Application of traditional Chinese medicine composition in hashimoto thyroiditis and / or recurrent abortion

Abstract

The invention relates to application of a traditional Chinese medicine composition in preparation of a medicine for hashimoto thyroiditis and / or recurrent abortion, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition can effectively prevent and / or treat hashimoto thyroiditis (HT) and / or recurrent abortion (RSA) aiming at the problem that no medicine for effectively controlling thyroid antibodies and hormone levels and preventing and treating abortion exists at present.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to application of a traditional Chinese medicine composition in treating Hashimoto's thyroiditis and / or recurrent spontaneous abortion. Background Art

[0002] In my country, the prevalence of recurrent spontaneous abortion (RSA) is approximately 1%-5% of women of childbearing age, severely impacting the physical and psychological well-being of patients and placing a significant financial burden on their families. The etiology of RSA is complex, and its pathogenesis remains unclear. Among patients with Hashimoto's thyroiditis (HT), elevated thyroid autoantibodies significantly increase the miscarriage rate and infertility. To date, the main treatment for recurrent miscarriage associated with Hashimoto's thyroiditis is levothyroxine sodium (L-T4). However, Chinese guidelines recommend that L-T4 be used only if the thyroid-stimulating hormone (TSH) level is ≥2.5 mIU / L. Furthermore, the appropriateness of intravenous immunoglobulin, prednisone, and selenium for these patients remains controversial. These treatments lack robust evidence-based evidence, and further, high-quality, large-sample studies are needed to confirm their efficacy and safety. Traditional Chinese medicine believes that the pathogenesis of HT and RSA is mainly related to the liver, kidneys and other internal organs. Patients with HT and RSA are often classified as having yang deficiency or qi deficiency. The treatment should be based on tonifying the kidneys and activating blood circulation, combined with liver-soothing and mind-calming treatment.

[0003] Therefore, it is necessary and urgent to research and develop a Chinese medicine composition that can be used for Hashimoto's thyroiditis and / or recurrent miscarriage, which can relieve the patient's symptoms in a short period of time, reduce the adverse reactions of the drug, the effects of thyroid autoantibodies and hormone levels, improve the quality of life, and has no toxic side effects. Summary of the Invention

[0004] To address the above-mentioned problems, the present invention provides a use of a traditional Chinese medicine composition in the preparation of a medicament for Hashimoto's thyroiditis and / or recurrent spontaneous abortion. This traditional Chinese medicine composition can effectively prevent and / or treat Hashimoto's thyroiditis (HT) and / or recurrent spontaneous abortion (RSA), as there is currently no effective drug for controlling thyroid antibodies and hormone levels or preventing and treating abortion in patients with HT combined with RSA.

[0005] In order to achieve the above object, the present invention provides a use of a traditional Chinese medicine composition in the preparation of a medicament for Hashimoto's thyroiditis and / or recurrent spontaneous abortion, wherein the active ingredients of the traditional Chinese medicine composition are mainly prepared from the following raw materials in parts by weight:

[0006]

[0007]

[0008] In one embodiment, the indications of the drug include: Hashimoto's thyroiditis, Hashimoto's thyroiditis combined with recurrent miscarriage; the active ingredients of the traditional Chinese medicine composition are mainly prepared from the following raw materials in the following weight ratios:

[0009]

[0010] The above-mentioned mugwort (charcoal) refers to mugwort after charcoal processing, white atractylodes (fried and charred) refers to white atractylodes after frying and charring, astragalus (processed) refers to astragalus after processing, licorice (processed) refers to licorice after processing, and white peony root (wine) refers to white peony root after wine processing.

[0011] In one embodiment, when the drug is a drug for treating Hashimoto's thyroiditis, the application includes: the drug reduces the concentration titer of anti-thyroglobulin antibodies and anti-thyroid peroxidase antibodies, increases the levels of iodine-containing thyroxine and free iodine-containing thyroxine, thereby reducing the infiltration of inflammatory cells in thyroid tissue.

[0012] In one embodiment, the drug is a drug for preventing and / or treating Hashimoto's thyroiditis combined with recurrent miscarriage, and the application includes: reducing the miscarriage rate of patients with Hashimoto's thyroiditis combined with recurrent miscarriage and / or increasing the pregnancy rate of patients with Hashimoto's thyroiditis combined with recurrent miscarriage.

[0013] The common pregnancy-preserving drugs in the current technology are mainly used for threatened abortion, while the Chinese medicine composition in this case is suitable for the clinical scenario of Hashimoto's thyroiditis combined with recurrent miscarriage, and has more advantages than the pregnancy-preserving drugs in the current treatment guidelines.

[0014] In one embodiment, the drug is a drug for preventing and / or treating Hashimoto's thyroiditis combined with recurrent miscarriage, and the application includes: the drug reduces the miscarriage rate of patients with Hashimoto's thyroiditis combined with recurrent miscarriage and / or increases the pregnancy rate of patients with Hashimoto's thyroiditis combined with recurrent miscarriage by reducing the concentration titer of TG-Ab, TPO-Ab, and TSH and increasing the levels of FT4 and T4.

[0015] The present invention also provides a medicine for Hashimoto's thyroiditis and / or recurrent miscarriage, which comprises a pharmaceutical active ingredient and a pharmaceutically acceptable excipient, wherein the pharmaceutical active ingredient is the Chinese medicine composition for use.

[0016] In one embodiment, the indications of the drug include: Hashimoto's thyroiditis, Hashimoto's thyroiditis combined with recurrent miscarriage.

[0017] In one embodiment, the dosage form of the drug is oral solution, pills, granules, capsules, tablets, pellets, injections or powders.

[0018] In one embodiment, the excipients include at least one of a solvent, a disintegrant, a flavoring agent, a colorant, a lubricant, an antioxidant, a preservative, a binder, a filler or a thickener.

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

[0020] The invention discloses a Chinese medicine composition for use in preparing a medicine for Hashimoto's thyroiditis and / or recurrent miscarriage. The Chinese medicine composition, Qianjin Baoyun Pills, is composed of 18 Chinese medicinal herbs, including eucommia bark, dodder seed, dipsaccharum officinale, charcoaled mugwort, stir-fried atractylodes macrocephala, processed astragalus, processed liquorice, baical scutellaria, fritillaria cirrhosa, prepared rehmannia root, angelica sinensis, ligusticum chuanxiong, donkey-hide gelatin, white peony root (wine), tangerine peel, amomum villosum, magnolia bark, and fructus aurantii. Eucommia ulmoides, Cuscuta chinensis, and Dipsacus asper in the Chinese medicine composition: these three herbs are the core of kidney tonification. Working together, they can not only improve the kidney deficiency constitution (such as fatigue and low back pain) that may be associated with Hashimoto's thyroiditis, but also consolidate Chong and Ren meridians to prevent miscarriage caused by embryonic instability; Atractylodes macrocephala (fried and charred), Astragalus membranaceus (processed), and Licorice (processed): these three herbs strengthen the spleen and replenish qi, can improve the deficiency of qi and blood biochemistry caused by spleen deficiency, and provide qi and blood support for embryo implantation and development; Rehmannia root, Angelica sinensis, Chuanxiong, White Peony Root (wine), and donkey-hide gelatin, together play the role of nourishing blood, activating blood circulation, and nourishing the fetus, and relieve the tendency of miscarriage caused by deficiency of both qi and blood; Scutellaria baicalensis and Fritillaria cirrhosa are two herbs that target Hashimoto's It can help improve the local pathological state and reduce the immune inflammatory response, as it can treat the problems of thyroiditis such as phlegm and blood stasis, and goiter. It can also warm the uterus and improve the unstable fetus caused by Chong and Ren deficiency and cold, and it can also stop bleeding and stabilize the fetus. It is suitable for the symptoms of vaginal bleeding that may occur in recurrent miscarriage. Tangerine peel, Amomum villosum, Magnolia officinalis, and Citrus aurantium can regulate the qi of the spleen and stomach, relieve abdominal distension, nausea and other discomforts caused by qi stagnation during pregnancy, and avoid overly nourishing tonics to ensure the smooth circulation of qi and blood. It also has an auxiliary regulating effect on the poor qi (such as depression, thyroid nodules, etc.) that may be associated with Hashimoto's thyroiditis. The whole prescription focuses on tonifying the kidney and strengthening the spleen, nourishing blood and stabilizing the fetus, while taking into account clearing away heat and resolving phlegm, regulating qi and dispersing cold. It targets the "deficiency, cold and stasis" pathogenesis of recurrent miscarriage, and improves the immune inflammation and pathological changes of Hashimoto's thyroiditis by clearing heat and resolving phlegm, regulating qi and dispersing stagnation. It embodies the treatment idea of ​​"taking into account both the symptoms and the root cause, and harmonizing the spleen and kidney", so that the kidney qi can be strengthened, the spleen qi can be strengthened, the qi and blood can be replenished, and the phlegm and stasis can be resolved, thereby achieving the purpose of preventing and treating the disease.

[0021] The present invention establishes a CBA / J female mouse HT model and a HT combined with RSA model, respectively, and uses indicators such as thyroid antibody and hormone levels, embryo loss rate, and tissue pathological changes to verify the effectiveness of the Chinese medicine composition for HT and / or RSA. The results show that the Chinese medicine composition can significantly reduce the concentration titer of anti-thyroglobulin antibodies (TG-Ab) and anti-thyroid peroxidase antibodies (TPO-Ab) in the serum of CBA / J female mice with HT model, significantly increase the levels of tetraiodothyronine (T4) and free tetraiodothyronine (FT4) in the serum and maintain the stability of related physiological indicators, and reduce thyroid tissue inflammatory cell infiltration. In addition, the Chinese medicine composition can significantly reduce the concentration titer of TG-Ab, TPO-Ab, and TSH in the serum of CBA / J female mice with HT combined with RSA model, significantly increase the levels of FT4 and T4, maintain the stability of related physiological parameters, significantly reduce the embryo loss rate of CBA / J female mice, and improve the thyroid and embryonic tissue inflammatory cell infiltration. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 This is the result diagram of the effect of Qianjin Baoyun Pills on thyroid pathological damage in HT mice;

[0023] Figure 2 This is the result of Qianjin Baoyun Pills' effect on thyroid pathological damage in HT mice combined with RSA;

[0024] Figure 3 This is the result of Qianjin Baoyun Pills' effect on placental pathological damage in mice with HT and RSA. DETAILED DESCRIPTION

[0025] To facilitate understanding of the present invention, the present invention will be described more fully below with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the accompanying drawings. However, the present invention may be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a more thorough and comprehensive understanding of the present disclosure.

[0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. The terms used herein in the specification of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0027] Unless otherwise specified, the reagents, materials, and equipment used in this example are all commercially available; and the experimental methods, unless otherwise specified, are all conventional experimental methods in the art.

[0028] Example

[0029] A traditional Chinese medicine composition for Hashimoto's thyroiditis and / or recurrent miscarriage and a preparation method thereof.

[0030] In this embodiment, the Chinese medicine composition is Qianjin Baoyun Pills, and the specific preparation method is as follows:

[0031] Eighteen Chinese medicinal herbs, including 100g of Eucommia ulmoides, 100g of Cuscuta australis, 50g of Dipsacus asper, 25g of Artemisia argyi (charcoal), 100g of Atractylodes macrocephala (fried and charred), 25g of Astragalus membranaceus (processed), 15g of Licorice (processed), 50g of Scutellaria baicalensis, 15g of Fritillaria cirrhosa, 70g of Rehmannia glutinosa, 50g of Angelica sinensis, 25g of Ligusticum chuanxiong, 25g of donkey-hide gelatin, 20g of White Peony Root (wine), 25g of Tangerine Peel, 15g of Amomum villosum, 50g of Magnolia officinalis, and 15g of Citrus aurantium, are ground into fine powder. 110-130g of refined honey is added to every 100g of powder to make large honey pills.

[0032] Experimental example

[0033] 1. Verify the effectiveness of the Chinese medicine composition in the example on the Hashimoto's thyroiditis model.

[0034] 1. Modeling.

[0035] The model control group and the Qianjin Baoyun Pills group were fed 0.64g / L sodium iodide-rich water. Porcine thyroglobulin (PTg) and complete Freund's adjuvant (CFA) were mixed and emulsified in equal volumes. 100μg of PTg and CFA were injected subcutaneously at multiple points on the feet and back of the mice once weekly for two weeks. For booster immunizations, PTg and incomplete Freund's adjuvant (IFA) were mixed and emulsified in equal volumes. 100μg of PTg and IFA were injected subcutaneously at multiple points on the mice once weekly for three weeks.

[0036] 2. Grouping and medication.

[0037] Modeling animals were randomly divided into two balanced groups based on body weight: a model control group and a Qianjin Baoyun Pills group, with eight animals in each group. Animals were continuously gavaged for two weeks at a rate of 0.1 mL / 10 g body weight. Drug preparation: The required dose of the test substance was administered using normal saline according to the concentration of the test substance in each group.

[0038]

[0039] 3. Observation indicators.

[0040] 3.1 Thyroid antibody and hormone level testing.

[0041] After the final dose, all animals were fasted for 12 hours, and then 1 mL of blood was collected from the eyeballs of mice into EP tubes. After standing, the serum was separated and stored in a refrigerator at 4°C. Serum levels of thyroid-stimulating hormone (TSH), thyroid antibodies, anti-thyroglobulin antibodies (TG-Ab), anti-thyroid peroxidase antibodies (TPO-Ab), tetraiodothyronine (T4), and free tetraiodothyronine (FT4) were measured using enzyme-linked immunosorbent assay (ELISA). The assay procedures were performed according to the kit instructions.

[0042] 3.2 Anatomy and histopathological examination.

[0043] After euthanasia, the thyroid gland was removed for examination and fixed in 4% paraformaldehyde tissue fixative. After routine sampling, dehydration, paraffin embedding, and HE staining, the sections were mounted and histopathological examination was performed under a light microscope.

[0044] 4. Statistical analysis methods.

[0045] One-way ANOVA was performed using statistical analysis software, and the results were expressed as mean ± standard deviation.

[0046] 5. Results.

[0047] 5.1 Thyroid antibody and hormone level testing.

[0048] Table 1 Effects of Qianjin Baoyun Pills on TG-Ab, TPO-Ab and TSH in HT mice

[0049]

[0050]

[0051] Note: Compared with the control group, “#” indicates P < 0.05, “##” indicates P < 0.01; compared with the model control group, “**” indicates P < 0.01, “***” indicates P < 0.001.

[0052] Table 2 Effects of Qianjin Baoyun Pills on FT4 and T4 in HT mice

[0053]

[0054] Note: Compared with the control group, “#” indicates P < 0.05; compared with the model control group, “*” indicates P < 0.05, and “**” indicates P < 0.01.

[0055] Compared with the model control group, 1.27g / kg Qianjin Baoyun Pills significantly reduced the concentrations of TG-Ab and TPO-Ab antibodies (P<0.01, P<0.001), significantly increased the levels of FT4 and T4 hormones (P<0.05, P<0.01) and maintained the indicators within the normal physiological range.

[0056] 5.2 Histopathological examination

[0057] Pathological HE sections of thyroid tissues in each group, see Figure 1 .

[0058] In the blank control group, follicles of different sizes and shapes were observed in the thyroid gland of CBA / J female mice. The follicles were filled with transparent colloid and no obvious inflammatory cell infiltration was observed. Compared with the blank control group, the follicular cells in the thyroid tissue of the mice in the model group were destroyed, the production of colloid in the follicles was reduced, and a large number of inflammatory cells infiltrated around them. Compared with the model group, the degree of follicular cell destruction in the thyroid tissue of the Qianjin Baoyun Pills group was reduced, and the inflammatory cell infiltration was relatively improved.

[0059] 2. Effectiveness of Qianjin Baoyun Pills in Hashimoto's thyroiditis combined with recurrent miscarriage

[0060] 1. Modeling.

[0061] The model control group and the Qianjin Baoyun Pills group were fed 0.64g / L sodium iodide-rich water. Porcine thyroglobulin (PTg) and complete Freund's adjuvant (CFA) were mixed and emulsified in equal volumes. 100μg of PTg and CFA were injected subcutaneously at multiple points on the feet and back of the mice once weekly for two weeks. For booster immunizations, PTg and incomplete Freund's adjuvant (IFA) were mixed and emulsified in equal volumes. 100μg of PTg and IFA were injected subcutaneously at multiple points on the mice once weekly for three weeks.

[0062] After two weeks of continuous gavage administration as described in "2. Grouping and Dosing" below, estrus CBA / J female mice were co-housed with BALB / C male mice in a 2:1 ratio between 7:30 PM and 8:00 PM the following evening to establish a normal pregnancy model. CBA / J female mice were co-housed with DBA / 2 male mice in a 2:1 ratio to establish a recurrent miscarriage model. Between 7:00 AM and 7:30 AM the following day, the mice were gently lifted by the tail and their vaginal openings were opened with forceps. The presence of a vaginal plug was considered a successful mating. The mice were removed and housed in separate cages. Embryos were sampled 14 days after development. Because the animal model of this experiment simulates the clinical "Hashimoto's thyroiditis combined with recurrent miscarriage" mother, and the drug is administered before mating but not during pregnancy, so as to prevent "recurrent miscarriage" after mating, and finally observe the live birth rate or miscarriage rate, therefore, the effect of this experiment can be used to observe whether the Chinese medicine composition has a preventive effect on Hashimoto's thyroiditis combined with recurrent miscarriage, and to increase the live birth rate or reduce the miscarriage rate.

[0063] 2. Grouping and medication.

[0064] Modeling animals were randomly divided into five balanced groups based on body weight: a model control group, a levothyroxine sodium tablet (L-T4) group, and low-, medium-, and high-dose Qianjin Baoyun pill groups, with 20 animals in each group. Animals were gavaged with 0.1 mL / 10 g body weight for two consecutive weeks after the successful establishment of the HT model. Drug preparation: The required dose of the test substance was administered using normal saline according to the concentration of the test substance in each group.

[0065]

[0066] 3. Observation indicators.

[0067] 3.1 Thyroid antibody and hormone level testing.

[0068] Same as Experimental Example 3, "3.1 Thyroid antibody and hormone level detection" under Observation Indicators.

[0069] 3.2 Embryo loss rate.

[0070] After the animals were euthanized, the uterus and embryos were removed, and the number of absorbed embryos and the number of surviving embryos were recorded, and the embryo loss rate was calculated.

[0071] 3.3 Anatomy and histopathological examination.

[0072] The thyroid gland and placenta were taken for examination and fixed in 4% paraformaldehyde tissue fixative. After routine sampling, dehydration, paraffin embedding, and HE staining and sealing, the tissue pathological examination was performed under light microscope.

[0073] 4. Statistical analysis methods.

[0074] One-way ANOVA was performed using statistical analysis software, and the correlation test of binary variables was performed using Fisher's exact test. The test results were expressed as mean ± standard deviation.

[0075] 5. Results.

[0076] 5.1 Thyroid antibody and hormone level testing.

[0077] Table 3 Effects of Qianjin Baoyun Pills on TG-Ab, TPO-Ab and TSH in HT mice combined with RSA

[0078]

[0079] Note: Compared with the control group, “###” indicates P < 0.001; compared with the model control group, “*” indicates P < 0.05, “**” indicates P < 0.01, and “***” indicates P < 0.001.

[0080] Table 4 Effects of Qianjin Baoyun Pills on FT4 in HT and RSA mice

[0081]

[0082] Note: Compared with the control group, “##” indicates P < 0.01; compared with the model control group, “*” indicates P < 0.05, and “***” indicates P < 0.001.

[0083] Table 5 Effects of Qianjin Baoyun Pills on T4 in HT and RSA mice

[0084]

[0085] Note: Compared with the control group, “##” indicates P < 0.01; compared with the model control group, “*” indicates P < 0.05, and “***” indicates P < 0.001.

[0086] Compared with the model group, the concentration titers of TG-Ab and TPO-Ab in each Qianjin Baoyun Pills group were significantly reduced (P<0.001), and the levels of FT4 and T4 were significantly increased (P<0.05, P<0.001), maintaining the stability of physiological indicators.

[0087] 5.2 Embryo loss rate.

[0088] Table 6 Comparison of pregnancy rate and embryo loss rate of Qianjin Baoyun Pills in HT combined with RSA mice

[0089]

[0090] Note: Compared with the control group, “#” indicates P < 0.05, “##” indicates P < 0.01; compared with the model control group, “*” indicates P < 0.05, “**” indicates P < 0.01.

[0091] Compared with the model group, the embryo loss rate in each Qianjin Baoyun Pill-administered group was significantly reduced (P<0.01, P<0.05). Furthermore, compared with the blank control group, the pregnancy rate and total number of embryos in CBA / J female mice in the Qianjin Baoyun Pill-administered groups increased, with the pregnancy rate significantly increased in the low- and high-dose Qianjin Baoyun Pill-administered groups (P<0.05). In this experiment, the embryo loss rate corresponds to the clinical miscarriage rate, which in turn corresponds to the live birth rate, and is the key indicator of interest. The data in the table above show that while the embryo loss rate increased with increasing Qianjin Baoyun Pill doses, it remained significantly different from the model control group. This indicates that the embryo loss rate was significantly reduced compared to the untreated group, indicating that Qianjin Baoyun Pill (low, medium, and high doses) has a beneficial preventive and therapeutic effect on Hashimoto's thyroiditis complicated by recurrent miscarriage. Combined with the embryo loss rate results, the data in the table above indicate that even a low dose of Qianjin Baoyun Pill can effectively prevent and treat Hashimoto's thyroiditis complicated by recurrent miscarriage.

[0092] 5.3 Histopathological examination

[0093] Pathological HE sections of thyroid and placenta tissues in each group, see Figure 2 、 3 .

[0094] The thyroid structure of CBA / J mice in the blank control group was intact, with normal follicular morphology, the alveolar cavity filled with transparent colloid stained light red, and no inflammatory cell infiltration. Compared with the blank control group, the thyroid follicular cells of CBA / J female mice in the model group were destroyed and arranged in a disorderly manner, the production of colloid in the alveolar cavity was reduced, and a large number of inflammatory cells infiltrated around them. Compared with the model group, the Qianjin Baoyun Pills treatment groups were able to reduce the infiltration of thyroid inflammatory cells, and the above-mentioned pathological morphological changes were improved to varying degrees.

[0095] In the blank control group, placental tissue cells were neatly arranged, with abundant, oval glands, loose and thick interstitial tissue, and numerous blood vessels. Compared with the blank control group, the model group showed significantly more congested and dilated placental tissue, with severely shrunken cells, a significantly reduced and irregular glandular structure, thin interstitial tissue, fewer and irregularly shaped blood vessels, and abundant inflammatory cell infiltration. Compared with the model group, all Qianjin Baoyun Pill-treated groups reduced placental tissue congestion, dilation, and cellular infiltration.

[0096] Qianjin Baoyun Pills significantly reduced serum TG-Ab and TPO-Ab titers in CBA / J female mice with HT, significantly increased serum FT4 and T4 levels, and maintained the stability of related physiological indicators, reducing inflammatory cell infiltration in thyroid tissue, indicating that Qianjin Baoyun Pills have a significant therapeutic effect on Hashimoto's thyroiditis. Furthermore, Qianjin Baoyun Pills not only significantly reduced serum TG-Ab, TPO-Ab, and TSH titers in CBA / J female mice with HT combined with RSA, significantly increased FT4 and T4 levels, and maintained the stability of related physiological parameters, but also increased pregnancy rates and reduced embryo loss rates, and improved inflammatory cell infiltration in thyroid and embryonic tissues, indicating that Qianjin Baoyun Pills have a good preventive and therapeutic effect on Hashimoto's thyroiditis combined with recurrent miscarriage.

[0097] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0098] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. Use of a Chinese medicine composition in the preparation of a medicament for Hashimoto's thyroiditis and / or recurrent spontaneous abortion, characterized in that: The effective ingredients of the Chinese medicine composition are mainly prepared from the following raw materials in parts by weight:

2. The use according to claim 1, characterized in that The indications of the drug include: Hashimoto's thyroiditis, Hashimoto's thyroiditis combined with recurrent miscarriage; the effective ingredients of the traditional Chinese medicine composition are mainly prepared from the following raw materials in parts by weight:

3. The use according to any one of claims 1-2, characterized in that When the drug is a drug for treating Hashimoto's thyroiditis, the application includes: the drug reduces the concentration titer of anti-thyroglobulin antibodies and anti-thyroid peroxidase antibodies, increases the levels of iodine-containing thyroxine and free iodine-containing thyroxine, and thus reduces the infiltration of inflammatory cells in thyroid tissue.

4. The use according to any one of claims 1-2, characterized in that The drug is a drug for preventing and / or treating Hashimoto's thyroiditis combined with recurrent miscarriage, and the application includes: reducing the miscarriage rate of patients with Hashimoto's thyroiditis combined with recurrent miscarriage and / or increasing the pregnancy rate of patients with Hashimoto's thyroiditis combined with recurrent miscarriage.

5. The use according to claim 4, characterized in that The drug is a drug for preventing and / or treating Hashimoto's thyroiditis complicated with recurrent miscarriage, and the application includes: the drug reduces the miscarriage rate of patients with Hashimoto's thyroiditis complicated with recurrent miscarriage and / or increases the pregnancy rate of patients with Hashimoto's thyroiditis complicated with recurrent miscarriage by reducing the concentration titers of TG-Ab, TPO-Ab, and TSH and increasing the levels of FT4 and T4.

6. A method for preparing the Chinese medicine composition for use according to any one of claims 1 to 5, characterized in that: The following steps are involved: The raw materials are crushed into fine powder and mixed to obtain a traditional Chinese medicine composition.

7. A medicine for Hashimoto's thyroiditis and / or recurrent miscarriage, characterized in that: The medicine comprises a pharmaceutically active ingredient and pharmaceutically acceptable excipients, wherein the pharmaceutically active ingredient is the traditional Chinese medicine composition used in any one of claims 1 to 5.

8. The drug according to claim 7, characterized in that The indications of the drug include: Hashimoto's thyroiditis, Hashimoto's thyroiditis combined with recurrent miscarriage.

9. The drug according to any one of claims 7-8, characterized in that The dosage form of the medicine is oral liquid, pill, granule, capsule, tablet, dripping pill, injection or powder.

10. The drug according to any one of claims 7 to 8, characterized in that The excipients include at least one of a solvent, a disintegrant, a flavoring agent, a colorant, a lubricant, an antioxidant, a preservative, a binder, a filler or a thickener.

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