Assesment of Adulterated Traditional Chinese Medicines in China: 2003-2017

Abstract

Traditional Chinese medicines (TCMs) represent one form of complementary and alternative medicine. The popularity and complexity in production make them attractive and vulnerable to adulteration in stages ranging from planting to production. Adulteration refers to the addition of extraneous, improper, or inferior ingredients that should not be present in TCMs. To detect and combat adulterated TCMs, supplementary testing methods (STMs), which expand the capability of routine testing standards, have been applied in China since 2003. From 2003 to 2017, a total of 184 STMs for TCMs were approved by the Chinese national drug regulatory authority. By assessing these STMs, this research intends to identify those TCMs vulnerable to adulteration, to list common adulterants, and to characterize the techniques of analysis. The results show that adulteration of TCMs can be classified into three main categories: the addition of undeclared drugs/chemical substances, substitution with non-drug components, and the addition of foreign non-drug materials. The top five therapeutic areas of TCMs vulnerable to adulteration are diabetes, calm and sleep, sexual dysfunction, pain relief, and rheumatism. A total of 166 adulterants were detected in the adulterated TCM preparations and herbal products studied here, with 158 adulterants in TCM preparations and 43 in herbal products, with 35 adulterants in common. Each STM consists of different pharmaceutical analysis techniques, including tests for physical-chemical properties, chromatography, spectroscopic techniques, and mass spectrometry. The analytical methodology of STMs relies on the combination of these techniques, with HPLC ranking the highest percentage (76.1%) and physical-chemical techniques the lowest percentage (11.4%). This research shows that STMs have played a crucial role in combating adulterated TCMs. However, STMs represent merely a product testing-centered regulatory strategy. The inspection of cultivation and manufacturing processes should also be strengthened. More importantly, the awareness and self-discipline of TCM manufacturers in implementing good manufacturing practices and regulating the planting and cultivation of raw materials should be improved.

Chemical Authentication of Botanical Ingredients: A Review of Commercial Herbal Products

“…All the intentional adulteration practices documented and reported repeatedly till now (Li et al, 2008;Ichim, 2019;Xu et al, 2019;Ichim et al, 2020;Upton et al, 2020) can be evidenced by peer-reviewed reports referring to the top selling herbal products containing highly valued or widely used medicinal species across countries and cultures. The prices of ginseng herbal medicines and supplements vary widely based on the species, quality, and purity of the ginseng, and this provides a strong driver for intentional adulteration (Ichim and de Boer, 2021).…”

“…The adulteration of commercial herbal products is an internationally widespread problem, as it has been reported for many countries from all inhabited continents (Ichim, 2019;Ichim et al, 2020). Moreover, large percentages of adulterated products have been reviewed, irrespective of the formal category of herbal products, being affected food and dietary supplements and medicines altogether (Ichim and de Boer, 2021), including products used in centuries or even millennia-old Ayurveda (Revathy et al, 2012;Seethapathy et al, 2019) and Asian traditional medicine systems (Masada, 2016;Xu et al, 2019). The substantial proportion of adulterated commercial herbal products described appears to be independent of the methods used for their analysis, traditional pharmacopoeial methods being employed, such as macroscopic inspection (van der Valk et al, 2017), microscopy (Ichim et al, 2020), chemical techniques (Li et al, 2008;Upton et al, 2020), or even the more recently developed DNA-based ones, such as the rapidly technologically evolving DNA barcoding and metabarcoding (Ichim, 2019;Grazina et al, 2020).…”

The prevalence of liquid chromatography-tandem mass spectrometry-confirmed paediatric poisoning at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa

“…(12) While in a retrospective study done at the same children's hospital as our study setting, indicated that less than 10% of the children who presented with poisoning had been exposed to more Traditional medicine use is not uncommon in LMICs, there have been previous reports of these medicines being adulterated, as was the case in one of our patients who ingested traditional medicine and LC-MS/MS identi ed nor uoxetine, trimethoprim and diphenhydramine. (24,(36)(37)(38)(39) While, both blood and urine samples can be analysed by LCMSMS, urine is usually readily available as a non-invasive specimen with minimal discomfort to children. Furthermore, unlike in blood, drugs and their metabolites are known to remain in urine for longer (up to one week) post last exposure depending on the drug.…”

The prevalence of liquid chromatography-tandem mass spectrometry-confirmed paediatric poisoning at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa

“…(12,34) Traditional medicine use is not uncommon in LMICs, there have been previous reports of these medicines being adulterated, as was the case in one of our patients who ingested traditional medicine and LC-MS/MS identi ed nor uoxetine, trimethoprim and diphenhydramine. (24,(36)(37)(38)(39) While, both blood and urine samples can be analysed by LCMSMS, urine is usually readily available as a non-invasive specimen with minimal discomfort to children. Furthermore, unlike in blood, drugs and their metabolites are known to remain in urine for longer (up to one week) post last exposure depending on the drug.…”