Recent Development of Quality Control Methods for Herbal Derived Drug Preparations

Abstract

Pharmaceutical industries should apply rigorous QC (quality control) to ensure the consistency, safety, and efficacy of their herbal derived drug-preparations. QC must be performed at every stage of the production line i.e. incoming raw materials, extractions, in-process control, finished products and keeping samples. Due to the complex nature of the chemical content of herbal drugs, two approaches to QC should be taken, that is quantitative determination of the selected marker(s) compound(s), and metabolite profiling. Contamination of herbal medicines by heavy metals, pesticides, toxic metabolites, microbial toxins, pathogenic microorganisms and other foreign matter should also be evaluated. A combination of chemical profiling and multivariate analysis (MVA) is recommended as the QC tool for the botanical identification method (BIM) of herbs, extracts, herb materials, and herbal drug preparations. Microscopic methods, DNA profiling or chemical marker(s) are not recommended for use as the sole BIM due to the lack of specificity. Only markers that meet certain criteria i.e. quality active (QA) markers can be utilized as a QC tool. The limit specification range of markers used as QC tools should be described in the analytical target profile (ATP). To gain reliable results of any analysis that has been performed at any QC laboratory, the analysis method must be validated according to the newest guidance. Sample detection limit of any toxic compound(s) should be lower than its cutoff value and MPL. The reliability of any results of analysis of a QC laboratory must be evaluated by using QC-samples for each series of measurements.

Metabolites of Siberian Raspberries: LC-MS Profile, Seasonal Variation, Antioxidant Activity and, Thermal Stability of Rubus matsumuranus Phenolome

“…An increase in the range of medicines based on plant raw materials is one of the directions of development of the pharmaceutical industry [1]. The investigation and implementation of traditional medicinal plants into practice is a promising area.…”

Phytochemicals of Gandarusa (Justicia gendarussa) and Its Preparations

“…This can be used for ensuring the reproducibility, efficacy, safety, and the quality of JG herbal drugs. 25 This work is still in progress.…”

Metabolite Profiling of Justicia gendarussa Herbal Drug Preparations

“…[3][4][5] Preclinical and clinical trials have been conducted on the leaf extract of JG for its development as an herbal drug. 1,[3][4][5] As the active markers of JG herbal drugs have not yet been specified, for quality control (QC) purposes a combination of metabolite profiling and multivariate analysis (MVA) was recommended 6 ; in addition, metabolite profiling could provide a better approach in comparison with a marker approach only. 7 For ensuring the reproducibility, efficacy, safety, and quality of the JG herbal drugs, all preparations at each step in the production line (A, E, and GR) must be analyzed and evaluated.…”

“…Soft Independent Modeling of Class Analogy (SIMCA), which generally is included in some MVA software, can be well applied for this classification purpose. 6,7 For determining the quality markers and their detailed specification, metabolite profiling of blood, urine, and sperm specimens of volunteers in new clinical trials should be evaluated 7 ; this work is in progress.…”

“…It is well known that metabolite profiling must be performed as a QC tool by the pharmaceutical industry, if quality markers have not yet been specified. 6 For this purpose, the application of classification analysis as a QC tool has been evaluated in this work. Classification of results using samples DS1, A1, E1, GR1, and GR K are summarized in Table 1 and Figure 7.…”