Preparation method of American ginseng and polygonatum kingianum freeze-dried flash-release tablet

Abstract

The invention discloses a preparation method of an American ginseng and rhizoma polygonati freeze-dried flash-release tablet, and relates to the technical field of traditional Chinese medicine processing. Extracting and concentrating to obtain a mixed extract; the preparation formula comprises the following steps: mixing the mixed extract and a composite freeze-drying protective additive in a homogenizer according to a mass ratio of 1: 0.8; freezing and drying; the preparation method comprises the following steps: performing freeze-drying on American ginseng, performing compound enzymolysis on rhizoma polygonati, performing freeze-drying on the American ginseng, quickly loading a flash release tablet into an aluminum-aluminum blister package in a low-temperature and low-humidity environment after freeze-drying is completed, and storing the packaged product in a shady, cool and dry place to avoid direct sunlight irradiation. The raw material treatment stage adopts a combined mode of ultra-low-temperature crushing of American ginseng, compound enzymolysis of rhizoma polygonati and ultrasonic extraction; according to the method, damage of high temperature and conventional processing to heat-sensitive active ingredients is avoided, nitrogen is introduced for protection in the extraction and concentration process, the active ingredients are further prevented from being oxidized, the extraction process is optimized through dynamic countercurrent extraction of American ginseng and stage heating extraction of rhizoma polygonati, and the retention rate of active ingredients such as American ginseng saponin and rhizoma polygonati polysaccharide is ensured.

Description

TECHNICAL FIELD

[0001] The application relates to the technical field of traditional Chinese medicine processing, in particular to a preparation method of a ginseng and rhizoma polygonati freeze-dried flash-release tablet. BACKGROUND

[0002] Both ginseng and rhizoma polygonati are traditional medicine and food homologous raw materials, have synergistic effects in immune regulation and anti-fatigue, and related processing products are concerned. At present, the processing of ginseng and rhizoma polygonati in the prior art mainly adopts traditional crushing and high-temperature extraction. However, high temperature and conventional crushing can easily damage the heat-sensitive active ingredients in the raw materials, such as ginsenosides and rhizoma polygonati polysaccharides, and thus reduce the drug efficacy. Meanwhile, the freeze-drying technology is mainly applied to single traditional Chinese medicine preparation. In the application of compound traditional Chinese medicine, it is difficult to balance the protection of active ingredients of the two raw materials and the stability of the preparation, and problems such as uneven distribution of components, easy moisture absorption of the product after freeze-drying, poor disintegration, and insufficient product stability and short shelf life are prone to occur, which cannot meet the needs of consumers for high efficiency, convenience and long-term preservation.

[0003] Therefore, in view of the problems of traditional processing damaging active ingredients and poor adaptability of compound freeze-drying in the prior art, a preparation method capable of effectively protecting active ingredients, adapting to compound traditional Chinese medicine and improving bioavailability and stability is urgently needed. SUMMARY

[0004] The purpose of the present application is to provide a high-calcium composite noodle containing wild amaranth powder and a preparation method thereof, aiming to solve the above-mentioned problems existing in the prior art.

[0005] To achieve the above-mentioned purpose, the technical scheme of the present application is a preparation method of a ginseng and rhizoma polygonati freeze-dried flash-release tablet, comprising the following steps: S1, raw material processing: Select ginseng, rinse with flowing purified water, ultrasonic-assisted cleaning for 15 minutes, then freeze at-45 DEG C for 2 hours, and then super-low temperature crushing to 300 mesh fineness at-50 DEG C; Select raw rhizoma polygonati, brush and remove the root hair and rough surface, cut into 3-5mm slices, and then treat for 2 hours by using composite enzymolysis technology, and then extract for 30 minutes by using 60kHz frequency ultrasonic extraction; S2, extraction and concentration: Mix the super-low temperature crushed ginseng powder with 70% ethanol according to a material-liquid ratio of 1:12, and extract for 3 times under the condition of 55 DEG C dynamic countercurrent extraction, 45 minutes each time, combine the extraction liquid, filter, and obtain ginseng extraction liquid; Mix the enzyme-treated and ultrasonic-treated rhizoma polygonati with distilled water according to a material-liquid ratio of 1:15, and extract by using the stage heating method, repeat 2 times, combine the extraction liquid, centrifuge, and obtain supernatant; The American ginseng extract and the rhizoma polygonati extract are concentrated by vacuum film at 60℃ and -0.08MPa, and the concentrated extract with a relative density of 1.10-1.15 is obtained, and nitrogen is introduced during the concentration process to prevent oxidation of the active ingredients, and then the American ginseng extract and the rhizoma polygonati extract are mixed at a mass ratio of 2:1 to obtain a mixed extract; S3, preparation formula: the mixed extract and the composite freeze-drying protective agent are mixed in a homogenizer at a mass ratio of 1:0.8, a natural flavoring agent is added to adjust the taste, the mixed liquid is homogenized by a high-pressure homogenizer at 50MPa for 3 times to ensure uniform distribution of the components and a particle size of less than 50μm, and a stable colloidal dispersion system is formed, and the homogenized liquid is placed at 4℃ for 2 hours to fully hydrate the material and eliminate bubbles; S4, freeze-drying: the aged liquid is injected into a specific mold at an injection amount of 0.5ml per piece and a thickness of 3mm, the mold is transferred to a freeze-drying machine, and a directional freeze-drying program is started, and the residual moisture of the final product is controlled to be between 3%-5% to ensure that the glass transition temperature of the product is higher than 40℃; S5, after the freeze-drying is completed, the flash-release tablets are quickly packaged in aluminum blister packaging in a low-temperature and low-humidity environment, and the packaged product is stored in a cool and dry place to avoid direct sunlight.

[0006] Preferably, in step S1, the American ginseng is selected according to the standard of four years old, a thick and disease-free root with a diameter of not less than 10mm, and the rhizoma polygonati is selected according to the standard of multi-year and large and fat, with a transparent cross-section without mold.

[0007] Preferably, in step S1, after the rhizoma polygonati is sliced, a composite enzyme hydrolysis technology of mixing cellulase and pectinase at a ratio of 1:1 is used to treat at pH4.5 and 45℃ for 2 hours.

[0008] Preferably, in step S2, the process of the stage heating method is to keep at 70℃ for 1 hour and then to keep at 90℃ for 30 minutes.

[0009] Preferably, in step S3, the composite freeze-drying protective agent includes the following raw materials with a mass ratio: trehalose 40%, β-cyclodextrin 30%, gelatin 20%, and mannitol 10%.

[0010] Preferably, in step S3, the natural flavoring agent includes licorice extract and stevioside, and the amount of the natural flavoring agent added is not more than 3% of the total solid.

[0011] Preferably, in step S4, the directional freeze-drying program includes: Pre-freezing stage: the temperature of the material solution is reduced from room temperature to-45℃ at a rate of 2℃ / min, and kept for 2 hours to ensure complete freezing, and the annealing process is introduced at an interval of-15℃ to-20℃, and kept for 30 minutes to promote the recrystallization of ice crystals and form a uniform ice crystal network; Primary drying: start the vacuum system to reduce the pressure in the freeze-drying chamber to 10 Pa, and then increase the temperature of the plate layer to-25℃ at a rate of 0.5℃ / min, and keep for 15 hours, and the drying endpoint is monitored by pressure rise test, and when the pressure change rate is less than 1 Pa / 10 min, it is judged that the primary drying is completed; Secondary drying: gradually increase the temperature of the plate layer to 30℃ at a rate of 0.3℃ / min, and keep for 6 hours to fully sublimate the bound water, and the vacuum degree is controlled at 5-8 Pa during this stage.

[0012] Preferably, in step S5, the conditions of the low-temperature and low-humidity environment are 20℃±2℃ and a relative humidity of less than 20%.

[0013] The beneficial effects of the present application are: 1、In the present application, the combination of ultralow-temperature pulverization of American ginseng, complex enzymatic hydrolysis of polygonatum and ultrasonic extraction is adopted in the raw material processing stage, which avoids the damage of high temperature and conventional processing to the heat-sensitive active ingredients, and nitrogen gas is introduced during the extraction and concentration process to further prevent the oxidation of active ingredients, thereby ensuring the retention rate of active ingredients such as American ginseng saponins and polygonatum polysaccharides.

[0014] 2、In the present application, the extraction process is optimized by dynamic countercurrent extraction of American ginseng and stage temperature increase extraction of polygonatum according to the characteristics of the compound traditional Chinese medicine, and the extract is mixed in a mass ratio of 2:1 to realize the synergistic effect of the two raw materials, and the specific ratio of the composite freeze-drying protective agent is adapted to the compound system to effectively maintain the stability of the active ingredients during freeze-drying.

[0015] 3、In the present application, a uniform ice crystal network is formed by a directional freeze-drying program and a stage annealing process, and the product residual moisture is controlled at 3%-5% by packaging in a low-temperature and low-humidity environment and aluminum-aluminum blister packaging, the glass transition temperature is higher than 40℃, and the accelerated stability test verifies that there is no obvious change in various quality indicators within 36 months, which greatly prolongs the shelf life.

[0016] 4、In the present application, a freeze-dried flash-release tablet form is adopted, a stable colloidal dispersion system is formed by high-pressure homogenization, the particle size is less than 50μm, the product can be quickly disintegrated and absorbed after taking, the bioavailability is improved, the natural flavoring agent is added to adjust the taste, the bitter taste of traditional preparations is avoided, and the tablet form is portable and easy to take, which is suitable for different people in different use scenarios. DETAILED DESCRIPTION

[0017] The present application will be further described below in conjunction with examples. EXAMPLE

[0018] Raw material processing stage The raw materials are four-year-old American ginseng and perennial polygonatum, which are sorted according to strict standards. The American ginseng is required to have a thick main root, no disease scars and insect holes, and a diameter of no less than 10 mm. The polygonatum is required to have a large and plump piece with a transparent cross section and no mildew. The American ginseng is first washed with flowing purified water to remove the surface soil, and then cleaned with ultrasonic wave for 15 minutes to thoroughly clean the surface grooves. The polygonatum needs to be brushed to remove the root hairs and the surface rough parts. The cleaned American ginseng is quickly frozen at -45°C for 2 hours to completely freeze the water in the cells, and then crushed to 300 mesh fineness at -50°C by using the ultra-low temperature crushing technology. This process can effectively destroy the cell wall structure, improve the saponin dissolution rate, and prevent the degradation of heat-sensitive components. The polygonatum is cut into 3 mm slices, and a composite enzymatic hydrolysis technology (cellulase and pectinase 1:1 mixed, pH 4.5, 45°C for 2 hours) is used to destroy the cell wall structure of the polygonatum, and then ultrasonic extraction is performed at a frequency of 60 kHz for 30 minutes to fully release the polysaccharides in the polygonatum.

[0019] Extraction and concentration stage American ginseng extraction: The ultra-low temperature crushed American ginseng powder is mixed with 70% ethanol at a ratio of 1:12, and dynamic countercurrent extraction is performed at 55°C for 3 times, 45 minutes each time. The combined extract is filtered to obtain the American ginseng extract. Studies have shown that the saponin extraction rate is highest under this condition, and degradation caused by high temperature is avoided. Polygonatum extraction: The enzyme-hydrolyzed and ultrasonically treated polygonatum is mixed with distilled water at a ratio of 1:15, and extraction is performed by using the stage heating method (70°C for 1 hour, then raised to 90°C for 30 minutes). The extraction is repeated twice. The combined extract is centrifuged to obtain the supernatant. The American ginseng extract and the polygonatum extract are concentrated by vacuum thin film concentration (60°C, -0.08 MPa) to a relative density of 1.10 (measured at 60°C) of the extract. Nitrogen is introduced during the concentration process to prevent oxidation of active ingredients. Then, the American ginseng extract and the polygonatum extract are mixed at a mass ratio of 2:1. This ratio has been experimentally verified to have the best synergistic effect on immune regulation and anti-fatigue.

[0020] Three, formulation stage The above-mentioned ginseng and rhizoma polygonati mixed extract and the composite freeze-drying protectant are mixed in a mass ratio of 1:0.8 in a homogenizer. The composition of the composite freeze-drying protectant is: trehalose 40%, beta-cyclodextrin 30%, gelatin 20%, and mannitol 10%. The formulation is optimized to effectively protect the active ingredients and form an ideal porous network structure. A suitable amount of natural flavoring agent licorice extract and steviol glycoside are added to adjust the taste, and the addition amount is not more than 3% of the total solids. The mixed material liquid is homogenized 3 times by a high-pressure homogenizer under the condition of 50 MPa to ensure uniform distribution of each component and particle size less than 50 μm, forming a stable colloidal dispersion system. The homogenized material liquid is placed at 4°C for 2 hours to fully hydrate the material and eliminate air bubbles.

[0021] IV. Freeze-drying stage The aged material liquid is injected into a specific mold, with an injection amount of 0.5 ml per piece and a thickness of about 3 mm. The mold is transferred to the freeze dryer and the directional freeze-drying program is started. Pre-freezing stage: the material liquid is cooled from room temperature to -45°C at a rate of 2°C / min, and kept for 2 hours to ensure complete freezing. The annealing process is introduced at -15°C and kept for 30 minutes to promote ice crystal recrystallization and form a uniform ice crystal network.

[0022] Primary drying: the vacuum system is started to reduce the pressure in the freeze-drying chamber to 10 Pa, and then the plate temperature is raised to -25°C at a rate of 0.5°C / min and kept for 15 hours. The drying endpoint is monitored by pressure rise test, and when the pressure change rate is less than 1 Pa / 10 min, the primary drying is considered complete.

[0023] Secondary drying: the plate temperature is gradually raised to 30°C at a rate of 0.3°C / min and kept for 6 hours to fully sublimate the bound water. The vacuum degree is controlled at 5 Pa in this stage. The final product has a residual moisture content of 3% to ensure that the glass transition temperature is higher than 40°C.

[0024] V. Packaging and storage stage After freeze-drying, the flash-release tablets are quickly packaged in aluminum blister packaging in a low-temperature and low-humidity environment (temperature 18°C, relative humidity <20%). The packaged product is stored in a cool and dry place to avoid direct sunlight. Accelerated stability testing (40°C±2°C, RH 75%±5%) shows that the product has no significant changes in quality indicators within 36 months. Example

[0025] Raw material processing stage The four-year-old American ginseng and perennial rhizoma polygonati are selected as raw materials and sorted according to strict standards. The American ginseng requires thick and strong main roots, no disease scars and insect holes, and a diameter of no less than 10 mm; the rhizoma polygonati requires large and fat pieces with transparent cross sections and no mildew. The American ginseng is first washed with flowing purified water to remove the surface soil, and then cleaned thoroughly with ultrasonic wave for 15 minutes to clean the surface grooves. The rhizoma polygonati needs to be brushed to remove the root hairs and the surface rough parts. The cleaned American ginseng is quickly frozen at-45℃ for 2 hours to completely freeze the water in the cells, and then crushed to 300 mesh fineness at-50℃ by using the ultra-low temperature crushing technology. This process can effectively destroy the cell wall structure, improve the saponin dissolution rate, and prevent the degradation of heat-sensitive components. The rhizoma polygonati is cut into 4 mm slices, and the cell wall structure is destroyed by using the composite enzymolysis technology (cellulase and pectinase mixed at 1:1, pH 4.5, treated at 45℃ for 2 hours), and then the polysaccharides are fully released by ultrasonic extraction at 60 kHz for 30 minutes.

[0026] Extraction and concentration stage American ginseng extraction: The ultra-low temperature crushed American ginseng powder is mixed with 70% ethanol at a ratio of 1:12, and dynamic countercurrent extraction is carried out at 55℃ for 3 times, each for 45 minutes. The extraction liquid is filtered to obtain the American ginseng extract. Studies have shown that the saponin extraction rate is the highest under this condition, and degradation caused by high temperature is avoided. Rhizoma polygonati extraction: The enzyme-treated and ultrasonically treated rhizoma polygonati is mixed with distilled water at a ratio of 1:15, and extraction is carried out by using the stage heating method (70℃ for 1 hour, then raised to 90℃ for 30 minutes). The extraction is repeated twice. The supernatant is obtained by centrifugation. The American ginseng extract and the rhizoma polygonati extract are concentrated by vacuum film concentration (60℃, -0.08 MPa) to a relative density of 1.12 (measured at 60℃) of extract. Nitrogen is introduced during the concentration process to prevent oxidation of active ingredients. Then, the American ginseng extract and the rhizoma polygonati extract are mixed at a mass ratio of 2:1. This ratio has been experimentally verified to have the best synergistic effect on immune regulation and anti-fatigue.

[0027] Three, formulation stage The above-mentioned mixed American ginseng and rhizoma polygonati extract is mixed with a composite freeze-drying protective agent at a mass ratio of 1:0.8 in a homogenizer. The composition of the composite freeze-drying protective agent is: trehalose 40%, β-cyclodextrin 30%, gelatin 20%, and mannitol 10%. This formula is optimally designed to effectively protect active ingredients and form an ideal porous network structure. An appropriate amount of natural flavoring agent, licorice extract, is added to adjust the taste, and the amount does not exceed 3% of the total solids. The mixed liquid is homogenized by a high-pressure homogenizer at 50 MPa for 3 times to ensure uniform distribution of each component and a particle size of less than 50 μm, forming a stable colloidal dispersion system. The homogenized liquid is aged (aged) at 4℃ for 2 hours to allow the material to fully hydrate and eliminate air bubbles.

[0028] IV. Freeze-drying stage The aged feed solution was injected into a specific mold, with each piece injected with 0.5 ml and a thickness of about 3 mm. The mold was transferred to the freeze dryer and the directional freeze-drying program was started: Pre-freezing stage: The feed solution was cooled from room temperature to -45°C at a rate of 2°C / min, and kept for 2 hours to ensure complete freezing. The annealing process was introduced at -18°C and kept for 30 minutes to promote ice crystal recrystallization and form a uniform ice crystal network.

[0029] Primary drying: The vacuum system was started to reduce the pressure in the freeze-drying chamber to 10 Pa, and then the plate temperature was raised to -25°C at a rate of 0.5°C / min and kept for 15 hours. The primary drying endpoint was monitored by the pressure rise test, and the primary drying was considered complete when the pressure change rate was less than 1 Pa / 10 min.

[0030] Secondary drying: The plate temperature was gradually raised to 30°C at a rate of 0.3°C / min and kept for 6 hours to fully sublimate the bound water. The vacuum degree was controlled at 7 Pa during this stage. The final product had a residual moisture content of 4%, ensuring a glass transition temperature higher than 40°C.

[0031] V. Packaging and storage stage After freeze-drying, the flash-release tablets were quickly packaged in aluminum blister packs in a low-temperature and low-humidity environment (temperature 20°C, relative humidity <20%), and the packaged products were stored in a cool and dry place to avoid direct sunlight. Accelerated stability testing (40°C±2°C, RH 75%±5%) showed that the product had no significant changes in quality indicators within 36 months. Example

[0032] Raw material processing stage Four-year-old American ginseng and perennial rhizoma polygonati were selected as raw materials and sorted according to strict standards. American ginseng was required to have a thick main root, no disease scars and insect holes, and a diameter not less than 10 mm; rhizoma polygonati was required to be large, plump, and have a transparent cross-section, with no mold. The American ginseng was first washed with flowing purified water to remove surface soil, and then cleaned thoroughly with ultrasonic assistance for 15 minutes. The rhizoma polygonati needed to be brushed to remove the root hairs and rough surface. The cleaned American ginseng was quickly frozen at -45°C for 2 hours to completely freeze the intracellular water, and then crushed to 300 mesh fineness at -50°C using ultra-low temperature crushing technology. This process effectively destroyed the cell wall structure, improved the saponin dissolution rate, and prevented the degradation of heat-sensitive components. The rhizoma polygonati was cut into 5 mm slices and treated with a composite enzymatic hydrolysis technique (cellulase and pectinase mixed at a ratio of 1:1, pH 4.5, 45°C for 2 hours) to destroy the cell wall structure, and then extracted under ultrasonic waves at a frequency of 60 kHz for 30 minutes to fully release the polysaccharides.

[0033] Extraction and concentration stage American ginseng extraction: The ultra-low temperature pulverized American ginseng powder was mixed with 70% ethanol at a solid-liquid ratio of 1:12, and dynamic countercurrent extraction was performed at 55°C for 3 times, each for 45 minutes. The extract was combined and filtered to obtain the American ginseng extract. Studies have shown that the saponin extraction rate is highest under this condition, and degradation caused by high temperature is avoided. Rhizoma polygonati extraction: The enzyme-processed and ultrasonically treated Rhizoma polygonati was mixed with distilled water at a solid-liquid ratio of 1:15, and extraction was performed using the staged temperature rise method (70°C for 1 hour, then raised to 90°C for 30 minutes). The extraction was repeated twice. The extract was combined and centrifuged to obtain the supernatant. The American ginseng extract and the Rhizoma polygonati extract were concentrated by vacuum thin film concentration (60°C, -0.08 MPa) to a relative density of 1.15 (measured at 60°C) of the extract. Nitrogen was introduced during the concentration process to prevent oxidation of active ingredients. Subsequently, the American ginseng extract and the Rhizoma polygonati extract were mixed at a mass ratio of 2:1. This ratio was experimentally verified to have the best synergistic effect on immune regulation and anti-fatigue.

[0034] Three, formulation stage The above-mentioned mixed extract of American ginseng and Rhizoma polygonati was mixed with a composite freeze-drying protective agent at a mass ratio of 1:0.8 in a homogenizer. The composition of the composite freeze-drying protective agent is: trehalose 40%, β-cyclodextrin 30%, gelatin 20%, and mannitol 10%. This formulation is optimally designed to effectively protect active ingredients and form an ideal porous network structure. An appropriate amount of natural flavoring agent steviol glycoside was added to adjust the taste, and the amount did not exceed 3% of the total solids. The mixed liquid was homogenized by a high-pressure homogenizer at 50 MPa for 3 times to ensure uniform distribution of the components and a particle size of less than 50 μm, forming a stable colloidal dispersion system. The homogenized liquid was allowed to stand (age) at 4°C for 2 hours to allow the material to fully hydrate and eliminate air bubbles.

[0035] Four, freeze-drying stage The aged liquid was injected into a specific mold, with an injection amount of 0.5 ml per piece and a thickness of about 3 mm. The mold was transferred to the freeze-drier and the directional freeze-drying program was started. Pre-freezing stage: The liquid was cooled from room temperature to -45°C at a rate of 2°C / min and kept for 2 hours to ensure complete freezing. The stage annealing process was introduced at -20°C and kept for 30 minutes to promote ice crystal recrystallization and form a uniform ice crystal network.

[0036] Primary drying: The vacuum system was started to reduce the pressure in the freeze-drying chamber to 10 Pa, and then the plate temperature was raised to -25°C at a rate of 0.5°C / min and kept for 15 hours. The pressure rise test was used to monitor the end of drying, and when the pressure change rate was less than 1 Pa / 10 min, the primary drying was considered complete.

[0037] Secondary drying: The temperature of the plate was gradually increased to 30℃ at a rate of 0.3℃ / min, and maintained for 6 hours to make the bound water sublimate sufficiently. The vacuum degree was controlled at 5-8 Pa in this stage. The residual moisture of the final product was controlled at 5%, and the glass transition temperature of the product was higher than 40℃.

[0038] V. Packaging and storage stage After the freeze-drying was completed, the flash-release tablets were quickly packed in aluminum blister packs in a low-temperature and low-humidity environment (temperature 22℃, relative humidity <20%), and the packed product was stored in a cool and dry place to avoid direct sunlight. The accelerated stability test (40℃±2℃, RH 75%±5%) proved that the product had no significant changes in various quality indicators within 36 months.

[0039] The above examples are only for illustrating the technical concept and characteristics of the present application, and the purpose is to enable those skilled in the art to understand the content of the present application and to implement it, and cannot limit the protection scope of the present application. Any equivalent changes or modifications made according to the spirit and essence of the present application shall be covered within the protection scope of the present application.

Claims

1. A method for preparing freeze-dried flash-release tablets of American ginseng and Polygonatum, characterized in that, Includes the following steps: S1. Raw material processing: American ginseng was selected, rinsed with running purified water, ultrasonically cleaned for 15 minutes, quick-frozen at -45℃ for 2 hours, and then pulverized at -50℃ to a fineness of 300 mesh. Select raw Polygonatum sibiricum, brush and wash to remove fibrous roots and rough parts of the surface, cut into 3-5 mm thin slices, process with compound enzymatic hydrolysis technology for 2 hours, and then extract by ultrasonic extraction at 60 kHz frequency for 30 minutes; S2. Extraction and Concentration: The ultra-low temperature pulverized American ginseng powder was mixed with 70% ethanol at a material-to-liquid ratio of 1:12 and extracted three times under dynamic countercurrent at 55℃ for 45 minutes each time. The extracts were combined, filtered, and American ginseng extract was obtained. The enzymatically hydrolyzed and ultrasonically treated Polygonatum odoratum was mixed with distilled water at a material-to-liquid ratio of 1:15, and extracted using a staged temperature increase method. The extraction was repeated twice, and the extracts were combined, centrifuged, and the supernatant was obtained. American ginseng extract and Polygonatum extract were concentrated separately through a vacuum membrane at 60°C and -0.08 MPa to obtain an extract with a relative density of 1.10-1.

15. Nitrogen gas was introduced during the concentration process to protect the active ingredients from oxidation. Then, the American ginseng extract and Polygonatum extract were mixed at a mass ratio of 2:1 to obtain a mixed extract. S3. Formulation: Mix the above-mentioned American ginseng and polygonatum mixed extract with the compound freeze-drying protectant in a mass ratio of 1:0.8 in a homogenizer. Add natural flavoring agents to adjust the taste. Homogenize the mixture three times under 50MPa using a high-pressure homogenizer to ensure that the components are evenly distributed and the particle size is less than 50μm, forming a stable colloidal dispersion system. After homogenization, let the mixture stand at 4℃ for 2 hours to allow the material to fully hydrate and eliminate air bubbles. S4. Freeze-drying: Inject the aged liquid into a specific mold, with an injection volume of 0.5ml and a thickness of 3mm per piece. Transfer the mold to the freeze dryer and start the directional freeze-drying process. The final product residual moisture is controlled between 3% and 5%, ensuring that the product glass transition temperature is higher than 40℃. S5. After freeze-drying, quickly pack the flash release tablets into aluminum blister packs under low temperature and low humidity conditions. Store the packaged products in a cool, dry place, away from direct sunlight.

2. The method for preparing freeze-dried flash-release tablets of American ginseng and Polygonatum sibiricum according to claim 1, characterized in that, In step S1, the selection criteria for American ginseng are four-year-old plants with thick, healthy main roots free from disease scars and insect infestation, and a diameter of not less than 10mm. The selection criteria for raw ginseng are plants that are several years old, large, plump, and with transparent cross-sections free from mold.

3. The method for preparing freeze-dried flash-release tablets of American ginseng and Polygonatum sibiricum according to claim 1, characterized in that, In step S1, after slicing raw Polygonatum sibiricum, it was treated for 2 hours at pH 4.5 and 45℃ using a compound enzymatic hydrolysis technique that mixes cellulase and pectinase in a 1:1 ratio.

4. The method for preparing freeze-dried flash-release tablets of American ginseng and Polygonatum sibiricum according to claim 1, characterized in that, In step S2, the staged heating method involves maintaining the temperature at 70°C for 1 hour, then raising it to 90°C and maintaining it for 30 minutes.

5. The method for preparing freeze-dried flash-release tablets of American ginseng and Polygonatum sibiricum according to claim 1, characterized in that, The composite freeze-drying protectant in step S3 comprises the following raw materials in the following mass ratio: trehalose 40%, β-cyclodextrin 30%, gelatin 20%, and mannitol 10%.

6. The method for preparing freeze-dried flash-release tablets of American ginseng and Polygonatum sibiricum according to claim 1, characterized in that, The natural flavoring agent mentioned in step S3 includes licorice extract and steviol glycosides, and the amount of the natural flavoring agent added does not exceed 3% of the total solids.

7. The method for preparing freeze-dried flash-release tablets of American ginseng and Polygonatum sibiricum according to claim 1, characterized in that, The directional freeze-drying process in step S4 includes: Pre-freezing stage: The liquid material is cooled from room temperature to -45°C at a cooling rate of 2°C / min and held for 2 hours to ensure complete freezing. Then, a staged annealing process is introduced in the range of -15°C to -20°C and held for 30 minutes to promote the recrystallization of ice crystals and form a uniform ice crystal network. First drying: Start the vacuum system to reduce the pressure in the freeze-drying chamber to 10 Pa, and then raise the temperature of the plate to -25 °C at a rate of 0.5 °C / min and maintain it for 15 hours. During this stage, the drying endpoint is monitored by pressure rise test. When the pressure change rate is less than 1 Pa / 10 min, the first drying is considered to be completed. Secondary drying: The temperature of the plate is gradually increased to 30℃ at a rate of 0.3℃ / min and maintained for 6 hours to allow the bound water to fully sublimate. During this stage, the vacuum degree is controlled at 5-8 Pa.

8. The method for preparing freeze-dried flash-release tablets of American ginseng and Polygonatum sibiricum according to claim 1, characterized in that, In step S5, the low temperature and low humidity environment conditions are: temperature 20℃±2℃ and relative humidity <20%.