Quality tracing evaluation strategies of compatible materials in Aconitum proprietary Chinese medicines

Abstract

The proprietary Chinese medicine (PCM) has become a significant supplement of modern medicine. Nevertheless, the absence of quality control standard of compatible materials in PCM has led to serious adulteration, which has an extremely bad effect on safety of drug use and clinical efficacy. Here, a quality tracing evaluation strategy of compatible materials in 32 Aconitum proprietary Chinese medicines (APCMs) was established, including data normalization, model development, model verification, and unknown prescription cracking. The model was delimited based on the weighted content of total 9 key alkaloids in 24 APCMs, which were 5.65-57.10 μg/g for extract medicines and 42.62-380.61 μg/g for powder medicines. Three newly published commercial APCMs, including Wangbi Tablet, Wangbi Granule, and Fengshigutong Capsule, were used to verify its reliability and the results proved to be positive. Moreover, a novel prescription cracking approach was proposed to decode the content of each material in five unknown prescriptions including Yaoxitong Capsule, Tongrendahuoluo Pill, Xinbao Pill, Dahuoluo Capsule, and Mugua Pill. Ultimately, the single or two compatible Aconitum materials in APCMs was successfully decoded and the processed level of the materials were effectively judged. This study for the first time established a practical strategy for supervision and cracking of compatible materials in PCMs and is of great significance to improve the quality control of PCMs.

Keywords: Aconitine; Aconitum carmichaeli Debx.; Aconitum kusnezoffii Reichb.; Aconitum proprietary Chinese medicines; Quality of compatible materials.