MXPA99003004A - Methods and compositions employing red yeast fermentation products - Google Patents

Abstract

Methods and compositions are disclosed which comprise red yeast fermentation products, that can be used as natural dietary supplements and/or medicaments for the treatment or prevention of hyperlipidemia and associated disorders and symptoms, such as cardiovascular diseases, cerebrovascular diseases, diabetes, hypertension, obesity, asthenic breathing, chronic headache, chest pain and tightness, limb swelling and distention, loss of appetite and excess expectoration. The methods and compositions are effective in lowering both the serum cholesterol and serum triglyceride levels in humans, and can be used for maintaining cardiovascular health. The invention also encompasses particular Monascus strains that yield fermentation products with the desired biological activities.

Description

METHODS AND COMPOSITIONS THAT USE PRODUCTS OF THE RED YEAST FERMENTATION 1. TECHNICAL FIELD The invention relates to compositions containing fermentation products of red yeast, which can be used as dietary supplements and / or therapeutic drugs. For example, the compositions can be used to reduce serum cholesterol and triglycerides in mammals. In addition, the invention relates to methods of treating cardiovascular disorders and other diseases using the red yeast fermentation products. In addition, the invention relates to the specific Monascus strains that produce the fermentation products with the desired biological activities. 2. BACKGROUND 2.1 RED YEAST AND ITS USES In general, red yeast (known in China as Hung-ch'u or Hogqu) has been known and used for hundreds of years in China in the production of rice wine and as a food preservative. . In addition, red yeast has been known for hundreds of years as an ancient Chinese medicine or an ingredient in certain ancient Chinese prescriptions; however, red yeast is best known for its use in foods as a preservative and colorant, and its uses in the dye industry. Red yeast is a mixture of different species of Monascus fungi, particularly Monascus purpureus. (Went, 1985, Ann Sci Nat Bot Ser, 8: 1: 1; Young, 1930, Trans Wisc Acad Sci Art Lett, 25: 227-244). The fungus genus Monascus was first described in 1884 by Van Tieghe (Van Tieghe 1884, Bull Soc Bot France, 31: 226). The fungus was initially known to the western world as a contaminant in cereals, starch and silage. A detailed description of the medical applications of red yeast was provided in the pharmacopoeia of ancient China, Pen Ts'ao Kang Mu, was published during the Ming Dynasty (1368-1644). In the Pen Ts'ao Kang Mu pharmacopoeia, which is still printed, red yeast is described as moderate, non-toxic and useful for the treatment of indigestion and diarrhea. Red yeast is also described as useful to improve blood circulation, and promote the health of spleen and stomach. In addition, various 'prescriptions' that use red yeast for the treatment of ailments], such as indigestion, diarrhea, and cardiac and abdominal pain, are also provided in this ancestral treatment.In an abbreviated English translation of Pen Ts'ao Kang Mu published in 1911, for red yeast is described as useful for fermentation and with medicinal value in the treatment of postpartum difficulties in women and dyspeptic conditions in children (Stuart, MD, in 'Chinase Materia Medica -Vegetable Kingdo', page 233-234, republished in 1979 by Southern Materials Center, Inc., Taipei, Republic of China). Red yeast, as described in Pen Ts'ao Kang Mu, was later recognized as the fungal species known as Monascus purpureus Went (Read BE, 1936, Chinase Medicinal Plants from the Pen Ts'ao Kang Mu 3rd edition, published by Peking National History Bulletin, Klein, G., 1932, Hanbuch der Pflanzenanalyse II, pp. 1422-1423, Wien, Verlag von Julius Springer). The manufacture of red yeast is considered in another publication of the Ming Dynasty, T'ien Kung K 'ai Wu by Sung Ying-Hsing, which was published in 1637 A.D. (see, pages 291-294) in the English translation of this ancient writing, T'ien Kung K 'ai Wu - "technology in the seventeenth century", translated by E-tu Zen Sun and Shiou-Chuan Sun, The Pensylvania State University Press 1966) Red yeast is described here as being useful for preserving the color and flavor of fish or meat.The manufacturing process uses red grape pulp and non-glutinous rice cooked as starting materials. Red yeast allowing the fungus to grow on the surface of cooked rice was also recorded by Voderman (1894, Analecta ob Cromatologisch Gebied. II. Geneesh Fydschrift voor Ned. Indie, 35, No.5). At present, red yeast, which is still the product of fermentation of Monascus species, is still used in traditional Chinese medicine, winemaking and food coloration in Asia and Asian communities in North America. The red and yellow pigments of Monascus Purpureus, such as monascorubin and monascin, have been purified and widely studied (Fielding et al., 1961, J Chem Soc, 4579-4589). The culture conditions and their effect on the pigmentation of Monascus Purpureus have also been studied (Broder et al., 1980, J Food Sci, 45: 567-469). The antibacterial activity, especially against Bacillus species, was also detected in the extract of Monascus purpureus (Wong, 1977, Plant Physiol, 60: 578-581). However, before the present invention, the extraordinarily broad medicinal spectrum and nutritional benefits of red yeast in general, and certain species in particular, have not been perfectly studied or appreciated. 2. 2 HYPERLIPIDEMIA AND INTERVENTION IN THE DIET Lipids and lipoproteins play an essential role in the transport of metabolites derived from fat between organs for absorption, metabolism and distribution (Feling et al., 1975, N End J Med, 293: 1078 - 1084). Susceptibility to diet-induced elevations in blood lipids including cholesterol is extremely common. The interaction of genetic predisposition and a diet high in fat and calories coupled with low activity can lead to heart disease, hypertension, hypertriglyceridemia and diabetes in a significant proportion of the population of the United States. The high level of serum cholesterol is an important risk factor for coronary artery disease. Cholesterol is a major component of atherosclerotic plaque. Other associated lipid abnormalities, including hypertriglyceridemia, especially in the presence of reduced HDL cholesterol levels, have been recognized as contributing to the risk of cardiovascular disease. There is a reciprocal relationship between high levels of triglycerides and reduced levels of HDL. The level of cholesterol in the circulation results from the balance between the production of apoB-100 particles and their elimination from circulation. Cholesterol is synthesized from acetyl-CoA by a series of more than 20 enzymatic reactions. This biosynthetic route is mainly regulated by the activity of HMG-CoA reductase (hydroxy ethylglutaryl coenzyme A reductase), which catalyzes the reduction of HMG-CoA mevalonate. Since most circulating cholesterol is synthesized endogenously in the liver and does not come from dietary cholesterol, enzyme inhibitors that are involved in cholesterol biosynthesis have been explored as the drug for the treatment of hypercholesterolemia (Grundy 1988, New Eng J Med, 319: 24-33). A class of compounds inhibits cholesterol biosynthesis by competing with a natural substrate, HMG-CoA (hydroxymethylglutaryl coenzyme A), for the key enzyme in the cholesterol biosynthetic pathway, HMG-CoA reductase. The first of these hypocholesterolemic compounds discovered was compactin, which was isolated from Penicilli um ci trinum cultures by Akira Endo (Endo et al., 1975, J Antibiotics, 29: 1346-1348, see also US Pat. Nos. 3,983,140, 4,049,495, 4,137,322). The hypocholesterolemic activity of this compound was demonstrated in various species of animals (Tsujita et al., 1979, Atherosclerosis, 32: 307-313). Next, a hypocholesterolemic compound structurally related to compactin was independently discovered by Endo in fermentation products Monascus ruber (the active compound was named monacolin K; Endo, 1979, J Antibiotics, 32: 852-854; Endo, 1980, J Antibiotics, 33 : 334-336, see also German patents DE 3051175, 3051099 and 3006216, British patent GB 2046737 and 2055100), and another culture group of Aspergillus terreus. The active compound was also named mevinolin, lovastatin, or Mevacor®; Tobert et al., 1982, J Clin Invest 69: 913-919), and has been available in the United States since 1987 as a prescription medication. The efficacy and long-term adverse effect of this active compound have been revised (Tobert, Am J Cardiol, 62: 28J-34J). The active compound isolated, its derivatives and methods of production of Aspergillus have been reported; see, U.S. Patent Nos. 4,231,938, 4,342,767, 4,294,926, 4,319,039, 4,294,926, 4,294,846, and 4,420,491. Although monacolin K or mevinolin have been used successfully to treat hypercholesterolemia, the compound has little or no effect on the serum level of the triglycerides. Other lipid regulating agents that have been used to treat hypertriglyceridemia, especially type IV and V hyperlipidemia, include nicotinic acid (e.g., niacin), and fibric acid derivatives (e.g., gemfibrozil and clofibrate). However, the uses of these agents are restricted due to their side effects, for example, high dose of niacin can cause gastric irratibility, hyperuricemia, hyperglycemia, pruritus, and genfibrosil can cause malignancy, gallbladder diseases and abdominal pain. In addition, the risk of myositis and rhabdomyolysis that can lead to increases in renal impairment when monacolin K is combined with gemfibrozil, clofibrate or niacin. These combinations are only used with careful supervision in special situations that guarantee risk (The Merck Manual 1922, 16th edition, pages 1044-1046). Since high concentrations of serum triglycerides are known to be a risk factor for a variety of disease states and can lead to medical complications. Thus, there is a need for the development of a composition that achieves the reduction of cholesterol serum levels as well as triglycerides. Regular exercise and healthy nutrition to achieve desirable body weights can prevent or reduce the incidence of common chronic diseases such as heart disease associated with elevated blood lipids (1991, Pi-Sunyer, Am J Clin Nutr, 53: 1995S-1603S ). The function of the diet in maintaining optimum health and even in slowing down or reversing the progression of disease or undesirable state, has been the subject of research and public attention. The development of an effective dietary supplement for use in the treatment of combined hyperlipidemia would be a significant benefit for the health of Americans to improve the results that would be obtained only with the diet. 3. SUMMARY OF THE INVENTION The invention relates to a product of the fermentation of at least one Monascus species that can be used as a dietary supplement to a therapeutic drug to reduce serum cholesterol and triglyceride levels in humans. The invention is based, in part, on the surprising discovery that red yeast, ie, the product of the fermentation of certain strains or mixtures of Monascus strains, is effective in reducing not only serum cholesterol level, but also also the level of serum triglycerides in mammals, particularly humans. Since monacolin K or mevinolin are known not to be significantly effective in reducing the level of serum triglycerides, the beneficial effect of red yeast products must be related to other components in the ferment. In different embodiments of the invention, the red yeast may be used as a natural dietary supplement or a medicine to treat or prevent a series of diseases, including, but not limited to, cardiovascular diseases, diabetes, fatty liver conditions, infarction, cerebral thrombosis, hypotension, hypertension and obesity, and to modulate levels of circulating lipids, such as cholesterol and triglycerides. In addition, the present invention comprises methods for the treatment or prevention of these diseases in a human, which comprise the administration to the human of a therapeutically effective amount of a product of the red yeast fermentation. The present invention also encompasses methods for improving or maintaining cardiovascular health in a human, which consists of administering to the human being an effective amount of the red yeast fermentation product. The. present invention further, comprises methods for reducing serum cholesterol and serum triglyceride levels to normal levels in a human, consisting of administering to a human a therapeutically effective amount of a red yeast fermentation product. Red yeast can also be used to treat or prevent a series of ailments or symptoms related to diseases of the cardiovascular system. According to the invention, the red yeast can be manufactured in different dosage forms and formulations. Also, the methods for the manufacture of red yeast are described, which are based on the traditional processes of fermentation. 4. DETAILED DESCRIPTION OF THE INVENTION In one embodiment, the invention relates to compositions containing the product of the fermentation of at least one species of Monascus. These compositions are useful for reducing serum cholesterol and serum triglyceride levels in mammals, and in particular humans. In addition, the compositions are useful for modulating serum cholesterol and triglyceride levels to maintain healthy levels despite intrinsic (age) or extrinsic (stress) factors that affect serum cholesterol and triglyceride levels. The compositions and methods of the present invention are based, in part, on the discovery that the fermentation of Monascus species shows hypocholesterolemic properties and, also unexpectedly, the ability to reduce serum triglyceride levels. Since monacolin K is known to not significantly reduce the level of triglycerides in serum, the beneficial effect of red yeast products must be related to other fermented components. The ability of red yeast products to reduce the level of serum triglycerides provides the technique with a unique, natural alternative to the use of prescription hypocholesterolemic compounds. The terms' red yeast fungi 'or * Monascus' as used herein refer to the pre-fermented organism, while the terms' red yeast', 'red yeast product', 'red yeast extract' and the like it refers to a product that results from the fermentation of at least one Monascus, in addition, the latter terms include the traditional and improved red yeast products, as described below.More specifically, 'red yeast product', as used herein, it refers to the product of fermentation, for example, fermentation, of one or a mixture of Monascus fungi. In addition, the red yeast product is the product of the fermentation of at least one of the following Monascus fungi: Monascus albidus, Monascus anka, Monascus araneous, Monascus aurantiacus, Monascus bakeri Dangerd, Monascus fuliginosus, Monascus kaoliang, Monascus major, Monascus paxii , Monascus pilosus, Monascus pubigerus, Monascus purpureus, Monascus ruber, Monascus rubiginosus, Monascus rubropunctatus, and Monascus serorubescens. In a preferred embodiment of the invention, the red yeast is the fermentation product of a mixture of fungi Monascus, which contains mainly Monascus purpureus Went, and in minor proportions other species of Monascus, for example, preferably, Monascus ruber van Tieghem, Monascus Fuliginosus Sato, Monascus Pilosus Sato and Monascus albidus Sato. In a more preferred aspect, the red yeast is the fermentation product of at least one of the following strains of Monascus fungi: Monascus purpureus Went ATCC 30141, AS 3,562, AS 3,991, AS 3,4446 [ATCC 16365], AS 3.4642 [ NRRL 2897], AS 3.4643 [NRRL 96], AS 3.4644, AS 3.4645, AS. 3.4651, Monascus ruber van Ti eghem AS 3,549, IFFI 05007, IFFI 05008, IFFI 05010, IFFI 05011 and Monascus anca IFFI 05038 (reference numbers provided in the Chinese culture catalog, 1992, China Co mittee for Culture Collection of Microorganism, China Machine Press, Beijing 1992); and Monascus Purpureus Went mutant strain M4027, 4028 and M4184. The term 'traditional red yeast' as used herein refers to a red yeast product which is the result of fermentation using a mixture of Monascus fungi which has traditionally been used for the manufacture of red yeast. invention, an 'improved red yeast' is produced by fermentation using one or more natural strains or mutants of the Monascus species, which produce a fermented with improved biological or nutritional properties, for example, higher hypocholesterolemic and hypotriglyceridemic activity than red yeast traditional. In general, the red yeast products of the present invention are red-purple powders that have a slightly bitter but mild and pleasant taste. In the same way, red yeast products have a pleasant smell. The color and / or smell may vary with the fermentation process, the strains used and the processing steps. According to the invention, the traditional or improved red yeast can be prepared by traditional fermentation processes or by modification of the traditional methods. According to the method first reported (Sung, 1637, T'ien Kung K'ai Wu; page 291-294, English translation by Sun et al., The Pennsylvania State Press 1966), red yeast can be prepared by fermentation of washed and cooked, non-glutinous rice using red grape pulp, natural juice of Polygonum grass, and solution of water and alum. The rice is fermented in the open for 7 days on bamboo trays under very clean conditions. The rice changes its color from white to black, from black to brown, from coffee to red and then from red to yellow, which is then harvested as red yeast. According to an alternative traditional method, non-glutinous rice can be fermented into a hole in the bamboo-covered soil, which is perfectly covered. The fermentation is allowed to take place for a year or more, up to four years. With respect to the present invention, the traditional method has been improved by the use of modern fermentation techniques and equipment to more accurately control the temperature, pH, pressure and other parameters of the fermentation, which, inter alia, reduce the time of fermentation. By way of example, and not as limitation, the improved red yeast of the invention can be prepared as follows: culture medium containing 2% bean juice, 4% sugar, 0.5% yeast added to the rice (40- 80 ml x 100 g) and sterilized by heat, while the pH is maintained at pH 3 to 8. The fungi of red yeast Monascus purpureus Went strain M4184 are added and cultured at 15-35 ° C for 9 days. At the end of the fermentation process, the fermentation broth is drained and discarded while the solid residue is sterilized by heat (for example, by high pressure steam), dried and ground into a powder. This powder can be used directly in different compositions and formulations provided by the present invention. Otherwise, the red dry-crushed yeast powder can be further processed, for example, extracted with organic solvents, such as, but not limited to, ethanol (75%) to remove the starch and / or agar. After evaporation to dryness, the extract can be used in different compositions and formulations as provided by the present invention. However, the isolation or purification of the specific components of the product is not desirable or contemplated in the present invention. In the different embodiments of the invention, the red yeast can be used as a natural dietary supplement or a pharmaceutical drug to maintain health or treat or prevent a series of diseases including but not limited to cardiovascular diseases, diabetes, infarction, hypertension and obesity, and to modulate levels of circulating lipids and lipoproteins, such as cholesterol and triglycerides. The red yeast can also be used to treat or prevent a series of symptoms related to these diseases mentioned above and associated with cardiovascular health due to age and other intrinsic and extrinsic factors. As used herein, examples of cardiovascular diseases may include, but are not limited to, myocardial infarction, coronary heart disease, atherosclerosis, arteriosclerosis. The present invention includes the treatment or prevention of cardiovascular diseases such as infarction, loss of memory due to infarction and cerebral thrombosis.

The present invention also comprises a composition containing a therapeutically effective amount of a red yeast product, eg, 2-4 grams per day, useful in humans for the treatment or prevention of hyperlipidemic disease, cardiovascular disease, cerebrovascular disease, hypertension , hypotension, diabetes, adipose liver conditions. or obesity, or a combination thereof. The present invention further comprises a composition containing a therapeutically effective amount of a red yeast product, useful for the modulation of serum lipids and lipoproteins in a human in need of therapy to maintain lipid and lipoprotein levels within a healthy normal range. In one embodiment of the invention, the composition is adapted for use in the treatment or prevention of hypertriglyceridemia. In a preferred embodiment, this composition is used to reduce serum cholesterol and serum triglyceride levels in humans. The present invention further comprises a composition containing a therapeutically effective amount of the improved red yeast product, useful for the treatment of any of the following symptoms: respiratory failure, asthenic respiration, lethargy, vertigo, chronic head pain, chest pain and tension, anguish, loss of appetite, swelling of limbs, tension and distension and excess expectoration. The phrase "'therapeutically effective amount" as used herein means an amount sufficient to provide a therapeutic benefit in the treatment or prevention of the disease, or in the level of serum lipids and lipoproteins. 4. 1 METHODS OF TREATMENT The present invention provides methods for the treatment of a human affected by a variety of disease, disorder or symptoms [sic]. In addition to the treatment of a human disease, the methods of the invention can also be used for prevention in a human susceptible to such diseases, disorders or symptoms. In one embodiment, the invention comprises the methods of treating hyperlipidemic disease, cardiovascular disease, cerebrovascular disease, hypertension (hereditary and non-hereditary), hypotension, angina, infarction, diabetes, fatty liver conditions, or obesity, or a combination thereof in a human, which consists of administering to the human a therapeutically effective amount of a red yeast product, or compositions containing such a product.

In another embodiment, the invention comprises the methods of preventing hyperlipidemic disease, cardiovascular disease, cerebrovascular disease, hypertension, hypotension, angina, infarction, diabetes, fatty liver conditions such as fatty deposits in the liver, obesity or a combination thereof. , which consists of administering an effective amount of a red yeast product of the present invention. In a preferred embodiment, the method of the invention is used to treat or prevent hypertriglyceridemia and associated diseases, such as hyperuricemia, pancreatitis and diabetes, in a human. As used herein, examples of cardiovascular diseases may include myocardial infarction, coronary heart disease, atherosclerosis, arteriosclerosis; and cerebrovascular diseases or conditions that include infarction, cerebral thrombosis or loss of memory due to infarction. The present invention also provides methods for modulating lipid and lipoprotein levels in serum, in a human in need of reducing the levels of lipids and lipoproteins to a healthy normal range, which consists of administering to humans a therapeutically effective amount of a product of red yeast, or compositions containing such a product. In a preferred embodiment, the method of the invention is used to reduce serum cholesterol and serum triglyceride levels in a human. The methods of the invention are particularly useful for the treatment of geriatric patients and women after menopause. The present invention also provides methods for the treatment of a human affected by respiratory failure, asthenic respiration, lethargy, dizziness, chronic headache, loss of appetite, swelling of limbs, tension and distension, abdominal distention and excess expectoration or a combination thereof, which consists of administering to a human a therapeutically effective amount of a red yeast product, or the compositions containing this product. The preventive or therapeutic dose of traditional red yeast or improved red yeast in the treatment or prevention of diseases and in the management of serum lipids and lipoproteins will vary with the condition in question and the severity of the condition that will be treated. The dose, and perhaps the frequency of the dose, will also vary according to the age, body weight and response of the individual patient. In general, the range of the total daily dose of red yeast, for the conditions described herein, is from about 0.1 g to about 5 g administered orally in single or divided doses. For example, a preferred range of oral daily dose should be from about 0.3 g to about 4 g, while an oral daily dose of about 1.2 to about 2.5 g is more preferable. For example, two capsules each containing 0.6 g of red yeast should be taken orally twice a day to obtain the preferred dose. A course of treatment should be at least 4 weeks. It may be necessary to use doses outside these ranges in some cases, as will be apparent to those skilled in the art. In addition, it should be noted that the nutritionist, dietician, clinician or general practitioner will know how and when to interrupt, adjust or terminate the therapy in relation to the response of the individual patient. It should be noted that the present invention comprises new uses of traditional red yeast and novel red yeast products and novel methods for the use of these products. 4. 1.1 USE AS A DIETETIC COMPLEMENT As already mentioned, the present invention comprises the compositions and methods of using the traditional and novel or improved red yeast products as dietary supplements. As such, the red yeast products provide the individual with a means to maintain normal or healthy levels of cholesterol and triglycerides in serum despite the intrinsic deterioration, for example, of aging and extrinsic factors such as stress, lack of exercise or poor nutrition. Dietary supplements also provide a means to prevent, or reduce the likelihood of experiencing, the diseases described above. Finally, dietary supplements can be used to prevent weight gain or obesity. Finally, dietary supplements containing red yeast products are particularly useful for women in the aging and postmenopausal stages. Dietary supplements should be taken daily for at least four weeks and can be used permanently and daily. A daily dose is from about 0.1 g to about 5.0 g, preferably about 1 to about 4 g; and more preferably about 1.2 to about 2.4 grams per day. 4. 2 FORMULATIONS The pharmaceutical and dietetic compositions of the present invention comprise a red yeast product, or an extract thereof, as an active ingredient, and may also contain a pharmaceutically acceptable carrier or excipient, and optionally other ingredients.

Other ingredients that can be incorporated into the dietetic or pharmaceutical compositions of the present invention may include, but are not limited to, vitamins, amino acids, metal salts and flavor improvers. For oral administration, compositions containing red yeast can be added directly to the food so that a therapeutically effective amount of red yeast is ingested during normal meals. Any of the methods known to those skilled in the art can be used to add or incorporate red yeast to natural or processed foods. The compositions of the present invention suitable for oral administration can be presented as small units such as capsules, tablets or tablets, each with a content of a predetermined amount of a red yeast product, such as powder or granules, or as a solution or a suspension in an aqueous liquid, a non-aqueous liquid, an oil-in-water emulsion or a water-in-oil liquid emulsion. In general, the compositions are prepared by uniformly and intimately admixing the active ingredient with liquid carriers or finely divided solid carriers or both, and then, if necessary, shaping the product into the desired presentation.

The compositions of the present invention may further include binding agents, (eg, pregelatinized maize starch, polyvinylpyrrolidone or hydroxypropylmethylcellulose); binders or fillers (for example, lactose, pentosana, microcrystalline cellulose or calcium acid phosphate); lubricants, (for example, magnesium stearate, talc or silica); disintegrants (e.g., potato starch or sodium starch glycolate); or wetting agents (e.g., sodium lauryl sulfate). Tablets or capsules can be covered by methods well known in the art. Liquid preparations for oral administration may take the form of, for example, solutions, syrups or suspensions, or they may be presented as a dry product for constitution with water or other suitable vehicle before use. These liquid preparations can be prepared by conventional means with pharmaceutically acceptable additives as suspending agents (for example, sorbitol syrup, cellulose derivatives or hydrogenated edible fats); emulsifying agents (for example, lecithin or acacia); non-aqueous vehicles (e.g., almond oil, oily esters, ethyl alcohol or fractionated vegetable oils); and preservatives (e.g., methyl or propyl p-hydroxybenzoates or sorbic acid) the preparations can also be made to resemble foods, containing buffer salts, flavors, colorants and sweetening agents as appropriate. Any dosage form can be employed to provide the patient with an effective dose of the red yeast product. Dosage forms include tablets, capsules, dispersions, suspensions, solutions, capsules and the like. Because of their ease of administration, tablets and capsules represent the most advantageous oral dosage unit form, in which case the solid pharmaceutical carriers are employed as already described. In addition to the common dosage forms set forth above, the compounds of the present invention may also be administered by controlled release means. However, the most preferred oral solid preparations are capsules. For example, a tablet can be prepared by compression or molding, optionally, with one or more auxiliary ingredients. Compressed tablets can be prepared by compressing in a suitable machine red yeast in a free-flowing form such as powder or granules, optionally mixed with the binder, lubricant, inert diluent, surface active agent or dispersant. More preferably, the composition is a capsule containing 0.3 g of red yeast in powder form. The invention is further defined by reference to the following examples which describe in detail the human clinical tests performed to study the efficacy and safety of red yeast. It will be apparent to those skilled in the art that many modifications, to materials and methods, may be practiced, which are within the scope of this invention.

PHARMACOLOGY AND TOXICOLOGY The red yeast pharmacological and toxicological studies of the present invention were performed in experimental animal models. It was shown that red yeast drastically decreases total cholesterol (CT) in serum of endogenous hyperlipidemic rabbits; markedly decreases TC and total triglycerides (TG) of exogenous hyperlipidemic rabbits; the inhibition of arteriosclerosis plaque formation and lipid deposition in liver in hyperlipidemic rabbits; and the decrease of CT and TG in serum of hyperlipidemic quail. In acute toxicity studies, an LD5o value could not be determined. The highest tolerance dose of red yeast in mice is about 16 g / kg, which is 533 times the dose used in clinical treatment.

In addition, in other experiments, rats were subjected to continuous forced feeding of red yeast for 4 months; No rat died or showed symptoms of toxicity due to this medication. The haematological indices, indexes of the main viscera, blood biological indexes, routine uroscopy, and pathological examination showed no difference between experimental groups and control groups. 6 EXAMPLES The following sections contain the methodologies and results of two human clinical trials that were conducted in China. The tests were directed to determine the efficacy of a red yeast product in the modulation of circulating serum lipids and lipoproteins, in humans, in the resolution of symptoms according to traditional Chinese medicine, and in - establishing safety of a red yeast product. 6. 1 CLINICAL TRIAL I In this clinical trial in humans, at random, 446 patients with hyperlipidemia, who were diagnosed with hypofunction and spleen disorder and excess speculation by traditional Chinese medicine were divided into two treatment groups. One group with 324 patients received Xuezhikang capsules, and the other control group with 122 patients received Jiaogulan tablets. The Xuezhikang capsule contains 0.3 g of a red yeast product. The Jiaogulan tablet is a lipid-regulating medication (gynostemma pentaphyllum) that is based on traditional Chinese herbal medicine. 6. 1.1 METHODOLOGY 6.1.1.1 CRITERIA FOR THE SELECTION OF PATIENTS All patients with primary hyperlipidemia who were interrupted the use of lipid modulators in serum two to four weeks before the start of the test and received advice for their diet. The serum sample was taken and the laboratory test was performed. Only patients who met the following criteria were entered into the test: total serum cholesterol (CT) > 230 mg / dL (5.95 mmol / L) and triglycerides (TG) > 200 mg / dl (> 2.26 mmol / L / L). The density lipoprotein cholesterol 'high (HDL-C) was also considered as a reference: men < 40 mg / dL (1.04 mmol / L), women < 45 mg / dl (1.16 mmol / L). All the patients were diagnosed as deficient in the function of the spleen and with an excess of expectoration by the traditional Chinese medicine. The patients also had the following symptoms: weakness of limbs, asthenic respiration, pain and tightness in the chest, loss of appetite, distension and swelling in the gastric region, whitish or purple spots on the tongue, thick white tartar or viscous thick in the tongue, tense or weak pulse. Patients who had the following disorders or disease were excluded from the test: myocardial infarction, cerebrovascular disease, severe wound or major surgery during the past 6 months, nephritic syndrome, hypothyroidism, acute and / or chronic hepatobiliary disorder, diabetes, gout, general allergic reactions and psychosis. The total number of patients admitted to the trial was 446. In the treated group there were 188 male patients and 126 female patients. The ratio of men to women was 1.38: 1 and the average age was 56.0 +/- 9 years. In the control group there were 73 male patients and 45 female patients. The ratio of men to women was 1.49: 1 and the average age was 56.4 +/- 9 years. 6. 1.1.2 TREATMENT PROTOCOL The treated group took Xuezhikan capsules orally, twice a day for 8 weeks. The control group took three tablets of Jiaogulan twice a day for 8 weeks. All patients maintained the same lifestyle and habits as before.

The following tests were performed at 4 weeks, and at 8 weeks after the start of the test: weight, blood pressure, heart rate, electrocardiogram and routine physical examination. The following parameters were monitored by laboratory tests: blood urea nitrogen (BLTN), creatinine, serum glutamic pyruvate transaminase (SGPT, ALT), serum glucose and creatinine kinase (CK). To determine serum lipid and lipoprotein levels, venous blood samples were taken from patients who were asked to fast for 12 hours and not to consume alcoholic beverages or high-fat foods at the last meal. The serum obtained from the patients was separated immediately and stored at -20 ° C during the analysis. CT, GT and HDL-C were analyzed, and the LDL-C value was calculated according to the formula: LDL-C = CT-HDL-C - (TG / 2.2). ' 6. 1.1.3 EFFECTIVENESS Efficacy was evaluated according to the criteria established in 'Clinical trial management: hyperlipidemis treatment using new Chinese medical material' avoided by the Ministry of Health of China as follows: 1. Cure: All symptoms were eliminated, or a reduction in the registration of the total symptom by more than 90%, and a return of all laboratory test parameters to normal 2. Effective: The symptoms were significantly relieved, that is, the symptom registration was reduced by 70% -89% The lipids and lipoproteins in serum did not reach normal, but were improved in one of the following aspects: 1) reduction of CT> 20%, 2) reduction of TG> 40%, 3) reduction of ( CT-HDL-C) / HDL-C> 20%, 4) HDL-C> 10 mg / dl increase 3. Improvement: Symptoms were released, ie the symptom registration was reduced by 30% - 69% The levels of lipids and lipoproteins in serum were not normal but were improved in one of the following aspects: 1) reduction of CT to 10% -20%, 2) reduction of TG > 20% but < 40%, 3) reduction (CT-HDL-C) / HDL-C > 10% but < 20%, 4) increase HDL-C > 4 mg / dl (0.14 mmol / L but <10 mg / dl) 4. Inefficacy: Symptoms were reduced by less than 30%, and the parameters of the laboratory test did not meet the effectiveness criteria. Data were subjected to statistical analysis, the Student test was used in the measurement data, the Chi-square test to count the data, the Ridit test for stratum data and the U diagram for the analysis of the percentiles.

Table 1: Comparison of Efficiency Radit analysis: u = 10.04, p < 0.001 Table 2: Comparison of lipid and lipoprotein levels in serum after treatment Note: (+) indicates increment, (-) indicates decrease *: p, 0.01, **: p < 0.001 vs. baseline +: p < 0.05; ++: p < 0.01; +++: p < 0.001 vs. control 6. 1.2 RESULTS Table 1 shows a comparison of the total efficacy in which the record of the treated group was much higher than in the control group (X2 = 9.7, P <0.001). The percentage of patients in the treated group, who reported the elimination of the symptoms diagnosed by traditional Chinese medicine, was much higher than in the control group (P <0.05 - 0.001). These symptoms were: condition of the tongue (whitish or purple spots on the tongue; thick, viscous tartar); pulse (tense or weak), feeling of tightness in the chest; loss of appetite; abdominal distension and swelling. With regard to the level of lipids and lipoproteins in serum, the efficacy records to cure or reduce the total level of serum cholesterol and total triglycerides in the treated group were higher than in the control group.

The registry to normalize or increase the level of HDL-C and the registry to reduce the rate of atherosclerosis in the -group treated were also much better than the control (P <0.001). Table 2 indicates that the groups treated with Xuezhikang and the control showed markedly desirable changes in levels of CT, TG, (CT-HDL-C) / HDL-C, serum levels of HDL-C markedly [sic]. The effectiveness of Xuezhikang was higher than that of Jiaogulan.

It was also observed that the higher the baseline CT and TG in serum, the more effective the reduction of CT and TG after using Xuezhikang. As for the HDL-C level, a greater increase was observed after treatment in patients who had a lower initial baseline.

Table 3: Effects of Xuezhikang capsule in patients with different abnormal levels of serum lipids and proteins. lA (0) indicates the increase in value (-U-) indicates decrease in value * P < 0.01; ** P < 0.001 v baseline Table 4: Xuezhikang capsule effect on apoA-I and apoB (average + S) •"4 (1) P < 0.05; (2) P < 0.01; (3) P < 0.001; vs. baseline (4) P < 0.05; (5) P < 0.05; vs. control 3d With respect to the effect of Xuezhikang on apolipoprotein A-I (apoA-I) and apolipoprotein B (apoB), serum levels of apoA-I in both groups were elevated after * therapy. The statistical results show a significant difference in apoA-I levels after a four-week treatment. The levels of apoB were somewhat reduced in both groups, however, these reductions are not statistically significant. The treated group showed greater improvement of apolipoprotein B and apoA-I / apoB over the control. With regard to rheology, there were significant changes in blood sedimentation and the value in both groups after treatment (P <0.05-0.01). However, the treated group showed better results than the control group (P <0.05-0.01). All 446 patients underwent the following laboratory tests before and after therapy: nitrogen in. blood urea (BUN), creatinine, serum pyruvic glutamic transaminase (SGPT, ALT), serum glucose and creatinine kinase (CK), and routine blood and urine tests. No clinically significant change was found at the end of the test. Some patients developed a burning sensation in the stomach (six patients, 1.8%), experienced fullness in the stomach (three patients, 0.9%), and suffered vertigo, (one patient, 0.3%). All had finished the test, and all symptoms were released spontaneously without treatment. Two patients suffered gastritis after taking Xuezhikang and had to leave the test. The results all suggest that Xuezhikang is a safe medication. 6. 1.3 ANALYSIS In this test, a known lipid regulating agent in traditional Chinese medicine was used as a positive control. Between the two groups, there was no difference (P> 0.05) found in the parameters of the baseline including age, sex and course of the disease, serum lipids and lipoprotein levels. The efficacy record in the group treated with Xuezhinkang was much higher than in the control group (P <0.001). Comparing the baseline in the group treated with Xuezhikang, the serum level of high density lipoprotein cholesterol was elevated by 19.6% and the total cholesterol, total triglycerides, low density lipoprotein cholesterol and the atherosclerosis index were reduced by 23%, 36.5%, 28.5% and 34.2%, respectively. It was also observed that the higher the abnormality of the level of lipids and lipoproteins in serum, the more drastic modulation of lipid and lipoprotein levels can be achieved by Xuezhikang therapy.

Xuezhikang can also reduce the level of apolipoprotein B, blood sedimentation and the K value of blood sedimentation. In general, the results show that red yeast is a safe, effective agent for modulating the levels of lipids and lipoproteins in serum. Red yeast can also be used as a therapeutic agent for coronary artery disease and cerebrovascular disease caused by hyperlipidemia and / or atirosis [sic] because red yeast not only significantly reduces TC, TG and the rate of atherosclerosis in plasma, but also markedly increases the level of apolipoprotein AI in plasma. 6. 2 CLINICAL TEST II In this clinical trial, 84 patients with hyperlipidemia and 56 patients who were also diagnosed with atherosclerosis were divided into two treatment groups: a group treated with Xuezhikang capsule and a control group treated with Jiaogulan tablet. 6. 2.1 METHODOLOGY 6.2.1.1 CRITERIA FOR THE SELECTION OF PATIENTS All patients were diagnosed as hyperlipidemic following the criteria established in 'Clinical trial management: hyperlipidemia treatment using new Chínese materia medica' published by the Ministry of Health of China. Regarding diet for 2 to 4 weeks, patients with abnormal lipids and lipoproteins were bled twice two weeks before the test Only patients who met the following criteria were entered into the test: total serum cholesterol (CT)> 230 mg / dl (5.95 mmol / l) and triglycerides (TG)> 200 mg / dl (> 2.26 mmol / L) High density lipoprotein cholesterol (HDL-C) was also considered as a reference: men <40 mg / dL (1.04 mmol / L), women <45 mg / dL (1.16 mmol / L) Patients who presented phlegm stagnation caused by deficiency in spleen function were also selected The symptoms included: tension in the limbs, asthenic breathing, pain and feeling of tightness in the chest, loss of appetite, distension and swelling in the gastric region, whitish or purple spots on the tongue, thick white tartar or thick glutinous the tongue, pulse tense and weak. 6. 2.1.2 CLASSIFICATION FOR CLINICAL SYMPTOMS The severity of symptoms as recognized by traditional Chinese medicine was classified as follows: asthenic respiration OR none (-) without asthenic respiration 2 light (+) asthenic respiration with moderate physical activity (++) ) with asthenic respiration medium with physical activity 4 severe (+++) with asthenic breathing at rest tension in the limbs 0 none (-) without tension in the limbs 2 light (+) with occasional tension in the limbs 3 moderate (+) + with medium tension in the limbs frequently 4 severe (+++) with severe tension in the limbs tension and pain in the chest 0 none (-) without tension and pain in the chest 2 light (+) with tension in the chest and occasionally moderate pain (++ with medium tension in chest and severe very frequent pain (+++) with severe tension in chest and pain at rest loss of appetite 0 none '(-) with normal appetite 2 slight (+) loss ofappetite in ^ -1 / 3 3 moderate (++ J loss of appetite in 1 / 3-1 / 2 severe (+++) loss of appetite more than distension and abdominal swelling or none (-) without this sign 2 light ( +) with occasional sign 3 moderate (++) with the sign very frequent 4 severe (+++ with distension and severe abdominal swelling aspect of the tongue 0 normal (-) 1 abnormal (+) pulse condition 0 normal (-) 1 abnormal (+) Symptom severity: light: classification < 12 moderate classification 12-20 severe classification > 20 Patients diagnosed by traditional Chinese medicine according to the above symptoms, and patients with primary hyperlipidemia were introduced into the test. The exclusion criteria of the patients were as follows: a: myocardial infarction, cerebrovascular disease, severe wound or major surgery during the last six months; b: nephritic syndrome, hypothyroidism, acute hepatobiliary disorder, and / or chronic, diabetes, gout; c: familial hypercholesterolemia (monogenic hypercholesterolemia); d: secondary hyperlipidemia caused by another medication, for example: phenothiazine, beta-adrenergic blocking agents, corticosteroids, oral contraceptives; e: patients who used other lipid modulators during the last four weeks and patients using heparin or were in thyroidization; f: pregnancy and breastfeeding women; g: patients with disorders of other organs; and h: hilaxis syndrome and psychosis. The total number of patients introduced was 116. There were 84 patients in the treated group and 32 patients in the control group. No difference in distribution in age, sex and course of the disease was found between the two groups. 6. 2.1.1 TREATMENT PROTOCOL A double-blind randomized trial was conducted with two groups. The treated group (84 cases) took two Xuezhikang capsules (ie, the red yeast product of the present invention) twice a day. The control group (32 cases) took three tablets of Jiaogulan (ShanXi factory of Chinese medical material, lot number: 940730) twice a day. The course of treatment was 8 weeks. Measurements of lipid levels - serum lipoproteins and other records were made before therapy, and at four weeks and eight weeks after therapy. The safety tests were performed before and after the therapy. Venous blood samples were taken from patients before breakfast, who were not allowed to consume alcohol or high-fat foods at the last meal. The following safety tests were performed: blood nitrogen and urea (BUN), creatinine, serum pyruvate glutamic transaminase (SGPT, ALT), serum glucose and creatine kinase (CK). The total serum cholesterol (TC), total serum triglycerides (TG) and high density lipoprotein cholesterol levels were measured to determine efficacy. Other relevant clinical signs such as weight, high blood pressure, pulse and heart rate and hepatosplen palpation were recorded. 6. 2.1.4 EFFECTIVENESS Efficacy was evaluated according to the criterion established in 'Clinical trial management: hyperlipidemia treatment using new Chínese materia medica' published by the Ministry of Health of China as follows: 1. Cure: all symptoms are eliminated or the Total symptom registration was reduced by more than 90%, and each of the laboratory test parameters reached normal levels 2. Effective: the symptoms are significantly released, that is, the symptom registration was reduced by 70 % -89% Lipids and lipoproteins in serum do not reach the normal level but improved in one of the following aspects: 1) reducing the CT> 20%, 2) reducing TG> 40%, 3) reducing (CT-) HDL-C) / HDL-C> 20%, 4) increasing HDL-C> 10 mg / dl 3. Improvement: the symptoms are released, that is, the symptom registration was reduced by 30% -39%. Lipids and lipoproteins in serum did not reach normal levels but were improved in one of the following aspects: 1) reducing TC by 10% -20%, 2) reducing TG > 20% but < 40%, 3) reducing (CT-HDL-C) / HDL-C > 1 0% but < 20%, 4) increasing HDL-C > 4 mg / dl (0.14 m mmol / L) [sic]. 4. Inefficacy: the symptom registration was reduced by less than 30% and the parameters of the laboratory tests did not meet the effectiveness criteria. All data were subjected to statistical analysis. Student's t-tests were used in the measurement of the data, the chi-squared test was used to count the data and in the Ridit test for stratum data. 6. 2.2 RESULTS Table five shows a comparison of the total efficacy record of the two groups.

Table 5 General Efficiency 7 Ridit analysis: u = 5.18, P < 0.01 Comparison: X2 = 0.0 P > 0.05 The total efficacy record in the treated group was much greater than 1 in the control group (X2 = 22.95, P <0.01). Table 6 shows a comparison of efficiencies as defined in the standards of traditional Chinese medicine.

Table 6 Comparison of efficacy Symptoms Red yeast Control Statistics Before after fading% Before after fading% Asthenic respiration 35 15 57.1 12 6 50 > 0.05 Sensation of tightness in chest 37 16 56.8 13 7 46.2 > 0.05 Chest pain 37 16 56.8 9 5 44.4 * Loss of appetite 8 1 87.5 2 1 50 * Bloating and swelling of 11 4 63.6 3 2 33.3. * Stomach 31 11 64.5 7 6 14.3 * Pale tongue 54 34 37 17 12 31.3 > 0.05 Purple dot on the tongue 9 4 55.6 3 4 0 * o » Whitish-thick tartar 21 16 23.8 11 6 45.5 > 0.5 Glutinous-thick tartar 11 8 27.3 5 4 0 Tense pulse 28 22 21.4 13 8 33.3 * Weak pulse 24 16 33.3 8 3 62.5 * Tense-fine pulse 28 16 42.9 9 8 11.1 * * P < 0.05 against control $ The percentage of patients who reported symptom elimination as diagnosed by traditional Chinese medicine in the treated group was much higher than in the control group (p <0.05), especially in the aspect of pain and sensation of oppression in the chest, loss of appetite, distension and swelling in the gastric region as well as purple spots on the tongue. The change in the total serum cholesterol level is shown in Table 7.

Table 7: Change in the level of total serum cholesterol Ridit analysis: u = 5.47 P > 0.05 Effectiveness ratio: X2 = 39.96, P < 0.001, vs. control The records to cure or reduce the level of total serum cholesterol in the treated group were higher than in the control group. The change in the total serum triglyceride level is shown in Table 8.

Table 8 Change in the total level of serum triglycerides Ridit analysis: u = 0.53 P > 0.05 Effectiveness ratio: X2 = 0.007, P < 0.05, vs. control No significant difference in the records to cure or reduce the level of total triglycerides in serum was observed between the two groups. The change in the level of high-density lipoprotein cholesterol is shown in Table 9.

Table 9 Change in HDL-C levels Ridit analysis: u = .1.03 P > 0.05 Effectiveness ratio: X2 = 1.15, P < 0.05, vs. control A similar efficacy to normalize or increase the level of HDL-C was found in both groups Table 10 shows the changes in the atherosclerotic index which is the ratio of (CT-HDL-C) / HDL-C.

Table 10 Change of (CT-HDL-C) / HDL-C Ridit analysis: u = 3.84 P > 0.01 Effectiveness ratio: X2 = 23.41, P < 0.01, vs. control The data in Table 10 indicate the groups treated with Xuezhikang and control markedly improved serum levels of HDL-C. The effectiveness of Xuezhikang was found superior to that of the control. Table 11 shows the effect of Xuezhikang on the regulation of lipid and lipoprotein levels in serum (X +/- S).

Table 11: Regulatory effect of Xuezhikang on serum lipids and lipoproteins (X ± S) 0: increase *** P < 0.001; ** P < 0.01; * P < 0.05 vs (baseline): decrease ## #P < 0.05) P < 0.05 vs. control Table 11 indicates that Xuezhikang improved levels of CT, Tg, (CT-HDL-C) / HDL-C, HDL-C in serum notably, but the control group only significantly improved the TG. The ability to regulate CT, LDL-C therapy with Xuezhikang was found superior to that of the control. Table 12 shows the efficacy of Xuezhikang therapy on the baseline other than lipids and lipoproteins in serum.

Table 12: Comparison of the effectiveness of Xuezhikang therapy on the different base line of lipids and lipoproteins in serum.

CT (mg / g) TG / mg / g) HDL-C (mg / dl) Parameter < 230 230-300 > 300 < 230 230-300 > 300 > 45 35-45 < 35 Case No. 8 60 16 49 20 15 55 17 12 Average baseline 129.01 261.8 327.1 134.3 247.6 327.3 56.4 40.1 5.4 (average) Average (4 weeks) 174.14 226.14 272.56 134.84 202.64 360.59 55.03 43.41 38.82 % of changes 9..31 U12.621 l7.62 4.05 l6.2 Ud.87 U2.68 07.49 024.05 Average (8 weeks) 156.08 208.21 Ü86.1 119.38 169.51 255.88 57.58 46.89 40.33 % of changes l8.72 IÍ19.53 Ü24.93 l5.05 29.9 1) 33.91 f? l.85 0l6.ll 028.89 Comparison * ** ** -k -k ** ** Ul ** P < 0.01; * P < 0.001 vs control. t > 5 A higher baseline CT and TG in serum plus reduction is achieved after using Xuezhikang. 6. 2.3 ANALYSIS The results indicate that the cure record, and the efficacy record were 46.4% (38/84), 29.8% (25/84) respectively in the group treated with Xuezhikang (treated with red yeast) and 9.4% (3 / 32), 18.8 (6/32) in the control group. The ratio of total efficacy in the treated group (72%) was much higher than in the control group 828.2%, P < 0.001). There were significant differences between the two groups in terms of improving CT, LDL-C and (CT. HDL-C) / HDL-C, but no differences were found in terms of regulation of TG and HDL-C even the Xuezhikang group showed better results. No clinically significant change of the following parameters was observed during and after therapy: serum pyruvate glutamic transaminase (SGPT), blood nitrogen and urea (BUN), creatinine, serum glucose, cardioelectrogram, and routine urine test and blood. Three cases reported an increase in creatinine kinase (CK) (252, 260, 466 IU / L against the normal standard at 200UI / L) in the treatment group and one (256 IU / L) in the control group. No clinical symptoms were observed in any of these cases. The results show that the red yeast product of the present invention is a safe and accept lipid modulating agent. It may be apparent to those skilled in the art that modifications and variations to the present invention are possible in light of the foregoing description. It will be understood that these modifications are within the spirit and scope of the invention which is defined by the appended claims.

Claims (27)

1. A method of treating or preventing cardiovascular disorders in a human, which consists of administering to a human an effective amount of a red yeast fermentation product.

The method of claim 1, wherein the red yeast fermentation product is produced from the fermentation of at least one species of Monascus.

The method of claim 1, wherein the cardiovascular disorder is selected from the group consisting of: myocardial infarction, coronary heart disease, hypertension, hypotension, atherosclerosis, and arteriosclerosis.

4. A method of treatment or prevention of infarction, cerebral thrombosis or 'memory loss due to infarction in a human, which consists in administering to a human an effective amount of a red yeast fermentation product.

5. A method of treating or preventing conditions of adipose liver in a human, which consists in administering to a human an effective amount of a fermentation product of red yeast.

6. The method of claim 4 or 5, wherein the product of the red yeast fermentation is produced from the fermentation of at least one of the Monascus species.

7. A method of improving or maintaining cardiovascular health which consists of administering to a human an effective amount of a fermentation product of red yeast.

The method of claim 7, wherein the red yeast fermentation product is produced from the fermentation of at least one of the Monascus species.

9. A method of treating or preventing diabetes in a human, which consists in administering to a human an effective amount of a red yeast fermentation product.

The method of claim 9, wherein the red yeast fermentation product is produced from the fermentation of at least one of the Monascus species.

11. A method of treating or preventing obesity in a human, which consists in administering to a human an effective amount of at least one red yeast fermentation product.

12. The method of claim 11, wherein the red yeast fermentation product is produced from the fermentation of at least one of the Monascus species.

13. A method of reducing serum cholesterol and triglyceride levels to normal levels in a human in need of this therapy, which consists of administering an effective amount of a red yeast fermentation product.

The method of claims 1, 4, 5, 7, 9 or 11, wherein the administration is done once or twice a day and for a sufficient period to treat or prevent said disorder.

The method of claims 1, 4, 5, 7, 9 or 11, wherein the product of the red yeast fermentation is produced from the fermentation of a mixture of Monascus purpureus Went, Monascus ruber van Ti eghem, Monascus Fuliginosus Sato, Monascus Pilosus Sato, and Monascus albidus Sato.

16. The method of claims 1, 4, 5, 7, 9 or 11, wherein the red yeast fermentation product is produced from the fermentation of a Monascus purpureus Went strain.

17. The method of claims 1, 4, 5, 7, 9 or 11, wherein the effective amount is about 1 to about 4 grams per day.

18. A pharmaceutical or nutritional composition suitable for oral or parenteral administration to a human, which contains an effective amount of a red yeast product.

The composition of claim 18, wherein the composition is suitable for oral administration as a capsule, tablet or capsule.

The composition of claim 18, wherein the composition is suitable for oral or parenteral administration as a suspension, solution or other suitable liquid delivery system.

21. The composition of claim 18 which further contains an excipient or carrier.

22. The composition of claim 18 which further comprises at least one vitamin supplement or flavor enhancer.

23. A medicine that contains approximately 600 mg of a red yeast fermentation product.

The composition of claims 18 or 23, wherein the red yeast fermentation product is produced from the fermentation of at least one of the Monascus species.

25. The composition of claims 18 or 23, wherein the red yeast fermentation product is produced from the fermentation of a mixture of Monascus purpureus Went and at least one other Monascus strain.

The composition of claims 18 or 23, wherein the red yeast fermentation product is produced from the fermentation of a Monascus purpureus Went strain M4027, M4028 or M4184.

27. A red yeast fermentation product suitable for oral delivery to humans which consists of: (a) fermenting at least one of the species of Monascus purpureus Went and non-glutinous rice; (b) draining the resulting fermentation broth; and (c) sterilizing the product with heat.