Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from a root – bulb – tuber – corm – or...
Reexamination Certificate
2001-08-09
2003-07-01
Prats, Francisco (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from a root, bulb, tuber, corm, or...
C424S725000, C424S747000, C424S756000, C424S757000
Reexamination Certificate
active
06586022
ABSTRACT:
TECHNICAL FIELD
The present invention relates to a therapeutic agent for treating ulcerative colitis, which contains peony root. More particularly, the invention relates to a therapeutic agent for treating ulcerative colitis, having peony root or a Chinese medicine formulation containing peony root, which is very effective in repairing damaged tissues of ulcerative colitis and yet has no fear of side effects as those of steroids.
BACKGROUND ART
Ulcerative colitis is a diffuse nonspecific inflammatory disease that only causes inflammation mainly in large intestines, that is, the regions from the rectum to the intestinum cecum and is characterized by continuous lesion. The disease is characterized in that the region of inflammation is localized in mucosa and submucosa, remission and exacerbation are repeated, and it cannot be completely cured. From the characteristics, it is said that patients can be relatively easily diagnosed as ulcerative colitis.
With respect to the cause of ulcerative colitis, although there are various theories such as a theory that it is caused by food and life style and a theory that the cause is autoimmunity, the cause has not been convinced yet and the true cause is still unknown. Meanwhile, the enlargement process of inflammation of ulcerative colitis has been uncovered to a considerable extent and its knowledge has been disclosed in literatures, academic meetings, and the like. Ulcerative colitis cannot be treated by etiotropic therapy as a matter of fact and is treated by conservative therapy under the present conditions.
At present, drugs based on the knowledge of the uncovered enlargement process of the inflammation of ulcerative colitis are being actively developed. For example, clinical development tests of leukocyte removing therapy, lymphocyte removing therapy, anti-CD4 antibody, anti-TNF-&agr; antibody and the like are being progressed.
In treatment of ulcerative colitis in actual clinical places, however, sulufasalazine (trade name: Salazopyrin) as a Sulfa drug or steroids which have been used for a long time is mainly administered. Treatment is given in which administration of the drugs, nutrition control, mental control, and the like are combined, and when it is still ineffective, surgical treatment is added. Such treatment is mainly given.
As for sulufasalazine and steroids used for drug therapy, sulufasalazine is relatively effective to patients with mild colitis and is used as a drug which is chosen first for the treatment of ulcerative colitis. The effect is, however, relatively weak on patients with severe colitis. Patients with mild colitis are often treated with both of sulufasalazine and steroids. In treatment in a remission phase of inflammation, in most cases, the combination of the drugs is switched to medication of only sulufasalazine. At an acute phase of inflammation, the medication of only sulufasalazine is often insufficient to produce an effect.
On the other hand, steroids often produce an excellent effect and are drugs mainly used in internal treatment. As its side effects have been known conventionally, it is necessary to be careful at the time of administration of steroids. It is also necessary to be very careful at the time of stopping the administration, what is called a withdrawal.
Although 5-ASA (5-aminosalicylate) which is considered to be an effective active part of sulufasalazine is clinically used, problems similar to those of sulufasalazine are also pointed out.
In view of the present conditions of treatment of ulcerative colitis, it is therefore an object of the invention to provide a therapeutic agent for treating ulcerative colitis, which is very effective in repairing tissues in an inflammatory region and yet exerts no side effects as those of steroids as a treatment agent based on the knowledge of the uncovered enlargement process of inflammation of ulcerative colitis.
Recently, a number of attempts to use Chinese herbal medicine to treat patients with ulcerative colitis are being made and a number of the following results have been published such as a case of enhancing anti-inflammatory power of, for example, steroids together with the medicine treatment (“Journal of society of Japanese and Chinese medical treatment” Vol. 8, p516, 1991; and Japanese Unexamined Patent Application No. 6-40931), a case of obtaining mental stability (“Gendai Toyo Igaku (Modern oriental medicine)”, Vol. 13, No. 1, p125, 1992), a case of improving constipation, diarrhea, and the like (“Gendai Toyo Igaku (Modern oriental medicine)”, Vol. 12, No. 1, p115, 1991), and description of the direct effect of inflammation remission by administration of Ren-Shen-Tang (Ninjin-to) (“Nihon Toyo Igaku Zasshi (Magazine of Japan Oriental Medicine)”, Vol. 42, No. 3, p337, 1992).
The inventors have paid attention to effects of treatment of ulcerative colitis by Chinese herbal medicine and have wholeheartedly studied. As a result, they have newly found that, among Chinese herbal medicine, peony root and Chinese medicine formulations containing peony root such as Jia-Wei-Xiao-Yao-San (Kami-shoyo-san), Dang-Gui-Shao-Yao-San (Toki-shakuyaku-san), Shao-Yao-Gan-Cao-Tang (Shakuyaku-kanzo-to), and Gui-Zhi-Fu-Ling-Wan (Keishi-bukuryo-gan) act on promotion of repairing tissues in an inflammatory region of ulcerative colitis and come to achieve the prevent invention.
DISCLOSURE OF INVENTION
In order to solve the problems, therefore, the invention provides a therapeutic agent for treating ulcerative colitis containing peony root as an active ingredient. As a specific embodiment, a therapeutic agent for treating ulcerative colitis containing dry powders of peony root as an active ingredient is provided.
As another embodiment of the present invention, it is provided a therapeutic agent for treating ulcerative colitis having a Chinese medicine formulation containing peony root as an active ingredient wherein, more particularly, the Chinese medicine formulation containing peony root is Jia-Wei-Xiao-Yao-San, Dang-Gui-Shao-Yao-San, Shao-Yao-Gan-Cao-Tan, or Gui-Zhi-Fu-Ling-Wan.
Peony root as an active ingredient of an ulcerative colitis treatment agent provided by the present invention may take forms of not only the peony root dry powders and the Chinese medicine formulation containing peony root as described above but also an infused dry extract of peony root or Chinese medicine formulation containing peony root.
As further embodiment of the present invention, it is provided a therapeutic agent for treating ulcerative colitis having, as an active ingredient, an infused dry extract of peony root, an infused dry extract of a Chinese medicine formulation containing peony root, or especially, an infused dry extract of Jia-Wei-Xiao-Yao-San, Dang-Gui-Shao-Yao-San, Shao-Yao-Gan-Cao-Tang, or Gui-Zhi-Fu-Ling-Wan.
Hitherto, Chinese medicine formulations play an auxiliary role in treatment of administrating sulufasalazine, steroids, and the like, that is, used only for the purpose of the effect which brings mental rest, the effect of suppressing diarrhea, and the like. Among Chinese medicine formulations, a formulation of the present invention containing, as an active ingredient, dry powders of peony root, an infused dry extract of peony root, or an infused dry extract of a Chinese medicine formulation containing peony root is very effective in repairing damaged tissues in ulcerative colitis as apparent from the results of tests which will be described hereinlater and yet has no fear of exerting side effects as those of steroids. The invention therefore can provide an excellent agent for treating ulcerative colitis.
BEST MODE FOR CARRYING OUT THE INVENTION
Peony root (paeniae radix) as an active ingredient in the treatment agent provided by the present invention is obtained by drying the root of a perennial plant of the peony family (paeonia albiflora var. trichocarpa) grown in China, Korea, and Japan or a relative plant. Peony root is used as astringent, emollient, antispasmodic, analgesic, a drug for oversensitive to the cold, and a drug for dermatosis. Further, it is use
Aono Shunji
Hattori Ken-ichi
Kawada Mitsuhiro
Coe Susan D
Crowell & Moring LLP
Prats Francisco
Teikoku Seiyaku Co., Ltd.
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