In order to prove safety and efficacy, herbal medicines must undergo the rigorous scientific researches such as pharmacokinetic and bioavailability, before they are put on the market in the foreign countries. Botanical Drug Products promulgated by the US FDA could guide industry sponsors to develop herbal drugs, which was also an important reference for investigating Chinese herbal medicines. This paper reviews and discusses novel approaches for how to assess systemic exposure and pharmacokinetic of Chinese herbal medicines, which were in line with FDA guidance. This mainly focus on identifying pharmacokinetic markers of botanical products, integral pharmacokinetic study of multiple components, Biopharmaceutics drug disposition classification system, and population pharmacokinetic-pharmacodynamic study in herb-drug interaction.
Animals ; Biomarkers, Pharmacological ; Drugs, Chinese Herbal ; chemistry ; pharmacokinetics ; Herb-Drug Interactions ; Herbal Medicine ; legislation & jurisprudence ; Humans

The necessity of establishing an evaluation system about the combination program of Chinese medical pharmacy and Western medical pharmacy was addressed in this paper. Besides, its contents were systematically clarified. Besides, existent problems and its future development trend were also explained. The author believed that it was necessary to perform researches on constructing the evaluation system on the basis of patients' needs and physicians' responsibilities. The ultimate goal of this system was to produce an optimal combination program of Chinese medical pharmacy and Western medical pharmacy for a specific disease. This optimal program was the results of comparing and analyzing the therapeutic efficacies of different combination programs. In this program, Chinese medical pharmacy and Western medical pharmacy combined together. On the one hand, it is safe; on the other hand, they do not produce adverse reaction. Their therapeutic effects were synergetic. Chinese medical pharmacy could not only advance the cure effects of Western medical pharmacy, but also supplement the insufficiency of Western medical pharmacy. Of course, the author put forward some assumptions only from the perspective of clinical application in this paper. The evaluation system will become perfect along with further deepening researches of basic sciences.
Drugs, Chinese Herbal ; adverse effects ; pharmacology ; Evaluation Studies as Topic ; Herb-Drug Interactions ; Integrative Medicine

China ; Drugs, Chinese Herbal ; pharmacology ; Evidence-Based Medicine ; Herb-Drug Interactions ; Humans ; Integrative Medicine

This article review and discuss the complimentary and alternative medicine (CAM), where it all began, practices and ideas self- defined by their users as preventing and treating illnesses or promoting health and well-being.
HERB-DRUG INTERACTIONS ; HERBALS ; ECHINACEA ; TANACETUM PARTHENIUM ; GARLIC ; GINKGO BILOBA ; PANAX ; KAVA ; VALERIAN ; HYPERICUM ; EPHEDRA

In the past century, as medical research has become increasingly precise, it has become clear that the incidence and progression of many diseases involve multiple factors and pathologies; this is particularly true for the degenerative and metabolic diseases facing industrialized societies. At the same time, it becomes increasingly clear that single-target action drugs cannot effectively treat these diseases. Researchers are looking toward the chemical industry as well as traditional herbal medicines to find multi-target interventions. Thus, a new era in drug discovery has begun. Specifically, three approaches have proven effective in seeking multi-target drugs. These are: (1) designing drugs with multiple components; (2) discovering drugs through the study of synergistic compound-compound interactions in medicinal herbs or among chemical drugs and herbal components; and (3) developing drugs to tackle complex multi-component diseases. The authors conclude that there is an increasing need for multi-component remedies to treat the complex chronic diseases afflicting modern populations. Given this situation and the growing body of evidence that these new approaches are effective, multi-target intervention appears to have great potential for discovering, designing, and developing effective new drugs for today's diseases.
Drug Design ; Drug Discovery ; trends ; Drug Synergism ; Herb-Drug Interactions ; Humans ; Molecular Targeted Therapy ; trends ; Plants, Medicinal

To explore the mechanism of the absorption enhancement of borneol, the effect of borneol on the intestinal absorption and the pharmacokinetics of tetramethylpyrazine phosphate after oral administration were investigated. In situ intestinal recirculation was performed to study the effect of various concentrations of borneol on the absorption of tetramethylpyrazine phosphate at duodenum, jejunum, ileum and colon. After oral administration of tetramethylpyrazine phosphate, the mixture of tetramethylpyrazine phosphate and borneol and the mixture of tetramethylpyrazine phosphate and verapamil in rats, the concentrations of tetramethylpyrazine phosphate in plasma were determined by RP-HPLC at predesigned time. The pharmacokinetic parameters were compared based on the results of the three animal experiments, and analyzed with software program 3p97. The result showed that tetramethylpyrazine phosphate could be absorbed at all of the four intestinal segments with increasing absorption amount per unit as follows: colon > duodenum > jejunum > ileum, but without saturation, which demonstrated that tetramethylpyrazine phosphate was absorbed via simple diffusion. Borneol could enhance the intestinal absorption of tetramethylpyrazine phosphate, however, not in proportion. There was no obvious difference between the test group and the control group when 10 microg x mL(-1) borneol was added (P > 0.05), while when the concentration comes to 25 microg x mL(-1) and 50 microg x mL(-1), significant differences were observed (P < 0.05). Borneol and verapamil did enhance the bioavailability of tetramethylpyrazine phosphate after oral administration in rats. The enhancing effect of borneol showed only when the concentration came to a certain level but with no specific sites existed in the intestine. One of the mechanisms of borneol on the enhancing effect on absorption of tetramethylpyrazine phosphate might be the inhibition of the metabolism of CYP 3A and exocytosis of P-gp.
Animals ; Biological Availability ; Bornanes ; pharmacokinetics ; Herb-Drug Interactions ; Intestinal Absorption ; drug effects ; Male ; Pyrazines ; pharmacokinetics ; Rats ; Rats, Sprague-Dawley

Cardiovascular diseases are a global public health problem, and the combination of Chinese and western medicine tends to be a major solution in China. However, the complex components in traditional Chinese medicine may interact with the therapeutic western medicines for the diseases, which will lead to the herb-drug interaction(HDI). The information on the interaction can serve as a reference for the rational combination of the Chinese and western medicines in the clinical treatment of cardiovascular diseases and help avoid the occurrence of clinical safety events. However, the research on the interaction of Chinese medicine is limited as compared with that on western medicine, and no systematic review on HDI in the treatment of cardiovascular diseases is available. Therefore, this study first introduced the mechanism of HDI, then summarized the research on HDI for the commonly used drugs for cardiovascular diseases, analyzed the problems in the available studies, and put forward suggestions on the application, regulation, and research. This study aims to highlight HDI in clinical drug use and provide a reference for rational use of combination of Chinese and western medicines in the treatment of cardiovascular diseases.
Humans ; Drugs, Chinese Herbal/therapeutic use* ; Cardiovascular Diseases/drug therapy* ; Herb-Drug Interactions ; Medicine, Chinese Traditional ; China

Animals ; Anticarcinogenic Agents ; pharmacology ; Cytochrome P-450 Enzyme System ; drug effects ; genetics ; metabolism ; Food-Drug Interactions ; Gene Expression Regulation, Enzymologic ; Herb-Drug Interactions ; Humans ; Plant Preparations ; pharmacology

Liver injury due to prescription and nonprescription medications is a growing medical, scientific and public health problem. Drug-induced liver injury (DILI) is the single most common reason for regulatory actions, including failure of approval, removal from the marketplace and restriction of prescription. Worldwide, the estimated annual incidence rate of DILI is 13.9-24.0 per 100,000 inhabitants. At the same time, there is increasing concern about the potential risk for hepatotoxicity from complementary and alternative medicines (CAM) including herbal products because they are unregulated and not standardized with regard to their contents. Determining hepatotoxicity remains a major challenge in clinical practice due to a lack of reliable markers. The RUCAM/CIOMS scale have been proposed to establish a causal relationship between offending drug and liver injury. The efforts of Drug-Induced Liver Injury Network (DILIN, USA) directed toward the development of an abridged instrument in evaluating suspected drug-induced hepatotoxicity were presented at the National Institute of Health (NIH) Workshop, titled Drug-induced liver injury: Standardization of nomenclature and causality assessment, December, 2008. The main contents of the presentations and discussions at the NIH workshop are introduced in this article. This fine-tuned operations of RUCAM/CIOMS scale would enable a more confident assessment of causality and facilitate the collection of bona fide cases of drug-induced hepatotoxicity in Korea. Several demanding tasks for the near future in Korea are also proposed at the end.
Alanine Transaminase/blood ; Complementary Therapies ; Guidelines as Topic ; Hepatitis, Toxic/*diagnosis ; Herb-Drug Interactions ; Humans ; Risk Factors ; Severity of Illness Index

The paper is aimed to investigate the effect of cyclosporine A (CyA) on the pharmacokinetics of ginkgolide B (GB) in rats, and to look for the mechanism of the changes in pharmacokinetic behaviors of GB. GB concentration in plasma, brain homogenate and urine samples of rats was determined by LC-MS. Effects of CyA on plasma levels, brain distributions as well as urinary excretions after intravenous administration of GB were evaluated. CyA co administrated intravenously at 10 mg kg(-1) or 20 mg kg(-1) significantly increased AUC(0-360 min) (P < 0.01) and decreased total CL of GB in rats. While co administrated CYP3A inhibitor itraconazole (ICZ) has no appreciable effect on the pharmacokinetic behavior of GB. CyA increased the brain uptake of GB in a dose-dependent manner. The brain distribution of GB was significantly increased at 5 min by different doses of CyA (P < 0.001), while at 20 and 60 min only high dose of CyA could significantly increase the levels of GB in the brain (P < 0.01 and P < 0.001). Different P-gp inhibitors CyA or verapamil (VER) or digoxin (DGX) decreased the urinary GB excretion, the urinary excretion of GB in 0-8 h were about 34.8% (P < 0.001), 59.4% (P < 0.001) and 79.7% (P < 0.05) of the control, separately. No appreciable effect of ICZ was observed on urinary excretion of GB. Coadministration of P-gp inhibitors CyA could significantly increase the plasma level, accelerate the brain distribution and decrease the urinary excretion of GB.
Animals ; Cyclosporine ; pharmacology ; Ginkgolides ; pharmacokinetics ; Herb-Drug Interactions ; Lactones ; pharmacokinetics ; Male ; Rats ; Rats, Sprague-Dawley ; Tissue Distribution