Traditional Chinese medicine composition for treating four highs and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating four highs and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition comprises a qi-tonifying and yin-nourishing group and a traditional Chinese medicine composition, wherein the qi-tonifying and yin-nourishing group comprises 10-40g of astragalus membranaceus, 10-30g of ginseng, 10-40g of Chinese yam, 8-18g of radix polygonati officinalis, 9-21g of radix ophiopogonis and A heat-clearing and diuresis-promoting group: 6-28 g of chicory, 6-14 g of cape jasmine, 10-17 g of semen cassiae, 8-16 g of dandelion, 16-60 g of semen coicis and 15-90 g of fresh bitter gourd; a blood circulation promoting and blood stasis removing group: 5-9g of peach kernel, 8-22g of turmeric, 10-20g of angelica sinensis and 15-60g of hawthorn; the spleen invigorating and digestion promoting group comprises 6-10 g of clove, 4-13 g of fructus amomi, 5-10 g of endothelium corneum gigeriae galli The wind dispelling and collateral dredging group comprises 10-30 g of radix puerariae, 10-20 g of rhizoma gastrodiae, 5-16 g of folium mori and 5-10 g of mint; the traditional Chinese medicine is prepared from, by weight, 8-17 g of cortex cinnamomi, 10-16 g of dried ginger, 10-30 g of fresh ginger and 5-14

Description

Technical Field

[0001] The present invention relates to a Chinese medicine composition and a preparation method thereof, and in particular to a Chinese medicine composition for treating hyperglycemia, hypertension, hyperlipidemia and hyperuricemia (four highs) and a preparation method thereof. Background Art

[0002] With the change of modern lifestyle, "four high" diseases represented by high blood sugar, high blood pressure, high blood lipids and high uric acid are becoming increasingly common. Existing Western medicine treatment plans are mostly targeted at a single disease and require combined medication, which not only increases the burden of drugs, but also may bring a variety of adverse reactions. Traditional Chinese medicine theory believes that the four high diseases are mostly derived from the same pathological basis, that is, "yin deficiency, internal heat, phlegm and blood stasis", and the treatment should be holistic. However, current Chinese medicine prescriptions are mostly limited to the treatment of a single symptom, lacking a systematic multi-target coordinated regulation scheme. Therefore, there is an urgent need for a Chinese medicine composition that can holistically regulate the symptoms of the four highs to achieve the goal of "one prescription to treat the four highs". Summary of the invention

[0003] In order to solve the above technical problems, the present invention provides a traditional Chinese medicine composition for the treatment of four highs and a preparation method thereof. The composition realizes multi-target and multi-dimensional metabolic regulation through the rational combination of six functional groups, thereby achieving the effect of synergistic treatment of four highs.

[0004] The object of the present invention is to provide a Chinese medicine composition for treating four highs, wherein the composition comprises the following six functional groups of drugs:

[0005] Qi-tonifying and Yin-nourishing group: Astragalus 10-40g, Ginseng 10-30g, Chinese Yam 10-40g, Polygonatum 8-18g, Ophiopogon 9-21g, Rehmannia glutinosa 10-19g;

[0006] Heat-clearing and dampness-removing group: chicory 6-28g, gardenia 6-14g, cassia seed 10-17g, dandelion 8-16g, coix seed 16-60g, fresh bitter melon 15-90g;

[0007] Blood circulation and stasis removal group: peach kernel 5-9g, turmeric 8-22g, angelica 10-20g, hawthorn 15-60g;

[0008] Spleen-strengthening and digestion-promoting group: clove 6-10g, Amomum villosum 4-13g, chicken gizzard 5-10g, Poria cocos 15-50g;

[0009] Wind-clearing and collateral-draining group: Pueraria root 10-30g, Gastrodia elata 10-20g, mulberry leaf 5-16g, mint 5-10g;

[0010] Regulating medicinal properties group: cinnamon bark 8-17g, dried ginger 10-16g, fresh ginger 10-30g, platycodon 5-14g.

[0011] Preferably, the mass ratio of astragalus to ginseng in the qi-tonifying and yin-nourishing group is (1-4):(1-3), and the amount of yam is 0.8-1.2 times the amount of astragalus; the mass ratio of rehmannia, ophiopogon and polygonatum is (1-2):(0.9-2.1):(0.8-1.8).

[0012] Preferably, the chicory in the heat-clearing and dampness-removing group is selected from the following types: European chicory, chicory roots or chicory stems and leaves; the bitter melon is fresh, and the mass ratio of fresh bitter melon to chicory is (1-9):(0.6-2.8); the gardenia is fried gardenia, and the coix seed is raw coix seed.

[0013] Preferably, the hawthorn in the blood circulation and blood stasis removing group is fried hawthorn, and the peach kernel is peeled peach kernel; the mass ratio of hawthorn to peach kernel is (3-12):(1-1.8); the turmeric is raw turmeric powder, and the mass ratio of turmeric to angelica is (0.8-2.2):(1-2).

[0014] Preferably, the mass ratio of clove to chicken's gizzard lining in the spleen-strengthening and digestion-promoting group is (1.2-2):(1-2); the Poria cocos is white Poria cocos, and its dosage accounts for 60-85% of the total dosage of the spleen-strengthening and digestion-promoting group; the Amomum villosum is ground at low temperature and has a particle size of 80-100 mesh.

[0015] Preferably, the kudzu root in the wind-clearing and collateral-unblocking group is wild kudzu root; the mass ratio of the kudzu root to the gastrodia elata is (1-3):(1-2); the mulberry leaf is spring mulberry leaf; the mint is mint leaf with a menthol content of not less than 1.8%; the cinnamon in the medicinal property-regulating group is high-quality cinnamon, and the mass ratio of cinnamon to dried ginger is (0.8-1.7):(1-1.6).

[0016] A method for preparing the Chinese medicine composition comprises the following steps:

[0017] (1) Raw material pretreatment: selecting, cleaning and cutting each group of Chinese medicinal materials;

[0018] (2) Group extraction: Add the medicinal materials of the Qi-tonifying and Yin-nourishing group, the heat-clearing and dampness-removing group, the blood-activating and blood-stasis-removing group, and the wind-clearing and collateral-draining group into 10-15 times of water respectively, and decoct them twice, the first decoction is 1-1.5 hours, and the second decoction is 0.5-1 hour. The two decoctions are combined and concentrated to a relative density of 1.10-1.25 (60°C);

[0019] (3) Special extraction: Ultra-low temperature cold extraction method is used for chicken gizzard lining, Amomum villosum and cinnamon bark. The medicinal materials are crushed into 80-120 mesh, 5-8 times the amount of 40-60% ethanol aqueous solution is added, and the mixture is soaked at -5°C to 5°C for 48-72 hours, and stirred for extraction;

[0020] (4) combining the extracts: combining the extracts from step (2) and (3), and concentrating under reduced pressure at 45-55° C. to a relative density of 1.15-1.30;

[0021] (5) Processing of auxiliary materials: Grind platycodon grandiflorum, dried ginger and fresh ginger into 80-100 meshes respectively, and pass through a 60-mesh sieve for later use;

[0022] (6) Mixed preparation: The concentrated solution of step (4) is mixed with the auxiliary materials of step (5), and dried to a water content of no more than 9% to prepare granules or tablets.

[0023] Preferably, the specific process parameters of the ultra-low temperature cold extraction method in step (3) are: the medicinal material is crushed into 100 mesh, 6 times the amount of 50% ethanol aqueous solution is added, and it is soaked at 0±1°C for 60 hours, stirred every 12 hours, filtered after the extraction is completed, and the filtrate is decompressed and ethanol is recovered at 40°C until the ethanol content is less than 5%.

[0024] Preferably, the process for preparing the granules in step (6) is as follows: the concentrate is mixed with the auxiliary materials, 5-10% of hydroxypropyl methylcellulose is added as a binder, granulated by fluidized bed, the obtained granules are dried at 50-60° C. to a moisture content of no more than 7%, and then packed into sealed bags.

[0025] Preferably, the process for preparing tablets in step (6) is as follows: mixing the concentrate with the auxiliary materials, adding 3-8% of microcrystalline cellulose and 1-3% of cross-linked polyvinylpyrrolidone as disintegrants, and 1-2% of magnesium stearate as a lubricant, granulating by dry method, and tableting. Under the condition that the tablet weight is 0.4-0.6g, the tablet is compressed by a tablet press machine, and the pressure is controlled at 8-12kN. After coating the obtained tablets, the tablets are dried at 45-55°C to a moisture content of no more than 5%.

[0026] The Chinese medicine composition of the present invention realizes multi-target and multi-dimensional metabolic regulation through the rational combination of six functional groups, and has the following significant technical effects:

[0027] 1. A "metabolic axis regulation" network was established to achieve coordinated metabolism of sugar, fat and uric acid through multi-target regulation of AMPK (ginseng-astragalus)-PPARγ (gardenia-mossmelon)-mTOR (Poria-yam);

[0028] 2. The "intestinal-islet axis intervention" mechanism has been optimized. Poria polysaccharide regulates intestinal flora, yam mucus repairs intestinal mucosa, and forms an "intestinal-pancreatic dialogue" regulation mechanism with bitter melon polypeptide;

[0029] 3. Innovative "blood rheology improvement" system, hawthorn-peach kernel-turmeric constitutes "triple blood purification" (viscosity reduction, anticoagulation, plaque dissolution), improves microcirculation, and dissolves plaques;

[0030] 4. "Neuro-endocrine balance" regulation has been established. Gastrodia elata-Pueraria root regulates the hypothalamus-sympathetic nerve axis, cinnamon bark-dried ginger activates TRPV1 channel to improve insulin sensitivity, and cloves and cinnamon bark together invigorate kidney qi and guide fire back to the origin;

[0031] 5. Aiming at the modern pathological chain of "staying up late to hurt Yin - drinking to generate dampness - long-term sitting to cause blood stasis", the overall regulatory effect of "three-burner elimination strategy" and "three-phase balance of Qi, blood and body fluid" is formed;

[0032] 6. Innovative application of ultra-low temperature cold extraction technology to process chicken gizzard lining, Amomum villosum and cinnamon bark, retaining heat-sensitive active ingredients and improving bioavailability;

[0033] 7. All medicinal materials are selected from the national designated catalog of medicine and food with similar origins. They are safe and have low risks for long-term use, which is in line with the concept of "medicine and food with similar origins".

[0034] This invention breaks through the traditional thinking of single disease treatment and realizes the integrated effect of "one prescription treating four highs" through multi-dimensional and multi-target network pharmacology regulation. It has significant advantages in solving the pathological intersection of insulin resistance and hyperuricemia (AMPK activation) and improving the vicious cycle of blood rheology and endothelial function, providing new ideas and methods for the comprehensive prevention and treatment of metabolic diseases. DETAILED DESCRIPTION

[0035] The technical scheme of the present invention will be clearly and completely described below in conjunction with specific embodiments. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present invention. In the following embodiments, unless otherwise specified, the reagents and materials used can be obtained through commercial channels, and the present embodiments are all completed under laboratory conditions.

[0036] Example 1

[0037] A Chinese medicine composition for treating four highs, comprising the following six functional groups of drugs:

[0038] Qi-tonifying and Yin-nourishing group: Astragalus 25g, Ginseng 20g, Chinese Yam 25g, Polygonatum 13g, Ophiopogon 15g, Rehmannia glutinosa 15g;

[0039] Heat-clearing and dampness-removing group: chicory 17g, gardenia 10g, cassia seed 14g, dandelion 12g, coix seed 38g, fresh bitter melon 53g;

[0040] Blood circulation and stasis removal group: peach kernel 7g, turmeric 15g, angelica 15g, hawthorn 38g;

[0041] Spleen-strengthening and digestion-promoting group: clove 8g, Amomum villosum 9g, chicken gizzard 8g, Poria 33g;

[0042] Wind-clearing and collateral-draining group: Pueraria root 20g, Gastrodia elata 15g, mulberry leaf 10g, peppermint 8g;

[0043] Medicinal properties harmonizing group: cinnamon bark 13g, dried ginger 13g, fresh ginger 20g, platycodon 10g.

[0044] Among them, in the Qi-tonifying and Yin-nourishing group, Astragalus and ginseng form a "Qi-tonifying double" combination, synergistically regulating T cell immune function and improving insulin resistance; Astragalus polysaccharide can significantly reduce fasting blood sugar and promote the phosphorylation of insulin receptor substrate (IRS-1). Ginsenoside Rg3 has the effect of activating the AMPK pathway, thereby promoting glucose and lipid metabolism. Radix Rehmanniae, Radix Ophiopogonis and Polygonatum odoratum form a "Yin-nourishing Golden Triangle", following the principle of "warming those with insufficient form with Qi, and replenishing those with insufficient essence with flavor", providing basic nutritional support for metabolic regulation.

[0045] In the heat-clearing and dampness-removing group, bitter melon and chicory form a "double acid antagonistic" combination, in which bitter melon saponins can inhibit the activity of xanthine oxidase and reduce the production of uric acid; while chicoric acid promotes the excretion of uric acid by inhibiting the URAT1 transporter, regulating uric acid metabolism in a two-pronged way. Gardenia and dandelion are "liver and gallbladder purifying drugs" that clear the accumulated heat in the triple energizer due to qi and blood deficiency, and improve the abnormal pancreatic islet and uric acid status caused by damp-heat stagnation. Gardenia glycosides significantly improve lipid metabolism disorders by activating the PPARγ pathway.

[0046] In the blood circulation and stasis group, hawthorn and peach kernel form a "double lipid and vein clearing" combination. Hawthorn flavonoids can regulate ABCA1-mediated cholesterol reverse transport and dissolve plaques; peach kernels can improve microcirculation and optimize blood rheology. Curcumin and angelica ferulic acid synergistically inhibit the NF-κB inflammatory pathway, showing a significant synergistic effect of lowering lipids and blood pressure. Curcumin can also downregulate LOX-1 expression, improve endothelial function, and reduce the occurrence and development of atherosclerosis.

[0047] The preparation method comprises the following steps:

[0048] (1) Raw material pretreatment: Select, clean and cut each group of Chinese medicinal materials;

[0049] (2) Group extraction: Add the medicinal materials of the Qi-tonifying and Yin-nourishing group, the heat-clearing and dampness-removing group, the blood-activating and blood-stasis-removing group, and the wind-clearing and collateral-draining group into 12-fold water, decoct twice, the first decoction for 1.2 hours, the second decoction for 0.8 hours, combine the two decoctions, and concentrate to a relative density of 1.18 (60°C);

[0050] (3) Special extraction: Ultra-low temperature cold extraction method is used for chicken gizzard lining, Amomum villosum and cinnamon bark. The medicinal materials are crushed into 100 mesh, 6 times the amount of 50% ethanol aqueous solution is added, and soaked at 0°C for 60 hours, stirred once every 12 hours, filtered after extraction, and the filtrate is decompressed and ethanol is recovered at 40°C until the ethanol content is less than 5%;

[0051] (4) combining the extracts: combining the extracts from step (2) and (3), and concentrating under reduced pressure at 50° C. to a relative density of 1.22;

[0052] (5) Processing of auxiliary materials: Grind platycodon grandiflorum, dried ginger and fresh ginger into 90 mesh size and pass through a 60 mesh sieve for later use;

[0053] (6) Mixed preparation: The concentrated solution of step (4) is mixed with the auxiliary materials of step (5), and 7% hydroxypropyl methylcellulose is added as a binder. The mixture is granulated by fluidized bed granulation. The obtained granules are dried at 55° C. to a moisture content of no more than 7%, and then divided into sealed bags.

[0054] Example 2

[0055] A Chinese medicine composition for treating four highs, comprising the following six functional groups of drugs:

[0056] Qi-tonifying and Yin-nourishing group: Astragalus 10g, Ginseng 10g, Chinese Yam 10g, Polygonatum 8g, Ophiopogon 9g, Rehmannia glutinosa 10g;

[0057] Heat-clearing and dampness-removing group: chicory 6g, gardenia 6g, cassia seed 10g, dandelion 8g, coix seed 16g, fresh bitter melon 15g;

[0058] Blood circulation and stasis removal group: peach kernel 5g, turmeric 8g, angelica 10g, hawthorn 15g;

[0059] Spleen-strengthening and digestion-promoting group: clove 6g, Amomum villosum 4g, chicken gizzard 5g, Poria 15g;

[0060] Wind-clearing and collateral-draining group: Pueraria root 10g, Gastrodia elata 10g, mulberry leaf 5g, mint 5g;

[0061] Medicinal properties harmonizing group: cinnamon bark 8g, dried ginger 10g, fresh ginger 10g, platycodon 5g.

[0062] Preferably, the astragalus in this embodiment uses raw astragalus, which is rich in astragalus polysaccharides. The polysaccharide component can effectively regulate T cell immune function and significantly improve insulin resistance. Chicory uses European chicory root, whose chicoric acid content is ≥5%, which can effectively inhibit the URAT1 transporter and promote uric acid excretion. Bitter melon uses fresh bitter melon, which retains the activity of its P-insulin polypeptide and has a significant insulin-like effect. Poria uses white Poria, whose polysaccharide content is ≥25%, which can effectively regulate intestinal flora, promote the production of short-chain fatty acids (SCFAs), and improve metabolic syndrome.

[0063] The preparation method comprises the following steps:

[0064] (1) Raw material pretreatment: Select, clean and cut each group of Chinese medicinal materials;

[0065] (2) Group extraction: Add the medicinal materials of the Qi-tonifying and Yin-nourishing group, the heat-clearing and dampness-removing group, the blood-activating and blood-stasis-removing group, and the wind-clearing and collateral-draining group into 10-fold water, decoct twice, the first decoction for 1 hour, the second decoction for 0.5 hour, combine the two decoctions, and concentrate to a relative density of 1.10 (60°C);

[0066] (3) Special extraction: Ultra-low temperature cold extraction method was used for chicken gizzard lining, Amomum villosum and cinnamon bark. The medicinal materials were crushed into 80 mesh, 5 times the amount of 40% ethanol aqueous solution was added, and the mixture was soaked at -5°C for 48 hours and stirred for extraction.

[0067] (4) combining the extracts: combining the extracts from step (2) and (3), and concentrating under reduced pressure at 45° C. to a relative density of 1.15;

[0068] (5) Processing of auxiliary materials: Grind platycodon grandiflorum, dried ginger and fresh ginger into 80 mesh size and pass through a 60 mesh sieve for later use;

[0069] (6) Mixed preparation: The concentrate of step (4) is mixed with the auxiliary materials of step (5), 3% of microcrystalline cellulose and 1% of cross-linked polyvinylpyrrolidone are added as disintegrants, and 1% of magnesium stearate is added as a lubricant. The mixture is granulated by a dry method and compressed into tablets. The tablets are compressed by a tablet press at a pressure of 8 kN under the condition that the tablet weight is 0.4 g. The obtained tablets are coated and dried at 45° C. until the moisture content does not exceed 5%.

[0070] This example adopts the lowest endpoint value formula, which is particularly suitable for patients in the early stage of metabolic disorders, and demonstrates a mild adjustment treatment strategy. Through the "three-burner elimination strategy", the upper burner mulberry clears lung heat (improves insulin resistance), the middle burner Amomum villosum transports spleen dampness (regulates lipid metabolism), and the lower burner Coix seed clears kidney turbidity (promotes uric acid excretion), achieving the initial adjustment of the "symptomatic reversal project".

[0071] Example 3

[0072] A Chinese medicine composition for treating four highs, comprising the following six functional groups of drugs:

[0073] Qi-tonifying and Yin-nourishing group: Astragalus 40g, Ginseng 30g, Chinese Yam 40g, Polygonatum 18g, Ophiopogon 21g, Rehmannia glutinosa 19g;

[0074] Heat-clearing and dampness-removing group: chicory 28g, gardenia 14g, cassia seed 17g, dandelion 16g, coix seed 60g, fresh bitter melon 90g;

[0075] Blood circulation and stasis removal group: peach kernel 9g, turmeric 22g, angelica 20g, hawthorn 60g;

[0076] Spleen-strengthening and digestion-promoting group: clove 10g, Amomum villosum 13g, chicken gizzard 10g, Poria 50g;

[0077] Wind-clearing and collateral-draining group: Pueraria root 30g, Gastrodia elata 20g, mulberry leaf 16g, mint 10g;

[0078] Medicinal properties harmonizing group: cinnamon bark 17g, dried ginger 16g, fresh ginger 30g, platycodon 14g.

[0079] Among them, clove and chicken gizzard lining in the spleen-strengthening and digestion-promoting group form a "synergistic" combination of digestion and supplementation. Radish seeds promote qi and relieve bloating, and its radish seeds can inhibit the activity of pancreatic lipase; chicken gizzard lining can digest food and eliminate accumulation, and synergistically improve lipid metabolism. The use of large doses of Poria cocos reflects the Chinese medical concept of "treating dampness and hindering urination is not the right treatment", which promotes the elimination of dampness and heat through urine by lowering qi. Poria cocos polysaccharide can significantly regulate the ecological balance of intestinal flora, promote the production of short-chain fatty acids, and improve the symptoms of metabolic syndrome.

[0080] In the wind-clearing and collateral-draining group, pueraria root and gastrodia elata form a "double-clearing neck vein" combination. Puerarin can significantly increase cerebral blood flow by 28% and improve vertebral artery blood supply; gastrodia elata regulates blood pressure by inhibiting sympathetic nerve activity. Mulberry leaf and mint form a "double-clearing liver and lung" medicine pair, which can clear wind and dredge collaterals, improve the state of hypertension caused by liver hyperactivity and meridian obstruction, and demonstrate the dialectical thought of "treating the upper disease from the lower part" in traditional Chinese medicine.

[0081] The preparation method comprises the following steps:

[0082] (1) Raw material pretreatment: Select, clean and cut each group of Chinese medicinal materials;

[0083] (2) Group extraction: Add the medicinal materials of the Qi-tonifying and Yin-nourishing group, the heat-clearing and dampness-removing group, the blood-activating and blood-stasis-removing group, and the wind-clearing and collateral-draining group into 15-fold water, decoct twice, the first decoction for 1.5 hours and the second decoction for 1 hour, combine the two decoctions, and concentrate to a relative density of 1.25 (60°C);

[0084] (3) Special extraction: Ultra-low temperature cold extraction method was used for chicken gizzard lining, Amomum villosum and cinnamon bark. The medicinal materials were crushed into 120 mesh, 8 times the amount of 60% ethanol aqueous solution was added, and the mixture was soaked at 5°C for 72 hours and stirred for extraction;

[0085] (4) combining the extracts: combining the extracts from step (2) and (3), and concentrating under reduced pressure at 55° C. to a relative density of 1.30;

[0086] (5) Processing of auxiliary materials: Grind the platycodon grandiflorum, dried ginger and fresh ginger into 100 mesh separately and pass through a 60 mesh sieve for later use;

[0087] (6) Mixed preparation: The concentrate of step (4) is mixed with the auxiliary materials of step (5), 8% of microcrystalline cellulose and 3% of cross-linked polyvinylpyrrolidone are added as disintegrants, and 2% of magnesium stearate is added as a lubricant. The mixture is granulated by a dry method, and tabletted. When the tablet weight is 0.6 g, the tablet is compressed by a tablet press machine with a pressure controlled at 12 kN. After coating the obtained tablets, the tablets are dried at 55° C. until the moisture content does not exceed 5%.

[0088] This example adopts the highest endpoint value formula, which is particularly suitable for patients with severe symptoms of the four highs, and reflects the treatment strategy of enhanced regulation. Through "metabolic axis regulation", the AMPK (ginseng-astragalus)-PPARγ (gardenia-balsam pear)-mTOR (Poria-yam) multi-target network regulation is achieved to achieve the overall regulation effect of the coordinated metabolism of sugar, fat and uric acid.

[0089] Example 4

[0090] A Chinese medicine composition for treating four highs, characterized by the optimization of the qi-invigorating and yin-nourishing group, comprising the following six functional group drugs:

[0091] Qi-tonifying and Yin-nourishing group: Astragalus 35g, Ginseng 25g, Chinese Yam 30g, Polygonatum 15g, Ophiopogon 18g, Rehmannia glutinosa 17g;

[0092] Heat-clearing and dampness-removing group: chicory 15g, gardenia 10g, cassia seed 12g, dandelion 12g, coix seed 35g, fresh bitter melon 50g;

[0093] Blood circulation and stasis removal group: peach kernel 7g, turmeric 16g, angelica 15g, hawthorn 35g;

[0094] Spleen-strengthening and digestion-promoting group: clove 8g, Amomum villosum 8g, chicken gizzard 7g, Poria 30g;

[0095] Wind-clearing and collateral-draining group: Pueraria root 18g, Gastrodia elata 15g, mulberry leaf 10g, mint 7g;

[0096] Medicinal properties harmonizing group: cinnamon bark 12g, dried ginger 12g, fresh ginger 18g, platycodon 8g.

[0097] In this embodiment, the mass ratio of Astragalus to Ginseng is 35:25. Astragalus replenishes qi and raises yang, while Ginseng greatly replenishes vital energy. The two are combined to form a "double-pipe for replenishing qi" and synergistically enhance the effect of replenishing qi. The amount of Chinese yam is about 0.85 times that of Astragalus, which plays a role in protecting spleen yin. The mass ratio of Radix Rehmanniae, Radix Ophiopogonis and Polygonatum odoratum is 17:18:15, forming a "golden triangle for nourishing yin" to nourish yin and moisten dryness. This optimized ratio particularly emphasizes the principle of TCM differentiation of syndromes that "those with insufficient form should be warmed with qi, and those with insufficient essence should be supplemented with flavor", providing a solid foundation of qi and yin for metabolic regulation.

[0098] From the perspective of modern pharmacology, astragalus polysaccharide regulates T cell immunity and improves insulin resistance; ginsenoside Rg3 activates the AMPK pathway to promote glucose and lipid metabolism; and Ophiopogon japonicus polysaccharide inhibits α-glucosidase. The combination of the three forms a complete "three-pathway" system for blood sugar regulation: ① Momordica charantia polypeptide activates insulin receptor (IRS-1); ② Astragalus polysaccharide improves GLUT4 translocation; ③ Mulberry leaf alkaloids inhibit α-glucosidase.

[0099] The preparation method comprises the following steps:

[0100] (1) Raw material pretreatment: Select and wash each group of Chinese medicinal materials, cut astragalus and yam into slices 1-2 cm thick, cut ginseng into slices 2-3 mm thick, and cut the remaining medicinal materials according to the conventional method;

[0101] (2) Group extraction: The medicinal materials of the Qi-tonifying and Yin-nourishing group, the heat-clearing and dampness-removing group, the blood-activating and blood-stasis-removing group, and the wind-clearing and collateral-draining group were added into 13-fold water, decocted twice, the first decoction was 1.3 hours, and the second decoction was 0.8 hours. The two decoctions were combined and concentrated to a relative density of 1.20 (60°C);

[0102] (3) Special extraction: Ultra-low temperature cold extraction method was used for chicken gizzard lining, Amomum villosum and cinnamon bark. The medicinal materials were crushed into 100 mesh, and 6.5 times the amount of 50% ethanol aqueous solution was added. The mixture was soaked at 0±1°C for 65 hours, and stirred every 13 hours. After the extraction was completed, the mixture was filtered, and the filtrate was decompressed at 42°C to recover ethanol until the ethanol content was less than 4%;

[0103] (4) combining the extracts: combining the extracts from step (2) and (3), and concentrating under reduced pressure at 50° C. to a relative density of 1.25;

[0104] (5) Processing of auxiliary materials: Grind platycodon grandiflorum, dried ginger and fresh ginger into 90 mesh size and pass through a 60 mesh sieve for later use;

[0105] (6) Mixed preparation: The concentrate of step (4) is mixed with the auxiliary materials of step (5), 7% hydroxypropyl methylcellulose is added as a binder, and the mixture is granulated by fluidized bed granulation. The obtained granules are dried at 55° C. to a moisture content of no more than 6%, and then divided into sealed bags.

[0106] This embodiment is particularly suitable for patients with four highs of the Qi and Yin deficiency type. By optimizing the ratio of the Qi-tonifying and Yin-nourishing group, "Qi, blood, body fluids and body fluids are in harmony": Astragalus-Angelica invigorates Qi and produces blood, Ophiopogon-Polygonatum nourishes Yin and moistens dryness, Poria-Coix lachryma-jobi promotes dampness and clears turbidity, forming an overall regulatory effect of "Qi, blood, body fluids and body fluids three-phase balance".

[0107] Example 5

[0108] A Chinese medicine composition for treating four highs, characterized by the optimization of the heat-clearing and dampness-removing group, including the following six functional group drugs:

[0109] Qi-tonifying and Yin-nourishing group: Astragalus 20g, Ginseng 15g, Chinese Yam 20g, Polygonatum 12g, Ophiopogon 15g, Rehmannia glutinosa 13g;

[0110] Heat-clearing and dampness-removing group: chicory 25g, gardenia 12g, cassia seed 15g, dandelion 14g, coix seed 50g, fresh bitter melon 75g;

[0111] Blood circulation and stasis removal group: peach kernel 6g, turmeric 15g, angelica 15g, hawthorn 35g;

[0112] Spleen-strengthening and digestion-promoting group: clove 8g, Amomum villosum 7g, chicken gizzard 7g, Poria 28g;

[0113] Wind-clearing and collateral-draining group: Pueraria root 15g, Gastrodia elata 15g, mulberry leaf 10g, mint 7g;

[0114] Medicinal properties harmonizing group: cinnamon bark 10g, dried ginger 12g, fresh ginger 18g, platycodon 8g.

[0115] In this embodiment, the mass ratio of bitter melon to chicory is 3:1, forming a "double acid antagonism" combination, in which bitter melon saponins inhibit xanthine oxidase and chicoric acid promotes uric acid excretion. Chicory is selected from European chicory roots, with a chicoric acid content of ≥6%, and bitter melon is selected from a specific variety of fresh bitter melon, with a saponin content of ≥0.8%. Gardenia is fried gardenia, and dandelion is selected from the whole dandelion plant. The two constitute a "liver and gallbladder purification drug" to remove the accumulated heat in the triple energizer. The amount of coix seed is relatively large, reaching 50g, which embodies the treatment idea of ​​"dispelling dampness and removing turbidity".

[0116] From the perspective of modern pharmacology, chicoric acid inhibits the URAT1 transporter; bitter melon polypeptide P-insulin has insulin-like effects; and gardenia glycoside improves lipid metabolism through the PPARγ pathway. This combination forms a "dual channel" regulation of uric acid metabolism: chicoric acid inhibits URAT1 reabsorption + coix seed promotes ABCG2 efflux, regulating uric acid metabolism disorders in a two-pronged manner.

[0117] The preparation method comprises the following steps:

[0118] (1) Raw material pretreatment: The Chinese medicinal materials of each group were selected and cleaned separately, among which the chicory root was cut into 3-5 mm thin slices, the gardenia was crushed, and the cassia seed was fried until slightly yellow. The remaining medicinal materials were cut as usual;

[0119] (2) Group extraction: Add the medicinal materials of the Qi-tonifying and Yin-nourishing group, the heat-clearing and dampness-removing group, the blood-activating and blood-stasis-removing group, and the wind-clearing and collateral-draining group into 12-fold water, decoct twice, the first decoction for 1.2 hours, the second decoction for 0.7 hours, combine the two decoctions, and concentrate to a relative density of 1.18 (60°C);

[0120] (3) Special extraction: Ultra-low temperature cold extraction method is used for chicken gizzard lining, Amomum villosum and cinnamon bark. The medicinal materials are crushed into 110 mesh, 7 times the amount of 55% ethanol aqueous solution is added, and soaked at 2°C for 60 hours, stirred every 12 hours, filtered after the extraction is completed, and the filtrate is decompressed at 43°C to recover ethanol until the ethanol content is less than 4.5%;

[0121] (4) combining the extracts: combining the extracts from step (2) and (3), and concentrating under reduced pressure at 52° C. to a relative density of 1.25;

[0122] (5) Processing of auxiliary materials: Grind platycodon grandiflorum, dried ginger and fresh ginger into 90 mesh size and pass through a 60 mesh sieve for later use;

[0123] (6) Mixed preparation: The concentrate of step (4) is mixed with the auxiliary materials of step (5), 8% hydroxypropyl methylcellulose is added as a binder, and the mixture is granulated by fluidized bed granulation. The obtained granules are dried at 56° C. to a moisture content of no more than 6.5%, and then divided into sealed bags.

[0124] This embodiment is particularly suitable for patients with the four highs of the internal accumulation of dampness and heat. By optimizing the ratio of the heat-clearing and dampness-removing groups, the "three-burner elimination strategy" is implemented: the upper-burner Morus alba clears lung heat (improves insulin resistance), the middle-burner Amomum villosum transports spleen dampness (regulates lipid metabolism), and the lower-burner Coix lachryma-jobi clears kidney turbidity (promotes uric acid excretion), providing a systematic solution to the modern pathological chain of "staying up late to damage yin - drinking to generate dampness - long-term sitting to cause blood stasis".

[0125] Example 6

[0126] A Chinese medicine composition for treating four highs, characterized by the optimization of blood circulation and stasis removal group, including the following six functional groups of drugs:

[0127] Qi-tonifying and Yin-nourishing group: Astragalus 22g, Ginseng 18g, Chinese Yam 22g, Polygonatum 12g, Ophiopogon 14g, Rehmannia glutinosa 15g;

[0128] Heat-clearing and dampness-removing group: chicory 15g, gardenia 10g, cassia seed 13g, dandelion 12g, coix seed 30g, fresh bitter melon 45g;

[0129] Blood circulation and stasis removal group: peach kernel 8g, turmeric 20g, angelica 18g, hawthorn 55g;

[0130] Spleen-strengthening and digestion-promoting group: clove 8g, Amomum villosum 7g, chicken gizzard 7g, Poria 30g;

[0131] Wind-clearing and collateral-draining group: Pueraria root 18g, Gastrodia elata 15g, mulberry leaf 8g, mint 7g;

[0132] Medicinal properties harmonizing group: cinnamon bark 12g, dried ginger 12g, fresh ginger 18g, platycodon 8g.

[0133] In this embodiment, hawthorn and peach kernel form a "fat and vein double clearing" combination, with a mass ratio of 55:8. Hawthorn uses fried hawthorn, which is rich in hawthorn flavonoids, and peach kernel uses peeled peach kernel, which is rich in fatty oil and amygdalin. The mass ratio of turmeric to angelica is 20:18. Turmeric uses raw turmeric powder with a curcumin content of ≥5%, and angelica uses angelica tail. The two synergistically inhibit the NF-κB pathway and reduce lipids and blood pressure.

[0134] From the perspective of modern pharmacology, hawthorn flavonoids regulate ABCA1-mediated reverse cholesterol transport; curcumin downregulates LOX-1 expression to improve endothelial function. This combination forms a "triple blood purification" system (viscosity reduction, anticoagulation, plaque dissolution) with improved blood rheology, breaking the vicious cycle of blood rheology and endothelial function, improving microcirculation, and dissolving plaques.

[0135] The preparation method comprises the following steps:

[0136] (1) Raw material pretreatment: The Chinese medicinal materials of each group were selected and cleaned, hawthorn was fried until slightly yellow, peach kernel was peeled, turmeric was crushed to 60 mesh, and angelica was cut into 3-5 mm thin slices;

[0137] (2) Group extraction: Add the medicinal materials of the Qi-tonifying and Yin-nourishing group, the heat-clearing and dampness-removing group, the blood-activating and blood-stasis-removing group, and the wind-clearing and collateral-draining group into 12-fold water, decoct twice, the first decoction for 1.3 hours, the second decoction for 0.8 hours, combine the two decoctions, and concentrate to a relative density of 1.20 (60°C);

[0138] (3) Special extraction: Ultra-low temperature cold extraction method is used for chicken gizzard lining, Amomum villosum and cinnamon bark. The medicinal materials are crushed into 105 mesh, and 6.5 times the amount of 52% ethanol aqueous solution is added. They are soaked at 1°C for 62 hours and stirred every 12 hours. After the extraction is completed, the filtrate is filtered and the ethanol is recovered under reduced pressure at 42°C until the ethanol content is less than 4.2%;

[0139] (4) combining the extracts: combining the extracts from step (2) and (3), and concentrating under reduced pressure at 53° C. to a relative density of 1.26;

[0140] (5) Processing of auxiliary materials: Grind platycodon grandiflorum, dried ginger and fresh ginger into 90 mesh size and pass through a 60 mesh sieve for later use;

[0141] (6) Mixed preparation: The concentrated solution of step (4) is mixed with the auxiliary materials of step (5), 6% of microcrystalline cellulose and 2% of cross-linked polyvinylpyrrolidone are added as disintegrants, and 1.5% of magnesium stearate is added as a lubricant. The mixture is granulated by a dry method, and tabletted. When the tablet weight is 0.5 g, the tablet is compressed by a tablet press machine with a pressure controlled at 10 kN. After coating the obtained tablets, the tablets are dried at 50° C. until the moisture content does not exceed 5%.

[0142] This embodiment is particularly suitable for patients with four highs of the phlegm and blood stasis type. By optimizing the ratio of the blood circulation and blood stasis removal group, a "four-link" regulatory network for blood lipid regulation is formed: hawthorn flavonoids promote cholesterol reverse transport + cassia anthraquinone inhibits HMG-CoA reductase + curcumin downregulates CD36 expression + taraxasterol blocks cholesterol absorption, thereby comprehensively regulating abnormal lipid metabolism.

[0143] Example 7

[0144] A Chinese medicine composition for treating four highs, characterized by the optimization of the spleen-strengthening and digestion-promoting group, including the following six functional group drugs:

[0145] Qi-tonifying and Yin-nourishing group: Astragalus 22g, Ginseng 18g, Chinese Yam 23g, Polygonatum 12g, Ophiopogon 14g, Rehmannia glutinosa 14g;

[0146] Heat-clearing and dampness-removing group: chicory 15g, gardenia 10g, cassia seed 13g, dandelion 11g, coix seed 35g, fresh bitter melon 50g;

[0147] Blood circulation and stasis removal group: peach kernel 7g, turmeric 15g, angelica 14g, hawthorn 30g;

[0148] Spleen-strengthening and digestion-promoting group: clove 9g, Amomum villosum 10g, chicken gizzard 8g, Poria cocos 45g;

[0149] Wind-clearing and collateral-draining group: Pueraria root 18g, Gastrodia elata 14g, mulberry leaf 9g, mint 7g;

[0150] Medicinal properties harmonizing group: cinnamon bark 12g, dried ginger 12g, fresh ginger 20g, platycodon 9g.

[0151] In this embodiment, cloves and chicken's gizzard lining constitute a "reducing and replenishing synergistic" combination, with a mass ratio of 9:8. Cloves are selected from radish seeds fried to slightly yellow, and chicken's gizzard lining is selected from ground chicken's gizzard lining. The former is used to promote qi and relieve bloating, and the latter is used to digest food and eliminate accumulation. Poria is used in large doses, up to 45g, reflecting the Chinese medical concept of "treating dampness and not urinating is not the right treatment" to lower qi and eliminate dampness and heat from urine. Poria uses white Poria, with a polysaccharide content of ≥28%, and Amomum villosum is crushed at low temperature to a particle size of 90 mesh, retaining volatile oil components.

[0152] From the perspective of modern pharmacology, Poria polysaccharide regulates the production of SCFAs in the intestinal flora; radix raphani inhibits the activity of pancreatic lipase. This combination optimizes the intervention mechanism of the intestinal-islet axis: Poria polysaccharide regulates the intestinal flora, yam mucus repairs the intestinal mucosa, and forms a "intestinal-pancreatic dialogue" regulation mechanism with bitter melon polypeptide, improving the source of metabolic disorders.

[0153] The preparation method comprises the following steps:

[0154] (1) Raw material pretreatment: Select and wash each group of Chinese medicinal materials, stir-fry radish seeds until slightly yellow, cut Poria cocos into small pieces of 1 cm square, and cut the remaining medicinal materials according to the conventional method;

[0155] (2) Group extraction: The medicinal materials of the Qi-tonifying and Yin-nourishing group, the heat-clearing and dampness-removing group, the blood-activating and blood-stasis-removing group, and the wind-clearing and collateral-draining group were added into 13-fold water, decocted twice, the first decoction was 1.3 hours, and the second decoction was 0.7 hours. The two decoctions were combined and concentrated to a relative density of 1.22 (60°C);

[0156] (3) Special extraction: Ultra-low temperature cold extraction method is used for chicken gizzard lining, Amomum villosum and cinnamon bark. The medicinal materials are crushed into 100 mesh, 7 times the amount of 55% ethanol aqueous solution is added, and soaked at 2°C for 65 hours, stirred every 12 hours, filtered after extraction, and the filtrate is decompressed and ethanol is recovered at 40°C until the ethanol content is less than 4%;

[0157] (4) combining the extracts: combining the extracts from step (2) and (3), and concentrating under reduced pressure at 48° C. to a relative density of 1.24;

[0158] (5) Processing of auxiliary materials: Grind platycodon grandiflorum, dried ginger and fresh ginger into 95 mesh separately, and pass through a 60 mesh sieve for later use;

[0159] (6) Mixed preparation: The concentrated solution of step (4) is mixed with the auxiliary materials of step (5), and 8% hydroxypropyl methylcellulose is added as a binder. The mixture is granulated by fluidized bed granulation. The obtained granules are dried at 58° C. to a moisture content of no more than 6%, and then divided into sealed bags.

[0160] This embodiment is particularly suitable for patients with spleen deficiency and dampness, and achieves "harmony of qi, blood and body fluids" by optimizing the ratio of the spleen-strengthening and digestion-promoting group: Poria cocos and coix seed can eliminate dampness and turbidity, strengthen the spleen and digestion, and improve the metabolic environment. It especially embodies the "symptomatic reversal engineering" treatment idea of ​​"treating the symptoms in an emergency and strengthening the root cause in a slow manner".

[0161] Example 8

[0162] A Chinese medicine composition for treating four highs, characterized by the optimization of the wind-clearing and collateral-unblocking group, comprising the following six functional group drugs:

[0163] Qi-tonifying and Yin-nourishing group: Astragalus 20g, Ginseng 18g, Chinese Yam 20g, Polygonatum 12g, Ophiopogon 15g, Rehmannia glutinosa 14g;

[0164] Heat-clearing and dampness-removing group: chicory 15g, gardenia 9g, cassia seed 12g, dandelion 11g, coix seed 30g, fresh bitter melon 45g;

[0165] Blood circulation and stasis removal group: peach kernel 7g, turmeric 15g, angelica 15g, hawthorn 30g;

[0166] Spleen-strengthening and digestion-promoting group: clove 8g, Amomum villosum 7g, chicken gizzard 7g, Poria 30g;

[0167] Wind-clearing and collateral-draining group: Pueraria root 28g, Gastrodia elata 18g, mulberry leaf 14g, mint 9g;

[0168] Medicinal properties harmonizing group: cinnamon bark 12g, dried ginger 13g, fresh ginger 22g, platycodon 10g.

[0169] In this embodiment, kudzu root and gastrodia elata form a "double-clearing neck and vein" combination, with a mass ratio of 28:18. The kudzu root is selected from wild kudzu root, with a puerarin content of ≥2.5%, and the gastrodia elata is selected from high-quality gastrodia elata slices, with a gastrodin content of ≥0.8%. The mulberry leaves are selected from spring mulberry leaves, and the mint is a mint leaf with a menthol content of not less than 1.8%. The two constitute a "double-clearing liver and lung" medicine pair, which can dispel wind and dredge meridians, and improve hypertension caused by liver hyperactivity and meridian obstruction.

[0170] From the perspective of modern pharmacology, puerarin increases cerebral blood flow by 28%; gastrodin inhibits sympathetic nerve activity. This combination optimizes the neuro-endocrine balance mechanism: gastrodia-pueraria regulates the hypothalamus-sympathetic nerve axis, cinnamon-dried ginger activates TRPV1 channels to improve insulin sensitivity, and regulates the interaction between the nervous system and the metabolic system.

[0171] The preparation method comprises the following steps:

[0172] (1) Raw material pretreatment: Select and clean each group of Chinese medicinal materials, cut Pueraria root into thin slices, cut Gastrodia elata into 3 mm thick slices, and gently crush mulberry leaves and mint;

[0173] (2) Group extraction: Add the medicinal materials of the Qi-tonifying and Yin-nourishing group, the heat-clearing and dampness-removing group, the blood-activating and blood-stasis-removing group, and the wind-clearing and collateral-draining group into 12-fold water, decoct twice, the first decoction for 1.2 hours, the second decoction for 0.8 hours, combine the two decoctions, and concentrate to a relative density of 1.20 (60°C);

[0174] (3) Special extraction: Ultra-low temperature cold extraction method was used for chicken gizzard lining, Amomum villosum and cinnamon bark. The medicinal materials were crushed into 110 mesh, 6.8 times the amount of 53% ethanol aqueous solution was added, and soaked at 1.5°C for 63 hours, stirred every 12 hours, filtered after the extraction was completed, and the filtrate was decompressed and ethanol was recovered at 41°C until the ethanol content was less than 4.3%;

[0175] (4) combining the extracts: combining the extracts from step (2) and (3), and concentrating under reduced pressure at 50° C. to a relative density of 1.23;

[0176] (5) Processing of auxiliary materials: Grind platycodon grandiflorum, dried ginger and fresh ginger into 95 mesh separately, and pass through a 60 mesh sieve for later use;

[0177] (6) Mixed preparation: The concentrate of step (4) is mixed with the auxiliary materials of step (5), and 7.5% of hydroxypropyl methylcellulose is added as a binder. The mixture is granulated by fluidized bed granulation. The obtained granules are dried at 57° C. to a moisture content of no more than 6.5%, and then divided into sealed bags.

[0178] This embodiment is particularly suitable for patients with four highs of liver yang hyperactivity type. By optimizing the ratio of the wind-clearing and collateral-draining group, "two-system" regulation of blood pressure control is achieved: gastrodin inhibits the RAAS system + puerarin enhances the NO-cGMP pathway, bidirectionally regulating blood pressure, reflecting the dialectical treatment idea of ​​"treating the upper disease from the lower part" in traditional Chinese medicine.

[0179] Example 9

[0180] A Chinese medicine composition for treating four highs, characterized by optimizing the harmonizing medicinal property group, includes the following six functional group drugs:

[0181] Qi-tonifying and Yin-nourishing group: Astragalus 23g, Ginseng 18g, Chinese Yam 23g, Polygonatum 12g, Ophiopogon 15g, Rehmannia glutinosa 14g;

[0182] Heat-clearing and dampness-removing group: chicory 16g, gardenia 10g, cassia seed 12g, dandelion 11g, coix seed 35g, fresh bitter melon 45g;

[0183] Blood circulation and stasis removal group: peach kernel 7g, turmeric 16g, angelica 15g, hawthorn 35g;

[0184] Spleen-strengthening and digestion-promoting group: clove 8g, Amomum villosum 8g, chicken gizzard 7g, Poria 30g;

[0185] Wind-clearing and collateral-draining group: Pueraria root 20g, Gastrodia elata 15g, mulberry leaf 10g, mint 7g;

[0186] Medicinal properties harmonizing group: cinnamon bark 16g, dried ginger 15g, fresh ginger 28g, platycodon 12g.

[0187] In this embodiment, cinnamon and dried ginger form a "fire and earth mutual generation" trend, with a mass ratio of 16:15. Cinnamon is selected from high-quality cinnamon, with a cinnamaldehyde content of ≥2.5%, and dried ginger is selected from old ginger, with a gingerol content of ≥0.8%. Platycodon grandiflorum is a "boat agent" that guides the medicine upward. The amount of fresh ginger is relatively large, reaching 28g, which enhances the power of warming the middle and dispersing cold. This combination not only prevents yin-nourishing drugs from hindering the stomach, but also helps yang drugs to transform qi, reflecting the Chinese medicine dialectical thought of "seeking yang in yin".

[0188] From the perspective of modern pharmacology, cinnamaldehyde and gingerol in dried ginger can activate TRPV1 receptors, improve insulin sensitivity, and regulate blood sugar metabolism. Platycodon saponins have anti-inflammatory effects and synergistically improve metabolic inflammatory states. This combination optimizes the metabolic axis regulatory network: through the regulation of the AMPK (ginseng-astragalus)-PPARγ (gardenia-balsam pear)-mTOR (Poria cocos-yam) multi-target network, the coordinated metabolism of sugar, fat and uric acid is achieved.

[0189] The preparation method comprises the following steps:

[0190] (1) Raw material pretreatment: Select and clean each group of Chinese medicinal materials, break cinnamon into small pieces, cut dried ginger into thin slices, cut platycodon into 3 mm thin slices, and wash and slice fresh ginger;

[0191] (2) Group extraction: The medicinal materials of the Qi-tonifying and Yin-nourishing group, the heat-clearing and dampness-removing group, the blood-activating and blood-stasis-removing group, and the wind-clearing and collateral-draining group were added into 12.5 times of water, decocted twice, the first decoction was 1.25 hours, and the second decoction was 0.75 hours. The two decoctions were combined and concentrated to a relative density of 1.21 (60°C);

[0192] (3) Special extraction: Ultra-low temperature cold extraction method is used for chicken gizzard lining, Amomum villosum and cinnamon bark. The medicinal materials are crushed into 105 mesh, 7 times the amount of 54% ethanol aqueous solution is added, and soaked at 1°C for 68 hours, stirred every 12 hours, filtered after the extraction is completed, and the filtrate is decompressed and ethanol is recovered at 40°C until the ethanol content is less than 4.5%;

[0193] (4) combining the extracts: combining the extracts from step (2) and (3), and concentrating under reduced pressure at 52° C. to a relative density of 1.25;

[0194] (5) Processing of auxiliary materials: Grind platycodon grandiflorum, dried ginger and fresh ginger into 95 mesh separately, and pass through a 60 mesh sieve for later use;

[0195] (6) Mixed preparation: The concentrate of step (4) is mixed with the auxiliary materials of step (5), 9% hydroxypropyl methylcellulose is added as a binder, and the mixture is granulated by fluidized bed granulation. The obtained granules are dried at 57° C. to a moisture content of no more than 6.5%, and then divided into sealed bags.

[0196] This embodiment is particularly suitable for patients with the four highs of the yang deficiency and cold excess type. By optimizing the ratio of the harmonizing medicinal property group and coordinating the effects of the other five groups of drugs, it embodies the Chinese medicine dialectical idea of ​​"seeking yang in yin" and provides balanced support for the comprehensive regulation of the four highs.

[0197] Example 10

[0198] A Chinese medicine composition for the treatment of four highs, characterized by a special dosage form preparation process, including the following six functional groups of drugs:

[0199] Qi-tonifying and Yin-nourishing group: Astragalus 25g, Ginseng 20g, Chinese Yam 25g, Polygonatum 13g, Ophiopogon 15g, Rehmannia glutinosa 15g;

[0200] Heat-clearing and dampness-removing group: chicory 17g, gardenia 10g, cassia seed 14g, dandelion 12g, coix seed 38g, fresh bitter melon 53g;

[0201] Blood circulation and stasis removal group: peach kernel 7g, turmeric 15g, angelica 15g, hawthorn 38g;

[0202] Spleen-strengthening and digestion-promoting group: clove 8g, Amomum villosum 9g, chicken gizzard 8g, Poria 33g;

[0203] Wind-clearing and collateral-draining group: Pueraria root 20g, Gastrodia elata 15g, mulberry leaf 10g, peppermint 8g;

[0204] Medicinal properties harmonizing group: cinnamon bark 13g, dried ginger 13g, fresh ginger 20g, platycodon 10g.

[0205] The components of this embodiment are the same as those of embodiment 1, but the preparation method is optimized for the dosage form, specifically comprising the following steps:

[0206] (1) Raw material pretreatment: Select, clean and cut each group of Chinese medicinal materials;

[0207] (2) Group extraction: Add the medicinal materials of the Qi-tonifying and Yin-nourishing group, the heat-clearing and dampness-removing group, the blood-activating and blood-stasis-removing group, and the wind-clearing and collateral-draining group into 12-fold water, decoct twice, the first decoction for 1.2 hours, the second decoction for 0.8 hours, combine the two decoctions, and concentrate to a relative density of 1.18 (60°C);

[0208] (3) Special extraction: Ultra-low temperature cold extraction method is used for chicken gizzard lining, Amomum villosum and cinnamon bark. The medicinal materials are crushed into 100 mesh, 6 times the amount of 50% ethanol aqueous solution is added, and soaked at 0°C for 60 hours, stirred once every 12 hours, filtered after extraction, and the filtrate is decompressed and ethanol is recovered at 40°C until the ethanol content is less than 5%;

[0209] (4) combining the extracts: combining the extracts from step (2) and (3), and concentrating under reduced pressure at 50° C. to a relative density of 1.22;

[0210] (5) Processing of auxiliary materials: Grind platycodon grandiflorum, dried ginger and fresh ginger into 90 mesh size and pass through a 60 mesh sieve for later use;

[0211] (6) Tablet preparation: The concentrate of step (4) is mixed with the auxiliary materials of step (5), 5% of microcrystalline cellulose and 1.5% of cross-linked polyvinylpyrrolidone are added as disintegrants, and 1.2% of magnesium stearate is added as a lubricant. The mixture is granulated by a dry method, and tablets are pressed. When the tablet weight is 0.5 g, the tablets are pressed by a tablet press, and the pressure is controlled at 10 kN.

[0212] (7) Coating treatment: Place the tablets in a coating pan and spray with a coating solution consisting of 10% hydroxypropyl methylcellulose, 1% polyethylene glycol 6000, and 0.5% titanium dioxide until the tablet weight increases by 3%;

[0213] (8) Drying and packaging: The coated tablets are dried at 50°C until the moisture content does not exceed 5%. After passing the quality inspection, they are placed in an aluminum-plastic package and sealed.

[0214] This embodiment optimizes the tablet preparation process, pays special attention to the stability of the dosage form and the drug release characteristics, and realizes the orderly release of the active ingredients: first, the wind-clearing and collateral-draining group and the heat-clearing and dampness-clearing group are released to quickly control the symptoms; then the blood circulation and stasis-removing group and the spleen-strengthening and digestion-promoting group are released to improve the metabolic environment; finally, the qi-invigorating and yin-nourishing group and the medicinal property-regulating group are released to consolidate the treatment effect, which embodies the "treating the symptoms in an emergency and consolidating the root cause in a slow manner" symptomatic reversal engineering treatment strategy.

[0215] In order to verify the effectiveness of the Chinese medicine composition of the present invention and the rationality of its formula design, a series of comparative experiments were conducted to evaluate in detail the regulatory effects of the composition on blood sugar, blood pressure, blood lipids and uric acid.

[0216] Comparative Example 1: Comparison of the composition of the present invention with commercially available single-target drugs

[0217] Experimental method: SD rats fed with high-fat and high-sugar diet for 8 weeks were used to establish the four-high model (n=60, body weight 250±20g), and randomly divided into six groups: blank control group (ordinary diet), model control group (high-fat and high-sugar diet), composition group of the present invention (Example 1, 1.5g / kg body weight), metformin group (150mg / kg body weight), atorvastatin group (10mg / kg body weight) and benzbromarone group (20mg / kg body weight). The rats were given oral administration every day for 4 weeks, and various indicators were monitored regularly.

[0218] Blood glucose measurement: fasting blood glucose was measured by glucose oxidase method, glucose tolerance test (OGTT) was used to evaluate glucose tolerance, and insulin resistance index (HOMA-IR) was used to evaluate insulin sensitivity.

[0219] Blood pressure measurement: The systolic and diastolic blood pressure of rats were measured by non-invasive tail pressure method twice a week, and the average of three stable readings was taken each time.

[0220] Blood lipid determination: Total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) were determined using an automatic biochemical analyzer.

[0221] Uric acid determination: Serum uric acid level was determined by uricase-peroxidase method.

[0222] The test results are shown in Table 1 below:

[0223] Table 1. Comparison of the four high indicators of the composition of the present invention and single-target drugs (after 4 weeks of administration, mean ± SD)

[0224]

[0225] *P<0.01 vs blank control group; **P<0.01 vs model control group

[0226] As can be seen from the data in Table 1, the composition of the present invention exhibits an obvious multi-target synergistic regulatory effect and can improve four metabolic indicators at the same time. In contrast, metformin only effectively improves blood sugar and insulin sensitivity, atorvastatin only reduces blood lipids, and benzbromarone only reduces uric acid. This fully confirms that the composition of the present invention achieves an integrated therapeutic effect of "one prescription to treat four highs" through a multi-target regulatory network.

[0227] Further histopathological analysis showed that the pancreatic β cells of rats in the composition group of the present invention were arranged more neatly, fat accumulation was significantly reduced, the degree of fatty degeneration of the liver was significantly reduced, the swelling of renal tubular epithelial cells was reduced, and the vascular endothelial function was improved. These results further verified the comprehensive benefits of the composition of the present invention in protecting tissues and organs.

[0228] Comparative Example 2: Comparison of the complete formulation of the present invention and the formulation with missing functional groups

[0229] In order to verify the necessity of the six functional groups in the present invention, an incomplete formula lacking a certain functional group was designed for comparative study. The experiment used the same high-fat and high-sugar diet-induced four-high SD rat model (n=49, body weight 260±15g) as in Comparative Example 1, and randomly divided into seven groups: model control group, complete formula group (Example 1, 1.5g / kg body weight), lack of qi-replenishing and yin-nourishing group formula, lack of heat-clearing and dampness-removing group formula, lack of blood circulation and stasis group formula, lack of spleen-strengthening and digestion-promoting group formula, and lack of wind-clearing and collateral-draining group formula. All groups were gavaged according to the same dosing regimen for 4 weeks.

[0230] The experimental results are shown in Table 2:

[0231] Table 2. Comparison of the efficacy of the complete formula of the present invention and the formula lacking a single function group (after 4 weeks of administration, mean ± SD)

[0232]

[0233] *P<0.05vs complete formula group

[0234] It can be clearly seen from Table 2 that the absence of any functional group will significantly affect the overall efficacy of the combination. Among them, after the absence of the Qi-tonifying and Yin-nourishing group, the blood sugar reduction rate and the insulin resistance improvement rate decreased significantly, which fully confirmed the key role of this functional group in "curing the root cause"; after the absence of the heat-clearing and dampness-clearing group, the uric acid reduction rate decreased significantly, verifying the important role of the bitter melon-chicory "double acid antagonism" combination in the regulation of uric acid metabolism; after the absence of the blood circulation and stasis-removing group, the blood lipid and blood pressure regulation effects were significantly weakened, indicating the necessity of the hawthorn-peach kernel "fat and vein double clearing" combination and the turmeric-angelica anti-inflammatory and antihypertensive compatibility; after the absence of the spleen-strengthening and digestion-promoting group, multiple indicators decreased to varying degrees, reflecting the basic role of this group in improving the metabolic environment; after the absence of the wind-clearing and collateral-dredging group, the blood pressure reduction rate decreased significantly, verifying the special role of the Pueraria-Gastrodia "neck vein double solution" combination in blood pressure regulation.

[0235] These results fully confirm the scientific nature and necessity of the six functional groups of the present invention. Each functional group targets a specific metabolic target and achieves systemic regulation of the four highs through synergistic effects.

[0236] Comparative Example 3: Comparison between ultra-low temperature cold extraction and conventional extraction methods

[0237] In order to verify the superiority of the ultra-low temperature cold extraction process of the present invention, the active ingredient content and biological activity of the Chinese medicine composition prepared by different extraction methods were compared. The experiment adopted the formula of Example 1, and used the ultra-low temperature cold extraction method of the present invention (0°C, 50% ethanol, 60 hours) and the conventional hot soaking extraction method (95°C, 60 minutes) to treat chicken gizzard lining, Amomum villosum and cinnamon bark, and then prepared them into the final product according to a unified process.

[0238] The contents of key active ingredients in the products of the two extraction methods were determined by high performance liquid chromatography (HPLC), and their biological activities were evaluated by in vitro enzyme activity assay. The results are shown in Table 3:

[0239] Table 3. Comparison of active ingredient content and biological activity between ultra-low temperature cold extraction and conventional extraction methods

[0240] index Ultra-low temperature cold extraction Conventional hot soaking extraction Improvement rate (%) Cinnamaldehyde content (mg / g) 8.76±0.85 4.38±0.42* 100 Volatile oil content of Amomum villosum (μL / g) 12.53±1.21 5.86±0.57* 113.8 Chicken gizzard enzyme activity (U / mg) 25.32±2.45 8.75±0.82* 189.4 α-Amylase inhibition rate (%) 48.35±4.65 21.68±2.15* 123 Pancreatic lipase inhibition rate (%) 53.26±5.12 25.42±2.53* 109.5 URAT1 transporter inhibition rate (%) 58.75±5.65 31.65±3.12* 85.6

[0241] *P<0.01 vs ultra-low temperature cold extraction group

[0242] As can be seen from Table 3, compared with the conventional hot-immersion extraction method, the ultra-low temperature cold extraction method can more effectively retain the heat-sensitive active ingredients, the cinnamaldehyde content increased by 100.0%, the volatile oil content of Amomum villosum increased by 113.8%, and the activity of Gallus gallus endometrium increased by 189.4%. In terms of biological activity, the ultra-low temperature cold extraction product showed significantly higher α-amylase inhibition rate, pancreatic lipase inhibition rate and URAT1 transporter inhibition rate, which increased by 123.0%, 109.5% and 85.6%, respectively.

[0243] Further animal experiments verified the manifestation of this difference in vivo. Using the same rat model of four highs, ultra-low temperature cold extraction products and conventional hot extraction products were given respectively (the dosage was 1.5g / kg body weight), and blood sugar, blood pressure, blood lipids and uric acid levels were measured after 2 weeks of continuous administration. The results showed that the improvement effect of ultra-low temperature cold extraction products in the four indicators was significantly better than that of conventional hot extraction products, with the improvement rates of 35.2%, 28.5%, 31.6% and 42.8% respectively.

[0244] These results fully confirm the scientificity and necessity of the ultra-low temperature cold extraction process used in the present invention to treat heat-sensitive medicinal materials. This process can better retain active ingredients, improve bioavailability, and thus enhance efficacy.

[0245] Comparative Example 4: Comparison of dose-effect relationships of compositions at different doses

[0246] In order to determine the optimal dosage range of the composition of the present invention, a dose-effect relationship study was designed. The experiment used the same rat four-high model as above (n=30, body weight 255±18g), and was randomly divided into six groups: model control group, low-dose group (0.5g / kg body weight), medium-low dose group (1.0g / kg body weight), medium-dose group (1.5g / kg body weight), medium-high dose group (2.0g / kg body weight), and high dose group (2.5g / kg body weight). All the administration groups used the composition of Example 1, and were gavaged daily according to their respective doses for 4 weeks.

[0247] In order to comprehensively evaluate the comprehensive regulatory effect of the composition, the metabolic regulation comprehensive index (MRCI) was calculated, which comprehensively considers the improvement of four indicators: blood sugar, blood pressure, blood lipids and uric acid. The experimental results are shown in Table 4:

[0248] Table 4. Comparison of dose-effect relationship of different doses of the composition (after 4 weeks of administration, mean ± SD)

[0249]

[0250]

[0251] *P<0.05vs the previous dose group

[0252] As can be seen from Table 4, the dose-effect relationship of the composition of the present invention presents a typical S-shaped curve characteristic. As the dose increases from 0.5 g / kg to 1.5 g / kg, the improvement of various metabolic indicators increases significantly; when the dose is further increased to 2.0 g / kg and 2.5 g / kg, the effect increase gradually decreases and tends to a plateau. Through nonlinear regression analysis, it is determined that the EC50 (half-maximal effect concentration) is 1.2 g / kg, and the optimal therapeutic dose window is 1.5-2.0 g / kg.

[0253] Safety assessment showed that no obvious adverse reactions were observed in the low, medium-low and medium dose groups; a few animals in the medium-high and high dose groups had mild gastrointestinal reactions, but no serious adverse events occurred. Liver and kidney function indicators remained within the normal range in all dose groups, with no obvious abnormalities.

[0254] These results show that the composition of the present invention can achieve the ideal four-high regulation effect at a dose of 1.5 g / kg. Although further increasing the dose can obtain a slight enhancement of the effect, the improvement is limited and may increase the risk of adverse reactions. Therefore, 1.5 g / kg can be used as a recommended dose for clinical application.

[0255] Comparative Example 5: Comparison of the compatibility effects of different formula compositions

[0256] In order to verify the synergistic effect between the functional groups in the formula of the present invention, the regulatory effects of different formula combinations were compared. The experimental model was the same as above, and was randomly divided into six groups (n=36): model control group, complete formula group (Example 1, 1.5g / kg), qi-tonifying and yin-nourishing + heat-clearing and dampness-removing combination, qi-tonifying and yin-nourishing + blood circulation and stasis-removing combination, heat-clearing and dampness-removing + blood circulation and stasis-removing combination, and three groups of single use groups (the three groups of drugs were simply mixed in the same weight ratio, and the total dose was 1.5g / kg). The dosing regimen was the same as above.

[0257] The experimental results are shown in Table 5:

[0258] Table 5. Comparison of the compatibility effects of different formula compositions (after 4 weeks of administration, mean ± SD)

[0259]

[0260]

[0261] *P<0.05vs model control group; vs Complete Formula Group

[0262] As can be seen from Table 5, although the incomplete formula group and the three groups used alone all showed certain metabolic regulation effects, their effects were significantly weaker than those of the complete formula group. It is particularly noteworthy that the effect of simply mixing the three main functional groups (Qi-replenishing and Yin-nourishing group, heat-clearing and dampness-removing group, and blood-activating and blood-stasis-removing group) was significantly lower than the effect of using them in combination according to the proportion of the formula of the present invention, and the synergistic effect index was only 0.48, indicating that the formula of the present invention has a significant synergistic effect of compatibility.

[0263] Further studies on the basis of pharmacodynamic substances showed that the blood concentrations of multiple active ingredients in the complete formula group were significantly higher than those in the incomplete formula group and the three groups of single use, including astragaloside, ginsenoside Rg3, chicoric acid, gardenia glycoside, hawthorn flavonoids, etc. This shows that the compatibility design of the present invention can improve the bioavailability of active ingredients and enhance the efficacy.

[0264] Molecular mechanism studies have found that the complete formula group can simultaneously activate the AMPK pathway, PPARγ pathway and inhibit the NF-κB pathway, forming a multi-target synergistic regulatory network; while the incomplete formula group and the three groups used alone can only partially activate a single or two signal pathways and fail to form a complete regulatory network. This further confirms the scientificity and rationality of the formula design of the present invention.

[0265] Comparative Example 6: Comparison of compositions of different embodiments of the present invention

[0266] In order to verify the effectiveness and characteristics of the formulations of different embodiments of the present invention, Example 1 (standard formulation), Example 3 (highest endpoint value formulation) and Example 2 (lowest endpoint value formulation) were selected for comparative study. The experiment used the same rat four-high model as mentioned above and was randomly divided into four groups (n=24): model control group, Example 1 group, Example 2 group and Example 3 group, with a dose of 1.5 g / kg body weight and the same administration regimen as mentioned above.

[0267] The experimental results are shown in Table 6:

[0268] Table 6. Comparison of the effects of the compositions of different embodiments of the present invention (after 4 weeks of administration, mean ± SD)

[0269]

[0270] *P<0.05vs model control group; vs Example 1 Group

[0271] As can be seen from Table 6, all three examples show significant four-high regulation effects, but there are certain differences. Example 3 (highest endpoint value formula) shows the strongest metabolic regulation effect, but the incidence of adverse reactions is relatively high; Example 2 (lowest endpoint value formula) has a relatively weak metabolic regulation effect, but the incidence of adverse reactions is the lowest; Example 1 (standard formula) shows a good balance between effect and safety.

[0272] Further subgroup analysis found that for animals with mild degrees of the four highs, the formula in Example 2 was able to provide sufficient regulatory effects and had the best tolerance; for animals with severe degrees of the four highs, the formula in Example 3 showed stronger regulatory ability and was able to improve metabolic indicators more quickly. This result supports the individualized treatment strategy of selecting different formulas based on the severity of the patient's condition.

[0273] Immunohistochemistry and molecular biology analysis showed that the three examples had slight differences in regulation mechanisms: Example 1 was more balanced in regulating various indicators; Example 2 was more prominent in improving insulin sensitivity; and Example 3 had obvious advantages in inhibiting inflammatory response and improving vascular endothelial function. These differences provide a theoretical basis for selecting the most suitable formula for patients with different pathological characteristics.

[0274] In summary, the present invention has fully verified the remarkable effect of the proposed Chinese medicine composition in the comprehensive regulation of the four highs through a systematic study of multiple comparative examples. Compared with commercially available single-target drugs, the composition of the present invention can improve four metabolic indicators at the same time; there is a clear synergistic effect between the functional groups, and a multi-target metabolic regulation network is jointly constructed; the ultra-low temperature cold extraction process can significantly increase the content of active ingredients and biological activity; different formulation embodiments show good results for the four highs of different severity.

Claims

1. A Chinese medicine composition for treating four highs, characterized in that: The composition includes the following six functional groups of drugs: Qi-tonifying and Yin-nourishing group: Astragalus 10-40g, Ginseng 10-30g, Chinese Yam 10-40g, Polygonatum 8-18g, Ophiopogon 9-21g, Rehmannia glutinosa 10-19g; Heat-clearing and dampness-removing group: chicory 6-28g, gardenia 6-14g, cassia seed 10-17g, dandelion 8-16g, coix seed 16-60g, fresh bitter melon 15-90g; Blood circulation and stasis removal group: peach kernel 5-9g, turmeric 8-22g, angelica 10-20g, hawthorn 15-60g; Spleen-strengthening and digestion-promoting group: clove 6-10g, Amomum villosum 4-13g, chicken gizzard 5-10g, Poria cocos 15-50g; Wind-clearing and collateral-draining group: Pueraria root 10-30g, Gastrodia elata 10-20g, mulberry leaf 5-16g, mint 5-10g; Regulating medicinal properties group: cinnamon bark 8-17g, dried ginger 10-16g, fresh ginger 10-30g, platycodon 5-14g.

2. The Chinese medicine composition according to claim 1, characterized in that: The mass ratio of astragalus to ginseng in the qi-tonifying and yin-nourishing group is (1-4):(1-3), and the amount of yam is 0.8-1.2 times the amount of astragalus; the mass ratio of rehmannia, ophiopogon and polygonatum is (1-2):(0.9-2.1):(0.8-1.8).

3. The Chinese medicine composition according to claim 1, characterized in that The chicory in the heat-clearing and dampness-removing group is selected from the following types: European chicory, chicory roots or chicory stems and leaves; the bitter melon is a fresh product, and the mass ratio of fresh bitter melon to chicory is (1-9):(0.6-2.8); the gardenia is fried gardenia, and the coix seed is raw coix seed.

4. The Chinese medicine composition according to claim 1, characterized in that: In the blood circulation and stasis removing group, the hawthorn is stir-fried hawthorn, and the peach kernel is peeled peach kernel; the mass ratio of the hawthorn to the peach kernel is (3-12):(1-1.8); the turmeric is raw turmeric powder, and the mass ratio of turmeric to angelica is (0.8-2.2):(1-2).

5. The Chinese medicine composition according to claim 1, characterized in that: The mass ratio of clove to chicken gizzard lining in the spleen-strengthening and digestion-promoting group is (1.2-2):(1-2); the poria cocos is white poria cocos, and its dosage accounts for 60-85% of the total dosage of the spleen-strengthening and digestion-promoting group; the amomum villosum is ground at low temperature and has a particle size of 80-100 meshes.

6. The Chinese medicine composition according to claim 1, characterized in that: The kudzu root in the wind-clearing and collateral-unblocking group is wild kudzu root; the mass ratio of the kudzu root to the gastrodia elata is (1-3):(1-2); the mulberry leaves are spring mulberry leaves; the mint is a mint leaf with a menthol content of not less than 1.8%; the cinnamon in the medicinal property-regulating group is high-quality cinnamon, and the mass ratio of cinnamon to dried ginger is (0.8-1.7):(1-1.6).

7. A method for preparing the Chinese medicine composition according to any one of claims 1 to 6, characterized in that: The following steps are involved: (1) Raw material pretreatment: selecting, cleaning and cutting each group of Chinese medicinal materials; (2) Group extraction: Add the medicinal materials of the Qi-tonifying and Yin-nourishing group, the heat-clearing and dampness-removing group, the blood-activating and blood-stasis-removing group, and the wind-clearing and collateral-draining group into 10-15 times of water respectively, and decoct them twice, the first decoction is 1-1.5 hours, and the second decoction is 0.5-1 hour. The two decoctions are combined and concentrated to a relative density of 1.10-1.25 (60°C); (3) Special extraction: Ultra-low temperature cold extraction method is used for chicken gizzard lining, Amomum villosum and cinnamon bark. The medicinal materials are crushed into 80-120 mesh, 5-8 times the amount of 40-60% ethanol aqueous solution is added, and the mixture is soaked at -5°C to 5°C for 48-72 hours, and stirred for extraction; (4) combining the extracts: combining the extracts from step (2) and (3), and concentrating under reduced pressure at 45-55° C. to a relative density of 1.15-1.30; (5) Processing of auxiliary materials: Grind platycodon grandiflorum, dried ginger and fresh ginger into 80-100 meshes respectively, and pass through a 60-mesh sieve for later use; (6) Mixed preparation: The concentrated solution of step (4) is mixed with the auxiliary materials of step (5), and dried to a water content of no more than 9% to prepare granules or tablets.

8. The method according to claim 7, characterized in that The specific process parameters of the ultra-low temperature cold extraction method described in step (3) are: the medicinal material is crushed into 100 mesh, 6 times the amount of 50% ethanol aqueous solution is added, and it is soaked at 0±1°C for 60 hours, stirred once every 12 hours, filtered after the extraction is completed, and the filtrate is decompressed and ethanol is recovered at 40°C until the ethanol content is less than 5%.

9. The method according to claim 7, characterized in that: The process for preparing the granules in step (6) is as follows: the concentrate is mixed with the auxiliary materials, 5-10% of hydroxypropyl methylcellulose is added as a binder, granulated by fluidized bed, the obtained granules are dried at 50-60° C. to a moisture content of no more than 7%, and then packed into sealed bags.

10. The method according to claim 7, characterized in that The process for preparing tablets in step (6) is as follows: mixing the concentrate with the auxiliary materials, adding 3-8% of microcrystalline cellulose and 1-3% of cross-linked polyvinylpyrrolidone as disintegrants, and 1-2% of magnesium stearate as a lubricant, granulating by dry method, and tableting. Under the condition that the tablet weight is 0.4-0.6g, the tablet is compressed by a tablet press machine with the pressure controlled at 8-12kN. After coating the obtained tablets, the tablets are dried at 45-55°C until the water content does not exceed 5%.

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