Device and method for preparing red ginseng oral instant film agent

Abstract

The present invention relates to the technical field of pharmaceutical preparations, and discloses a red ginseng oral instant film agent preparation device, which comprises: a multi-component dynamic mixing module, which is used for adjusting the ratio of a red ginseng extract to an auxiliary material in the film agent stock solution preparation process so as to ensure the consistency of different batches of products; according to the method, the consistency and the high efficiency of products are ensured by accurately controlling all the process steps, firstly, the multi-component dynamic mixing module can ensure the uniform proportion of red ginseng extracts and auxiliary materials and ensure that the quality of each batch of products is consistent, and the vacuum coating module realizes uniform coating in a vacuum environment and effectively controls the thickness of a coating; the quality problem caused by non-uniform coating is avoided, the directional drying module controls the moisture content of the film through temperature control and an electric field, active ingredients of red ginseng are evenly arranged, efficient absorption and release of the film are guaranteed, the precision of the film is further improved through the intelligent cutting and separating module, flaws are removed, and it is guaranteed that each film agent reaches the expected specification.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations, and in particular to a device and method for preparing a red ginseng oral fast-dissolving film. Background Art

[0002] As a new drug delivery vehicle, oral fast-dissolving films have gradually attracted widespread attention in recent years due to their unique advantages. Their main features include rapid disintegration, no need for water, ease of portability, and precise dosage control. These advantages have made them a popular research and application direction in the field of functional food and drug development. In practice, traditional methods for preparing red ginseng oral fast-dissolving films present the following challenges: First, ensuring ingredient uniformity can be difficult, potentially leading to inconsistent results across batches. Second, the film's coating thickness can be uneven, impacting product quality. Furthermore, the high temperatures used in traditional drying processes can decompose the active ingredients in red ginseng, reducing its efficacy. Finally, existing moisture-proofing measures are insufficient, making the film susceptible to moisture, leading to deformation or failure, and compromising its storage and performance. Consequently, traditional methods struggle to ensure the stability and effectiveness of red ginseng oral fast-dissolving films. Summary of the Invention

[0003] In view of the shortcomings of the existing technology, the present invention provides a device and method for preparing a red ginseng oral fast-dissolving film, which solves the problem that traditional methods are difficult to ensure the uniformity, stability and efficiency of red ginseng oral films.

[0004] To achieve the above objectives, the present invention is implemented through the following technical solutions: A preparation device for a red ginseng oral fast-dissolving film, comprising: A multi-component dynamic mixing module is used to adjust the ratio of red ginseng extract and excipients during the preparation of the film solution to ensure consistency across different batches of products; The vacuum coating module includes a vacuum chamber and an adjustable scraper device, which is used to evenly apply the film agent solution to the substrate surface under vacuum conditions, with the coating thickness controlled between 10 μm and 50 μm. Directional drying module, including multiple temperature-controlled zones and an electric field generator, is used to gradually reduce the moisture content of the film and align the active ingredients of red ginseng through the electric field; Intelligent cutting and separation module, including a multi-axis cutting device for cutting films according to preset specifications and removing defective parts; The moisture-resistant coating module includes an electrostatic spraying device, which is used to add a moisture-resistant coating on the surface of the film to improve the storage stability and performance of the product.

[0005] Preferably, the multi-component dynamic mixing module can adjust the ratio of the red ginseng extract and the auxiliary materials through a stirring and ratio control device to ensure that the ingredients are mixed evenly.

[0006] Preferably, the vacuum degree control range of the vacuum coating module is 0.01 MPa to 0.05 MPa, and the angle and pressure of the scraper are adjustable.

[0007] Preferably, the electric field strength of the directional drying module is controlled between 0.1 kV / cm and 1 kV / cm, and the moisture content of the film is gradually reduced in combination with the temperature control area.

[0008] Preferably, the moisture-proof coating sprayed by the moisture-resistant coating module has a thickness of 1 μm to 5 μm and is made of natural ingredients, which does not affect the quick-dissolving performance of the film.

[0009] A method for preparing a red ginseng oral fast-dissolving film comprises the following steps: S1: Dynamic ratio solution preparation: Red ginseng extract and excipients are mixed in a set ratio and stirred until uniform; S2: Vacuum coating molding: The film agent liquid is evenly coated on the substrate surface through a scraper device under a vacuum environment; S3: Multi-stage directional drying: The coated film is dried through multiple temperature-controlled zones, and an electric field is applied during the drying process to uniformly align the active ingredients of red ginseng. S4: Cutting and separation: Cut the dried film into preset sizes and remove defective parts; S5: Surface coating and post-processing: spray a moisture-proof coating on the surface of the cut film and dry it at low temperature.

[0010] Preferably, the red ginseng extract is prepared by a low-temperature concentration process, and the temperature of the concentration process is controlled below 50° C. to maintain the stability of the active ingredients.

[0011] Preferably, the auxiliary materials include film-forming materials, moisturizing agents and flavoring agents, wherein the film-forming materials are carboxymethyl cellulose and chitosan, the moisturizing agent is glycerol, and the flavoring agents are natural peppermint oil and steviol glycoside.

[0012] Preferably, the temperature of each stage of the multi-stage directional drying is 30° C., 40° C. and 50° C., respectively, and the drying time of each stage is 5 minutes to 15 minutes.

[0013] Preferably, the moisture-proof coating is made of polydextrose and natural antioxidants, and forms a protective film with a thickness of 2 μm to 4 μm after spraying, which can significantly improve the storage stability of the film. Beneficial effects

[0014] The present invention provides a device and method for preparing a red ginseng oral fast-dissolving film. Compared with the prior art, it has the following advantages: In the present invention, the consistency and efficiency of the product are ensured by precisely controlling each process step. First, the multi-component dynamic mixing module can ensure the uniform ratio of red ginseng extract and excipients, ensuring the consistent quality of each batch of products. The vacuum coating module realizes uniform coating under a vacuum environment, effectively controls the coating thickness, and avoids quality problems caused by uneven coating. The directional drying module uses temperature control and electric field to control the moisture content of the film and uniformly arrange the active ingredients of red ginseng, ensuring the efficient absorption and release of the film. The intelligent cutting and separation module further improves the accuracy of the film, eliminates defects, and ensures that each film meets the expected specifications. The moisture-resistant coating module improves the storage stability of the film by adding a natural moisture-proof coating, prevents moisture from affecting product quality, and extends its service life. The overall process ensures the efficiency, stability and excellent performance of the red ginseng oral instant film, effectively improving the quality of the product and consumer experience. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 This is a schematic diagram of the three-dimensional structure of a device and method for preparing a red ginseng oral fast-dissolving film according to the present invention; Figure 2 This is a schematic diagram of the preparation process of a red ginseng oral fast-dissolving film preparation device and method proposed in the present invention; Figure 3 This is a functional diagram showing the components of the preparation device and method for the red ginseng oral fast-dissolving film proposed in the present invention.

[0016] Legend: 1. Vacuum coating module; 2. Directional drying module; 3. Multi-component dynamic mixing module; 4. Anti-wetting coating module; 5. Intelligent cutting and separation module. DETAILED DESCRIPTION

[0017] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0018] See also Figure 1 - Figure 3 , the present invention provides a technical solution, specifically including the following embodiments: Example

[0019] A device for preparing a red ginseng oral fast-dissolving film, comprising: Multi-component dynamic mixing module 3 is used to adjust the ratio of red ginseng extract and excipients during the preparation of the film solution to ensure the consistency of different batches of products; The vacuum coating module 1 includes a vacuum chamber and an adjustable scraper device, which is used to evenly coat the film agent solution onto the substrate surface under vacuum conditions, with the coating thickness controlled to be between 10 μm and 50 μm. Directional drying module 2, including multiple temperature control zones and an electric field generator, is used to gradually reduce the moisture content of the film and align the active ingredients of red ginseng through the electric field; Intelligent cutting and separation module 5, including a multi-axis cutting device for cutting the film according to preset specifications and removing defective parts; The moisture-proof coating module 4 includes an electrostatic spraying device for adding a moisture-proof coating on the surface of the film to improve the storage stability and performance of the product.

[0020] The multi-component dynamic mixing module 3 can adjust the ratio of red ginseng extract and auxiliary materials through the stirring and proportion control device to ensure that the ingredients are evenly mixed; the main function of the multi-component dynamic mixing module 3 is to adjust the ratio of red ginseng extract and auxiliary materials to ensure the uniformity and stability of each component in the film stock solution. By precisely controlling the stirring and proportion adjustment device, the multi-component dynamic mixing module 3 can automatically adjust the ratio of red ginseng extract and auxiliary materials according to the production requirements of different batches to ensure that each batch of stock solution is evenly mixed. The stirring system adopts an efficient stirring device, which ensures that the material does not have caking or component stratification problems during the entire mixing process through appropriate speed and strength. The proportion control device accurately measures and automatically adds auxiliary materials and red ginseng extract according to the set ratio, thereby avoiding errors caused by manual operation and ensuring that the ingredients of each batch of products are consistent and meet quality standards.

[0021] The vacuum coating module 1 has a vacuum control range of 0.01 MPa to 0.05 MPa, and the angle and pressure of the scraper are adjustable. The core function of the vacuum coating module 1 is to evenly apply the red ginseng film to the surface of the substrate. In a vacuum environment, the vacuum chamber uses conditions lower than the normal atmospheric pressure to help the solution be evenly applied and effectively remove moisture from the air, reducing the viscosity of the solution, making the coating more uniform and thin. The adjustable vacuum range is 0.01 MPa to 0.05 MPa, ensuring that the best coating effect can be maintained under different materials and process conditions. The adjustable scraper device plays a vital role in the coating process. The angle and pressure of the scraper can be adjusted according to actual needs to form a uniform film layer on the surface of the substrate. Through precise control of the scraper, the thickness of the film layer can be adjusted from 10μm to 50μm, ensuring the quality and controllability of the film layer.

[0022] The directional drying module 2 controls the electric field strength between 0.1 kV / cm and 1 kV / cm, and, in conjunction with the temperature-controlled zone, gradually reduces the moisture content of the film. This directional drying module 2 plays a key role in the film drying process, employing a combination of staged temperature control and electric field drying technology to achieve optimal drying results. During the drying process, the moisture content of the film gradually decreases, while the multi-stage temperature-controlled zone ensures that the temperature at each stage remains within the optimal range (e.g., 30°C, 40°C, and 50°C), preventing high temperatures from damaging the active ingredients of red ginseng. The drying time for each stage is typically controlled between 5 and 15 minutes, ensuring uniform moisture removal from the film during the drying process. Simultaneously, the electric field generator applies an electric field strength between 0.1 kV / cm and 1 kV / cm during the drying process, which not only promotes uniform moisture distribution within the film but also promotes the alignment of the active ingredients of red ginseng, improving their stability and dissolution rate. The electric field helps evenly distribute the ingredients within the film, preventing accumulation or uneven distribution, thereby enhancing the efficacy of the final film.

[0023] The moisture-proof coating sprayed by the moisture-proof coating module 4 has a thickness of 1 μm to 5 μm and is made of natural ingredients, which does not affect the quick-dissolving properties of the film. The moisture-proof coating module 4 forms a thin and strong moisture-proof coating on the surface of the film through electrostatic spraying technology to prevent the film from being affected by moisture during storage and use. The thickness of the moisture-proof coating is controlled between 1 μm and 5 μm, which can ensure the integrity of the surface of the film without affecting the quick-dissolving properties of the film. The coating uses natural ingredients such as polydextrose and natural antioxidants to ensure that it does not affect the bioavailability and dissolution rate of the film while being moisture-proof. The electrostatic spraying technology allows the coating to be evenly and firmly attached to the surface of the film, with strong adhesion and water resistance, which can effectively improve the storage stability of the film. Through the protection of this moisture-proof coating, the film can maintain stability for a long time in a humid environment and quickly dissolve and release its active ingredients when used.

[0024] A method for preparing a red ginseng oral fast-dissolving film comprises the following steps: S1: Dynamic ratio solution preparation: Red ginseng extract and excipients are mixed in a set ratio and stirred until uniform; S2: Vacuum coating molding: The film agent liquid is evenly coated on the substrate surface through a scraper device under a vacuum environment; S3: Multi-stage directional drying: The coated film is dried through multiple temperature-controlled zones, and an electric field is applied during the drying process to uniformly align the active ingredients of red ginseng. S4: Cutting and separation: Cut the dried film into preset sizes and remove defective parts; S5: Surface coating and post-processing: spray a moisture-proof coating on the surface of the cut film and dry it at low temperature.

[0025] The red ginseng extract is prepared by a low-temperature concentration process, and the temperature of the concentration process is controlled below 50°C to maintain the stability of the active ingredients; the low-temperature concentration process of the red ginseng extract is intended to maintain the active ingredients in red ginseng to the greatest extent by controlling the temperature. During the concentration process, the temperature is strictly controlled below 50°C to ensure the stability of heat-sensitive components in red ginseng and avoid degradation of active ingredients caused by high temperature. The low-temperature concentration process can retain more nutrients, especially active ingredients such as ginsenosides in red ginseng, maintain their high biological activity, and thus enhance the efficacy of the final product. The red ginseng extract obtained by this process has better dissolution characteristics and stronger bioavailability, providing a solid foundation for the high performance of oral fast-dissolving films.

[0026] Excipients include film-forming materials, humectants, and flavorings. The film-forming materials used are carboxymethyl cellulose and chitosan, the humectant is glycerol, and the flavorings are natural peppermint oil and steviol glycosides. The film-forming materials primarily consist of carboxymethyl cellulose (CMC) and chitosan. These materials have excellent solubility and film-forming properties, ensuring rapid oral dissolution without affecting the mouthfeel. Carboxymethyl cellulose, a commonly used water-soluble polymer, exhibits excellent binding properties, effectively promoting film stability. Chitosan helps enhance the film's biocompatibility and promotes the release of the active ingredient. Glycerol, the primary humectant, not only increases the film's wettability but also prevents cracking due to excessive drying, improving its mechanical strength and durability. Natural peppermint oil and steviol glycosides are used as flavorings. Peppermint oil provides a refreshing taste, enhancing the consumer experience, while steviol glycosides, a natural sweetener, are low in calories, natural, and sugar-free, ensuring the film's palatable texture while maintaining its health benefits.

[0027] The temperature of each stage of the multi-stage directional drying is 30°C, 40°C and 50°C, and the drying time of each stage is 5 minutes to 15 minutes; the multi-stage directional drying module 2 in the preparation process plays a vital role in the quality of the film and the maintenance of the active ingredients. During the multi-stage directional drying process, the film will undergo three different drying stages with temperatures of 30°C, 40°C and 50°C. The drying time of each stage is controlled between 5 and 15 minutes to ensure that the moisture in the film layer is gradually and evenly removed, while avoiding the effect of high temperature on the active ingredients of red ginseng. In the initial stage of 30°C, the moisture content of the film layer is high and the temperature is relatively low, which helps to remove most of the moisture; in the later stages of 40°C and 50°C, by gradually increasing the temperature, the remaining moisture can be more effectively removed, ensuring that the film finally has good storage performance and rapid dissolution characteristics.

[0028] The moisture-proof coating is made of polydextrose and natural antioxidants, and forms a protective film with a thickness of 2μm to 4μm after spraying, which can significantly improve the storage stability of the film; the moisture-proof coating sprayed on the surface of the film is made of polydextrose and natural antioxidants, and the thickness of the protective film formed is controlled between 2μm and 4μm. Polydextrose, as a natural edible polymer, can form a uniform, thin protective layer on the surface of the film, effectively preventing the penetration of water and improving the stability of the film in a humid environment. Natural antioxidants have antioxidant and antibacterial effects, which can extend the shelf life of the film and ensure that it does not lose its activity during long-term storage. The moisture-proof coating not only protects the film from the influence of moisture, but also ensures that the film can dissolve quickly when used without affecting its instant dissolving properties. With the blessing of this moisture-proof coating, the film can maintain stability for a long time during storage, transportation and use, thereby greatly improving the market competitiveness of the product.

[0029] During operation, the multi-component dynamic mixing module 3 plays a core role in the preparation of raw materials. The red ginseng extract and the auxiliary materials are mixed in a set ratio to ensure the uniformity and consistency of the ingredients. The module accurately controls the addition ratio of each ingredient through the stirring and proportion control device, so that the red ginseng extract and the auxiliary materials can be fully integrated, avoiding the problem of unstable product quality caused by uneven ingredients or proportion deviation. This stage lays the foundation for subsequent coating, drying and other processes. Next, the vacuum coating module 1 is responsible for evenly coating the prepared film agent solution onto the surface of the substrate. Under a vacuum environment, the film agent is accurately coated by a scraper device. The thickness of the coating is adjustable and controlled between 10μm and 50μm, ensuring the consistency and uniformity of the film layer. The precise control of the vacuum degree (0.01 MPa to 0.05 MPa) helps to improve the uniformity of coating and avoid the influence caused by fluctuations in air pressure or humidity. Subsequently, the directional drying module 2 gradually reduces the moisture content of the film through the combined action of multiple temperature control areas and electric field generating devices, and at the same time arranges the active ingredients of red ginseng in an orderly manner through the action of the electric field. In this process, the temperature of each stage (30℃, 40℃, 50℃) is precisely controlled to ensure that the active ingredients of red ginseng will not be destroyed under low temperature conditions, thereby retaining its medicinal effect. In addition, the application of the electric field helps to evenly distribute the active ingredients of red ginseng and avoid decomposition or unevenness of the ingredients. After the film layer is dried, the intelligent cutting and separation module 5 uses a multi-axis cutting device to cut the film into the required size according to the preset specifications and remove any defective parts to ensure The quality of the finished product, the shape and size of the cut film remain consistent, meet the standard requirements, and avoid affecting the use effect due to irregular shape. Finally, the anti-moisture coating module 4 adds a moisture-proof coating on the surface of the film through an electrostatic spraying device to form a protective layer with a thickness of 1μm to 5μm. The coating is made of natural ingredients and can effectively prevent the intrusion of moisture and protect the stability of the film during storage and use. At the same time, it does not affect the instant dissolution performance of the film. This moisture-proof treatment ensures the long-term stability and use effect of the product. Overall, the working principle of the preparation device ensures the efficient and uniform production of red ginseng oral instant film through precise control and the synergistic effect of multiple modules, ensuring the stability of the product, the protection of active ingredients and the high quality of the final product.

[0030] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent replacements and improvements made within the spirit and principles of the application should be included in the scope of protection of the present application.

Claims

1. A preparation device for a red ginseng oral fast-dissolving film, characterized in that: include: A multi-component dynamic mixing module (3) is used to adjust the ratio of red ginseng extract to excipients during the preparation of the film solution to ensure the consistency of different batches of products; A vacuum coating module (1) comprises a vacuum chamber and an adjustable scraper device, and is used to evenly coat the film agent stock solution onto the surface of the substrate under a vacuum environment, with the coating thickness being controlled within a range of 10 μm to 50 μm; A directional drying module (2) comprising a plurality of temperature control zones and an electric field generating device, which is used to gradually reduce the moisture content of the film and arrange the active ingredients of red ginseng through the electric field; An intelligent cutting and separation module (5), comprising a multi-axis cutting device, for cutting the film according to preset specifications and removing defective parts; The moisture-proof coating module (4) comprises an electrostatic spraying device, which is used to add a moisture-proof coating on the surface of the film to improve the storage stability and use performance of the product.

2. The preparation device of a red ginseng oral fast-dissolving film according to claim 1, characterized in that: The multi-component dynamic mixing module (3) can adjust the ratio of the red ginseng extract and the auxiliary materials through a stirring and ratio control device to ensure uniform mixing of the components.

3. The preparation device of a red ginseng oral fast-dissolving film according to claim 1, characterized in that: The vacuum degree control range of the vacuum coating module (1) is 0.01 MPa to 0.05 MPa, and the angle and pressure of the scraper are adjustable.

4. The device for preparing a red ginseng oral fast-dissolving film according to claim 1, characterized in that: The electric field strength of the directional drying module (2) is controlled between 0.1 kV / cm and 1 kV / cm, and the moisture content of the film is gradually reduced in combination with the temperature control area.

5. The device for preparing a red ginseng oral fast-dissolving film according to claim 1, characterized in that: The moisture-proof coating sprayed by the moisture-proof coating module (4) has a thickness of 1 μm to 5 μm and is made of natural ingredients, without affecting the quick-dissolving performance of the film.

6. A method for preparing a red ginseng oral fast-dissolving film for use in the device according to any one of claims 1 to 5, characterized in that: The following steps are involved: S1: Dynamic ratio solution preparation: red ginseng extract and excipients are mixed in a set ratio and stirred evenly; S2: Vacuum coating molding: The film agent solution is evenly coated on the surface of the substrate through a scraper device under vacuum environment; S3: Multi-stage directional drying: The coated film is dried through multiple temperature-controlled zones, and an electric field is applied during the drying process to evenly arrange the active ingredients of red ginseng; S4: Cutting and separation: Cut the dried film into preset sizes and remove defective parts; S5: Surface coating and post-treatment: spray a moisture-proof coating on the surface of the cut film and dry it at low temperature.

7. The method for preparing a red ginseng oral fast-dissolving film according to claim 6, characterized in that: The red ginseng extract is prepared by a low-temperature concentration process, and the temperature of the concentration process is controlled below 50° C. to maintain the stability of the active ingredients.

8. The method for preparing a red ginseng oral fast-dissolving film according to claim 6, characterized in that: The auxiliary materials include film-forming materials, moisturizing agents and flavoring agents, wherein the film-forming materials are carboxymethyl cellulose and chitosan, the moisturizing agent is glycerol, and the flavoring agents are natural peppermint oil and stevioside.

9. The method for preparing a red ginseng oral fast-dissolving film according to claim 6, characterized in that: The temperature of each stage of the multi-stage directional drying is 30° C., 40° C. and 50° C., respectively, and the drying time of each stage is 5 minutes to 15 minutes.

10. The method for preparing a red ginseng oral fast-dissolving film according to claim 6, characterized in that: The moisture-proof coating is made of polydextrose and natural antioxidants, and forms a protective film with a thickness of 2 μm to 4 μm after spraying, which can significantly improve the storage stability of the film.

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