Quality Control Of Traditional Chinese Medicine Research Articles

Quality markers based on biological activity: A new strategy for the quality control of traditional Chinese medicine

BackgroundThe quality and quality evaluation system of traditional Chinese medicine (TCM) are crucial in the safety and effectiveness assessment of TCM. However, they are also the major bottlenecks that restrict the quality control of TCM. Given the nature of Chinese medicine and the limitations of science and technology, the quality evaluation of TCM involves a few difficulties. Therefore, scholars have conducted considerable amount of research on this topic and obtained promising results. Biological potency and biomarkers have been used to evaluate the quality of TCM. Previous studies provided new strategies and methods to establish a system on quality evaluation. PurposeThis review aims to provide a new strategy for the quality control of Chinese herbal medicine by combining biological potency and biomarkers based on biological effects. MethodsWe reviewed the quality evaluation system of Chinese herbal medicine, focusing on quality markers (Q-markers) based on biological effects and the application of these markers in the quality evaluation of Chinese herbal medicine. We also reviewed the factors affecting quality, the difficulties related to the quality evaluation system and the attempt of researchers to improve the quality control of TCM. ResultsWe propose Q-biomarkers by integration of biological potency and biomarkers to evaluate the quality of TCM. The quality markers provided us significant insights in the process of definition. We further optimised the concept of Q-markers and summarised their definition and properties (including quantification, specificity and related to biological response) in accordance with the requirement of the quality evaluation of TCM. ConclusionWe propose the use of Q-biomarkers in vivo related to specific diseases as a new strategy for the quality evaluation of Chinese herbal medicine. The quality evaluation system of Q-biomarkers would provide a new perspective to standardise and globalise TCM.

From quality markers to data mining and intelligence assessment: A smart quality-evaluation strategy for traditional Chinese medicine based on quality markers

BackgroundThe quality of traditional Chinese medicine (TCM) forms the foundation of its clinical efficacy. The standardization of TCM is the most important task of TCM modernization. In recent years, there has been great progress in the quality control of TCM. However, there are still many issues related to the current quality standards, and it is difficult to objectively evaluate and effectively control the quality of TCM. PurposeTo face these challenge, we summarized the current quality marker (Q-marker) research based on its characteristics and benefits, and proposed a reasonable and intelligentized quality evaluation strategy for the development and application of Q-markers. MethodsUltra-performance liquid chromatography-quadrupole/time-of-flight with partial least squares-discriminant analysis was suggested to screen the chemical markers from Chinese medicinal materials (CMM), and a bioactive-guided evaluation method was used to select the Q-markers. Near-infrared spectroscopy (NIRS), based on the distinctive wavenumber zones or points from the Q-markers, was developed for its determination. Then, artificial intelligence algorithms were used to clarify the complex relationship between the Q-markers and their integral functions. Internet and mobile communication technology helped us to perform remote analysis and determine the information feedback of test samples. ChaptersThe quality control research, evaluation, standard establishment and quality control of TCM must be based on the systematic analysis of Q-markers to study and describe the material basis of TCM efficacy, define the chemical markers in the plant body, and understand the process of herb drug acquisition, change and transmission laws affecting metabolism and exposure. Based on the advantages of chemometrics, new sensor technologies, including infrared spectroscopy, hyperspectral imaging, chemical imaging, electronic nose and electronic tongue, have become increasingly important in the quality evaluation of CMM. Inspired by the concept of Q-marker, the quantitation can be achieved with the help of artificial intelligence, and these subtle differences can be discovered, allowing the quantitative analysis by NIRS and providing a quick and easy detection method for CMM quality evaluations. ConclusionThe concept of Q-markers focused on unique CMM differences, dynamic changes and their transmission and traceability to establish an overall quality control and traceability system. Based on the basic attributes, an integration model and artificial intelligence research path was proposed, with the hope of providing new ideas and perspectives for the TCM quality management.

Discrimination and identification of Q-markers based on ‘Spider-web’ mode for quality control of traditional Chinese medicine

BackgroundThe safety and effectiveness of traditional Chinese medicine (TCM) in clinical practice is directly related to the quality of TCM. And, the quality control of TCM is a pivotal issue to the quality of TCM, but also an obstacle impeding the modernization of TCM. PurposeThe purpose of this work is to compile and develop a strategy based on discrimination and identification of quality markers (Q-markers) for quality control of TCM. MethodsMainly established by seven variables derived from four dimensions including content, stability, pharmacokinetics and pharmacology, the ‘Spider-web’ mode was undertaken to assess the Q-marker property of candidate compounds originated from TCM by taking regression area (A) and coefficient variation (CV) of the tested compounds into account. The importance index (ImI), ImI = A × 1/CV, was suggested to focus Q-markers. ResultsThe compounds with larger regression area (A) and less coefficient variation (CV) are preferentially adopted as Q-markers, which should possess the satisfactory properties of content, stability, pharmacokinetics and pharmacological activity. To the contrary, the compounds are excluded on the grounds of the unsatisfactory Q-markers’ property, less regression area (A) and larger coefficient variation (CV), which cannot represent the quality of TCM. ConclusionsThe ‘Spider-web’ mode can filter out the redundant constituents and focus on the key indexes of quality control – Q-markers. The screened Q-markers possess the optimal integrated properties of content, stability, pharmacokinetics and pharmacology among the numerous and complicated ingredients of TCM, which can comprehensively characterize inherent quality of TCM. In summary, the novel strategy established in this work provides a valuable perspective for the quality control of TCM.

Development of whole process quality control and management system of traditional Chinese medicine decoction pieces based on traditional Chinese medicine quality tree

The whole process quality control and management of traditional Chinese medicine (TCM) decoction pieces is a system engineering, involving the base environment, seeds and seedlings, harvesting, processing and other multiple steps, so the accurate identification of factors in TCM production process that may induce the quality risk, as well as reasonable quality control measures are very important. At present, the concept of quality risk is mainly concentrated in the aspects of management and regulations, etc. There is no comprehensive analysis on possible risks in the quality control process of TCM decoction pieces, or analysis summary of effective quality control schemes. A whole process quality control and management system for TCM decoction pieces based on TCM quality tree was proposed in this study. This system effectively combined the process analysis method of TCM quality tree with the quality risk management, and can help managers to make real-time decisions while realizing the whole process quality control of TCM. By providing personalized web interface, this system can realize user-oriented information feedback, and was convenient for users to predict, evaluate and control the quality of TCM. In the application process, the whole process quality control and management system of the TCM decoction pieces can identify the related quality factors such as base environment, cultivation and pieces processing, extend and modify the existing scientific workflow according to their own production conditions, and provide different enterprises with their own quality systems, to achieve the personalized service. As a new quality management model, this paper can provide reference for improving the quality of Chinese medicine production and quality standardization.

Application of random forest algorithm in fingerprint of Chinese medicine: different brands of Xiasangju granules as example

To establish a random forest algorithm for identifying and classifying different brands of Xiasangju granules, and provide effective reference for identifying multi-index complex fingerprint. HPLC method was used to collect the fingerprint of 83 batches of Xiasangju granules from different manufacturers. The classification of Xiasangju granules samples based on chromatographic fingerprints was identified by chemometric methods including principal component analysis (PCA), partial least squares discriminate analysis (PLS-DA) and random forest analysis (RF). The superiority of the above three chemometric methods was compared. The results showed that the fingerprints of 83 batches of Xiasangju granules were established in this study. PCA could only explicate 56.52% variance contribution rate and could not completely classify the samples; PLS-DA analysis was superior to PCA, explicating 63.43% variance contribution rate and could obtain certain separation; RF could well classify the samples into 3 types, and the predication accuracy of the proposed method was 96.5%. Therefore, The results indicate that RF combined with HPLC fingerprint could effectively construct traditional Chinese medicine quality control and analysis system.

Application of immunoassay in fast quality evaluation of traditional Chinese medicine

The quality evaluation of traditional Chinese medicine can be divided into two aspects, effectiveness and safety. The existing methods for evaluating the quality of traditional Chinese medicine(TCM) are mostly based on the testing instruments, which can not meet the practical needs of simple, rapid and on-site in production and life. Immunoassay, characterized by simple, rapid, sensitive, specific, low-cost and high-throughput, is widely used in the fields of clinical diagnosis, environmental pollution monitoring, food safety testing, and other fields. In recent years, immunoassay technology has been gradually applied in the field of quality control of TCM, involving quantitative detection of effective components of TCM, detection of harmful substances in TCM, and detection of exogenous pollutants in TCM. This paper summarizes the principle of the wide application of ELISA and colloidal gold immunostrip technology and its application in quality evaluation of TCM, this technique has a good application prospect in the field of rapid detection of the quality of TCM. In this paper, the principles of the widely used ELISA and colloidal gold immune test strip technology as well as their application in quality evaluation of TCM were reviewed, and the results showed that this technique had a good application prospect in the field of rapid detection of the quality of TCM.

Application progress on near infrared spectroscopy in quality control and process monitoring of traditional Chinese medicine

The industry of traditional Chinese medicine (TCM) encounters problems like quality fluctuation of raw materials and unstandardized production process. Near infrared (NIR) spectroscopy technology is widely used in quality control of TCM because of its abundant information, fast and nondestructive characters. The main applications include quantitative analysis of Chinese medicinal materials, intermediates and Chinese patent medicines; the authenticity of TCM, species, origins and manufacturers; monitoring and control of the extraction, alcohol precipitation, column chromatography and blending process. This article reviews the progress on the application of NIR spectroscopy technology in TCM field. In view of the problems existing in the application, the article proposes that the standardization of NIR analysis method should be developed according to specific characteristics of TCM, which will promote the application of NIR technology in the TCM industry.

Rapid Screening of Chemical Constituents in Rhizoma Anemarrhenae by UPLC-Q-TOF/MS Combined with Data Postprocessing Techniques.

Rhizoma Anemarrhenae, a famous traditional Chinese medicine (TCM), is the dried rhizome of Anemarrhena asphodeloides Bge. (Anemarrhena Bunge of Liliaceae). The medicine presents anti-inflammatory, antipyretic, sedative, and diuretic effects. The chemical constituents of Rhizoma Anemarrhenae are complex and diverse, mainly including steroidal saponins, flavonoids, phenylpropanoids, benzophenones, and alkaloids. In this study, UPLC-Q-TOF/MS was used in combination with data postprocessing techniques, including characteristic fragments filter and neutral loss filter, to rapidly classify and identify the five types of substances in Rhizoma Anemarrhenae. On the basis of numerous literature reviews and according to the corresponding characteristic fragments produced by different types of compounds in combination with neutral loss filtering, we summarized the fragmentation patterns of the main five types of compounds and successfully screened and identified 32 chemical constituents in Rhizoma Anemarrhenae. The components included 18 steroidal saponins, 6 flavonoids, 4 phenylpropanoids, 2 alkaloids, and 2 benzophenones. The method established in this study provided necessary data for the study on the pharmacological effects of Rhizoma Anemarrhenae and also provided the basis for the chemical analysis and quality control of TCMs to promote the development of a method for chemical research on TCMs.

Supercritical fluid chromatography for separation and preparation of tautomeric 7-epimeric spiro oxindole alkaloids from Uncaria macrophylla

Increasing challenge arising from configurational interconversion in aqueous solvent renders it rather difficult to isolate high-purity tautomeric reference standards and thus largely hinders the holistic quality control of traditional Chinese medicine (TCM). Spiro oxindole alkaloids (SOAs), as the markers for the medicinal Uncaria herbs, can easily isomerize in polar or aqueous solvent via a retro-Mannich reaction. In the present study, supercritical fluid chromatography (SFC) is utilized to separate and isolate two pairs of 7-epimeric SOAs, including rhynchophylline (R) and isorhynchophylline (IR), corynoxine (C) and corynoxine B (CB), from Uncaria macrophylla. Initially, the solvent that can stabilize SOA epimers was systematically screened, and acetonitrile was used to dissolve and as the modifier in SFC. Then, key parameters of ultra-high performance SFC (ultra-performance convergence chromatography, UPC2), comprising stationary phase, additive in modifier, column temperature, ABPR pressure, and flow rate, were optimized in sequence. Two isocratic UPC2 methods were developed on the achiral Torus 1-AA and Torus Diol columns, suitable for UV and MS detection, respectively. MCI gel column chromatography fractionated the U. macrophylla extract into two mixtures (R/IR and C/CB). Preparative SFC, using a Viridis Prep Silica 2-EP OBD column and acetonitrile-0.2% diethylamine in CO2 as the mobile phase, was finally employed for compound purification. As a result, the purity of four SOA compounds was all higher than 95%. Different from reversed-phase HPLC, SFC, by use of water-free mobile phase (inert CO2 and aprotic modifier), provides a solution to rapid analysis and isolation of tautomeric reference standards for quality control of TCM.

Research progress on standardization study of NIR spectroscopy based method for quality control of traditional Chinese medicine

In recent years, the near infrared (NIR) spectroscopy has gained wide acceptance within the quantitative analysis of traditional Chinese medicine (TCM). However, the lack of technical standards is the bottleneck problem in this process. To address this issue, standardization study of the NIR spectroscopy based method for the quantitative analysis of TCM is needed, in which the specific characteristics of TCM should be given full considerations. The main research contents include:the scope definition for the application of NIR spectroscopy in the TCM quantitative analysis field, the selection criteria for the sample pretreatment and spectral acquisition conditions, the rules for the model optimization and evaluation, and the regulations for the model update and transfer. In this paper, some foreign studies in the agricultural areas are reviewed for reference. Different chemometrics methods reported in the literature are investigated and compared systematically. This research is important actual significance to the theoretical development of NIR spectroscopy analytical techniques, and will effectively promote the application of the technology in the TCM industry. Furthermore, it is beneficial to improve the technical level of TCM quality control, and can also be used as references to achieve similar purposes for other natural products.

Investigation On Biological Quality Control Of Traditional Chinese Medicine – Cerebralcare Granule As An Example

Quality control is one of the biggest issues for the modernization of traditional Chinese medicine (TCM). It is the bottleneck of bringing TCM to the global world. Bioassay has been considered as a desirable quality control technique for drugs, especially TCM, which consists of complex substances and difficult to be determined using regular physical and chemical methods. Cerebralcare granule (CG), which has effective and widespread applications, was taken as a practical example. Utilizing zebrafish as animalmodel, protection efficiency of nerve cells was measured to assess the quality of Cerebralcare granule. By comparing different batches CG products, and study the necessity and feasibility in quality specification of CG through establishing bioactivity assay. This method exhibited excellent precision (intra-day RSD = 2.2 – 3.7%, inter-day RSD = 1.2%), reproducibility (RSD = 4.9%) and stability (RSD = 8.4%); and the method met the requirements of guiding principles of the biological activity determination. According to the results of the protection efficiency of nerve cells, CG in different batches showed significantly differences in bioactivity. This novel method could reflect the pharmacological effects on neuroprotective effect and be helpful for the quality control of CG. This study provides reference for the bio-evaluation of the quality control of TCM.

Direct analysis of traditional Chinese medicines by mass spectrometry.

Analysis of traditional Chinese medicines (TCMs) plays important roles in quality control of TCMs and understanding their pharmacological effects. Mass spectrometry (MS) is a technique of choice for analysis of TCMs due to its superiority in speed, sensitivity and specificity. However, conventional MS analysis of TCMs typically requires extensive sample pretreatment and chromatographic separation, which could be time-consuming and laborious, prior to the analysis. The expanding usage of TCMs worldwide demands development of rapid, cost-effective and reliable methods for analysis of TCMs. In recent years, new sample preparation and ionization techniques have been developed to enable direct analysis of TCMs by MS, significantly reducing the analysis time and cost. In this review, various MS-based techniques, mainly including ambient ionization-MS and MALDI-MS based techniques, applied for direct analysis of TCMs are summarized and their applicability and future prospects are discussed.

Discussion of HPLC fingerprint of traditional Chinese medicine of Corydalis yanhusuo and its preparation

Fingerprint of traditional Chinese medicine (TCM) is in the guidance of the basic theory of TCM, according to the variety and quality of TCM and using a variety of analytical methods and technology, to establish the objective, overall and multi index comprehensive evaluation system. The TCM fingerprint in one of the strategic subjects for TCM modernization. As more and more technologies have been applied to the fingerprint research of TCM, it is sure to play a much more important role in many aspects, such as the quality control of TCM, the researches of efficient components, and the mechanism in TCM, and so on. The fingerprint technology includes many modern technologies such as high-pressure liquid chromatography (HPLC). Corydalis yanhusuo is an ancient TCM, and recent years appears many researches about fingerprint of C. yanhusuo. This paper generalizes the research in progresses in research and analytical methods on fingerprint technology of C. yanhusuo, processed products (vinegar), and painkillers, to provide the scientific basis for fingerprint method and quality control of C. yanhusuo.

Application of microscopy technique and high-performance liquid chromatography for quality assessment of the flower bud of Tussilago farfara L. (Kuandonghua).

Background:Quality control is one of the bottleneck problems limiting the application and development of traditional Chinese medicine (TCM). In recent years, microscopy and high-performance liquid chromatography (HPLC) techniques have been frequently applied in the quality control of TCM. However, studies combining conventional microscopy and HPLC techniques for the quality control of the flower bud of Tussilago farfara L. (Kuandonghua) have not been reported.Objective:This study was undertaken to evaluate the quality of the flower bud of T. farfara L. and to establish the relationships between the quantity of pollen grains and four main bioactive constituents: tussilagone, chlorogenic acid, rutin and isoquercitrin.Materials and Methods:In this study, microscopic examination was used to quantify microscopic characteristics of the flower bud of T. farfara L., and the chemical components were determined by HPLC. The data were analyzed by Statistical Package for the Social Sciences statistics software.Results:The results of the analysis showed that tussilagone, chlorogenic acid, rutin and isoquercitrin were significantly correlated with the quantity of pollen grains in the flower bud of T. farfara L. There is a positive correlation between them. From these results, it can be deduced that the flower bud of T. farfara L. with a greater quantity of pollen grains should be of better quality.Conclusion:The study showed that the established method can be helpful for evaluating the quality of the flower bud of T. farfara L. based on microscopic characteristic constants and chemical quantitation.

A Useful Strategy to Evaluate the Quality Consistency of Traditional Chinese Medicines Based on Liquid Chromatography and Chemometrics.

Evaluation of the batch consistency of traditional Chinese medicines (TCMs) is essential for the promotion of the development and quality control of TCMs. The aim of the present work was to develop a useful strategy via liquid chromatography and chemometrics to evaluate the batch consistency of TCM preparations. Xin-Ke-Shu (XKS) tablet was chosen as a model for this method development. Four types of chromatographic fingerprint approaches were compared by using similarity analysis based on cosine of angel or correlation coefficient. Differences in the fingerprints of 71 batches of XKS tablet were illustrated by hierarchical cluster analysis. Then, Mahalanobis distance was employed for estimating the probability level (P < 0.05) of the differences mentioned above. Additionally, t-test was applied to find out the chromatographic peaks which had significant differences. For XKS tablet, the maximum wavelength fingerprint had the largest range and dispersion degree of similarity as compared with the other three ones. There were two clear clusters in all the batches of samples. And we clearly arrived at the conclusion that higher similarity does not exactly indicate small Mahalanobis distance, while lower similarity indicated larger Mahalanobis distance. Finally, a useful strategy was proposed for evaluation of the batch consistency of XKS tablet.

Nobel Prize for Artemisinin Inspires Modern TCM Research

Half of the 2015 Nobel Prize in Physiology or Medicine was awarded to Chinese scientist Youyou Tu in recognition of her pioneering work on the antimalarial artemisinin, extracted from Artemisia annua, a traditional Chinese herbal remedy used to treat fever. This is clearly a great encouragement for scientists who engage traditional medicine research. As Youyou Tu stated in her Nobel Prize awarding lecture, artemisinin is a gift from traditional Chinese medicine (TCM) to the world, this definitely will generate great interest in not only TCM but also other traditional medicine systems from other parts of the world, including Europe, Africa, India, Americas, etc. Though the Nobel Prize selection committee did not confess that the prize is to award traditional Chinese medicine, rather a new drug discovery inspired from TCM, this is indeed the exciting and encouraging event for Chinese TCM scientists. In my opinion, it is meaningless to dispute if artemisinin is still belonging to TCMor westernmedicine. Any contribution or new discovery derived from TCM to benefit for the human health should be recognized and respected. TCM needs to be developed and modernized. Any standpoint that developed or modernized TCM does not belong to TCM may drastically hinder the TCM modernization and integration with modern medicine process, or even deepen the gap between TCM and modern medicine. Evidence-based medicine is the future of TCM by means of modern biomedicine advances and novel approaches. In the past 20 years, TCM has undergone rapid development period evidenced by a number of achievements including the geometric growth of TCM research papers, booming TCM industry, TCM new drug research and development, etc. However, TCM is still facing grand challenges in the future development. Shortage of modern scientific evidence for safety, effectiveness, quality and mode of action should be emphasized and dealt with solutions. TCM experienced-based feature should be turned into evidence-based and science-based one. Following several aspects are suggested for the future modern TCM research: a) TCM-based new drug discovery. TCM is still a non-fully explored treasure house for new drug discovery and development. According to TCM resource survey, there are over 12000 TCM species, among which majority are herbs. Apart from artemisinin and its derivatives, a number of single chemical entity drugs have been developed and successfully marketed, such as arsenic trioxide, ginsenoside Rg3, bifendate, β-elemene, indirubin, etc. It is anticipated that more new drugs could be discovered from this vast TCM resource with modern drug discovery technology and methodology. b) Research on the holistic TCM quality control. The current quality control approach is more focused on a single marker or a few marker determinations, which follows the western drug quality control model and hence, could not really monitor the quality of TCM products. Systemic and comprehensive quality control method should be developed for the TCM crude drugs, prepared slices and finished products, especially for those multiple-ingredient herbal products. c) Research on TCM processing. All TCM crude drugs should be processed in different extent before they can be used either for decoction or for herbal production. TCM processing method is mainly based on the traditional knowledge or experience. Mechanism of processing either for the purpose of enhancing efficacy or eliminating toxicity should be thoroughly investigated and clarified. d) TCM efficacy and safety research. During the development of TCM, greater attention needs to be paid to the integrated evaluation of the effectiveness and safety based on TCM theory and modern scientific research. New evaluation methodology fit for TCM complex feature should be developed with international collaborations. Globally recognized evaluation criteria should be constructed. Other TCM research focuses include pharmacokinetics, geo-authenticity, active principles and giant data library. It is firmly believed that TCM will contribute more than ever to the human health along with the rapid advances of biomedicine science and eventually developed into an evidence-based medicine system.

Application of multivariate statistical analysis and thinking in quality control of Chinese medicine

The study of quality control of Chinese medicine has always been the hot and the difficulty spot of the development of traditional Chinese medicine (TCM), which is also one of the key problems restricting the modernization and internationalization of Chinese medicine. Multivariate statistical analysis is an analytical method which is suitable for the analysis of characteristics of TCM. It has been used widely in the study of quality control of TCM. Multivariate Statistical analysis was used for multivariate indicators and variables that appeared in the study of quality control and had certain correlation between each other, to find out the hidden law or the relationship between the data can be found,.which could apply to serve the decision-making and realize the effective quality evaluation of TCM. In this paper, the application of multivariate statistical analysis in the quality control of Chinese medicine was summarized, which could provided the basis for its further study.

Qualitative and quantitative analysis of Rhizoma Smilacis glabrae by ultra high performance liquid chromatography coupled with LTQ OrbitrapXL hybrid mass spectrometry.

Rhizoma Smilacis glabrae, a traditional Chinese medicine (TCM) as well as a functional food, has been commonly used for detoxification treatments, relieving dampness and as a diuretic. In order to quickly define the chemical profiles and control the quality of Smilacis glabrae, ultra high performance liquid chromatography coupled with electrospray ionization hybrid linear trap quadrupole orbitrap mass spectrometry (UHPLC-ESI/LTQ-Orbitrap-MS) was applied for simultaneous identification and quantification of its bioactive constituents. A total of 56 compounds, including six new compounds, were identified or tentatively deduced on the basis of their retention behaviors, mass spectra, or by comparison with reference substances and literature data. The identified compounds belonged to flavonoids, phenolic acids and phenylpropanoid glycosides. In addition, an optimized UHPLC-ESI/LTQ-Orbitrap-MS method was established for quantitative determination of six marker compounds from five batches. The validation of the method, including linearity, sensitivity (LOQ), precision, repeatability and spike recoveries, was carried out and demonstrated to be satisfied the requirements of quantitative analysis. The results suggested that the established method would be a powerful and reliable analytical tool for the characterization of multi-constituent in complex chemical system and quality control of TCM.

Recent advances in cell membrane chromatography for traditional Chinese medicines analysis

Traditional Chinese medicines (TCMs) have been used for preventative care for thousands of years. The active components are the basis for the pharmacodynamics of TCMs, and they can be an important source of lead compounds. As a bioaffinity chromatography technique, cell membrane chromatography (CMC) has been developed for almost 20 years since 1996. It has been proven to be a useful method for studying drug–receptor interactions and screening active components from medicinal herbs. In our review in 2007 (Drug Discov. Ther., 1 (2007) 104–107), the preparation, identification, evaluation, and preliminary applications of CMC stationary phases were presented. In this article, we briefly review some of the latest progress and applications about CMC including instrument development, research on drug–receptor interactions, screening active components from TCMs, and quality control of TCMs.

English

Validity of traditional Chinese medicine (TCM) is oppugned very often because of the bugs of quality, effectiveness, and repeatability. Standardization of TCMs is one way to make a change. How to realize standardization of TCMs and with what measures to shape the quality control system, is provoking much debate in the TCM field. Genetic and chemical profiling were comparatively performed on Alstonia scholaris in China through amplified fragment length polymorphism (AFLP) analysis and alkaloid high performance liquid chromatography (HPLC) scanning, aiming to evaluate the attributes of chemical and DNA fingerprinting as applicable tools for quality control of TCMs and explore theoretic strategy of TCM standardization. Each individual of A. schlolaris displayed a unique AFLP or HPLC profile, indicating well individual-distinguishing ability of the two techniques. Patterns of variance structure disclosed by the HPLC and AFLP profiling were similar, and more than 50% of alkaloid loci were kept constant across any single population, suggesting a genetic basis of the alkaloid secondary metabolism in the plant and justifying DNA fingerprinting as a qualified identifier for quality control of the TCM. Compared to the alkaloid HPLC scanning, the AFLP analysis produced much more loci with lower polymorphic loci percentage, suggesting that AFLP can be more statistically informative and with moderate sensitivity. In passing, a strategy pursuing genetically identical TCMs by popularizing plantation of selected germplasm of medicinal plants was suggested for TCM standardization. Key words: Traditional Chinese Medicine (TCM), standardization, Alstonia scholaris, alkaloid scanning, genetic profiling. &nbsp;