JP2000119190A - Tablet containing chinese orthodox medicine and capsule filled with chinese orthodox medicine and tablet containing crude drug and capsule filled with crude drug, production of tablet containing chinese orthodox medicine, production of capsule filled with chinese orthodox medicine, production of tablet containing crude drug and production of capsule filled with crude drug mature - Google Patents

Abstract

PROBLEM TO BE SOLVED: To produce a tablet containing a Chinese orthodox medicine and having a short disintegrating time. SOLUTION: A mixture is obtained by mixing a Chinese orthodox medicine powder with a powdery calcium silicate in (1:1) to (20:1) weight ratio and adding an excipient thereto. Water is then added to the resultant mixture to granulate a granule according to a wet granule compression method. A disintegrating agent and a lubricant are subsequently added to the granule and mixed therewith to afford a granule for tableting. A tablet is then produced from the granule for tableting using a tableting machine.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD The present invention is used as a medicine, health food or dietary supplement, and is used for the preparation of a herbal extract powder (hereinafter referred to as "Kampo extract") or a herbal extract powder (hereinafter referred to as "herbal extract"). The present invention relates to tablets and capsules and a method for producing these tablets and capsules.

[0002]

2. Description of the Related Art It is known that it is difficult to produce tablets or capsules of Kampo extract powder or crude drug extract powder by a wet granulation method using mainly water for granulation.
This is because the Chinese medicine extract powder or the crude drug extract powder rapidly absorbs water and becomes muddy and cannot be granulated.

[0003] In Japanese Patent Publication No. 63-243034,
A technique for obtaining a solid preparation containing a low-melting substance by blending calcium silicate is disclosed. However, this technique is limited to low melting point oily substances and features the use of calcium silicate as an adsorbent for these substances. Further, among the low-melting point oils exemplified, the herbal extract is limited to a soft extract.

[0004]

As described above, according to the conventional technique, water is used for a Kampo extract powder or a crude drug extract powder.
When the granulation method is used, the extract powder rapidly absorbs water and
There is a problem that it cannot be granulated in a state. If ethanol is used instead of water in the wet granulation method, granulation is possible, but there is a problem in terms of occupational health because a large amount of ethanol is used, and there is a problem in that the production cost increases because ethanol is expensive. .

Accordingly, a first object of the present invention is to produce a tablet containing a Chinese medicine extract and having a short disintegration time. A second object of the present invention is to manufacture a capsule filled with a Chinese herbal extract and having a short disintegration time. A third object of the present invention is to produce a tablet containing a crude drug extract and having a short disintegration time.

[0006] A fourth object of the present invention is to produce a capsule filled with a crude drug extract and having a short disintegration time.

[0007]

Means for Solving the Problems As a result of research conducted by the inventor of the present invention , petal-like powder was added to a Kampo extract powder and a crude drug extract powder.
When calcium silicate having a crystal structure is blended,
Even if water is used in the wet granulation method, Chinese medicine extract powder or crude drug extract
Granulate so that the powder absorbs water and does not become muddy
It turned out to be possible.

Therefore, in order to achieve the first object,
The present invention provides a Kampo-containing tablet characterized by comprising a Kampo extract and calcium silicate. In the Chinese medicine-containing tablet, by mixing calcium silicate with the Chinese medicine extract, granulation can be performed using water by a wet granulation method. For this reason, since it is not necessary to use ethanol, there is no problem in occupational health and the production cost can be reduced. Further, since the disintegrant is effective, the disintegration time of the tablet is shortened. In the present invention, the Chinese herbal extract is an extract powder of a Chinese herbal medicine obtained by blending and extracting a crude drug according to a Chinese herbal prescription.

[0009] In the Chinese medicine-containing tablet having the above structure,
It is preferable that the Kampo extract and the calcium silicate are blended at a weight ratio of 1: 1 to 20: 1. This is because if the ratio of calcium silicate exceeds 1: 1, the value of the tablet as a pharmaceutical, health food or dietary supplement is lost, and if the ratio of calcium silicate is less than 20: 1, granulation cannot be performed. It is.

[0010] Further, in the Kampo-containing tablet having the above structure, the Kampo extract preferably accounts for 5% to 90% of the weight of the tablet. This is because if the amount of the Kampo extract is less than 5%, the value of the tablet as a pharmaceutical, health food or dietary supplement is lost, and if the amount of the Kampo extract exceeds 90%, granulation becomes impossible. Further, in the Kampo-containing tablet having the above-mentioned constitution, it is preferable to apply a film coating or a sugar coating to the tablet. This makes the tablet easier to drink.

In order to achieve the first object, the present invention provides a mixing step of mixing a Kampo extract and calcium silicate in a weight ratio of 1: 1 to 20: 1 to obtain a mixture; Using water or aqueous alcohol,
A Chinese medicine, comprising: a granulation step of forming granules from the mixture by a wet granulation method; and a tableting step of forming tablets from the granules through a normal drying, sizing / granulating step. Provided is a method for producing a tablet containing the composition.

According to the method for producing a Kampo tablet, a tablet of a Kampo extract can be suitably produced.
Further, in order to achieve the second object, the present invention provides a Kampo filling capsule characterized by being filled with a mixture of a Kampo extract and calcium silicate.

In the above-mentioned Kampo filling capsule, by blending calcium silicate with the Kampo extract, granulation can be performed using water by a wet granulation method. For this reason, since it is not necessary to use ethanol, there is no problem in occupational health and the production cost can be reduced. In addition,
In the Kampo filling capsule having the above constitution, it is preferable that the Kampo extract and calcium silicate are blended at a weight ratio of 1: 1 to 20: 1. This means that if the ratio of calcium silicate exceeds 1: 1, the value of the capsule as a pharmaceutical, health food or dietary supplement is lost, and if the ratio of calcium silicate is less than 20: 1, granulation cannot be performed. Because.

Further, in the Chinese medicine-filled capsule having the above-mentioned composition, the Chinese medicine extract comprises 5% to 9% of the weight of the mixture.
It is preferably 0%. This is because if the amount of the Kampo extract is less than 5%, the value of the capsule as a pharmaceutical, health food or dietary supplement is lost, and if the amount of the Kampo extract exceeds 90%, granulation becomes impossible.

Further, in order to achieve the second object, the present invention provides a mixing step of mixing a Kampo extract and calcium silicate at a weight ratio of 1: 1 to 20: 1 to obtain a mixture; Using water or aqueous alcohol,
Chinese medicine filling, comprising: a granulation step of forming granules from the mixture by a wet granulation method; and a filling step of filling the capsules into capsules through ordinary drying, sizing / granulating steps. Provided is a method for producing a capsule.

[0016] In the above-mentioned method for producing a Kampo filled capsule,
Thus, capsules of Kampo extract can be suitably produced. In addition, in order to achieve the third object, the present invention provides a crude drug-containing tablet characterized by comprising a crude drug extract and calcium silicate. In the above crude drug-containing tablet, by blending calcium silicate with the crude drug extract, granulation can be performed using water by a wet granulation method. For this reason, since it is not necessary to use ethanol, there is no problem in occupational health and the production cost can be reduced. Further, since the disintegrant is effective, the disintegration time of the tablet is shortened. In the present invention, the crude drug extract is a crude drug extract powder containing at least one or more powders obtained by extracting and extracting a crude drug.

In the crude drug-containing tablet having the above structure,
It is preferable that the crude drug extract and the calcium silicate are blended at a weight ratio of 1: 1 to 20: 1. This is because if the ratio of calcium silicate exceeds 1: 1, the value of the tablet as a pharmaceutical, health food or dietary supplement is lost, and if the ratio of calcium silicate is less than 20: 1, granulation cannot be performed. It is.

Further, in the crude drug-containing tablet having the above structure, the crude drug extract preferably accounts for 5% to 90% of the weight of the tablet. This is because if the amount of the crude drug extract is less than 5%, the value of the tablet as a pharmaceutical, health food or dietary supplement is lost, and if the amount of the crude drug extract exceeds 90%, granulation cannot be performed. Further, in the crude drug-containing tablet having the above structure, it is preferable to apply a film coating or a sugar coating to the tablet. This makes the tablet easier to drink.

Further, in order to achieve the third object, the present invention provides a mixing step of mixing a crude drug extract and calcium silicate at a weight ratio of 1: 1 to 20: 1 to obtain a mixture; Using water or aqueous alcohol,
A crude drug comprising a granulation step of forming granules from the mixture by a wet granulation method, and a tableting step of forming tablets from the granules through ordinary drying, sizing / granulating steps. Provided is a method for producing a tablet containing the composition.

According to the method for producing a crude drug-containing tablet, a tablet of a crude drug extract can be suitably produced.
In order to achieve the fourth object, the present invention provides a herbal medicine-filled capsule characterized by being filled with a mixture of a herbal extract and calcium silicate.

In the herbal medicine-filled capsule, by mixing calcium silicate into the herbal extract, granulation can be performed using water by a wet granulation method. For this reason, since it is not necessary to use ethanol, there is no problem in occupational health and the production cost can be reduced. In addition,
In the herbal medicine-filled capsule having the above structure, it is preferable that the herbal extract and the calcium silicate are blended at a weight ratio of 1: 1 to 20: 1. This means that if the ratio of calcium silicate exceeds 1: 1, the value of the capsule as a pharmaceutical, health food or dietary supplement is lost, and if the ratio of calcium silicate is less than 20: 1, granulation cannot be performed. Because.

Further, in the herbal medicine-filled capsule having the above-mentioned composition, the herbal extract is used in an amount of 5% to 9% by weight of the mixture.
It is preferably 0%. This is because if the amount of the crude drug extract is less than 5%, the value of the capsule as a pharmaceutical, health food or dietary supplement is lost, and if the amount of the crude drug extract exceeds 90%, granulation cannot be performed.

In order to achieve the fourth object, the present invention provides a mixing step of mixing a crude drug extract and calcium silicate at a weight ratio of 1: 1 to 20: 1 to obtain a mixture; Using water or aqueous alcohol,
A herbal medicine filling comprising: a granulation step of forming granules from the mixture by a wet granulation method; and a filling step of filling the capsules into capsules through ordinary drying, sizing / granulating steps. Provided is a method for producing a capsule.

In the above method for producing a herbal medicine-filled capsule,
Capsules of the crude drug extract can be suitably manufactured.

[0025]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described in more detail with reference to embodiments. Note that the present invention is not limited by this. -1st Embodiment-In 1st Embodiment of this invention, the manufacturing method of the Chinese medicine containing tablet containing a Chinese medicine extract powder is demonstrated.

First, in a mixing step, a required amount of a Kampo extract powder, calcium silicate, and additives are mixed in a required ratio. Hereinafter, the mixture obtained by mixing the Kampo extract powder, calcium silicate, and the additive is referred to as a mixture. Examples of Chinese herbal extract powders include Chinese herbal medicines Sho-saiko-to, Sairei-to, Hochu-ekki-to, Saiboku-to, Gushi-jin-ki-maru, Kami-shoyo-san, Bakumondo-to, Hachimi-jio-maru, Dai Kenchuyu,
Shoseiryuto, Rikkunshito, Tokishakuyakusan, Juzentaihoto, Kakkonto, Saikokeishito, Keishibukuryogan, Chotosan, Oisaikoto, Saikokaryukotsuboreito, Choreito , Onkyo-to, Oren-gedoku-to, Ho-yo-go-to, Gorei-san, Byakko-ka-nin-jin-to, Shakuyaku-kanzo-to, Hanatsu-hakujutsu-tenma-to, Nin-jin-yoei-to, Hofu-tsu-sei-san, Han-sha-shin-to, Sho-saiko-to-ka-kikyo-gypsum, Keishi-ka-jutsu-tsu-to, Jingaku-ren-go-to, Hangesa-koboku-to, Kami-ki-sple-to, Onsen-ryu, Seibung-to, Daio-kanzo-to, Jumi-toshi-to-to,
Tokiko Yoko, Shinyoku Seikoto, Toki Shigyakaku Goshuyu Ginger-To, Mao-bushi-Hoshinshinto, Otoji-to, Kakane-yu Kagawa Kyu-Koi, Annaka Spray, Shofu-San, Keishika-Ryukoshi Oyster-To , Maoto, Ginseng, Ryokeijutsukanto, Keishito, Makyokansekito, Kiyohofufuto, Toukonjokito, Shokenchuto, Keishikashakuyakuto, Kikyoto, Shigyakusan A powdered extract such as Satsuma Jinto, Keishibukuryogan-ryo-ka-yokuinin, or Jizu acne, or Shichimono-descent-to, Take-bo-yu-bai-to, Mysterious-to, Gotoro-to is used. In addition, the method of obtaining the extract of the Chinese medicine and the method of obtaining the powder from the extract are the same as those in the related art, and thus the description thereof will be omitted.

The amount of the Kampo extract powder in one tablet is determined based on the amount of the daily extract and the number of tablets per day necessary for exerting the medicinal effect or effect. The amount of the Kampo extract powder is usually from 5% by weight to 90% by weight per tablet, more preferably from 20% by weight to 80% by weight per tablet.
Up to% by weight. Calcium silicate is a standard for pharmaceutical excipients (standards for pharmaceutical additives) and a standard for ingredients outside of cosmetics (standards for cosmetics)
It conforms to the standard of the chemical name "calcium silicate" described in the above. In addition, it was found that it is preferable to use a special calcium silicate having a petal-like crystal structure having a large pore diameter and a large pore volume. Calcium silicate is used.

The amount of calcium silicate in one tablet is
Determined based on the amount of Kampo extract powder blended in one tablet. The amount of the calcium silicate is usually in the range of 1 to 20 times the weight of the Kampo extract powder, but preferably 2 minutes by weight based on the Kampo extract powder. It is blended in 1 to 1/16 amount. An excipient may be added as an additive. Among the excipients, those classified into sugars and sugar alcohols, lactose, sucrose, glucose, mannitol, sorbite, etc., are classified into starch and starch derivatives, such as corn starch, potato starch, gelatinized Among those classified into cellulose and cellulose derivatives, such as starch, dextrin and carboxymethyl starch,
Crystalline gum, hydroxypropylcellulose, carboxymethylcellulose, and others, such as gum arabic, dextran, pullulan, light anhydrous silicic acid,
Examples include synthetic aluminum silicate, magnesium metasilicate aluminate, calcium phosphate, calcium carbonate, calcium sulfate, and the like.

Next, in the granulation step, water is added to the mixture, and the mixture is wet-granulated by a fluidized bed method, a kneading method or the like to produce granules. Note that the granulation is performed by the same method as in the related art, and thus the description thereof is omitted. In the granulation step, a binder may be added to water. As the binder, crystalline cellulose, saccharides (mannitol, sucrose, etc.), dextrin,
Hydroxycellulose, hydroxypropylmethylcellulose, polyvinylpyrrolidone, macrogol and the like can be considered. These binders are dissolved or dispersed in water, and usually added as a binder solution of 10% by weight or less.

In the above description, water is used in the granulation step, but an ethanol aqueous solution of 50% by weight or less may be used. Next, normal drying,
A sizing / granulation step is performed. Since these steps are the same as those in the related art, the description thereof will be omitted. Next, a disintegrant and a lubricant were added as additives to the granules and mixed,
Produce granules for tableting.

Examples of the disintegrant include potato starch, crystalline cellulose, carboxymethylcellulose, carboxymethylcellulose calcium, low-substituted hydroxypropylcellulose, croscarmellose sodium, sodium carboxymethyl starch, and crosslinked polyvinylpyrrolidone. The amount of the disintegrant or lubricant in one tablet is determined based on the amounts of the Kampo extract powder and calcium silicate. For the amount of disintegrant,
Not more than 35% by weight of one tablet. If the compounding amount of the disintegrant is too large, the moldability of the tablet will deteriorate and the production cost will increase. On the other hand, if the amount of the disintegrant is too small, the disintegration of the tablet will be poor and the disintegration time will be long. The most desirable amount of the disintegrant is 2 tablets per tablet weight.
It is from 5% to 10% by weight.

Examples of the lubricant include metal stearates (magnesium and calcium), talc, hydrogenated castor oil, sodium stearyl fumarate and the like. The amount of the lubricant is from 0.1% by weight to 5% of the weight of one tablet.
%, Preferably from 0.3% to 2% by weight. Finally, in the tableting step, the granules for tableting are formed into tablets using a tableting machine. In addition, since the method of making the granules for tableting into a tablet is the same as the conventional method, the description is omitted.

A coating step of applying a film coating or a sugar coating to the tablet thus produced may be provided. By applying a film coating or a sugar coating, the taste of the tablet can be masked, so that the tablet can be easily taken. In addition, the stability over time of the tablet is improved. In the tablet of the present invention, the steps and materials to be used are not limited except that the enteric coating and the sustained-release coating are not used.

Chinese medicine-containing tablets were produced by the method described above, and the disintegration time was measured for six tablets of each Chinese medicine according to the disintegration test method of the Japanese Pharmacopoeia. As a result, although the disintegration time varies depending on the Kampo extract used,
It turned out that it was within 15 minutes at the longest. The extract amount (%) in the tablet and the disintegration time (minute) obtained in the studied Chinese herbal medicines are shown below. Disintegration time is the maximum of the six tablets tested. The Kampo medicine studied was Sho-saiko-to (7
5%, 8 minutes), Sairei-to (80%, 12 minutes), Hochu-ekki-to (75%, 10 minutes), Saiboku-to (75%, 11 minutes), Gurisha-Nekiki-maru (75%, 9 minutes), Kami Shoyosan (70%, 9
Minutes), Bakumondoyu (75%, 12 minutes), Hachimi Jiwang-maru (70 minutes)
%, 8 minutes), Daikenchuyu (60%, 6 minutes), Shoseiryuto (7 minutes)
Rikkunshito (75%, 10 minutes), Tokishakuyakusan (66%, 3 minutes), Juzentaihoto (75%, 9 minutes), Kakkonto (75%, 10 minutes) Minutes), Saiko Keishi-to (80%, 9
Minutes), Keishibukuryogan (75%, 10 minutes), Chotosan (75
%, 6 minutes), Daisaikoto (70%, 8 minutes), Saikokaryukotsuboreito (75%, 12 minutes), Choreito (50%, 6 minutes), Unkeito (75%, 9 minutes) Minutes), Oren-dokuto (50%, 5 minutes),
Hokyo Toki (70%, 10 minutes), Goreisan (50%, 7 minutes)
Minutes), Hakutorakajinjinto (80%, 14 minutes), Shakuyakukanzoto (50%, 6 minutes), Hanatsu Shirajutsutenmato (75%, 8 minutes),
Ninjin Yoeiyu (80%, 12 minutes), Windbreak Tsushosan (70%,
9 minutes), Hangeshashinshinto (74%, 10 minutes), Sho-saiko-to-ka-kikyo-gypsum (75%, 10 minutes), Keishika-jutsubetsu-to (70%, 7)
Min), Jingaku Liyuanyu (70%, 10 minutes), Hangatsu Kobokuyu (8
0%, 13 minutes), Kami-kihi-to (80%, 12 minutes), Onsei-in (70%, 8 minutes), Seibui-to (80%, 12.5 minutes),
Daio-kanzo-to (50%, 8 minutes)
0 minutes), Toki Yonko (65%, 9.5 minutes), Shinyeiseito (80%, 13 minutes), Toki Shikagaku Goshuyushokyoto (75 minutes)
%, 12 minutes), Mao-bushi-saishin-shin-to (55%, 6 minutes) and Otoji-to (65%, 9 minutes).

The disintegration time (3 minutes) of the tablet of Tokishakuyakusan extract produced by the method of the present invention was compared with the disintegration time (25 minutes to 50 minutes) of the tablet of Tokishakuyakusan extract currently on the market. As a result, it was found that the disintegration time of the tablet according to the present invention was 1/10 or less of the disintegration time of the currently marketed tablet. -1st application example-In the 1st application example of this invention, the tablet of the Shoseiryuto extract powder was manufactured as follows.

73 parts by weight of the Shoseiryuto extract powder and 12 parts by weight of calcium silicate (trade name: FLORITE RE) were sieved and then charged into a vertical granulator (granulator) and mixed. Thereafter, 70% by weight of water based on the mixed weight of the Shoseiryuto extract powder and calcium silicate was sprayed and added using a spray to granulate. After granulation, drying and then cross-linking polyvinylpyrrolidone (trade name: Kollidon CL
) And 0.5 parts by weight of magnesium stearate were added to obtain granules for tableting. Next, circular tablets were produced using a tableting machine.

The tablets were subjected to a disintegration test method. As a result, the disintegration times of the six tablets were 5 minutes, 6 minutes, 6.5 minutes,
7 minutes, 7 minutes and 8 minutes. FIG. 1 shows the dissolution characteristics of the tablets of the present invention and the conventional Shoseiryuto extract powder. It can be seen that the tablets of the present invention dissolve faster than conventional tablets. -2nd application example-In the 2nd application example of this invention, the tablet of the Tokishakuyakusan extract powder was manufactured as follows.

66 parts by weight of the Tokishakuyakusan extract powder and 17 parts by weight of calcium silicate (trade name: FLORITE RE) were sieved, then charged into a high-speed mixer and mixed. Thereafter, 50% by weight of water, based on the mixed weight of the powder of the Tokishakuyakusan extract and the calcium silicate, was sprayed and injected using a spray to granulate. After granulation and drying, then add 1% of croscarmellose sodium (trade name: Ac-Di-Sol)
6.5 parts by weight and 0.5 parts by weight of magnesium stearate were added to obtain granules for tableting. Next, an oval tablet was produced using a tableting machine.

As a result of a disintegration test performed on the tablets, the disintegration times of the six tablets were 6 minutes, 7 minutes, 8 minutes, and 8.
5 minutes, 8.5 minutes, and 10 minutes. -Third application example- In a third application example of the present invention, tablets of Otojito extract powder were produced as follows. 65 parts by weight of the Otojito extract and 20 parts by weight of calcium silicate (trade name: FLORITE RE) were sieved, then charged into a vertical granulator, and mixed. Thereafter, 45% by weight of water, based on the mixed weight of the Otojito extract powder and calcium silicate, was sprayed and injected using a spray to granulate. After granulation, drying and then cross-linking polyvinylpyrrolidone (trade name: Kollidon CL)
) And 0.5 parts by weight of magnesium stearate were added to obtain granules for tableting. Next, a circular tablet was produced using a tableting machine.

The tablets were subjected to a disintegration test method. As a result, the disintegration times of the six tablets were 6 minutes, 6 minutes, 6.5 minutes,
7, 8 and 9 minutes. -Fourth application example- In a fourth application example of the present invention, shellac, castor oil, glycerin monostearate, sucrose, talc, gum arabic, titanium oxide, Sugar coating was performed using Macrogol 6000, carnauba wax.

As a result of performing a disintegration test on the sugar-coated tablets, the disintegration times of the six tablets were 6 minutes, 6.5 minutes, and 6.5, respectively.
Minutes, 7.5 minutes, 8.5 minutes, and 9.5 minutes. -Fifth application example- In a fifth application example of the present invention, hydroxypropylmethylcellulose (TC-5R), macrogol 4000, and titanium oxide are used in the tablets of the Toki-Shakuyakusan extract powder obtained in the second application example. To perform film coating.

A disintegration test was performed on the film-coated tablets. As a result, the disintegration time of each of the six tablets was 6.5.
Minutes, 6.5 minutes, 7.5 minutes, 8.5 minutes, 9 minutes, and 10 minutes. According to the Chinese medicine-containing tablet according to the first embodiment,
By adding calcium silicate to the Kampo extract powder, granulation can be performed even with water by a wet granulation method.
For this reason, since it is not necessary to use ethanol at the time of granulation, there is no problem in occupational health and the production cost can be suppressed. Further, since the disintegrant can be effectively used, a tablet having a short disintegration time can be produced. -2nd Embodiment-In 2nd Embodiment of this invention, the manufacturing method of the Chinese medicine filling capsule filled with a Chinese medicine extract powder is demonstrated.

First, in the mixing step, as in the first embodiment, a required amount of a Chinese medicine extract powder, calcium silicate, and additives are mixed in a required ratio to obtain a mixture. The same Kampo extract powder, calcium silicate and additives as those described in the first embodiment are used. In addition, the amounts of the Kampo extract powder, calcium silicate and additives in one capsule are the same as in the first embodiment.

Next, in the granulation step, as in the first embodiment, water is added to the mixture, and the mixture is wet-granulated by a fluidized bed method, a kneading method or the like to produce granules. Further, a binder may be added to water in the granulation step. In the granulation step, an ethanol aqueous solution of 50% by weight or less may be used instead of water. Next, the granules are subjected to ordinary drying, sizing / granulating steps, and the like.

Next, a disintegrant and a lubricant are added to the granules as additives to produce granules for capsule filling. As the disintegrant and the lubricant, the same ones as described in the first embodiment are used. Also, the blending amount of the disintegrant and the lubricant in one capsule is the same as in the first embodiment. Finally, in the filling step, the capsule filling granules are filled into appropriate capsules using a capsule filling machine. The method for filling the capsules with the granules for filling capsules is the same as the conventional method, and the description is omitted. -Sixth application example-In a sixth application example of the present invention, a hard capsule of Toki-Shakuyakusan extract powder was produced as follows.

74 parts by weight of the Tokishakuyakusan extract powder and 9 parts by weight of calcium silicate were sieved and then charged into a vertical granulator (granulator) and mixed. Thereafter, 70% by weight of water, based on the mixed weight of the Tokishakuyakusan extract powder and calcium silicate, was sprayed and added using a spray to granulate. After granulation, the selected granules were dried using a shelf dryer and sized. Thereafter, the crosslinked polyvinylpyrrolidone was added to 1
6 parts by weight and 1 part by weight of magnesium stearate were added and mixed by a usual mixer to obtain granules for filling capsules.
The obtained granules were filled into empty hard capsules using a usual capsule filling machine to prepare hard capsules.

A disintegration test was performed on the obtained hard capsules. As a result, the average disintegration time of the six capsules was about 10
Minutes. According to the Kampo filling capsule according to the second embodiment, by mixing calcium silicate into the Kampo extract powder, granulation can be performed even by using water by a wet granulation method. For this reason, since it is not necessary to use ethanol at the time of granulation, there is no problem in occupational health and the production cost can be suppressed. Further, since the disintegrant can be effectively used, a capsule having a short disintegration time can be produced. -3rd Embodiment-In 3rd Embodiment of this invention, the manufacturing method of the crude drug containing tablet containing a crude drug extract powder is demonstrated.

First, in the mixing step, a required amount of crude drug extract powder, calcium silicate and additives are mixed in a required ratio. Hereinafter, a mixture obtained by mixing a crude drug extract powder, calcium silicate, and an additive is referred to as a mixture. The crude drug extract powders include herbal medicines such as peonies, papayas, cabbage, sagebush, sojutsu, bakuryo, buttonpi, spruce, kobushi, jiou, kanzo, carrot, spinach, shrimp, gingerbread, carrot, carrot, chimpanzee, engosaku, kankosou, maggot And the like are powdered and contain one kind or two or more kinds. The method of obtaining a crude drug extract and the method of obtaining a powder from the extract are the same as those in the related art, and thus description thereof is omitted.

The amount of the crude drug extract powder in one tablet is determined based on the amount of the extract to be taken daily and the number of tablets to be taken per day necessary for exhibiting the medicinal effect or effect. The amount of the crude drug extract powder is usually from 5% by weight to 90% by weight per tablet, more preferably from 20% by weight to 80% by weight per tablet.
Up to% by weight. Calcium silicate is a standard for pharmaceutical excipients (standards for pharmaceutical additives) and a standard for ingredients outside of cosmetics (standards for cosmetics)
It conforms to the standard of the chemical name "calcium silicate" described in the above. As a result of the experiment, it was found that it is preferable to use a special calcium silicate having a petal-like crystal structure having a large pore diameter and a large pore volume. We decided to use calcium silicate distributed as "RE".

The amount of calcium silicate in one tablet is
It is determined based on the amount of the crude drug extract powder to be blended in one tablet. The amount of the calcium silicate is usually in the range of from 1 to 20 times the weight of the herbal extract powder, but preferably 2 minutes by weight based on the herbal extract powder. It is blended in 1 to 1/16 amount. An excipient may be added as an additive. Among the excipients, those classified into sugars and sugar alcohols, lactose, sucrose, glucose, mannitol, sorbite, etc., are classified into starch and starch derivatives, such as corn starch, potato starch, gelatinized Among those classified into cellulose and cellulose derivatives, such as starch, dextrin and carboxymethyl starch,
Crystalline gum, hydroxypropylcellulose, carboxymethylcellulose, and others, such as gum arabic, dextran, pullulan, light anhydrous silicic acid,
Examples include synthetic aluminum silicate, magnesium metasilicate aluminate, calcium phosphate, calcium carbonate, calcium sulfate, and the like.

Next, in the granulation step, water is added to the mixture, and the mixture is wet-granulated by a fluidized bed method, a kneading method or the like to produce granules. Note that the granulation is performed by the same method as in the related art, and thus the description thereof is omitted. In the granulation step, a binder may be added to water. As the binder, crystalline cellulose, saccharides (mannitol, sucrose, etc.), dextrin,
Hydroxycellulose, hydroxypropylmethylcellulose, polyvinylpyrrolidone, macrogol and the like can be considered. These binders are dissolved or dispersed in water, and usually added as a binder solution of 10% by weight or less.

In the above description, water was used in the granulation step, but an ethanol aqueous solution of 50% by weight or less may be used. Next, a disintegrant and a lubricant are added as additives to the granules to produce granules for tableting. Disintegrators include potato starch, crystalline cellulose, carboxymethylcellulose, carboxymethylcellulose calcium, low-substituted hydroxypropylcellulose,
Croscarmellose sodium, sodium carboxymethyl starch, cross-linked polyvinyl pyrrolidone, and the like can be considered.

The amount of the disintegrant or lubricant in one tablet is determined based on the amount of herbal extract powder and calcium silicate. The blending amount of the disintegrant is 35% by weight or less based on the weight of one tablet. If the compounding amount of the disintegrant is too large, the moldability of the tablet will deteriorate and the production cost will increase. On the other hand, if the amount of the disintegrant is too small, the disintegration of the tablet will be poor and the disintegration time will be long. The most desirable amount of the disintegrant is from 25% to 10% by weight of one tablet.

Examples of the lubricant include metal stearates (magnesium and calcium), talc, hydrogenated castor oil, sodium stearyl fumarate and the like. The amount of the lubricant is from 0.1% by weight to 5% of the weight of one tablet.
%, Preferably from 0.3% to 2% by weight. Finally, in the tableting step, the granules for tableting are formed into tablets using a tableting machine. In addition, since the method of making the granules for tableting into a tablet is the same as the conventional method, the description is omitted.

The tablets thus produced may be coated with a film or sugar coating. By applying a film coating or a sugar coating, the taste of the tablet can be masked, so that the tablet can be easily taken.
In addition, the stability over time of the tablet is improved. In the tablet of the present invention, the steps and materials to be used are not limited, except that enteric coating and sustained release coating are not performed.

The peony (15) is obtained by the method described above.
Copy), Touki (15 copy), Keihi (11 copy), Engo Saku (10 copy), Senkyo (10 copy), Buttonpi (10 copy)
Parts), Bukuryu (5 parts), Soujutsu (5 parts), Jiou (4 parts), Spruce (4 parts), Licorice (3 parts), Kobushi (3 parts), Tonin (3 parts), Spinach (2 parts) ,
Using herbal extract powder obtained by mixing ginger (1 part), clove (1 part) and carrot (1 part) (in the ratio shown in parentheses), the amount of herbal extract per tablet is 60
% Tablets containing crude drugs were produced. Then, the disintegration time of this crude drug-containing tablet was measured according to the disintegration test method of the Japanese Pharmacopoeia. As a result, it was found that the disintegration time was 10 minutes.

The disintegration time of the products currently marketed with these crude drug formulations is about 55 minutes, and the disintegration time of the tablets according to the invention is less than one fifth of the disintegration time of the currently marketed tablets. I understood that. -Seventh application example-In a seventh application example of the present invention, tablets of crude drug extract powder were produced as follows.

Peonies, touki, Keihi, Engosaku, Senkyu, Ponpi, Bukuryu, Soujutsu,
After sieving 67 parts by weight of extract powder and 11 parts by weight of calcium silicate (trade name: FLORITE RE) obtained from dirt, spruce, liquorice, kobushi, tonin, spinach, ginger, carrot, and vertical granulator And mixed. Thereafter, 1.5 parts of hydroxypropylcellulose was dissolved in 50 ml of water to form an aqueous solution (3% by weight), and the mixture was sprayed and charged using a spray to granulate. After granulation and drying, 20 parts by weight of crosslinked polyvinyl pyrrolidone (trade name: Kollidon CL) and 0.5 parts by weight of magnesium stearate were added to obtain granules for tableting. Next, circular tablets were produced using a tableting machine.

As a result of performing a disintegration test on these tablets, the disintegration time of the 6 tablets was 7 minutes, 8 minutes, 8.5 minutes,
9, 9.5 minutes and 10 minutes. According to the crude drug-containing tablet according to the third embodiment, by blending calcium silicate with the crude drug extract powder, granulation can be performed even with water by a wet granulation method. For this reason, since it is not necessary to use ethanol at the time of granulation, there is no problem in occupational health and the production cost can be suppressed. Further, since the disintegrant can be effectively used, tablets having a short disintegration time can be produced. -4th Embodiment-In 4th Embodiment of this invention, the manufacturing method of the crude drug filling capsule filled with a crude drug extract powder is demonstrated.

First, in the mixing step, as in the third embodiment, a required amount of crude drug extract powder, calcium silicate, and additives are mixed in a required ratio to obtain a mixture. As the herbal extract powder, calcium silicate and additives, the same ones as described in the third embodiment are used. The compounding amounts of the crude drug extract powder, calcium silicate and additives in one tablet are the same as in the third embodiment.

Next, in the granulation step, as in the third embodiment, water is added to the mixture, and the mixture is wet-granulated by a fluidized bed method, a kneading method or the like to produce granules. Further, a binder may be added to water in the granulation step. In the granulation step, an ethanol aqueous solution of 50% by weight or less may be used instead of water. Next, the granules are subjected to ordinary drying, sizing / granulating steps, and the like.

Next, a disintegrant and a lubricant are added to the granules as additives to produce granules for capsule filling. Note that the same disintegrant and lubricant as described in the third embodiment are used. The blending amount of the disintegrant and the lubricant in one tablet is the same as in the third embodiment. Finally, in the filling step, the capsule filling granules are filled into appropriate capsules using a capsule filling machine. In addition,
The method for filling the capsule filling granules into the capsule is the same as the conventional method, and the description thereof is omitted. -Eighth application example-In an eighth application example of the present invention, a hard capsule of a crude drug extract powder was produced as follows.

Peonies, touki, keihi, engosaku, senkyu, botanpi, bukuro, sakuju,
67 parts by weight of an extract powder obtained from dirt, spruce, liquorice, kobushi, tounin, spinach, ginger, clove, and carrot were sieved through 11 parts by weight of calcium silicate, and then charged into a vertical granulator and mixed. Thereafter, 70% by weight of water with respect to the weight of the mixture was sprayed and added by using a spray to granulate. After granulation, the selected granules were dried and sized using a fluid bed dryer. Thereafter, 21.5 parts by weight of crosslinked polyvinylpyrrolidone and 0.5 part by weight of stearic acid were added and mixed by a usual mixer,
Granules for capsule filling were obtained. The obtained granules were filled into empty hard capsules using a usual capsule filling machine to prepare hard capsules.

A disintegration test was performed on the obtained hard capsules. As a result, the average disintegration time of the six capsules was about 13
Minutes. According to the herbal medicine-filled capsule according to the second embodiment, by blending calcium silicate with the herbal extract powder, granulation can be performed even with water by a wet granulation method. For this reason, since it is not necessary to use ethanol at the time of granulation, there is no problem in occupational health and the production cost can be suppressed. Further, since the disintegrant can be effectively used, a capsule having a short disintegration time can be produced.

[0065]

As described above, in the present invention, a Kampo-containing tablet is produced by blending calcium silicate with a Kampo extract powder. For this reason, since it becomes possible to granulate using water by a wet granulation method, there is no problem in occupational health, and the production cost can be reduced. Further, since the disintegrant can be effectively used, a tablet having a short disintegration time can be produced.

[Brief description of the drawings]

FIG. 1 is an explanatory diagram of dissolution characteristics of a tablet of the present invention and a conventional tablet.

──────────────────────────────────────────────────続 き Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI Theme coat ゛ (Reference) A61K 9/48 A61K 9/48 C A61P 3/02 31/00 603B 43/00 643D A61K 47/02 47 / 02 BF term (reference) 4C076 AA36 AA54 CC21 DD24A DD27 DD27A DD28C DD38A DD41C DD45C DD67A EE16A EE16B EE30A EE31A EE31B EE32A EE32B EE38A EE38B EE53C EE58A FF36 AB12 AB18 AB18 AB18 AB18 AB18 AB18 AB14 AB40 AB41 AB43 AB46 AB51 AB52 AB54 AB58 AB59 AB60 AB62 AB64 AB65 AB73 AB76 AB77 AB80 AB81 AB85 AB89 AC01 AC02 AC03 AC04 AC05 AC06 AC11 AC13 AC18 AD01 AD09 AD13 AD14 BA01 BA03 BA04 BA08 MA08 MA09 MA35 MA37 ZC21 ZC80 (54) ] Chinese medicine-containing tablets, herbal medicine-filled capsules, crude drug-containing tablets and herbal medicine-filled capsules METHOD OF MANUFACTURING AND KAMPOUS CONTAINING TABLET, METHOD OF MANUFACTURING KAMPOUS FILLING CAPSULE, METHOD OF MANUFACTURING Crude Drug-containing Tablet, and Manufacturing Method of Crude Drug-filled Capsule

Claims (36)

[Claims] 1. A Kampo-containing tablet comprising a Kampo extract and calcium silicate. 2. The Kampo-containing tablet according to claim 1, wherein the Kampo extract and the calcium silicate are blended at a weight ratio of 1: 1 to 20: 1. 3. The Kampo-containing tablet according to claim 1, wherein the Kampo extract accounts for 5% to 90% of the weight of the tablet. 4. A Kampo-containing tablet according to any one of claims 1 to 3, which is coated with a film or a sugar coating. 5. The tablet according to claim 1, wherein the calcium silicate has a petal-like crystal structure having a large pore diameter and a large pore volume. 6. The herbal extract according to any one of claims 1 to 4, wherein a crude drug is blended with a herbal prescription,
A herbal tablet containing a herbal medicine powder extract obtained by extraction. 7. A mixing step of obtaining a mixture by mixing a Kampo extract and calcium silicate at a weight ratio of 1: 1 to 20: 1, and a wet granulation method using water or an alcohol aqueous solution. A method for producing Kampo-containing tablets, comprising: a granulating step of forming granules from the mixture; and a tableting step of forming tablets from the granules through ordinary drying, sizing / granulating steps. 8. The method according to claim 7, further comprising a coating step of applying a film coating or a sugar coating to the tablet. 9. The method according to claim 7, wherein the calcium silicate has a petal-like crystal structure having a large pore diameter and a large pore volume. 10. The method according to claim 7, wherein said Kampo extract is a powdered extract of a Kampo medicine obtained by blending and extracting a crude drug according to a Kampo prescription. Method. 11. A capsule filled with a Chinese medicine, which is filled with a mixture of a Chinese medicine extract and calcium silicate. 12. The herbal filling capsule according to claim 11, wherein the herbal extract and calcium silicate are blended at a weight ratio of 1: 1 to 20: 1. 13. The method according to claim 11, wherein the Chinese herb extract comprises 5% to 90% of the weight of the mixture.
A herbal filling capsule, characterized in that: 14. The herbal filling capsule according to claim 11, wherein the calcium silicate has a petal-like crystal structure having a large pore diameter and a large pore volume. 15. The Chinese herb filling according to any one of claims 11 to 13, wherein the Chinese herbal extract is a herbal medicine powder extract obtained by blending and extracting a crude drug according to a Chinese herbal prescription. Capsules. 16. A mixing step of obtaining a mixture by mixing a Kampo extract and calcium silicate at a weight ratio of 1: 1 to 20: 1, and a wet granulation method using water or an alcohol aqueous solution. A method for producing a Chinese herb-filled capsule, comprising: a granulating step of forming granules from the mixture; and a filling step of filling the granules into capsules through usual drying, sizing / granulating steps. 17. The method according to claim 16, wherein the calcium silicate has a petal-like crystal structure having a large pore diameter and a large pore volume. 18. The method according to claim 16, wherein said Kampo extract is a powder extract of a Kampo medicine obtained by blending and extracting a crude drug according to a Kampo prescription. 19. A crude drug-containing tablet comprising a crude drug extract and calcium silicate. 20. The crude drug-containing tablet according to claim 19, wherein the crude drug extract and calcium silicate are blended at a weight ratio of 1: 1 to 20: 1. 21. The crude drug-containing tablet according to claim 19, wherein the crude drug extract accounts for 5% to 90% of the weight of the tablet. 22. A crude drug-containing tablet according to any one of claims 19 to 21, which is coated with a film or a sugar coating. 23. The crude drug-containing tablet according to claim 19, wherein the calcium silicate has a petal-like crystal structure having a large pore diameter and a large pore volume. 24. The crude drug-containing tablet according to any one of claims 19 to 22, wherein the crude drug extract is a crude drug extract powder containing at least one kind of powder extracted and extracted from a crude drug. . 25. A mixing step of obtaining a mixture by mixing a crude drug extract and calcium silicate at a weight ratio of 1: 1 to 20: 1, and a wet granulation method using water or an alcohol aqueous solution. A method for producing a crude drug-containing tablet, comprising: a granulation step of forming a granule from the mixture; and a tableting step of forming a tablet from the granule through a normal drying, sizing / granulating step. 26. The method for producing a crude drug-containing tablet according to claim 25, wherein a coating step of applying a film coating or a sugar coating to the tablet is provided. 27. The method for producing a crude drug-containing tablet according to claim 25, wherein the calcium silicate has a petal-like crystal structure having a large pore diameter and a large pore volume. 28. The method for producing a crude drug-containing tablet according to claim 25, wherein the crude drug extract is a crude drug extract powder containing at least one kind of powder extracted and extracted from a crude drug. . 29. A herbal medicine-filled capsule filled with a mixture of a herbal extract and calcium silicate. 30. The herbal medicine-filled capsule according to claim 29, wherein the herbal extract and the calcium silicate are blended at a weight ratio of 1: 1 to 20: 1. 31. The method according to claim 29, wherein the crude drug extract comprises 5% to 90% of the weight of the mixture.
A herbal medicine-filled capsule, characterized in that: 32. The herbal medicine-filled capsule according to claim 29, wherein the calcium silicate has a petal-like crystal structure having a large pore diameter and a large pore volume. 33. A crude drug-filled capsule according to any one of claims 29 to 31, wherein the crude drug extract is a crude drug extract powder containing at least one kind of powder extracted and extracted from a crude drug. Agent. 34. A mixing step of obtaining a mixture by mixing a crude drug extract and calcium silicate at a weight ratio of 1: 1 to 20: 1, and a wet granulation method using water or an aqueous alcohol solution. A method for producing a herbal medicine-filled capsule, comprising: a granulation step of forming granules from the mixture; and a filling step of filling the capsules into capsules through ordinary drying, sizing / granulating steps. 35. The method for producing a herbal medicine-filled capsule according to claim 34, wherein the calcium silicate has a petal-like crystal structure having a large pore diameter and a large pore volume. 36. The method for producing a herbal medicine-filled capsule according to claim 34, wherein the herbal extract is a herbal extract powder containing at least one or more powders obtained by extracting and extracting a herbal medicine.