Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2001-08-28
2002-09-10
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Reexamination Certificate
active
06447814
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a novel Chinese herbal composition for improving blood circulation and for treating patients with coronary heart diseases and stroke. The composition comprises 30-50 wt % of Dang Gui (Radix Angelicae sinensis), 35-65 wt % of Chuan Xiong (Radix Ligustici Chuanxiong), and 7-13 wt % of Renshen (Radix Ginseng), preferably Red Ginseng (Radix Ginseng Rubra). The present invention also relates to methods for preparing and using the same.
BACKGROUND OF THE INVENTION
The so-called blood stasis in Chinese medicine is generally referred to as an abnormal state in blood rheology where the blood tends to thicken, become viscous, coagulate and aggregate, or the condition of stagnant or discontinuous blood flow that leads to all kinds of disease symptoms. Blood stasis has been shown to be the main characteristic of at least one hundred types of disease, in particular, the cardiovascular and cerebroascular diseases.
A recent report published by the World Health Organization (WHO) indicates that cardiovascular disease has been the single greatest cause of death, with 15 millions of people dying from it every year worldwide. Among the cardiovascular and cerebrovascular diseases, coronary heart disease and stroke are particularly of concerns in most of the developed countries. The incidence of these diseases is increasing, while the onset age of the patients is decreasing.
Besides a few surgical adaptation approaches, the primary management of stroke and coronary heart disease still relies on drug treatments. In the early stage, the treatment focuses on decreasing the mortality rate and the occurrence of complications; later on, the treatment focuses on rehabilitation and the prevention of recurrence.
The commonly used medications include anti-coagulants, anti-thrombosis agents, vasodilators, medicines for enhancing cerebral metabolism, decreasing cerebral pressure, and blood pressure, and medicines for decreasing myocardial oxygen consumption and facilitating coronary blood flow. Although these medications have therapeutic effects, they tend to produce adverse effects or have diminished activity after prolonged use. This is particularly true for anti-coagulants, e.g., aspirin and/or ticlopidine, which are used to prevent cerebrovascular diseases. Also, although these drugs can improve blood circulating, they have adverse side effects on humans. Aspirin has been shown to affect appetite, cause stomachache, gastric ulcer and even bleeding. In some cases, aspirin has also been found to induce asthma. Ticlopidine can cause nausea, dullness, headache, palpitation, fatigue, liver disorder, jaundice, bleeding tendency, and abnormal blood formation, leading to decreased platelet count, granulocytopenia and even anemia due to blood regeneration failure. More importantly, these medications only control the symptoms of the diseases without having any effect on the pathogenesis of the diseases.
In recent years, there have been studies which demonstrated that sex hormone disturbance is a common cause of many frequently seen diseases found in the middle-aged and the elderly, including coronary heart disease, angina pectoris, myocardial infarction, hypertension, diabetes, sinoatrial nodal dysfunction and so on. In males, the regular pattern of disturbance entails the increase of plasma estradiol (E2) level, while the level of testosterone (T) remains unchanged or decreases, resulting in elevated E2/T ratio. In females, both the E2 level and T level decrease. Aspirin and ticlopidine are ineffective for the disorders described above. Some alternative herbal medicines, such as gingko or its derived products have also been shown to improve blood circulation in clinical applications, but they fail to improve the conditions of sex hormone disturbance.
Thus, finding a medication, which can improve cardiovascular functions, regulate the levels of sex hormones, prevent cardiovascular diseases, and help slow down the aging process so as to improve and preserve health, is a pressing task, especially in an aging society.
In the invention to be presented in the following sections, a novel herbal composition for treating patients with invigorating blood and expelling stasis will be introduced. This herbal composition is particularly effective on treating patients with blood stasis while in the meantime having common and recurrent clinical diseases. The present invention can also be used to prevent many common diseases found in the middle-aged and the elderly.
SUMMARY OF THE INVENTION
The present invention provides a novel herbal composition for improving blood circulation and treating patients with coronary heart disease and stroke. This herbal composition has been shown to be safe and reliable by having consistent active ingredient(s) and enhanced therapeutic effects, with minimal side effects. The present invention also provides methods for making the same. The therapeutic effects of the herbal composition have been demonstrated successful in human subjects.
The herbal composition contains (a) 30-50 wt %, preferably 33-45 wt %, of Dang Gui root (Radix Angelicae sinensis); (b) 35-65 wt %, preferably 42-58 wt %, of Chuan Xiong root (Ligustici Chuanxiong), and (c) 7-13 wt %, preferably 8-12 wt %, of Renshen root (Radix Ginseng), also known as Ginseng root. The preferred Ginseng is Red Ginseng (Radix Ginseng Rubra). The herbal composition is preferably administered orally.
Dang Gui root, Chuan Xiong root, and Ginseng root are extracted with an extractant. The extracts of the herbs are filtered, condensed, and granulated to form granules. The granules can be further encapsulated.
The preferred extractant is alcohol and water, particularly 60% alcohol.
The present invention also provides methods for preparing the herbal composition: (1) combined herbal extraction; and (2) single herbal extraction.
The method for preparing combined herbal extraction contains the following steps: (a) mixing Dang Gui root, Chuan Xiong root, and Ginseng root in an extraction tank to form an herbal mixture; (b) adding an extractant to the herbal mixture to form an herbal mixture extract; (c) heating the herbal mixture extract; (d) filtering the heated herbal mixture extract to obtain a filtrate; (e) putting the filtrate into a condensation tank for decompressed condensation to obtain an extraction paste; and (f) granulating the extraction paste to form granules.
Dang Gui root, Chuan Xiong root and Ginseng root are preferred to be ground into powder or cut into small pieces before mixing together in the extraction tank.
The heating condition is preferred to be at about 70-80° C. for about 4 hours.
After extracting, heating and filtering of the herbal mixture, optionally, the herbal mixture can be extracted and filtered for a second and third times by repeating steps (b)-(d). The second and third filtrates can be combined with the filtrate and subject to decompressed condensation. Preferably, the extraction paste (i.e., the condensate) is about {fraction (1/10)} by volume of the filtrate. Also preferably, the extraction paste is mixed with a soluble starch before granulation. The granulation is proceeded with a heat-dry step using a fluidized bed. The granules produced by the granulation process can be further capsulated.
The extraction paste contains 0.5 to 2.8 mg of ferulic acid per gram of the extraction paste and 0.2 to 1.6 mg of tetra-methyl pyrazine per gram of the extraction paste. The granules contain 0.08 to 0.42 mg of ferulic acid per gram of the granules and 0.04 to 0.25 mg of tetra-methyl pyrazine per gram of the granules.
The method for preparing single herbal extraction is as follows: (a) extracting Dang Gui root, Chuan Xiong root, and Ginseng root by adding an adequate amount of extractant to Dang Gui root, Chuan Xiong root, and Ginseng root respectively to form individual extracts; (b) heating the individual herb extracts; (c) filtering the heated individual herb extracts to obtain individual filtrates; (d) mixing the individual filtrates together to form a final filtrate; (e) p
Chang Ming Ching
Lee Fang-Yu
Wu Huan
Chao Fei-Fei
Patten Patricia D
Tate Christopher R.
Venable Baetjer Howard & Civiletti LLP
Yung Shin Pharma Ind. Co. Ltd.
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