Application of processed American ginseng in preparation of drugs for treating hypothyroidism

Abstract

The application discloses a processed American ginseng product for treating hypothyroidism, which is prepared from American ginseng as raw material and is obtained through nine times of steaming and drying; the black American ginseng is crushed into coarse powder, and is extracted three times through heating reflux extraction with 50-70% ethanol solution, and each time is 1-3 hours, and the extract is concentrated to obtain the product. The application further discloses application of the processed American ginseng product in preparation of a medicine for treating hypothyroidism. The processed American ginseng product can improve the unbalanced hypothalamus-pituitary-thyroid axis function of a hypothyroidism patient, promote secretion of thyroid hormone, improve thyroid function, and has a remarkable improvement effect on hypothyroidism.

Description

TECHNICAL FIELD

[0001] The application belongs to the field of food and medicine processing, and particularly relates to a Panax quinquefolium L. processed product with improved thyroid function and application thereof in preparation of a medicine for treating hypothyroidism. BACKGROUND

[0002] Panax quinquefolium L. is the dried root of Panax quinquefolium L. in Araliaceae, also known as American ginseng, American ginseng, etc. Panax quinquefolium L. contains complex chemical components, including saponins, polysaccharides, volatile oils, amino acids, etc. Ginsenosides are one of the main active components of Panax quinquefolium L. Pharmacological studies have shown that Panax quinquefolium L. saponins have analgesic, antioxidant, anti-tumor, cardiovascular and cerebrovascular protection, nerve cell protection, memory loss reduction, blood glucose regulation, immune function regulation, etc. After being processed into black ginseng by steaming, the large molecular weight ginsenosides in Panax quinquefolium L. are converted into rare ginsenosides RG3, RG5, RH1, RH2, RH4, RK1 and RK5 with smaller molecular weight. The biological activity of rare ginsenosides is higher and the bioavailability is better. Studies have shown that ginsenoside Rg5 has an inhibitory effect on breast cancer cells, Rg3 can promote the apoptosis of human gallbladder cancer cells, and Rg3 combined with other drugs can improve the efficacy or reduce adverse reactions. Ginsenosides Rg3 and Rg1 can enhance immune function; Rg5 has an anti-heart failure effect. There is no application of Panax quinquefolium L. processed product black ginseng in the treatment of hypothyroidism.

[0003] At present, pure traditional Chinese medicine treatment can only phase the symptoms and signs of hypothyroidism, and the curative effect is unstable, so it often needs to be combined with western medicine thyroid hormone for treatment, and the effect is obvious. Western medicine thyroid hormone replacement therapy can improve laboratory indicators, but the relief of clinical symptoms is poor, and it cannot fundamentally change the lesion of the thyroid itself, and it needs to be taken for life. During the treatment process, especially in elderly patients, serious side effects such as tachycardia, arrhythmia, angina pectoris, heart failure, etc. may occur. SUMMARY

[0004] The purpose of the present application is to provide a medicine and food dual-use Panax quinquefolium L. processed product for treating hypothyroidism, which can significantly improve thyroid function, increase thyroid hormone secretion, maintain thyroid-stimulating hormone releasing hormone (TRH), hypothalamic-pituitary-gonadal axis factor follicle-stimulating hormone (FSH), and thyroid hormone dynamic balance.

[0005] The purpose of the present application is achieved by the following technical scheme:

[0006] A panax ginseng processing product for treating hypothyroidism is prepared by using panax ginseng as raw material, black panax ginseng is obtained through nine times of steaming and drying; the black panax ginseng is crushed into coarse powder, 50-70% ethanol solution is used as extraction solvent, heated reflux extraction is carried out for 3 times, 1-3 hours each time, and the extraction liquid is concentrated to obtain the product.

[0007] The nine times of steaming and drying are as follows: panax ginseng is steamed in a high-pressure steamer at 105-115 DEG C for 1 hour, the temperature is lowered to 50-60 DEG C, and the steamed panax ginseng is taken out and dried at 50 DEG C + / - 2 DEG C for 1-5 hours; the above-mentioned steaming and drying is repeated for 9 times.

[0008] The panax ginseng is four-year-old panax ginseng.

[0009] The dosage ratio of the coarse powder of black panax ginseng and 50-70% ethanol solution is 1:5-1:20 g / mL.

[0010] Another object of the present application is to provide the use of the panax ginseng processing product in the preparation of a medicine for treating hypothyroidism.

[0011] Preferably, the medicine is prepared by using 50-70% ethanol extract of the panax ginseng processing product as effective component and pharmaceutically acceptable excipient.

[0012] Preferably, the medicine is prepared by using 50-70% ethanol extract of the panax ginseng processing product as effective component and pharmaceutically acceptable excipient.

[0013] Specifically, the medicine is prepared by using panax ginseng as raw material, black panax ginseng is obtained through nine times of steaming and drying, the black panax ginseng is crushed into coarse powder, 50-70% ethanol solution is used as extraction solvent, heated reflux extraction is carried out for 3 times, 1-3 hours each time, ethanol in the extraction liquid is recovered under reduced pressure, the extraction liquid is concentrated to a relative density of 1.10-1.20 (20-25 DEG C), filtered, and the filtrate is mixed with pharmaceutically acceptable excipient to obtain granules. The mass ratio of the filtrate (based on the coarse powder of black panax ginseng) and the pharmaceutically acceptable excipient is about 1:5-1:2; the pharmaceutically acceptable excipient is selected from glucose.

[0014] More preferably, the medicine is prepared by using 60% ethanol extract of the panax ginseng processing product as effective component, using glucose as excipient, and spray granulating to obtain granules.

[0015] Preferably, the panax ginseng processing product is used in the preparation of a medicine for treating hypothyroidism by improving the unbalanced hypothalamic-pituitary-thyroid axis function of patients with hypothyroidism, promoting the secretion of thyroid hormone, and improving thyroid function.

[0016] Another object of the present application is to provide the use of panax ginseng in the preparation of a medicine for treating hypothyroidism.

[0017] Preferably, the medicine is prepared with 50-70% ethanol extract of American ginseng as the active ingredient and pharmaceutically acceptable excipients.

[0018] Specifically, the drug is made from American ginseng as a raw material, which is crushed into coarse powder, and a 50-70% ethanol solution is used as an extraction solvent. The extraction is heated and refluxed for 3 times, each time for 1-3 hours. The extract is decompressed to recover ethanol, concentrated to a relative density of 1.10-1.20 (20-25°C), filtered, and the filtrate is mixed with a pharmaceutically acceptable excipient to prepare a granule. The amount ratio of the coarse powder of American ginseng to the 50-70% ethanol solution is 1:5-1:20 g / mL. The mass ratio of the filtrate (calculated as American ginseng coarse powder) to the pharmaceutically acceptable excipient is about 1:5-1:2; the pharmaceutically acceptable excipient is selected from glucose.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] The extract obtained by processing and extracting American ginseng has a significant improvement effect on hypothyroidism, expanding the scope of its functions and indications.

[0021] American ginseng is both a medicine and a food, and is highly safe. Its processed products can improve thyroid function without worrying about side effects. DETAILED DESCRIPTION

[0022] The technical solution of the present invention is further described below through specific embodiments.

[0023] Example 1

[0024] Preparation of processed American ginseng product, Black American ginseng granules

[0025] Step (1), selecting 500g of four-year-old sun-dried American ginseng, laying a layer of gauze on a stainless steel net in a high-pressure steamer, evenly placing the American ginseng on the gauze, heating to 105-108°C, and maintaining for 1 hour; cutting off the steam source, and opening the high-pressure steamer when the temperature in the pot drops to 50-60°C;

[0026] Step (2), air-drying the steamed American ginseng, placing it in a drying room at 50±2°C for 1 hour, accompanied by 50±2°C air blowing;

[0027] Step (3), repeat step (1) and step (2) 9 times to obtain about 550g of black ginseng;

[0028] Step (4), grinding the black ginseng into coarse powder, taking about 550g of the coarse powder and placing it in a multifunctional extraction tank, using a 50% ethanol aqueous solution (i.e., 2750mL) with a volume of 5 times the weight of the coarse powder, heating and refluxing extraction for 3 times, each time for 1.5 hours, combining the extracts, recovering ethanol under reduced pressure, concentrating to a relative density of 1.10-1.20 (20-25°C), filtering, and spraying the filtrate with about 980g of auxiliary material glucose to obtain 1000g of black ginseng granules.

[0029] Example 2

[0030] Preparation of processed American ginseng product, Black American ginseng granules

[0031] Step (1), selecting 500g of four-year-old sun-dried American ginseng, laying a layer of gauze on a stainless steel net in a high-pressure steamer, evenly placing the American ginseng on the gauze, heating to 109-112°C, and maintaining for 1 hour; cutting off the steam source, and opening the high-pressure steamer when the temperature in the pot drops to 50-60°C;

[0032] Step (2), air-drying the steamed American ginseng, placing it in a drying room at 50±2°C for 2 hours, accompanied by 50±2°C air blowing;

[0033] Step (3), repeat step (1) and step (2) 9 times to obtain about 550g of black ginseng;

[0034] Step (4), grinding the black ginseng into coarse powder, taking about 550g of the coarse powder and placing it in a multifunctional extraction tank, using a 60% ethanol aqueous solution with a volume of 10 times the weight of the coarse powder, heating and refluxing extraction for 3 times, each time for 1.5 hours, combining the extracts, recovering ethanol under reduced pressure, concentrating to a relative density of 1.10-1.20 (20-25°C), filtering, and spraying the filtrate with about 980g of auxiliary material glucose to obtain 1000g of black ginseng granules.

[0035] Example 3

[0036] Preparation of processed American ginseng product, Black American ginseng granules

[0037] Step (1), selecting 500g of four-year-old sun-dried American ginseng, laying a layer of gauze on a stainless steel net in a high-pressure steamer, evenly placing the American ginseng on the gauze, heating to 113-115°C, and maintaining for 1 hour; cutting off the steam source, and opening the high-pressure steamer when the temperature in the pot drops to 50-60°C;

[0038] Step (2), cooling the steamed American ginseng, and drying it in a drying room at 50±2°C for 5 hours with a blast of air at 50±2°C;

[0039] Step (3), repeat step (1) and step (2) 9 times to obtain about 550g of black ginseng;

[0040] Step (4), grinding the black ginseng into coarse powder, taking about 550g of the coarse powder and placing it in a multifunctional extraction tank, using a 70% ethanol aqueous solution with a volume 20 times the weight of the coarse powder, heating and refluxing extraction for 3 times, each time for 1.5 hours, combining the extracts, recovering ethanol under reduced pressure, concentrating to a relative density of 1.10-1.20 (20-25°C), filtering, and spraying the filtrate with about 980g of auxiliary material glucose to obtain 1000g of black ginseng granules.

[0041] Example 4

[0042] 500 g of four-year-old sun-dried American ginseng was selected and crushed into coarse powder. About 500 g of the coarse powder was placed in a multifunctional extraction tank, and 60% ethanol aqueous solution with a volume 10 times the weight of the coarse powder was used for heating and reflux extraction 3 times, each time for 1.5 hours. The extracts were combined, ethanol was recovered under reduced pressure, and the extracts were concentrated to a relative density of 1.10-1.20 (20-25° C.). The extracts were filtered, and the filtrate was spray-granulated with about 980 g of auxiliary material glucose to obtain 1000 g of American ginseng granules.

[0043] Example 5

[0044] Combined with specific pharmacological experiments and results, the role of black ginseng or its preparation (black ginseng granules) in improving the unbalanced hypothalamic-pituitary-thyroid axis function in patients with hypothyroidism, increasing the secretion of thyroid hormones, and improving thyroid function is further explained.

[0045] Healthy SD rats (male-female ratio of 1:1, body weight 160-180 g, certificate number: SYXK (Shanghai) 2022-0028, purchased from Via Biotech (Shanghai) Co., Ltd.) were selected and randomly divided into 4 groups: normal group, model group, treatment group 1, and treatment group 2, with 8 rats in each group. Except for the rats in the normal group, the other 3 groups of rats were treated with the Kolajia method to establish a hypothyroidism model. After successful modeling, group 1 was treated with the black ginseng granules prepared in Example 2, which were dissolved in water and administered orally at a granule dose of 1.08 g / (kg·d) for 3 consecutive weeks; group 2 was treated with the following: The American ginseng granules prepared in Example 4 were dissolved in water and administered orally at a dose of 1.08 g / (kg·d) for 3 consecutive weeks. The rats in the normal group and the model group were given normal saline orally. After 3 weeks of administration, the levels of hypothalamic-pituitary-thyroid axis factors thyroxine (T4), triiodothyronine (T3), thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), free thyroxine (FT4), thyrotropin-releasing hormone (TRH) and hypothalamic-pituitary-gonadal axis factor follicle-stimulating hormone (FSH) in the rats of each group were detected by radioimmunoassay. The results are shown in Table 1.

[0046] Table 1. Effects of Heixishen Granules on Plasma FT3, FT4, T3, T4, TSH and TRH Concentrations in Hypothyroidism Rats ( n=8)

[0047]

[0048] As shown in Table 1, the difference between the model group and the normal group was statistically significant (P < 0.05), indicating successful modeling. The difference between Group 1 and the model group was statistically significant (P < 0.05). However, a comparison between Groups 1 and 2 revealed that the black ginseng extract, through its action on the hypothalamus-pituitary-thyroid gland, regulates the balance between TRH, TSH, and thyroid hormones, ultimately promoting thyroid secretion with a more significant improvement. The model group rats showed decreased appetite, dull eyes, slow movements, chills, and huddled bodies, with dull fur. In contrast, the fur of the Group 1 rats gradually regained its luster, their diet, water intake, and activity levels gradually increased, and their stools became firm, similar to those of the normal group. Group 2 experienced increased diet and activity levels, but still experienced loose stools. This suggests that the processed black ginseng, obtained from American ginseng, has a more pronounced warming and tonic effect, a stronger thyroid-improving effect, and a superior therapeutic effect for hypothyroidism.

Claims

1. Use of a processed American ginseng product in the preparation of a drug for treating hypothyroidism; the processed American ginseng product is prepared from American ginseng, which is steamed and dried nine times to obtain black American ginseng; the black American ginseng is crushed into coarse powder, extracted with 50-70% ethanol solution, heated and refluxed three times for 1-3 hours each time, and the extract is concentrated to obtain the product.

2. The use according to claim 1, characterized in that: The nine-steaming and nine-drying process comprises the following steps: steaming the American ginseng in a high-pressure steamer at 105-115° C. for 1 hour, cooling the temperature to 50-60° C., taking the steamed American ginseng out to cool, and drying the steamed American ginseng at a temperature of 50±2° C. for 1-5 hours; and repeating the steaming and drying process 9 times.

3. The use according to claim 1, characterized in that: The usage ratio of the crude powder of black ginseng to 50-70% ethanol solution is 1:5-1:20 g / mL.

4. The use according to claim 1, characterized in that: The medicine is prepared with processed American ginseng as an effective ingredient and pharmaceutically acceptable auxiliary materials.

5. The use according to claim 1, characterized in that: The medicine is a granule prepared by taking processed American ginseng as an effective ingredient and adding pharmaceutically acceptable excipients.

6. The use according to claim 5, characterized in that: The medicine is prepared from American ginseng as raw material, and is steamed and dried nine times to obtain black American ginseng. The black American ginseng is crushed into coarse powder, and extracted three times with 50-70% ethanol solution as extraction solvent, and heated under reflux for 1-3 hours each time. The extract is decompressed to recover ethanol, and concentrated to a relative density of 1.10-1.20 at 20-25°C, filtered, and the filtrate is mixed with pharmaceutically acceptable excipients to prepare granules.

7. The use according to claim 1, characterized in that: The American ginseng processed product is used in the preparation of a drug for treating hypothyroidism by exerting the following functions: improving the unbalanced hypothalamus-pituitary-thyroid axis function of hypothyroid patients, promoting the secretion of thyroid hormones, and improving thyroid function.

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