Specifications herbal medicines

GIT characteristics, either to improve or limit specific function, and thereby influence host health. However, the complex, multiple and varied nature of the combinations of phytochemicals present in plants and traditional herbal medicines has complicated efforts to better understand the specific interactions between phytochemicals and the GIT (Yuan and Lin, 2000). Phytochemicals have other applications, such as the use of guar gum as a vehicle to deliver therapeutics (Krishnaiah et al, 2001). 

The pith was used by Native Americans as a moxibustion sort of treatment, where the herb is burned to cause heat on a particular part of the body. Modern-day biologists still use elder pith to hold scientific specimens as it can easily be sliced. The pith has also been used for electrical experiments and in toy making. The hollowed elder stalk has also been used as a smoking tube, especially for the inhalation of specific herbal medicines in both early America and Europe. 

In 1994, the Dietary Supplement Health and Education Act was passed by the U.S. Congress. This allowed herbal medications to be advertised and sold without oversight from the FDA. Specifically, it states that a substance will not legally be classified as a "drug" if it is not represented as treatment for a disease (Heiligenstein and Guenther. 1998 Dietary Supplement Health and Education Act of 1994). Thus, many herbal medicines are now sold and regulated as dietary supplements. 

In order for Chinese herbal medicine to be accepted as reliable alternative medicine, the safety of medicinal herbs and their efficacy for the treatment of specific diseases must be demonstrated.368-385 397 400 A first step is establishing reliable sources... 

EMEA Comparative table of current and proposed specifications. Batch analysis data on two production batches for all tests in the new specification. Where appropriate, comparative dissolution profile data for the finished product on at least one pilot batch containing the excipient complying with the current and proposed specification. For herbal medicinal products, comparative disintegration data may be acceptable. Minor change type IB requires approval... 

Pulsatilla possesses sedative, analgesic, antispasmodic, and bactericidal properties. Traditionally, it is used for dysmenorrhea, orchitis, ovaralgia, epididymitis, tension headache, hyperactive states, insomnia, boils, skin eruptions associated with bacterial infection, asthma and pulmonary disease, earache, and specifically for painful conditions of the male and female reproductive systems. Pulsatilla is widely used in homoeopathic preparations as well as in herbal medicine. 

Skullcap is known to have anticonvulsant and sedative properties. Traditionally, it has been used for epilepsy, chorea, hysteria, nervous tension states, and specifically for grand mal. In Chinese herbal medicine, the roots of Scutellaria baicalensis Georgi have been used traditionally as a remedy for inflammation, suppurative dermatitis, allergic diseases, hyperlipidemia, and atherosclerosis. 

Plants will have a specific DNA bar code, which will be a useful forensic tool. The DNA bar code is made up of a standard short region (or regions) of DNA selected from one or more of the genomes. It can be applied universally across land plants but is also variable enough to provide individual identification at species level. The bar code system can be applied to access a database for identification of known plants. It can be used to identify unknown samples from fragments of plant material by comparing them to the known standards and has applications for verification of material in natural products like herbal medicines and foodstuffs. 

Herbal medicinal traditions can be traced back to our primate forebears. Thus, parasite-infected chimpanzees make recourse to particular plants, which they evidently associate with symptomatic relief. Human cultures in general have accumulated medicinal protocols based on use of plants, major traditions including Chinese medicine and Indian Ayurvedic herbal medicine. As detailed in this book, in some instances, specific bioactive substances from medicinal plants (or derivatives of such compounds) have found application in conventional medicine. Thus, the cardiotonic cardiac glycoside sodium pump (Na+, K+-ATPase) inhibitors derived from the initial use for cardiac insufficiency of digitalis (dried leaves of the foxglove, Digitalis purpuremri). 

Herbal products are considered a type of alternative medicine (e.g., herbal medicines, Chinese herbs, homeopathy, acupuncture, biofeedback, color therapy, music therapy, hypnotherapy, aromatherapy. Ayurvedic medicine, massage, therapeutic touch, Bach flower remedies, chiropractic, reflexology, naturopathy, and more). According to the Office of Alternative Medicine of the National Institutes of Health (NIH), characteristics of alternatives medicine include treatments that lack sufficient documentation in the United States for safety and effectiveness against specific disease and... 

Herbs are specifically defined as non-woody, low-growing plants such as basil and parsley. Herbal medicine is considered to be the use of crude drugs of plant origin to treat illness or to promote health. A more correct term for this would be botanical medicine. Phytomedicinals are those common preparations, including capsules, tablets, tinctures, and fluidextracts that have been prepared from plant sources. This should be distinguished from plant-derived drugs that have been isolated, purified, and standardized from plant sources. 

In a German hospital specializing in Chinese herbalism of 145 patients who had been treated within 1 year 53% reported having had at least one adverse effect attributable to Chinese herbal medicines (107). Nausea, vomiting, and diarrhea were the most common complaints. It should be noted that causality in these cases can only be suspected and not proven. In the same institution about 1 % of 1507 consecutive patients treated with Chinese herbal mixtures had clinically relevant rises in liver enzymes (108,109). Glycyrrhiza radix and Atractylodis macro-cephalae rhizome were most consistently associated with such problems. In most of these cases there were no associated clinical signs and the abnormalities tended to normalize without specific therapy and in spite of continued treatment with the Chinese herbal mixtures. 

In the present investigation, supercritical carbon dioxide and carbon dioxide -h co-solvent mixtures were used to extract and isolate a model pyrrolizidine alkaloid from its parent plant. Pyrrolizidine alkaloids have been used in herbal medicine to combat tumors as long ago as the fourth century A.D. (4) and to treat cancer since the tenth century A.D. (5). More recently, they have received increasing attention as chemotherapeutic drugs. Processes for their separation, however, are specific to each alkaloid, and either lead to chemical modification of the alkaloid or require the use of solvents which must then be completely removed from the extract. 

Note for Guidance on Specifications Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products — CPMP/QWP/2820/00. 

Herbal medicines and functional foods are chemically complex and there may be synergistic effects of not only one compound across targets but also multiple compounds across multiple targets. This makes substantiation of pharmacological activity even more difficult. Considering that herbal medicines have been developed over centuries of observational evidence of effect on the patient, the problem of MOA can be even more complex since it may be different but specific organs that bioactives target to produce an overall effect. The same may be true for functional foods. 

The European use of phytomedicines for specific diseases or conditions has been well documented and researched. Much of the research done on herbal medicines over the last 50 years has been conducted by German, French, Italian, and Swiss researchers at major phytopharmaceutical companies. 

The person responsible for handling complaints and deciding on the measures to be taken to deal with them should have appropriate training and/or experience in the specific features of the quality control of herbal medicines. 

Technical aspects of the contract should be drawn up by competent persons suitably knowledgeable on the specific characteristics of herbal medicines, including their production and quality control testing. 

The release of herbal medicines should be authorized by aperson who has been trained in the specific features of the processing and quality control of herbal materials, herbal preparations and finished herbal products. 

Personnel dealing with the production and quality control of herbal medicines should have adequate training in the specific issues relevant to herbal medicines. 

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