Construction and application of the project approval evaluation system for traditional Chinese medicine prepara-tion in medical institutions / 中国药房

OBJECTIVE To establish the project approval evaluation system for traditional Chinese medicine （TCM） preparations in medical institutions guided by new drug conversion， to improve the success rate of approval for TCM preparations in medical institutions and lay the foundation for the later drug conversion. METHODS Research and development team used the literature research method and brainstorming method to list and organize relevant elements of project evaluation and determine the initial indicator system. Experts were consulted using the Delphi method to confirm the evaluation index. The weights were calculated based on the proportion of importance scores for each indicator and assigned specific scores to each item. The indicator system was used to evaluate 31 TCM preparations applied for filing by various departments of our hospital from April to July 2023. RESULTS After two rounds of 17 experts’ consultation， the final TCM preparation system included five primary indicators， i.e. theoretical basis， clinical research foundation， pharmaceutical foundation， prescription， and clinical value， as well as 17 secondary indicators including prescription source， traditional Chinese medicine theory， clinical positioning and so on. Human experience was considered as the item which would be rejected as one vote. Based on the above indicator system， our hospital further improved the filing and project approval process for TCM preparations in medical institutions. Among the 31 TCM preparations applied for filing by various departments from April to July 2023， 8 TCM preparations with a score ≥65 were selected for development. CONCLUSIONS The evaluation system is objective， comprehensive， and highly operable. It is suitable for the selection of TCM preparations in medical institutions before research and development.

Preliminary Discussion on Post-marketing Comprehensive Evaluation Indicator System of Ancient Famous Classical Formula Preparations / 中国实验方剂学杂志

The construction of the comprehensive evaluation index system of the famous classical formula preparations after the marketing has both theoretical and practical significance. In this study， literature related to the post-marketing comprehensive evaluation of traditional Chinese medicine（TCM） compound preparations was retrieved from China National Knowledge Infrastructure（CNKI）， China Science and Technology Journal Database（VIP）， Wanfang Data Knowledge Service Platform（WanFang） and SinoMed from January 1， 2000 to April 30， 2022. CiteSpace 6.1.R2， a scientometrics software， was used to visualize the keywords involved， and to analyze the dynamic evolution trend and research hotspots in this field. Then， the existing comprehensive post-marketing evaluation index system of TCM compound preparations was screened and extracted， and the research status was systematically analyzed by mathematical statistics. It was found that there were problems such as the generalized boundaries between assessment dimensions and assessment elements， the lack of data sources for individual evaluation indexes， unset weight of some index system and insufficient application degree. In addition， according to the characteristics of famous classical formulas， the authors discuss the importance of evidence evaluation based on combination of disease and syndrome， pharmacovigilance of famous classical formulas preparations， and whole-process quality control of famous classical formulas， and put forward the construction strategy of comprehensive post-marketing evaluation of the famous classical formula preparations， which is oriented by clinical value， centered on evidence evaluation， and guaranteed by the whole-process quality control.

Analysis and reflection on the filing management of traditional Chinese medicine preparations in medical institu- tions / 中国药房

OBJECTIVE To compare and study the supporting policies for the filing man agement system of traditional Chinese medicine preparation prepared by traditional technology （hereinafter referred to as “TCM preparation ”）in medical institutions issued by the state and various provinces ，and their development ，so as to provide reference for the improvement of the follow-up supervision and management of the filing works. METHODS According to Announcement on the Filing Management of TCM Preparations Prepared by Medical Institutions Using Traditional Processes issued by former National Food and Drug Administration （hereinafter referred to as the Announcement）as well as notices and specific implementation rules issued by provincial bureaus ，the filing work data of 10 provinces in recent 3 years were selected for comparison ，sorting，statistics，classification and induction. The policy characteristics and progress of filing work were studied. RESULTS & CONCLUSIONS According to the local actual situation，some provinces had refined or expanded the contents of several parts of the Announcement，such as the scope of TCM preparations，the situation not allowed to record ，the filing process and working time requirements ，the disclosure ，change and cancellation of filing information ，and the implementation of supervision and management. The statistical results of filing data in 10 provinces showed that compared with 2019，the number of TCM preparation declared for filing and medical institutions declared for filing had increased with growth rate of 91.0％ and 48.8％ respectively in 2020. There is still room for improvement in the supporting policies for the filing of TCM preparations ，which can be optimized by referring to the features of some provinces ’ implementation policies ，refining the construction of norms and standards ，and strengthening the construction of regulatory system platform. It is necessary to optimize policy and strengthen the capacity building of reporting institutions in advance ；carry out daily supervision and control risk based on risk during the filing management ；emphasize follow-up supervision ，strengthen the construction of ADR monitoring system in medical institutions ，and carry out life cycle supervision and management constructively afterwards，in order to promote the further development of TCM preparations in medical institutions.

Application Advantages of Nanoemulsion in Field of Traditional Chinese Medicine Preparation：A Review / 中国实验方剂学杂志

As a new technology with unique drug delivery advantages， nanoemulsion has been widely used in the field of traditional Chinese medicine （TCM） preparations. By searching， classifying and sorting out the literature reports at home and abroad in recent years， this paper systematically expounded the application advantages and production mechanism of nanoemulsion in delivering effective components of TCM from three aspects of improving oral bioavailability， enhancing targeting effect and delaying drug release. The current formulation optimization strategies， preparation processes and quality evaluation indicators commonly used in TCM nanoemulsion were summarized. Based on the research status of TCM nanoemulsion with different active components， the common problems and possible solutions in the development of TCM nanoemulsion were discussed， and the future research hotspots and directions of TCM nanoemulsion were prospected. This article clarifies the feasibility of nanoemulsion for enriching the selection of TCM dosage forms， which can provide reference for the subsequent rational design and improvement of TCM preparations. At the same time， it is revealed that the research focus of TCM nanoemulsion in the future lies in the integrated research of TCM compounds， and shows a trend of multi-disciplinary joint and targeted research.

Material classification of decoction pieces based on physical properties of powder / 中国中药杂志

Chinese medicinals feature different medicinal parts and enriched components, which makes their powders show obvious microscopic identification characteristics and specific physical properties. On this basis, the commonly used Chinese medicinals can be divided into several categories, such as powdery, fibrous, sugar, oil, and brittle materials, which is of great importance to the research and development of personalized Chinese medicinal preparation technology. However, the existing classification methods are highly subjective and thus difficult to meet the requirements for the development of personalized Chinese medicinal preparations with high quality. In this study, 55 representative Chinese medicinals, such as Dioscoreae Rhizoma and Leonuri Herba, were selected, and the physical properties of their powders were systematically characterized by comprehensive powder tester, torque rheometer, texture analyzer, etc., based on which a data set encompassing physical properties of these powders was built. The typical physical fingerprints of powders from the above 5 categories were established by multivariate statistical analysis. Then, the Chinese medicinals were classified according to the Euclidean distance between each of them and the typical value in the PCA score plot. For those with multiple material properties, whose classification boundary was fuzzy, the proportions of different types of materials were calculated with the combination of Euclidean distance, powder properties, microscopic identification characteristics, and chemical composition, so as to achieve the multivariate quantitative classification of Chinese medicinals. This lays the foundation for the further creation of intelligent personalized Chinese medicinal preparation technology.

Nanometer preparation of traditional Chinese medicine for rheumatoid arthritis / 中国中药杂志

Rheumatoid arthritis( RA) is a chronic autoimmune disease,which can occur at any age. Repeated severe attacks can cause joint deformities. Its pathogenesis is complex,and the pathophysiological process involves many different types of cells. At present,the pathogenesis of RA is still unclear,and the clinical medication mainly aims to alleviate inflammation and symptoms.DMARDs,non-steroidal anti-inflammatory drugs,adrenocortical hormones,biological agents and traditional Chinese medicine are all applied in clinic. Traditional Chinese medicine has a long history in the treatment of RA. In particular,traditional Chinese medicine compounds can treat RA through multiple target points. The combination of nanotechnology and anti-inflammatory traditional Chinese and western medicines has also attracted extensive attention. Nanotechnology can selectively deliver drugs to articular cavity by taking advantage of its small carrier size and biodegradable materials. It can reduce the size of drug delivered,and increase the accuracy,safety and effectiveness of drugs,and further improve the therapeutic efficacy of drugs on RA. In this paper,traditional Chinese and western medicines and their nano-preparations used in the treatment of RA were reviewed in the past five years. The researches of nano-preparation were discussed in terms of pharmacology category. This paper provided reference for the research and development of new-type nano-preparation with outstanding clinical efficacy.

Innovation Strategy in the Modern Chinese Medicine Based on Scientific Representation of Classic Herbs Dosage Forms / 世界科学技术-中医药现代化

Excavating and characterizing the dosage forms characteristics of classic Chinese medicine preparations is the basis for the innovation of modern preparations of Chinese medicine. Through the combing statistics of the National Natural Science Foundation of China (NSFC) on the establishment of traditional Chinese medicine preparations, the research literature on Chinese medicine preparations at home and abroad, and the registration of new Chinese medicines in the past ten years, this paper finds that the research projects of classic Chinese medicines have been greatly reduced. The market share of traditional Chinese medicine classics has shrunk year by year. The modern preparation produced in the "preparation of traditional Chinese medicine by western medicine technology" mode dominates the market. However, because of its "degraded" effect, it is less competitive. Therefore, with the wave of classic dosage forms research promoted by national policies, accelerating the study of classical Chinese medicine preparations will not only promote the development of pharmaceutical discipline of traditional Chinese medicine, enhance the classic medical culture literacy, but also promote the protection and inheritance of classic medicine.

Analysis and countermeasure for quality risk in process of traditional Chinese medicine preparations / 中国中药杂志

Product quality relies on not only testing methods,but also the design and development, production control and product manufacturing all aspects of logistics management. Quality comes from the process control level.Therefore, it is very important to accurately identify the factors that may induce quality risk in the production process and quality control measures correspondingly.This article systematically analyzes the source of the quality risk of all aspects of the production process in traditional Chinese medicine preparation. Discussing ways and methods of quality risk identification of traditional Chinese medicine preparation and providing references for perfecting the whole process quality management of traditional Chinese medicine preparation.

Neutralization of Lecithin and Polysorbate-80 in Antibacterial Activity of Traditional Chinese Medicine Preparations / 中国药师

Objective:To investigate the neutralization of lecithin and polysorbate-80 in antibacterial activity of oral solid tradition-al Chinese medicine preparations without Chinese medicinal herb powder. Methods:According to the requirements in Chinese Pharma-copeia (2015 edition), the applicability of microbial counting method was tested in the diluent containing lecithin and polysorbate-80 and the conventional diluent, respectively, and the results were compared. Results: The recovery results of applicability of microbial counting method using neutralizers (lecithin and polysorbate-80) conformed to the standard of Chinese pharmacopoeia (2015 edition). Conclusion:The combination of lecithin and polysorbate-80 has notable neutralization in antibacterial activity of oral solid traditional Chinese medicine preparations without Chinese medicinal herb powder.

Research progress on Chinese medicines with topical administration in umbilical region / 中国中药杂志

Based on the Chinese medicines with topical administration in umbilical region approved by China Food and Drug Administration (CFDA), this paper would comb and analyze their dosage forms, varieties and clinical applications. On the other hand, through consulting literature materials, the research progress was reviewed and the main challenges faced by the medicines were discussed in detail as well. This paper elaborates that the preparations with topical administration in umbilical region, as an important branch in Chinese medicine external therapy, have unique advantages. However, there are still some problems such as rough workmanship, lacking internationally accepted quality control standards, scarcity of pharmacological and clinical evidences and biopharmaceutical researches. Meanwhile, proper measures and suggestions are put forward.

Perspectives on current protection of intellectual property rights for traditional Chinese medicine / 国际药学研究杂志

Traditional Chinese medicine (TCM), a treasure o f the Chinese nation, is the intellectual essence of Chinese traditional culture. In the 21st Century, TCM industry is one of the most prospective industry. It is quite important to protect the intellectual property rights of TCM and develop the TCM industry for maintaining the heritage of traditional cultural and defending our position as the TCM original country. This paper summarizes the status quo of the protection and the dilemma facing TCM intellectual property protection, and discusses the effective measures with cultural characteristics for intellectual property rights of TCM.

Perspectives on current protection of intellectual property rights for traditional chinese medicine / 国际药学研究杂志

Traditional Chinese medicine (Td), a treasure of the Chinese nation, is the intellectual essence of Chinese traditional culture. In the 21st Century, TCM industry is one of the most prospective industry. It is quite important to protect the intellectual property rights of TCM and develop the TCM industry for maintaining the heritage of traditional cultural and defending our position as the TCM original country. This paper summarizes the status quo of the protection and the dilemma facing TCM intellectual property protection, and discusses the effective measures with cultural characteristics for intellectual property rights of TCM.

Detection of Glibenclamide Mixed Illegally in Shenqi Hypoglycemic Granules / 中国药房

OBJECTIVE:To establish a method for detection of glibenclamide mixed illegally in Shenqi hypoglycemic granules,a hypoglycemic traditional Chinese medicine preparation.METHODS:The constituents were identified by TLC,and the content of glibenclamide was determined by HPLC on Kromasil C18 column(250 mm?4.6 mm,5 ?m) with a ammonium dihydrogen phosphate(adjusted pH=3.15 with phospharic acid)-methanol(25∶75) as the mobile phase.The detection wave-length was set at 240 nm.RESULTS:The linear range of glibenclamide was 0.030 1～0.481 6 mg?mL-1(r=0.999 2) with an average recovery at 98.62%(RSD=0.54%,n=9).CONCLUSION:The method is sensitive and reliable,simple and feasible,and suitable for the detection of glibenclamide mixed illegally in hypoglycemic traditional Chinese medicine preparations.