OBJECTIVE To investigate the components and characteristic chromatograms of natural myrrh and colloidal myrrh from different origins using gas chromatography-mass spectrometry(GC-MS).METHODS Based on the study of molecular identification techniques for determining the botanical origins of myrrh, GC-MS was utilized to conduct a qualitative analysis of the volatile oil components in 10 batches of colloidal myrrh and 15 batches of natural myrrh. Furthermore, the Traditional Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System was used to establish the characteristic chromatograms for natural myrrh and colloidal myrrh,respectively.The similarity between different origins and the same commercial type of myrrh with their common mode chromatograms was evaluated. RESULTS Natural myrrh contained significantly more volatile components than colloidal myrrh. Colloidal myrrh primarily consisted of low-boiling-point components,whereas natural myrrh contained both low-and high-boiling-point components.The main components of the volatile oils in both types of myrrh were sesquiterpenes. CONCLUSION There are notable differences in the characteristic chromatograms between natural myrrh and colloidal myrrh. However,there are no significant differences in the volatile components between myrrh of the same commercial type but different botanical origins. There are significant differences in the volatile components between natural myrrh and colloidal myrrh.The volatile components of myrrh are related to its commercial type but not to its botanical origin.

OBJECTIVE To study the chemical composition of Gukang Capsules by ultra-high performance liquid chromatography-quadrupole/electrostatic field orbitwell high resolution mass spectrometry(UPLC-QE-Orbitrap-MS/MS).METHODS The analysis of 70%methanol extract of the drug was performed on a 45 ℃ thermostatic Hypersil GOLD C₁₈ column(2.1 mm×100 mm,1.9 μm)with mobile phase consisting of 0.1%formic acid solution-acetonitrile gradiently eluted at 0.3 mL·min^-1,and the injection volume was 1 μL.The information of the chemical constituents of Gukang Capsules was acquired in positive and negative ion modes by electrospray ion source,and the chemical composition was analyzed and identified by software combined with control comparison,database matching,literature reports and mass spectrometry rules. RESULTS A total of 137 compounds were identified from Gukang Capsules,mainly including flavonoids,saponins,organic acids and coumarins,etc.,among which 27 compounds were identified by comparison with reference substances and their origins of medicinal materials were determined.CONCLUSION In this study,the main chemical composition of Gukang Capsules was identified by this rapid and efficient analytic method,which laid a foundation for further research on pharmacodynamic substance base and quality control.

OBJECTIVE To establish a method for the quantitative detection of bacterial endotoxin in glutamic acid and verify its feasibility. METHODS Verification test of the reliability of bacterial endotoxin standard curve, interference test of calcium ion buffer and sodium ammonium hydrogen phosphate used in pre-treatment, and interference test of test product and additional endotoxin recovery test were carried out in sequence by using limulus reagents from two manufacturers according to the standard of kinetic chromogenic assay in bacterial endotoxin inspection method (General Chapter 1143 in Chinese Pharmacopoeia2020 Edition). A method for the detection of bacterial endotoxin in glutamic acid was successfully established, and three batches of samples were quantitatively detected by this method. RESULTS Glutamic acid was dissolved with sodium ammonium hydrogen phosphate together to the concentration of 20 mg·mL^-1, then diluted by calcium ion buffer to the concentration of 5 mg·mL^-1, which had no interference effects on bacterial endotoxin test. The contents of endotoxin in three batches of samples were all lower than the limit of 12 EU·g^-1, the RSD values were all lower than 10%, and the endotoxin recovery rates were in the range of 50% to 200%, which met the requirements. CONCLUSION The bacterial endotoxin test method established in this study can be used to detect the bacterial endotoxin in glutamic acid and control its quality.

OBJECTIVE To analyze the results of three NMPA's Microbial Proficiency Testing Programs, NIFDC-PT-288, NIFDC-PT-340, and NIFDC-PT-446, to evaluate the microbiological testing abilities of laboratories nationwide in drug detection, thus the regulatory agencies can learn the microbiological proficiency status of drug inspection laboratories and the laboratories can improve the microbiological detection ability. METHODS The results of the three proficiency testing programs were analyzed regarding the satisfaction rate, identified problems, and key technical points, and the laboratory types, number of laboratories and capability of the laboratories participating the three proficiency testing projects were analyzed. RESULTS The result satisfaction rates of provincial food and drug inspection institutions were 95.7% (NIFDC-PT-288), 86.4% (NIFDC-PT-340) and 100.0% (NIFDC-PT-446), while the satisfaction rates of municipal food and drug control institutions were 95.5% (NIFDC-PT-288), 83.9% (NIFDC-PT-340) and 92.5% (NIFDC-PT-446), respectively. The satisfaction rates of enterprise laboratory were 86.7% (NIFDC-PT-288), 65.7% (NIFDC-PT-340) and 80.2% (NIFDC-PT-446), respectively. The satisfaction rates of other types of laboratories were 100.0% (NIFDC-PT-288), 61.5% (NIFDC-PT-340) and 86.7% (NIFDC-PT-446), respectively. CONCLUSION The successful implementation of the three microbiological proficiency testing programs has provided the laboratories with effective external quality control means, and it also provides the first-hand reference for regulatory authorities on the microbiological testing capability of nationwide drug laboratories. The qualitative microorganism testing ability of drug laboratories is basically good, while the quantitative microorganism testing ability needs to be improved.

OBJECTIVE To explain the main content of the Special Regulations on the Management of Traditional Chinese Medicine Standards and propose suggestions on management of traditional Chinese medicine standards. METHODS The main content and key features of the Special Regulations on the Management of Traditional Chinese Medicine Standards was analyzed, and the suggestions were proposed to strengthen the management of traditional Chinese medicine standards. RESULTS The Special Regulations on the Management of Traditional Chinese Medicine Standards was focused on the reform of mechanism of management of Chinese medicine standards, such as building standard system that conforms to the key characteristics of traditional Chinese medicine, optimizing the management program of traditional Chinese medicine standards, clarifying the responsibilities of interested parties, and improving the technical system of traditional Chinese medicine standards. CONCLUSION The mechanism for traditional Chinese medicine standards should be optimized, the technical requirements related to traditional Chinese medicine standards should be improved, and all kinds of standards should be coordinated.

OBJECTIVE To establish a Chinese medicine standard based onprocessing, reflect the quality characteristics of Chinese medicine decoction pieces and provide a basis forquality control andevaluation of Chinese medicine decoction piece. METHODS Encouraged by the Special Regulations on the Management of Traditional Chinese Medicine Standards, highlighting the characteristics of traditional Chinese medicine processing and emphasizing the research and inheritance of traditional processing experience as the guiding principle, taking Chinese medicine processing technology as the starting point for establishing quality standards for Chinese medicine decoction pieces, summarizing processing experience and technology, comprehensively proposing the items and indicators that should be paid attention to in the standard formulation process, and making suggestions based on the problems existing in the current Chinese medicine decoction piece quality standards.RESULTS Establishing Chinese medicine standards that meet the quality characteristics of traditional Chinese medicine decoction pieces should be able to explain the scientific connotation of processing, with a focus on the changes in chemical composition or component groups caused by different processing purposes. In addition, attention should be paid to the scientificity and specificity of indicators, their correlation with drug efficacy, and their content limits.CONCLUSION It is recommended to conduct comprehensive and in-depth research to grasp the changes in the material basis of traditional Chinese medicine decoction pieces before and after processing, establish scientific, reasonable, and feasible quality control projects and indicators, and achieve control and evaluation of the quality of traditional Chinese medicine.

In recent years, National Medical Products Administration has successively issued special documents such as “Several Measures to Further Strengthen the Scientific Regulation of Traditional Chinese Medicine(TCM) and Promote the Inheritance, Innovation and Development of TCM”, “Special Regulations on Registration and Management of TCM” and “Special Regulations on the Management of TCM Standards”, which put forward new requirements for the research, formulation and management of TCM standards, and is of great significance for the comprehensive construction of a new system for the management of TCM standards, the establishment of the most rigorous TCM standards, and the promotion of high-quality development of TCM industry. Due to the natural source of TCM, the complex composition of drug components, the unique theoretical system and the safety and effectiveness derived from clinical practice, it is difficult to objectively evaluate and effectively control the quality of TCM preparations based on qualitative and quantitative quality control models based on chemical components and the quality standards established thereby. How to realize the advanced characterization and objective identification of TCM quality based on the characteristics of TCM, and to study and establish the corresponding quality standard of TCM preparation has become an important content of TCM quality research, the focus and difficulty of TCM supervision scientific research, and the bottleneck of TCM quality improvement and standard formulation. At present, the quality control of TCM preparations has established a whole process quality control system from TCM crude drugs, decoction pieces to preparations, and formed a quality standard system of TCM preparations based on the characteristics of TCM consisting of the standards of TCM crude drugs, decoction pieces, extracts and preparations. By sorting out the development history of TCM quality standards, this paper analyzs the problems and challenges in the research of TCM quality standards, and discusss the strategies and methods for the research of TCM preparation quality standards based on the characteristics of TCM in combination with the scientific research results of TCM regulatory science in recent years, and the actual research and development and review of TCM, so as to provide reference for colleagues in the industry.

OBJECTIVE To strengthen the role of Chinese medicine standards in ensuring drug quality, based on the analysis of Special Regulations on the Management of Traditional Chinese Medicine Standards, propose the suggestions on establishment of standard system conforming to the characteristics of traditional Chinese medicine. METHODS The scientific connotation of standard system conforming to the characteristics of traditional Chinese medicine was analyzed, the basic considerations for construction of traditional Chinese medicine standard system were proposed. RESULTS The scientific connotation of standard system conforming to the characteristics of traditional Chinese medicine mainly includes respecting the tradition of Chinese medicine, complying with the theory of traditional Chinese medicine and observing the objective laws of traditional Chinese medicine. CONCLUSION In the process of establishment of standard system conforming to the characteristics of traditional Chinese medicine, the quality control strategies of comprehensive quality evaluation and key quality factors should be persisted, the quality control strategies of inheritance and innovation should be persisted. Moreover, the traditional thinking of Chinese medicine should be reflected in Chinese medicine standards.

With the continuous progress of biotechnology and drug research and development, small molecule drugs play an increasingly important role in the treatment of nervous system diseases because of their unique physical and chemical properties and biological effects. However, most of the previous studies tried to increase the brain exposure and retention time of the subjects, while ignoring the brain transport and efflux clearance pathways. In this paper, the recent research progress on the efflux clearance pathway of small molecule drugs in the brain was reviewed, focusing on the involvement of blood-brain barrier transport, metabolic enzymes in the brain, and aquaporin-4(AQP4) pathway, in order to further understand the efflux clearance pathway of small molecule drugs in the brain, which will not only help optimize the efficacy of existing drugs and reduce the adverse reactions caused by drug accumulation. It can also provide new ideas and directions for the research and development of drugs for neurological diseases in the future.

Ganoderma lucidum is a fungus belonging to the genus Ganoderma in the family of Polyporaceae. As a precious medicinal herb which can be used for both medicine and food, it has various biological activities such as antioxidant, antibacterial, anti-tumor, anti-inflammatory, and neuroprotective properties. However, due to the difficulty in dissolution, low bioavailability, difficulty in absorption by the human body, and the increased burden on liver injury patients caused by direct use, the application of Ganoderma lucidum is greatly limited. In recent years, in order to improve the application efficiency of Ganoderma lucidum and expand its scope of application, the research on its nanoparticle size has received widespread attention from researchers. The article introduces the preparation of Ganoderma lucidum nanoparticles (including biological, chemical and physical methods) and their applications and mechanisms of action in different fields such as biomedicine, health care, environment and agriculture. It points out the shortcomings of existing related research and future development directions, and provides reference for in-depth research on Ganoderma lucidum nanoparticles.