Methods for identification, purification, and manufacturing...

Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from labiatae

Reexamination Certificate

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C424S725000

Reexamination Certificate

active

06299910

ABSTRACT:

FIELD OF THE INVENTION
This invention relates to methods for the water extraction and purification of Dansheng's active constituents; methods to identify a marker compound as well as an active compound in Dansheng; methods to qualitatively set up quality standards for Dansheng; and methods to eliminate toxic substances, such as Protocatechualdehyde, from the Dansheng extract.
BACKGROUND OF THE INVENTION
Dansheng, also known by its botanical name Salvia miltiorrhiza, belongs to the Labiatae family. The Dansheng herb is indigenous to the mountainous southern and central parts of China. Outwardly, the root is red. Internally, it is purplish when fresh. It is commonly sold in short, shriveled pieces of bright, brick-red color.
The Dansheng root is one of the traditional remedies for the five elements which are thought to correspond to five specific colors: yellow, white, black, purple, and red, which in turn are thought to correlate with the five principal visceral organs—spleen, lungs, kidneys, liver, and heart. Dansheng particularly belongs to the heart, and its red color traditionally suggests the blood and the circulation system.
Dansheng has been recommended for all blood difficulties including circulation, hemorrhages, menstrual disorders, and many heart disorders. In the thousands of years following its first appearance in old Chinese pharmacopoeia, the herb became one of the most significant remedies in Chinese folk medicine.
The chemical constituents of Dansheng can be divided into two categories: water-soluble and fat soluble. Due to limitations in chemical techniques, the herbal extract products manufactured up until recent years were confined primarily to fat-soluble compounds such as Tanshenone and its diperpenoid derivatives. These fat-soluble compounds were proven, to a limited degree, to be beneficial in treating physiological activities.
In 1980, Chen et al. began investigating some water-extracted components: Protocatechualdehydes, Danshensu (3′,4 phenyllatic Acid), and the Salvianolic Acids A and B. These preliminary water-soluble chemicals were found to increase animal endurance capacity under hypoxia conditions.
There have been many articles published about the beneficial affects of Dansheng. Some of these include:
Nishioka I. et al., Magnesium and Amonium-Potassium Lithospermates B, the Active Principles Having a Uremia-Preventive Effect from Salvia miltiorrhiza,
Chem. Pharm. Bulletin
37(2) 340-344(1989);
Yokozawa T. et al., Renal Response to Magnesium Lithospermate B in Rats with Adenine-induced Renal Failure,
Phytotherany Research
, Vol. 7. 235-239(1993);
Chen C. et al., Chemical Investigation on water soluble components of Salvia miltiorrhiza,
Phytotherapy Research
, Vol. 16, No. 9:536-538 (1981); and,
Li L-N et al., Salvianolic Acid A, a New Depside from Roots of Slvia miltiorrhiza,
Planta Medica
, 227-228 (1994).
SUMMARY OF THE INVENTION
A feature of this invention is a method for the water extraction and purification of Dansheng's active constituents.
Another feature of this invention is a method to identify a marker compound as well as an active compound in Dansheng.
Another feature of this invention is a method to qualitatively set up quality standards for Dansheng.
Another feature of this invention is a method to eliminate toxic substances, such as Protocatechualdehyde, from the Dansheng extract.
Another feature of this invention is a method to extract active Magnesium Salvianolate compounds from Dansheng without creating additional unwanted polysaccharides, proteins and resins as are commonly created during the traditional water extract-alcohol precipitation.


REFERENCES:
patent: 4999376 (1991-03-01), Liu
patent: 5358962 (1994-10-01), Oura et al.
Tanaka, Takashi et al.; Magnesium and Ammonium-Potassium Lithospermates B . . . Chem Pharm Bull vol. 37 No. 2 340-344 (1989).
Lian-Niang, Li Lian et al.;Salvianoclic aCID a nEW dEPOSIDE FROM rOOTS OFsALVIA MILTIORRHIZA, Planta Medica 1984 p 227-228.
YOKOZAWA, TAKAKO et al; RENAL RESPONSES TO MAGNESIUM LITHOSPERMATE B IN RATS WITH ADENINE-INDUCED RENAL FAILURE, Phytotherapy Research vol. 7. 235-239 (1993).

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