1.Preparation of Cuiru Oral Liquid
Shuangcheng MA ; Long NI ; Dechang CHEN
Chinese Traditional and Herbal Drugs 1994;0(09):-
Cuiru oral liquid (COL ) for the promotion of lactation is prepared from an aqueous extract of Angelica sinensis, Astragalus membranaceus (Fisch.) Bge., Rehmbnnia glutinosa Libosch.,et al. Its formulatiou and processing were briefly desctibed, and the quality standard and stability of the finished product were studied. Results showed that the formu lation processing and stability of COL were suitable for clinical trial. Moreover, its pharmacology was briefly described.
2.Studies on chemical constituents of Selaginella stauntoniana (Ⅰ)
Haiqing LIU ; Ruichao LIN ; Shuangcheng MA ; Fang FENG
Chinese Traditional and Herbal Drugs 1994;0(04):-
Object To study the chemical constituents of the whole plant of Selaginella stauntoniana Spring. Methods Various chromatographic techniques were employed for the isolation and purification of its constituents, and structurally identified by spectral analysis (IR, UV, MS, 1HNMR, 13CNMR) and chemical evidence. Results Four compounds were identified from its extract as: emodin (Ⅰ), ginkgetin (Ⅱ), hinokiflavone (Ⅲ), amentoflavone (Ⅳ). Conclusion All the compounds were isolated in this plant for the first time; compound Ⅰ was found from the plants of Selaginellaceae Beauv. for the first time.
3.Chemical constituents of Helicia nilagirica seeds (Ⅰ)
Guiyan LIU ; Shuangcheng MA ; Jian ZHENG ; Ji ZHANG ; Ruichao LIN
Chinese Traditional and Herbal Drugs 1994;0(06):-
Objective To study the chemical constituents of Helicia nilagirica. Methods The ethanol extract was seperated by petroleum ether, dichloromethane, and n-butanol in sequence, then isolated by silica gel column chromatography. The structures were identified and elucidated by physicochemical pro-(perties) and spectral analysis. Results Four compounds were isolated from the petroleum ether extract and identified as n-hexadecane acid (Ⅰ), ?-sitosterol (Ⅱ), ?-sitosterol-3-O-?-D-glucoside-6′-acetate (Ⅲ), and daucosterol (Ⅳ). Conclusion All the compounds are isolated from the plant for the first time. Compounds Ⅰ, Ⅲ, Ⅳ are isolated from the plants of Helicia Lour. for the first time, and compound Ⅲ is a new natural product.
4.Brief introduction on the development of Chinese Pharmacopoeia 2025 Edition
HONG Xiaoxu ; SONG Zonghua ; MA Shuangcheng ; LAN Fen ; SHU Rong
Drug Standards of China 2025;26(1):001-010
The Pharmacopoeia of the People’s Republic of China 2025 edition is to be issued in March 2025. Chinese Pharmacopoeia is the basic requirements on the drug manufacture, drug testing, drug use and drug administration. The new edition Chinese Pharmacopoeia will be dramatically improved on the pharmacopoeia monographs included, establishing the standards system, standards conversion and application of drug quality control for the new technology, new method & new tool, drug control on the safety and effectiveness as well as the drug standard international harmonization. It will take important role on improving the drug quality, ensuring the safety of drugs for public use, strengthen technical support for drug administration, promoting the high-quality development of China’s medical and pharmaceutical industry. This paper introduces the development and revision of the Chinese Pharmacopoeia 2025 Edition,aim at helping the industries well understanding and implantation the new edition Chinese Pharmacopoeia.
5.The development and characteristics of general notice in Chinese Pharmacopoeia 2025 Edition
WANG Fei ; SONG Zonghua ; MA Shuangcheng ; SHU Rong
Drug Standards of China 2025;26(1):011-016
Objective: Introduce and briefly describe the status, characteristics, and writing ideas of general notice in the Chinese Pharmacopoeia 2025 edition, providing reference and suggestions for better understanding and implementation of the Chinese Pharmacopoeia 2025 edition.
Methods:This article elaborates on the content and revision of general notice in the Chinese Pharmacopoeia 2025 edition from the perspective of frame structure and main contents.
Results:Compared with other pharmacopoeias of various countries, Chinese Pharmacopoeia includes standards for traditional Chinese medicine, chemical drugs, biological products and excipients, pharmaceutical packaging materials, etc. Each section of Chinese Pharmacopoeia has its own general notice, with 34 to 48 items arranged in 11 to 12 chapters. Depending on the type of products included and the development history, the general notice in each section present differences in format and content. Given the importance and significance of the standards in Chinese Pharmacopoeia, it is necessary for the industry to coordinate and unify the general notice in various parts of Chinese Pharmacopoeia. With the introduction and revision of regulations, changes in the content of pharmacopoeias, and the application of new technologies, methods, and concepts in drug quality control, considering the unique characteristics of various drugs in quality control and supervision, Chinese Pharmacopoeia has comprehensively standardized relevant requirements. While taking into account the characteristics of the first, second, third, and fourth parts of the pharmacopoeia, it retains the characteristics of relative uniformity and the content of each part, achieving the unified standardization of the general rules of each general notice in the Chinese Pharmacopoeia 2025 edition and the coordination and consistency of common content.
Conclusion: The current version of Chinese Pharmacopoeia has undergone significant changes and improvements in both form and content. By introducing the overall situation and revised content of general notice in the Chinese Pharmacopoeia 2025 edition, pharmacopoeia users can have a deeper understanding of Chinese Pharmacopoeia and use it correctly.
6.The introduction on standards system of the pharmaceutical packaging materials in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; YU Hui ; WANG Yan ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):067-076
The standard of Pharmaceutical packaging materials is an important part of the Chinese Pharmacopoeia. This article focuses on working background, general idea, working process, main framework, and its role and significance of the pharmaceutical packaging materials standards system in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in the Chinese Pharmacopoeia 2025 Edition.
7.The introduction on the standards system of water for pharmaceutical purposes in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; WANG Lin ; ZHANG Gongchen ; MA Shihong ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):077-082
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the standards system of Water for Pharmaceutical Purposes has been perfected. This article focuses on the Work Background, Overall Approach,Work Methodology,Standard Framework,Key Content and Significance on the standards system of Water for Pharmaceutical Purposes in the Chinese Pharmacopoeia 2025, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.
8.A holistic strategy for quality and safety control of traditional Chinese medicines by the"iVarious"standard system
Chen ANZHEN ; Sun LEI ; Yuan HANG ; Wu AIYING ; Lu JINGGUANG ; Ma SHUANGCHENG
Journal of Pharmaceutical Analysis 2017;7(5):271-279
An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines (TCMs). However, the current quality standard research lacks top-level design and systematic design, mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "iVarious" system. This system highlighted a holistic strategy for effectiveness, security, integrity and systematization of quality and safety control standards of TCMs. The establishment of "iVarious" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.
9.A holistic strategy for quality and safety control of traditional Chinese medicines by the"iVarious"standard system
Chen ANZHEN ; Sun LEI ; Yuan HANG ; Wu AIYING ; Lu JINGGUANG ; Ma SHUANGCHENG
Journal of Pharmaceutical Analysis 2017;7(5):271-279
An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines (TCMs). However, the current quality standard research lacks top-level design and systematic design, mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "iVarious" system. This system highlighted a holistic strategy for effectiveness, security, integrity and systematization of quality and safety control standards of TCMs. The establishment of "iVarious" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.
10.Three Determination Methods for Residual Sulfite in Traditional Chinese Medicinal Materials and Pieces
Weiyi XU ; Yaolei LI ; Fang GAO ; Ruichao LIN ; Hongyu JIN ; Shuangcheng MA
China Pharmacist 2015;(5):782-783,786
Objective:To determine residual sulfite in traditional Chinese medicinal materials or pieces processed by sulfur fumi-gation respectively by iodine titration, acid-base titration and ion chromatography and compare the results. Methods:The three meth-ods were used to determine four kinds of Chinese herbal medicines including Codonopsis radix, Dioscoreae rhizoma, Achyranthis bident-atae Radix and Atractulodis Macrocephalae Rhizoma, the recovery tests were also performed and the results were analyzed and compared to summarize the characteristics and quality control requirements of each method. Results:Iodine titration and acid-base titration had the advantages of simple operation process and low cost. However, there were many interference factors in the two methods, and due to different principles, they were suitable for the determination of different varieties of herbal medicines. Ion chromatography method had the advantages of high sensitivity and strong specificity, while the cost was high. Conclusion: It is suggested that proper methods should be chosen for the determination of sulfur dioxide residues according to actual situations.