Chinese Medicine

Quality consistency is one of the basic attributes of medicines, but it is also a difficult problem that natural medicines and their preparations must face. The complex chemical composition and comprehensive pharmacological action of natural medicines make it difficult to simply apply the commonly used evaluation methods in chemical drugs. It is thus urgent to explore the novel evaluation methods suitable for the characteristics of natural medicines. With the rapid development of analytical techniques and the deepening understanding of the quality of natural herbs, increasing numbers of researchers have proposed many new ideas and technologies. This review mainly focuses on the basic principles, technical characteristics and application examples of the chemical evaluation, biological evaluation methods and their combination in quality consistency evaluation of natural herbs. On the bases of chemical evaluation and clinical efficacy, new methods reflecting their pharmacodynamic mechanism and safety characteristics will be developed, and gradually towards accurate quality control, to achieve the goal of quality consistency. We hope that this manuscript can provide new ideas and technical references for the quality consistency of natural drugs and their preparations, thus better guarantee their clinical efficacy and safety, and better promote industrial development.

The raw and processed roots of Polygonum multiflorum Thunb (PM) are commonly used in clinical practice to treat diverse diseases; however, reports of hepatotoxicity induced by Polygoni Multiflori Radix (PMR) and Polygoni Multiflori Radix Praeparata (PMRP) have emerged worldwide. Thus, it is necessary for researchers to explore methods to improve quality standards to ensure their quality and treatment effects. In the present study, an ultra-high performance liquid chromatography triple quadrupole mass spectrometry (UHPLC-QQQ-MS/MS) method was optimized and validated for the determination of dianthrones in PMR and PMRP using bianthronyl as the internal standard. Chromatographic separation with a gradient mobile phase [A: acetonitrile and B: water containing 0.1% formic acid (v/v)] at a flow rate of 0.25 mL/min was achieved on an Agilent ZORBAX SB-C18 column (2.1 mm × 50 mm, 1.8 μm). The triple quadrupole mass spectrometer (TQMS) was operated in negative ionization mode with multiple reaction monitoring for the quantitative analysis of six dianthrones. Moreover, compounds 5 and 6 were further evaluated for their cytotoxicity in HepaRG cells by CCK-8 assay. The UHPLC-QQQ-MS/MS method was first developed to simultaneously determine six dianthrones in PMR and PMRP, namely, polygonumnolides C1–C4 (1–4), trans-emodin dianthrones (5), and cis-emodin dianthrones (6). The contents of 1–6 in 90 batches of PMR were in the ranges of 0.027–19.04, 0.022–13.86, 0.073–15.53, 0.034–23.35, 0.38–83.67 and 0.29–67.00 µg/g, respectively. The contents of 1–6 in 86 batches of commercial PMRP were in the ranges of 0.020–13.03, 0.051–8.94, 0.022–7.23, 0.030–12.75, 0.098–28.54 and 0.14–27.79 µg/g, respectively. Compounds 1–4 were almost completely eliminated after reasonable processing for 24 h and the contents of compounds 5 and 6 significantly decreased. Additionally, compounds 5 and 6 showed inhibitory activity in HepaRG cells with IC50 values of 10.98 and 15.45 μM, respectively. Furthermore, a systematic five-step strategy to standardize TCMs with endogenous toxicity was proposed for the first time, which involved the establishment of determination methods, the identification of potentially toxic markers, the standardization of processing methods, the development of limit standards and a risk–benefit assessment. The results of the cytotoxicity evaluation of the dianthrones indicated that trans-emodin dianthrones (5) and cis-emodin dianthrones (6) could be selected as toxic markers of PMRP. Taking PMR and PMRP as examples, we hope this study provides insight into the standardization and internationalization of endogenous toxic TCMs, with the main purpose of improving public health by scientifically using TCMs to treat diverse complex diseases in the future.

Poor access to healthcare in rural communities causes many people to seek herbalists who use medicinal plants for the treatment of various disease conditions. Most knowledge of traditional herbal medicine makes use of indigenous remedies which are often undocumented and are at risk of being lost. The preservation of this knowledge may facilitate scientific inquiry into promising new therapeutic molecules. Semi-structured questionnaires were used to collect the sociodemographic information of 30 herbalists in Kisumu East Sub County. The local names of medicinal plants used in managing illnesses of the respiratory system, their habit, active parts, indications, methods of preparation, routes of administration, scientific identity, and conservation status were also recorded. Other reported traditional uses, pharmacological activities, and toxicological data were identified via a literature search. Most herbalists were female (86.7%), aged between 61 and 70 years (43.3%) with no formal education (56.7%), and had 21–30 years of practice (30%). 44 plant species, belonging to 43 genera and 28 families were identified. Leguminosae and Rutaceae plant families were predominant, leaves were frequently used (33%), and trees were the most common habit (44.4%). Most plants were collected in the wild (79.2%), preparation was mainly by decoction (68.8%), and the administration was mainly orally. The main indication was cough and 79.5% of all documented plant species had previously been reported to have a pharmacological activity relevant to the mitigation of respiratory illnesses. Toxicological data was available for 84.1% of the plant species identified. The predominant use of roots, root barks, and root tubers by herbalists in Kisumu East Sub County threatens to negatively impact the ecological survival of some plant species. The preservation of herbalists’ knowledge of medicinal plants in the study area is a pressing concern considering their advanced age and little formal education. There is a need to conserve some of the medicinal plants documented in this study. The medicinal claims made by herbalists also warrant scientific scrutiny.

Tienchi (Panax notoginseng) has been used in conservative treatments for back pain as a major ingredient of many herbal medicines. This study aims to investigate the effects of a herbal medicine containing tienchi on compressed intervertebral discs in rats. Using an in vivo rat tail model, intervertebral disc compression was simulated in the caudal 8–9 discs of 25 rats by continuous static compression (11 N) for 2 weeks. An herbal medicine plaster (in which the major ingredient was tienchi) was externally applied to the compressed disc (n=9) for three weeks, and held in place by an adhesive bandage, in animals in the Chinese Medicine (CM) group. The effect of the bandage was evaluated in a separate placebo group (n=9), while no intervention with unrestricted motion was provided to rats in an additional control group (n=7). Disc structural properties were quantified by in vivo disc height measurement and in vitro morphological analysis. Disc height decreased after the application of compression (P < 0.001). The disc height decreased continuously in the control (P = 0.006) and placebo (P = 0.003) groups, but was maintained in the CM group (P = 0.494). No obvious differences in disc morphology were observed among the three groups (P = 0.896). The tienchi-containing herbal plaster had no significant effect on the morphology of compressed discs, but maintained disc height in rats.

This study aims to establish a diagnostic scoring scheme for Shanghuo (Heatiness) and to evaluate whether Shanghuo is associated with biochemical parameters of salivary lysozyme (LYZ), salivary secreted immunoglobulin (S-IgA), salivary amylase (AMS), and saliva flow rate (SFR). We collected 121 Shanghuo patients at the Affiliated Hospitals of Guangzhou University of Traditional Chinese Medicine in Guangdong Province, 60 cases as a Shanghuo recovered group, and 60 healthy cases as a healthy control group. The diagnostic scoring scheme was established by probability theory and maximum likelihood discriminatory analysis on the basis of epidemiology with the design of self-controlled clinical trial. Subsequently, we used the same methods to collect 120 Shanghuo patients, 60 Shanghuo recovered cases, and 60 healthy cases in both Hunan Province and Henan Province. The levels of LYZ, S-IgA, AMS, and SFR were tested when the patients suffered from Shanghuo or recovered, respectively. The diagnostic score table for Shanghuo syndrome was established first. In the retrospective tests, the sensitivity, specificity, accuracy, and positive likelihood ratio of the diagnostic score table were 98.9%, 93.5%, 97.5%, and 14.34%, respectively. In the prospective tests, the corresponding values were 94.9%, 85.7%, 91.7%, and 6.64%, respectively. Shanghuo was classified into three degrees based on the diagnostic scores, common Shanghuo: 63–120; serious Shanghuo: 121–150; very serious Shanghuo: >150. A negative correlation was found between Shanghuo and S-IgA (R = -0.428; P = 0.000). The level of S-IgA was also affected by seasonal and regional factors. No significant correlations were found between Shanghuo and the levels of LYZ, AMS, and SFR. In this study, Shanghuo could be diagnosed by the combination of the diagnostic score table and S-lgA level.

We demonstrated that a Chinese herbal formula, which we refer to as RCM-101, developed from a traditional Chinese medicine formula, reduced nasal and non-nasal symptoms of seasonal allergic rhinitis (SAR). The present study in primary and cultured cells was undertaken to investigate the effects of RCM-101 on the production/release of inflammatory mediators known to be involved in SAR. Compound 48/80-induced histamine release was studied in rat peritoneal mast cells. Production of leukotriene B4 induced by the calcium ionophore A23187 was studied in porcine neutrophils using an HPLC assay and lipopolysaccharide-stimulated prostaglandin E2 production was studied in murine macrophage (Raw 264.7) cells by immune-enzyme assay. Expression of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) was determined in Raw 264.7 cells, using western blotting techniques. RCM-101 (1–100 μg/mL) produced concentration-dependent inhibition of compound 48/80-induced histamine release from rat peritoneal mast cells and of lipopolysaccharide-stimulated prostaglandin E2 release from Raw 264.7 cells. Over the range 1 – 10 μg/mL, it inhibited A23187-induced leukotriene B4 production in porcine neutrophils. In addition, RCM-101 (100 μg/mL) inhibited the expression of COX-2 protein but did not affect that of COX-1. The findings indicate that RCM-101 inhibits the release and/or synthesis of histamine, leukotriene B4 and prostaglandin E2 in cultured cells. These interactions of RCM-101 with multiple inflammatory mediators are likely to be related to its ability to reduce symptoms of allergic rhinitis.