پاورپوینت کامل Quality Control of Herbal Drugs 42 اسلاید در PowerPoint

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پاورپوینت کامل Quality Control of Herbal Drugs 42 اسلاید در PowerPoint

اسلاید ۴: The term “herbal drugs” denotes plants or plant parts that have been converted into phytopharmaceuticals by means of simple processes involving harvesting, drying, and storage. A practical addition to the definition is also to include other crude products derived from plants, which no longer show any organic structure, such as essential oils, fatty oils, resins, and gums. Derived or isolated compounds in the processed state such as extracts or even isolated purified compounds (e.g. strychnine from Strychnos nux-vomica) or mixtures of compounds (e.g. abrin from Abrus precatorius) are, as a rule, not included in the definition.

اسلاید ۵: In general, quality control is based on three important pharmacopoeial definitions:Identity: Is the herb the one it should bePurity: Are there contaminants, e.g., in the form of other herbs which should not be thereContent or assay: Is the content of active constituents within the defined limits

اسلاید ۶: It is obvious that the content is the most difficult one to assess, since in most herbal drugs the active constituents are unknown. Sometimes markers can be used which are, by definition, chemically defined constituents that are of interest for control purposes, independent of whether they have any therapeutic activity or not.To prove identity and purity, criteria such as type of preparation, physical constants, adulteration, contaminants, moisture, ash content and solvent residues have to be checked. The correct identity of the crude herbal material, or the botanical quality, is of prime importance in establishing the quality control of herbal drugs.

اسلاید ۷: Identity can be achieved by macro- and microscopical examinations. Voucher specimens are reliable reference sources. Outbreaks of diseases among plants may result in changes to the physical appearance of the plant and lead to incorrect identification. At times an incorrect botanical quality with respect to the labeling can be a problem. For example, in the 1990s, a South American product labeled as “Paraguay Tea” was associated with an outbreak of anticholinergic poisoning in New York. Subsequent chemical analysis revealed the presence of a class of constituents that was different from the metabolites normally found in the plant from which Paraguay tea is made.

اسلاید ۸: Purity is closely linked with the safe use of drugs and deals with factors such ash values, contaminants (e.g. foreign matter in the form of other herbs), and heavy metals. However, due to the application of improved analytical methods, modern purity evaluation also includes microbial contamination, aflatoxins, radioactivity, and pesticide residues. Analytical methods such as photometric analysis, thin layer chromatography (TLC), high performance liquid chromatography (HPLC), and gas chromatography (GC) can be employed in order to establish the constant composition of herbal preparations.

اسلاید ۹: Content or assay is the most difficult area of quality control to perform, since in most herbal drugs the active constituents are not known. Sometimes markers can be used. In all other cases, where no active constituent or marker can be defined for the herbal drug, the percentage extractable matter with a solvent may be used as a form of assay, an approach often seen in pharmacopeias. The choice of the extracting solvent depends on the nature of the compounds involved, and might be deduced from the traditional uses. For example, when a herbal drug is used to make a tea, the hot water extractable matter, expressed as milligrams per gram of air-dried material, may serve this purpose.

اسلاید ۱۰: A special form of assay is the determination of essential oils by steam distillation. When the active constituents (e.g. sennosides in Senna) or markers (e.g. alkylamides in Echinacea) are known, a vast array of modern chemical analytical methods such as ultraviolet/visible spectroscopy (UV/VIS), TLC, HPLC, GC, mass spectrometry (MS), or a combination of GC and MS (GC/MS), can be employed.

اسلاید ۱۱: Several problems not applicable to synthetic drugs influence the quality of herbal drugs:Herbal drugs are usually mixtures of many constituents.The active principle(s) is (are), in most cases unknown.Selective analytical methods or reference compounds may not be available commercially.Plant materials are chemically and naturally variable.The source and quality of the raw material are variable.The methods of harvesting, drying, storage, transportation, and processing (for example, mode of extraction and polarity of the extracting solvent, instability of constituents, etc.) have an effect.

اسلاید ۱۲: Strict guidelines have to be followed for the successful production of a quality herbal drug. Among them are proper botanical identification, phytochemical screening, and standardization.

اسلاید ۱۳: Standardization involves adjusting the herbal drug preparation to a defined content of a constituent or a group of substances with known therapeutic activity by adding excipients or by mixing herbal drugs or herbal drug preparations. Botanical extracts made directly from crude plant material show substantial variation in composition, quality, and therapeutic effects. Standardized extracts are high-quality extracts containing consistent levels of specified compounds, and they are subjected to rigorous quality controls during all phases of the growing, harvesting, and manufacturing processes.

اسلاید ۱۴: No regulatory definition exists for standardization of dietary supplements. As a result, the term “standardization” may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word “standardized” on a supplement label does not necessarily indicate product quality. When the active principles are unknown, marker substance(s) should be established for analytical purposes and standardization.Marker