CN114159516B - Traditional Chinese medicine composition for preventing and treating hashimoto thyroiditis and application thereof - Google Patents

Traditional Chinese medicine composition for preventing and treating hashimoto thyroiditis and application thereof Download PDF

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CN114159516B
CN114159516B CN202010950834.4A CN202010950834A CN114159516B CN 114159516 B CN114159516 B CN 114159516B CN 202010950834 A CN202010950834 A CN 202010950834A CN 114159516 B CN114159516 B CN 114159516B
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杨雪军
杨涛
杨茗橘
程芬
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Shanghai Resurrection Stone Medical Technology Co ltd
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Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating hashimoto thyroiditis, which is prepared from the following raw materials in parts by weight: 1-30 parts of fritillaria cirrhosa, 1-30 parts of smilax glabra, 1-18 parts of ginseng and 1-30 parts of selfheal. In addition, the invention also discloses application of the traditional Chinese medicine composition in preparing medicines and health care products for preventing and treating hashimoto thyroiditis. Proved by experimental animals and clinical trial, the traditional Chinese medicine composition has the advantages of good safety and good curative effect, can prevent and treat hashimoto thyroiditis, improve fatigue of patients and improve life quality of the patients. The traditional Chinese medicine composition is a traditional Chinese medicine with good effect of improving clinical symptoms and good clinical application prospect.

Description

Traditional Chinese medicine composition for preventing and treating hashimoto thyroiditis and application thereof
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for preventing hashimoto thyroiditis.
Background
Hashimoto's thyroiditis (HT for short), also known as chronic lymphocytic thyroiditis (chronic lymphocytic thyroiditis, CLT), autoimmune thyroiditis and Hashimoto's thyroiditis. Is a clinically common autoimmune thyroid disease (AITD), the most common cause of hypothyroidism, the main phenotype is immune diseases characterized by massive lymphocyte infiltration into thyroid tissues and follicular cell destruction, and serological tests are shown by significant increases in the concentration of thyroperoxidase antibodies (TPOAb), thyroglobulin antibodies (TgAb) and free thyroxine (FT 4). The disease has hidden onset, can have no typical clinical symptoms at the beginning, has thyrotoxicosis in a few patients, has goiter in the progress, and finally has hypothyroidism in the development direction. HT occurs in women aged 30-50 years, and the proportion of men and women is about 1:8, and the explanation of the etiology of the HT is not clear in modern medicine. HT is about 5% in caucasians, about 1.6% domestic, adult prevalence is far higher than in minors, female prevalence is higher than in men, and the prevalence increases with age. The occurrence of hashimoto thyroiditis is thought to be associated with a variety of factors including genetics, trace elements, infection, nutrition, gender, mental stress, immunity, radiation exposure, fetal microchimerism, and the like. Along with the continuous improvement of the prevalence rate and the detection rate of the thyroiditis in China, the prevention and treatment of the thyroiditis become urgent.
At present, the Western medicine mainly adopts treatment means including glucocorticoid treatment, chemokine receptor antagonist treatment, nutrition treatment, operation and the like to relieve local thyroid symptoms, but has poor curative effect on systemic symptoms of patients. Among them, the most conventional therapy is hormone replacement therapy, and the hormone has no immunomodulatory effect, cannot reduce thyroid autoantibody titer, and patients need to take medicine for life. And secondly, patients need continuous physical examination, the dosage of hormone is adjusted according to the index of thyroid function, adverse reactions are more, and medicine stopping is easy to be repeated.
The pathogenesis of HT in the theory of traditional Chinese medicine should be attributed to four aspects of constitution factors, diet water and soil, emotional disturbance and internal injury due to overstrain. The pathological mechanism is that pathological products such as phlegm coagulation, blood stasis, hepatitis and the like are caused to occur on the neck by qi stagnation and phlegm coagulation, qi deficiency and blood stasis and liver depression transforming into fire, so that thyroid gland dysfunction and even enlargement (called goiter in traditional Chinese medicine) are caused. The traditional Chinese medicine has the advantages of treating both symptoms and root causes, improving symptoms, regulating immune function, having small side effect, being not easy to relapse and the like in the aspect of treating thyroid diseases.
The research is an improvement based on the earlier-stage patent application (patent application number 201810888640.9), and the traditional Chinese medicine comprises single or multiple medicines such as fritillaria, smilax, tripterygium wilfordii, selfheal and the like. During the earlier application of patent application number 201810888640.9, the party was found to have the following three disadvantages: (1) because of the certain liver toxicity of the tripterygium wilfordii, some liver injuries are found in animal experiments. (2) Because the hashimoto thyroiditis patients have symptoms of qi deficiency, the patients generally show strong fatigue, the symptoms of qi deficiency of the patients cannot be relieved by the prescription, and (3) the treatment period of the prescription is longer, and the time for 6 months is required. Therefore, the patent improves and optimizes the prior patent, so that the safety and the effectiveness of the prior patent are greatly improved, and particularly three aspects of reducing liver injury, reducing fatigue of patients and shortening treatment time are obviously improved compared with the prior patent.
Disclosure of Invention
The invention aims to solve the technical problem of providing the traditional Chinese medicine composition for preventing and treating hashimoto thyroiditis, which has great improvement in safety and effectiveness, and particularly can reduce liver injury, reduce fatigue of patients and shorten treatment time.
The second technical problem to be solved by the invention is to provide an application of the traditional Chinese medicine composition.
In one aspect of the invention, a traditional Chinese medicine composition for preventing and treating hashimoto thyroiditis is provided, and the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 1-30 parts of fritillaria cirrhosa, 1-30 parts of smilax glabra, 1-18 parts of ginseng and 1-30 parts of selfheal. Wherein, the most preferable weight part ratio is: 15 parts of fritillaria cirrhosa, 15 parts of smilax glabra, 9 parts of ginseng and 15 parts of selfheal.
The traditional Chinese medicine adopted by the invention has definite curative effect, safety and reliability, obvious curative effect and obviously shortened treatment time compared with the prior patent application (patent application number 201810888640.9). The Bulbus Fritillariae Cirrhosae is a dried bulb of Bulbus Fritillariae Cirrhosae Fritillaria cirrhosa D.don, bulbus Fritillariae Ussuriensis Fritillaria unibracteata Hsiao et K.C.Hsia, bulbus Fritillariae Gansuensis Fritillaria przezvalskii maxim, bulbus Fritillariae Thunbergii Fritillaria delavayi Franch, bulbus Fritillariae Thunbergii Fritillaria taipaiensis P.Y.Li or Bulbus Fritillariae Cirrhosae Fritillaria unibracteata Hsiao et K.C Hsiavan wabuensis (Y.Tang et S.C.Yue) Z.D.Liu, S.Wan g et S.C.C.h e n of Liliaceae described in Chinese pharmacopoeia (2015). Ginseng is derived from plants of the araliaceae family (Tripterygium wilfordii hook.f.). Spica Prunellae is a dry ear of Prunella vulgaris Prunella vulgaris L belonging to Labiatae, and rhizoma Smilacis chinensis is a rhizome of Smilax china L belonging to Liliaceae.
The traditional Chinese medicine composition is a traditional Chinese medicine compound which is clinically applied according to a reasonable formula of the traditional Chinese medicine theory, wherein the fritillaria cirrhosa can eliminate phlegm and dissipate stagnation; the chinaroot greenbrier rhizome has the functions of dispelling wind and removing blood stasis, and the ginseng has the functions of invigorating primordial qi, clearing heat and detoxicating, and the four medicines of clearing away heat and toxic materials are combined to relieve qi deficiency and qi stagnation and phlegm coagulation of the thyroiditis. The whole prescription combination can eliminate phlegm and remove blood stasis, tonify qi, activate blood and dissipate stagnation, is used for treating qi stagnation and phlegm coagulation, and has good curative effect on clinical superficiality and bridge thyroiditis.
The traditional Chinese medicine composition can be directly or after being extracted and processed, can be prepared into various traditional Chinese medicine oral administration conventional medicaments with pharmaceutically acceptable medicine carriers according to a conventional method in the field and is used for preventing and treating hashimoto thyroiditis. The extraction process may use a traditional Chinese medicine extraction method known in the prior art, such as, but not limited to, a solvent extraction method, a steam distillation method, a solvent extraction method (including but not limited to methanol, ethanol, acetone, etc.), a sublimation method, a supercritical extraction method, etc.
The pharmaceutical formulation may be in any pharmaceutically acceptable dosage form, including: tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, capsules, hard capsules, soft capsules, oral liquids, buccal agents, granules, medicinal granules, pills, powders, pastes, pellets, suspensions, powders, solutions, injections, suppositories, ointments, plasters, creams, sprays, drops and patches; preferred are oral dosage forms, such as: capsules, tablets, oral liquid, granules, pills, powder, pills, paste and the like. The oral dosage form may contain conventional excipients such as binders, fillers, diluents, tabletting agents, lubricants, disintegrants, colorants, flavors and wetting agents, and if necessary, the tablets may be coated. Suitable fillers include cellulose, mannitol, lactose and other similar fillers; suitable disintegrants include starch, polyvinylpyrrolidone and starch derivatives, such as sodium starch glycolate; suitable lubricants include, for example, magnesium stearate. Suitable pharmaceutically acceptable wetting agents include sodium lauryl sulfate and the like.
The second aspect of the invention provides application of the traditional Chinese medicine in preparing medicines and health care products for preventing and treating hashimoto thyroiditis.
Animal experiment results prove that the traditional Chinese medicine composition has obvious effect of treating hashimoto thyroiditis, and is remarkably improved in safety and effectiveness compared with patent application 201810888640.9. The traditional Chinese medicine composition disclosed by the invention not only can treat hashimoto thyroiditis, but also can increase the load swimming time of a model mouse, so that the traditional Chinese medicine composition can obviously increase the endurance of the model mouse and relieve the fatigue of the model mouse, and the combination of fritillary bulb, chinaroot greenbrier rhizome, selfheal and ginseng plays a synergistic effect, so that unexpected technical effects are achieved. Clinical experiment results show that the traditional Chinese medicine composition has remarkable curative effect on hashimoto thyroiditis, and compared with patent application 201810888640.9, the traditional Chinese medicine composition can effectively improve fatigue of patients, reduce liver injury, shorten treatment period and achieve unexpected technical effects.
Drawings
FIG. 1 is a comparative schematic diagram of HE staining results in test example 1 according to the present invention. Of these, FIG. 1A represents ZHW, FIG. 1B represents ZHW-D, and FIG. 1C represents the positive drug group.
Detailed Description
The invention will be further illustrated with reference to specific examples. It is to be understood that these examples are illustrative of the present invention and are not intended to limit the scope of the present invention. The experimental procedures, which do not address the specific conditions in the examples below, are generally carried out under conventional conditions or under conditions recommended by the manufacturer. All percentages, ratios, proportions, or parts are by weight unless otherwise indicated.
Example 1: oral liquid
The raw materials are taken according to the following weight proportion: 300 g of fritillaria cirrhosa, 300 g of chinaroot greenbrier rhizome, 180 g of ginseng and 300 g of selfheal. Decocting the above four materials with water for 2 times, boiling for 1 hr, adding 8 times of water for the first time and 6 times of water for the second time, mixing the decoctions, cooling at 3000rpm for 10 min, centrifuging to remove supernatant, concentrating, adding appropriate adjuvant, making into oral liquid 1L according to the known method, and packaging with 10ml per bottle to obtain the final product for oral administration for 3 times per day, 1 bottle per time.
Example 2: granule preparation
The raw materials are taken according to the following weight proportion: 300 g of fritillaria cirrhosa, 300 g of chinaroot greenbrier rhizome, 180 g of ginseng and 300 g of selfheal. Decocting the above four materials with water for 2 times, boiling for 1 hr, adding 8 times of water for the first time and 6 times of water for the second time, mixing decoctions, cooling at 3000rpm for 10 min, removing supernatant, concentrating to obtain extract with specific gravity of 1.35, adding appropriate amount of dextrin and sugar powder, drying at 70deg.C, granulating into 1000g granules, and packaging 5g per bag for 3 times per day for 1 bag.
Example 3: tablet formulation
The raw materials are taken according to the following weight proportion: 300 g of fritillaria cirrhosa, 300 g of chinaroot greenbrier rhizome, 180 g of ginseng and 300 g of selfheal. Decocting the above four materials with water for 2 times, boiling for 1 hr, adding 8 times of water for the first time and 6 times of water for the second time, mixing the decoctions, cooling at 3000rpm for 10 min, collecting supernatant, concentrating to obtain dry extract, and making into tablet (0.3 g each tablet) for 3 times daily for 3 tablets.
Example 4: pill
The raw materials are taken according to the following weight proportion: 300 g of fritillaria cirrhosa, 300 g of chinaroot greenbrier rhizome, 180 g of ginseng and 300 g of selfheal. Pulverizing the Chinese medicinal materials into fine powder, and adding appropriate amount of adjuvants. Then the water-honeyed pill 3000 granules are prepared according to the known method in the prior art, each granule is 0.5 g, and the oral administration is carried out 3 times a day, and each granule is 5. Example 5: decoction
The six traditional Chinese medicine compound compositions for treating hashimoto thyroiditis are prepared by weighing raw materials according to the weight ratio provided in table 1, and respectively forming five traditional Chinese medicine compound compositions of compound A, compound B, compound C, compound D and compound E. The formula is shown in Table 1, the decoction is carried out for 2 times by adding a proper amount of water, the dosage is 100 g for each time, the boiling is carried out for 1 hour each time, and after the decoction is finished, the two decoction are combined, and the taking method is as follows: is taken twice a day. Alternatively, it can be concentrated and dried to obtain dry extract.
TABLE 1 five Chinese medicinal compound composition forms
Compound recipe Substance (B) Proportion of the amount of the used
Compound A Fritillaria cirrhosa, smilax glabra, ginseng and selfheal 1:1:18:30
Compound B Fritillaria cirrhosa, smilax glabra, ginseng and selfheal 30:30:1:1
Compound C Fritillaria cirrhosa, smilax glabra, ginseng and selfheal 15:15:9:15
Compound D Fritillaria cirrhosa, smilax glabra, ginseng and selfheal 5:5:9:15
Compound E Fritillaria cirrhosa, smilax glabra, ginseng and selfheal 30:1:1:30
Compound F Fritillaria cirrhosa, smilax glabra, ginseng and selfheal 1:30:18:1
The following test examples prove the efficacy of the traditional Chinese medicine:
test example 1: the invention relates to a research on curative effect and hepatotoxicity of a traditional Chinese medicine composition
The raw materials are taken according to the following weight proportion: 300 g of fritillaria cirrhosa, 300 g of chinaroot greenbrier rhizome, 180 g of ginseng and 300 g of selfheal. Decocting with water for 2 times, boiling for 1 hr each time, mixing decoctions, concentrating under reduced pressure, and lyophilizing to obtain dry powder (ZHW). In addition, 240 parts of fritillaria cirrhosa, 60 parts of smilax glabra, 30 parts of tripterygium wilfordii and 60 parts of selfheal (fritillaria cirrhosa: smilax glabra: tripterygium wilfordii: selfheal ratio of 8:2:1:2) are selected as the optimal ratio prescription of patent application number 201810888640.9, extracted and dried according to the sample prescription to be used as a control composition (ZHW-D).
SPF-grade Kunming mice (females, weighing 14-16 g, purchased from Shanghai Sipule-BiKai laboratory animal Co., ltd.) were used as laboratory animals. All mice were randomly divided into 2 groups: blank (12) and model (84), wherein the model group adopts a subcutaneous multipoint injection thyroglobulin (PTg) antigen periodate method to prepare a hashimoto thyroiditis mouse model. Model group mice were subcutaneously multi-injected with 0.2 mL/dose of complete freund's adjuvant antigen containing PTg (0.25 mg/mL) for 2 consecutive weeks, 1 time per week. The injection was performed subcutaneously with PTg (0.25 mg/mL) of incomplete Freund's adjuvant antigen 0.2 mL/dose from week 3, 3 weeks in succession, 1 time a week. The whole experimental cycle model group and drug group mice were given 0.05% of the high-iodine drinking water daily and were carefully protected from light.
After the bridge thyroiditis mice model is established, the model mice are randomly divided into a model group, a positive medicine group (tripterygium glycosides tablet 0.2mg/kg body weight, produced by Huangshi Feiyun pharmaceutical Co., ltd.), a ZHW group (according to crude drug 2.5g/kg body weight), a ZHW-D group (according to crude drug 2.5g/k body weight), 12 mice in each group and 8 times per day, and the blank group and the model group are filled with equal volume of common drinking water. After the experiment is finished, the mice are fasted for 12 hours before being treated, eyeballs are picked up for blood taking, and serum is centrifugally taken for standby; the thyroid gland of the mouse is taken, fixed by 4% paraformaldehyde, dehydrated and embedded to prepare wax blocks, and morphological observation is carried out by adopting HE (high-order) staining. The indicators of anti-thyroglobulin antibody (TgAb) and anti-thyroperoxidase antibody (TPOAb) in the serum of the mice are measured by adopting a chemiluminescence method.
The pathological results show that: the thyroid cells of the normal mice are orderly arranged and distributed, the follicular oval shape is dyed in light red, and abnormal infiltration is avoided; the thyroid follicles of the model group are arranged in disorder and are different in size, the thyroid follicles are damaged or atrophic to be flat in a large amount, the dyed light red color is formed, plasma cell infiltration is visible in the follicles, obvious lymphocyte infiltration exists around the follicles, and the thyroid glands are infiltrated by about 45%. Thyroid morphology of the positive medicine group is still available, but there are gonosome cells and plasma cells among thyroid cells and in the follicular, and the lymphocyte infiltrates 25-40% of thyroid tissue; ZHW the thyroid follicles have good layout arrangement, no lymphocyte infiltration exists among thyroid cells, no plasma cell infiltration exists among the follicular morphology rules, ZHW-D the thyroid follicles have good layout arrangement, lymphocyte infiltration exists among thyroid cells, and plasma cell infiltration does not exist among the follicular morphology rules. In addition, the indexes such as anti-thyroglobulin antibody (TgAb), anti-thyroperoxidase antibody (TPOAb) and the like are shown in table 2, and the results show that the TgAb and the TPOAb are extremely remarkably increased (P < 0.01) after molding, and the indexes are extremely remarkably decreased (P < 0.01) and are more remarkably decreased (P < 0.01) than single ZHW-D after treatment by adopting the ZHW antibody disclosed by the invention. Experimental results show that the traditional Chinese medicine composition ZHW has obvious effect ZHW on treating hashimoto thyroiditis, namely, the traditional Chinese medicine composition ZHW has more obvious curative effect (P < 0.01) than the control medicine ZHW-D.
The results show that the positive medicine and ZHW-D of the tripterygium wilfordii have obvious liver injury, and ALT and AST are obviously higher than those of a normal group and a model group. However, the levels of ZHW, ALT and AST of the invention are not significantly different from that of the normal group, which suggests that there is no liver injury, and the pathological results further indicate that:
as shown in FIG. 1, compared with the ZHW group of the invention, HE staining results show that the cytoplasm and nucleus of the liver cells in the ZHW-D group are light, the cytoplasm is loose, but the liver plate structure is complete and clear, the liver cells are normal in size, and mild inflammatory cell infiltration exists around the sink area and the central vein; the positive medicine group of the tripterygium wilfordii has loose and light dyeing of the cytoplasm of the hepatic cells around the central vein, shrinking of the nucleus, incomplete arrangement of hepatic plates, slight disorder, necrosis and dissolution of a small amount of hepatic cells, and certain inflammatory cell infiltration around the central vein of a necrosis focus and a collecting pipe area; compared with ZHW-D, the positive medicine group of the tripterygium wilfordii has the advantages of heavy cytochalasing, normal nucleus size, complete liver plate structure and no obvious necrotic liver cells. The method has important significance for application and popularization of the method.
Through the research, the traditional Chinese medicine composition has obviously better medicine effect than the patent application (201810888640.9) and no hepatotoxicity, and achieves the effect which cannot be expected by the patent application (201810888640.9).
Table 2 results of influence of the Chinese medicinal composition on TgAb and TPOAb of the Hashimoto thyroid model rat
Figure SMS_1
Note that: ** has very significant difference with the model group, P<0.01; # Compared with ZHW group, the P is significantly different<0.05, ## Very significant differences compared with group ZHW, P<0.01。
Test example 2: the invention relates to a comparative study of the curative effect of traditional Chinese medicine compositions with different proportions on hashimoto thyroiditis mice
Taking six compounds A, B, C, D, E and F prepared in the 'example 5' as experimental objects, preparing a mice model of hashimoto thyroiditis by adopting a method of injecting thyroglobulin (PTg) antigen with high iodine subcutaneously in multiple points according to the 'experimental example 1', and observing the effect of treating infectious hashimoto thyroiditis by adopting the compositions with different proportions, wherein the main investigation indexes are as follows: anti-thyroglobulin antibody (TgAb), anti-thyroperoxidase antibody (TPOAb) in serum. Compared with the model group, the composition group with different proportions is significantly lower than the model group P <0.01, and no significant difference exists between the proportion groups. The results are shown in Table 3. The experimental results show that the traditional Chinese medicine composition has obvious curative effects on the treatment of hashimoto thyroiditis according to different proportions, namely, the proportions within the range of the application can be used for the treatment of hashimoto thyroiditis, and the effect is obvious. From the results in Table 3, it is clear that the effect of Compound C is most remarkable.
TABLE 3 results of therapeutic effects of different compounds on Hashimoto thyroiditis mice (mean.+ -. SD)
Figure SMS_2
Note that: ** there were very significant differences compared to the model set.
Test example 3: the invention relates to a comparative research on the effect of ginseng on the curative effect of hashimoto thyroiditis mice
The prescription with the best screening effect is optimized according to test example 2, wherein the prescription composition of the prescription C is the compound C of example 5 and is taken as a study object, and the prescription composition of the prescription is 15 parts of fritillaria cirrhosa, 15 parts of smilax china, 9 parts of ginseng and 15 parts of selfheal. The part of the prescription compound C, 150 g of fritillaria cirrhosa, 150 g of chinaroot greenbrier rhizome, 90 g of ginseng and 150 g of selfheal according to the 'example 5' is prepared into decoction, and then concentrated and dried to prepare 109 g of dry paste (equivalent to 4.95 g of medicinal materials in each gram) which is taken as ZHW-C for standby. In addition, 150 g of fritillaria cirrhosa, 150 g of chinaroot greenbrier rhizome and 150 g of selfheal are taken to prepare 81 g of dry paste (equivalent to 5.55 g of medicinal materials in each g) by the same method, and the dry paste is taken as ZHW-D group for standby; in addition, 90 g of ginseng is also prepared into 22.8 g of dry paste (corresponding to 3.94 g of medicinal materials in each g) by the same method and is used as an RS group.
A hashimoto thyroiditis mouse model was prepared according to "test example 1" using subcutaneous multipoint injection of thyroglobulin (PTg) antigen with periodate. After model establishment, model mice were randomly divided into model group, positive drug group (tripterygium glycosides tablet 0.2mg/kg body weight, produced by Huangshi Feiyun pharmaceutical Co., ltd.), ZHW-R group (according to crude drug 2.5g/kg body weight), ZHW-C group (according to crude drug 2.5g/k body weight), RS group (according to crude drug 2.5g/k body weight), 12 groups each, and gavage 8 weeks, 1 time per day, blank group and model group gavage equal volume of common drinking water. After the last 1-time stomach infusion for 1 hour, the mass of the mice is weighed, and then lead skin with 4% of the mass of the mice is loaded at the position of 1cm at the root of the tail of the mice, and the mice are placed in a swimming box [60cm multiplied by 40cm, (30+/-1) ] DEG C ]. The exhaustion judging standard is that the head of the mouse is immersed in water, and the head of the mouse cannot return to the water surface after 10s, and the disappearance of the regular reflection is regarded as exhaustion. The time from the swimming start time to the exhaustion time was recorded as the swimming time of the mice. Blood was taken before mice were sacrificed, serum was isolated for detection: analysis of anti-thyroglobulin antibodies (TgAb) and anti-thyroperoxidase antibodies (TPOAb) in serum.
The results of the treatment effect study of different administration groups on the hashimoto thyroiditis mice are shown in table 4, and compared with a model group, the positive drug group and ZHW-C, ZHW-D can obviously reduce the levels of TgAb and TPOAb (P < 0.01); while ZHW-C is significantly better than ZHW-D (P < 0.01), suggesting that ZHW-C is better than ZHW-D on Hashimoto thyroiditis; the RS is used alone, and the treatment effect on hashimoto thyroiditis is not obvious. The effect of the different dosing groups on the mice' load swimming time is shown in table 5. Experimental results show that ZHW-C and RS can greatly increase the load swimming time (P < 0.01) of a model mouse, compared with a model group, the elongation rates are 68.46% and 29.67%, and ZHW-C is very obviously better than that of the RS group. While ZHW-D can obviously increase the load swimming time (P < 0.05) of the model mice, but the elongation rate is only 9.12%, and the effect is not obvious.
According to the test result, the traditional Chinese medicine composition disclosed by the invention not only can be used for treating hashimoto thyroiditis, but also can be used for increasing the load swimming time of a model mouse, so that the endurance of the model mouse can be obviously increased, the fatigue of the model mouse is relieved, and the combination of fritillary bulb, chinaroot greenbrier, selfheal and ginseng plays a synergistic effect, so that unexpected technical effects are achieved.
TABLE 4 therapeutic results of different administration groups on Hashimoto thyroiditis mice (mean.+ -. SD)
Figure SMS_3
Figure SMS_4
Note that: ** very significant differences compared to model group (P<0.01); * Has significant differences compared with the model group (P<0.05); ## Very significant differences compared to group ZHW-D (P<0.01)
TABLE 5 influence of different administration groups on the swimming time of mice with load (mean.+ -. SD)
Figure SMS_5
* Very significant differences compared to model group (P < 0.01) significant differences compared to model group (P < 0.05); very significant differences compared to group ZHW-C (P < 0.01)
Test example 4: clinical study of the traditional Chinese medicine composition for treating hashimoto thyroiditis
To demonstrate the clinical efficacy of the present invention, patients with hashimoto thyroiditis were clinically included, and the study was divided into treatment groups (ZHW + base treatment) and control groups (ZHW-s+ base treatment). ZHW used was prepared as described in "example 4: pill "pill prepared by the compound prescription C: ZHW-S is a pill prepared from the optimal composition (8 parts of Bulbus Fritillariae Cirrhosae, 2 parts of rhizoma Smilacis chinensis, 1 part of radix Tripterygii Wilfordii, and 2 parts of Prunellae Spica) in patent application (201810888640.9). The basic treatment refers to western medicine treatment method adopted for targeted clinical symptoms. The treatment period was 4 weeks. ZHW-S was entered into 30 cases of the group, 30 cases of each of the treatment group and the control group.
The established diagnosis of the hashimoto thyroiditis is selected in the study, accords with the relevant diagnosis standard proposed in the Chinese diagnosis and treatment guidelines for thyroid diseases in 2007, and is combined with clinical specifications as follows: meets the diagnostic standard of hashimoto thyroiditis: clinical symptoms and signs of hypothyroidism such as fatigue, weakness, aversion to cold, edema of the face or limbs, dry skin, slow reaction, amnesia, and may be accompanied by menstrual disorder in women, etc.: laboratory diagnosis of hypothyroidism is met: serum thyroid hormone (FT 3, FT 4) concentration is low, and Thyroid Stimulating Hormone (TSH) concentration is high. Main observations and observation time the main observations were used for fatigue scoring by visual analog scale (Christensen score). The main observation time points are respectively before and after the treatment.
Therapeutic effect criterion
The following are formulated by referring to the guidelines of clinical research on new traditional Chinese medicines: the effect is shown: the symptoms are obviously relieved or disappeared, the thyroid gland volume is reduced, the texture is softened, the nodules are softened, the size is reduced or disappeared, the thyroid functions FT3, FT4 and TSH are recovered to be normal, the anti-thyroid peroxidase antibody is obviously reduced, and the relapse does not occur after stopping taking ZHW: the method is effective: the symptoms are obviously relieved, the thyroid gland volume is reduced, the texture is softened, the nodules are softened, the thyroid gland functions FT3 and FT4, TSH and an anti-thyroid peroxidase antibody are obviously improved, and no recurrence occurs after the HW is stopped taking: invalidation: the above criteria are not met.
5. Results:
after 1 month of treatment, the patients with hashimoto thyroiditis are treated by taking the anti-goiter pill, and symptoms and signs, thyroid functions (FT 3, FT4 and TSH) and anti-thyroid peroxidase antibodies of the patients are obviously improved before and after treatment (P is less than 0.01), and the effective rate is 96.7%. The treatment group had significantly improved fatigue compared to the placebo group, and the experimental results are shown in tables 6 and 7 and 8.
The test shows that ZHW not only can treat hashimoto's thyroid, but also can effectively improve fatigue of patients and improve life quality of the patients. In addition, the traditional Chinese medicine composition can achieve better effect only by 4 weeks in the treatment course of hashimoto thyroiditis, the effective rate is greatly improved compared with 70% of ZHW-S group, the treatment period of patent 20181088640.9 is 8 weeks, the effective rate can reach 95%, the treatment time can be effectively shortened compared with the traditional Chinese medicine composition, the fatigue of patients can be obviously improved, and unexpected technical effects are achieved.
Table 6 comparison of therapeutic effects between hashimoto thyroiditis groups
Figure SMS_6
TABLE 7 changes in correlation index before and after treatment (mean.+ -. SD) for treatment group and control group
Figure SMS_7
Note that P <0.01 is very significant difference before and after treatment; # very significant differences compared to group ZHW-S, P < 0.01;
TABLE 8 fatigue comprehensive score (mean.+ -. SD) before and after treatment of treatment group and control group
Figure SMS_8
Note that P <0.01 is very significant difference before and after treatment; # is very significantly different from the control group after treatment, P < 0.01.

Claims (2)

1. The traditional Chinese medicine composition for preventing and treating hashimoto thyroiditis is characterized by being prepared from the following raw material medicines in parts by weight: 15 parts of fritillaria cirrhosa, 15 parts of smilax glabra, 9 parts of ginseng and 15 parts of selfheal.
2. The use of the Chinese medicinal composition according to claim 1 in the preparation of a medicament for preventing and treating hashimoto thyroiditis.
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