Brief Introduction to Alternative Research of Chemical Reference Substances of Traditional Chinese Medicine

Compared with chemicals, the application history of chemical reference substances in Chinese medicine is relatively short

Table 1-1 The application of chemical reference substances of traditional Chinese medicine in each edition of the pharmacopoeia

However, the vast majority of Chinese medicine chemical reference substances are extracted from plants.

The application of natural product reference substances in foreign drug standards is also common

1.

Same as the conventional content determination method, the monomer component is used as the reference substance to determine the content of the component in the medicinal materials and corresponding preparations

2.

Multiple components are measured at the same time under the item category, and the reference substance is used as one of the measured components and also used as a control for other measured components

3.

The measured sample does not contain the corresponding component, which is used as a control for similar internal standard components

For another example, St.

4.

The reference extract with the labeled content is used as the reference substance for content determination, and multiple components can be measured at the same time

For another example, under the item of American ginseng, the powdered American GinSeng Extract with the labeled value is used as the control, and the content of ginsenoside Rg1, Re, Rb1, Rc, Rb2 and Rd is determined by HPLC, and the total saponins content is calculated (Figure 1-5)

The diversification of the application mode of the reference substance for content determination can relieve the pressure of the preparation of the natural product monomer reference substance to a large extent and reduce the inspection cost; at the same time, it overcomes the limitations of the one-to-one determination of the simple reference substance, and can measure the natural product at the same time.
The biologically active components or index components coexisting in the product show the superiority of multi-index evaluation
.
However, the exact value of the control extract for content determination is also one of the difficulties in preparing this type of control substance, which requires in-depth research and discussion
.

Figure 1-4 Typical chromatogram of USP Ginkgo Terpene Lactones RS

Figure 1-5 Typical chromatogram of USP American ginseng control extract

Related Links: Categories, Characteristics and Applications of Chemical Reference Substances of Traditional Chinese Medicine