Rasagiline mesylate oral disintegrating film composition and preparation method and application thereof

Abstract

This invention provides an orally disintegrating film composition of rasagiline mesylate, its preparation method, and its uses. The orally disintegrating film composition of rasagiline mesylate comprises an active pharmaceutical ingredient, a film-forming material, and a flavor masking agent; the active pharmaceutical ingredient is one or more of N-propynyl-1(R)-aminoindene methanesulfonate (rasagiline mesylate) as shown in Formula I and its solvates. The orally disintegrating film composition of rasagiline mesylate of this invention has the advantages of thin thickness, good taste, stable properties, good dissolution rate, immediate dissolution in the oral cavity without the need for drinking water, no gritty feeling after dissolution in the oral cavity, and rapid oral absorption. It also has a uniform appearance, good flexibility, and a simple preparation process. No sedimentation occurs during the preparation of the film solution, the content uniformity meets requirements, and the drug loading capacity is high. It solves the defects of existing formulations such as inconvenience of administration and poor patient compliance, and is particularly suitable for patients with dysphagia.

Description

Rasagiline mesylate orally disintegrating film composition, preparation method and use thereof The present invention claims priority to a prior application, patent application number 202310059727.6, filed with the State Intellectual Property Office of China on January 19, 2023, entitled "Rasagiline Mesylate Orally Dissolving Film Composition, Preparation Method, and Use Thereof." The entire text of the prior application is incorporated herein by reference. The present invention relates to the field of pharmaceutical preparations, and in particular to a rasagiline mesylate orally disintegrating film composition, a preparation method and uses thereof. Parkinson's disease (PD) is a common neurodegenerative disorder that is more common in the elderly, with an average age of onset around 60 years. Younger onset, with Parkinson's disease before 40 years of age, is less common. The prevalence of PD in people over 65 years of age in China is approximately 1.7%. Most cases are sporadic, with less than 10% of patients having a family history. The primary pathological change in Parkinson's disease is the degeneration and death of dopamine (DA) neurons in the substantia nigra of the midbrain, which leads to a significant decrease in DA content in the striatum and contributes to the disease. The exact cause of this pathological change remains unclear, but genetic, environmental, aging, and oxidative stress may all contribute to the degeneration and death of dopamine neurons in PD. Current treatments for Parkinson's disease include oral, parenteral, and neurosurgery, depending on the stage and severity of the disease. Various drug classes are available to treat this complex neurological disorder. There is no definitive cure for Parkinson's disease. Drug therapy is the mainstay of treatment, with surgery serving as an effective supplement. Rehabilitation therapy, psychotherapy, and good nursing care can also improve symptoms to a certain extent. Although the treatments used can only improve symptoms and cannot prevent the progression of the disease or cure the disease, effective treatment can significantly improve the patient's life quality. The current drug strategies used to control symptoms are levodopa, catechol-O-methyltransferase (COMT) inhibitors, dopamine agonists, monoamine oxidase B (MAO-B) inhibitors, anticholinergics, and amantadine drugs. Although there are many drugs to treat Parkinson's disease, effective relief of the characteristics associated with the disease remains elusive. Long-term treatment with most drugs can lead to several complications and non-motor manifestations. MAO-B inhibitors have been used to treat Parkinson's disease, both as monotherapy in the early stages and in combination therapy for patients with advanced disease. MAO-B inhibitors, also known as monoamine oxidase type B inhibitors, are a first-line anti-Parkinson's drug class; this class includes selegiline and rasagiline. Their mechanism of action for Parkinson's disease is two-fold: neuroprotection and symptom improvement. Research has demonstrated that MAO-B inhibitors protect neurons by combating oxidative stress, inhibiting synuclein aggregation, reducing apoptosis, and exerting neurotrophic effects. Some clinical trials have shown that these drugs may slow the progression of Parkinson's disease. Rasagiline, currently the leading MAO-B inhibitor for the clinical treatment of Parkinson's disease, was first marketed in Israel in March 2005, followed by the UK in June, Ireland in September, the US in 2006, and officially in China in 2017. Compared to selegiline, it has many advantages, including being 5-10 times more potent, having dose-dependent selectivity, having fewer adverse reactions, and not being metabolized to amphetamine derivatives. A double-blind, delayed-dose trial of rasagiline, called ADAGIO, showed that 1 mg / day of rasagiline reduced the average daily "off" time and improved Parkinson's disease symptoms in patients with motor fluctuations treated with L-dopa. Multiple studies have suggested that rasagiline may have neuroprotective and disease-modifying effects. Oral rasagiline is rapidly absorbed from the gastrointestinal tract, reaching peak plasma concentrations within one hour. Among the currently approved MAO-B inhibitors, rasagiline is the most widely used for the treatment of Parkinson's disease. In Europe, rasagiline (Azilect) received approval from the European Medicines Agency (EMA) in February 2005 for the treatment of idiopathic Parkinson's disease as monotherapy (without levodopa) or as adjunctive therapy (with levodopa) for patients with end-stage motor fluctuations. Azilect is available only as a 1 mg immediate-release conventional film-coated tablet. According to the approved dose, it should be taken once daily with or without levodopa. In Japan, Azilect was approved in March 2018 and is available only as immediate-release conventional film-coated tablets in 0.5 mg and 1 mg strengths, for the same indications as in Europe. Rasagiline undergoes high first-pass hepatic metabolism, with an oral bioavailability of approximately 36%. This dosage form is not suitable for elderly patients with swallowing difficulties and is not convenient for patients to take without water. Furthermore, dosage forms containing rasagiline are known to cause dry mouth and, if absorbed orally, may cause local numbness. Therefore, finding a rasagiline preparation with stable properties, rapid onset of action, easy administration, and good patient compliance is a technical problem that urgently needs to be solved. The technical problem to be solved by the present invention is to improve the defects of the prior art rasagiline pharmaceutical preparations such as poor stability and poor patient compliance, and to provide a rasagiline mesylate orally disintegrating film composition, a preparation method and use thereof. The present invention provides a rasagiline mesylate orally disintegrating film composition, which comprises an active drug, a film-forming material, and a taste-masking agent; the active drug is one or more of N-propargyl-1(R)-aminoindene mesylate (rasagiline mesylate) and its solvates as shown in Formula I; I . According to an embodiment of the present invention, the weight percentage of the active drug is 1.0% to 40.0%, for example, 1.6%, 3.9%, 6.5%, 10%, 15.6%, 20%, 25%, 30%, 31.2% or 35%, and the weight percentage refers to the percentage of the weight of the active drug to the total weight of the rasagiline mesylate orosoluble film composition. According to an embodiment of the present invention, the particle size D of the active drug 90 Less than 200 μm. According to an embodiment of the present invention, the film-forming material is a drug carrier, preferably one or more of xanthan gum, guar gum, pectin, gelatin, shellac, gum arabic, starch, dextrin (such as maltodextrin), agar, sodium alginate, zein, hydroxypropyl methylcellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl alcohol, polyvinyl pyrrolidone, polyethylene glycol, polyoxyethylene, pullulan, acrylic acid copolymer, polylactic acid and silicone rubber. In some embodiments, the film-forming material is one or more of polyvinyl alcohol, hydroxypropyl methylcellulose, hydroxypropyl cellulose, dextrin (eg, maltodextrin), and polyethylene glycol (eg, polyethylene glycol 6000). In some embodiments, the film-forming material is selected from a mixture of a first film-forming material and a second film-forming material, the first film-forming material is selected from one or more of polyvinyl alcohol, hydroxypropyl methylcellulose and hydroxypropyl methylcellulose, and the second film-forming material is selected from one or more of dextrin (e.g., maltodextrin) and polyethylene glycol (e.g., polyethylene glycol 6000); preferably, the weight percentage of the first film-forming material is greater than the weight percentage of the second film-forming material, for example, the weight ratio of the first film-forming material to the second film-forming material is not less than 2:1, such as (2-40):1, and also such as (3-30):1, exemplified by 3:1, 6:1, 7:1, 10:1, 15:1, 20:1, and 25:1. In some embodiments, the film-forming material is selected from polyvinyl alcohol, hypromellose, a mixture of hypromellose and polyethylene glycol (e.g., polyethylene glycol 6000), a mixture of polyvinyl alcohol and polyethylene glycol (e.g., polyethylene glycol 6000), a mixture of polyvinyl alcohol and dextrin (e.g., maltodextrin), and a mixture of hypromellose and dextrin (e.g., maltodextrin). According to an embodiment of the present invention, the weight percentage of the film-forming material is 30.0% to 80.0%, for example, 35%, 38.2%, 40%, 45%, 50.0%, 44.4%, 51.8%, 53.5%, 58.0%, 59.7%, 60%, 67.3%, 70% or 75%, and the weight percentage refers to the percentage of the weight of the film-forming material to the total weight of the rasagiline mesylate orosoluble film composition. According to an embodiment of the present invention, the taste masking agent refers to a substance used to cover up the bad taste of the active drug and reduce the oral absorption of the active drug, preferably one or more of sodium polystyrene sulfonate, polyacrylamide potassium and polacrilin resin. According to an embodiment of the present invention, the weight percentage of the taste masking agent is 10.0% to 50.0%, for example, 10.0%, 15.0%, 20.0%, 21.5%, 21.9%, 25.0%, 25.9%, 30.0%, 35%, 41.7% or 45%, and the weight percentage refers to the percentage of the weight of the taste masking agent to the total weight of the rasagiline mesylate orosoluble film composition. According to an embodiment of the present invention, the rasagiline mesylate orally disintegrating film composition may further include one or more of a disintegrant, a plasticizer, a flavoring agent, a filler, and a colorant. According to an embodiment of the present invention, the disintegrant refers to an excipient that promotes the rapid disintegration of the drug into small particles in the gastrointestinal tract, preferably one or more of low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose and sodium carboxymethyl starch. According to an embodiment of the present invention, the weight percentage of the disintegrant is 0-5.0%, for example, 0, 2.0% or 3.0%, and the weight percentage refers to the percentage of the weight of the disintegrant to the total weight of the rasagiline mesylate orally disintegrating film composition. According to an embodiment of the present invention, the plasticizer refers to a substance used to lower the glass transition temperature of the film, increase plasticity and toughness, and improve elongation; the plasticizer is preferably one or more of glycerol, propylene glycol, silicone oil, polypropylene glycol and hexylene glycol. According to an embodiment of the present invention, the weight percentage of the plasticizer is preferably 0-20.0%, for example, 0, 6.0%, 7.0%, 10.0%, 15.0% or 20.0%, and the weight percentage refers to the percentage of the weight of the plasticizer to the total weight of the rasagiline mesylate orosoluble film composition. According to an embodiment of the present invention, the flavoring agent refers to a substance that acts as a flavoring agent in the film, preferably one or more of aspartame, sucralose, fructose, sucrose, steviol glycosides, glycyrrhizin, flavors, spices, menthol, sodium chloride, saccharin and saccharin sodium. According to an embodiment of the present invention, the weight percentage of the flavoring agent is preferably 0-5.0%, for example, 0, 2.4%, 2.6%, 2.8%, 3.0% or 4.0%, and the weight percentage refers to the percentage of the weight of the flavoring agent to the total weight of the rasagiline mesylate orosoluble film composition. According to an embodiment of the present invention, the filler refers to a solid substance that is added to the material to improve the material properties, or to increase the volume, increase the weight, and reduce the cost of the material, preferably one or more of mannitol, starch, microcrystalline cellulose, pregelatinized starch, lactose, sorbitol, xylitol, maltitol, galactitol, erythritol, dextrin and trehalose. According to an embodiment of the present invention, the weight percentage of the filler is preferably 0-30.0%, for example, 0, 10.0% or 26.0%, and the weight percentage refers to the percentage of the weight of the filler to the total weight of the rasagiline mesylate orosoluble film composition. According to an embodiment of the present invention, the colorant refers to a substance that can improve the appearance color of the preparation and can be used to identify the concentration of the preparation, distinguish the application method and reduce the patient's aversion to taking the medicine. It is preferably one or more of titanium dioxide, pigments and lakes. According to an embodiment of the present invention, the weight percentage of the colorant is preferably 0-1.0%, for example, 0, 0.1% or 0.2%, where the weight percentage refers to the percentage of the weight of the colorant to the total weight of the rasagiline mesylate orosoluble film composition. According to an embodiment of the present invention, the rasagiline mesylate orosoluble film composition can be any of the following formulas: Formula 1: 31.2% rasagiline mesylate, 50.0% polyvinyl alcohol, 6.0% glycerol, 10.0% polyclinic potassium and 2.8% sucralose, and the weight percentage refers to the percentage of the weight of each component to the total weight of the rasagiline mesylate orosoluble film composition; Formula 2: 15.6% rasagiline mesylate, 50.0% hydropropyl methylcellulose, 10.0% glycerol, 10.0% sodium polystyrene sulfonate, 2.4% steviol glycosides, 2.0% sodium carboxymethyl starch and 10.0% pregelatinized starch, and the weight percentage refers to the percentage of the weight of each component to the total weight of the rasagiline mesylate orosoluble film composition; Prescription 3: 15.6% rasagiline mesylate, 44.4% polyvinyl alcohol, 10.0% glycerol and 30.0% polyclinic potassium, the weight percentages of which refer to the percentages of the weight of each component in the total weight of the rasagiline mesylate orosoluble film composition; Prescription 4: 3.9% rasagiline mesylate, 58.0% hydropropyl methylcellulose, 20.0% glycerol, 15.0% polyclinic potassium, 2.5% stevioside, 0.3% menthol, 0.2% flavor and 0.1% lake, the weight percentages of which refer to the percentages of the weight of each component in the total weight of the rasagiline mesylate orosoluble film composition; Prescription 5: 3.9% rasagiline mesylate, 40.5% hypromellose, 13.0% polyethylene glycol 6000, 15.0% glycerin, 25.0% polyclinic potassium, 2.5% sucralose and 0.1% flavor, the weight percentages refer to the percentages of the weight of each component in the total weight of the rasagiline mesylate orosoluble film composition; Prescription 6: 1.6% rasagiline mesylate, 38.2% polyvinyl alcohol, 7.0% glycerin, 20.0% sodium polystyrene sulfonate, 2.0% sucralose, 1.0% menthol, 1.0% flavor, 0.1% lake, 0.1% titanium dioxide, 3.0% sodium carboxymethyl starch, 16.0% pregelatinized starch and 10.0% microcrystalline cellulose, the weight percentages refer to the percentages of the weight of each component in the total weight of the rasagiline mesylate orosoluble film composition; Formula 7: 6.5% rasagiline mesylate, 50.0% polyvinyl alcohol, 1.8% polyethylene glycol 6000 and 41.7% polyclinic potassium, the weight percentages refer to the weight percentages of each component in the total weight of the rasagiline mesylate orosoluble film composition; Formula 8: 4.0% rasagiline mesylate, 51.9% hydropropyl methylcellulose, 7.8% maltodextrin, 10.4% glycerol and 25.9% sodium polystyrene sulfonate, the weight percentages refer to the weight percentages of each component in the total weight of the rasagiline mesylate orosoluble film composition; Formula 9: 3.4% rasagiline mesylate, 65.9% hydroxypropyl cellulose, 6.6% maltodextrin, 2.2% titanium dioxide and 21.9% sodium polystyrene sulfonate, the weight percentages refer to the weight percentages of each component in the total weight of the rasagiline mesylate orodissolving film composition; Formulation 10: 3.4% rasagiline mesylate, 64.4% hydroxypropyl cellulose, 10.7% maltodextrin, and 21.5% sodium polystyrene sulfonate, the weight percentages refer to the weight percentages of each component in the total weight of the rasagiline mesylate orodissolving film composition. The present invention also provides a method for preparing the rasagiline mesylate orally disintegrating film composition, which comprises the following steps: 1) preparing an active drug aqueous solution; 2) adding a taste masking agent to the active drug aqueous solution obtained in step 1) and stirring to obtain a sample; 3) centrifuging the sample obtained in step 2), discarding part of the supernatant, and making the weight of the remaining lower layer material 10 to 15 times that of the active drug to obtain a drug-loaded resin; 4) dissolving the film-forming material in water and mixing it with a flavoring agent (optionally adding or not adding one or more of a plasticizer, a colorant and a filler), stirring evenly to obtain a glue solution; 5) transferring the drug-loaded resin obtained in step 3) to the glue solution obtained in step 4) and stirring thoroughly to obtain a uniform glue solution. After the stirring is completed, the glue solution is vacuum-degassing to remove bubbles, coating, drying, and cutting to obtain the rasagiline mesylate orally disintegrating film preparation; 6) uniformly coating the drug-containing glue solution obtained in step 5) on a release film using a coating machine, heating, drying, and cutting to obtain the rasagiline mesylate orally disintegrating film composition. According to an embodiment of the present invention, in step 1), the water is preferably purified water. According to an embodiment of the present invention, in step 2), the stirring time is preferably more than 1 hour. According to an embodiment of the present invention, in step 3), the centrifugation is preferably performed in a centrifuge; the centrifuge may be a desktop centrifuge, or a low-speed centrifuge. According to an embodiment of the present invention, the thickness of the rasagiline mesylate orally disintegrating film composition is 10 μm to 300 μm, for example, 10 μm to 100 μm. According to an embodiment of the present invention, the rasagiline mesylate orally disintegrating film composition can be completely disintegrated within 2 minutes in 900 mL of simulated saliva at 37±1°C. The present invention also provides use of the rasagiline mesylate orally disintegrating film composition in preparing a drug for treating and / or preventing primary Parkinson's disease as a single-drug therapy and a combined therapy for patients with end-of-dose fluctuations. According to an embodiment of the present invention, the rasagiline mesylate orally disintegrating film composition is a pharmaceutical preparation, and the dosage form of the pharmaceutical preparation can be an orally disintegrating film. The present invention also provides a method for treating idiopathic Parkinson's disease and patients with end-of-dose fluctuations, comprising administering a therapeutically effective amount of the rasagiline mesylate orosoluble film composition to a patient in need. Unless otherwise indicated, definitions of terms in the present specification and claims, including definitions used as examples, exemplary definitions, preferred definitions, and specific definitions in embodiments, may be arbitrarily combined and coupled with each other. Such combinations and couplings shall fall within the scope of the present specification. The term "therapeutically effective amount" refers to an amount of the pharmaceutically active agent of the present invention sufficient to achieve the intended application (including but not limited to the treatment of diseases as defined below). The therapeutically effective amount may vary depending on factors such as the intended application (in vitro or in vivo), or the subject and disease condition being treated, such as the weight and age of the subject, the severity of the disease condition, and the mode of administration, which can be readily determined by one of ordinary skill in the art to which the present invention pertains. The specific dosage will vary depending on factors such as the specific active agent selected, the dosing regimen followed, whether it is administered in combination with other compounds, the timing of administration, the tissue to which it is administered, and the physical delivery system used. Without violating the common sense in the art, the above-mentioned preferred conditions can be arbitrarily combined to obtain preferred embodiments of the present invention. The reagents and raw materials used in the present invention are commercially available. The present invention has the following beneficial effects: The orally disintegrating film composition of rasagiline mesylate has a thin thickness, good mouthfeel, stable properties, and a good dissolution rate. It dissolves instantly in the oral cavity without drinking water, does not leave a gritty sensation after dissolution in the oral cavity, and has a rapid oral absorption rate. Furthermore, it has a uniform appearance and good flexibility. Furthermore, the preparation process is simple, no sedimentation occurs during the film liquid preparation process, the content uniformity meets requirements, and the drug loading capacity is high. This overcomes the drawbacks of existing preparations, such as inconvenient administration and poor patient compliance, and is particularly suitable for patients with dysphagia. The present invention is further illustrated by way of examples below, but the present invention is not limited to the scope of the examples. Experimental methods without specific conditions in the following examples were performed according to conventional methods and conditions, or selected according to the product specifications. Example 1-10: The prescription is as follows Table 1 *Indicates removal during the manufacturing process; **Indicates the weight of raw and auxiliary materials after removing water. Preparation method: 1) an active drug is mixed with purified water to prepare an active drug aqueous solution; 2) a taste masking agent is added to the active drug aqueous solution obtained in step 1) and stirred (for 2-3 hours) to obtain a sample; 3) the sample obtained in step 2) is centrifuged (a low-speed centrifuge can be used), part of the supernatant is discarded, and the weight of the remaining lower layer material is 10 to 15 times that of the active drug to obtain a drug-loaded resin; 4) the film-forming material is dissolved in water and mixed with a flavoring agent (one or more of a plasticizer, a colorant and a filler are added according to the prescription), and stirred evenly to obtain a glue solution; 5) the drug-loaded resin obtained in step 3) is transferred to the glue solution obtained in step 4) and stirred thoroughly to obtain a uniform glue solution. After the stirring is completed, the glue solution is vacuum-degassing to remove bubbles, coated, dried, and cut to obtain the said rasagiline mesylate orally disintegrating film preparation; 6) the drug-containing glue solution obtained in step 5) is evenly coated on a release film using a coating machine, heated, dried, and cut to obtain the rasagiline mesylate orally disintegrating film composition. 1. Disintegration time test According to the prescriptions of Examples 1 to 10, the preparation method provided by the present invention was used to prepare orally disintegrating film preparations of rasagiline mesylate, and the disintegration time thereof was measured. The specific measurement method was as follows: 6 films obtained in each example were randomly selected, one film was taken at a time, and gently placed in 900 ml of artificial saliva at 37±1°C. The time for the product to completely disintegrate was observed under static conditions. The results are shown in Table 2. Table 2 2. Dissolution Determination The dissolution rates of the orally disintegrating film-dissolving formulations of rasagiline mesylate from Examples 1 to 10 were determined using the following method: Test medium: 900 ml of pH 1.0 hydrochloric acid solution (37°C ± 0.5°C). Dissolution method: Dissolution and Release Determination Method 2 (Paddle Method) according to the Chinese Pharmacopoeia (2020 Edition) 0931, at a rotation speed of 50 rpm. Sampling time: 30 minutes. Six tablets of the orally disintegrating film-dissolving formulation of rasagiline mesylate obtained in each example were collected, one tablet at a time, and the dissolution rates were determined using the above method. The results are shown in Table 3. Table 3 3. Mechanical strength test Use a texture analyzer (Model: Rapid TA + , Manufacturer: Shanghai Tengba Instrument Technology Co., Ltd.) The mechanical strength test of the rasagiline mesylate orally disintegrating film preparations of Examples 1 to 10 was performed. The results are shown in Table 4. Table 4 Orally dissolving film related substance test The orally disintegrating film preparations of rasagiline mesylate of Examples 1 to 10 were placed at a high temperature of 50° C. for 30 days, and the levels of related substances in the preparations were tested. The detection method for related substances is determined by high performance liquid column chromatography. Solvent perchloric acid buffer For the test solution, take two sheets of high-temperature 10-day rasagiline orally dissolving film, cut them into appropriate sizes, accurately weigh an appropriate amount (equivalent to approximately 1.3 mg of rasagiline), and place them in a 10 ml volumetric flask; add an appropriate amount of mobile phase to the above sample and sonicate for 5 minutes to dissolve it; dilute to the scale with mobile phase and shake well; take an appropriate amount of solution, centrifuge at 10,000 rpm for 5 minutes, and then collect the supernatant. Column chromatography conditions used were Wondasil C18, 250x4.6 mm, 5 μm column chromatography column; perchloric acid buffer (pH to 2.5)-acetonitrile (8:2) was used as the mobile phase; the detection wavelength was 210 nm; the flow rate was 1.0 mL / min; the column temperature was 30°C; the injection volume was 30 μL, and the execution time was 40 min. System suitability requires that in the column chromatogram of the test solution, the separation between the main peak and the adjacent column chromatographic peaks should meet the requirements. Impurity Correction Factors and Limits The test results of relevant substances are shown in Table 5. Table 5 The results showed that the rasagiline mesylate orally disintegrating films of Examples 1 to 10 of the present invention had good stability. Based on the above experimental data, it can be seen that the rasagiline mesylate orally disintegrating film composition provided by the present invention has the advantages of thin thickness, rapid disintegration, stable properties, good mechanical properties, instant dissolution in the mouth without drinking water, and rapid oral absorption. The above describes the embodiments of the present invention. However, the present invention is not limited to the above embodiments. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention shall be included in the scope of protection of the present invention. none

Claims

1. A rasagiline mesylate orally disintegrating film composition, characterized in that it comprises: an active pharmaceutical ingredient, a film-forming material, and a flavor masking agent; wherein the active pharmaceutical ingredient is one or more of N-propargyl-1(R)-aminoindene methanesulfonate and its solvates as shown in Formula I; wherein the weight percentage of the active pharmaceutical ingredient is 1.0% to 40.0%, and the weight percentage refers to the percentage of the weight of the active pharmaceutical ingredient to the total weight of the rasagiline mesylate orally disintegrating film composition; wherein the weight percentage of the film-forming material is 30.0% to 80.0%, and the weight percentage refers to the percentage of the weight of the film-forming material to the total weight of the rasagiline mesylate orally disintegrating film composition; wherein the film-forming material is selected from polyvinyl alcohol, hydroxypropyl methylcellulose, or a mixture of a first film-forming material and a second film-forming material, wherein the first film-forming material is selected from one or more of polyvinyl alcohol, hydroxypropyl methylcellulose, and hydroxypropyl cellulose, and the second film-forming material is selected from one or more of dextrin and polyethylene glycol.

2. The orally disintegrating film composition of rasagiline mesylate as claimed in claim 1, wherein, The particle size of the active drug is less than 200 μm (D90).

3. The orally disintegrating film composition of rasagiline mesylate as claimed in claim 1, wherein, The masking agent is one or more of sodium polystyrene sulfonate, potassium polycrylene, and polacrine resin.

4. The orally disintegrating film composition of rasagiline mesylate as claimed in claim 1, wherein, The masking agent has a weight percentage of 10.0% to 50.0%, where the weight percentage refers to the percentage of the weight of the masking agent relative to the total weight of the rasagiline mesylate oral disintegrating film composition.

5. The orally disintegrating film composition of rasagiline mesylate as claimed in any one of claims 1 to 4, wherein, The oral disintegrating film composition of rasagiline mesylate further comprises one or more of a disintegrant, a plasticizer, a flavoring agent, a filler, and a colorant.

6. The orally disintegrating film composition of rasagiline mesylate as claimed in claim 5, wherein, The disintegrant is one or more of low-substituted hydroxypropyl cellulose, crospovidone, crospovidone sodium carboxymethyl cellulose, and sodium carboxymethyl starch; and / or, the plasticizer is one or more of glycerol, propylene glycol, silicone oil, polypropylene glycol, and hexanediol; and / or, the flavoring agent is one or more of aspartame, sucralose, fructose, sucrose, steviol glycosides, glycyrrhizin, flavoring, fragrance, menthol, sodium chloride, saccharin, and sodium saccharin; and / or, the filler is one or more of mannitol, starch, microcrystalline cellulose, pregelatinized starch, lactose, sorbitol, xylitol, maltitol, galactitol, erythritol, dextrin, and trehalose; and / or, the coloring agent is one or more of titanium dioxide, pigments, and lakes.

7. The orally disintegrating film composition of rasagiline mesylate as claimed in claim 5, wherein, The disintegrant has a weight percentage of 0-5.0%, where the weight percentage refers to the percentage of the weight of the disintegrant in the total weight of the rasagiline mesylate oral soluble film composition; and / or, the plasticizer has a weight percentage of 0-20.0%, where the weight percentage refers to the percentage of the weight of the plasticizer in the total weight of the rasagiline mesylate oral soluble film composition; and / or, the flavoring agent has a weight percentage of 0-5.0%, where the weight percentage refers to the percentage of the weight of the flavoring agent in the total weight of the rasagiline mesylate oral soluble film composition; and / or, the filler has a weight percentage of 0-30.0%, where the weight percentage refers to the percentage of the weight of the filler in the total weight of the rasagiline mesylate oral soluble film composition; and / or, the colorant has a weight percentage of 0-1.0%, where the weight percentage refers to the percentage of the weight of the colorant in the total weight of the rasagiline mesylate oral soluble film composition.

8. The orally disintegrating film composition of rasagiline mesylate as claimed in claim 1, wherein, The rasagiline mesylate oral dissolving film composition is any of the following formulations: Formulation 1: 31.2% rasagiline mesylate, 50.0% polyvinyl alcohol, 6.0% glycerin, 10.0% potassium polykrylamide, and 2.8% sucralose, where the weight percentage refers to the percentage of each component's weight relative to the total weight of the rasagiline mesylate oral dissolving film composition; Formulation 2: 15.6% rasagiline mesylate, 50.0% hydroxypropyl methylcellulose, 10.0% glycerin, 10.0% sodium polystyrene sulfonate, 2.4% steviol glycosides, 2.0% sodium carboxymethyl starch, and 10.0% pregelatinized starch, where the weight percentage refers to the percentage of each component's weight relative to the total weight of the rasagiline mesylate oral dissolving film composition; Formula 3: 15.6% rasagiline mesylate, 44.4% polyvinyl alcohol, 10.0% glycerin, and 30.0% potassium polykrylamide, where the weight percentage refers to the percentage of each component's weight relative to the total weight of the rasagiline mesylate oral disintegrating film composition; Formula 4: 3.9% rasagiline mesylate, 58.0% hydroxypropyl methylcellulose, 20.0% glycerin, 15.0% potassium polykrylamide, 2.5% steviol glycosides, 0.3% menthol, 0.2% flavoring, and 0.1% lake, where the weight percentage refers to the percentage of each component's weight relative to the total weight of the rasagiline mesylate oral disintegrating film composition; Formula 5: 3.9% rasagiline mesylate, 40.5% hydroxypropyl methylcellulose, 13.0% polyethylene glycol 6000, 15.0% glycerin, 25.0% polycrylamide potassium, 2.5% sucralose, and 0.1% flavoring. The weight percentages refer to the percentage of each component's weight relative to the total weight of the rasagiline mesylate oral disintegrating film composition. Formula 6: 1.6% rasagiline mesylate, 38.2% polyvinyl alcohol, 7.0% glycerin, 20.0% sodium polystyrene sulfonate, 2.0% sucralose, 1.0% menthol, 1.0% flavoring, 0.1% lake, 0.1% titanium dioxide, 3.0% sodium carboxymethyl starch, 16.0% pregelatinized starch, and 10.0% microcrystalline cellulose. The weight percentages refer to the percentage of each component's weight relative to the total weight of the rasagiline mesylate oral disintegrating film composition. Formula 7: 6.5% rasagiline mesylate, 50.0% polyvinyl alcohol, 1.8% polyethylene glycol 6000, and 41.7% polycrylene potassium, where the weight percentage refers to the percentage of each component's weight relative to the total weight of the rasagiline mesylate oral disintegrating film composition; Formula 8: 4.0% rasagiline mesylate, 51.9% hydroxypropyl methylcellulose, 7.8% maltodextrin, 10.4% glycerin, and 25.9% sodium polystyrene sulfonate, where the weight percentage refers to the percentage of each component's weight relative to the total weight of the rasagiline mesylate oral disintegrating film composition; Formula 9: 3.4% rasagiline mesylate, 65.9% hydroxypropyl cellulose, 6.6% maltodextrin, 2.2% titanium dioxide, and 21.9% sodium polystyrene sulfonate, where the weight percentage refers to the percentage of each component's weight relative to the total weight of the rasagiline mesylate oral disintegrating film composition; Formulation 10: 3.4% rasagiline mesylate, 64.4% hydroxypropyl cellulose, 10.7% maltodextrin, and 21.5% sodium polystyrene sulfonate, where the weight percentage refers to the percentage of each component's weight relative to the total weight of the rasagiline mesylate oral disintegrating film composition.

9. A method for preparing an orally disintegrating film composition of rasagiline mesylate as described in any one of claims 1 to 8, wherein, Includes the following steps: 1) Prepare an aqueous solution of the active drug; 2) Add a masking agent to the aqueous solution of the active drug obtained in step 1), stir, and obtain a sample; 3) Centrifuge the sample obtained in step 2), discard part of the supernatant, and make the weight of the remaining lower layer material 10-15 times that of the active drug to obtain a drug-loaded resin; 4) Dissolve the film-forming material in water and mix it with one or more of the flavoring agent, plasticizer, colorant, and filler, stir evenly, and obtain a glue solution; 5) Transfer the drug-loaded resin obtained in step 3) to the glue solution obtained in step 4) and stir thoroughly to obtain a homogeneous glue solution. After stirring, remove air bubbles from the glue solution under vacuum, coat, dry, and cut to obtain the oral dissolving film formulation of rasagiline mesylate; 6) Coat the drug-containing glue solution obtained in step 5) evenly on the release film using a coating machine, heat, dry, and cut to obtain the oral dissolving film composition of rasagiline mesylate.

10. Use of any of claims 1 to 8 of the oral disintegrating film composition of rasagiline mesylate in the preparation of a medicament for the treatment and / or prevention of primary Parkinson's disease as monotherapy and for combination therapy of patients with end-of-dose fluctuations.