CN113750141A

CN113750141A - Composition for treating hashimoto thyroiditis and preparation method and application thereof

Info

Publication number: CN113750141A
Application number: CN202111249372.4A
Authority: CN
Inventors: 丁治国
Original assignee: Individual
Current assignee: Individual
Priority date: 2021-10-26
Filing date: 2021-10-26
Publication date: 2021-12-07

Abstract

The invention provides a composition for treating hashimoto's thyroiditis and a preparation method and application thereof, belonging to the technical field of traditional Chinese medicines, wherein the composition is prepared from the following raw materials: prunellae Spica, Scutellariae radix, cortex moutan, radix Platycodi, radix Ranunculi Ternati and radix astragali. After a patient with hashimoto thyroiditis takes 1 month as 1 course of treatment, the TPOAb and TGAb antibody titer of the patient can be obviously reduced after 1-3 courses of treatment, clinical symptoms are obviously relieved, and the using effect is good.

Description

Composition for treating hashimoto thyroiditis and preparation method and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a composition for treating hashimoto's thyroiditis, and a preparation method and application thereof.

Background

Hashimoto Thyroiditis (HT), chronic lymphocytic Thyroiditis, is a common autoimmune disease. In the early 20 th century, the disease was first proposed and described by Hashimoto, a japanese scholar. HT has certain genetic characteristics, and is clinically characterized in that the titer of thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TGAb) is higher than the normal value. In recent years, the incidence of HT has been increasing year by year as the pressure of life increases, the living environment changes and medical diagnostic techniques have been improved. The female incidence rate is higher than that of the male incidence rate, the former is 3-4 times of that of the latter, and the female incidence rate is more than that of the young and middle-aged people, and the age range is 30-50 years. Modern research suggests that: the disease is latent in onset and has no typical clinical manifestations in the early stage. Partial HT patients have goiter, most of the diseases develop irreversible hypothyroidism in later stage, and thyroid hormone needs to be taken for the whole life, so that the life quality is obviously reduced.

The etiology and pathological mechanism of HT are not clear, and research shows that environmental factors, genetic factors and high-iodine diet are the main factors of pathogenesis and influence. Modern medical research suggests that the damage of HT to thyroid cells is realized by apoptosis of epithelial cells, and is characterized by infiltration of fused lymphocytes mainly composed of thyroid-specific B cells and T cells and destruction of follicular follicles, and the generated TPOAb and TGAb are key bioactive substances for directly damaging thyroid cells and glands. The laboratory detects that the titer of TPOAb and TGAb is increased, and the ultrasonic prompts that the thyroid tissue is subjected to diffuse lesion or swelling, and the TPOAb and TGAb are important indexes for HT diagnosis.

HT is not typical in clinical manifestations, has a hidden onset and a long course of disease, and is mainly characterized by diffuse enlargement of the thyroid gland, tough texture and up and down movement with swallowing. When the thyroid gland functions normally, some patients may have symptoms such as pharyngeal discomfort or mild dysphagia, neck oppression, occasional local pain and tenderness, hypodynamia, insomnia, and the like. When the thyrotoxicosis is combined, patients can have clinical manifestations of palpitation, hyperhidrosis, and bulimia, and free triiodothyronine (FT3) is increased, free thyroxine (FT4) is increased, and Thyrotropin (TSH) is reduced; in combination with hypothyroidism, patients may manifest symptoms and signs such as aversion to cold, bradycardia, constipation, or myxedema. Modern medicine has made multi-angle attempts at the treatment of HT, but there is no standard and effective treatment scheme, and at present, low-iodine diet schemes, selenium preparations and vitamin D preparations are relatively deep and extensive studied intervention schemes, but the results of international studies are inconsistent, and the above approaches have poor efficacy in delaying the development of HT.

Disclosure of Invention

In view of the above, the invention aims to provide a composition for treating hashimoto's thyroiditis, and a preparation method and application thereof.

In order to achieve the above purpose, the invention provides the following technical scheme:

the invention provides a composition for treating hashimoto's thyroiditis, which is prepared from the following raw materials: prunellae Spica, Scutellariae radix, cortex moutan, radix Platycodi, radix Ranunculi Ternati and radix astragali.

Preferably, the raw materials also comprise raw dragon bones, salvia miltiorrhiza, raw oysters, rhizoma anemarrhenae, nacre, dandelion, burdock and gypsum.

Preferably, the mass ratio of the selfheal to the scutellaria baicalensis, the moutan bark, the platycodon grandiflorum, the radix ranunculi ternati, the raw astragalus membranaceus, the raw dragon bone, the salvia miltiorrhiza, the raw oyster to the rhizoma anemarrhenae, the mother-of-pearl to the dandelion, the burdock and the gypsum is 20-40: 20-50: 10-30: 30-70: 10-40: 20-50: 50-70: 5-20: 100-200.

Preferably, the raw materials also comprise radix codonopsitis, radix astragali preparata, raw oyster, mother-of-pearl, red paeony root, white paeony root, rhizoma anemarrhenae and rhizoma alismatis.

Preferably, the mass ratio of the selfheal to the scutellaria baicalensis, the moutan bark, the platycodon grandiflorum, the radix ranunculi ternati, the raw astragalus membranaceus, the codonopsis pilosula, the radix astragali preparata, the raw oyster, the nacre, the red peony root, the white peony root, the rhizoma anemarrhenae and the rhizoma alismatis is 20-40: 10-30: 10-40: 20-50: 10-30: 10-40: 10-30.

Preferably, the raw materials also comprise radix bupleuri, red paeony root, white paeony root, raw oyster, albizia flower, rhizoma cyperi and rhizoma alismatis.

Preferably, the mass ratio of the selfheal to the scutellaria baicalensis, the moutan bark, the platycodon grandiflorum, the ternate buttercup root, the raw astragalus mongholicus, the radix bupleuri, the red paeony root, the white paeony root, the raw oyster, the albizia flower, the rhizoma cyperi and the rhizoma alismatis is 10-50: 5-40: 5-50: 10-70: 5-60: 10-50: 10-70: 10-60: 5-60: 10-40.

The invention also provides a preparation method of the composition in the technical scheme, which comprises the following steps: soaking the raw materials in water, boiling with strong fire, and then decocting with slow fire for 30-40 min to obtain decoction as the composition.

The invention also provides a preparation method of the composition in the technical scheme, which comprises the following steps: soaking the raw materials in water, decocting for 1.5-2 h, and drying the obtained decoction to obtain dry powder as the composition.

The invention also provides application of the composition in the technical scheme in preparation of a medicine for treating hashimoto's thyroiditis.

The invention has the beneficial effects that:

according to the constitution characteristics and the disease characteristics of patients with Hashimoto's thyroiditis, a prescription is formed by selecting a plurality of medicines according to the monarch, minister, assistant and guide compatibility principle, and the traditional Chinese medicine composition plays a good treatment effect in the treatment process and does not cause any case harm to the safety of the patients. 1 month is taken as 1 course of treatment, and after 1-3 courses of treatment, the TPOAb and TGAb antibody titer of patients can be obviously reduced, clinical symptoms are obviously relieved, and the using effect is good.

Drawings

FIG. 1 is a graph showing the trend of TPOAb titer change in 60 patients with HT treated with the pharmaceutical composition of the present invention.

FIG. 2 is a TGAb titer profile of 60 HT patients treated with the pharmaceutical composition of the present invention.

Detailed Description

In the invention, the raw materials also preferably comprise raw dragon bones, salvia miltiorrhiza, raw oyster shells, rhizoma anemarrhenae, mother-of-pearl, dandelion, burdock and gypsum. In the invention, the mass ratio of the selfheal to the scutellaria baicalensis, the moutan bark, the platycodon grandiflorum, the radix ranunculi ternati, the raw astragalus membranaceus, the raw dragon bone, the salvia miltiorrhiza, the raw oyster to the rhizoma anemarrhenae, the nacre to the 40: 20-50: 10-30: 30-70: 10-30: 30-70: 10-40: 20-50: 50-70: 5-20: 100-200 is preferred, and the preferred ratio is 30:28:28:12:20:15: 30:25:35:65:12: 150. In the present invention, the composition is preferably effective in treating patients with HT thyrotoxicosis. In the invention, when the raw materials of the composition are selfheal, scutellaria baicalensis, moutan bark, platycodon grandiflorum, radix ranunculi ternati, raw astragalus mongholicus, raw dragon bones, salvia miltiorrhiza, raw oysters, rhizoma anemarrhenae, nacre, dandelion, burdock and raw gypsum, the raw gypsum is used as a monarch drug, and the composition has the effects of clearing heat and purging fire, relieving restlessness and quenching thirst; the dandelion has the functions of clearing away heat and toxic materials, relieving swelling and dissipating stagnation, the selfheal has the functions of clearing liver, purging fire, dissipating stagnation and relieving swelling, the raw oyster has the effects of suppressing yang and nourishing yin, softening and resolving hard mass, and the raw dragon bones and the mother-of-pearl have the effects of calming liver and suppressing yang, and are ministerial medicines together to play the functions of clearing liver, purging fire, softening and resolving hard mass; the scutellaria baicalensis has the functions of clearing heat and drying dampness, purging fire and removing toxicity, the cortex moutan has the functions of clearing heat and cooling blood, and activating blood and dissolving stasis, the rhizoma anemarrhenae has the functions of clearing heat and purging fire, promoting the production of body fluid and moistening dryness, the radix ranunculi ternati has the functions of resolving masses and reducing swelling, the salvia miltiorrhiza has the functions of removing stasis and relieving pain, and clearing heart and relieving restlessness, and the cortex moutan is used as adjuvant drugs together and aims to enhance the functions of clearing heat and resolving masses, and clearing heat and nourishing yin; the raw astragalus root, radix astragali tonifies qi and strengthens exterior, the platycodon root, the great burdock achene and the great burdock achene are used as guiding drugs, and the three drugs are carried to move upwards. In general, the whole formula can be reviewed, the ascending middle energizer can be reduced, the tonifying middle energizer can be reduced, and the diarrhea can be relieved, so that the pathogenesis can be hit.

In the invention, the raw materials also preferably comprise codonopsis pilosula, radix astragali preparata, raw oyster, mother-of-pearl, red paeony root, white paeony root, rhizoma anemarrhenae and rhizoma alismatis. In the invention, the mass ratio of the selfheal to the scutellaria baicalensis, the moutan bark, the platycodon grandiflorum, the radix ranunculi ternate, the raw astragalus membranaceus, the codonopsis pilosula, the radix astragali preparata, the raw oyster, the nacre, the red peony root, the white peony root, the rhizoma anemarrhenae and the rhizoma alismatis is preferably 20-40: 10-30: 20-50: 10-30: 10-40: 10-30, and more preferably 30:28: 12:20:35:15:35: 18:15:25: 20. In the present invention, the composition is preferably effective in treating patients with stage HT transmethylation. In the invention, when the raw materials of the composition are selfheal, scutellaria baicalensis, moutan bark, platycodon grandiflorum, radix ranunculi ternati, raw astragalus, codonopsis pilosula, roasted astragalus, raw oyster, nacre, red paeony root, white paeony root, rhizoma anemarrhenae and rhizoma alismatis, the raw astragalus and the roasted astragalus are used as monarch drugs for tonifying middle-warmer energy; the selfheal has the effects of clearing liver, purging fire, dissipating stagnation and relieving swelling, the raw oyster can subdue yang and tonify yin, soften hardness and dissipate stagnation, and the nacre can subdue liver and subdue yang, and is used as a ministerial drug to play the effects of clearing liver, purging fire, softening hardness and dissipating stagnation; the scutellaria baicalensis has the effects of clearing heat and drying dampness, purging fire and removing toxicity, the cortex moutan has the effects of clearing heat and cooling blood, and activating blood and dissolving stasis, the rhizoma anemarrhenae has the effects of clearing heat and purging fire, promoting fluid production and moistening dryness, the radix ranunculi ternati has the effects of resolving masses and reducing swelling, the radix paeoniae rubra has the effects of clearing heat and cooling blood, the radix paeoniae alba has the effects of nourishing blood and softening liver, and the codonopsis pilosula has the effects of tonifying middle-jiao and Qi, and are used as adjuvant drugs together for enhancing the effects of soothing liver and clearing heat, and tonifying middle-jiao and Qi; alisma orientale, rhizoma alismatis clears heat and promotes diuresis, Platycodon grandiflorum, radix Platycodi relieves lung qi and relieves sore throat, and the two are used as guiding drugs together and aim at ascending and descending qi. The whole formula is used together, the ascending and descending of the middle energizer are realized, the tonifying and the purging are realized, and the pathogenesis is hit.

In the invention, the raw materials also preferably comprise radix bupleuri, red paeony root, white paeony root, raw oyster, albizia flower, rhizoma cyperi and rhizoma alismatis. In the invention, the mass optimal ratio of the selfheal to the scutellaria baicalensis, the moutan bark, the platycodon grandiflorum, the ternate buttercup root, the raw astragalus membranaceus, the radix bupleuri, the red paeony root, the white paeony root, the raw oyster, the albizia flower, the rhizoma cyperi and the rhizoma alismatis is 10-50: 5-40: 5-70: 5-60: 10-50: 10-70: 10-60: 5-60: 10-40, and the more optimal ratio is 30:28:20:15:25:55:25:15:15:30:30:15: 10. In the present invention, the composition is preferably effective in treating patients in the normotensive stage of HT. In the present invention, the cyperus tuber is preferably cyperus tuber. In the invention, when the raw materials are selfheal, scutellaria baicalensis, moutan bark, platycodon grandiflorum, ternate buttercup root, raw astragalus mongholicus, radix bupleuri, red paeony root, white paeony root, raw oyster, albizia flower, rhizoma cyperi and rhizoma alismatis, the selfheal is used as a key medicine for softening and resolving hard mass, and the treatment of thyroid diseases has a long history. It is mainly indicated in Shen nong Ben Cao Jing (Shen nong's herbal Jing) for cold and heat, scrofula, eczema, head fistula, mass, goiter and qi stagnation, and foot swelling and damp arthralgia. Pungent and bitter in flavor, cold in nature, liver and gallbladder meridians, clearing liver-fire, dissipating nodulation and relieving swelling. The three medicines are the essential medicines for soothing the liver and regulating the flow of qi: bupleurum root and cyperus tuber are mutually reinforced, and are mostly used for irritability and irritability; albizzia julibrissin Durazz is mostly used for depression and low mood. Baikal skullcap root, bark of peony root, root of herbaceous peony and radix paeoniae rubrathe are used to clear heat in the qi and blood system. For long-term stagnation of liver qi, spleen soil is not transported, and radix astragali is combined with radix Codonopsis and Atractylodis rhizoma to strengthen transportation and middle energizer; for stagnation of qi, phlegm-dampness accumulation is often seen, so mu Li and Mao Cao are added to resolve phlegm-resolving and hardness-softening herbs, and they are combined cold and warm to resolve tangible and invisible phlegm pathogen. Balloonflower root, radix Platycodi, being good at dispersing lung qi and resolving phlegm, can carry various herbs to ascend, so it is indicated for yellow, and ascends by the action of radix Platycodi to directly reach the diseased part. In the general formula, the selfheal is monarch, the radix bupleuri, the albizia flower and the rhizoma cyperi are ministerial, the radix scutellariae, the cortex moutan and the red white paeony root are ministerial, and the traditional Chinese medicine can disperse liver qi, clear liver heat and directly center the core pathogenesis; radix astragali, oyster, radix ranunculi ternati and rhizoma alismatis are used as adjuvants to strengthen spleen, reduce phlegm and soften hard masses; balloonflower root, radix Platycodi is used to guide the herbs upward. The whole formula is used together, the ascending and descending of the middle energizer are realized, the tonifying and the purging are realized, and the pathogenesis is hit.

The raw materials are not particularly limited in source, and the medicine can be prepared by using a commercially available medicine or a conventional preparation method.

The invention also provides a preparation method of the composition in the technical scheme, which comprises the following steps: soaking the raw materials in water, boiling with strong fire, and then decocting with slow fire for 30-40 min to obtain decoction as the composition. In the present invention, the mass of the water is preferably 2 to 4 times of the total mass of the raw materials. In the invention, the soaking time is preferably 30-60 min. In the invention, the soup is preferably concentrated to 150-200 ml, and the composition is obtained after concentration.

The invention also provides a preparation method of the composition in the technical scheme, which comprises the following steps: soaking the raw materials in water, decocting for 1.5-2 h, and drying the obtained decoction to obtain dry powder as the composition. In the present invention, the mass of the water is preferably 5 to 15 times of the total mass of the raw materials. In the invention, the soaking time is preferably 30-40 min. The method for drying is not particularly limited in the present invention, and a method for drying the decoction may be conventionally employed by those skilled in the art.

The invention also provides application of the composition in the technical scheme in preparation of a medicine for treating hashimoto's thyroiditis. In the present invention, the dosage form of the medicament preferably includes decoction, granules, capsules, tablets, pills or powder. The preparation method of the dosage form of the medicament is not particularly limited, and the medicament can be prepared by a person skilled in the art according to a conventional preparation method.

The technical solutions provided by the present invention are described in detail below with reference to examples, but they should not be construed as limiting the scope of the present invention.

Example 1

The medicine comprises the following components:

the pharmaceutical composition is as follows (in weight g): 20g of selfheal, 10g of platycodon grandiflorum, 35g of raw dragon bone, 20g of salvia miltiorrhiza, 35g of raw oyster, 20g of scutellaria baicalensis, 25g of moutan bark, 15g of rhizoma anemarrhenae, 50g of nacre, 15g of radix ranunculi ternati, 55g of dandelion, 10g of burdock, 100g of gypsum and 20g of raw astragalus membranaceus.

(II) the preparation method comprises the following steps:

decoction: weighing the raw materials according to the formula proportion, firstly adding water with the mass 3 times of that of the raw materials for soaking for 30min, then decocting with strong fire for boiling, then decocting with slow fire for 30min, and concentrating to 150ml to obtain decoction.

Example 2

The medicine comprises the following components:

the pharmaceutical composition is as follows (in weight g): 30g of selfheal, 12g of platycodon grandiflorum, 55g of raw dragon bone, 15g of salvia miltiorrhiza, 30g of raw oyster, 28g of scutellaria baicalensis, 28g of moutan bark, 25g of rhizoma anemarrhenae, 35g of nacre, 20g of radix ranunculi ternati, 65g of dandelion, 12g of burdock, 150g of gypsum and 15g of raw astragalus membranaceus.

(II) the preparation method comprises the following steps:

preparing granules: weighing raw material medicaments according to a formula proportion, decocting the raw material medicaments in water for 3 times, preferably soaking the raw materials in water which is 10 times of the mass of the raw materials each time for 60min, then decocting the raw materials for 1.5h, recovering the obtained water extract under reduced pressure, drying the water extract at a low temperature of below 60 ℃ in vacuum to obtain extract dry powder, concentrating the extract dry powder for convenient storage and subsequent use to obtain effective components, and finally preparing the effective components into clinically acceptable granules, wherein each bag of the granules is 40 g.

Example 3

The medicine comprises the following components:

the pharmaceutical composition is as follows (in weight g): 25g of selfheal, 25g of platycodon grandiflorum, 65g of crude dragon bone, 20g of salvia miltiorrhiza, 55g of crude oyster, 30g of scutellaria baicalensis, 30g of moutan bark, 28g of rhizoma anemarrhenae, 50g of nacre, 28g of ternate buttercup root, 50g of dandelion, 8g of burdock, 120g of gypsum and 30g of raw astragalus membranaceus.

(II) the preparation method comprises the following steps:

decoction: weighing the raw materials according to the formula proportion, firstly adding water with the mass 2 times of that of the raw materials for soaking for 40min, then decocting with strong fire for boiling, and then decocting with slow fire for 35min to obtain concentrated liquid medicine; adding equal amount of water, decocting for the second time, and mixing the two concentrated liquid medicines to obtain decoction.

Drug action example 1

General data:

a total of 27 patients with HT thyrotoxicosis were treated using the Chinese medicinal composition formulated in example 2, of which 3 were male and 24 were female. The patient with the longest course of disease is more than 5 years, and the patient with the shortest course of disease is 1 month.

(II) diagnosis standard:

according to the diagnosis standard in the Chinese guide for thyroid diseases diagnosis and treatment issued by the Chinese medical society:

HT: diffuse goiter, tough texture, positive serum TPOAb and TGAb, and can be used for diagnosis of HT.

Thyroid toxicosis stage: FT3 and FT4 increased and TSH decreased.

(III) treatment mode:

the Chinese medicinal composition is in the form of granule, and is administered 2 times daily, 1 bag each time, with boiled water, half an hour after breakfast and supper, and the treatment time is 3 months.

(IV) observation indexes:

thyroid-associated antibody: TPOAb, TGAb titers.

Thyroid hormone: TT3, TT4, FT3, FT4, TSH.

(V) statistical method:

a nonparametric test was used, described by the median (interquartile range) M (P25P 75), and statistical significance was given by P < 0.05.

(VI) the observations are shown in tables 1 and 2:

table 127 results of TPOAb, TGAb titer levels after patient treatment

TABLE 227 results of TT3, TT4, FT3, FT4, TSH levels after treatment of patients

(VII) treatment effects:

the titer of TPOAb and TGAb is compared with that of TPOAb and TGAb before and after treatment of 27 patients, and the TPOAb and the TGAb are in a descending trend; thyroid hormones TT3, TT4, FT3, FT4 and TSH also show a descending trend before and after treatment; the invention can effectively relieve the relevant indexes of patients in HT thyrotoxicosis stage.

Drug action example 2

The female, 30 years old, has more than 1 year of diagnosis of neck enlargement, with the symptoms: thick neck, red eyes, swollen eyes, tremor of both hands, irritability, bitter taste, thirst with profuse drinking, aversion to heat, hyperhidrosis, occasional palpitation, sticky stool in one day, good sleep, red tongue with yellow coating, tooth marks on the edge, and wiry and rapid pulse. Physical examination: the thyroid gland is swollen at II degree and has a slightly tough texture. Sunken edema of both lower limbs. Thyroid function: 2.28ng/mL of total triiodothyronine (TT3), 13.04. mu.g/dL of total thyroxine (TT4), 8.99pg/mL of free triiodothyronine (FT3), 3.68ng/dL of free thyroxine (FT4), 0.00. mu.IU/mL of Thyrotropin (TSH), and (+) -antithyroid peroxidase autoantibody (TPOAb). Thyroid B-mode ultrasound recall: bilateral goiter and diffuse lesion. And (3) diagnosis: hashimoto's thyroiditis (thyrotoxicosis stage)

The decoction of the invention in the embodiment 1 is taken 2 times a day after half an hour of a morning and evening meal. The methimazole tablets are taken 30mg/d on empty stomach; order a low iodine diet and review thyroid function after half a month.

And B, diagnosis: the neck is thick and big, the emotion is controllable, the dry heat sensation is obviously relieved earlier, the lower limb is slightly edematous,

tremor of both hands, no sweating, no palpitation, palpitations, good sleep, improved defecation, proper stool quality, urinary incontinence, red tongue with thin and yellow coating, tooth marks on the tongue edge, and wiry and rapid pulse. Taking the above medicine sequentially, taking methimazole tablet at the same time, and taking low-iodine diet.

Three diagnoses: the patients have mild emotion, no dry heat sensation, no obvious change of thick neck, reduced edema of lower limbs, palpitation, no obvious trembling of hands, easy sleep, convenient adjustment, pale red tongue with thin and white fur and wiry pulse. And (4) reexamining thyroid function: TT3, TT4 normal, FT34.72pg/mL, FT41.95ng/dL, TSH0.00 μ IU/mL, TPOAb (+). Taking 14 doses sequentially, and taking the above medicines in the same way, wherein the dosage of the methimazole tablet is reduced, and the dosage is 20mg/d, and the diet is low in iodine.

Four diagnosis: the neck becomes thin, the lower limbs have no obvious edema, no palpitation, no dry heat feeling, easy sleep, convenient adjustment, pale red tongue with thin and white tongue coating and wiry pulse. Thyroid function was reviewed TSH 0.00. mu.IU/mL, TPOAb (+). Taking 14 doses sequentially, the dosage of the above medicines is reduced, the dosage of the medicine is 10mg/d, and the medicine is taken with low iodine.

Five diagnoses: the improvement of various indexes of thyroid function is rechecked, and all symptoms are improved after the traditional Chinese medicine is continuously taken for half a month. After 1 month, stop taking the traditional Chinese medicine, advocate to avoid excessive fatigue at ordinary times, pay attention to harmonize emotion, keep a light and balanced low-iodine diet, and check again at regular intervals.

Example 4

The medicine comprises the following components:

the pharmaceutical composition is as follows (in weight g): 20g of selfheal, 10g of platycodon grandiflorum, 20g of codonopsis pilosula, 30g of raw astragalus membranaceus, 30g of radix astragali preparata, 30g of raw oyster, 15g of scutellaria baicalensis, 15g of moutan bark, 20g of nacre, 15g of ternate buttercup root, 10g of red paeony root, 10g of white paeony root, 15g of rhizoma anemarrhenae and 10g of rhizoma alismatis.

(II) the preparation method comprises the following steps:

decoction: weighing the raw materials according to the formula proportion, firstly adding water with the mass 3 times of that of the raw materials for soaking for 40min, then decocting with strong fire for boiling, then decocting with slow fire for 30min, and concentrating to 150ml to obtain decoction.

Example 5

The medicine comprises the following components:

the pharmaceutical composition is as follows (in weight g): 30g of selfheal, 12g of platycodon grandiflorum, 15g of codonopsis pilosula, 35g of raw astragalus membranaceus, 35g of radix astragali preparata, 30g of raw oyster, 28g of scutellaria baicalensis, 28g of moutan bark, 35g of nacre, 20g of ternate buttercup root, 18g of red paeony root, 15g of white paeony root, 25g of rhizoma anemarrhenae and 20g of rhizoma alismatis.

(II) the preparation method comprises the following steps:

Example 6

The medicine comprises the following components:

the pharmaceutical composition is as follows (in weight g): 35g of selfheal, 20g of platycodon grandiflorum, 20g of codonopsis pilosula, 40g of raw astragalus membranaceus, 40g of radix astragali preparata, 40g of raw oyster, 20g of scutellaria baicalensis, 20g of moutan bark, 40g of nacre, 25g of ternate buttercup root, 25g of red paeony root, 25g of white paeony root, 18g of rhizoma anemarrhenae and 20g of rhizoma alismatis.

(II) a preparation process:

decoction: weighing the raw materials according to the formula proportion, firstly adding water with the mass 2 times of that of the raw materials for soaking for 40min, then decocting with strong fire for boiling, then decocting with slow fire for 35min, and concentrating to 150ml to obtain concentrated liquid medicine; adding equal amount of water, decocting for the second time, and mixing the two concentrated liquid medicines to obtain decoction.

Drug effect example 3

General data:

92 patients with HT hypothyroidism were treated with the Chinese medicinal composition prepared in example 2 of the present invention, 4 of which were male, 88 of which were female, and the average age was 42.61 years.

(II) diagnosis standard:

diffuse goiter, tough texture, positive serum TPOAb and TGAb, and can be used for diagnosis of HT.

Hypothyroidism: thyrotropin (TSH) is elevated with a concomitant decrease in free thyroxine (FT 4).

(III) treatment mode:

The levothyroxine sodium tablet (Youmele) is treated according to the hypothyroidism condition.

(IV) observation indexes:

thyroid associated antibody TPOAb, TGAb titers.

Thyroid hormone: TT3, TT4, FT3, FT4, TSH.

(V) statistical method:

the DAY of the group (DAY 0), DAY 28 after treatment (DAY 28), and DAY 56 after treatment (DAY 28) were recorded and counted, respectively 56) And DAY84 after treatment (DAY 84).The Mauchly sphere test is carried out by adopting a single-group repeated measurement method, and the statistical significance is that P is less than 0.05.

(VI) the observations are shown in tables 3-7:

TABLE 3 comparison of the results of 92 patients before and after treatment with Youmele dose

TABLE 4 reduction of Youmele dose in 92 patients before and after treatment

TABLE 5 TSH recovery in 92 patients before and after treatment

TABLE 6 TPOAb recovery in 92 patients before and after treatment

TABLE 7 TGAb recovery before and after treatment in 92 patients

(VII) treatment effects:

the comparison of the TPOAb titer and the TGAb titer shows a descending trend before and after the treatment of 92 patients; the use amount of Youmeile can be obviously reduced after the traditional Chinese medicine is dried for most patients; TSH is obviously reduced compared with that before treatment, and can effectively relieve hashimoto's thyroiditis.

Drug effect example 4

Patient, woman, 30 years old, complaint: the cervical swelling is uncomfortable for more than 1 year, phlegm exists in the pharynx voluntarily, cough cannot appear, the pharynx cannot descend, intolerance of cold and cold limbs, soreness and weakness of waist and knees, chest distress and palpitation, mental fatigue and hypodynamia, scanty menstruation, menostaxis, sunken edema of both lower limbs, purple dark tongue quality, white fur, deep pulse, capability of receiving, poor sleep and convenient adjustment. Nine examinations were performed: 2.04ng/mL (reference value range 0.66-1.61 ng/mL) of total triiodothyronine (TT3), 10.24 μ g/dL (reference value range 5.44-11.85 μ g/dL) of total thyroxine (TT4), 3.15pg/mL (reference value range 2.14-4.27 pg/mL) of free triiodothyronine (FT3), 0.51ng/dL (reference value range 0.59-1.25 ng/dL) of free thyroxine (FT4), 23.22 μ IU/mL (reference value range 0.49-4.91 μ IU/mL) of Thyrotropin (TSH), antithyroid peroxidase antibody (TPOAb)>600IU/mL (reference value range 0-34 IU/mL), thyroglobulin antibody (TGAb)842.3IU/mL (reference value range 0-115 IU/mL), thyroid stimulating receptor antibody (TRAb)<0.300IU/L (reference value range is 0-1.75 IU/L); and (3) carrying out thyroid ultrasound: for diffuse thyroid disease, please bind Jiagong. And (3) Western diagnosis: qianbe's thyroiditis (hypothyroidism stage)Hypothyroidism. Traditional Chinese medical diagnosisBreaking: goiter, syndrome differentiation: stagnation of liver Qi and yang deficiency of spleen and kidney. Therapeutic principle: soothing the liver, strengthening the spleen and warming yang.

The pharmaceutical composition of example 4 of the present invention was administered 2 times daily, half an hour after breakfast and supper. Youmele 25 μ g, 1/d, and the re-diagnosis after 2 weeks.

And B, diagnosis: after the medicine is taken for 2 weeks, the mental fatigue and the fatigue are relieved, the edema of the lower limbs and the lower limbs is obviously improved, the neck is still felt to be swollen and uncomfortable, the sleep is not good, the tongue coating is white and dry, and the pulse is deep. The 14 doses are taken sequentially, and the dosage of western medicines is kept unchanged before the administration.

Three diagnoses: the symptoms of hypodynamia and intolerance of cold are obviously relieved, the sleep is improved, and the symptoms of cold hands and feet, dark red tongue, white fur and deep pulse are seen. The upper 14 doses are taken sequentially, and the administration is the same as before.

Four diagnosis: the emotion is obviously improved compared with the emotion before, the throat is still felt to be swollen, dry throat, dry mouth and bitter mouth in the morning, hypodynamia is improved, cold limbs are improved, the two lower limbs are still slightly edematous, the tongue tip is red, the tongue fur is thin and white, and the pulse is smooth. Rechecking the Jiagong: TT32.26ng/mL, TPOAb >600IU/mL, TGAb990.9IU/mL, the rest are in the normal range. And (3) reviewing thyroid ultrasonography: diffuse thyroid lesion. The upper 14 doses are taken sequentially, the dosage of the Youmele is adjusted to 12.5 mu g before the administration, the Youmele is taken every other day, and the doctor is retested after 2 weeks.

Five diagnoses: the prescription takes 14 doses of the recipe successively, and adjusts the Youmei 2 times a week with 12.5 mug each time. The treatment is repeated after 2 weeks.

Six diagnoses: the patients have no self-description of feelings of hypodynamia, aversion to cold, soreness and weakness of waist and knees, chest distress, chest fullness and distention, normal color of menses, steady emotion, no edema of both lower limbs, red tongue with thin and white coating, and deep and forceful pulse. Rechecking the Jiagong: TPOAb, TGAb values are above the normal range.

Example 7

The medicine comprises the following components:

the pharmaceutical composition is as follows (in weight g): 30g of selfheal, 20g of radix bupleuri, 30g of radix scutellariae, 15g of radix paeoniae rubra, 15g of radix paeoniae alba, 50g of raw oyster, 20g of cortex moutan, 30g of flos albiziae, 15g of platycodon grandiflorum, 30g of radix ranunculi ternate, 15g of prepared rhizoma cyperi, 50g of raw radix astragali and 10g of rhizoma alismatis.

(II) the preparation method comprises the following steps:

decoction: weighing the raw materials according to the formula proportion, firstly adding water with the mass 3 times of that of the raw materials for soaking for 30min, then decocting with strong fire for boiling, then decocting with slow fire for 30min, and concentrating to 200ml to obtain decoction.

Example 8

The medicine comprises the following components:

the pharmaceutical composition is as follows (in weight g): 30g of selfheal, 25g of radix bupleuri, 28g of radix scutellariae, 15g of radix paeoniae rubra, 15g of radix paeoniae alba, 30g of raw oyster, 20g of cortex moutan, 30g of flos albiziae, 15g of platycodon grandiflorum, 25g of radix ranunculi ternate, 15g of prepared rhizoma cyperi, 55g of raw radix astragali and 10g of rhizoma alismatis.

(II) the preparation method comprises the following steps:

preparing granules: weighing raw material medicaments according to a formula proportion, decocting the raw material medicaments in water for 3 times, preferably soaking the raw materials in water which is 10 times of the mass of the raw materials each time, soaking for 60min, then decocting for 1.5h, recovering the obtained water extract under reduced pressure, carrying out vacuum drying treatment at a low temperature of below 60 ℃ to obtain extract dry powder, conveniently storing and subsequently using the extract dry powder for concentration to obtain effective components, and finally preparing the effective components into clinically acceptable granules, wherein each packet of granules is 35 g.

Example 9

The medicine comprises the following components:

the pharmaceutical composition is as follows (in weight g): 15g of selfheal, 10g of radix bupleuri, 15g of radix scutellariae, 12g of radix paeoniae rubra, 12g of radix paeoniae alba, 15g of raw oyster, 10g of cortex moutan, 15g of flos albiziae, 18g of platycodon grandiflorum, 10g of radix ranunculi ternate, 10g of prepared rhizoma cyperi, 30g of raw radix astragali and 20g of rhizoma alismatis.

(II) the preparation method comprises the following steps:

Drug action example 5

General data:

60 patients with normal nail function and hypothyroidism HT (4 in males and 56 in females) with age 18-67 years are treated by using the traditional Chinese medicine composition prepared in the preparation method of the embodiment 8 of the invention.

(II) diagnosis standard:

(III) treatment mode:

(IV) observation indexes:

thyroid associated antibody TPOAb, TGAb titers.

(V) statistical method:

the data were corrected using Mauchly sphericity test, and if not, Greenhouse-Geisser correction, and antibody titers were compared using multiple measurement analysis of variance.

(VI) the observations are shown in tables 8-9 and FIGS. 1-2:

TABLE 860 patient Pre-treatment TPOAb Titer levels

TABLE 960 patient Pre-treatment TGAb Titer levels

As can be seen in FIG. 1, TPOAb titers were significantly reduced in 60 patients treated with the present invention. As can be seen from FIG. 2, TGAb titers were significantly reduced in 60 patients treated with the present invention.

(VII) treatment effects:

comparison of the titer of TPOAb and the titer of TGAb before and after treatment of 60 patients shows a descending trend, and can effectively relieve hashimoto's thyroiditis.

Drug effect example 6

A certain female is 34 years old, has discomfort in the front of the neck, is reluctant in emotion, is easy to fatigue, has shortness of breath and no speaking desire, is occasionally stuffy in chest and has normal defecation. Thyroid gland I degree swelling, slightly tough quality and no tenderness. A red tongue with thin and white coating and a wiry and slippery pulse. First work: TPOAb 78.24U/mL, TGAb 175.30U/mL. And (3) diagnosis: hashimoto's thyroiditis (stage of hypothyroidism).

The pharmaceutical composition of the embodiment 8 is used, the dosage form is granules, the granules are taken with boiled water, 1 bag is taken each time, 2 times a day, and half an hour after breakfast and supper.

After 1 treatment course, the emotion of the patient is obviously improved, and fatigue and weakness are relieved. A red tongue with thin and white coating and a wiry pulse. Rechecking the Jiagong: TPOAb 68.43U/mL, TGAb 126.26U/mL.

After 2 treatment courses, the patient has no obvious discomfort, stable emotion, fatigue alleviation, red tongue and wiry pulse. Rechecking the Jiagong: TPOAb 41.68U/mL, TGAb 73.25U/mL.

After 3 treatment courses, the patients have stable emotion and no obvious fatigue and weakness, and the first disease is rechecked: TPOAb 27.57U/mL, TGAb 29.97U/mL. (reference values: TPOAb 0-34U/mL, TGAb 0-115U/mL).

Drug effect example 7

For a female, the female is 40 years old, the neck is swollen and uncomfortable for more than 3 years, the female is neutral in spirit, tired in spirit, poor appetite, unsmooth defecation, pale red tongue with white greasy coating and deep pulse. Thyroid gland with swelling degree II, slightly tough quality and no tenderness. First work: TPOAb 13U/mL, TGAb 340U/mL. And (3) diagnosis: hashimoto's thyroiditis(Jiagong Normal phase)。

After 1 treatment course, the emotion of the patient is better than before, fatigue and weakness are relieved, neck discomfort still exists, and defecation is smooth. A red tongue with thin and white coating and a deep pulse. Rechecking the Jiagong: TPOAb 18.03U/mL, TGAb 242.3U/mL.

After 2 treatment courses, the emotion of the patient is stable, the discomfort of the neck is relieved earlier, the mental fatigue and the fatigue are relieved, and the patient can take the medicine for two times and is convenient to adjust. A red, thin and white tongue with a slippery pulse. Rechecking the Jiagong: TPOAb 12U/mL, TGAb 183.6U/mL

The embodiment can show that in the clinical application process, the pharmaceutical composition is widely accepted by patients due to safety and effectiveness, and has good application and popularization prospects.

The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.

Claims

1. A composition for treating hashimoto's thyroiditis is prepared from the following raw materials: prunellae Spica, Scutellariae radix, cortex moutan, radix Platycodi, radix Ranunculi Ternati and radix astragali.

2. The composition of claim 1, wherein said raw materials further comprise raw Os Draconis, radix Salviae Miltiorrhizae, raw Concha Ostreae, rhizoma anemarrhenae, Concha Margaritifera, herba Taraxaci, fructus Arctii, and Gypsum Fibrosum.

3. The composition according to claim 2, wherein the mass ratio of the selfheal to the scutellaria baicalensis, the moutan bark to the platycodon grandiflorum to the radix ranunculi ternati, the raw astragalus membranaceus to the raw keel, the salvia miltiorrhiza to the radix salviae miltiorrhizae, the raw oyster to the rhizoma anemarrhenae to the nacre to the dandelion to the burdock to the gypsum is 20-40: 20-50: 10-30: 30-70: 10-40: 20-50: 50-70: 5-20: 100-200.

4. The composition of claim 1, wherein said materials further comprise codonopsis pilosula, astragalus membranaceus preparata, raw oyster, mother-of-pearl, red peony root, white peony root, anemarrhena, and alisma orientale.

5. The composition according to claim 4, wherein the mass ratio of the selfheal to the scutellaria baicalensis, the moutan bark to the platycodon grandiflorum to the radix ranunculi ternati, the raw astragalus membranaceus to the codonopsis pilosula, the radix astragali preparata to the oyster to the nacre to the mother of pearl to the red peony root to the white peony root, the rhizoma anemarrhenae to the rhizoma alismatis is 20-40: 10-30: 10-40: 20-50: 10-30: 10-40: 10-30.

6. The composition of claim 1, wherein the raw materials further comprise bupleurum, red peony root, white peony root, raw oyster shell, albizia flower, cyperus rotundus and alisma orientale.

7. The composition according to claim 6, wherein the mass ratio of the selfheal to the scutellaria baicalensis, the moutan bark to the platycodon grandiflorum to the ternate buttercup root, the radix astragali to the radix bupleuri, the radix paeoniae rubra to the radix paeoniae alba to the raw oyster shell, the flos albiziae to the rhizoma cyperi to the rhizoma alismatis is 10-50: 5-40: 10-50: 10-40: 5-50: 10-70: 5-60: 10-50: 10-70: 10-60: 5-60: 10-40.

8. A process for the preparation of a composition according to any one of claims 1 to 7, characterized in that it comprises the following steps: soaking the raw materials in water, boiling with strong fire, and then decocting with slow fire for 30-40 min to obtain decoction as the composition.

9. A process for the preparation of a composition according to any one of claims 1 to 7, characterized in that it comprises the following steps: soaking the raw materials in water, decocting for 1.5-2 h, and drying the obtained decoction to obtain dry powder as the composition.

10. Use of a composition according to any one of claims 1 to 7 in the manufacture of a medicament for the treatment of hashimoto's thyroiditis.