JPS63239229A - Immunoactivating agent - Google Patents

Abstract

PURPOSE:To obtain an immunoactivating agent for person infected by virus of acquired immune deficiency syndrome, containing the Chinese medicine NINJINTO (blend of Ginseng Radix, etc. with ingredients) and having extremely low toxicity and high safeness. CONSTITUTION:A diluting agent, auxiliary agent, etc., used in a conventional formulation is added to a dried extract powder of NINJINTO (a Chinese medicine produced from blend of GINSENG Radix with the following ingredients) produced according to blend ratio of crude drugs as described in old books such as SHOKANRON and KINKIYORYAKU, and formulated by a conventional method to provide the aimed agent. The agent can be prepared in a form such as inhalant, granule, tablet, capsule agent, etc., and administered in dose of 1-10g / day / three times as an amount of dried extract powder. A blend ratio of each crude medicine of the above-mentioned NINJINTO is illustrated by 3pts.wt. Glycyrrhizac, 2-3pts.wt. Zingiberis Siccatum Rhizoma, 3pts.wt. Atratylodis Rhizoma and 3pts.wt. Ginseng Radix.

Description

DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to an immunostimulant for people infected with a virus of acquired immunodeficiency syndrome.

[Prior Art] Acquired immunodeficiency syndrome (AIDS) is a disease mainly caused by severe cellular immunodeficiency caused by immunodeficiency syndrome virus infection. This disease has developed into a social problem because no radical treatment has been established and the mortality rate is extremely high.

Currently, therapeutic drugs for acquired immunodeficiency syndrome include antiviral agents such as azidothymidine (AZT) and immunostimulants such as interleukin-2 and interferon-γ, but these drugs do not require definitive treatment. There was a desire to develop a therapeutic drug for the treatment of acquired immunodeficiency syndrome.

[Problems to be Solved by the Invention] The present invention provides an immunostimulant for the treatment of acquired immunodeficiency syndrome in virus-infected individuals.

[Means for Solving the Problem] The present inventors conducted research on the immunostimulatory effect of various Chinese herbal prescriptions on virus-infected patients with acquired immunodeficiency syndrome. We have discovered that a prescription, ninjinto, has an immunostimulatory effect on people infected with the virus of acquired immunodeficiency syndrome. The present invention is based on this knowledge, and is an immunostimulant for virus-infected patients with acquired immunodeficiency syndrome, which consists of ninjinto. Ninjinto is described in the classic Chinese herbal medicine prescriptions (Shokanron, Metals Koro), including its constituent herbal medicines, amounts, extraction methods, etc. Although it has been used to treat various diseases, it was previously unknown that it had an immunostimulatory effect on people infected with the acquired immunodeficiency syndrome virus.

In the present invention, ninjinto can be any ninjinto as long as it is manufactured using the proportions of herbal medicines that comply with the descriptions of classics such as Shokanron and Metal Koro.

In particular, 3g of licorice, 39 points of kanban according to the theory of cold weather and the metal route.
, t 39, and carrots in a composition ratio of 3 g is preferable from the viewpoint of its action.

Carrot soup is 3g of licorice, 3g of dried fruit, 39g of 71t, and 3g of carrot.
It is also possible to boil it with 600-g water to make 350111, remove the dregs, and boil the medicinal solution again to make 2007d, which can be taken in three doses as an immunostimulant.
In consideration of ease of administration and portability, dry extract powders or herbal medicine extract preparations prepared by preparing extracts can also be used as immunostimulants.

For example, 3 parts by weight of licorice, 2 to 3 parts by weight of dry extract, 3 parts by weight of raw carrot, and 3 parts by weight of carrot are extracted with 10 times the amount of water. Obtain hot water-dried extract powder, add appropriate excipients, adjuvants, etc. used in ordinary formulations, and prepare powders, granules, tablets, etc. according to the usual method for manufacturing formulations.
It can be made into a preparation such as a capsule.

A specific example of the production of the immunostimulant of the present invention is as follows.

Specific Example 1 Licorice 39, Inui 39, frr, 3g, Ginseng 3917) Add 10 times the amount of water, i.e. 120 - to a mixed herbal medicine, heat and extract at 100°C for 1 hour, filter the resulting extract, Spray drying yielded 2.4 g of dry extract powder.

Effects of the Invention The fact that the immunostimulant of the present invention has an immunostimulatory effect on virus-infected individuals with acquired immunodeficiency syndrome will be explained with reference to experimental examples.

Experimental Example 1 2.5 g of the extract powder obtained in the above specific example 1 was administered to four cases of virus-infected patients with acquired immunodeficiency syndrome in three divided doses a day for three months. Before administration, 1 month, 2 months after administration,
Mitsuki's white blood cell count, lymphocyte count, helper T cells (OK
T4) number, suppressor T cell (OKT8) number, 0KT
410KTB ratio and Two-colo
r) Changes in analytical values were measured.

The results are shown in Table 1 From the results shown in Table 1 and above, it was confirmed that the immunostimulant of the present invention has an immunostimulatory effect on virus-infected patients with acquired immunodeficiency syndrome.

Next, an acute toxicity test for oral administration of the immunostimulant of the present invention was conducted on ddY male mice and Wistar (W 1sta) mice.
When conducted using male rats of the r) strain, the immunostimulant of the present invention obtained in Specific Example 1 was found to have a dosage of 15 g/kg (dosage limit).
There were no deaths even after oral administration.

Thus, the immunostimulant of the present invention has extremely low toxicity and high safety. Ninjinto has been clinically used as a Chinese herbal medicine since ancient times to the present, and it has been confirmed that it has few side effects. Considering the experimental data and acute toxicity test results of the present invention, the effective dose of the immunostimulant of the present invention varies depending on the patient's age, weight, and degree of disease, but is usually an adult dose of dry extract powder. When administered orally, the daily dose is considered to be ff1l to Log, and it is considered appropriate to take the drug in three divided doses a day, depending on the symptoms.

Next, the present invention will be specifically explained by showing examples, but the present invention is not limited thereto.

Example 1 200g of dry extract powder produced according to Example 1 above
was mixed with 89 g of lactose and Ig of magnesium stearate, and this mixture was compressed using a single-shot tablet machine to form tablets with a diameter of 20 mm.
A slug tablet having a size of 2.3 mm and a weight of about 2.3 g was prepared, which was pulverized with an oscillator, sized, and sieved to obtain good granules having particles of 20 to 50 mesh.

This granule has a dosage of 0.5 to 4.5 g depending on the symptoms.
(0.0% as the weight of the dry extract powder of the immunostimulant of the present invention.
(equivalent to 34 to 3.10 g) three times a day.

Example 2 200g of dry extract powder produced according to Example 1 above
was mixed with 20 g of microcrystalline cellulose and 5 g of magnesium stearate, and this mixture was compressed using a single-shot key press to produce tablets with a diameter of 7 mm and a weight of 225 mg. One tablet of the present invention contains 200 mg of the dry extract powder of the immunostimulant of the present invention.

Take 2 to 16 tablets of the same amount three times a day depending on your symptoms.

Example 3 500ml of dry extract powder produced according to Example 1 above
g was filled into hard capsules. This capsule is taken in 2 to 20 capsules three times a day, depending on the symptoms.

Claims (1)

[Claims] Immune stimulant for people infected with acquired immunodeficiency syndrome virus, consisting of ninjinto