A traditional Chinese medicine composition for invigorating the spleen, tonifying the kidney, promoting blood circulation, expelling phlegm and reducing lipid and a preparation method thereof

Abstract

The present application relates to the field of traditional Chinese medicine preparation, and particularly discloses a traditional Chinese medicine composition for invigorating the spleen, tonifying the kidney, promoting blood circulation and eliminating phlegm and lipid, and a preparation method thereof. The traditional Chinese medicine composition is prepared from fourteen kinds of raw medicinal materials, including raw red yeast rice, gynostemma pentaphyllum, cleaned hawthorn, astragalus, salvia miltiorrhiza, corn silk, prunella vulgaris, prepared rhizoma polygonati, alisma orientale, radix coicis, prepared radix falcaliae, giant knotweed, semen cassiae and licorice root. The present application can further comprise poria cocos and dried tangerine or orange peel. The present application is aimed at the pathogenesis of spleen deficiency as the root, phlegm-dampness as the branch and phlegm and blood stasis as the combination. The combination principle of invigorating the spleen, eliminating dampness, resolving phlegm, regulating qi and promoting blood circulation is adopted, and the prescription is rigorous. In the preparation method, the present application adopts the combined enzymatic hydrolysis and ultrasonic extraction technology, and combines the low-temperature drying and ultrafine grinding process, so that the extraction efficiency of effective components is significantly improved. The present application also provides various dosage forms, such as decoction, granules, tablets, capsules, pills, powders, oral liquid and ointment, which have good lipid-lowering, phlegm-eliminating and blood-activating effects and safety.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparations, specifically a traditional Chinese medicine composition for invigorating the spleen and kidneys, promoting blood circulation, eliminating phlegm, and lowering lipids, and its preparation method. Background Technology

[0002] Hyperlipidemia is a metabolic disorder characterized by elevated levels of triglycerides and / or total cholesterol in the blood plasma, possibly accompanied by elevated low-density lipoprotein cholesterol (LDL-C) and decreased high-density lipoprotein cholesterol (HDL-C). Early stages are often asymptomatic, but as the condition progresses, it can lead to atherosclerosis, subsequently causing serious cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke. Traditional Chinese medicine (TCM) classifies hyperlipidemia under the categories of "phlegm turbidity," "blood stasis," and "accumulation," with its pathogenesis often related to dysfunction of the spleen, kidneys, and liver. The spleen, responsible for transportation and transformation, is the source of phlegm. If the spleen is weak and its transportation and transformation functions are impaired, dampness accumulates internally, forming phlegm. Phlegm and dampness obstruct the flow of qi and blood, leading to blood stasis. The mutual binding of phlegm and blood stasis adheres to the blood vessels, ultimately resulting in elevated blood lipids and atherosclerosis. Therefore, spleen deficiency is the root cause, phlegm and dampness are the manifestations, and the mutual binding of phlegm and blood stasis constitutes the core pathogenesis of hyperlipidemia. Treatment should focus on strengthening the spleen and replenishing qi, eliminating dampness and resolving phlegm, and promoting blood circulation and removing blood stasis.

[0003] Currently, there are numerous traditional Chinese medicine (TCM) compound formulas used clinically to treat hyperlipidemia. However, existing TCM compound formulas often focus on a single treatment method, such as only strengthening the spleen and removing dampness or only promoting blood circulation and removing blood stasis. They are unable to simultaneously address the three pathological aspects of spleen deficiency, phlegm-dampness, and blood stasis. Existing TCM compound formulas suffer from incomplete formulation and a single treatment method, failing to achieve a holistic regulation that combines the five methods of strengthening the spleen, removing dampness, resolving phlegm, promoting blood circulation, and regulating qi. Consequently, their efficacy in treating hyperlipidemia caused by phlegm-blood stasis is limited. Summary of the Invention

[0004] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine composition for invigorating the spleen and kidneys, promoting blood circulation, resolving phlegm, and lowering lipids, as well as its preparation method. This addresses the issue that existing traditional Chinese medicine compound prescriptions often have a single treatment method and fail to simultaneously address the five principles of invigorating the spleen, removing dampness, resolving phlegm, promoting blood circulation, and regulating qi to holistically regulate phlegm-blood stasis type hyperlipidemia.

[0005] This invention provides a traditional Chinese medicine composition for strengthening the spleen and kidneys, promoting blood circulation, eliminating phlegm, and lowering lipids, made from the following raw materials in parts by weight:

[0006] Raw red yeast rice 12-30 parts, Gynostemma pentaphyllum 9-20 parts, hawthorn 12-30 parts, Astragalus membranaceus 15-60 parts, Salvia miltiorrhiza 12-30 parts, corn silk 9-20 parts, Prunella vulgaris 12-30 parts, processed Polygonatum sibiricum 12-30 parts, Alisma plantago-aquatica 12-30 parts, Coix lacryma-jobi 20-60 parts, processed Polygonum multiflorum 12-30 parts, Polygonum cuspidatum 9-20 parts, Cassia tora 9-20 parts, Glycyrrhiza uralensis 3-9 parts.

[0007] Preferably, the active pharmaceutical ingredient further comprises one or more of the following medicinal materials in parts by weight:

[0008] 10-30 parts Poria cocos, 6-15 parts dried tangerine peel, and 15-30 parts Dioscorea opposita.

[0009] Preferably, the active pharmaceutical ingredient is made from the following parts by weight:

[0010] 15 parts raw red yeast rice, 15 parts gynostemma pentaphyllum, 20 parts hawthorn, 30 parts astragalus, 20 parts salvia miltiorrhiza, 9 parts corn silk, 21 parts prunella vulgaris, 20 parts processed polygonatum sibiricum, 20 parts alisma plantago-aquatica, 40 parts coix seed, 12 parts processed polygonum multiflorum, 14 parts polygonum cuspidatum, 12 parts cassia seed, 6 parts licorice, 15 parts poria cocos, 9 parts tangerine peel, and 20 parts dioscorea opposita.

[0011] This invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0012] Step 1: Raw material pretreatment: Weigh out the remaining raw materials except for raw red yeast rice according to the weight proportions, remove impurities, soak and wash them in clean water at 25-35℃ for 10-20 minutes, and then drain the surface water.

[0013] Step 2, Low-temperature drying: Place the cleaned raw materials in a constant temperature drying oven at 30-45℃ and dry for 6-12 hours until the moisture content drops below 8%;

[0014] Step 3, Ultrafine Grinding: Mix the dried raw materials and grind them into ultrafine powder with a particle size of 10-50μm in an ultrafine grinder for later use;

[0015] Step 4: Raw red yeast rice processing: Grind the raw red yeast rice separately and pass it through a 100-200 mesh sieve to obtain fine raw red yeast rice powder;

[0016] Step 5, Compound Enzymatic Hydrolysis: Add the ultrafine powder obtained in Step 3 to water at 8-12 times its weight, adjust the pH to 4.5-6.0, add a compound enzyme accounting for 0.5%-1.5% of the total weight of the raw materials, and enzymatically hydrolyze at 40-55℃ for 1-3 hours. The compound enzyme is composed of cellulase, pectinase and xylanase in a mass ratio of 2:1:1.

[0017] Step 6, Ultrasonic Extraction: Place the enzymatically hydrolyzed liquid in an ultrasonic extraction device and extract for 30-60 minutes at an ultrasonic power of 200-400W and a frequency of 20-40kHz.

[0018] Step 7, Centrifugation and Filtration: Centrifuge the ultrasonically extracted liquid at 3000-5000 r / min for 10-20 minutes, collect the supernatant, and keep the filter residue for later use;

[0019] Step 8, Secondary Extraction: Add 6-10 times its weight of water to the filter residue obtained in Step 7, heat to 90-100℃ and boil for 40-60 minutes, filter, and combine the two extracts;

[0020] Step 9, Mixing and Concentration: Combine the supernatant obtained in Step 7 with the extract obtained in Step 8, add the raw red yeast rice powder obtained in Step 4, stir evenly, and concentrate under reduced pressure at 60-80℃ to an extract with a relative density of 1.10-1.25.

[0021] Step 10, Formulation: Add pharmaceutically acceptable excipients to the extract obtained in Step 9 and formulate the desired dosage form according to any of the following methods:

[0022] Decoction: Dilute the extract with water to a concentration of 0.5-2.0g of raw herb per milliliter, fill into sterile bags or glass bottles, seal, and the decoction is obtained.

[0023] Granules: Mix the extract with fillers and binders to form a soft material, granulate it through a 10-30 mesh sieve, dry it at 50-70℃ until the moisture content is ≤5%, and then granulate it to obtain granules;

[0024] Tablets: Mix the extract with fillers and disintegrants evenly, add binder to granulate, dry, granulate, add lubricant and mix evenly, compress into tablets to obtain tablets;

[0025] Capsules: Mix the extract and filler evenly, dry, pulverize, pass through a 60-100 mesh sieve, and fill into hard capsule shells, or make soft capsule contents and then compress them into soft capsules to obtain capsules.

[0026] Pills: The extract is mixed with excipients, and the mixture is granulated using the pan-coating or plasticizing method, dried, and the granules are selected to obtain pills.

[0027] Powder: The extract is dried at low temperature, pulverized, passed through an 80-120 mesh sieve, and packaged in aluminum foil bags to obtain the powder;

[0028] Oral liquid: Dilute the extract with water to the specified concentration, adjust the pH to 4.5-6.5, add flavoring agent and preservative, filter, fill into oral liquid bottles, seal, sterilize, and the oral liquid is obtained.

[0029] Ointment: The extract is further concentrated to a relative density of 1.35-1.40, then refined honey or sucrose is added, the extract is collected, and then it is bottled to obtain the ointment.

[0030] Preferably, in step five, the amount of compound enzyme added is 1.0% of the total weight of the raw materials, the enzymatic hydrolysis temperature is 48±2℃, and the enzymatic hydrolysis time is 2 hours.

[0031] Preferably, in step six, the ultrasonic extraction conditions are: ultrasonic power 300W, frequency 30kHz, and extraction time 45 minutes.

[0032] Preferably, in step eight, the decocting conditions are: add 8 times the amount of water and decoct for 50 minutes.

[0033] Preferably, in step nine, the temperature for vacuum concentration is 70°C and the relative density is 1.15-1.20.

[0034] Preferably, in step ten, the pharmaceutically acceptable excipient is selected from one or more of the following: fillers, binders, disintegrants, lubricants, flavoring agents, preservatives, and excipients.

[0035] Preferably, the process also includes step eleven: packaging and sterilizing the preparation obtained in step ten.

[0036] Compared with the prior art, the present invention has the following beneficial effects:

[0037] The formula uses raw red yeast rice and Gynostemma pentaphyllum as the principal herbs to clear heat, resolve phlegm, lower lipids, and promote blood circulation. It also uses Alisma plantago-aquatica, hawthorn, astragalus, and salvia miltiorrhiza as the assistant herbs to strengthen the spleen, eliminate dampness, invigorate qi, and promote blood circulation. It further uses Poria cocos, tangerine peel, yam, Polygonum cuspidatum, and Prunella vulgaris to regulate qi, resolve phlegm, benefit the kidneys, and reduce turbidity. Finally, it uses licorice to harmonize the herbs. The whole formula works together to strengthen the spleen and benefit the kidneys, promote blood circulation, resolve phlegm, reduce turbidity, and lower lipids. The formula is well-structured and addresses both the root cause and the symptoms.

[0038] In terms of preparation process, this invention adopts a combined enzymatic hydrolysis and ultrasonic extraction technology. Through the synergistic effect of cellulase, pectinase and xylanase, the plant cell wall is destroyed. Combined with the ultrasonic cavitation effect, the extraction efficiency of effective ingredients is significantly improved, so that the medicinal resources can be fully utilized. At the same time, this invention adopts low temperature drying and ultra-micro pulverization technology, which effectively protects the heat-sensitive components in the medicinal materials and avoids the destruction of effective ingredients by traditional high temperature decoction.

[0039] Furthermore, this invention provides various dosage forms such as decoctions, granules, tablets, capsules, pills, powders, oral liquids, and ointments to meet the medication needs of different patients and improve the convenience and compliance of patients. Clinical observations show that the traditional Chinese medicine composition of this invention can effectively improve related metabolic indicators such as hyperlipidemia, hyperuricemia, and fatty liver, and relieve clinical symptoms such as heaviness, fatigue, and distension in the hypochondrium. It has no adverse effects on liver and kidney function, has good safety, and has broad clinical application prospects and industrialization value. Attached Figure Description

[0040] Figure 1 This is a flowchart illustrating the preparation process of the traditional Chinese medicine composition in Example 1 of the present invention. Detailed Implementation

[0041] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0042] Example 1: Preparation of a traditional Chinese medicine composition, such as... Figure 1 As shown

[0043] Weigh the following raw materials in the indicated weights: 15 parts raw red yeast rice, 15 parts gynostemma pentaphyllum, 20 parts hawthorn, 30 parts astragalus, 20 parts salvia miltiorrhiza, 9 parts corn silk, 21 parts prunella vulgaris, 20 parts processed polygonatum sibiricum, 20 parts alisma plantago-aquatica, 40 parts coix seed, 12 parts processed polygonum multiflorum, 14 parts polygonum cuspidatum, 12 parts cassia seed, and 6 parts licorice.

[0044] Preparation method:

[0045] Step 1: Raw material pretreatment: Weigh out the remaining raw materials except for raw red yeast rice according to the weight proportions, remove impurities, soak and wash them in 30℃ clean water for 15 minutes, and then drain the surface water.

[0046] Step 2, Low-temperature drying: Place the cleaned raw material in a constant temperature drying oven at 40℃ and dry for 10 hours until the moisture content drops below 8%.

[0047] Step 3, Ultrafine Grinding: Mix the dried raw materials and put them into an ultrafine grinder to grind them into ultrafine powder with a particle size of 30μm, and set aside.

[0048] Step 4: Raw red yeast rice processing: Grind the raw red yeast rice separately and pass it through a 150-mesh sieve to obtain fine raw red yeast rice powder.

[0049] Step 5, Compound Enzymatic Hydrolysis: Add the ultrafine powder obtained in Step 3 to 10 times its weight of water, adjust the pH to 5.0, add a compound enzyme accounting for 1.0% of the total weight of the raw materials, and enzymatically hydrolyze at 50℃ for 2 hours. The compound enzyme is composed of cellulase, pectinase and xylanase in a mass ratio of 2:1:1.

[0050] Step 6, Ultrasonic Extraction: Place the enzymatically hydrolyzed liquid in an ultrasonic extraction device and extract for 45 minutes at an ultrasonic power of 300W and a frequency of 30kHz.

[0051] Step 7, Centrifugation and Filtration: Centrifuge the ultrasonically extracted liquid at 4000 r / min for 15 minutes, collect the supernatant, and keep the filter residue for later use.

[0052] Step 8, Secondary Extraction: Add 8 times the weight of water to the filter residue obtained in Step 7, heat to 95℃ and boil for 50 minutes, filter, and combine the two extracts.

[0053] Step 9, Mixing and Concentration: Combine the supernatant obtained in Step 7 with the extract obtained in Step 8, add the raw red yeast rice powder obtained in Step 4, stir evenly, and concentrate under reduced pressure at 70℃ to an extract with a relative density of 1.15-1.20.

[0054] Step 10, Formulation: Add pharmaceutically acceptable excipients to the extract obtained in Step 9 and formulate it into a finished product according to the required dosage form.

[0055] Example 2: Preparation of Traditional Chinese Medicine Composition

[0056] Weigh the following raw materials in the indicated weights: 15 parts raw red yeast rice, 15 parts gynostemma pentaphyllum, 20 parts hawthorn, 30 parts astragalus, 20 parts salvia miltiorrhiza, 9 parts corn silk, 21 parts prunella vulgaris, 20 parts processed polygonatum sibiricum, 20 parts alisma plantago-aquatica, 40 parts coix seed, 12 parts processed polygonum multiflorum, 14 parts polygonum cuspidatum, 12 parts cassia seed, 6 parts licorice, 15 parts poria cocos, 9 parts tangerine peel, and 20 parts dioscorea opposita.

[0057] The preparation method is the same as in Example 1.

[0058] Example 3: Preparation of Traditional Chinese Medicine Composition

[0059] Weigh the following raw materials in the indicated weights: 12 parts raw red yeast rice, 12 parts gynostemma pentaphyllum, 30 parts hawthorn, 15 parts astragalus, 30 parts salvia miltiorrhiza, 15 parts corn silk, 15 parts prunella vulgaris, 20 parts processed polygonatum sibiricum, 15 parts alisma plantago-aquatica, 30 parts coix seed, 20 parts processed polygonum multiflorum, 9 parts polygonum cuspidatum, 9 parts cassia seed, 6 parts licorice, 20 parts poria cocos, 6 parts tangerine peel, and 15 parts dioscorea opposita.

[0060] The preparation method is the same as in Example 1.

[0061] Example 4: Preparation of decoction

[0062] Take the extract obtained in step nine of Example 1, dilute it with water to a concentration of 1.0g of raw herb per milliliter, fill it into a glass bottle, seal it, and you will get the decoction.

[0063] Example 5: Preparation of Granules

[0064] Take the extract obtained in step nine of Example 1, add lactose (filler) and hydroxypropyl methylcellulose (binder), mix to form a soft material, granulate through a 20-mesh sieve, dry at 60°C until the moisture content is ≤5%, and granulate to obtain granules.

[0065] Example 6: Preparation of tablets

[0066] Take the extract obtained in step nine of Example 1, add microcrystalline cellulose (filler) and crospovidone (disintegrant) and mix evenly, add polyvinylpyrrolidone (binder) to granulate, dry and granulate, then add magnesium stearate (lubricant) and mix evenly, compress with 10kN pressure to obtain tablets (each tablet contains 0.5g of crude drug).

[0067] Example 7: Preparation of Capsules

[0068] Take the extract obtained in step nine of Example 1, mix it evenly with dextrin (filler), dry it, pulverize it, pass it through an 80-mesh sieve, and fill it into hard capsule shells, with each capsule containing 0.3g, to obtain the capsule preparation.

[0069] Example 8: Preparation of pills

[0070] Take the extract obtained in step nine of Example 1, mix it with refined honey (excipient), and use the plasticizing method to form pellets. After drying and pelleting, the pellets are obtained (each 10 pellets weighs 1.5g).

[0071] Example 9: Preparation of Powder

[0072] Take the extract obtained in step nine of Example 1, dry it at low temperature, pulverize it, pass it through a 100-mesh sieve, and package it into aluminum foil bags, with 2g in each bag, to obtain the powder.

[0073] Example 10: Preparation of oral liquid

[0074] Take the extract obtained in step nine of Example 1, dilute it with water to a concentration of 0.5g of raw drug per milliliter, adjust the pH to 5.5, add sucrose (flavoring agent) and sodium benzoate (preservative), filter, fill into oral liquid bottles (10mL per bottle), seal, and sterilize at 105℃ for 20 minutes to obtain the oral liquid.

[0075] Example 11: Preparation of Ointment

[0076] Take the extract obtained in step nine of Example 2, continue to concentrate it to a relative density of 1.35-1.40, add refined honey (the mass ratio of refined honey to extract is 1:2), collect the extract, and fill it into glass bottles, 200g per bottle, to obtain the ointment.

[0077] Example 12: Treatment of dyslipidemia of phlegm-dampness retention type with decoction (Case: Ning)

[0078] Case source: Ning, male, 35 years old. First visit on October 18, 2025.

[0079] Diagnosis: Traditional Chinese Medicine (TCM) diagnosis: Accumulation-type disease; TCM syndrome: Phlegm-dampness obstruction syndrome. Western Medicine diagnosis: Dyslipidemia.

[0080] Pre-treatment examination (October 18, 2025): Uric acid 465 μmol / L↑, triglycerides 3.27 mmol / L↑. Current symptoms: heaviness in the body, fatigue, headache centered on the right side, lower back pain, sticky stools. Red tongue with a white, greasy coating, and a wiry, hesitant pulse.

[0081] Treatment plan: The modified formula from Example 2 (15g raw red yeast rice, 15g Gynostemma pentaphyllum, 20g hawthorn, 30g astragalus, 20g salvia miltiorrhiza, 9g corn silk, 21g prunella vulgaris, 20g prepared polygonatum sibiricum, 20g alisma plantago-aquatica, 40g coix seed, 12g prepared polygonum multiflorum, 14g polygonum cuspidatum, 12g cassia seed, 6g licorice, 15g poria cocos, 9g tangerine peel, 20g dioscorea opposita) was prepared as a decoction according to the method in Example 4. One dose was taken daily, decocted in water and taken orally in two divided doses, for 8 consecutive weeks.

[0082] Post-treatment examination (December 27, 2025):

[0083] detection indicators Before treatment After treatment Reference range change Triglycerides 3.27 mmol / L ↑ 2.08 mmol / L ↑ 0.56-1.70 mmol / L Down 36.4% uric acid 465 μmol / L ↑ 356 μmol / L 150-420 μmol / L Return to normal Total cholesterol — 4.0 mmol / L 3.12-6.21 mmol / L normal Alanine aminotransferase — 51U / L ↑ 7-40U / L —

[0084] Clinical Conclusion: After 8 weeks of medication, the patient's triglyceride level decreased from 3.27 mmol / L to 2.08 mmol / L (a decrease of 36.4%), and uric acid level decreased from 465 μmol / L to 356 μmol / L (returning to the normal range). Symptoms such as heaviness, fatigue, and headache significantly improved. No significant adverse reactions occurred during the treatment. This indicates that the traditional Chinese medicine composition of this invention has a significant therapeutic effect on dyslipidemia caused by phlegm-dampness retention.

[0085] Example 13: Treatment of hyperlipidemia of phlegm-dampness obstruction type with granules (Case: Mr. Chen)

[0086] Case source: Chen, male, 23 years old. First visit on February 16, 2025.

[0087] Diagnosis: Traditional Chinese Medicine (TCM) diagnosis: Dampness obstruction disease, accumulation-type disease; TCM syndrome: Phlegm-dampness obstruction syndrome. Western Medicine diagnosis: Hyperlipidemia, hyperuricemia.

[0088] Pre-treatment examination (February 16, 2025): Uric acid 563 μmol / L↑, LDL cholesterol 3.87 mmol / L↑, HDL cholesterol 1.19 mmol / L↓. Current symptoms: Reduced sleep, weight gain for over six months, feeling heavy, difficulty falling asleep, greasy and heavy mouth. White tongue with yellow coating, wiry and slippery pulse.

[0089] Treatment regimen: The modified formula of Example 2 (same as Example 12) was prepared into granules according to the method of Example 5. One sachet (containing 10g of raw herbs) was taken orally twice daily for 4 consecutive weeks.

[0090] Post-treatment examination (March 23, 2025):

[0091] detection indicators Before treatment After treatment Reference range change uric acid 563 μmol / L ↑ 356 μmol / L 150-420 μmol / L Return to normal Low-density lipoprotein 3.87 mmol / L ↑ 2.85 mmol / L <3.37mmol / L Return to normal High-density lipoprotein 1.19 mmol / L ↓ 1.32 mmol / L >1.04mmol / L Increased by 10.9% Total cholesterol — 4.3 mmol / L 3.12-6.21 mmol / L normal Triglycerides — 1.15 mmol / L 0.56-1.70 mmol / L normal

[0092] Clinical Conclusion: After 4 weeks of medication, the patient's uric acid level decreased from 563 μmol / L to 356 μmol / L (returning to normal), low-density lipoprotein (LDL) decreased from 3.87 mmol / L to 2.85 mmol / L (returning to normal), and high-density lipoprotein (HDL) increased from 1.19 mmol / L to 1.32 mmol / L (an increase of 10.9%). Symptoms such as heaviness in the body, difficulty falling asleep, and a greasy or heavy taste in the mouth significantly improved. No significant adverse reactions occurred during the treatment. This indicates that the traditional Chinese medicine composition of this invention has a significant therapeutic effect on hyperlipidemia and hyperuricemia of the phlegm-dampness obstruction type.

[0093] Example 14: Tablet therapy for fatty liver due to phlegm-dampness retention (Case: Mr. Zheng)

[0094] Case source: Zheng, male, 61 years old. First visit on April 5, 2025.

[0095] Diagnosis: Traditional Chinese Medicine diagnosis: Accumulation disease; Traditional Chinese Medicine syndrome: Phlegm-dampness obstruction syndrome. Western Medicine diagnosis: Fatty liver.

[0096] Pre-treatment examination (April 5, 2025): Color Doppler ultrasound showed mild fatty liver. Laboratory results showed: glucose 6.3 mmol / L↑, high-density lipoprotein 1.86 mmol / L↑. Current symptoms: distension in the hypochondrium, abdominal distension, central obesity, fatigue, bitter taste in the mouth, dry throat, and yellow urine. Pale tongue with a slightly yellow coating, thready and hesitant pulse. Blood pressure: 141 / 83 mmHg.

[0097] Treatment regimen: The basic formula from Example 1 (15g raw red yeast rice, 15g Gynostemma pentaphyllum, 20g hawthorn, 30g astragalus, 20g salvia miltiorrhiza, 9g corn silk, 21g prunella vulgaris, 20g processed polygonatum sibiricum, 20g alisma plantago-aquatica, 40g coix seed, 12g processed polygonum multiflorum, 14g polygonum cuspidatum, 12g cassia seed, 6g licorice) was prepared into tablets according to the method in Example 6 (each tablet contains 0.5g of raw herbs). Three tablets were taken orally three times daily for eight consecutive weeks.

[0098] Post-treatment examination (June 1, 2025):

[0099] detection indicators Before treatment After treatment Reference range change glucose 6.3 mmol / L ↑ 5.4 mmol / L 3.9-6.1 mmol / L Return to normal High-density lipoprotein 1.86 mmol / L ↑ 1.52 mmol / L >1.04mmol / L trending towards normal blood pressure 141 / 83 mmHg 128 / 78mmHg <140 / 90mmHg Return to normal Fatty liver (ultrasound) Mild fatty liver Normal liver echo — disappear

[0100] Clinical Conclusion: After 8 weeks of medication, the patient's blood glucose decreased from 6.3 mmol / L to 5.4 mmol / L (returning to normal range), and blood pressure decreased from 141 / 83 mmHg to 128 / 78 mmHg (returning to normal). A follow-up abdominal ultrasound showed the disappearance of fatty liver. Symptoms such as hypochondriac distension, fatigue, bitter taste in the mouth, and dry throat significantly improved. No significant adverse reactions occurred during treatment. This indicates that the herbal composition of this invention has a significant therapeutic effect on fatty liver of the phlegm-dampness obstruction type complicated by glucose and lipid metabolism disorders.

[0101] Example 15: Capsule therapy for hyperlipidemia due to blood stasis in the heart vessels (Case: Mr. Qian)

[0102] Case source: Ms. Qian, female, 67 years old. First visit on April 9, 2025.

[0103] Diagnosis: Traditional Chinese Medicine (TCM) diagnosis: Chest pain and heart pain, accumulation-type disease; TCM syndrome: Blood stasis in the heart vessels, damp-heat syndrome in the Qi level. Western Medicine diagnosis: Hyperlipidemia, hyperuricemia, fatty liver.

[0104] Pre-treatment examination (April 9, 2025): Uric acid 444.7 μmol / L↑, total cholesterol 5.96 mmol / L↑, triglycerides 3.3 mmol / L↑, LDL cholesterol 3.5 mmol / L↑, HDL cholesterol 1.23 mmol / L↓, estimated glomerular filtration rate 77 ml / min↓. Current symptoms: palpitations and shortness of breath, occasional palpitations. Red and moist tongue, thready and hesitant pulse.

[0105] Treatment regimen: The modified formula of Example 2 (same as Example 12) was used to prepare capsules according to the method of Example 7. Take 4 capsules each time, 3 times a day, orally, for 8 consecutive weeks.

[0106] Post-treatment examination (June 4, 2025):

[0107] detection indicators Before treatment After treatment Reference range change uric acid 444.7 μmol / L ↑ 356 μmol / L 150-420 μmol / L Return to normal Total cholesterol 5.96 mmol / L ↑ 5.32 mmol / L 3.12-6.21 mmol / L Down 10.7% Triglycerides 3.3 mmol / L ↑ 2.58 mmol / L ↑ 0.56-1.70 mmol / L Down 21.8% Low-density lipoprotein 3.5 mmol / L ↑ 2.94 mmol / L <3.37mmol / L Return to normal High-density lipoprotein 1.23 mmol / L ↓ 1.20 mmol / L >1.04mmol / L Maintain normal Estimating glomerular filtration rate 77ml / min ↓ 75ml / min ≥90ml / min Stablize

[0108] Clinical Conclusion: After 8 weeks of medication, the patient's uric acid decreased from 444.7 μmol / L to 356 μmol / L (returning to normal), total cholesterol decreased from 5.96 mmol / L to 5.32 mmol / L (a decrease of 10.7%), and low-density lipoprotein decreased from 3.5 mmol / L to 2.94 mmol / L (returning to normal). Creatinine and blood urea nitrogen remained stable, indicating no damage to renal function. Symptoms of palpitations and shortness of breath significantly improved. No significant adverse reactions occurred during treatment. This demonstrates that the herbal composition of this invention has a significant therapeutic effect on hyperlipidemia complicated with hyperuricemia due to blood stasis obstructing the heart vessels, and has no damage to liver and kidney function.

[0109] Example 16: Treatment of Hypercholesterolemia of Liver Blood Stasis Type with Pills (Case: Mr. Wu)

[0110] Case source: Ms. Wu, 73 years old. First visit on May 15, 2023.

[0111] Diagnosis: Traditional Chinese Medicine (TCM) diagnosis: Chest pain, abdominal mass; TCM syndrome: Liver blood stasis. Western Medicine diagnosis: Hypercholesterolemia, fatty liver.

[0112] Pre-treatment examination (May 15, 2023): Total cholesterol 6.36 mmol / L↑, LDL cholesterol 5.12 mmol / L↑. Current symptoms: Chest tightness and abdominal distension, difficulty falling asleep, preference for warm food, and aversion to cold. Pale tongue with a white, greasy coating, and wiry pulse.

[0113] Treatment regimen: The basic formula of Example 1 (same as Example 14) was used, and pills were prepared according to the method of Example 8 (10 pills weigh 1.5g). 10 pills were taken orally twice a day for 12 consecutive weeks.

[0114] Post-treatment examination (August 10, 2023):

[0115] detection indicators Before treatment After treatment Reference range change Total cholesterol 6.36 mmol / L ↑ 5.18 mmol / L 3.12-6.21 mmol / L Return to normal Low-density lipoprotein 5.12 mmol / L ↑ 3.35 mmol / L <3.37mmol / L Significant improvement Triglycerides 1.03 mmol / L 0.95mmol / L 0.56-1.70 mmol / L normal

[0116] Clinical Conclusion: After 12 weeks of medication, the patient's total cholesterol decreased from 6.36 mmol / L to 5.18 mmol / L (returning to normal), and low-density lipoprotein decreased from 5.12 mmol / L to 3.35 mmol / L (significant improvement). Symptoms such as chest tightness, abdominal distension, and difficulty falling asleep were significantly improved. No significant adverse reactions occurred during the treatment. This indicates that the herbal composition of this invention has a significant therapeutic effect on hypercholesterolemia of the liver blood stasis type.

[0117] Example 17: Treatment of fatty liver of phlegm-dampness stagnation type with powder (Case: Mr. Yang)

[0118] Case source: Ms. Yang, 56 years old. First visit on July 24, 2025.

[0119] Diagnosis: Traditional Chinese Medicine (TCM) diagnosis: Accumulation-type disease; TCM syndrome: Phlegm-dampness stagnation syndrome. Western Medicine diagnosis: Fatty liver.

[0120] Pre-treatment examination (July 24, 2025): Glucose 6.7 mmol / L↑, Total cholesterol 6.5 mmol / L↑, LDL cholesterol 3.89 mmol / L↑. Current symptoms: Heaviness in the body, fatigue, abdominal distension. Red tongue with thin white coating, thready and wiry pulse.

[0121] Treatment regimen: The modified formula of Example 2 (same as Example 12) was prepared into a powder according to the method of Example 9. One packet (2g) was taken orally three times a day for eight consecutive weeks.

[0122] Post-treatment examination (September 18, 2025):

[0123] detection indicators Before treatment After treatment Reference range change glucose 6.7 mmol / L ↑ 5.6 mmol / L 3.9-6.1 mmol / L Return to normal Total cholesterol 6.5 mmol / L ↑ 5.2 mmol / L 3.12-6.21 mmol / L Return to normal Low-density lipoprotein 3.89 mmol / L ↑ 3.15 mmol / L <3.37mmol / L Return to normal

[0124] Clinical Conclusion: After 8 weeks of medication, the patient's blood glucose, total cholesterol, and low-density lipoprotein all returned to normal ranges. Symptoms such as heaviness, fatigue, and abdominal distension significantly improved. No significant adverse reactions occurred during the treatment. This indicates that the herbal composition of this invention has a significant therapeutic effect on fatty liver of phlegm-dampness stagnation type complicated with glucose and lipid metabolism disorders.

[0125] Example 18: Treatment of hyperlipidemia of Qi and Blood Deficiency and Phlegm-Dampness Retention Type with Powder (Case: Mr. Yu)

[0126] Case source: Ms. Yu, female, 65 years old. First visit on June 7, 2025.

[0127] Diagnosis: Traditional Chinese Medicine (TCM) diagnosis: dizziness, accumulation-type disease, dampness obstruction disease; TCM syndrome: Qi and blood deficiency syndrome, phlegm-dampness retention syndrome. Western medicine diagnosis: dizziness, dyslipidemia, chronic fatigue syndrome.

[0128] Pre-treatment examination (May 22-23, 2025, Liangcheng Xincun Street Community Health Service Center, Hongkou District, Shanghai): Total cholesterol 6.50 mmol / L↑, LDL cholesterol 3.86 mmol / L↑, apolipoprotein B 55 mg / L↑, amyloid protein 12.77 mg / L↑. Carotid ultrasound showed: right carotid artery sclerosis with plaque formation, and left carotid artery intima roughness.

[0129] Current symptoms (June 7, 2025): Dizziness, neck and shoulder discomfort, occasional numbness in the right hand, loss of thirst, aversion to heat, difficulty falling asleep, light sleep with frequent awakenings, good appetite, normal bowel movements. Physical examination: Temperature 36.5℃, pulse 80 beats / min, respiration 16 breaths / min, blood pressure 133 / 82 mmHg, sallow complexion, dry, thin, small tongue with a thin white coating, thready and hesitant pulse, weak left Guan pulse.

[0130] Treatment plan: The modified formula of Example 2 (15g raw red yeast rice, 15g Gynostemma pentaphyllum, 20g hawthorn, 30g astragalus, 20g salvia miltiorrhiza, 9g corn silk, 21g prunella vulgaris, 20g prepared polygonatum sibiricum, 20g alisma plantago-aquatica, 40g coix seed, 12g prepared polygonum multiflorum, 14g polygonum cuspidatum, 12g cassia seed, 6g licorice, 15g poria cocos, 9g tangerine peel, 20g dioscorea opposita) was prepared into a powder according to the method of Example 9. One packet (2g) was taken orally three times a day for five consecutive weeks.

[0131] Post-treatment examination (July 12, 2025, Shanghai Dexin Hospital):

[0132] detection indicators Before treatment (May 23, 2025) Post-treatment (July 12, 2025) Reference range change Total cholesterol 6.50 mmol / L ↑ 5.40 mmol / L ↑ <5.20mmol / L Down 16.9% Low-density lipoprotein 3.86 mmol / L ↑ 3.27 mmol / L ↑ <3.37mmol / L Down 15.3% High-density lipoprotein — 1.72 mmol / L ↑ >1.04mmol / L normal albumin — 39.7g / L ↓ 40-53g / L Near normal

[0133] Clinical Conclusion: After 5 weeks of medication, the patient's total cholesterol decreased from 6.50 mmol / L to 5.40 mmol / L (a decrease of 16.9%), low-density lipoprotein decreased from 3.86 mmol / L to 3.27 mmol / L (a decrease of 15.3%, close to the normal range), while high-density lipoprotein remained at normal levels. Symptoms such as dizziness, neck and shoulder discomfort, and difficulty falling asleep significantly improved. No significant adverse reactions occurred during the treatment period. This indicates that the herbal composition of this invention has significant efficacy in treating hyperlipidemia and carotid artery sclerosis caused by qi and blood deficiency and phlegm-dampness retention.

[0134] Example 19

[0135] Prepared according to the method of Example 1, the difference being that in step five, the amount of compound enzyme added is 1.0% of the total weight of the raw materials, the enzymatic hydrolysis temperature is 48℃, and the enzymatic hydrolysis time is 2 hours. All other parameters are the same as in Example 1.

[0136] Example 20

[0137] Prepared according to the method of Example 1, except that in step six, the ultrasonic extraction conditions are: ultrasonic power 300W, frequency 30kHz, and extraction time 45 minutes. All other parameters are the same as in Example 1.

[0138] Example 21

[0139] Prepared according to the method of Example 1, except that in step eight, the decoction conditions are: add 8 times the amount of water and decoct for 50 minutes. The other parameters are the same as in Example 1.

[0140] Comparative Example 1

[0141] Weigh the raw materials according to the weight proportions of Example 1, and prepare them using the traditional water decoction method: mix the raw materials except for raw red yeast rice, soak them in water for 30 minutes, bring to a boil over high heat, then simmer over low heat for 40 minutes, and filter; add water to the dregs and decoct for another 30 minutes, and filter; combine the two filtrates, add the raw red yeast rice powder, mix well, and the decoction is obtained.

[0142] Experimental Example: Comparative Experiment of Extraction Processes

[0143] The same formulation of raw materials was extracted using the method of Example 1 (enzymatic hydrolysis + ultrasound) and the method of Comparative Example 1 (traditional water decoction), respectively. The extraction rates were compared using Monacolin K (the lipid-lowering active ingredient in raw red yeast rice) and total saponins of Gynostemma pentaphyllum as indicators.

[0144] Experimental methods: Each group was extracted in triplicate, and the average value was taken. Monacoline K was determined by HPLC, and total saponins from Gynostemma pentaphyllum were determined by UV spectrophotometry.

[0145] Experimental results:

[0146] Extraction method Monacoline K extraction rate (mg / g crude drug) Total saponin extraction rate of Gynostemma pentaphyllum (mg / g crude drug) Comparative Example 1 (Traditional Boiling) 0.52±0.06 8.35±0.72 Example 1 (Enzymatic hydrolysis + sonication) 0.89±0.08* 14.62±1.15*

[0147] Note: *P<0.05, compared with the traditional decoction method (t-test).

[0148] Experimental conclusion: Compared with traditional hot water decoction extraction, the method of combined enzymatic hydrolysis and ultrasonic extraction in this invention can significantly improve the extraction rate of monacolin K and total saponins of Gynostemma pentaphyllum (P<0.05), with extraction rates increasing by approximately 71% and 75%, respectively.

[0149] Clinical safety observation: No significant adverse reactions were observed in the clinical treatment of a total of 7 patients in Examples 12-18. Taking patient Qian in Example 15 as an example, the results of liver and kidney function tests before and after treatment are as follows:

[0150] detection indicators Before treatment (April 9, 2025) Post-treatment (2025-06-04) Reference range Alanine aminotransferase (ALT) Untested 18U / L 7-40U / L Aspartate aminotransferase (AST) Untested 64U / L 15-150U / L Creatinine (Cr) Untested 71 μmol / L 41-81 μmol / L Urea Untested 5.0 mmol / L 3.1-8.8 mmol / L Estimating glomerular filtration rate (eGFR) 77ml / min 75ml / min ≥90ml / min

[0151] Safety Conclusion: No liver or kidney damage or other significant adverse reactions were observed when the herbal composition of this invention was used at clinical therapeutic doses for 8-12 weeks. No abnormalities were found in blood routine tests, urine routine tests, electrocardiograms, or other examinations during the treatment period. This indicates that the herbal composition of this invention has good safety at therapeutic doses.

[0152] The embodiments of the present invention are given for the purposes of illustration and description. Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Any changes, modifications, substitutions and variations made by those skilled in the art to the above embodiments within the scope of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for invigorating the spleen and kidneys, promoting blood circulation, resolving phlegm, and lowering lipids, characterized in that, Made from the following parts by weight of active pharmaceutical ingredient: Raw red yeast rice 12-30 parts, Gynostemma pentaphyllum 9-20 parts, hawthorn 12-30 parts, Astragalus membranaceus 15-60 parts, Salvia miltiorrhiza 12-30 parts, corn silk 9-20 parts, Prunella vulgaris 12-30 parts, processed Polygonatum sibiricum 12-30 parts, Alisma plantago-aquatica 12-30 parts, Coix lacryma-jobi 20-60 parts, processed Polygonum multiflorum 12-30 parts, Polygonum cuspidatum 9-20 parts, Cassia tora 9-20 parts, Glycyrrhiza uralensis 3-9 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The active pharmaceutical ingredient also contains one or more of the following medicinal materials in parts by weight: Poria cocos 10-30 parts, dried tangerine peel 6-15 parts, and yam 15-30 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The active pharmaceutical ingredient is made from the following parts by weight: 15 parts raw red yeast rice, 15 parts gynostemma pentaphyllum, 20 parts hawthorn, 30 parts astragalus, 20 parts salvia miltiorrhiza, 9 parts corn silk, 21 parts prunella vulgaris, 20 parts processed polygonatum sibiricum, 20 parts alisma plantago-aquatica, 40 parts coix seed, 12 parts processed polygonum multiflorum, 14 parts polygonum cuspidatum, 12 parts cassia seed, 6 parts licorice, 15 parts poria cocos, 9 parts tangerine peel, and 20 parts dioscorea opposita.

4. A method for preparing a traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Includes the following steps: Step 1: Raw material pretreatment: Weigh out the remaining raw materials except for raw red yeast rice according to the weight proportions, remove impurities, soak and wash them in clean water at 25-35℃ for 10-20 minutes, and then drain the surface water. Step 2, Low-temperature drying: Place the cleaned raw materials in a constant temperature drying oven at 30-45℃ and dry for 6-12 hours until the moisture content drops below 8%; Step 3, Ultrafine Grinding: Mix the dried raw materials and grind them into ultrafine powder with a particle size of 10-50μm in an ultrafine grinder for later use; Step 4: Raw red yeast rice processing: Grind the raw red yeast rice separately and pass it through a 100-200 mesh sieve to obtain fine raw red yeast rice powder; Step 5, Compound Enzymatic Hydrolysis: Add the ultrafine powder obtained in Step 3 to water at 8-12 times its weight, adjust the pH to 4.5-6.0, add a compound enzyme accounting for 0.5%-1.5% of the total weight of the raw materials, and enzymatically hydrolyze at 40-55℃ for 1-3 hours. The compound enzyme is composed of cellulase, pectinase and xylanase in a mass ratio of 2:1:

1. Step 6, Ultrasonic Extraction: Place the enzymatically hydrolyzed liquid in an ultrasonic extraction device and extract for 30-60 minutes at an ultrasonic power of 200-400W and a frequency of 20-40kHz. Step 7, Centrifugation and Filtration: Centrifuge the ultrasonically extracted liquid at 3000-5000 r / min for 10-20 minutes, collect the supernatant, and keep the filter residue for later use; Step 8, Secondary Extraction: Add 6-10 times its weight of water to the filter residue obtained in Step 7, heat to 90-100℃ and boil for 40-60 minutes, filter, and combine the two extracts; Step 9, Mixing and Concentration: Combine the supernatant obtained in Step 7 with the extract obtained in Step 8, add the raw red yeast rice powder obtained in Step 4, stir evenly, and concentrate under reduced pressure at 60-80℃ to an extract with a relative density of 1.10-1.

25. Step 10, Formulation: Add pharmaceutically acceptable excipients to the extract obtained in Step 9 and formulate the desired dosage form according to any of the following methods: Decoction: Dilute the extract with water to a concentration of 0.5-2.0g of raw drug per milliliter, fill into sterile bags or glass bottles, seal, and the decoction is obtained; Granules: Mix the extract with fillers and binders to form a soft material, granulate it through a 10-30 mesh sieve, dry it at 50-70℃ until the moisture content is ≤5%, and then granulate it to obtain granules; Tablets: Mix the extract with fillers and disintegrants evenly, add binder to granulate, dry, granulate, add lubricant and mix evenly, compress into tablets to obtain tablets; Capsules: Mix the extract and filler evenly, dry, pulverize, pass through a 60-100 mesh sieve, and fill into hard capsule shells, or make soft capsule contents and then compress them into soft capsules to obtain capsules. Pills: The extract is mixed with excipients, and the mixture is granulated using the pan-coating or plasticizing method, dried, and the granules are selected to obtain pills. Powder: The extract is dried at low temperature, pulverized, passed through an 80-120 mesh sieve, and packaged in aluminum foil bags to obtain the powder; Oral liquid: Dilute the extract with water to the specified concentration, adjust the pH to 4.5-6.5, add flavoring agent and preservative, filter, fill into oral liquid bottles, seal, sterilize, and the oral liquid is obtained. Ointment: The extract is further concentrated to a relative density of 1.35-1.40, then refined honey or sucrose is added, the extract is collected, and then it is bottled to obtain the ointment.

5. The preparation method according to claim 4, characterized in that, In step five, the amount of compound enzyme added is 1.0% of the total weight of the raw materials, the enzymatic hydrolysis temperature is 48±2℃, and the enzymatic hydrolysis time is 2 hours.

6. The preparation method according to claim 4, characterized in that, In step six, the ultrasonic extraction conditions are: ultrasonic power 300W, frequency 30kHz, and extraction time 45 minutes.

7. The preparation method according to claim 4, characterized in that, In step eight, the decocting conditions are: add 8 times the amount of water and decoct for 50 minutes.

8. The preparation method according to claim 4, characterized in that, In step nine, the temperature for vacuum concentration is 70°C, and the relative density is 1.15-1.

20.

9. The preparation method according to claim 4, characterized in that, In step ten, the pharmaceutically acceptable excipients are selected from one or more of the following: fillers, binders, disintegrants, lubricants, flavoring agents, preservatives, and excipients.

10. The preparation method according to claim 4, characterized in that, It also includes step eleven: packaging and sterilizing the preparation obtained in step ten.

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