Araliaceae plant extract oral soluble membrane and preparation method thereof

By optimizing the composition and preparation process of oral disintegrating film made from Araliaceae plant extracts, the problems of unsatisfactory disintegration rate and permeability have been solved, enabling convenient use and low-cost large-scale production, and showing good commercial application prospects.

CN121489912APending Publication Date: 2026-02-10SUZHOU WAYNES BIOTECHNOLOGY CO LTD
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Patent Information

Application Number
CN202512009231.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-12-29
Publication Date
2026-02-10

AI Technical Summary

Technical Problem

In the existing technology, the disintegration rate and active ingredient penetration of oral disintegrating films made from Araliaceae plant extracts are not ideal, and the preparation process is complex, costly, and difficult to achieve large-scale industrial production.

Method used

Oral disintegrating films are prepared by combining Araliaceae plant extracts, chitosan polymers, fillers, binders, penetration enhancers, plasticizers, and flavorings through specific mixing, pulverization, coating, and drying steps. The film-forming process is optimized to improve disintegration rate and permeability.

Benefits of technology

This provides a new dosage form that improves user compliance, simplifies the preparation process, reduces costs, is suitable for large-scale industrial production, and meets the requirements of sustainable development.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention discloses an araliaceae plant extract oral soluble membrane and a preparation method thereof, and relates to the technical field of traditional Chinese medicines and medicinal and edible preparations. The prepared araliaceae plant extract oral soluble membrane is prepared by the following steps: crushing an acanthopanax senticosus extract or an acanthopanax sessiliflorus extract, adding a chitosan polymer, a filling agent, an adhesive, a penetration enhancer, a plasticizing forming agent and seasoning essence, uniformly mixing, standing, degassing, coating, drying, sterilizing, cutting and packaging. Compared with an injection, the compliance of a user can be greatly improved; and the preparation process is simple, the requirement on preparation instruments is low, the cost is low, large-scale industrial production is facilitated, no or little three wastes are generated, the requirement of sustainable development is met, and good commercial application prospects are achieved.
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Description

TECHNICAL FIELD

[0001] The present application relates to a kind of aralia plant extract oral dissolving film, specifically to a kind of aralia plant extract oral dissolving film and preparation method thereof, belong to traditional Chinese medicine and the technical field of food and medicine. BACKGROUND

[0002] Acanthopanax senticosus and Acanthopanax gracilistylus both belong to Araliaceae Acanthopanax, and they are different species in the same genus and family, mainly produced in Liaoning, Jilin, Heilongjiang, Hebei, Shanxi and other places, with light smell, slightly bitter taste, dry and slightly bitter medicinal properties, and warm. Acanthopanax senticosus has been regarded as a good medicine for tonifying essence and marrow and anti-aging since ancient times. Acanthopanax senticosus rhizome contains various glycosides and sugars, such as triterpenoid saponins, lignan glycosides, gomisin, isofraxidin, sesamin and polysaccharides. Acanthopanax senticosus has the effects of enhancing immunity, anti-platelet aggregation, thrombosis, anti-cardiac ischemia, vasodilation, anti-aging, anti-stress, antibacterial, antiviral, antitumor, antioxidant, anti-inflammatory, sedation, etc., and can also treat cardiovascular and cerebrovascular diseases, diabetes, neurasthenia, etc. It is mainly used in clinical practice for treating spleen-kidney yang deficiency, physical weakness, loss of appetite, soreness of waist and knees, and preventing atherosclerosis, etc. Acanthopanax gracilistylus fruit is a food and medicine product, balancing yin and yang, belonging to spleen, kidney and heart meridians; it can tonify kidney and strengthen waist, invigorate qi and calm the mind, promote blood circulation and unblock collaterals, and improve human immunity. It contains rich anthocyanins and flavonoid glycosides, and anthocyanins have the effects of antioxidant, radiation protection, anticancer, protection of vascular endothelium and blood pressure reduction. Acanthopanax gracilistylus fruit contains hyperoside, which has the effects of protecting myocardial ischemia and enhancing immunity. The common Acanthopanax senticosus and Acanthopanax gracilistylus products in clinical practice and on the market include Acanthopanax senticosus injection / intravenous drip solution, syrup, Acanthopanax senticosus tablets / capsules and granules / powder, and oral disintegrating tablets and drinks, etc.

[0003] Oral dissolving films (ODF), also known as oral dispersible films, oral fast-dissolving films, oral quick-dissolving films, sublingual films, or tongue films, are a novel drug delivery system. The Chinese Pharmacopoeia defines film-like preparations as those made by processing drugs with suitable film-forming materials into a film-like formulation for oral or mucosal use. Their size, shape, and thickness are similar to a postage stamp. Placed on the tongue, they rapidly dissolve and release the drug in saliva without the need for drinking water, greatly improving user compliance. Generally, oral dissolving films can carry active ingredients of different properties in varying proportions. Their core lies in the formulation's components and proportions, as well as the film-forming process, demonstrating specific innovation. Currently, the components of oral dissolving films loaded with small-molecule Western medicines have been publicly disclosed. For example, patent CN115400099A discloses a method for preparing an oral dissolving film of the Western medicine cariprazine. The oral dissolving film composition includes an active ingredient, a film-forming material, and a plasticizer. It may also include sweeteners, absorption promoters, disintegrants, salivary stimulants, fillers, and colorants. Its core is that the active ingredient is cariprazine, belonging to the oral dissolving film dosage form of Western medicine. Due to the inherent characteristics of traditional Chinese medicine and small-molecule Western medicines, such as the complexity of their components, physicochemical properties, and film-forming abilities, no patents or publicly available process technologies for oral dissolving films with active traditional Chinese medicine powder as the core component have been found. Patent CN1634390A discloses an orally disintegrating tablet made from Acanthopanax senticosus and its preparation process. The method involves loading Acanthopanax senticosus powder into a binder, filler, effervescent agent, flavoring agent, gliding agent, and lubricant, then mixing it with a coating material and compressing it into tablets using a tableting machine. Each tablet weighs up to 500mg, with Acanthopanax senticosus extract comprising 150mg (30%). However, the disintegration rate of the orally disintegrating film and the penetration of the active ingredients are not ideal. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide an orally soluble film made from extracts of Acanthopanax senticosus and Acanthopanax breviscapus from Araliaceae plants and a method for preparing the same, so as to overcome the shortcomings of the prior art.

[0005] To address the aforementioned technical problems, the present invention proposes the following technical solution: an oral dissolving film made from Araliaceae plant extract, comprising an extract, a chitosan polymer, a filler, a binder, a penetration enhancer, a plasticizer, and a flavoring agent; wherein the extract is Acanthopanax senticosus extract or Acanthopanax brevis extract; wherein the Acanthopanax senticosus extract comprises any one or a combination of two or more of Acanthopanax senticosus extract, Acanthopanax senticosus extract crystals, Acanthopanax senticosus saponins, Acanthopanax senticosus polysaccharides, and Acanthopanax senticosus flavonoids.

[0006] Preferably, the mass ratio of the extract, filler, binder, penetration enhancer, plasticizer and flavoring is 5: (0.1~0.3): (1~20): (0.1~10): (0.1~1.0): (0.1~1): (0.1~2).

[0007] Preferably, the mass ratio of the extract, filler, binder, penetration enhancer, plasticizer and flavoring is 5: (0.15~0.25): (5~15): (1~5): (0.1~1.0): (0.1~0.5): (0.1~1).

[0008] Preferably, the mass ratio of the extract, filler, binder, penetration enhancer, plasticizer and flavoring is 5: (0.2~0.25): (7~15): (1~5): (0.1~1.0): (0.1~0.5): (0.1~1).

[0009] Preferably, the mass ratio of the extract, filler, binder, penetration enhancer, plasticizer and flavoring is 5: (0.22~0.25): (5~10): (1~5): (0.1~1.0): (0.1~0.5): (0.1~1).

[0010] Preferably, the preparation method of the chitosan polymer is as follows: carboxymethyl-β-cyclodextrin and deionized water are mixed at a mass ratio of 1:20~30, stirred evenly, and then 0.8~0.9 times the mass of carboxymethyl-β-cyclodextrin, carbodiimide and 0.5~0.6 times the mass of carboxymethyl-β-cyclodextrin, N-hydroxysuccinimide are added, the reaction is activated for 1~2 hours, and then 100~120 times the mass of carboxymethyl-β-cyclodextrin chitosan solution is added. The chitosan solution is prepared by mixing chitosan with 1% glacial acetic acid at a mass ratio of 1:100. The mixture is stirred evenly and transferred to a 2000 Da dialysis bag. Dialysis is performed with deionized water for 3~5 days, with the deionized water replaced every 14~16 hours. Finally, the mixture is centrifuged and freeze-dried at -40~-60℃ to obtain the chitosan polymer.

[0011] Preferably, the Acanthopanax senticosus extract includes any one or a combination of two or more of Acanthopanax senticosus extract, Acanthopanax senticosus extract crystals, Acanthopanax senticosus flavonoids, and Acanthopanax senticosus glycosides.

[0012] Preferably, the penetration enhancer comprises any one or a combination of two or more of sodium 8-(2-hydroxybenzamido)octanoate, sodium caprylate, and sodium decanoate; the filler comprises any one or a combination of two or more of modified starch, hydroxypropyl methylcellulose, mannose, xylitol, hydroxypropyl cellulose, sodium carboxymethyl starch, and croscarmellose sodium; the binder comprises any one or a combination of two or more of dextrin, polyethylene glycol, oligocellulose, and carboxymethyl cellulose; the plasticizer comprises any one or a combination of two or more of titanium dioxide, calcium stearate, and magnesium stearate; the flavoring comprises any one or a mixture of two of sucralose or peppermint flavoring; and the side length of the Araliaceae plant extract oral dissolving film is 2-5 cm, and the thickness is 0.1-2 mm, preferably 0.5-1.0 mm.

[0013] Preferably, the preparation method of the oral dissolving film of the Araliaceae plant extract is as follows: pulverize Acanthopanax senticosus extract or Acanthopanax gracilistylus extract, add filler, binder, penetration enhancer, plasticizer and flavoring agent, mix evenly, let stand to degas, coat, dry, sterilize, cut and package.

[0014] Preferably, the particle size of the pulverized Acanthopanax senticosus extract or Acanthopanax gracilistylus extract is less than 50µm.

[0015] Compared with the prior art, the beneficial effects achieved by the present invention are: The oral disintegrating film tablets of Araliaceae plant extracts provided by this invention are a new dosage form that is easy to take and carry, and can greatly improve user compliance compared with injections. The preparation process of the oral dissolving film of Araliaceae plant extract provided by this invention is simple, requires low-level equipment, and is low-cost, which is conducive to large-scale industrial production. Moreover, it generates little or no waste, meets the requirements of sustainable development, and has good commercial application prospects. Attached Figure Description

[0016] Figure 1 This is a physical image of the Acanthopanax senticosus oral solution film from Embodiment 1 of the present invention. Detailed Implementation

[0017] The present invention will be specifically described below through embodiments. It should be noted that the following embodiments are only used to further illustrate the present invention and should not be construed as limiting the scope of protection of the present invention. Those skilled in the art can make some non-essential improvements and adjustments to the present invention based on the above description. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those skilled in the art.

[0018] The preparation method of chitosan polymer in the examples and comparative examples is as follows: Carboxymethyl-β-cyclodextrin and deionized water are mixed at a mass ratio of 1:25, stirred evenly, and then 0.85 times the mass of carbodiimide and 0.55 times the mass of N-hydroxysuccinimide are added. The reaction is activated for 1.5 h. Then, 110 times the mass of chitosan solution is added. The chitosan solution is prepared by mixing chitosan with 1% glacial acetic acid at a mass ratio of 1:100. The mixture is stirred evenly and transferred to a 2000 Da dialysis bag. Dialysis is performed with deionized water for 4 days, with the deionized water being replaced every 15 h. Finally, the mixture is centrifuged and freeze-dried at -50 °C to obtain the chitosan polymer.

[0019] Example 1: The preparation method of the oral dissolving film tablets made from Araliaceae plant extracts in this example is as follows: 5.0g of Acanthopanax senticosus extract was pulverized using an air jet mill and filtered to reduce the particle size to less than 50µm. Then, 0.1g of chitosan polymer, 12.0g of hydroxypropyl methylcellulose, 10.6g of hydroxypropyl cellulose, 2.0g of polyethylene glycol, 0.2g of sodium 8-(2-hydroxybenzamido)octanoate (SNAC), 0.2g of titanium dioxide, 0.3g of sucralose, and 120g of purified water were homogenized and stirred for 1 hour. The mixture was then allowed to stand for 30 minutes and degassed for 2 hours. After that, it was coated, dried, sterilized, cut, and packaged to obtain Acanthopanax senticosus oral soluble film, which was cut into rectangles with a side length of 3cm and a thickness of 0.8mm.

[0020] Example 2: The preparation method of the oral dissolving film tablets made from Araliaceae plant extracts in this example is as follows: 5.0g of Acanthopanax senticosus extract was pulverized using an air jet mill and filtered to reduce the particle size to less than 50µm. Then, 0.12g of chitosan polymer, 12.5g of hydroxypropyl methylcellulose, 8.4g of hydroxypropyl cellulose, 3.4g of polyethylene glycol, 0.2g of sodium 8-(2-hydroxybenzamido)octanoate (SNAC), 0.1g of titanium dioxide, 0.2g of sucralose, 0.3g of peppermint flavoring, and 120g of purified water were homogenized and stirred for 1 hour. The mixture was then allowed to stand for 30 minutes and degassed for 2 hours. After that, it was coated, dried, sterilized, cut, and packaged to obtain Acanthopanax senticosus oral soluble film, which was cut into rectangles with a side length of 3cm and a thickness of 0.7mm.

[0021] Example 3: The preparation method of the oral dissolving film tablets made from Araliaceae plant extracts in this example is as follows: 5.0g of Acanthopanax senticosus extract was pulverized using an air jet mill and filtered to reduce the particle size to less than 50µm. Then, 0.15g of chitosan polymer, 12.2g of cross-linked sodium carboxymethyl cellulose, 10.1g of hydroxypropyl cellulose, 0.2g of sodium octanoate, 2.0g of polyethylene glycol, 0.4g of sucralose, and 120g of purified water were homogenized and stirred for 1 hour. The mixture was then allowed to stand for 30 minutes and degassed for 2 hours. After that, it was coated, dried, sterilized, cut, and packaged to obtain Acanthopanax senticosus oral soluble film, which was cut into rectangles with a side length of 3cm and a thickness of 0.6mm.

[0022] Example 4: The preparation method of the oral soluble film of Araliaceae plant extract in this example is as follows: 5.0g of Acanthopanax senticosus extract is pulverized by an air jet mill, filtered, and its particle size is less than 50µm. Then, 0.18g of chitosan polymer, 13.5g of hydroxypropyl methylcellulose, 8.5g of hydroxypropyl cellulose, 0.2g of sodium decanoate, 2.5g of polyethylene glycol, 0.3g of peppermint flavoring, and 120g of purified water are homogenized and stirred for 1h. Then, it is allowed to stand for 30min, degassed for 2h, coated, dried, sterilized, cut and packaged to finally obtain Acanthopanax senticosus oral soluble film, which is cut into rectangles with a side length of 3cm and a thickness of 0.7mm.

[0023] Example 5: The preparation method of the oral soluble film of Araliaceae plant extract in this example is as follows: 5.0g of Acanthopanax senticosus extract was pulverized by an air jet mill, filtered, and its particle size was reduced to less than 50µm. Then, 0.2g of chitosan polymer, 4.8g of modified starch, 6.5g of xylitol, 10.0g of hydroxypropyl cellulose, 2.2g of dextrin, 0.2g of sodium 8-(2-hydroxybenzamido)octanoate (SNAC), 0.6g of calcium stearate, 0.6g of sucralose, and 120g of purified water were homogenized and stirred for 1h. Then, the mixture was allowed to stand for 30min, degassed for 2h, coated, dried, sterilized, cut, and packaged to finally obtain Acanthopanax senticosus oral soluble film, which was cut into rectangles with a side length of 3cm and a thickness of 0.7mm. Example 6: The preparation method of the oral soluble film of Araliaceae plant extract in this example is as follows: 5.0g of Acanthopanax senticosus extract is pulverized by an air jet mill, filtered, and its particle size is less than 50µm. Then, 0.22g of chitosan polymer, 3.6g of sodium carboxymethyl starch, 9.8g of cross-linked sodium carboxymethyl cellulose, 10.5g of hydroxypropyl cellulose, 0.4g of magnesium stearate, 0.2g of sodium 8-(2-hydroxybenzamido)octanoate (SNAC), 0.4g of peppermint flavoring, and 120g of purified water are homogenized and stirred for 1h. Then, it is allowed to stand for 30min, degassed for 2h, coated, dried, sterilized, cut and packaged to finally obtain Acanthopanax senticosus oral soluble film, which is cut into rectangles with a side length of 3cm and a thickness of 0.6mm.

[0024] Example 7: The preparation method of the oral soluble film of Araliaceae plant extract in this example is as follows: 5.0g of Acanthopanax senticosus extract is pulverized by an air jet mill, filtered, and its particle size is less than 50µm. Then, 0.24g of chitosan polymer, 15.4g of hydroxypropyl methylcellulose, 8.6g of sodium carboxymethyl starch, 0.2g of sodium 8-(2-hydroxybenzamido)octanoate (SNAC), 0.6g of peppermint flavoring, and 120g of purified water are homogenized and stirred for 1h. Then, it is allowed to stand for 30min, degassed for 2h, coated, dried, sterilized, cut and packaged to finally obtain Acanthopanax senticosus oral soluble film, which is cut into rectangles with a side length of 3cm and a thickness of 0.7mm.

[0025] Example 8: The preparation method of the oral soluble film of Araliaceae plant extract in this example is as follows: 5.0g of Acanthopanax senticosus extract is pulverized by an air jet mill, filtered, and its particle size is less than 50µm. Then, 0.26g of chitosan polymer, 18.0g of hydroxypropyl methylcellulose, 6.4g of carboxymethyl cellulose, 0.2g of sodium 8-(2-hydroxybenzamido)octanoate (SNAC), 0.6g of peppermint flavoring, and 120g of purified water are homogenized and stirred for 1h. Then, it is allowed to stand for 30min, degassed for 2h, coated, dried, sterilized, cut and packaged to finally obtain the oral soluble film of Acanthopanax senticosus. The cut size is a rectangle with a side length of 3cm and a thickness of 0.7mm.

[0026] Example 9: The preparation method of the oral soluble film of Araliaceae plant extract in this example is as follows: 5.0g of Acanthopanax senticosus extract is pulverized by an air jet mill, filtered, and its particle size is less than 50µm. Then, 0.28g of chitosan polymer, 12.4g of hydroxypropyl methylcellulose, 8.6g of hydroxypropyl cellulose, 3.3g of polyethylene glycol, 0.2g of sodium 8-(2-hydroxybenzamido)octanoate (SNAC), 0.1g of titanium dioxide, 0.2g of sucralose, 0.3g of peppermint flavoring, and 120g of purified water are homogenized and stirred for 1h. Then, it is allowed to stand for 30min, degassed for 2h, coated, dried, sterilized, cut and packaged to finally obtain the oral soluble film of Acanthopanax senticosus. The film is cut into rectangles with a side length of 3cm and a thickness of 0.7mm.

[0027] Example 10: The preparation method of the oral soluble film tablets of Araliaceae plant extract in this example is as follows: 5.0g of Acanthopanax senticosus extract was pulverized by an air jet mill, filtered, and its particle size was reduced to less than 50µm. Then, 0.3g of chitosan polymer, 13.5g of hydroxypropyl methylcellulose, 8.5g of hydroxypropyl cellulose, 0.2g of sodium decanoate, 2.5g of polyethylene glycol, 0.3g of peppermint flavoring, and 120g of purified water were homogenized and stirred for 1 hour. After standing for 30 minutes and degassing for 2 hours, the mixture was coated, dried, sterilized, cut, and packaged to obtain the final Acanthopanax senticosus oral soluble film tablets, cut into rectangles with a side length of 3cm and a thickness of 0.7mm. Comparative Example 1: The preparation method of Comparative Example 1 is the same as that of Example 1. The difference between this Araliaceae plant extract oral disintegrating film and Example 1 is that sodium 8-(2-hydroxybenzamido)octanoate was not added.

[0028] 5.0g of Acanthopanax senticosus extract was pulverized using an air jet mill and filtered to reduce the particle size to less than 50µm. Then, 0.1g of chitosan polymer, 12.0g of hydroxypropyl methylcellulose, 10.6g of hydroxypropyl cellulose, 2.0g of polyethylene glycol, 0.2g of titanium dioxide, 0.3g of sucralose, and 120g of purified water were homogenized and stirred for 1 hour. The mixture was then allowed to stand for 30 minutes, degassed for 2 hours, coated, dried, sterilized, cut, and packaged to obtain Acanthopanax senticosus oral soluble film without sodium 8-(2-hydroxybenzamide)octanoate. The film was cut into rectangles with sides of 3cm and a thickness of 0.8mm. In a dissolution comparison experiment between this sample and the sample in Example 1, the dissolution time of the sample without sodium 8-(2-hydroxybenzamide)octanoate was 65 seconds, while the dissolution time of the sample with sodium 8-(2-hydroxybenzamide)octanoate was 34 seconds. The two samples differ in taste. The sample with added sodium 8-(2-hydroxybenzamide)octanoate has a smooth melting texture and a better taste experience; the sample without added sodium 8-(2-hydroxybenzamide)octanoate has a gritty texture and a less desirable taste.

[0029] Comparative Example 2: The preparation method of Comparative Example 2 is the same as that of Example 1. The difference between this Araliaceae plant extract oral dissolving film and Example 1 is that chitosan polymer was not added.

[0030] 5.0g of Acanthopanax senticosus extract was pulverized using an air jet mill and filtered to reduce the particle size to less than 50µm. Then, 12.0g of hydroxypropyl methylcellulose, 10.6g of hydroxypropyl cellulose, 2.0g of polyethylene glycol, 0.2g of sodium 8-(2-hydroxybenzamido)octanoate (SNAC), 0.2g of titanium dioxide, 0.3g of sucralose, and 120g of purified water were homogenized and stirred for 1 hour. The mixture was then allowed to stand for 30 minutes, degassed for 2 hours, coated, dried, sterilized, cut, and packaged to obtain Acanthopanax senticosus oral soluble film without chitosan polymer. The film was cut into rectangles with sides of 3cm and a thickness of 0.8mm. Compared to the Acanthopanax senticosus oral soluble film with chitosan polymer in Example 1, which had a smooth surface and good water resistance, the Acanthopanax senticosus oral soluble film without chitosan polymer had a less smooth surface, affecting the taste experience; it was also more susceptible to moisture, softening, and sticking to the packaging bag.

[0031] Obviously, the above embodiments are merely examples to clearly illustrate the embodiments of the present invention, and are not intended to limit the embodiments of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively list all embodiments here. However, these obvious variations or modifications derived from the spirit of the present invention are still within the protection scope of the present invention.

Claims

1. An oral dissolving film containing an extract from an Araliaceae plant, characterized in that, It includes extracts, chitosan polymers, fillers, binders, penetration enhancers, plasticizers, and flavorings; the extract is Acanthopanax senticosus extract or Acanthopanax brevis extract; the Acanthopanax senticosus extract includes any one or a combination of two or more of Acanthopanax senticosus extract, Acanthopanax senticosus extract crystals, Acanthopanax senticosus saponins, Acanthopanax senticosus polysaccharides, and Acanthopanax senticosus flavonoids.

2. The oral dissolving film of Araliaceae plant extract according to claim 1, characterized in that, The mass ratio of the extract, chitosan polymer, filler, binder, penetration enhancer, plasticizer and flavoring is 5: (0.1~0.3): (1~20): (0.1~10): (0.1~1.0): (0.1~1): (0.1~2).

3. The oral dissolving film containing Araliaceae plant extract according to claim 2, characterized in that, The preferred mass ratio of the extract, chitosan polymer, filler, binder, penetration enhancer, plasticizer and flavoring is 5: (0.15~0.25): (5~15): (1~5): (0.1~1.0): (0.1~0.5): (0.1~1).

4. The oral dissolving film containing Araliaceae plant extract according to claim 2, characterized in that, The preferred mass ratio of the extract, chitosan polymer, filler, binder, penetration enhancer, plasticizer and flavoring is 5: (0.2~0.25): (7~15): (1~5): (0.1~1.0): (0.1~0.5): (0.1~1).

5. The oral dissolving film containing Araliaceae plant extract according to claim 2, characterized in that, The preferred mass ratio of the extract, chitosan polymer, filler, binder, penetration enhancer, plasticizer and flavoring is 5: (0.22~0.25): (5~10): (1~5): (0.1~1.0): (0.1~0.5): (0.1~1).

6. The oral dissolving film of Araliaceae plant extract according to claim 1, characterized in that, The preparation method of the chitosan polymer is as follows: Carboxymethyl-β-cyclodextrin and deionized water are mixed at a mass ratio of 1:20~30, stirred evenly, and then 0.8~0.9 times the mass of carboxymethyl-β-cyclodextrin, carbodiimide and 0.5~0.6 times the mass of carboxymethyl-β-cyclodextrin, N-hydroxysuccinimide are added, and the activation reaction is carried out for 1~2 hours. Then, 100~120 times the mass of carboxymethyl-β-cyclodextrin chitosan solution is added. The chitosan solution is prepared by mixing chitosan with 1% glacial acetic acid at a mass ratio of 1:

100. The mixture is stirred evenly and transferred to a 2000 Da dialysis bag. Dialysis is performed with deionized water for 3~5 days, and the deionized water is replaced every 14~16 hours. Finally, the mixture is centrifuged and freeze-dried at -40~-60℃ to obtain the chitosan polymer.

7. The oral dissolving film of Araliaceae plant extract according to claim 1, characterized in that, The Acanthopanax gracilistylus extract includes any one or a combination of two or more of Acanthopanax gracilistylus extract, Acanthopanax gracilistylus extract crystals, Acanthopanax gracilistylus flavonoids, and Acanthopanax gracilistylus glycosides.

8. The oral dissolving film of Araliaceae plant extract according to claim 1, characterized in that, The penetration enhancer includes any one or a combination of two or more of sodium 8-(2-hydroxybenzamido)octanoate, sodium caprylate, and sodium decanoate; the filler includes any one or a combination of two or more of modified starch, hydroxypropyl methylcellulose, mannose, xylitol, hydroxypropyl cellulose, sodium carboxymethyl starch, and croscarmellose sodium; the binder includes any one or a combination of two or more of dextrin, polyethylene glycol, oligocellulose, and carboxymethyl cellulose; the plasticizer includes any one or a combination of two or more of titanium dioxide, calcium stearate, and magnesium stearate; and the flavoring includes any one or a mixture of two of sucralose or peppermint flavoring.

9. The oral dissolving film of Araliaceae plant extract according to claim 1, characterized in that, The oral dissolving film made from Araliaceae plant extract has a side length of 2-5 cm and a thickness of 0.1-2 mm, preferably 0.5-1.0 mm.

10. The method for preparing the oral dissolving film of Araliaceae plant extract as described in any one of claims 1-9, characterized in that, The preparation method of the oral dissolving film made from Araliaceae plant extract is as follows: pulverize Acanthopanax senticosus extract or Acanthopanax gracilistylus extract, add chitosan polymer, filler, binder, penetration enhancer, plasticizer and flavoring agent, mix evenly, let stand to degas, coat, dry, sterilize, cut and package; the particle size of the pulverized Acanthopanax senticosus extract or Acanthopanax gracilistylus extract is less than 50µm.

Citation Information

Patent Citations

  • Wilsonii oral disintegrating tablet and preparation method thereof

    CN1634390A