In line with the international "detailed rules for the preparation of national standards for pharmaceutical excipients" published in 2019

Original: dishishsinan On the last day of 2019 (December 31), in order to further improve the preciseness, standardization and operability of the standards for pharmaceutical excipients in the Chinese Pharmacopoeia, the notice of the State Food and Drug Administration on further improving the related review, approval and supervision of drugs (2019) was implemented No 56) on the quality standards of pharmaceutical excipients, standardizing the preparation methods and contents of pharmaceutical excipients standards, taking the establishment of "the most rigorous standards" as the criteria, and benchmarking the international advanced standards The official website of the National Pharmacopoeia Commission issued a letter on Soliciting Opinions on the detailed rules for the preparation of national pharmaceutical excipients standards The deadline for publicity is February 10, 2020 Yishi arouses thousands of waves The pharmaceutical excipients industry has far-reaching significance It points out the direction for domestic excipients enterprises to improve their own quality, and provides support for solving key technical problems of excipients Pharmaceutical excipients refer to excipients and additives used in the production and formulation of drugs They have been reasonably evaluated in terms of safety and are included in pharmaceutical preparations The quality of pharmaceutical excipients has an important impact on the safety, effectiveness and stability of drugs They play a key role in the formulation and production of drugs and are substances to ensure the production and development of pharmaceutical preparations Foundation is the basic material and important component of pharmaceutical preparations Although the pharmaceutical excipients in 2015 edition of Chinese Pharmacopoeia were first recorded in a separate volume, the number of drug excipients collected increased significantly, and the guiding principles for research on functional indicators of pharmaceutical excipients were also defined for the first time, but the perfect standard system of pharmaceutical excipients has not been formed, and the varieties of pharmaceutical excipients collected in Pharmacopoeia still can not meet the needs of current drug production and drug supervision in China It is reported that at present, there are more than 500 kinds of commonly used excipients for drug production in China, while only 100 kinds of excipients have been registered by the drug regulatory authorities Most of the excipients for drug production are chemical reagents or edible products, which are far from meeting the needs of drug production in China In addition, the pharmaceutical excipients industry in China is relatively backward, and the management system is not perfect Lack of national standards and other factors, the quality of pharmaceutical excipients is not high, which affects and restricts the production, use and effective government supervision of pharmaceutical excipients in China When formulating standards for pharmaceutical excipients, we should consider not only the common problems of different production process products, but also the particularity of various production process products We should also consider the degradation and microbial pollution of pharmaceutical excipients in the process of storage, circulation and use We should try our best to adopt the advanced technical methods of foreign general Pharmacopoeia and the actual situation of domestic pharmaceutical excipients production At the same time, under the premise of strict methodology verification, the detection technology and methods researched by our country should be collected in time The following principles shall be followed in the revision of standards for pharmaceutical excipients: The standards for pharmaceutical excipients are generally composed of name, structure and limit, character, identification, inspection, content determination, labeling, category, storage, etc for each part, the detailed rules and reference examples can be found in the detailed rules for the preparation of national pharmaceutical excipients standards The general template for standard formulation is as follows: 1 Name: Chinese name, Pinyin, English name 2 Structural formula, molecular formula, molecular weight, CAS number 3 Source and system 4 Content limit The appearance, general stability, dissolution characteristics, physical constants (relative density, distillation range, melting point, freezing point, specific rotation, refractive index, viscosity, absorption coefficient, acid value, hydroxyl value, iodine value, peroxide value, saponification value) of pharmaceutical excipients are described under the properties 1 Color reaction, precipitation reaction and other chemical reactions 2 Chromatography (TLC, HPLC, GC and electrophoresis) 3 Characteristics of UV-Vis absorption spectrum 4 Characteristics of infrared absorption spectrum 5 Ion reaction 6, others 1 Functional indicators: particle size, crystallinity, crystal type, viscosity or molecular weight and molecular weight distribution 2 Acidity, alkalinity or pH 3 Clarity and color of solution 4 Inorganic anions (chloride, sulfate, sulfide, phosphate and other inorganic anions) 5 Insolubles in ×× 6 Organic impurities and related substances (thin layer chromatography, high performance liquid chromatography, gas chromatography and UV-vis spectrophotometry, as well as volumetric analysis, gravimetric method, color reaction or turbidimetric method, etc.) 7 Loss on drying and moisture 8 Scorching residue 9 Metal ions and heavy metals 10 Selenium or arsenate 11 Biosafety test (abnormal toxicity, pyrogen or bacterial endotoxin, sterility and microbial limit, etc.) Experts from the Pharmacopoeia Committee pointed out that there are some problems in the standards of pharmaceutical excipients in China, such as lack of standards, incomplete standards and outdated methods Therefore, it is very important to scientifically build the standard system of pharmaceutical excipients in China Although the 2015 edition of China Pharmacopoeia has greatly improved the standards of pharmaceutical excipients, the perfect standard system of pharmaceutical excipients still hasn't been formed In 2020, it will be "national economy and society" During the implementation of the 13th five year plan, it is a critical period for China to build a healthy China and achieve the goal of building a moderately prosperous society in an all-round way In the new regulatory era, pharmaceutical enterprises, especially the high-speed development of biomedical enterprises, have an urgent demand for high-quality pharmaceutical excipients, and also promote the active adjustment of domestic pharmaceutical excipients enterprises After the implementation of the detailed rules for the preparation of national pharmaceutical excipients standards It is believed that most pharmaceutical excipients manufacturers in China will attach great importance to and support the preparation and implementation of pharmaceutical excipients Pharmacopoeia standards From spectator to participant, they will strive to be the makers and executors of pharmaceutical excipients Pharmacopoeia standards.