The development of an herbal material quality control strategy considering the effects of manufacturing processes.

ABSTRACT:

Background

Quality by design (QbD) is an advanced drug quality control concept that has been gradually implemented in the optimization of manufacturing processes of Chinese medicines. However, the variation of Chinese medicinal material quality has rarely been considered in published works. Because manufacturing processes may lower the variation introduced through different batches of materials, a material quality control strategy should be developed considering the influences of manufacturing processes.

Methods

In this work, the processes of extraction, concentration, water precipitation, and chromatography for notoginseng total saponin (NTS) production were investigated while considering Panax notoginseng quality variation as a sample. Ten process parameters were st

SUBMITTER: Pan J 

PROVIDER: S-EPMC6760055 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature