Quality and safety control of tumor-shrinking decoction (TSD): A Chinese herbal preparation for the treatment of uterine fibroids.

ABSTRACT

Reproducible efficacy assessments of Chinese herbal medicines are largely based on well-established quality control procedures. This study presents a comprehensive quality control procedure for tumor-shrinking decoction (TSD), a 15-herb preparation under study as a potential therapy for uterine fibroids. Morphological, microscopic, and physicochemical authentications were first carried out on individual herbal medicines composing TSD. Contaminant tests on TSD for the presence of heavy metals and pesticide residues were performed by atomic absorption spectrophotometry and gas chromatography-mass spectrometry analysis. Furthermore, batch-to-batch quality monitoring of the decoction was investigated via ultra-performance liquid chromatography (UPLC) and high-performance liquid chromatography (HPLC). An aqueous extract of the herbal medicines was prepared and formulated into TSD. The tested contaminants were within the maximum permitted levels of the Hong Kong government in proprietary Chinese medicines. UPLC and HPLC fingerprints for quality tracking on TSD were established. The decoction was quantitatively standardized by UPLC and HPLC, respectively, with five and three chemical compounds serving as references. Collectively, the procedure established in this study will not only serve as a fundamental basis for the investigation and development of TSD as a novel therapy for uterine fibroids, but also as a protocol for studying other polycomponent herbal preparations.