KR20160009856A - Method of preparing extended release tablet - Google Patents

Abstract

The present invention relates to a method for preparing a sustained release tablet. The sustained release tablet prepared according to the present invention maximizes the medicinal effect of herbal medicine extracts included in the tablet by rapidly being enriched in a stomach and suspended for a long period of time, and effectively masks the odor of the herbal medicine extracts to improve convenience in administration. The method of the present invention comprises: a step of manufacturing granules from a solution containing herbal medicine extracts and a pharmaceutically acceptable additive using a fluidized bed granulator; and a step of manufacturing tablets from the granules.

Description

TECHNICAL FIELD [0001] The present invention relates to a method for preparing sustained release tablets,

The present invention relates to a method for producing a tablet containing a herbal medicine ingredient as an active ingredient. More specifically, the present invention relates to a method for producing tablets, which allows tablets to float rapidly from above and stay for a long time by preparing tablets containing a herbal composition as an active ingredient through a fluidized bed granulator.

Most of the commercially available tablets are made by compression molding. The formulation method is classified into direct compression method and granular compression method according to compression method. Granulation method can be divided into dry method, wet method and fluidized bed method according to the granulation method. have. In the wet process, the granules are prepared by mixing the granules and the excipients, and then coalescing, granulating, drying and sizing the granules using a previously prepared combination liquid. On the other hand, the fluidized bed granulation process proceeds through a fluidized bed granulator in a single process of mixing-coalescing-drying.

On the other hand, pharmaceutical preparations containing herbal medicine extracts as active ingredients have excellent effects and have fewer side effects, and they are actively under development in recent years. However, herbicides have a strong hygroscopicity of herbal medicine extracts even though they are powdered, and are difficult to formulate due to their properties such as density, fluidity and adhesion cohesion. Moreover, due to the nature of the herbal medicine, the odor of herbal medicine is often found in the finished product. In the case of herbal extracts absorbed or localized in the upper gastrointestinal tract, such as a leaf extract or a pseudo-acantholyticus extract, it is desirable to develop a sustained-release formulation using a herbal extract-containing stomach retention system in order to maximize its efficacy.

However, studies on sustained-release sustained-release containing synthetic drugs have been actively conducted. However, due to the material properties of the herbal extract itself, it is difficult to study the sustained-release sustained-release formulation containing herbal medicine extracts. To solve this problem, And developed and published in Korean Registered Patent No. 10050015.

However, there is a need for a new process for preparing tablets, which floats on top of it more rapidly, emits the herbicidal active ingredient over a long period of time, and can be more easily applied to mass production.

KR 10-050015

The present invention relates to a process for preparing tablets containing herbal extracts as active ingredients.

The present invention relates to a method for producing a sustained-release tablet containing an herbal medicine extract as an active ingredient.

The present invention provides a method for preparing granules comprising the steps of: preparing granules from a solution comprising a herbal extract and a pharmaceutically acceptable additive using a fluidized bed granulator;

Comprising the steps of: preparing a bead from said granules,

Wherein the granules are at least 70% by weight of granules having a particle size of less than 250 [mu] m with respect to the whole granules.

The present invention includes tablets containing the granules so that the granules having a particle size of less than 250 占 퐉 become not less than 70% by weight of the total granules and the tablets containing the granules float rapidly from above, The herbal active ingredient can be released as much as possible from the top, thus maximizing the drug efficacy of the herbal medicine extract. Also, by using a fluidized-bed granulator, the mixing, coalescence and drying of the herbal composition and the pharmaceutically acceptable additives can be carried out in a single process, and since the particle size of the granules is uniform, there is no need to separately form the granules, It is possible to produce tablets having excellent uniformity, and as a result, they can be more effectively applied to the mass production of tablets.

In general, when a granule is manufactured using a conventional granulation method such as a wet granulation method, the granules have a high density even when the granules have the same particle size, It is not released completely even when it reaches this small intestine, and as a result, the drug efficacy of the herbal medicine extract may be lowered. Further, it is possible to consider a method of lowering the hardness of tablets in order to facilitate floating in the production of tablets by using the conventional granulation method. In this case, however, the degree of abrasion of tablets is increased and film coating or the like is uniformly performed And it is difficult to shield the odor caused by the herbal medicine extract and the like.

However, when the granules are prepared so that the granules having a particle size of less than 250 占 퐉 become not less than 70% by weight by using the fluidized bed granulator as in the method of the present invention, the herbal medicine extracts contained in the tablets can be sufficiently released. In addition, since the tablets prepared from the granules have appropriate hardness, the film can be easily coated, and as a result, the odor due to the herbal extract, which is an active ingredient, can be easily shielded, and the convenience of medication can be remarkably improved.

In the present invention, the step of producing the granules may comprise:

Preparing a mixture comprising said pharmaceutically acceptable additive;

Placing the mixture in a fluidized bed granulator and allowing it to flow by air stream stirring; And

Spraying a solution containing the crude drug extract onto the moving mixture through a nozzle of a fluidized bed granulator.

In the present invention, the herbal medicine extract may include various kinds of herbal medicine extracts, for example, extracts of leaf livers, or mixed extracts of pale yellow and black livers. The leaf extract or the mixed extract may be an extract of various solvents as long as its efficacy is not deteriorated. The extract may be preferably a C2 to C6 alcohol extract, more preferably an ethanol or isopropanol extract, More preferably an extract of ethanol.

In addition, the weight ratio of the progeny and progeny extracts may be 5: 1, and the progeny and the progeny may be mixed at the above weight ratio and then extracted. Alternatively, : 1. ≪ / RTI >

In the present invention, the solution containing the herbal medicine extract may further comprise a sticky substance.

In the present invention, the viscous substance may be povidone, methylcellulose, hydroxymethylcellulose, hydroxypropylcellulose, hydroxypropylethylcellulose, gelatin, guar gum, xanthan gum or a mixture thereof.

In the present invention, the pharmaceutically acceptable additive may include a swelling polymer. The swelling polymer swells the tablet to rapidly float the tablet. The swelling polymer is not particularly limited as long as it makes it easier to suspend the tablet. Examples of the swelling polymer include hypromellose, polyethylene oxide, xanthan gum, carbomer, hydroxyethyl methylcellulose, hydroxypropylcellulose, Hydroxymethylcellulose, polyvinyl acetate, polyether glycol, or a mixture thereof, preferably, it may be hypromellose.

In the present invention, the above-mentioned pharmaceutically acceptable additives may further include an additive which does not inhibit floating of the tablet in addition to the swelling polymer. The pharmaceutically acceptable excipient may further include a carrier, diluent, excipient and the like, for example, a buffer, citric acid, calcium silicate, microcrystalline cellulose or a mixture thereof.

In the present invention, the process conditions of the fluidized bed granulator are such that the granules having a granule size of less than 250 μm can be adjusted to 70% by weight, and the inlet temperature, the spray rate, the atomizing air pressure, the bed temperature, Outlet Temperature and so on. For example, a mixture comprising the above-mentioned pharmaceutically acceptable additives may be prepared, and the mixture may be put into a fluidized bed granulator and kept in motion under air stream agitation. Wherein the mixture is introduced into the fluidized bed granulator at a temperature of about 40-60 < 0 > C. On the other hand, a solution containing the herbal medicine extract may be sprayed through a nozzle of a fluidized bed granulator on a mixture containing an agriculturally acceptable additive which is actuated by the air stream agitation. At this time, the solution containing the herbal extract may be injected at an appropriate speed and injection pressure, the speed may be about 40 to 60 rpm, and the injection pressure may be 1.5 bar or more. During the reaction, the temperature in the fluidized bed granulator may be maintained at a temperature of about 30 to 50 < 0 > C.

In the present invention, the tablets and tablets comprising granules prepared using fluid bed granulators as described above can be floated rapidly above. For example, the tablets and tablets can be floated within 15 minutes, preferably within 10 minutes when the suspension time is measured using the first solution of the Pharmacokinetics Test Method.

The tablets prepared according to the production method of the present invention can float more rapidly at the same hardness than the tablets produced by the wet granulation method or the like. The tablets prepared according to the present invention can be floated rapidly at a high hardness even at a high hardness. However, when tablets prepared by the conventional wet granulation method have the same hardness as tablets of the present invention, the density of the tablets is increased, It takes a long time, and the ability to stay on the ground is significantly reduced. In addition, when the hardness of the tablets is lowered in order to accelerate the floating, the film coating is not uniformly performed due to the high degree of grindability of the prepared nail, and as a result, the odor of the herbal medicine extract, Is difficult to medicate.

However, according to the method for preparing tablets of the present invention, a film having a high hardness can be prepared and the film coating can be uniformly performed. Therefore, the smell of the herbal medicine extract can be effectively shielded, have. In addition, despite its high hardness, it has an appropriate density and can stay for a long time in a short period of time, thereby maximizing the drug efficacy of herbal medicine extracts.

In the present invention, the tablets and tablets may have a hardness of about 7 to 14 KP, preferably about 7 to 12.5 KP.

In the present invention, the tablet may be a sustained-release tablet. The sustained-release tablet may be delayed release of the active ingredient over about 12 hours. That is, the tablets of the present invention float on the surface of the tablet and float on the tablet for a long time, so that the active ingredient of the herbal medicine extract is sufficiently released over a long period of time and exhibits excellent sustained release properties.

The present invention provides tablets prepared according to the above method. The tablets rapidly float above and stay there for a long time. Thus, the tablets exhibit excellent sustained release properties, maximizing the effect of the drug, and effectively shielding the odor of herbal medicine extracts contained in tablets, thereby exhibiting excellent convenience of medication.

According to the method for preparing tablets of the present invention, the prepared tablets can float rapidly from above and can stay for a long time, so that the herbal medicine extracts contained in the tablets are sufficiently released to maximize the drug efficacy of the tablets. In addition, despite the rapid float, the nail has a proper hardness, and the film coating is uniform, and the smell of the herbal medicine extract is effectively shielded, so that convenience of medication of the tablet can be remarkably improved.

Fig. 1 is a diagram showing floating states of tablets according to Examples and Comparative Examples. Fig.
Fig. 2 is a view showing the sensory evaluation score and the sensory evaluation score table of tablets according to Examples and Comparative Examples. Fig.

Hereinafter, the present invention will be described in more detail with reference to Examples. These examples are for illustrating the present invention specifically, and the scope of the present invention is not limited by these examples.

< Example  1 > Lady  Containing extract Stay Sue castle  Manufacture of pharmaceutical preparations

450 g of the leaf extract and 350 g of poloxamer were dissolved in 1,000 g of 95% by weight ethanol to prepare a solution containing the ethanol extract of the leaf leaf. Ethanol softening extracts of 95% (w / v) leaf softening extracts (Daepyeong, Daepyeong) were used.

Separately, 400 g of hypromellose 2208, 300 g of sodium bicarbonate, 150 g of citric acid, 450 g of calcium silicate and 250 g of microcrystalline cellulose were mixed to prepare a mixture. The mixture was placed in a fluidized bed granulator (Glatt Co.), allowed to move by air stream stirring, and a solution containing the ethanol extract of the leaves was injected into the moving mixture through a nozzle of a fluidized bed granulator to prepare granules. At this time, the fluidized bed process parameters were controlled so that the particles having a particle size of less than 250 μm accounted for 70% by weight or more of the total granule weight, and the fluidized bed process conditions were as follows.

&Lt; Process conditions of fluidized bed granulator &

- Inlet Temperature: 80 degrees

- Spray rate: 50 rpm

- Atomizing air pressure: 1.5 bar

- Bed Temperature: 40 degrees

- Outlet Temperature: 35 degrees

Magnesium stearate was added to the prepared granules so as to contain 5 mg per tablet, homogeneously mixed, and a rectangular bead having a limiting sugar content of 475 mg and a hardness of 10 KP was prepared using a continuous tabletting machine (Erweka, Germany). The film coatings were film-coated with a nap using a pan coater. Coated with 1% by weight of loam weight using OPA DRY 03B28796 and secondary coated by 4% by weight of loam weight using OPA DRY AMB to prepare film coated tablets.

Whether more than 70% by weight of the prepared granules have a particle diameter of less than 250 [mu] m is determined by weighting the granules passed through the sieve by 70% by weight, Or more, and the granules prepared in Example 1 were found to have a particle size of less than 250 μm in an amount of 70% by weight or more.

< Example  &Lt; 2 &gt; &lt; - &gt; Stay Sue castle  Manufacture of pharmaceutical preparations

450 g of pale yellow and persimmon extract and 350 g of poloxamer were dissolved in 1,000 g of 50% by weight ethanol to prepare a solution containing a pale yellow and a sperm ethanol extract. A 50% (w / v) ethanol softening extract (Daepyeong, Daepyeong) was used as the extract of the pale yellow and black bean curd (5: 1).

Separately, 400 g of hypromellose 2208, 300 g of sodium bicarbonate, 150 g of citric acid, 450 g of calcium silicate and 250 g of microcrystalline cellulose were mixed to prepare a mixture. The mixture was placed in a fluidized bed granulator (Glatt Co.) and allowed to move in an aerobic state by stirring, and a solution containing a pale yellow powder and an ethanol extract of the powdery moth was sprayed onto the moving mixture through a nozzle of a fluidized bed granulator to prepare granules Respectively. The process conditions of the fluidized bed granulator were set to the same conditions as those of the first embodiment. Then, tabular and film-coated tablets were prepared in the same manner as in Example 1, except that the tablet had a weight of 237.5 mg and a hardness of 10KP. On the other hand, the prepared granules were sieved with a sieve having a sieve size of 250 μm, and it was confirmed that at least 70% by weight of the granules prepared in Example 2 had a particle size of less than 250 μm.

< Example  3 > Lady  Containing extract Stay Sue castle  Mass Production Research

27 kg of the lobate extract and 21 kg of poloxamer were dissolved in 60 kg of 95% by weight ethanol to prepare a solution containing the leaf extract. Ethanol softening extracts of 95% (w / v) leaf softening extracts (Daepyeong, Daepyeong) were used.

Separately, a mixture was prepared by mixing 24 kg of heptromelose 2208, 18 kg of bicarbonate, 9 kg of citric acid, 27 kg of calcium silicate and 15 kg of microcrystalline cellulose. The mixture was placed in a fluidized bed granulator (Glatt Co.), which was in a state of motion by airflow agitation, and a solution containing the extract of the leaves was injected through the nozzle of the fluidized bed granulator into the moving mixture to prepare granules. At this time, the process parameters of the fluidized bed granulator were controlled so that the particles smaller than 250 μm accounted for 70% by weight or more of the total granule weight, and the process conditions of the fluidized bed granulator were as follows.

&Lt; Process conditions of fluidized bed granulator &

- Inlet Temperature: 65 degrees

- Spray rate: 120 rpm

- Atomizing air pressure: 500 NL / min

- Bed Temperature: 40 degrees

- Outlet Temperature: 35 degrees

Magnesium stearate was added to the granules so as to contain 5 mg per tablet, homogeneously mixed, and 475 mg of restricted sugar and a hardness of 10 KP were prepared using a continuous tabletting machine (Erweka, Germany). The film coatings were film-coated with a nap using a pan coater. Coated with 1% by weight of loam weight using OPA DRY 03B28796 and secondary coated by 4% by weight of loam weight using OPA DRY AMB to prepare film coated tablets.

On the other hand, the prepared granules were sieved with a sieve having a sieve size of 250 μm, and it was confirmed that at least 70% by weight of the granules prepared in Example 2 had a particle size of less than 250 μm.

< Comparative Example  1> Wet Granulation method  through Lady  Containing extract Stay Sue castle  Manufacture of pharmaceutical preparations

450 g of the leaf extract and 350 g of poloxamer were dissolved in 1,000 g of 95% by weight ethanol to prepare a solution containing the leaf extract. Ethanol softening extracts of 95% (w / v) leaf softening extracts (Daepyeong, Daepyeong) were used.

Separately, 400 g of hypromellose 2208, 300 g of sodium bicarbonate, 150 g of citric acid, 450 g of calcium silicate and 250 g of microcrystalline cellulose were homogeneously mixed to prepare a mixture, and the solution containing the prepared lobule extract was added to the mixture After drying slowly at 60 ° C, the mixture was injected into a roller compact equipped with a No. 20 sieve (body size: 850 μm) to prepare granules. Magnesium stearate was added to the prepared granules so as to contain 5 mg per tablet, uniformly mixed, and 475 mg of restricted sugar and a hardness of 10 KP were prepared using a continuous tabletting machine (Erweka, Germany). The film coatings were film-coated with a nap using a pan coater. Coated with 1% by weight of loam weight using OPA DRY 03B28796 and secondary coated by 4% by weight of loam weight using OPA DRY AMB to prepare film coated tablets.

< Comparative Example  2> Wet Granulation method  through Lady  Containing extract Stay Sue castle  Formulation My article

The granules were prepared in the same manner as in Comparative Example 1, except that the granules were injected into a roller compact equipped with a No. 60 sieve (sieve size: 250 μm) so that the granules had a fineness of less than 250 μm, . At this time, the limiting amount per unit weight was 475 mg and the hardness was 10 KP.

< Comparative Example  3> Wet Granulation method  Contains precursor and sperm extract Stay Western Manufacture of sexual preparation

450 g of a pale and hazelnut extract and 350 g of poloxamer were dissolved in 1,000 g of 50% by weight ethanol to prepare a solution containing a precolored and crude extract. A 50% (w / v) ethanol softening extract (Daepyeong, Daepyeong) was used as an extract of the pale yellow and black beetles.

Separately, 400 g of hypromellose 2208, 300 g of sodium bicarbonate, 150 g of citric acid, 450 g of calcium silicate and 250 g of microcrystalline cellulose were homogeneously mixed to prepare a mixture. Subsequent steps were carried out in the same manner as in Comparative Example 1 to prepare granules, tablets and film-coated tablets, wherein the weight per tablet was 237.5 mg and the hardness was 10 KP.

< Comparative Example  4 to 5> Granulator  through Lady  Containing extract Stay Sue castle  Manufacture of pharmaceutical preparations

In Comparative Examples 4 and 5, granules were prepared in the same manner as in Example 1, except that the granules were prepared by controlling the injection pressure of the fluidized bed granules so that the granules having a particle size of 250 m or more accounted for 30% And film-coated tablets were prepared. The fluidized bed granulation process conditions of Comparative Examples 4 to 5 are shown in Table 1 below.

Table 1. Comparison of fluidized bed conditions of 4 to 5

<Comparative Example 6 to 7> Granulator  Contains precursor and sperm extract top visit Sue castle  Manufacture of pharmaceutical preparations

In Comparative Examples 6 and 7, granules were prepared in the same manner as in Example 2, except that the granules were prepared by controlling the injection pressure of the fluidized bed granulator so that the granules having a particle size of 250 m or more accounted for 30% And film-coated tablets were prepared. The fluidized bed granulation process conditions of Comparative Examples 6 and 7 are shown in Table 2 below.

Table 2. Fluidized bed process conditions of Comparative Examples 6 to 7

< Experimental Example  1> granule particle size evaluation

The particle size distribution of the granules was evaluated by evaluating the particle size by applition to a 60-well body (body size: 250 μm).

As a result, it was found that all of the granules produced by Examples 1 to 3 and Comparative Example 2 accounted for more than 70% by weight of the total granule weight (see Table 3).

Table 3. Granule particle size evaluation results

< Experimental Example  2> Mud  Hardness and Secondary ability  evaluation

The tumbling test was carried out using the first solution of the Korean Pharmacopoeia (10th Edition) Disintegration Test. The tablets were placed in 900 ml of test solution and the time taken for the tablets to float to the test solution surface was measured.

In order to confirm the correlation between the hardness and the roughness of the roughness, the roughness was manufactured by the method of Example 3, and the hardness of the roughness was changed to evaluate the hardness of the roughness according to the hardness of the roughness. As a result, it was found that the swelling polymer swelled as the hardness of the hardness increased, so that it took a long time to lower the density of the tablet and the initial floatation time became longer (see Table 4).

Table 4. Initial flotation time change according to hardness

FIG. 1 shows photographs of the flotation behavior of the nylon prepared by the compositions of Example 3 and Comparative Examples 1, 2 and 5 for 15 minutes. As a result of the flotation test, as shown in Fig. 1, only Example 3 prepared through the fluidized bed granulator floated while controlling the particle size of the granules to less than 250 mu m. In addition, when the granules were prepared by the wet granulation method, granules having a larger density than the granules prepared by the fluidized bed granulator were produced, and the granules were not floated even though the granule particle size was adjusted to less than 250 μm.

On the other hand, when the initial float time is long, the tablets do not float on the upper side and increase the possibility of transition to the small intestine. Therefore, the maximum floating hardness within 10 minutes was studied.

The maximum float hardness of the nappes prepared according to the methods of Examples 1 to 3 and Comparative Examples 1 to 7 was investigated while varying the hardness of the nappes by preparing the nappies according to the methods of Examples 1 to 3 and Comparative Examples 1 to 7 Respectively. The flotation time of the flask was carried out using 900 mL of the first solution of the Korean Pharmacopoeia (10 revised edition) Disintegration Test Method.

The maximum float hardness was found to be 11.6 to 12.5 KP for the nuggets prepared according to the methods of Examples 1 to 3 whereas the maximum float hardness for the nuggets prepared according to the methods of Comparative Examples 1 to 7 was lowered to 5.1 to 6.7 KP And it was found.

Table 5. Maximum Float Hardness

< Experimental Example  3> Massono  evaluation

Ten tablets were placed in a rotary drum, and the drum was rotated at 25 rpm for 4 minutes. The mass of the tablet before rotation and the rotation of the rotary drum in the rotary drum were compared with the mass of the tablet, .

In the case of the tablets used for the evaluation of the degree of abrasion, the noodles prepared according to the methods of Examples 1 to 3 or Comparative Examples 1 to 7 were used but the hardness was adjusted to have a maximum floating hardness within 10 minutes, The degree of fretting was evaluated by the roughness having the maximum floating stiffness to float.

As a result of the evaluation of the degree of carcass damage, the scratches produced by Examples 1 to 3 were as small as 0.1% or less, whereas the scratches produced by Comparative Examples 1 to 7 had scratches of 2.0 to 2.5% (See Table 6).

Table 6. Machinability evaluation results

< Experimental Example  4> Coating  Dissolution evaluation

Evaluation of film coating definition elution prepared by Example 3 was performed. The dissolution rate was evaluated in 900 ml of pH 1.2 solution containing 0.025M sodium lauryl sulfate. The amount of the tiline released from the preparation was determined by HPLC to calculate the dissolution rate.

As a result, as shown in Table 7, it was found that the film-coated tablet prepared in Example 3 slowly floated on the upper side of the eluent for 12 hours while slowly releasing the tiline.

Table 7. Dissolution Test Results

< Experimental Example  5> Coating  Characteristic evaluation and unique sensory evaluation of herbal medicine odor

Coating definition properties and sensory evaluation were carried out. The coated tablets used in the experiment were prepared by preparing the tablets according to the method of Example 3 or Comparative Example 5 and controlling the hardness so that the tablets contained in the tablets floated within 10 minutes, The above properties and sensory evaluation were carried out with coated tablets prepared by using a tablet having a maximum floating hardness in a range of floating within 10 minutes.

Coating properties were observed with naked eyes. In the case of the coating compositions prepared by the methods of Comparative Examples 1 to 7 when observed on the coating property, the low hardness of the hardness caused the wrinkles in the engraved portions of the tablet surface during coating, The coated tablets prepared by the methods of to 3 did not show any fraying on the engraved portions of the tablet surface.

Sensory evaluation was performed on 30 volunteers by sensory evaluation of the odor of the film-coated tablet prepared by the method of Example 3 and Comparative Example 5 and the degree of discomfort. As a control, the film-uncoated lozenge of Example 3 was used as Control 1 and the uncoated lozenge of Comparative Example 5 was used as Control 2.

The results of the sensory evaluation are shown in Table 8 and FIG. 2, and as shown in Table 8 and FIG. 2, in the case of the control films 1 and 2 not coated with film, the specific odor of the herbal medicine was strong, . Particularly, some of the volunteers who took the control group showed severe vomiting after taking. In addition, the film-coated tablet prepared in Comparative Example 5 showed a slight odor of the herbal medicine due to incomplete coating due to the wrinkle, and showed discomfort when taken. On the other hand, the film-coated tablets prepared by the method of Example 3 were able to block the odor of the herbal medicines, and the discomfort could be solved upon taking them.

Table 8. Sensory evaluation results

Claims (16)

Preparing a granule from a solution comprising a herbal extract and a pharmaceutically acceptable additive using a fluidized bed granulator; And
Comprising the steps of: preparing a bead from said granules,
Wherein the granules have a granule having a particle size of less than 250 占 퐉 of not less than 70% by weight based on the entire granules
&Lt; / RTI &gt; 2. The method of claim 1,
Preparing a mixture comprising said pharmaceutically acceptable additive;
Placing the mixture in a fluidized bed granulator and allowing it to flow by air stream stirring; And
Spraying a solution comprising the herbal extract through a nozzle of a fluidized bed granulator onto the moving mixture. The method for producing a tablet according to claim 1, wherein the solution containing the herbal extract further comprises a sticky substance. The method of claim 3, wherein the viscous material is selected from the group consisting of povidone, methylcellulose, hydroxymethylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, hydroxypropylethylcellulose, gelatin, guar gum, xanthan gum, &Lt; / RTI &gt; The method of claim 1, wherein the pharmaceutically acceptable excipient comprises a swellable polymer. The swelling polymer according to claim 5, wherein the swelling polymer is at least one selected from the group consisting of hypromellose, polyethylene oxide, xanthan gum, carbomer, hydroxyethyl methyl cellulose, hydroxypropyl cellulose, hydroxymethyl cellulose, polyvinylacetate, polyether glycol, &Lt; / RTI &gt; 3. The method according to claim 1 or 2, wherein the herbal medicine extract is an extract of a leaf or a mixed extract of a hawthorn and a hawk. The method of claim 1 or 2, wherein the extract is an extract of ethanol or an extract of isopropanol. 3. The method of claim 1 or 2, wherein the pharmaceutically acceptable additive is hypromellose, sodium bicarbonate, citric acid, calcium silicate, microcrystalline cellulose or a mixture thereof. The method for producing tablets according to claim 1 or 2, wherein the tablets are suspended within 10 minutes when measured using the first solution of the Pharmacopoeia (10th Edition) Disintegration Test. The process for producing tablets according to claim 1, wherein the hardness of the lozenge is 7 to 14 KP. 2. The method of claim 1, wherein the tablet releases herbal extracts over a period of 12 hours. 2. The method of claim 1, further comprising film coating the tumbler. A tablet made according to the method of claim 1. The tablet according to claim 14, wherein the tablets are suspended within 10 minutes when measured using the first solution of the Korean Pharmacopoeia (10th Edition) Disintegration Test. 15. The tablet according to claim 14, wherein the tablet has a hardness of 7 to 14 KP.

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