Cosmetic compositions comprising a native mineral substance for the treatment of phlebectasiae and process for preparing same

The invention relates to cosmetic compositions for the treatment of phlebectasiae, particularly haemorrhoids and phlebectasiae mainly occurring on the lower limbs optionally accompanied with phlebitis, as well as for relieving the phlebalgia thereby induced, with comprises potassium aluminum sulfate and/or one or more hydrates thereof in admixture with one or more cosemtically acceptable carriers, auxiliary and optionally odorizing materials commonly used in the preparation of cosmetics. The compositions according to the invention preferably contain potassium aluminum sulfate dodecahydrate in an amount of 10 to 90% by weight, most preferably 40 to 70% by weight and are preferably formulated to ointments, creams, lotions or pastes.

The invention relates to cosmetic compositions for treating phlebectasiae, 
particularly haemorrhoids and phlebectasiae mainly occurring on the lower 
limbs and optionally accompanied with phlebitis as well as for relieving 
the phlebalgia thereby induced, which comprise a native mineral substance. 
According to an other aspect of the invention, there is provided a process 
for the preparation of these new compositions. 
Hereinafter, by the term "haemorrhoids", there are meant the dilatations of 
the valve-free venour vascular system in the lowest segment of the rectum 
("nodi haemorrhoidales"). 
A long-standing effort of the persons skilled in the art has been aimed to 
treat the haemorrhoids without any surgical intervention since the cure by 
a surgical operation requires an extended period of disability to work, it 
can be carried out only by hospitalization and involves an infection ratio 
of about 10% being common in the surgery of the colon and rectum [Pharm. 
Intern. 7, 142 (1986)]. Other problems can also be raised by the surgical 
intervention in the elderly or in the case of other accompanying diseases. 
The therapy of phlebectasiae mainly occurring on the lower limbs is also a 
frequent task and the surgical intervention may also here be accompanied 
by the disadvantages discussed above though the risk of infection is lower 
here. 
The formation of both the haemorrhoids and phlebectasiae is highly frequent 
in all age-groups of the adult population. Thus, an important demand 
exists on a composition that may topically be used for a long time, 
provides a relief of phlebalgia and is suitable to ensure the working 
ability as well as to reduce or alleviate the pathological alterations 
mentioned above without side-effects. 
It is known from the literature to topically use metal salts for relieving 
complaints caused by haemorrhoids. Basic bismuth gallate, basic bismuth 
nitrate and basic bismuth iodogallate are e.g. suitable salts for this 
purpose. 
Till now, the metal salts have in every case been used together with plant 
extracts, oils, corticoids or other drugs [Rote Liste 1983, Main Class 46, 
Ed. Cantor Aulendorf (Wurttemberg, German Federal Republic)]. 
According to the literature alums, i.e. double salts of the general formula 
Me.sup.I Me.sup.III (SO.sub.4).sub.2. 12H.sub.2 O, wherein Me.sup.I stands 
for potassium, sodium, ammonium, thallium, rubidium or caesium ion and 
Me.sup.III means aluminium, iron, chromium, cobalt or manganese ion, and 
among them, potassium aluminium sulfate have never been used as active 
ingredients of one-component compositions for treating phlebectasiae. 
Oral compositions commonly induce a number of undesired side effects within 
even a short period whereas the treatment of haemorrhoids or other 
phlebectasiae requires a long time. Thus, Venoruton.RTM. [chemically 
O-(.beta.-hydroxyethyl)-rutoside] may e.g. induce rubedo (erythema) and 
dropsy tumescence of the face after a treatment period of only 6 to 8 
days. 
The aim of the present invention is to provide a cosmetic composition which 
is simple and cheap to prepare and contains only a single active 
ingredient whereby the drawbacks of the known solutions can be eliminated. 
Now it has been found that phlebectasiae, particularly the haemorrhoids and 
phlebectasiae mainly occurring on the lower limbs and optionally 
accompanied with phlebitis, and the phlebalgia induced thereby can 
significantly be reduced or alleviated by the topical use of a composition 
containing exclusively potassium aluminium sulfate or its hydrates (alum) 
as active ingredient. 
According to a preferable embodiment of the present invention, potassium 
aluminium sulfate dodecahydrate is mixed with a hydrophilic ointment base 
(carrier) [methylcellulose hydrogel (Hydrogelum methylcellulosi), 
glycerolic ointment base (Unguentum glycerini), stearin ointment base 
(Unguentum stearini) or a hydrophilic anionic ointment base (Unguentum 
hydrophilici anionicum)], which is convenient for preparing cosmetics. 
The composition according to the invention may contain also other carriers, 
auxiliary and odourizing materials commonly used in the preparation of 
cosmetics. 
Suitable carriers, auxiliary and odourizing substances are listed in the 
Hungarian Pharmacopoea VII, Formulae Normales Ed. VI as well as H. 
Fiedler: "Lexikon der Hilfstoffe fur Pharmazie, Kosmetik . . . Ed. Contor 
KG. Aulendorf, German Federal Republic, 1971, pages 490 to 494; and 
"Angewandte Biopharmazie, Ed. Wissenschaftliche Verlagges. Stuttgart, 
German Federal Republic, 1973, Chapters 26 and 28. 
The compositions according to the invention preferably contain potassium 
aluminum sulfate dodecahydrate in an amount of 10 to 90% by weight, most 
preferably 40 to 70% by weight. 
According to our observations, when the varicose veins to be treated were 
smeared thrice in a day by using the ointment according to the invention, 
i.e. an ointment containing 70% by weight of potassium aluminum sulfate, 
the pain (phlebalgia), pruritus and inflammation were strongly reduced and 
then alleviated after 1 to 3 treatments; after a treatment lasting 3 to 20 
days, the working ability was restored (with a complete painlessness); 
whereas the phlebectasiae (vein varicosities were eliminated and the 
protruding vein vessels retreated to their original place after further 
treatment. These observations were made on 18 patients with an age between 
20 and 70 years. 
The invention also relates to a method for treating phlebectasiae, 
particularly haemorrhoids and phlebectasiae mainly occurring on the lower 
limbs as well as for relieving phlebalgia. This method can be excellently 
used with persons working in standing position.

The compositions according to the invention are illustrated in detail by 
the following non-limiting Examples. 
EXAMPLE 1 
1400 g of crystalline potassium aluminum sulfate dodecahydrate are powdered 
and mixed with 600 g of glycerolic ointment base (Unguentum glycerini). 
The stirring is continued until obtaining a homogeneous mass which is then 
filled in 50 g portions into tubes. 
EXAMPLE 2 
After mixing 1400 g of potassium aluminum sulfate dodecahydrate with 600 g 
of a glycerolic ointment base as described in Example 1, 60 ml of 
chamomile oil are mixed to and the ointment thus obtained is filled into 
glass jars. 
EXAMPLE 3 
210 g of potassium aluminum sulfate dodecahydrate are stirred with 90 g of 
a glycerolic ointment base and 2 g of menthol to a homogeneous mass and 
then filled into tubes. 
EXAMPLE 4 
100 g of crystalline potassium aluminum sulfate dodecahydrate are stirred 
with 900 g of an emulsifying aqueous ointment base (Unguentum emulsificans 
aquosum) and 7 g of menthol to a homogeneous mixture and then filled in 50 
g portions into tubes. The ointment thus obtained is suitable for treating 
mainly phlebectasiae. 
EXAMPLE 5 
500 g of cocoa butter are transformed together with 500 g of potassium 
aluminum sulfate dodecahydrate to a homogeneous cream and filled in 50 g 
portions into tubes. The cream thus obtained is useful for treating mainly 
haemorrhoids. 
EXAMPLES 6 
The process described in Example 4 is followed, except that 900 g of a 
hydrophilic ointment USP (Unguentum hydrophilicum USP) are used as 
ointment base.