TCM has been prominent for many years as a way to improve and maintain health among the Chinese, and is progressively being accepted by more consumers in other countries. However, many remain sceptical of its quality, and have raised concerns regarding its use.
As TCM is considered herbal medicine or a 'natural product', an evaluation system different from the current pharmacopoeia quality monographs used for Western medicine — which can ensure consistency only in assigned chemical markers — is required to assess it, so as not to deviate from basic TCM theory.
This led Chinese researchers to conduct a review of the background, definition and properties of Q markers, as well as the technology necessary for them to develop a suitable system.
The researchers defined TCM Q-markers as “the intrinsic or processing- / preparation-resultant chemical substances closely associated with the functional properties that exist in the raw materials and products of TCM, which can be used as indicators for quality control of TCM to embody its safety and effectiveness”.
They also elaborated on the basic properties of Q-markers: apart from being intrinsic chemical components in TCM, the result of processing or preparation, and associated with functional properties, “they can be qualitatively characterised and quantitatively determined”.
In order to establish suitable Q-markers, the researchers suggested that aspects like natural products chemistry, analytical chemistry, chemometrics, systems biology, bionics, pharmacology and pharmacology must be integrated.
Firstly, samples representative of a specific species based on Chinese pharmacopoeia requirements for TCM should be obtained and processed according to the same requirements, or the approaches used in major TCM-producing regions.
Decoction and its quality examination should follow, after which peaks in the decoction should be counted and identified. Specific peaks related to the effect of TCM are then to be selected as Q-markers.
The review’s authors assessed case studies of an efficient Q-marker system for TCM, using ginseng as a prime example.
They claimed to have successfully developed or improved the quality standard monographs of three ginseng species for the Herbal Medicines Compendium of United States Pharmacopoeia, which are used as a successful example for determining Q-marker quality standards.
They said an established library containing multiple batches of samples for each ginseng species, in addition to “strictly authenticated” clear information on purchasing channels and production locations, allowed them to effectively set Q-markers for ginseng, one of the world’s most popular TCM products.
‘A reasonable system’
The review called the concept of Q-markers “a reasonable system that can guide quality investigations following basic TCM theory”, adding that using multidisciplinary techniques aids in establishing Q-markers.
In conclusion, it stated: “Q-marker-based quality standards will be regarded as a more scientific quality-control approach for TCM. It is also a general conception that Q-marker-based quality control for Chinese medicine production…would be more beneficial for transitivity and traceability in the TCM production process.”
Source: Acta Pharmaceutica Sinica B
“Approaches to establish Q-markers for the quality standards of traditional Chinese medicines”
Authors: Wenzhi Yang, et al.