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Abstract

This invention belongs to the field of traditional Chinese medicine and radiation protection technology. It discloses an active extract of Polygonatum sibiricum and its application in radiation protection preparations. The active extract of Polygonatum sibiricum is prepared by using authentic Polygonatum sibiricum as raw material, through pretreatment, ultrasonic-assisted extraction, column chromatography purification, concentration and drying. With Polygonatum sibiricum extract as the core active ingredient, it is compounded with cyclodextrin, stabilizer and solubilizer to prepare oral capsule radiation protection preparations. This invention is the first to apply the active extract of Polygonatum sibiricum to the field of radiation protection, filling the technological gap of natural Chinese medicine radiation protection. The product is natural, safe and has no side effects, can be used for a long time, has a mature process that can be mass-produced, has a lower cost than existing chemical radiation protection preparations, and has a stable protective effect. It is suitable for various scenarios such as nuclear industry, medical radiation, and daily radiation protection, and has extremely high innovative value and transformation prospects.

Description

Technical Field

[0001] This invention relates to the fields of traditional Chinese medicine extraction technology and radiation protection technology, and more specifically, to an active extract of Polygonatum odoratum and its application in radiation protection preparations. Background Technology

[0002] Currently, most commonly used radiation protection agents in clinical practice are chemically synthesized drugs. Although they have a certain protective effect, they generally have drawbacks such as high cost, significant toxic side effects, large gastrointestinal reactions, unsuitability for long-term oral administration, and limited applicable scenarios, making it difficult to meet the daily protection needs of the general population and the long-term radiation protection needs of special occupational groups.

[0003] Polygonatum is a traditional Chinese medicinal herb used in both food and medicine. It is rich in active ingredients such as Polygonatum polysaccharides and Polygonatum saponins, possessing antioxidant, immunomodulatory, organ-protective, and free radical scavenging effects, and shows significant potential in radiation damage protection. However, current technologies still have significant shortcomings: 1. Polygonatum is mostly a crude extract, with low content of effective ingredients, poor purity, and uneven activity; 2. Lack of efficient, green, and scalable refining and purification processes; 3. A stable integrated process for extraction, purification, inclusion, and formulation has not been established; 4. There are significant technological gaps in the standardization and industrialization of Polygonatum extract in the field of radiation protection; 5. Existing natural radiation protection products generally suffer from problems such as poor stability and low bioavailability.

[0004] Therefore, developing a Polygonatum odoratum active extract and radiation protection preparation that is readily available, uses green processes, has clearly defined activity, is safe and non-toxic, and can be taken for a long time has important practical significance and industrial application value. Summary of the Invention

[0005] In view of the shortcomings of the existing technology, the purpose of this invention is to provide an active extract of Polygonatum odoratum and its application in radiation protection preparations, so as to solve the problems of large side effects, low purity of Polygonatum odoratum extract, poor stability of preparations and low bioavailability of existing radiation protection products, and to achieve natural, efficient, safe and stable radiation protection.

[0006] To achieve the above objectives, the present invention provides the following technical solution: In a first aspect, the present invention provides a method for preparing an active extract of Polygonatum sibiricum, comprising the following steps: Step T1, Raw material pretreatment: Select Polygonatum, remove impurities, wash, slice and dry to obtain Polygonatum slices; Step T2, Ultrasonic-assisted extraction: The pretreated Polygonatum slices were subjected to ultrasonic-assisted extraction using deionized water as solvent, and the extract was collected. Step T3, Macroporous Resin Purification: Load the collected extract onto a macroporous resin column, first wash away impurities with deionized water until the eluent is colorless and transparent, then wash away the active part with ethanol solution and collect the eluent; Step T4, Concentration and Drying: Concentrate the collected eluent to obtain a concentrated solution; freeze-dry the concentrated solution to constant weight to obtain the active extract of Polygonatum odoratum.

[0007] As a further improvement to the preparation method, in step T1, the material is cut into thin slices with a thickness of 2-3 mm and dried at a temperature of 60°C.

[0008] As a further improvement to the preparation method, the specific process for collecting the extract in step T2 is as follows: The pretreated Polygonatum slices were added to deionized water at a material-to-liquid ratio of 1:15 g / ml. Ultrasonic-assisted extraction was carried out for 1.5 h at an ultrasonic frequency of 40 kHz and an extraction temperature of 50 ℃. The mixture was stirred every 20 min during the extraction process. After extraction, the mixture was centrifuged and filtered for 10 min at a speed of 3000 r / min, and the extract was collected.

[0009] As a further improvement to the preparation method, in step T3, the deionized water elution rate is 2 ml / min, the macroporous resin column is type D101, and the ethanol solution concentration is 50%.

[0010] As a further improvement to the preparation method, the specific process for obtaining the concentrated solution in step T4 is as follows: The collected eluent was concentrated to 1 / 5 of its original volume under reduced pressure at 60°C and 0.08 MPa to obtain the concentrate.

[0011] As a further improvement to the preparation method, in step T4, the specific process of freeze-drying the concentrated solution to constant weight to obtain the active extract of Polygonatum odoratum is as follows: The concentrate was freeze-dried to constant weight to obtain the active extract of Polygonatum odoratum.

[0012] Secondly, the present invention provides a method for preparing anti-radiation oral capsules of Polygonatum odoratum active extract, comprising the following steps: Step S1: Mix the active extract of Polygonatum sibiricum with cyclodextrin, add deionized water, freeze dry to obtain inclusion complex; Step S2: Add vitamin E and polyethylene glycol to the inclusion complex, mix well, and obtain the capsule contents; Step S3: Fill the empty capsule with the contents of the capsule, and after polishing and screening, obtain the radiation protection oral capsule.

[0013] As a further improvement to the preparation method, the specific process for obtaining the inclusion complex in step S1 is as follows: The active extract of Polygonatum sibiricum was mixed with cyclodextrin at a mass ratio of 1:3, deionized water was added, and the mixture was stirred at 200 r / min for 2 h at 60 °C. The mixture was then freeze-dried to obtain the inclusion complex.

[0014] As a further improvement to the preparation method, the specific process for obtaining the capsule contents in step S2 is as follows: Add 0.5% vitamin E and 2% polyethylene glycol by mass of the inclusion complex to the inclusion complex, mix well, and obtain the capsule contents.

[0015] Thirdly, an active extract of Polygonatum sibiricum and its application in radiation protection agents include the following steps: Step 1: Raw material pretreatment: Select Polygonatum, remove impurities, wash, slice and dry to obtain Polygonatum slices; Step 2, Ultrasonic-assisted extraction: The pretreated Polygonatum slices were subjected to ultrasonic-assisted extraction using deionized water as solvent, and the extract was collected. Step 3: Macroporous resin purification: Load the collected extract onto a macroporous resin column, first wash away impurities with deionized water until the eluent is colorless and transparent, then wash away the active part with ethanol solution and collect the eluent. Step 4, Concentration and Drying: Concentrate the collected eluent to obtain a concentrated solution; freeze-dry the concentrated solution to constant weight to obtain the active extract of Polygonatum odoratum; Step 5: Mix the active extract of Polygonatum sibiricum with cyclodextrin, add deionized water, and freeze-dry to obtain the inclusion complex; Step 6: Add vitamin E and polyethylene glycol to the inclusion complex, mix well, and obtain the capsule contents; Step 7: Fill the empty capsule with the contents of the capsule, and after polishing and screening, obtain the radiation protection oral capsule.

[0016] The advantages of this invention are: This invention uses Polygonatum sibiricum, a medicinal and edible plant, as its raw material. It contains no chemically toxic components, and animal experiments have confirmed its lack of hepatotoxicity and nephrotoxicity, making it suitable for long-term daily protection. Ultrasonic extraction offers high efficiency, macroporous resin purification is simple, it involves no strong acids or alkalis, has low energy consumption, and produces minimal waste. The content of active ingredients is clearly defined, and it exhibits significant antioxidant and radiation protection effects with good batch stability. Cyclodextrin inclusion enhances solubility and stability, reducing the loss of active ingredients. It possesses antioxidant, hematopoietic protection, hepatotoxic and nephrotoxic protection, and immunomodulatory functions, demonstrating outstanding protection against chronic low-dose radiation damage. This integrated radiation protection technology, encompassing Polygonatum sibiricum refining, extraction, inclusion, and formulation, has broad application prospects. Attached Figure Description

[0017] Figure 1 This is a flowchart illustrating the steps of a method for preparing an active extract of Polygonatum odoratum according to the present invention. Figure 2This is a flowchart illustrating the steps of preparing an anti-radiation oral capsule made from Polygonatum odoratum active extract according to the present invention. Figure 3 This is a flowchart illustrating the steps of an active extract of Polygonatum sibiricum and its application in radiation protection preparations according to the present invention. Detailed Implementation

[0018] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0019] Current traditional methods for preparing active extracts of Polygonatum sibiricum mostly employ conventional extraction methods such as water decoction and alcohol reflux. These methods involve long extraction times and high temperatures, which can easily damage heat-sensitive active ingredients, resulting in low extraction efficiency and significant loss of effective components. The extracts are only subjected to simple filtration or concentration, lacking efficient purification steps. As a result, the extracted extracts contain many impurities, have a dark color, low content of effective components, and are difficult to guarantee in terms of purity. The extracts also exhibit poor stability, are prone to moisture absorption and aggregation, and have poor dispersibility and low bioavailability during formulation. The processes are mostly intermittent operations, with cumbersome procedures, high energy consumption, and difficulty in industrial scale-up. Furthermore, the lack of an integrated system process encompassing extraction, purification, modification, and formulation makes it difficult to meet the stringent requirements for purity, activity, and stability of extracts in high-end applications such as radiation protection.

[0020] This invention addresses the shortcomings of existing processes for preparing active extracts of Polygonatum odoratum, such as low extraction efficiency, easy destruction of active ingredients, insufficient purification, poor product stability, poor dispersibility, and difficulty in industrial production. It systematically integrates and optimizes these processes by employing four key technologies: ultrasound-assisted enhanced extraction, precise purification with D101 macroporous resin, vacuum-sealed low-temperature concentration, and cyclodextrin inclusion stabilization. This constructs a highly efficient, green, stable, and scalable preparation system from raw materials to finished products, significantly improving the extraction rate and purity of active ingredients such as Polygonatum odoratum polysaccharides and Polygonatum odoratum saponins, and enhancing the stability and dispersibility of the extracts, thus providing a high-quality raw material guarantee for radiation protection preparations.

[0021] This invention uses deionized water as a green solvent and performs ultrasound-assisted extraction at a mild temperature. The ultrasonic cavitation effect breaks down cell walls, shortening extraction time, reducing energy consumption, and avoiding degradation of active ingredients caused by prolonged high-temperature processing. This significantly improves the dissolution efficiency of Polygonatum polysaccharides and Polygonatum saponins, achieving efficient, mild, and low-cost extraction. The extract is then adsorbed and separated using D101 macroporous resin. Impurities such as inorganic salts, pigments, and starch are first washed away with water, followed by targeted elution of the effective components with ethanol solution. This achieves efficient separation of active ingredients and impurities, significantly improving the purity of the extract and ensuring stable quality and controllable efficacy in subsequent formulations. The eluent is concentrated under reduced pressure at low temperature, lowering the concentration temperature and shortening the heating time to maximize the preservation of the structure and efficacy of the active ingredients. Subsequent processing... Freeze-drying yields a loose, powdered extract, avoiding component damage caused by high-temperature drying. This process ensures the extract has good flowability, is less hygroscopic, and facilitates formulation processing. The active extract of Polygonatum sibiricum is encapsulated with cyclodextrin to form a stable inclusion complex structure, effectively masking odors, improving solubility, and enhancing antioxidant stability. Simultaneously, it improves the uniformity of the extract's dispersion in formulations, reduces agglomeration, and increases oral bioavailability, resulting in a more stable and significant radiation protection effect. The pretreatment-ultrasonic extraction-resin purification-low-temperature concentration and drying-encapsulation formulation process is continuous, without the use of hazardous reagents such as strong acids and alkalis. It features low energy consumption, minimal waste, stable process parameters, and good reproducibility, making it directly suitable for industrial-scale production and meeting the industrialization needs of radiation protection formulations.

[0022] Example 1 like Figure 1 As shown, the present invention provides a method for preparing an active extract of Polygonatum sibiricum, comprising the following steps: Step T1, raw material pretreatment: Select Polygonatum rhizome, remove impurities, clean it, cut it into thin slices with a thickness of 2-3 mm, and dry it at 60℃ until constant weight; Step T2, Ultrasonic-assisted extraction: Add the pretreated Polygonatum slices to deionized water at a material-to-liquid ratio of 1:15 g / ml, and perform ultrasonic-assisted extraction for 1.5 h at an ultrasonic frequency of 40 kHz and an extraction temperature of 50 ℃. Stir once every 20 min during the extraction process. After extraction, centrifuge and filter at 3000 r / min for 10 min and collect the extract. Step T3, column chromatography purification: Load the collected extract onto a D101 macroporous resin column with a column diameter to column height ratio of 1:8. First, elute the impurities with deionized water at a flow rate of 2 ml / min until the eluent is colorless and transparent. Then, elute with 50% ethanol at a flow rate of 2 ml / min and collect the eluent. Step T4, Concentration and Drying: The collected eluent is concentrated to 1 / 5 of its original volume under reduced pressure at 60°C and 0.08 MPa to obtain a concentrated solution; the concentrated solution is freeze-dried to constant weight to obtain the Polygonatum active extract.

[0023] Example 2 Based on Example 1, the present invention provides a method for preparing an active extract of Polygonatum sibiricum, which specifically includes: Manually select the raw materials to remove surface dirt, weeds, damaged parts, and other impurities to ensure purity. Rinse the selected Polygonatum sibiricum under running deionized water 3-5 times until the surface is free of dirt and stains, then blot dry with filter paper. Place the washed Polygonatum sibiricum into a slicer and cut it into thin slices of uniform thickness, strictly controlling the slice thickness to 2-3mm (error ≤ 0.2mm). Avoid slices that are too thick, which may lead to insufficient extraction, or slices that are too thin, which may cause breakage during drying. Spread the sliced ​​Polygonatum sibiricum flat on a drying tray and place it in a forced-air drying oven. Set the drying temperature to 60℃ and maintain constant temperature drying. Take a sample and weigh it every 1 hour until the difference between two weighings is ≤ 0.002g, which indicates constant weight. Remove the dried Polygonatum sibiricum slices and place them in a desiccator to cool to room temperature for later use. Weigh 100g of pretreated Polygonatum slices cooled to room temperature using an electronic balance. Place the weighed slices in a 500ml beaker and add 1500ml of deionized water at a ratio of 1:15g / ml (i.e., the mass of Polygonatum slices to the volume of deionized water). Stir thoroughly with a stirring rod to ensure the slices are fully immersed in the deionized water. Place the beaker in an ultrasonic extractor, set the ultrasonic frequency to 40kHz and the extraction temperature to 50℃ (temperature control accuracy ±1℃), and start the ultrasonic extraction program for 1.5 hours. During the extraction process, stir every 20 minutes. Stir once with a stirring rod for 30 seconds each time to ensure that the Polygonatum slices are in full contact with the extraction solvent and promote the dissolution of active ingredients. After extraction, transfer the extraction mixture to a centrifuge tube and place it in a high-speed centrifuge. Set the speed to 3000 r / min and centrifuge and filter for 10 minutes. Collect the clear upper layer of extract and discard the lower layer of precipitate (Polygonatum residue). Place the extract in a clean beaker for later use. The residue can be extracted a second time (repeat this step) to improve the utilization rate of raw materials. In this example, a single extraction is used. If it is necessary to increase the extraction rate, the number of extractions can be increased. Pretreated D101 macroporous resin was packed into a chromatography column, ensuring uniform packing and no air bubbles. The column height was controlled at 16 cm (forming a 1:8 column diameter-to-height ratio with a 2 cm column diameter). The resin column was rinsed with deionized water until the eluent was colorless and transparent, and the column was equilibrated for 30 min. The collected extract was slowly loaded onto the resin column using a constant flow pump at a flow rate of 1 ml / min to ensure that the active ingredients in the extract were fully adsorbed onto the resin. After loading, deionized water was used as the eluent, and elution was performed using a constant flow pump at a flow rate of 2 ml / min. During the elution process using a resin column, continuously observe the color of the eluent until it becomes colorless and transparent. Stop water elution at this point; this process primarily removes water-soluble impurities (such as starch and inorganic salts) from the extract. After water elution, switch to 50% ethanol as the eluent and continue eluting the resin column at a flow rate of 2 ml / min. Collect the eluent until no obvious active ingredients are found (this can be detected using the phenol-sulfuric acid method; if no obvious color development occurs after adding phenol-sulfuric acid reagent, stop collecting). Combine the collected ethanol eluents and place them in a clean flask for later use. The collected eluent was transferred to a flask in a vacuum concentrator. The concentration temperature was set to 60℃ and the vacuum degree to 0.08MPa. The vacuum concentration program was started and the concentration was continued. The volume of the concentrate was observed every 30 minutes until the volume of the concentrate reached 1 / 5 of the original eluent volume. The concentration was then stopped, and a viscous concentrate was obtained. The concentrate was transferred to the freeze-drying tray of a freeze dryer and spread evenly (thickness ≤ 5mm). The freeze-drying parameters were set as follows: pre-freezing temperature -40℃ and pre-freezing time 2h. Then, the vacuum freeze-drying program was started and the product was freeze-dried to constant weight (the difference between two weighings ≤ 0.002g). The freeze-dried product was then taken out, which is the active extract of Polygonatum sibiricum. Example 3 like Figure 2 As shown, based on the active extracts of Polygonatum sibiricum extracted in Examples 1 and 2, this invention provides a method for preparing anti-radiation oral capsules of Polygonatum sibiricum active extract, comprising the following steps: Step S1: Mix the active extract of Polygonatum sibiricum with cyclodextrin at a mass ratio of 1:3, add deionized water, stir at 200 r / min for 2 h at 60℃ for inclusion, freeze dry to obtain inclusion complex; Step S2: Add 0.5% (by mass) of vitamin E and 2% (by mass) of polyethylene glycol to the inclusion complex, mix well, and obtain the capsule contents; Step S3: Fill the empty capsule with the contents of the capsule, and after polishing and screening, obtain the radiation protection oral capsule.

[0024] Example 4 Based on Example 3, the present invention provides a method for preparing anti-radiation oral capsules of Polygonatum odoratum active extract, which further includes: Material weighing: Accurately weigh 100g of Polygonatum active extract and 300g of β-cyclodextrin on an electronic balance, ensuring that the mass ratio is strictly 1:3. After weighing, place the two materials separately in dry beakers for later use. Mixing and dissolving: Place the weighed Polygonatum active extract and β-cyclodextrin into a high-speed mixer and mix at low speed (50 r / min) for 5 min to make the two materials initially mixed evenly; then transfer the mixture to a reaction vessel with a constant temperature magnetic stirrer, add 1000 mL of deionized water (the amount of deionized water is 2.5 times the total mass of the two materials to ensure that the materials are fully dissolved and form a homogeneous system); Isothermal inclusion reaction: Turn on the isothermal magnetic stirrer, adjust the temperature to 60℃, adjust the speed to 200r / min, and maintain this condition for continuous stirring and inclusion for 2 hours; during the stirring process, observe the state of the reaction system regularly to ensure that there is no precipitation or layering, so that the active extract of Polygonatum sibiricum is fully included by cyclodextrin to form a stable inclusion complex system. Freeze-drying: After the inclusion reaction is completed, the reaction system is quickly transferred to the material tray of the freeze dryer, with a thickness not exceeding 1 cm. The freeze dryer is turned on, and the vacuum degree is set to 5 Pa and the condensation temperature to -55℃. The freeze dryer is freeze-dried for 12 hours until the material is completely dry and forms a loose, uniform white powdery inclusion complex. After drying, the inclusion complex is removed and placed in a desiccator to cool to room temperature for later use. Material weighing: Accurately weigh 400g of the cooled inclusion complex (theoretical yield; actual yield may vary slightly depending on drying loss), then weigh 0.5% of the inclusion complex's mass of vitamin E (i.e., 2g) and 2% of the inclusion complex's mass of polyethylene glycol (i.e., 8g), and set aside for later use. Mixing uniformly: Place the inclusion complex, vitamin E, and polyethylene glycol into a high-speed mixer, adjust the speed to 2000 r / min, and mix for 10 minutes to ensure that the three materials are fully mixed to form a uniform and fine powdery capsule contents; after mixing, take a sample to test the mixing uniformity to ensure that the mixing uniformity is ≥95%. If the requirement is not met, continue to extend the mixing time for 2-3 minutes. Capsule filling: Place the empty capsules (0#) into the hopper of the capsule filling machine, and at the same time put the prepared capsule contents into the material bin of the filling machine. Adjust the filling amount to 0.5g / capsule (adjust according to the specifications of the empty capsules to ensure that the filling amount error is within ±2%). Turn on the capsule filling machine to automatically fill. During the filling process, check the filling status regularly to avoid underfilling, overfilling or capsule breakage. Capsule polishing: Place the filled capsules into a capsule polishing machine, adjust the speed to 800 r / min, polish for 5 minutes to remove dust, residual powder and impurities from the capsule surface, so that the capsule surface is smooth, clean and has a uniform appearance; Screening: The polished capsules are placed in a screening machine and screened through a 0.8mm sieve to remove damaged, deformed, or improperly filled capsules (filling amount exceeds the error range), and qualified radiation protection oral capsules are screened out. Finished product collection: Collect the qualified capsules after screening, place them in a sterile sealed container, label them, and set them aside for later use.

[0025] Example 5 like Figure 3 As shown, based on the specific implementation processes of Examples 1, 2, 3, and 4, the present invention provides an active extract of Polygonatum odoratum and its application in radiation protection preparations, including the following steps: Step 1: Raw material pretreatment: Select Polygonatum, remove impurities, wash, slice and dry to obtain Polygonatum slices; Step 2, Ultrasonic-assisted extraction: The pretreated Polygonatum slices were subjected to ultrasonic-assisted extraction using deionized water as solvent, and the extract was collected. Step 3: Macroporous resin purification: Load the collected extract onto a macroporous resin column, first wash away impurities with deionized water until the eluent is colorless and transparent, then wash away the active part with ethanol solution and collect the eluent. Step 4, Concentration and Drying: Concentrate the collected eluent to obtain a concentrated solution; freeze-dry the concentrated solution to constant weight to obtain the active extract of Polygonatum odoratum; Step 5: Mix the active extract of Polygonatum sibiricum with cyclodextrin, add deionized water, and freeze-dry to obtain the inclusion complex; Step 6: Add vitamin E and polyethylene glycol to the inclusion complex, mix well, and obtain the capsule contents; Step 7: Fill the empty capsule with the contents of the capsule, and after polishing and screening, obtain the radiation protection oral capsule.

[0026] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of the present invention is defined by the appended claims and their equivalents.

Claims

1. A method for preparing an active extract of Polygonatum sibiricum, characterized in that, Includes the following steps: Step T1, Raw material pretreatment: Select Polygonatum, remove impurities, wash, slice and dry to obtain Polygonatum slices; Step T2, Ultrasonic-assisted extraction: The pretreated Polygonatum slices were subjected to ultrasonic-assisted extraction using deionized water as solvent, and the extract was collected. Step T3, Macroporous Resin Purification: Load the collected extract onto a macroporous resin column, first wash away impurities with deionized water until the eluent is colorless and transparent, then wash away the active part with ethanol solution and collect the eluent; Step T4, Concentration and Drying: Concentrate the collected eluent to obtain a concentrated solution; freeze-dry the concentrated solution to constant weight to obtain the active extract of Polygonatum odoratum.

2. The method for preparing an active extract of Polygonatum odoratum according to claim 1, characterized in that: In step T1, the slices are cut into thin slices with a thickness of 2-3 mm and dried at a temperature of 60°C.

3. The method for preparing an active extract of Polygonatum odoratum according to claim 1, characterized in that: In step T2, the specific process for collecting the extract is as follows: The pretreated Polygonatum slices were added to deionized water at a material-to-liquid ratio of 1:15 g / ml. Ultrasonic-assisted extraction was carried out for 1.5 h at an ultrasonic frequency of 40 kHz and an extraction temperature of 50 ℃. The mixture was stirred every 20 min during the extraction process. After extraction, the mixture was centrifuged and filtered for 10 min at a speed of 3000 r / min, and the extract was collected.

4. The method for preparing an active extract of Polygonatum odoratum according to claim 1, characterized in that: In step T3, the deionized water elution rate is 2 ml / min, the macroporous resin column is type D101, and the ethanol solution concentration is 50%.

5. The method for preparing an active extract of Polygonatum odoratum according to claim 1, characterized in that: In step T4, the specific process for obtaining the concentrated solution is as follows: The collected eluent was concentrated to 1 / 5 of its original volume under reduced pressure at 60°C and 0.08 MPa to obtain the concentrate.

6. The method for preparing an active extract of Polygonatum odoratum according to claim 1, characterized in that: In step T4, the specific process of freeze-drying the concentrated solution to constant weight to obtain the active extract of Polygonatum odoratum is as follows: The concentrate was freeze-dried to constant weight to obtain the active extract of Polygonatum odoratum.

7. A method for preparing an anti-radiation oral capsule of Polygonatum odoratum active extract, characterized in that: Includes the following steps: Step S1: Mix the active extract of Polygonatum sibiricum with cyclodextrin, add deionized water, freeze dry to obtain inclusion complex; Step S2: Add vitamin E and polyethylene glycol to the inclusion complex, mix well, and obtain the capsule contents; Step S3: Fill the empty capsule with the contents of the capsule, and after polishing and screening, obtain the radiation protection oral capsule.

8. The method for preparing an anti-radiation oral capsule of Polygonatum active extract according to claim 7, characterized in that: In step S1, the specific process for obtaining the inclusion complex is as follows: The active extract of Polygonatum sibiricum was mixed with cyclodextrin at a mass ratio of 1:3, deionized water was added, and the mixture was stirred at 200 r / min for 2 h at 60 °C. The mixture was then freeze-dried to obtain the inclusion complex.

9. The preparation method of the anti-radiation oral capsule of Polygonatum active extract according to claim 7, characterized in that: In step S2, the specific process of obtaining the capsule contents is as follows: Add 0.5% (by mass) of vitamin E and 2% (by mass) of polyethylene glycol to the inclusion complex, mix well, and obtain the capsule contents.

10. An active extract of Polygonatum odoratum and its application in radiation protection preparations, characterized in that: The method for performing any one of claims 1-9 comprises: Step 1: Raw material pretreatment: Select Polygonatum, remove impurities, wash, slice and dry to obtain Polygonatum slices; Step 2, Ultrasonic-assisted extraction: The pretreated Polygonatum slices were subjected to ultrasonic-assisted extraction using deionized water as solvent, and the extract was collected. Step 3: Macroporous resin purification: Load the collected extract onto a macroporous resin column, first wash away impurities with deionized water until the eluent is colorless and transparent, then wash away the active part with ethanol solution and collect the eluent. Step 4, Concentration and Drying: Concentrate the collected eluent to obtain a concentrated solution; freeze-dry the concentrated solution to constant weight to obtain the active extract of Polygonatum odoratum; Step 5: Mix the active extract of Polygonatum sibiricum with cyclodextrin, add deionized water, and freeze-dry to obtain the inclusion complex; Step 6: Add vitamin E and polyethylene glycol to the inclusion complex, mix well, and obtain the capsule contents; Step 7: Fill the empty capsule with the contents of the capsule, and after polishing and screening, obtain the radiation protection oral capsule.

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