of water and decoct for 40 minutes. Place the water from the soaking tub and the soaked components into the decoction tub. Bring to a boil over high heat, then simmer over low heat for 15 minutes. Add cinnamon and continue simmering for 10 minutes. After simmering, lift the filter screen of the decoction machine, and remove the non-woven decoction bag and dregs. Divide the decoction obtained from the decoction tub into sealed plastic bags to obtain the decoction.

[0076] Example 4

[0077] Weigh out 60g of Codonopsis pilosula, 40g of stir-fried Atractylodes macrocephala, 40g of Poria cocos, 20g of Citrus reticulata peel, 40g of salt-processed Eucommia ulmoides, 40g of Achyranthes bidentata, 40g of Loranthus parasiticus, 40g of Dipsacus asper, 60g of calcined Ostrea gigas, 40g of Poria cocos, 40g of Albizia julibrissin bark, 20g of stir-fried Citrus aurantium, 34g of stir-fried Paeonia lactiflora, 20g of Scutellaria baicalensis, 16g of Coptis chinensis, 16g of Cinnamomum cassia, and 20g of Glycyrrhiza uralensis. Place all the herbs except calcined Ostrea gigas and Cinnamomum cassia into a non-woven fabric decoction bag, seal the bag, and place it in a decoction bucket with 1kg of water to soak for 20 minutes. Place the weighed calcined Ostrea gigas into a separate non-woven fabric decoction bag, seal it, and place it in a decoction bucket with an inner filter. Add 0.5kg of water and decoct for 20 minutes. Place the water from the soaking tub and the soaked components into the decoction tub. Bring to a boil over high heat, then simmer over low heat for 35 minutes. Add cinnamon and continue simmering for 3 minutes. After simmering, lift the filter screen of the decoction machine, and remove the non-woven decoction bag and dregs. Divide the decoction obtained from the decoction tub into sealed plastic bags to obtain the decoction.

[0078] Example 5

[0079] Weigh out 63g of Codonopsis pilosula, 42g of stir-fried Atractylodes macrocephala, 70g of Poria cocos, 21g of Citrus reticulata peel, 42g of salt-processed Eucommia ulmoides, 42g of Achyranthes bidentata, 63g of Loranthus parasiticus, 63g of Dipsacus asper, 63g of calcined Ostrea gigas, 63g of Poria cocos, 42g of Albizia julibrissin bark, 21g of stir-fried Citrus aurantium, 42g of stir-fried Paeonia lactiflora, 21g of Scutellaria baicalensis, 7g of Curcuma longa, 7g of Cinnamomum cassia, and 7g of Glycyrrhiza uralensis. Mix all components except Cinnamomum cassia and pulverize them using a grinder until they just pass through a 10-mesh sieve. Soak the sieved components in 7.5kg of water for 80 minutes, bring to a boil over high heat, then simmer over low heat for 2 hours. Collect the decoction to obtain the first decoction. Add another 7.5kg of water to the remaining herb residue, bring to a boil over high heat, then simmer over low heat for 2 hours. Collect the decoction to obtain the second decoction. Combine the two decoctions, filter, and collect the filtrate. The filtrate was placed in a vacuum concentration apparatus, and the temperature was set to 60°C. After concentration for 12 hours, an extract was obtained. Cinnamon was pulverized to pass through a 10-mesh sieve to obtain coarse cinnamon powder. 70g of water was added to the coarse cinnamon powder, and after soaking for 1 hour, steam distillation was performed for 6 hours to obtain volatile oil. The volatile oil was mixed with the extract and spray-dried to obtain a powder.

[0080] Example 6

[0081] Weigh out 60g of Codonopsis pilosula, 40g of stir-fried Atractylodes macrocephala, 40g of Poria cocos, 20g of Citrus reticulata peel, 40g of salt-processed Eucommia ulmoides, 40g of Achyranthes bidentata, 40g of Loranthus parasiticus, 40g of Dipsacus asper, 60g of calcined Ostrea gigas, 40g of Poria cocos, 40g of Albizia julibrissin bark, 20g of stir-fried Citrus aurantium, 34g of stir-fried Paeonia lactiflora, 20g of Scutellaria baicalensis, 16g of Coptis chinensis, 16g of Cinnamomum cassia, and 20g of Glycyrrhiza uralensis. Mix all components except Cinnamomum cassia and pulverize them using a grinder until they just pass through a 10-mesh sieve. Place the sieved components in 4.5kg of water and soak for 40 minutes. Bring to a boil over high heat, then simmer over low heat for 30 minutes. Collect the decoction to obtain the first decoction. Add another 4.5kg of water to the remaining herb residue, bring to a boil over high heat, then simmer over low heat for 30 minutes. Collect the decoction to obtain the second decoction. The two decoctions were combined, filtered, and the filtrate was collected. The filtrate was placed in a vacuum concentration apparatus, the temperature was set to 90℃, and concentration was carried out for 8 hours to obtain an extract. Cinnamon was pulverized to pass through a 10-mesh sieve to obtain coarse cinnamon powder. 220g of water was added to the coarse cinnamon powder, and it was soaked for 3 hours. Then, steam distillation was performed for 12 hours to obtain volatile oil. The volatile oil was mixed with the extract, and spray-dried to obtain a powder.

[0082] Experimental Example

[0083] The powder for treating Hashimoto's thyroiditis prepared using the method of Example 2 is referred to as HT-FF.

[0084] 1. Animal modeling, grouping, and intervention methods

[0085] 1) Twenty healthy SPF-grade female SD rats were selected and acclimatized for one week. Four rats were randomly selected as the normal control group and fed with normal feed and water. The remaining 16 rats were used to establish an EAT rat model using an immune-mediated high-iodine method.

[0086] 2) After successful preparation of the EAT model, the models were randomly assigned to the following 4 groups: model group, model + low dose HT-FF (HT-FF-L) group, model + high dose HT-FF (HT-FF-H) group, and model + selenium yeast tablet group.

[0087] 3) HT-FF was respectively prepared with 0.5% sodium carboxymethyl cellulose solution in an amount of 0.5-1 mL / 100 g / d according to the corresponding dose (HT-FF-L: 1 g / kg·d; HT-FF-H: 3 g / kg·d), and then the model + HT-FF-L group and the model + HT-FF-H group of rats were given intragastric administration. The administration time and interval: once a day at 09:00-11:00. The model + selenium yeast tablet group was given intragastric administration according to the dose of 20 μg / kg·d. The normal control group and the simple model group of rats were given intragastric administration with the same amount of 0.5% sodium carboxymethyl cellulose solution. All rats were given normal diet and water, and the intragastric administration was continued for 8 weeks. After the last administration, the rats in each group were fasted for 12 h, and then 1.5 mL / kg of 1% sodium pentobarbital solution was injected intraperitoneally. After the rats were anesthetized, the abdominal aorta was opened, 5 mL of blood was taken, and then the blood was naturally coagulated at room temperature. After centrifugation at 3000 r / min for 10 min, the supernatant was taken, 0.5 mL / tube was divided into EP tubes, and then the tubes were labeled and stored at -80°C for detection. After the abdominal aorta was taken, the thyroid gland of the rat was removed, washed with PBS, and then the excess tissue was cut off. The filter paper was used to dry, and then the weight was measured and the scale was photographed. Then the left and right lobes of the thyroid gland were separated, and then the left side was fixed with 4% paraformaldehyde, dehydrated with gradient concentration alcohol, treated with xylene, and then paraffin-embedded, sliced, HE-stained, and mounted. Three non-consecutive sections were randomly selected from each group, and then the pathological changes of the thyroid tissue were observed under a microscope.

[0088] 4) During the experiment, the mental state, activity, and hair color of the rats were observed every day. The food and water intake of the rats in each group was recorded by weighing the water at a fixed time every day. The body weight of the rats was measured once a week.

[0089] 2. Evaluation index

[0090] The thyroid organ index (thyroid weight / rat body weight), the serum thyroid function and thyroid antibody of the rats were detected by ELISA, and the pathological changes of the thyroid tissue of the rats in each group were observed by HE staining, so as to judge the effect of the traditional Chinese medicine composition on Hashimoto's thyroiditis.

[0091] 3. Experimental results

[0092] After 8 weeks of continuous administration, the body weight and the wet weight of the thyroid gland of the rats in each group were shown in Tables 1 and 2. The thyroid organ index of the model group of rats was significantly higher than that of the control group (0.14±0.02 vs. 0.09±0.01, P<0.01); the thyroid organ index of the model + HT-FF-H group was significantly lower than that of the model group (0.10±0.01 vs. 0.14±0.02, P<0.05); and the thyroid organ index of the model + selenium yeast tablet group was also significantly lower than that of the model group (0.11±0.01 vs. 0.14±0.02, P<0.05). The results were shown in Figure 1 .

[0093] Table 1 Body weight of rats in each group after 8 weeks of administration (g)

[0094]

[0095] Table 2 Wet weight of thyroid of rats in each group after 8 weeks of administration (mg)

[0096]

[0097] After 8 weeks of administration, the TSH level of the model group was higher than that of the control group (5.30 ± 0.36 vs. 1.13 ± 0.17, P < 0.01), and the TPOAb and TGAb levels were significantly higher than those of the control group (436.53 ± 19.63 vs. 109.78 ± 5.13, P < 0.01; 139.13 ± 11.48 vs. 39.55 ± 2.50, P < 0.05), and the TT4, TT3, FT4, and FT3 levels were significantly lower than those of the control group, as shown in Table 3. The TSH level of the model + HT-FF-L group was significantly lower than that of the model group (3.98 ± 0.22 vs. 5.30 ± 0.36, P < 0.05), but there was no significant difference in the TPOAb, TGAb, TT4, TT3, FT4, and FT3 levels between the two groups. The TSH level of the model + HT-FF-H group was more significantly decreased than that of the model group (3.38 ± 0.28 vs. 5.30 ± 0.36, P < 0.01), and the TPOAb level was significantly decreased (337.45 ± 13.34 vs. 436.53 ± 19.63, P < 0.05), and the TT4 and TT3 levels were significantly increased (106.83 ± 4.42 vs. 82.53 ± 3.70, P < 0.01; 4.0 ± 0.18 vs. 2.67 ± 0.25, P < 0.05) compared with the model group. The TSH level of the model + selenium yeast tablet group was also significantly decreased compared with the model group, and the TPOAb, TT4, and TT3 levels were also significantly improved, as shown in Table 3.

[0098] Table 3 Comparison of thyroid function and thyroid-related antibodies of rats in each group after 8 weeks of administration

[0099]

[0100]

[0101] Note: * indicates a significant difference compared with the control group, P < 0.05; ** indicates a very significant difference compared with the control group, P < 0.01; # indicates a significant difference compared with the model group, P < 0.05; ## indicates a very significant difference compared with the model group, P < 0.01.

[0102] After 8 weeks of continuous administration, the thyroid tissue of rats in each group was observed under a microscope after HE staining. The results showed that the thyroid follicle structure of rats in the normal group was complete, and there was no inflammatory lymphocyte infiltration. The thyroid follicle of the model group was diffusely damaged, the follicular cell integrity was destroyed, and the cell nucleus was dispersed in the thyroid parenchyma. The model + low-dose traditional Chinese medicine group and the model group had no great difference, and also appeared diffuse follicle damage and inflammatory cell infiltration. Compared with the model group, the model + high-dose traditional Chinese medicine group was improved, the follicle was relatively complete, only a small amount of inflammatory cell infiltration, and the thyroid parenchyma was full. Compared with the model group, the thyroid follicle of the model + selenium yeast tablet group was relatively complete, and there was a small amount of inflammatory infiltration, as shown in Table 2. Figure 2

[0103] The traditional Chinese medicine composition can significantly improve the thyroid organ index of EAT rats, improve the damage of thyroid follicle and inflammatory cell infiltration of EAT rats, and also has a significant improvement and inhibition on the abnormality of EAT rat thyroid function and thyroid related antibodies. The results show that the traditional Chinese medicine composition has a certain therapeutic effect on Hashimoto's thyroiditis.

[0104] The above only describes the preferred embodiments of the present application, and it should be pointed out that for ordinary skilled in the art, without departing from the principles of the present application, a number of improvements and refinements can be made, and these improvements and refinements should also be considered as the protection scope of the present application.​

Claims

1. A traditional Chinese medicine composition for treating Hashimoto's thyroiditis, characterized in that, It is composed of the following components by weight: Codonopsis pilosula 9-30 parts, stir-fried Atractylodes macrocephala 6-20 parts, Poria cocos 10-20 parts, Citrus reticulata peel 3-10 parts, salt-processed Eucommia ulmoides 6-20 parts, Achyranthes bidentata 6-20 parts, Loranthus parasiticus 9-20 parts, Dipsacus asper 9-20 parts, calcined Ostrea gigas 9-30 parts, Poria cocos sclerotium 9-20 parts, Albizia julibrissin bark 6-20 parts, stir-fried Citrus aurantium 3-10 parts, stir-fried Paeonia lactiflora 6-17 parts, Scutellaria baicalensis 3-10 parts, Curcuma longa 1-8 parts, Cinnamomum cassia 1-8 parts, Glycyrrhiza uralensis 1-10 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is composed of the following components by weight: Codonopsis pilosula 12-20 parts, stir-fried Atractylodes macrocephala 10-18 parts, Poria cocos 12-17 parts, Citrus reticulata peel 5-8 parts, salt-processed Eucommia ulmoides 10-18 parts, Achyranthes bidentata 10-18 parts, Loranthus parasiticus 12-18 parts, Dipsacus asper 11-15 parts, calcined Ostrea gigas 12-20 parts, Poria cocos sclerotium 12-18 parts, Albizia julibrissin bark 10-18 parts, stir-fried Citrus aurantium 5-8 parts, stir-fried Paeonia lactiflora 10-15 parts, Scutellaria baicalensis 5-8 parts, Curcuma longa 2-5 parts, Cinnamomum cassia 2-5 parts, Glycyrrhiza uralensis 2-5 parts.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It is composed of the following components by weight: Codonopsis pilosula 15 parts, stir-fried Atractylodes macrocephala 15 parts, Poria cocos 15 parts, Citrus reticulata peel 6 parts, salt-processed Eucommia ulmoides 15 parts, Achyranthes bidentata 15 parts, Loranthus parasiticus 15 parts, Dipsacus asper 12 parts, calcined Ostrea gigas 15 parts, Poria cocos sclerotium 15 parts, Albizia julibrissin bark 15 parts, stir-fried Citrus aurantium 6 parts, stir-fried Paeonia lactiflora 12 parts, Scutellaria baicalensis 6 parts, Coptis chinensis 3 parts, Cinnamomum cassia 3 parts, Glycyrrhiza uralensis 3 parts.

4. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a drug for treating Hashimoto's thyroiditis.

5. The application according to claim 4, characterized in that, The drug is in the form of a decoction or powder.

6. A decoction for treating Hashimoto's thyroiditis, characterized in that, The preparation method of the decoction is as follows: (6.1) Take the traditional Chinese medicine component from the traditional Chinese medicine composition according to any one of claims 1 to 3, mix the other components except calcined oyster shell and cinnamon, soak them, and obtain traditional Chinese medicine component A; (6.2) Simmer calcined oysters separately; (6.3) Mix the Chinese herbal component A with the separately decocted calcined oyster shell, continue to decoct for 15-35 minutes, add cinnamon and continue to decoct, filter, and take the filtrate to obtain the decoction.

7. The decoction according to claim 6, characterized in that, In step (6.2), the mass ratio of calcined oyster to water in the separate decoction of calcined oyster is 1:8 to 12; the decoction time of the calcined oyster is 20 to 40 minutes.

8. A powder for treating Hashimoto's thyroiditis, characterized in that, The powder is prepared as follows: (8.1) Take the traditional Chinese medicine components in the traditional Chinese medicine composition according to any one of claims 1 to 3, mix the components other than cinnamon, crush them, sieve them, and take the components that pass through the sieve; (8.2) Soak, boil, filter, and concentrate the sieved components to obtain an extract; (8.3) Crush cinnamon, soak it, and extract the volatile oil; (8.4) Mix the volatile oil and extract evenly and dry to obtain the powder.

9. The powder according to claim 8, characterized in that, The soaking time in step (8.2) is 40–80 min; The decocting time is 30–120 minutes; the concentration is vacuum concentration.

10. The powder according to claim 8, characterized in that, The soaking time in step (8.3) is 60 to 180 minutes; the extraction is performed by steam distillation.

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