Medical paper model article 1
Analysis on the development of new biopharmaceutical technology
[Abstract] Biotechnology drugs are an industry that integrates advanced technologies of biology, medicine and pharmacy, based on high technologies such as combinatorial chemistry and pharmaceutical genes (functional antigenicity and bioinformatics), and backed by breakthroughs in basic disciplines such as molecular genetics, molecular biology and biophysics. This paper analyzes that the creation of new biopharmaceutical technology can greatly broaden the space of new drug invention and increase the opportunity and speed of new drug invention.
[Keywords:] Analysis of new biopharmaceutical technology
Biotechnology drugs, or biopharmaceuticals, is an industry that combines advanced technologies of biology, medicine and pharmacy, relying on high technologies such as combinatorial chemistry and pharmaceutical genes (functional antigenicity and bioinformatics), and backed by breakthroughs in basic disciplines such as molecular genetics, molecular biology and biophysics.
Biopharmaceutical technology
At present, biopharmaceuticals are mainly concentrated in the following directions:
1, tumor
Cancer mortality ranks first in the world. In the United States, 6,543,800 patients are diagnosed with tumors and 547,000 people die of tumors every year. The cost of cancer treatment is $6543.8+$02 million. Tumor is a complex disease with many mechanisms. At present, early diagnosis, radiotherapy and chemotherapy are still used for comprehensive treatment. In the next 10 year, the number of anti-tumor biological drugs will increase sharply. Such as the application of genetically engineered antibodies to inhibit tumors, the application of fusion toxins targeting IL-2 receptors to treat CTCL tumors, and the application of gene therapy to treat tumors (such as application? Interferon gene therapy for myeloma). Matrix metalloproteinase inhibitors can inhibit the growth of tumor blood vessels and prevent tumor growth and metastasis. These inhibitors may become broad-spectrum antitumor agents, and three compounds have entered clinical trials.
2. Neurodegenerative diseases.
Insulin growth factor rhIGF- 1 has entered the third stage of clinical treatment for Alzheimer's disease, Parkinson's disease, stroke and spinal trauma. Nerve growth factor (NGF) and BDNF (brain-derived neurotrophic factor) have been used to treat end-stage neuritis and amyotrophic sclerosis, and both of them have entered phase III clinical practice. There are 600,000 stroke patients in the United States every year, and the number of people who die from stroke reaches 1.5 million. There are not many effective drugs to prevent and treat stroke, especially those that can treat irreversible brain injury. Cerestal has been proved to significantly improve and stabilize the brain power of stroke patients, and has now entered the third phase of clinical practice. Genentech's thrombolytic active enzyme (Activase recombinant tPA) can be used for the treatment of stroke patients, which can eliminate symptoms by 30%.
3. Autoimmune diseases.
Many inflammations are caused by autoimmune deficiency, such as asthma, rheumatoid arthritis, multiple sclerosis and lupus erythematosus. There are more than 40 million patients with rheumatoid arthritis, and the annual medical expenses reach hundreds of billions of dollars. Some pharmaceutical companies are actively dealing with this disease.
4, coronary heart disease.
In the United States, 6.5438 million people died of coronary heart disease, and the annual treatment cost is higher than 654.38+0.65438+0.7 billion dollars. In the future 10 years, drugs for preventing and treating coronary heart disease will be an important growth point of the pharmaceutical industry. Centocor？ SReopro successfully used monoclonal antibodies to treat angina pectoris and restore cardiac function of coronary heart disease, which marked the promotion of new drugs for coronary heart disease.
With the establishment of genome science and the maturity of gene manipulation technology, it is possible to commercialize gene therapy and gene sequencing technology, which is reaching a new height in future therapeutics. Transgenic technology is used to construct transgenic plants and animals, and has gradually entered the stage of industrialization. Using transgenic sheep to produce protease inhibitor ATT to treat emphysema and cystic fibrosis has entered clinical phase II and III. A large number of research results show that transgenic animals and plants will become another important development field of pharmaceutical industry in the future.
Analysis of biopharmaceutical development
In the future, biotechnology will create more effective drugs for the treatment of contemporary major diseases, and form new fields in all frontier medical fields.
The revolution of biology depends not only on the development of biological science and biotechnology, but also on the technical trends in many related fields, such as MEMS, materials science, image processing, sensors and information technology. Although the rapid development of biotechnology makes it difficult for people to make accurate predictions, the progress in genome mapping, cloning technology, genetic modification technology, biomedical engineering, disease treatment and drug development is accelerating.
Besides genetics, biotechnology can continue to improve the prevention and treatment of diseases. These new therapies can block the ability of pathogens to enter and spread, make pathogens more fragile and make people's immune function respond to new pathogens. These methods can overcome the bad trend of pathogens becoming more and more resistant to antibiotics and form a new offensive against infection.
In addition to solving the traditional problems of bacteria and viruses, people are developing new treatments to solve the chemical imbalance and the accumulation of chemical components. For example, antibodies being developed can attack cocaine in the body and can be used to treat addiction in the future. This method not only helps to improve the situation of drug addicts, but also has a great impact on solving the problem of global illegal drug trade.
The emergence of various new technologies contributes to the development of new drugs. The combination of computer simulation and molecular image processing technologies (such as atomic force microscope, mass spectrometer and scanning detection microscope) can continuously improve the ability to design molecules with specific functional characteristics and become a powerful tool for drug research and drug design. Using drugs to simulate the interaction between drugs and biological systems will become an increasingly useful tool to understand the efficacy and safety of drugs. For example, the US Food and Drug Administration (FDA) used DennisNoble's virtual heart simulation system to understand the mechanism of action of cardiac drugs and the significance of clinical trial observation results in the drug approval process. By 20 15, this method may become the mainstream method for clinical drug trials of heart and other systems, and clinical drug trials of complex systems (such as brain) need more in-depth research on the functions and biology of these systems.
At present, the cost of drug research and development has reached an unsustainable level, and the average cost of each drug before listing is about 600 million US dollars. Such a high cost will force the pharmaceutical industry to invest heavily in technological progress to improve its long-term viability. The comprehensive application of gene map, customized drug development based on phenotype, chemical simulation program and engineering program, and drug trial simulation technology has changed drug development from experimental method to customized development, that is, designing, testing and using new drugs according to drug addicts' in-depth understanding of drug reactions. This method can also save drugs that were rejected by a few patients in clinical trials in the past, but may be accepted by most patients. This method can improve the success rate, reduce the test cost, open up a new market for drugs with narrow application range, and make drugs more suitable for symptomatic people. If this technology is mature, it can have a great impact on the pharmaceutical industry and the health insurance industry.
Three conclusions
In short, the creation of new technologies can greatly broaden the space for new drug discovery, and increase the opportunities and speed of new drug discovery through the comprehensive efforts of multiple disciplines. Because these methods can find the target of rapid identification of drug action, more new lead chemical entities can be found more effectively, thus providing a broader prospect for the invention of new drugs.
refer to
[1] Qiu, Analysis of New Pharmaceutical Technology, paper net, 2009, August.
Pharmaceutical model ii
Analysis on the present situation and development strategy of biopharmaceutical industry in China
This paper studies the present situation and development strategy of biopharmaceutical industry in China. The outstanding problems in China's biopharmaceutical industry are pointed out, such as insufficient innovation research, poor financing channels and chaotic industrial structure. In view of the existing problems, this paper puts forward corresponding solutions, including imitating innovation, broadening financing channels and standardizing management. The full text is compact in structure, hoping to promote the research on related issues.
Biopharmaceuticals; Development; reform
In recent 20 years, modern biotechnology, represented by enzyme engineering, cell engineering, fermentation engineering and genetic engineering, has developed rapidly, changing and influencing people's life and production methods day by day. Since the 1990s, with major technological breakthroughs such as genomics, the industrialization of biotechnology has been significantly accelerated. At present, two-thirds of biotechnology achievements have been applied to the pharmaceutical industry, which is used to improve traditional medicine or develop new drugs with characteristics, which has brought about major changes in the pharmaceutical industry.
1 Status of biopharmaceutical industry in China
1. 1 Overview China's biopharmaceutical industry started late. After more than 20 years of development, the research, development and industrialization of genetically engineered drugs have reached a certain scale. At present, there are more than 400 registered biotechnology companies in China, and one quarter of them have obtained the approval for trial production or production of genetically engineered drugs, which are mainly distributed in some economically developed provinces, cities and regions, such as Beijing, Shanghai, Zhejiang, Guangdong, Shandong and Jiangsu. In recent ten years, a large number of new specific drugs have been developed in China, which has greatly solved the problem that traditional methods can not be produced or the production cost is very expensive. These drugs can be used to prevent and treat difficult diseases that seriously threaten human health, such as heredity, heart, brain, lung, blood bamboo, immunity, tumor, endocrine and so on, and their effects in avoiding toxic and side effects are obviously superior to those of traditional drugs.
1.2 outstanding problems
1.2. 1 Lack of innovative research and development.
After joining the World Trade Organization, China must abide by the agreement on trade-related intellectual property rights. If a new drug is copied during the patent period, the developer has the right to claim compensation of 454.38 billion US dollars. For large international biopharmaceutical enterprises, R&D expenses can account for more than 20% of sales revenue. In this regard, China's biopharmaceutical industry has long been in a weak position.
The reason for the lack of innovation in domestic biopharmaceutical industry is that biopharmaceutical enterprises are relatively backward in R&D thinking. The process of new drug research and development follows the academic work method, starting with the literature index, but in fact it is still a road of imitation and lacks originality. On the one hand, most of the research results of the institute of science and technology are still stored in laboratories or safes; On the other hand, compared with product innovation, enterprises pay more attention to the transformation and improvement of existing products. The market conversion rate leading to innovation results is very low, which is still far from the demand of industrialization and scale.
1.2.2 Poor financing channels
As a high-tech industry, biopharmaceuticals need a lot of upfront capital investment because of its industrial characteristics. Therefore, in addition to the profit accumulation of enterprises and government funding, capital financing has become very important. Venture capital institutions play an important role in biopharmaceutical investment, but due to the unsatisfactory return on investment, investment has been greatly reduced in recent years, from comprehensive investment to key investment. Due to the obvious guiding role of venture capital, other investments are shrinking, which seriously hinders the development of biopharmaceutical industry in China.
1.2.3 chaotic industrial structure
China's biopharmaceutical industry has not formed a certain pattern, and product production has entered a barrier period. Domestic enterprises underestimate the market risk, and for some foreign best-selling products, there is a serious overcapacity, which leads to low-level vicious competition in the whole market. Except for the first few companies whose products were listed first, it is difficult for most companies to obtain a large gross profit margin, and some are even on the verge of loss.
2 China biopharmaceutical industry development strategy
2. 1 Imitation and innovation at the same time
There is only one truly valuable product in the pharmaceutical industry: medication for patients. Innovation is not only an academic process, but also a commercial process. Enterprise innovation should start from the demand first, and then find the function to meet this demand. Technical concept should be confirmed by function, and technical scheme should be considered by technical concept to reduce the technical risk of product development. In the pharmaceutical industry, the industrial chain is divided into upstream innovation stage, midstream material separation stage, product processing stage, downstream marketing planning stage and channel distribution stage. The research and development methods of biopharmaceuticals should be integrated, and the whole process from research and experiment to production to market should be integrated, and an integrated consortium of enterprises and research institutions should be established, so that technology, capital, market, talents and management can develop interactively and penetrate each other.
2.2 Broaden financing channels
Open capital market financing can provide capital channels for biopharmaceutical enterprises with mature products. However, for most enterprises in the initial stage or seed stage, it is difficult to get support from the indirect capital market due to the lack of stable cash, realistic commercial products and reliable solvency (such as creditor's capital provided by banks), and the heavy interest burden brought by high debt will greatly restrict the subsequent development of enterprises.
Foreign venture capital funds are gradually entering China. Multinational companies, including large biopharmaceutical companies and technology companies, use alliances to invest in biopharmaceutical enterprises in China, and China's own private equity funds and venture capital funds are developing. The Growth Enterprise Market is coming out, which will play a powerful role in promoting the development of biopharmaceutical industry in China. China's biopharmaceutical enterprises can effectively integrate financial and biopharmaceutical technologies only by enhancing their project operation capabilities, forming a comprehensive development chain around their growth, and then forming a good cycle of project operation.
2.3 standardized management
In international trade, developed countries in Europe and America, relying on their own economic and technological advantages, have formulated harsh technical regulations, technical standards and technical certification systems, which have greatly restricted the export transactions of developing countries. Pharmaceutical trade has also become one of the most commonly used technical barriers in European and American countries. The environmental safety awareness of domestic pharmaceutical enterprises is still very weak, and the number of internationally certified enterprises is also very small. Will it be formed in the export of pharmaceutical products in China in the future? Technical barriers? . Therefore, domestic biopharmaceutical enterprises need to clearly understand that standardized management is the fundamental way for domestic biopharmaceutical enterprises to break through technical barriers and improve commodity exports. Actively introduce and cultivate expert talents who are familiar with international rules and have practical experience in pharmacy, so that enterprises can reach the international advanced level.
refer to
[1] Dong,: When will the biopharmaceutical industry be sunny? China securities network.2010 (7) .45438+00-14
[2] China Statistical Yearbook. Beijing: China Statistics Publishing House.2009 (4) .20-40.
[3], Cai: On the inhibitory effect of technical barriers to trade and the countermeasures of China's export industry. International trade issues. 2008 (7)。
[4] Hu Ling spectrum, Huang Sujian. Key factors of success or failure of enterprise merger and acquisition. Economic Management. 2009 (3) .3-5
Pharmaceutical model 3
Talking about Adverse Drug Reactions and Safe Drug Use
Abstract: In recent years, there have been many reports and discussions about adverse drug reactions, which have attracted attention from all sides. Clinical requirements for drugs are not only limited to the therapeutic effect on diseases, but also require that the drugs used should treat diseases with as few adverse drug reactions (ADR) as possible. According to the WHO report, nearly 65,438+0/7 patients died of irrational drug use. In China, according to the statistics of relevant departments, the incidence of adverse drug reactions of inpatients is about 20%, and 1/4 is caused by antibiotics.
Every year, the economic loss caused by drug-resistant bacteria infection caused by abuse of antibiotics reaches10 billion yuan. Adverse drug reactions [1] refer to harmful and irrelevant reactions of qualified drugs under normal usage and prescribed dosage. With the development of medicine, the clinical requirements for drugs are not only limited to prevention and treatment, but also pay attention to the possible adverse reactions during use. How to use drugs safely and effectively has become a top priority. Rational drug use always goes hand in hand with rational treatment, which is an ancient and novel topic and an eternal topic for hospital pharmacists. The purpose of hospital pharmacy work is to serve patients as the center and promote clinical scientific medication based on clinical pharmacy, and its core is to ensure the safety of clinical medication. At present, it is recognized that the basic elements of rational drug use are: using drugs safely, effectively, economically and appropriately according to the systematic knowledge and theory of contemporary drugs and diseases.
Keywords rational drug use
Introduction:
With the development of society, how to use drugs safely, effectively and rationally has become a hot spot of social concern. In recent years, there have been many reports and discussions about adverse drug reactions, which have attracted attention from all sides. The clinical requirements for drugs are not only limited to the therapeutic effect on diseases, but also require the drugs used to treat diseases with as few adr as possible. According to the report of WHO, nearly17 deaths worldwide are caused by irrational drug use [1]. In China, according to the statistics of relevant departments, the incidence of adverse drug reactions of inpatients is about 20%, and 1/4 is caused by antibiotics. Every year, the economic loss caused by drug-resistant bacteria infection caused by abuse of antibiotics reaches10 billion yuan [2].
Rational drug use always goes hand in hand with rational treatment, which is an ancient and novel topic and an eternal topic for hospital pharmacists. The purpose of hospital pharmacy work is to serve patients as the center and promote clinical scientific medication based on clinical pharmacy, and its core is to ensure the safety of clinical medication. At present, it is recognized that the basic elements of rational drug use are: using drugs safely, effectively, economically and appropriately according to the systematic knowledge and theory of contemporary drugs and diseases [2].
Combined with clinical practice and literature, the common clinical adverse drug reactions and safe medication were discussed.
First, the abuse of antibiotics leads to irrational drug use.
Nowadays, frequent medical disputes, iatrogenic or drug-induced incidents and high medical and drug costs have become problems faced by most countries and regions. China also has many similarities in these aspects. The practice of rational drug use is difficult and slow, which has not attracted enough attention. In fact, adverse drug reactions have become the main killer of human health, and the abuse of antibiotics has become very common in China. According to some data, the utilization rate of antibiotics in inpatients in tertiary hospitals in China is about 70%, 80% in secondary hospitals and 90% in primary hospitals [3]. The abuse of antibiotics not only leads to the high utilization rate of drugs and the sharp rise of medical expenses, but also brings serious consequences to clinical treatment. At present, few doctors have a systematic and comprehensive understanding of antibiotics, and their use is very blind. They don't consider choosing antibiotics, don't pay attention to pathogenic examination, and are obsessed with? Foreign, new and expensive? Blind use of high-dose broad-spectrum antibiotics or simultaneous use of several antibacterial drugs leads to a large number of drug-resistant bacteria, more and more refractory infections and higher medical expenses. Many seriously infected people died in clinic, mostly because antibiotics were ineffective in drug-resistant infections. Antibiotics rank first in adr.
For example, more than 90% of upper respiratory tract infections are caused by viruses, but there are not a few clinical antibiotics. The consequence of abuse is that the drug resistance of bacteria increases and the effectiveness of antibiotics decreases.
Even lost, eventually leading to no medicine available to human beings; Microscopically, it will cause drug-induced damage to the patient's body. Because there are many flora in the human body, under normal circumstances, they restrict each other and form a balance, and the abuse of antibiotics may cause damage to some beneficial flora, making some harmful bacteria or viruses take advantage of it, leading to double infection and even death. In addition, the clinical division is too detailed, and doctors lack correct knowledge of antibacterial drugs; It is difficult to obtain correct drug information; Doctors' lack of comprehensive pharmaceutical knowledge is also an important reason for medication errors. For a long time, people have become accustomed to taking antibiotics as a standing medicine at home when they have a slight headache and brain fever. However, some patients take the initiative to prescribe good drugs and expensive drugs, which leads to waste of resources and bacterial resistance.
It can be seen that rational drug use is not only a medical problem, but also a problem that clinicians need to pay attention to. To achieve rational drug use, doctors, patients, pharmacists and drug management departments need to cooperate with each other.
Second, improve self-protection awareness and prevent the occurrence of adverse drug reactions.
The causes of adverse drug reactions are very complicated and difficult to predict. Mainly including drug factors, patients' own factors and other factors.
2. 1 drug factors (1) the function of the drug itself: if a drug has more than two functions, one of them may become a side effect. For example, ephedrine has both antiasthmatic and excitatory effects, which can cause insomnia when used to prevent and treat bronchial asthma. (2) Adverse drug effects: Some drugs themselves are harmful to some tissues and organs of the human body. If glucocorticoids are used in large quantities for a long time, it can cause capillary degeneration and bleeding, leading to petechiae and ecchymosis on skin and mucosa. (3) Drug quality: Impurities mixed in the production process or improper storage can cause adverse drug reactions. (4) Drug dosage: If the dosage is too large, poisoning reaction and even death may occur. (5) Influence of dosage forms: Different dosage forms of the same drug will lead to different absorption in the body, that is, different bioavailability. If the dosage is not mastered, it will also cause adverse reactions.
2.2 the patient's own reasons
(1) Sex: There are more men than women with drug dermatitis, the ratio is about 3 ∶ 2; Granulopenia is more common in women than in men.
(2) Age: Old people and children have different reactions to drugs from adults, and are prone to adverse reactions due to slow metabolism and excretion of drugs; Infants and young children are immature, sensitive to some drugs and prone to adverse reactions. The survey found that the incidence of adverse reactions in people under 60 years old was 5.9%(52/887), and that in the elderly over 60 years old was15.85% (113/713) [4].
(3) Individual differences: Different races have different sensitivities to the same drug, and different individuals of the same race have different reactions to the same drug. (4) Disease factors: When the liver and kidney function declines, the drug action can be enhanced and prolonged, which is easy to cause adverse reactions.
2.3 Other factors
(1) irrational drug use: misuse, abuse, improper prescription compatibility, etc. These will all lead to adverse reactions.
(2) Long-term medication: it is easy to have adverse reactions, even accumulation and poisoning.
(3) Combined medication: The incidence of adverse reactions was 3.5% when two or more drugs were used, 65,438+00% when six or more drugs were used, and 80% when 65,438+05 drugs were used [5].
(4) Drug reduction or withdrawal: Drug reduction or withdrawal can also cause adverse reactions. For example, in the treatment of severe rash, stopping taking glucocorticoids or reducing the dosage too quickly will lead to rebound phenomenon.
All kinds of drugs may have adverse reactions, and traditional Chinese medicine is no exception, but the degree is different, or the probability of happening to different people is different. When there are adverse drug reactions, there is no need to be too alarmed. Patients must read the instructions carefully when taking drugs. If there are serious adverse reactions or those not specified in the instructions, you should report them to the doctor in time.
Third, how to use drugs safely
(1) Don't trust drug advertisements. Some drug advertisements exaggerate the efficacy of drugs, but make no mention of the adverse reactions of drugs, which is easy to mislead.
(2) Don't blindly believe in new drugs, expensive drugs and imported drugs. Some patients think that all new drugs, expensive drugs and imported drugs must be good drugs, and it is not appropriate to prescribe drugs by name in hospitals or buy drugs in pharmacies without knowing the condition.
(3) Take the medicine in strict accordance with the prescribed usage and dosage. Read the instructions carefully before taking the medicine, and don't increase the dose by yourself. Especially for traditional medicines, many people think that it doesn't matter to eat more and eat less. The larger the dose, the better. This is an important reason for the prevalence of irrational drug use.
(4) Drug addicts should improve their awareness of self-protection. If you have abnormal feelings or symptoms after taking the medicine, you should stop taking the medicine and accept the diagnosis and treatment of the clinician. What needs to be warned to users here is that some people have suspicious adverse reactions after taking the medicine, so don't jump to conclusions easily. Experienced professional technicians should carefully analyze and evaluate the causal relationship.
With people's increasing concern about health and quality of life, the harm of adverse drug reactions has attracted more and more attention from the whole society. The state is establishing and improving the monitoring and reporting system of adverse drug reactions, so as to avoid and reduce all kinds of harm caused by adverse drug reactions as much as possible. Therefore, people should adopt the attitude of not taking drugs casually without illness, using drugs rationally in case of illness, correctly treating adverse drug reactions, using drugs correctly and keeping drugs, and constantly improve the level of drug use to achieve truly safe, effective, economical and appropriate rational drug use.
refer to
1 Xu nianhui, Lin Guosheng, Jeff, etc. Discussion on the experience of rational application of antibacterial drugs. Chinese journal of nosocomiology, 20 14,12 (2):143-144.
2 Tang Jingbo. Evaluation and practice points of rational drug use. Abstract of the symposium on clinical rational drug use in the whole army,1990,64.
Liu Zhensheng, Jin Dapeng and Chen Zenghui. Hospital infection management. Beijing: Military Medical Science Press, 2014,314.
4 Sun Dingren. Adverse drug reactions, 2nd edition. Beijing: People's Health Publishing House, 1998, 103.
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