Pharmaceutical composition for treating hashimoto thyroiditis

Abstract

The invention discloses a pharmaceutical composition for treating hashimoto thyroiditis, and belongs to the technical field of traditional Chinese medicines. According to the pharmaceutical composition, astragalus membranaceus and codonopsis pilosula are used as monarch drugs to tonify qi, raise yang, tonify qi and strengthen body resistance; radix bupleuri, rhizoma cyperi and radix curcumae are used as ministerial drugs for soothing liver-qi stagnation, expelling evil, soothing liver-qi, regulating qi and harmonizing blood; humifuse euphorbia herb, lucid ganoderma and oldenlandia diffusa are used as adjuvant drugs for clearing away heat and toxic materials, reinforcing qi, nourishing blood and tranquilizing; the whole formula has the effects of tonifying qi, soothing the liver and clearing heat together. All the medicines are combined to effectively improve the symptoms of patients with hashimoto thyroiditis and reduce the thyroid autoantibody level. In addition, the pharmaceutical composition is good in safety, and a traditional Chinese and western medicine combined treatment strategy for hashimoto thyroiditis can be further popularized in the future.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a pharmaceutical composition for treating Hashimoto's thyroiditis. Background Art

[0002] Hashimoto's Thyroiditis (HT), also known as chronic lymphocytic thyroiditis, is a chronic inflammation of the thyroid gland mediated by autoimmune disorders. HT has an insidious onset and a long course. In the early stage, there is usually no obvious discomfort, or it may be accompanied by fatigue, swelling in the front of the neck, and poor mood. As the disease progresses, some patients will experience symptoms of hyperthyroidism, such as palpitations, sweating, and irritability. In the later stage, there is often hypothyroidism, with hypometabolic syndrome as the main manifestation, manifested as fear of cold, edema, slow reaction, memory loss and other symptoms, which seriously affect the quality of life of patients. HT is the main cause of hypothyroidism, which can affect female reproduction and intellectual development of offspring, and is associated with papillary thyroid carcinoma and thyroid lymphoma. Therefore, HT has received increasing attention worldwide.

[0003] HT patients are characterized by diffuse changes in the thyroid gland and elevated levels of thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibodies (TGAb) in the serum. The levels of these antibodies reflect the severity of HT to a certain extent and can be used as an important indicator for the occurrence, development and prognosis of the disease. The pathogenesis of HT is still inconclusive. Most studies believe that the onset of Hashimoto's thyroiditis is due to the disruption of the local immune balance of the thyroid gland. The body mistakenly identifies its own thyroid cell structure as an antigen and produces antibodies, and the antigen-antibody complex initiates inflammation. As Hashimoto's thyroiditis progresses, the imbalanced immune response and recognition process regulate the initiation of the cell apoptosis program, increasing follicular cell apoptosis, irreversible fibrosis of the follicular structure, and a decrease in the number of cells that effectively synthesize thyroid hormones, ultimately leading to irreversible hypothyroidism.

[0004] At present, there are certain limitations in the treatment of HT with Western medicine. There is no effective way to delay the progression of the disease, and treatment mainly focuses on replacement therapy and symptom control. Selenium supplements may help regulate thyroid function and reduce inflammation, but the dosage range of selenium is very narrow. Too little dose often fails to improve HT. Improper intake can be toxic, causing hair loss, onychomycosis, fatigue, depression, bad breath, and even nausea, vomiting, dizziness, headache, decreased sensation, and intellectual changes, and other neurological dysfunctions. Summary of the invention

[0005] In order to solve the problems existing in the prior art, the purpose of the present invention is to provide a pharmaceutical composition for treating Hashimoto's thyroiditis, so as to achieve the therapeutic purpose of safely and effectively regulating the immune status, delaying the development of Hashimoto's thyroiditis, and improving patients' symptoms and quality of life.

[0006] The technical solution of the present invention to solve the above technical problems is as follows: a pharmaceutical composition for treating Hashimoto's thyroiditis is provided, comprising the following raw materials in parts by weight: 10-20 parts of Astragalus, 10-20 parts of Codonopsis, 9-18 parts of Bupleurum, 6-14 parts of Cyperus, 6-12 parts of Curcuma, 9-18 parts of Ganoderma, 6-18 parts of Euphorbia, 12-30 parts of Hedyotis diffusa and 6-9 parts of raw Licorice.

[0007] Further, the invention comprises the following raw materials in parts by weight: 15 parts of astragalus, 15 parts of codonopsis, 12 parts of bupleurum, 12 parts of cyperus, 9 parts of curcuma, 15 parts of ganoderma lucidum, 15 parts of euphorbia pulex, 30 parts of oldenlandia diffusa and 9 parts of raw licorice.

[0008] The present invention provides an application of the above-mentioned pharmaceutical composition in preparing a preparation for treating Hashimoto's thyroiditis.

[0009] The present invention also provides a preparation for treating Hashimoto's thyroiditis, which comprises the above-mentioned pharmaceutical composition.

[0010] Furthermore, the preparation is an oral preparation.

[0011] Further, the preparations include decoctions, granules, capsules, tablets, oral liquids, pills, tinctures and syrups.

[0012] The present invention has the following beneficial effects: the pharmaceutical composition of the present invention comprises a plurality of components, wherein the Radix Astragali is a holy medicine for invigorating qi, mainly invigorating qi and raising yang, the Radix Codonopsis is a medicine for invigorating qi and strengthening the body, and the two are the main medicines; the Radix Bupleuri soothes the liver and relieves depression, and expels evil spirits, and the Radix Cyperi is an important medicine for qi stagnation in the twelve meridians, and the "Compendium of Materia Medica" praises it as "the general director of qi diseases", and adds the function of soothing the liver and regulating qi. If the stagnation of liver qi turns into heat for a long time, and the heat disturbs the mind, the patient often has symptoms such as irritability and insomnia at this time, and the Radix Curcumae is used to purge liver heat and nourish the mind, which is a medicine for qi in the blood, and the "Compendium of Materia Medica" says: "This medicine can reduce qi, and the reduction of qi is the reduction of fire, and its nature enters the blood, so it can reduce the fire, and the blood will not flow indiscriminately", so the Radix Curcumae is used to take into account to reconcile qi and blood, and the three are the ministerial medicines; and the "Medical Records of Zhongzhong Canxi" points out: "The nature of Radix Astragali is warm, and the nature of liver wood is also warm, which means that the same qi seeks each other". It is supplemented with Herba Epimedii, Ganoderma Lucidum and Hedyotis Diffusa; Ganoderma Lucidum has always been a precious tonic medicine that can nourish qi, nourish blood and calm the mind; Herba Epimedii and Hedyotis Diffusa have the effect of clearing away heat and detoxifying. Modern studies have shown that Hedyotis Diffusa and Herba Epimedii have anti-inflammatory pharmacological effects, and Hashimoto's thyroiditis involves the participation of a series of inflammatory factors in the pathogenesis. Licorice is a guiding drug to coordinate the whole prescription, and the whole prescription plays the effect of invigorating qi and soothing the liver, and clearing heat. Therefore, the pharmaceutical composition of the present invention can effectively improve the symptoms of patients with Hashimoto's thyroiditis and reduce the level of thyroid autoantibodies, and the pharmaceutical composition of the present invention has good safety, and the treatment strategy of combining traditional Chinese and Western medicine for Hashimoto's thyroiditis can be further promoted in the future. DETAILED DESCRIPTION

[0013] The principles and features of the present invention are described below in conjunction with the examples, which are only used to explain the present invention and are not intended to limit the scope of the present invention. If no specific conditions are specified in the examples, the conditions are carried out according to conventional conditions or the conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments is not specified, they are all conventional products that can be purchased commercially.

[0014] Embodiment 1: A pharmaceutical composition for treating Hashimoto's thyroiditis comprises the following raw materials in parts by mass: 15 parts of astragalus, 15 parts of codonopsis, 12 parts of bupleurum, 12 parts of cyperus, 9 parts of curcuma, 15 parts of ganoderma, 15 parts of euphorbia pulex, 30 parts of oldenlandia diffusa and 9 parts of raw liquorice.

[0015] Embodiment 2: A pharmaceutical composition for treating Hashimoto's thyroiditis comprises the following raw materials in parts by mass: 10 parts of astragalus, 10 parts of codonopsis, 9 parts of bupleurum, 6 parts of cyperus, 6 parts of curcuma, 9 parts of ganoderma, 6 parts of euphorbia pulex, 12 parts of oldenlandia diffusa and 6 parts of raw liquorice.

[0016] Embodiment 3: A pharmaceutical composition for treating Hashimoto's thyroiditis comprises the following raw materials in parts by mass: 20 parts of astragalus, 20 parts of codonopsis, 18 parts of bupleurum, 14 parts of cyperus, 12 parts of curcuma, 18 parts of ganoderma, 18 parts of euphorbia pulex, 18 parts of euphorbia pulex, 30 parts of oldenlandia diffusa and 9 parts of raw liquorice.

[0017] Test example: (1) Diagnostic criteria Western medicine diagnosis meets the diagnostic criteria for HT (the 2008 edition of the "Guidelines for the Diagnosis and Treatment of Thyroid Diseases in China" compiled by the Endocrinology Branch of the Chinese Medical Association sets the diagnostic criteria for Hashimoto's thyroiditis), as follows: ① Diffuse thyroid enlargement with a tough texture, especially with enlargement of the pyramidal lobe of the isthmus; ② Serum thyroid peroxidase antibody (TPOAb) or globulin antibody (TgAb) is positive; ③Thyroid fine needle aspiration cytology (FNAC) showed: Hashimoto’s thyroiditis; ④ The conditions for diagnosis are: ① and ② are met, or ③ is met alone.

[0018] The diagnosis of traditional Chinese medicine is based on the "Guidelines for Clinical Research of New Chinese Medicines (Trial)" and clinical experience to determine the classification criteria for HT of Qi deficiency and liver depression type: 5 main symptoms (swelling in the front of the neck, foreign body sensation in the throat, fatigue, sighing, and poor mood); 3 secondary symptoms (spontaneous sweating, dry mouth and thirst, chest tightness or chest and flank pain); tongue: pale red tongue or with teeth marks, thin white or thin yellow fur; pulse: stringy and thin pulse. If the patient meets no less than 3 main symptoms, or meets 2 main symptoms plus 1 secondary symptom, combined with tongue and pulse, this syndrome is identified.

[0019] (2) Inclusion criteria ①18 to 80 years old; ② Meet the diagnosis of HT by traditional Chinese and Western medicine; ③ Thyroid peroxidase antibody (TPOAb) and / or thyroglobulin antibody (TgAb) are positive; ④Thyroid-stimulating hormone (TSH) 0.25~10.00 mIU / L; ⑤ Informed consent and ability to cooperate with the research.

[0020] (3) Exclusion criteria ① Pregnancy or lactation; ②The thyroid gland is significantly enlarged, compressing adjacent organs; ③History of using vitamin D supplements in the past 3 months; ④Allergic to the drugs used in this study; ⑤ Taking other drugs that affect thyroid hormones and antibodies, such as levothyroxine sodium tablets, methimazole tablets, selenium yeast, etc.; ⑥ Kidney stones or hypercalcemia; ⑦Severe heart, liver and kidney diseases; ⑧ Participating in other clinical studies; ⑨Mental disorder or cognitive dysfunction.

[0021] (4) Elimination and shedding standards ① Failure to take medication as required; ②Serious adverse reactions occur during treatment; ③Serious illness occurs during treatment; ④ Unwilling to continue research midway.

[0022] (5) Treatment methods 38 cases were included in the experimental group and 37 cases in the control group. The control group was given general basic treatment, i.e. iodine-appropriate diet, and thyroid function and antibody titer were followed up. The experimental group was treated with the pharmaceutical composition of Example 1 on the basis of the control group. It was uniformly decocted by the Chinese Medicine Preparation Room of Longhua Hospital and vacuum-packed into 180mL / bag, 2 bags per dose, and warmed twice a day after meals in the morning and evening. All patients were treated for 12 consecutive weeks. Among them, there were 3 males and 35 females in the experimental group, with an onset age of 21-68 years and a course of 1-9 years; there was 1 male and 36 females in the control group, with an onset age of 23-76 years and a course of 2-9 years.

[0023] (6) Comparison of thyroid-related indicators After treatment, the levels of TgAb and TPOAb in the experimental group were significantly lower than before treatment (P < 0.05), while there was no significant difference in the control group (P > 0.05). After treatment, the change rates of TPOAb and TgAb in the experimental group were better than those in the control group (P < 0.05), and there was no significant difference in TSH changes between the two groups before and after treatment, as shown in Table 1.

[0024] Table 1 Comparison of thyroid-related indicators

[0025] Note: The data were not normally distributed. Nonparametric tests were used to compare the differences between the two groups and the median (interquartile range) was used to express the differences. Compared with before treatment, *P<0.05; compared with the control group, #P<0.05.

[0026] (7) Comparison of total scores of TCM syndromes TCM syndrome score: TCM symptom score method is used. The main symptoms (swelling in front of the neck, foreign body sensation in the throat, fatigue, sighing, and emotional depression) are scored 0, 2, 4, and 6 points according to the severity. The secondary symptoms (spontaneous sweating, dry mouth and thirst, chest tightness or chest and flank pain) are scored 0, 1, 2, and 3 points. The sum of each item is the total syndrome score. This score scale is followed up and judged by two or more attending physicians twice before and after, and the comprehensive evaluation is combined with the medical records. Observe the changes in the total score of TCM syndrome of patients before and after treatment.

[0027] After treatment, the total score of TCM syndrome in the experimental group was lower than before (10.61±3.40 before treatment, 5.26±2.61 after treatment), and was better than that in the control group (10.86±2.68 before treatment, 9.76±2.85 after treatment). The differences were statistically significant (P<0.05), as shown in Table 2.

[0028] Table 2 Comparison of TCM syndrome scores before and after treatment

[0029] Note: □ is the comparison between before and after treatment. P <0.05.

[0030] (8) Comparison of clinical efficacy The main observation index of clinical efficacy is clinical efficacy (reference: Zheng Xiaoyu. Guiding Principles for Clinical Research of New Chinese Medicines. 1st edition. Beijing: China Medical Science and Technology Press, 2002: 230-231.). Significantly effective: clinical symptoms and signs of traditional Chinese medicine are significantly improved, the score is reduced by ≥70%, and the thyroid autoantibody index is reduced by ≥30%; effective: symptoms and signs are improved, the score is reduced by ≥30%, but <70%, and the antibody is reduced by ≥10%, but <30%; ineffective: symptoms and signs are not improved or even aggravated, the score is reduced by <30%, and the antibody is reduced by <10%. Total effective rate = (significantly effective + number of effective cases) / total number of cases × 100%. Secondary indicators are TPOAb, TgAb, TSH levels and traditional Chinese medicine syndrome scores. Safety indicators include monitoring of patients' blood routine, blood calcium, liver and kidney function and gastrointestinal reactions.

[0031] After treatment, 21 cases (55.26%) of the experimental group showed marked effect, 9 cases (23.69%) showed effective, 8 cases showed ineffective, and 30 cases (78.95%) showed effective. There was no marked effect in the control group, 15 cases (40.54%) showed effective, 22 cases showed ineffective, and 15 cases (40.54%) showed effective.

[0032] (9) Safety evaluation During the treatment period, one patient in the experimental group had diarrhea, and was advised to take Chinese medicine at half the dose, and the condition improved after 3 days. No other abnormalities were found.

[0033] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A pharmaceutical composition for treating Hashimoto's thyroiditis, characterized in that: The invention comprises the following raw materials in parts by weight: 10-20 parts of astragalus, 10-20 parts of codonopsis, 9-18 parts of bupleurum, 6-14 parts of cyperus, 6-12 parts of curcuma, 9-18 parts of ganoderma lucidum, 6-18 parts of euphorbia pulex, 12-30 parts of oldenlandia diffusa and 6-9 parts of raw liquorice.

2. The pharmaceutical composition for treating Hashimoto's thyroiditis according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 15 parts of astragalus, 15 parts of codonopsis, 12 parts of bupleurum, 12 parts of cyperus, 9 parts of curcuma, 15 parts of ganoderma lucidum, 15 parts of euphorbia pulex, 30 parts of oldenlandia diffusa and 9 parts of raw liquorice.

3. Use of the pharmaceutical composition according to any one of claims 1 to 2 in the preparation of a preparation for treating Hashimoto's thyroiditis.

4. A preparation for treating Hashimoto's thyroiditis, characterized in that: The preparation comprises the pharmaceutical composition according to claim 1 or 2.

5. The preparation for treating Hashimoto's thyroiditis according to claim 4, characterized in that The preparation is an oral preparation.

6. The preparation for treating Hashimoto's thyroiditis according to claim 5, characterized in that The preparations include decoctions, granules, capsules, tablets, oral liquids, pills, tinctures and syrups.

Images