Application of Yupingfeng pharmaceutical preparation in preparation of medicine for preventing and treating hashimoto thyroiditis

Abstract

The invention relates to the technical field of biological medicine, in particular to application of a Yupingfeng pharmaceutical preparation in preparation of a medicine for preventing and treating hashimoto thyroiditis. The Yupingfeng pharmaceutical preparation provided by the invention has a good prevention and treatment effect on hashimoto thyroiditis, can be used for the whole course of hashimoto thyroiditis, including hashimoto thyroiditis in a transient hyperthyroidism stage, clinical and subclinical hypothyroidism stage and the like, and can play a role in improvement from two aspects of prevention and treatment; the pharmaceutical composition is used for preventing generation of hashimoto thyroiditis and / or treating related diseases of hashimoto thyroiditis in progress.

Description

Technical Field

[0001] The present application relates to the field of biomedicine technology, and specifically to an application of a Yupingfeng pharmaceutical preparation in the preparation of a drug for preventing and treating Hashimoto's thyroiditis. The raw materials for the preparation of the Yupingfeng pharmaceutical preparation include Atractylodes macrocephala, Astragalus membranaceus and Saposhnikovia divaricata. Background Art

[0002] Hashimoto's thyroiditis (HT) is a chronic autoimmune disease with its own thyroid tissue as an antigen. The main clinical identification features are thyroid enlargement and positive test results for thyroglobulin antibody (TGAb) and thyroid peroxidase antibody (TPOAb). The clinical manifestations of Hashimoto's thyroiditis are not obvious in the early stage. It is generally painless thyroid enlargement. Thyroid antibodies are found in the examination, but the thyroid function is normal. As the disease progresses, the thyroid follicular cells are gradually destroyed, and patients develop subclinical hypothyroidism, hyperthyroidism, and clinical hypothyroidism.

[0003] Hashimoto's thyroiditis is an autoimmune thyroid disease. Its pathological changes are mainly lymphocyte infiltration of thyroid tissue, which results in the destruction of thyroid tissue and often leads to hypothyroidism. However, when chronic lymphocytic thyroiditis develops to a certain stage, the thyroid follicles are destroyed due to immune factors and other factors. The thyroid hormone stored in the follicles is released into the blood, which increases the concentration of thyroid hormone in the blood circulation and causes hyperthyroidism symptoms. When the thyroid hormone released into the blood is metabolized (consumed), the symptoms of hyperthyroidism disappear. Hyperthyroidism symptoms can last for many years, and those with a long course of illness often develop into myxedema. Surgery and radioactive iodine treatment are not suitable for treatment, otherwise permanent hypothyroidism is likely to occur.

[0004] As the number of patients with Hashimoto's thyroiditis increases year by year, how to effectively control the progression of the disease and help patients restore normal thyroid function has become a hot topic in current research.

[0005] At present, clinical guidelines at home and abroad recommend thyroid hormone replacement therapy (levothyroxine tablets L-T4) for subclinical hypothyroidism and hypothyroidism in Hashimoto's thyroiditis. The purpose is to relieve the hypometabolic symptoms of hypothyroidism and restore the patient's serum thyroid hormone and TSH to normal. Currently, LT4 has gradually become the standardized treatment method and preferred preparation for thyroid hormone replacement therapy. Other related reports also use glucocorticoid treatment (dexamethasone), selenium treatment, statin treatment (pravastatin), etc. These drugs can improve the patient's clinical symptoms to a certain extent, but the treatment dose of the treatment plan is not easy to master and can easily cause permanent hypothyroidism. In addition, Western medicine intervention is difficult to achieve significant therapeutic effects for most patients with no clinical symptoms and normal thyroid function and patients with subclinical hypothyroidism. The condition of such patients will continue to progress, and eventually the condition will be difficult to control. Summary of the invention

[0006] To solve the above problems, this application introduces the concept of "treating illness before it occurs" in traditional Chinese medicine. "Pre-illness" can be broadly summarized as treatment during the peri-disease period. In a narrow sense, treating illness before it occurs refers to various uncomfortable symptoms caused by the imbalance of qi, blood, yin and yang due to the lack of postnatal conditioning. This group of people has no abnormalities or mild abnormalities in the physical and chemical examinations of Western medicine, and is in the gray area between health and disease - sub-health. "Pre-illness treatment" is a method of taking preventive or therapeutic measures to prevent the occurrence and development of diseases. It includes multiple aspects such as prevention before illness, prevention of changes after illness, and prevention of gradual changes after changes. For some chronic diseases with long courses, low controllability, and large individual development differences, early intervention is of great significance.

[0007] So far, there are literature reports on the effects of Yupingfeng related preparations and modified prescriptions or other drugs added to Hashimoto's thyroiditis. Wang Xue et al. (Wang Xue. Clinical intervention study of Yupingfeng granules on Hashimoto's thyroiditis antibodies (TgAb, TPOAb) [D]. Shandong University of Traditional Chinese Medicine, 2015.) Yupingfeng granules were given to patients with Hashimoto's thyroiditis in the hypothyroid stage on the basis of L-T4. Lu Donglei et al. (Lu Donglei. Clinical observation of Yupingfeng powder modified prescription in the treatment of Hashimoto's thyroiditis [D]. Anhui University of Traditional Chinese Medicine, 2021.) Yupingfeng powder modified prescription granules were given to patients with Hashimoto's thyroiditis in the hypothyroid stage on the basis of L-T4. Wang Juan et al. (Wang Juan, Du Jihui, Chu Weijiang. Clinical observation of Yupingfeng granules combined with Xiaoyao pills in the treatment of Hashimoto's thyroiditis [J]. Health Care Guide, 2018(5):357.) Yupingfeng granules and Xiaoyao pills were given to patients with hypothyroidism (TSH values ​​exceeded the normal range, FT3 and FT4 values ​​were below the normal range) with Hashimoto's thyroiditis on the basis of selenium yeast capsules. The Yupingfeng preparations (granules, powders or loaded with other drugs) studied in the above literature are all for people in the hypothyroid stage of Hashimoto's thyroiditis, or in a state where thyroid hormone levels have returned to normal after taking LT4. There is a lack of evidence that Yupingfeng preparations (such as granules, powders, etc.) are effective for the hypothyroid stage of Hashimoto's thyroiditis; since Hashimoto's thyroiditis has different stages (subclinical hypothyroidism, hyperthyroidism, clinical hypothyroidism), there is also a lack of evidence that Yupingfeng preparations alone are effective for the subclinical hypothyroidism and transient hyperthyroidism of Hashimoto's thyroiditis.

[0008] The technical solution of this application includes the following contents:

[0009] The invention discloses an application of a Yupingfeng medicine preparation in preparing medicine for preventing and treating Hashimoto's thyroiditis. The raw materials for preparing the Yupingfeng medicine preparation include Atractylodes macrocephala, Astragalus membranaceus and Saposhnikovia divaricata.

[0010] Furthermore, the Hashimoto's thyroiditis includes Hashimoto's thyroiditis in the subclinical hypothyroidism stage, hyperthyroidism stage and hypothyroidism stage.

[0011] Furthermore, the Hashimoto's thyroiditis is Hashimoto's thyroiditis in the subclinical hypothyroidism stage or the hyperthyroidism stage.

[0012] Furthermore, the Hashimoto's thyroiditis is Hashimoto's thyroiditis in the hyperthyroidism stage.

[0013] Further, the raw materials for preparing the Yupingfeng pharmaceutical preparation include 300-350 parts of Atractylodes macrocephala, 900-1100 parts of Astragalus membranaceus and 300-350 parts of Saposhnikovia divaricata in parts by weight; and / or,

[0014] The raw materials for preparing the Yupingfeng pharmaceutical preparation also include pharmaceutically acceptable carriers and / or excipients.

[0015] Furthermore, the preparation method of the Yupingfeng pharmaceutical preparation comprises the following steps:

[0016] Grinding the Atractylodes macrocephala to obtain a first powder;

[0017] Adding water to the mixture of the Radix Astragali and the Radix Saposhnikoviae to boil and prepare a water decoction;

[0018] The decoction is concentrated to obtain a thick paste;

[0019] The thick paste and the first powder are mixed and dried to obtain a second powder;

[0020] The second powder and a pharmaceutically acceptable carrier and / or auxiliary material are prepared to obtain the Yupingfeng pharmaceutical preparation.

[0021] Further, the step of adding water to the mixture of Astragalus and Saposhnikovia divaricata for decoction to obtain a decoction comprises:

[0022] The astragalus, the fangfeng and water are mixed, boiled at 110° C. to 130° C., and filtered to obtain the water decoction;

[0023] Wherein, the ratio of the sum of the weight of the astragalus and the siler to the weight of the water is (9-11):1;

[0024] The decoction is performed 1 to 2 times, each time for 0.5 to 2.5 hours.

[0025] Furthermore, the Yupingfeng pharmaceutical preparation is an oral preparation.

[0026] Furthermore, the Yupingfeng pharmaceutical preparation is a tea bag preparation.

[0027] Furthermore, the medicine for preventing and treating Hashimoto's thyroiditis contains a therapeutically effective amount of Yupingfeng pharmaceutical preparation.

[0028] The Yupingfeng pharmaceutical preparation of the embodiment of the present application can be used in the preparation of drugs for preventing and treating Hashimoto's thyroiditis, and can be used in different stages of Hashimoto's thyroiditis, including subclinical hypothyroidism, hyperthyroidism, hypothyroidism, etc., and can play an improvement role in both prevention and treatment, and can be used to prevent the development of Hashimoto's thyroiditis. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the specific implementation methods of the present application or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0030] Figure 1 This is the HE staining image of the thyroid tissue of each group of mice in the HT subclinical hypothyroidism experiment in the examples of this application.

[0031] Figure 2 This is the HE staining image of the thyroid tissue of each group of mice in the HT hyperthyroidism experiment in the examples of this application.

[0032] Figure 3 This is the HE staining image of the thyroid tissue of each group of mice in the HT hypothyroidism experiment in the examples of this application.

[0033] Figure 4 This is a positive ion flow diagram of the Yupingfeng tea bag soaking liquid in the embodiment of the present application.

[0034] Figure 5 This is a negative ion flow diagram of the Yupingfeng tea bag soaking liquid in the embodiment of the present application.

[0035] Figure 6 This is the positive ion flow diagram of Yupingfeng particles in the examples of this application.

[0036] Figure 7 This is the negative ion flow diagram of Yupingfeng particles in the embodiments of the present application. DETAILED DESCRIPTION

[0037] The present application will be further described below in conjunction with the embodiments and examples. It should be understood that these examples are only used to illustrate the present application and are not intended to limit the scope of the present application. In addition, it should be understood that after reading the content taught in the present application, those skilled in the art may make various changes or modifications to the present application, and these equivalent forms also fall within the protection scope of the claims attached to the present application.

[0038] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0039] the term

[0040] Unless otherwise specified or incompatible herewith, the terms and phrases used herein shall have the following meanings:

[0041] The terms "and / or", "or / and", and "and / or" used in this article include any one of two or more related listed items, and also include any and all combinations of related listed items, and the arbitrary and all combinations include any two related listed items, any more related listed items, or a combination of all related listed items. It should be noted that when at least three items are connected by at least two conjunctions selected from "and / or", "or / and", and "and / or", it should be understood that in this application, the technical solution undoubtedly includes technical solutions that are all connected by "logical and", and undoubtedly includes technical solutions that are all connected by "logical or". For example, "A and / or B" includes three parallel solutions of A, B and A+B. For example, the technical solution of "A, and / or, B, and / or, C, and / or, D" includes any one of A, B, C, and D (that is, the technical solution that is all connected by "logical OR"), and also includes any and all combinations of A, B, C, and D, that is, the combination of any two or any three of A, B, C, and D, and also includes the combination of four of A, B, C, and D (that is, the technical solution that is all connected by "logical AND").

[0042] Herein, "preferred", "preferable", "better", etc. are only used to describe implementation methods or examples with better effects. It should be understood that they do not constitute limitations on the scope of protection of this application.

[0043] In the present application, "further", "further", "particularly" and the like are used for descriptive purposes to indicate differences in content, but should not be construed as limiting the scope of protection of the present application.

[0044] In the present application, the technical features described in an open manner include closed technical solutions composed of the listed features, and also include open technical solutions containing the listed features.

[0045] In this application, when it comes to numerical intervals (i.e., numerical ranges), unless otherwise specified, the optional numerical distribution is considered continuous within the above numerical interval, and includes the two numerical endpoints (i.e., the minimum and maximum values) of the numerical range, and each numerical value between the two numerical endpoints. Unless otherwise specified, when the numerical interval only refers to integers within the numerical interval, it includes the two endpoint integers of the numerical range, and each integer between the two endpoints. In addition, when multiple ranges are provided to describe features or characteristics, these ranges can be combined. In other words, unless otherwise specified, the ranges disclosed herein should be understood to include any and all subranges included therein.

[0046] In the present application, weight may be μg, mg, g, kg, or other mass units known in the medical field.

[0047] In this application, "prevention and treatment" includes concepts such as prevention, treatment, and auxiliary treatment.

[0048] In the present application, a "composition" may be a combination of multiple substances, and further, may be used in combination, or may be a mixture of the combination.

[0049] In the present application, "effective amount" refers to the dosage of the component corresponding to the term to achieve the treatment, prevention, alleviation and / or relief of a specific disease, disease and / or symptom in a subject. In the present invention, unless otherwise specified, it refers to the dosage for achieving the treatment and prevention of Hashimoto's thyroiditis.

[0050] In the present application, "subject" is an animal, preferably a mammal, more preferably a human, and the subject includes but is not limited to a food consumer, a health product user, and a patient with a disease, illness, and / or symptom. The subject in the present invention is preferably a mammal. The term "mammal" mainly refers to warm-blooded vertebrate mammals, including but not limited to: such as cats, dogs, rabbits, bears, foxes, wolves, monkeys, deer, mice (such as rats, mice), pigs, cattle, sheep, horses, humans, etc., preferably primates, more preferably humans. Taking the subject of a Chinese medicine composition as an example, it refers to an animal that receives a Chinese medicine composition to treat, prevent, alleviate and / or relieve a disease, illness, or symptom.

[0051] In the present application, "patient" refers to an animal, preferably a mammal, more preferably a human. The term "mammal" mainly refers to warm-blooded vertebrate mammals, including but not limited to: cats, dogs, rabbits, bears, foxes, wolves, monkeys, deer, mice, pigs, cattle, sheep, horses, humans, etc., preferably primates, more preferably humans.

[0052] In the present application, "pharmaceutical composition" refers to a composition that has a pharmaceutical preventive and / or therapeutic effect and can be used in medicine.

[0053] In this application, "drug" includes any agent, compound, composition or mixture that provides physiological and / or pharmacological effects in vivo or in vitro, and often provides beneficial effects. The scope of the physiological and / or pharmacological effects produced by the "drug" in vivo is not particularly limited, and it can be a systemic effect or only a local effect. The activity of the "drug" is not particularly limited, and it can be an active substance that can interact with other substances, or it can be an inert substance that does not interact.

[0054] In the present application, "therapeutically effective amount" refers to the amount of active pharmaceutical ingredient that will cause a biological or medical response in an individual to a disease, disorder and / or symptom, for example, the amount of the compound of the present invention that brings a physiological and / or pharmacologically positive effect to an individual, wherein the physiological and / or pharmacologically positive effect includes but is not limited to reducing or inhibiting enzyme or protein activity or improving symptoms, alleviating symptoms, slowing or delaying disease progression or preventing disease, etc.

[0055] As used herein, "pharmaceutically acceptable" refers to those ligands, materials, compositions and / or dosage forms that are suitable for administration to a patient within the scope of sound medical judgment and commensurate with a reasonable benefit / risk ratio.

[0056] In this application, "pharmaceutically acceptable carrier" refers to a pharmaceutically acceptable material, composition or vehicle, such as a liquid or solid filler, diluent, excipient, solvent or encapsulating material. As used herein, the language "pharmaceutically acceptable carrier" includes buffers, sterile water for injection, solvents, dispersion media, coatings, antibacterial and antifungal agents, isotonic and absorption delaying agents, and the like that are compatible with drug administration. Each carrier must be "pharmaceutically acceptable" in the sense of being compatible with the other ingredients in the formulation and not harmful to the patient. Suitable examples include, but are not limited to: (1) sugars such as lactose, glucose and sucrose; (2) starches such as corn starch, potato starch and substituted or unsubstituted β-cyclodextrins; (3) cellulose and its derivatives such as sodium carboxymethylcellulose, ethylcellulose and cellulose acetate; (4) powdered tragacanth; (5) malt; (6) gelatin; (7) talc; (8) excipients such as cocoa butter and suppository waxes; (9) oils such as peanut oil, cottonseed oil, safflower oil, sesame oil, olive oil, corn starch, etc. Rice oil and soybean oil; (10) glycols, such as propylene glycol; (11) polyols, such as glycerol, sorbitol, mannitol and polyethylene glycol; (12) esters, such as ethyl oleate and ethyl laurate; (13) agar; (14) buffers, such as magnesium hydroxide and aluminum hydroxide; (15) alginic acid; (16) pyrogen-free water; (17) isotonic saline; (18) Ringer's solution; (19) ethanol; (20) phosphate buffered saline; and (21) other non-toxic compatible substances used in pharmaceutical formulations.

[0057] In a first aspect of the present application, a Yupingfeng pharmaceutical preparation is provided for use in the preparation of a drug for preventing and treating Hashimoto's thyroiditis. The raw materials for the preparation of the Yupingfeng pharmaceutical preparation include Atractylodes macrocephala, Astragalus membranaceus and Saposhnikovia divaricata.

[0058] Hashimoto's thyroiditis belongs to the category of modern medicine. There is no corresponding record in traditional medicine. According to its clinical manifestations, it can be classified into the categories of "goiter" and "consumption". Clinically confirmed, Hashimoto's thyroiditis is treated from the perspective of qi deficiency, and the therapeutic effect is achieved by regulating the functions of various internal organs, balancing the yin and yang in the body, and restoring the body's own immune function. The treatment effect is satisfactory by using the methods of invigorating qi, strengthening the spleen, and removing "wind" evil.

[0059] This application has studied a large number of ancient Chinese medicine prescriptions and found that the traditional prescription "Yupingfeng" is very likely to have a good therapeutic effect on patients with Hashimoto's thyroiditis. The prescription contains Astragalus and Atractylodes, which are the monarch and minister, to make the Qi strong and the exterior strong, solve the problem of "Qi deficiency", and improve the state of low immune function. Saposhnikovia is a "moisturizing agent among wind medicines", an important medicine for treating wind, and is good at removing internal and external wind to solve the problem of "hidden evil" and inhibit immune hyperactivity. The whole prescription strengthens the exterior and eliminates evil in a moderate way, and has a bidirectional immune regulatory effect, thus producing excellent preventive and therapeutic effects. Later experiments also verified its efficacy.

[0060] In some embodiments, the raw materials for preparing the Yupingfeng pharmaceutical preparation include 300-350 parts of Atractylodes macrocephala, 900-1100 parts of Astragalus membranaceus and 300-350 parts of Saposhnikovia divaricata.

[0061] In some embodiments, the weight ratio of Atractylodes macrocephala, Astragalus membranaceus and Saposhnikovia divaricata is 1:3:1.

[0062] In some embodiments, the raw materials for preparing the Yupingfeng pharmaceutical preparation further include pharmaceutically acceptable carriers and / or excipients.

[0063] In some embodiments, the Yupingfeng pharmaceutical preparation is the sole active ingredient for preparing a drug for preventing and treating Hashimoto's thyroiditis.

[0064] The Yupingfeng drug preparation of the present application has the effects of invigorating qi, strengthening the exterior, and stopping sweating. Due to the unique process, it inherits the "essence" of the original powder, retains the polysaccharide components of the whole formula, and gives full play to the immunomodulatory effect of "strengthening the body and eliminating evil". Compared with oral liquid, granules and capsules, it greatly retains the polysaccharide that regulates the immune function ( Figure 1 ), which can effectively regulate immune function.

[0065] In some embodiments, the Yupingfeng pharmaceutical preparation is an oral preparation.

[0066] In some embodiments, the dosage form of the Yupingfeng pharmaceutical preparation includes a solid preparation and a liquid preparation.

[0067] In some embodiments, the dosage form of the Yupingfeng pharmaceutical preparation is selected from any of the following groups or a suitable combination thereof:

[0068] (1) Tablets, capsules, granules, powders, granules, pills, pills, ointments, creams, suspensions or solutions;

[0069] (2) Oral solution, lozenge, injection, suppository, spray, drops or patch.

[0070] In some embodiments, the Yupingfeng pharmaceutical preparation is a granule, a powder or a granule.

[0071] In some embodiments, the Yupingfeng pharmaceutical preparation is a suspension or a solution.

[0072] In some embodiments, the Yupingfeng pharmaceutical preparation is a tea bag.

[0073] In this embodiment, the Yupingfeng pharmaceutical preparation can be taken by brewing, and the method of taking is unique and convenient, the dosage is accurate, and the taste is better.

[0074] In some embodiments, the Yupingfeng pharmaceutical preparation comprises: (a) aqueous extracts of Astragalus and Saposhnikovia; (b) powder of Atractylodes macrocephala; and (3) pharmaceutically acceptable carriers and / or excipients.

[0075] In some embodiments, the preparation method of the Yupingfeng pharmaceutical preparation comprises the following steps:

[0076] Grinding the Atractylodes macrocephala to obtain a first powder;

[0077] Adding water to the mixture of the Radix Astragali and the Radix Saposhnikoviae to boil and prepare a water decoction;

[0078] The decoction is concentrated to obtain a thick paste;

[0079] The thick paste and the first powder are mixed and dried to obtain a second powder;

[0080] The second powder and a pharmaceutically acceptable carrier and / or auxiliary material are prepared to obtain the Yupingfeng pharmaceutical preparation.

[0081] In some embodiments, the step of adding water to the mixture of Radix Astragali and Radix Saposhnikoviae to boil the mixture to obtain a decoction comprises:

[0082] The astragalus, the fangfeng and water are mixed, boiled at 110° C. to 130° C., and filtered to obtain the water decoction;

[0083] Wherein, the ratio of the sum of the weight of the astragalus and the siler to the weight of the water is (9-11):1;

[0084] The decoction is performed 1 to 2 times, each time for 0.5 to 2.5 hours.

[0085] In some embodiments, in the Yupingfeng pharmaceutical preparation, the mass percentage of the second powder is 85% to 90%, and examples of the mass percentage are 85%, 86%, 87%, 88%, 89%, 90%, etc.

[0086] In some embodiments, the drug for preventing or treating Hashimoto's thyroiditis contains a therapeutically effective amount of the Yupingfeng pharmaceutical preparation.

[0087] In some embodiments, the subject of the drug for preventing or treating Hashimoto's thyroiditis is a mammal.

[0088] In some embodiments, the subject of the drug for preventing or treating Hashimoto's thyroiditis is a rat or a human.

[0089] In some embodiments, the subject of the drug for preventing or treating Hashimoto's thyroiditis is SD rat.

[0090] The present application also found that compared with other dosage forms, Yupingfeng teabags alone have excellent therapeutic effects. It has therapeutic effects not only on the hypothyroidism stage of Hashimoto's thyroiditis, but also on the subclinical hypothyroidism and hyperthyroidism stages of Hashimoto's thyroiditis. Other dosage forms only have certain effects on the late stage of the disease, and the effect is not as good as Yupingfeng teabags. Yupingfeng teabags have therapeutic effects on subclinical hypothyroidism, hyperthyroidism, and hypothyroidism in different stages of Hashimoto's thyroiditis.

[0091] In some embodiments, the preparation method of Yupingfeng pharmaceutical preparation comprises:

[0092] Grind 333g of Atractylodes macrocephala (fried) into coarse powder, add 1000g of Astragalus membranaceus and 333g of Saposhnikovia divaricata to 10 times the amount of water and boil twice, the first time for 1.5 hours and the second time for 1 hour, filter, combine the filtrate, and concentrate into a thick paste; Grind 16.7g of Stevia into coarse powder, mix it with the above-mentioned Atractylodes macrocephala coarse powder and auxiliary materials (Stevia) in appropriate amounts, add it to the above-mentioned thick paste, mix well, dry, and grind into coarse powder.

[0093] Representative routes of administration include, but are not limited to, oral administration.

[0094] Solid dosage forms for oral administration include tablets, capsules, granules, powders, granules, pills, pills, suspensions and solutions. Among these solid dosage forms, the method for making pills is to take the fine powder of the crushed medicinal materials, or the extract of the medicinal pieces, add an appropriate amount of adhesive or other excipients, and make them into spherical or quasi-spherical dosage forms. The adhesive includes water, honey, wine, vinegar, and medicinal juice, and different types of pills can be made, such as water pills, honey pills, water-honey pills, wax pills, etc.

[0095] In some embodiments, the administration frequency is 1 to 3 times / day, for example, once / day, twice / day, or three times / day.

[0096] In some embodiments, the dosage is 6 g / time to 12 g / time, for example 6 g / time, 7 g / time, 8 g / time, 10 g / time, 12 g / time, etc.

[0097] In some embodiments, the administration is oral.

[0098] In some embodiments, the administration method is intragastric administration. Intragastric administration in the present application means: dissolving the drug in a solvent, and using an intragastric instillation device to directly inject the drug solution into the stomach of the animal through the animal's mouth.

[0099] The following are some specific embodiments.

[0100] For experimental parameters not specified in the following specific embodiments, reference is made to the instructions given in the present application document, and reference may also be made to experimental manuals in the art or other experimental methods known in the art, or to experimental conditions recommended by manufacturers.

[0101] The raw materials and reagents involved in the following specific examples can be obtained from commercial sources, or can be prepared by those skilled in the art according to known methods.

[0102] In the following examples, the preparation process and standards of Yupingfeng teabags and other preparations with the same name are shown in Table 1.

[0103] Table 1 Comparison of Yupingfeng teabags with other preparations of the same name

[0104]

[0105] Preparation method of Yupingfeng tea bag: 333g of Atractylodes macrocephala (fried) is crushed into coarse powder, 1000g of Astragalus membranaceus and 333g of Saposhnikovia divaricata are decocted twice with 10 times the amount of water, the first time for 1.5 hours and the second time for 1 hour, filtered, combined the filtrate, and concentrated into a thick paste; 16.7g of Stevia is crushed into coarse powder, mixed with the above-mentioned Atractylodes macrocephala coarse powder and auxiliary materials (Stevia) in appropriate amounts, added to the above-mentioned thick paste, mixed well, dried, crushed into coarse powder, made into 1000g, and packaged, 3g / bag.

[0106] How to use Yupingfeng tea bag and when to use it: Soak in boiling water for 15 minutes and drink.

[0107] Example 1

[0108] In this example, animal models of Hashimoto's thyroiditis in subclinical hypothyroidism, hyperthyroidism, and hypothyroidism were constructed respectively, and the effectiveness of Yupingfeng tea bag on Hashimoto's thyroiditis (hypothyroidism, hyperthyroidism, and hypothyroidism) was evaluated using indicators such as thyroid stimulating hormone (TSH), peroxidase antibody (TPOAb), thyroglobulin antibody (TGAb), free thyroxine T3 (fT3), free thyroxine T4 (fT4), and thyroid tissue pathology.

[0109] (1) Establishment of HT (subclinical hypothyroidism, hyperthyroidism, hypothyroidism) model

[0110] ①Subclinical hypothyroidism

[0111] After the quarantine of 4-5 week old NOD female mice, they were treated with 0.05% NaI solution for 8 weeks, and the blank control group was given normal drinking water. After the model was established for 8 weeks, a certain proportion of model mice were randomly selected to take serum to detect TPOAb, TGAb, TSH, fT3, and fT4 levels. At the same time, the thyroid tissue was dissected for pathological examination. The relative proportion of mice with the ratio of the area of ​​lymphocyte infiltration in the thyroid gland to the entire gland area >2% was not less than 80%. Compared with the blank control group, the levels of TPOAb, TGAb, and TSH were significantly increased, and the levels of fT3 and fT4 did not change significantly, which was the standard for successful modeling; the blank control group was treated with an equal amount of normal drinking water.

[0112] ②Hyperthyroidism model

[0113] After the quarantine of 4-5 week old NOD female mice, porcine thyroglobulin (Tg)-complete Freund's adjuvant (CFA) solution was injected subcutaneously at the base of the mouse tail and back on days 0 and 7 (total injection volume 0.1 ml); on day 14, porcine thyroglobulin (Tg)-incomplete Freund's adjuvant (IFA) solution was injected subcutaneously at the base of the mouse tail (total injection volume 0.1 ml). After continued feeding and observation for 6 weeks after the booster injection, a certain proportion of modeling mice were randomly selected to take serum to detect TPOAb, TGAb, TSH, fT3, and fT4 levels, and thyroid tissue pathology was performed by dissection. The ratio of the area of ​​lymphocyte infiltration in the thyroid gland to the entire gland area >2% was not less than 80%, and the TPOAb and TGAb antibodies were significantly increased compared with the blank control group, the TSH level was significantly reduced, and the fT3 and fT4 levels were significantly increased, which was the standard for successful modeling; the blank control group was injected with an equal amount of normal saline under the same operation.

[0114] ③Hypothyroidism stage model

[0115] After the quarantine of 4-5 week old NOD female mice, they were treated with 0.05% NaI solution for 8 weeks, and the blank control group was given normal drinking water. After the model was established at 12 weeks, a certain proportion of model mice were randomly selected to take serum to detect TPOAb and TSH levels, and the thyroid tissue was dissected for pathological examination. The ratio of the area of ​​lymphocyte infiltration in the thyroid gland to the entire gland area was >2%, and the relative proportion of mice was not less than 80%. Compared with the blank control group, TPOAb and TGAb antibodies were significantly increased, TSH levels were significantly increased, and fT3 and fT4 levels were significantly reduced, which was the standard for successful modeling; the blank control group was given an equal amount of normal drinking water.

[0116] (2) Processing of Yupingfeng tea bags and other Yupingfeng preparations (taking Yupingfeng granules as an example)

[0117] ① Take an appropriate amount of teabag, add boiling water at a solid-liquid ratio of 6:200, and soak for 15 minutes. Then, concentrate the soaking liquid under reduced pressure at 60℃ to a concentration of 1ml equal to 1g of Yupingfeng teabag product; Yupingfeng teabag dosage design: daily dosage for adults is 6g / time, once a day. The human body weight is calculated as 70kg. According to the human-mouse dosage conversion coefficient, the mouse dosage is 0.78g / kg. The dosage of Yupingfeng teabag in this study is 0.5, 1, and 2 times of the clinical dosage, i.e., 0.39, 0.78, and 1.56g / kg.

[0118] ②Take an appropriate amount of Yupingfeng granules, add an appropriate amount of boiling water to melt, and then concentrate under reduced pressure at 60℃ until 1ml is equal to 1g of Yupingfeng granules product. Yupingfeng granules dosage design: Adult daily dosage is 5g / time, 3 times a day. Adults are calculated as 70 kg. According to the body weight-body surface area conversion, the mouse dosage is 0.65g / kg. The dosage of Yupingfeng granules in this study is the clinical dose equivalent dosage, that is, 0.65g / kg.

[0119] (3) Experimental groups

[0120] ① Experiment on subclinical hypothyroidism of Hashimoto's thyroiditis, as shown in Table 2.

[0121] Table 2

[0122]

[0123] ② Experiments on Hashimoto's thyroiditis in the hyperthyroid stage, as shown in Table 3.

[0124] Table 3

[0125]

[0126] ③The experiments of Hashimoto's thyroiditis in the hypothyroid stage are shown in Table 4.

[0127] Table 4

[0128]

[0129] (4) Index detection

[0130] ① Serum hormone and antibody testing

[0131] Twelve hours after the last administration, mice in the hyperthyroid and hypothyroid stages were anesthetized with 1% sodium pentobarbital (40 mg / kg) intraperitoneally at 150-200 mg / kg. 1 ml of blood was collected from the eyeball and placed in an EP tube. After standing, the serum was separated and stored in a refrigerator at 4°C. Electrochemiluminescence immunoassay (ECLIA) was used to determine serum TGAb antibody, TPOAb antibody, TSH level and free fT3 and fT4 concentration. The operation steps were strictly in accordance with the instructions of the kit.

[0132] ②Pathological analysis of thyroid tissue

[0133] After blood was drawn, mice in the hyperthyroid and hypothyroid stages were killed, and the mice were quickly dissected to remove thyroid tissue, which was fixed with 4% paraformaldehyde. After fixation for 24 h, the sections were dehydrated with gradient alcohol, transparentized with xylene, immersed in wax and embedded, and cut into 5 μm thick sections using a slicer for HE staining. After paraffin sections were dewaxed and hydrated, they were stained with hematoxylin for 5 min, rinsed with tap water, differentiated in 1% hydrochloric acid ethanol solution for 5 s, rinsed with tap water, stained with 0.5% eosin for 2 min, dehydrated and transparent, sealed with neutral gum, observed under an optical microscope and photographed.

[0134] (5) Statistical analysis methods

[0135] SPSS 18.0 software was used to perform statistical analysis on the experimental data, and one-way analysis of variance was used to test the measurement data.

[0136] (6) Results

[0137] ①Subclinical hypothyroidism

[0138] 1) Hormone and antibody levels

[0139] Serum hormone level detection after the last administration of each group showed that compared with the blank control group, the levels of TPOAb, TGAb, and TSH in the model group mice were significantly increased (P < 0.001), and the levels of fT3 and fT4 did not change significantly (P > 0.05), indicating that the HT subclinical hypothyroidism model was successfully established. The low, medium, and high doses of Yupingfeng teabags showed a significant down-regulation effect on the TSH hormone level of the model mice (P < 0.05, P < 0.01); the positive drugs selenium yeast tablets and Yupingfeng granules had no significant regulatory effect on the TSH hormone level of the model mice (P > 0.05). The low, medium, and high doses of Yupingfeng teabags showed a significant down-regulation effect on the levels of TPOAb antibodies and TGAb antibodies (P < 0.05, P < 0.01); the positive drugs selenium yeast tablets and Yupingfeng granules significantly down-regulated the TPOAb antibodies (P < 0.05), and had no significant regulatory effect on the TGAb antibodies. Compared with the Yupingfeng granule group, the low-dose, medium-dose, and high-dose Yupingfeng teabag groups showed significant differences in reducing the levels of TSH hormone and TGAb antibodies in model mice (P < 0.05, P < 0.01), and the medium-dose and high-dose Yupingfeng teabag groups showed significant differences in reducing the levels of TPOAb antibodies (P < 0.05). Different doses of positive drugs, such as selenium yeast tablets, Yupingfeng granules, and Yupingfeng teabags, had no significant regulatory effect on the levels of fT3 and fT4 (P > 0.05), as shown in Table 5.

[0140] Table 5 Hormone and antibody results ( ), N=12

[0141]

[0142] In Table 5, compared with the blank control group, ### " indicates that P < 0.001 has significant difference; compared with the model group, " ** "Indicates P<0.01, there is a significant difference," * " indicates that P < 0.05 has significant difference; compared with the Yupingfeng granule group, " △△ "Indicates P<0.01, there is a significant difference," △ ” indicates a significant difference when P < 0.05.

[0143] 2) Thyroid tissue pathological analysis

[0144] See also Figure 1 The blank control group mice had normal thyroid follicle structure and less lymphocyte infiltration; compared with the blank control group, the model group mice had obvious thyroid lymphocyte infiltration; compared with the model group, the low, medium and high dose groups of Yupingfeng tea bag had an improvement effect on the pathological degree of thyroid lymphocyte infiltration, and the effect was dose-dependent, while the positive drug selenium yeast tablets group and Yupingfeng granules group had no obvious improvement effect.

[0145] ②Hyperthyroidism model

[0146] 1) Hormone and antibody levels

[0147] The detection of serum hormone and antibody levels after the last administration of each group showed that compared with the model group, the positive drug methimazole and low, medium and high doses of Yupingfeng teabags all showed a significant up-regulation effect on the TSH hormone level of the model mice (P < 0.05), while the Yupingfeng granule group had no improvement (P > 0.05); the Yupingfeng granule group and the low, medium and high doses of Yupingfeng teabags all showed a significant down-regulation effect on the levels of small TPOAb antibodies and TGAb antibodies in the model (P < 0.05, P < 0.01), while the positive drug methimazole group had no improvement; the positive drug methimazole group and the low, medium and high doses of Yupingfeng teabags all showed a significant down-regulation effect on fT3 and fT4 in serum (P < 0.05, P < 0.01), while the Yupingfeng granule group had no significant improvement (P > 0.05). Compared with the Yupingfeng granule group, the low-dose Yupingfeng tea bag group had no significant difference in the levels of TGAb and TPOAb antibodies in the model mice (P>0.05), but showed a strong downward trend, while the medium and high-dose Yupingfeng tea bag groups had a significant downward effect (P<0.05), see Table 6.

[0148] Table 6 Hormone and antibody results ( ), N=12

[0149]

[0150] In Table 6, compared with the blank control group, ### "Indicates P<0.001 has significant difference," ## " indicates that P < 0.01 has significant difference; compared with the model group, " ** "Indicates P<0.01, there is a significant difference," * " indicates that P < 0.05 has significant difference; compared with the Yupingfeng granule group, " △△ "Indicates P<0.01, there is a significant difference," △ ” indicates a significant difference when P < 0.05.

[0151] 2) Thyroid tissue pathological analysis

[0152] See also Figure 2 The blank control group mice had normal thyroid follicle structure and less lymphocyte infiltration; compared with the blank control group, the model group mice had obvious thyroid lymphocyte infiltration; compared with the model group, the positive drug methimazole group and Yupingfeng tea bag low, medium and high dose groups had improved the pathological degree of thyroid lymphocyte infiltration, while the Yupingfeng granule group had no obvious improvement; with the increase of dose, Yupingfeng tea bag (low, medium and high dose groups) had a dose-dependent effect on the improvement of thyroid lymphocyte infiltration.

[0153] ③Hypothyroidism stage model

[0154] 1) Hormone and antibody levels

[0155] The detection of serum hormone and antibody levels after the last administration of each group showed that the positive drugs Euthyrox, Yupingfeng granules, and Yupingfeng teabags at low, medium, and high doses all showed a significant down-regulation effect on the TSH hormone level of the model mice (P < 0.05, P < 0.01). The Yupingfeng granules group and the Yupingfeng teabags low, medium, and high dose groups all showed a significant down-regulation effect on the TPOAb antibody level (P < 0.05, P < 0.01); the Yupingfeng teabags medium and high dose groups all showed a significant down-regulation effect on the TGAb antibody level (P < 0.05); the positive drugs Euthyrox and Yupingfeng teabags low, medium, and high dose groups all had a significant up-regulation effect on serum fT3 (P < 0.05, P < 0.01); the positive drugs Euthyrox, Yupingfeng granules, and Yupingfeng teabags low, medium, and high doses all had a significant up-regulation effect on serum fT4 (P < 0.05, P < 0.01). Compared with the Yupingfeng granule group, the low-dose Yupingfeng teabag group had no significant difference in the TSH hormone level, TGAb antibody, and TPOAb antibody level of the model mice (P>0.05), but showed a strong downward trend, while the medium and high-dose Yupingfeng teabag groups had significant differences (P<0.05); compared with the Yupingfeng granule group, the low-dose Yupingfeng teabag group had no significant difference in the fT3 and fT4 hormone levels (P>0.05), but showed an upward trend, while the medium and high-dose Yupingfeng teabag groups had significant differences in fT3 and fT4 hormones (P<0.05), see Table 7.

[0156] Table 7 Hormone and antibody results ( ), N=12

[0157]

[0158] In Table 7, compared with the blank control group, ### "Indicates P<0.001 has significant difference," ## " indicates that P < 0.01 has significant difference; compared with the model group, " ** "Indicates P<0.01, there is a significant difference," * " indicates that P < 0.05 has significant difference; compared with the Yupingfeng granule group, " △ ” indicates a significant difference when P < 0.05.

[0159] 2) Thyroid tissue pathological analysis

[0160] See also Figure 3In the blank control group, a large number of intact thyroid follicles with regular shapes and moderate sizes were observed, with colloid filling in the cavity and less interstitial inflammatory infiltration. In the model group, the thyroid follicles were mostly irregular in shape, with thinning or destruction of the follicular wall, and most of the follicular cavities were damaged or reduced. The colloid content in the cavity was significantly reduced, and lymphocyte infiltration was present in the interfollicular space. Compared with the model group, the degree of thyroid lymphocyte infiltration in the positive drug Euthyrox group, Yupingfeng granules, and Yupingfeng teabag low, medium, and high groups showed an improvement trend; with the increase in dose, Yupingfeng teabag had a dose-dependent effect on the improvement of thyroid lymphocyte infiltration, and the improvement effect was more obvious compared with the Yupingfeng granules group.

[0161] (7) Analysis of the differences in material composition between Yupingfeng tea bags and other Yupingfeng preparations, taking granules as an example

[0162] Different production processes will lead to different material components, which will have different effects on the same disease. Yupingfeng tea bags and other Yupingfeng preparations, taking granules as an example, are made differently. In order to more clearly understand the differences in the therapeutic effects of Yupingfeng tea bags and other Yupingfeng preparations (taking granules as an example) on HT (subclinical hypothyroidism, hyperthyroidism, hypothyroidism), this application also analyzes the components of Yupingfeng tea bags and Yupingfeng granules.

[0163] ①Method:

[0164] 1) Sample treatment: add 10 mL of 50% methanol (50%, v / v) to 1 g of Yupingfeng granules and weigh the sample; perform ultrasonic treatment for 30 min and make up the lost weight with 50% methanol; centrifuge at 12,000 rpm for 15 min, take the supernatant and filter through a 0.22 μm microporous filter to obtain the Yupingfeng granule test solution; soak 2 bags of Yupingfeng teabags in 200 ml of boiling water for 15 minutes, take 2 ml of the soaking liquid and treat it in the same way as Yupingfeng granules to obtain the Yupingfeng teabag test solution.

[0165] 2) Analysis by UPLC-Q / TOF-MS / MS:

[0166] Chromatographic separation was performed using a Nexera X2 Shimadzu ultra-high performance liquid phase system with an ACQUITY UPLC® BEH C18 column (1.7 μm, 200 × 2.1 mm). The mobile phase consisted of (phase A) 0.1% formic acid in water and (phase B) 0.1% formic acid in acetonitrile. The gradient elution program was shown in Table 8. The flow rate was 0.3 mL / min, the column temperature was 40 °C, and the injection volume was 2 μL.

[0167] Table 8

[0168]

[0169] Mass spectrometry conditions: Data were collected using an AB SCIEX 5600+ Triple TOF quadrupole time-of-flight mass spectrometer with an electrospray ionization source (ESI), and full scan analysis was performed in positive (POS) and negative (NEG) ion modes. The data collection range of the parent ion mass-to-charge ratio scan was m / z 100 ~ 1200, and the product ion m / z 50 ~ 1200. The optimized mass spectrometry parameters in POS mode were: capillary spray voltage 5.5 kV; turbine spray temperature, 500°C; nebulizer gas, 50 L / min; heating gas, 50 L / min; curtain gas, 35 L / min. The optimized declustering voltage, collision energy, and collision energy interval were set to 80 V, 35 eV, and 15 eV, respectively. In NEG mode, the capillary spray voltage, declustering voltage, and collision energy were set to -4.5 kV, -80 V, and -35 eV, respectively, and the other parameters were the same as in POS mode. The mass spectra were tuned and calibrated using an online automatic calibration system (CDS) for MS and MS / MS.

[0170] Figures 4 to 7 is the test result, the horizontal axis represents the generation time of ions (min), and the vertical axis represents the total current intensity of the collected and stored ions. It can be seen from the mass spectrometry positive and negative ion diagrams that due to different processes, there are significant differences in the composition of Yupingfeng teabags and Yupingfeng granules. SCIEX OS 3.1.0 software was used to extract some peaks and perform peak matching analysis, and then the mass spectrometry data was compared with the Chinese medicine chemical component database (TCM·MS / MS·2.1) and the natural product high-resolution mass spectrometry database (naturalprocducts HR-MSMS2.0). On the basis of satisfying the mass deviation ≤5, isotope abundance ratio ≤5, and database matching score ≥90, the quasi-molecular ion peaks and fragmentation rules of the compounds in the database were compared and analyzed to obtain preliminary compound information, as shown in Table 9 for details.

[0171] Table 9

[0172]

[0173] In Table 9, A is the Yupingfeng tea bag soaking liquid, and B is the Yupingfeng granules. A preliminary study was conducted on the chemical composition comparison of the two products. If accurate compound information is to be obtained, it is necessary to further combine other methods such as nuclear magnetic resonance, standard products, etc. to determine the compound information.

[0174] In summary, due to the different preparation methods and material components of Yupingfeng tea bags and other Yupingfeng preparations, the therapeutic effects on HT (subclinical hypothyroidism, hyperthyroidism, and hypothyroidism) are different. Other Yupingfeng preparations, such as granules, only have a certain therapeutic effect on HT hypothyroidism, while Yupingfeng tea bags (low 0.39g / kg, medium 0.78g / kg, and high 1.56g / kg doses are equivalent to 0.5 times, 1 times, and 2 times the clinical dose) have good therapeutic effects on HT subclinical hypothyroidism, hyperthyroidism, and hypothyroidism, regulating TSH, fT3, fT4 hormones, TGAB, and TPOAB antibody levels to restore homeostasis, relieving thyroid tissue inflammation, and the therapeutic effect is dose-dependent; in the treatment of Hashimoto's thyroiditis hypothyroidism, the low dose of Yupingfeng tea bags (0.39g / kg, equivalent to 0.5 times the clinical dose) is compared with Yupingfeng granules (0.65g / kg, equivalent to 1 times the clinical dose), there is no significant difference, but it shows a better trend. Comprehensive analysis shows that the therapeutic effect of Yupingfeng teabag alone on Hashimoto's thyroiditis is better than that of Yupingfeng granules.

[0175] All documents mentioned in this application are cited as references in this application, just as each document is cited as reference separately. Unless they conflict with the application purpose and / or technical solution of this application, the cited documents involved in this application are cited with all contents and all purposes. When the cited documents are involved in this application, the definitions of relevant technical features, terms, nouns, phrases, etc. in the cited documents are also cited. When the cited documents are involved in this application, the examples and preferred methods of the cited relevant technical features can also be incorporated into this application as references, but are limited to the implementation of this application. It should be understood that when the cited content conflicts with the description in this application, the present application shall prevail or be modified adaptively according to the description of this application.

[0176] The technical features of the above-mentioned implementation modes and examples can be combined in any appropriate manner. To make the description concise, not all possible combinations of the technical features in the above-mentioned implementation modes and examples 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.

[0177] The above-described embodiments only express several implementation methods of the present application, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for those of ordinary skill in the art, without departing from the concept of the present application, several variations and improvements can also be made, which all belong to the protection scope of the present application. In addition, it should be understood that after reading the above-mentioned teaching content of the present application, those skilled in the art can make various changes or modifications to the present application, and the equivalent forms obtained also fall within the protection scope of the present application. It should also be understood that the technical solutions obtained by those skilled in the art on the basis of the technical solutions provided in the present application through logical analysis, reasoning or limited experiments are all within the protection scope of the claims attached to the present application. Therefore, the protection scope of the patent of the present application shall be based on the attached claims, and the description can be used to interpret the content of the claims.

Claims

1. An application of a Yupingfeng pharmaceutical preparation in the preparation of a drug for preventing and treating Hashimoto's thyroiditis, wherein the raw materials for preparing the Yupingfeng pharmaceutical preparation include Atractylodes macrocephala, Astragalus membranaceus and Saposhnikovia divaricata.

2. The use according to claim 1, characterized in that The Hashimoto's thyroiditis includes Hashimoto's thyroiditis in the subclinical hypothyroidism stage, hyperthyroidism stage and hypothyroidism stage.

3. The use according to claim 1, characterized in that The Hashimoto's thyroiditis is Hashimoto's thyroiditis in the subclinical hypothyroidism stage or the hyperthyroidism stage.

4. The use according to claim 1, characterized in that The Hashimoto's thyroiditis is Hashimoto's thyroiditis in the hyperthyroidism stage.

5. The use according to claim 1, characterized in that In parts by weight, the raw materials for preparing the Yupingfeng pharmaceutical preparation include 300-350 parts of Atractylodes macrocephala, 900-1100 parts of Astragalus membranaceus and 300-350 parts of Saposhnikovia divaricata; and / or, The raw materials for preparing the Yupingfeng pharmaceutical preparation also include pharmaceutically acceptable carriers and / or excipients.

6. The use according to claim 1, characterized in that The preparation method of the Yupingfeng pharmaceutical preparation comprises the following steps: Grind the Atractylodes macrocephala to obtain a first powder; Adding water to the mixture of the Radix Astragali and the Radix Saposhnikoviae to boil and prepare a water decoction; The decoction is concentrated to obtain a thick paste; The thick paste and the first powder are mixed and dried to obtain a second powder; The second powder and a pharmaceutically acceptable carrier and / or auxiliary material are prepared to obtain the Yupingfeng pharmaceutical preparation.

7. The use according to claim 6, characterized in that The step of adding water to the mixture of Radix Astragali and Radix Saposhnikoviae to boil and prepare a decoction comprises: The astragalus, the fangfeng and water are mixed, boiled at 110° C. to 130° C., and filtered to obtain the water decoction; Wherein, the ratio of the sum of the weight of the astragalus and the siler to the weight of the water is (9-11):1; The decoction is performed 1 to 2 times, each time for 0.5 to 2.5 hours.

8. The use according to any one of claims 1 to 7, characterized in that: The Yupingfeng pharmaceutical preparation is an oral preparation.

9. The use according to any one of claims 1 to 7, characterized in that: The Yupingfeng pharmaceutical preparation is a tea bag preparation.

10. The use according to any one of claims 1 to 7, characterized in that: The medicine for preventing and treating Hashimoto's thyroiditis contains a therapeutically effective amount of Yupingfeng pharmaceutical preparation.

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