Dosage of safety evaluation system to establish the formulas

China's traditional Chinese medicine to

        And adverse events of Chinese medicine disease reaction easily confused. The so-called disease response is drugs into the body, promote vital qi and pathogenic factors, process of the disease evil out of the body. For adverse reactions and disease response identification method, still needs further research and discussion.

        Traditional Chinese medicine composition is complicated, so the vast majority of Chinese medicine in quantity - effect - poison relationship. There is no clear boundary points. Should strengthen the "volume - effect - poison relations" research, looking for "dose threshold" and "the therapeutic window", as well as the effect - poison optimum demarcation point, as a reference of clinical medication.

        Through the analysis epidemiology cohort studies, case-control studies, and the use of evidence-based medicine method such as the relations between the drug dose and adverse events, the reliable assessment of drug safety.

        In recent years, excess (or large doses) using the fine effect of traditional Chinese medicine (TCM) harvest we see an endless test case, and a growing number of experts and scholars and clinical medical workers put forward authority prescribed dose and clinical effective dose, there is a big gap between should be adjusted. But at the same time, traditional Chinese medicine (TCM) adverse events also appear from time to time. Therefore, adverse events caused by excessive use of Chinese medicine should be thinking about.

        Overcommitment for different reasons

        Difficult critically ill condition required. "The agent status", facing difficult critically ill, past dynasties basis in bold use of large dose of Chinese medicine, to confront a record of the work. Such as Zhang Xichun therapy with plaster stone 6 two a day held by the eldest son 7 years old, big heat syndrome; Wu Peiheng treatment with 400 grams of aconite typhoid Yin ChengGeYang intensive, and so on.

        Because of people, because when, adjust measures to local conditions. Patients with individual differences, sensitivity and reactivity of traditional Chinese medicine is different, the conditions of the same, may be different dose effect. Such as ephedra sweating treatment of exogenous, cou justified osteoporosis, frail people with 3 g is enough, cou justified compact, robust physique person only need 9 grams or more of the sweat. Geography, climate impact.

        The decrease of the quality of the Chinese medicinal materials. Modern wild medicinal materials is very scarce, commercial medicinal materials for artificial cultivation, and many herbs planting time is shorter, picked ahead of time, the clinical curative effect. In addition, drug prohibition adulteration, make more and more clinical.

        Use drug blindly. Some doctors and patients mistakenly think that Chinese medicine has no side effects, to achieve therapeutic purposes and blindly increase the dose of drug.

        Adverse events reported in literatures

        No poison indefinitely. Ginseng, ancient and modern herbal medicine that its non-toxic. But large doses of ginseng, often can lead to high blood pressure, hypokalemia, nervousness, sleeplessness, irritability, skin rashes, itching, are becoming "ginseng poisoning syndrome", etc. Again, such as "the old" licorice, sexual flavour, how to mediate in the Chinese traditional medicine prescription drugs. But long-term or short-term doses of licorice root may appear edema, high blood pressure, hypokalemia, limb weakness, dizziness, headache, etc. Visible, even non toxic as defined in the "pharmacopoeia" kind of traditional Chinese medicine, if excess or long time application, a significant proportion of adverse events will occur. Mild and non-toxic drug has many adverse events, and other ingredients are more difficult to avoid biased obviously.

        There is overcommitment poison (small). Asarum have small poison, has "the dosage but money" since ancient times, especially when alone, a high incidence of adverse events. Have reported that patients with a careless mistake asarum about 6 grams, after the headache, restlessness, face flush, and vomiting, gastric contents.

        Poisons overcommitment is not careful. Such as containing aristolochic acid clearance akebiaquinata, containing aconitine sichuan kusnezoff monkshood, contain TWHF extract of tripterygium wilfordii alkaloid, adverse events, and even lead to death, has aroused highly attention. Now also, radix aristolochiae banned use. Other poisonous drug doctors use within the prescribed dose. For certain drug toxicity, clinical dosage while greatly exceeded the scope of the pharmacopoeia, such as radix aconiti, but many medicine after processing, using methods such as frying, combining its dosage and usage, to ensure safe and effective.

        Traditional Chinese medicine safety countermeasures

        Difference between traditional Chinese medicine disease and adverse events

        The so-called disease response is drugs into the body, promote vital qi and pathogenic factors, process of the disease evil out of the body. Since ancient times have "if medicine Ming is dizzy, faint disease not Chou", such as the "sweat out of the" treatise on febrile disease, "non-traumatic is the solution", etc., are described respectively show the sweating, epistaxis "reaction". At times and adverse events of Chinese medicine disease response easily confused. Adverse events after, the body weak, illness; Row of disease was observed in most of the reaction, reaction disappeared after illness to heal. For adverse reactions and disease response identification method, still needs further research and discussion.

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