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Detection of adulterated drugs in traditional Chinese medicine and dietary supplements using hydrogen as a carrier gas.

ABSTRACT: Helium, a minor component of natural gas and radioactive minerals, is most commonly used as a carrier in gas chromatography-mass spectrometry (GC-MS). Its scarcity leads to limited availability and higher costs. In this experiment, hydrogen from a safe source of a hydrogen generator was tested as a substitutive carrier gas for the detection of adulterant in traditional Chinese medicine (TCM) and food supplements by GC-MS analysis. We found that the limits of detection (LODs) of using hydrogen were from 10 to 1000 ?g/g. The levels of LODs tested among 170 drugs remain the same whether hydrogen or helium was used as a carrier gas with the exception of 7 drugs-benzbromarone, estradiol benzoate, bezafibrate, mefenamic acid, oxymetholone, piperidenafil and cetilistat. The real sample analysis results using hydrogen were as satisfactory as those using helium. In addition, the retention time was shortened after the chromatographic performance was optimized. In summary, it is worth considering hydrogen as a carrier gas due to its affordable costs, energy efficiency, carbon reduction and chromatographic advantages to detect adulterated drugs in TCM and dietary supplement using GC-MS.

SUBMITTER: Lin YP

PROVIDER: S-EPMC6179279 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Detection of adulterated drugs in traditional Chinese medicine and dietary supplements using hydrogen as a carrier gas.

Lin Yen-Ping YP Lee Ying-Lin YL Hung Chien-Ya CY Chang Chuan-Fa CF Chen Yi Y

PloS one 20181010 10

Helium, a minor component of natural gas and radioactive minerals, is most commonly used as a carrier in gas chromatography-mass spectrometry (GC-MS). Its scarcity leads to limited availability and higher costs. In this experiment, hydrogen from a safe source of a hydrogen generator was tested as a substitutive carrier gas for the detection of adulterant in traditional Chinese medicine (TCM) and food supplements by GC-MS analysis. We found that the limits of detection (LODs) of using hydrogen we ...[more]

PMID: 30304050

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Project description: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.

Project description:Background:Traditional, complementary, and alternative medicine (TCAM) has attracted increasing attention in developed countries, but its mainstream status in China, the home of TCAM, is unclear. Over the period of 2004-2016, we analyze the health resources and health resource utilization of traditional medicine in traditional Chinese medicine (TCM) hospitals in China. Methods:Over 2004-2016, we obtained data from all TCM hospitals in all Chinese provinces to create a hospital-based, longitudinal dataset. TCM health resources and their utilization were measured by two outcome variables: (1) primary outcome variables comprising the proportion of TCM physicians, TCM pharmacists, revenue from TCM drugs, and TCM prescriptions and (2) the secondary outcome variables, as proxies of westernization for TCM hospitals, comprising the number of medical equipment above RMB 10,000 and the proportion of surgery in inpatient visits. We used linear regression models with hospital-fixed effects to analyze time trends for the outcome variables. Results:The number of public TCM hospitals remained stable from 2004 to 2016, while the number of private TCM hospitals increased from 294 in 2004 to 1560 in 2016. There was a small percentage increase in the proportion of TCM physicians (0.280%), TCM pharmacists (0.298%), and revenue from Chinese medicines (0.331%) and TCM prescriptions (1.613%) per hospital per year. Chinese drugs accounted for less than a half of the total drug prescriptions, and accordingly, just one-third of the drug revenue was from Chinese medicines at TCM hospitals. The proportions of physicians, pharmacists, revenue from Chinese drug sales, and traditional medicine prescriptions never reach the 60% benchmark target for mainstream in TCM hospitals. As proxies for Western medicine practices in TCM hospitals, the number of medical equipment above RMB 10,000 rapidly rose by over 13 percent per hospital per year, but the proportion of inpatient surgeries declined by 0.830 percentage points per hospital per year, reflecting a mixed trend in the use of Western medicine practices. Conclusion:For the 2004-2016 period, traditional medicine, although making progress towards the mainstream benchmark of 60% TCM services, was still not mainstream at TCM hospitals.

Project description:Background: Hypertension, a risk factor for cardiovascular events, is often associated with chronic kidney disease. This is called hypertensive nephropathy (HN), which negatively affects physical fitness and body mass, leading to economic burden. Traditional Chinese medicine injections (TCMIs) are common traditional Chinese-patent medicine preparations in China. There was a lack of evidence to prove which TCMIs combine with ADs (TCMIs+ADs) may be a therapeutic option for HN. Thus, we systematically reviewed the efficacy and safety of various TCMIs + ADs in patients with HN. Methods: We conducted a comprehensive search of PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform, and VIP information resource integration service platform databases for relevant Chinese- and English-language randomized controlled trials (RCTs) published from database inception until May 2021. Literature screening, data extraction, and quality assessment was performed by two reviewers independently but using the same criteria. We performed the effect modeling to analyze the data for all outcomes and ranked each intervention using the P-score. Furthermore, sensitivity analysis, meta-regression, and funnel plots were used to test the stability, heterogeneity, and publication bias, respectively. Results: We included 69 RCTs with 6373 patients and including six TCMIs + ADs. Network analysis indicated that the ginkgo leaf extract and dipyridamole combined with ADs (GLED + ADs) was the most efficacious in terms of 24-h urinary protein excretion [mean difference (MD) = -0.70, 95% confidence interval (CI): -0.82 to -0.58; P-score = 1] and systolic blood pressure (MD = -12.95, 95% CI: -21.03 to -4.88; P-score = 0.88), whereas the salvianolate combined with ADs (SA + ADs) showed the highest effectiveness for diastolic blood pressure (MD = -6.88, 95% CI: -10.55 to -3.21; P-score = 0.9). Based on the combined P-score of network meta-analysis results (88% and 85.26%) and sensitivity analysis results (72% and 71.54%), the biplots showed that the GLED + ADs was the most efficacious intervention in all TCMIs + ADs for primary outcomes, followed by the SA + ADs and sodium tanshinone IIA sulfonate combined with ADs (STS + ADs). There was no significant difference in terms of safety between TCMIs + ADs and ADs alone. Conclusion: Of all the TCMIs + ADs, GLED + ADs, SA + ADs, and STS + ADs may demonstrate a higher efficacy than ADs alone for HN. Weighing with the potential benefits and limitations in methodology, potential heterogeneity and outcomes, we should use various TCMIs with caution in clinical practice. Nevertheless, additional high-quality RCTs are warranted and future research should focus on the clinical value of core outcomes to confirm the effectiveness and safety of TCMIs for HN. Systematic Review Registration: clinicaltrials.gov, identifier CRD42020205358.

Dataset Information

Detection of adulterated drugs in traditional Chinese medicine and dietary supplements using hydrogen as a carrier gas.

Publications

Detection of adulterated drugs in traditional Chinese medicine and dietary supplements using hydrogen as a carrier gas.

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