JP2018058830A - tablet - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a tablet that is thin and small and easy to take, containing bofu-tsusho-san extract powder.SOLUTION: A tablet contains (A) bofu-tsusho-san extract powder, and (B) dai-saiko-to extract powder.SELECTED DRAWING: None

Description

  The present invention relates to a tablet containing Chinese medicine. Specifically, the present invention relates to a tablet containing a wind-proof sangsan extract powder having a small tablet thickness that is easy to take.

  In recent years, increased obesity has become a major problem due to the intake of high-fat food and lack of exercise. Obesity is a condition in which fat accumulates excessively in the body and is considered to be one of the causes of lifestyle-related diseases such as diabetes, heart disease, stroke, hypertension, and hyperlipidemia. As a method for relieving obesity, Chinese herbal medicine is used together with dietary improvement and exercise habits.

  As herbal medicines for improving obesity, Chinese herbal medicines such as Fufutsu Seisaku, Dai-saiko-to and Ho-Kai-Yu-to are known. Among them, Futsutsu Seisaku is known as a traditional Chinese medicine that can improve symptoms such as obesity with high subcutaneous fat in the abdomen, palpitations associated with high blood pressure and obesity, stiff shoulders, hot flashes, swelling, and constipation. Yes. For example, Patent Document 1 discloses an anti-obesity agent including Fukatsu Tsushosan.

  Such herbal medicines are generally provided in the form of powders, granules, and tablets containing herbal medicine extract powder depending on ease of taking. These Chinese medicine preparations are produced, for example, by blending an additive such as an excipient for obtaining a predetermined dosage form into a mixed herbal extract extracted from a Chinese medicine or an extract powder obtained by drying the extract.

  However, Futsutsu Seisan has a large amount of components per day, and conventionally, when tableted, the number of tablets to be taken increases, and there is a problem that the compliance with medication deteriorates. Therefore, when tableting, it is required to reduce additives such as excipients as much as possible and to reduce the number and size of tablets. However, if the addition amount of excipients and the like is reduced, the tablet cannot be sufficiently molded, and it has been difficult to reduce the thickness of the tablet by reducing the thickness of the tablet, particularly with the amount of the component as it is.

Japanese Patent Laid-Open No. 11-130686

  The present invention has been made in view of the above-described situation, and an object of the present invention is to provide a tablet containing a wind-proof seisan extract powder that is thin and easy to take.

  The present inventor conducted intensive research to solve the above-mentioned problems, and the anti-obesity effect was impaired by substituting a part of Fengtsu Seisaku Extract powder with Daisaikoto extract powder having the same kind of medicinal effect. In the case of molding into tablets, it has been found that tablets having a high thickness and a thin thickness can be obtained. The present invention has been completed by further studies based on these findings.

That is, this invention provides the invention of the aspect hung up below.
Item 1. A tablet characterized by containing (A) Fufutsu Seisaku extract powder and (B) Daisaikoto extract powder.
Item 2. Item 2. The tablet according to Item 1, wherein the weight ratio of the component (A) to the component (B) is 0.05 to 10 parts by weight of the component (B) with respect to 1 part by weight of the component (A).
Item 3. Item 3. The tablet according to Item 1 or 2, wherein the content of the component (A) is 20 to 95% by weight. Item 4. Item 4. The tablet according to any one of Items 1 to 3, wherein the content of the component (B) is 5 to 80% by weight.
Item 5. The tablet according to any one of claims 1 to 4, which is an anti-obesity pharmaceutical composition.

  According to the present invention, it is possible to provide a tablet having a high hardness and a smaller thickness than conventional ones without increasing the amount of additives such as excipients. Since the tablet of the present invention can be reduced in size compared with the conventional one without impairing the anti-obesity improving effect, it is easy to take.

It is a graph which shows the thickness of the tablet of an Example and a comparative example. It is a graph which shows the hardness of the tablet of an Example and a comparative example.

  The tablet of the present invention is characterized by containing (A) Fufutsu Seisaku extract powder and (B) Daisaikoto extract powder. Below, the tablet containing the Chinese medicine of this invention is explained in full detail.

Tablets The tablet of the present invention comprises (A) Fufutsu Seisaku Extract powder (hereinafter also referred to as “(A) component”) and (B) Daisaikoto extract powder (hereinafter also referred to as “(B) component”). ).

(A) Windproof Tsushosan extract powder The tablet of the present invention contains Windproof Tsushosan extract powder. Fengtsu Sansho is preferably a Kampo prescription described in “New General Kampo Prescription Guide” (supervised by Yukihiro Aida and Takashi Sasuka, edited by the Japanese Herbal Medicines Association, published by Jiho Co., Ltd.). It is a mixed herbal medicine consisting of Sangoshi, Forsythia, Hakka, Pepper, Keigai, Koufuu, Maou, Daio, Byakujutsu, Kyoukyo, Ogon, Ganzo, Gypsum, Kaseki, and Pepper. In addition, as specified in the “Basic Policy for Handling Kampo Preparations” established by the Kampo Medicine Research Committee, the Kampo prescriptions (herbal medicine blends) described in the currently used Kampo-related letters and these Extracts obtained from traditional Chinese medicine formulations are included.

  Fufutsu Seisaku extract powder is obtained by concentrating an extract obtained by extracting herbal medicines according to the Fufutsu Seisaku prescription and drying to obtain a dry extract powder. Although it does not specifically limit as an extraction solvent used for the extraction process of Fufutsu Seisaku, For example, water or water-containing ethanol is mentioned. There is no particular limitation on the extraction process of Fuyutsu Seiki, but for example, after extraction with about 20 times the amount of extraction solvent with respect to the total weight of herbal medicines (converted to dry weight) contained in Fufutsu Seiki, 1 A method of concentrating to a volume of 2 and removing the solid content (extract) as an anti-futsu sansho extract is mentioned. Next, by subjecting this extract to a drying treatment, a wind-proof Tsushosan extract powder is obtained. The drying treatment is not particularly limited, and a known method may be used. For example, an appropriate adsorbent (for example, silicic anhydride, starch, etc.) is added to the spray-drying method or a soft extract with increased extract concentration. For example, a method for obtaining an adsorbed powder.

  In the present invention, the dry extract powder prepared by the above-described method may be used as the Fufutsu Seisaku extract powder, or a commercially available one may be used. For example, Fufutsu Seisan Dry Extract A, Fufutsu Seisan Dry Extract AM, Fufutsu Seisan Dry Extract E, and Fufutsu Seisan Dry Extract EM (all manufactured by Nihon Powder Co., Ltd.), and Dried extract-C, Fengtsu-san Seiyaku dried extract-F (all manufactured by Alps Yakuhin Kogyo Co., Ltd.) and the like are known as products, and can also be obtained commercially.

  In the tablet of the present invention, the content of the component (A) is not particularly limited as long as the effect of the present invention is exhibited, but is usually 20 to 95% by weight, preferably 25 to 95% by weight, more preferably 30 to 95%. % By weight, more preferably 30 to 75% by weight. In addition, in this invention, the quantity of (A) component is the quantity except the said additive, when (A) component contains additives, such as adsorption agent added at the time of manufacture.

(B) Daisaikoto extract powder The tablet of the present invention also contains Daisaikoto extract powder. Osaisaikoto is preferably a Kampo prescription described in “New General-Purpose Kampo Prescription Guide” (supervised by Yukihiro Goda, Takashi Sasuka, edited by the Japanese Herbal Medicines Association, published by Jiho Co., Ltd.). It is a mixed herbal medicine consisting of pheasants, peonies, ginger, taiso, and daiou.

  Dai-saiko-to extract powder is obtained by concentrating an extract obtained by extracting a herbal medicine in accordance with Dai-saiko-to formulation and drying it to obtain a dry extract powder. It does not specifically limit as an extraction solvent used for the extraction process of daisaikoto, Water or water-containing ethanol is mentioned. The extraction treatment of daisaikoto is not particularly limited. For example, after extraction with about 20 times the amount of extraction solvent with respect to the total weight (in terms of dry weight) of the herbal medicine contained in daisaikoto, A method of concentrating to a volume and removing a solid content (extract) as Daisaikoto extract is mentioned. Next, by applying this extract to a drying treatment, Daisaikoto extract powder is obtained. The drying treatment is not particularly limited, and a known method may be used. For example, an appropriate adsorbent (for example, silicic anhydride, starch, etc.) is added to the spray-drying method or a soft extract with increased extract concentration. For example, a method for obtaining an adsorbed powder.

  In the present invention, Daisaikoto extract powder may be a dry extract powder prepared by the method described above, or a commercially available one. For example, Daisaikoto dried extract, Daisaikoto dried extract AM, Daisaikoto dried extract SN, and Daisaikoto dried extract powder (all manufactured by Nippon Powder Co., Ltd.), and Daisaikoto dried extract F, Daisaikoto. Dry extract-F (all manufactured by Alps Pharmaceutical Co., Ltd.) is known as a commercial product, and can also be obtained commercially.

  In the tablet of the present invention, the content of the component (B) is not particularly limited as long as the effect of the present invention is exhibited, but is usually 5 to 80% by weight, preferably 5 to 70% by weight, more preferably 7 to 70%. % By weight, more preferably 10 to 50% by weight. In addition, in this invention, the quantity of (B) component is the quantity except the said additive, when (B) component contains additives, such as adsorption agent added at the time of manufacture.

(A) Component and (B) component weight ratio In the tablet of this invention, the weight ratio of (A) component and (B) component is not specifically limited as long as there exists an effect of this invention, However, (A) Component 1 weight Component (B) is usually 0.05 to 10 parts by weight, preferably 0.1 to 5 parts by weight, more preferably 0.25 to 4 parts by weight, and still more preferably 0.5 to 3 parts by weight with respect to parts by weight. It is.

Other components In addition to the aforementioned components (A) and (B), the tablet of the present invention may contain other pharmacological components as necessary. The type of such pharmacological component is not particularly limited, but for example, antacids, gastric agents, digestive agents, intestinal agents, antispasmodic agents, mucosal repair agents, anti-inflammatory agents, astringents, antiemetics, antitussives, expectorants, antiphlogistics Enzymes, sedative hypnotics, antihistamines, caffeine, cardiotonic diuretics, antibacterial agents, vasoconstrictors, vasodilators, local anesthetics, herbal medicines, herbal extract powders, vitamins, menthols and the like. These pharmacological components may be used alone or in combination of two or more. Moreover, what is necessary is just to set suitably about the content of these pharmacological components from a well-known thing according to the kind etc. of pharmacological component to be used.

  The tablet of the present invention may contain a pharmaceutically acceptable base or additive as necessary in order to prepare a desired dosage form. Examples of such bases and additives include excipients, binders, disintegrants, lubricants, isotonic agents, plasticizers, dispersants, emulsifiers, solubilizers, wetting agents, and stabilization. Agent, suspending agent, adhesive, coating agent, brightening agent, water, fats and oils, waxes, hydrocarbons, fatty acids, higher alcohols, esters, water-soluble polymer, surfactant, metal soap , Lower alcohols, polyhydric alcohols, pH adjusters, buffers, antioxidants, UV inhibitors, preservatives, flavoring agents, fragrances, powders, thickeners, dyes, chelating agents, and the like. These bases and additives may be used individually by 1 type, and may be used in combination of 2 or more type. Moreover, what is necessary is just to set suitably about content of these bases and additives from a well-known thing according to the kind, dosage form, etc. of the additive component to be used.

Formulation Properties The hardness of the tablet of the present invention is not particularly limited as long as it does not break during packaging or transportation, but specifically 40 to 400 N, preferably 50 to 350 N, more preferably 60 to 300 N. Is mentioned. In the present invention, the hardness of the tablet refers to a value measured by a Kiyama hardness tester.

Formulation Form The tablet of the present invention may be coated with a sugar coating base, a water-soluble film coating base or the like, if necessary. The tablet of the present invention can be suitably used as a gastric tablet (usually a tablet) or an enteric tablet.

  In addition, the weight per tablet of the tablet of the present invention may be appropriately set according to the dose per time, the content of the component (A), etc., and examples include 200 to 500 mg.

Production Method The tablet of the present invention can be obtained according to a known production method. Specifically, it can be produced by subjecting a mixture of raw material components to tableting. Moreover, the mixture of the raw material components used for tableting may be a granulated product obtained by granulating all or part of the raw material components.

Tableting can be performed by using a single tablet machine, a rotary tablet machine, a high-speed rotary tablet machine or the like. Moreover, the tableting pressure at the time of tableting molding is not particularly limited as long as the tablet can be molded, but it is usually set to about 250 to 6000 kg / cm ² .

Use Since the tablet of the present invention contains Fufutsu Seisan extract powder and Daisaikoto extract powder, based on these medicinal effects, for example, the purpose of improving obesity, constipation, swelling, hot flashes, stiff shoulders, etc. Can be used in The tablet of the present invention is used for the purpose of anti-obesity, preferably fat reduction, more preferably visceral fat reduction and / or liver fat reduction, more preferably liver fat reduction.

Dosage The dosage of the tablet of the present invention is appropriately set according to the degree of obesity, the age of the patient, etc., for example, as a daily dosage, Fufutsu Seisaku extract powder is preferably 500 to 10,000 mg, preferably Is 500 to 8000 mg, more preferably 400 to 5000 mg, and Daisaikoto extract powder is 400 to 8000 mg, preferably 400 to 5000 mg, more preferably 500 to 5000 mg. In the present invention, the amount of Fufutsu Seisaku extract powder and Daisaikoto extract powder, when these extract powders contain additives such as adsorbents added during the production of the extract powder, the addition It is the amount excluding the amount of the agent.

  The tablet of the present invention is easy to take because it has a high hardness, a small thickness, and a small shape as compared with the conventional Fengtsu Sansho tablet. In addition, since the tablet of the present invention can be downsized without increasing the amount of additives such as excipients, the active ingredient can be efficiently ingested without increasing the number of tablets. be able to. The tablet of the present invention is suitably used as an anti-obesity pharmaceutical composition.

  EXAMPLES Next, although an Example demonstrates this invention further in detail, this invention is not limited at all by these examples.

Experimental example
1. Preparation of test sample (1) Fufutsu Seisaku extract powder Raw material herb, Toki 1.2 (parts by weight, the same shall apply hereinafter), Peonies 1.2, Senkyu 1.2, Sanshi 1.2, Forsythia 1.2, mint 1.2, Show 1.2, Kei-Gai 1.2, Bow Fu 1.2, Maou 1.2, Daio 1.5, Bow Show 1.5, Sandalwood 2.0, Kyo 2.0, Ogon 2.0, Use at a ratio of licorice 2.0, gypsum 2.0 and Kasseki 3.0. After chopping these, extract with 20 times the weight of water (560 parts by weight) at about 100 ° C. for 1 hour and centrifuge. An extract was obtained, concentrated under reduced pressure, and dried using a spray drier to obtain Futsutsu Seisaku extract powder. The drying with a spray dryer was performed by dropping the extract into an atomizer with a rotation speed of 10,000 rpm and supplying hot air of 150 ° C. air.

(2) Dai-saiko-to extract powder Raw material crude drug is Psycho 6.0 (parts by weight, the same applies hereinafter), Hange 4.0, Showa 1.0, Ogon 3.0, Peonies 3.0, Taiso 3.0, After using them at a ratio of pheasant 2.0 and diaoh 1.0, chopping them, using 20 times the weight of water (460 parts by weight), extracting at about 100 ° C. for 1 hour, centrifuging to obtain an extract, Concentrated under reduced pressure and dried using a spray dryer to obtain Daisaikoto extract powder. The drying with a spray dryer was performed by dropping the extract into an atomizer with a rotation speed of 10,000 rpm and supplying hot air of 150 ° C. air.

2. Experimental Method Windproof Tsushosan extract powder, Daisaikoto extract powder, and magnesium stearate (manufactured by Taihei Chemical Industrial Co., Ltd.) obtained above were mixed at the blending ratios shown in Table 1, respectively. 400 mg of the obtained mixture was tableted at 5 kN using a hydraulic tableting machine table press TB-20H (manufactured by NP System Co., Ltd.) to obtain a convex tablet having a diameter of 9.6 mm.
The thickness and hardness of the obtained tablet were measured. The thickness was measured using a digital outer micrometer (manufactured by MonotaRO Co., Ltd.), and the average value of 6 samples was calculated. About hardness, the hardness of the perpendicular | vertical direction was measured with respect to a tablet using the Kiya type digital hardness meter KHT-20N type (made by Fujiwara Manufacturing Co., Ltd.), and the average value of 6 samples was computed.

  The obtained results are shown in Table 2 and FIGS. From these results, in comparison with the case where tableting was performed with Fufutsu Seisaku extract powder alone (Comparative Example 1), when Daisaikoto extract powder was added to tableting (Example 1 to Example 1). In 5), it was clarified that the thickness of the obtained tablet was reduced and the hardness was improved. In addition, when Fushitsu-san-san extract powder is added and tableted with Dai-saiko-to extract powder (Examples 1 to 5), Fengtsu-Dongsan powder powder or Dai-saiko-to extract powder alone is tableted. It was confirmed that the thickness of the tablet was thinner than (Comparative Example 1 and Comparative Example 2). In this way, tableting combined with Fufutsu Seisan extract powder and Daisaikoto extract powder not only improves tablet hardness, but also reduces tablet thickness, making tablets more compact Was shown to be possible.

Formulation Examples Tablets having the compositions shown in Tables 3 to 6 were prepared according to a conventional method. Each of the obtained tablets was thin and could be formulated with a thickness of about 0.1 to 1.0 mm, and was small and easy to take.

Claims (5)

A tablet characterized by containing (A) Fufutsu Seisaku extract powder and (B) Daisaikoto extract powder.   The tablet of Claim 1 whose weight ratio of the said (A) component and (B) component is 0.05-10 weight part of (B) component with respect to 1 weight part of (A) component.   The tablet according to claim 1 or 2, wherein the content of the component (A) is 20 to 95% by weight.   The tablet in any one of Claims 1-3 whose content of the said (B) component is 5 to 80 weight%.   The tablet according to any one of claims 1 to 4, which is an anti-obesity pharmaceutical composition.