Unit 1 Green pharmacy-herbal medicine1) Plant kingdom once was mere pharmacy of the human race, but now when you get into the modern pharmacy, plant-derived drugs have been hardly found.2) Although today the number of plant-based drugs has been decreased, the effective chemicals in many tables, capsule and bottle-contained drugs are originated from plant kingdom.3) Among chemical substances contained in plants, some must be toxic, but some must be drugs available to us.4) During the millions of years since man came to the earth, he has been doing experiments on a variety of plants about him.5) There exist mistrust, suspicion and hostility between the orthodox medicine and herbal practitioners for many years, which are threatening the possibility of establishing good working relationship.6) When we think of the effectiveness of quinine, the great contributions made by herbal medicine to medical science are quite evident.7) However, in the past few decades, the number of newly-introduced drugs has obviously decreased.8) The medical legacy of our motherland is an inexhaustible new-drug treasure, which remains us to tap with new methods.9) If pharmacological method had not been introduced to the study of vinca rosea, the discovery of vincaleukoblastine would have been postponed by many years.10) Western medicine hardly believes that someone who knows nothing of a disease mechanism could be capable of curing it.Unit 2 How does human body fight disease?People tend to believe that antibiotics were invented by human being, but in fact, they are purely natural products. Since Alexander Fleming, a British biologist discovered anti-microbial substance released by the Penicillium fungi in 1928, it has been learned that this substance can produce powerful antibiotic effect. In fact, antibiotics, are exactly manufactured by organisms, namely, bacteria and fungi, which people aim to destroy. After Fleming’s discovery of penicillin, Selma Walksman in 1943 isolated Streptomycin from a soil bacterium, Streptomycus griseus. Scientists have not made it clear completely why organisms can produce antibiotics. This question has become the topic for discussion.Why antibiotics are useful in medicine is that they can not only kill microbes, but also not kill the body cells as they do to the microbes, body cells are entirely different from those of bacteria cells, so that they can avoid being destroyed at the same time. Thus, antibiotics are called “magic bullet”because they may be particularly used to aim at certain microbes. This feature of antibiotics also makes them essentially different from anti-microbial agents: the latter tends to have poison to a majority of cells, whether the cells of bacteria or the body cells.Unit 3 Drug dependenceStudies indicate that drug dependencies both a health problem and a social concern. The drug dependence affects not only individual’s health but also the public health at the same time. The drug use has obviously and severely negative effects on the human brain and physical health. But drug abuse and addiction have huge and potential threat, because whether the drug is used directlyor indirectly has become the main transmitting ways for many severe communicable diseases, AIDS, hepatitis and pulmonary tuberculosis in particular, plus violent behaviors, etc. The drug addiction is such a complicated and widely health-associated problem that we must duty-boundly put the measures about the public health, extensively-launched education, prevention, treatment and scientific research into our total strategy. Science is offering the foundation to the exploration of public health, which keeps the opposite attitude to the extensively-accepted point of view. It thinks that the drug dependents are made to lose all abilities by drugs, so they cannot rectify their own behaviors. It also offers the suggestions of the foundation for revising the total strategy, so as to reduce the negative effects produced by injection of drugs on the individual and society.Unit 4 The scope of pharmacology1) The science that drugs act on the human body is known as pharmacology, while the scientists who studies this science is called pharmacologist.2) Pharmacology is not a science which can be studied alone, but one that is closely related to other sciences.3) Pharmacologist should not only learn the normal reaction process, but also know how the functions of the human body are affected by diseases.4) If the drug is properly used, it will be a boon to the human race, if not, it will destroy the human race.5) In the first half of the 20th century, the fantastic development has been achieved in the pharmacological field.6) The human race makes constant efforts not only for increasing life expectancy, but also for more healthy life.7) If a patient, the old in particular, constantly uses more than one therapeutic agent, the correlation of the drugs causing toxin tends to occur.8) The clinician is interested primarily in the drugs that are useful in the prevention, diagnosis, and treatment of human disease.9) As most of the natural drugs are now highly purified and differ little from synthetic chemical drugs, the interests of the clinicians in pharmacognosy are correspondingly limited.10) Pharmacodynamics, as a border science, borrows greatly from both the subject matter and the experimental techniques of physiology, biochemistry, microbiology, immunology, genetics, pathology and so on.Unit 5 Combinatorial chemistry and new drugs1) To fight against disease, the immune system generates proteins known as antibodies that bind to invading organisms. But the real case is that the immune system is not to develop a specialized antibody each time it is faced with a new pathogen. In fact, the immune system select the most effective one by mass screening of its antibody repertoire, thus identifying the ones that work best.2) In a process called combinatorial chemistry, chemicals generate a large number of related compounds and then screen the collection for the ones that could have medicinal value.3) In a parallel synthesis, chemists often use a so-called microtiter plate to assemble all the products separately in their own reaction vessels.4) A parallel synthesis and a split-and-mix synthesis are different with that in a parallel synthesis, all the products are assembled separately in their own reaction containers, while in a split-and-mixsynthesis, the related compound are mixed up in the same reaction vessel, which reduces the number of containers required.5) At the end of a split-and-mix synthesis, all the molecules attached to a single bead are found to be of the same structure. Chemists pull out from the mixture the beads that bear biologically active molecules and then, use sensitive detection techniques to determine the molecular makeup of the compound attached.Unit 6 Drug discovery and natural products1) Plant natural products have had, and continue to have, an important role as medicinal and pharmaceutical agents, not only as purified isolates and extractives, but also as lead compounds for synthetic optimization.2) Plant secondary metabolites also show promise for cancer chemoprevention, which has been defined as “the use of non-cytotoxic nutrients or pharmacological agents to enhance intrinsic physiological mechanisms that protect the organism against mutant clones of malignant cells”.3) Nevertheless, the vast majority of the world’s quarter of a million plant species has not been evaluated in pharmaceutical screens, and the small percentage that has been tested has generally been screened for activity against only a few therapeutic targets.4) Although many sampling programs designed to generate large numbers of samples for high-throughput screening programs have been characterized as random, it has been shown that they are neither truly random nor haphazard, but that sampling occurs without preconceived selection of species.5) Three main research approaches are used in drug discovery and development processes：（1）bioactivity- or mechanism of action directed isolation and characterization of active compounds, (2)rational drug design-based modification and analog synthesis, and (3)mechanism of action studies.Unit 7 New drugs and drug delivery systems1) Every drug has its innate pharmacological characteristics. With the right dosage, frequency of administration and route of administration, most patients can get the expected pharmacological eficacy.2) But to different patients, there may be certain ,or even very obvious differences. Patients’physique, quality of drug, microorganisms and environmental factors can all affect drug fuctioning. They can enhance or decrease drug efficacy.3) The main factors that produce individual differences are the differences in drug absorption, distribution, biotransformation and elimination.4) In order to achieve the goal of maximum efficacy and minimum side effect for every patient, it is far from enough just to select drugs according to their pharmaceutical functioning.5) Other factors that influence the efficacy of different drugs must be taken into account, and appropriate therapies should be made according to the particular conditions of different patients. These therapies must be adjusted in time in the course of treatment to conform to patients’changed conditions until they recover.Unit 8 What analytical chemists do ?1) Analytical chemistry aims to resolve two questions:what it is and how much it is, that isqualitative analysis and quantitative analysis. Qualitative analysis is to identify the elements, ions and compounds contained in a sample while quantitative analysis is to determine the exact quantity.2) Analytical chemistry has expanded beyond the bounds of just chemistry, and many have advocated using the name analytical science to describe the field. Even this term falls short of recognition of the role of instrumentation development and application. One suggestion is that we use the term analytical science and technology.3) Analytical chemists work to improve the reliability of existing techniques to meet the demands for better chemical measurements which arise constantly in our society. They adopt proven methodologies to new kinds of materials or to answer new questions about their composition and their reactivity mechanisms.4) Qualitative tests may be performed by selective chemical reactions or with the use of instrumentation. For example, the formation of a white precipitate when adding a solution of silver nitrate to a dissolved sample indicateds the presence of chloride. Infrared spectra will give “fingerprints” of organic compounds or their functional groups.5) The first phase in the testing of banned substances is called fast-screening phase, in which qualitative analysis such as GC or LC is adopted to test suspicious samples. In the second phase, GC-MS is employed for further testing of those suspicious samples. Finally, spectrophotometry or GC is applied for accurate quantification.Unit 9 Nonclinical development of biopharmaceuticals1) The development of a new therapeutic agent involves a multidisciplinary group in many years of work, and with the development of genetic engineering and the production of monoclonal antibodies, it is likely that even more agents should be produced.2) The activity of biopharmaceuticals depends on their complicated conformation based on secondary, tertiary and quaternary structures. These structures cannot be fully defined with our present set of analytical techniques and approaches for potency testing.3) Apart from the intravenous route of drug administration, where a drug is introduced directly into the blood circulation, all other routesof adminstering systemically acting drugs involve the absoption of drug from the place of adminstration into the blood.4) Biopharmaceuticals are pharmaceutical products consisting of (glyco)proteins, and they have a number of characteristics that set them aside from low molecular weight drugs.5) In safety testing and clinical test programs of biopharmaceuticals, questions have to be addressed regarding species specific responses, selection of dosing schedules and route of administration, and the possible occurrence of immunogenicity.Unit 10 The package insert and prescription1) The information the package insert contains is derived from data supplied by investigators and submitted by pharmaceuticalfirm to the FDA, including the chemical structure of the drug, a summary of its pharmacological and toxicological action, its clinical indications and contraindications, precautions, reported adverse reactions, dosage recommendations, and available dosage forms.2) The physician may exercise his professional judgment in the use of any drug. However, if he deviates from the instructions in the package insert and adverse reactions occur, he must beprepared to defend his position in court if there is a malpractice suit.3) If a severe reaction occurred and litigation followed, how would a court react if a physician admitted to the use of this drug for the treatment of some diseases in view of the prohibitions in the package insert? Would the published clinical study, plus the physician’s judgment in prescribing the drug, suffice?4) The FDA cannot requirea pharmaceutical firm to include a new use for the drug product in the insert even if it has been clinically tested and found useful for a given problem. But, if a new use for a drug is not yet included in the package insert, the manufacturer cannot advertise his product for that particular use.5) Today, the FDA’s regulatory scope and authority include ensuring the safety and purity of foods, drugs, medical devices, nutritional supplements, vaccines and cosmetics. Of particular concern to the anesthesiologist is the timely access to drug evaluation, pharmacologic, and medical device data. With the dramatic upsurge in the number of new prescription drugs and over-the-counter supplements, the need for up-to-date drug information has never been more crucial.Unit 11 Development od new drugs(1)1) Formerly, drugs were extracted from natural plant and animal sources. Therapeutic use was empirical and based on traditional experiences.2) The strategies of the drug research include occasional discoveries, random molecular combination, and a planned research of synthesis of a certain specific chemical element.3) Although this is a ideal method of the development of new drugs, it is expensive and there is no guarantee of success.4) When a drug is used by millions of people, it is sure to develop unhealthy response, though this harm is not too big to particular people.5) Most drugs have a maximum safe dose, if the dose exceeds the limited extent, it will produce toxic side effects.6) Penicillin, one of the most powerful bacterium-killers in the world, was incidentally discovered by Fleming.7) The pharmacological experiment of a new drug will determine whether the drug has the desired medicinal functions in model systems.8) The addition of awareness of the biochemical mechanism will make the development of new drugs more rational.9) Extensive formal toxicological tests are required before new drugs can be used on patients.10) Now chemists and biologists attach importance to research fields of molecular biology, biochemical pharmacology, and so on.Unit 12 Development od new drugs(2)1) The rationale for the development of new drugs should be to provide better drugs, better in the sense of being either more effective, safer or cheaper.2) The promotion representative of the pharmaceutical manufacturer has been trained to promote a certain new product.3) The clinical evaluation of new drugs should be made after the study on animals proves effective.4) A new drug evaluation in man can be considered in four phases, each of which should be doneunder the strict supervision.5) Dose-ranging study should only be performed in volunteers who are informed about the implications of the tests, and who give their consent freely.6) As dose-ranging study may have a certain dangerous nature, it can only be carried out under medical supervision.7) A large scale of clinical trials in phase 3 will establish the new drug’s profile of action and frequency of adverse effects.8) The large cost of the drug development is borne by the pharmaceutical industry, which justifiably expects to recoupe it when the product is finally marketed.9) Information about new drugs published in well-established journals is more believable than the introductions by the representatives living on promotion.10) Heavy investment used in promotion of new drugs has not only led to the use of undistinguished new drugs but also raised the cost of the drugs.Unit 13 The impact of pharmaceutical care on drug therapy1) The focus of pharmaceutical care is to optimize drug therapy, minimize drug-related problems, and improve self-management for the purpose of achieving the optimal outcome to improve the patients’ quality of life.2) Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia resulting from defects in insulin secretion, insulin action, or both. Ultimately, it is likely to lead to complications.3) The Pharmaceutical Care process for the patients in the Intervention Group consists of three sections. One of them is provided at hospital, then seamless care at the time of discharge from hospital and the last in the ambulatory setting.4) Pharmaceutical care has a clear benefit and positive impact on patient’s HRQoL, which is feasible in the hospital and in the community setting.5) The result of the study demonsreates that patients who do not receive intensified PC have a higher chance of deteriorationg their quality of life.Unit 14 FDA’s responsibilities and activities1) Before a new drug goes to the market and is widely used, the manufacturer should get the license from the corresponding authorized government agency(Drug Safety Commiittee in Britain; Food and Drug Administration in USA;Medical Products Agency in Sweden and etc).2) The new drug probably has been taken by more than 3000 healthy volunteers or patients in controlled studies before marketed unless it is only designed for some orphan diseases in small scale trials.3) At the present stage, most of the pharmacological effects are well-known and the side effects caused by overdosages have been documented. However, the recognition of unpredicted toxic and side effects are rarely known by humans until after the extensive use of the drugs.4) Continuous use of beta receptor blocking drug practolol for a comparative period of time may produce a syndrome of ocular mucosa and dermis, which had been discovered after several years.5) In similar manner, when thalidomide was discovered to make pregnant women who had taken the medicine during their early pregnancy bear babies with limb deformity, it had been sold on market for a few years.Unit 15 Good manufacturing practices(GMP)1) GMP is probably the most widespread quality system followed across the pharmaceutical industry as a whole. GMP compliance is a requirement within the R&D environment for the manufacture and testing of clinical trial materials (both drug product and API) and for commercial manufacture and testing of these materials.2) Although the FD&C Act requires all drugs (products and APIs) to be manufactured to cGMP, the regulations 21CFR parts 210 and 211 are only mandatory for the manufacture of drug products and not APIs. It is only with the issue of ICH Q7 A that the worldwide pharmaceutical industry finally received detailed guidance for manufacture of APIs for boh commercial and R&D purposes.3) There have been distinct and fundamental differences between USA regulation and EU/UK requirements for GMP. The US required all drugs to be made to GMP requirements and performed inspections throughout the world in support of these requirements. In the UK, only drug products and biological manufacturers (not APIs, except some specified antibiotics) were inspected by the regulatory authority fot compliance to GMP.4) An API is normally prepared by chemical processes and even if purification is involved at each stage of manufacture, impurities in APIs can not be removed thoroughly. Therefore, trace impurities are allowed to be present in drug product to a limited extent.5) Harmonization with the US through a Mutual Recognition Agreement（MRA）is seen as a big saving of inspection resources to both the EU and the USA, through mutual acceptance of API facility inspection reports.。
