Technology and Cooperation
At present, the company has established a mature pharmaceutical preparation research and development platform, and actively carried out cooperation with China pharmaceutical university and nanjing university in many projects, gradually forming a professional development team led by scientists.
The company focuses on the following areas of drug development
(1) children's medicine and drug delivery system
According to the 2010 population statistics, the number of children aged 0 to 14 in China has exceeded 220 million, accounting for 16.6% of the total population and about 20% of the total population, and the incidence of children is increasing year by year. Safe and effective medication for children could have effectively treated the disease and minimized the harm of the disease to children. However, due to the lack of drug information, the empirical (often inaccurate) adjustment of the dosage for adults and the lack of dosage forms for children make children's medication in an unsafe state.
At present, the field of children's drug use has been the focus of state support, and children's drug development is also one of the priority items of state food and drug administration. The company focuses on the development of taste masking technology for drugs to solve the problems of taste masking, release and in vivo absorption of estimated drugs in estimated preparations and liquid preparations. The main research directions are: (1) particle flavor masking technology; (2) liquid drug flavor masking technology; (3) liquid drug flavor masking technology. It focuses on solving the current problems of children's drug compliance, preparation masking and quantitative techniques. To provide more effective and safe new drug varieties for clinical children, and solve the situation of lack of drug varieties and single dosage form for children.
(2) development of reproductive and gynecological drugs
With the improvement of living standard, medicine and medical level, the state also encourages the normal two-child policy. Therefore, the number of pregnant women in China and the medication in this aspect will definitely increase significantly. Therefore, our company takes the drug development of pregnant women as the main development direction. Development in three directions :(1) development of topical preparations; (2) development of drugs for artificial reproductive assistance technology and (3) development of drugs for pregnancy complications in women.
(3) development of improved preparation
With the rapid development of pharmaceutical industry, auxiliary materials, pharmaceutical machinery and GMP transformation, the development of pharmaceutical preparations in China has also been gradually promoted. At present, the domestic level of pharmaceutical preparations has problems such as multiple varieties, low-level duplication, r&d and low quality of pharmaceutical preparations, and the lack of truly improved new preparations. The company according to the characteristics of drugs and drug compliance, combined with clinical trials to improve the preparation development. At present, the company focuses on the secondary development of aerosol preparations, oral instant preparations and insoluble drugs that can change drug delivery routes, improve clinical effects and reduce toxicity.
(4) consistency evaluation study
The 12th five-year plan for national drug safety issued by the state council clearly proposes to comprehensively improve the quality of generic drugs and carry out consistency evaluation of generic drugs quality. According to statistics, by the end of 2013, more than 4,000 drug manufacturers in China had 187,000 drug approval document Numbers. Among them, the approval number of chemical drugs is 121,000, and most of them are generic drugs. The rapid development of generic drugs in China has effectively solved the outstanding problem of shortage of doctors and drugs among the people and played an important role in maintaining public health.
At present, the quality of most generic drugs in China is uneven, good and bad coexist, and some of them are not equivalent. In order to ensure the safety and effectiveness of drug use by ordinary people, the state has pushed the idea and arrangement of drug consistency evaluation onto the fast track. Consistency evaluation is a systematic, complex and long-term process. How to effectively promote it is still a process of trial and error.
The reasons for the quality gap between generic drugs and the original developed drugs are as follows: in the case of the same prescription, ingredients and other external indicators, the differences in the design process, preparation process and other internal factors between generic drugs and the original developed drugs are enough to produce different clinical effects; On the other hand, for a long time, China has been one-sided emphasis on generic drug standard research, while ignoring the comparative research.
At present, the company has formed the SOP of consistency evaluation, which carries out in-depth research on many industrial pharmacy elements, such as the original preparation, the characteristics of raw materials, the impurity spectrum, the composition and characteristics of auxiliary materials, pharmaceutical equipment and process, preparation personnel, process amplification, etc., and can achieve multiple dissolution curves consistent with reference preparations.
The dissolution test of oral solid preparation is the core evaluation index, especially the evaluation method of whether multiple dissolution curves of generic drugs are consistent with the original developed drugs. Because this measurement is a data microscopic expression of all elements of the preparation (such as the characteristics of raw materials, auxiliary materials, preparation technology, preparation equipment, preparation personnel, etc.).
Only comprehensive and consistent evaluation studies should be carried out to achieve the consistency of in vitro pharmacology, in vivo bioavailability and clinical efficacy of the developed drugs and reference drugs.