pharmaceutical preparation
Pharmaceutical preparation majors train senior scientific and technological talents with basic theoretical knowledge and basic experimental skills in pharmacy, pharmacy and pharmaceutical preparation engineering, who can engage in research, development, process design, production technology improvement and quality control in pharmaceutical preparations and related fields.
development status
Development of new preparation varieties
In addition to tablets, capsules and other commonly used dosage forms, it is an important aspect to develop new preparations from various dosage forms, new ways and new methods to improve drug efficacy, reduce side effects and improve patient compliance. For example, estradiol, progesterone and megestrol acetate are developed into soft capsules, salbutamol sulfate and other drugs are developed into nasal administration preparations and atomized inhalers, and acyclovir and cyclosporine are made into slow-release preparations and microemulsion preparations respectively.
Preparations for children and the elderly, such as drops and suppositories, and preparations for otorhinolaryngology, such as dental floss, nanoparticles, gum, eye glue, instant and quick-acting preparations, are all preparations with therapeutic or technical characteristics. In addition to dispersible tablets, there are many dosage forms that can achieve immediate results. Such as soft capsules and drops containing water-soluble drugs, soluble inclusion compound preparations, solid dispersion preparations, soluble tablets and the like.
The research of compound preparation is also an important direction of foreign preparation industry. A large number of OTC drugs are compound preparations. Compared with the development of common preparations, there are few compound preparations in China, and the development of compound preparations should have sufficient clinical medication basis and pharmacodynamic basis, and the development of compound preparations for treating critical diseases should be fully investigated. The development principle is to have synergy and reduce side effects.
Development of oral sustained and controlled release preparations
There are more and more sustained and controlled release preparations, and the requirements for their technology and quality are getting higher and higher. Foreign countries put forward higher requirements for the development of this kind of preparations, that is, from only requiring stable blood concentration to improving the curative effect of patients in disease state. There are three key problems to be solved in developing this kind of products: ① Can the preparation improve the therapeutic value? That is, can the preparation have the release speed, release time, location or target required for treatment? ② How does this preparation meet the above requirements? That is, are the above drug release characteristics optimized? Is the correlation between pharmacokinetics and pharmacodynamics obtained through pharmacodynamic and pharmacological experiments, especially in disease state? ③ Is the dosage form and process selected for this preparation the most suitable for the above characteristics? Whether it includes comprehensive consideration of economy, convenience of medication and formulation of dosage plan. According to this standard, only a few sustained and controlled release preparations meet the requirements.
However, according to the current development, the varieties of slow and controlled release have greatly increased. Many drugs with strong effects, drugs with short or long half-lives, antibiotics and addictive drugs are made into sustained-release preparations to adapt to special medical applications. It is an important trend in the future to develop sustained-release and controlled-release varieties, compound sustained-release and controlled-release preparations and liquid sustained-release and controlled-release preparations with daily administration 1 time.
Injection form
1, microspheres for injection The main purpose of developing microspheres for injection is to achieve sustained release and long-term effect. 1986 ipsen, France, intramuscular injection of triptorelin-polylactic acid-glycolide microspheres; Since then, leuprorelin acetate, Duanlin from Bscher and Mitraline intramuscular injection microspheres have come out one after another. Other microsphere preparations under study include subcutaneous injection of growth hormone releasing factor (GRF) nanoparticles, carboxyl camptothecin n-butyl cyanoacrylate nanoparticles, testosterone microspheres and so on.
2. Liposomes for intravenous injection. Liposomes of various anticancer drugs have been studied, including adriamycin, amphotericin and daunorubicin. The production of extrusion freeze-drying equipment and the inclusion of blank liposomes are important technical improvements to develop liposomes. It is reported that various cytokines, such as IFN-γ, IL- 1 and TNF-α, are embedded in liposomes. Intravenous injection can achieve sustained release effect, change the distribution characteristics in vivo, make it easier to enter cells, improve receptor sensitivity and enhance cytotoxicity. It is worth mentioning that liposomes are used as vectors for gene therapy. Liposomes can carry various gene fragments, protect genes from being degraded by nucleases, fuse lipids with cell membranes, and introduce target genes into cells. Liposome-mediated gene transfer has been approved by American Cancer Society as the first choice for clinical gene therapy.
3. One of the main goals of WHO's vaccine development plan is to vaccinate controlled-release vaccine preparations at one time, achieve complete immunization, improve vaccination types and reduce vaccination costs. At present, the controlled release preparations of vaccines are mainly microspheres or other microparticle preparations. Through material selection and embedding degree. The release rate of vaccine can be controlled, such as rapid release, constant release and pulse release. The vaccines studied include toxoid vaccine, virus vaccine, nucleic acid vaccine and synthetic vaccine.
4. In recent years, the mature emulsion production technology and emulsion auxiliary materials have created conditions for the development and production of drug-containing fat emulsion. Such as etomidate, propofol, dexamethasone palmitate fat emulsion, flurbiprofen axetil ethoxyα-ethyl ester fat emulsion, prostaglandin E 1 fat emulsion, etc.
Nasal and pulmonary inhalation drug delivery system
The dosage forms studied include solutions and powders or microspheres; Generally, it is administered by spray and penetrates into the nasal cavity; Powder or microsphere has long retention time, good absorption, high drug content and small taking volume, which is beneficial to the stability of drugs; The use of absorption enhancers and enzyme inhibitors can improve the nasal absorption of drugs and prolong the retention time. FluMist is a kind of influenza vaccine administered by nasal cavity, which is composed of live vaccine. Flumist has stronger effect and longer protection than inactivated virus products. Three phases have been studied in the United States, and other varieties studied include vitamin B 12, nerve growth factor, salbutamol and so on.
Generally speaking, the first choice for lung inhalation system is small dose powder aerosol system. Dry powder inhalation avoids the degradation of drugs in solution, and micronization technology ensures that drugs will not stay in trachea or bronchus and enter lung tissue smoothly. Insulin inhalation therapy is a hot spot developed by many pharmaceutical companies. The second phase clinical trial of insulin lung inhalant jointly developed by inhalation therapy company and Pfizer has been completed. The results showed that inhalation of this product combined with oral metformin or sulfonylurea drugs can improve the blood sugar control of patients with type II diabetes.
Oral polypeptide and protein drug delivery system
1. The enteric-coated acrylic resin coating on insulin capsules or pellets can reduce the damage of gastric acid and some enzymes, realize local release, and release drugs at pH7.5-8.0.
2. Microspheres and nanospheres The preparation of insulin into microspheres of biodegradable or non-degradable materials less than 2μ m can not only reduce the destruction of drugs, but also slowly release drugs through the gap or Payer's junction formed after the cells at the tip of jejunum villi fall off, reducing the accumulation of blood sugar and glycogen. Poly (isobutyl nitrile acrylic acid) microspheres with the size of 250-300nm can penetrate intestinal mucosa, including intercellular pathways and Payer's connected M cells within 30-60min.
3. Microemulsions, Multiple Emulsions and Liposomes A W/O insulin microemulsion of 65438 0.5 IU/kg was given to the duodenum of dogs, and the plasma concentrations of insulin in superior vena cava and inferior vena cava were determined. The results showed that the main route of oral absorption of microemulsion was lymphatic route. Oral insulin emulsion has a definite hypoglycemic effect on diabetic model mice. Liposomes, as carriers of oral protein and polypeptide drugs, are still under study, including insulin, glucose oxidase, coagulation factor V Ⅲ and various cytokines. It is reported that diabetic rats have significant hypoglycemic effect after oral administration of insulin liposomes.
4. Oral mucosa is used to absorb insulin and interferon, which quickly enters the mandibular vein of oral mucosa instead of blood circulation, avoiding liver metabolism. It is considered that the absorption degree of this mucosal absorption preparation has a great relationship with the preparation factors.
5. The application of penetration enhancers and enzyme inhibitors such as surfactants, fatty acids or bile salts can increase the permeability of mucus layer and epithelial cell layer and expand the intercellular space. The most commonly used oral absorption enhancers are bile salts and fatty acids. A promising penetration enhancer is protein toxin (ZOT) produced by a special bacterium, which is only effective on the receptors of small intestine and duodenum, but not on rectum and colon. Therefore, its intracellular channel function is safe, reversible, time-and dose-dependent, and limited to some parts. Protease inhibitors can inhibit the damage of gastrointestinal digestive enzymes to insulin. Commonly used enzyme inhibitors include sodium glycocholate, aprotinin, bacitracin, soybean trypsin inhibitor and so on.
Development trend of 2 1 century pharmaceutical preparations
1. The challenge of pharmaceutical chemistry to pharmacy. With the development of structure-activity relationship, combinatorial chemistry, biology and cell biology, the design of chemical drugs is more reasonable, the purpose is clearer and the success rate is higher. In the past, a large number of problems that needed to be solved by pharmacists, such as absorption, solubility and targeting, were all completed in the drug molding stage.
2. Programmatic and standardized formula and process design. With the standardization of excipients and computerization of pharmaceutical equipment, the formula and technology are controlled by artificial intelligence system, and most dosage forms and preparations are programmed, so that computer operators can solve problems that need to be solved by pharmacists.
3. Theory and technology of drug delivery system design: design of new oral sustained-release system, target discovery and location of targeted drug delivery system, design and methodology research of non-invasive other drug delivery systems.
4. The challenge of the rapid development of biotechnology to pharmacy: With the rapid increase of biological macromolecules, the demand for non-injection dosage forms is also increasing, especially the research on safe and noninvasive oral dosage forms and transdermal dosage forms is an important development direction.
5. Gene therapy vector system Gene therapy uses gene transfer technology to introduce foreign recombinant genes or nucleic acids into human target cells to correct gene defects or abnormal expression. Inactivated virus, liposome and other particles are common vector systems, and the design of this delivery system is an important link to realize effective gene transfer and smooth development.
6. Biochip has become an important part of pharmaceutical preparations. Biochip is a revolutionary breakthrough in the field of biomedicine. The standardization, accuracy and practicality of biochip have become a reality, and will be widely used in life science, medical research, environmental protection and agriculture. The appearance of biochip will accelerate the development of gene therapy and greatly improve the decoding speed of human genes. The perfect combination of biochip, computer chip and micro-transmission system will realize the integration of biosensor, information control and feedback and drug delivery.
7. Modernization of traditional Chinese medicine dosage forms The modernization of traditional Chinese medicine dosage forms depends on the organic combination of internal and external material basis, efficacy basis and traditional Chinese medicine theory.
basic requirement
1, professional students love the socialist motherland, support the leadership of China * * * production party, study Marxism, Mao Zedong Thought and Deng Xiaoping Theory hard, love medical science, and have the enterprising spirit of developing medical science and serving people's health; Strict scientific style, law-abiding, diligent and realistic; Have good ideological quality, social morality and professional ethics.
2. Have a solid basic theory, knowledge and skills of modern pharmacy; Master the basic theories and skills of medicinal chemistry, pharmaceutical analysis, pharmacy, pharmacology, chemical engineering principles, pharmaceutical engineering, etc. Have the ability to acquire knowledge independently and strong practical work ability.
3. Have extensive knowledge of humanities, social sciences and natural sciences, and have the cultural literacy that college students should have; Master a foreign language and be able to read foreign language books and periodicals of this major; Have the ability to analyze and solve problems and the quality to carry out scientific research; Able to use computer skillfully.
4. Master certain basic knowledge of sports and military affairs, and develop good habits of labor, physical exercise and hygiene; Meet the national standards for college students' physical education and military training; Physical and mental health, able to fulfill the sacred obligation of building and defending the motherland.
course
compulsory course
This major offers 29 compulsory courses, accounting for 2499 class hours. Among them, examination course 17 and examination course 12.
Public * * * class:
1, Principles of Marxist Philosophy (54 class hours); 2. Introduction to Mao Zedong Thought (36 hours); 3. Political Economy (40 class hours); 4. Deng Xiaoping Theory and Theory of Three Represents (70 class hours); 5. Ideological and moral cultivation (5 1 class); 6, legal basis (34 hours); 7. English (288 class hours); 8. Physical education (128 class hours); 9, computer culture foundation (108 hours); 10, College Chinese (54 class hours);
Professional basic courses:
1 1, higher education (80 hours); 12, physics (74 hours); 13, inorganic chemistry (82 class hours); 14, Organic Chemistry (156 class hours); 15, chemical analysis (82 class hours); 16, instrumental analysis (76 class hours); 17, Physical Chemistry (1 10 class hour); 18, human anatomy (40 class hours), 19, physiology (90 class hours); 20, industrial drawing (46 hours); 2 1, biochemistry (108 class); 22, medical mathematical statistics (50 hours); 23, microbiology and immunology (60 hours);
Professional courses:
24, medicinal chemistry (90 hours); 25, the principle of chemical engineering (70 hours); 26. Pharmacology (1 16 class hours); 27, pharmacy (144 hours); 28, pharmaceutical engineering (56 hours); 29, drug analysis (108 hours)
optional course
Elective courses are divided into limited elective courses and arbitrary elective courses, and students with limited elective courses must take them. Elective courses implement flexible credit system, that is, students can choose courses independently in the elective courses provided by the teaching plan and complete the required total credits.
Elective courses * * * offer 48 courses, 1 158 hours, with 64438+0 credits. Among them, there are 8 elective courses with 254 class hours; 40 elective courses, 904 hours. Students need to complete 26 credits before they are allowed to graduate.
Professional direction course module
This major has a special course module, which requires students to complete all courses of this major module, and they are not allowed to graduate until they pass the examination.
Pharmacy direction: * * 6 courses, 402 hours;
Pharmacognosy (80 hours), medicinal polymer materials (32 hours), natural medicinal chemistry (96 hours), introduction to clinical medicine I (diagnostics, internal medicine; 104 class hours), biopharmaceutics and pharmacokinetics (50 class hours), pharmacy management and GMP(40 class hours).
Graduation practice and graduation examination
In the eighth semester, students will be arranged to go to pharmaceutical factories, drug control institutes, medical research institutions and other departments for graduation practice, 16 weeks. Under the guidance of the tutor, he participated in the specific work of drug research, production and inspection, and finally completed his graduation thesis and passed the defense. Take the graduation exam (the content is professional knowledge) before graduation.
self-study course
There are 6 self-study courses in this major, and students are required to complete more than 3 courses by themselves. Only by passing the exam can they be allowed to graduate.
Self-study course:
Introduction to Pharmacy Introduction to Drugs Toxicology Chinese Patent Medicines
Introduction to nuclear pharmacy pharmaceutical paper writing
Quality training
1. Extracurricular academic activities: Students who participate in academic activities get certain credits.
(1) Writing academic papers: Students write academic papers and publish them publicly while in school. According to different grades of academic journals, each paper is given 1-5 credits;
(2) Participating in academic competitions: Students who write papers or participate in academic activities will be rewarded by the school and above, and each item (time) will be given 0.5-3 credits;
(3) Attending school-wide academic lectures: Students attend school-wide academic lectures and are given 1 credit every 8 times after confirmation by the organization department;
(4) Participating in extracurricular academic activities: Students will be given 1-2 credits if they participate in the second classroom activities officially approved by teachers' scientific research or projects for more than 30 class hours, which will be confirmed by relevant teachers and departments;
2. Extracurricular reading: Students read 30 or more books (non-teaching materials, including professional journals) during their school days, submit corresponding reading reports, and pass the acceptance, giving 2 credits.
3. Vocational skills training: During school, students take part in vocational training recognized by the state in their spare time, such as computer technology, driving technology, hairdressing technology and artistic skills. , and obtain the corresponding certificate, each certificate gives 1-2 credits.
The credits obtained from the above-mentioned quality development training can be offset by 70% of the credits required for elective courses.
Quality training course
In the form of playing audio-visual products or multimedia, the Academic Affairs Office arranges no less than 8 hours of content each semester. Students are free to listen and watch, and each time they will be given a study card. Before graduation, they will submit their study cards to the Academic Affairs Office for confirmation. You must complete 42 hours of study before you can graduate.
other
1, national defense education course (military training): the whole course is arranged 120 class hours (including 36 theoretical class hours), which is the responsibility of the school's armed forces department, and the passing system is implemented and recorded in the students' achievement files.
2. Social practice course: the whole course is arranged for 2 weeks, which is the responsibility of the school youth league Committee, and is usually arranged on holidays. Implement the passing system and record it in the students' achievement files.
3. Labor class: 60 class hours are arranged in the whole course, which is in the charge of the school's infrastructure and logistics management office, and the passing system is implemented and recorded in the students' achievement files.
National defense education (military training), social practice and labor are compulsory courses. Those who fail are not allowed to graduate, and their time (hours) is not included in the total hours.
Examination and score record
(a) compulsory courses (including courses in the professional direction curriculum module) compulsory examinations are divided into two categories: examination and assessment, and the scores are recorded with a percentage system. Examination courses usually account for 20~30%, and final papers account for 70 ~ 80%; The average score of examination courses accounts for more than 60%.
(2) Elective courses and self-study courses. , must be assessed by written examination, oral examination, discussion, submission of homework or papers. And report the results as passing or failing, and those who pass will be given corresponding credits and grade points.
(three) the national defense education course (military training), social practice course and labor course are assessed, and the responsible department reports the results according to the passing or failing grade one semester before graduation.
Length of schooling and years of study
(1) academic system: this major implements the academic year credit system, that is, compulsory courses implement the academic year system and elective courses implement the credit system.
(2) Length of study: The standard length of study for this major is four years.
Graduation and degree awarding
1. Graduation: All students who have a formal school status, meet the requirements of training objectives, have completed all the courses specified in the teaching plan, have passed the grades, have completed the required credits in elective courses, have reached the qualified standards specified by the school in foreign languages and computer knowledge, and have passed the graduation thesis and graduation examination are allowed to graduate, and graduation certificates are issued.
2. Degree awarding: Students who have obtained graduation certificates meet the requirements for awarding bachelor's degrees in Dali University, and are awarded bachelor's degree of science after evaluation by the Academic Degrees Committee.
Teaching arrangement
The whole course of this major is * * * arranged 199 weeks, including teaching 158 weeks (including class 126 weeks, examination and maneuver 16 weeks, graduation practice 16 weeks); Labor category 1 week; Military training for 2 weeks; Social practice for 2 weeks; Entrance education and graduation education for 2 weeks; Vacation is 34 weeks.
This major implements the semester system, each semester is 20 weeks (including 18 weeks of classes, 2 weeks of exams and maneuvers), and the two semesters are one academic year. The whole learning process is 4 academic years and 8 semesters.
Description of course arrangement:
1. Organic chemistry is offered in the second and third semesters. In the second semester, the theoretical class is 70 hours and the experimental class is 50 hours. In the third semester, the theoretical class lasts for 36 hours.
2. Medicinal botany is limited to elective courses, including 24-hour experimental courses.
3. In the seventh semester, 30 probation hours were arranged in pharmaceutical factories and drug control institutes, and 10~ 14 students were arranged as probation groups.
4. In the eighth semester, arrange students to go to pharmaceutical factories, drug control institutes, medical research institutions and other departments for graduation practice, 16 weeks. Under the guidance of the tutor, he participated in the specific work of drug research, production and inspection, and finally completed his graduation thesis and passed the defense.
Knowledge and ability
1. Master the basic theories and knowledge of physical chemistry, medicinal chemistry, medicinal polymer materials, industrial pharmacy, preparation equipment and workshop process design;
2. Master the preparation research, formulation design and improvement, and process design of pharmaceutical preparation production;
3. Have the preliminary ability of pharmaceutical preparation research and development, dosage form design and improvement, and pharmaceutical preparation production process design;
4. Familiar with the regulations and policies of pharmaceutical affairs management;
5. Understand the development of modern pharmaceutical preparations;
6. Master the basic methods of literature retrieval and information inquiry, and have preliminary scientific research and practical work ability.
pharmaceutical specialty
Pharmacy majors train senior scientific and technological talents with basic pharmaceutical theories, basic knowledge and experimental skills, who can engage in identification, drug design, common pharmaceutical preparations and clinical rational drug use in the fields of drug production, inspection, circulation, use and research and development. Business training requirements: students in this major mainly study the basic theories and knowledge of the main branches of pharmacy, receive basic training in pharmaceutical experimental methods and skills, have the basic ability of drug preparation, quality control and evaluation, and guide rational drug use.
Curriculum design of pharmacy specialty
Main subjects: pharmacy, chemistry, biology.
Main courses: organic chemistry, physical chemistry, biochemistry, microbiology, medicinal chemistry, pharmacy, pharmacology, pharmaceutical analysis, pharmaceutical affairs management, introduction to clinical medicine.
Main practical teaching links: including production practice and graduation thesis design. , generally arranged for about 22 weeks.
Study time: four years
Degree award: Bachelor of Medicine or Science.
Similar major: cultivation and identification of pharmaceutical Chinese herbal medicines; Development and application of Tibetan medicine resources; Pharmacy; Mongolian medicine; Pharmacy management pharmacy.
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Employment prospect of pharmacy specialty
There is a growing demand for pharmaceutical talents in society, and the employment rate of college students in this major is as high as 95%. With the rapid development of the pharmaceutical industry, especially after the improvement of living standards, people's demand for health care products is increasing, and enterprises prefer pharmaceutical talents. Another piece is biochemical drugs, which is a new frontier industry with good development prospects.
Pharmaceutical graduates are mainly assigned to pharmaceutical factories and pharmaceutical research institutes to engage in various drug development, research, production quality assurance and rational drug use, and many of them are engaged in drug sales agents.
Analysis of Unique Career Consultants: Pharmacy is one of the fastest growing categories in the world's major economic fields, and the annual economic growth rate of pharmaceutical enterprises has been higher than the national economic growth rate. And because it is related to everyone's health, it has been paid more and more attention by the state and society. The pharmaceutical industry in China has also developed very rapidly in recent years. Many drugs have been recognized by the international market and established cooperative relations with foreign enterprises. However, the shortage of professional talents shows that pharmacy has broad prospects for development. Professions engaged in drug development and research have very high requirements for professional ability, and correspondingly higher requirements for academic qualifications. Engaged in production quality assurance, the requirements for academic qualifications are not so high, but the requirements for relevant professional knowledge are still very strict. In contrast, the professional requirements of sales work are lower, and sales ability is more important.
Looking for a job depends not only on your major, but also on your own different situation. You should consider your own ability, specialty, personality and popularity. Don't take the pharmaceutical R&D industry as the object of employment just because of the high salary, measure whether your various abilities meet the requirements, and then make a preliminary understanding of the specific work of this profession to see if your personality is suitable.