JPH07206694A - Agent for treatment of hepatitis - Google Patents

Abstract

PURPOSE:To obtain an agent containing a herb mixture or its extract as an active component, having high safety, exhibiting remarkable therapeutic effect and useful for the treatment of hepatitis. CONSTITUTION:This hepatopathy improving agent contains JIOU (root of Rehmannia glutinosa), TOUKI (root of Angelica acutiloba), JUTSU (rhizome of Curcuma zedoaria), BUKURYO (fungus of Pachyma hoelen), NINJIN (root of Panax ginseng), KEIHI (bark of Cinnamomum cassia), ONJI (root of Polygala tenuifolia), SHAKUYAKU (root of Paeonia albiflora), CHINPI (peel of Citrus unshu), OUGI (root of Astragalus huantchy), KANZOU (root of Glycyrrhiza glabra) and GOMISHI (fruit of Schizandra chinensis) or their extracts as active components. The antiviral agent contains the above herb mixture or its extract as active component.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a therapeutic drug for hepatitis containing a mixed crude drug or an extract thereof as an active ingredient.

[0002]

2. Description of the Related Art In recent years, liver disorders such as hepatitis have been increasing, and liver disease is said to be a national disease in the 21st century.

Of these, most of the hepatitis transmitted by blood transfusion, injection, etc. has been reported to be viral hepatitis, particularly viral hepatitis caused by hepatitis C virus (clinician, vol. 16 no. 5, p. 22). -27,199
0).

In recent years, it has been reported in many cases that interferon or a combination of interferon and other medicines (such as cyclosporin) is effective for these hepatitis caused by hepatitis C virus, and they are used in clinical situations. However, on the other hand, it has been reported that the effect is difficult to be exerted in the case of a large amount of blood virus, and that GOT / GPT is increased when a slightly higher amount of interferon is administered. As a result, treatment of hepatitis C virus with advanced chronic hepatitis, cirrhosis, etc. is difficult.

Therefore, there has been a demand for the development of a drug useful for viral hepatitis, particularly for hepatitis caused by hepatitis C virus.

On the other hand, Jihuang, Toki, Shu, Hui, carrot,
Ginseng nutritional bath, which is made up of Keishi, Enshi, Peony, Chiku, Astragalus, Licorice and Gomiko, is used for anorexia, anemia, postoperative indefinite complaints (due to loss of physical strength, etc.), coldness, etc. , There is no example used as a liver damage improving agent or an antiviral agent.

[0007]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a pharmaceutical composition which contains a mixed crude drug or an extract thereof as an active ingredient and is highly safe and has a remarkable therapeutic effect, which is useful for the treatment of hepatitis.

[0008]

SUMMARY OF THE INVENTION The present invention is based on
朮, 茯 Ryo, carrot, katsura, distant, peony, Chen skin, yellow radish,
A hepatic disorder-improving agent containing licorice and schisandra, or an extract thereof as an active ingredient, and an antiviral agent containing the same mixed crude drug or an extract thereof as an active ingredient.

The blending ratio of each crude drug in the active ingredient of the present invention is preferably 3 to 5 parts by weight of ground yellow, 3 to 5 parts by weight of toki, 3 to 5 parts by weight, 3 to 5 parts by weight of carrot, and ginseng 2. ~
4 parts by weight, Keieda 1.5-3.5 parts by weight, Enshi 0.5-3
Parts by weight, peony 1-5 parts by weight, Chen skin 1-3.5 parts by weight, Astragalus 0.5-3.5 parts by weight, licorice 0.5-2.5 parts by weight and schizandra 0.5-2.5. Parts by weight.

An example of a Kampo prescription consisting of each crude drug in such a preferable mixing ratio is ginseng nutrition hot water.

The prescription of the above-mentioned ginseng nutrition hot water is described in the classical Chinese medicine prescription (Ohira Keimin Japanese Pharmacopoeia, etc.) and there are some differences, but the range of each crude drug is generally as follows. is there. [Ginseng Yoeito] Ground yellow 4.0 parts by weight Enshi 1.0-2.0 parts by weight Toki 4.0 parts by weight Shakuyaku 2.0-4.0 parts by weight Saku 4.0 parts by weight Chikin 2.0 2.5 parts by weight Husky Ryo 4.0 parts by weight Yellow Radix 1.5-2.5 parts by weight Ginseng 3.0 parts by weight Licorice 1.0-1.5 parts by weight Keishi 2.5 parts by weight Gomiza 1.0 ~ 1.5 parts by weight

Examples of the crude drug extract include various aqueous solvent extracts, and it is preferable to use a water extract. As a specific example of preparation of the extract, there is a method of extracting the crude drug mixture having the above composition with 10 to 20 times the amount of hot water and filtering the obtained extract. This extract can be dried if necessary and used as a dry powder.

Specific examples of the active ingredients of the present invention will be shown and described in detail.

Concrete Example 1 Ground yellow 4.0g, toki 4.0g, white jelly 4.0g, oyster syrup 4.0g, carrot 3.0g, katsushi 2.5g, distant 2.0
g, Shakuyaku 2.0g, Chen peel 2.0g, Astragalus 2.0g, Licorice 1.0 and Gomiko 1.0g (ninjinyoeito: 31.5g)
To the mixture was added 600 ml of distilled water, and the mixture was decocted until the volume became half. The obtained extract was filtered and freeze-dried to obtain a dried extract.

Concrete Example 2 Ground yellow 4.0g, toki 4.0g, white jelly 4.0g, oyster root 4.0g, carrot 3.0g, katsura 2.5g, distant 2.0
g, Shakuyaku 2.0g, Chen skin 2.0g, Astragalus 1.5g, Licorice 1.0 and Gomiko 1.0g (Ginseng Yoeito: 31.0g)
Was added with 600 g of purified water, and the mixture was heated and extracted at 100 ° C. for 1 hour. The obtained extract was filtered and then spray-dried to obtain 6.0 g of dry extract powder.

Concrete Example 3 400 g of ground yellow, 400 g of toki, 400 g of white shrimp, 400 g of sardine, 300 g of carrot, 250 g of Katsushika, 200 of Enshi
60 g of purified water was added to g, 200 g of peony root, 200 g of crust, 150 g of yellow radish, 100 g of licorice and 100 g of licorice (ninjinyoeito: 3.1 g), and the mixture was heated and extracted for 1 hour after reaching 100 ° C. The obtained extract was centrifuged and the residue was separated to obtain a solution.

This solution was subjected to aseptic clarification with a 0.3 μm membrane filter (manufactured by Toyo Roshi Kaisha, Ltd.). The obtained filtrate was ultrafiltered using a diafilter G-10T (manufactured by Bio Engineering Co., Ltd .: molecular weight cut off 10,000). For this ultrafiltration, a membrane with a diameter of 152 mm was set on the lower surface of a container with an internal volume of 2.0 l and the pressure was 3 kg / cm ^2.
Then, purified water was added as the liquid in the container was concentrated. As a result, an ultrafiltrate was obtained.

Next, the fact that the active ingredient of the present invention has an action of improving liver damage of hepatitis C virus hepatitis and suppresses the growth of hepatitis C virus will be described with reference to experimental examples.

Experimental Example In this experiment, hepatitis C virus (HCV) antibody positive (C
The active ingredient of the present invention obtained in Example 1 above was administered to a subject (infected with hepatitis C virus) 3 times / day after meal for 60 days (subject 1 was combined with interferon) and evaluated. Details of the subjects are shown in Table 1.

[0020]

[Table 1]

(Experimental Results) 6 subjects and 6 total prescription days
It went in 0 days. As a result, as is clear from Table 2 below, almost all the subjects showed an effect of not less than effective, and there were some markedly effective cases, and it was confirmed that the active ingredient of the present invention markedly had an effect of improving liver damage. Similarly, it was confirmed that the hepatitis C virus was inverted and decreased, and that the active ingredient of the present invention suppressed the growth of the virus in the subjects infected with hepatitis C virus.

[0022]

[Table 2]

From the above results, the active ingredient of the present invention has an effect of improving liver damage of hepatitis C virus hepatitis, and also has an effect of suppressing the growth of hepatitis C virus, and is effective against hepatitis. Was confirmed.

Next, an acute toxicity test of oral administration of ginseng nutrition hot water, which is the active ingredient of the present invention, was conducted using male ddY mice and male Wistar rats, and the dried extract obtained in Example 1 was obtained. In the case of 15,000 mg / kg (limit dose), no death was observed.
As described above, the present invention has extremely low toxicity.

Next, the dose and formulation of the active ingredient of the present invention will be described.

The dosage form of the active ingredient of the present invention is not particularly limited and may be appropriately selected and used as needed. Oral preparations such as tablets, capsules, granules, fine granules and powders, injection preparations, Parenteral agents such as suppositories may be mentioned.

[0027] In order to exert the intended effect, it depends on the age, weight and degree of disease of the patient, but usually 2 to 15 g of the active ingredient of the present invention is divided into several times a day in adults. Seems to be appropriate.

The active ingredient of the present invention includes tablets, capsules,
Oral preparations such as granules are produced by a conventional method using starch, lactose, sucrose, mannitol, carboxymethyl cellulose, corn starch, inorganic salts and the like.

In addition to the above-mentioned excipients, a binder, a disintegrating agent, a surfactant, a lubricant, a fluidity promoter, a flavoring agent, a coloring agent, a flavoring agent, etc., may be appropriately used in this type of formulation. You can
Specific examples of each are as shown below.

[Binder] Starch, dextrin, gum arabic powder, gelatin, hydroxypropyl starch,
Methyl cellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, crystalline cellulose, ethyl cellulose, polyvinylpyrrolidone, macrogol.

[Disintegrant] Starch, hydroxypropyl starch, sodium carboxymethyl cellulose, calcium carboxymethyl cellulose, carboxymethyl cellulose, low-substituted hydroxypropyl cellulose.

[Surfactant] sodium lauryl sulfate,
Soy lecithin, sucrose fatty acid ester, polysorbate 80.

[Lubricant] Talc, waxes, hydrogenated vegetable oil, sucrose fatty acid ester, magnesium stearate, calcium stearate, aluminum stearate, polyethylene glycol.

[Fluidity promoter] Light anhydrous silicic acid, dried aluminum hydroxide gel, synthetic aluminum silicate, magnesium silicate.

The active ingredient of the present invention can also be administered as a suspension, emulsion, syrup or elixir, and these various dosage forms contain a flavoring agent and a coloring agent. Good.

On the other hand, parenteral preparations are manufactured according to a conventional method,
Generally, distilled water for injection, physiological saline, aqueous glucose solution, vegetable oil for injection, sesame oil, peanut oil, soybean oil, corn oil, propylene glycol, polyethylene glycol and the like can be used as the diluent. Further, if necessary, a bactericide, a preservative, and a stabilizer may be added. Further, from the viewpoint of stability, this parenteral preparation may be filled in a vial or the like, frozen, and then water may be removed by an ordinary freeze-drying technique, and a liquid preparation may be re-prepared from the freeze-dried product immediately before use. Further, an isotonicity agent, a stabilizer, a preservative, a soothing agent and the like may be added as needed.

Hereinafter, the present invention will be described in more detail with reference to examples, but the present invention is not limited thereto.

Example 1 200 g of ginseng yoeito obtained in Example 1 was mixed with 89 g of lactose and 1 g of magnesium stearate, and this mixture was tabletted with a single-shot tableting machine to give a diameter of 20 mm and a weight of about 10. 2.3 g of slug tablet was prepared, and this was crushed by an oscillator, sized, and identified to obtain a good granule of 20 to 50 mesh particles. This granule is taken at a dose of 0.5 to 4.5 g (corresponding to a dry extract weight of Ninjinyoeito of 0.34 to 3.10 g) three times a day according to the symptoms.

Example 2 200 g of ginseng yoeito obtained in Example 2 was mixed with 20 g of microcrystalline cellulose and 5 g of magnesium stearate, and this mixture was tabletted with a single-shot tableting machine to give a diameter of 7 m.
m, weight 225 mg tablets were produced. One tablet of the present invention contains 200 mg of dried extract of Ginseng Yoeito. This tablet is taken at a daily dose of 2 to 16 tablets 3 times a day according to the symptoms.

[0040]

INDUSTRIAL APPLICABILITY According to the present invention, it is possible to provide a medicine which contains a mixed crude drug or an extract thereof as an active ingredient and is highly safe and which has a remarkable therapeutic effect and is useful for the treatment of hepatitis. that's all

Claims (6)

[Claims] 1. A liver disorder-improving agent containing, as an active ingredient, ground yellow, toki, shrimp, sardines, carrots, ginseng, radish, peony, peony, yellow radish, licorice and chanterelle or extract thereof. 2. An antiviral agent comprising ground yellow, toki, shrimp, sardines, carrots, katsura, edible ginseng, peony, peony, citrus peel, yellow radish, licorice and chanterelle or its extract as an active ingredient. 3. The liver damage ameliorating agent according to claim 1, wherein the active ingredient is ginseng yoeito or an extract thereof. 4. The antiviral agent according to claim 2, wherein the active ingredient is ginseng yoeito or its extract. 5. The liver damage improving agent according to claim 1 or 3, wherein the liver damage is viral hepatitis. 6. The antiviral agent according to claim 2 or 4, wherein the virus is hepatitis C virus.