CN112089708A

CN112089708A - Loratadine oral dispersion film agent and preparation method thereof

Info

Publication number: CN112089708A
Application number: CN202011067328.7A
Authority: CN
Inventors: 任霞; 赵刚; 吴雪英; 余丽花; 郭平; 张梦婷; 黄珮闻
Original assignee: Jianmin Pharmaceutical Groups Corp ltd
Current assignee: Jianmin Pharmaceutical Groups Corp ltd
Priority date: 2020-10-06
Filing date: 2020-10-06
Publication date: 2020-12-18
Anticipated expiration: 2040-10-06
Also published as: CN112089708B

Abstract

The invention relates to a loratadine oral dispersible film agent, which comprises the following raw and auxiliary materials in percentage by mass: 25-40% loratadine, 0.3-1% polysorbate 80, 1-10% plasticizer, 0.001-0.02% glyceride fatty acid, 2-5% povidone K30, 22-35% hypromellose-E5, 10-25% hydroxypropyl cellulose-SL, 1-8% maltose, 0.5-5% saccharin sodium and 1-6% opacifier; the particle size of the loratadine is X90 which is less than or equal to 10 mu m. The preparation process is simple and controllable, and is suitable for industrial mass production; the prepared oral dispersible film has the advantages of remarkably improving the performances of tensile strength, disintegration speed, taste and stability, having high drug-loading rate, small volume, portability, convenient dose control and taking, and being rapidly disintegrated in the oral cavity without drinking water, realizing the rapid release of active ingredients of the drug, having good taste and easy acceptance, and improving the compliance and safety of children taking the drug.

Description

Loratadine oral dispersion film agent and preparation method thereof

Technical Field

The invention belongs to the technical field of medicines and preparation methods thereof, and particularly relates to a loratadine oral cavity dispersion film agent and a preparation method thereof.

Background

Loratadine is an antihistamine. Can be used for relieving symptoms related to allergic rhinitis, such as sneeze, watery nasal discharge, nasal pruritus, nasal obstruction, and itching and burning sensation of eyes. After the medicine is taken orally, the symptoms and physical signs of the nose and eyes are rapidly relieved. It is also suitable for relieving symptoms and signs of chronic urticaria, pruritic dermatoses, and other allergic dermatoses. Research shows that the highest allergic rhinitis of Asian adults can reach 30 percent, and the highest prevalence rate of the Asian adults in children can reach 46 percent.

At present, a plurality of loratadine oral preparations (common tablets, capsules, syrup, orally disintegrating tablets, orally fast dissolving tablets and the like) are on the market at home and abroad. The loratadine common tablets and capsules can start to release the medicament only by being disintegrated in the stomach, have slow effect, need to be swallowed by water, are often difficult for the old, children and patients with swallowing difficulty, and have particularly prominent problems when the dosage and the specification of the medicament are larger or the number of tablets needed to be taken once is larger. Syrup can take effect quickly, but needs a spoon or a glass cup when being taken, is inconvenient to take and quantitative to take, is inconvenient to carry and poor in stability, and is inconvenient to package, transport and store. The orally disintegrating tablet is prepared by adopting a wet granulation and tabletting process, and has the problems of slow disintegration, large required disintegrating dosage, poorer mouthfeel and the like. The preparation process of the oral freeze-drying tablet is complex, special equipment is needed, the freeze-drying time is long, the yield is low, the cost is high, and the defects of unsatisfactory appearance, fragility and easy moisture absorption exist in the freeze-drying preparation process.

Patent application No. CN201310046849.8 discloses a loratadine film-shaped preparation, which is prepared by preparing a plurality of film belts, wherein one film contains an acidic agent such as citric acid, tartaric acid and the like, and the other film contains an alkaline agent such as sodium carbonate, sodium bicarbonate or calcium carbonate and the like, and becomes an effervescent film after contacting water, so that a large amount of bubbles are generated, the taste is paralyzed, the taste is masked, and the dissolution can be accelerated. However, the preparation method of the loratadine film-shaped preparation is complicated, the packaging difficulty is high, and the production cost is high. In addition, the taste masking mechanism of the loratadine film-shaped preparation is that the loratadine film-shaped preparation becomes an effervescent film after meeting water, a large number of bubbles are generated, taste cells on taste buds are paralyzed temporarily, the bitter taste sensing threshold is improved, and the sensitivity to bitter molecules is reduced, so that the loratadine film-shaped preparation has a taste correcting effect. The auxiliary materials without bitter taste cell selectivity can also influence other taste sense, so that the taste sense is paralyzed, and the taste is tasteless. Therefore, the loratadine film preparation has a general taste-modifying effect.

Patent with application number CN106619577A discloses a novel loratadine oral instant film and a preparation method thereof. The preparation process is simple and controllable, no special production equipment is needed, and the production cost is low. But the loratadine oral instant film has poor performances in tensile strength, disintegration speed, mouthfeel and stability.

Disclosure of Invention

The invention provides a loratadine oral dispersible film agent and a preparation method thereof, aiming at the technical problems in the prior art.

The technical scheme for solving the technical problems is as follows:

the loratadine oral dispersion film agent comprises the following raw and auxiliary materials in percentage by mass: 25-40% loratadine, 0.3-1% polysorbate 80, 1-10% plasticizer, 0.001-0.02% glyceride fatty acid, 2-5% povidone K30, 22-35% hypromellose-E5, 10-25% hydroxypropyl cellulose-SL, 1-8% maltose, 0.5-5% saccharin sodium and 1-6% opacifier; the particle size of the loratadine is X90 which is less than or equal to 10 mu m.

On the basis of the technical scheme, the invention can be further improved as follows.

Further, the oral dispersing film agent comprises the following raw and auxiliary materials in percentage by mass: 30-35% of loratadine, 0.5-0.8% of polysorbate 80, 6-7% of plasticizer, 0.007-0.014% of glyceride fatty acid, 3-4% of povidone K30, 28-30% of hypromellose-E5, 15-20% of hydroxypropyl cellulose-SL, 3-5% of maltose, 1.7-4.2% of saccharin sodium and 4-5% of opacifier.

Further, the plasticizer is at least one of polyethylene glycol 400, propylene glycol and glycerol; the opacifier is titanium dioxide.

Further, the thickness of the oral cavity dispersion film agent is 100-130 μm.

Further, the breaking force of the oral cavity dispersion film agent with an area of 2.5cm × 5cm is more than 30N.

Further, the disintegration time of the oral cavity dispersion film agent in water with 37 +/-2 ℃ is not more than 25S.

Another object of the present invention is to provide a method for preparing the loratadine orally dispersible film.

The specific technical scheme is as follows:

the preparation method of the loratadine oral dispersion film agent comprises the following steps:

1) adding polysorbate 80, plasticizer and glyceride fatty acid into purified water at 80 ℃ under stirring, and uniformly stirring;

2) adding povidone K30, hydroxypropyl methylcellulose-E5 and hydroxypropyl cellulose-SL into the dispersion system obtained in the step 1) under the stirring state, uniformly stirring, and cooling the solution to room temperature;

3) adding ethanol with the amount of the prescription into the solution obtained in the step 2), uniformly mixing, adding loratadine with the particle size of X90 being less than or equal to 10 mu m, and uniformly stirring to obtain a membrane liquid;

4) adding maltose, saccharin sodium and an opacifier into the membrane liquid obtained in the step 3), stirring uniformly, and then sequentially carrying out homogenization, defoaming, coating, drying and cutting treatment to obtain the loratadine oral dispersion membrane agent.

Further, in the step (1) and the step (2), the stirring speed is 2000-3000 r/min.

Further, in the step (4), the homogenizing time is 3-8 times, the coating speed is 60-70cm/min, and the drying temperature is 60-80 ℃.

Further, in the step (4), the size of the cut was 2.5cm × 5 cm.

The invention has the beneficial effects that: the invention provides the loratadine oral dispersible film agent and the preparation method thereof, which are stable, simple and controllable in preparation process, free of special production equipment, suitable for industrial mass production, safe in auxiliary materials and reasonable in price, and effectively solves the complexity and uncontrollable property of the preparation process on the market. The prepared oral dispersible film agent has obviously improved performances in the aspects of tensile strength, disintegration speed, taste and stability; the oral liquid has the advantages of high drug-loading capacity, small volume, portability, safe storage, convenient dosage control, convenient taking and rapid disintegration in the oral cavity without drinking water, realizes the rapid release of the active ingredients of the drug, has good taste and easy acceptance, and greatly improves the compliance and safety of the drug administration for children. The loratadine is uniformly distributed in the film forming agent, and has accurate content, good stability and strength.

Detailed Description

The principles and features of this invention are described below in conjunction with examples which are set forth to illustrate, but are not to be construed to limit the scope of the invention.

All percentages used in the present invention are by weight unless otherwise indicated.

The raw materials adopted by the invention are conventional commercial products, and can be purchased in the market.

The invention discloses a loratadine oral dispersible film agent which comprises the following raw and auxiliary materials in percentage by mass: 25-40% loratadine, 0.3-1% polysorbate 80, 1-10% plasticizer, 0.001-0.02% glyceride fatty acid, 2-5% povidone K30, 22-35% hypromellose-E5, 10-25% hydroxypropyl cellulose-SL, 1-8% maltose, 0.5-5% saccharin sodium and 1-6% opacifier; the particle size of the loratadine is X90 which is less than or equal to 10 mu m.

Among them, polysorbate 80 is used as a solubilizer and a surfactant; glyceride fatty acids are used as antifoaming agents; povidone K30 was used as a binder; maltose and saccharin sodium are used as flavoring agents to mask bitterness while enhancing the mouthfeel of the oral dispersion film.

The plasticizer of the present invention is preferably at least one of polyethylene glycol 400, propylene glycol and glycerin. The opacifier is titanium dioxide.

Polyethylene glycol 400 also functions as a dispersant and stabilizer in the present invention.

Propylene glycol is a clear colorless liquid that also functions as a stabilizer and preservative in the present invention.

Glycerol is a colorless, sweet, clear, viscous liquid. No smell, warm sweet taste. It also functions as a sweetener in the present invention.

The titanium dioxide has stable property, and has better ultraviolet shielding effect and good shielding effect. The stability of the oral dispersing film agent is obviously improved by adding the titanium dioxide.

Further, the thickness of the oral cavity dispersion film agent is 100-130 μm.

Hydroxypropyl cellulose is a hydrophilic polymer material, and is dissolved in polar organic solvents such as water, methanol, ethanol, etc. The inventor uses four kinds of hydroxypropyl cellulose (HPC-SL, HPC-L, HPC-M, HPC-H with different viscosities of 3.0-5.9 mPa.s, 6.0-10.0 mPa.s, 150-400 mPa.s and 1000-4000 mPa.s) to respectively prepare the film agent, and determines the importance of the rapid release of the medicine by researching the disintegration of the oral cavity dispersion film agent and the release condition of the effective components of the medicine. The results show that the disintegration of the orally dispersible film and the release of the active pharmaceutical ingredients are influenced by the viscosity of the polymer. The greater the viscosity of HPC, the slower the disintegration of the orally dispersible film and the release of the active pharmaceutical ingredient, and the similar release rates of HPC-SL and HPC-L, HPC-M and HPC-H, and the much faster the release rates of HPC-SL and HPC-L than HPC-M and HPC-H. Considering the breaking force of the oral dispersion film agent and other factors comprehensively, the inventor selects hydroxypropyl cellulose-SL with the viscosity of 3.0-5.9 mPas as the film forming agent.

Hypromellose is a nontoxic, non-irritating material and is widely used as an adjuvant for oral and topical preparations. It is white or white-like fibrous or granular powder, odorless, and can be dissolved in cold water to obtain clear or slightly turbid colloidal solution. Similarly, the inventor uses six types of hypromellose (hypromellose-E3, hypromellose-E5, hypromellose-E15, hypromellose-E30, hypromellose-E50 and hypromellose-E100) with different viscosities to divide into film agents, and determines the importance of the rapid release of the medicine by researching the disintegration of the oral dispersible film agent and the release condition of the effective components of the medicine. The results show that the disintegration of the orally dispersible film and the release of the active pharmaceutical ingredients are influenced by the viscosity of the polymer. The greater the viscosity of hypromellose, the slower the disintegration of the orally dispersing film and the release of the active pharmaceutical ingredients. Considering the factors of the breaking force of the oral dispersion film agent and the like comprehensively, the inventor selects hypromellose-E5 as the film forming agent.

The oral cavity dispersion film agent has the following advantages: (1) the volume is small, the weight is light, and the carrying, the storage and the transportation are convenient; (2) the dosage is accurate, the preparation process is simple, the cost is lower, the property is stable, and the composition can be safely stored; (3) the medicine can be taken without water, can be dissolved by being placed on the tongue tip, and can be taken at any time and any place; (4) after being taken, the medicine can be dissolved quickly, the medicine release is quick, and a part of medicine can directly enter a blood system through mucous membrane, so that the first pass effect is avoided; (5) the oral liquid has good compliance, is especially suitable for children, the elderly and dysphagia patients with emesis symptoms to take, and can be immediately dissolved in the mouth, so as to prevent children from spitting; (6) has good taste and easy acceptance, and greatly improves the compliance and safety of children taking medicines.

The invention also provides a preparation method of the loratadine oral dispersible film agent.

The specific technical scheme is as follows:

Further, in the step (1) and the step (2), the stirring speed is 2000-3000 r/min. In the step (4), the homogenizing time is 3-8 times, the coating speed is 60-70cm/min, the drying temperature is 60-80 ℃, and the cutting size is 2.5cm multiplied by 5 cm.

The invention can adopt a coater produced by German HH company to coat the film liquid, and the film liquid is coated on a PET film and dried at 60-80 ℃.

The preparation method is simple and controllable, does not need special production equipment, is suitable for industrial mass production, is easy and uniform to coat, and the obtained oral dispersible film agent obtained by cutting has good flexibility, rapid disintegration and better taste.

TABLE 1

Example 1

1) adding polysorbate 80, propylene glycol and glyceride fatty acid into purified water at 80 ℃ under stirring, and uniformly stirring; wherein the stirring speed is 2000 r/min;

2) adding povidone K30, hydroxypropyl methylcellulose-E5 and hydroxypropyl cellulose-SL into the dispersion system obtained in the step 1) under the stirring state, uniformly stirring, and cooling the solution to room temperature; wherein the stirring speed is 3000 r/min;

3) adding ethanol with the amount of the prescription into the solution obtained in the step 2), uniformly mixing, adding loratadine with the particle size of X90 ═ 1 mu m, and uniformly stirring to obtain a membrane liquid;

4) adding maltose, saccharin sodium and titanium dioxide into the membrane liquid obtained in the step 3), stirring uniformly, and then sequentially carrying out homogenization, defoaming, coating, drying and cutting treatment to obtain the loratadine oral dispersible membrane; wherein the homogenizing time is 3 times, the coating speed is 60cm/min, the drying temperature is 80 deg.C, and the cutting size is 2.5cm × 5 cm.

Example 2

1) adding polysorbate 80, polyethylene glycol 400 and glyceride fatty acid into purified water at 80 ℃ under stirring, and stirring uniformly; wherein the stirring speed is 2300 r/min;

2) adding povidone K30, hydroxypropyl methylcellulose-E5 and hydroxypropyl cellulose-SL into the dispersion system obtained in the step 1) under the stirring state, uniformly stirring, and cooling the solution to room temperature; wherein the stirring speed is 2700 r/min;

3) adding ethanol with the amount of the prescription into the solution obtained in the step 2), uniformly mixing, adding loratadine with the particle size of X90 ═ 4 mu m, and uniformly stirring to obtain a membrane liquid;

4) adding maltose, saccharin sodium and titanium dioxide into the membrane liquid obtained in the step 3), stirring uniformly, and then sequentially carrying out homogenization, defoaming, coating, drying and cutting treatment to obtain the loratadine oral dispersible membrane; wherein the homogenizing time is 5 times, the coating speed is 66cm/min, the drying temperature is 66 deg.C, and the cutting size is 2.5cm × 5 cm.

Example 3

1) adding polysorbate 80, glycerol and glyceride fatty acid into purified water at 80 ℃ under stirring, and stirring uniformly; wherein the stirring speed is 2700 r/min;

2) adding povidone K30, hydroxypropyl methylcellulose-E5 and hydroxypropyl cellulose-SL into the dispersion system obtained in the step 1) under the stirring state, uniformly stirring, and cooling the solution to room temperature; wherein the stirring speed is 2300 r/min;

3) adding ethanol with the amount of the prescription into the solution obtained in the step 2), uniformly mixing, adding loratadine with the particle size of X90 ═ 10 mu m, and uniformly stirring to obtain a membrane liquid;

4) adding maltose, saccharin sodium and titanium dioxide into the membrane liquid obtained in the step 3), stirring uniformly, and then sequentially carrying out homogenization, defoaming, coating, drying and cutting treatment to obtain the loratadine oral dispersible membrane; wherein the homogenizing time is 6 times, the coating speed is 70cm/min, the drying temperature is 72 deg.C, and the cutting size is 2.5cm × 5 cm.

Example 4

1) adding polysorbate 80, polyethylene glycol 400 and glyceride fatty acid into purified water at 80 ℃ under stirring, and stirring uniformly; wherein the stirring speed is 3000 r/min;

2) adding povidone K30, hydroxypropyl methylcellulose-E5 and hydroxypropyl cellulose-SL into the dispersion system obtained in the step 1) under the stirring state, uniformly stirring, and cooling the solution to room temperature; wherein the stirring speed is 2000 r/min;

3) adding ethanol with the amount of the prescription into the solution obtained in the step 2), uniformly mixing, adding loratadine with the particle size of X90 ═ 7 mu m, and uniformly stirring to obtain a membrane liquid;

4) adding maltose, saccharin sodium and titanium dioxide into the membrane liquid obtained in the step 3), stirring uniformly, and then sequentially carrying out homogenization, defoaming, coating, drying and cutting treatment to obtain the loratadine oral dispersible membrane; wherein the homogenizing time is 8 times, the coating speed is 63cm/min, the drying temperature is 60 deg.C, and the cutting size is 2.5cm × 5 cm.

Comparative example 1

Example 2 of the specific embodiment of patent application CN106619577A was taken as comparative example 1 of the present invention. The loratadine oral instant film in the comparative example 1 comprises the following components in percentage by weight: 30% of loratadine, 45% of film-forming material, 2% of poloxamer, 5% of phospholipid, 1.5% of sorbitol, 1% of essence, 2% of sucralose and 13.5% of water.

The preparation method of the loratadine oral instant membrane comprises the following steps:

(1) adding a formula amount of surfactant into water under the heating condition of 62 ℃, and stirring to obtain an aqueous solution as a water phase;

(2) adding the medicine and the surfactant in the prescription amount into a proper amount of ethanol under the heating condition of 62 ℃, and stirring to dissolve the medicine to form an oil phase;

(3) adding the oil phase at 62 ℃ into the water phase at the same temperature, stirring for 30 minutes at 750rpm by using a high-speed disperser while adding, adding at a constant speed controlled as much as possible, and homogenizing for 10 times at 1000bar by using a high-pressure homogenizer to obtain a uniform film agent intermediate;

(4) after the intermediate is cooled to room temperature, adding the film-forming material, the plasticizer and other auxiliary materials, and in order to fully swell the polymer auxiliary materials, placing the film material overnight and degassing at the same time;

(5) pouring the film material on the lower edge of a glass plate at the same temperature, pushing the film material forwards by a push rod, drying at 50 ℃, stripping the film material from a plastic film, and cutting into 2.5cm multiplied by 5 cm-sized films.

Examples 1 to 4 in table 1 are all examples of the present invention, comparative example 1 is prior art and is comparative example of the present invention, and the performance test was performed on the loratadine oral dispersion film prepared in examples 1 to 4 and the loratadine oral instant film prepared in comparative example 1, respectively, and the test results are shown in tables 3 and 4 below.

The breaking force is the ultimate strength of the material under tensile load, the breaking force is large, and the strength of the surface film agent is high. The present invention adopts an intelligent electronic tensile testing machine (XLM type, denham-langue electromechanical technology, ltd.), sets a speed of 100mm/min, and under this condition, measures the physical properties of the oral cavity dispersion film prepared in examples 1-4 and the oral cavity instant film prepared in comparative example 1, respectively, and the test results are shown in table 3 below.

Determination of disintegration time: the orodispersible films prepared in examples 1 to 4 and the orodispersible film prepared in comparative example 1 were sandwiched by two stainless steel wires having mesh openings of 2.0mm, and were put into 6 baskets of a disintegrator, respectively, a proper amount of water was charged in a beaker, the temperature was controlled to 37. + -. 2 ℃ and the timing was started when the films were in contact with water, and the timing was ended when all the films passed through a 710 μm sieve, and the disintegration time of each film was recorded by a stopwatch. In order to ensure the accuracy of the measurement, only 1 piece of the drug film is put into the hanging basket at a time for measurement.

And (3) measuring the mouthfeel: 10 subjects were selected and the mouth feel measurements were randomly performed on the orodispersible films prepared in examples 1 to 4 and the orodispersible film prepared in comparative example 1. The measurement results were rated according to the rating scale shown in table 1 below. The 10 subjects, for each oral cavity dispersion film, were evaluated by removing one of the highest and one of the lowest values for each grade, and then calculating the average values, the results of which are shown in Table 3 below.

And (3) measuring the stability of the long-term test: the orodispersible films prepared in examples 1 to 4 and the orodispersible film prepared in comparative example 1 were left for 12 months at 25 ℃. + -. 2 ℃ and RH 60%. + -. 10% to perform various index tests, and the measurement results are shown in Table 4 below.

The content of the loratadine oral dispersible film agent (loratadine) and related substances (impurities) are determined according to a high performance liquid chromatography. This is the prior art and will not be described herein.

TABLE 2

Grade	0-1	1.1-2	2.1-3	3.1-4	4.1-5	5.1-6
							Taste of the product	Is poor	In general	Go and can	Is preferably used	Good effect	Satisfaction

TABLE 3

Item	Thickness/mum	Breaking force/N	Disintegration time/S	Taste of the product
					Example 1	130	41.6	25	5.1
Example 2	110	36.1	22	5.3
					Example 3	100	31.7	20	4.6
Example 4	120	35.2	24	4.8
					Comparative example 1	90	7.964	55	3.4

Referring to table 3, from the analysis of the test data of examples 1 to 4 and comparative example 1, it can be seen that the technical effect of example 1 in terms of disintegration rate is the worst of the 4 groups of examples, and the technical effect of example 3 in terms of tensile strength and mouthfeel is the worst of the 4 groups of examples. However, as can be seen from the comparison of the test data of examples 1, 3 and comparative example 1, the technical solutions of examples 1 and 3 are significantly better than comparative example 1 in terms of tensile strength, disintegration rate and mouthfeel. Therefore, it can be confirmed that the technical solution of the present invention has a technical effect significantly superior to that of comparative example 1. The loratadine oral dispersible film prepared by the technical scheme of the invention has obviously improved performances in the aspects of tensile strength, disintegration speed, taste and the like, and can effectively solve the technical problems in the prior art.

TABLE 4

Referring to table 4, according to the analysis of the test data of examples 1 to 4 and comparative example 1, the orodispersible films of examples 1 to 4 are left for 12 months at 25 ℃ ± 2 ℃ and RH 60% ± 10%, and the indexes such as mouth feel, disintegration time, related substances and contents are not significantly changed compared with those before placement, and are significantly better than the stability of the orodispersible film of comparative example 1. Therefore, it can be confirmed that the technical solution of the present invention has a technical effect significantly superior to that of comparative example 1. The loratadine oral dispersible film prepared by the technical scheme of the invention has obviously improved performance in stability, and can effectively solve the technical problems in the prior art. Namely, the oral cavity dispersion film agent has excellent stability and can be safely stored.

The present invention does not describe any specific techniques, such as high performance liquid chromatography.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. The loratadine oral dispersing film agent is characterized by comprising the following raw and auxiliary materials in percentage by mass: 25-40% loratadine, 0.3-1% polysorbate 80, 1-10% plasticizer, 0.001-0.02% glyceride fatty acid, 2-5% povidone K30, 22-35% hypromellose-E5, 10-25% hydroxypropyl cellulose-SL, 1-8% maltose, 0.5-5% saccharin sodium and 1-6% opacifier; the particle size of the loratadine is X90 which is less than or equal to 10 mu m.

2. The orodispersible film of claim 1, comprising the following raw and auxiliary materials in percentage by mass: 30-35% of loratadine, 0.5-0.8% of polysorbate 80, 6-7% of plasticizer, 0.007-0.014% of glyceride fatty acid, 3-4% of povidone K30, 28-30% of hypromellose-E5, 15-20% of hydroxypropyl cellulose-SL, 3-5% of maltose, 1.7-4.2% of saccharin sodium and 4-5% of opacifier.

3. The orodispersible film of claim 1, wherein the plasticizer is at least one of polyethylene glycol 400, propylene glycol and glycerin; the opacifier is titanium dioxide.

4. The orally dispersing film of claim 1 wherein the thickness of said orally dispersing film is 100 μm and 130 μm.

5. The orodispersible film of claim 4, wherein the force to break of the orodispersible film is greater than 30N for an area of 2.5cm x 5 cm.

6. The orodispersible film of claim 4 or 5, having a disintegration time in water at 37 ± 2 ℃ of no more than 25S.

7. A method of preparing a loratadine orally dispersing film according to any of claims 1-6 comprising the steps of:

8. The method for preparing a loratadine orally dispersible film according to claim 7, wherein the stirring speed in step (1) and step (2) is 2000-3000 r/min.

9. The method for preparing a loratadine orally dispersing film according to claim 7 wherein in step (4), the number of homogenization is 3-8, the coating speed is 60-70cm/min, and the drying temperature is 60-80 ℃.

10. The method of preparing a loratadine orally dispersing film according to claim 7 wherein in step (4), the size of the cut is 2.5cm x 5 cm.