CN1679525A - Compound Acetaminophen Orally Disintegrating Tablets - Google Patents

Abstract

An oral disintegrating tablet of compound paracetamol is prepared from paracetamol, pseudoephedrine hydrochloride, dextromethorphan HBr, chlorphenamine maleate, filler, disintegrant, adhesive or moistening agent, lubricant, flavouring and pigment through direct tabletting.

Description

Compound Acetaminophen Orally Disintegrating Tablets

technical field

The invention belongs to the field of pharmaceutical preparations and relates to an orally disintegrating tablet form, in particular to a compound acetaminophen orally disintegrating tablet with quick release and good taste.

Background technique

Influenza is the modal frequently-occurring disease, and according to data statistics, my country has 36% employee's absenteeism and 67% student's absence from school to be caused by cold. Influenza seriously affects the normal life and health of humans, especially children. If it is not treated in time, it will not only bring misery to children, but also easily induce other serious diseases. However, at present, there are few varieties of antipyretic and analgesic drugs specially used for children in China, and the dosage forms are monotonous. It is necessary to add more varieties in clinical practice, so as to meet the requirements of different patients for drug selection.

Acetaminophen is a commonly used antipyretic and analgesic drug in clinical practice. At present, the varieties of acetaminophen compound preparations sold in the domestic market mainly include ordinary tablets, chewable tablets and oral solutions. Children, especially infants, often have difficulty swallowing the tablet whole. Although the oral solution is convenient to take, it is difficult to cover the bad taste of the compound preparation, and the stability of the preparation is relatively poor. Chewable tablet can overcome above-mentioned shortcoming, but its hardness is big, and the compliance of children's taking medicine is relatively poor.

Orally disintegrating tablet (orally disintegrating tablet) is a new type of solid immediate-release preparation developed abroad in the past ten years. Compared with ordinary tablets, this dosage form does not require water or chewing. The drug is placed on the tongue and disintegrates quickly when it meets saliva After that, it enters the stomach by swallowing action and takes effect quickly. Therefore, making the acetaminophen compound preparation into orally disintegrating tablets will provide patients with a very convenient way of taking medicine, and has broad market prospects.

Contents of the invention

The purpose of the present invention is to overcome the deficiency of the existing preparation varieties, and provide patients with a compound acetaminophen orally disintegrating tablet with quick-release effect and good taste.

The compound acetaminophen orally disintegrating tablet of the present invention contains four main ingredients, wherein acetaminophen acts as an antipyretic and analgesic, pseudoephedrine hydrochloride is a decongestant, and dextromethorphan hydrobromide is an antitussive , Chlorpheniramine maleate is an antihistamine. The main ingredients are their original form or other pharmaceutically acceptable salts. The drug content of each tablet of the orally disintegrating tablet is respectively: 40-500 mg of paracetamol dose, 3.75-30 mg of pseudoephedrine hydrochloride dose, 1.25-15 mg of dextromethorphan hydrobromide dose, and 1.25-15 mg of chlorpheniramine maleate dose 0.25-2 mg. Clinically, 1 to several tablets are administered each time.

The orally disintegrating tablet of the present invention includes pharmaceutically effective auxiliary materials, such as fillers, disintegrating agents, binders (wetting agents), lubricants, flavoring agents and coloring agents, in addition to the main ingredient.

In order to make the tablet disintegrate quickly when it meets saliva in the mouth, it is very important to choose a good disintegrant. The disintegrating agent of the present invention is selected from one or more of the following substances: low-substituted hydroxypropyl cellulose (L-HPC), crospovidone (PPVP), croscarmellose sodium (CCNa), cross-linked sodium carboxymethyl starch (CCMS-Na) and effervescent disintegrant. Its dosage is 0.5%-20% of the sheet weight, wherein the dosage of L-HPC is preferably 2-15%, the dosage of PPVP is preferably 4-8%, the dosage of CCNa is preferably 3-8%, and the dosage of CCMS-Na Preferably it is 4-8%, and the dosage of the effervescent disintegrant is preferably 1-20%.

The filler in the present invention is selected from one or more of microcrystalline cellulose (MCC), lactose, mannitol, erythritol, pregelatinized starch, and starch. The dosage is 40-80% of the weight of the tablet, which is adjusted according to the weight of the tablet and the application of other auxiliary materials in the prescription.

The binder in the present invention is selected from povidone, hydroxypropyl methylcellulose, methylcellulose, sodium carboxymethylcellulose, ethylcellulose or starch slurry, and its concentration is 2-20%.

The wetting agent can be selected from water or ethanol of different concentrations.

Described lubricant is selected from magnesium stearate, magnesium lauryl sulfate, talcum powder or silicon dioxide, and its consumption is the conventional dosage prescribed in pharmacy.

In order to cover the bitter taste of the main ingredient and make the orally disintegrating tablet taste good, the compound paracetamol orally disintegrating tablet of the present invention is added with one or more of the following correctives: sweeteners such as aspartame, Stevioside, sodium saccharin, disodium glycyrrhizinate, sugars and derivatives, polyols and derivatives, and other natural and artificial sweeteners, alone or in admixture. Fragrance agent can be one or more in peppermint oil (brain), bitter taste masking agent, food essence. Edible essence can choose orange juice, pineapple, strawberry, banana, mint, vanilla, fresh milk, chocolate essence, etc., and the dosage is 0.1-5% of the tablet weight. Flavors can be added to tablets in liquid or powder form. Mucilage agent plays the role of passivating taste buds and is often used in combination with sweeteners. Gelatin, gum arabic, cellulose derivatives, etc. can be selected.

In order to cover the bitter taste of dextromethorphan hydrobromide and chlorpheniramine maleate, the compound paracetamol orally disintegrating tablet of the present invention adds cyclodextrin and derivatives thereof, such as β-cyclodextrin ( βCD), hydroxypropyl-β-cyclodextrin (HPβCD), methyl-β-cyclodextrin (MeβCD), the amount of which is 2-10% of the tablet weight. The two main ingredients can form clathrates with cyclodextrins individually or as a mixture, and then added to the tablet. The preparation of cyclodextrin inclusion compound adopts conventional methods, such as saturated solution method, ultrasonic method, grinding method and so on.

The compound acetaminophen orally disintegrating tablet of the present invention uses a coating process to cover up the bitter taste of the four main ingredients, and the four main ingredients can be coated separately, or mixed to form drug-containing granules before coating . The granules used for coating are required to have relatively high hardness, and the particle size is preferably in the range of about 150-500 microns. The granules that meet the coating requirements are obtained by centrifugal granulation, high-speed stirring granulation, extrusion granulation, etc. pellets required. The coating material adopts the material used for film coating in pharmacy, such as hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose (HPC), methylcellulose (MC), hydroxyethylcellulose ( HEC), polyvinylpyrrolidone (PVP), aminoalkyl methacrylate copolymer (Eudragit E), ammonium methacrylate copolymer (Eudragit RL). It is generally used as an organic coating solution or an aqueous dispersion coating solution, wherein the concentration of the polymer is about 5-20%. Plasticizers, anti-sticking agents, colorants and opacifiers can also be added to the coating solution. Calculated by the total weight of the granule, the weight of the film layer covering the granule increases by 5-80%, which can better cover the bitter taste of the main drug, and at the same time, the release property of the drug remains unchanged.

In order to make the tablet look good and patients are willing to accept it, the compound acetaminophen orally disintegrating tablet of the present invention is added with colorants, including natural and synthetic colorants. The selected color should correspond to the food flavor, and the dosage should be within the allowed usage range in pharmacy.

The compound acetaminophen orally disintegrating tablet of the present invention can be prepared by a direct compression method, which has a simple preparation process and little adverse effect on disintegration. However, the fluidity and compressibility of the excipients and the performance of the tablet press are relatively high. In order to overcome the defects of large amount of main drug and poor fluidity of the compound preparation, the preparation of the compound paracetamol orally disintegrating tablet of the present invention can also adopt wet granulation and tabletting technology, that is, the main drug, Add disintegrant and some fillers and mix to make drug-containing granules, then mix drug-containing granules with other fillers, additional disintegrants, flavoring agents and lubricants, and then compress into tablets. Tablet hardness is controlled at 1.0-4.0kg. Experiments show that the obtained tablet has little difference in tablet weight, disintegration both in vivo and in vitro meets the requirements, has a good taste, and achieves the expected purpose.

Detailed ways:

Example 1

prescription

                                                                                                                

                                             

                                                                       

                                                     

                                                                                                                                             

    Low-substituted hydroxypropyl cellulose (L-HPC)                                                                                      

Aspartame 1.6mg

                                             

Magnesium stearate 3.2mg

Preparation: Weigh each component. The main ingredient and auxiliary materials are mixed uniformly according to the method of equal volume addition, passed through a 40-mesh sieve twice, magnesium stearate is added, mixed evenly, and then compressed into tablets.

Tablet hardness: 3-3.5kg, tablet weight difference: -2.59%～2.55%.

The in vitro disintegration time limit of the orally disintegrating tablet was determined by static method: the tablet was placed in a small beaker filled with 2ml of water (37±1°C), and the time required for the complete disintegration of the tablet was measured with a stopwatch. The disintegration time limit of the tablet in vitro: 50s.

Refer to the method reported in the literature (Chem.Pharm.Bull., 2003, 51 (10) 1121-1127) to evaluate the in vivo disintegration time limit and mouthfeel of orally disintegrating tablets: 6 healthy volunteers, each randomly took a tablet and placed it on the tongue Do not chew vigorously, do not drink water, use a stopwatch to record the time required for the orodisintegrating tablet to completely disperse in the mouth; then spit out the powder and rinse your mouth, describe the taste after the test: whether there is bitterness, whether the sweetness is appropriate , Whether there is a gritty feeling after disintegration.

Oral disintegration time: 48.5±4.2s

Taste: The grit is not obvious, you can taste the aroma of orange, not enough sweetness, slightly bitter.

Example 2

prescription

                                                                                                      

                                                                                                     

                                                               

                                                           

                                                                                                                           

Mannitol 83.8mg

                                                                                                  

Aspartame 2mg

                                                           

Micronized silica gel 2mg

Preparation: Weigh each component. After the main ingredient and the auxiliary materials are mixed evenly, an 8mm punch is used to directly compress the tablet.

Tablet hardness: 2.5kg, friability: 0.47%, in vitro disintegration time: 32s

Taste: The feeling of grit is not obvious, sweet and fragrant at first, and bitter taste can be tasted after the tablet is completely dispersed.

Example 3

prescription

Acetaminophen 25%

Pseudo ephedrine hydrochloride 2.34 %

                                                                    0.78%

                                                                                   

Micro crystal cellulose (MCC) 25 %

Mannitol 25.5%

Lactose 12.7%

                                                                  

Crospovidone (PVPP) 3%

Stevioside 2%

Peppermint Flavor 0.5%

Magnesium Stearate 1%

Preparation: Weigh each component. After mixing the main ingredient and auxiliary materials evenly, directly compress the tablet.

Tablet hardness: 2.8~3.0kg, tablet weight difference: -3.27%~2.55%

Disintegration time in vitro: 40s, disintegration time in oral cavity: 38.3±4.7s

Taste: Sweet enough, refreshing after rinsing, not easy to taste bitterness.

Example 4

prescription

                                                                                      

                                                                                                         

                                                                 

                                 

                                                                     

    Croscarmellose sodium (CCNa)                                                          

    Microcrystalline Cellulose (MCC)                                                                                                    

    Low-substituted hydroxypropyl cellulose (L-HPC)         31mg

Sodium Saccharin 8mg

                                                                                      

Magnesium Stearate 8mg

Preparation: Grind the main ingredient through a 80-mesh sieve, take the prescription amount, mix it with corn starch and croscarmellose sodium, add water to moisten the soft material, pass through a 36-mesh sieve to granulate, dry at 70°C, and 36-mesh Sieve the granules, mix the granules with MCC, L-HPC, flavoring agent, lubricant, etc. evenly, and then press into tablets.

Tablet hardness: 2.5-3kg, tablet weight difference: -2.56%～2.60%, friability: 0.32%

In vitro disintegration time: 48s

Taste: Slightly gritty, a bit hard in the heart, sweet enough, with pineapple aroma, and still slightly bitter after rinsing.

This orally disintegrating tablet is larger in size and is mainly used in adults.

Example 5

prescription

24.2 % to acetaminol

                                                               

                                                                                 

                                                                   

  Pregelatinized Starch                                                                                           = 7.58%

Anhydrous citric acid 1%

Erythritol 53.7%

Crospovidone (PVPP) 5%

Sodium bicarbonate 1.36%

Strawberry Flavor 1%

Disodium Glycyrrhizinate 2%

Color Lake 0.5%

Magnesium Stearate 0.5%

Preparation: Grind the main ingredient and anhydrous citric acid through an 80-mesh sieve. Weigh the prescription amount, pregelatinized starch and an appropriate amount of color lake, add equal amounts and mix evenly, add an appropriate amount of 50% ethanol solution dropwise to make a soft material, pass through a 36-mesh sieve to make granules, dry the wet granules at 70°C, and pass through a 36-mesh sieve For granulation, dry granules are mixed with the remaining excipients in the prescription, and then compressed into tablets.

Tablet hardness: 2.5-3kg, friability: 0.56%, tablet weight difference: -2.87%～4.49%

Disintegration time in vitro: 24.3±4.9s, disintegration time in oral cavity: 29.5±7.50s,

Taste: All 6 volunteers said that the taste is acceptable, sweet, strawberry flavor can be tasted, and there is no gritty feeling.

Example 6

prescription

Paracetamol 62.5%

                                                          

                                                                           

                                                                           

Anhydrous citric acid 1%

Mannitol 16.35%

                                                                              

Sodium bicarbonate 1%

Gelatin 1.17%

                                                         

Peppermint Flavor 1.5%

Aspartame 3%

Color Lake 0.6%

Magnesium Stearate 0.5%

The preparation method is the same as in Example 5, that is, the main ingredient is mixed with anhydrous citric acid, mannitol, and an appropriate amount of color lake, and a 50% ethanol solution is added to make a soft material, passed through a 36-mesh sieve to make granules, dried at 70°C, and granulated. After the dry granules are mixed with the remaining excipients in the prescription, they are compressed into tablets.

Tablet hardness: 2.4-3.5kg, friability: 0.65%, in vitro disintegration time: 37s Taste: sweet and sweet taste, a bit bitter in throat after spit out, tablet core is not hard.

Example 7

prescription

22.2 % of acetaminol

                                                     

                                                                                 

                                                                               

Micro -crystal cellulose (MCC) 23.6 %

Mannitol 28.3%

Lactose 7.22%

  Croscarmellose Sodium (CCNa)   5%

                                                                           

Sodium bicarbonate 1.67%

                                                                       

Orange Juice Flavor 3%

Stevioside 2%

Color Lake 0.5%

Magnesium Stearate 0.5%

Preparation: Weigh each component. After mixing the main ingredient and auxiliary materials evenly, directly compress the tablet to obtain the product.

Tablet hardness: 2-2.5kg, in vitro disintegration time: 27±1.3s

Taste: orange flavor is obvious, sweet, caramel taste after tablet disintegration, no bitterness.

Example 8

prescription

22.2 % of acetaminol

  Pseudoephedrine Hydrochloride                                                    

                                                                 

                                                                       

                                                                                                          

Mannitol 35.3%

Micro -crystal cellulose (MCC) 22.9 %

                                                                                                                      , 

                                                                           

Sodium bicarbonate 1.67%

Vanilla Flavor 2%

Sodium Saccharin 2%

Color Lake 0.6%

Micronized Silica Gel 1%

Preparation: first prepare a saturated aqueous solution of βCD, add dextromethorphan hydrobromide and chlorpheniramine maleate respectively, and stir at room temperature for a certain period of time until inclusions are formed. Filter, dry, and measure the content of the two main medicines in the clathrate. Crush the clathrate through an 80-mesh sieve, weigh the prescription amount, mix it evenly with the rest of the excipients in the prescription, and directly compress it into tablets.

Taste: The tablet is slightly hard, without gritty feeling, relatively fragrant, slightly bitter after rinsing.

Example 9

prescription

Paracetamol 17.8%

                                                               

                                                                                 

                                                                                 

4.44 % of hydroxygl-β-cyclic vascular (HPβCD)

Mannitol 40.5%

Lactose 17.4%

Crospovidone (PVPP) 5%

Anhydrous citric acid 2%

Sodium Bicarbonate 2%

                                                                             

Chocolate Flavor 3.5%

Aspartame 2.2%

Color Lake 0.6%

Magnesium Lauryl Sulfate 1%

Preparation: Grind dextromethorphan hydrobromide and chlorpheniramine maleate through an 80-mesh sieve, mix a certain amount with HPβCD, put them in a mortar, and start the grinder to grind for a certain period of time until the bitter taste cannot be tasted ( Placed on the tongue for 1 to 2 minutes), indicating that the drug has been included in HPβCD. Weigh the prescription amount, mix it with the rest of the excipients in the prescription, and directly compress it into tablets.

Tablet hardness: 1.5-2kg, in vitro disintegration time: 23±1.7s

Taste: The tablet is not hard, without gritty feeling, with obvious chocolate flavor and no bitterness.

Example 10

Prescription 0

Prescription of coated granules (according to 1000 tablets)

Paracetamol 80g

Hypromellose/Polyethylene Glycol (Opadry) 15g

Silica 1.2g

Titanium dioxide pigment 0.5g

 Distilled water                                                                            

Preparation: Disperse 15g of hydroxypropylmethylcellulose/polyethylene glycol dispersion coating material, 1.2g of silicon dioxide, and 0.5g of titanium dioxide colorant in 133ml of water, and homogenize to prepare a coating suspension.

Sieve the acetaminophen, and take the particles with a particle size of 150-500 microns (ie 30-100 mesh) and place them in a fluidized bed device (for example, Glatt GPCG1 type), and spray them at a rate of about 3-5g/min Speed and 1-1.5bar suspension spray pressure for fluidized coating. Finally, the weight of the coating film is increased by about 15%, and the whole grain is taken, and the grains below 40 mesh are taken for subsequent use.

Coat the other three main ingredients in the same way.

Prescription for orally disintegrating tablets:

Coated Granules 26%

Erythritol 56.8%

Micro -crystal cellulose (MCC) 3.75 %

    Low-substituted hydroxypropyl cellulose (L-HPC)   3.75%

Crospovidone (PVPP) 5%

Peppermint Flavor 1.5%

Aspartame 1.5%

Color Lake 0.75%

Magnesium Stearate 1%

Preparation: Mix the coated granules with the excipients in the prescription evenly, and directly compress the tablets.

Tablet hardness: 1.5-2kg, disintegration time in vitro: 22.3±2.1s, disintegration time in oral cavity: 31.5±3.2s

Taste: No bitterness, moderate sweetness, slightly gritty.

Example 11

prescription

Prescription of drug-containing granules: (according to 1000 tablets)

Paracetamol 80g

                                                         

                                                                     

Chlorpheniramine maleate 0.5g

Microcrystalline Cellulose 20g

Povidone (k30) 3.5g

Preparation: Pass the main ingredient and microcrystalline cellulose through a 100-mesh sieve respectively, take the prescription amount and mix them uniformly by equal addition method, dissolve polyvinylpyrrolidone in water to make a 20% solution, add it to the above mixture and stir to make a soft material, Pass through a 30-mesh sieve to make granules. Dry at 70°C and granulate. The drug-containing granules with a particle size of 30-100 mesh are taken for coating.

Coated Granules Prescription:

                                                                                                 

Eudragit E PO 22.8g

Sodium Lauryl Sulfate 1.6g

                                         

Talc powder 5.7g

                                                               

Titanium Dioxide 400mg

                                 

Preparation: Put about 1/2 amount of water in a beaker, add sodium lauryl sulfate and dibutyl sebacate and stir well, slowly add Eudragit E PO under stirring, and keep stirring for 2 hours; Add the color lake and titanium dioxide into the water, and homogenize at high speed for 5 minutes; pour the suspension of talcum powder and other auxiliary materials into the Eudragit E PO aqueous dispersion, and stir well.

The drug-containing granules are fluidized in a fluidized bed device (fine DPL-0.5), and fluidized coating is carried out at a spray speed of about 3-5 g/min and a suspension spray pressure of 1-1.5 bar. Finally, the weight of the coating film is increased by about 20%, the granules are whole, and the granules below 40 mesh are taken for later use.

Orally disintegrating tablet prescription:

Coated Granules 30.4%

Mannitol 53.2%

                                                                                                         

    Low-substituted hydroxypropyl cellulose (L-HPC)   3.33%

  Croscarmellose sodium (CCNa) 4%

                                                                                                                  

Aspartame 2%

Color Lake 0.78%

Magnesium Stearate 1%

Preparation: Mix the coated granules with the excipients in the prescription evenly, and directly compress the tablets.

Tablet hardness: 1.5-2kg, in vitro disintegration time: 20s

Taste: No heart, sweet and slightly gritty.

Example 12

Prescription of drug-containing granules: (according to 1000 tablets)

Paracetamol 80g

                                                     

                                                               

Chlorpheniramine maleate 0.5g

                                                     

                                                                                                          

Preparation: crush the main drug through a 100-mesh sieve, take the prescription amount and mix it with cornstarch, dissolve hydroxypropyl methylcellulose in 50% ethanol to make a 6% solution, add it to the above mixture and stir to make a soft material , 30 mesh sieve system granules. Dry at 70°C for 2-3 hours, and granulate. The drug-containing granules with a particle size of 30-100 mesh are taken for coating.

Coated Granules Prescription:

                                                                                                                              

Eudragit RL 30D 44.6g

Sodium carboxymethylcellulose 1.49g

Tween 80 3.01g

                                                                                                        

Talc powder 7.43g

                                                                     

Titanium Dioxide 800mg

                                 

Preparation: Add Tween 80 (prepared as a 33% aqueous solution) to an appropriate amount of water, add sodium carboxymethylcellulose, stir to dissolve, slowly add Eudragit RL 30D while stirring, and continue stirring for 30 minutes; add the rest of the excipients to the remaining water , high-speed homogenization, and mix this suspension with the above-mentioned Eudragit RL aqueous dispersion.

The drug-containing granules are fluidized in a fluidized bed device, and the fluidized coating is carried out at a spray speed of about 3-5 g/min and a suspension spray pressure of 1-1.5 bar. Finally, the weight of the coating film increases by about 40%, and the granules are whole, and the granules below 40 mesh are taken for subsequent use.

Orally disintegrating tablet prescription:

Coated Granules 34.7%

Mannitol 41%

Lactose 10.3%

  Croscarmellose Sodium (CCNa) 4%

Crospovidone (PVPP) 4%

Strawberry Flavor 2%

                                                                                  

Color Lake 0.78%

Magnesium Stearate 1%

Preparation: After mixing the coated granules with the excipients in the prescription evenly, use a 12mm punch to directly compress the tablet.

Tablet hardness: 1.3-2kg, disintegration time in vitro: 21±1.5s, disintegration time in oral cavity: 27.1±3.5s

Dissolution: 15min in vitro dissolution is close to 100%.

Taste: Sweet and obvious, no bitterness, slightly gritty.

The present invention is illustrated by the above description and examples, which are non-limiting and do not limit the scope of the claims of the present invention.

Claims (16)

1, a kind of Aminodyne Compound oral cavity disintegration tablet, it is characterized in that described oral cavity disintegration tablet contains the principal agent acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate, and effective auxiliary materials comprises filler, disintegrating agent, binding agent or wetting agent, lubricant, correctives and coloring agent on the pharmaceutics, described disintegrating tablet wherein every content of dispersion is respectively: acetaminophen 40-500mg, pseudoephedrine hydrochloride 3.75-30mg, the right romilar 1.25-15mg of hydrobromic acid, chlorphenamine maleate 0.25-2mg; Contain disintegrating agent and be sheet heavy 0.5%～20%; Contain correctives and be sheet heavy 0.1～10%.

2, by the described oral cavity disintegration tablet of claim 1, it is characterized in that wherein said disintegrating agent is selected from one or more of low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium or gas-producing disintegrant.

3, by the described oral cavity disintegration tablet of claim 2, wherein said disintegrating agent wherein the consumption of low-substituted hydroxypropyl cellulose be sheet heavy 2～15%, the consumption of polyvinylpolypyrrolidone be sheet heavy 4～8%, the consumption of cross-linking sodium carboxymethyl cellulose be sheet heavy 3～8%, the consumption of crosslinked carboxymethyl fecula sodium be sheet heavy 4～8%, the consumption of gas-producing disintegrant be sheet heavy 1～20%.

4, by the described oral cavity disintegration tablet of claim 1, it is characterized in that described filler is selected from one or more in microcrystalline Cellulose, lactose, mannitol, erithritol, pregelatinized Starch, the starch, its consumption be sheet heavy 40～80%.

5, by the described oral cavity disintegration tablet of claim 1, it is characterized in that described binding agent is selected from polyvidone, hydroxypropyl emthylcellulose, methylcellulose, sodium carboxymethyl cellulose, ethyl cellulose or starch slurry, its concentration is 2～20%; Described wetting agent is selected from water or Different concentrations of alcohol.

6, by the described oral cavity disintegration tablet of claim 1, it is characterized in that described lubricant is selected from magnesium stearate, Stepanol MG, Pulvis Talci or silicon dioxide, its consumption is the routine dose of defined on the pharmaceutics.

7, by the described oral cavity disintegration tablet of claim 1, it is characterized in that adopting sweeting agent and aromatic or/and mucilage or/and the preparation clathrate, or/and coating is covered the bitterness of principal agent.

8, by the described oral cavity disintegration tablet of claim 7, it is characterized in that described sweeting agent is selected from aspartame, stevioside, saccharin sodium, disodium glycyrrhizinate, sugar and derivant, polyhydric alcohol and derivant or other natural and artificial sweetening agents, its type of service is independent or mixture.

9, by the described oral cavity disintegration tablet of claim 7, it is characterized in that described aromatic is selected from one or more in Oleum menthae (brain), bitterness covering agent or the edible essence, wherein edible essence is selected from orange juice, Fructus Ananadis comosi, Fructus Fragariae Ananssae, Fructus Musae, Herba Menthae, Rhizoma et radix valerianae, fresh milk or chocolate essence, consumption be sheet heavy 0.1～5%; Add tablet with liquid or powder type.

10, by the described oral cavity disintegration tablet of claim 7, it is characterized in that described mucilage is selected from gelatin, arabic gum or cellulose derivative.

11, by the described oral cavity disintegration tablet of claim 7, it is characterized in that described clathrate adopts cyclodextrin and derivant and dextromethorphan hydrobromide and chlorphenamine maleate formation, wherein cyclodextrin and derivant thereof are selected from beta-schardinger dextrin-(β CD), HP-(HP β CD) or methyl-beta-schardinger dextrin-(Me β CD), its consumption are the heavy 2-10% of sheet.

12, by the described oral cavity disintegration tablet of claim 7, it is characterized in that described coating, its technology is coating again for coating respectively or after being mixed and made into medicine-containing particle earlier.

13, by the described oral cavity disintegration tablet of claim 12, it is characterized in that described coated granules, its particle diameter is the 150-500 micron.

14, by the described oral cavity disintegration tablet of claim 12, it is characterized in that described coating, its coating material is selected from hydroxypropyl emthylcellulose, hydroxypropyl cellulose, methylcellulose, hydroxyethyl-cellulose, polyvinylpyrrolidone, aminoalkyl methacrylate copolymer or ammonium and closes methacrylate copolymer, the rete weightening finish 5-80% of described enwrapped granule.

15, by the described oral cavity disintegration tablet of claim 1, it is characterized in that adding coloring agent in the described oral cavity disintegration tablet, comprise natural and synthetic coloring agent, its consumption is the scope that pharmaceutics allows use.

16, by the preparation method of the described oral cavity disintegration tablet of claim 1, it is characterized in that adopting direct compression process or wet granule compression tablet method.