JPH0611701B2 - Pharmaceutical composition for the treatment of venous ectasia and venous neuralgia and process for its preparation - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to potassium aluminum sulfate and / or one or more hydrates thereof, and one or more pharmaceutically usable carriers, adjuvants and optionally There is provided a pharmaceutical composition for the treatment of venous dilatation and venous neuralgia, characterized in that it contains, mixed with a cosmetic agent and a flavoring agent which are commonly used in the manufacture of pharmaceutical agents. And potassium aluminum sulfate 1
A pharmaceutical composition containing 10 to 90% by weight of dihydrate as an active ingredient is suitable. The carrier is preferably a hydrophilic ointment base. Furthermore, as the active ingredient, potassium aluminum sulphate and / or one or more hydrates thereof and one or more pharmaceutically usable carriers, auxiliaries and optionally cosmetics and medicaments which are usually used for the preparation of A method for producing a pharmaceutical composition for the treatment of venous dilatation and venous neuralgia by mixing with a flavoring agent and converting the resulting mixture into a liquid or solid composition.

The present invention provides a natural inorganic substance for the treatment of venous dilatation, especially hemorrhoids, and venous dilatation, which appears mainly in the lower limbs and is sometimes accompanied by phlebitis, and for treating venous neuralgia caused by phlebitis. The present invention relates to a drug containing the drug and a method for producing the novel drug.

Hereinafter, in this specification, the term "hemorrhoids" refers to the dilation of the valveless venous system at the lowermost part of the rectum ("hemorrhoid nodule").

[Conventional technology]

In the treatment of hemorrhoids, surgical treatment is possible only by hospitalization, prolongs the period of inactivity, and colon and rectal surgery is said to have a common infection rate of about 10%. , Long-term efforts have been made by interested parties to treat hemorrhoids without surgery (see Pharm. Intern. 7 , p. 142 (1986)).

In addition, another problem arises when the surgery is performed for the elderly or if they have another illness.

Treatment of venous ectasia, which primarily appears in the lower limbs, is tedious, and while surgery has a low risk of infection,
There are problems as mentioned above.

Hemorrhoidal and venous ectasia tissues are common in all age groups of the adult population. Therefore, there is a long-felt need for a drug that can be used locally for a long period of time, reduces venous neuralgia, and ensures that work can be performed reliably, and that it can cure the above-mentioned pathological alterations without side effects. There is.

According to the literature, to alleviate complaints of hemorrhoids,
A method of locally using a metal salt has been reported. Suitable salts used for this purpose are, for example, basic lead zinc gallate, basic lead nitrate, and basic iodine lead gallate.

To date, all metal salts have been used together with plant extracts, oils, corticoids, or other drugs (Rote Liste 1983, main classification 46, published by Contor Aulendorf). (Wurttemberg, West Germany).

According to the above document, alum, that is, the general formula Me ^I Me ^III (S
O ₄ ) ₂ · 12H ₂ O (In the formula, Me ^I represents an ion of potassium, sodium, ammonium, thallium, rubidium or cesium, and Me ^III represents aluminum, iron, chromium,
Represents an ion of cobalt or manganese. There is no fact that a double salt represented by the formula (4), especially, aluminum potassium sulfate was used as one active ingredient of a drug for treating venous ectasia.

Oral medications usually cause many adverse side effects even after short-term use. However, it takes a long time to treat hemorrhoids and other venous ectasias.

For example, Venoruton (trade name) (chemically, 0- (β-hydroxyethyl) rutoside) causes skin flushing (erythema) or skin redness (erythema) only 6 to 8 days after administration.
May cause edema of the face.

[Problems to be Solved by the Invention]

The object of the present invention is to provide a drug which can be manufactured simply and at low cost and which contains only a single active ingredient,
Thereby, the drawbacks of conventional drugs are eliminated.

[Means for Solving the Problems]

Venous dilatation, especially hemorrhoids, and, in some cases, venous dilatation, which appears in the lower limbs and is sometimes accompanied by phlebitis, and venous neuralgia caused by phlebitis, is almost always aluminum potassium sulfate or its water as the active ingredient. By locally using a drug consisting of Japanese alum, it is significantly reduced and cured.

According to a preferred embodiment of the present invention, potassium aluminum sulfate dodecahydrate compound is used as a hydrophilic ointment base (carrier).
(Methyl cellulose hydrogel (Hydrogelum methylcel
lulosi), glycerin ointment base (Unguentum glycerin
i), stearin ointment base (Unguentum stearini),
Unguentum hydrophilici ani
onicum)). This hydrophilic ointment base is suitable for preparing cosmetics and medicines.

The medicament according to the invention may also contain other carriers, auxiliaries and flavoring agents which are commonly used in the manufacture of cosmetics and medicaments.

Suitable carriers, auxiliaries and flavors are Hungarian Pharmacopoea VII,
Formula Le Normales Edition VI and H. Fiedler, published by Contor KG., Aurendorf, West Germany (1971), "Lexicon del Hilffstoffe Fur Pharma" Twee cosmetics (Lexikon der Hil
fstoffefr Pharmazie, Kosmetik) ”, pages 490-494, and“ Angewandte B. ”(1973) published by Visen Vascherige Verlages, Stuttgart, West Germany.
iopharmazie) ”, chapters 26 and 28.

The pharmaceutical composition according to the invention preferably comprises 90% by weight of potassium aluminum sulphate dodecahydrate compound. Particularly, the range of 40 to 70% by weight is preferable.

According to the observation result, when the ointment according to the present invention, that is, the ointment containing 70% by weight of aluminum potassium sulfate, was applied to the varicose vein to be treated three times a day,
The pain (venous neuralgia), pruritus and inflammation were severely squeezed and then much easier after 1 to 3 treatments. After 3 to 20 days of treatment, no pain at all,
I am able to work. The venous distension (variceal swelling) was resolved, and the swollen veins returned to their original state after further treatment.

The above observations were made in 18 patients aged 20 to 70 years.

According to the present invention there is provided a method of using a therapeutically effective amount of a pharmaceutical composition according to the present invention for the treatment of venous dilatation, in particular hemorrhoids, venous dilatation mainly presenting in the lower limbs, and venous neuralgia. It

〔Example〕

Hereinafter, the present invention will be described in detail based on preferred embodiments.
However, these examples do not limit the present invention.

Example 1 1400 g of crystals of potassium aluminum sulfate dodecahydrate compound
Is made into a powder and mixed with 600 g of glycerol ointment base. Continue stirring to make it homogenous, then 50
Fill g into tube.

Example 2 In the same manner as in Example 1, potassium aluminum sulfate.
1400g of 12-hydrate compound and 600g of glycerol ointment base
After mixing and, add 60m chamomile oil to it and mix. The ointment so obtained is packed in a glass jar.

Example 3 210 g of potassium aluminum sulphate dodecahydrate compound, 90 g of glycerol ointment base and 2 g of menthol, were stirred until homogeneous and filled into a tube.

Example 4 100 g of potassium aluminum sulfate dodecahydrate compound was added to an emulsified aqueous ointment base (Unguentum emulsificans aquosum)
From 900g and 7g menthol, stirred until homogeneous, take 50g and fill into a tube.

The ointment thus obtained is suitable mainly for treating venous ectasia.

Example 5 500 g of cocoa milk fat and 500 g of aluminum potassium sulfate dodecahydrate compound are combined to make a homogeneous cream, and 50 g of the cream is taken and packed in a tube.

The cream thus obtained is mainly useful for treating hemorrhoids.

Example 6 The procedure was as described in Example 4, except that 900 g of hydrophilic ointment USP was used as the ointment base.

Claims (4)

[Claims] 1. Potassium aluminum sulphate and / or one or more hydrates thereof and one or more pharmaceutically usable carriers, auxiliaries and optionally cosmetics and medicaments which are customarily used for the preparation of the products. A pharmaceutical composition for the treatment of venous dilatation and venous neuralgia, characterized in that it contains, mixed with a flavoring agent. 2. A potassium aluminum sulfate dodecahydrate,
The pharmaceutical composition according to claim 1, which comprises 10 to 90% by weight as an active ingredient. 3. The pharmaceutical composition according to claim 1, wherein the carrier is a hydrophilic ointment base. 4. An active ingredient, potassium aluminum sulphate and / or one or more hydrates thereof, and one or more pharmaceutically usable carriers, auxiliaries and optionally cosmetics and medicaments for use in the manufacture thereof. The method for producing a pharmaceutical composition according to claim 1, wherein the composition is mixed with a commonly used flavoring agent and the resulting mixture is made into a liquid or solid composition.