Preparation method of ondansetron oral soluble film agent

Abstract

The invention provides a preparation method of an ondansetron oral soluble film agent, which comprises the following steps: adding a liposome material into an organic solvent in proportion, and completely dissolving to obtain a lipid phase; adding ondansetron into a buffer solution, and completely dissolving to obtain a water phase; mixing the lipid phase and the water phase to obtain a liposome suspension, and removing the organic solvent; mixing the liposome suspension, a filling agent and water, and stirring to obtain an API suspension; uniformly mixing the API suspension, a film-forming agent and a flavoring agent, adjusting the pH value, standing and defoaming; and coating the defoamed mixture, drying, slicing and packaging to obtain the ondansetron oral dissolving film agent. According to the technical scheme, a high-temperature-resistant buffer system is adopted, the loss of acidic substances can be reduced and the pH stability of the preparation can be maintained in the heating and drying process of the oral soluble film, so that the stability of ondansetron is further improved, meanwhile, the liposome cannot be damaged, and the taste masking effect is good.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations, and particularly relates to a preparation method of ondansetron orally disintegrating film. Background Art

[0002] Ondansetron hydrochloride is a selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, and its mechanism of action is not fully clear. It may block the vomiting reflex caused by the release of 5-hydroxytryptamine from enterochromaffin cells in the small intestine promoted by factors such as chemotherapy and surgery by antagonizing 5-HT3 receptors in peripheral vagus nerve endings and the central chemoreceptor area. Currently, there are specific applications for the production of ondansetron orally disintegrating films, and these orally disintegrating films can play a taste masking role to a certain extent and facilitate oral administration by patients.

[0003] Patent 201911142482.3 discloses an orally disintegrating film preparation, which contains ondansetron or a pharmaceutically acceptable salt thereof encapsulated inside the micelles of a nonionic surfactant, an organic acid as a release aid, a film-forming agent, and a pharmaceutically acceptable additive, wherein the organic acid is citric acid.

[0004] For the orally disintegrating film containing ondansetron drug, the drug stability needs to be ensured under a certain acid-base system. During the production process of the orally disintegrating film, the drug can be encapsulated by liposomes to achieve taste masking, but the crystal water in the freeze-drying process will damage the liposome structure, resulting in unsatisfactory taste masking effect and high production cost; if the coating and then heating and drying process is adopted, the acid-base system is easily damaged at high temperature, thereby reducing the drug stability; at the same time, due to the volatilization of acidic substances, the pH of the acid-base system rises, and the solubility of the drug may also decrease accordingly, which will cause the drug release rate in the patient's mouth to be too slow, the drug efficacy to decrease, and the drug residence time in the mouth to be too long, and the taste masking effect to become poor. Summary of the Invention

[0005] The main object of the present invention is to propose a preparation method of ondansetron orally disintegrating film, aiming to solve the technical problem that in the production process of the existing orally disintegrating film, the acid-base system is easily damaged, resulting in poor drug stability and taste masking effect.

[0006] To achieve the above object, a preparation method of ondansetron orally disintegrating film proposed by the present invention includes the following steps: Adding liposome material into an organic solvent and completely dissolving to obtain a lipid phase; Adding ondansetron into a buffer solution and completely dissolving to obtain an aqueous phase; Mixing the lipid phase and the aqueous phase to obtain a liposome suspension, and removing the organic solvent; Mix the liposome suspension, filler and water, and stir to obtain the API suspension; Mix the API suspension, film-forming agent and flavoring agent evenly, adjust the pH, and then let it stand to remove bubbles; Coat the defoamed mixture, dry it, slice it and package it to obtain the ondansetron orally disintegrating film.

[0007] Optionally, in the step of adding the liposome material to the organic solvent in proportion and completely dissolving to obtain the lipid phase, the liposome material includes soybean lecithin and cholesterol.

[0008] Optionally, in the step of adding ondansetron to the buffer solution and completely dissolving to obtain the aqueous phase, the acidic compound of the buffer solution is one or more of gallic acid, succinic acid, fumaric acid, malic acid, tartaric acid.

[0009] Optionally, in the step of adding ondansetron to the buffer solution and completely dissolving to obtain the aqueous phase, the dosage of the acidic compound of the buffer pair accounts for 0.1 - 0.5% of the prescription amount of the ondansetron orally disintegrating film.

[0010] Optionally, in the step of adding ondansetron to the buffer solution and completely dissolving to obtain the aqueous phase, the basic compound of the buffer solution is the sodium salt of the acidic compound, and the dosage of the sodium salt accounts for 0.5 - 1% of the prescription amount of the ondansetron orally disintegrating film.

[0011] Optionally, in the step of mixing the liposome suspension, filler and water and stirring to obtain the API suspension, the filler is one or several of mannitol, lactose, microcrystalline cellulose.

[0012] Optionally, in the step of mixing the API suspension, film-forming agent and flavoring agent evenly, adjusting the pH and then letting it stand to remove bubbles, the film-forming agent is an aqueous solution of one or several of hydroxypropyl methylcellulose, methylcellulose, sodium carboxymethylcellulose, hydroxypropyl cellulose.

[0013] Optionally, in the step of mixing the API suspension, film-forming agent and flavoring agent evenly, adjusting the pH and then letting it stand to remove bubbles, the flavoring agent is one or several of aspartame, stevioside, glycyrrhizin, sucralose, fructose, sucrose, maltose.

[0014] Optionally, in the step of mixing the API suspension, film-forming agent and flavoring agent evenly, adjusting the pH and then letting it stand to remove bubbles, adjust the pH with hydrochloric acid or sodium hydroxide solution.

[0015] Optionally, in the step of mixing the API suspension, film-forming agent and flavoring agent evenly, adjusting the pH and then letting it stand to remove bubbles, adjust the pH to 4.0 - 5.5.

[0016] In the technical solution of the present invention, a high-temperature resistant buffer system is adopted, which can reduce the loss of acidic substances during the heating and drying process of the orally disintegrating film, maintain the pH stability of the preparation, thereby improving the stability of ondansetron. At the same time, the liposome will not be damaged and has a good taste masking effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on the structures shown in these drawings.

[0018] Figure 1 It is a schematic flowchart of an embodiment of the preparation method of the ondansetron orally disintegrating film provided by the present invention; Figure 2 It is a pH trend chart of the samples of the embodiments and comparative examples provided by the present invention after redissolution at different time periods; Figure 3 It is a liquid chromatogram of ondansetron in Example 1 provided by the present invention; Figure 4 It is a liquid chromatogram of ondansetron in Comparative Example 2 provided by the present invention.

[0019] The realization, functional features and advantages of the object of the present invention will be further described with reference to the embodiments and the drawings. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0020] In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some of the embodiments of the present invention, rather than all of the embodiments.

[0021] It should be noted that for those not specified in the embodiments, they are carried out according to the conventional conditions or the conditions recommended by the manufacturer. For the reagents or instruments not specified by the manufacturer, they are all conventional products that can be obtained through commercial purchase. In addition, the meaning of "and / or" appearing throughout the text includes three parallel solutions. Taking "A and / or B" as an example, it includes solution A, solution B, or a solution that satisfies both A and B at the same time. In addition, the technical solutions between the embodiments can be combined with each other, but it must be based on the fact that those of ordinary skill in the art can implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present invention.

[0022] Patent 201911142482.3 discloses an orally disintegrating film preparation, which contains ondansetron or a pharmaceutically acceptable salt thereof encapsulated inside the micelles of a non-ionic surfactant, an organic acid as a release aid, a film-forming agent, and a pharmaceutically acceptable additive, wherein the organic acid is citric acid. With the coating and then heating and drying procedure, the organic acid is easily destroyed at high temperatures, thereby reducing the stability of the drug; at the same time, due to the volatilization of acidic substances, the pH of the acid-base system rises, and the solubility of the drug may also decrease accordingly. This will cause the release rate of the drug in the orally disintegrating film in the patient's mouth to be too slow, the drug efficacy to decrease, and the residence time of the drug in the mouth to be too long, resulting in a poor taste masking effect.

[0023] In view of this, the present invention proposes a preparation method of an ondansetron orally disintegrating film, combined with Figure 1 The flow schematic diagram of an embodiment of the preparation method of the ondansetron orally disintegrating film provided, the specific steps of this preparation method are as follows.

[0024] Step S10: Add the liposome material to an organic solvent in proportion and completely dissolve to obtain a lipid phase.

[0025] In this embodiment, through the high-frequency oscillation of an ultrasonic machine, the liposome material is completely dissolved in the organic solvent. It should be noted that a liposome is an artificial membrane, which refers to a microvesicle formed by encapsulating a drug within a lipid bilayer. In this embodiment, the liposome material is selected from natural phospholipids or synthetic phospholipids, cholesterol, etc. The natural phospholipid is preferably soybean lecithin, and the mass ratio of soybean lecithin to cholesterol is selected as (0.5 - 2):(1 - 2). The organic solvent is selected from volatile substances such as ethanol and ether.

[0026] Step S20: Add ondansetron to a buffer solution and completely dissolve to obtain an aqueous phase.

[0027] In this embodiment, through the high-frequency oscillation of an ultrasonic machine, the ondansetron drug is completely dissolved in the buffer solution. It should be noted that the solvent of the buffer solution is water, and its acidic compound is one or more of gallic acid, succinic acid, fumaric acid, malic acid, tartaric acid, etc. It has a relatively high boiling point and can adapt to the coating and drying procedure of the orally disintegrating film. The dosage of the acidic compound accounts for 0.1 - 0.5% of the prescription amount of the ondansetron orally disintegrating film; the basic compound is the sodium salt of the acidic compound, and the dosage of the sodium salt accounts for 0.5 - 1% of the prescription amount of the ondansetron orally disintegrating film. At this time, the pH of the buffer solution should be controlled at 4 - 8, which is beneficial to the dissolution of ondansetron.

[0028] Step S30: Mix the lipid phase and the aqueous phase to obtain a liposome suspension and remove the organic solvent.

[0029] In this embodiment, a T-shaped or Y-shaped microfluidic mixer is used to mix the lipid phase and the aqueous phase. The lipid phase and the aqueous phase enter from two separate inlets respectively and are mixed when flowing in the common channel. The organic solvent is removed by heating or negative pressure distillation.

[0030] Step S40: Mix the liposome suspension, the filler and water, and stir to obtain the API suspension.

[0031] In this embodiment, API refers to other active pharmaceutical additives, that is, the filler. The filler is one or more of mannitol, lactose, and microcrystalline cellulose.

[0032] Step S50: Mix the API suspension, the film-forming agent, and the flavoring agent evenly, adjust the pH, and then stand for defoaming.

[0033] In this embodiment, the film-forming agent is an aqueous solution of one or more of hydroxypropyl methylcellulose, methylcellulose, sodium carboxymethylcellulose, and hydroxypropyl cellulose, and the solid content in the aqueous solution is 5%. The flavoring agent is one or more of aspartame, stevioside, glycyrrhizin, sucralose, fructose, sucrose, and maltose. These sweeteners are used to mask the taste of ondansetron itself. Specifically in implementation, hydrochloric acid or sodium hydroxide solution is used to adjust the pH to 4.0 - 5.5, preferably 5.

[0034] Step S60: Coat the defoamed mixture, dry it, slice it, and package it to obtain the ondansetron orally disintegrating film.

[0035] In this embodiment, the mixture is scraped into a thin film by the doctor blade of a coater, and then dried. The temperature of the drying equipment is controlled at 50 - 90 °C. Within this temperature range, it can effectively prevent incomplete water volatilization or evaporation due to too low temperature, as well as too fast water volatilization or evaporation and embrittlement of the thin film due to too high temperature.

[0036] In the technical solution of the present invention, buffer systems such as citric acid are avoided, and other heat-resistant buffer systems are adopted. During the heating and drying process of the orally disintegrating film, it can reduce the loss of acidic substances, maintain the pH stability of the preparation, thereby improving the stability of ondansetron. At the same time, the liposome will not be damaged and the taste masking effect is good. And the dissolution rate of the drug is fast, which will cause the drug in the orally disintegrating film to stay in the patient's mouth for too short a time, and the taste masking effect is good.

[0037] The following further details the technical solution of the present invention in conjunction with specific embodiments and drawings. It should be understood that the following embodiments are only used to explain the present invention and are not used to limit the present invention. Example 1 Prescription 1 and Its Preparation

[0038] Table 1 Prescription 1

[0039] Preparation method: Add 2 g of soy lecithin and 1 g of cholesterol into absolute ethanol, and ultrasonically dissolve until completely dissolved to obtain a lipid phase; dissolve 0.2 g of gallic acid and 1 g of sodium gallate in 10 mL of water to obtain a buffer solution, add 0.5 g of ondansetron into the buffer solution, and ultrasonically dissolve until completely dissolved to obtain an aqueous phase; mix the above lipid phase and aqueous phase to obtain a liposome suspension, and remove absolute ethanol by negative pressure distillation; mix the liposome suspension, 10 g of mannitol and 40 mL of water, and stir to obtain an API suspension; mix the API suspension, 5 g of cross-linked carboxymethyl cellulose sodium, and 0.3 g of aspartame evenly, adjust the pH to 5.0 with dilute hydrochloric acid or sodium hydroxide solution, and then stand for defoaming; coat the defoamed mixture and dry it at 60 °C, slice and package to obtain ondansetron orally disintegrating film agent. Example 2 Prescription 2 and its preparation

[0040] Table 2 Prescription 2

[0041] Preparation method: Add 2 g of soy lecithin and 1 g of cholesterol into absolute ethanol, and ultrasonically dissolve until completely dissolved to obtain a lipid phase; dissolve 0.2 g of succinic acid and 1 g of sodium succinate in 10 mL of water to obtain a buffer solution, add 0.5 g of ondansetron into the buffer solution, and ultrasonically dissolve until completely dissolved to obtain an aqueous phase; mix the above lipid phase and aqueous phase to obtain a liposome suspension, and remove absolute ethanol by negative pressure distillation; mix the liposome suspension, 10 g of mannitol and 40 mL of water, and stir to obtain an API suspension; mix the API suspension, 5 g of cross-linked carboxymethyl cellulose sodium, and 0.3 g of aspartame evenly, adjust the pH to 5.0 with dilute hydrochloric acid or sodium hydroxide solution, and then stand for defoaming; coat the defoamed mixture and dry it at 60 °C, slice and package to obtain ondansetron orally disintegrating film agent. Example 3 Prescription 3 and its preparation

[0042] Table 3 Prescription 3

[0043] Preparation method: Add 2 g of soy lecithin and 1 g of cholesterol into absolute ethanol, and ultrasonically dissolve until completely dissolved to obtain a lipid phase; dissolve 0.2 g of fumaric acid and 1 g of sodium fumarate in 10 mL of water to obtain a buffer solution, add 0.5 g of ondansetron into the buffer solution, and ultrasonically dissolve until completely dissolved to obtain an aqueous phase; mix the above lipid phase and aqueous phase to obtain a liposome suspension, and remove absolute ethanol by negative pressure distillation; mix the liposome suspension, 10 g of mannitol and 40 mL of water, and stir to obtain an API suspension; mix the API suspension, 5 g of cross-linked carboxymethyl cellulose sodium, and 0.3 g of aspartame evenly, adjust the pH to 5.0 with dilute hydrochloric acid or sodium hydroxide solution, and then stand for defoaming; coat the defoamed mixture and dry it at 60 °C, slice and package to obtain an ondansetron orally disintegrating film agent. Example 4 Prescription 4 and Its Preparation

[0044] Table 4 Prescription 4

[0045] Preparation method: Add 2 g of soy lecithin and 1 g of cholesterol into absolute ethanol, and ultrasonically dissolve until completely dissolved to obtain a lipid phase; dissolve 0.2 g of malic acid and 1 g of sodium malate in 10 mL of water to obtain a buffer solution, add 0.5 g of ondansetron into the buffer solution, and ultrasonically dissolve until completely dissolved to obtain an aqueous phase; mix the above lipid phase and aqueous phase to obtain a liposome suspension, and remove absolute ethanol by negative pressure distillation; mix the liposome suspension, 10 g of mannitol and 40 mL of water, and stir to obtain an API suspension; mix the API suspension, 5 g of cross-linked carboxymethyl cellulose sodium, and 0.3 g of aspartame evenly, adjust the pH to 5.0 with dilute hydrochloric acid or sodium hydroxide solution, and then stand for defoaming; coat the defoamed mixture and dry it at 60 °C, slice and package to obtain an ondansetron orally disintegrating film agent. Example 5 Prescription 5 and Its Preparation

[0046] Table 5 Prescription 5

[0047] Preparation method: Add 2 g of soy lecithin and 1 g of cholesterol into absolute ethanol, and ultrasonically dissolve until completely dissolved to obtain a lipid phase; dissolve 0.2 g of tartaric acid and 1 g of sodium tartrate in 10 mL of water to obtain a buffer solution, add 0.5 g of ondansetron into the buffer solution, and ultrasonically dissolve until completely dissolved to obtain an aqueous phase; mix the above lipid phase and aqueous phase to obtain a liposome suspension, and remove absolute ethanol by negative pressure distillation; mix the liposome suspension, 10 g of mannitol and 40 mL of water, and stir to obtain an API suspension; mix the API suspension, 5 g of cross-linked carboxymethyl cellulose sodium, and 0.3 g of aspartame evenly, adjust the pH to 5.0 with dilute hydrochloric acid and sodium hydroxide solution, and then stand for defoaming; coat the defoamed mixture and dry it at 60 °C, slice and package to obtain an ondansetron orally disintegrating film agent. Example 6 Prescription 6 and Its Preparation

[0048] Table 6 Prescription 6

[0049] Preparation method: Add 2 g of soy lecithin and 1 g of cholesterol into absolute ethanol, and ultrasonically dissolve until completely dissolved to obtain the lipid phase; dissolve 1 g of gallic acid and 2 g of sodium gallate in 10 mL of water to obtain a buffer solution, add 0.5 g of ondansetron into the buffer solution, and ultrasonically dissolve until completely dissolved to obtain the aqueous phase; mix the above lipid phase and aqueous phase to obtain a liposome suspension, and remove absolute ethanol by negative pressure distillation; mix the liposome suspension, 10 g of mannitol and 40 mL of water, and stir to obtain an API suspension; mix the API suspension, 5 g of croscarmellose sodium, and 0.3 g of aspartame evenly, adjust the pH to 5.0 with dilute hydrochloric acid or sodium hydroxide solution, and then stand for defoaming; coat the defoamed mixture and dry it at 60 °C, slice and package to obtain ondansetron orally disintegrating film agent. Comparative Example 1 Prescription 7 and its preparation

[0050] Table 7 Prescription 7

[0051] Preparation method: Add 2 g of soy lecithin and 1 g of cholesterol into absolute ethanol, and ultrasonically dissolve until completely dissolved to obtain the lipid phase; dissolve 0.2 g of citric acid and 1 g of sodium citrate in 10 mL of water to obtain a buffer solution, add 0.5 g of ondansetron into the buffer solution, and ultrasonically dissolve until completely dissolved to obtain the aqueous phase; mix the above lipid phase and aqueous phase to obtain a liposome suspension, and remove absolute ethanol by negative pressure distillation; mix the liposome suspension, 10 g of mannitol and 40 mL of water, and stir to obtain an API suspension; mix the API suspension, 5 g of croscarmellose sodium, and 0.3 g of aspartame evenly, adjust the pH to 5.0 with dilute hydrochloric acid or sodium hydroxide solution, and then stand for defoaming; coat the defoamed mixture and dry it at 60 °C, slice and package to obtain ondansetron orally disintegrating film agent. Comparative Example 2 Prescription 8 and its preparation

[0052] Table 8 Prescription 8

[0053] Preparation method: Add 2 g of soy lecithin and 1 g of cholesterol into absolute ethanol, and ultrasonically dissolve until completely dissolved to obtain a lipid phase; add 0.5 g of ondansetron into a dilute hydrochloric acid solution, and ultrasonically dissolve until completely dissolved to obtain an aqueous phase; mix the above lipid phase and aqueous phase to obtain a liposome suspension, and remove absolute ethanol by negative pressure distillation; mix the liposome suspension, 10 g of mannitol and 40 mL of water, and stir to obtain an API suspension; mix the API suspension, 5 g of croscarmellose sodium, and 0.3 g of aspartame evenly, adjust the pH to 5.0 with dilute hydrochloric acid or sodium hydroxide solution, and then let it stand to defoam; coat the defoamed mixture and dry it at 60 °C, slice and package to obtain ondansetron orally disintegrating film agent. Stability investigation

[0054] Place the products of the above Examples 1-6 and the product of Comparative Example 1 (25 °C ± 2 °C, RH 60% ± 5%) for 1 month, 2 months, 3 months, and 6 months, respectively take samples and dissolve them in water, make up the volume to 50 mL, and use a pH meter to detect their acidity and related substances. The experimental results are shown in the following table.

[0055] Table 9 - Summary table of stability results (experimental data stored at 25 °C ± 2 °C, RH 60% ± 5% for 12 months)

[0056] According to Figure 2 the trend in, combined with the above experimental data, it can be obtained that the orally disintegrating film prepared with a buffer system without citric acid still maintains a very stable acidity after the coating and drying process. At the same time, compared with Comparative Examples 1-2 with a buffer system added with citric acid or without using a buffer system, it has relatively better stability. Figure 3 and Figure 4 compared with, the peak area of Example 1 is greater than that of Comparative Example 2. Therefore, the orally disintegrating film prepared with a buffer system without citric acid in this application has good stability within 6 months at room temperature.

[0057] The technical features of the above examples can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above examples are described. However, as long as the combinations of these technical features do not conflict, they should all be considered as the scope described in this specification.

[0058] The above examples only represent several implementation manners of this application, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of this application, several modifications and improvements can still be made, and these all belong to the protection scope of this application. Therefore, the protection scope of this application patent should be subject to the appended claims.

Claims

1. A preparation method of ondansetron orally disintegrating film, characterized in that, The preparation method comprises the following steps: Adding liposome material into an organic solvent and completely dissolving it to obtain a lipid phase; Adding ondansetron into a buffer solution and completely dissolving it to obtain an aqueous phase; Mixing the lipid phase and the aqueous phase to obtain a liposome suspension, and removing the organic solvent; Mixing the liposome suspension, a filler and water, and stirring to obtain an API suspension; Mixing the API suspension, a film-forming agent and a flavoring agent uniformly, adjusting the pH, and then standing for defoaming; Coating the defoamed mixture, drying, slicing and packaging to obtain an ondansetron orally disintegrating film; 2. The preparation method of ondansetron orally disintegrating film according to claim 1, characterized in that, In the step of adding the liposome material into the organic solvent according to a proportion and completely dissolving it to obtain a lipid phase, the liposome material includes soybean lecithin and cholesterol; 3. The preparation method of ondansetron orally disintegrating film according to claim 1, characterized in that, In the step of adding ondansetron into the buffer solution and completely dissolving it to obtain an aqueous phase, the acidic compound of the buffer solution is one or more of gallic acid, succinic acid, fumaric acid, malic acid and tartaric acid; 4. The preparation method of the ondansetron orally disintegrating film according to claim 3, wherein In the step of adding ondansetron into the buffer solution and completely dissolving it to obtain an aqueous phase, the dosage of the acidic compound of the buffer pair accounts for 0.1-0.5% of the prescription amount of the ondansetron orally disintegrating film; 5. The preparation method of ondansetron orally disintegrating film according to claim 4, characterized in that, In the step of adding ondansetron into the buffer solution and completely dissolving it to obtain an aqueous phase, the basic compound of the buffer solution is the sodium salt of the acidic compound, and the dosage of the sodium salt accounts for 0.5-1% of the prescription amount of the ondansetron orally disintegrating film; 6. The preparation method of ondansetron orally disintegrating film according to claim 1, characterized in that, In the step of mixing the liposome suspension, the filler and water, and stirring to obtain an API suspension, the filler is one or several of mannitol, lactose and microcrystalline cellulose; 7. The preparation method of ondansetron orally disintegrating film according to claim 1, characterized in that, In the step of mixing the API suspension, the film-forming agent and the flavoring agent uniformly, adjusting the pH, and then standing for defoaming, the film-forming agent is an aqueous solution of one or several of hydroxypropyl methylcellulose, methylcellulose, sodium carboxymethylcellulose and hydroxypropyl cellulose; 8. The preparation method of ondansetron orally disintegrating film according to claim 1, characterized in that, In the step of mixing the API suspension, the film-forming agent and the flavoring agent uniformly, adjusting the pH, and then standing for defoaming, the flavoring agent is one or several of aspartame, stevioside, glycyrrhizin, sucralose, fructose, sucrose and maltose; 9. The preparation method of ondansetron orally disintegrating film according to claim 1, wherein, In the step of mixing the API suspension, the film-forming agent and the flavoring agent uniformly, adjusting the pH, and then standing for defoaming, the pH is adjusted with hydrochloric acid or sodium hydroxide solution; 10. The preparation method of ondansetron orally disintegrating film according to claim 1, characterized in that, In the step of mixing the API suspension, the film-forming agent and the flavoring agent uniformly, adjusting the pH, and then standing for defoaming, the pH is adjusted to 4.0-5.5.

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