Drug for treating diabetic nephrosis

Details Drug for treating diabetic nephrosis Drug for treating diabetic nephrosis

1999-10-25

2001-03-06

Criares, Theodore J. (Department: 1617)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Ester doai

Reexamination Certificate

active

06197818

ABSTRACT:

TECHNICAL FIELD
The present invention relates to an anthraquinone carboxylic acid or the salt thereof, especially to the use of rhein or the salt thereof, more particularly the use in preparing medicine.
BACKGROUND OF THE INVENTION
Diabetes is a frequently occurring disease, and the main medicament for its treatment is insulin at present. However, insulin has no therapeutic effect to the kidney damage caused by diabetes, such as renal hypertrophy, although it can decrease the urinary glucose. Until now, no report has been found on the medicine for treatment of renal hypertrophy caused by diabetes and no effective medicine has been found for treatment of diabetic nephropathy.
SUMMARY OF THE INVENTION
The object of the present invention is to provide a new use of rhein or the salt thereof, that is the new application in preparing medicine.
Actually the present invention relates to the application of rhein or the salt thereof in preparing medicine for treatment of diabetic nephropathy.
The present invention provides a medicine of low toxicity for treatment of diabetic nephropathy.
The general formula of rhein or the salt thereof can be shown as the following:
wherein M represents sodium or potassium.
The preparation of the medicine containing rhein or the salt thereof is very simple, in which the rhein or the salt thereof is grounded into power and then prepared into capusula or aqueous solution for oral. The dosage of rhein is not larger than 200 mg/day and may be given twice or thrice by oral.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to new application of rhein or the salt thereof in preparing medicine for treatment of diabetic nephropathy.
The object of the present invention is to provide a new use of rhein or the salt thereof in preparing medicine for treatment of diabetic nephropathy. The present invention provides a medicine of low toxicity for treatment of diabetic nephropathy.
Rhubarb (
Rheum Officinale
, a Chinese herb) is a particular medicine in China and has been commonly used as a laxative for many years in traditional Chinese medicine. It has been found that rhubarb is valuable in preventing progression of chronic renal failure. Rhein is a major component of anthraquinones extracted from rhubarb. It has been known that rhein possesses effects on anti-bacterial, anti-inflammatory, and anti-tumor et al.
Rhein is a needle-like yellow crystal with melting point of 318-320° C., and soluble slightly in water but soluble in organic solvent. It remains steady in room temperature for more than one year. The general formula of rhein or the salt thereof is shown as the following:
wherein M represents sodium or potassium.
As a natural product, rhein is of low toxicity and safe for therapy. The half lethal dose (LD
50
) is 3.2 g/Kg for SD rats.
There are not marked gastro-intestinal reactions caused by the oral route of rhein in volunteers treated by rhein. Of the thirty-six volunteers given rhein at dose of 200 mg/day (100 mg, b.i.d) for 3 days, only 5 persons experience gastro-intestinal disorders. Diarrhea occurred twice or thrice a day in three of these persons, and four times in only one person.
In pharmacolinetical study, rhein can be easily absorbed from gastro-intestinal trace after the agent is given orally, and the blood concentration of rhein maintains for a longer period. The blood level of rhein reaches peak in one and half hours to three hours after one single dose of rhein at 200 mg in health man. The blood level of rhein still kept at 200 to 500 ng/ml at 24th hour in volunteers.
Thus, rhein possesses advantageous as medicine.
As shown in further investigation of rhein, hyperglycemia in experimental diabetic rats can be controlled or reduced effectively by rhein or sodium rheinate given orally. Particularly rhein is able to control or suppress renal hypertrophy, and decrease the kidney index (kidney weight/body weight ratio) obviously in diabetic rats. Rhein also can ameliorate the urinary albumin excretion significantly in diabetic nephropathy patients.
The medicine containing rhein or the salt thereof for treatment of diabetic nephropathy may be supplied in capsula or solution for oral.
A dosage of rhein up to 200 mg/day is feasible, and may be given twice or thrice a day.
The following Examples will illustrate the present invention in more details.


REFERENCES:
patent: 5652265 (1997-07-01), Vittori et al.
patent: 2-149515 (1990-08-01), None
Debord, et al., “Influence Of Renal Function On The Pharmacokinetics Of Diacerein After A Single Oral Dose”Fundam. Clinical Pharmacol., vol. 7 (8) 1993, pp. 435-441 (Abstract only).
Zheng, et al., “Effect of Rheum Officinal on the Proliferation of Renal Tubular Cells in Vitro”National Medical Journal of China, vol. 73, (6), 1993, pp. 343-345 (Abstract).
Leishi, et al., “Rheum Officinale: A New Lead in Preventing Progression of Chronic Renal Failure,”Chinese Medical Journal, vol. 109 (1), 1996, pp. 35-37.

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