CN1273115C - Quick acting and heart resurrecting oral disintegrating tablet and its preparation process - Google Patents

Abstract

The present invention relates to a quick acting and heart resurrecting oral disintegrating tablet and a preparation process thereof, which belongs to an oral disintegrating type traditional Chinese medicine preparation containing easily subliming medicinal components and a preparation technology thereof. The problems are solved that an effective constituent, namely borneol is easy to sublime to make medicinal effect content unstable in the process of producing and storing quick acting and heart resurrecting medicines at present, and comatose patients and patients with serious diseases can not take the medicines conveniently. In the present invention, the borneol is prepared into solid microcapsules (ball) or dispersive bodies which are uniformly mixed with szechwan lovage rhizome, a corrective, a bulking agent, a disintegrating agent, a lubricating agent and glidant and then processed through sieving and tabletting so as to obtain the oral disintegrating tablet through a modern package technology. The preparation can be taken conveniently and sufficiently disintegrated without taking water in the mouth cavity, and the operation of disintegration can be completed within 10 to 50 seconds so as to rapidly obtain the effects of efficiently releasing the medicine, rapidly taking effects and early peaking. Accordingly, the oral disintegrating tablet is especially suitable for partial patients with dysphagia or narcose patients to take with conspicuous curative effects. The present invention has the advantages of simple and direct preparation processes, optimized working environment and obtained economic benefit and social benefit.

Description

Quick-acting Jiuxin orally disintegrating tablet and its preparation method

technical field

The invention belongs to an orally disintegrating Chinese patent medicine preparation and a preparation method thereof, and relates to a quick-acting heart-relief orally disintegrating tablet containing borneol drug-loaded microcapsules or solid dispersion drug-loaded particles to stabilize the drug effect content and a preparation method thereof; Quick-acting Jiuxin orally disintegrating tablet for increasing coronary blood flow, relieving angina pectoris, mainly treating coronary heart disease, chest tightness, suffocation, precordial pain, easy to take, and quick onset for indications, and its preparation method.

Background technique

Suxiao Jiuxin Pill is a classic Chinese patent medicine with sedative, analgesic and anti-myocardial ischemia effects. It is used for the treatment of coronary heart disease, chest tightness, suffocation, precordial pain and other diseases. However, traditional pills often have shortcomings such as incomplete absorption and slow curative effect, and it is inconvenient to take for coma and severe patients. Such as Suxiao Jiuxin Dropping Pill, it takes about 5 minutes to contain it, and the onset of effect is slow, which affects first aid. Although the liquid preparation avoids the containing process, it is inconvenient to store and carry, and for those who have difficulty swallowing, it is often easy to choke the liquid medicine into the trachea.

Orally disintegrating tablet (orally disiuteg rating tablet) is a new dosage form developed in recent years. Compared with ordinary tablets, this dosage form does not require water or chewing. The drug is placed on the tongue, and it will disintegrate quickly when it meets saliva, and it will take effect by swallowing. It can also be placed under the tongue, and after rapid disintegration, the drug will be absorbed through the mucous membrane to take effect. At present, many western medicines are made into orally disintegrating tablets, and the effect is very good, but there are few traditional Chinese medicine orally disintegrating tablets at present, especially for Chinese medicines with volatile and sublimable components, there is no report of making orally disintegrating tablets on the market.

The present commercially available quick-acting heart-resisting preparation also has the problem of unstable drug effect content. Its reason is that the main ingredient borneol of this medicine is easily sublimated. Borneol is used as a resuscitating medicine in the pharmacy of the motherland, and it plays the role of "fragrance travels away, and the medicine goes up" in the quick-acting heart-relief medicine, and is one of the main ingredients for relieving chest tightness. Due to the physical property of the drug that is easy to sublimate, there are always many problems in the conventional production and storage of Chinese patent medicines; It not only wastes medicinal material resources, but also makes the production environment harsh and unbearable for workers; due to the sublimation of borneol, the effective content in the finished medicine is continuously lost, so that the medicinal content is unstable within the validity period. Accelerated tests and observation of reserved samples prove that some contain borneol The sublimation and loss of borneol components in Chinese patent medicines can be as high as 30% per year during the validity period, which is one of the technical problems hindering the modernization of traditional Chinese medicines; and the lack of stable and controllable medicinal content standards limits its smooth access to the international market ; Because the sublimation of borneol causes many difficulties for the packaging and appearance of preparations containing borneol, such as the transparent plastic packaging of modern patent medicines with "bubble eyes" packaging, they are often returned due to the contamination of borneol sublimates. The above problems need to be solved urgently. It is imperative to develop new formulations of the drug.

To sum up, the key to the modernization of traditional Chinese medicine is to use modern pharmaceutical technology and new pharmaceutical auxiliary materials, and to find a packaged drug loading technology suitable for volatile and sublimable drugs; it is urgent to prepare a new dosage form of quick-acting heart-relief tablets.

Contents of the invention

Problem to be solved:

In view of the above situation, in order to solve the problem that the borneol is easy to sublime, the content of Suxiao Jiuxin Pill is unstable, and it is inconvenient to take it for coma and severe patients. It provides a modern packaging drug loading technology, and quick-acting heart-relief orally disintegrating tablets that are convenient to take, have quick onset of effects on indications, early peak, and significant curative effect. Thereby adding a new dosage form to the medicine.

Technical solutions:

Quick-acting Jiuxin Kouban Tablets, the medicinal ingredients are Chuanxiong and Borneol, the medicinal dosage of each ingredient is in accordance with the commonly used doses stipulated in the Ministry of Standards WS3-B-3484-98, the quality of the two traditional Chinese medicines is 40% to 60% higher than that of Chuanxiong. Borneol is 60%～40%.

Orally disintegrating tablet formula is by weight percentage:

Medicinal ingredients 3.8～18.9%

Filler 48.0～71.0%

Disintegrant 9.0～27.8%

Flavoring agent 0.5～1.1%

Lubricant 0.9～2.1%

Glidant 0.9～2.1%

It should be noted:

The medicinal form of the medicinal ingredient Chuanxiong is the volatile oil obtained by one of the methods of water extraction, alcohol extraction, ether extraction, supercritical extraction, and steam extraction of the medicinal material, or the volatile oil-coated drug-loaded microcapsules, microspheres, Or it is the direct pulverization of medicinal materials. The medicinal form of the medicinal ingredient borneol is its solid dispersion, wrapped drug-loaded microcapsules, and microspheres.

Borneol is one of the main components of Quick-acting Jiuxin to relieve chest tightness. In the pharmaceutical process of the invention, the borneol is made into a solid dispersion or coated with drug-loaded microcapsules and microspheres to limit the sublimation loss of the borneol. And because the borneol has been dispersed on the water-soluble solid dispersion, the solubility and dispersibility of the water-insoluble medicine of borneol in water are improved.

The above filler is selected from one or two of microcrystalline cellulose, dextrin, lactose, starch or mannitol.

The disintegrant is selected from low-substituted hydroxypropylmethylcellulose (L-HPC), cross-linked polyvinylpyrrolidone (PVPP), cross-linked sodium carboxymethyl starch (CCMS-Na) or cross-linked sodium carboxymethylcellulose One or two of (CMC-Na).

The above-mentioned solid dispersion carrier is selected from polyethylene glycol, (ie PEG-6000, PEG-4000, PEG-12000, PEG-60000), polyvinylpyrrolidone (ie PVP-K ₁₅ , K ₃₀ , K ₆₀ , K ₉₀ ) and One or both of β-cyclodextrin and its derivatives.

The flavoring agent is selected from one or two of menthol, peppermint oil, stevioside or aspartame.

The lubricant is selected from one or both of magnesium stearate, magnesium lauryl sulfate and talcum powder.

The glidant is selected from one or both of micropowder silica gel and talcum powder.

The specific steps for the preparation of orally disintegrating tablets are as follows:

(1) Selection and pretreatment of medicinal ingredients

· Selection of medicinal ingredients:

The medicinal form of the medicinal ingredient Chuanxiong is the volatile oil obtained by one of the methods of water extraction, alcohol extraction, ether extraction, supercritical extraction, and steam extraction of the medicinal material, or the volatile oil-coated drug-loaded microcapsules, microspheres, Or the direct pulverization of medicinal materials.

The medicinal form of the medicinal ingredient borneol is its solid dispersion, coated drug-loaded microcapsules, and microspheres.

· Pretreatment of medicinal ingredients:

The volatile oils of the above-mentioned medicinal materials and the pulverized materials of the medicinal materials are all handled according to the provisions of the Pharmacopoeia.

The preparation method of the above-mentioned encapsulating drug-loaded microcapsules or microspheres is:

Coagulation method or interfacial polymerization method is adopted; the medicinal ingredients and capsule material are dissolved in an organic solvent that can be used for pharmaceuticals as stipulated in the Pharmacopoeia to form an organic phase; another water is taken, and 2 to 3% of surfactant is added to disperse to form an aqueous phase; Under the conditions of fully stirring the water phase or ultrasound, drop the organic phase into the water phase at a uniform speed, and carry out cross-linking and curing under the action of the cross-linking agent to obtain pharmaceutically encapsulated drug-loaded microcapsules or microspheres; Excess water extracts the organic solvent to obtain a drug-loaded microcapsule or microsphere powder that can release the medicinal ingredients and is easy to flow. The above stirring or ultrasonic time is 0.5 to 2 hours; the crosslinking and curing time is not less than 2 hours. It should be pointed out that, in the above preparation of the coated drug-loaded microcapsules, the concentration of the capsule material in the organic phase is 1-10%.

The capsule material is selected from natural and synthetic polymer pharmaceutical excipients. Natural polymer pharmaceutical excipients include gelatin, acacia, sodium alginate, cellulose and cellulose derivatives, and chitosan; synthetic polymer pharmaceutical excipients include Polymethacrylic acid, polymethylmethacrylate, copolymer of polymethacrylic acid and polymethacrylate, Eudragit E-100, Eudragit EPO, polyvinyl alcohol, 1-3 of polyvinylpyrrolidone and polyethylene glycol. The organic solvent is selected from organic solvents approved in Pharmacopoeia, such as ethanol, ethyl acetate, ethyl formate and chloroform. The surfactant is selected from Tween, Span, sodium lauryl sulfate, polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol. Plasticizers such as citric acid, triethyl citrate, polyethylene glycol, crosslinking agents such as formaldehyde and glutaraldehyde.

Ligusticum chuanxiong is treated by the above method to obtain solid microcapsules or microspheres of Ligusticum chuanxiong with a drug loading of 60-90%, and the particle size is 1-100um;

After the borneol is treated by the above method, borneol drug-loaded microcapsules, microspheres or solid dispersion particles with a drug loading of 50-30% are obtained, and the particle size is 1-100um;

(2) Production

Homogenization and tableting:

Grind the medicinal ingredients and flavoring agent through 80-mesh sieve respectively, weigh them according to the above-mentioned formula quantity, and mix them evenly. Weigh separately, mix evenly, then evenly mix with the medicinal ingredients mixed with flavoring agent, sieve, and compress into tablets; conventional tablet pharmaceutical equipment and compression process can be used for tablet compression to obtain orally disintegrating tablets.

Beneficial effect:

The invention provides a modern drug-carrying technology of easy sublimation traditional Chinese medicine, and a quick-acting heart-resisting orally disintegrating tablet which is convenient to take, has quick onset of effect on indications, and remarkable curative effect. It uses modern solid dispersion technology and new pharmaceutical auxiliary materials, and uses strong hydrophilic carriers to increase the solubility and dissolution rate of insoluble drugs and improve the bioavailability of drugs. By applying the encapsulation technology, Chuanxiong and borneol can be prepared into solid-coated drug-loaded microcapsules, microspheres or dispersions, so as to ensure that the orally disintegrating tablets will not be sublimated and lost during the storage of the drug, and the active ingredients will be released rhythmically to ensure the efficacy of the drug The content is stable during the storage period; it solves the problem that in the current production and storage, the active ingredient of medicines such as Suxiao Jiuxin Pills - borneol is easy to sublimate, and the problem of unstable drug content is caused. Through the synergistic effect of the drug-loaded dispersion technology and the disintegrating agent, the drug can be fully disintegrated without water in the mouth after oral administration. The disintegration time of the preparation can be completed within 10-50 seconds, and there is no gritty feeling. The drug has quick onset, early peak, no side effects, and no toxicity. It is an ideal drug delivery method for the elderly or patients with swallowing disorders. It can quickly relieve chest tightness and distress, and is convenient for first aid and prevention of patients with coronary heart disease; thereby solving the problems of inconvenient administration and slow onset for coma and severe patients, and the use of the carrier can also cover up the bad smell of the drug. The invention not only adds a new dosage form to the traditional quick-acting heart-saving medicine, but also has a simple and convenient preparation method, low resistance in the preparation process, and can be directly compressed into tablets using conventional tablet pharmaceutical equipment. In addition, because the problem of easy sublimation of borneol is controlled, the production environment is optimized and the quality of medicines is improved, which has both economic and social benefits.

The present invention will be further described below in conjunction with specific embodiments. The specific embodiments thereof should be understood as illustrative only and not limiting the scope of the invention in any way.

Detailed ways

Example 1:

· Selection and pretreatment of medicinal ingredients

Take 1 kg of Ligusticum chuanxiong and 10 liters of ethanol into a reaction tank, heat back to reheat, extract for 10 hours, concentrate under reduced pressure, recover ethanol and volatile oil, and combine the volatile oil and concentrate. Take 10 g of the above-mentioned volatile oil and add it into 50 g of ethanol solution containing 6% Eudragit E-100 to obtain an oil phase. Take another 1000ml of water, add 30g of polyethylene glycol to disperse, and form a water phase; under the condition of stirring the water phase, drop the organic phase into the water phase at a constant speed, and obtain the medicinal Ligusticum chuanxiong package through cross-linking and solidification. Drug microcapsules; then use excess water 1000ml to extract the organic solvent, and then filter and dry to obtain the easy-flowing coated Ligusticum chuanxiong drug-loaded microcapsules that can release the medicinal ingredients. The solid Ligusticum chuanxiong microcapsules or microspheres with a drug load of 80% have a particle size of 1-100um.

Take 10g of borneol, dissolve it in 50ml of ethanol, add 0.5g of polyvinylpyrrolidone and ethyl cellulose each to form an oil phase, take another 1000ml of water, add 30g of sodium lauryl sulfate and 0.5g of polyethylene glycol to disperse, The water phase is formed; under the condition of stirring the water phase, the organic phase is dropped into the water phase at a uniform speed, and the medicinal borneol is obtained by cross-linking and curing to obtain the drug-loaded microcapsules; the organic solvent is extracted with excess water, and then After filtering and drying, the easy-flowing drug-loaded microcapsules coated with borneol capable of releasing medicinal components are obtained.

The traditional Chinese medicine borneol is processed by the above method to obtain borneol drug-loaded microcapsules with a drug loading capacity of 30%, and the particle diameter is 1-100 um.

·Producer

The formula (by weight) components are:

Medicinal ingredients Ligusticum Chuanxiong 4.40g

            borneol 5.60g

Microcrystalline Cellulose 14.6g

Mannitol 22g

Croscarmellose Sodium 12.00g

Aspartame 0.15g

Mint 0.15g

Magnesium stearate 0.55g

Micropowder silica gel 0.55g

It is made in 1000 pieces

The specific preparation method is:

The pre-prepared drug-loaded medicinal ingredients Chuanxiong and borneol, aspartame and peppermint were respectively crushed through an 80-mesh sieve, mixed evenly, and then croscarmellose sodium, microcrystalline cellulose, mannitol, Micropowder silica gel and magnesium stearate are passed through 80-mesh sieve respectively. Weigh them according to the prescription amount, mix them evenly, mix them with the medicinal ingredients mixed with flavoring agents aspartame and peppermint, pass through 80 mesh sieves, and use conventional tablet pharmaceutical equipment and compression technology to compress the tablets. Orally disintegrating tablets were prepared. The orally disintegrating tablet has a disintegration time limit of 20 to 30 seconds in an aqueous medium at 37°C.

Example 2:

The selection and pretreatment of medicinal ingredients and the preparation of tablets are the same as in Example 1.

Tablet formulation (by weight) components are:

Medicinal Ingredients Ligusticum Chuanxiong 4.40g

                    borneol 5.60g

Microcrystalline Cellulose 19.0g

Mannitol 14.4g

Sodium carboxymethyl starch 15.0g

Mint 0.25g

Stevioside 0.05g

Magnesium stearate 0.65g

Micropowder silica gel 0.65g

A total of 1000 pieces were made

Production: the specific preparation method is:

Grind the stevioside, peppermint, Ligusticum chuanxiong and borneol separately, mix them evenly, and pass through an 80-mesh sieve. Separately pass sodium carboxymethyl starch, microcrystalline cellulose, mannitol, micropowder silica gel, and magnesium stearate through an 80-mesh sieve according to the prescription amount, mix them evenly, and then mix them with the medicinal ingredients mixed with stevioside and peppermint, and pass through them. Sieve and compress into tablets to obtain orally disintegrating tablets. The orally disintegrating tablet has a disintegration time limit of 20 to 30 seconds in water at 37°C.

Example 3:

The selection and pretreatment of medicinal ingredients and the preparation of tablets are the same as in Example 1.

The formula (by weight) components are:

Medicinal Ingredients Ligusticum Chuanxiong 4.40g

                    borneol 5.60g

Microcrystalline Cellulose 21.00g

Mannitol 15.60g

Cross-linked polyvinylpyrrolidone 12.00g

Stevioside 0.05g

Mint 0.25g

Magnesium stearate 0.55g

Micropowder silica gel 0.55g

A total of 1000 pieces were made

The specific preparation method is:

Grind stevioside, Ligusticum chuanxiong and borneol separately, pass through an 80-mesh sieve, weigh according to the prescription amount, and mix evenly. In addition, cross-linked polyvinylpyrrolidone, microcrystalline cellulose, mannitol, micropowder silica gel, and magnesium stearate were respectively passed through an 80-mesh sieve, weighed according to the prescription amount, and mixed uniformly. Then it is sieved and mixed evenly with the medicinal ingredients mixed with stevioside, and pressed into tablets to obtain orally disintegrating tablets, and the disintegrating time limit of the orally disintegrating tablets in 37° C. water medium is 40 to 50 seconds.

Example 4:

· Selection and pretreatment of medicinal ingredients:

Take 1 kg of Ligusticum chuanxiong and 10 liters of ethanol into a reaction tank, heat back to reheat, extract for 10 hours, concentrate under reduced pressure, recover ethanol and volatile oil, and combine the volatile oil and concentrate. Take 10 g of the above-mentioned volatile oil, add it to 40 ml of water-soluble solution containing 4% gelatin and 4% gum arabic, add 1 g of hydroxyethylcellulose and stir to make it fully mixed to form an organic phase. Take another 1000ml of water, add 30g of polyethylene glycol, and disperse to form a water phase; under the condition of stirring the water phase or ultrasonic, add the organic phase dropwise to the water phase at a uniform speed, and then add 20% formaldehyde and 50% glutaraldehyde 5ml, adjust the pH value to 8-9, cross-link and solidify for 2 hours to obtain medicinal Chuanxiong-coated drug-loaded microcapsules; then filter and dry to obtain the easy-flowing Chuanxiong-coated drug-loaded microcapsules that can release medicinal ingredients .

Take 10g of borneol, dissolve it in 50ml of ethanol, add 3g of polyvinylpyrrolidone and 1g of ethyl cellulose to form an oil phase, take another 1000ml of water, add 10g of sodium lauryl sulfate and 10g of polyethylene glycol to disperse, The water phase is formed; under the condition of stirring the water phase, the organic phase is dropped into the water phase at a uniform speed, and the medicinal borneol is obtained through cross-linking and solidification to wrap the drug-loaded microcapsules; then the organic solvent is extracted with excess water, and then After filtering and drying, the easy-flowing drug-loaded microcapsules coated with borneol capable of releasing medicinal components are obtained.

Tablet-making: the ingredients of the formula (by weight) are:

Medicinal Ingredients Ligusticum Chuanxiong 4.40g

                    borneol 5.60g

Lactose 10.7g

Starch 24.2g

Cross-linked polyvinylpyrrolidone 13.7g

Aspartame 0.15g

Mint 0.15g

Magnesium Lauryl Sulfate 0.55g

Micropowder silica gel 0.55g

It is made in 1000 pieces

The specific preparation method is:

Grind the pre-prepared drug-loaded medicinal ingredients Chuanxiong and Borneol, aspartame and peppermint through an 80-mesh sieve, and mix evenly; then weigh cross-linked polyvinylpyrrolidone, lactose, starch, micropowder silica gel, Magnesium sulfate, respectively through 80 mesh sieves. Weigh them according to the prescription amount, mix them evenly, mix them with the medicinal ingredients mixed with flavoring agents aspartame and peppermint, pass through 80 mesh sieves, and use conventional tablet pharmaceutical equipment and compression technology to compress the tablets. Orally disintegrating tablets were prepared. The orally disintegrating tablet has a disintegration time limit of 20 to 30 seconds in an aqueous medium at 37°C.

Example 5:

The selection and pretreatment of medicinal ingredients and the preparation of tablets are the same as in Example 1.

Tablet formulation (by weight) components are:

Medicinal Ingredients Ligusticum Chuanxiong 6g

                  borneol 4g

Dextrin 20g

Lactose 13.4g

Sodium carboxymethyl starch 15.0g

Mint 0.25g

Stevioside 0.05g

Magnesium stearate 0.65g

Micropowder silica gel 0.65g

A total of 1000 pieces were made

Grind the pre-prepared drug-loaded Rhizoma Chuanxiong and Borneol medicinal ingredients, stevioside, and mint through an 80-mesh sieve, and mix evenly; then weigh sodium carboxymethyl starch, lactose, dextrin, micropowder silica gel, and magnesium stearate, Pass through 80 mesh sieve respectively. Weigh them separately according to the prescription amount, mix them evenly, mix them with the medicinal ingredients mixed with flavoring agents stevioside and peppermint, pass through 80 mesh sieves respectively, and use conventional tablet pharmaceutical equipment and compression technology to compress tablets to obtain Mouth disintegration. The disintegration time limit of the tablet in 37°C water medium is 30-40 seconds.

Embodiment 6:

The selection and pretreatment of medicinal ingredients and the preparation of tablets are the same as in Example 1.

Its tablet formula (by weight) component is:

Medicinal ingredients Ligusticum Chuanxiong 4.4g

Ice flakes 5.6g

Microcrystalline Cellulose 21g

Mannitol 15g

Cross-linked polyvinylpyrrolidone 11.4g

Stevioside 0.15g

Mint 0.25g

Magnesium stearate 1.1g

Talc powder 1.1g

Grind the pre-prepared medicinal ingredients of Rhizoma Chuanxiong and Borneol, stevioside and peppermint through an 80-mesh sieve, and mix evenly; Magnesium acid, respectively through 80 mesh sieves. Weigh them separately according to the prescription amount, mix them evenly, mix them with the medicinal ingredients mixed with flavored stevioside and peppermint, pass through 80 mesh sieves respectively, and use conventional tablet pharmaceutical equipment and compression technology to compress tablets to obtain oral Crash. The disintegration time limit of the tablet in 37°C water medium is 30-40 seconds.

Claims (9)

1. fast-acting heart disease curing oral cavity disintegration tablet, medicinal ingredient is Chinese medicine Rhizoma Chuanxiong, Borneolum Syntheticum, its pharmaceutical dosage is by ministry standard WS ₃The common dose of-B-3484-98 regulation, the mass ratio of two flavor Chinese medicines is a Rhizoma Chuanxiong 40%～60%, Borneolum Syntheticum is 60%～40%, it is characterized in that, the volatile oil that the form of being used as medicine of medicinal ingredient Rhizoma Chuanxiong is that the water of this medical material is carried, alcohol extraction, ether are carried, a kind of method in the supercritical extraction, vapor extraction method obtains and parcel medicine carrying microcapsule, the microsphere of concentrate, or the solid ground product of medical material; The form of being used as medicine of medicinal ingredient Borneolum Syntheticum is solid dispersion, parcel medicine carrying microcapsule, the microsphere of Borneolum Syntheticum; This fast-acting heart disease curing oral cavity disintegration tablet is in mentioned component and ratio uniform mixing, crosses 80 mesh sieves, and as the medicinal ingredient of oral cavity disintegration tablet, with the correctives uniform mixing, the homogeneous mixture with filler, disintegrating agent, lubricant, fluidizer all mixes, sieves again, tabletting makes;

The oral cavity disintegration tablet prescription is by weight percentage:

Medicinal ingredient 3.8～18.9%

Filler 48.0～71.0%

Disintegrating agent 9.0～27.8%

Correctives 0.5～1.1%

Lubricant 0.9～2.1%

Fluidizer 0.9～2.1%.

2. according to the described fast-acting heart disease curing oral cavity disintegration tablet of claim 1, it is characterized in that filler is selected from one or both in microcrystalline Cellulose, dextrin, lactose, starch or the mannitol.

3. according to right 1 described fast-acting heart disease curing oral cavity disintegration tablet, it is characterized in that disintegrating agent is selected from one or both among low substituent group hydroxypropyl methylcellulose L-HPC, crospolyvinylpyrrolidone PVPP, crosslinked carboxymethyl fecula sodium CCMS-Na or the cross-linking sodium carboxymethyl cellulose CMC-Na.

4. according to the described fast-acting heart disease curing oral cavity disintegration tablet of claim 1, it is characterized in that the solid dispersion carrier is selected from Polyethylene Glycol, promptly PEG-6000, PEG-4000, PEG-12000, PEG-60000, polyvinylpyrrolidone are PVP-K ₁₅, PVP-K ₃₀, PVP-K ₆₀, PVP-K ₉₀With in beta-schardinger dextrin-and the derivant thereof one or both.

5. according to the described fast-acting heart disease curing oral cavity disintegration tablet of claim 1, it is characterized in that correctives is selected from one or both in Mentholum, Oleum menthae, stevioside or the aspartame.

6. according to the described fast-acting heart disease curing oral cavity disintegration tablet of claim 1, it is characterized in that lubricant is selected from one or both in magnesium stearate, Stepanol MG, the Pulvis Talci.

7. according to the described fast-acting heart disease curing oral cavity disintegration tablet of claim 1, it is characterized in that fluidizer is selected from one or both in micropowder silica gel, the Pulvis Talci.

8. the preparation method of the described fast-acting heart disease curing oral cavity disintegration tablet of claim 1, medicinal ingredient is Rhizoma Chuanxiong, Borneolum Syntheticum, its pharmaceutical dosage is by ministry standard WS ₃The common dose of-B-3484-98 regulation, the ratio of two flavor Chinese medicines is a Rhizoma Chuanxiong 40%～60%, Borneolum Syntheticum is 60%～40%, it is characterized in that the fast-acting heart disease curing oral cavity disintegration tablet is in mentioned component and ratio uniform mixing, cross 80 mesh sieves, as the medicinal active ingredient of oral cavity disintegration tablet, mix with correctives, filler, disintegrating agent, lubricant, fluidizer respectively, sieve, tabletting makes;

The oral cavity disintegration tablet prescription is by weight percentage:

Medicinal ingredient 3.8～18.9%

Filler 48.0～71.0%

Disintegrating agent 9.0～27.8%

Correctives 0.5～1.1%

Lubricant 0.9～2.1%

Fluidizer 0.9～2.1%

The concrete steps of oral cavity disintegration tablet preparation are as follows:

(1) selection of medicinal ingredient and pretreatment

The selection of medicinal ingredient:

The volatile oil that the form of being used as medicine of medicinal ingredient Rhizoma Chuanxiong is that the water of this medical material is carried, alcohol extraction, ether are carried, a kind of method in the supercritical extraction, vapor extraction method obtains, or parcel medicine carrying microcapsule, the microsphere of this volatile oil, or the direct ground product of medical material; The form of being used as medicine of medicinal ingredient Borneolum Syntheticum is solid dispersion, parcel medicine carrying microcapsule, the microsphere of Borneolum Syntheticum;

The pretreatment of medicinal ingredient:

The volatile oil of above-mentioned medical material, the ground product of medical material are all handled by the conventional method of pharmacopeia regulation;

The preparation method of parcel medicine carrying microcapsule or microsphere is:

Adopt coacervation or interfacial polymerization, medicinal ingredient and capsule material are dissolved in the pharmacopeia regulation, can be used in the organic solvent of pharmacy the formation organic facies; Water intaking adds 2～3% surfactant in addition, disperses, and forms water; Under to water stirring or ultrasound condition, organic facies at the uniform velocity is added drop-wise to aqueous phase, make its dispersion, add plasticizer or cross-linking agent or regulate pH value to 4～10, carry out crosslinked and curing, obtain medicinal parcel medicine carrying microcapsule or microsphere; With excessive water extraction organic solvent, more after filtration, drying, obtain discharging medicinal ingredient, runny parcel medicine carrying microcapsule or microsphere; Stirring or ultrasonic time 0.5～2 hour; Be not less than 2 hours crosslinked and hardening time;

Wherein the capsule material is selected from natural and the synthetic high polymer pharmaceutic adjuvant, and natural polymer medical adjuvant comprises gelatin, arabic gum, sodium alginate, cellulose and cellulosic derivant, chitosan; The synthetic high polymer pharmaceutic adjuvant comprises the copolymer of poly-methyl-prop diluted acid, polymethyl acrylate, poly-methyl-prop diluted acid and poly-methyl-prop diluted acid ester, Youteqi E-100, Youteqi EPO, polyvinyl alcohol, the 1-3 kind in polyvinylpyrrolidone and the Polyethylene Glycol; Organic solvent is selected from organic solvent ethanol, ethyl acetate, Ethyl formate and the chloroform of approval usefulness in the pharmacopeia; Surfactant is selected from tween, class of department, sodium lauryl sulphate, polyvinyl alcohol, polyvinylpyrrolidone, Polyethylene Glycol; Plasticizer is selected from citric acid, triethyl citrate, Polyethylene Glycol, and cross-linking agent is selected from formaldehyde and glutaraldehyde; Above-mentioned stirring or ultrasonic time are 0.5～2 hour; Be not less than 2 hours crosslinked and hardening time;

The Chinese medicine Rhizoma Chuanxiong is handled through said method, promptly obtains drug loading and be 60%～90% solid Rhizoma Chuanxiong microcapsule or microsphere, and its particle diameter is 1～100 μ m;

The Chinese medicine Borneolum Syntheticum is handled through said method, promptly obtains drug loading and be 50～30% Borneolum Syntheticum medicine carrying microcapsule or solid dispersion medicine carrying microgranule, and its particle diameter is 1～100 μ m;

(2) film-making

Medicinal ingredient and correctives pulverize separately are crossed 80 mesh sieves, take by weighing respectively by above-mentioned formula ratio, mix homogeneously, in addition filler, disintegrating agent, fluidizer, lubricant are crossed 80 mesh sieves respectively, by formula ratio take by weighing respectively, mix homogeneously, all mix with the ingredient that is mixed with correctives again, sieve, tabletting; Tabletting adopts conventional tablet pharmaceutical equipment and pressing process can make oral cavity disintegration tablet.

9. according to the preparation method of the described fast-acting heart disease curing oral cavity disintegration tablet of claim 9, it is characterized in that capsule material concentration is 1～10% in the organic facies in preparation parcel medicine carrying microcapsule.