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Part 1 pharmacology The word “pharmacology” derives from the Greek word for drug, pharmakon. It is the branch of medicine and biology concerned with the study of the actions, uses, mechanisms, and adverse effects of drugs. More specifically, it is the study of the interactions that occur between a living organism and chemicals that affect normal or abnormal biochemical function. If substances have medicinal properties, they are considered pharmaceuticals. The field of pharmacology encompasses drug composition and properties, interactions, toxicology, therapy, and medical applications and anti-pathogenic capabilities.The two main areas of pharmacology are pharmacodynamics and pharmacokinetics. The former studies the effects of the drugs on biological systems, and the latter studies the effects of biological systems on the drugs. In broad terms, pharmacodynamics discusses the interactions of chemical with biological receptors, and pharmacokinetics discusses the absorption, distribution, metabolism, and excretion of chemicals from the biological systems.Pharmacokinetics describes the effect of the body on the drug. When describing the pharmacokinetic properties of a drug, pharmacologists are often interested in LADME:l Liberation-disintegration, dispersal and dissolutionl Absorption-Is the medication absorbed through the skin, the intestine, or the oral mucosal Distribution-How does it spread through the organism?l Metabolism-Is the medication converted chemically inside the body and into which substances? Are these active? Could they be toxic?l Excretion-Is the medication eliminated through the bile, urine, breath, or skin?Pharmacology is not synonymous with pharmacy and the two terms are frequently confused. Pharmacology deals with how drugs interact within biological systems to affect function. It is the study of drugs, of the reactions of the body and drug on each other. In contrast , pharmacy is a biomedical science concerned with preparation, dispensing, dosage, and the safe and effective use of medicines. The study of pharmacology is offered in many universities worldwide in programs that differ from pharmacy programs. Students of pharmacology are trained as researchers, studying the effects of substances in order to better understand the mechanisms which might lead to new drug discoveries. Whereas a pharmacy student will eventually work in a pharmacy dispensing medications or some other position focused on the patient. Part 2 Pharmaceutical chemistry Medicinal or pharmaceutical chemistry is a discipline at the intersection of chemistry and pharmacology, and involves the identification, synthesis and development of new chemical entities suitable for therapeutic use. The content of medicinal chemistry also includes the study of existing drugs, their chemical structure, physical and chemical properties, chemical stability, biological properties, structure-activity relationships (SAR), metabolism, chemical mechanism of interaction between drugs and biological target, etc.The science of medicinal chemistry involves the design and synthesis of novel drugs. There are two major considerations that have to be taken into in any drug design project. First of all, drugs interact with molecular targets in the body, and so it is important to choose the correct target for the desired pharmaceutical effect. It is then a case of designing a drug will interact as powerfully and selectively as possible for that target an area of medicinal chemistry known as pharmacodynamics, Secondly, a drug has to travel through the body in order to reach its target, so it is important to design the drug so that it is able to carry out that journey. This is an area known as pharmacokinetics.The chief role of the medicinal chemist is to design and synthesize the target structures required. Therefore, the medicinal chemist is an essential member of any drug design team since he or she has to identify whether proposed target structures are likely to be stable and whether they can be synthesized or not.In medicinal chemistry, the search of lead compound and its structural modification are important two steps for looking for new drugs. The lead discovery processes include random screening, drug metabolism studies, clinical observations of drug action, rational approaches to lead discovery and computer-assisted drug design techniques, etc. Many approaches can be used for optimization of lead compound, such as lead optimization by pro-drug design, by bioisosterism, by soft drug or hard drug design, by QSAR method, etc. Computer aided drug design (CADD), a sophistic drug discovering techniques, is a topic area in modern medicinal chemistry for the discovery of lead compound and its pharmaceutical development.Part 3 PharmaceuticsPharmaceutics is a branch of pharmacy of studying how to get effective and stable pharmaceutical dosage forms without disturbing its quality by the systematic approach. Primitively, it is concerned with the scientific and technological aspects of the design and manufacture of dosage forms. Meanwhile, pharmaceutics is the science of drug delivery system for seeking the optimal drug delivery product or device and its subsequent performance in the delivery of the drug forms following its administration to a patient. The study involves preparation and stability of suitable dosage forms, design and manufacture of dosage forms that overcome the physiologic barrier and optimize the drug action, quantitative characterization of both the drug concentration-effect relationship and the concentration-time relationship after the drug enters the body and evaluating the dosage regimen, avoidance and elimination of microorganisms in the medicines.Pharmaceutics is a multidisciplinary area, with significant underpinnings from such basic scientific disciplines as physical chemistry, biochemistry, analytical chemistry, mathematics, chemical engineering, molecular and cellular biology, pharmacology, anatomy and physiology. It tries to gather the knowledge of pharmacy from China to western countries, run through the whole history of pharmacy and touch upon the introduction of the most important pharmacy subjects.Arguably, it is the most diverse of all the subject area in pharmaceutical science and encompasses. Specifically, the study includes the physical pharmaceutics (application of the basic physical chemistry necessary for the efficient design of dosage forms), biopharmaceutics (study of relevant drug delivery systems and how drugs arrive there following the drug administration), drug dosage forms design and compounding, pharmaceutical technology and pharmaceutical microbiology (avoidance and elimination of microorganisms in medicines). The course also includes the new pharmaceutical techniques and new dosage forms such as transdermal drug delivery system, nanoparticle drug delivery systems, traditional Chinese medicine drug delivery systems, solid dispersion technique, inclusion techniques and application techniques of new excipients.Pharmaceutics specifically explains the major considerations in the design of dosage forms: Physicochemical properties consideration The absorption of the drug in the body is strongly dependent on the resolution properties of the drug, such as degree of dissociation and speed of diffusion of the drug molecules. Knowledge of the flow properties of liquids is useful in solving certain problems relating to the manufacture and performance solutions and semi-solids as dosage forms in their own right. By far the majority of drugs are solid (mainly crystalline) powders and, unfortunately most of these have numerous adverse characteristics, the macroscopic properties of powders influence their performance of dosage forms. So, the characteristic must be considered during the design of medicines to enable their satisfactory manufacture and subsequent performance in dosage forms. Biopharmaceutical considerationThe administration route of a dosage form affects the absorption rate into the body, and therapeutic considerations of the disease state to be treated, which in turn in decide the most suitable type of dosage form, possible routes of administration and the most suitable duration of action and dose frequency for the drug. The factors influencing the bioavailability of a drug and methods of its assessment are described. It is concerned with a consideration of the manner in which the frequency of drug administration and the rate at which it is released affect its concentration in the blood plasma at any given time. Microbiology considerationIt is necessary to eliminate microorganisms from the product both before and during manufacture. Microbiology is a very wide-ranging subject. Pharmaceutics concentrates only on those aspects of microbiology that are directly relevant to the design, production and distribution of dosage forms. This mainly involves avoiding (asepsis) and eliminating (sterilization) the microorganism in medicines, and preventing the growth of any microorganism which might enter the product during manufacture, storage and use of the medicine. The principles and techniques of sterilization are discussed in pharmaceutics.Pharmaceutics will also tell us about the development of pharmacy, the responsibility and mission of a pharmaceutical practitioner and the direction to pharmacy professional subjects. The course fits all students who major pharmacy and teach the students how to master their profession study. Having gathered this understanding of the basics of pharmaceutics, the formulation scientist should now be equipped to begin a consideration of the design and manufacture of the most suitable dosage form for the drug in question.Part 4 Drug analysisDrug analysis has evolved from a technique of the 20th century into an ever-maturing science-the science of pharmaceutical analysis. By utilizing the methodologies and techniques in physics, chemistry, biology and microbiology, pharmaceutical analysis focuses on qualitative and quantitative analysis of drugs, quality control and development of new drugs. This science relates to a wide range of studies, including quality control, clinical pharmacy, analysis of traditional Chinese medicine and natural drugs, drug metabolic analysis, forensic toxicological analysis, doping control and formulation analysis, etc.Pharmaceutical science assumes the most important task in drug quality control, which involves physical and chemical inspection of finished drugs, quality control in drug production, quality observation in storage, quick analysis of preparations formulated in hospitals, establishment of quality standards in the R & D of novel drugs as well as the analysis of drugs in vivo.In the first aspect, it relates to physical and chemical testing, through which it is possible to judge whether the drug is in compliance with the quality standards before being marketed and used. During drug production, raw material, intermediate and by-products should be analyzed and monitored to ensure the quality of the final products. Quality examination should be performed on drugs in storage on a regular basis so that appropriate storage conditions and methods can be employed to guarantee the stability of the drugs in storage and use. Techniques of pharmaceutical analysis are also needed in quick analysis of the preparations formulated in hospitals to safeguard their quality.In the second aspect, apart from the studies on synthesizing route, pharmacology and toxicology as well as drug manufacturing technologies, studies on quality standards and stability are nevertheless necessary in the development of new drug. Based on the chemical structures, physicochemical properties and the potential negative impacts on quality, it is possible to design methods for the identification of counterfeit medicines, purity test and content assay and to establish quality standards for new drugs.Furthermore, in pharmacokinetics, bioavailability test of preparations, clinical pharmacology and clinical monitoring and adjustment of plasma concentration, methods and means of drug analysis are also needed to conduct qualitative and quantitative analysis of drugs in blood, tissues and organs, to understand in-vivo absorption, distribution, metabolism and excretion of drugs, and to investigate characteristics and mechanisms of action, thereby providing necessary information for rational drug use, detection of active metabolites and discovery of lead compounds.Thus it can be seen that the methods and means of pharmaceutical analysis are indispensable in the development, production, storage, supply and application of drugs as well as clinical monitoring of plasma concentration. With the vigorous development of pharmaceutical sciences, the science of pharmaceutical analysis is facing increasing challenges from various related sciences. Instead of being only limited to static quality control of drugs, it has developed into a comprehensive and dynamic analytical study on drug manufacturing, in-vivo dynamics and metabolism.Part 5 PharmacognosyThe word “pharmacognosy” is derived from the Greek words “pharmakon” (drug), and “gonsis” or “knowledge”. Pharmacognosy is a study of drugs that originate in the plant and animal kingdoms. Modern aspects of the science include not only the crude drugs but also their natural derivatives. Digitalis leaf and its isolated glycoside, digitoxin; rauwolfia root and its purified alkaloid, reserpine; and thyroid gland with its extracted hormone, thyroxin;are all part of the subject matter of pharmacognosy.In a broad sense, pharmacognosy embraces knowledge of the history, distribution, cultivation, collection, selection, preparation, commerce, identification, evaluation, preservation, and use of drugs and economic substances that affect the health of humans and other animals. Such economic substances extend beyond the category of crude and their derivatives to include a variety of commercial and medicinal products often requiring complicated methods of preparation: allergens, allergenic extracts, antibiotics, immunizing biologics, flavoring agents, and condiments. In a restricted sense, the definition on pharmacognosy implies a particular knowledge of methods of identification and evaluation of drugs.Part 6 BiopharmacyBiopharmacy is the study of biopharmaceuticals of those medical drugs produced with the aid if biotechnology or derived from life forms. These include proteins and nucleic acids that are used for therapeutic purposes among others. The term biopharmacology describes a field of research closely related to pharmacokinetics, sometimes called biopharmacy.Biopharmaceuticals are medical drugs produced using biotechnology. They are proteins (including antibodies), nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes, and are produced by means other than direct extraction from a native (non-engineered) biological source. The first such substance approved for therapeutic use was biosynthetic human insulin made via recombinant DNA technology. The large majority of biopharmaceutical products are pharmaceuticals that are derived from life forms. Small molecule drugs are not typically regarded as biopharmaceutical in nature by the industry.However members of the press and the business and the financial community often extend the definition to include pharmaceuticals not created through biotechnology. That is, the term has become an oft-used buzzword for a variety of different companies producing new, apparently high-tech pharmaceutical products.When a biopharmaceutical is developed, the company will typically apply for a patent, which is a grant for exclusive manufacturing rights. This is the primary means by which the developer of the drug can recover the investment cost for development of biopharmaceutical. The patent laws in the United States and Europe differ somewhat on the requirements for a patent, with the European requirements are perceived as more difficult to satisfy. The total number of patents granted for biopharmaceuticals has risen significantly since the 1970s. In 1978 the total patents granted was 30. This had climbed to 15,600 in 1995, and by 2001 there were 34 527 patent applications.Within the United States, the Food Administration (FDA) exerts strict control over the commercial distribution of a pharmaceutical product, including biopharmaceuticals. Approval can require several years of clinical trials, including trials with human volunteers. Even after the drug is released, it will still be monitored for performance and safety risks.The manufacture of the drug must satisfy the “current Good Manufacturing Practices” regulations of the FDA. They are typically manufactured in a clean room environment with set standards of the amount of airborne particles.Classification of biopharmaceuticals:Blood factors (Factor and );Thrombolytic agents (tissue plasminogen activat
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