Improve the quality of pharmaceutical products, and put forward new standard requirements for pharmaceutical excipients in Pharmacopoeia 2020

[pharmaceutical Station policies and regulations] no standards, no products, no control, no safety Whether the drug quality standard is scientific, reasonable and feasible is directly related to the controllability, safety and effectiveness of drug quality At present, the preparation of the first draft of the general principles of the four parts of Chinese pharmacopoeia in 2020 has been completed The industry said that the new pharmacopoeia will be of great significance for the improvement of pharmaceutical quality It is understood that the new pharmacopoeia also puts forward new standard requirements for the high-quality development of pharmaceutical excipients, and the market of pharmaceutical excipients may receive more and more attention To improve the pharmaceutical quality, more and more attention has been paid to pharmaceutical excipients (picture source: pharmaceutical Station) As the basic materials and important components of pharmaceutical preparations, pharmaceutical excipients have the important functions of improving the stability, solubilization, solubilization, slow and controlled release of drugs However, in the past, the concept of "heavy API, light excipients" appeared in the development of pharmaceutical preparations in China, and the development of pharmaceutical excipients started relatively late Nowadays, with the integration of policies, the development of pharmaceutical excipients industry has been paid more and more attention It is understood that China proposes to improve the construction of the standard system of pharmaceutical excipients, increase the collection of the standards of commonly used pharmaceutical excipients, and promote the renewal and upgrading of the varieties of pharmaceutical excipients For example, on April 1, the State Pharmacopoeia Commission issued information that 11 standards for pharmaceutical excipients, such as l (+) - tartaric acid, would be included in the Chinese Pharmacopoeia 2020 In addition, the implementation of policies such as generic drug consistency evaluation, related review and approval, and volume purchase will also make the market environment of pharmaceutical excipients more standardized For this reason, the market of pharmaceutical excipients in China may be expanded rapidly, and the industry concentration will be further improved Mr Xu also said that in addition to the inclination of policies, the scale of pharmaceutical preparations in China is also expanding, and the demand for pharmaceutical excipients market will continue to expand In this regard, the market of pharmaceutical excipients will also be further expanded Pharmaceutical excipients are important ingredients that affect the quality, safety and effectiveness of preparations Nowadays, with the increasing of policy and market demand, the market of pharmaceutical excipients in China has a broad development space According to the prediction of relevant data, the pharmaceutical excipients industry in China will reach 70-130 billion yuan in the future In addition, with the development of pharmaceutical preparations in the direction of quick, long-term, small dosage and side effects, it also promotes the upgrading of pharmaceutical excipients The industry says that new pharmaceutical excipients will play an important role in the development of pharmaceutical preparations "The key to the success or failure of the new preparation is to find a good pharmaceutical excipients as scaffolds The new excipients are the key factors to determine the success or failure of the new preparation." Said the head of an enterprise Promote the high-quality development of pharmaceutical excipients and help the progress of China's pharmaceutical industry With the support of the state and the continuous expansion of market demand, China's pharmaceutical excipients market will usher in a huge development space At the same time, in order to better improve the quality of pharmaceutical preparations, the quality of pharmaceutical excipients is also increasingly valued Pharmaceutical ingredients mainly include APIs and excipients, of which the proportion of excipients reaches 90-99% But for a long time, there is a big gap between the quality of pharmaceutical excipients in China and that in foreign countries The poor quality of excipients even affects the improvement of drug quality to a certain extent, hinders the progress of China's pharmaceutical industry In order to improve the quality of drugs, we must first improve the quality of pharmaceutical excipients It is understood that in order to improve the quality of pharmaceutical excipients, Pharmacopoeia 2020 proposed to further strengthen the control of the safety of pharmaceutical excipients, which is consistent with the relevant international requirements, such as further strengthening the quality control of animal derived excipients According to pharmacopoeia 2020, the quality control of pharmaceutical excipients from animal sources should involve raw material collection, transportation, production, storage, circulation, use and other links Generally, comprehensive quality research and stability research should be carried out for raw materials, intermediates and key products, and the whole process quality traceability system should be established Nowadays, the quality requirements of drugs are increasingly strict, and the high quality development of pharmaceutical excipients is imperative Improving the quality of pharmaceutical excipients is one of the important elements of pharmaceutical quality assurance However, at present, there are still many challenges for pharmaceutical excipients in China, such as the international standard system needs to be further optimized, the technical threshold and R & D investment need to be further broken However, it is fortunate that in recent years, some domestic enterprises are also making efforts for the high-quality development of pharmaceutical excipients For example, an enterprise has formed core technologies such as ether polymerization, ester oriented synthesis, separation and purification, "we should, on the basis of ensuring product quality benchmarking internationally, serve domestic pharmaceutical enterprises with cost and price advantages, and help China's pharmaceutical high-quality development." The head of the enterprise said so.