Traditional Chinese medicine extract with gene repair and cell repair effects and preparation process thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine extracts, in particular to a traditional Chinese medicine extract with gene repair and cell repair effects and a preparation process thereof, and the traditional Chinese medicine extract is prepared from astragaloside, fisetin, HA-PLGA, FA-PEG-CRGDK and other raw materials. By constructing a core-shell structure delivery system, sequential release of active ingredients is realized, ROS is quickly cleared, and an Nrf2 pathway is activated to promote DNA damage repair. The preparation process comprises the steps of construction of an inner core drug-loading system, assembly of a core-shell structure, coating of a phospholipid membrane, freeze drying and the like. The application can improve the utilization rate of active ingredients, enhance stability and targeting, is suitable for DNA damage repair caused by oxidative stress, solves the problem of poor synergistic effect of a traditional Chinese medicine compound preparation, reduces the production cost, and has wide application prospects.

Description

Technical Field

[0001] The present invention belongs to the technical field of biomedicine and traditional Chinese medicine, and specifically relates to a traditional Chinese medicine extract with gene repair and cell repair effects and its preparation process. Background Art

[0002] With the in-depth research of modern medicine on gene repair and cell repair, traditional Chinese medicine extracts have shown unique advantages in related fields due to their multi-target and multi-pathway action mechanisms. However, there are still certain limitations in the existing technology for achieving deep cell gene repair. After retrieval, a skin repair agent prepared by mixing stem cell extract and traditional Chinese medicine extract and its application, with the publication number CN107550934B, was disclosed on December 29, 2020. This patent prepared a skin repair agent for scar and stretch mark repair by mixing umbilical cord mesenchymal stem cell extract with traditional Chinese medicine extracts such as reed rhizome, blue lotus flower, hibiscus flower, and licorice. Its main mechanism is to achieve the therapeutic effect by promoting tissue regeneration and killing fibroblasts. However, the action mechanism of this technical solution mainly focuses on the repair of epidermal tissue, does not involve the repair effect at the deep cell gene level, and lacks a detailed description of the specific synergistic action mechanism between stem cell extract and traditional Chinese medicine extract, which may limit the breadth and depth of its repair effect. In addition, the types of traditional Chinese medicine extracts used in this solution are relatively single, and may not comprehensively cover the various active ingredients required for gene repair.

[0003] After retrieval, an extract for repairing damaged pancreatic islet cells and improving pancreatic islet cell function and its application, with the publication number CN118576633B, was disclosed on October 29, 2024. This patent prepared a traditional Chinese medicine extract that can directly restore the organizational structure of diseased pancreatic islet cells and improve pancreatic islet function by ethanol reflux extraction of different parts of Lonicera japonica and combining macroporous resin purification technology. This extract can significantly repair damaged liver cells in type II diabetic rats and reduce blood sugar levels. However, the main objective of this technical solution is the functional repair of pancreatic islet cells, does not clearly mention the repair effect on gene-level damage, and its extraction process depends on specific solvent concentrations and purification steps, which may have problems of process complexity and high cost. In addition, the application scope of this solution is relatively limited, mainly concentrated on cell repair related to diabetes, and does not reflect its universality in other types of cells or tissues.

[0004] In traditional Chinese medicine compound preparations, due to the difference in metabolic half-life between ROS scavengers and Nrf2 pathway activators, it is difficult to achieve temporal synergistic effects in cells, resulting in affected DNA repair efficiency. This phenomenon indicates that how to achieve efficient synergistic effects of active ingredients in cells by optimizing the delivery system or regulating the release behavior is still an important research direction at present. Summary of the Invention

[0005] In order to solve the above problems, the present application proposes a Chinese medicine extract with gene repair and cell repair effects and a preparation process thereof.

[0006] The preparation process of the Chinese medicine extract comprises the following steps:

[0007] Step 1: Constructing the core drug delivery system: 200-300 mg of PLGA and 30-50 mg of astragaloside IV were weighed and dissolved in 5 mL of dichloromethane. 0.5 mL of PBS solution containing HA-Tyr was added and emulsified using a microfluidic chip at a flow rate ratio of 3:1 for the aqueous phase:organic phase. The primary emulsion was transferred to a rotary evaporator to remove the organic solvent, and 0.1% Pluronic F127 stabilizer was added. The suspension was stirred under magnetic stirring for 2 hours and sterilized through a 0.22 μm filter to obtain a core suspension with a particle size of 50 ± 3 nm.

[0008] Step 2: Core-shell structure assembly: 80-100 mg of fisetin-PEG complex was dispersed in 20-50 mL of PBS, added to the core suspension, and ultrasonicated at 45°C for 15 min. FA-PEG3400-CRGDK peptide was added, and the mixture was slowly stirred at 4°C overnight. Core-shell nanoparticles were obtained after purification by ultrafiltration and centrifugation.

[0009] Step 3: Phospholipid membrane coating: prepare a chloroform solution containing DSPE-SS-PEG2000, rotary evaporate the chloroform solution to form a lipid membrane, add the core-shell nanoparticle suspension prepared in step 2, hydrate at 55°C for 30 minutes, extrude through a 0.1 μm polycarbonate membrane three times, and add 0.05% vitamin E as an antioxidant to finally obtain nanoparticles with a phospholipid membrane on the surface;

[0010] Step 4: Freeze drying: add freeze-drying protectant, quick freeze at -80°C for 4 hours and then freeze dry.

[0011] Preferably, the volume ratio of HA-Tyr in step 1 is 0.01% w / v.

[0012] Preferably, the solid content of the core suspension in step 2 is 2% w / v; and the FA-PEG3400-CRGDK peptide is added at a molar ratio of 1:50.

[0013] Preferably, in step 3, the concentration of DSPE-SS-PEG2000 is 1.5 mg / mL.

[0014] Preferably, in step 3, the parameters of the high-pressure homogenization treatment are 1200 bar, 5 cycles, and temperature control at 4°C ± 1°C.

[0015] Preferably, in step four, the lyoprotectant consists of 5 - 10 g of trehalose and 2 - 5 g of mannitol per 100 mL.

[0016] Preferably, in step four, the conditions for freeze - drying are as follows: primary drying stage: maintain at - 45°C / 10 Pa for 24 h; secondary drying stage: maintain at 25°C / 5 Pa for 6 h. After nitrogen filling and sealing, the residual moisture is controlled to be ≤1.5%.

[0017] In the present invention, the purification method of astragaloside IV is as follows: Take 10 g of crude astragalus extract (containing astragaloside IV ≥ 40%), dissolve it in 200 mL of 60% ethanol solution, and elute impurities successively with 3 BV of water and 2 BV of 30% ethanol through a macroporous resin AB - 8 column (column volume 200 mL). Collect 5 BV of 70% ethanol eluate, and concentrate it under reduced pressure to dryness (45°C / -0.08 MPa) to obtain astragaloside IV with a purity ≥ 95%.

[0018] In the present invention, the preparation method of fisetin - PEG complex is as follows: Dissolve fisetin (purity 98%) and mPEG5000 in a molar ratio of 1:2 in DMSO, stir and react at 60°C for 6 h under nitrogen protection, dialyze (MWCO 3500) to remove free molecules, and obtain a yellow powdery complex after freeze - drying, with an encapsulation efficiency ≥ 92%.

[0019] The present invention also provides a traditional Chinese medicine extract with the function of gene repair and cell repair, which is prepared by the preparation process of a traditional Chinese medicine extract with the function of gene repair and cell repair.

[0020] In addition, the freeze - dried medicament of this product can also be prepared into a liquid form, which is not limited in this application.

[0021] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0022] By constructing a core - shell structure delivery system, the present invention distributes astragaloside IV and fisetin in the inner core and outer shell respectively, and realizes sequential release behavior by using the difference in their metabolic half - lives (2.5 h vs 8 h). Astragaloside IV, as a ROS scavenger, is preferentially released to rapidly reduce the intracellular oxidative stress level, providing a suitable environment for the subsequent activation of the Nrf2 pathway by fisetin; fisetin prolongs the action time through a slow - release mechanism and promotes the expression of genes related to DNA damage repair. In addition, HA - PLGA endows the nanoparticles with good biocompatibility and stability, and the FA - PEG - CRGDK peptide segment realizes targeted delivery to diseased cells, further improving the utilization rate of active ingredients. The phospholipid membrane coating not only enhances the mechanical strength of the nanoparticles but also improves the antioxidant performance by adding vitamin E, ensuring the stability of active ingredients during storage and transportation.

[0023] The traditional Chinese medicine extract provided by the present invention is applicable to gene repair and cell repair of various cell types and tissues, and has remarkable effects especially on DNA damage caused by oxidative stress. By optimizing the design of the delivery system, the problem that active ingredients in traditional Chinese medicine compound preparations are difficult to act synergistically is solved, and at the same time, the production cost is reduced and the universality of the application scope is improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 It is a verification result diagram of the gene repair and cell repair effects;

[0025] Figure 2 It is a statistical chart of the verification results of the gene repair and cell repair effects.

[0026] The drawings are used to provide a further understanding of the present invention, and constitute a part of the specification. Together with the embodiments of the present invention, they are used to explain the present invention, and do not constitute a limitation to the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0027] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments; based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0028] Unless otherwise defined, all professional and scientific terms used herein have the same meaning as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to the described content can be applied to the present invention. The preferred implementation methods and materials described herein are only for illustrative purposes and do not limit the content of this application.

[0029] The experimental methods in the following embodiments are all conventional methods unless otherwise specified; the test materials and test strains used in the following embodiments are all obtained from commercial channels unless otherwise specified.

[0030] Example 1

[0031] A traditional Chinese medicine extract with gene repair and cell repair effects and its preparation process

[0032] The preparation process of the traditional Chinese medicine extract includes the following steps:

[0033] Step 1: Construction of the core drug-loading system. Weigh 200 mg of PLGA (50:50, MW 15 kDa) and 36 mg of astragaloside IV (mass ratio 5.5:1), dissolve them in 5 mL of dichloromethane, add 0.5 mL of PBS solution containing HA-Tyr (0.01% w / v), and use a microfluidic chip (model: FluidicLab HT-100) to perform emulsification treatment at a flow rate ratio of aqueous phase:organic phase = 3:1. After transferring the primary emulsion to a rotary evaporator (35°C / -0.09 MPa) to remove the organic solvent, add 0.1% Pluronic F127 stabilizer, and continuously stir for 2 h under magnetic stirring conditions (500 rpm). Sterilize through a 0.22 μm filter membrane to obtain a core suspension with a particle size of 50 ± 3 nm.

[0034] Step 2: Assembly of the core-shell structure. Disperse 80 mg of fisetin-PEG complex in 20 mL of PBS (pH 7.4), add the above core suspension (solid content 2% w / v), and ultrasonically treat (40 kHz) for 15 min at 45°C to form a core-shell structure through π-π stacking self-assembly. Monitor the change of Zeta potential by dynamic light scattering until it reaches -18 mV. Subsequently, add the FA-PEG3400-CRGDK peptide segment (synthesis purity > 98%) at a molar ratio of 1:50, slowly stir (200 rpm) overnight at 4°C, and obtain core-shell nanoparticles after purification by ultrafiltration centrifugation (MWCO 100 kDa).

[0035] Step 3: Coating with a phospholipid membrane. Prepare a chloroform solution containing DSPE-SS-PEG2000 (1.5 mg / mL). Using the thin-film hydration method: After rotating and evaporating the chloroform solution to form a lipid membrane, add the above core-shell nanoparticle suspension, hydrate at 55°C for 30 min, extrude 3 times through a 0.1 μm polycarbonate membrane, add 0.05% vitamin E as an antioxidant, and then perform high-pressure homogenization treatment (1200 bar, 5 cycles, temperature controlled at 4°C ± 1°C) to finally obtain nanoparticles with a phospholipid membrane coated on the surface.

[0036] Step 4: Freeze-drying. Add a freeze-drying protectant (trehalose 6.4 g + mannitol 3.2 g / 100 mL), dispense it into vials (2 mL / vial), quickly freeze at -80°C for 4 h and then perform freeze-drying. Primary drying stage: Maintain at -45°C / 10 Pa for 24 h; secondary drying stage: Maintain at 25°C / 5 Pa for 6 h. After filling with nitrogen and sealing, control the residual moisture to ≤ 1.5% (determined by the Karl Fischer method).

[0037] Among them, the purification method of astragaloside IV is as follows: Take 10 g of crude astragalus extract (containing astragaloside IV ≥ 40%), dissolve it in 200 mL of 60% ethanol solution, and elute impurities with 3 BV of water and 2 BV of 30% ethanol successively through a macroporous resin AB-8 column (column volume 200 mL). Collect 5 BV of 70% ethanol eluate, concentrate it under reduced pressure to dryness (45°C / -0.08 MPa) to obtain astragaloside IV with a purity ≥ 95%.

[0038] Among them, the preparation method of fisetin-PEG complex is as follows: Dissolve fisetin (purity 98%) and mPEG5000 in DMSO at a molar ratio of 1:2. Under nitrogen protection, stir and react at 60°C for 6 h, dialyze (MWCO 3500) to remove free molecules, and obtain a yellow powdery complex after freeze-drying, with an encapsulation efficiency ≥ 92%.

[0039] A traditional Chinese medicine extract with the function of gene repair and cell repair is prepared by the above method.

[0040] Example 2

[0041] A traditional Chinese medicine extract with the function of gene repair and cell repair and its preparation process

[0042] The preparation process of the traditional Chinese medicine extract includes the following steps:

[0043] Step 1: Construction of the core drug-loading system. Weigh 300 mg of PLGA (50:50, MW 15 kDa) and 50 mg of astragaloside IV, dissolve them in 5 mL of dichloromethane, add 0.5 mL of PBS solution containing HA-Tyr (0.01% w / v), and use a microfluidic chip (model: FluidicLab HT-100) for emulsification treatment at a flow rate ratio of aqueous phase: organic phase = 3:1. Transfer the primary emulsion to a rotary evaporator (35°C / -0.09 MPa) to remove the organic solvent, then add 0.1% Pluronic F127 stabilizer, continuously stir under magnetic stirring conditions (500 rpm) for 2 h, and sterilize through a 0.22 μm filter membrane to obtain a core suspension with a particle size of 50 ± 3 nm.

[0044] Step 2: Core-shell structure assembly. Take 100 mg of luteolin-PEG complex and disperse it in 50 mL of PBS (pH 7.4). Add the above-mentioned core suspension (solid content 2% w / v), and ultrasonically treat it at 45 °C (40 kHz) for 15 min. A core-shell structure is formed through π-π stacking self-assembly, and the Zeta potential change is monitored by dynamic light scattering until it reaches -18 mV. Subsequently, add the FA-PEG3400-CRGDK peptide segment (synthetic purity > 98%) at a molar ratio of 1:50, and slowly stir it at 4 °C (200 rpm) overnight. After purification by ultrafiltration centrifugation (MWCO 100 kDa), core-shell nanoparticles are obtained.

[0045] Step 3: Phospholipid membrane coating. Prepare a chloroform solution containing DSPE-SS-PEG2000 (1.5 mg / mL). Using the thin film hydration method: after the chloroform solution is rotary evaporated to form a lipid film, add the above-mentioned core-shell nanoparticle suspension, and hydrate it at 55 °C for 30 min. Extrude it 3 times through a 0.1 μm polycarbonate membrane, add 0.05% vitamin E as an antioxidant, and then perform high-pressure homogenization treatment (1200 bar, 5 cycles, temperature controlled at 4 °C ± 1 °C) to finally obtain nanoparticles with a phospholipid membrane coated on the surface.

[0046] Step 4: Freeze-drying. Add a freeze-drying protectant (trehalose 10 g + mannitol 5 g / 100 mL), dispense it into vials (2 mL / vial), and quickly freeze it at -80 °C for 4 h and then perform freeze-drying. Primary drying stage: maintain it at -45 °C / 10 Pa for 24 h; secondary drying stage: maintain it at 25 °C / 5 Pa for 6 h. After filling with nitrogen and sealing, the residual moisture is controlled to be ≤ 1.5% (determined by the Karl Fischer method).

[0047] A traditional Chinese medicine extract with the function of gene repair and cell repair is obtained through the above preparation process.

[0048] Example 3

[0049] A traditional Chinese medicine extract with the function of gene repair and cell repair and its preparation process

[0050] The preparation process of the traditional Chinese medicine extract includes the following steps:

[0051] Step 1: Construction of the core drug-loading system. Weigh 250 mg of PLGA (50:50, MW 15 kDa) and 30 mg of astragaloside IV, dissolve them in 5 mL of dichloromethane, add 0.5 mL of PBS solution containing HA-Tyr (0.01% w / v), and use a microfluidic chip (model: FluidicLab HT-100) to perform emulsification treatment at a flow rate ratio of aqueous phase:organic phase = 3:1. After transferring the primary emulsion to a rotary evaporator (35 °C / -0.09 MPa) to remove the organic solvent, add 0.1% Pluronic F127 stabilizer, and continuously stir under magnetic stirring conditions (500 rpm) for 2 h. Then, sterilize through a 0.22 μm filter membrane to obtain a core suspension with a particle size of 50 ± 3 nm.

[0052] Step 2: Assembly of the core-shell structure. Disperse 90 mg of fisetin-PEG complex in 40 mL of PBS (pH 7.4), add the above core suspension (solid content 2% w / v), and ultrasonically treat (40 kHz) at 45 °C for 15 min to form a core-shell structure through π-π stacking self-assembly. Monitor the change of Zeta potential by dynamic light scattering until it reaches -18 mV. Subsequently, add the FA-PEG3400-CRGDK peptide segment (synthesis purity > 98%) at a molar ratio of 1:50, slowly stir (200 rpm) at 4 °C overnight, and obtain core-shell nanoparticles after purification by ultrafiltration centrifugation (MWCO 100 kDa).

[0053] Step 3: Coating with a phospholipid membrane. Prepare a chloroform solution containing DSPE-SS-PEG2000 (1.5 mg / mL). Using the thin film hydration method: After rotating the chloroform solution to form a lipid film, add the above core-shell nanoparticle suspension, hydrate at 55 °C for 30 min, extrude through a 0.1 μm polycarbonate membrane 3 times, add 0.05% vitamin E as an antioxidant, and then perform high-pressure homogenization treatment (1200 bar, 5 cycles, temperature controlled at 4 °C ± 1 °C) to finally obtain nanoparticles with a phospholipid membrane coated on the surface.

[0054] Step 4: Freeze-drying. Add a freeze-drying protectant (5 g of trehalose + 2 g of mannitol / 100 mL), dispense it into vials (2 mL / vial), quickly freeze at -80 °C for 4 h and then perform freeze-drying. Primary drying stage: Maintain at -45 °C / 10 Pa for 24 h; secondary drying stage: Maintain at 25 °C / 5 Pa for 6 h. After filling with nitrogen and sealing, control the residual moisture to ≤ 1.5% (determined by the Karl Fischer method).

[0055] A traditional Chinese medicine extract with the effect of gene repair and cell repair is obtained through the above preparation process.

[0056] Experimental Example 1

[0057] Verification of Gene Repair and Cell Repair Effects

[0058] Human skin fibroblasts (HSF) were selected as the cell model and divided into the Example 1 group, the Example 2 group, the Example 3 group and the control group, with three replicates in each group. Oxidative stress and DNA damage were induced by hydrogen peroxide (H2O2). Among them, the control group was not treated after induction of damage, and the rest were treated with the traditional Chinese medicine compositions prepared in Examples 1-3 after damage to the cell model. The culture medium containing hydrogen peroxide was removed, and the cells were washed 1-2 times with PBS. Then, the culture medium containing the traditional Chinese medicine extracts prepared in Examples 1-3 was added respectively, and the cells were continued to be cultured in the cell incubator for 72 hours. The DNA double-strand break sites were labeled with anti-γ-H2AX antibody, and the cell nuclei were counterstained with DAPI to detect the cell DNA strand breakage situation, and the repair effect was evaluated by tail moment; the cell viability was measured by the CCK-8 method.

[0059] Result analysis: As Figure 1 shown, the fluorescence effect of the control group was the strongest, and the fluorescence effect of the Example 2 group was the weakest, indicating that the DNA repair of the Example 2 group was the best, followed by the Example 3 group and the Example 2 group. As Figure 2 shown, the cell viability was the highest in the Example 2 group, followed by the Example 3 group and the Example 2 group, while the cell viability of the control group was the lowest.

[0060] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirits of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

[0061] The above describes the present invention and its embodiments, and this description is not restrictive. What is shown in the drawings is only one of the embodiments of the present invention, and the actual structure is not limited thereto. Generally speaking, if those of ordinary skill in the art are inspired by it and design similar structural modes and embodiments without creative work without departing from the purpose of the present invention, they should all fall within the protection scope of the present invention.

Claims

1. Preparation process of traditional Chinese medicine extract with gene repair and cell repair effects, characterized in that: The preparation process of the traditional Chinese medicine extract comprises the following steps: Step 1: Construction of the core drug-loading system. Weigh 200 - 300 mg of PLGA and 30 - 50 mg of astragaloside IV, dissolve them in 5 mL of dichloromethane, add 0.5 mL of PBS solution containing HA-Tyr, and use a microfluidic chip to perform emulsification treatment at a flow rate ratio of aqueous phase:organic phase = 3:

1. After transferring the primary emulsion to a rotary evaporator to remove the organic solvent, add 0.1% Pluronic F127 stabilizer, continuously stir for 2 h under magnetic stirring conditions, and sterilize through a 0.22 μm filter membrane to obtain a core suspension with a particle size of 50 ± 3 nm; Step 2: Assembly of the core-shell structure. Disperse 80 - 100 mg of fisetin-PEG complex in 20 - 50 mL of PBS, add the above core suspension, ultrasonically treat for 15 min at 45°C, add FA-PEG3400-CRGDK peptide segment, slowly stir overnight at 4°C, and obtain core-shell nanoparticles after ultrafiltration and centrifugal purification; Step 3: Coating with a phospholipid membrane. Prepare a chloroform solution containing DSPE-SS-PEG2000, rotate and evaporate the chloroform solution to form a lipid membrane, then add the core-shell nanoparticle suspension in Step 2, hydrate at 55°C for 30 min, extrude 3 times through a 0.1 μm polycarbonate membrane, and add 0.05% vitamin E as an antioxidant to finally obtain nanoparticles with a phospholipid membrane-coated surface; Step 4: Freeze-drying. Add a freeze-drying protectant, quickly freeze at -80°C for 4 h and then perform freeze-drying.

2. The preparation process of a traditional Chinese medicine extract with the function of gene repair cell repair according to claim 1, characterized in that: In Step 1, the volume ratio of HA-Tyr is 0.01% w / v.

3. The preparation process of a traditional Chinese medicine extract with a gene repair cell repair effect according to claim 1, characterized in that: In Step 2, the solid content of the core suspension is 2% w / v; the FA-PEG3400-CRGDK peptide segment is added at a molar ratio of 1:

50.

4. The preparation process of a traditional Chinese medicine extract with the function of gene repair cell repair according to claim 1, characterized in that: In Step 3, the concentration of DSPE-SS-PEG2000 is 1.5 mg / mL.

5. The preparation process of a traditional Chinese medicine extract with a gene repair cell repair effect according to claim 1, characterized in that: In Step 3, the parameters of high-pressure homogenization treatment are 1200 bar, 5 cycles, and the temperature is controlled at 4°C ± 1°C.

6. The preparation process of a traditional Chinese medicine extract with the function of gene repair cell repair according to claim 1, characterized in that: In Step 4, the freeze-drying protectant is composed of 5 - 10 g of trehalose and 2 - 5 g of mannitol per 100 mL.

7. The preparation process of a traditional Chinese medicine extract with the function of gene repair cell repair according to claim 1, characterized in that: In Step 4, the conditions of freeze-drying are: primary drying stage: maintain at -45°C / 10 Pa for 24 h; secondary drying stage: maintain at 25°C / 5 Pa for 6 h. After nitrogen filling and sealing, the residual moisture is controlled at ≤1.5%.

8. A traditional Chinese medicine extract with the function of gene repair and cell repair, which is prepared by the preparation process of a traditional Chinese medicine extract with the function of gene repair and cell repair according to any one of claims 1 - 7.

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