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Biological "clinical" trials

Following the treatment of fruit wool by physical scouring, the municipal greening and urban appearance bureau is collecting the chemicals in the prevention and control of sycamore fruit balls in this city and other cities, testing and screening the best types of chemicals, optimizing the use methods of chemicals, and exploring a new way for sycamore fruit control. Due to the long growth cycle of fruit balls and great differences in individual conditions of trees, the pharmacological reaction needs long-term observation to draw a conclusion. At present, researchers are stepping up "clinical" trials in order to promote their application in the future. As a street tree, Platanus acerifolia has strong stress resistance and can adapt to the urban growth environment. While purifying the urban air, it also weakens the urban heat island effect and effectively improves the urban ecological structure. However, in recent years, the sycamore fruit wool catkins in the downtown area have had a certain impact on citizens' travel. Therefore, the city's greening Department has carried out research on key technologies for prevention and control of sycamore fruit wool catkins from many aspects. In view of the characteristics of tall trees and difficult prevention and control in the central urban area, the scientific and technological personnel of the municipal greening management guidance Station summarized the research achievements in recent years, collected the current chemicals in the prevention and control of sycamore fruit balls in this city and other cities, tested and screened the best types of chemicals and optimized the application methods of chemicals, in order to explore a new way for sycamore fruit control. At present, drug prevention and control is still in the continuous experimental stage. Due to the long growth cycle of fruit balls and great differences in individual conditions of trees, the pharmacological reaction needs long-term observation to draw a conclusion. In the face of the current situation of great difficulty, long cycle and little preliminary data of pharmaceutical test, researchers are paying close attention to "clinical" test and constantly accumulating experience in order to promote its application in the future.
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05
2020-03

"Medicament cleaning"

Release time : 2020-03--05 Hits : 0
In April and may every year, the sky of Weifang will be filled with flocs such as Yangxu and LiuXu, which is really a big test for our allergic people. " Mr. Tan, a citizen of Weifang, told reporters, "there is no way. At this time, I can only go out with a mask every day. Otherwise, once I am allergic, it will be very troublesome. The flying catkins not only affect the urban environment, but also affect my normal travel." As soon as the catkins appeared, many citizens put on masks one after another. Citizens complain and sanitation workers worry. It's another "floating season" On the morning of the 15th, on Dongfeng Street in Weifang, the reporter saw that many citizens went out wearing masks because flying catkins began to appear in the sky. "It's hard to go out by car. When you're tired, you can't avoid shortness of breath. These flying catkins in the air are really annoying. They can easily be sucked into your nostrils, which is very uncomfortable." Ms. Wang, who is waiting for the red light on a public bicycle, told reporters, "It is reasonable to say that spring is the best season for outdoor activities, but there are a large number of Yang catkins and willow catkins in Weifang, which directly affects our citizens' outdoor activities. In particular, these catkins fall to the ground and float everywhere at the sight of the wind. It is difficult to clean and affect environmental sanitation, which has become a persistent disease affecting the appearance of the city." In the selection of tree species, tree species such as French Tung are gradually used to replace poplar and willow. Then, the reporter interviewed Master Cheng, an environmental sanitation worker who was cleaning the road. He told reporters that the temperature in Weifang rose slowly this year, and the appearance of Yang catkins and willow catkins was slightly later than in previous years. "Now the catkins have just appeared. It is estimated that during May Day, the catkins will usher in their heyday. At that time, piles of Yang catkins and willow catkins can be seen everywhere on the road, which is very difficult to clean." Mr. Cheng told reporters, "The management of flying catkins has to be managed from the source. If there are fewer poplar and willow species, the flying catkins will naturally be reduced, and the cleaning work in the city will be much easier." "Chemical floc cleaning" has entered the experimental stage, which will reduce the production of flying floc from the optimization of tree species For the "flying catkins" reflected by the public The reporter consulted Weifang natural resources and Planning Bureau. According to the staff, from the perspective of urban greening, although poplar catkins and willow catkins have an impact on citizens' daily life, they should not cut poplar and willow in a large area, but should optimize and adjust the existing forest structure, and gradually reduce the proportion of poplar, willow and other tree species prone to flying catkins during afforestation At the same time, Weifang will select optimized poplar and willow to reduce or even eliminate the production of flying catkins from the source. The work of drug floc cleaning has entered the experimental stage As the maintenance unit of urban landscape tree, Weifang garden is in the "clearing work" According to the staff of the garden department, according to the current statistical data, the poplar or willow that produces flying catkins in Weifang is basically planted on both sides of the highway, the forest protective belt and the junction of urban and rural areas. The planting proportion of poplar and willow in the urban street trees is low, and at present, the street trees are mainly Fatong and other tree species. From the perspective of urban management, this year's Weifang urban Starting from Beihai Road, some poplar trees are selected for drug floc removal experiment. The production of flying catkins is reduced from the source by spraying inhibitors. With the increase of temperature, in the flourishing period of flying catkins, the garden department will send large spraying vehicles to wet the poplar catkins and catkins hanging on the branches by spraying water mist at high altitude, and speed up the cleaning of flying catkins by accelerating the landing of flying catkins to avoid them Drift with the wind. In addition, for the roadside trees that die naturally on both sides of the road, in terms of tree species replacement, priority will be given to the tree species that will not produce flying catkins, so as to reduce the proportion of poplar and willow from the source and achieve both symptoms and treatment. If the experimental work of drug catkin removal is progressing smoothly, this treatment measure will be popularized in time to reduce the occurrence of flying catkins disturbing residents, so as to further improve The urban environment of Weifang in spring.
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05
2020-03

ICH is based on biological agents

Release time : 2020-03--05 Hits : 0
Whether generic drugs can apply for bioequivalence test exemption has always been a matter of great concern in the industry. In October 2016, the concept paper and drafting plan of bioequivalence test exemption guidelines based on biopharmaceutical classification system. The guidelines are currently in the first stage of the development process (step 1). The document is included in the comprehensive discipline series. The purpose is to provide guiding suggestions for the exemption of bioequivalence test of drugs classified according to the biopharmaceutical classification system. 1. Reasons and necessity of drafting Based on BCS classification, bcs1 and bcs3 drugs can be exempted from bioequivalence test. Prior to this, the European Union, the United States, Canada and who have issued the draft guiding principles / guidelines on the feasibility of drug bioequivalence test exemption based on BCS. The relevant principles of Japan also include the possibility of exemption from drug bioequivalence test based on changes in formulation (see Table 1). However, the BCS based drug bioequivalence test exemption has not yet reached a global consensus, mainly because there are differences in the supporting data requirements for applying for exemption in these guidelines, and even if the scientific data used to support the BCS based bioequivalence test exemption in different countries or regions are the same, there are still differences in the understanding of these data. In addition, there are differences in the theory of biopharmaceutical classification system in different countries or organizations, which makes pharmaceutical companies need to follow different technical requirements when applying for drug marketing license in different countries and regions. In view of the above problems, it is expected that these problems can be solved by coordinating the formulation of a general consensus and exemption requirements for bioequivalence test exemption based on BCS. 2. Problems to be solved 2.1. Description of relevant characteristic indexes of drugs based on BCS classification system Solubility: to judge whether a drug has high solubility or low solubility, it should be defined according to the maximum therapeutic dose or the maximum dose specification on the specific drug label. Permeability: at present, there are differences in measurement methods, whether they are based on in vitro data, in vivo data, or both, and they need to be coordinated; If the applicable method is determined, it shall also clearly judge whether the drug is high permeability or low permeability. 2.2. Consideration of supporting data on bioequivalence test exemption Threshold criteria for dissolution studies need to be established to determine whether the drug is BCS class 1 or class 3 (please note that the bioequivalence test exemption for BCS class 1 and class 3 drugs is applicable and acceptable). It is necessary to formulate the requirements for the comparison between the test drug and the reference drug or the prescription of the reference drug, and what are the key excipients affecting the drug absorption rate and degree. Formulate the standards for quantitative comparison of prescriptions and provide data to prove that excipients are non key factors. The in vitro dissolution test data need to clearly establish the dissolution test conditions. It also needs to be clear whether it is feasible to adopt standards different from the determined conditions, such as the variation range of mixing speed. If it can be adopted, what instructions need to be provided. It should be clear whether the bioequivalence test exemption based on BCS is only applicable to pharmaceutically equivalent products. In addition, when multiple specifications are listed in the reference preparation or reference prescription, for example, 10mg and 20mg rapid release tablets. It should also be clear whether each specification of BCS based bioequivalence test exemption needs to be matched one by one, whether 10mg reference preparation / reference article is compared with 10mg test sample, 20mg reference preparation / reference article is compared with 20mg test sample, or whether after a comprehensive BCS based bioequivalence test exemption is conducted for one specification, other specifications can be exempted according to this result. 3. Significance of drafting guiding principles After the formal introduction of BCS based bioequivalence test exemption guidelines, some in vivo studies used to prove the bioequivalence of drugs may be exempted, which reduces the number of healthy subjects to be exposed to drugs and reduces the cost and time of drug research and development. By accepting the same test methods adopted by pharmaceutical enterprises in different regulatory regions, member states have accelerated the speed of drug approval. In addition, the principle can also be used for reference by the regulatory authorities of developing countries that are not members of IC
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05
2020-03

The era of "anti drug prohibition" is coming, and the abuse of antibiotics is "cooling down"

Release time : 2020-03--05 Hits : 0
On April 25, according to outlook Newsweek, the survey found that the concentration of antibiotics in the Yangtze River Basin was high and the water ecosystem was damaged. This can not help but remind people of CCTV news reports. The survey results of the school of public health of Fudan University on thousands of children aged 8-11 and 516 pregnant women in recent years show that 21 kinds of human, veterinary or human and veterinary antibiotics have been detected in children's urine samples, and 79.6% of school-age children have detected one or more antibiotics in their urine, some of which have been banned clinically. In addition, 16 kinds of antibiotics were detected in the urine of pregnant women in Jiangsu, Zhejiang and Shanghai, and the detection rate of one or more antibiotics was 41.6%. The exposure of pregnant women was common and the risk was high. Veterinary antibiotics are a general term for a class of drugs used in livestock to treat or prevent diseases, or to improve economic benefits by accelerating animal growth. According to the chemical structure of veterinary antibiotics, veterinary antibiotics can be divided into the following categories: 1. Polypeptides are not easy to produce drug resistance and cross resistance with human antibiotics. It mainly includes bacitracin zinc, colistin, virginiamycin, thiopeptomycin, persistent mycin, enramycin and avomycin. The Chinese Veterinary Pharmacopoeia 2010 contains bacitracin zinc, thiocolin raw materials and preparations. 2. Tetracyclines are broad-spectrum antibiotics. Continuous low concentration administration has a good growth promoting effect, but tetracycline antibiotics are shared by humans and animals and are easy to produce drug resistance. Chinese Veterinary Pharmacopoeia 2010 contains tetracycline hydrochloride, doxycycline hydrochloride (doxycycline), Chlortetracycline Hydrochloride, oxytetracycline hydrochloride, oxytetracycline hydrochloride and other raw materials and preparations. 3. Macrolide, which is the general name of antibiotics with macrolide ring produced by actinomycetes or Micromonospora. It is alkaline because it contains amino sugar. These antibiotics can inhibit Gram-positive bacteria, some Gram-negative bacteria, penicillin resistant Staphylococcus and mycoplasma. It mainly includes tylosin, beilimycin, erythromycin and spiramycin. The Chinese Veterinary Pharmacopoeia 2010 contains varieties and preparations of kitasamycin, kitasamycin tartrate, erythromycin, erythromycin lactose, erythromycin thiocyanate, tylosin, tylosin tartrate, tylosin phosphate, tilmicosin, etc. 4. Phosphorus containing polysaccharides. These antibiotics are particularly effective against drug-resistant strains of Gram-positive bacteria. They have the characteristics of large molecular weight, not easy to be digested, absorbed and excreted quickly, resulting in their wide use in Europe and America, among which Flavomycin and macromycin are more common. 5. Polyether antibiotics have a wide antibacterial spectrum and have the function of ion transport. They are not only good growth promoters, but also effective anticoccidial agents. It is hardly absorbed and has no residue in the animal digestive tract. Monensin, salinomycin, lassarimycin and Maduramycin are commonly used. 6、 β- Lactam antibiotics, Chinese Veterinary Pharmacopoeia, 2010 edition, contains raw materials and preparations such as benzathine penicillin, amoxicillin, penicillin sodium, penicillin potassium, oxacillin sodium, ampicillin, cloxacillin sodium, procaine penicillin, ceftiofur sodium and ceftiofur. 8. Chemical synthetic antibiotics are being phased out because of their large side effects. Most of them are only allowed to be veterinary drugs rather than feed additives. Such antibiotics include sulfonamides, amides, alcohols, etc. 1910 German doctor Ehrlich invented asvanamin, which can kill syphilis bacteria invading the human body. 1928 British microbiologist Alexander Fleming first discovered penicillin with anti Staphylococcus aureus activity from Penicillium, and entered the golden age of antibiotics. In the Second World War, penicillin, as a first-line medicinal antibiotic, saved thousands of lives and became famous for a time. 1939 to 1943 Selman Waxman isolated 10000 strains of actinomycetes from soil and found that 10 of them could produce antibiotics that could inhibit pathogenic bacteria. In 1943, he isolated streptomycin from Streptomyces and systematically defined the concept of "antibiotic" for the first time. Aureomycin (1947), chloramphenicol (1948), oxytetracycline (1950), nystatin (1950), erythromycin (1952) and kanamycin (1958) were found during this period. 1950 The US Food and Drug Administration (FDA) approved antibiotics as feed additives for the first time. 1956 Vancomycin appeared. 1961-1980s The era of semi synthetic penicillin, cephalosporin, semi synthetic tetracycline and semi synthetic erythromycin began. 1962-1990s Quinolones. The continuous develo
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