Herbal substances control

The control tests on the finished product should allow the qualitative and quantitative determination of the composition of the active substance(s). A specification should be provided and this may include the use of markers where constituents with known therapeutic activity are unknown. In the case of herbal substances or herbal preparations with constituents of known therapeutic activity, these constituents should be specified and quantitatively determined. For traditional herbal medicinal products for human use containing vitamins and/or minerals, the vitamins and/or minerals should also be specified and quantitatively determined. 

Markers These are chemically defined constituents of a herbal substance that are of interest for control purposes independent of whether they have any therapeutic activity... 

Antihistamines such as diphenhydramine are known for their sedating properties and are frequently used over-the-counter medications (usual doses 25-50 mg) for difficulty sleeping. Diphenhydramine is approved by the FDA for the treatment of insomnia and can be effective at reducing sleep latency and increasing sleep time.43 However, diphenhydramine produces undesirable anticholinergic effects and carryover sedation that limit its use. As with TCAs and BZDRAs, diphenhydramine should be used with caution in the elderly. Valerian root is an herbal sleep remedy that has inconsistent effects on sleep but may reduce sleep latency and efficiency at commonly used doses of 400 to 900 mg valerian extract. Ramelteon, a new melatonin receptor agonist, is indicated for insomnia characterized by difficulty with sleep onset. The recommended dose is 8 mg at bedtime. Ramelteon is not a controlled substance and thus may be a viable option for patients with a history of substance abuse. 

Determining the molecular sites of action of bioactive medicinal plant constituents is clearly important for establishing the chemical and physiological basis for herbal medicinal efficacy, for quality control of commercial herbal preparations and for the discovery of lead compounds for synthetic (or semi-synthetic) pharmaceutical development. Of course, it must be recognized that medicinal plant efficacy may derive from complex synergistic effects or even from quasi-placebo effects connected with the taste, mild effects and appearance of the preparation. While recognizing these possible holistic complications, in order to find out how such preparations work, it is clearly important to initially isolate, structurally characterize and define the biochemical targets of plant bioactive substances. 

Since 1967 medicines have systematically been called up for registration purposes by means of pharmacological and therapeutic groups 34 such groups are stipulated by regulation emd all substances used within such a group are subjected to control. Consequently, allopathic and complementary medicines in most paradigms are subject to control (e.g., herbal and homoeopathically prepared medicines). This also includes special foods used in a medicinal context. 

The control tests and specifications for the finished herbal product should be such as to allow the qualitative and quantitative determination of the main active constituents. If the therapeutic activity of constituents is known, these constituents should be indicated in the docmnentation. If such substances are not known (e.g. because they are part of a complex mixture), the constituents useful for assessing the quality should be identified as markers. In both cases, the assay (i.e. quantitative determination) specifications should be defined. When the therapeutic activity of the constituents cannot be determined quantitatively, specifications should be based on the determination of markers. 

Herbal medicines with constituents of known therapeutic activity are often standardized (i.e. adjusted to a defined content of such constituents). The methods used to achieve such standardization should be documented. If another substance is added for these purposes, it is necessary to specify, as a range, the quantity that may be added. Blending different batches of a specific herbal material (e.g. before extraction) or by mixing different lots of similar herbal preparations may also be acceptable. Records should be maintained to ensure traceability. The blending process should be adequately controlled and documented and the blended batch should be tested for conformity with established specifications where appropriate. 

The composition of any solvent or solvent mixture and the physical state of the extract must be indicated. If any other substance is added during the manufacture of the herbal preparation to adjust the preparation to a defined content of constituents with known therapeutic activity, or for any other purpose, the added substance must be mentioned as an "other substance" and the genuine extract as the "active substance." However, where different batches of the same extract are used to adjust constituents with known therapeutic activity to a defined content, or, for any other purpose, the final mixture shall be regarded as the genuine extract and listed as the "active substance" in the unit formula. Full details of production and control must however be provided in the dossier. 

Herbal products are regulated differently in countries other than the United States. For example, in the United Kingdom, any substance not granted a license as a medicinal product by the Medicines Control Agency is treated as a food, and cannot carry a health claim or medical advice on the label, although many do (Marwick, 1995). Canada is moving toward a system resembling that in the U.S. (Allen,... 

As for the anticancer action of these plant-derived or herbal medicines, or still other chemicals, the most probable route is that of enzyme inhibitors. In fact, this is seen as the role of modem medicines such as antibiotics, which act against a critical enzyme in bacterial cells (prokaryotes), bnt in the dosages used, not against human cells (eukaryotes). Each and every body biochemical reaction in the body is in fact catalyzed and controlled by a particular enzyme. In turn, there are other substances that may inhibit, block, control, or modnlate the action of these enzymes. These substances are known as enzyme inhibitors, and in rare instances may also promote a biochemical reaction. More than this, a particnlar substance will usually act against or inhibit more than one enzyme. This diversity produces side effects. 

Ethnic dishes that have become popular in recent years use a variety of interesting herbs and spices that provide healthful substances in addition to their unique flavors. A variety of common herbal products are available for the treatment of cardiovascular problems, for improving glyce-mic control, enhancing immune function, and providing cancer chemopreventive activity. 

Several controlled studies appear to support the use of certain herbal preparations in rational detoxification treatment programs. Exhibit 3 displays findings of selected studies on natural products with apparent efficacy in treating syndromes of substance abuse, withdrawal or addiction. 

Soaps are still major components of modem detergents, On the one hand, the formation of lather will be controlled by the addition of soap with long carbon chains. On the other hand, soaps based on coconut oil acids are components of liquid soaps, where they form lime soap by reaction with the components in hard water. In this way, they bind the polyvalent ions resulting from the water hardness. The formed insoluble lime soap is dispersed by an excess of soap or by other surfactants in the product so that it cannot deposit on the fibres. The major application of soap lies mainly in the field of human cleansing agents. Toilet soaps with different properties are easily obtained by the addition of lime soap dispersants, perfume oils, re-fatting agents, herbal extracts and other active substances. 

The constituents of the extracts are generally represented by a complex mixture of compounds and it is practically impossible within quality assurance to take account of all constituents of an herbal extract, apart from the fact that in most cases the complete spectrum of constituents is far from being known or analytically detectable. Reproduction and control of a defined spectrum of constituents can only be based on those substances or groups of substances that, according to the state of scientific knowledge, are pharmaceutically, pharmacologically, or toxicologically relevant. 

Real Life 8-1), preventing or slowing the removal of certain substances. This can cause the effective concentration of a drug to be greatly increased, reaching dangerous—even lethal—levels. Another example is the herbal antidepressant hypericum (St. John s wort), which can cause abortions and also interferes with the action of the birth control pill (Real Life 4-3). 

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