Echinacoside oral instant film agent as well as preparation method and application thereof

Abstract

The invention relates to an echinacoside oral instant film agent and a preparation method and application thereof.The formula of the echinacoside oral instant film agent is reasonably designed, echinacoside serves as an active pharmaceutical ingredient, a mixture of hydroxypropyl methyl cellulose, sodium alginate and carbomer serves as a film forming material, a dispersing agent is used in cooperation, and the echinacoside oral instant film agent is prepared. Effect tests show that the prepared echinacoside oral instant film is uniform in thickness, good in appearance, good in toughness, high in drug loading capacity and rapid in disintegration, and the purpose of rapid drug release is achieved. Besides, the echinacoside oral instant film preparation can ensure higher drug loading capacity to better exert efficacy, can be conveniently taken by patients with senile dementia and improve the compliance of the patients, and has higher clinical application potential.

Description

Technical Field

[0001] The present application relates to the technical field of pharmaceutical preparations, and in particular to an oral fast-dissolving echinacoside film preparation, a preparation method thereof, and an application thereof. Background Art

[0002] Echinacoside is a compound first isolated from the root of Echinacea angustifolia (or Echinacea angustifolia) in 1950. Its molecular formula is C 35 H 46 O 20 , molecular weight 786.73, has multiple pharmacological activities such as anti-tumor, liver protection and immune regulation, can play an anti-aging, memory improvement and neuroprotective role, and is a very potential drug for the treatment of Alzheimer's disease. However, echinacoside requires a higher drug loading to exert its clinical efficacy. The dose must be at least 100 mg to exert its clinical efficacy in the treatment of Alzheimer's disease, and it is slightly soluble in water. After oral administration, it undergoes extensive metabolism in the gastrointestinal tract and can be metabolized into more than 10 metabolites. The oral bioavailability is extremely low, only 0.83%.

[0003] At present, there is no preparation of echinacoside on the market. There are studies on preparations such as echinacoside tablets, orodisintegrating tablets, gel sustained-release tablets, solid lipid nanoparticles, and liposome thermosensitive gels, but there are no reports on oral fast-dissolving films of echinacoside. Although orodisintegrating echinacoside tablets can solve the problem of dysphagia, due to the use of insoluble excipients in the preparation process, there will be a sense of gravel in the mouth, and orodisintegrating tablets will absorb moisture in the air in conventional blister packaging and automatically disintegrate or break during transportation, so the packaging and transportation conditions are also very demanding. In addition, due to their old age, patients with Alzheimer's disease often have poor coordination of nerve and muscle movements in the throat during swallowing, and will experience a certain degree of dysphagia when taking ordinary tablets and capsules orally. Summary of the invention

[0004] Based on this, it is necessary to provide an oral fast-dissolving film of echinacoside, which has a high drug loading, uniform thickness, good appearance, and good toughness, and can significantly improve the bioavailability of echinacoside and the medication compliance of patients with Alzheimer's disease.

[0005] The technical solution of this application is as follows:

[0006] In a first aspect of the present invention, there is provided an oral fast-dissolving echinacoside film, comprising echinacoside and auxiliary materials; the auxiliary materials include a film-forming material and a dispersant;

[0007] The film-forming material comprises a mixture of hydroxypropyl methylcellulose, sodium alginate and carbomer.

[0008] In one embodiment, in the film-forming material, the weight ratio of hydroxypropyl methylcellulose, sodium alginate and carbomer is (6-10): (1-3): (0.1-1).

[0009] In one embodiment, the weight ratio of the film-forming material to the dispersant is (1-25):1.

[0010] In one embodiment, the dispersant is polyethylene glycol; optionally, the dispersant includes one or both of polyethylene glycol 4000 and polyethylene glycol 6000.

[0011] In one embodiment, the auxiliary material further includes one or more of a plasticizer, a disintegrant and a flavoring agent.

[0012] In one embodiment, the plasticizer is one or more of glycerol, propylene glycol and polyethylene glycol 400.

[0013] In one embodiment, the disintegrant is one or more of cross-linked sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose and sodium carboxymethyl starch; and / or

[0014] The flavor corrector is one or more of aspartame, steviol glycoside, sucralose and menthol.

[0015] In one embodiment, the echinacoside oral fast-dissolving film comprises the following components in parts by weight:

[0016] 50-80 parts of echinacoside, 10-48 parts of film-forming material and 2-8 parts of dispersant.

[0017] The second aspect of the present invention provides a method for preparing the above-mentioned echinacoside oral fast-dissolving film, comprising the following steps:

[0018] Mixing the film-forming material and water to prepare a colloidal solution;

[0019] The echinacoside and the dispersant are mixed, added into the colloidal solution, stirred, and dried to prepare an echinacoside oral fast-dissolving film.

[0020] The third aspect of the present invention provides use of the above-mentioned oral fast-dissolving echinacoside film in the preparation of a drug for treating Alzheimer's disease.

[0021] Compared with the prior art, this application has the following beneficial effects:

[0022] The present application rationally designs the formula of the echinacoside oral fast-dissolving film, takes echinacoside as the active pharmaceutical ingredient, selects a mixture of hydroxypropyl methylcellulose, sodium alginate and carbomer as the film-forming material, and uses a synergistic dispersant to prepare the echinacoside oral fast-dissolving film, which is found through effect testing to have uniform thickness, good appearance, good toughness, high drug loading, and rapid disintegration, thereby achieving the purpose of rapid drug release.

[0023] In addition, the oral fast-dissolving film preparation of echinacoside of the present application can ensure a higher drug loading to better exert the drug efficacy, can facilitate medication for patients with Alzheimer's disease, improve patient compliance, and has great potential for clinical application. DETAILED DESCRIPTION

[0024] The following is a further detailed description of the oral fast-dissolving echinacoside film of the present application in conjunction with specific examples. The present application can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present application more thoroughly understood.

[0025] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0026] Unless otherwise specified or incompatible herewith, the terms and phrases used herein shall have the following meanings:

[0027] As used herein, "one or more" refers to any one, any two, or any two or more of the listed items.

[0028] Herein, the optional scope of "and / or", "or / and", and "and / or" includes any one of two or more relevant listed items, and also includes any and all combinations of the relevant listed items, wherein said any and all combinations include any two relevant listed items, any more relevant listed items, or a combination of all relevant listed items.

[0029] Herein, "further", "further", "particularly" and the like are used for descriptive purposes to indicate differences in content, but should not be construed as limiting the scope of protection of this application.

[0030] Herein, "first aspect", "second aspect", "third aspect", "fourth aspect", etc. are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or quantity, nor can they be understood as implicitly indicating the importance or quantity of the indicated technical features. In addition, "first", "second", "third", "fourth", etc. only serve the purpose of non-exhaustive enumeration and description, and it should be understood that they do not constitute a closed limitation on quantity. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present application, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined. In the description of the present application, the meaning of "several" is at least one, such as one, two, etc., unless otherwise clearly and specifically defined.

[0031] In this application, when it comes to numerical ranges, unless otherwise specified, the above numerical ranges are deemed to be continuous and include the minimum and maximum values ​​of the range, as well as each value between such minimum and maximum values. Further, when a range refers to an integer, each integer between the minimum and maximum values ​​of the range is included. In addition, when multiple ranges are provided to describe features or characteristics, the ranges can be merged. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges included therein.

[0032] The percentage contents involved in this application, unless otherwise specified, refer to mass percentage for solid-liquid mixing and solid-solid mixing, and refer to volume percentage for liquid-liquid mixing.

[0033] The percentage concentrations mentioned in this application, unless otherwise specified, refer to the final concentration, which refers to the percentage of the added component in the system after the addition of the component.

[0034] The temperature parameters in this application, unless otherwise specified, allow both constant temperature treatment and treatment within a certain temperature range. The constant temperature treatment allows the temperature to fluctuate within the accuracy range controlled by the instrument. Fluctuations within the range of ±5°C, ±2°C, ±1°C, ±0.5°C, ±0.4°C, ±0.3°C, ±0.2°C, and ±0.1°C are allowed. Normal temperature or room temperature in this application refers to no temperature control operation, generally 4°C to 35°C, preferably 20±5°C.

[0035] Oral fast-dissolving film is a film prepared by dissolving, dispersing or wrapping the drug in a film-forming material and then preparing it into a single-layer, multi-layer or composite film. It does not need to be taken with water when used, and can quickly dissolve and release the drug in saliva. The drug can directly enter the systemic circulation through the sublingual portal vein, and can also be absorbed into the blood through the non-keratinized cells of the sublingual mucosa, inner lip mucosa, buccal mucosa and other parts, avoiding the first-pass effect of the liver and damage to the gastrointestinal tract, thereby improving bioavailability. As a new type of oral mucosal rapid-release preparation, oral fast-dissolving film has many advantages such as a wide range of applications, easy to carry and safe to use. It is especially suitable for the elderly, children and people with swallowing difficulties, and has gradually become a new highlight in the research and development of pharmaceutical preparations.

[0036] A typical oral dissolving film formulation usually includes: active pharmaceutical ingredients (5%-30% w / w), film-forming materials (40%-60% w / w), and if necessary, plasticizers (0%-20% w / w), surfactants, disintegrants, sweeteners, salivary stimulants, fillers, flavors and pigments. Film-forming materials are an important component of film preparations, and their properties directly affect the drug loading, film release, dissolution time, mechanical strength, etc. of the film preparations. The drug loading of oral fast-dissolving films is generally low, at 30-60 mg. When the poorly soluble drugs are made into oral fast-dissolving films according to the conventional oral fast-dissolving film preparation method, the drug loading is often even lower. In order for echinacoside to exert its clinical efficacy in treating Alzheimer's disease, the dosage must be at least 100 mg and it is slightly soluble in water. When preparing an oral fast-dissolving film, as the drug loading increases, it will lead to uneven dispersion when the drug and the glue are mixed, and a large number of bubbles that are difficult to dissipate will be generated. After drying, there are obvious particles and bubble holes on the surface of the film, the thickness is uneven, and it is easy to break when cutting. Therefore, how to optimize the film-forming material and increase the dispersibility of echinacoside, and develop an oral fast-dissolving echinacoside film preparation with high drug loading, uniform thickness, good appearance and good toughness, has high technical difficulty.

[0037] The commonly used film-forming materials for preparing oral fast-dissolving films mainly include hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinyl alcohol, polyoxyethylene, povidone, gelatin, xanthan gum, shellac, pullulan, etc. Hydroxypropyl methylcellulose (HPMC) can be divided into E / K / F model series according to the difference in methoxyl group and hydroxypropyl methyl group. Among them, the E series has good film-forming properties, especially HPMC-E15, HPMC-E30 and HPMC-E50 can be used alone as film-forming materials to prepare oral fast-dissolving films, but the drug loading is not high, which is suitable for highly active drugs. Sodium alginate is used alone as a film-forming material, and the viscosity is too high, making it very difficult to prepare oral dissolving films. The use of sodium alginate in combination with HPMC can greatly reduce the amount of HPMC used, increase the drug loading, and at the same time improve the problem of uneven thickness caused by dehydration during the film drying process. Although the use of HPMC and sodium alginate can increase the drug loading of echinacoside, as the drug loading continues to increase, uneven dispersion of the drug and the glue solution will occur, and a large number of bubbles that are difficult to dissipate will be generated. Carbomer has good water absorption and water retention, which can not only increase the uniformity of echinacoside when mixed with the glue solution, but also increase the toughness of the film to prevent rupture during demoulding and cutting. Dispersant polyethylene glycol can further increase the drug loading, improve the uniformity of echinacoside when mixed with the glue solution, and significantly reduce the generation of bubbles during the mixing process.

[0038] Based on this, the present application selects hydroxypropyl methylcellulose, sodium alginate and carbomer as film-forming materials through the optimization of excipients, and uses polyethylene glycol as a dispersant to prepare an oral fast-dissolving film of echinacoside, with a drug loading of up to 100mg-160mg, uniform thickness, good appearance and toughness, and can be completely disintegrated within 45 seconds to achieve the purpose of rapid drug release, which is of great significance for improving the medication compliance of patients with Alzheimer's disease and improving the bioavailability of echinacoside.

[0039] In a first aspect of the present invention, there is provided an oral fast-dissolving echinacoside film, comprising echinacoside and auxiliary materials; the auxiliary materials include a film-forming material and a dispersant;

[0040] The film-forming material comprises a mixture of hydroxypropyl methylcellulose, sodium alginate and carbomer.

[0041] In one specific example, the hydroxypropyl methylcellulose includes one or more of HPMC-E15, HPMC-E30 and HPMC-E50.

[0042] In one specific example, the carbomer includes carbomer 974P.

[0043] In some examples, the dispersant is polyethylene glycol.

[0044] In one specific example, the dispersant includes one or both of polyethylene glycol 4000 and polyethylene glycol 6000.

[0045] In one of the specific examples, the film-forming material includes a mixture of propyl methylcellulose-E15, sodium alginate and carbomer 974P. Specifically, echinacoside requires a higher drug loading to exert clinical efficacy. The mixture of hydroxypropyl methylcellulose-E15, sodium alginate and carbomer 974P can significantly increase the drug loading of echinacoside, and the obtained film is flat, smooth, and has no drug particle precipitation, uniform thickness, good toughness, fracture resistance, and is not easy to break. At the same time, adding polyethylene glycol as a dispersant in the prescription can further increase the drug loading, improve the uniformity of echinacoside when mixed with the glue, significantly reduce the generation of bubbles during the mixing process, avoid drug precipitation during drying, and make the obtained film surface smooth, uniform in color, and free of bubble holes.

[0046] In some examples, the weight ratio of hydroxypropyl methylcellulose, sodium alginate and carbomer in the film-forming material is (6-10): (1-3): (0.1-1). It can be understood that the weight ratio of hydroxypropyl methylcellulose, sodium alginate and carbomer in the film-forming material includes but is not limited to 6:1:1, 7:1:1, 8:1:1, 6:2:0.5, 7:2:0.5, 8:2:0.5.

[0047] In some examples, the weight ratio of the film-forming material to the dispersant is (1-25): 1. It can be understood that the weight ratio of the film-forming material to the dispersant includes but is not limited to 1:1, 5:1, 10:1, 15:1, 20:1, 25:1.

[0048] In some examples, the excipients further include one or more of a plasticizer, a disintegrant and a flavoring agent.

[0049] In some examples, the plasticizer is one or more of glycerol, propylene glycol, and polyethylene glycol 400.

[0050] In some examples, the disintegrant is one or more of cross-linked sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose and sodium carboxymethyl starch.

[0051] In some examples, the flavoring agent is one or more of aspartame, steviol glycosides, sucralose, and menthol.

[0052] In some examples, the echinacoside oral fast-dissolving film comprises the following components in parts by weight:

[0053] 50-80 parts of echinacoside, 10-48 parts of film-forming material and 2-8 parts of dispersant.

[0054] In some examples, the echinacoside oral fast-dissolving film comprises the following components in parts by weight:

[0055] 50-80 parts of echinacoside, 10-48 parts of film-forming material, 2-8 parts of dispersant, 0-4 parts of plasticizer, 0-6 parts of disintegrant and 0-3 parts of flavoring agent.

[0056] The second aspect of the present invention provides a method for preparing the above-mentioned echinacoside oral fast-dissolving film, comprising the following steps:

[0057] Mixing the film-forming material and water to prepare a colloidal solution;

[0058] The echinacoside and the dispersant are mixed, added into the colloidal solution, stirred, and dried to prepare an echinacoside oral fast-dissolving film.

[0059] In one specific example, the preparation method of the echinacoside oral fast-dissolving film comprises the following steps:

[0060] Mixing the film-forming material and water to prepare a colloidal solution;

[0061] The echinacoside and the dispersant are mixed, added to the colloidal solution, and the plasticizer, disintegrant and flavoring agent are added according to weight proportions, stirred, and dried to prepare an echinacoside oral fast-dissolving film.

[0062] In some examples, the conditions of the preparation method of the echinacoside oral fast-dissolving film include: the stirring time is 1 hour to 2 hours. It can be understood that in the preparation method of the echinacoside oral fast-dissolving film, the stirring time includes but is not limited to 1 hour, 1.2 hours, 1.4 hours, 1.6 hours, 1.8 hours, and 2 hours.

[0063] In some of the examples, the conditions of the preparation method of the echinacoside oral fast-dissolving film include: the drying temperature is 40°C 50°C. It can be understood that in the preparation method of the echinacoside oral fast-dissolving film, the drying temperature includes but is not limited to 40°C, 42°C, 44°C, 46°C, 48°C, and 50°C.

[0064] The third aspect of the present invention provides use of the above-mentioned oral fast-dissolving echinacoside film in the preparation of a drug for treating Alzheimer's disease.

[0065] The following is further described in conjunction with specific embodiments. The raw materials involved in the following specific embodiments, unless otherwise specified, can all be commercially available; the instruments used, unless otherwise specified, can all be commercially available; the processes involved, unless otherwise specified, are all routinely selected by those skilled in the art.

[0066] The formulas of the echinacea glycoside oral fast-dissolving film preparations of Examples 1-6 and their dosages (parts by weight) and the performance test results are shown in Table 1, and the formulas of the echinacea glycoside oral fast-dissolving film preparations of Comparative Examples 1-7 and their dosages (parts by weight) and the performance test results are shown in Table 2.

[0067] The specific preparation methods of the echinacoside oral fast-dissolving film preparations of Examples 1-6 and Comparative Examples 1-7 are as follows:

[0068] (1) crushing the echinacoside raw material to control the particle size of the raw material, passing the powder through a 100-150 mesh pharmacopoeia sieve (preferably a 120 mesh pharmacopoeia sieve), and weighing each raw material and excipient according to the prescribed amount;

[0069] (2) adding the membrane-forming material into purified water, and measuring the pH value after sufficient swelling. If the pH value is lower than 6, adding 10% NaOH solution to adjust the pH to 6-7 (preferably 6.5) to form a colloidal solution;

[0070] (3) Mixing echinacoside with a dispersant, adding the mixture to the above-mentioned glue solution to make it uniformly dispersed; continuing to add a plasticizer, a disintegrant, and a flavoring agent, stirring for 1-2 hours (preferably 1.5 hours) to make the mixture uniformly mixed, thereby obtaining a drug-containing glue solution, and vacuum degassing to form a uniform drug-containing glue solution;

[0071] (4) Add the drug-containing glue solution into a coating machine, evenly coat it on a flat backing material, and dry it at 40°C-50°C (preferably 45°C);

[0072] (5) The film is demoulded and peeled off from the backing, cut into pieces of 3 cm*5 cm in size, and sealed and packaged.

[0073] The effect detection method is as follows:

[0074] 1. Average tablet weight: Take 20 tablets of the test sample, accurately weigh them, and calculate the average weight.

[0075] 2. Content uniformity: According to the requirements of the content uniformity test method in Part IV of the 2020 edition of the "Chinese Pharmacopoeia", take 10 portions of the test sample, determine the content separately, calculate the relative average content and standard deviation, and A+2.2S should be ≤15.

[0076] 3. Thickness: Randomly select 5 points on the prepared film, measure their thickness with a micrometer and calculate the average value.

[0077] 4. Disintegration time limit: There is currently no standard method for determining the in vitro disintegration time limit of orodisintegrating films. Refer to the disintegration basket inspection method for orodisintegrating tablets in the disintegration time limit inspection method of Part IV of the 2020 edition of the Chinese Pharmacopoeia. The lifting bracket and the stainless steel tube with a screen at the lower end, the lifting metal bracket moves up and down a distance of 10mm±1mm, and the reciprocating frequency is 30 times per minute. Fix the stainless steel tube on the bracket and immerse it in a 1000mL cup. The cup contains about 900mL of water at a temperature of 37℃±1℃. Adjust the water level so that the screen is 15mm±1mm below the water surface when the stainless steel tube is at the lowest position. Start the instrument. Take 1 tablet of this product and place it in the above-mentioned stainless steel tube for inspection. It should be completely disintegrated and pass through the screen within 60 seconds. If there is a small amount of light floating or adhering to the inner wall of the stainless steel tube or the screen, but there is no hard core, it can be considered as meeting the regulations. Repeat the measurement of 6 tablets, and all should meet the regulations.

[0078] 5. Tensile strength: Cut the prepared film into small films of 3 cm × 2 cm and place them between the two clamps of an XLW-PC electronic tensile testing machine (Jinan Rongqian Intelligent Technology Co., Ltd.), so that the center line of the small film coincides with the center line of the two clamps. Set the speed to 20 mm / min and start the tensile testing machine until the film breaks. Record the tensile strength and measure 3 times to get the average value.

[0079] Table 1

[0080]

[0081]

[0082] Table 2

[0083]

[0084]

[0085] As shown in Tables 1 and 2, HPMC-E15 alone can be used as a film-forming material to prepare a film, but the surface is rough and uneven, the thickness is uneven, there are a small number of air bubbles, a large number of drug particles are precipitated, the content uniformity is poor, the tensile strength is low, and it is easy to break (Comparative Example 1); when sodium alginate or carbomer 974P is used alone, or a mixture of sodium alginate and carbomer 974P is used as a film-forming material, the viscosity is too large and it is difficult to prepare an orally soluble film (Comparative Examples 2-3); when a mixture of HPMC-E15 and sodium alginate is used to prepare a film, the surface is rough and uneven, the thickness uniformity is slightly poor, there are a small number of air bubbles, a large number of drug particles are precipitated, and the content uniformity is poor (Comparative Example 5); when HPMC-E15 and carbomer 974P are used to prepare a film , the surface is rough and uneven, the thickness is uneven, a small amount of drug particles are precipitated, and the content uniformity is poor (Comparative Example 6); HPMC-E15, sodium alginate and carbomer 974P are used as film-forming materials, and polyethylene glycol 4000 is not added as a dispersant. The surface of the prepared film is rough and uneven, there are a large number of bubble holes, and a small amount of drug particles are precipitated (Comparative Example 4); while Examples 1-6 use HPMC-E15, sodium alginate and carbomer 974P as film-forming materials at the same time, and polyethylene glycol 4000 is added to improve the uniformity of echinacoside when mixed with the glue, reduce bubbles during the mixing process, and obtain a film with a smooth surface, uniform color and thickness, no bubble holes, no drug particles are precipitated, good content uniformity, high tensile strength, and not easy to break.

[0086] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0087] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims, and the description may be used to interpret the content of the claims.

Claims

1. An echinacoside oral fast-dissolving film, characterized in that: It comprises echinacea glycoside and auxiliary materials; the auxiliary materials comprise film-forming materials and dispersants; The film-forming material comprises a mixture of hydroxypropyl methylcellulose, sodium alginate and carbomer.

2. The echinacoside oral fast-dissolving film according to claim 1, characterized in that In the film-forming material, the weight ratio of hydroxypropyl methylcellulose, sodium alginate and carbomer is (6-10): (1-3): (0.1-1).

3. The echinacoside oral fast-dissolving film according to claim 1, characterized in that The weight ratio of the film-forming material to the dispersant is (1-25):

1.

4. The echinacoside oral fast-dissolving film according to claim 1, characterized in that The dispersant is polyethylene glycol; optionally, the dispersant includes one or both of polyethylene glycol 4000 and polyethylene glycol 6000.

5. The echinacoside oral fast-dissolving film according to claim 1, characterized in that The auxiliary materials also include one or more of plasticizers, disintegrants and flavoring agents.

6. The echinacoside oral fast-dissolving film according to claim 5, characterized in that: The plasticizer is one or more of glycerol, propylene glycol and polyethylene glycol 400.

7. The echinacoside oral fast-dissolving film according to claim 5, characterized in that The disintegrant is one or more of cross-linked sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose and sodium carboxymethyl starch; and / or The flavor corrector is one or more of aspartame, steviol glycoside, sucralose and menthol.

8. The echinacoside oral fast-dissolving film according to any one of claims 1 to 7, characterized in that: In parts by weight, it includes the following components: 50-80 parts of echinacoside, 10-48 parts of film-forming material and 2-8 parts of dispersant.

9. A method for preparing the echinacoside oral fast-dissolving film according to any one of claims 1 to 8, characterized in that: The following steps are involved: Mixing the film-forming material and water to prepare a colloidal solution; The echinacoside and the dispersant are mixed, added into the colloidal solution, stirred, and dried to prepare an echinacoside oral fast-dissolving film.

10. Use of the echinacoside oral fast-dissolving film according to any one of claims 1 to 8 in the preparation of a drug for treating Alzheimer's disease.

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