ANTIPSORIATIC PHARMACEUTICAL COMPOSITIONS AND PROCESS FOR PREPARING SAME

Abstract: The invention relates to an antipsoriatic pharmaceutical composition (useful for healing psoriasis), which comprises as active ingredient a complex active agent extract obtained by heating and subsequently pressing wheat grain and/or a grist thereof in admixture with carriers and/or additives commonly used in the pharmaceutical industry. According to the invention, this composition is prepared in such a way that wheat grain and/or a grist thereof is (are) heated by using metal plates and subsequently, the thus-obtained complex active agent extract is transformed in a known way to a cream, emulsion, gel, tonic or solution by mixing it with carriers and/or additives commonly used in the pharmaceutical industry.

Description: ANTIPSORIATIC PHARMACEUTICAL COMPOSITIONS AND PROCESS FOR PREPARING SAME This invention relates to novel antipsoriatic pharmaceutical compositions, particularly to novel pharmaceutical compositions useful for healing psoriasis. The invention furthermore relates to a process for preparing these compositions. Psoriasis is a worldwide occurring disease being particularly frequent in the moderate zone. Both men and women of various ages suffer from this disease. More than 1 % and in Europe 2 - 5 % of the entire population are psoriatic. Characteristics of psoriasis are: silvery squamae, desquamation of high grade and a well-circumscribed, round, usually lens-size skin tuber. This tuber occurs most frequently in the knee, elbow and scalp. At present it is recognized that psoriasis is hereditable, which is characteristic of families in some geographical areas. The most characteristic types of psoriasis are: gyrate psoriasis, palm-and-sole psoriasis as well as psoriasis of the scalp. The number of psoriatic people is continuously increasing. One of the most important reasons therefor lies in the phenomenon of the recessive type genetic transmission. According to the present scientific knowledges, 75910-1815-SZO/KmO psoriasis can only symptomatically be treated. This is achieved on the one part by diminishing the accelerated growth of epithelial cells and ceasing of the inflamma¬ tion. The use of cytostatics proved to be effective, how¬ ever, due to their toxicity, they can be used for treat¬ ment only twice or three times. It has been recognized in 1979 and published in 1982 that native terpenes isolated from the rhizome of DRYOPTERIS arrasi or from the leaves and rhizome of POLODIUM vulgare lium, POLIDIUM laucotomos, PLEBODIUM decumanum and CYATHEA tacivaniana are useful to treat psoriatic patients of any sex and age. Hundred fifty two patients were orally treated with daily 200 mg, which resulted in a symptom- ree state lasting 1 - 3 month(s) in 80 % of the treatments. Recently, the salt-water bathes can be considered to be an important supplementary treatment, chiefly due to the removal of squamae and relieving of the inflammations. It is obvious from those said above that the healing of psoriasis has not been solved up to the present and the drugs have several side effects. Thus, the present invention is aimed to develop a pharmaceutical composition being useful for healing psoriasis, by which the psoriasis can entirely be ceased without any adverse side effects and the original condition and colour of skin surface can be restored. It has been observed in the course of our experi¬ ments that, on carrying out the extraction of wheat grain and/or the grist thereof by pressing and heating, a complex active agent is obtained which, after being formulated to a pharmaceutical composition and used for treatment of the ill psoriatic skin, firstly results in the diminution of the psoriatic skin surface within a short period, then entirely heals it, depending on the severity of the disease and size of the skin surface, within 1-3 month(s) . The skin surface has the same consistency and colour as those of the healthy skin and the psoriasis ceases once for all. Thus, the present invention relates to an anti- psoriatic pharmaceutical composition (being useful for healing psoriasis) , which comprises as active ingredient a complex active agent extract obtained by heating and subsequently pressing wheat grain and/or a grist thereof. According to the invention, the novel antipsoriatic compositions are prepared by heating and then pressing wheat grain and/or a grist thereof and subsequently, formulating the thus-obtained complex active agent extract to a therapeutically useful composition, suitably cream, emulsion, gel, tonic or solution. According to an embodiment of the process of the invention the complex active agent is obtained by placing wheat and/or a grist thereof onto a metal plate and pressing it at a temperature between 200 and 800 °C. After mixing with one or more solid and/or liquid carrier(s) and/or additiv (s) , the complex active agent extract is transformed to a cream, emulsion, gel, tonic or solution. The composition according to the invention does not contain any other therapeutically active substance in addition to the complex active agent. For formulation of the compositions according to the invention known substances such as talc, wheat, maize or potato starch may be employed as solid carriers and one or more therapeutically acceptable liquid solvent(s) , e.g. water, ethanol, and oils of plant or animal origin causing no skin irritation as liquid carrier(s) may be used. In addition to these oleic acid, stearic acid or lanolin fatty acid may also be used as liquid carriers. Oils or their mixtures commonly used in the cosmetical industry, e.g. liquid paraffin, vaseline, coco butter or cod liver oil may also be employed as liquid carriers in the compositions according to the invention. Menthol and camphor are suitable tonicizing agents. In the compositions according to the invention distilled or deionized water may be used in an amount of 15 - 70 % calculated for the total weight of the compo¬ sition. The water amount of creams or ointments is 50-70 %, whereas tonics and solutions preferably contain water in an amount of 30 - 80 %. The invention is illustrated in detail by the following non-limiting Examples. Example 1 Wheat grains placed in a single-row layer onto a copper plate with a smooth surface are pressed by an iron plate having a smooth surface of 500 °C temperature. Under the effect of heat and pressure, the complex active agent leaves the wheat and is then washed off with distilled water. The extract thus obtained is transformed to a solution of 80 % by using distilled water. Example 2 The process described in Example 1 is followed. The complex active agent extract obtained is dissolved off by 40 % ethanol and further diluted to a solution of 60 %. This composition is used for painting. The effect of the compositions according to the invention has been proven by the experiments described hereinafter. The therapeutically active solution prepared was tested on 20 patients (5 children of 12 - 14 years, 7 women of 18 - 56 years and 8 men of 25 - 72 years) . The patients had been psoriatic for seven years in average. The patients were treated once daily or every two or three days. It has been observed during the treatment that after the first treatment an itching, burning sensation occurred, simultaneously the stretching and strain of the skin ceased. After the second or third treatment, the ill skin surface healed beginning from the outer edge towards its inside; a ring-like clear streak developed on the skin, which became similar to the colour of skin after 3-5 days. Subsequently, the extension of the ill skin surface was further diminished, the psoriatic part was contracted to a pinhead size and finally, it completely disappeared from the formerly ill skin. The duration of treatment is 1-3 month(s) in average; this depends on the size of the ill skin surface, on the interval passed from the beginning of the disase and age of the patients. The time of healing of children is significantly shorter, about the half of that of adults. The healing was evaluated as follows: Child Woman Man The degree of psoriasis was severe in all cases. The longest period of treatment was three months. After treatment, the psoriasis ceased on all patients (20 persons) , the skin surface became smooth and identical to other skin surfaces of the body. After the termination of treatment, 1-3-6 mont (s) passed, during this time the patients were symptom-free.

Claims: Claims 1. Antipsoriatic pharmaceutical composition (useful for healing psoriasis) which comprises as active ingredient a complex active agent extract, obtained by heating and pressing wheat grain and/or a grist thereof, in admixture with carriers and/or additives commonly used in the pharmaceutical industry. 2. A pharmaceutical composition as claimed in claim 1, which comprises the active agent in an amount of 0.05 - 99.0 % calculated for the total weight of the composi¬ tion. 3. A process for the preparation of an anti¬ psoriatic pharmaceutical composition as claimed in claim 1 or claim 2, which comprises heating and then pressing wheat grain and/or a grist thereof and subsequently, formulating the thus-obtained complex active agent extract to a pharmaceutical composition useful for healing psoriasis, preferably to a cream, emulsion, gel, tonic or solution with carriers and/or additives commonly used in the pharmaceutical industry. 4. A process as claimed in claim 3, which comprises carrying out the heating and pression by using metal plates, suitably iron, copper or aluminium plates. 5. A process as claimed in claim 3 or 4, which comprises carrying out the heating of wheat grain and/or a grist thereof at a temperature range of 200 - 800 °C, suitably at 500 - 600 °C. 6. A process as claimed in any of the claims 3 to 5, which comprises using the active agent in an amount of 0.05 - 99.0 % calculated for the total weight of the composition.

Inventors: ARKOSI MARGIT, MOLNAR ANTAL, MOLNAR LAJOS, PAJTAS ZSIGMOND, VARGA JANOS, ARKOSI, MARGIT, MOLNAR, ANTAL, MOLNAR, LAJOS, PAJTAS, ZSIGMOND, VARGA, JANOS
Applicants: FLORIN VEGYIPARI SZOEVETKEZET, FLORIN, VEGYIPARI, SZOEVETKEZET
Application year: 1992
Main classification: A61K35
IPC codes: A61K8, A61K36, A61Q19