Public consultation on the determination of bacteriostatic in eye drops

[policies and regulations of chinapharma.com] on March 28, the State Pharmacopoeia Committee publicly solicited opinions on the method for the determination of bacteriostatic agents in eye drops (Draft for comments) According to the announcement, the State Pharmacopoeia Committee is responsible for organizing and carrying out the research on the determination of the content of bacteriostatic agents in eye drops in accordance with the requirements of the outline of China Pharmacopoeia (version 2020) and the approval of the State Food and drug administration At present, it has completed the "determination of the content of bacteriostatic agents in eye drops" (Revised Draft) The national pharmacopoeia committee has attached the draft for comments, and the website is open for comments for three months In order to make the relevant units better understand the updating of the draft, the drafting will be explained together Industry insiders said that the eye is very sensitive to bacteria, so it is easy to be infected by bacteria, which requires that eye drops must be sterile In the production of eye drops, pharmaceutical enterprises must strictly control the bacteria - aseptic workshop, final sterilization, to a large extent to ensure that the eye drops produced are aseptic, but, as a multi dose packaging eye drops, every time they are opened, it means that the risk of bacterial pollution is more Eye drops belong to a class of high-risk eye preparations In order to prevent microbial contamination in the use process, suitable antimicrobial agents are usually added to multi dose eye drops Nonstandard addition of bacteriostatic will lead to the damage of eye epithelial cells, and cause safety risks to users It is reported that all kinds of ophthalmic preparations have been defined as sterile preparations in the general rules of Appendix II of Chinese Pharmacopoeia (2005 Edition) In addition, antimicrobial agents have been added to almost all ophthalmic preparations (including antibiotics) in the domestic market However, the current situation is that the control of antimicrobial agents in eye drops in China is not perfect, and there is a lack of control research on the dosage and content of antimicrobial agents, resulting in the selection and use of antimicrobial agents are not standardized, and there are potential risks According to the data, 43 eye drops were collected in the 2015 edition of Chinese Pharmacopoeia, only 11 of which were included in the content inspection of bacteriostatic agents, accounting for only 25%; secondly, there was no unified and standardized test method for common bacteriostatic agents of eye drops, which was not conducive to the implementation of effective supervision Compared with USP, USP, ICH and EU, the quality and use of antimicrobial agents are clearly defined In China, the establishment of a unified, standardized, highly sensitive and specific method for the detection of antimicrobial agents in eye drops will provide technical support for the self-examination of enterprises, provide a powerful weapon for the effective law enforcement of regulatory authorities, and further guarantee the safety and effectiveness of eye drops in clinical use The author learned from the appendix issued this time that the commonly used antibacterial agents in eye drops are quaternary ammonium salts (benzalkonium chloride, benzalkonium bromide), hydroxybenzoesters (hydroxymethyl ester, hydroxyethyl ester, hydroxypropyl ester, hydroxybutyl ester), thiomersal, tert butyl trichloride and other alcohols, etc., which require the content of antibacterial agents to be controlled This also means that the drug companies that contain the above antibacterial agents in eye drops will have more standardized standards in the future, and will be subject to strict inspection, and the products that do not meet the content standards will be eliminated from the market Generally speaking, with the improvement of GMP standard in China, the national drug regulatory authorities are more and more strict in drug supervision Drug quality testing technology is also constantly developing and improving It can be said that China's drug regulation is gradually in line with international standards.