In line with the international "National Standards for the Preparation of medicinal materials" 2019 press shaft publicity

On the last day of 2019 (31 December), in order to further enhance the rigor, normative and operability of the standards for medicinal accessories in the Chinese Pharmacopoeia, implement the relevant provisions of the Bulletin of the State Drug Administration on Further Improving the Approval and Supervision of Drug Association Review and Supervision (No56 of 2019), and standardize the preparation and content of the standards for medicinal accessories, in order to establish the "most rigorous standards" For the guidelines, the national pharmacopeia committee official website issued a letter on soliciting the opinions of the "National Pharmaceutical Auxiliary Standards Preparation Rules", the publicity deadline of February 10, 2020, a stone stirs a thousand waves, has far-reaching significance for the pharmaceutical accessories industry, for domestic auxiliary enterprises to improve their own quality to indicate the direction, in order to solve the key technical problems of auxiliary materials to do a good job ofsupport, this article on the relevant policies and regulations of the standard son of medicinal accessories, the current situation of the construction of the standard system of pharmaceutical accessories
medicinal accessories refers to the production of drugs and the deployment of prescriptions used in the excipients and additives, in terms of safety has been reasonably assessed, and the quality of the substances contained in the pharmaceutical preparations, the quality of pharmaceutical accessories on the safety, effectiveness, stability of the drug has an important impact, in the formulation form and production plays a key role in the production and development of pharmaceutical preparations, is the basis for the production and development of pharmaceutical preparations, is the basic material and components of pharmaceutical preparationsAlthough the 2015 edition of the Chinese Pharmacopoeia pharmaceutical accessories part was first singled out, the number of medicinal accessories has increased significantly, but also for the first time clear the "Guidelines for the study of functional indicators of medicinal accessories", but the perfect standard system of medicinal accessories has not yet been formed, pharmacopeia collection of medicinal accessories varieties still can not meet the current needs of China's pharmaceutical production and drug regulation, it is known that the current domestic pharmaceutical production of commonly used auxiliary materials about 5 More than 00 kinds, and access to drug regulatory departments have registered information on pharmaceutical accessories only a hundred kinds of pharmaceutical accessories, the vast majority of pharmaceutical production with auxiliary materials level for chemical reagents or edible products, far from meeting the current needs of China's pharmaceutical production, coupled with China's pharmaceutical accessories industry is relatively backward, the management system is not perfect, lack of national standards and other factors, the quality of pharmaceutical accessories is not high, affecting and restricting the production, use and effective government supervision of medicinal accessories in ChinaII, pharmacopeia auxiliary materials standards based on thethe development of pharmaceutical accessories standards, should not only consider the common problems of different production process products, but also consider the specific problems of various production process products, but also should consider the chemical auxiliary materials in the storage, circulation and use of degradation and microbial pollution and other issues, should be used as far as possible foreign general pharmacopocode more advanced technology methods, combined with the actual situation of domestic pharmaceutical auxiliary materials production, realistic reflection of China's pharmaceutical auxiliary production, the current situation of china's pharmaceutical auxiliary materials, The addition and revision of the standard of medicinal accessories should follow the following principles:principle one: reference to the U.S.- and European-Japanese Pharmacopoeia, supplementtheon of the specifications of pharmacopeia accessories varieties, improve quality standards,principle II: reference to the U.S.- and Europe-Japan Pharmacopeia, compare domestic conditions, draft new varieties, to ensure the feasibility of standardsprinciple three: should be combined with the production process, in the quality standard severity can be added to the lawIf the process can be identified, the process should be introduced to the impurities analysis, if necessary to increase the inspection items, toxic and harmful impurities should be developed strict control methodsPrinciple IV: To refer to the Guidelines for the Study of Performance Indicators for Medicinal Accessories, update and revise the relevant functional inspection items3, pharmacopeia auxiliary materialstandards to develop a common template
the standard of medicinal accessories generally by name, structure and limits, characteristics, identification, inspection, content determination, marking, category, storage, etc, each part in the "National Standards for pharmaceutical accessories" can find the preparation rules and reference examples, the standard formulation of common templates as follows:(i), name, structure and limit
1, name: Chinese, Chinese phonetic, English name 2, Structural, Molecular, Molecular Weight, CAS 3, source and system 4, content limit (ii), the properties of characteristics respectively record the appearance of pharmaceutical accessories, general stability, dissolution characteristics, physical constants (relative density, distillation, melting point, coagulation point, ratio rotation, refractive light rate, viscosity, absorption coefficient, acid value, hydroxy value, iodine value, peroxide value, saponification value) and so on (iii), identification 1, chromatography reaction, precipitation reaction, other chemical reactions
2, chromatography (thin layer chromatography, high-efficiency liquid chromatography, gas chromatography and electrophoresis) 3, ultraviolet-visible absorption spectroscopy features
4, infrared absorption spectroscopy 5, ion reaction 6, other (iv), check
1, functionally related indicators: granularity, crystalline, crystalline, and functionally related indicators 2, acidity, alkalinity or acidity 3, solution clarity and color 4, inorganic anions (chlorides, sulfates, sulphides, phosphates and other inorganic anions) 5, x insoluble sin 6, organic impurities and related substances (thin-layer chromatography, high-efficiency liquid chromatography, gas chromatography and uv-visible light, or than turbid method) 7, dryweight and moisture
8, burning residue
9, metal ions and heavy metals
10, selenium or arsenic 11, biosafety check (abnormal toxicity, pyrogen or bacterial endotoxins, aseptic and microbial limits), (5), content determination (six), category (seven), storage (eight), labeling (9), attached, attached
, attached Pharmacopeia Committee experts pointed out that China's standards for medicinal accessories are missing, standards are not perfect and methods are old problems, therefore, it is very important to scientifically construct China's pharmaceutical supplements standard system, although the 2015 edition of the Chinese Pharmacopoeia in the pharmaceutical supplements standard has been greatly improved, but the perfect standard system of medicinal accessories has not yet been formed, in 2020, when the implementation of the "National 13th Five-Year Plan" is China's health and achieve a well-off society Target of the key period, the new regulatory era, preparation enterprises, especially high-speed development of biopharmaceutical enterprises, high-quality pharmaceutical accessories have generated an urgent need, but also prompted domestic pharmaceutical accessories enterprises to actively adjust, "National Pharmaceutical Accessories Standards Writing Rules" after landing, I believe that most domestic pharmaceutical accessories production enterprises on the preparation and implementation of pharmaceutical supplements standards will be very important and support, from bystanders to participants, will strive to become the standard-setter of pharmaceutical supplements References