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.

Successful Pregnancy after Treatment with Chinese Herbal Medicine in a 43‐Year‐Old Woman with Diminished Ovarian Reserve and Multiple Uterus Fibrosis: A Case Report

“…Among of them, Radix Salvia miltiorrhizae , Radix Paeoniae lactiflorae , Spica Prunellae vulgaris and Rhizoma Curcuma phaeocaulis have strong effects on blood stasis which is involved in mass (fibroids) formation in the reproductive system. Pharmacological studies have shown that these herbs reduce inflammation and inhibit neoplasia [ 12 , 13 ]. Meanwhile, the combination of Radix Rehmannia glutinosa , Semen Cuscutae chinensis , Fructus mori , Fructus lycii , Radix Morindae officinalis are commonly used in infertility due to ovarian factors, such as PCOS and primary ovarian insufficiency [ 13 , 14 , 15 , 16 ].…”

Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial

“…The herbs will be provided by qualified CM wholesalers approved by the Hospital Authority in Hong Kong. The heavy metal levels (arsenic, mercury, and lead) in the herbs will be evaluated, in order to ensure safety [26].…”

Gyejibongneyong-hwan, a herbal medicine for the treatment of dysmenorrhoea with uterine fibroids: a protocol for a randomised controlled trial

“…The main symptoms may include heavy, painful or prolonged menstrual periods; bleeding between periods; pelvic or low back pain; fullness in the lower abdomen, with or without urinary or rectal symptoms, due to compression; and reproductive problems, such as infertility, multiple miscarriages or early onset of labour 2. Although several surgical approaches have been recommended for the management of UFs, these methods are invasive and cause tissue injury and other adverse events 3. There are also pharmacological therapies, such as gonadotrophin-releasing hormone agonists, but rapid recurrence, wide-ranging adverse side effects and reduced bone mineral density have limited their usage 3…”