Guangming net news (reporter Shenyang) in recent years, ZBD Pharmaceutical relying on the "five-in-one" research and development strategy -- independent research and development, secondary development, joint research and development, investment research and development, cooperative introduction mode to carry out innovative drug research and development and introduction, invested tens of millions of yuan to build a modern drug research institute. Reporters in July 1 solstice6, in the Heilongjiang headquarters of ZBD pharmaceutical 185,000 square meters of factory with many departments of comrades exchange, interview.Among them, the reporter to visit and interview ZBD Institute of Medicine left a deep impression. In this article, I would like to share with you the modern procedures and norms of the research and development process of traditional Chinese medicine when I first walked into ZBD Institute of Pharmaceutical Research.
 

　　 ZBD Institute of Pharmaceutical Research has advanced equipment for drug research and development.
 

　　 Harbin Pharmaceutical Research Institute of ZBD was established in 2011, covering an area of more than 3,700 square meters, including the chemical preparation laboratory on the first floor, the administrative office area on the second floor, the analysis and testing laboratory on the third floor and the chemical synthesis laboratory on the fourth floor. I introduced Feng Hui from Harbin Pharmaceutical Research Institute of ZBD to the reporter of Guangming. She is a senior analyst researcher, deputy chief pharmacist and licensed pharmacist. She has been engaged in drug research and development for 8 years after graduation.She said: "we drug research institute is equipped with high-end in line with international standards of modern analysis instruments, such as super high performance liquid - high resolution mass spectrometry, gas chromatography - mass spectrometry, inductively coupled plasma mass spectrometer, gas chromatograph, ion chromatograph, etc., which can realize the rapid screening of unknown components analysis of pesticide residues, heavy elements residues, solvent residues and other kinds of trace material analysis.Ultra-performance liquid chromatography-mass spectrometer is equipped with a complete set of detectors such as UV-visible light detector, diode array, fluorescence, parallax refraction, electrospray, evaporative light and so on, which can achieve quantitative detection of various substances. Through the application of various high-end instruments, we can develop and develop strict quality control standards for the whole process of drugs to ensure the safety, effectiveness and quality control of drugs."

　　 In addition to the equipment is advanced, treasured island drug research institute is mainly engaged in product research and development, product analysis, testing the medicine, Chinese medicine such as secondary development core work, also has more than 50 a high-end research and development personnel, among them: 3 degree, post-doctoral researchers, graduate student above staff accounted for more than sixty percent, the main technical backbone has 5 years experience in new drug research, in the field of pharmaceutical research has formed a strong research and development strength.

　　 ZBD Harbin Institute of Pharmaceutical Sciences has obtained the qualifications of "Provincial Enterprise Technology Center", "National Postdoctoral Research Workstation", "Key Laboratory of Traditional Chinese Medicine Preparation Technology", etc. 
 

　　 Now treasured island Harbin pharmaceutical drug research institute in a total of 33 varieties (including: 27 generic project, three innovation project, three from the research project), drugs mainly anti-tumor, cardiovascular system (high blood pressure, blood ester, etc.), the endocrine system (diabetes, etc.), anti-infection, respiratory system (cough, asthma, etc.), mental system (such as antidepressant) multiple varieties, major disease areas such as r&d spending close to $one hundred million in 2018. 
 

　　 It is reported that ZBD Pharmaceutical Harbin Pharmaceutical Research Institute cooperated with Shanghai WuXi AppTech to develop class 1 innovative drugs AKT kinase inhibitor HZB0071 and PAN-FGFR inhibitor HZB1006 with independent intellectual property rights.In July 2018 and September 2018, HZB0071, an Akt kinase inhibitor, received clinical approval from the State Food and Drug Administration. AKT kinase inhibitors and pan - FGFR inhibitors are the current domestic hot anti-cancer drug targets to declare, because drug mechanism, drug targets, high selectivity, respectively in the treatment of breast cancer and cancer of the liver has significant curative effect, the preliminary evidence-based medical research data showed that the drug efficacy in the body to achieve even more than similar foreign products in development indicators, in terms of the safety of medicines, controllable has high value of clinical development.Akt kinase inhibitor HZB0071 is the first Akt kinase inhibitor approved by the State Food and Drug Administration in China.
 

　　 ZBD Institute of Medicine researchers talk about Chinese medicine injection to measure particles.
 

　　 ZBD Pharmaceutical has always been focusing on the research and development of traditional Chinese medicine. Therefore, experts including members of the Chinese Pharmacopoeia Committee are invited to do the top-level design for the molecular pharmacology and pharmacoepidemiology research of traditional Chinese medicine, so as to ensure the advancement of the research direction in the industry and provide multi-disciplinary support and collaboration for the problems encountered. During the interview with Harbin Pharmaceutical Research Institute of ZBD, Guangming Net reporter asked teacher Feng Hui about the particle size measurement of TCM injections and the particle size and adverse reactions of TCM injections. The following is our conversation: 
 

　　 Guangming Net: Is this instrument specially designed for analyzing injection particles? What is the range of particle size that this instrument can measure?
 

　　 Feng Hui: Yes, this is a special instrument for detecting insoluble particles in injection. Particle sizes ranging from 2 microns to 100 microns can be detected.
 

　　 Guangming: In your experience, can the particles of traditional Chinese medicine injections be compared with those of chemical drugs, such as antibiotics? 
 

　　 Feng Hui: The principle of insoluble particles detection is photoresist method. Both Chinese medicine and chemical medicine are tested using the same principle instrument, and the standards implemented are all pharmacopoeia standards. Therefore, the requirements of insoluble particles for TCM injections are the same as those for chemical medicine injections. 
 

　　 Kwangmyong: according to the state food and drug administration issued the clinical adverse drug reaction report data in China, nearly two years of western medicine injection adverse reaction is 4.6 times that of the traditional Chinese medicine injections, a lot of people who learn west medicine (medical) of a view is that the traditional Chinese medicine injection adverse reactions associated with particles is very big, researcher's point of view on your analysis, how to go to see the problem?

　　 Feng Hui: I don't think this view can be generalized. Western medicine and traditional Chinese medicine injections have the same standard in terms of insoluble particles, which is consistent from the perspective of quality standards in the Chinese Pharmacopoeia. In addition, the incidence of ADR varies with different varieties of TCM injections. We treasured island pharmaceutical industry in terms of TCM injections to evaluate did a lot of work and investment, one work is large sample clinical safety of 30000 cases of active monitoring, including varieties have via "injection of blood" and "shu ning injection blood", is entrusted tianjin university of traditional Chinese medicine of TCM clinical basic medical research institute of traditional Chinese medicine (TCM) and Chinese Academy of Sciences, led by zhang bl academicians and Wang Yongyan academicians making study plan, monitoring results according to the national medical science organization committee (CIOMS) standard, incidence of adverse reactions for the "accidental" level, the incidence of adverse reactions to clinical manifestations as "rare" or "rare" level,The incidence of such an adverse reaction is much lower than that of some chemical drugs.
 

　　 Kwangmyong: before I went to a pharmaceutical company, know that the traditional "ginkgo biloba injection adverse reaction is bigger, easy to cause vasculitis diseases, but they will after purification of effective components, which is less impurities, almost rare adverse reactions, don't say, adverse reaction is actually related to the impurity? 
 

　　 Feng Hui: There are some reasons. After the purification of Ginkgo injection, its pharmacodynamic composition and material basis are more clear. Now the reevaluation of TCM injections requires enterprises to clarify the material basis of TCM injections, that is, to clarify the composition of TCM injections and the major components. We are also actively carrying out the work in this field, in which the content of 5 active components of Xuesaitong for injection reaches more than 90%, and the quantifiable components reach more than 97%. In cooperation with Zhejiang University, 127 chemical components have been identified and concluded, and the uniformity of the impurities levels between batches has been controlled, and 9 articles have been published in world-class journals (SCI).We also studied the clinical effect of Xuesaitong for injection on coronary heart disease angina pectoris and cerebral infarction, and the effective rate was more than 92%.
 

　　 Guangming Net: So, the quality of TCM injections can be controlled and adverse reactions can be reduced clinically through some detection methods and quality indicators? 
 

　　 Feng Hui: You can say that. Our ZBD Pharmaceutical is to monitor the difference between each batch of product quality through fingerprint or characteristic map.
 

　　 Guangming Net: What kind of products does your laboratory analyze, mainly from your own enterprises? You serve outside as well?
 

　　 Feng Hui: We all develop products for ZBD Pharmaceutical Company. No external services, mainly engaged in their own company's key varieties of development.
 

　　 Guangming: Do different people need to be familiar with different equipment like you? I just noticed that you guys here are also a lot of gay, I have been to several corporate pharmaceutical research institute are mostly female colleagues.
 

　　 Feng Hui: Different people have different levels of cognition and proficiency in different instruments, and different people have different emphases in mastering the instruments.    Yes, there are more gay men in our research institute, so we should study together.

　　 ZBD Institute of Pharmaceutical Research researchers on drug development out of small samples
 

　　 On the 4th floor of Harbin Institute of Pharmaceutical Research, ZBD, the reporter of Guangming met Comrade Shi Cheng, who is a senior synthetic researcher and chief pharmacist in the synthesis department of the institute. Teacher Shi Cheng showed the reporter how to make a small sample of the first batch of drugs after the results of the institute came out, that is, small batch synthesis in the laboratory.According to comrade ishinari, their this layer of lab equipment is advanced, including traditional laboratory need several working procedure process, using a combination of European equipment (they are a set of more expensive than traditional several sets of cost several times) process, a lot of time, also reduces the experiment personnel's operational risk, thus greatly improves the speed of the drug developed in small sample.

　　 Heard comrade Feng Hui and ishinari these introduced, finally understand the importance of drug research institute in drug research and development, they introduce this information, help the public understand traditional Chinese medicine research and development of modern process and specification, to ensure drug safety, effectiveness, controllability, and thus truly achieve economy has higher value and significance.