Medical composition kit for treating lesioned abnormal tissue

#The present invention relates to a medical composition kit of a local injection preparation for treating rectal submucous lesioned abnormal tissue such as hemorrhoid and, more particularly, it relates to a medical composition kit comprising a local injection preparation for treating rectal submucous lesioned abnormal tissue containing a water-soluble aluminum compound and tannic acid and a local anesthetic for treating the same.

#Treatment of internal hemorrhoid by injection has a history of not shorter than 100 years and, with regard to a composition, a ferric sulfate solution or a solution of phenol in olive oil was used in early years. After that, alcohol, kinin hydrochloride, mercury chloride, urethane, ergot, etc. had been used. In recent 30 years, a solution of phenol in vegetable oil, a solution of alum, etc. have been mainly used.

#However, those compositions, the following problems for curing the internal hemorrhoid have not been well solved. Thus, in a sclerosing treating method for hemorrhoid by injection preparations, it is demanded that fibrogenesis of hemorrhoid tissue is finished with stopping the bleeding, inhibiting the growth microbes and remaining no hard nodule or causing no necrosis. However, the injection preparations up to now do not satisfy all of or most of those demands. Further, in injection preparations used in clinic fields, it is difficult to decide appropriate concentration and amount and also to decide a method for sclerosing the internal hemorrhoid without causing necrosis of the tissue. When the above-mentioned composition is injected, the site where the medicament is concentrated is limited to the submucous tissue only and, therefore, the injected site is to be expanded and the administration method is to be improved as well.

#FIG. 1 is a drawing which shows the incarnation action of the medical composition kit of the present invention in terms of weight of the granulation. The data show mean value±standard error of 8 examples for each group and, in the drawing, N. S. stands for “not significant difference”.

#FIG. 2 is a drawing which shows the changes in aluminum concentration in serum after administration of the medical composition kit of the present invention. The data show mean value±standard error of 5 examples for each group.

#Examples of the water-soluble aluminum compound in the present invention are aluminum chloride, aluminum sulfate, aluminum carbonate, aluminum acetate, aluminum nitrate, aluminum lactate, aluminum tartrate, aluminum salicylate, aluminum sodium sulfate, aluminum potassium sulfate, aluminum cesium sulfate and aluminum ammonium sulfate. Those water-soluble aluminum compounds may be used either solely, or two or more thereof may be used jointly. Particularly optimum one among them is aluminum potassium sulfate. Its action is that blood flow of hemorrhoid tissue is blocked whereby hemostatic action is achieved quickly and hemorrhoid is degenerated. In addition, hemorrhoid interstitium tissue is fibrosed via an aseptic inflammation inducing action and mucosa and submucous layer of hemorrhoid (including overextended blood vessel and sustentaculum) are fused and fixed to muscle layer whereupon hemorrhoid is sclerosed and degenerated.

#It is preferred that the above-mentioned water-soluble aluminum compound during the fractional charging is 0.01 to 0.5 molar concentration or, preferably, 0.03 to 0.3 molar concentration. Effective concentration in the fractionally charged preparation is within a range of about 1% to about 10%, preferably about 2% to about 5% or, more preferably, about 4%. The said fractionally charged preparation is one of the two constitutions of the medical composition kit of the present invention and its preparation is carried out in such a manner that the final concentration of the water-soluble aluminum compound in the mixed final preparation is made about 2%.

#With regard to tannic acid in the present invention, those derived from various plants, etc. may be used and that derived from gallnut is particularly preferred. This tannic acid plays a role that it does not suppress the tissue sclerosing action of the water-soluble aluminum compound but reduces an excessive acute inflammation reaction having a possibility of causing tissue disorder. During the fractional charging, it is compounded together with the water-soluble aluminum compound and its contained ratio in terms of effective concentration in the fractionally charged preparation is within a range of 0.01% to 2%, preferably, 0.0-5% to 1.5% and, more preferably, about 0.15%. The said concentration is adjusted in such a manner that the final concentration of tannic acid in the mixed final preparation is about 0.075%. Incidentally, tannic acid may be added in more amount than the above range provided that amount of other components, particularly sodium hydrogen sulfite, is adjusted but, in that case, coloration and precipitation are apt to occur when the prepared composition is preserved for a long term and utmost carefulness is to be paid for preparation and preservation whereby that is inconvenient.