Traditional Chinese medicine composition for treating diabetes and / or thyroid nodules and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and provides a traditional Chinese medicine composition for treating diabetes and / or thyroid nodules and a preparation method thereof. The traditional Chinese medicine composition comprises the following components: poria cocos, salvia miltiorrhiza, rhizoma alismatis, cassia twig, radix aconiti lateralis preparata, prepared rehmannia root, safflower, angelica sinensis, radix achyranthis bidentatae, platycodon grandiflorum, radix paeoniae rubra, liquorice, bupleurum chinense, selfheal, oyster, radix scrophulariae, vinegar-processed rhizoma cyperi, vinegar-processed pericarpium citri reticulatae viride, stevia rebaudiana, fructus aurantii stir-fried with bran, wine-processed fructus corni, ligusticum wallichii and scalded peach kernel. Through multi-target cooperation, the traditional Chinese medicine composition can improve yin deficiency and dryness-heat, blood stasis and water retention of diabetes mellitus, can also relieve phlegm stasis and qi stagnation of thyroid nodules, fully embodies the thinking of simultaneous treatment of different diseases and overall regulation of traditional Chinese medicine, and has excellent clinical application prospects and good popularization and application values.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and relates to a traditional Chinese medicine composition for treating diabetes and / or thyroid nodules and its preparation method. Background Technology

[0002] Type 2 diabetes causes severe disruption to the body's endocrine system, leading to abnormal metabolism and damage to other systems. Type 2 diabetes is characterized by insulin resistance or insufficient insulin secretion, resulting in hyperglycemia.

[0003] The thyroid gland plays a vital role in human metabolism. Abnormal thyroid hormone levels often induce nodular lesions. Although small nodules do not have a significant impact on health, large nodules can compress nearby tissues and affect swallowing, speech, and other abilities.

[0004] In recent years, it has been found that the incidence of thyroid disease is significantly higher in people with diabetes. The manifestations of thyroid abnormalities in diabetic patients are diverse, and thyroid nodules are also very common clinically. Type 2 diabetes can have a significant impact on metabolism, mostly due to insulin secretion defects. This leads to higher insulin concentrations in patients, increasing the activity of insulin-like growth factor, accelerating the growth rate of thyroid cells, forming more thyroid cells, and increasing the risk of thyroid nodules.

[0005] Patients with type 2 diabetes often have impaired fasting glucose. Benign nodules can be treated with levothyroxine to regulate hormone metabolism and eliminate nodule lesions. However, continuous use of this medication has significant adverse reactions and can easily lead to osteoporosis, cardiovascular disease, and other problems.

[0006] Currently, finding a treatment for diabetic thyroid nodules is a pressing problem that the medical community needs to solve. Summary of the Invention

[0007] In view of the above situation and to overcome the defects of the prior art, the purpose of this invention is to provide a traditional Chinese medicine composition for treating diabetes and / or thyroid nodules and its preparation method. The traditional Chinese medicine composition is scientifically and rationally formulated and has a definite therapeutic effect on diabetes and / or thyroid nodules.

[0008] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating diabetes and / or thyroid nodules.

[0009] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition for treating diabetes and / or thyroid nodules in the preparation of a drug for treating diabetes and / or thyroid nodules.

[0010] The technical solution adopted by the present invention to achieve the above objectives is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating diabetes and / or thyroid nodules, comprising, by weight, the following components: Poria cocos 130-150 parts, Salvia miltiorrhiza 95-115 parts, Alisma plantago-aquatica 65-75 parts, Cinnamomum cassia 65-75 parts, Aconitum carmichaelii 33-38 parts, Rehmannia glutinosa 95-115 parts, Carthamus tinctorius 60-65 parts, Angelica sinensis 95-115 parts, Achyranthes bidentata 95-115 parts, ... Platycodon grandiflorus 33-38 parts, Paeonia lactiflora 40-45 parts, Glycyrrhiza uralensis 40-45 parts, Bupleurum chinense 19-23 parts, Prunella vulgaris 95-115 parts, Ostrea gigas 95-115 parts, Scrophularia ningpoensis 95-115 parts, Cyperus rotundus (processed with vinegar) 80-90 parts, Citrus reticulata (processed with vinegar) 80-90 parts, Stevia reticulata 2-4 parts, Citrus aurantium (processed with wheat bran) 95-115 parts, Cornus officinalis (processed with wine) 95-115 parts, Ligusticum chuanxiong 33-38 parts, Prunus persica (processed with vinegar) 80-90 parts.

[0011] As a preferred technical solution of the present invention, the following components are contained in parts by weight: 140 parts of Poria cocos, 105 parts of Salvia miltiorrhiza, 70 parts of Alisma plantago-aquatica, 70 parts of Cinnamomum cassia, 35 parts of Aconitum carmichaelii (processed), 105 parts of Rehmannia glutinosa (processed), 63 parts of Carthamus tinctorius, 105 parts of Angelica sinensis, 105 parts of Achyranthes bidentata, 35 parts of Platycodon grandiflorus, 42 parts of Paeonia lactiflora (red), 42 parts of Glycyrrhiza uralensis, 21 parts of Bupleurum chinense, 105 parts of Prunella vulgaris, 105 parts of Ostrea gigas, 105 parts of Scrophularia ningpoensis, 84 parts of Cyperus rotundus (processed with vinegar), 84 parts of Citrus reticulata (processed with vinegar), 3 parts of Stevia reticulata, 105 parts of Citrus aurantium (processed with wheat bran), 105 parts of Cornus officinalis (processed with wine), 35 parts of Ligusticum chuanxiong, and 84 parts of Prunus persica (processed with vinegar).

[0012] In a second aspect, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating diabetes and / or thyroid nodules, comprising the following steps: preparing the above-mentioned traditional Chinese medicine materials into formulation granules, weighing the formulation granules, and thus obtaining the product.

[0013] As some preferred technical solutions of the present invention, the preparation method of the traditional Chinese medicine composition for treating diabetes and / or thyroid nodules includes the following steps: The preparation method of the formula granules is as follows: Weigh the Chinese medicinal materials, add 8-10 times the weight of water, decoct for 0.5-1h to obtain decoction 1 and dregs; add 8-10 times the weight of water to the dregs, decoct for 0.5-1h to obtain decoction 2 and dregs; combine decoction 1 and decoction 2 to obtain an extract; concentrate the extract at a temperature of 50-70℃ and a pressure of -0.060--0.085 MPa, and the relative density of the concentrate is 1.03-1.07 to obtain a concentrated solution; dry the concentrated solution to obtain an extract powder; sieve the extract powder and maltodextrin, wherein the amount of maltodextrin is 0.4%-0.8% of the weight of the Chinese medicinal materials, mix, and granulate to obtain the traditional Chinese medicine formula granules.

[0014] As a preferred technical solution of the present invention, the preparation method of the traditional Chinese medicine composition for treating diabetes and / or thyroid nodules includes the following steps: the preparation method of the formula granules is as follows: weigh the Chinese medicinal materials, add 8 times the weight of water, decoct for 0.5 hours to obtain decoction 1 and dregs; add 10 times the weight of water to the dregs, decoct for 1 hour to obtain decoction 2 and dregs; combine decoction 1 and decoction 2 to obtain an extract; concentrate the extract at a temperature of 50°C and a pressure of -0.075 MPa, and the relative density of the concentrate is 1.07 to obtain a concentrated solution; dry the concentrated solution to obtain an extract powder; sieve the extract powder and maltodextrin, wherein the amount of maltodextrin is 0.6% of the weight of the Chinese medicinal materials, mix, and granulate to obtain the traditional Chinese medicine formula granules.

[0015] A third aspect of the invention provides the use of the traditional Chinese medicine composition for treating diabetes and / or thyroid nodules in the preparation of a medicament for the prevention or treatment of diabetes.

[0016] In another aspect of the invention, the use of the traditional Chinese medicine composition for treating diabetes and / or thyroid nodules in the preparation of a medicament for the prevention or treatment of thyroid nodules is provided.

[0017] In another aspect, the present invention provides the use of the traditional Chinese medicine composition for treating diabetes and / or thyroid nodules in the preparation of a medicament for the prevention or treatment of diabetes with thyroid nodules.

[0018] Explanation of the formula of the traditional Chinese medicine composition of this invention: This formula targets diabetes mellitus complicated by thyroid nodules, whose pathogenesis involves yin deficiency and dryness-heat, phlegm and blood stasis, and qi stagnation and blood stasis. The formula's treatment principles are nourishing yin and clearing heat, promoting blood circulation and removing blood stasis, regulating qi and resolving phlegm, and softening and dispersing nodules. A detailed analysis follows: Principal drug (targeting the core pathogenesis, with a prominent dosage): Poria cocos promotes diuresis and eliminates dampness, strengthens the spleen and calms the mind: it is effective for diabetes with spleen deficiency and dampness, abnormal water metabolism, and improves the retention of phlegm and dampness.

[0019] Danshen invigorates blood circulation, removes blood stasis, clears heat and cools the blood: it directly targets blood stasis and yin deficiency with dryness and heat, and improves microcirculatory disorders in diabetes and blood stasis-type thyroid nodules.

[0020] Assistant herbs (those that assist the principal herb and enhance its therapeutic effect): Rehmannia glutinosa and Scrophularia ningpoensis nourish yin and kidneys, clear heat and generate fluids: relieve yin deficiency and fire excess in diabetes, balance dryness and heat, and protect yin fluids.

[0021] Prunella vulgaris and oyster shell clear liver heat, soften and disperse nodules: targeting thyroid nodules with phlegm and blood stasis, dissolving local lumps.

[0022] Achyranthes bidentata, safflower, angelica sinensis, and roasted peach kernel invigorate blood circulation, promote menstruation, nourish blood, and remove blood stasis. Together with Salvia miltiorrhiza, they remove blood stasis and unblock the meridians, improving poor blood circulation and blood stasis.

[0023] Adjuvant herbs (working synergistically with the principal and assistant herbs, while also counteracting their imbalances): Alisma plantago-aquatica and Cinnamomum cassia: Alisma plantago-aquatica promotes diuresis and clears heat, while Cinnamomum cassia warms and unblocks the blood vessels, transforms qi and promotes water metabolism, assists Poria cocos in promoting diuresis, and prevents Rehmannia glutinosa from being too rich and greasy.

[0024] Lightly processed aconite root warms and transforms Qi, enhancing the efficacy of diuretics while preventing cold-natured drugs from damaging Yang Qi.

[0025] Vinegar-processed Cyperus rotundus, vinegar-processed Citrus reticulata peel, and wheat bran-fried Citrus aurantium can soothe the liver, regulate qi, resolve phlegm, and dissipate nodules: regulate qi flow and resolve qi stagnation and phlegm accumulation (key pathogenesis of thyroid nodules).

[0026] Red peony root and Sichuan lovage rhizome: Red peony root clears heat and cools the blood, while Sichuan lovage rhizome invigorates blood and promotes qi circulation; it assists salvia miltiorrhiza in resolving blood stasis and also clears latent heat in the blood.

[0027] Bupleurum chinense (Bei Chai Hu) soothes the liver and relieves stagnation, guiding the medicine to the liver: it harmonizes liver qi and addresses the liver stagnation background associated with diabetes and thyroid diseases.

[0028] Cornus officinalis nourishes the liver and kidneys and consolidates yin essence; it assists Rehmannia glutinosa in nourishing yin and prevents blood-activating drugs from damaging the liver and kidneys.

[0029] Envoy (harmonizes the properties of other medicines, guides them to their respective channels): Platycodon grandiflorum carries the medicine upwards: it guides the medicine to the throat and thyroid region, directly reaching the affected area.

[0030] Licorice harmonizes the effects of various herbs and relieves urgency and harmonizes the middle jiao: it alleviates the adverse effects of herbs such as aconite and bupleurum, and protects the spleen and stomach.

[0031] Stevia has a milder, more pleasant taste, which helps improve patient adherence to long-term medication.

[0032] Compatibility characteristics: The formula addresses both phlegm, blood stasis, and qi stagnation: Cyperus rotundus, Citrus reticulata peel, and Citrus aurantium regulate qi and resolve phlegm, while Prunus persica kernel and Angelica sinensis invigorate blood and unblock collaterals, thus aligning with the pathogenesis chain of "qi stagnation-phlegm coagulation-blood stasis" in thyroid nodules.

[0033] Balance of cold and heat: Cinnamon twig and aconite root warm and invigorate, while scrophularia root and red peony root clear heat, avoiding excessively cold yin-nourishing herbs or yin-damaging warm and drying herbs.

[0034] This formula, through multi-target synergy, not only improves the yin deficiency and dryness-heat, blood stasis and water retention in diabetes, but also resolves phlegm and qi stagnation in thyroid nodules, fully embodying the TCM concepts of "treating different diseases with the same method" and "holistic regulation".

[0035] Compared with the prior art, the present invention has the following beneficial effects: 1. Traditional Chinese medicine advocates a holistic approach, and "treating different diseases with the same method" is an important model of syndrome differentiation and treatment. External symptoms can reflect internal pathological changes. If different diseases exhibit the same pathogenesis during their development, they can be diagnosed as the same syndrome and treated with the same method, which is the so-called "same syndrome, same treatment" and "corresponding formula and syndrome." Pharmacological studies have shown that the traditional Chinese medicine composition of this invention significantly reduces fasting blood glucose and increases the levels of FT3 and FT4, suggesting that the traditional Chinese medicine composition of this invention significantly improves blood glucose and thyroid function in diabetic rats with thyroid nodules, thus exerting a therapeutic effect.

[0036] 2. The formula of this invention includes Poria cocos, Salvia miltiorrhiza, Alisma plantago-aquatica, Cinnamomum cassia, Aconitum carmichaelii (processed), Rehmannia glutinosa (processed), Carthamus tinctorius, Angelica sinensis, Achyranthes bidentata, Platycodon grandiflorus, Paeonia lactiflora, Glycyrrhiza uralensis, Bupleurum chinense, Prunella vulgaris, Ostrea gigas, Scrophularia ningpoensis, Cyperus rotundus (processed with vinegar), Citrus reticulata (processed with vinegar), Stevia reticulata, Citrus aurantium (processed with wheat bran), Cornus officinalis (processed with wine), Ligusticum chuanxiong, and Prunus persica (processed with vinegar). The components work synergistically to regulate phlegm, blood stasis, and qi stagnation, and balance cold and heat. While improving diabetes, it also has a good effect on preventing and treating thyroid nodules. Furthermore, this product has good stability, excellent clinical application prospects, and good promotional value. Attached Figure Description

[0037] Figure 1 The FT3 content of rats in each group was compared. Different lowercase letters above the bars indicate significant differences between different groups (P < 0.05).

[0038] Figure 2 The FT4 content of rats in each group was compared. Different lowercase letters above the bars indicate significant differences between different groups (P < 0.05). Detailed Implementation

[0039] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0040] The terms “contains,” “includes,” “has,” “possesses,” “may,” “contains,” and their variations are open-ended conjunctions or terms that do not exclude the possibility of other components or structures.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0042] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all chemical reagents used in the embodiments of the present invention are obtained through conventional commercial means.

[0043] Example 1 The formulation (by weight) of the pharmaceutical composition in this embodiment is as follows: Poria cocos 140 parts, Salvia miltiorrhiza 105 parts, Alisma plantago-aquatica 70 parts, Cinnamomum cassia 70 parts, Aconitum carmichaelii (processed) 35 parts, Rehmannia glutinosa (processed) 105 parts, Carthamus tinctorius 63 parts, Angelica sinensis 105 parts, Achyranthes bidentata 105 parts, Platycodon grandiflorus 35 parts, Paeonia lactiflora 42 parts, Glycyrrhiza uralensis 42 parts, Bupleurum chinense 21 parts, Prunella vulgaris 105 parts, Ostrea gigas 105 parts, Scrophularia ningpoensis 105 parts, Cyperus rotundus (processed with vinegar) 84 parts, Citrus reticulata (processed with vinegar) 84 parts, Stevia reticulata 3 parts, Citrus aurantium (processed with wheat bran) 105 parts, Cornus officinalis (processed with wine) 105 parts, Ligusticum chuanxiong 35 parts, Prunus persica (processed with vinegar) 84 parts.

[0044] The preparation method of the pharmaceutical composition in this embodiment is as follows: Prepare the above-mentioned Chinese medicinal materials into formula granules, weigh out the formula granules, and you will get the product.

[0045] The preparation method of the formula granules is as follows: Weigh the Chinese medicinal materials, add 8 times the weight of water, decoct for 0.5 hours to obtain decoction 1 and dregs; add 10 times the weight of water to the dregs, decoct for 1 hour to obtain decoction 2 and dregs; combine decoction 1 and decoction 2 to obtain extract; concentrate the extract at a temperature of 50°C and a pressure of -0.075 MPa, and obtain a relative density of 1.07; dry the concentrate to obtain extract powder; sieve the extract powder and maltodextrin, wherein the amount of maltodextrin is 0.6% of the weight of the Chinese medicinal materials, mix, and granulate to obtain Chinese medicinal material formula granules.

[0046] Example 2 The formulation (by weight) of the pharmaceutical composition in this embodiment is as follows: Poria cocos 130 parts, Salvia miltiorrhiza 115 parts, Alisma plantago-aquatica 75 parts, Cinnamomum cassia 65 parts, Aconitum carmichaelii (processed) 38 parts, Rehmannia glutinosa (processed) 95 parts, Carthamus tinctorius 65 parts, Angelica sinensis 115 parts, Achyranthes bidentata 95 parts, Platycodon grandiflorus 38 parts, Paeonia lactiflora (red) 40 parts, Glycyrrhiza uralensis 45 parts, Bupleurum chinense 19 parts, Prunella vulgaris 115 parts, Ostrea gigas 95 parts, Scrophularia ningpoensis 115 parts, Cyperus rotundus (processed with vinegar) 90 parts, Citrus reticulata (processed with vinegar) 80 parts, Stevia reticulata 2 parts, Citrus aurantium (processed with wheat bran) 115 parts, Cornus officinalis (processed with wine) 95 parts, Ligusticum chuanxiong 33 parts, Prunus persica (processed with vinegar) 84 parts.

[0047] The preparation method of the pharmaceutical composition in this embodiment is as follows: Prepare the above-mentioned Chinese medicinal materials into formula granules, weigh out the formula granules, and you will get the product.

[0048] The preparation method of the formula granules is as follows: Weigh the Chinese medicinal materials, add 10 times the weight of water, decoct for 1 hour to obtain decoction 1 and dregs; add 8 times the weight of water to the dregs, decoct for 0.5 hours to obtain decoction 2 and dregs; combine decoction 1 and decoction 2 to obtain extract; concentrate the extract at a temperature of 70℃ and a pressure of -0.060 MPa, and the relative density of the concentrate is 1.05 to obtain concentrate; dry the concentrate to obtain extract powder; sieve the extract powder and maltodextrin, wherein the amount of maltodextrin is 0.4% of the weight of the Chinese medicinal materials, mix, and granulate to obtain Chinese medicinal material formula granules.

[0049] Example 3 The formulation (by weight) of the pharmaceutical composition in this embodiment is as follows: Poria cocos 140 parts, Salvia miltiorrhiza 105 parts, Alisma plantago-aquatica 70 parts, Cinnamomum cassia 70 parts, Aconitum carmichaelii (processed) 35 parts, Rehmannia glutinosa (processed) 105 parts, Carthamus tinctorius 63 parts, Angelica sinensis 105 parts, Achyranthes bidentata 105 parts, Platycodon grandiflorus 35 parts, Paeonia lactiflora 42 parts, Glycyrrhiza uralensis 42 parts, Bupleurum chinense 21 parts, Prunella vulgaris 105 parts, Ostrea gigas 105 parts, Scrophularia ningpoensis 105 parts, Cyperus rotundus (processed with vinegar) 84 parts, Citrus reticulata (processed with vinegar) 84 parts, Stevia reticulata 3 parts, Citrus aurantium (processed with wheat bran) 105 parts, Cornus officinalis (processed with wine) 105 parts, Ligusticum chuanxiong 35 parts, Prunus persica (processed with vinegar) 84 parts.

[0050] The preparation method of the pharmaceutical composition in this embodiment is as follows: Prepare the above-mentioned Chinese medicinal materials into formula granules, weigh out the formula granules, and you will get the product.

[0051] The preparation method of the formula granules is as follows: Weigh the Chinese medicinal materials, add 8 times the weight of water, decoct for 1 hour to obtain decoction 1 and dregs; add 10 times the weight of water to the dregs, decoct for 0.5 hours to obtain decoction 2 and dregs; combine decoction 1 and decoction 2 to obtain extract; concentrate the extract at a temperature of 60℃ and a pressure of -0.085 MPa, and obtain a relative density of 1.03 to obtain a concentrate; dry the concentrate to obtain extract powder; sieve the extract powder and maltodextrin, wherein the amount of maltodextrin is 0.8% of the weight of the Chinese medicinal materials, mix, and granulate to obtain Chinese medicinal material formula granules.

[0052] Example 4 The formulation (by weight) of the pharmaceutical composition in this embodiment is as follows: Poria cocos 140 parts, Salvia miltiorrhiza 105 parts, Alisma plantago-aquatica 70 parts, Cinnamomum cassia 70 parts, Aconitum carmichaelii (processed) 35 parts, Rehmannia glutinosa (processed) 105 parts, Carthamus tinctorius 63 parts, Angelica sinensis 105 parts, Achyranthes bidentata 105 parts, Platycodon grandiflorus 35 parts, Paeonia lactiflora 42 parts, Glycyrrhiza uralensis 42 parts, Bupleurum chinense 21 parts, Prunella vulgaris 105 parts, Ostrea gigas 105 parts, Scrophularia ningpoensis 105 parts, Cyperus rotundus (processed with vinegar) 84 parts, Citrus reticulata (processed with vinegar) 84 parts, Stevia reticulata 3 parts, Citrus aurantium (processed with wheat bran) 105 parts, Cornus officinalis (processed with wine) 105 parts, Ligusticum chuanxiong 35 parts, Prunus persica (processed with vinegar) 84 parts.

[0053] The preparation method of the pharmaceutical composition in this embodiment is as follows: Prepare the above-mentioned Chinese medicinal materials into formula granules, weigh out the formula granules, and you will get the product.

[0054] The preparation method of the formula granules is as follows: Weigh the Chinese medicinal materials, add 10 times the weight of water, decoct for 0.5 hours to obtain decoction 1 and dregs; add 8 times the weight of water to the dregs, decoct for 1 hour to obtain decoction 2 and dregs; combine decoction 1 and decoction 2 to obtain extract; concentrate the extract at a temperature of 55℃ and a pressure of -0.070 MPa, and the relative density of the concentrate is 1.06 to obtain a concentrated solution; dry the concentrated solution to obtain extract powder; sieve the extract powder and maltodextrin, wherein the amount of maltodextrin is 0.6% of the weight of the Chinese medicinal materials, mix, and granulate to obtain Chinese medicinal material formula granules.

[0055] Comparative Example 1 Salvia miltiorrhiza 105 parts, Alisma plantago-aquatica 70 parts, Cinnamomum cassia 70 parts, Aconitum carmichaelii 35 parts, Rehmannia glutinosa 105 parts, Carthamus tinctorius 63 parts, Angelica sinensis 105 parts, Achyranthes bidentata 105 parts, Platycodon grandiflorus 35 parts, Paeonia lactiflora 42 parts, Glycyrrhiza uralensis 42 parts, Bupleurum chinense 21 parts, Prunella vulgaris 105 parts, Ostrea gigas 105 parts, Scrophularia ningpoensis 105 parts, Cyperus rotundus 84 parts, Citrus reticulata 84 parts, Stevia reticulata 3 parts, Citrus aurantium 105 parts, Cornus officinalis 105 parts, Ligusticum chuanxiong 35 parts, Prunus persica 84 parts.

[0056] Unlike Example 1, the composition of the traditional Chinese medicine composition is different; the traditional Chinese medicine composition does not contain the component Poria cocos.

[0057] Everything else is the same as in Example 1.

[0058] Comparative Example 2 Poria cocos 140 parts, Salvia miltiorrhiza 105 parts, Alisma plantago-aquatica 70 parts, Cinnamomum cassia 70 parts, Aconitum carmichaelii (processed) 35 parts, Carthamus tinctorius 63 parts, Angelica sinensis 105 parts, Achyranthes bidentata 105 parts, Platycodon grandiflorus 35 parts, Paeonia lactiflora 42 parts, Glycyrrhiza uralensis 42 parts, Bupleurum chinense 21 parts, Prunella vulgaris 105 parts, Ostrea gigas 105 parts, Scrophularia ningpoensis 105 parts, Cyperus rotundus (processed with vinegar) 84 parts, Citrus reticulata (processed with vinegar) 84 parts, Stevia reticulata 3 parts, Citrus aurantium (processed with wheat bran) 105 parts, Cornus officinalis (processed with wine) 105 parts, Ligusticum chuanxiong 35 parts, Prunus persica (processed with vinegar) 84 parts.

[0059] Unlike Example 1, the composition of the traditional Chinese medicine composition is different; the traditional Chinese medicine composition does not contain the component Rehmannia glutinosa.

[0060] Everything else is the same as in Example 1.

[0061] Animal models were used to conduct detailed pharmacodynamic studies on the formulation to evaluate its efficacy.

[0062] The efficacy of the traditional Chinese medicine composition of this invention on diabetes mellitus with thyroid nodules 1. Experimental Methods Forty-six SPF-grade SD rats, weighing 180±20g, were fed a standard diet and had free access to water. After one week of acclimatization, six rats were randomly selected according to their weight to serve as the normal control group.

[0063] Except for the normal control group, the remaining rats were used to establish a diabetic rat model with thyroid nodules by intraperitoneal injection of streptozotocin solution.

[0064] Modeling method: First, inject 0.5 mL of Freund's adjuvant intraperitoneally. The next day, inject streptozotocin solution (30 mg / kg body weight) intraperitoneally. The streptozotocin solution was prepared with 0.1 mL of sterile sodium citrate buffer at pH 4.2. Administer once a week for 3 consecutive weeks. Blood glucose and body weight were measured after each injection. A blood glucose level >16 mmol / L indicated successful establishment of the diabetic model.

[0065] The model rats were randomly divided into four groups according to their body weight: model control group, experimental group 1, experimental group 2, experimental group 3, control group 1, and control group 2, with 6 rats in each group.

[0066] In Experiment 1, rats were administered 21.6 g / kg (based on crude drug weight) of Solution 1 from Example 1 via gavage; in Experiment 2, they were administered 21.6 g / kg (based on crude drug weight) of Solution 2 from Example 2 via gavage; in Experiment 3, they were administered 21.6 g / kg (based on crude drug weight) of Solution 3 from Example 3 via gavage; in Control Group 1, they were administered 21.6 g / kg (based on crude drug weight) of Solution 1 from Comparative Example 2 via gavage; and in Control Group 2, they were administered 21.6 g / kg (based on crude drug weight) of Solution 2 from Comparative Example 2 via gavage. Rats in the normal control group and the model control group were administered an equal volume of physiological saline via gavage. All treatments were administered once daily for 6 consecutive weeks.

[0067] 2. Indicator Testing 2.1 Fasting blood glucose measurement After fasting for 6 hours but not watering, fasting blood glucose levels were measured in rats 48 days after administration of the drug by tail vein sampling.

[0068] 2.2 Measurement of thyroid hormone levels After the experiment, all rats were anesthetized, and blood was collected from the abdominal aorta. The blood was placed in test tubes without any anticoagulant, centrifuged at 3000 r / min for 15 min at 4℃, and 1 mL of serum was separated and stored at -20℃ for the determination of FT3 and FT4 levels. The determination was strictly performed in accordance with the kit instructions.

[0069] 3. Statistical Methods Data processing was performed using GraphPad Prism 7.0 software, with the measurement data presented in... ±s indicates the mean. One-way ANOVA was used for comparisons between groups, and P < 0.05 was considered statistically significant.

[0070] 4. Experimental Results 4.1 Comparison of fasting blood glucose results among different groups of rats Table 1 Comparison of fasting blood glucose levels in rats of different groups Note: Different lowercase letters in the same column indicate significant differences between different groups (P < 0.05).

[0071] Elevated blood glucose levels are one of the main characteristics of type 2 diabetes. Its symptoms include persistently elevated blood glucose levels, which can lead to disorders of glucose metabolism and glucotoxicity to some extent. Blood glucose levels also reflect the function of pancreatic β cells in secreting insulin.

[0072] Compared with the normal control group, the fasting blood glucose level in the model control group was significantly elevated. Experimental groups 1, 2, and 3 significantly reduced fasting blood glucose levels, showing significant differences compared with the model control group. Experimental groups 1, 2, and 3 also showed significant differences compared with control groups 1-2. The results are shown in Table 1.

[0073] Compared with the normal control group, the model control group showed a significant decrease in FT3 and FT4 levels. Experimental groups 1, 2, and 3 showed significant increases in FT3 and FT4 levels, with statistically significant differences compared to the model control group. Experimental groups 1, 2, and 3 also showed significant differences compared to control groups 1-2. Results are shown below. Figure 1 , Figure 2 .

[0074] The herbal composition of this invention significantly reduces fasting blood glucose and increases the content of FT3 and FT4, suggesting that the herbal composition of this invention significantly improves blood glucose and thyroid function in diabetic rats with thyroid nodules and exerts a therapeutic effect.

[0075] The traditional Chinese medicine composition in Comparative Example 1 does not contain the component Poria cocos, and the traditional Chinese medicine composition in Comparative Example 2 does not contain the component Rehmannia glutinosa. The effects of Comparative Examples 1 and 2 in reducing fasting blood glucose and increasing FT3 and FT4 content are not as good as those in Examples 1 and 3. The components of the traditional Chinese medicine composition of the present invention have synergistic effects. Discarding some of the components or changing the composition will significantly affect the therapeutic effect of the traditional Chinese medicine composition.

[0076] Typical cases First visit on August 16, 2024, chief complaint: intermittent dry mouth and thirst for 9 years.

[0077] Present Illness: Nine years ago, the patient developed symptoms of dry mouth, thirst, polydipsia, and polyuria without any obvious cause, but without polyphagia, fever, or night sweats. The patient visited the Affiliated Hospital of Qinghai University, where blood glucose monitoring confirmed a diagnosis of type 2 diabetes. The patient was prescribed metformin hydrochloride tablets 0.5g orally three times daily and acarbose tablets 50mg orally three times daily for blood glucose control. The patient subsequently underwent intermittent hospitalizations. During the course of the illness, the patient intermittently monitored blood glucose, and recent blood glucose control has been poor. Fasting plasma glucose (FPG) has ranged from 6.0 to 9.0 mmol / L, and 2-hour postprandial glucose (2hPG) has ranged from 8.0 to 14.0 mmol / L. The patient presented to this hospital for further integrated traditional Chinese and Western medicine treatment. The patient was admitted to the emergency department with a diagnosis of type 2 diabetes. Since the onset of the illness, the patient's appetite has been fair, sleep has been poor, bowel movements and urination have been normal, and weight is normal.

[0078] Physical examination: body temperature 36.7℃, pulse 87 beats / min, respiration 20 breaths / min, blood pressure 110 / 70 mmHg, height 156.0cm, weight 54.00kg.

[0079] The patient's random blood glucose level upon admission was 8.7 mmol / L.

[0080] Laboratory tests: Glycated hemoglobin: 5.7%↑; Blood cell analysis: White blood cell count 2.84 (10⁹ / L)↓, Red blood cell count 3.58 (10¹² / L)↓, Mean corpuscular volume 101.9 (fL)↑, Mean corpuscular hemoglobin 34.3 (pg)↑, Platelet count 74 (10⁹ / L)↓, Plateletcrit 0.073%↓; 25-hydroxyvitamin D: 21.18 (ng) / mL)↓; Thyroid function tests: anti-thyroid peroxidase antibody 296.8 (U / mL)↑, thyroid-stimulating hormone (TSH) 0.175 (uIU / mL)↓, serum free triiodothyronine 4.4 (pg / mL)↑, anti-thyroglobulin antibody 246.4 (IU / mL)↑; No significant abnormalities were found in the remaining routine urine tests, urine microalbumin-creatinine ratio, liver and kidney function tests, electrolytes, myocardial enzymes, blood lipids, and coagulation tests.

[0081] Imaging examinations: Thyroid Doppler ultrasound: Thyroid isthmus thickness: 0.4cm. Right lobe thickness approximately 1.6cm, with clear borders, heterogeneous decreased echogenicity of the parenchyma, and a 0.5x0.5cm hypoechoic nodule with clear borders, regular shape, and heterogeneous internal echogenicity detectable within the parenchyma. Left lobe thickness approximately 1.4cm, with clear borders and heterogeneous decreased echogenicity of the parenchyma. No abnormally enlarged lymph nodes were seen in the corresponding lymphatic drainage area.

[0082] CDFI: No blood flow signal was detected around and inside the hypoechoic nodule in the right lobe of the thyroid gland.

[0083] Diagnosis: Changes in the thyroid parenchyma. Please combine thyroid function tests with a hypoechoic nodule in the right lobe of the thyroid gland, suggestive of inflammatory changes, TI-RADS category 3.

[0084] Preliminary diagnosis: Traditional Chinese medicine diagnosis: Diabetes mellitus, lung heat and fluid depletion syndrome.

[0085] Western medical diagnosis: Type 2 diabetes, thyroid nodules, Hashimoto's thyroiditis, vitamin D deficiency.

[0086] Treatment Process: Intravenous infusion of thioctic acid was administered to improve circulation, nourish nerves, and provide antioxidant effects for symptomatic relief; vitamin D supplementation was also given for symptomatic relief. In Traditional Chinese Medicine (TCM), acupoint application (Sanyinjiao, Yongquan, Shenshu) and local herbal fumigation were used to harmonize Yin and Yang and soothe the meridians. Ear pressure pills (Acupoints: Spleen, Stomach, Liver, Pancreas, Endocrine, Diabetes Point, Sanjiao, Subcortex) were applied to improve glucose and lipid metabolism and promote restful sleep. Given the presence of thyroid nodules and the patient's history of diabetes, a goiter syndrome with phlegm and blood stasis was considered. A TCM combination (Formula 1 in Example 1, a dosage of 10 doses) was used for symptomatic treatment. The specific formula is as follows: Usage: Dissolve in hot water and drink, twice a day, one dose each time.

[0087] Follow-up visit: June 9, 2025.

[0088] The patient underwent thyroid Doppler ultrasound examination, which showed: thyroid isthmus thickness: 4mm. The right lobe was approximately 16mm thick with clear borders and coarse, heterogeneous parenchymal echogenicity. The left lobe was approximately 17mm thick with clear borders and coarse, heterogeneous parenchymal echogenicity. No abnormally enlarged lymph nodes were seen in the corresponding lymphatic drainage area. CDF1: No abnormal blood flow signal was observed in the thyroid parenchyma. Diagnosis: Thyroid parenchymal abnormalities; please correlate with thyroid function tests.

[0089] Laboratory tests: 2-hour postprandial blood glucose was 7.1 mmol / L. Thyroid function: TSH 3.617 (uIU / mL), serum free triiodothyronine 2.86 (pg / mL), serum free thyroxine 0.900 ng / dL. Glycated hemoglobin 5.7%, 25-hydroxyvitamin D 24.84 (ng / mL)↓. Renal function: uric acid 368 umol / L. No significant abnormalities were found in the remaining routine urine tests, routine stool tests, urine microalbumin-to-creatinine ratio, liver function tests, electrolytes, myocardial enzymes, lipid profile, and coagulation panel.

[0090] Case description: In 2024, the patient's laboratory test results showed abnormalities in blood glucose, thyroid function, and thyroid ultrasound. After taking one course of traditional Chinese medicine composition, the patient did not use other drugs for symptomatic treatment. In this follow-up examination, it was found that the patient's blood glucose, thyroid function, and thyroid ultrasound had significantly improved compared to before. This case proves that the traditional Chinese medicine composition of the present invention has significant clinical efficacy for diabetes and thyroid nodules.

[0091] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating diabetes and / or thyroid nodules, characterized in that, The traditional Chinese medicine composition for treating diabetes and / or thyroid nodules contains the following components in parts by weight: Poria cocos 130-150 parts, Salvia miltiorrhiza 95-115 parts, Alisma orientalis 65-75 parts, Ramulus cinnamomi 65-75 parts, light Fufang tablets 33-38 parts, Radix Rehmanniae Preparata 95-115 parts, Carthamus tinctorius 60-65 parts, Angelica sinensis 95-115 parts, Radix Achyranthis Bidentatae 95-115 parts, Platycodon grandiflorum 33-38 parts, Radix Paeoniae Rubra 40-45 parts, Glycyrrhiza uralensis 40-45 parts, Bupleurum chinense 19-23 parts, Prunella vulgaris 95-115 parts, Mactra veneriformis 95-115 parts, Scrophularia ningpoensis 95-115 parts, Vinegar Xiangfu 80-90 parts, Vinegar Qingpi 80-90 parts, sweet leaf chrysanthemum 2-4 parts, Poria fructus 95-115 parts, Jiumu 95-115 parts, Chuanxiong 33-38 parts, Baked Peach Kernel 80-90 parts. 2.The traditional Chinese medicine composition for treating diabetes and / or thyroid nodules according to claim 1, characterized in that, The traditional Chinese medicine composition for treating diabetes and / or thyroid nodules contains the following components in parts by weight: Poria cocos 140 parts, Salvia miltiorrhiza 105 parts, Alisma orientalis 70 parts, Ramulus cinnamomi 70 parts, light Fufang tablets 35 parts, Radix Rehmanniae Preparata 105 parts, Carthamus tinctorius 63 parts, Angelica sinensis 105 parts, Radix Achyranthis Bidentatae 105 parts, Platycodon grandiflorum 35 parts, Radix Paeoniae Rubra 42 parts, Glycyrrhiza uralensis 42 parts, Bupleurum chinense 21 parts, Prunella vulgaris 105 parts, Mactra veneriformis 105 parts, Scrophularia ningpoensis 105 parts, Vinegar Xiangfu 84 parts, Vinegar Qingpi 84 parts, sweet leaf chrysanthemum 3 parts, Poria fructus 105 parts, Jiumu 105 parts, Chuanxiong 35 parts, Baked Peach Kernel 84 parts. 3.The traditional Chinese medicine composition for treating diabetes and / or thyroid nodules according to claim 1, characterized in that, The traditional Chinese medicine composition for treating diabetes and / or thyroid nodules contains the following components in parts by weight: Poria cocos 130 parts, Salvia miltiorrhiza 115 parts, Alisma orientalis 75 parts, Ramulus cinnamomi 65 parts, light Fufang tablets 38 parts, Radix Rehmanniae Preparata 95 parts, Carthamus tinctorius 65 parts, Angelica sinensis 115 parts, Radix Achyranthis Bidentatae 95 parts, Platycodon grandiflorum 38 parts, Radix Paeoniae Rubra 40 parts, Glycyrrhiza uralensis 45 parts, Bupleurum chinense 19 parts, Prunella vulgaris 115 parts, Mactra veneriformis 95 parts, Scrophularia ningpoensis 115 parts, Vinegar Xiangfu 90 parts, Vinegar Qingpi 80 parts, sweet leaf chrysanthemum 2 parts, Poria fructus 115 parts, Jiumu 95 parts, Chuanxiong 33 parts, Baked Peach Kernel 84 parts. 4.The traditional Chinese medicine composition for treating diabetes and / or thyroid nodules according to claim 1, characterized in that, The traditional Chinese medicine composition for treating diabetes and / or thyroid nodules contains the following components in parts by weight: Poria cocos 140 parts, Salvia miltiorrhiza 105 parts, Alisma orientalis 70 parts, Ramulus cinnamomi 70 parts, light Fufang tablets 35 parts, Radix Rehmanniae Preparata 105 parts, Carthamus tinctorius 63 parts, Angelica sinensis 105 parts, Radix Achyranthis Bidentatae 105 parts, Platycodon grandiflorum 35 parts, Radix Paeoniae Rubra 42 parts, Glycyrrhiza uralensis 42 parts, Bupleurum chinense 21 parts, Prunella vulgaris 105 parts, Mactra veneriformis 105 parts, Scrophularia ningpoensis 105 parts, Vinegar Xiangfu 84 parts, Vinegar Qingpi 84 parts, sweet leaf chrysanthemum 3 parts, Poria fructus 105 parts, Jiumu 105 parts, Chuanxiong 35 parts, Baked Peach Kernel 84 parts.

5. The method of claim 1-4, wherein the method is characterized in that, The preparation method comprises the following steps: preparing the above-mentioned traditional Chinese medicinal materials into formula granules, and weighing the formula granules by parts by weight, to obtain. The preparation method of the formula granules is as follows: the traditional Chinese medicinal materials are weighed, 8-10 times of water by weight is added, and decoction is performed for 0.5-1 h to obtain decoction 1 and residues; 8-10 times of water by weight is added to the residues, and decoction is performed for 0.5-1 h to obtain decoction 2 and residues; the decoction 1 and the decoction 2 are combined to obtain an extraction liquid; the extraction liquid is concentrated, the concentration temperature is 50-70 DEG C, the concentration pressure is -0.060 to -0.085 Mpa, and the relative density of the concentrated liquid is 1.03-1.07 to obtain a concentrated liquid; the concentrated liquid is dried to obtain extract powder; the extract powder and malt dextrin are sieved, the amount of the malt dextrin is 0.4%-0.8% of the mass of the traditional Chinese medicinal materials, mixed, granulated, and the traditional Chinese medicinal material formula granules are obtained.

6. The method of claim 5, wherein the Chinese medicine composition for treating diabetes and / or thyroid nodules is prepared by the method, characterized in that, The preparation method of the formula granules is as follows: the traditional Chinese medicinal materials are weighed, 8 times of water by weight is added, and decoction is performed for 0.5 h to obtain decoction 1 and residues; 10 times of water by weight is added to the residues, and decoction is performed for 1 h to obtain decoction 2 and residues; the decoction 1 and the decoction 2 are combined to obtain an extraction liquid; the extraction liquid is concentrated, the concentration temperature is 50 DEG C, the concentration pressure is -0.075 Mpa, and the relative density of the concentrated liquid is 1.07 to obtain a concentrated liquid; the concentrated liquid is dried to obtain extract powder; the extract powder and malt dextrin are sieved, the amount of the malt dextrin is 0.6% of the mass of the traditional Chinese medicinal materials, mixed, granulated, and the traditional Chinese medicinal material formula granules are obtained.

7. The use of the traditional Chinese medicinal composition for treating diabetes and / or thyroid nodules according to claim 1 in the preparation of a medicine for preventing or treating diabetes.

8. The use of the traditional Chinese medicinal composition for treating diabetes and / or thyroid nodules according to claim 1 in the preparation of a medicine for preventing or treating thyroid nodules.

9. The use of the traditional Chinese medicinal composition for treating diabetes and / or thyroid nodules according to claim 1 in the preparation of a medicine for preventing or treating diabetes with thyroid nodules.

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