A traditional Chinese medicine effervescent tablet for preventing and treating obesity, and a preparation method and use thereof

Abstract

The present application provides a kind of prevention and cure obesity Spleen-Invigorating and Damp-Expelling Chinese medicine effervescent tablet, comprising the following weight parts of raw materials: 2-3 parts of radix codonopsis, 2-3 parts of atractylodes, 2-3 parts of poria, 3-5 parts of Chinese yam, 1-2 parts of gynostemma pentaphyllum, 2-3 parts of coix seed, 2-3 parts of dried tangerine or orange peel, 1-2 parts of hawthorn, 1-2 parts of lotus leaf, 0.5-1 parts of citric acid, 0.5-1 parts of sodium bicarbonate, 0.4-1 parts of lactose, 0.05-0.2 parts of mannitol; the present application also provides a kind of preparation method of prevention and cure obesity Spleen-Invigorating and Damp-Expelling Chinese medicine effervescent tablet and the use of prevention and cure obesity Spleen-Invigorating and Damp-Expelling Chinese medicine effervescent tablet in preventing and treating obesity; the prevention and cure obesity Spleen-Invigorating and Damp-Expelling Chinese medicine effervescent tablet of the present application combines the exact curative effect of traditional Chinese medicine prescription with the dosage form advantages of effervescent tablet, achieves convenient carrying and taking, exact curative effect, more easily absorbed, side effects or small treatment means, has higher application value.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to an effervescent tablet of traditional Chinese medicine for preventing and treating obesity, strengthening the spleen and removing dampness, as well as its preparation method and uses. Background Technology

[0002] The global incidence of obesity is increasing year by year, and the incidence of various chronic diseases caused by obesity is also rising annually, seriously threatening human health. Modern Traditional Chinese Medicine (TCM) analyzes the symptoms and differentiates syndromes based on the clinical manifestations of obese patients, believing that irregular eating habits, especially excessive consumption of rich and fatty foods, leading to dysfunction of the liver, spleen, and kidneys, is the primary cause of obesity. Obese patients often experience fatigue, lack of exercise, overeating, and a preference for rich and fatty foods, which over time leads to the accumulation of phlegm and dampness, affecting the Qi circulation of the liver, spleen, and kidneys. The main pathogenesis is spleen deficiency and dampness accumulation.

[0003] Besides diet control and exercise, treatment for obesity includes Western medicine and traditional Chinese medicine (TCM). However, Western medicine often has many side effects, high risks, and is prone to drug resistance and dependence. With the deepening of modern TCM chemical research, the application of TCM has become increasingly flexible in recent years. The field of TCM is also continuously researching the prevention of obesity. In recent years, numerous TCM preparations for the prevention and treatment of obesity have emerged. Most focus on promoting blood circulation and lowering lipids, primarily achieving weight loss by increasing intestinal peristalsis and promoting defecation. However, many patients experience adverse reactions such as diarrhea and bloating. While they may have short-term weight loss effects, they are not suitable for long-term use. Furthermore, due to the limitations of traditional TCM dosage forms, most are powders or oral liquids, which are unpalatable to many patients, leading them to avoid long-term use. In recent years, the application of TCM combined with effervescent tablets has gradually gained popularity. However, due to the relatively new technology, the current TCM tablets produced for effervescent production suffer from insufficient stability and cannot be stored for long periods, thus hindering large-scale production and limiting clinical application, resulting in a lack of large-scale efficacy evaluation data. Summary of the Invention

[0004] In view of the shortcomings of the prior art described above, the purpose of this invention is to provide a traditional Chinese medicine effervescent tablet for preventing and treating obesity, strengthening the spleen and removing dampness, as well as its preparation method and uses, to solve the problems of insignificant efficacy of traditional Chinese medicine preparations and poor stability of effervescent tablets in the prior art.

[0005] To achieve the above and other related objectives, this invention provides an effervescent tablet of traditional Chinese medicine for preventing and treating obesity, which strengthens the spleen and removes dampness. The tablet comprises the following ingredients in parts by weight: 2-3 parts Codonopsis pilosula, 2-3 parts Atractylodes macrocephala, 2-3 parts Poria cocos, 3-5 parts Dioscorea opposita, 1-2 parts Gynostemma pentaphyllum, 2-3 parts Coix lacryma-jobi, 2-3 parts Citrus reticulata peel, 1-2 parts Crataegus pinnatifida, 1-2 parts Nelumbo nucifera leaf, 0.5-1 part Citric acid, 0.5-1 part Sodium bicarbonate, 0.4-1 part Lactose, and 0.05-0.2 parts Mannitol.

[0006] This invention also provides a method for preparing the above-mentioned effervescent tablets of traditional Chinese medicine for preventing and treating obesity, which strengthens the spleen and removes dampness, comprising the following steps:

[0007] S1. Preparation of the extract: Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Dioscorea opposita, Gynostemma pentaphyllum, Coix lacryma-jobi, Citrus reticulata peel, Crataegus pinnatifida, and Nelumbo nucifera leaf were mixed and decocted with water, then filtered. The residue was decocted again with water, filtered, and the filtrates were combined. The filtrate was concentrated to 1.05-1.1, adsorbed overnight through macroporous resin, and then eluted and collected. The eluent was concentrated to 1.20-1.50, dried, and pulverized to obtain the extract.

[0008] S2. Preparation of citric acid granules: Citric acid powder, lactose, mannitol and the extract obtained in step S1 are subjected to fluidized bed granulation. The mixture is preheated and then sprayed with PVP-K30 solution for granulation. After the granules are fully dried, they are sieved and granulated to obtain citric acid granules.

[0009] S3. Preparation of sodium bicarbonate granules: Sodium bicarbonate pulverizer and lactose are granulated in a fluidized bed, preheated, and then sprayed with PVP-K30 solution for granulation. After the granules are fully dried, they are sieved and granulated to obtain sodium bicarbonate granules.

[0010] S4. Mix the citric acid granules prepared in step S3 with the sodium bicarbonate granules prepared in step S4, add lubricant, mix evenly, and compress into tablets to obtain spleen-strengthening and dampness-removing traditional Chinese medicine effervescent tablets.

[0011] The present invention also provides the use of the above-mentioned spleen-strengthening and dampness-removing effervescent tablets for the prevention and treatment of obesity.

[0012] As described above, the effervescent tablets of traditional Chinese medicine for preventing and treating obesity, strengthening the spleen, and removing dampness, as well as their preparation method and application, of the present invention have the following beneficial effects:

[0013] This invention relates to an effervescent tablet for preventing and treating obesity, based on the principle of strengthening the spleen and removing dampness. It utilizes a spleen-strengthening and dampness-removing formula to treat obesity, exhibiting minimal side effects in clinical application. It can be used to prevent and treat obesity and is suitable for most obese patients, making it applicable to a wide range of people. The effervescent tablet manufacturing process allows for adjustments to the taste of the traditional Chinese medicine, increasing palatability and masking the bitterness of traditional decoctions. Its easily absorbed dosage form further enhances the therapeutic efficacy of the traditional Chinese medicine. This invention combines the definite efficacy of traditional Chinese medicine formulas with the advantages of effervescent tablets, achieving a convenient, effective, easily absorbed treatment with few or no side effects, thus possessing high application value. Detailed Implementation

[0014] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0015] The first aspect of this invention provides an effervescent tablet of traditional Chinese medicine for preventing and treating obesity, which strengthens the spleen and removes dampness, comprising the following raw materials in parts by weight: 2-3 parts, 2-2.2 parts, 2.2-2.4 parts, 2.4-2.6 parts, 2.6-2.8 parts, or 2.8-3 parts of Codonopsis pilosula; 2-3 parts, 2-2.2 parts, 2.2-2.4 parts, 2.4-2.6 parts, 2.6-2.8 parts, or 2.8-3 parts of Atractylodes macrocephala; 2-3 parts, 2-2.2 parts, 2.2-2.4 parts, 2.4-2.6 parts, 2.6-2.8 parts, or 2.8-3 parts of Poria cocos; 3-5 parts, 3-3.2 parts, 3.2-3 parts, or 3.2-3 parts of Dioscorea opposita. 4 parts, 3.4–3.6 parts, 3.6–3.8 parts, 3.8–4 parts, 4–4.2 parts, 4.2–4.4 parts, 4.4–4.6 parts, 4.6–4.8 parts, or 4.8–5 parts; Gynostemma pentaphyllum 1–2 parts, 1–1.2 parts, 1.2–1.4 parts, 1.4–1.6 parts, 1.6–1.8 parts, or 1.8–2 parts; Coix seed 2–3 parts, 2–2.2 parts, 2.2–2.4 parts, 2.4–2.6 parts, 2.6–2.8 parts, or 2.8–3 parts; Dried tangerine peel 2–3 parts, 2–2.2 parts, 2.2–2.4 parts, 2.4–2.6 parts, 2.6–2.8 parts or 2.8–3 parts; hawthorn 1–2 parts, 1–1.2 parts, 1.2–1.4 parts, 1.4–1.6 parts, 1.6–1.8 parts or 1.8–2 parts; lotus leaf 1–2 parts, 1–1.2 parts, 1.2–1.4 parts, 1.4–1.6 parts, 1.6–1.8 parts or 1.8–2 parts; citric acid 0.5–1 part, 0.5–0.6 parts, 0.6–0.7 parts, 0.7–0.8 parts, 0.8–0.9 parts or 0.9–1 part; sodium bicarbonate 0.5–1 part, 0.5–0.6 parts, 0.6–0.7 parts, 0.7–0. 8 parts, 0.8-0.9 parts, or 0.9-1 parts; lactose 0.4-1 part, 0.4-0.5 parts, 0.5-0.6 parts, 0.6-0.7 parts, 0.7-0.8 parts, 0.8-0.9 parts, or 0.9-1 parts; mannitol 0.05-0.2 parts, 0.05-0.06 parts, 0.06-0.07 parts, 0.07-0.08 parts, 0.08-0.09 parts, 0.09-0.1 parts, 0.1-0.12 parts, 0.12-0.14 parts, 0.14-0.16 parts, 0.16-0.18 parts, or 0.18-0.2 parts.

[0016] In a preferred embodiment of the present invention, the spleen-strengthening and dampness-removing effervescent tablets for preventing and treating obesity comprise the following ingredients by weight: Codonopsis pilosula 2-2.4 parts, Atractylodes macrocephala 2-2.4 parts, Poria cocos 2-2.4 parts, Dioscorea opposita 3-3.8 parts, Gynostemma pentaphyllum 1-1.6 parts, Coix lacryma-jobi 2-2.4 parts, Citrus reticulata 2-2.4 parts, Crataegus pinnatifida 1-1.6 parts, Nelumbo nucifera leaf 1.2-1.8 parts, Citric acid 0.5-0.8 parts, Sodium bicarbonate 0.5-0.8 parts, Lactose 0.5-0.8 parts, and Mannitol 0.06-0.14 parts.

[0017] Among them, Codonopsis pilosula: taste: sweet, neutral; meridians: spleen and lung; function: tonify the spleen and lungs, nourish blood and generate fluids; main indications: spleen and lung qi deficiency syndrome, qi and blood deficiency syndrome and qi and fluid deficiency syndrome.

[0018] Atractylodes macrocephala: Properties: sweet, bitter, warm; Channels entered: spleen and stomach; Functions: strengthens the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating; Indications: spleen qi deficiency syndrome, phlegm retention, spontaneous sweating due to qi deficiency.

[0019] Poria cocos: Properties: sweet, bland, neutral; Channels entered: heart, lung, spleen, kidney; Functions: promotes diuresis and eliminates dampness, strengthens the spleen, calms the mind; Indications: edema, diarrhea due to spleen deficiency, phlegm retention, palpitations.

[0020] Yam: Properties: sweet, neutral; Channels entered: spleen, lung, kidney; Functions: tonifies the spleen and stomach, promotes the production of body fluids and benefits the lungs, tonifies the kidneys and astringes essence; Indications: deficiency syndromes of the lungs, spleen, and kidneys.

[0021] Gynostemma pentaphyllum: Properties: sweet, bitter, cold; Channels entered: spleen, lung; Functions: invigorates qi and strengthens the spleen, resolves phlegm and relieves cough, clears heat and detoxifies; Indications: spleen qi deficiency syndrome, lung deficiency cough.

[0022] Job's tears: Properties: sweet, bland, cool; Channels entered: spleen, stomach, lung; Functions: promotes diuresis and eliminates dampness, strengthens the spleen and stops diarrhea; Indications: edema, diarrhea due to spleen deficiency, lung abscess.

[0023] Dried tangerine peel: Properties: bitter, pungent, warm; Channels entered: spleen, lung; Functions: regulate qi and strengthen the spleen, dry dampness and resolve phlegm; Indications: spleen and stomach qi stagnation syndrome, cough with excessive phlegm.

[0024] Hawthorn: Properties: sour, sweet, slightly warm; Channels entered: spleen, stomach, liver; Functions: promotes digestion and strengthens the spleen, regulates qi and disperses blood stasis, resolves turbidity and lowers lipids; Indications: food stagnation syndrome, blood stasis syndrome.

[0025] Lotus leaf: Properties: bitter, neutral; Channels entered: liver, spleen, stomach; Functions: clears heat and detoxifies, promotes the upward movement of clear yang, cools blood and stops bleeding; Indications: diarrhea due to spleen deficiency, diarrhea due to summer heat and dampness.

[0026] This invention's spleen-strengthening and dampness-removing effervescent tablets are based on traditional Chinese medicine (TCM) theory's differentiation of obesity syndromes. Research indicates that spleen deficiency with dampness is the most common type of obesity. Therefore, the treatment principle is to strengthen the spleen and remove dampness, resulting in a TCM formula with the effects of invigorating qi, strengthening the spleen, and removing dampness. In this invention's spleen-strengthening and dampness-removing effervescent tablet formula, Codonopsis pilosula, Atractylodes macrocephala, and Poria cocos are the principal herbs for invigorating the spleen, replenishing qi, and removing dampness. Dioscorea opposita and Gynostemma pentaphyllum assist Codonopsis pilosula in invigorating qi and strengthening the spleen; Coix lacryma-jobi assists Atractylodes macrocephala and Poria cocos in invigorating the spleen and eliminating dampness, serving as assistant herbs; Citrus reticulata peel is added to promote qi circulation and resolve stagnation; Crataegus pinnatifida eliminates the accumulation of greasy meat; and Nelumbo nucifera leaf clears heat and lowers lipids. The entire formula works synergistically to invigorate qi, strengthen the spleen, and remove dampness.

[0027] The second aspect of this invention provides a method for preparing the above-mentioned effervescent tablets of traditional Chinese medicine for preventing and treating obesity, which strengthens the spleen and removes dampness, comprising the following steps:

[0028] S1. Preparation of the extract: Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Dioscorea opposita, Gynostemma pentaphyllum, Coix lacryma-jobi, Citrus reticulata peel, Crataegus pinnatifida, and Nelumbo nucifera leaf were mixed and decocted in water, then filtered. The residue was decocted again in water, filtered, and the filtrates were combined. The filtrates were concentrated to a relative density (water = 1, room temperature and pressure) of 1.05–1.11, 1.05–1.06, 1.06–1.07, 1.07–1.08, 1.08–1.09, 1.09–1.10, or 1.10–1.11. The resin was adsorbed overnight, then eluted and the eluent was collected. The eluent was concentrated to a relative density (water = 1, room temperature and pressure) of 1.20–1.50, 1.20–1.22, 1.22–1.24, 1.24–1.24, 1.26–1.28, 1.28–1.30, 1.30–1.34, 1.34–1.38, 1.38–1.42, 1.42–1.46, or 1.46–1.50. The eluent was then dried and pulverized to obtain the extract.

[0029] S2. Preparation of citric acid granules: Citric acid powder, lactose, mannitol and the extract obtained in step S1 are subjected to fluidized bed granulation. The mixture is preheated and then sprayed with PVP-K30 solution for granulation. After the granules are fully dried, they are sieved and granulated to obtain citric acid granules.

[0030] S3. Preparation of sodium bicarbonate granules: Sodium bicarbonate pulverizer and lactose are granulated in a fluidized bed, preheated, and then sprayed with PVP-K30 solution for granulation. After the granules are fully dried, they are sieved and granulated to obtain sodium bicarbonate granules.

[0031] S4. Mix the citric acid granules prepared in step S3 with the sodium bicarbonate granules prepared in step S4, add lubricant, mix evenly, and compress into tablets to obtain spleen-strengthening and dampness-removing traditional Chinese medicine effervescent tablets.

[0032] In the preparation method of the spleen-strengthening and dampness-removing effervescent tablets of traditional Chinese medicine for preventing and treating obesity according to the present invention, in step S1, the amount of water used for mixing and decocting is 8 to 10 times the mass of the traditional Chinese medicine composition. For example, 8 to 9 times or 9 to 10 times. The decoction time for mixing and decocting is 1 to 2 hours. For example, 1 to 1.5 hours or 1.5 to 2 hours.

[0033] When re-decocting the dregs, the amount of water added should be 8 to 10 times the volume of the dregs. For example, 8 to 9 times or 9 to 10 times the volume of the dregs. The decoction time should be 1 to 2 hours. For example, 1 to 1.5 hours or 1.5 to 2 hours.

[0034] In step S1, the macroporous resin is AB-8 macroporous adsorption resin. The specific adsorption process is as follows: after packing the macroporous resin into a column, a concentrated solution with a relative density of 1.05 is loaded onto the column, adsorbed overnight, then eluted, and the eluent is collected.

[0035] In step S1, the concentration temperature is 65–75°C. For example, it is 65–67°C, 67–70°C, 70–73°C, or 73–75°C. The concentration includes filtrate concentration and washing liquid concentration.

[0036] In step S1, the drying temperature is 65–75°C, for example, 65–67°C, 67–70°C, 70–73°C, or 73–75°C. The drying time is 18–24 hours, for example, 18–20 hours, 20–22 hours, or 22–24 hours.

[0037] In step S1, the elution is performed with pure water at a rate of 8–12 BV / h. For example, it is 8–10 BV / h or 10–12 BV / h.

[0038] In the preparation method of the spleen-strengthening and dampness-removing effervescent tablets of traditional Chinese medicine for preventing and treating obesity of the present invention, in step S2, the citric acid pulverized material is obtained by passing citric acid through an 80-100 mesh, 80-90 mesh, or 90-100 mesh pharmacopoeia sieve, and drying the sieve material in a vacuum drying oven at 50-60℃, 50-55℃, or 55-60℃ for 1-3 hours, 1-2 hours, or 2-3 hours.

[0039] In step S2, the mass ratio of the citric acid powder, lactose, and mannitol is 1:0.23-0.27:0.15-0.19. For example, it could be 1:0.23-0.24:0.15-0.19, 1:0.24-0.25:0.15-0.19, 1:0.25-0.26:0.15-0.19, 1:0.26-0.27:0.15-0.19, 1:0.23-0.27:0.15-0.16, 1:0.23-0.27:0.16-0.17, 1:0.23-0.27:0.17-0.18, or 1:0.23-0.27:0.18-0.19.

[0040] In step S2, the fluidized bed granulation is carried out in the fluidization chamber of the fluidized bed.

[0041] In step S2, the parameters in the fluidized bed granulation process are set as follows: inlet air temperature: 50-60℃, 50-55℃, or 55-60℃; peristaltic pump flow rate: 40-50 rpm, 40-45 rpm, or 45-50 rpm; atomization pressure: 0.15-0.20 MPa, 0.15-0.17 MPa, 0.17-0.19 MPa, or 0.19-0.20 MPa; damper pressure: 0.10-0.15 MPa, 0.10-0.12 MPa, 0.12-0.14 MPa, or 0.14-0.15 MPa.

[0042] In step S2, the preheating temperature is 50–60°C. For example, it is 50–52°C, 52–54°C, 54–56°C, 56–58°C, or 58–60°C.

[0043] In step S2, the preheating time is 3 to 7 minutes. For example, it is 3 to 4 minutes, 4 to 5 minutes, 5 to 6 minutes, or 6 to 7 minutes.

[0044] In steps S2 and S3, the PVP-K30 solution is an ethanol or aqueous solution of PVP-K30. The ethanol is a 30-50%, 30-35%, 35-40%, 40-45%, or 45-50% ethanol solution.

[0045] In steps S2 and S3, the concentration of the PVP-K30 solution is 12-15% g / mL. For example, it is 12-13% g / mL, 13-14% g / mL, or 14-15% g / mL.

[0046] In step S2, the mass ratio of the amount of PVP-K30 sprayed to the total mass of citric acid powder, lactose, mannitol, and the extract obtained in step S1 is 6% to 13%. For example, it is 6% to 7%, 7% to 8%, 8% to 9%, 9% to 10%, 10% to 11%, 11% to 12%, or 12% to 13%.

[0047] In this invention, PVP-K30 is polyvinylpyrrolidone.

[0048] In step S2, the sieving and granulation is performed by passing the material through a pharmacopoeia sieve of 60-80 mesh, 60-70 mesh, or 70-80 mesh.

[0049] In the preparation method of the spleen-strengthening and dampness-removing effervescent tablets of traditional Chinese medicine for the prevention and treatment of obesity of the present invention, in step S3, the sodium bicarbonate powder is obtained by pulverizing sodium bicarbonate through a pharmacopoeia sieve of 80-100, 80-90 or 90-100 mesh, and drying the sieve material in a vacuum oven at 50-60°C, 50-55°C or 55-60°C for 1-3 hours, 1-2 hours or 2-3 hours.

[0050] In step S3, the mass ratio of the sodium bicarbonate powder to lactose is 1:0.70 to 0.75. For example, it is 1:0.70 to 0.71, 1:0.71 to 0.72, 1:0.72 to 0.73, 1:0.73 to 0.74, or 1:0.74 to 0.75.

[0051] In step S3, the fluidized bed granulation is carried out in the fluidization chamber of the fluidized bed.

[0052] In step S3, the parameters during the fluidized bed granulation process are set as follows: inlet air temperature: 50-60℃, 50-55℃, or 55-60℃; peristaltic pump flow rate: 40-50 rpm, 40-45 rpm, or 45-50 rpm; atomization pressure: 0.15-0.20 MPa, 0.15-0.17 MPa, 0.17-0.19 MPa, or 0.19-0.20 MPa; damper pressure: 0.10-0.15 MPa, 0.10-0.12 MPa, 0.12-0.14 MPa, or 0.14-0.15 MPa.

[0053] In step S3, the preheating temperature is 50–60°C. For example, it is 50–52°C, 52–54°C, 54–56°C, 56–58°C, or 58–60°C.

[0054] In step S3, the preheating time is 3 to 7 minutes. For example, it is 3 to 4 minutes, 4 to 5 minutes, 5 to 6 minutes, or 6 to 7 minutes.

[0055] In step S3, the ratio of the amount of PVP-K30 solution sprayed to the total amount of citric acid powder, lactose, and mannitol is 8.0% to 15.0%. For example, it is 8.0% to 9.0%, 9.0% to 10.0%, 10.0% to 11.0%, 11.0% to 12.0%, 12.0% to 13.0%, 13.0% to 14.0%, or 14.0% to 15.0%.

[0056] In step S3, the sieving and granulation process involves passing the material through a pharmacopoeia sieve of 60-80 mesh, 60-70 mesh, or 70-80 mesh.

[0057] In the preparation method of the spleen-strengthening and dampness-removing effervescent tablets of traditional Chinese medicine for preventing and treating obesity according to the present invention, in step S4, the mass ratio of citric acid granules to sodium bicarbonate granules is 1.0–1.3:1. For example, it is 1.0–1.05:1, 1.05–1.1:1, 1.1–1.15:1, 1.15–1.2:1, 1.2–1.25:1, or 1.25–1.3:1.

[0058] In step S4, the mass ratio of the lubricant to the total amount of citric acid particles and sodium bicarbonate particles is 1.5% to 3%. For example, it is 1.5% to 2%, 2% to 2.5%, or 2.5% to 3%.

[0059] In step S4, the lubricant is PEG4000. PEG stands for polyethylene glycol.

[0060] In step S4, the tablet is 0.5g / tablet.

[0061] In step S4, the pressure for compressing the tablets is 70–75 N. For example, it is 70–71 N, 71–72 N, 72–73 N, 73–74 N, or 74–75 N.

[0062] To facilitate long-term use by patients, this invention combines the latest effervescent tablet manufacturing technology, perfecting the acid-base ratio and significantly improving stability. The flavor of the traditional Chinese medicine was also appropriately adjusted during the manufacturing process to increase palatability and mask the bitterness of traditional decoctions. The effervescent tablet form, with its easier absorption, further enhances the preventative and therapeutic efficacy of traditional Chinese medicine. Furthermore, this effervescent tablet is easy to transport and carry, contains safe ingredients with minimal or no side effects, and exhibits excellent stability after dissolving, making it worthy of widespread market promotion and possessing high practical value.

[0063] The third aspect of this invention provides the use of the effervescent tablets of traditional Chinese medicine for preventing and treating obesity, as described above, in the prevention and treatment of obesity.

[0064] Example 1

[0065] Preparation of effervescent tablets of traditional Chinese medicine for preventing and treating obesity, strengthening the spleen, and removing dampness:

[0066] S1. Weigh 2kg of Codonopsis pilosula, 2kg of Atractylodes macrocephala, 2kg of Poria cocos, 3kg of Dioscorea opposita, 1kg of Gynostemma pentaphyllum, 2kg of Coix lacryma-jobi, 2kg of Citrus reticulata peel, 1kg of Crataegus pinnatifida, and 1.2kg of Nelumbo nucifera leaf. Add 10 times the amount of water and decoct for 1 hour, then filter. Add 8 times the amount of water to the dregs and decoct for 1 hour, then filter. Combine the two filtrates. Concentrate the filtrate to a relative density of 1.05, then load it onto an AB-8 resin column for overnight adsorption. Elute with 10 BV / h of pure water, collect the washings, and concentrate the washings at no more than 70℃ to a relative density greater than 1.20. Dry and pulverize to obtain the extract for later use.

[0067] S2. Citric acid was pulverized and passed through an 80-mesh pharmacopoeia sieve. The sieved material was dried in a vacuum oven at 55℃ (-0.1 MPa) for 2 hours to obtain citric acid pulverized material. Then, 500g of the citric acid pulverized material, 129g of lactose, 86g of mannitol, and 285g of the concentrated extract from step S1 were poured into the fluidized bed chamber and preheated for 5 minutes. Then, 80g of 13% PVP-K30 (w / v) was sprayed in for granulation. The granulation parameters were as follows: inlet air temperature: 60℃; peristaltic pump flow rate: 45 rpm; atomization pressure: 0.18 MPa; damper pressure: 0.14 MPa. After the granules were fully dried, they were granulated through a 65-mesh pharmacopoeia sieve to obtain citric acid granules, which were then placed in a desiccator for later use.

[0068] S3. Sodium bicarbonate was pulverized and passed through an 80-mesh pharmacopoeia sieve. The sieved material was dried in a vacuum oven at 55℃ (-0.1 MPa) for 2 hours to obtain pulverized sodium bicarbonate. Then, 500g of the pulverized sodium bicarbonate and 362g of lactose were poured into the fluidization chamber of a fluidized bed and preheated at 55℃ for 5 minutes. Next, 105g of 13% PVP-K30 (w / v) was sprayed in for granulation. The granulation parameters were as follows: inlet air temperature: 60℃; peristaltic pump flow rate: 45 rpm; atomization pressure: 0.18 MPa; damper pressure: 0.14 MPa. After the granules were fully dried, they were granulated through a 65-mesh pharmacopoeia sieve to obtain sodium bicarbonate granules, which were then placed in a desiccator for later use.

[0069] S4. The citric acid granules and sodium bicarbonate granules prepared above are mixed at a mass ratio of 1.16:1. Then, 2% lubricant PEG4000 is added and the mixture is thoroughly mixed. The mixture is then compressed using a tablet press into tablets with an average weight of 0.5g / tablet and a pressure of 75N, thus obtaining effervescent tablets. Each tablet weighs 0.5g and contains 0.2685g of citric acid granules and 0.2315g of sodium bicarbonate granules. Based on the drug extraction concentration, each tablet contains 0.0765g of extract, equivalent to 1.29g of crude drug per tablet.

[0070] Example 2

[0071] Preparation of effervescent tablets of traditional Chinese medicine for preventing and treating obesity, strengthening the spleen, and removing dampness:

[0072] S1. Weigh out 3 kg of Codonopsis pilosula, 3 kg of Atractylodes macrocephala, 3 kg of Poria cocos, 4.5 kg of Dioscorea opposita, 2 kg of Gynostemma pentaphyllum, 3 kg of Coix lacryma-jobi, 3 kg of Citrus reticulata peel, 2 kg of Crataegus pinnatifida, and 2 kg of Nelumbo nucifera leaf. Add 10 times the amount of water and decoct for 1 hour, then filter. Add 8 times the amount of water to the dregs and decoct for 1 hour, then filter. Combine the two filtrates. Concentrate the filtrate to a relative density of 1.05, then load it onto an AB-8 resin column for overnight adsorption. Elute with 10 BV / h pure water, collect the washing liquid, concentrate the washing liquid at no more than 70℃ to a relative density greater than 1.20, dry, and pulverize to obtain the extract for later use.

[0073] S2. Citric acid was pulverized and passed through an 80-mesh pharmacopoeia sieve. The sieved material was dried in a vacuum oven at 55℃ (-0.1 MPa) for 2 hours to obtain citric acid pulverized material. Then, 750g of the citric acid pulverized material, 195g of lactose, 130g of mannitol, and 430g of the concentrated extract from step S1 were poured into the fluidized bed chamber and preheated for 5 minutes. Then, 120g of 13% PVP-K30 (w / v) was sprayed in for granulation. The granulation parameters were as follows: inlet air temperature: 60℃; peristaltic pump flow rate: 45 rpm; atomization pressure: 0.18 MPa; damper pressure: 0.14 MPa. After the granules were fully dried, they were granulated through a 65-mesh pharmacopoeia sieve to obtain citric acid granules, which were then placed in a desiccator for later use.

[0074] S3. Sodium bicarbonate was pulverized and passed through an 80-mesh pharmacopoeia sieve. The sieved material was dried in a vacuum oven at 55℃ (-0.1 MPa) for 2 hours to obtain pulverized sodium bicarbonate. Then, 800g of the pulverized sodium bicarbonate and 550g of lactose were poured into the fluidization chamber of a fluidized bed and preheated at 55℃ for 5 minutes. Next, 105g of 13% PVP-K30 (w / v) was sprayed in for granulation. The granulation parameters were as follows: inlet air temperature: 60℃; peristaltic pump flow rate: 45 rpm; atomization pressure: 0.18 MPa; damper pressure: 0.14 MPa. After the granules were fully dried, they were granulated through a 65-mesh pharmacopoeia sieve to obtain sodium bicarbonate granules, which were then placed in a desiccator for later use.

[0075] S4. The citric acid granules and sodium bicarbonate granules prepared above are mixed at a mass ratio of 1.16:1. Then, 2% of lubricant PEG4000 is added and mixed evenly. The mixture is then compressed into tablets with an average weight of 0.5g / tablet and a pressure of 75N using a tablet press to finally prepare effervescent tablets.

[0076] Comparative Example 1

[0077] Preparation of effervescent tablets of traditional Chinese medicine for preventing and treating obesity, strengthening the spleen, and removing dampness:

[0078] Weigh out 1.3 kg of Codonopsis pilosula, 1.3 kg of Atractylodes macrocephala, 1.3 kg of Poria cocos, 1.3 kg of Dioscorea opposita, 0.66 kg of Gynostemma pentaphyllum, 1.3 kg of Coix lacryma-jobi, 1.3 kg of Citrus reticulata peel, 0.66 kg of Crataegus pinnatifida, and 0.8 kg of Nelumbo nucifera leaf. Add 10 times the amount of water and decoct for 1 hour. Filter the decoction. The remaining steps and dosages are the same as in the previous example. Prepare effervescent tablets of traditional Chinese medicine for preventing and treating obesity, strengthening the spleen and removing dampness.

[0079] Comparative Example 2

[0080] Preparation of effervescent tablets of traditional Chinese medicine for preventing and treating obesity, strengthening the spleen, and removing dampness:

[0081] Weigh out 0.66 kg of Codonopsis pilosula, 0.66 kg of Atractylodes macrocephala, 0.66 kg of Poria cocos, 0.66 kg of Dioscorea opposita, 0.33 kg of Gynostemma pentaphyllum, 0.66 kg of Coix lacryma-jobi, 0.66 kg of Citrus reticulata peel, 0.33 kg of Crataegus pinnatifida, and 0.4 kg of Nelumbo nucifera leaf. Add 10 times the amount of water and decoct for 1 hour. Filter the decoction. The remaining steps and dosages are the same as in the previous example. Prepare effervescent tablets of traditional Chinese medicine for preventing and treating obesity, strengthening the spleen and removing dampness.

[0082] Clinical efficacy:

[0083] A total of 135 obese patients aged 18-60 years were recruited for this clinical study and randomly divided into three groups of 45 patients each. The treatment group received the spleen-strengthening and dampness-removing effervescent tablets prepared in Example 1, taken twice daily, one tablet each time, dissolved in warm water. Control group 1 received the spleen-strengthening and dampness-removing effervescent tablets prepared in Comparative Example 1, taken twice daily, one tablet each time, dissolved in warm water. Control group 2 received the spleen-strengthening and dampness-removing effervescent tablets prepared in Comparative Example 2, taken twice daily, one tablet each time, dissolved in warm water.

[0084] All three groups were treated for 3 months, and the efficacy was observed monthly. The results are shown in Table 1 below:

[0085] Table 1

[0086]

[0087] As shown in Table 1, taking the effervescent tablets of the traditional Chinese medicine described in this invention can reduce the patient's weight, and improve the patient's appetite and fatigue through the spleen-strengthening and dampness-removing effects of traditional Chinese medicine.

[0088] The therapeutic effects after three months of treatment are shown in Table 2:

[0089] Table 2

[0090] Treatment group 18 25 2 95.6％ Control group 1 9 18 18 60％ Control group 2 3 11 31 31.11％

[0091] Efficacy assessment:

[0092] Significant effect: Weight loss of 10% or more, and significant improvement in symptoms such as appetite, fatigue, and thick, greasy tongue coating.

[0093] Effective: Weight loss of 5%-10%, and improvement in symptoms such as appetite, fatigue, and thick, greasy tongue coating.

[0094] Ineffective: Weight loss is less than 5% or more than before treatment, and there is no improvement in symptoms such as appetite, fatigue, or thick, greasy tongue coating.

[0095] As shown in Table 2, the dosage of the effervescent Chinese medicine tablets in the treatment group had a better effect on weight reduction and improving patients' appetite and fatigue, with an effective rate of 95.6%, which was significantly better than that of control groups 1 and 2. Therefore, the effervescent Chinese medicine tablets of this invention have the effect of strengthening the spleen and removing dampness, and can be used to prevent obesity. Furthermore, the formula is reasonable, safe, and has significant therapeutic effects.

[0096] Clinical indicators:

[0097] Thirty obese patients aged 18-60 years were selected for clinical trials and randomly divided into a treatment group and a control group, with 15 patients in each group. The control group was given atorvastatin calcium tablets 10mg once nightly, one tablet each time, orally; the treatment group was given spleen-strengthening and dampness-removing effervescent tablets prepared in Example 1, one tablet twice daily, dissolved in warm water and taken orally. After three months of treatment, the clinical laboratory indicators are shown in Table 3 below.

[0098] Table 3 Comparison of changes in blood lipid and liver function indicators before and after treatment in the two groups (x±s)

[0099]

[0100] Note: *P<0.05 compared with pre-treatment levels in this group; #P<0.05 compared with post-treatment levels in the control group. Total cholesterol (TC), triglycerides (TG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) were measured.

[0101] As shown in Table 3, after treatment, serum TC and TG levels in both groups were significantly lower than before treatment (P < 0.05), and the control group had significantly lower levels than the treatment group (P < 0.05). After treatment, ALT, AST, and GGT levels in the treatment group were significantly lower than before treatment (P < 0.05), while no significant decrease was observed in the control group (P > 0.05), and the treatment group had significantly lower levels than the control group (P < 0.05). These differences were statistically significant.

[0102] In summary, the spleen-strengthening and dampness-removing effervescent tablets of this invention are based on research and treatment of obesity using traditional Chinese medicine theory in recent years. Traditional Chinese medicine emphasizes a holistic approach. Through years of continuous research and clinical practice on obesity, it has been concluded that modern obesity is mostly caused by improper diet, excessive consumption of rich and fatty foods, overwork or lack of rest, or emotional distress, leading to impaired spleen function, liver dysfunction, fluid retention, and phlegm production, resulting in spleen deficiency and dampness stagnation, which is the root cause of this disease. The primary location of the disease is the spleen, and the main pathological factors are phlegm and dampness. Treatment mainly focuses on strengthening the spleen and resolving phlegm. The spleen-strengthening and dampness-removing effervescent tablets of this invention have the effects of strengthening the spleen and removing dampness, and lowering blood lipids to prevent and treat obesity. Clinical research and testing have shown that its efficacy is definite, and no adverse events have occurred in terms of safety indicators such as liver and kidney function. It can effectively improve patients' clinical symptoms, regulate patients' lipid metabolism levels, and has a high safety profile, making it suitable for clinical promotion.

[0103] In summary, this invention effectively overcomes the various shortcomings of the prior art and has high industrial application value.

[0104] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by those skilled in the art without departing from the spirit and technical concept disclosed in the present invention should still be covered by the claims of the present invention.

Claims

1. A traditional Chinese medicine effervescent tablet for preventing and treating obesity, strengthening the spleen, and removing dampness, characterized in that... It is made from the following ingredients in parts by weight: Codonopsis pilosula 2 parts, Atractylodes macrocephala 2 parts, Poria cocos 2 parts, Dioscorea opposita 3 parts, Gynostemma pentaphyllum 1 part, Coix lacryma-jobi 2 parts, Citrus reticulata 2 parts, Crataegus pinnatifida 1 part, Nelumbo nucifera 1.2 parts, Citric acid 0.5-1 part, Sodium bicarbonate 0.5-1 part, Lactose 0.4-1 part, Mannitol 0.05-0.2 parts.

2. A method for preparing an effervescent tablet of traditional Chinese medicine for preventing and treating obesity, strengthening the spleen, and removing dampness as described in claim 1, characterized in that, Includes the following steps: S1. Preparation of the extract: Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Dioscorea opposita, Gynostemma pentaphyllum, Coix lacryma-jobi, Citrus reticulata peel, Crataegus pinnatifida, and Nelumbo nucifera leaf were mixed and decocted with water, then filtered. The residue was decocted again with water, filtered, and the filtrates were combined. The filtrate was concentrated to a relative density of 1.05-1.1, adsorbed overnight through macroporous resin, eluted, and the washings were collected. The washings were concentrated to a relative density of 1.20-1.50, dried, and pulverized to obtain the extract. S2. Preparation of citric acid granules: Citric acid powder, lactose, mannitol and the extract obtained in step S1 are subjected to fluidized bed granulation. The mixture is preheated and then sprayed with PVP-K30 solution for granulation. After the granules are fully dried, they are sieved and granulated to obtain citric acid granules. S3. Preparation of sodium bicarbonate granules: Sodium bicarbonate pulverizer and lactose are granulated in a fluidized bed, preheated, and then sprayed with PVP-K30 solution for granulation. After the granules are fully dried, they are sieved and granulated to obtain sodium bicarbonate granules. S4. Mix the citric acid granules prepared in step S2 with the sodium bicarbonate granules prepared in step S3, add lubricant, mix evenly, and compress into tablets to obtain spleen-strengthening and dampness-removing traditional Chinese medicine effervescent tablets.

3. The preparation method of the spleen-strengthening and dampness-removing effervescent tablets for preventing and treating obesity according to claim 2, characterized in that, In step S1, the amount of water used for mixing and decocting is 8 to 10 times the mass of the traditional Chinese medicine composition. And / or, in step S1, the decoction time for mixing and decocting with water is 1-2 hours; And / or, in step S1, the macroporous resin is AB-8 macroporous adsorption resin; And / or, in step S1, the concentration temperature is 65~75°C; And / or, in step S1, the drying temperature is 65~75°C; And / or, in step S1, the drying time is 18~24h; And / or, in step S1, the elution is elution with pure water at a rate of 8~12 BV / h.

4. The preparation method of the spleen-strengthening and dampness-removing effervescent tablets for preventing and treating obesity according to claim 2, characterized in that, In step S2, the citric acid pulverized material is obtained by passing citric acid through an 80-100 mesh pharmacopoeia sieve, and drying the sieved material in a vacuum drying oven at 50-60°C for 1-3 hours. And / or, in step S2, the mass ratio of the citric acid powder, lactose, and mannitol is 1:0.23~0.27:0.15~0.19; And / or, in step S2, the fluidized bed granulation is carried out in the fluidization chamber of the fluidized bed; And / or, in step S2, the parameters during the fluidized bed granulation process are set as follows: inlet air temperature: 50~60℃; peristaltic pump flow rate: 40~50rpm; atomization pressure: 0.15~0.20Mpa; damper pressure: 0.10~0.15Mpa; And / or, in step S2, the preheating temperature is 50~60℃; And / or, in step S2, the preheating time is 3~7 minutes; And / or, in step S2, the mass ratio of the amount of PVP-K30 solution sprayed to the total mass of citric acid pulverizer, lactose, mannitol, and the extract obtained in step S1 is 6%-13%; And / or, in step S2, the sieving and granulation is performed by passing the material through a 60-80 mesh pharmacopoeia sieve.

5. The preparation method of the spleen-strengthening and dampness-removing effervescent tablets for preventing and treating obesity according to claim 2, characterized in that, In steps S2 and S3, the PVP-K30 solution is an ethanol or aqueous solution of PVP-K30 solution; And / or, in steps S2 and S3, the concentration of the PVP-K30 solution is 12~15% g / mL.

6. The preparation method of the spleen-strengthening and dampness-removing effervescent tablets for preventing and treating obesity according to claim 2, characterized in that, In step S3, the sodium bicarbonate pulverizer is obtained by pulverizing sodium bicarbonate through an 80-100 mesh pharmacopoeia sieve, and then drying the sieve material in a vacuum oven at 50-60°C for 1-3 hours. And / or, in step S3, the mass ratio of the sodium bicarbonate powder to lactose is 1:0.70~0.75; And / or, in step S3, the fluidized bed granulation is carried out in the fluidization chamber of the fluidized bed; And / or, in step S3, the parameters during the fluidized bed granulation process are set as follows: inlet air temperature: 50~60℃; peristaltic pump flow rate: 40~50rpm; atomization pressure: 0.15~0.20Mpa; damper pressure: 0.10~0.15Mpa; And / or, in step S3, the preheating temperature is 50~60℃; And / or, in step S3, the preheating time is 3~7 minutes; And / or, in step S3, the ratio of the amount of PVP-K30 solution sprayed to the total amount of sodium bicarbonate powder and lactose is 8.0%~15.0%; And / or, in step S3, the sieving and granulation is performed by passing the material through a 60-80 mesh pharmacopoeia sieve.

7. The preparation method of the spleen-strengthening and dampness-removing effervescent tablets for preventing and treating obesity according to claim 2, characterized in that, In step S4, the mass ratio of citric acid granules to sodium bicarbonate granules is 1.0~1.3:1; And / or, in step S4, the mass ratio of the lubricant to the total amount of citric acid particles and sodium bicarbonate particles is 1.5% to 3%; And / or, in step S4, the lubricant is PEG4000.

8. The preparation method of the spleen-strengthening and dampness-removing effervescent tablets for preventing and treating obesity according to claim 2, characterized in that, In step S4, the tablet weighs 0.45~0.55g / tablet; And / or, in step S4, the pressure for compressing the tablets is 70~75N.

9. The use of the spleen-strengthening and dampness-removing effervescent tablets of traditional Chinese medicine for preventing and treating obesity according to claim 1 in the preparation of a drug for treating obesity.

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