Lucid ganoderma liver-protecting pill and preparation method thereof

Abstract

The invention discloses a ganoderma lucidum liver-protecting pill and a preparation method thereof, and the ganoderma lucidum liver-protecting pill comprises the following components: 8-20% of ganoderma lucidum polysaccharide extract, 5-15% of coptis chinensis extract, 4-10% of pulvis fellis saponin extract, 3-8% of oriental wormwood, 2-8% of taurine, 1-3% of vitamin E and 2-6% of scleroprotein (ganoderma lucidum sclerotium extract). The auxiliary materials comprise microcrystalline cellulose, corn starch, licorice extract, polyvinyl alcohol and the like, and the balance is 100%. Therefore, the problem of ingredient inactivation caused by traditional high-temperature / solvent extraction is solved through process innovation (such as supercritical CO2 pressure 300bar / enzymolysis pH 5.0 parameter optimization), the dissolution rate is increased to be more than or equal to 90% in 30 minutes (traditional pills need 45 minutes and only 75%), the limitation of single ingredient liver protection is broken through through the synergistic effect of the composite ingredients, and the liver protection effect is improved. Animal experiments prove that a liver injury marker ALT / AST can be reduced by more than 50%, the hepatic fibrosis area can be reduced by 40%, the degradation rate of the active ingredients within 6 months in a stability test is less than or equal to 5%, and the comprehensive bioavailability is improved by 30% compared with that of a traditional product.

Description

Technical Field

[0001] The present invention relates to the technical field of the preparation of Ganoderma lucidum liver-protecting pills, and particularly to a Ganoderma lucidum liver-protecting pill and a preparation method thereof. Background Art

[0002] Currently, liver-protecting pills and health products on the market usually use extracts of Chinese herbal medicines such as Ganoderma lucidum and Coptis chinensis, etc., and traditional methods such as solvent extraction and hot water extraction are used to extract active ingredients. With the progress of technology, some products have begun to use new technologies such as supercritical CO2 extraction and low-temperature ultrasonic extraction. These methods can better retain active ingredients and improve the efficacy of products;

[0003] However, there are still some problems in the existing technology. Traditional solvent and high-temperature extraction are prone to cause the degradation of some active ingredients, affecting the efficacy and stability of products. In addition, most of the existing formulations are single extraction methods, lacking systematic optimization, with low uniformity and bioavailability of ingredients, and failing to effectively solve the comprehensive problems of various liver diseases, resulting in unstable and limited product effects. Summary of the Invention

[0004] The present invention aims to solve at least one of the technical problems in the related art to some extent.

[0005] Therefore, the object of the present invention is to provide a Ganoderma lucidum liver-protecting pill and a preparation method thereof. By adopting advanced extraction technologies such as low-temperature ultrasonic extraction, supercritical CO2 extraction, and enzymatic hydrolysis, the active ingredients in the herbs are effectively retained, the efficacy and stability of the liver-protecting pill are improved, and various herbal ingredients are innovatively combined with modern biological preparations. By optimizing the extraction and preparation processes, the uniform distribution and bioavailability of the ingredients are ensured, effectively solving the problems of low extraction efficiency, ingredient loss, and unstable efficacy in the existing technology, and providing a more comprehensive and efficient liver-protecting effect.

[0006] To achieve the above object, the present invention provides a Ganoderma lucidum liver-protecting pill and a preparation method thereof, including extracts of the following ingredients:

[0007] Schisandra chinensis 100g, Taraxacum mongolicum 100g, Phaseolus radiatus 50g, Ganoderma lucidum 70g, Isatis indigotica 50g, Bupleurum chinense 70g, Artemisia capillaris 100g, Pig bile powder 50g, Coptis chinensis 100g, Arisaema cum Bile 70g;

[0008] The present invention relates to a Ganoderma lucidum liver-protecting pill and its preparation method. Directed extraction techniques are used according to the characteristics of different medicinal materials (for example, Ganoderma lucidum polysaccharide is extracted by low-temperature ultrasonic-assisted extraction to avoid destroying its molecular structure at high temperature, Coptis chinensis is extracted by supercritical CO2 extraction to avoid solvent residues and improve purity, and Artemisia capillaris is extracted by enzymatic hydrolysis to precisely release active ingredients). Combining freeze-drying technology (-70°C low-temperature concentration to retain thermosensitive substances) with three-roll pill-making machine technology (low-pressure high-temperature molding to reduce ingredient loss), efficient retention of active ingredients (polysaccharide / saponin retention rate ≥ 95% vs traditional method ≤ 80%) and uniform distribution (RSD ≤ 3%) are achieved. At the same time, Ganoderma lucidum polysaccharide and sclerotium protein (extracted by microbial fermentation) in the formula synergistically enhance the hepatocyte repair ability, taurine and vitamin E regulate lipid metabolism and neutralize free radicals, saponins in swine bile powder and Artemisia capillaris inhibit liver fibrosis and promote microcirculation, and are supplemented with licorice extract to enhance the detoxification function, forming a multi-target liver protection mechanism. This design solves the problem of ingredient inactivation caused by traditional high-temperature / solvent extraction through process innovation (such as optimizing the parameters of supercritical CO2 pressure of 300 bar / enzymatic hydrolysis pH 5.0), increasing the dissolution rate to ≥ 90% in 30 minutes (traditional pills require 45 minutes and only reach 75%), and breaking through the limitations of single-ingredient liver protection through the synergistic effect of composite ingredients (combining antioxidant, anti-fibrotic, and pro-regenerative effects in one). Verified by animal experiments, it can reduce liver injury markers ALT / AST by more than 50%, reduce the liver fibrosis area by 40%, the degradation rate of active ingredients in the stability test is ≤ 5% in 6 months, and the comprehensive bioavailability is increased by 30% compared with traditional products.

[0009] Specifically, the Ganoderma lucidum polysaccharide extract is obtained by low-temperature ultrasonic-assisted extraction technology. The extract is concentrated by rotary evaporation, and finally an extract with a complete Ganoderma lucidum polysaccharide molecular structure and high activity is obtained, which has significant antioxidant, immune-enhancing, and anti-liver fibrosis effects.

[0010] Specifically, the Coptis chinensis extract is obtained by supercritical CO2 extraction method, which can efficiently extract the main active ingredients of Coptis chinensis without loss of Coptis chinensis ingredients caused by traditional solvent extraction, and has the functions of enhancing liver repair, antioxidant, and regulating immunity.

[0011] Specifically, the swine bile powder saponin extract uses low-pressure ultrasonic extraction technology, avoiding the destruction of active ingredients by high temperature during the extraction process, and having the effects of anti-liver injury, promoting liver detoxification, and enhancing hepatocyte regeneration.

[0012] Specifically, Artemisia capillaris is extracted by enzymatic hydrolysis, which can more effectively release its flavonoid and phenolic acid active ingredients. Especially while retaining its functions of clearing heat and promoting diuresis, soothing the liver and reducing jaundice, it enhances the protective effect on hepatocytes and the improvement effect on liver microcirculation, thereby increasing its application value in anti-liver injury and anti-liver fibrosis.

[0013] A preparation method of Ganoderma lucidum liver protection pills, comprising the following steps:

[0014] S1. Crush Ganoderma lucidum, Coptis chinensis, pig bile powder and other herbs in proportion. Ganoderma lucidum is extracted by low-temperature ultrasonic assistance, Coptis chinensis is extracted by supercritical CO2 extraction method, pig bile powder saponins are extracted by low-pressure ultrasonic extraction, and enzymatic hydrolysis method is used to obtain extracts of each medicinal material;

[0015] S2. Mix the obtained extracts evenly with active ingredients such as taurine, vitamin E, and sclerotium protein, concentrate the solvent by rotary evaporation method and maintain the active ingredients by low-temperature freeze-drying technology;

[0016] S3. Mix the concentrated liquid after mixing evenly with the pretreated excipients to ensure that all components are evenly distributed;

[0017] S4. Use three-roll pill-making machine technology to make pills from the mixture, ensure that the active ingredients are not damaged during the pill forming process, and ensure the bioavailability of the pills;

[0018] S5. Conduct high-precision dissolution test, content uniformity test and quality inspection on the obtained liver protection pills, and conduct packaging after ensuring the stability of the drug effect and the quality of the pills.

[0019] Specifically, the pressure of the supercritical CO2 extraction method is 100 - 300 bar, the temperature is 30 - 60 °C, and the extraction time is 1 - 3 hours to ensure the efficient extraction of Coptis chinensis; the freezing temperature of the low-temperature freeze-drying technology is -50 °C to -80 °C to effectively maintain the active ingredients of the medicinal materials.

[0020] Specifically, the pill-making process uses a low-pressure and high-temperature three-roll pill-making machine to ensure the hardness, dissolution degree and uniform distribution of components of the pills, avoid component loss, and improve bioavailability.

[0021] Additional aspects and advantages of the present invention will be given in part in the following description, become apparent in part from the following description, or be understood through the practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The above and / or additional aspects and advantages of the present invention will become apparent and be easily understood from the following description of the embodiments in conjunction with the drawings, wherein:

[0023] Figure 1 It is the experimental data graph of Embodiment 1 of the present invention;

[0024] Figure 2 It is the experimental data graph of Embodiment 2 of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0025] Embodiments of the present invention will be described in detail below. Examples of the embodiments are shown in the accompanying drawings, where the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by referring to the accompanying drawings are exemplary and are intended to explain the present invention and should not be construed as limiting the present invention. On the contrary, the embodiments of the present invention include all variations, modifications, and equivalents falling within the spirit and scope of the appended claims.

[0026] The Ganoderma lucidum liver-protecting pill and its preparation method according to the embodiments of the present invention will be described below in conjunction with the accompanying drawings.

[0027] As Figure 1 - Figure 2 shown, the Ganoderma lucidum liver-protecting pill and its preparation method according to the embodiments of the present invention

[0028] include extracts of the following ingredients: Schisandra chinensis 100 g, Taraxacum mongolicum 100 g, mung bean 50 g, Ganoderma lucidum 70 g, Isatis indigotica 50 g, Bupleurum chinense 70 g, Artemisia capillaris 100 g, pig bile powder 50 g, Coptis chinensis 100 g, and Arisaema cum Bile 70 g.

[0029] It should be noted that the Ganoderma lucidum liver-protecting pill described in this embodiment uses a total of ten medicinal materials, namely Schisandra chinensis, Taraxacum mongolicum, mung bean, Ganoderma lucidum, Isatis indigotica, Bupleurum chinense, Artemisia capillaris, pig bile powder, Coptis chinensis, and Arisaema cum Bile. By scientifically combining and extracting their active ingredients, a liver-protecting action system with multiple targets and multiple mechanisms is formed. Among them, Ganoderma lucidum is rich in triterpenoids and polysaccharides, and has significant immunomodulatory and hepatocyte protection effects. Schisandra chinensis and Bupleurum chinense can jointly regulate the function of the liver and gallbladder in dispersing and discharging, and enhance the detoxification ability. Medicinal materials such as Coptis chinensis, Artemisia capillaris, and Isatis indigotica have the effects of clearing heat and detoxifying, anti-inflammatory, and antiviral. The combination of pig bile powder and Arisaema cum Bile can improve bile secretion and reduce damp-heat in the liver. The overall formula has comprehensive effects of clearing heat and detoxifying, protecting the liver and reducing enzyme levels, soothing the liver and regulating qi, and nourishing the liver. It provides an effective auxiliary intervention means for abnormal liver function, fatty liver, drug-induced liver injury, etc.

[0030] Excipients: microcrystalline cellulose, corn starch, licorice extract, polyvinyl alcohol, etc., with the remaining part up to 100%.

[0031] It should be noted that the reasonable use of excipients such as microcrystalline cellulose, corn starch, licorice extract, and polyvinyl alcohol described in this embodiment not only ensures the stability of the liver-protecting pill and good taste, but also improves the bioavailability of the ingredients. Microcrystalline cellulose, as a good filler, can effectively increase the hardness and dissolution rate of the pill, ensuring the release of drug efficacy. Corn starch and licorice extract, as auxiliary ingredients, can promote the absorption of drugs and synergistically enhance the liver-protecting effect, while polyvinyl alcohol helps to enhance the formability and stability of the pill, ensuring the uniform distribution of drug components during the preparation process.

[0032] Furthermore, as Figure 1 - Figure 2As shown, the Ganoderma lucidum polysaccharide extract is obtained by low-temperature ultrasonic-assisted extraction technology. The extract is concentrated by rotary evaporation, and finally an extract with a complete molecular structure and high activity of Ganoderma lucidum polysaccharide is obtained, which has significant antioxidant, immune-enhancing and anti-hepatic fibrosis effects.

[0033] It should be noted that the Ganoderma lucidum polysaccharide extract described in this embodiment is obtained by low-temperature ultrasonic-assisted extraction technology, effectively avoiding the problem of degradation of active ingredients that may be brought about by the traditional high-temperature extraction method, and ensuring the integrity and biological activity of the molecular structure of Ganoderma lucidum polysaccharide. Subsequently, the extract is concentrated by rotary evaporation technology, which can remove the solvent under low-temperature conditions, maximally retain the antioxidant and immune-enhancing effects of Ganoderma lucidum polysaccharide, and at the same time improve its effectiveness in liver repair. The combination of this extraction and concentration process not only improves the extraction efficiency of Ganoderma lucidum polysaccharide, but also ensures the significant effect of the final extract in the treatment of hepatic fibrosis and immune function enhancement.

[0034] Furthermore, as Figure 1 - Figure 2 shown, the Coptis chinensis extract is obtained by supercritical CO2 extraction method, which can efficiently extract the main active ingredients of Coptis chinensis and is not affected by the loss of Coptis chinensis components caused by traditional solvent extraction, and has the functions of enhancing liver repair, antioxidant and immune regulation.

[0035] It should be noted that the Coptis chinensis extract described in this embodiment is obtained by supercritical CO2 extraction method. This technology can efficiently extract the main active ingredients in Coptis chinensis at a relatively low temperature, avoiding the degradation of active ingredients that may be caused by traditional solvent extraction. Supercritical CO2 extraction has high selectivity, can effectively retain the natural activity of Coptis chinensis, and enhance its antioxidant, liver repair and immune regulation functions. Compared with traditional methods, this extraction method not only improves the extraction efficiency, but also ensures the high purity and biological activity of Coptis chinensis, further enhancing its effect in the liver protection pill.

[0036] Furthermore, as Figure 1 - Figure 2 shown, the extract of porcine bile powder saponins uses low-pressure ultrasonic extraction technology, which avoids the destruction of active ingredients by high temperature during the extraction process, and has the effects of anti-hepatic injury, promoting liver detoxification and enhancing hepatocyte regeneration.

[0037] It should be noted that the extract of porcine bile powder saponins described in this embodiment uses low-pressure ultrasonic extraction technology. This method extracts under relatively low temperature and pressure conditions, which can effectively avoid the destruction of active ingredients of porcine bile powder saponins by high temperature and retain its maximum pharmacological activity. The low-pressure ultrasonic extraction technology ensures the full release of the active ingredients of porcine bile powder saponins by improving the extraction efficiency, and at the same time enhances its functions of anti-hepatic injury and promoting liver detoxification. This extraction process also promotes hepatocyte regeneration, helps to enhance the self-repair ability of the liver, and makes its effect in the liver protection pill more significant and lasting.

[0038] Furthermore, as Figure 1 - Figure 2 shown, Artemisia capillaris Thunb. is extracted by enzymatic hydrolysis, which can better retain its active ingredients. In particular, the significant effect of saponins on inhibiting liver fibrosis can enhance liver microcirculation and improve the anti-injury ability of the liver.

[0039] It should be noted that in this embodiment, Artemisia capillaris Thunb. is extracted by enzymatic hydrolysis. This method can better release the active ingredients under mild conditions and avoid the possible degradation of active ingredients during high-temperature extraction. Enzymatic hydrolysis can efficiently retain saponins, especially its significant effect on inhibiting liver fibrosis and improving liver microcirculation, ensuring that its pharmacological activity is maximally exerted. Through this extraction process, Artemisia capillaris Thunb. can enhance the anti-injury ability of the liver, contribute to the self-repair of the liver, and significantly improve the therapeutic effect of Hugan Pills.

[0040] Furthermore, as Figure 1 - Figure 2 shown, Artemisia capillaris Thunb. is extracted by enzymatic hydrolysis, which can better retain its active ingredients. In particular, tauroursodeoxycholic acid is an ingredient extracted from natural marine organisms, which can maintain the balance of bile acid metabolism in the liver, regulate lipid metabolism, improve the symptoms of fatty liver, and enhance the detoxification function of the liver, promoting the recovery of fatty liver.

[0041] It should be noted that in this embodiment, tauroursodeoxycholic acid, as an ingredient extracted from natural marine organisms, ensures its high purity through precise extraction technology, effectively maintaining the balance of bile acid metabolism in the liver and helping to regulate lipid metabolism. The addition of tauroursodeoxycholic acid can significantly improve the symptoms of fatty liver. By promoting the metabolism and transformation of fatty acids, it reduces the accumulation of liver fat and improves liver function. This ingredient also has a significant detoxification effect, which can enhance the liver's ability to remove harmful substances and promote the recovery of fatty liver, providing strong support for the overall therapeutic effect of Hugan Pills.

[0042] Furthermore, as Figure 1 - Figure 2 shown, sclerotium protein is extracted by a special microbial fermentation technology, which has a high concentration of bioactive substances, can significantly improve the self-repair ability of the liver, and has a certain anti-hepatotoxic effect, which can further promote the regeneration of liver cells.

[0043] It should be noted that in this embodiment, sclerotium protein is extracted by a special microbial fermentation technology. By controlling the fermentation conditions, its bioactivity and concentration are improved to ensure the maximum release of active ingredients. Sclerotium protein is rich in various bioactive substances with repair functions, which can significantly improve the self-repair ability of the liver and promote the regeneration of damaged liver cells. Its anti-hepatotoxic effect helps to reduce the accumulation of liver toxins and further protects liver health by enhancing the liver's detoxification function, improving the overall therapeutic effect of Hugan Pills.

[0044] A preparation method of Ganoderma lucidum liver protection pills, comprising the following steps:

[0045] S1. Crush Ganoderma lucidum, Coptis chinensis, pig bile powder and other herbs in proportion. Ganoderma lucidum is extracted by low-temperature ultrasonic assistance, Coptis chinensis is extracted by supercritical CO2 extraction method, pig bile powder saponins are extracted by low-pressure ultrasonic extraction, and enzymatic hydrolysis method is used to obtain the extracts of each medicinal material;

[0046] S2. Mix the obtained extracts evenly with active ingredients such as taurine, vitamin E, and sclerotium protein, concentrate the solvent by rotary evaporation method and maintain the active ingredients by low-temperature freeze-drying technology;

[0047] S3. Mix the concentrated liquid after mixing evenly with the pretreated excipients to ensure that all components are evenly distributed;

[0048] S4. Use the three-roll pill-making machine technology to make pills from the mixture, ensure that the active ingredients are not damaged during the pill forming process, and ensure the bioavailability of the pills;

[0049] S5. Conduct high-precision dissolution test, content uniformity test and quality inspection on the obtained liver protection pills, and conduct packaging after ensuring the stability of the drug effect and the quality of the pills.

[0050] It should be noted that in this embodiment, by adopting advanced extraction technologies such as low-temperature ultrasonic assistance extraction, supercritical CO2 extraction, low-pressure ultrasonic extraction, and enzymatic hydrolysis method, the extraction efficiency of herbal components such as Ganoderma lucidum, Coptis chinensis, and pig bile powder can be effectively improved, and their active ingredients can be retained, avoiding the destruction of high temperature and chemical solvents. The solvent is concentrated by rotary evaporation method and combined with low-temperature freeze-drying technology to ensure the stability and activity of the effective components in the extract, and further improve the biological activity of active ingredients such as taurine, vitamin E and sclerotium protein. During the mixing process, high-precision homogenization technology is used to ensure that all components are evenly distributed in the excipients, ensuring the content and drug effect consistency of each pill; the three-roll pill-making machine technology can not only maintain the stability of the active ingredients in the pills, but also improve the dissolution rate and bioavailability of the pills, ensuring the rapid exertion of the drug effect. In addition, through strict quality control such as dissolution test and content uniformity test, the stability and efficacy of the final liver protection pills are ensured, providing high-quality liver protection health products for consumers.

[0051] Furthermore, as Figure 1 - Figure 2 shown, the pressure of the supercritical CO2 extraction method is 100 - 300 bar, the temperature is 30 - 60 °C, and the extraction time is 1 - 3 hours to ensure the efficient extraction of Coptis chinensis; the freezing temperature of the low-temperature freeze-drying technology is -50 °C to -80 °C, effectively maintaining the active ingredients of the medicinal materials.

[0052] It should be noted that the supercritical CO2 extraction method described in this embodiment can efficiently extract Coptis chinensis and its main active ingredients from Coptis chinensis by performing extraction under the conditions of a pressure of 100 - 300 bar and a temperature of 30 - 60 °C. This avoids the loss of components that may occur during traditional solvent extraction, while improving the extraction efficiency and purity. By precisely controlling the extraction time to 1 - 3 hours, the maximum extraction amount of Coptis chinensis can be ensured, further enhancing its efficacy in the liver - protecting pill. The low - temperature freeze - drying technology is carried out at a freezing temperature of - 50 °C to - 80 °C, which can effectively maintain the activity of heat - sensitive components in the medicinal materials and quickly remove moisture at low temperature, ensuring that the biological activity and stability of the extract are not affected after drying.

[0053] Furthermore, as Figure 1 - Figure 2 shown, the pill - making process uses a low - pressure and high - temperature three - roll pill - making machine to ensure the hardness, dissolution rate of the pills, and uniform distribution of components, avoiding component loss and improving bioavailability.

[0054] It should be noted that the pill - making process described in this embodiment uses a low - pressure and high - temperature three - roll pill - making machine. Through precise pressure and temperature control, this equipment can ensure the hardness and morphological stability of the pills under low - pressure conditions, and at the same time promote the uniform compaction of components through high - temperature settings, thus avoiding the possible loss of components during the pressing process. The double - shaft rotation design ensures the uniform distribution of raw materials during the pill - making process, effectively improving the dissolution rate of the pills, ensuring that the medicinal effect can be quickly released, and increasing bioavailability. In addition, by precisely controlling the operating parameters of the pill - making machine, the dissolution rate of the drug can be further enhanced, optimizing its biological effects, so that each liver - protecting pill has higher efficacy and stability during the digestion and absorption process.

[0055] Example 1:

[0056] Preparation and Performance Verification of Ganoderma lucidum Liver - Protecting Pills

[0057] 1. Raw Materials and Equipment

[0058] Active Ingredients:

[0059] Ganoderma lucidum polysaccharide extract (14%): Extracted by low - temperature ultrasonic assistance (equipment: KQ - 800KDE type ultrasonic extractor, frequency 40 kHz, temperature 25 °C, time 1.5 hours), and the polysaccharide purity ≥ 85% after concentration.

[0060] Coptis chinensis extract (10%): Extracted by supercritical CO2 (equipment: HA220 - 50 - 06 type, pressure 200 bar, temperature 45 °C, time 2 hours), and the yield ≥ 92%.

[0061] Saponin extract of pig bile powder (7%): Extracted by low-pressure ultrasonic wave (pressure 0.5 bar, temperature 40 °C, time 1 hour), saponin content ≥ 80%.

[0062] Artemisia capillaris (5.5%): Enzymatic hydrolysis method (ratio of cellulase to pectinase 1:1, enzymatic hydrolysis temperature 50 °C, pH 5.0, time 3 hours), saponin retention rate ≥ 95%.

[0063] Taurine (5%): Extracted from natural oysters (purity ≥ 99%).

[0064] Vitamin E (2%): Synthetic type (d l-α-tocopherol).

[0065] Sclerotial protein (4%): Fermented from Ganoderma lucidum sclerotia by Aspergillus niger (fermentation time 72 hours, temperature 28 °C), protein content ≥ 60%.

[0066] Excipients: Microcrystalline cellulose (30%), corn starch (15%), licorice extract (5%), polyvinyl alcohol (2.5%).

[0067] 2. Preparation steps

[0068] Extraction process:

[0069] Ganoderma polysaccharide: Ganoderma powder (100 mesh) is mixed with pure water at a ratio of 1:20, centrifuged after ultrasonic extraction (8000 rpm, 15 minutes), and the filtrate is concentrated by rotary evaporation (temperature 50 °C, vacuum degree -0.08 MPa).

[0070] Coptis chinensis: The extract is collected in the separation kettle after supercritical CO2 extraction, eluted with ethanol and then dried under reduced pressure.

[0071] Mixing and freeze-drying:

[0072] Each extract is mixed with taurine and vitamin E, pure water is added to form a suspension, and it is rotary evaporated to a solid content of 40%, and then freeze-dried at low temperature (-70 °C, 48 hours, vacuum degree 10 Pa).

[0073] Pill-making process:

[0074] The freeze-dried powder is mixed with excipients (V-type mixer, rotation speed 20 rpm, time 30 minutes), and pills are made using a three-roll pill-making machine (pressure 8 kN, temperature 40 °C) (each pill is 500 mg).

[0075] 3. Comparative experiment (as Figure 1 shown)

[0076] Retention rate of active ingredients (compared with traditional hot water extraction):

[0077] Dissolution test (USPI I method, pH 6.8 medium, rotation speed 50 rpm):

[0078] Example 1: dissolution rate ≥ 90% in 30 minutes; traditional pill: dissolution rate 75% in 45 minutes.

[0079] Animal experiment (CC l 4-induced mouse liver injury model):

[0080] In the Example 1 group, the ALT / AST level decreased by 50%, and the liver fibrosis area decreased by 40%, which was significantly better than that of the traditional liver protection pill (decrease of 30% / 25%).

[0081] Example 2:

[0082] Optimized preparation of high-activity Ganoderma lucidum liver protection pill

[0083] 1. Raw material and process adjustment

[0084] Optimization of the proportion of active ingredients:

[0085] Ganoderma lucidum polysaccharide (20%), Coptis chinensis (15%), swine bile powder saponin (10%), Artemisia capillaris (8%), taurine (8%), vitamin E (3%), sclerotium protein (6%).

[0086] Strengthening of the extraction process:

[0087] The pressure of supercritical CO2 extraction of Coptis chinensis was increased to 300 bar, and the time was 3 hours, and the yield was increased to 98%.

[0088] The enzymatic hydrolysis temperature was adjusted to 55 °C, and the enzymatic hydrolysis time was extended to 4 hours, and the purity of saponin was increased to 98%.

[0089] 2. Key parameter setting

[0090] Freeze-drying process: gradient cooling in the pre-freezing stage (-50 °C for 2 hours, then cooled to -80 °C), vacuum degree of 5 Pa in the sublimation drying stage, and the total freeze-drying time was shortened to 36 hours.

[0091] Pill-making parameters: low-pressure and high-temperature mode (pressure 6 kN, temperature 50 °C), pill hardness controlled at 50-60 N, disintegration time ≤ 15 minutes.

[0092] 3. Performance verification

[0093] Component uniformity (random sampling of 10 pills detected by HPLC method):

[0094] RSD (relative standard deviation) ≤ 3%, which is better than that of traditional pills (RSD ≥ 8%).

[0095] Accelerated stability test (40 °C / 75% RH, 6 months):

[0096] The degradation rate of active ingredients ≤ 5%, and the degradation rate of traditional pills ≥ 15%.

[0097] Preclinical efficacy (rat model of alcoholic liver injury):

[0098] In the liver steatosis score of the Example 2 group decreased by 60%, and the glutathione (GSH) level increased by 120%, which was significantly better than that of the commercially available competitor product (decreased by 40%, GSH increased by 80%).

[0099] Summary of Example comparison (as Figure 2 shown);

[0100] Description of innovation points:

[0101] High-efficiency retention of active ingredients is achieved through a composite extraction technology (ultrasonic + supercritical CO2 + enzymatic hydrolysis);

[0102] The licorice extract and sclerotium protein in the excipients synergistically enhance the detoxification function;

[0103] The biaxial pill-making process balances hardness and dissolution rate, and the bioavailability is increased by more than 30%.

[0104] In summary, targeted extraction technologies are adopted according to the characteristics of different medicinal materials (for example, Ganoderma lucidum polysaccharide is extracted by low-temperature ultrasonic wave assistance to avoid the destruction of its molecular structure at high temperature, Coptis chinensis is extracted by supercritical CO2 to avoid solvent residues and improve purity, and Artemisia capillaris is enzymatically hydrolyzed to accurately release active ingredients), combined with freeze-drying technology (-70°C low-temperature concentration to retain heat-sensitive substances) and three-roll pill-making machine technology (low-pressure high-temperature molding to reduce ingredient loss), to achieve high-efficiency retention (polysaccharide / saponin retention rate ≥ 95% vs traditional method ≤ 80%) and uniform distribution (RSD ≤ 3%) of active ingredients. At the same time, Ganoderma lucidum polysaccharide and sclerotium protein (extracted by microbial fermentation) in the formula synergistically enhance the hepatocyte repair ability, taurine and vitamin E regulate lipid metabolism and neutralize free radicals, the saponins of swine bile powder and Artemisia capillaris inhibit liver fibrosis and promote microcirculation, and the licorice extract is supplemented to enhance the detoxification function, forming a multi-target liver protection mechanism. This design solves the problem of ingredient inactivation caused by traditional high-temperature / solvent extraction through process innovation (such as optimizing the parameters of supercritical CO2 pressure of 300 bar / enzymatic hydrolysis pH 5.0), increases the dissolution rate to ≥ 90% in 30 minutes (traditional pills require 45 minutes and only reach 75%), and breaks through the limitations of single-ingredient liver protection through the synergistic effect of composite ingredients (combining antioxidant, anti-fibrotic, and pro-regenerative effects in one). Verified by animal experiments, it can reduce liver injury markers ALT / AST by more than 50%, reduce the liver fibrosis area by 40%, the degradation rate of active ingredients in the stability test is ≤ 5% in 6 months, and the comprehensive bioavailability is increased by 30% compared with traditional products.

[0105] Although the embodiments of the present invention have been shown and described above, it can be understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those of ordinary skill in the art can make changes, modifications, substitutions, and variations to the above embodiments within the scope of the present invention.

Claims

1. A Lingzhi liver-protecting pill, characterized in that: Includes the following ingredients: 100g Schisandra chinensis, 100g Taraxacum mung bean, 50g Ganoderma lucidum, 50g Isatis root, 70g Bupleurum, 100g Artemisia capillaris, 50g pig bile powder, 100g Coptis chinensis, 70g Arisaema consanguineum.

2. The Lingzhi Liver Protecting Pill according to claim 1, characterized in that: The ganoderma lucidum polysaccharide extract is obtained by low-temperature ultrasonic-assisted extraction technology, and the extract is concentrated by rotary evaporation to finally obtain an extract with intact ganoderma lucidum polysaccharide molecular structure and high activity, which has significant antioxidant, immune-enhancing and anti-liver fibrosis effects.

3. The Lingzhi Liver Protecting Pill according to claim 1, characterized in that: The coptis chinensis extract is obtained by supercritical CO2 extraction, which can efficiently extract the main active ingredients of coptis chinensis without suffering from the loss of coptis chinensis components caused by traditional solvent extraction. It has the functions of enhancing liver repair, anti-oxidation and immune regulation.

4. The Lingzhi Liver Protecting Pill according to claim 1, characterized in that: The pig bile powder saponin extract adopts low-pressure ultrasonic extraction technology, which avoids the destruction of effective ingredients by high temperature during the extraction process, and has the effects of resisting liver damage, promoting liver detoxification, and enhancing liver cell regeneration.

5. The Lingzhi Liver Protecting Pill according to claim 1, characterized in that: The enzymatic extraction of the Artemisia capillaris can more effectively release the flavonoids and phenolic acid active ingredients contained therein, especially while retaining its functions of clearing away heat and dampness, soothing the liver and relieving jaundice, it enhances the protective effect on liver cells and the improvement effect on liver microcirculation, thereby improving its application value in resisting liver damage and liver fibrosis.

6. A method for preparing Lingzhi liver-protecting pills, according to the Lingzhi liver-protecting pills according to any one of claims 1 to 7, characterized in that: The following steps are involved: S1. Ganoderma lucidum, Coptis chinensis, pig gall powder and other herbs are crushed in proportion, Ganoderma lucidum is extracted by low-temperature ultrasonic assisted extraction, Coptis chinensis is extracted by supercritical CO2 extraction, pig gall powder saponin is extracted by low-pressure ultrasonic extraction, and enzymatic hydrolysis is used to obtain extracts of each medicinal material; S2. The obtained extract is mixed evenly with active ingredients such as taurine, vitamin E, and sclerotin, and the solvent is concentrated by rotary evaporation and the active ingredients are retained by freeze-drying technology; S3. Mix the mixed concentrate with the pre-treated excipients to ensure that all ingredients are evenly distributed; S4. The mixture is pelletized using a three-roller pelletizing machine to ensure that the active ingredients are not damaged during the pill forming process and to ensure the bioavailability of the pills; S5. The obtained liver protection pills are subjected to high-precision dissolution test, content uniformity test and quality inspection to ensure the stability of the efficacy and the quality of the pills before packaging.

7. The preparation method according to claim 6, characterized in that: The supercritical CO2 extraction method has a pressure of 100-300 bar, a temperature of 30-60°C, and an extraction time of 1-3 hours, ensuring efficient extraction of Coptis chinensis; the low-temperature freeze-drying technology has a freezing temperature of -50°C to -80°C, effectively preserving the active ingredients of the medicinal material.

8. The preparation method according to claim 6, characterized in that: The pill making process adopts a low-pressure and high-temperature three-roller pill making machine to ensure the hardness, dissolution and uniform distribution of ingredients of the pills, avoid the loss of ingredients and improve the bioavailability.

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