HU208251B - Process for producing pharmaceutical compositions for reducing vasodilatation of veins - Google Patents

Abstract

The invention relates to a process for the preparation of a preparation for the treatment of vein dilations, in particular for the treatment of haemorrhoids, or occurring on the lower limbs, possibly entzuendeten varicose veins and to reduce the pain caused by them. According to the invention, the preparations are prepared by mixing aluminum potassium sulfate and / or one or more of its hydrates with physiologically acceptable carriers, excipients and possibly fragrances and preparing from the mixture in a known manner liquid or solid preparations, preferably ointments, creams, lotions, pastes ,

Description

FIELD OF THE INVENTION The present invention relates to pharmaceutical compositions containing an active ingredient for the treatment of phlebitis and, in particular, for the reduction of pain caused by phlebitis in the lower limb, particularly in the lower limb, possibly phlebitis.

The golden lobe is hereinafter referred to as the dilatation of the unicastric cerebral artery (nodi haemorrhoidales).

The treatment of hemorrhoids in the larynx has long been pursued by those skilled in the art, since surgical healing results in significant incapacity, can only be performed in a hospital setting, and the infection rate, typically around 10% in colorectal surgery [Pharm. Intern. 7 (6) p 142 (1986)]. Surgery may cause other problems in older age or in the presence of other diseases.

Treatment of varicose veins, particularly in the extremities, is also a common task, although surgery may have the disadvantages mentioned above, although the risk of infection is lower.

Both hemorrhoidal nodules and varicose veins are common in all ages of the adult population. Thus, there is a significant need for a topical pharmaceutical composition for prolonged periods of time which also provides analgesia and, without side effects, is capable of providing working capacity and of reducing or eliminating the above pathological lesions.

Topical application of metal salts to alleviate complaints of gold-bearing lumps, such as basic bismuth gallate, basic bismuth nitrate, basic bismuth iodogallate, is known in the art (Issekutz: Drug Order 408, Bp. Medicina Publisher 1975).

Metal salts, such as aluminum salts, including aluminum stearates, have always been used in combination with plant extracts, oils, corticoids or other drugs. (Rote Liste 1983, main group 46, Editio Cantor Aulendorf / Württ. USSR).

The alum salts, i.e., Me ¹ Me ^HI (SO 4) ₂ x 12 H ₂ O - where Me ¹ is potassium, sodium, ammonium, thallium, rubidium or cesium ion, Me ¹¹¹ is aluminum, iron, chromium, cobalt or manganese ion - double salts, including aluminum potassium sulphate, have not been used as active ingredients in a one-component pharmaceutical formulation for treating vasodilatation, as reported in the literature.

Austrian Patent 171661 discloses an eye ointment consisting of flower honey, anhydrous alum and sucrose. Hungarian Patent Publication No. 190667 describes a composition for stimulating the healing of living tissues, in which casein of milk is precipitated and filtered out with alum. The hymen itself, or mixed with herbal extracts, has a curative effect on closed bone fractures, bruises, and joint injuries. Oral medications generally have several undesirable side effects within a short period of time, and treatment of hemorrhoids and other vasodilatations takes a long time, such as Venoruton ^R [active ingredient: O- (P-hydroxyethyl) -rutoside] can cause swelling even after 6-8 days of application. I have found that dilatations of the collecting vessels, especially the hemorrhoids and the phlebitis, possibly caused by phlebitis, can be significantly reduced and can be achieved only with aluminum potassium sulphate and hydrates of alum with topical application.

Preferred embodiments of the pharmaceutical composition of the present invention are:

A hydrophilic pharmaceutically acceptable ointment base (carrier) (e.g., Hydrogelum methylcellulose, Unguentum glycerin, Unguentum stearin, Unguentum hydrophylici anionicum) is mixed with aluminum potassium sulfate dodecahydrate and a homogeneous ointment is prepared.

The pharmaceutical composition of the invention may also contain other carriers, excipients, and fragrances commonly used in pharmaceutical technology.

Applicable carriers, excipients and fragrances may be found in Table VII. Hungarian Pharmacopoeia, Formule Normales VI. and H. Fiedler: Lexikon hoar Hilfstoffe für Pharmazie ... Editio Contor KG. Aulendorf, Germany, 1971, 490-494. and Angewandte Biopharmazie Wissenschaftliche Verlagges. Stuttgart, Germany, 1973 Kapitel 26 and 28 give guidance.

The compositions of the invention preferably contain from 10 to 90% by weight of aluminum potassium sulfate dodecahydrate, most preferably from 40 to 70% by weight.

According to our experience, applying the ointment containing 70% by weight of aluminum potassium sulfate according to the invention three times a day to the treated nodules, the pain, itching and flaking are greatly reduced after 1 to 3 treatments and disappear after 320 days of treatment (total pain relief). ) In 6-10 months the dilatations (varicose veins) disappear and the prominent vascular segments retract to their original position. We gained this experience by monitoring the condition of eighteen patients aged 20-70 years.

The following examples illustrate the preparation of the compositions of the present invention without limiting my claims.

Example 1

1400 g of crystalline aluminum potassium sulfate dodecabridate is pulverized and mixed with 600 g of Unguentum glycerin. Stirring is continued until a homogeneous mass is obtained which is filled into tubes in portions of 50 g.

Example 2

1400 g of aluminum potassium sulphate dodecahydrate and 600 g of Ung. glycerin was mixed as in Example 1 and then 60 cm ^{3 of} Oleum Chamomilla was added to the resulting ointment in glass jars.

HU 208 251 B

Example 3

210 g of aluminum potassium sulphate dodecahydrate g Ung. glycerolite and 2 g of menthol into a homogeneous mixture and filled into tubes.

Example 4

100 g of crystalline aluminum potassium sulphate dodecahydrate and 900 g of Unguentum emulsifieans aquosum and 7 g of menthol are mixed into homogeneous mixtures and filled in 50 g portions. The resulting cream is useful for treating varicose veins.

Example 5

500 g of cocoa butter and 500 g of aluminum potassium sulfate dodecahydrate are made into a homogeneous cream and filled in 50 g portions into a tube. The resulting cream is used to treat the golden clumps.

Example 6

All proceed as in Example 4 with the exception that 900 g of Unguentum hydrophi 11 icum USP is used as the ointment base.

Claims (4)

CLAIMS 1. A process for the preparation of a pharmaceutical composition comprising 10 to 90% by weight of crystalline aluminum potassium sulfate dodecahydrate with one or more pharmaceutically acceptable carriers, excipients and optionally fragrances, which are known per se in the lower limb. In this case, it is formulated into a pharmaceutical composition, preferably an ointment, cream or paste, for the treatment of inflammatory varicose veins and for the reduction of the pain caused by them. 2. A process according to claim 1 wherein 40 to 70 weight percent of aluminum potassium sulfate dodecahydrate is used. 3. The process of claim 1, wherein the carrier is a hydrophilic ointment base. A process according to claim 1 wherein the ointment base is selected from the group consisting of Unguentum glycerinite, Unguentum emulsifeans aquosum, cocoa butter, Unguentum hydroprhillicum USP.