Objective: To study the status of pharmaceutical excipients quality standards under the bunding evaluation system, in order to help fully understand the connotation of pharmaceutical excipients quality standards and the relationship between quality standards under the bunding evaluation system. Methods: The classifi cation and characteristics of the quality standards of pharmaceutical excipients under the bunding evaluation system were introduced in detail, and the requirements, status, changes, effectiveness and status of the current filing management system of pharmaceutical excipients and the filing standards of pharmaceutical excipients were systematically summarized and expounded. At the same time, the relationship between the fi ling standards and pharmacopoeia standards of pharmaceutical excipientswere analyzed and discussed. Results and Conclusion: The quality standard of pharmaceutical excipients is an important measure of the quality of pharmaceutical excipients, including pharmacopoeia standard, registration standard, fi ling standard and internal control standard, among which the pharmacopoeia standard of pharmaceutical excipients is the basic standard and threshold for the quality control of the excipients. The fi ling standard of pharmaceutical excipients produced under the new system of bunding review is an important document for regulators to confi rm the quality of excipients. In the new era of the bunding evaluation system, while further deepening the understanding of the connotation and relationship of the quality standards of pharmaceutical excipients, on the one hand, it is necessary for enterprises to conduct more extensive and in-depth research on the pharmaceutical excipients they have fi led in order to provide more reference basis for the reviewers in the bunding evalutaion; On the other hand, it is necessary for regulatory agency to continue to improve the pharmacopoeia standard system of medicinal excipients in China, and promote the overall improvement of the quality standards of domestic medicinal excipients, so as to lay a solid foundation for improving the overall quality of preparations in China and promoting the innovation and development of preparations.

Objective: To introduce the development of transdermal patches in the market, the progress of dosage forms technology and the requirements of quality control. Method: The patches marketing status, the relevant research literature and the technical guidelines of patches type, matrix type, skin absorption, penetration enhancement, and quality control were searched and summarized. Results and Conclusion: The dosage forms characteristics, technological progress of transdermal patches were reviewed, and the quality control indicators of transdermal patches were summarized systematically. It was suggested that more attention should be paid on the key quality attributes of transdermal patches such as in vitro drug release, skin permeability, adhesion, cold fl ow, and drug residue.

Objective: Based on the equally important quality standard itemsand functionality-related characteristics, to put forward a process stability evaluation strategy as a new method for the process stability control of pharmaceutical excipients. Methods: Firstly, the quality standard items (loss on drying, ignition loss, pH and content) and functionality-related items (moisture absorption, specific surface area, particle size, and particle size distribution) of a total of 14 batches of silica from manufacturers A and B were determined. Subsequently, the quality standard items stability difference (PQ) and functionality-related characteristics stability difference (PF) were obtained by the process stability evaluation strategy. Results: The PQ values of silica of manufacturers A and B were 31.1% and 58.1%, and the PF values were 15.6% and 50.0%, respectively. Conclusion: By comparing PQ values and PF values of two manufacturers, it could refl ect the quality of product impurity control effect of specific manufacturers, the control of functionality-relatedcharacteristics and the difference in control requirements, so as to fully reflect the process stability control of specific manufacturers on their products. The PQ value and PF value provide a comprehensive and eff ective method for monitoring the process stability evaluation of silica, which can provide a reference for the process stability evaluation monitoring of other pharmaceutical excipients.

Objective: To investigate the medication information and existing problems in the instructions of child-specifi c medicine (chemicals and biological products) in our country and provide references for promoting the improvement of drug information for children. Methods: The child-specifi c medicines were summarized, and the information sheet was fi lled and statistically analyzed according to the drug instructions, and the problems existed in the special drug instructions for children were analyzed. Results: A total of 1214 drug instructions for children were collected, including 1180 domestic drugs (97.20%) and 34 imported drugs (2.80%). The largest number of child-specific medicine was respiratory system drugs (42.01%).There were 1094 oral dosage forms (90.11%), 57 injectable dosage forms (4.70%), 59 external dosage forms (4.86%) and 4 inhalation dosage forms (0.33%) for child-specific medicine. The dose adjustment was mainly based on age and weight (45.80%), and only 41.02% of the drugs were adjusted based on age, while 7.91% of the drugs were not labeled with the dose adjustment basis. In the instructions, only 17.46% of the drugs had the maximum dose, 28.01% of the drugs had the course of medication, and 16.72% of the drugs had the pharmacokinetics. Conclusion: The child-specific medicines in our country exist some problems such as non-standard instructions label, imperfect content and great diff erences in the same drug instructions and so on. It is suggested that the relevant departments should strengthen the specifi cation and management of the child-specifi c medicines, strengthen the supervision and monitoring data after listing, and supervise the pharmaceutical production enterprise improve the contents of the child-specifi c medicines and promote the level of rational drug use of children

Objective: The emergence of new technologies for mRNA vaccines has brought new opportunities to biopharmaceutical companies. The aim of this article is to evaluate the social value of mRNA vaccines in a quantitative way, as well as to provide references for the development of their products. Methods: Using the fuzzy comprehensive evaluation method, the social value of mRNA vaccines is divided into positive externality characteristic value and negative externality characteristic infl uence, and the positive external characteristic value index is divided into innovation value, functional advantage, price advantage and other intangible value, and the negative external characteristic infl uence index is divided into impact on materials, impact on production process, impact after use or disposal, and impact on human environment. At the same time, experts are hired to evaluate social indicators, determine weights and calculate social evaluation coefficients. Results: The social value coeffi cient of mRNA-1273 was 1.84, and that of BNT162b2 was 1.98. The social value coeffi cients of both were much greater than 1, and the overall advantages of developing mRNA vaccines outweighed the disadvantages. Conclusion: mRNA vaccines have important social value in the field of biomedicine. The results of this evaluation can provide a reference for developers and help decision makers understand the potential value, so as to promote the further development and application of related technologies.

Objective: To analyze the quality and the problems of Morindae Offi cinalis Radix decoction pieces in the market through national drug sampling and testing in order to put forward data support for the improvement of quality standards and market supervision on Morindae Offi cinalis Radix decoction pieces. Methods: Morindae Officinalis Radix decoction pieces were sampled from 24 provincial administrative regions in China. The test work was carried by using the method of character item and TLC identification item for Morindae Officinalis Radix decoction pieces in Volume I, Chinese Pharmacopoeia (2015 edition), and four exploratory studies on DNA barcoding technology, fi ngerprints, content detection of cycloid, and mycotoxin residues were carried out. The test results were analyzed to evaluate the market situation of Morindae Offi cinalis Radix decoction pieces. Results: A total of 108 batches of Morindae Offi cinalis Radix decoction pieces from 88 enterpriseswere tested andthe qualifi ed rate was 100% according to the national legal standards. Morindae Offi cinalis Radix decoction pieces and the fakes can be distinguished eff ectively based on the method of DNA barcoding technology. The results of fi ngerprint analysis showed that the similarity of Morindae Offi cinalis Radix was more than 95% and the similarity of adulterants was less than 70%. The results of content determination showed the iridoids in diff erent processed products of Morinda Officinalis have significant difference in species and content. Mycotoxin screening test results showed that afl atoxin G1 in 1 of 30 batches of samples exceeded the limit of pharmacopoeia. Conclusion: According to the standard test results, the quality of Morinda Offi cinalis Radix decoction pieces in the market was basically qualifi ed. Based on the exploratory research results, it is suggested that standard determination of iridoid content and afl atoxins limit should be added.

Objective: To understand the quality management situation of biological products industry and quality management in Shandong Province, to discern the common observed defi ciencies and the main risks points in the production of biological products, and standardize the Good Manufacturing Practices of biological products. Methods: Statistical analysis of the inspection situation and defect items of biological products manufacturing enterprises from 2019 to 2021 in Shandong Province. Discuss and analyze the risk points of biological products found in the inspection. Results and Conclusion: The inspection defects of biological products production inspection in Shandong Province focus on qualification and validation, quality control and quality assurance, sterility assurance and manufacturing management and other aspects, it is recommended that enterprises should pay more attention to them in the quality management system operating process.