Application of radix puerariae powder-based iodine complex in preparation of medicine for preventing or treating hyperthyroidism

The preparation of kudzu root powder-based iodine complex has solved the problems of stability and tolerability of iodine preparations in the treatment of hyperthyroidism, achieving stable iodine loading and slow release, thereby improving patient tolerance and treatment compliance.

CN121775162APending Publication Date: 2026-04-03ANHUI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-01-22
Publication Date
2026-04-03

AI Technical Summary

Technical Problem

Existing treatments for hyperthyroidism suffer from problems such as poor long-term adherence, numerous adverse reactions, incomplete treatment effects, and inconvenient administration. Traditional iodine preparations are unstable, volatile, and highly irritating, affecting patient tolerance.

Method used

Using kudzu root powder as a carrier, a stable kudzu root powder-based iodine complex is formed with iodine. Through gelatinization and retrogradation, a porous structure is formed, and iodine is slowly released in the gastric acid environment, reducing gastrointestinal irritation. Furthermore, the synergistic effect of puerarin improves tolerance.

Benefits of technology

It achieves stable iodine loading and targeted delivery, reduces gastrointestinal irritation, improves patient tolerance and compliance, and provides a safe, stable, and convenient treatment option for hyperthyroidism.

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Abstract

The invention discloses a novel application of a kudzuvine root powder-based iodine complex in preparation of a medicine for preventing or treating hyperthyroidism. Experimental research shows that compared with a traditional iodine preparation, the radix puerariae powder-based iodine compound can achieve effective loading and stable wrapping of iodine and can effectively reduce the concentration of free iodine, so that the direct stimulation and injury risk of iodine to gastrointestinal mucosa is greatly reduced, the tolerance and compliance of patients taking medicine for a long time are remarkably improved, and the curative effect is good. The medicine is suitable for long-term health management of hyperthyroidism patients, and a novel treatment choice which is safe, stable, convenient and good in tolerance is provided for long-term medicine intervention of hyperthyroidism.
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Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, and in particular relates to the application of a kudzu root powder-based iodine complex in the preparation of drugs for the prevention or treatment of hyperthyroidism. Background Technology

[0002] Hyperthyroidism, also known as overactive thyroid, is an endocrine disorder caused by excessive synthesis and secretion of thyroid hormones by the thyroid gland, leading to hypermetabolism and sympathetic nervous system excitation. Clinical manifestations include goiter, increased appetite, and weight loss. Notably, the incidence of hyperthyroidism is showing a year-on-year upward trend due to changes in environmental and lifestyle factors. There are significant gender and age differences in the incidence of hyperthyroidism; women are approximately 5-10 times more likely to be affected than men. The peak age of onset is 20-50 years, and the proportion of cases in younger populations is increasing, indicating that hyperthyroidism has become a widespread and increasingly serious public health problem.

[0003] Currently, the main clinical interventions for hyperthyroidism include antithyroid drug therapy, radioactive iodine-131 (¹³¹I) therapy, and subtotal / total thyroidectomy. Among these, antithyroid drugs (methimazole, propylthiouracil) inhibit thyroid peroxidase, reducing thyroid hormone synthesis, and are the first-line treatment option both domestically and internationally. Their advantages include being non-invasive, reversible, and preserving thyroid function. However, the treatment course is typically as long as two years, leading to poor patient compliance and a high relapse rate after discontinuation (up to 50%). Furthermore, a small number of patients may experience adverse drug reactions such as agranulocytosis and liver damage, requiring close monitoring during treatment.

[0004] Radioactive iodine-131 (¹³¹I) can be highly taken up by thyroid tissue, and the released beta rays can selectively destroy hyperactive thyroid follicular cells, thereby reducing hormone synthesis. This method is effective and has a high one-time cure rate, especially suitable for moderate to severe patients who are intolerant to drugs or have relapsed. However, its core drawback is that the use of radioactive iodine in special populations, such as pregnant and lactating women and children, is strictly limited, and the treatment can lead to dose-dependent permanent hypothyroidism.

[0005] Thyroidectomy, by directly removing most or all of the thyroid tissue, can quickly and thoroughly control hyperthyroidism. It is mainly suitable for patients with significantly enlarged thyroid glands accompanied by compressive symptoms, suspected malignancy, or those unsuitable for the two treatments mentioned above. However, surgery is an invasive procedure with risks such as recurrent laryngeal nerve injury and hypoparathyroidism. More importantly, similar to radioactive iodine therapy, the vast majority of patients will develop permanent hypothyroidism after the surgery.

[0006] In the core pathological process of hyperthyroidism, thyroid follicular cells excessively synthesize and secrete thyroid hormones, especially triiodothyronine (T3) and thyroxine (T4), leading to hypermetabolism. Under these pathological conditions, the significantly elevated T3 / T4 levels strongly inhibit the secretion of pituitary thyroid-stimulating hormone (TSH) through the negative feedback mechanism of the hypothalamus-pituitary-thyroid axis. Therefore, reducing the synthesis and release of thyroid hormones is a key objective of this study.

[0007] The pharmacological mechanism of traditional iodine preparations (such as Lugol's solution, i.e., an aqueous solution of iodine and potassium iodide) in treating hyperthyroidism has been clearly demonstrated: high doses of iodine (>6 mg / d) rapidly inhibit the hydrolysis of thyroglobulin, thereby quickly blocking the release of T3 / T4 synthesized in the thyroid gland; it can also affect the iodination and coupling process of tyrosine by inhibiting the activity of thyroid peroxidase, ultimately reducing the synthesis of T3 / T4. Clinically, it is used for emergency rescue of hyperthyroid storm and preoperative preparation for subtotal or partial thyroidectomy.

[0008] However, these directly administered iodine preparations are highly irritating, resulting not only in a poor taste but also causing oral and gastrointestinal discomfort, severely impacting their clinical use. Clinically, to improve patient tolerance, they are often mixed with juice, milk, or food before administration, and the liquid is quickly swallowed after being delivered to the back of the tongue using a straw. Patients must rinse their mouths immediately afterward to remove any residue and avoid prolonged contact with teeth and gums, preventing tooth discoloration or mucosal damage. This series of complex administration requirements makes it impossible to administer on an empty stomach or via direct oral administration, significantly reducing the convenience of medication and patient adherence to long-term treatment. Furthermore, the chemical instability of iodine preparations, their volatile and easily oxidized properties, make it difficult to maintain a constant effective concentration, resulting in precise dosage control. Summary of the Invention

[0009] To address the shortcomings of the prior art, the present invention aims to provide a new application of kudzu root powder-based iodine complex in the preparation of drugs for the prevention or treatment of hyperthyroidism, providing a safe, stable, convenient and well-tolerated new treatment option for long-term drug intervention for hyperthyroidism.

[0010] This invention is achieved through the following technical solution:

[0011] This invention provides the application of kudzu root powder-based iodine complex in the preparation of drugs for the prevention or treatment of hyperthyroidism, wherein the kudzu root powder-based iodine...

[0012] The complex comprises a kudzu root powder carrier and iodine loaded on the kudzu root powder carrier. The starch in the kudzu root powder undergoes gelatinization retrogradation, and the iodine molecules are embedded into the starch molecular chains through coordination with the starch molecules to form a kudzu root powder-based iodine complex.

[0013] This invention uses kudzu root powder as a natural carrier, which undergoes gelatinization and retrogradation to form a porous structure. Within this carrier, iodine forms a complex with starch molecules in the kudzu root powder, thus being stably encapsulated. This effectively reduces the volatilization and oxidation of iodine, ensuring the stability of the complex during storage.

[0014] Based on the above structure, this invention achieves targeted delivery and controlled release of iodine. Resistant starch is formed through gelatinization-retrogradation, with iodine attached to the hollow helical structure of the resistant starch. This structure provides a physical barrier against iodine in the acidic environment of the stomach, resisting rapid digestion by pepsin and trypsin. After the complex enters the intestine, the anchored iodine is continuously and in low doses released through the slow decomposition of starch by intestinal flora, thus avoiding direct irritation and damage to the upper gastrointestinal mucosa caused by high concentrations of iodine.

[0015] In a preferred embodiment of the present invention, the iodine loading in the kudzu root powder-based iodine complex is 5-20 wt%. Each helix of amylose (about 6 glucose units) can linearly encapsulate one iodine molecule, thereby estimating the maximum theoretical loading of the carrier.

[0016] The kudzu root powder of this invention is rich in flavonoids such as puerarin. Multiple studies have confirmed that these components have clear anti-inflammatory, antioxidant, and gastrointestinal mucosal protective activities. While achieving iodine loading, this invention, through the synergistic effect of puerarin, can further reduce the direct irritation of iodine to the upper gastrointestinal mucosa, fundamentally improving patients' tolerance to long-term medication and significantly enhancing the safety of oral administration.

[0017] In a preferred embodiment of the present invention, the kudzu root powder is derived from at least one of kudzu root powder or wild kudzu root.

[0018] As a preferred embodiment of the present invention, the kudzu root powder has a particle size of 75-212 μm. This medium-sized powder has good flowability and a suitable specific surface area, which is beneficial for subsequent uniform compounding and mixing processes with iodine. It also provides a suitable material science basis for possible solid dosage form molding operations such as tableting.

[0019] The preparation method of the kudzu root powder-based iodine complex of the present invention can be referred to the following steps:

[0020] (1) Mix kudzu root powder with water to form a kudzu root powder aqueous suspension;

[0021] (2) The kudzu root powder water suspension was subjected to hydrothermal gelatinization-retrogradation treatment to obtain gelatinized-retrograded kudzu root powder suspension;

[0022] (3) Add potassium iodide, potassium iodate and acid to the gelatinized-reclaimed kudzu powder suspension, adjust the pH of the system to acidic, carry out the reaction, and obtain kudzu powder-based iodine complex after post-treatment.

[0023] Preferably, in step (2), the hydrothermal gelatinization-retrogradation treatment includes: heating at 60-90 ℃ for 5-15 min, followed by refrigeration at 0-4 ℃ for 2-6 h. Heating for 5-15 min disrupts the starch granule crystal structure, causing it to absorb water, swell, and gelatinize, forming a viscous paste-like gel. Refrigeration for 2-6 h promotes the rearrangement and crystallization of amylose molecules, forming a stable and dense three-dimensional network gel structure, thus achieving retrogradation.

[0024] Preferably, in step (2), the hydrothermal gelatinization-retrogradation treatment results in an energy value of 3087~5733 J / g per gram of kudzu root powder. The energy value per gram of kudzu root powder in this invention is based on the total energy input during the hydrothermal treatment process. This value is calculated by using the heat transferred by water as the heat transfer medium.

[0025] Preferably, in step (3), the molar ratio of potassium iodide to potassium iodate is 5:1; the acid is any one of hydrochloric acid, dilute sulfuric acid or phosphoric acid; and the pH of the system is adjusted to 1.4-3.4.

[0026] In a preferred embodiment of the present invention, the drug comprises an effective amount of kudzu root powder-based iodine complex and a pharmaceutically acceptable carrier.

[0027] The pharmaceutically acceptable carriers include conventional diluents, excipients (such as water), fillers (such as starch), binders (such as cellulose derivatives, gelatin, etc.), humectants (such as glycerin, etc.), disintegrants (such as agar, calcium carbonate, etc.), absorption promoters (such as quaternary ammonium compounds, etc.), lubricants (such as talc, etc.), coating materials, etc., in amounts that are conventional in the field.

[0028] The drug of the present invention can be prepared in any pharmaceutically acceptable dosage form according to conventional methods in the art. Preferably, the dosage form of the drug includes, but is not limited to, oral suspensions, capsules, granules or enteric-coated tablets.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] This invention provides a novel application of kudzu root powder-based iodine complex in the preparation of drugs for the prevention or treatment of hyperthyroidism. Experimental studies have shown that, compared with traditional iodine preparations, the kudzu root powder-based iodine complex of this invention can achieve effective loading and stable encapsulation of iodine, effectively reducing the concentration of free iodine, thereby significantly reducing the risk of direct irritation and damage to the gastrointestinal mucosa by iodine, and significantly improving patients' tolerance and compliance to long-term medication, making it suitable for long-term health management of hyperthyroidism patients.

[0031] This invention leverages the synergistic effect of the anti-inflammatory, antioxidant, and immunomodulatory pharmacological effects of kudzu root components with the therapeutic effects of iodine. This can further reduce the direct irritation of iodine to the upper gastrointestinal mucosa, help alleviate symptoms of hyperthyroidism such as palpitations and sweating, and reduce adverse reactions such as granulocytopenia and liver damage caused by the use of chemical drugs alone. This provides a gentler and safer treatment or adjunctive treatment option for hyperthyroidism patients. Attached Figure Description

[0032] Figure 1 To investigate the irritant effect of each group on the gastric mucosa of mice;

[0033] Figure 2 The weight trend graph of each group of hyperthyroid mice after intervention;

[0034] Figure 3 Serum T3, T4, and TSH levels in each group of hyperthyroid mice treated with the intervention (different letters in the figure indicate significant differences (p<0.05)).

[0035] Figure 4 HE staining images of thyroid tissue in each group of hyperthyroid mice after intervention;

[0036] Figure 5 PAS staining images of thyroid tissue in mice after intervention in each group of hyperthyroid mice. Detailed Implementation

[0037] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. The described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0038] Example 1:

[0039] (1) Mix 0.5 g of kudzu root powder with a particle size of 75 μm with 10 mL of water to form a 5% kudzu root powder aqueous suspension;

[0040] (2) The kudzu root powder suspension was heated by hydrothermal method, the temperature was maintained at 60 ℃, the heating time was 5 min, the energy value obtained per gram of kudzu root powder was controlled to be 3087 J / g, and the gelatinized-retrograded kudzu root powder suspension was obtained by standing and refrigerating.

[0041] (3) Potassium iodide and potassium iodate (molar ratio of 5:1) were added sequentially to the gelatinized-reclaimed kudzu root powder suspension. The pH of the system was adjusted to 2.1 with hydrochloric acid, and the reaction was carried out to obtain an iodine-loaded kudzu root powder suspension. The suspension was first filtered, and the precipitate was washed and then freeze-dried to finally obtain a kudzu root powder-based iodine complex HT with an iodine negative content of 6.12%.3087 PL 75 @I2.

[0042] Example 2:

[0043] (1) Mix 0.5 g of kudzu root powder with a particle size of 75 μm with 10 mL of water to form a 5% kudzu root powder aqueous suspension;

[0044] (2) The kudzu root powder suspension was heated by hydrothermal method, the temperature was maintained at 90 ℃, the heating time was 5 min, the energy value obtained per gram of kudzu root powder was controlled to be 5733 J / g, and the gelatinized-retrograded kudzu root powder suspension was obtained by standing and refrigerating.

[0045] (3) Potassium iodide and potassium iodate (molar ratio of 5:1) were added sequentially to the gelatinized-reclaimed kudzu root powder suspension, and the pH of the system was adjusted to 2.1 with hydrochloric acid. The reaction was carried out to obtain an iodine-loaded kudzu root powder suspension. The suspension was first filtered, and the precipitate was washed and then freeze-dried to finally obtain a kudzu root powder-based iodine complex HT with an iodine content of 17.00%. 5733 PL 75 @I2.

[0046] Comparative Example 1:

[0047] (1) Mix 0.5 g of kudzu root powder with a particle size of 75 μm with 10 mL of water to form a 5% kudzu root powder aqueous suspension;

[0048] (2) The kudzu root powder suspension was heated by hydrothermal method, the temperature was maintained at 90 ℃, the heating time was 5 min, the energy value obtained per gram of kudzu root powder was controlled to be 5733 J / g, and the gelatinized-retrograded kudzu root powder suspension was obtained by standing and refrigerating.

[0049] (3) After filtering the suspension, freeze-drying was performed to finally obtain blank gelatinized-regenerated kudzu root powder.

[0050] The gastrointestinal irritation of the samples in the above embodiments and comparative examples was investigated, and their effects on hyperthyroid mice were explored. The methods are as follows:

[0051] 1. Measurement of gastrointestinal irritation

[0052] Four groups of mice (10-week-old female BALB / c mice, weighing approximately 20 g) were administered physiological saline (normal group), HT, and other treatments, respectively. 5733 PL 75@I2 (Example 2 group), blank gelatinized-reclaimed kudzu root powder (Comparative Example 1 group), and povidone-iodine solution (povidone-iodine solution group, iodine content consistent with Example 2 group) were administered for one week. The mice were fasted for 12-16 hours before the endoscopic examination. Urapan was injected intraperitoneally at a dose of 1500 mg / kg. Under anesthesia, the lens of the mini-endoscope was coated with sterile lubricant. The mouse's maxilla was gently fixed with the left thumb and forefinger, and the tongue base was gently pressed with the middle finger. The endoscope was held in the right hand and slowly inserted along the midline of the palate, naturally advancing through the pharynx and esophagus (the longitudinal folds of the esophageal mucosa could be observed) until the lens entered the stomach. The field of view suddenly widened, revealing the gastric mucosa and gastric juice. Images were saved for subsequent analysis.

[0053] The results are as follows Figure 1 As shown, the gastrointestinal mucosa of the normal group mice was smooth and intact, without congestion or damage. The gastrointestinal mucosa morphology of the mice in Example 2 and Comparative Example 1 was similar to that of the normal group mice. Using commercially available povidone-iodine solution as a control, the gastrointestinal mucosa of the mice in the povidone-iodine solution group showed obvious irritant damage, manifested as petechial hemorrhage. This indicates that the gelatinized kudzu root powder carrier system constructed in this invention can effectively avoid the direct irritant effect of iodine on the gastrointestinal tract.

[0054] 2. The therapeutic effect of kudzu root powder-based iodine complex on hyperthyroid mice:

[0055] 2.1 Construction of a mouse model of hyperthyroidism

[0056] Sixty 10-week-old female BALB / c mice (weighing approximately 20 g) were randomly divided into a normal control group and a model group. The normal control group was administered physiological saline by gavage, while the model group was administered levothyroxine sodium 1250 μg / kg by gavage for 21 days to induce a hyperthyroidism model, characterized by excessive sweating, increased appetite, increased thirst, and behavioral changes such as restlessness.

[0057] 2.2 Effects of different intervention methods on changes in mouse body weight

[0058] The model group mice were randomly divided into four groups: model group, positive drug group (propylthiouracil: 10 mg / kg), Example 2 group (iodine content: 3 g / kg), and comparative example 1 group (with the same content of gelatinized kudzu root powder as in Example 2 group), with 10 mice in each group. Each group of mice was administered the corresponding dose of drug by gavage daily for 21 days, and the weight of the mice was recorded daily during this period.

[0059] The body weights of mice in each group are as follows: Figure 2As shown in the figure, the body weight of the normal group mice showed a steady increasing trend. Compared with the normal group, the body weight gain of the model group mice was slow and then significantly reduced, with their body weight consistently lower than that of the normal group. The body weight of the mice in Example 2 group and the positive drug group recovered well over time, returning to the level of the normal group, while the body weight of the mice in Comparative Example 1 group decreased in the early stage of drug administration, and recovered somewhat in the later stage, but was still lower than that of the normal group mice, indicating that HT 5733 PL 75 @I2 kudzu root powder-based iodine complex can effectively improve the weight loss problem in hyperthyroidism model mice.

[0060] 2.3 Effects of different intervention methods on serum T3, T4, and TSH levels in mice

[0061] Mice in the model group were randomly divided into four groups: the model group, the positive control group (propylthiouracil: 10 mg / kg), the Example 2 group (iodine content: 3 g / kg), and the comparative example group (with the same gelatinized kudzu root powder content as in the Example 2 group), with 10 mice in each group. Mice in each group were administered the corresponding dose of the drug by gavage daily for 21 days. After 21 days, the mice were first anesthetized with sodium pentobarbital. Serum samples were then obtained by enucleating the mice's eyeballs. To ensure adequate coagulation and centrifugation of the serum, the blood samples were allowed to stand at room temperature for 30 minutes. The samples were then centrifuged at 3500 r / min for 10 minutes at 4°C. After centrifugation, the supernatant was carefully collected and stored at -80°C for subsequent determination of thyroid hormone-related levels.

[0062] like Figure 3 In the model group, the levels of T3 and T4 were significantly higher than those in the normal group, while the level of TSH was lower. After drug intervention, the levels of T3 and T4 in the positive drug group and the Example 2 group were significantly reduced, while the level of TSH was significantly increased. However, the levels of T3, T4, and TSH in the Comparative Example 1 group showed no significant change compared to the model group, indicating that HT... 5733 PL 75 @I2 kudzu root powder-based iodine complex can effectively improve thyroid dysfunction in hyperthyroidism model mice: significantly reduce their abnormally elevated serum T3 and T4 concentrations, and increase the suppressed TSH level.

[0063] 2.4 Effects of different intervention methods on mouse thyroid tissue

[0064] Mice in the model group were randomly divided into 5 groups: model group, positive drug group (propylthiouracil: 10 mg / kg), Example 1 group (iodine content: 1.5 g / kg), Example 2 group (iodine content: 3 g / kg), and Comparative Example 1 group (with the same content of gelatinized kudzu root powder as in Example 2 group), with 10 mice in each group. Mice in each group were administered the corresponding dose of drug by gavage daily for 21 days. After 21 days, the mice were first anesthetized with sodium pentobarbital. Under normal temperature conditions, thyroid tissue was carefully removed and fixed in 4% paraformaldehyde solution to fix and preserve its morphology and structure. These fixed tissues will be used for subsequent hematoxylin-eosin (HE) staining and glycogen staining (PAS) detection.

[0065] HE staining results of mouse thyroid tissue are as follows Figure 4 As shown, in the normal group of mice, the thyroid follicles were mostly round or oval and uniform in size; the follicular lumen was filled with homogeneous red-stained colloid, and the edges were neat. Compared with the normal group, the thyroid follicles in the model group of mice were often of varying sizes, with some follicles dilated or atrophied, reduced colloid content, lighter staining, and serrated or vacuolated edges. The thyroid follicle structure of the positive drug group of mice was restored, approaching the normal morphology. In the mice of Example 1 group, some thyroid follicles were still dilated, with reduced colloid content and lighter staining, and the structural improvement was limited; while in the mice of Example 2 group, the thyroid structure was basically restored to normal, and the follicle morphology and colloid state were close to those of the normal group. In the comparative example 1 group, the follicles were irregular in size, and no significant improvement in tissue morphology was observed.

[0066] PAS staining results of mouse thyroid tissue are as follows Figure 5 As shown, compared with the normal group, the PAS-positive colloid in the thyroid follicle lumen of the model group mice was significantly reduced, and the staining intensity was significantly decreased. Compared with the model group, the PAS-positive colloid in the thyroid follicle lumen of the positive drug group and the Example 2 group mice was restored, the thyroid follicles were significantly enlarged, and the lumen was filled with uniform, deeply stained colloid. The thyroid follicles of the mice in the Example 1 group were shrunken, and some areas with darker staining were visible, but the overall staining was still light. The thyroid follicles of the mice in the Comparative Example 1 group were significantly shrunken, and the colloid in the lumen was sparse and lightly stained. The above results indicate that the kudzu root powder-based iodine complex has a relieving effect on the pathological damage of thyroid tissue in hyperthyroid mice, and the improvement effect of the Example 2 group is more obvious.

[0067] In summary, the HT prepared by this invention 5733 PL 75 @I2 kudzu root powder-based iodine complex can improve the symptoms of hyperthyroidism in mice induced by levothyroxine sodium.

[0068] Preparation Example 1: Preparation of Capsules

[0069] (1) Weigh out kudzu root powder-based iodine complex, microcrystalline cellulose (filler), and povidone K30 (binder), add an appropriate amount of purified water to make a soft material, and granulate it through a 20-mesh sieve;

[0070] (2) Dry the granules under vacuum at 45°C for 4 hours, sieve them through an 18-mesh sieve, add 0.5% magnesium stearate (lubricant) by weight of the granules, mix well, fill capsules, and the product is obtained.

[0071] Preparation Example 2: Preparation of Enteric-coated Tablets

[0072] (1) Weigh out kudzu root powder-based iodine complex, lactose (filler), hydroxypropyl cellulose (binder), and magnesium stearate (lubricant), prepare granules, and dry and granulate them;

[0073] (2) The particles are coated with a pH-sensitive coating material to obtain enteric tablets.

Claims

1. The application of kudzu root powder-based iodine complex in the preparation of drugs for the prevention or treatment of hyperthyroidism, wherein the kudzu root powder-based iodine complex comprises a kudzu root powder carrier and iodine loaded on the kudzu root powder carrier, wherein the starch in the kudzu root powder undergoes gelatinization retrogradation, and iodine molecules are embedded in the helical cavity of the starch molecule chain through coordination with starch molecules to form the kudzu root powder-based iodine complex.

2. The application according to claim 1, characterized in that, The loading of iodine in the kudzu root powder-based iodine complex is 5-20 wt%.

3. The application according to claim 1, characterized in that, The kudzu root powder is derived from at least one of kudzu root or wild kudzu.

4. The application according to claim 1, characterized in that, The particle size of the kudzu root powder is 75-212 μm.

5. The application according to claim 1, characterized in that, The preparation method of the kudzu root powder-based iodine complex includes the following steps: (1) Mix kudzu root powder with water to form a kudzu root powder aqueous suspension; (2) The kudzu root powder water suspension is subjected to hydrothermal gelatinization-retrogradation treatment to obtain gelatinized-retrograded kudzu root powder suspension; the hydrothermal gelatinization-retrogradation treatment includes: heating at 60-90 ℃ for 5-15 min, followed by refrigeration at 0-4 ℃ for 2-6 h; (3) Add potassium iodide, potassium iodate and acid to the gelatinized-reclaimed kudzu powder suspension. The molar ratio of potassium iodide to potassium iodate is 5:

1. Adjust the pH of the system to 1.4-3.4 and carry out the reaction. After post-treatment, kudzu powder-based iodine complex is obtained.

6. The application according to claim 5, characterized in that, In step (2), the hydrothermal gelatinization-retrogradation treatment results in an energy value of 3087~5733 J / g per gram of kudzu root powder.

7. The application according to claim 1, characterized in that, The drug contains an effective amount of kudzu root powder-based iodine complex and a pharmaceutically acceptable carrier.

8. The application according to claim 7, characterized in that, The dosage form of the drug is oral suspension, capsule, granule or enteric-coated tablet.