Abstract
Chinese patent medicines (CPMs) are of great value for the prevention and treatment of diseases. However, adulterants and pesticide residues in CPMs have become the “bottleneck” impeding the globalization of traditional Chinese medicine. In this study, 12 batches of commercially available Qipi pill (a famous CPM recorded in Chinese Pharmacopeia) from different manufacturers were investigated to evaluate their authenticity and quality safety. Considering the severely degraded DNA in CPMs, kompetitive allele specific PCR (KASP) technology combined with DNA mini-barcodes was proposed for the quality regulation of a large number of products in CPM market. The residues of four kinds of pesticides including pentachloronitrobenzene (PCNB), hexachlorocyclohexane (HCH), aldrin, and dichlorodiphenyltrichloroethane (DDT) were quantified using gas chromatography and tandem mass spectrometry (GC-MS/MS). The results indicated that in two of the 12 batches of Qipi pill, the main herbal ingredient Panax ginseng was completely substituted by P. quinquefolius, and one sample was partially adulterated with P. quinquefolius. The PCNB residue was detected in 11 batches of Qipi pill, ranging from 0.11 to 0.46 mg/kg, and the prohibited pesticide HCH was present in four samples. Both adulteration and banned pesticides were found in two CPMs. This study suggests that KASP technology combined with DNA mini-barcodes can be used for the quality supervision of large sample size CPMs with higher efficiency but lower cost. Our findings also provide the insight that pesticide residues in CPMs should be paid more attention in the future.
Highlights
Chinese patent medicines (CPMs) play a vital role in health care and disease prevention and treatment in China [1, 2]
The quality of the extracted DNA from 12 batches of Qipi pills was measured by the spectrophotometer NanoDrop 2000, and the value of A260/280 ranged from 1.8 to 2.0, indicating that the DNA quality met the requirements of subsequent experiments
kompetitive allele specific polymerase chain reaction (PCR) (KASP) technology cooperating with DNA minibarcoding and GC-MS/MS were utilized to investigate the herbal components and pesticide residues of 12 batches of commercially available CPMs
Summary
Chinese patent medicines (CPMs) play a vital role in health care and disease prevention and treatment in China [1, 2]. The frequent adulteration of original materials has become a great challenge for the modernization of CPMs [3]. A previous survey on the authenticity of herbal medicines from China’s markets found that ∼4.2% of 1,260 tested samples were adulterated [4]. It will be extremely challenging to identify their botanical origin by traditional methods based on morphological and microscopic characteristics especially when the medicinal ingredients are Adulteration and Pesticides in CPMs pulverized into superfine powder and made into CPMs. A previous study found that in 33 root samples and 70 powder samples of Withania somnifera (L.) Dunal, 23% were identified to be counterfeit, among which 22% of the non-authentic samples were powder, suggesting that the adulteration was more prevalent in processed products [5]. The adulteration and substitution of original materials, which weakens their pharmacological function, and these chemical pesticides processed together with medicinal herbs into various CPMs, may pose a potential risk to the health and safety of end users [9]. It is imperative to investigate the authenticity and quality safety of CPMs in market
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