Based on the research goal of "traditional Chinese medicine standards lead in the international standard-setting", scientific strategies for the elaboration of traditional Chinese medicine (TCM) comprehensive quality standard system were introduced. TCM is a complex multi-component system which was used under the guidance of traditional Chinese medical theory. The present paper has put forward the basic principle of " deep research and simplified standard" to construct the quality standards of TCM. " Deep research" refers to systematic, thorough investigations on active constituents and biological mechanisms. On the basis of deep research, "simplified standard" means to establish a scientific and feasible standard, which should be practical and less complicated, to control the quality of Chinese herbs. Three key issues related to the elaboration of the quality standards are suggested. For reference substances, we propose the research methodology using reference extract to develop the qualitative and quantitative determination methods. Compared with that of using reference compounds, the preparation of reference extract is more accessible, economical and practical. Moreover, compared with reference crude drugs, the reference extract showed better batch-to-batch consistency. For identification, in addition to conventional methods, high performance liquid chromatography (HPLC), chemical fingerprints and characteristic chromatogram are proposed, in which more major marker compounds are monitored. And then LC-MS technique is employed to comprehensively analyze and characterize the peaks in the fingerprint. For multi-component quantification, the method of single standard to determine multi-components (SSDMC) is suggested, providing solutions for the lack of reference standards in quality evaluation. The SSDMC method uses a single reference standard to simultaneously determine the content of multiple compounds. In general, the integrate quality control standard of TCM is established based on combining innovative technology with practical applications.
Chemistry Techniques, Analytical ; Medicine, Chinese Traditional ; standards ; Quality Control ; Reference Standards

Traditional Chinese medicines (TCMs) are in great demand all over the world, especially in the developing world, for primary health care due to their superior merits such as low cost, minimal side effects, better cultural acceptability, and compatibility with humans. However, Chinese medicines consist of several herbs which may contain tens, hundreds, or even thousands of constituents. How these constituents interact with each other, and what the special active ones are, may be the biggest bottleneck for the modernization and globalization of TCMs. Valid methods to evaluate the quality of TCMs are therefore essential and should be promoted and be developed further through advanced separation and chromatography techniques. This paper reviews the strategies used to control the quality of TCMs in a progressive perspective, from selecting single or several ingredients as the evaluation marker, to using different kinds of chromatography fingerprint methods. In summary, the analysis and quality control of TCMs are developing in a more effective and comprehensive manner to better address the inherent holistic nature of TCMs.
Chemistry Techniques, Analytical ; methods ; Drugs, Chinese Herbal ; chemistry ; standards ; Medicine, Chinese Traditional ; standards ; Plants, Medicinal ; chemistry ; Quality Control

It is imperative that any newly established bio-analytical method is validated thoroughly, using standardised parameters. The purpose of this article is to provide recommendations on how to validate a new bio-analytical method. Based on author's personal experience and some interesting discussion points from the conference of "International Association of Forensic Toxicologists" in 2007, the authors propose these essential requirements for validating a new analytical method. The key parameters of method validation include selectivity, linearity, accuracy, precision, LOD (limit of detection), LLOQ (the lower limit of quantitation), stability and the extraction recovery. For any bio-analytical method using LC-MSn (Liquid chromatography-mass spectrometry), studies of matrix effect should also be included in addition of the above parameters.
Chemistry Techniques, Analytical/standards* ; Chromatography, Liquid/methods* ; Forensic Toxicology ; Mass Spectrometry/methods* ; Reproducibility of Results ; Validation Studies as Topic

Pressurized solvent extraction (PSE) is a new extraction technology which has been developed in recent years and widely used as sample analysis in environmental, food and pharmaceutical fields. Extraction technique is a key technology in quality control of Chinese herb. Conventional extraction techniques have been a bottleneck of blocking the development of quality control of Chinese herb. This article attempts to review the basic principle, methods, apparatus and main characteristics of PSE and its applications to quality control of Chinese herb.
Chemistry Techniques, Analytical ; methods ; standards ; Drugs, Chinese Herbal ; isolation & purification ; Plants, Medicinal ; chemistry ; Pressure ; Quality Control ; Solvents ; Technology, Pharmaceutical ; methods ; standards

The content of SO2 in Paeoniae Radix Alba (RPA) was determined by the method documented in Chinese Pharmacopoeia (CP) 2010 edition to validate the repeatability of the method for evaluating RPA, and the contents of paeoniflorin sulfonate in both the residual material and distilled solution of RPA were determined by HPLC to study the transformation of paeoniflorin sulfonate to SO2 by HCl. It was found that the repeatability of the method in CP for evaluating RPA is unacceptable, and paeoniflorin sulfonate was detectable in both the residual material and distilled solution of RPA even at "the end point" of SO2 determination, merely about 50% of paeoniflorin sulfonate was transformed to SO2 by HCl, indicating that the current SO2 determination method in CP is not able to accurately quantify SO2 in RPA. It is recommended that more special method for determining SO2 content in RPA should be developed regarding the chemical characteristics of sulfur-fumigated RPA.
Chemistry Techniques, Analytical ; methods ; Chemistry, Pharmaceutical ; Drugs, Chinese Herbal ; analysis ; Fumigation ; Glucosides ; analysis ; Monoterpenes ; analysis ; Paeonia ; chemistry ; Pharmacopoeias as Topic ; standards ; Sulfur Dioxide ; chemistry