Q-Marker: An Integrative Approach and Scientific Validation in the Indian
System of Medicine

Akanksha; Atiqul      Islam; Harjeet      Singh; Amrat   Pal   Singh; Alok      Sharma

Abstract

The prevalence of plant-based medicine has risen worldwide, not only as part of conventional treatment but also for health care management. The authenticity and quality of herbal medicines impact these medications' safety and effectiveness in clinical treatment. So, it is necessary to identify the chemical composition and quality of pharmacologically active ingredients in the plants as there is no pertinent data regarding the exact dose of the Herbal based medicine. Similarly, the Indian system of Medicine (ISM) based products may vary in composition and properties, and increasing reports of adverse reactions have drawn the attention of many regulatory agencies for the quality evaluation of traditional formulations. Moreover, ISM's quality control has always been an important domain, and its current quality standards have a complex effect to assure clinical efficacy. The Quality marker (Q-marker) technique is a new approach in Chinese traditional medicines to enhance and empower Chinese herbal drugs by focusing on each step of the plant processing from its growing phases to the marketed product formulation. The present review highlights the application of Q-marker and its tools for the establishment of quality standards of herbal drugs. Besides, this work also highlighted complies few Q-marker-based traditional Chinese medicines case studies. We expect that it would benefit the manufacturing process control and quality management of the Indian system of medicine. This work could provide a new direction for Q marker in the Indian system of medicine and contribute in the modernization and globalization of the Indian system of Medicine.

Keywords: Indian system of medicine, Quality marker, multidisciplinary technologies, multicomponent determination, Quality control system

[1]
Ravishankar B, Shukla VJ. Indian systems of medicine: A brief profile. Afr J Tradit Complement Altern Med  2007; 4(3): 319-37.
 [http://dx.doi.org/10.4314/ajtcam.v4i3.31226] [PMID: 20161896]

[2]
Hamilton AC. Medicinal plants, conservation and livelihoods. Biodivers Conserv  2004; 13(8): 1477-517.
 [http://dx.doi.org/10.1023/B:BIOC.0000021333.23413.42]

[3]
Sen S, Chakraborty R. Revival, modernization and integration of Indian traditional herbal medicine in clinical practice: Importance, challenges and future. J Tradit Complement Med  2016; 7(2): 234-44.
 [http://dx.doi.org/10.1016/j.jtcme.2016.05.006] [PMID: 28417092]

[4]
Patwardhan B. Traditional medicine: Modern approach for affordable global health. Geneva: World Health Organization 2005.

[5]
Tariq M, Nandi SK, Bhatt ID, Bhavsar D, Roy A, Pande V. Phytosociological and niche distribution study of Paris polyphylla smith, an important medicinal herb of Indian Himalayan region. Trop Ecol  2021; 62(2): 163-73.
 [http://dx.doi.org/10.1007/s42965-020-00125-2]

[6]
Dubey NK, Kumar R, Tripathi P. Global promotion of herbal medicine: India’s opportunity. Curr Sci  2004; 86(1): 37-41.

[7]
Lewis WH, Elvin-Lewis MP. Medical botany: Plants affecting human health. John Wiley & Sons 2003.

[8]
Li XJ, Huang YY, Yang Z, Wu X, Zhuang PW, Zhang YJ. Research strategy for quality-biomarkers of traditional Chinese medicine based on effect benchmarks. Yao Xue Xue Bao  2019; 204-10.

[9]
Xie J, Zhang AH, Sun H, Yan GL, Wang XJ. Recent advances and effective strategies in the discovery and applications of natural products. RSC Adv  2018; 8(2): 812-24.
 [http://dx.doi.org/10.1039/C7RA09475B] [PMID: 35538992]

[10]
Goudie AS. Human impact on the natural environment. John Wiley & Sons 2018.

[11]
Karunamoorthi K, Jegajeevanram K, Xavier J, Vijayalakshmi J, Melita L. Tamil traditional medicinal system-siddha: An indigenous health practice in the international perspectives. Cell Med  2012; 2(2): 12.

[12]
Sen S, Chakraborty R. Toward the integration and advancement of herbal medicine: A focus on traditional Indian medicine. Botanics  2015; 5: 33-44.
 [http://dx.doi.org/10.2147/BTAT.S66308]

[13]
Elujoba AA, Odeleye OM, Ogunyemi CM. Traditional medicine development for medical and dental primary health care delivery system in Africa. Afr J Trad Comp Alt Med  2005; 2(1): 46-61.
 [http://dx.doi.org/10.4314/ajtcam.v2i1.31103]

[14]
Former VN, Narayanaswamy V. Origin and development of Ayuverda. Anc Sci Life  1981; I(1): 1-7.
 [PMID: 22556454]

[15]
Patwardhan B. Ayurveda: The designer medicine. Indian Drugs  2000; 37(5): 213-27.

[16]
Balachandran P, Govindarajan R. Ayurvedic drug discovery. Expert Opin Drug Discov  2007; 2(12): 1631-52.
 [http://dx.doi.org/10.1517/17460441.2.12.1631]

[17]
Dev S. Ancient-modern concordance in Ayurvedic plants: Some examples. Environ Health Perspect  1999; 107(10): 783-9.

[18]
Patwardhan B, Warude D, Pushpangadan P, Bhatt N. Ayurveda and traditional Chinese medicine: A comparative overview. Evid Based Complement Alternat Med  2005; 2(4): 465-73.
 [http://dx.doi.org/10.1093/ecam/neh140] [PMID: 16322803]

[19]
Lakshmi T, Rajendran R. Estimation of biomarker epicatechin in ethanolic bark extract of Acacia catechu willd by HPLC method. J Pharm Sci Res  2012; 4(3): 1764.

[20]
Singh G, Maurya S, De Lampasona MP, Catalan C. Chemical constituents, antifungal and antioxidative potential of Foeniculum vulgare volatile oil and its acetone extract. Food Control  2006; 17(9): 745-52.
 [http://dx.doi.org/10.1016/j.foodcont.2005.03.010]

[21]
Acharya CK. Ethnicity and Scientific validation of West Bengal Amla (Phyllanthus emblica L.) with special reference to GC-MS screening. Int J Exp Res Rev  2016; 3: 51-9.

[22]
Pandey P, Mehta R, Upadhyay R. Physico-chemical and preliminary phytochemical screening of Psoralea corylifolia. Arch Appl Sci Res  2013; 5(2): 261-5.

[23]
Schaneberg BT, Khan IA. Quantitative analysis of forskolin in Coleus forskohlii (Lamiaceae) by reversed-phase liquid chromatography. J AOAC Int  2003; 86(3): 467-70.
 [http://dx.doi.org/10.1093/jaoac/86.3.467] [PMID: 12852560]

[24]
Lehner AF, Craig M, Fannin N, Bush L, Tobin T. Electrospray[+] tandem quadrupole mass spectrometry in the elucidation of ergot alkaloids chromatographed by HPLC: Screening of grass or forage samples for novel toxic compounds. J Mass Spectrom  2005; 40(11): 1484-502.
 [http://dx.doi.org/10.1002/jms.933] [PMID: 16278935]

[25]
Sharma I, Khan W, Ahmad S. In vitro and ex vivo approach for anti-urolithiatic potential of bioactive fractions of gokhru with simultaneous HPLC analysis of six major metabolites and their exploration in rat plasma. Pharm Biol  2017; 55(1): 701-11.
 [http://dx.doi.org/10.1080/13880209.2016.1266671] [PMID: 27982733]

[26]
Sharma R, Amin H, Galib PP, Prajapati PK. Validation of standard manufacturing procedure of guduchi ghana [dried aqueous extract of Tinospora cordifolia (Willd.) Miers] and its tablets. Ayurpharm Int J Ayurveda Allied Sci  2013; 2(7): 224-32.

[27]
Shawky E, El Sohafy SM. Untargeted and targeted chemical profiling for efficacy-directed discrimination of Hedera helix L. subspecies using HPTLC-image analysis and HPTLC/MS. Ind Crops Prod  2020; 145: 111980.
 [http://dx.doi.org/10.1016/j.indcrop.2019.111980]

[28]
Shah B, Modi DC, Bhuva HA, Maheshwari KM. Phyto-pharmacological profile and potential therapeutic uses of Curcuma aromatica. Pharmacologyonline  2010; 2: 918-30.

[29]
Mamatha A. Validation and Application of HPTLC methods for evaluation of Ashwagandha and Kalmegh. Doctoral Dissertation The Rajiv Gandhi University of Health Science 

[30]
Shailajan S, Menon S, Singh D, Swar G, Bhosale S. Application of modern RP-HPLC technique for the quantitation of betulinic acid from traditional drug Symplocos racemosa Roxb. J Appl Pharm Sci  2017; 7(03): 129-34.

[31]
Jain PK, Agrawal RK. High performance liquid chromatographic analysis of asiaticoside in Centella asiatica (L.). Urban Chiang Mai J Sci  2008; 35(3): 521-5.

[32]
Ma W, Lu Y, Dai X, Liu R, Hu R, Pan Y. Determination of anti-tumor constitute mollugin from traditional Chinese medicine Rubia cordifolia: Comparative study of classical and microwave extraction techniques. Sep Sci Technol  2009; 44(4): 995-1006.
 [http://dx.doi.org/10.1080/01496390802691265]

[33]
Prashanth GK, Krishnaiah GM. Chemical composition of the leaves of Azadirachta indica Linn (Neem). International Journal of Advancement in Engineering and Technology  2014; 1(3): 21-31.

[34]
Hamrapurkar PD, Jadhav K, Zine S. Quantitative estimation of piperine in Piper nigrum and Piper longum using high performance thin layer chromatography. J App Pharm Sci  1930; 11: 117-20.

[35]
Adegbe AA, Larayetan RA, Omojuwa TJ. Proximate analysis, physicochemical properties and chemical constituents characterization of Moringa oleifera (Moringaceae) seed oil using GC-MS analysis. Am J Chem  2016; 6(2): 23-8.

[36]
Hussein HJ, Hadi MY, Hameed IH. Study of chemical composition of Foeniculum vulgare using Fourier transform infrared spectrophotometer and gas chromatography-mass spectrometry. J Pharmacogn Phytother  2016; 8(3): 60-89.
 [http://dx.doi.org/10.5897/JPP2015.0372]

[37]
Demirezer LO, Karahan N, Ucakturk E, Kuruuzum-Uz A, Guvenalp Z, Kazaz C. HPLC fingerprinting of sennosides in laxative drugs with isolation of standard substances from some senna leaves. Rec Nat Prod  2011; 5(4): 261-70.

[38]
Kapadia NS, Acharya NS, Suhagia BN, Shah MB. A pharmacognostical study on convolvulus prostratus forssk. J Nat Rem  2005; 5(2): 108-14.

[39]
Ray A, Jena S, Kar B, et al. Volatile metabolite profiling of ten Hedychium species by gas chromatography mass spectrometry coupled to chemometrics. Ind Crops Prod  2018; 126: 135-42.
 [http://dx.doi.org/10.1016/j.indcrop.2018.10.012]

[40]
Patel N, Kanaki N, Movaliya V. Assessment of diurnal variation in Ocimum sanctum Linn. by gas chromatographic fingerprint analysis coupled with chemometric methods. Plant Sci Today  2018; 5(3): 131-4.
 [http://dx.doi.org/10.14719/pst.2018.5.3.413]

[41]
Lele RD. Beyond reverse pharmacology: Mechanism-based screening of Ayurvedic drugs. J Ayurveda Integr Med  2010; 1(4): 257-65.
 [http://dx.doi.org/10.4103/0975-9476.74435] [PMID: 21731372]

[42]
Jabin F. A guiding tool in Unani Tibb for maintenance and preservation of health: A review study. Afr J Tradit Complement Altern Med  2011; 8(5) (Suppl.): 140-3.
 [http://dx.doi.org/10.4314/ajtcam.v8i5S.7] [PMID: 22754067]

[43]
Rahman SZ, Khan RA, Latif A. Importance of pharmacovigilance in Unani system of medicine. Indian J Pharmacol  2008; 40 (Suppl. 1): S17-20.
 [PMID: 21369407]

[44]
Ozawa S, Evans DR, Bessias S, et al. Prevalence and estimated economic burden of substandard and falsified medicines in low-and middle-income countries: A systematic review and meta-analysis. JAMA Netw Open  2018; 1(4): e181662.
 [http://dx.doi.org/10.1001/jamanetworkopen.2018.1662] [PMID: 30646106]

[45]
Bandaranayake WM. Quality control, screening, toxicity, and regulation of herbal drugs. Modern Phytomedicine: Turning Medicinal Plants into Drugs  2006; 25-57.
 [http://dx.doi.org/10.1002/9783527609987.ch2]

[46]
Altemimi A, Lakhssassi N, Baharlouei A, Watson DG, Lightfoot DA. Phytochemicals: Extraction, isolation, and identification of bioactive compounds from plant extracts. Plants  2017; 6(4): 42.
 [http://dx.doi.org/10.3390/plants6040042] [PMID: 28937585]

[47]
Atis I, Konuskan O, Duru M, Gozubenli H, Yilmaz S. Effect of harvesting time on yield, composition and forage quality of some forage sorghum cultivars. Int J Agric Biol  2012; 14(6)

[48]
Oladosu Y, Rafii MY, Abdullah N, et al. Fermentation quality and additives: A case of rice straw silage. BioMed Res Int  2016; 2016: 7985167.
 [http://dx.doi.org/10.1155/2016/7985167] [PMID: 27429981]

[49]
Miguel MG, Duarte J, Figueiredo AC, Barroso JG, Pedro LG. Thymus carnosus Boiss.: Effect of harvesting period, collection site and type of plant material on essential oil composition. J Essent Oil Res  2005; 17(4): 422-6.
 [http://dx.doi.org/10.1080/10412905.2005.9698950]

[50]
Nisbet AJ. Azadirachtin from the neem tree Azadirachta indica: Its action against insects. An Soc Entomol Bras  2000; 29: 615-32.
 [http://dx.doi.org/10.1590/S0301-80592000000400001]

[51]
Stokes JB, Redfern RE. Effect of sunlight on azadirachtin: Antifeeding potency. J Environ Sci Health, Part A: Environ Sci Eng  1982; 17(1): 57-65.
 [http://dx.doi.org/10.1080/10934528209375019]

[52]
Day SD. Biological and mechanical approaches to sunscald management in bell pepper production. MS Thesis. Utah State University, Logan, Utah 2014.

[53]
Tanko HM, Carrier DJ, Sokhansanj S, Crowe TG. Effects of drying temperature and storage on parthenolide concentration of feverfew (Tanacetum parthenium L.) leaves. J Nutraceuticals Funct Med Foods  2003; 4(1): 27-37.

[54]
Kang T, Dou D, Xu L. Establishment of a quality marker (Q-marker) system for Chinese herbal medicines using burdock as an example. Phytomedicine  2019; 54: 339-46.
 [http://dx.doi.org/10.1016/j.phymed.2018.04.005] [PMID: 30318153]

[55]
Zhang C, Su J. Application of near infrared spectroscopy to the analysis and fast quality assessment of traditional Chinese medicinal products. Acta Pharm Sin B  2014; 4(3): 182-92.
 [http://dx.doi.org/10.1016/j.apsb.2014.04.001] [PMID: 26579382]

[56]
Yang W, Zhang Y, Wu W, Huang L, Guo D, Liu C. Approaches to establish Q-markers for the quality standards of traditional Chinese medicines. Acta Pharm Sin B  2017; 7(4): 439-46.
 [http://dx.doi.org/10.1016/j.apsb.2017.04.012] [PMID: 28752028]

[57]
Gao X, Du X, An L, et al. Wilforine, the Q-marker and PK-maker of Tripterygium glycosides tablet: Based on preparation quantitative analysis and PK-PD study. Phytomedicine  2019; 54: 357-64.
 [http://dx.doi.org/10.1016/j.phymed.2018.03.031] [PMID: 30318152]

[58]
Qi Y, Zhao X, Liu H, et al. Identification of a quality marker (Q-Marker) of Danhong injection by the zebrafish thrombosis model. Molecules  2017; 22(9): 1443.
 [http://dx.doi.org/10.3390/molecules22091443] [PMID: 28858254]

[59]
Dong X, Zheng F, Liu X, et al. Simultaneous quantitative analysis of Q-marker with one single reference in Glycyrrhiza uralensis fisch. J Chromatogr Sci  2020; 58(6): 511-9.
 [http://dx.doi.org/10.1093/chromsci/bmaa015] [PMID: 32266386]

[60]
Xiong H, Zhang AH, Zhao QQ, Yan GL, Sun H, Wang XJ. Discovery of quality-marker ingredients of Panax quinquefolius driven by high-throughput chinmedomics approach. Phytomedicine  2020; 74: 152928.
 [http://dx.doi.org/10.1016/j.phymed.2019.152928] [PMID: 31451286]

[61]
Liang YZ, Wang WP. Chromatographic fingerprinting coupled with chemometrics for quality control of traditional Chinese medicines. Chimia (Aarau)  2011; 65(12): 944-51.
 [http://dx.doi.org/10.2533/chimia.2011.944] [PMID: 22273377]

[62]
Ren JL, Zhang AH, Kong L, et al. Analytical strategies for the discovery and validation of quality-markers of traditional Chinese medicine. Phytomedicine  2020; 67: 153165.
 [http://dx.doi.org/10.1016/j.phymed.2019.153165] [PMID: 31954259]

[63]
Li Y, Xie Y, He Y, Hou W, Liao M, Liu C. Quality markers of traditional Chinese medicine: Concept, progress, and perspective. Engineering (Beijing)  2019; 5(5): 888-94.
 [http://dx.doi.org/10.1016/j.eng.2019.01.015] [PMID: 32288963]

[64]
Zhao Y, Liu Q, Zhang Z, et al. Estimating the Q-marker concentrations of Salvia miltiorrhiza via a long short-term memory algorithm using climatic factors and metabolic profiling. Ind Crops Prod  2020; 156: 112883.
 [http://dx.doi.org/10.1016/j.indcrop.2020.112883]

[65]
Li ZT, Zhang FX, Fan CL, et al. Discovery of potential Q-marker of traditional Chinese medicine based on plant metabolomics and network pharmacology: Periplocae Cortex as an example. Phytomedicine  2021; 85: 153535.
 [http://dx.doi.org/10.1016/j.phymed.2021.153535] [PMID: 33819766]

[66]
Zhang Y, Wang Z, Xu J, et al. Optimization of the extraction and purification of Corydalis yanhusuo WT Wang based on the Q-marker uniform design method. BMC Chem  2020; 14(1): 1-1.
 [http://dx.doi.org/10.1186/s13065-020-00666-6] [PMID: 31922150]

[67]
Zhang T, Bai G, Han Y, et al. The method of quality marker research and quality evaluation of traditional Chinese medicine based on drug properties and effect characteristics. Phytomedicine  2018; 44: 204-11.
 [http://dx.doi.org/10.1016/j.phymed.2018.02.009] [PMID: 29551645]

[68]
Yang L, Hou A, Zhang J, et al. Panacis quinquefolii radix: A review of the botany, phytochemistry, quality control, pharmacology, toxicology and industrial applications research progress. Front Pharmacol  2020; 11: 602092.
 [http://dx.doi.org/10.3389/fphar.2020.602092]

[69]
Thomford NE, Senthebane DA, Rowe A, et al. Natural products for drug discovery in the 21st century: Innovations for novel drug discovery. Int J Mol Sci  2018; 19(6): 1578.
 [http://dx.doi.org/10.3390/ijms19061578] [PMID: 29799486]

[70]
Ahmad S, Zahiruddin S, Parveen B, et al. Indian medicinal plants and formulations and their potential against COVID-19–preclinical and clinical research. Front Pharmacol  2021; 11: 578970.
 [http://dx.doi.org/10.3389/fphar.2020.578970] [PMID: 33737875]

[71]
Rezaie R, McGahan AM, Daar AS, Singer PA. Innovative drugs and vaccines in China, India and Brazil. Nat Biotechnol  2012; 30(10): 923-6.
 [http://dx.doi.org/10.1038/nbt.2380] [PMID: 23051806]

[72]
Nilashi M, Samad S, Yusuf SYM, Akbari E. Can complementary and alternative medicines be beneficial in the treatment of COVID-19 through improving immune system function? J Infect Public Health  2020; 13(6): 893-6.
 [http://dx.doi.org/10.1016/j.jiph.2020.05.009] [PMID: 32451258]

[73]
Balekundri A, Mannur V. Quality control of the traditional herbs and herbal products: A review. Future J Pharm Sci  2020; 6(1): 1-9.
 [http://dx.doi.org/10.1186/s43094-020-00091-5]

[74]
Johns T. The Origins of Human Diet and Medicine: Chemical Ecology. Tucson, Arizona, USA: University of Arizona Press 1996.

[75]
Bahadur B, Reddy KJ, Rao ML. Medicinal plants: An overview. Advances in Medicinal Plants.  Chennai, Hyderabad, India: Universities Press 2007; pp. 1-50.

[76]
Cragg GM, Newman DJ. Natural product drug discovery in the next millennium. Pharm Biol  2001; 39 (Suppl 1): 8-17.

[77]
Kumar V. Herbal medicines: Overview on regulations in India and South Africa. World J Pharm Res  2017; 6(8): 690-8.
 [http://dx.doi.org/10.20959/wjpr20178-9091]

[78]
Sharma A, Shanker C, Tyagi LK, Singh M, Rao CV. Herbal medicine for market potential in India: An overview. Acad J Plant Sci  2008; 1(2): 26-36.

[79]
Vaidya AD, Devasagayam TP. Current status of herbal drugs in India: An overview. J Clin Biochem Nutr  2007; 41(1): 1-11.
 [http://dx.doi.org/10.3164/jcbn.2007001] [PMID: 18392106]

Cite As

Current Traditional Medicine

Q-Marker: An Integrative Approach and Scientific Validation in the Indian System of Medicine

Abstract