JP3269131B2 - Method for producing Chinese herbal hard capsules - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for producing hard capsules of Chinese medicine in the pharmaceutical industry.

[0002]

2. Description of the Related Art Crude drugs have been used for Chinese medicines since ancient times, and the Chinese medicine prescriptions are described in many classics (such as the theory of kankan, the outline of Kim Jong, etc.) as an accumulation of many years of experience.

[0003] However, in accordance with those classics, decoctions obtained by cutting crude drugs each time and decocting them with water to extract ingredients in Chinese herbal medicine are not only difficult to take due to their unique smell and condiment, but also many. It takes time and effort.

[0004] Originally, it is preferable to take this decoction for Chinese herbal medicines, but at present, Kampo extract preparations are used in the fields of over-the-counter medicines and prescription medicines. This is because Chinese herbal extract preparations have the advantage that there is no need to extract components, they are easy to store, and they can be easily carried, which greatly contributes to medical practice.

[0005] This Chinese herbal extract preparation is usually prepared by extracting a crude drug with water or alcohol, and extracting or concentrating the obtained extract as it is, and drying it to obtain a herbal medicine dry extract powder, which contains lactose, corn starch, Add and mix appropriate excipients such as microcrystalline cellulose, tablets, capsules,
It has been obtained by a method of preparing powders, fine granules, granules and the like.

[0006] Capsules have the advantage that the content of ingredients in one capsule is accurate, convenient for dispensing, convenient to carry, and the like. Particularly in the case of hard capsules of traditional Chinese medicine, the unique taste, odor, and There is an advantage that the color tone can be masked to give a beautiful appearance to the preparation.

[0007] However, in the case of producing hard capsules of traditional Chinese medicine, if the obtained powder is directly packed in hard capsules, the hard capsules require a very long time to elute the contents. It cannot be said that the drug effect is sufficiently satisfied.

[0008] Therefore, there has been a demand for the development of a hardened Chinese herbal medicine capsule having good dissolution properties.

[0009]

Means for Solving the Problems The present inventors have conducted intensive studies in search of a method for producing a hard capsule of Chinese medicine with good dissolution, and extracted the Chinese medicine with an extraction solvent and concentrated it as necessary. After that, the extract powder obtained by drying this is compressed and crushed, and magnesium stearate is added to the particles, and the capsules are filled into the capsules, whereby it is possible to provide a herbal hard capsule with good dissolution properties. Thus, the present invention has been completed.

That is, the present invention is as described below.

(1) A method for producing a hard capsule of a Chinese medicine, comprising adding magnesium stearate to particles obtained by compacting a dry extract powder of the Chinese medicine.

(2) The amount of magnesium stearate to be added is 0.5 to 0.5 by weight based on 100 dry extract powders of Chinese medicine.
3. The method for producing a Chinese herbal hard capsule according to (1), wherein the capsule is 3.

(3) The herbal medicines are Oren-dokuto, Ninjin-to, Sho-saiko-to, Mao-bushi-saishin-to, Annakasan, Keishi-bukuryo-gan, Hakuto-ka-ka-jin-sin-to, Shakuyaku-kanzo-to, San-o-shashin-to and Shiba-to The method for producing a Chinese herbal hard capsule according to (1), which is at least one selected from Ryoto.

Hereinafter, the method for producing hardened Chinese herbal capsules described in the present specification is collectively referred to as the production method of the present invention.

Hereinafter, the present invention will be described in more detail.

The herbal medicine used in the production method of the present invention is not particularly limited, and includes not only a herbal medicine in Chinese medicine but also a so-called crude drug or a crude drug preparation comprising one or a mixture of two or more crude drugs.

Specific examples of Kampo medicines include a guide to general Kampo prescriptions (supervised by the Ministry of Health and Welfare Pharmaceutical Affairs Bureau, published by Pharmaceutical Tohokusha 1983
8th edition, 4th and 6th editions) and Chinese herbal prescriptions listed in Tsumura's Kampo preparations for medical use [Comprehensive catalog]. For details, Annaka-san, Ganrei-to, Eppikajutsuto, Oren-detox Hot water, Orenyu, Orokikenchu, Oji-ji, Onkyo, Onsen, Onsui, Kami-ki-sui, Kami-shoyo-san, Kakkon-to, Kakkon-yu, Kagawa-ku-spei, Kanmu-daijutsu , Kiibetsu-to, Kikyo-to, Gyukuri-neki-maru, Keishi-to, Keishika-ryukotsuboreito, Keishika-shakuyakuto, Keishika-jutsutsuto,
Keishi-ninjin-to, Keishi-to, Keishi-ka-shakuyaku-daioh-to, Keishi-bukuryo-gan,
Keishibukuryomaruka yokaiin, ginger ginger jujube yellow sprinkling hot water, Ikuyakurenyoto, Gotorayu, Gozokusan, Goonsan, Goreisan, Goshuyuto, Kososan, Sanohshashinto, San Mono-on-go-to, Sanso-drink, Soju-jin-to, Shigyakusan, Shikunshi-to, Shimono-to, Shi-in-ho-ken-to, Shi-in-ji-ho-to, Ji-toku-boku, Jizu-choku, Shichimono-descent , Saikaito, Saikokaryukotsuboreito, Saikokeishikankyoto, Saikokeishito, Saikoseikoto,
Saibaku-to, Sairei-to, Juzen-taiho-to, Jyomi-toshi-to-to, Junchu-to, Meishin-san, Shouma-kakkon-to, Shokenchu-to, Sho-saiko-to-ka-kikyo-gypsum, Sho-saiko-to, Sho-saiko-to Eka Shakuyaku-yu, Sho-saiko-to, Ginger gauze, Bakuryo, Shoseiryu-to, Kohanatsu-kabuku-ryo-to, Shofusan, Shinbu-to,
Mysterious hot water, Shinyi-sei-to, Ninjin-to, Nin-san-yoei-to, Seishatsu-ekki-to, Kiyo-kami-hofu-to, Seishin-Renko-drink, Seiryu-to, Kawakyu-cha-san-san, Sokyo-ketsuto-to, Seimei-to, Daio-kotanki-to, Daio-kanzo-to,
Daikenchuyu, Daijoki-yu, Daihofu-yu, Takejo-on-bile-yu, Chorei-toshi-shimotsu-yu, Chorei-to, Cho-gaso-joki-to, Totsu-san, Choto-san, Toko-san Keto, Toki-inko, Tokikenchu-to, Toki-shika-ka-goshuyu-sho-gyo-to, Toki-to, Toki-shakuyaku-san, Nichin-to, Nijutsu-to, Toyosan-san-to, Hakuto-ka-ka-jin-sin Hot water, Bakumondoyu, Hachimijiomaru, Hangesatsu-koboku-to, Hangesuka-jutsutenma-to, Hangeshashin-shin-to, Hiragan-san, Hochu-ekki-to, Hofu-tsusho-san, Ho-myo-go-to, Makyo-kan Ishiyu, Makyo-yokanto, Mao-to, Mao-bushi-saishin-to, Asako-ninmaru, Kibomi-to, Yokukansan, Yokukansan-Ken-Han-Hatsuka, Rikkansan, Ryuchoshakoto, Ryokan Jangjing Hot Spring Natsuinto, Ryokeijutsukanto, Ryojyojutsukanto, Rikkunshito, Rokumimaru, Akanomasoto, Shakuyakukanzoto, Inchinchinreirei, Inchinkototo, Bukuryoengohatsuhatsubokuto, Bukuryoin And Kyukyo Ai-to, often okuin-to.

Particularly suitable Kampo formulas for the production method of the present invention include Oren-dokuto-to, Ninjin-to, Sho-saiko-to, Mao-bushi-saishin-to, Annaka-san, Keishi-bukuryo-gan, Hakutoraka-ninto-to, Shakuyaku Licorice bath,
Sankoshashinto, Saireito, and the like.

As specific examples of crude drugs, there are Japanese color book of primary color Japanese and Chinese medicine (1st volume, 2nd volume, written by Tsuneo Namba, published by Hoikusha Co., Ltd. on April 1, 1980) and the 12th revised edition of the Japanese Pharmacopoeia Herbal Medicines, published by Hirokawa Shoten].

In order to make the above-mentioned herbal medicine or crude drug into a dry extract powder, it may be carried out according to the usual method for producing a dry extract powder. Specifically, in the case of a herbal medicine, the constituent crude drug is used, and in the case of a crude drug preparation, Cuts, weighs and extracts herbal medicine,
Concentration and drying are performed.

Examples of the extraction solvent for Chinese herbs include water, ethanol, and acetic acid. Hot or cold extraction may be performed, and a method of hot extraction at 90 to 100 ° C. using water is particularly preferable.

For concentration of the extract, vacuum concentration is generally used. Specifically, concentration under reduced pressure is performed under the conditions of a degree of vacuum of 30 to 760 mmHg and an evaporation temperature of 100 ° C or lower, preferably 30 to 50 ° C.

The above extract or its concentrate is dried by a commonly used spray drying method, reduced pressure drying method or freeze drying method to obtain a dried herbal medicine extract powder. For example, in the case of the spray drying method, the extract or the concentrate thereof is sprayed into a hot air stream of a drying chamber maintained at a high temperature of 60 to 300 ° C., and the solvent is instantaneously evaporated and dried.

Typical methods of contacting the spray droplets with the hot air flow include a cocurrent method, a countercurrent method, and a mixed flow method. The liquid atomization mechanism includes a centrifugal method, a pressurized atomizing method, and the like. And a two-fluid nozzle type.

In the case of the vacuum drying method, the extract is sufficiently concentrated under reduced pressure and dried at 760 mmHg or less at 5 to 100 ° C. In the case of lyophilization, extract or concentrate
Cool to -80 ° C to 0 ° C and freeze, sublimate the solvent directly under vacuum of 1 mmHg or less and dry.

When obtaining a dry extract powder of a Chinese medicine, a suitable excipient for a carrier can be blended. As a carrier excipient, for example, starch, dextrin, lactose, sucrose, mannitol, crystalline cellulose, silicic anhydride, etc. are used, and if necessary, a binder, a disintegrant, a surfactant, a flavoring agent, and a flavor are compounded. can do.

As a means for dissolving or dispersing the carrier excipient in the solvent, any means can be used as long as the excipient can be uniformly dissolved or dispersed in the solvent. For example, it can be carried out using a suitable stirring device. it can.

Specific examples of each of the excipients are as shown below.

[Binder] Gum arabic powder, gelatin, hydroxypropyl starch, methylcellulose, sodium carboxymethylcellulose, hydroxypropylcellulose, ethylcellulose, polyvinylpyrrolidone,
Macro goal.

[Disintegrant] Starch, hydroxypropyl starch, sodium carboxymethylcellulose, calcium carboxymethylcellulose, carboxymethylcellulose, low-substituted hydroxypropylcellulose.

[Surfactant] Sodium lauryl sulfate, soy lecithin, sucrose fatty acid ester, polysorbate 8
0.

[Lubricant] Talc, wax, hydrogenated vegetable oil, sucrose fatty acid ester, magnesium stearate, calcium stearate, aluminum stearate, polyethylene glycol, light anhydrous silicic acid, dry aluminum hydroxide gel, synthetic silicic acid Aluminum, magnesium silicate.

The obtained powder is subjected to a roller compactor,
After compacting with a briquetting machine or slug tableting machine, pulverize.

The size of the particles obtained by pulverization may be any size as long as it can be filled in a hard gelatin capsule, for example, 10 mesh (1.7 mm) to 200 mesh (75 mesh).
It is possible to obtain high specific gravity particles of Kampo extract of size (μm).

The production method of the present invention is carried out by adding 0.01% to 5%, preferably 0.5% to 3.0% of magnesium stearate to the particles obtained as described above, mixing and filling the mixture into a hard gelatin capsule. You.

Here, magnesium stearate has been conventionally used as a lubricant, a fluidity promoter and the like, but has not been used to improve the dissolution property, and was first made by the present inventors. It is knowledge.

[Effects of the Invention] As an effect of the present invention, it is possible to obtain a herbal hard capsule preparation having a high extract content and excellent dissolution properties.

Next, the good dissolution property of the herbal hard capsule obtained by the production method of the present invention will be described with reference to experimental examples.

Experimental Example 1 A hard capsule of Oren-gedokuto (capsule of the present invention) was obtained according to Example 1 described later.

In the same manner as described in Example 1,
(However, magnesium stearate was not added to the extract granules), and 313 mg / capsule of Oren-Gedokuto hardened capsule (conventional capsule) was obtained.

Here, the dissolution time of the capsule of the present invention and the conventional capsule was measured.

The dissolution property of the capsule was confirmed by using the dissolution test method (paddle method) of the Japanese Pharmacopoeia XII.

That is, inner diameter 100 mm, height 160 mm, radius 50
90 in a 1000 ml glass tester with a semi-circular spherical bottom
0 ml of distilled water was added, and the temperature of the solution was maintained at 37 ± 0.5 ° C.

An acid-resistant wire having a wire diameter of 1 mm has an inner diameter of 12 mm and a length of 25 m.
m, spirally wound with a winding interval of 3 mm, linear 1 m around the circumference
The capsules of the present invention and the conventional capsules were placed in a sinker with 10 m-resistant acid wires fixed in parallel at 3 mm intervals and the sides fixed in a cross with two acid-resistant wires. Was put into the bottom of the tester, and stirred at 100 rpm with a paddle composed of an acid-resistant stirring blade and a rotating shaft.

The eluate was sampled over time, and the time when the active ingredient in the sampled eluate reached 75% of the time of complete elution was defined as the elution time.

As a result, the elution time of the conventional capsule was 120 minutes, whereas the elution time of the capsule of the present invention was 13 minutes, and the components were eluted quickly.

Experimental Example 2 Shosaikoto hard capsules (capsules of the present invention) were obtained according to Example 2 described later.

In the same manner as described in Example 2,
(However, magnesium stearate is not added to the extract granules), 1 capsule of 590 mg Shosaikoto hard capsule
(Conventional capsule) was obtained, and the elution time of both capsules was measured in the same manner as in Experimental Example 1.As a result, the elution time of the conventional capsule was 80 minutes, whereas the elution time of the capsule of the present invention was 80 minutes. The time was 15 minutes, and the components were eluted quickly.

Experimental Example 3 Ninjinto hard capsules (capsules of the present invention) were obtained according to Example 3 described later.

In the same manner as described in Example 3,
(However, magnesium stearate was not added to the extract granules), one capsule obtained 404 mg of Ninjin-to hard capsule (conventional capsule), and the dissolution time of both capsules was
As a result of measurement in the same manner as in Experimental Example 1, the elution time of the conventional capsule was 52 minutes, whereas the elution time of the capsule of the present invention was 18 minutes, and the components were eluted quickly.

Experimental Example 4 A hard capsule of mao-bushi-saishin-to (capsule of the present invention) was obtained according to Example 5 described later.

In the same manner as described in Example 5,
(However, magnesium stearate was not added to the extract granules), one capsule obtained 320 mg of mao-bushi-saishin-to hard capsule (conventional capsule), and the elution time of both capsules was the same as in Experimental Example 1. As a result of the measurement, the elution time of the conventional capsule was 85 minutes, while the elution time of the capsule of the present invention was 14 minutes, and the components were eluted quickly.

Experimental Example 5 Annaka powder hardened capsules (capsules of the present invention) were obtained according to Example 6 described later.

In the same manner as described in Example 6,
(However, magnesium stearate was not added to the extract granules), one capsule obtained 321 mg of annaka hardened capsule (conventional capsule), the elution time of both capsules,
As a result of measurement in the same manner as in Experimental Example 1, the elution time of the conventional capsule was 50 minutes, whereas the elution time of the capsule of the present invention was 17 minutes, and the components were eluted quickly.

Experimental Example 6 Keishibukuryogan capsule (the capsule of the present invention) was obtained according to Example 7 described later.

Further, in the same manner as described in Example 7,
(However, magnesium stearate is not added to the extract granules), 1 capsule is 300mg Keishibukuryogan capsule
(Conventional capsule-) was obtained. As a result of measuring the dissolution time of both capsules in the same manner as in the method of Experimental Example 1, the dissolution time of the conventional capsule was 60 minutes or more, whereas the dissolution time of the capsule of the present invention was 8 minutes. Yes, components eluted quickly.

Experimental Example 7 By the Example 8 described below, a capsule of Byakutora Ninjin-to (capsule of the present invention) was obtained.

In the same manner as described in Example 8,
(However, magnesium stearate was not added to the extract granules), and one capsule obtained 278 mg of Baitora Kaninjinto capsule (conventional capsule-). As a result of measuring the elution time of both capsules in the same manner as in the method of Experimental Example 1, the elution time of the conventional capsule was 50 minutes, whereas the elution time of the capsule of the present invention was 20 minutes. The components eluted quickly.

Experimental Example 8 A capsule of Shakuyakukanzoto (the capsule of the present invention) was obtained according to Example 9 described later.

In the same manner as described in Example 9,
(However, magnesium stearate is not added to the extract granules), one capsule is 340 mg of Shakuyakukanzoto capsule
(Conventional capsule-) was obtained. As a result of measuring the dissolution time of both capsules in the same manner as in the method of Experimental Example 1, the dissolution time of the conventional capsule was 60 minutes or more, whereas the dissolution time of the capsule of the present invention was 7 minutes. Yes, components eluted quickly.

EXPERIMENTAL EXAMPLE 9 According to Example 10 described later, Saireito capsules (capsules of the present invention) were obtained.

Further, in the same manner as described in Example 10,
(However, magnesium stearate was not added to the extract granules), so that one capsule obtained 315 mg of Sairei-to capsule (conventional capsule-). As a result of measuring the dissolution time of both capsules in the same manner as in the method of Experimental Example 1, the conventional capsules-
The elution time was 60 minutes or more, whereas the elution time of the capsule preparation of the present invention was 11 minutes, and the components were eluted quickly.

From the above results, it was confirmed that the herbal hard capsules obtained by the production method of the present invention had excellent dissolution properties.

Next, the present invention will be described in more detail with reference to working examples according to the manufacturing method of the present invention, but the present invention is not limited thereto.

Example 1 Oren-dokuto (3 parts of yellow sesame, 2 parts of yellow ren, 2 parts of gardenia, 1.5 parts of yellow oak)
To 10 kg of the prescription crude drug of Part (2), 200 l of water was added, and the mixture was heated and extracted at 100 ° C. After the extraction, solid-liquid separation was performed under heat to obtain an extract. After concentrating this, it was spray-dried (blast temperature: 160 ° C., exhaust air temperature: 110 ° C.) to obtain Oren-gedokuto extract powder.

[0066] 200 parts of Oren-gedokuto extract powder and Aerosil
1 part of [AEROSIL200 (Nippon Aerosil Co., Ltd., same hereafter)] was mixed and compression molded, crushed and classified to obtain granules of 0.5 to 1.4 mm. 100 parts of the obtained granules and magnesium stearate 1
Parts, mix into 2 gelatin capsules and 1 capsule
315 mg of Oren-gedokuto hard capsules were obtained.

Example 2 Prescription of Sho-saiko-to (7 parts of saiko, 5 parts of midsummer, 3 parts of yellow candy, 3 parts of jujube, 3 parts of ginseng, 2 parts of licorice, 1 part of ginger) 10 kg of crude drug and 200 l of water Was added, and the mixture was heated and extracted at 100 ° C. After the extraction, solid-liquid separation was performed while heating to obtain an extract. After concentrating this, spray drying (blast temperature 160 °
C, exhaust temperature 100 ° C) to obtain Sho-saiko-to extract powder.

200 parts of Sho-saiko-to extract powder, 1 part of Aerosil and 2 parts of magnesium stearate were mixed, compression-molded, crushed and classified to obtain 0.5-1.4 mm Sho-saiko-to extract granules. 100 parts of the obtained granules and magnesium stearate 2
The capsules were mixed and filled in a No. 0 gelatin capsule to obtain 600 mg of Shosaikoto hard capsules per capsule.

Example 3 To 10 kg of a prescribed crude drug of ginseng-to (3 parts of licorice, 3 parts of sojujutsu, 3 parts of ginseng, 3 parts of ginger), 200 l of water was added, and the mixture was heated and extracted at 100 ° C. Separation was performed to obtain an extract. After concentration, this was spray-dried (blast temperature 150 ° C, exhaust temperature 100 ° C) to obtain Ninjin-to extract powder.

A mixture of 500 parts of Ninjin-to extract powder, 1 part of Aerosil and 5 parts of magnesium stearate was compression-molded, crushed and classified to obtain 0.35 to 1.4 mm Ninjin-to extract granules. 100 parts of the obtained granules were mixed with 1 part of magnesium stearate, and filled in No. 1 gelatin capsule, 407 mg per capsule.
Ninjin-to hard capsules were obtained.

Example 4 Prescription of Sankoshashin-to (3 parts of yellowishon, 3 parts of oren, 3 parts of rhubarb)
200 l of water was added to 0 kg, and the mixture was heated and extracted at 100 ° C. After the extraction, solid-liquid separation was performed while heating to obtain an extract. After concentrating this, it was spray-dried (blast temperature 150 ° C, exhaust air temperature 100 ° C) to obtain San-o-shashin-to extract powder.

A mixture of 100 parts of San-o-shashin-to extract powder, 5 parts of carboxymethylcellulose calcium (manufactured by Gotoku Pharmaceutical Co., Ltd., the same applies hereinafter) and 0.3 part of magnesium stearate was mixed, compression-molded, pulverized and classified to obtain a 0.35 to 1.4 mm tria. The granules of Yoshashinto extract were obtained. 100 parts of the obtained granules and 0.7 part of magnesium stearate were mixed and filled in a No. 1 gelatin capsule to obtain 388 mg of a hard capsule of San-o-shashin-to, one capsule.

Example 5 20 kg of water was added to 1 kg of a crude drug formulation of Mao-Fushi-Saishin-to (Ma-o 4 parts, Spicy 3 parts, Shuji Bushi powder 1 part), and the mixture was heated and extracted at 100 ° C. Liquid separation was performed to obtain an extract. After concentrating this,
Lyophilization (freezing temperature -40 ° C, vacuum degree 0.1 torr, shelf temperature 20
° C) to obtain a powdered mao-bushi-saishin-to extract powder.

100 parts of mao-bushi-saishin-to extract powder and 3 parts of carboxymethylcellulose calcium were mixed, compression-molded, pulverized and classified to obtain 0.15 to 1.0 mm of mao-bushi-saishin-to extract granules. 100 parts of the obtained granules and 1 part of magnesium stearate were mixed and filled into a No. 2 gelatin capsule to obtain 323 mg of Mao-Bushi-Saishin-To hard capsule in one capsule.

Example 6 Prescription of Annaka-san (4 parts of cinnamon bark, 3 parts of Yancho cord, 3 parts of oyster, 1.5 parts of Fenka, 1.0 part of licorice, 1.0 part of compacted sand, 0.5 part of ginger) 20 kg of water in 1 kg of crude drug
Was added, and the mixture was heated and extracted at 100 ° C. After the extraction, solid-liquid separation was performed while heating to obtain an extract. After concentration, freeze drying (freezing temperature-
Annaka-san extract powder was obtained at 40 ° C, a degree of vacuum of 0.1 torr, and a shelf temperature of 20 ° C).

100 parts of Annaka-san extract powder and 3 parts of carboxymethylcellulose calcium were mixed, compression-molded, pulverized and classified to obtain 0.15-1.0 mm Annaka-san extract granules. 100 parts of the obtained granules were mixed with 1 part of magnesium stearate and filled in a No. 2 gelatin capsule, and 323 m in 1 capsule.
g of Annaka-san hardened capsules were obtained.

Example 7 Prescription of Keishibukuryogan (3 parts of cinnamon, 3 parts of peony, 3 parts of peach, 3 parts of bukuryo, 3 parts of peony), 200 l of water was added to 10 kg of crude drug, and the mixture was heated and extracted at 100 ° C. After the extraction, solid-liquid separation was performed while heating to obtain an extract. After concentrating this, spray drying (blast temperature 160 ° C, exhaust temperature 110 °
C) to obtain Keishibukuryogan extract powder.

200 parts of Keishibukuryogan extract powder, 20 parts of low-substituted hydroxypropylcellulose “LHPC LH-11 (Shin-Etsu Chemical Co., Ltd.)” and 1 part of light anhydrous silicic acid “Syloid 266 (Fuji Devison Co., Ltd.)” After mixed compression molding, the mixture was pulverized and classified to obtain granules of 0.3 to 1.2 mm. 100 parts of the obtained granules and 1 part of magnesium stearate were mixed and filled in a No. 2 gelatin capsule to obtain a hard capsule of Keishibukuryogan of 300 mg per capsule.

Example 8 Byakutora-Kinjin-to (15 parts of plaster, 5 parts of Chimo, 2 parts of licorice, 1.5 parts of ginseng)
100 l of water was added to 10 kg of the prescription crude drug of 10 parts, 8 parts of non-glutinous rice), and the mixture was heated and extracted at 100 ° C. After concentrating this, it was spray-dried (blast temperature: 160 ° C, exhaust air temperature: 100 ° C) to obtain a white tiger kainjinto extract powder.

After mixing 200 parts of Hakutora Kajinjinto extract powder, 1 part of light anhydrous silicic acid “Syloid 266 (Fuji Devison Co., Ltd.)” and 2 parts of magnesium stearate, compression molding was performed.
The mixture was pulverized and classified to obtain 0.3-1.2 mm white tiger kanin ginseng extract granules. 100 parts of the obtained granules and magnesium stearate 1
The capsules were mixed and filled into No. 2 gelatin capsules to obtain 280 mg of a hard capsule of Baitora Kaninjinto for one capsule.

Example 9 Prescription of Shakuyakukanzoto (licorice 6 parts, peony 6 parts)
Was added, and the mixture was heated and extracted at 100 ° C. After the extraction, solid-liquid separation was performed while heating to obtain an extract. After concentrating this, spray drying (air temperature 1
60 ° C, exhaust temperature 100 ° C) to obtain Shakuyakukanzoto extract powder.

200 parts of Shakuyakukanzoto extract powder, 10 parts of low-substituted hydroxypropylcellulose "LHPC LH-11 (Shin-Etsu Chemical Co., Ltd.)", 1 part of light anhydrous silicic acid "Syloid 266 (Fuji Devison Co., Ltd.)" and stearin Magnesium acid
One part was mixed and compression molded, pulverized and classified to obtain 0.3-1.2 mm shakuyakukanzoto extract granules. 100 parts of the obtained granules and 0.5 part of magnesium stearate were mixed and filled in a No. 2 gelatin capsule to obtain 340 mg of one capsule of hard capsule of Shakuyaku-kanzo-to.

Example 10 Sairei-to (7 parts of Saiko, 5 parts of Sawashatsu, 5 parts of midsummer, 3 parts of yellow sesame, 3 parts of Sojutsu
Department, Dajuju 3 parts, Chorei 3 parts, Ginseng 3 parts, Bukuryo 3 parts, Licorice 2 parts,
(2 parts of cinnamon, 1 part of ginger))
Extraction was carried out with heating at ° C, and after the extraction, solid-liquid separation was performed under heat to obtain an extract. After concentrating this, it was spray-dried (blast temperature: 160 ° C, exhaust temperature: 110 ° C) to obtain Saireito extract powder.

After mixing and compression molding 200 parts of Saireito extract powder and 1 part of magnesium stearate, pulverize and classify to 0.3
1.2 mm Saireito extract granules were obtained. 100 parts of the obtained granules and 1 part of magnesium stearate were mixed and filled in a No. 2 gelatin capsule to obtain a hard capsule of Sairei-to of 315 mg per capsule.

──────────────────────────────────────────────────続 き Continued on the front page (58) Field surveyed (Int.Cl. ⁷ , DB name) A61K 35/78 A61K 9/48

Claims (2)

(57) [Claims] (1) Particles obtained by compacting a dry extract powder of a Chinese medicine.
A method for producing hardened Chinese herbal capsules, comprising adding 0.5 to 3 of magnesium stearate by weight to 100 . 2. The herbal medicine is Oren-dokuto, Ninjin-to, Sho-saiko-to,
Mapo-bushi-saishin-to, Annaka-san, Keishi-bukuryo-gan, Byakutora-jinjin-to,
The method according to claim 1 , wherein the capsule is at least one selected from shakuyakukanzoto, sankoshashinto and saireito.