Composition capable of improving thyroid function and antibody as well as preparation method and application of composition

Abstract

The invention relates to the technical field of preparation and application of traditional Chinese medicine compositions, and discloses a composition capable of improving thyroid function and an antibody, a preparation method and application, and the composition is prepared from the following raw materials: bupleurum chinense, parched white peony root, red peony root, rhizoma pinellinae praeparata, thunberg fritillary bulb, selfheal, vinegar-processed rhizoma cyperi, codonopsis pilosula, inula flower, fried spina date seed, lily and roasted herba epimedii. The composition comprises the following raw materials in parts by mass: 6-30g of bupleurum chinense; 9-30g of parched white peony root; 9-30 g of radix paeoniae rubra; 6 to 30g of rhizoma pinellinae praeparata; 9 to 30g of thunberg fritillary bulb; 9 to 30g of spica prunellae; 6-30 g of vinegar rhizoma cyperi; 6 to 30g of codonopsis pilosula; 9 to 30g of inula flower; 9-30 g of fried spina date seeds; 9 to 30g of lily; 3 to 30g of roasted herba epimedii; the traditional Chinese medicine compound composition provided by the invention has a good effect of improving thyroid function and antibody level, can be used for treating hashimoto thyroiditis combined with subclinical or clinical hypothyroidism, is convenient to clinically take, has no obvious toxic or side effect, and is good in safety.

Description

Technical Field

[0001] The present invention relates to the technical field of preparation and application of traditional Chinese medicine compositions, and in particular to a composition capable of improving thyroid function and antibodies, a preparation method and application thereof. Background Art

[0002] Hashimoto's thyroiditis is a common clinical organ autoimmune thyroid disease caused by immune system disorders, also known as chronic lymphocytic thyroiditis, which causes immune damage to thyroid cells through T cell and antibody-mediated immune processes. The high incidence age of this disease is 30 to 50 years old, and the incidence rate in women is 5 to 10 times that in men. Western medicine treatment is still mainly based on thyroid hormone replacement therapy, but this therapy and other non-specific immunotherapy are ineffective in intervening in the immune damage process of HT and the accompanying multi-system damage that endangers health and quality of life. Traditional Chinese medicine has unique advantages in treating HT. It can not only reduce the level of anti-thyroid autoantibodies and improve thyroid function, but also adjust the organ function and immune function as a whole, and has the characteristics of good safety and low toxicity and side effects. To this end, a composition, preparation method and application of improving thyroid function and antibodies are proposed. Summary of the invention

[0003] The object of the present invention is to provide a composition, preparation method and application for improving thyroid function and antibodies, so as to solve the problems raised in the above background technology.

[0004] To achieve the above object, the present invention provides the following technical scheme: a composition for improving thyroid function and antibodies, the composition is prepared from the following raw materials: northern bupleurum, stir-fried white peony root, red peony root, French pinellia, thunbergia thunbergii, selfheal, vinegar cyperus, codonopsis, inula flower, stir-fried spiny jujube seed, lily and roasted epimedium;

[0005] The mass ratio of the constituent raw materials of the composition is:

[0006] Bupleurum chinense 6-30g;

[0007] Stir-fried white peony root 9-30g;

[0008] Red peony root 9-30g;

[0009] French Pinellia 6-30g;

[0010] Fritillaria thunbergii 9-30g;

[0011] Prunella vulgaris 9-30g;

[0012] Vinegar-scented Cyperus rotundus 6-30g;

[0013] Codonopsis pilosula 6-30g;

[0014] Inula 9-30g;

[0015] Stir-fried Chinese date seeds 9-30g;

[0016] Lily 9-30g;

[0017] Roasted Epimedium 3-30g.

[0018] The present invention provides a method for preparing the above composition, comprising the following steps:

[0019] S1. Selecting raw materials of medicinal materials for the composition;

[0020] S2. Mix the raw materials of medicinal materials, add water or ethanol to extract, and obtain the extract

[0021] S3, combining the extracts of the medicinal materials;

[0022] S4, reducing pressure and concentrating the combined medicinal material extract;

[0023] S5, drying the concentrated extract to obtain a dry extract powder;

[0024] S6. Prepare an oral preparation by mixing the dry powder with a pharmaceutically acceptable carrier.

[0025] Preferably, in S2, the weight of the water or ethanol is 5 to 15 times the weight of the Chinese medicinal materials.

[0026] Preferably, in S2, the concentration of ethanol is 10-60%.

[0027] Preferably, in S2 above, the medicinal raw material is extracted 1 to 3 times.

[0028] Preferably, in S2, the extraction time of each medicinal material is 0.5 to 2 hours.

[0029] Preferably, in S5, the dried and concentrated extract may be dried by air blast drying, vacuum drying or spray drying.

[0030] Preferably, in S6, the oral preparations include tablets, dispersible tablets, effervescent tablets, orally disintegrating tablets, lozenges, chewable tablets, hard capsules, soft capsules, granules, pills, powders, pellets, and oral liquid preparations.

[0031] Preferably, the above-mentioned composition is used to improve thyroid function and antibodies.

[0032] Compared with the prior art, the present invention adopts the above technical scheme and has the following technical effects: the Chinese medicine compound composition provided by the present invention has a good effect of improving thyroid function and antibody level, and can be used to treat Hashimoto's thyroiditis combined with subclinical or clinical hypothyroidism. It is convenient to take clinically, and the Chinese medicine composition has no obvious toxic and side effects and has good safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0034] Figure 1 It is a schematic diagram for comparing two groups of general situations of the present invention;

[0035] Figure 2 This is a schematic diagram of the comparison of clinical efficacy of two groups of the present invention;

[0036] Figure 3 It is a schematic diagram comparing two groups of thyroid autoantibodies of the present invention;

[0037] Figure 4 It is a schematic diagram comparing the thyroid function and dosage of levothyroxine sodium tablets of two groups of the present invention;

[0038] Figure 5 This is a schematic diagram of the comparison of the sizes of two groups of thyroid glands of the present invention;

[0039] Figure 6 This is a schematic diagram of the comparison of two groups of TCM symptom scores of the present invention;

[0040] Figure 7 This is a schematic diagram for comparing the two groups of quality of life scores of the present invention;

[0041] Figure 8 This is a schematic diagram for comparing the anxiety and depression scores of two groups of the present invention;

[0042] Fig. 9 It is a schematic diagram of comparison of two groups of MoCA scores of the present invention;

[0043] Fig.10 This is a schematic diagram comparing the ratios of Treg / Th17 in two groups of the present invention;

[0044] Fig.11 It is a schematic diagram of the comparison of Foxp3 and RORγt mRNA levels of the present invention. DETAILED DESCRIPTION

[0045] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0046] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the conditions under which this application can be implemented. Therefore, they have no substantive technical significance. Any structural modification, change in proportional relationship or adjustment of size should still fall within the scope of the technical content disclosed in this application without affecting the effects and purposes that can be achieved by this application.

[0047] Example

[0048] See also Figure 1-11 The present invention provides a technical solution: a composition for improving thyroid function and antibodies, the composition is made of the following raw materials: northern bupleurum, stir-fried white peony root, red peony root, French pinellia, thunbergia thunbergii, selfheal, vinegar cyperus, codonopsis, inula, stir-fried spiny jujube seeds, lily and roasted epimedium;

[0049] The composition of the composition has the following raw materials in proportion by weight: 10g of northern bupleurum; 15g of stir-fried white peony root; 15g of red peony root; 10g of French pinellia; 15g of thunbergii bulb; 15g of selfheal; 10g of vinegar-soaked cyperus; 12g of codonopsis pilosula; 30g of inula flower; 15g of stir-fried spiny jujube seed; 30g of lily; and 10g of roasted epimedium.

[0050] The present invention selects Chinese medicine raw materials under the guidance of traditional Chinese medicine theory, selects northern bupleurum, stir-fried white peony root 1, red peony root, French pinellia, thunbergia thunbergii, herba prunellae and the like for compatibility, and determines the dosage of each medicinal material through the relationship between the effective component and the function, so that each component can act synergistically. In the prescription, bupleurum and inula flower are the main ingredients, bupleurum is pungent and bitter in taste, slightly cold in nature, enters the liver and gallbladder meridians, and its qi mainly rises, and can relieve liver qi and relieve depression; inula flower is pungent, bitter and salty in taste, slightly warm in nature, and the product is pungent and bitter, slightly warm and descends, and mainly enters the lung and stomach meridians, and is good at descending qi and resolving phlegm and relieving asthma, and also eliminates phlegm and promotes water circulation and eliminates fullness, and the combination of bupleurum, one rises and one falls, regulates qi, soothes liver qi and resolves phlegm and disperses stagnation. Peony root nourishes blood and dissolves blood stasis, while pinellia, fritillaria and prunella vulgaris can dissolve phlegm and resolve stagnation. Semen jujuba is used for its sour taste, which means "the liver is in pain and urgent, so eat sweet food to relieve it, and sour food to purge it", "the master of the wood position, purge it with sour food, and supplement it with pungent food", "the guest of Jueyin, supplement it with pungent food, purge it with sour food, and relieve it with sweet food", and it can also calm the mind and soothe the nerves. The whole prescription uses simple medicines, with both moving and dispersing, sour and bitter food, and both tonifying and purging. It has the effects of soothing the liver and relieving depression, calming the mind and strengthening the spleen, and dissolving phlegm and resolving stagnation.

[0051] The present invention provides a method for preparing a composition having the function of improving thyroid function and antibodies, comprising the following steps:

[0052] S1. Selecting raw materials of medicinal materials for the composition;

[0053] S2, mixing the medicinal materials, adding water or ethanol to extract, and obtaining an extract; the weight of water or ethanol is 13 times the weight of the Chinese medicinal materials; the concentration of ethanol is 50%; the medicinal materials are extracted 3 times; the extraction time of each medicinal material is 1.5 hours;

[0054] S3, combining the extracts of the medicinal materials;

[0055] S4, reducing pressure and concentrating the combined medicinal material extract;

[0056] S5, drying the concentrated extract to obtain a dry extract powder; the concentrated extract can be dried by air drying, vacuum drying or spray drying;

[0057] S6. Prepare oral preparations by mixing the dry powder with a pharmaceutically acceptable carrier. The oral preparations include tablets, dispersible tablets, effervescent tablets, orally disintegrating tablets, lozenges, chewable tablets, hard capsules, soft capsules, granules, pills, powders, pellets, and oral liquid preparations.

[0058] The present invention also provides an application of a composition capable of improving thyroid function and antibodies, and an application of the composition in improving thyroid function and antibodies.

[0059] The composition is used in the treatment of improving thyroid function and antibodies. By adopting a randomized, double-blind, single-simulation parallel control method, 110 patients with Hashimoto's thyroiditis combined with hypothyroidism were randomly divided into an experimental group and a control group according to the block randomization method, with 55 cases in each group. On the basis of basic treatment, the experimental group took the Chinese medicine Chaihu Xuanfuhua Decoction, and the control group took a placebo. Both groups took the medicine for 12 weeks and followed up for half a year. The thyroid function and autoantibody levels, TCM symptom scores, quality of life scores, depression and anxiety scores, and levothyroxine sodium doses of the two groups of patients before and after treatment were observed, and the clinical efficacy of the two groups was compared.

[0060] 1. Comparison of general conditions between the two groups:

[0061] There was no statistical difference in age, gender, and course of disease between the two groups (P>0.05). Figure 1 , Figure 1 Comparison of general conditions between the two groups. Note: A is age, B is gender, and C is disease course. ns means no statistical difference.

[0062] 2. Comparison of clinical efficacy between the two groups:

[0063] After treatment, 17 cases in the Chinese medicine group showed marked effect, 18 cases were effective, and 15 cases were ineffective, with a total effective rate of 70.0%. In the control group, 5 cases showed marked effect, 14 cases were effective, and 26 cases were ineffective, with a total effective rate of 42.2%. Inter-group comparison showed that the experimental group had better efficacy than the control group, and the difference was statistically significant (P < 0.01). Figure 2 .

[0064] 3. Comparison of thyroid autoantibodies between the two groups:

[0065] There was no significant difference in TPOAb and TGAb levels between the two groups before treatment (P>0.05). After 12 weeks of treatment, the antibody level in the experimental group decreased compared with before treatment (P<0.01), and the difference was significant compared with the control group (P>0.05). The antibody level in the control group did not change significantly (P>0.05). After 36 weeks of follow-up, the autoantibody level in the experimental group was still lower than the level before treatment (P<0.05), and the difference was significant compared with the control group (P<0.05). Figure 3 Note: A is TPOAb, B is TGAb. ns means no statistical difference, *P<0.05, **P<0.01.

[0066] 4. Comparison of thyroid function and dosage of levothyroxine sodium tablets between the two groups:

[0067] Before treatment, there were no significant differences in TSH, FT3, FT4 levels and levothyroxine dosage between the experimental group and the control group (P>0.05). After 12 weeks of treatment, the TSH levels of both groups decreased significantly (P<0.05) and reached normal levels. After 36 weeks of follow-up, it was found that TSH in both groups was at normal levels, and there was no significant difference between the two groups (P>0.05). There were no significant differences in FT3 and FT4 levels before and after treatment and during the follow-up period (P>0.05). After 12 weeks of treatment, the dosage of levothyroxine sodium tablets in the experimental group was significantly reduced (P<0.05), and there was no significant change in the dosage in the control group (P>0.05). After 36 weeks of follow-up, it was found that the dosage of the experimental group was lower than that of the control group, and the difference was statistically significant (P<0.01). See Figure 4 Note: A is TSH, B is FT3, and C is FT4. ns means no statistical difference, *P<0.05, **P<0.01.

[0068] 5. Comparison of thyroid size between the two groups:

[0069] Before treatment, there was no significant difference in the thickness of the lateral lobe and isthmus of the thyroid gland between the experimental group and the control group (P>0.05). After 12 weeks of treatment, the thickness of the lateral lobe of the experimental group decreased compared with before treatment (P<0.05), but there was no significant difference compared with the control group (P>0.05), and there was no significant change in the thickness of the isthmus (P>0.05). After 36 weeks of follow-up, there was no significant difference in the thickness of the lateral lobe of the experimental group compared with before treatment (P<0.05). There was no significant change in the thickness of the lateral lobe and isthmus before, after treatment and during the follow-up period in the control group (P>0.05). Figure 5 Note: A is the thickness of the left lobe of the thyroid gland, B is the thickness of the right lobe of the thyroid gland, and C is the thickness of the isthmus. ns means no statistical difference.

[0070] 6. Comparison of TCM symptom scores between the two groups:

[0071] There was no statistical difference in TCM symptom scores between the two groups before treatment (P>0.05). After 12 weeks of treatment, the clinical symptoms of both groups improved, and the improvement in the experimental group was significantly better than that in the control group (P<0.01). After 36 weeks of follow-up, the improvement in clinical symptoms in the experimental group was still better than that in the control group (P<0.01). Figure 6 Note: ns means no statistical difference, *P<0.05, **P<0.01.

[0072] 7. Comparison of quality of life scores between the two groups:

[0073] There was no significant difference in the quality of life score between the two groups before treatment (P>0.05). After 12 weeks of treatment, the physiological, psychological, and social scores of the two groups were significantly improved compared with those before treatment (P<0.01), and the increase was more obvious in the experimental group (P<0.05). After 36 weeks of follow-up, the physiological and social scores were still significantly different from those before treatment (P<0.01). There was no significant change in the environmental score after treatment and during the follow-up period (P>0.05). Figure 7 Note: A is the physiological function score, B is the psychological function score, C is the social function score, and D is the environmental function score. ns means no statistical difference, *P<0.05, **P<0.01.

[0074] 8. Comparison of anxiety and depression scores between the two groups:

[0075] There was no statistical difference in SDS and SAS between the two groups before treatment (P>0.05). After 12 weeks of treatment, the anxiety and depression scores of the two groups decreased significantly (P<0.01), and the improvement degree of the experimental group was significantly better than that of the control group (P<0.01). After 36 weeks of follow-up, the improvement degree of anxiety and depression scores in the experimental group was still better than that in the control group (P<0.05). Figure 8 Note: A is the depression score, B is the anxiety score. ns means no statistical difference, *P<0.05, **P<0.01.

[0076] 9. Comparison of MoCA scores between the two groups:

[0077] There was no significant change in MoCA scores before and after treatment and during follow-up in the two groups of patients. Fig. 9 Note: ns means no statistical difference.

[0078] The effect of Chaihu Xuanfuhua decoction on the immune damage of Hashimoto's thyroiditis. The traditional Chinese medicine Chaihu Xuanfuhua decoction can intervene in the immune damage process of Hashimoto's thyroiditis by reducing the titer of thyroid antibodies, regulating the balance of Treg / Th17 and the levels of related cytokines. The data are as follows:

[0079] 1. Comparison of Treg / Th17 ratio between the two groups:

[0080] There was no significant difference in the Treg / Th17 ratio between the two groups before treatment (P>0.05). After treatment, the Treg / Th17 ratio in the experimental group increased (P<0.01), which was significantly different from that in the control group (P<0.01). No significant change was observed in the control group after treatment (P>0.05). Fig.10 Note: ns means no statistical difference, **P<0.01.

[0081] 2. Comparison of Foxp3 and RORγt mRNA levels:

[0082] There was no significant difference in the mRNA levels of Foxp3 and RORγt between the two groups before treatment (P>0.05). After treatment, the Foxp3 level in the experimental group increased (P<0.01), and the RORγt level decreased (P<0.01), which was significantly different from that in the control group (P<0.01). There was no significant change in the RNA level in the control group after treatment (P>0.05). Fig.11 Note: A is Foxp3, B is RORγt, ns means no statistical difference, **P<0.01.

[0083] It will be appreciated by those skilled in the art that the features described in the various embodiments and / or claims of the present invention may be combined and / or combined in various ways, even if such combinations and / or combinations are not explicitly described in the present invention. In particular, the features described in the various embodiments and / or claims of the present invention may be combined and / or combined in various ways without departing from the spirit and teachings of the present invention. All of these combinations and / or combinations fall within the scope of the present invention.

Claims

1. A composition for improving thyroid function and antibodies, characterized in that: The composition is prepared from the following raw materials: northern bupleurum, stir-fried white peony root, red peony root, French pinellia, thunbergia thunbergii, selfheal, vinegar cyperus, codonopsis, inula, stir-fried spiny jujube seed, lily and roasted epimedium; The mass ratio of the constituent raw materials of the composition is: Bupleurum chinense 6-30g; Stir-fried white peony root 9-30g; Red peony root 9-30g; French Pinellia 6-30g; Fritillaria thunbergii 9-30g; Prunella vulgaris 9-30g; Vinegar-scented Cyperus rotundus 6-30g; Codonopsis pilosula 6-30g; Inula flower 9-30g; Stir-fried Chinese date seeds 9-30g; Lily 9-30g; Roasted Epimedium 3-30g.

2. The method for preparing a composition for improving thyroid function and antibodies according to claim 1, characterized in that: The following steps are involved: S1. Selecting raw materials of medicinal materials for the composition; S2, mixing the medicinal materials, adding water or ethanol for extraction, and obtaining an extract; S3, combining the extracts of the medicinal materials; S4, reducing pressure and concentrating the combined medicinal material extract; S5, drying the concentrated extract to obtain a dry extract powder; S6. Prepare an oral preparation by mixing the dry powder with a pharmaceutically acceptable carrier.

3. The method for preparing a composition for improving thyroid function and antibodies according to claim 2, characterized in that: In S2, the weight of the water or ethanol is 5 to 15 times the weight of the Chinese medicinal materials.

4. The method for preparing a composition for improving thyroid function and antibodies according to claim 2, characterized in that: In S2, the concentration of ethanol is 10-60%.

5. The method for preparing a composition for improving thyroid function and antibodies according to claim 2, characterized in that: In S2, the medicinal material raw material is extracted 1 to 3 times.

6. The method for preparing a composition for improving thyroid function and antibodies according to claim 2, characterized in that: In S2, the extraction time of the medicinal material raw material is 0.5 to 2 hours each time.

7. The method for preparing a composition for improving thyroid function and antibodies according to claim 2, characterized in that: In S5, the dried and concentrated extract may be dried by air blowing, vacuum drying or spray drying.

8. The method for preparing a composition for improving thyroid function and antibodies according to claim 2, characterized in that: In S6, oral preparations include tablets, dispersible tablets, effervescent tablets, orally disintegrating tablets, lozenges, chewable tablets, hard capsules, soft capsules, granules, pills, powders, pellets, and oral liquid preparations.

9. The use of a composition for improving thyroid function and antibodies according to claims 1-2, characterized in that: The composition is used in improving thyroid function and antibodies.

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