CN1043628A - Composition for alleviating varicose veins and its preparation method - Google Patents

Abstract

The invention relates to a composition for treating varicose veins, in particular lower rectal vasodilatation and venous dilatation mainly in the lower extremities with any concomitant phlebitis, and for alleviating venous pain caused thereby, comprising a mixture of potassium aluminium sulphate and/or its monohydrate or polyhydrate with one or more pharmaceutically acceptable carriers, auxiliary materials and optionally odorizing substances commonly used for the preparation of cosmetics and pharmaceuticals.

The compositions according to the invention preferably contain 10 to 90% by weight, preferably 40 to 70% by weight, of potassium aluminium sulphate and are preferably formulated as ointments, creams, lotions or ointments.

Description

The present invention relates to a composition for treating varicose veins, especially for haemorrhcids (see translation below) and varicose veins that mainly appear in the lower extremities and any accompanying phlebitis, and can also be used to relieve venous pain caused by them. These compositions contain a natural mineral.

According to another aspect of the invention, there is also provided a process for preparing these novel compositions.

Thus, the term haemorrhoids means "dilation of the valveless venous vasculature of the lowermost rectum" (the Latin name "nodi haemorrhoidales").

There has been a long-standing effort by those skilled in the art to treat vasodilation of the lower rectum nonsurgically. Because the person cannot work for a long period of time after treatment with this operation, and this operation can only be performed in hospital conditions, its infection rate is the same as other colon and rectal surgery, about 10% [ Pharm. Intern. 7, 142 (1986)]. Additional problems can arise when performing surgery on older patients or patients with other medical conditions.

The treatment of dilated veins, mainly in the lower extremities, is also a frequent task, although the risk of surgical infection is lower here, but it is also accompanied by the above-mentioned disadvantages.

Lower rectal vasodilation and venous dilation have a higher incidence in all age groups of the adult population. Therefore need to have a kind of drug compound that can be used locally for a long time very much, it can alleviate venous pain, be suitable for ensuring the working ability of the patient, can also alleviate or alleviate above-mentioned pathological change and have no side effect.

It is known from the literature that topical application of metal salts can relieve pain caused by haemorrhoids in the lower rectum, such as basic bismuth gallate, basic bismuth nitrate and basic bismuth iodogallate, etc. are suitable for this purpose of salt.

Hitherto, these metal salts have been used in various cases together with plant extracts, oils, corticosteroids or other drugs [1983 Red List, main class 46, edited by Cantor Aulendorf (Württmmberg, German Federal Republic) ].

According to the literature, alum, that is, a double salt with the general formula Me ^Ⅰ Me ^Ⅲ (SO ₄ ) ₂ 12H ₂ O, where Me ^Ⅰ represents potassium, sodium, ammonium, thallium, rubidium or cesium ions, and Me ^Ⅲ represents aluminum, iron, chromium , cobalt or manganese ions. Among them, aluminum potassium sulfate has never been used as an active ingredient in a single composition when used for treating venous dilatation.

Oral compounding usually causes some adverse side effects in a short period of time, whereas treatment of rectal vasodilation and other venous dilations takes longer. For example, vitamin P [chemical name triserutin] can be used as an example. Symptoms such as facial erythema and edema can appear after only 6-8 days of treatment with it.

The object of the present invention is to provide a composition containing only a single active ingredient, which not only can be prepared very conveniently and cheaply, but also can eliminate some disadvantages of existing drugs.

It has been found that topical application of a formulation consisting of monopotassium aluminum sulfate or its hydrate (alum) as active ingredient significantly reduces or relieves venous dilatation, especially in the lower rectum and occurs mainly in the lower extremities and any accompanying Phlebitis dilation of the veins, and the resulting pain in the veins.

According to a preferred embodiment of the present invention, aluminum potassium sulfate dodecahydrate is mixed with a hydrophilic ointment base (as a carrier) [methylcellulose gel (Hydrogelum methylcellulosi), glycerin ointment base (Unguentum glycerini), hard Fatty acid glyceride ointment base (Unguentum stearini) or hydrophilic anionic ointment base (Unguentum hydrophilicianionicum)], this hydrophilic ointment base is very convenient for the preparation of cosmetics and medicines.

According to the present invention, the composition may also contain other carriers, auxiliary materials and flavoring agents which are usually used in the preparation of cosmetics and medicines.

Suitable carriers, auxiliary substances and flavoring substances are listed in the following monographs, Hungarian Pharmacopoea VII, Formulae Normales Ed. VI and H. Fiedler: "Lexikon der Hilfstoffe fur Pharmazie, Kosmetik...Ed.ContorKG.Aulendorf, German 1 Federal 1 pp. 490-494; and "Angewandte Biopharmazie, Ed. Wissenschaftliche Verlagges. Stuttgart, German Federal Republic, 1973, Chapters 26-28.

According to the present invention, the composition preferably contains aluminum potassium sulfate dodecahydrate in an amount of 10-90% by weight, most preferably 40-70% by weight.

According to our observation, when the ointment provided by the present invention, i.e. containing 70% (by weight) aluminum potassium sulfate ointment treatment of varicose veins, coated three times a day, vein pain, itching and inflammation and other symptoms can be significantly reduced , After 1-3 treatments, further relief can be achieved. After the treatment lasts 3-20 days, the patient returns to working ability (no pain at all); dilated veins (varicose veins) are also eliminated, and with further treatment, prominent veins can be restored to their original position. These results were observed on 18 patients aged 20-70 years.

The invention also relates to a method for treating venous dilatation, especially vasodilation in the lower rectum and venous dilatation mainly in the lower extremities, and a method for alleviating venous pain. This method comprises administering a therapeutically effective amount of a composition provided herein.

The compositions provided by the present invention are illustrated in detail by the following non-limiting examples.

Example 1

1400 g of powdered crystalline potassium aluminum sulfate dodecahydrate were mixed with 600 g of glycerin ointment base (Unguentum glycerini), stirred until a homogeneous mass was obtained, and then dispensed into tubes in 50 g portions.

Example 2

1400g aluminum potassium sulfate dodecahydrate and 600g glycerin ointment base are mixed by the method described in solid side 1, then mix into 60ml chamomile oil, and the ointment that obtains is packed in the jar.

Example 3

Stir and mix 210 g of potassium aluminum sulfate dodecahydrate with 90 g of glycerin ointment base and 2 g of menthol to obtain a homogeneous mass, which is put into a tube.

Example 4

100g of crystalline potassium aluminum sulfate dodecahydrate is mixed with 900g of emulsified hydration ointment base (Unguentum emulsificans aguosum) and 7g of menthol to form a homogeneous mixture, and then filled into tubes at 50g per portion. The resulting ointment is mainly suitable for Treat dilated veins.

Example 5

Transfer 500g of cocoa butter into 500g of potassium aluminum sulfate dodecahydrate to make a uniform cream, which is divided into tubes by 50g each, and the cream thus obtained is mainly used for the treatment of dilation of blood vessels in the lower rectum.

Example 6

The procedure described in Example 4 was also followed except that 900 g of Hydrophilic Ointment USP (Unguentum hydrophilicum USP) was used as the ointment base.

Claims (7)

1. A composition for treating venous dilatation, especially vasodilation in the lower rectum and venous dilatation mainly occurring in the lower extremities with any accompanying phlebitis and relieving the resulting venous pain, comprising aluminum potassium sulfate and/or A mixture of its monohydrate or polyhydrate with one or more pharmaceutically acceptable carriers, auxiliary materials and optional odorants commonly used in the preparation of cosmetics and pharmaceuticals. 2. The composition as claimed in claim 1, which comprises potassium aluminum sulfate dodecahydrate as an active ingredient in an amount of 10-90% by weight, preferably 40-70% by weight. 3. The composition of claim 1 comprising a hydrophilic ointment base as a carrier. 4. The composition of claim 1, which comprises glycerin ointment (Unauentum glycerini), emulsifying hydration ointment (Unguentum emulsificans aguosum), cocoa butter or hydrophilic ointment USP (Unguentum hydrophilicum USP) as an ointment base. 5. The method for preparing the composition according to claim 1, which comprises the active ingredient potassium aluminum sulfate and/or its monohydrate or polyhydrate with one or more pharmaceutically acceptable carriers, auxiliary materials and commonly used Mixing of optional odorants in the preparation of cosmetics and pharmaceuticals, and converting the resulting mixture into liquid or solid compositions, usually into ointments, creams, lotions or creams. 6. A method for treating venous dilation, especially vasodilation in the lower rectum and venous dilatation mainly in the lower extremities, and relieving venous pain, the method is characterized in that the effective therapeutic dose of the composition in claim 1 is used. 7. Use aluminum potassium sulfate and its hydrates to treat venous dilatation, especially vasodilation in the lower rectum and mainly in the lower extremities, and any venous dilatation accompanied by phlebitis, and relieve the resulting venous pain.