Herbal combinations

Herbal combinations which reduce serum cholesterol and triglyceride levels comprise (1) herbs having substantial recognized activity in enhancing circulatory function (ECF herbs) and (2) herbs having substantial recognized effects in promoting bowel motility (PBM herbs). Preferred combinations have a combined total of at least 16% (dry weight basis) of at least two ECS herbs in combination with a combined total of at least 16% (dry weight basis) of at least two PBM herbs. Particularly preferred combinations are selected from the following herbs: Crataegus, Ho Shou Wu, Chrysanthemum, Lotus Leaf, Alisma and Hu-Zhang, Cassia Seed, and Rhubarb.

I. FIELD OF THE INVENTION 
The field of the invention is herbal combinations. 
II. BACKGROUND OF THE INVENTION 
Coronary heart disease (CHD) is the leading cause of death for both men and 
women in the United States, accounting for approximately 500,000 deaths 
each year. A significant percentage of CHD is associated with abnormal 
cholesterol and triglyceride levels, and numerous pharmaceuticals have 
been developed to treat these conditions. Unfortunately, some of the most 
popular cholesterol and triglyceride lowering pharmaceuticals, including 
statins (lovastatin, pravastatin, simvastatin, and fluvastatin) and 
fibrates (gemfibrozil, marketed as Lopid), have been linked to undesirable 
side effects. For example, recent clinical studies have indicated that 
these drugs can be carcinogenic. Lovastatin was reported to cause excess 
stomach, liver, and lung tumors in mice, and the other statins reviewed 
were said to cause rodent cancers. Gemfibrozil was reported to cause liver 
cancers in mice. 
One possible solution for reducing toxicity is to use herbal formulations 
rather than purified pharmaceuticals. Herbs have been used throughout the 
world for many conditions, including circulatory conditions, and there is 
at least some evidence that herbal remedies may tend to have less 
deleterious side effects than corresponding pharmaceuticals. 
There are, however, numerous problems encountered in using herbs in the 
treatment of medical conditions. One such difficulty is that a single herb 
may contain a multitude of active, and sometimes conflicting components. 
The common herb, rhubarb, for example, causes constipation in small doses 
because of its tannic acid component, but is a potent laxative in larger 
doses because of other components. Additional potential difficulties arise 
from plant-to-plant variation in the concentration and activity of active 
components. 
Moreover, the situation is considerably exacerbated with respect to herbal 
combinations. In addition to the above-mentioned problems, combinations 
raise the possibility of synergistic effects among components in the 
various herbs, and increase the difficulties associated with anticipating 
and analyzing side effects. 
Many herbs are reported to have substantial effects on the circulatory 
system. Herbs within this group include, for example, Ho Shou Wu (Polygoni 
multiflori radix), which reportedly decreases absorption of cholesterol 
from the intestines, Chrysanthemum (Chrysanthemi flos) and Hu-Zhang 
(Polgoni cuspidati rhizoma) which reportedly increase coronary 
circulation, Lotus leaf (Nelumbinis folium) which reportedly inhibits the 
elevation of total and free cholesterol, and Alisma (Alisma rhizoma) which 
reportedly improves hydrolysis of lipids. 
Many herbs are also reported to have substantial effects on the digestive 
tract. Herbs within this group include, for example, Crataegus (Crataegi 
fructus), which reportedly promotes digestion, Cassia Seed (Cassiae torae 
semen), which reportedly acts as a laxative, and Rhubarb (Rhei rhizoma), 
which reportedly promotes bowel movements and removes accumulation from 
the digestive tract. 
While many effects of individual herbs are known, it is often unclear in 
the art which herbs to combine, and in which percentages, to achieve 
improved results. It is especially unclear in the art which herbs, and in 
what combinations, one would combine the herbs to enhance reduction in 
serum cholesterol and triglyceride levels. 
III. SUMMARY OF THE INVENTION 
The present invention is directed to cholesterol and triglyceride reducing 
herbal combinations comprising (1) herbs having substantial recognized 
activity in enhancing circulatory function (ECF herbs) and (2) herbs 
having substantial recognized effects in promoting bowel motility (PBM 
herbs). 
Preferred combinations have a combined total of at least 16% (dry weight 
basis) of at least two ECF herbs in combination with a combined total of 
at least 16% (dry weight basis) of at least two PBM herbs. In particularly 
preferred combinations the ECF herbs are selected from Crataegus, Ho Shou 
Wu, Chrysanthemum, Lotus Leaf, Alisma and Hu-Zhang, and the PBM herbs are 
selected from Crataegus, Ho Shu Wu, Cassia Seed, and Rhubarb. 
Various objects, features, aspects, and advantages of the present invention 
will become more apparent from the following detailed description of 
preferred embodiments of the invention, along with the accompanying 
drawings.

V. DETAILED DESCRIPTION 
Referring first to FIG. 1, the table lists eight types of herbs which are 
contemplated to be included in one or more of the claimed combinations. 
Columns one through four provide basic identifying information for the 
various types of herbs, while columns five and six provide preferred 
combinations of those types. In particular, the first column sets forth 
common names of the herbs, the second column sets forth Latin names of a 
representative member of the respective genus, the third column sets forth 
the transliterated Chinese common names, the fourth column sets forth 
important medicinal characteristics of the herbs, the fifth column sets 
forth percentages of the herbs included in the most preferred combination, 
while the sixth column sets forth preferred ranges of herbs found in 
exemplary combinations. 
All formulation percentages herein are given as dry weight percent of the 
normally used medicinal part of the herb. The following descriptions 
further clarify the herbs listed in the table of FIG. 1. 
Crataegus is generally known in the West as hawthorn (Crataegus 
oxyacantha). Crataegi are usually encountered as a tree or a bush, and the 
normally used medicinal parts are the flowers and the fruit. The active 
principles are reported to be chlorogenic acid, caffeic acid, citric acid, 
crataegolic acid, malinic acid, ursolic acid. Crataegus is used to treat 
hypercholesterolemia, angina pectoris, and hypertension. Chinese medicine 
considers Crataegus to be useful in reducing food stagnancy and blood 
stasis. 
Ho Shou Wu is a perennial which grows one to three feet high. One species 
is known in the West as Solomon's Seal, and the normally used medicinal 
part of the plant is the rootstock. The active principles are reported to 
be chrysophenol, emodin, emodin methyl ester, rhein, and the glycoside 
rhaphantin. Ho Shou Wu has traditionally been used as a laxative which 
lowers plasma cholesterol by decreasing its absorption. 
Cassia is an annual plant of the Leguminosae family. The normally used 
medicinal part is the seed. Cassia seed is reported to contain many active 
substances, including chrysophenol, emodin, aloe emodin, rhein, physcion, 
obtusin, aurantioobtusin, chrysobtusin, rubrofusarin, norrubrofusarin, 
toralactone, obtusifolin, rubrofusarin gentiobioside, torachrysone, 
carotin and glycosides. Cassia seed has been used to treat 
hypercholesterolemia and hypertension. In traditional medicine, Cassia 
seed was used to remove "heat" from the liver, improve visual acuity, and 
as a laxative. 
Chrysanthemum is a common flowering plant, and the normally used medicinal 
part is the flower. The active substances are reported to be bornol, 
chrysanthenone and camphor. Chrysanthemum has been used to treat angina 
pectoris and hypertension and hypercholesterolemia. In China, 
chrysanthemum is used to clear the eye and the mind, as well as an 
antitoxin. Chrysanthemum is also widely used as a remedy for the common 
cold, headache, dizziness, red eyes, swelling, and hypertension. 
Lotus is a member of the family that includes the common water lily. The 
normally used medicinal part is the leaf, which is reported to contain 
several alkaloids including nuciferine, roemerine, O-nornuciferine, 
anonine, lirodenine, dihydronuciferine, anneparine, N-methylcoclaurine, 
and N-methylisococlaurine. Lotus leaf is used to disperse body heat and is 
said to increase essential body energies, in particular those of the 
defensive systems. The alkaloids said to have a relaxing effect on smooth 
muscles, and thus to lower blood pressure. 
Alisma is a perennial plant with small, white, umbrella-shaped flowers. The 
normally used medicinal part is the root or tuber. The active substances 
are reported to be triterpenoids, alisol A, B, and C, alisol monoacetate, 
sugars, Amino acids, and essential oil epialisol A. Alisma has been shown 
in clinical trials to lower plasma cholesterol levels, protect hepatic 
function, and increase the urinary excretion of Na, Cl, and urea. Alisma 
is said to affect hydrolysis of lipids and to decrease the formation of 
acetyl CoA. A combination of Crataegi fructus and Alisma rhizoma given to 
patients with hyperlipidemia produced significant decreases in serum 
cholesterol and triglyceride levels, along with an increase of HDL 
cholesterol. 
Hu-Zhang is a perennial bush with green, white and red flowers. The 
normally used medicinal parts are the stem and tuber. The active 
principles are said to include several glucosides, anthroquinones, 
flavonoids, and organic acids such as oxalic and tartaric. Hu-Zhang has 
been used medicinally to lower blood cholesterol levels, and to increase 
myocardial contractility and coronary circulation. 
Rhubarb is a perennial herb which is grown both for nutritive and 
ornamental purposes. The normally used medicinal part is the rootstock. 
The active components are anthraquinones and their monoglucoside 
derivatives, Dianthraquinones, Naphtalins, as well as gallic acid, 
glucogallin, rheum tannic acids, catechol, and cinnamic acid. Rhubarb can 
stimulate the secretion of bile acid, and the rhubarb polyglycosides can 
significantly decrease levels of serum and liver total cholesterol. 
Rhubarb has long been used in Chinese medicine to treat constipation, 
especially when due to high body temperature. It is also used in small 
doses to treat chronic diarrhea, indigestion, and acute intestinal 
infections, such as appendicitis and peritonitis, ileitis, and acute 
hepatic jaundice. Rhubarb is also effective in gallstone removal and in 
cholecystitis. As an adjuvant agent, Rhubarb is used as a hemostatic in 
hempotysis, ulcer hematemesis, ulceration of the oral mucosa, ulcerative 
wounds, and so forth. 
FIG. 2 is a table comparing especially preferred embodiments of the claimed 
combinations (CR-201 and variants) with modern anti-hyperlipidemia 
pharmaceutical combinations. The table is self explanatory. 
FIGS. 3 and 4 summarize experimental results of CR-201 (including 
experimental variants) in over a thousand human subjects. FIG. 3 shows 
reduction in mean serum triglyceride levels of about 45% (from 274.29 
mg/dl to 150.71 mg/dl) and reduction in mean serum cholesterol levels of 
about 18% (from 260.7 mg/dl to 212.6 mg/dl). 
The results set forth in FIGS. 3 and 4 strongly support the efficacy of 
CR-201 in reducing elevated serum triglyceride and cholesterol levels. The 
results also support the theory that a combination of herbs, some of which 
have substantial salutary effects on the circulatory system, and some of 
which primarily improve bowel motility, have an unexpectedly large 
positive effect on reducing serum triglyceride and cholesterol. Indeed, 
many combinations falling within these general guidelines are now expected 
to have similarly positive results. 
It is contemplated that the claimed herbal combinations can be taken 
according to any acceptable protocol. At present the preferred form for 
the CR-201 combination is tablets, although gelatin or gelatin-like 
capsules, tinctures and other forms of administration are entirely 
possible. Presumably the various forms would include appropriate binders, 
excipients, stabilizers, flavorings and so forth. 
Thus, while specific embodiments and applications of this invention have 
been shown and described, it would be apparent to those skilled in the art 
that many more modifications are possible without departing from the 
inventive concepts herein. The invention, therefore, is not to be 
restricted except in the spirit of the appended claims.