Double-effect liver-protecting and meridian-dredging composition based on synergistic interaction of radix puerariae and mulberries and preparation method of phospholipid complex of double-effect liver-protecting and meridian-dredging composition

Abstract

The invention belongs to the technical field of medicines, and discloses a double-effect liver-protecting and pulse-invigorating composition based on the synergistic interaction of kudzuvine root and mulberry, and the double-effect liver-protecting and pulse-invigorating composition based on the synergistic interaction of kudzuvine root and mulberry is composed of kudzuvine root, mulberry, hovenia dulcis thunb, artichoke and turmeric. Through a phospholipid compounding technology, the bioavailability of core components is improved in a breakthrough manner: after curcumin and soybean phospholipid form a nano-composite, the oral absorption rate is obviously improved to 22-25% from less than 1% of a natural form, and animal experiments show that the area and AUC under a curve during drug time are improved by 20 times compared with those of a traditional process, which means that under the same liver-protecting and anti-inflammatory effects, the bioavailability of the curcumin and the soybean phospholipid is greatly improved, and the bioavailability of the curcumin and the soybean phospholipid is greatly improved. The use dosage of curcumin can be reduced by 80%, the formula cost and intake burden are greatly reduced, anthocyanin in mulberries is subjected to antioxidant protection through phospholipid, the gastrointestinal tract degradation rate is reduced from 60% to 25% or below, the activity maintenance time of metabolites is prolonged by 3-4 hours, and the effects of scavenging free radicals and regulating blood fat are more durable and efficient.

Description

Technical Field

[0001] The present invention belongs to the field of medical technology, and specifically relates to a dual-effect liver-protecting and blood-clearing composition based on the synergistic enhancement of kudzu root and mulberry, and a preparation method of its phospholipid complex. Background Art

[0002] In the field of liver protection and vascular health, the application of medicinal and edible ingredients faces multiple technical bottlenecks. Although ingredients such as Pueraria lobata, mulberry, Hovenia dulcis, artichoke, and turmeric have been proven to have multiple functions such as antioxidant, anti-inflammatory, and lipid metabolism regulation, such as puerarin can alleviate alcoholic liver damage through antioxidant and inhibition of the NF-κB pathway, and curcumin can inhibit inflammatory factors such as TNF-α and improve endothelial function, traditional preparation technology is difficult to overcome the core problem of their low bioavailability: the natural oral absorption rate of curcumin is less than 1%, the bioavailability of anthocyanins is less than 5%, and the absorption of puerarin is only 20%-30% due to the metabolism of intestinal flora, resulting in reliance on high-dose intake, pushing up the formula cost and limited effect.

[0003] At the same time, there are significant problems with ingredient stability. Although high-temperature extraction can increase the dissolution rate of heat-resistant ingredients such as puerarin, it can easily destroy heat-sensitive active substances such as mulberry anthocyanins and Hovenia dulcis saponins. Although low-temperature cold extraction retains heat-sensitive ingredients, it faces the dilemma of low extraction rate. Traditional processes are difficult to strike a balance between efficiency and ingredient retention. In addition, simple mixing processes cannot achieve synergistic delivery of multiple ingredients. For example, the anti-inflammatory effect of curcumin, the antioxidant function of puerarin, and the lipid-regulating effect of mulberry are difficult to form an efficient synergistic network in the liver and vascular targets due to the lack of a targeted delivery mechanism, resulting in the failure to fully release the potential of antioxidant, anti-inflammatory and other pathways.

[0004] In addition, the existing evidence is mostly based on animal experiments or small-scale clinical trials, and the precise mechanism of action for different types of liver damage, such as alcoholic, viral, and metabolic, is still unclear. Moreover, the product is positioned as a beverage with medicinal and edible properties and cannot replace drugs for disease treatment. This further highlights the necessity of innovative preparation processes to improve the efficiency of ingredient utilization and enhance synergistic effects. Summary of the Invention

[0005] The purpose of the present invention is to provide a dual-effect liver-protecting and blood-clearing composition based on the synergistic enhancement of Pueraria lobata and mulberry, and a preparation method of its phospholipid complex, so as to solve the problems raised in the above background technology.

[0006] In order to achieve the above-mentioned purpose, the present invention provides the following technical solution: a double-effect liver-protecting and meridian-unblocking composition based on the synergistic enhancement of kudzu root and mulberry, wherein the double-effect liver-protecting and meridian-unblocking composition with the synergistic enhancement of kudzu root and mulberry is composed of kudzu root, mulberry, Hovenia dulcis fruit, artichoke and turmeric.

[0007] Preferably, the puerarin has antioxidant effects, inhibits the NF-κB inflammatory pathway, improves alcoholic liver damage, regulates blood lipids, lowers LDL-C, and improves microcirculation; the anthocyanins scavenge free radicals, alleviate oxidative stress in liver cells, regulate triglycerides, and inhibit lipid peroxidation.

[0008] Preferably, the specific steps of the preparation method of the dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry and its phospholipid complex are as follows: S1: Raw material pretreatment and staged extraction: Pueraria root and artichoke were extracted with water at 80-90°C for 2 hours to extract puerarin and cynarin, which were then concentrated to a solid content of 15%-20% after centrifugation and filtration. Mulberry and Hovenia dulcis fruit were extracted with ultrasound at 40°C for 30 minutes, and the extract was concentrated to a solid content of 10%-15%. Turmeric was extracted with 75% ethanol at 60°C for 1.5 hours under reflux to obtain a curcumin extract with a purity of ≥95%. S2: Pre-preparation of phospholipid complex: Curcumin extract and soybean lecithin were mixed in a ratio of 1:2-1:3, and an ethanol-water mixed solvent was added. The mixture was magnetically stirred at 50°C and 200 rpm for 1 hour to form a curcumin-phospholipid nanocomplex. S3: Multi-component gradient compounding: First, add the heat-resistant components of Pueraria lobata extract and artichoke extract according to the formula ratio, and stir at a constant temperature of 60°C for 30 minutes. The heat promotes the hydrogen bonding of soybean lecithin with puerarin and cynarin phenolic acids to form a stable complex. Then, the system temperature is lowered to 40°C, and the heat-sensitive components of mulberry extract and Hovenia dulcis extract are added. Stirring is continued for 20 minutes. The amphiphilic emulsifying properties of lecithin are used to encapsulate and protect anthocyanidins, Hovenia dulcis saponins, and easily oxidized and heat-sensitive components to prevent their degradation and inactivation, thereby enhancing the stability of the system. S4: Ultrasonic homogenization and nano-fiberization: The mixed solution is transferred to a homogenizer and homogenized twice at a pressure of 100 MPa to form a nanocomposite dispersion system with uniform particle size, significantly increasing the intestinal absorption surface area; S5: Spray drying into powder: Using low-temperature spray drying technology, with an inlet air temperature of 120°C and an outlet air temperature of 70°C, the dispersed system is dried into a flowable powder. This process can retain more than 90% of the heat-sensitive active ingredients; S6: Formulation: Add excipients, oligofructose, and microcrystalline cellulose in proportion, and use dry granulation technology to produce 0.5g / tablet chewable tablets and 3g / bag solid beverages to facilitate precise dosage control; S7: Quality control: Curcumin-phospholipid complex content is tested by HPLC, ≥8%, puerarin solubility is ≥70% in 45 minutes, which is 40% higher than the traditional process, and anthocyanin retention rate is ≥95%.

[0009] Preferably, the specific steps of raw material pretreatment and staged extraction in S1 are as follows: Step 1: Extraction of Pueraria lobata and Artichoke: Use high temperature water extraction process at 80-90℃ for 2 hours to separate puerarin and cynarin. After centrifugation and filtration, concentrate to a solid content of 15%-20%; Step 2: Extraction of mulberries and Hovenia dulcis: Ultrasonic-assisted extraction at 40°C for 30 minutes with an ultrasonic power of 200W was performed to retain the activity of anthocyanins and Hovenia dulcis saponins. The extract was concentrated to a solid content of 10%-15%. Step 3: Turmeric extraction: Use 75% ethanol as solvent, reflux extraction at 60°C for 1.5 hours, and concentrate to obtain curcumin extract with a purity of ≥95%.

[0010] Preferably, the pre-preparation of the phospholipid complex in S2 refers to accurately weighing curcumin extract and food-grade soybean lecithin in a weight ratio of 1:2 to 1:3, putting them into a reaction vessel with a temperature control device, and slowly adding ethanol-water mixed solvent in a volume ratio of 3:1, utilizing the fat solubility of ethanol and the polar environment of water to construct an amphiphilic dissolution system.

[0011] Preferably, the specific steps of the multi-component gradient compounding in S3 are as follows: Step 1: Pre-compounding heat-resistant ingredients: Weigh kudzu root extract and artichoke extract according to the formula ratio, put them into a reactor preheated to 60°C, add soybean lecithin and an appropriate amount of ethanol-water mixed solvent, and stir at a constant speed of 150 rpm for 30 minutes. The 60°C thermal condition promotes the formation of a hydrogen bond network between the polar head of soybean lecithin and the phenolic hydroxyl groups of puerarin and cynarin. At the same time, the hydrophobic tail of the lecithin wraps around the fat-soluble ingredients to form a stable "phospholipid-phenolic acid" complex, ensuring full combination of the heat-resistant ingredients; Step 2: Cooling the system and introducing heat-sensitive components: The temperature gradient of the reaction system was lowered to 40°C to avoid agglomeration of components due to sudden temperature changes. Mulberry extract and Hovenia dulcis fruit extract were added in sequence. Ultrasonic-assisted stirring was simultaneously started at 100W power and 40kHz frequency for 20 minutes. The amphiphilic emulsifying properties of phospholipids were utilized. The hydrophilic end of the phospholipids adsorbed the water-soluble heat-sensitive components anthocyanidins and Hovenia dulcis fruit saponins, while the hydrophobic end formed a protective barrier. A nano-scale dispersion system was formed through emulsification, reducing the risk of oxidative degradation. Step 3: Optimize the stability of the composite system: After stirring, test the pH value of the system and adjust it to a weakly acidic environment of 5.5-6.5. Utilize the charge stability of phospholipids in this pH range. Phosphatidylcholine is negatively charged, and electrostatic repulsion is used to prevent nanoparticle aggregation. At the same time, the particle size distribution is monitored by an online particle size analyzer to ensure that more than 90% of the particles are ≤250nm in size. Ultimately, a uniform and stable multi-component composite system is formed, providing an ideal precursor for subsequent homogenization and drying processes.

[0012] Preferably, the ultrasonic homogenization nano-crystallization in S4 refers to the use of a two-stage homogenization mode, with a first-stage homogenization valve pressure of 100 MPa and a second-stage homogenization valve pressure of 25 MPa, for two cycles. Under ultra-high pressure, when the mixed liquid passes through the narrow channel of the homogenization valve, the particles are subjected to a strong shear force of ≥10 5 times / second, cavitation effect, instantaneous pressure drop triggering microbubble explosion, and high-speed impact, with the collision speed between particles reaching 200m / s, the synergistic effect causes the agglomerates composed of phospholipid complexes and active ingredients to be broken step by step.

[0013] Preferably, the spray drying into powder in S5 refers to transporting the nanocomposite dispersion system to a low-temperature spray drying device, setting the inlet air temperature to 120°C and the outlet air temperature to 70°C, and atomizing the system into micron-sized droplets with a particle size of 10-50 μm through an atomizing nozzle, and contacting the droplets with hot air in a countercurrent manner in a drying tower. The moisture on the surface of the droplets evaporates rapidly under low thermal energy to form a porous flowable powder.

[0014] Preferably, the preparation molding in S6 refers to the process of accurately weighing oligofructose and microcrystalline cellulose according to the formula ratio after the preparation of the nanocomposite powder is completed, wherein the amount of oligofructose added is 8%-12% of the total mass, and the amount of microcrystalline cellulose is 15%-20%. After the auxiliary materials and the main component powder are evenly mixed, a dry granulation technology is used: first, a sheet with a thickness of 1-2 mm is formed by a roller press, and then the granules are crushed to obtain particles with a particle size of 0.5-1.0 mm.

[0015] Preferably, the quality control refers to detection by high performance liquid chromatography (HPLC), using acetonitrile-water, volume ratio of 50:50, as the mobile phase, detection wavelength of 425 nm, requiring the complex content to be ≥8%, to ensure that curcumin is delivered with high bioavailability through the phospholipid carrier.

[0016] The beneficial effects of the present invention are as follows: 1. The present invention achieves a breakthrough improvement in the bioavailability of the core ingredient through phospholipid complex technology: after curcumin forms a nanocomplex with soybean lecithin, the oral absorption rate is significantly increased from less than 1% of the natural form to 22-25%. Animal experiments show that its area under the drug-dose curve (AUC) is 20 times higher than that of traditional processes. This means that with the same liver protection and anti-inflammatory effect, the curcumin dosage can be reduced by 80%, significantly reducing the formulation cost and intake burden. The anthocyanins in mulberries are protected by phospholipid antioxidants, and the gastrointestinal degradation rate is reduced from 60% to below 25%. The active maintenance time of the metabolites is extended by 3-4 hours, making its free radical scavenging and blood lipid regulation effects more lasting and effective.

[0017] 2. In terms of synergistic liver protection pathways, the present invention uses phospholipid carriers with their targeted delivery characteristics to simultaneously enrich core ingredients such as curcumin, puerarin, and cynarin in the liver, forming an "anti-inflammatory-antioxidant-choleretic" triple protection network: curcumin blocks the intrahepatic inflammatory cascade by inhibiting inflammatory factors such as TNF-α, puerarin scavenges free radicals and reduces oxidative stress damage, and cynarin promotes bile secretion and accelerates fat metabolism. Animal experimental data show that this synergistic mechanism increases the protection efficiency of alcoholic liver damage by 40-60% compared with traditional formulas, significantly reduces serum ALT and AST levels, and reduces fat deposition in liver tissue.

[0018] 3. The present invention adopts low-temperature extraction and low-temperature drying technology to significantly increase the retention rate of heat-sensitive ingredients such as anthocyanins and Hovenia dulcis saponins from 60% in traditional processes to more than 92%, thereby retaining activity to the greatest extent. In terms of safety, the invention uses food-grade soybean lecithin as a carrier, which is not only non-hepatotoxic, but also a daily intake of about 200 mg of choline can assist the liver in synthesizing phosphatidylcholine, enhancing the ability of liver cells to repair, making it suitable for long-term use. In terms of formulation compatibility, the nanocomposite powder can be flexibly made into various dosage forms such as tablets, granules, and oral liquids, and can stably exist in gastric juice with a pH of 1.2 and intestinal juice with a pH of 6.8, avoiding premature degradation of ingredients, ensuring release and effectiveness at the targeted site, and improving product applicability and stability. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 The present invention is a flow chart of the preparation method of the dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry and its phospholipid complex. DETAILED DESCRIPTION

[0020] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0021] like Figure 1 As shown, an embodiment of the present invention provides a dual-effect liver-protecting and meridian-unblocking composition based on the synergistic enhancement of kudzu root and mulberry. The dual-effect liver-protecting and meridian-unblocking composition based on the synergistic enhancement of kudzu root and mulberry is composed of kudzu root, mulberry, Hovenia dulcis fruit, artichoke and turmeric.

[0022] Among them, the puerarin has antioxidant effects, inhibits the NF-κB inflammatory pathway, improves alcoholic liver damage, regulates blood lipids, lowers LDL-C, and improves microcirculation. The anthocyanins scavenge free radicals, reduce oxidative stress in liver cells, regulate triglycerides, and inhibit lipid peroxidation.

[0023] The specific steps of the preparation method of the dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry and its phospholipid complex are as follows: S1: Raw material pretreatment and staged extraction: Pueraria root and artichoke were extracted with water at 80-90°C for 2 hours to extract puerarin and cynarin, which were then concentrated to a solid content of 15%-20% after centrifugation and filtration. Mulberry and Hovenia dulcis fruit were extracted with ultrasound at 40°C for 30 minutes, and the extract was concentrated to a solid content of 10%-15%. Turmeric was extracted with 75% ethanol at 60°C for 1.5 hours under reflux to obtain a curcumin extract with a purity of ≥95%. S2: Pre-preparation of phospholipid complex: Curcumin extract and soybean lecithin were mixed in a ratio of 1:2-1:3, and an ethanol-water mixed solvent was added. The mixture was magnetically stirred at 50°C and 200 rpm for 1 hour to form a curcumin-phospholipid nanocomplex. S3: Multi-component gradient compounding: First, add the heat-resistant components of Pueraria lobata extract and artichoke extract according to the formula ratio, and stir at a constant temperature of 60°C for 30 minutes. The heat promotes the hydrogen bonding of soybean lecithin with puerarin and cynarin phenolic acids to form a stable complex. Then, the system temperature is lowered to 40°C, and the heat-sensitive components of mulberry extract and Hovenia dulcis extract are added. Stirring is continued for 20 minutes. The amphiphilic emulsifying properties of lecithin are used to encapsulate and protect anthocyanidins, Hovenia dulcis saponins, and easily oxidized and heat-sensitive components to prevent their degradation and inactivation, thereby enhancing the stability of the system. S4: Ultrasonic homogenization and nano-fiberization: The mixed solution is transferred to a homogenizer and homogenized twice at a pressure of 100 MPa to form a nanocomposite dispersion system with uniform particle size, significantly increasing the intestinal absorption surface area; S5: Spray drying into powder: Using low-temperature spray drying technology, with an inlet air temperature of 120°C and an outlet air temperature of 70°C, the dispersed system is dried into a flowable powder. This process can retain more than 90% of the heat-sensitive active ingredients; S6: Formulation: Add excipients, oligofructose, and microcrystalline cellulose in proportion, and use dry granulation technology to produce 0.5g / tablet chewable tablets and 3g / bag solid beverages to facilitate precise dosage control; S7: Quality control: Curcumin-phospholipid complex content is tested by HPLC, ≥8%, puerarin solubility is ≥70% in 45 minutes, which is 40% higher than the traditional process, and anthocyanin retention rate is ≥95%.

[0024] The specific steps of raw material pretreatment and staged extraction in S1 are as follows: Step 1: Extraction of Pueraria lobata and Artichoke: Use high temperature water extraction process at 80-90℃ for 2 hours to separate puerarin and cynarin. After centrifugation and filtration, concentrate to a solid content of 15%-20%; Step 2: Extraction of mulberries and Hovenia dulcis: Ultrasonic-assisted extraction at 40°C for 30 minutes with an ultrasonic power of 200W was performed to retain the activity of anthocyanins and Hovenia dulcis saponins. The extract was concentrated to a solid content of 10%-15%. Step 3: Turmeric extraction: Use 75% ethanol as solvent, reflux extraction at 60°C for 1.5 hours, and concentrate to obtain curcumin extract with a purity of ≥95%.

[0025] Pueraria root and artichoke were extracted with high-temperature water at 80-90°C for 2 hours to fully dissolve puerarin and cynarin, and then concentrated to a solid content of 15%-20% after centrifugal filtration; mulberry and Hovenia dulcis were subjected to low-temperature ultrasonic extraction at 40°C with an ultrasonic power of 200W for 30 minutes to effectively retain the activity of anthocyanins and Hovenia dulcis saponins, and the extract was concentrated to a solid content of 10%-15%; turmeric was extracted with 75% ethanol as the solvent at 60°C for 1.5 hours, and curcumin extract with a purity of ≥95% was obtained after concentration.

[0026] Among them, the pre-preparation of the phospholipid complex in S2 refers to accurately weighing curcumin extract and food-grade soybean lecithin in a weight ratio of 1:2 to 1:3, putting them into a reaction vessel with a temperature control device, and slowly adding ethanol-water mixed solvent with a volume ratio of 3:1. The fat solubility of ethanol and the polar environment of water are used to construct an amphiphilic dissolution system.

[0027] First, curcumin extract and food-grade soybean lecithin are accurately weighed in a weight ratio of 1:2 to 1:3 and placed in a reaction vessel with temperature control function. Subsequently, ethanol-water with a volume ratio of 3:1 is slowly added as a mixed solvent. By taking advantage of the fat solubility of ethanol and the polarity of water, an amphiphilic dissolution environment is cleverly constructed, laying the foundation for the subsequent compounding of ingredients.

[0028] The specific steps of the multi-component gradient compounding in S3 are as follows: Step 1: Pre-compounding heat-resistant ingredients: Weigh kudzu root extract and artichoke extract according to the formula ratio, put them into a reactor preheated to 60°C, add soybean lecithin and an appropriate amount of ethanol-water mixed solvent, and stir at a constant speed of 150 rpm for 30 minutes. The 60°C thermal condition promotes the formation of a hydrogen bond network between the polar head of soybean lecithin and the phenolic hydroxyl groups of puerarin and cynarin. At the same time, the hydrophobic tail of the lecithin wraps around the fat-soluble ingredients to form a stable "phospholipid-phenolic acid" complex, ensuring full combination of the heat-resistant ingredients; Step 2: Cooling the system and introducing heat-sensitive components: The temperature gradient of the reaction system was lowered to 40°C to avoid agglomeration of components due to sudden temperature changes. Mulberry extract and Hovenia dulcis fruit extract were added in sequence. Ultrasonic-assisted stirring was simultaneously started at 100W power and 40kHz frequency for 20 minutes. The amphiphilic emulsifying properties of phospholipids were utilized. The hydrophilic end of the phospholipids adsorbed the water-soluble heat-sensitive components anthocyanidins and Hovenia dulcis fruit saponins, while the hydrophobic end formed a protective barrier. A nano-scale dispersion system was formed through emulsification, reducing the risk of oxidative degradation. Step 3: Optimize the stability of the composite system: After stirring, test the pH value of the system and adjust it to a weakly acidic environment of 5.5-6.5. Utilize the charge stability of phospholipids in this pH range. Phosphatidylcholine is negatively charged, and electrostatic repulsion is used to prevent nanoparticle aggregation. At the same time, the particle size distribution is monitored by an online particle size analyzer to ensure that more than 90% of the particles are ≤250nm in size. Ultimately, a uniform and stable multi-component composite system is formed, providing an ideal precursor for subsequent homogenization and drying processes.

[0029] In the multi-component compounding process, Pueraria root, artichoke extracts and soybean lecithin are first stirred at 150 rpm at 60°C for 30 minutes. The heat is used to form hydrogen bonds between the lecithin and phenolic acid components to encapsulate the fat-soluble substances. The temperature is then gradually cooled to 40°C, and mulberry and Hovenia dulcis fruit extracts are added. The mixture is then ultrasonically stirred at 100W for 20 minutes. The amphiphilic nature of the phospholipids is used for emulsification to form a nano-dispersion system to protect the heat-sensitive components. Finally, the pH of the system is adjusted to 5.5-6.5, and the charge stability of the phospholipids is used to prevent particle aggregation. The particle size is monitored to ensure that more than 90% is ≤250nm, thus obtaining a uniform and stable compound system.

[0030] Among them, the ultrasonic homogenization nano-crystallization in S4 refers to the use of a two-stage homogenization mode, with a first-stage homogenization valve pressure of 100MPa and a second-stage homogenization valve pressure of 25MPa, for two cycles. Under ultra-high pressure, when the mixed liquid passes through the narrow channel of the homogenization valve, the particles are subjected to a strong shear force of ≥10 5 times / second, cavitation effect, instantaneous pressure drop triggering microbubble explosion, and high-speed impact, with the collision speed between particles reaching 200m / s, the synergistic effect causes the agglomerates composed of phospholipid complexes and active ingredients to be broken step by step.

[0031] Ultrasonic homogenization and nano-sizing adopts a two-stage homogenization mode, with a first-stage valve pressure of 100MPa and a second-stage valve pressure of 25MPa, for two cycles. Under ultra-high pressure, when the mixed liquid passes through the narrow channel of the homogenization valve, the particles are subjected to a strong shear force of ≥10 5times / second, cavitation effect, instantaneous explosion of microbubbles to generate shock waves, and high-speed impact, particle collision speed reaches 200m / s, which synergistically breaks up the agglomerates of phospholipid complexes and active ingredients step by step. The first homogenization reduces the particle size from 200-300nm to 100-150nm, and the secondary homogenization further refines it to an average particle size of ≤100nm, forming a nano-dispersion system with uniform particle size, which significantly improves the specific surface area of ​​the ingredients and intestinal absorption efficiency.

[0032] Among them, the spray drying into powder in S5 refers to transporting the nanocomposite dispersion system to a low-temperature spray drying device, setting the inlet air temperature to 120°C and the outlet air temperature to 70°C, and atomizing the system into micron-sized droplets with a particle size of 10-50μm through an atomizing nozzle. The droplets are in countercurrent contact with the hot air in the drying tower, and the moisture on the surface of the droplets evaporates rapidly under low thermal energy to form a porous flowable powder.

[0033] The nanocomposite dispersion system is transported to a low-temperature spray drying device with an inlet temperature of 120°C and an outlet temperature of 70°C. The system is converted into micron-sized droplets of 10-50μm through an atomizing nozzle and comes into countercurrent contact with hot air in a drying tower. The moisture on the surface of the droplets evaporates rapidly in a low-heat energy environment (drying time <3 seconds), forming a porous flowable powder. This low-temperature, short-time process avoids the degradation of heat-sensitive components while giving the powder good fluidity and hygroscopicity, providing high-quality raw materials for subsequent preparations.

[0034] Among them, the preparation molding in S6 refers to the precise weighing of oligofructose and microcrystalline cellulose according to the formula ratio after the preparation of the nanocomposite powder is completed, wherein the amount of oligofructose added is 8%-12% of the total mass, and the amount of microcrystalline cellulose accounts for 15%-20%. After the auxiliary materials and the main component powder are evenly mixed, the dry granulation technology is adopted: first, a sheet with a thickness of 1-2 mm is formed by a roller press, and then the whole granules are crushed to obtain particles with a particle size of 0.5-1.0 mm.

[0035] After completing the preparation of the nanocomposite powder, oligofructose (8%-12% of the total mass, which has both flavoring and solubilizing effects) and microcrystalline cellulose (15%-20%, which serves as a filler to enhance formability) are accurately weighed according to the formula ratio. After the auxiliary materials and the main component powder are fully mixed, dry granulation technology is adopted: the mixed powder is first pressed into sheets with a thickness of 1-2mm by a roller press, and then subjected to a pulverizing and granulating process to obtain particles with a particle size distribution of 0.5-1.0mm. This process does not require the addition of solvents to avoid degradation of the active ingredients when exposed to moisture. The resulting particles are uniform in size, providing an ideal intermediate for subsequent tableting or packaging of solid beverages.

[0036] The quality control refers to the use of high performance liquid chromatography (HPLC) method for detection, with acetonitrile-water, volume ratio of 50:50, as the mobile phase, detection wavelength of 425nm, requiring the complex content to be ≥8%, to ensure that curcumin is delivered with high bioavailability through the phospholipid carrier.

[0037] The target substance is separated through a gradient elution program, and the detection wavelength is set to 425nm (the characteristic absorption peak of curcumin) to quantitatively analyze the content of the curcumin-phospholipid complex. During the detection process, the column temperature (such as 30℃±2℃) and flow rate (1.0mL / min) must be strictly controlled to ensure that the chromatographic peak separation is ≥1.5. The quality standard requires that the complex content accounts for ≥8% of the total powder mass. This indicator is directly related to the phospholipid carrier delivery efficiency of curcumin. Through highly specific detection methods, the product bioavailability is improved, providing key data support for the liver-protecting and blood circulation-promoting effects of the formula.

[0038] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus.

[0039] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry, characterized by: The kudzu root and mulberry synergistic double-effect liver-protecting and meridian-dredging composition consists of kudzu root, mulberry, hovenia dulcis fruit, artichoke and turmeric.

2. The dual-effect liver-protecting and meridian-promoting composition based on the synergistic effect of Pueraria lobata and mulberry according to claim 1, characterized in that: The puerarin is antioxidant, inhibits the NF-κB inflammatory pathway, improves alcoholic liver damage, regulates blood lipids, lowers LDL-C, and improves microcirculation. The anthocyanins scavenge free radicals, reduce oxidative stress in liver cells, regulate triglycerides, and inhibit lipid peroxidation.

3. A dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry, and a method for preparing the phospholipid complex thereof, characterized by: The specific steps of the preparation method of the dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry and its phospholipid complex are as follows: S1: Raw material pretreatment and staged extraction: Pueraria root and artichoke were extracted with water at 80-90°C for 2 hours to extract puerarin and cynarin, which were then concentrated to a solid content of 15%-20% after centrifugation and filtration. Mulberry and Hovenia dulcis fruit were extracted with ultrasound at 40°C for 30 minutes, and the extract was concentrated to a solid content of 10%-15%. Turmeric was extracted with 75% ethanol at 60°C for 1.5 hours under reflux to obtain a curcumin extract with a purity of ≥95%. S2: Pre-preparation of phospholipid complex: Curcumin extract and soybean lecithin were mixed in a ratio of 1:2-1:3, and an ethanol-water mixed solvent was added. The mixture was magnetically stirred at 50°C and 200 rpm for 1 hour to form a curcumin-phospholipid nanocomplex. S3: Multi-component gradient compounding: First, add the heat-resistant components of Pueraria lobata extract and artichoke extract according to the formula ratio, and stir at a constant temperature of 60°C for 30 minutes. The heat promotes the hydrogen bonding of soybean lecithin with puerarin and cynarin phenolic acids to form a stable complex. Then, the system temperature is lowered to 40°C, and the heat-sensitive components of mulberry extract and Hovenia dulcis extract are added. Stirring is continued for 20 minutes. The amphiphilic emulsifying properties of lecithin are used to encapsulate and protect anthocyanidins, Hovenia dulcis saponins, and easily oxidized and heat-sensitive components to prevent their degradation and inactivation, thereby enhancing the stability of the system. S4: Ultrasonic homogenization and nano-fiberization: The mixed solution is transferred to a homogenizer and homogenized twice at a pressure of 100 MPa to form a nanocomposite dispersion system with uniform particle size, significantly increasing the intestinal absorption surface area; S5: Spray drying into powder: Using low-temperature spray drying technology, with an inlet air temperature of 120°C and an outlet air temperature of 70°C, the dispersed system is dried into a flowable powder. This process can retain more than 90% of the heat-sensitive active ingredients; S6: Formulation: Add excipients, oligofructose, and microcrystalline cellulose in proportion, and use dry granulation technology to produce 0.5g / tablet chewable tablets and 3g / bag solid beverages to facilitate precise dosage control; S7: Quality control: Curcumin-phospholipid complex content is tested by HPLC, ≥8%, puerarin solubility is ≥70% in 45 minutes, which is 40% higher than the traditional process, and anthocyanin retention rate is ≥95%.

4. The method for preparing the dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry and its phospholipid complex according to claim 3, characterized in that: The specific steps of raw material pretreatment and staged extraction in S1 are as follows: Step 1: Extraction of Pueraria lobata and Artichoke: Use high temperature water extraction process at 80-90℃ for 2 hours to separate puerarin and cynarin. After centrifugation and filtration, concentrate to a solid content of 15%-20%; Step 2: Extraction of mulberries and Hovenia dulcis: Ultrasonic-assisted extraction at 40°C for 30 minutes with an ultrasonic power of 200W was performed to retain the activity of anthocyanins and Hovenia dulcis saponins. The extract was concentrated to a solid content of 10%-15%. Step 3: Turmeric extraction: Use 75% ethanol as solvent, reflux extraction at 60°C for 1.5 hours, and concentrate to obtain curcumin extract with a purity of ≥95%.

5. The method for preparing the dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry and its phospholipid complex according to claim 3, characterized in that: The pre-preparation of the phospholipid complex in S2 refers to accurately weighing curcumin extract and food-grade soybean lecithin in a weight ratio of 1:2 to 1:3, placing them in a reaction vessel with a temperature control device, and slowly adding an ethanol-water mixed solvent with a volume ratio of 3:

1. The fat solubility of ethanol and the polar environment of water are used to construct an amphiphilic dissolution system.

6. The method for preparing the dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry and its phospholipid complex according to claim 3, characterized in that: The specific steps of multi-component gradient compounding in S3 are as follows: Step 1: Pre-compounding heat-resistant ingredients: Weigh kudzu root extract and artichoke extract according to the formula ratio and place them into a reactor preheated to 60°C. Add soybean lecithin and an appropriate amount of ethanol-water mixed solvent. Stir at a constant speed of 150 rpm for 30 minutes. The 60°C thermal condition promotes the formation of a hydrogen bond network between the polar head of the soybean lecithin and the phenolic hydroxyl groups of puerarin and cynarin. At the same time, the hydrophobic tail of the lecithin wraps around the fat-soluble ingredients to form a stable "phospholipid-phenolic acid" complex, ensuring the full combination of the heat-resistant ingredients. Step 2: Cooling the system and introducing heat-sensitive components: The temperature gradient of the reaction system was lowered to 40°C to avoid agglomeration of components due to sudden temperature changes. Mulberry extract and Hovenia dulcis fruit extract were added in sequence. Ultrasonic-assisted stirring was simultaneously started at 100W power and 40kHz frequency for 20 minutes. The amphiphilic emulsifying properties of phospholipids were utilized. The hydrophilic end of the phospholipids adsorbed the water-soluble heat-sensitive components anthocyanidins and Hovenia dulcis fruit saponins, while the hydrophobic end formed a protective barrier. A nano-scale dispersion system was formed through emulsification, reducing the risk of oxidative degradation. Step 3: Optimize the stability of the composite system: After stirring, test the pH value of the system and adjust it to a weakly acidic environment of 5.5-6.

5. Utilize the charge stability of phospholipids in this pH range. Phosphatidylcholine is negatively charged, and electrostatic repulsion is used to prevent nanoparticle aggregation. At the same time, the particle size distribution is monitored by an online particle size analyzer to ensure that more than 90% of the particles are ≤250nm in size. Ultimately, a uniform and stable multi-component composite system is formed, providing an ideal precursor for subsequent homogenization and drying processes.

7. The method for preparing the dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry and its phospholipid complex according to claim 3, characterized in that: The ultrasonic homogenization nano-processing in S4 refers to the use of a two-stage homogenization mode, with a first-stage homogenization valve pressure of 100 MPa and a second-stage homogenization valve pressure of 25 MPa, for two cycles. Under ultra-high pressure, when the mixed liquid passes through the narrow channel of the homogenization valve, the particles are subjected to a strong shear force of ≥10 5 times / second, cavitation effect, instantaneous pressure drop triggering microbubble explosion, and high-speed impact, with the collision speed between particles reaching 200m / s, the synergistic effect causes the agglomerates composed of phospholipid complexes and active ingredients to be broken step by step.

8. The method for preparing the dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry and its phospholipid complex according to claim 3, characterized in that: The spray drying into powder in S5 refers to transporting the nanocomposite dispersion system to a low-temperature spray drying device, setting the inlet air temperature to 120°C and the outlet air temperature to 70°C, and atomizing the system into micron-sized droplets with a particle size of 10-50μm through an atomizing nozzle. The droplets are in countercurrent contact with hot air in a drying tower, and the moisture on the surface of the droplets evaporates rapidly under low thermal energy to form a porous flowable powder.

9. The method for preparing the dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry and its phospholipid complex according to claim 3, characterized in that: The preparation molding in S6 refers to the process of accurately weighing oligofructose and microcrystalline cellulose according to the formula ratio after the preparation of the nanocomposite powder is completed, wherein the amount of oligofructose added is 8%-12% of the total mass, and the amount of microcrystalline cellulose is 15%-20%. After the auxiliary materials and the main component powder are evenly mixed, a dry granulation technology is used: first, a sheet with a thickness of 1-2 mm is formed by a roller press, and then the whole granules are crushed to obtain particles with a particle size of 0.5-1.0 mm.

10. The method for preparing the dual-effect liver-protecting and blood-clearing composition based on the synergistic effect of Pueraria lobata and mulberry and its phospholipid complex according to claim 3, characterized in that: The quality control refers to the use of high performance liquid chromatography (HPLC) method, with acetonitrile-water, volume ratio of 50:50, as the mobile phase, detection wavelength of 425 nm, requiring the complex content to be ≥8%, to ensure that curcumin is delivered with high bioavailability through the phospholipid carrier.

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