Review on “Standardization an Imp Tool for Herbal Drug Development”
The medicinal plants are important source for pharmaceutical manufacturing. Medicinal plants & herbal medicines account for a significant percentage of the pharmaceutical market. There is increasing awareness and general acceptability of the use of herbal drugs in today’s medical practice although most of these applications are not scientific. Herbal medicines are not a simple task since many factors influence the biological efficacy and Reproducible therapeutic effect. So it is necessary to improve safety of herbal drugs by developing certain quality control parameters & by following the WHO guidelines for herbal medicines. This review seeks to enlighten the need to establish quality parameters for collection, handling, processing and production of herbal medicine as well as employ such parameters in ensuring the safety of the global herbal market. It is necessary to introduce measures on the regulation of herbal medicines to ensure quality, safety, efficacy of herbal medicines by using modern suitable standards & GMP. The processes of good quality assurance and standardization of herbal medicines and products using various spectroscopic, chromatographic and electrophoretic methods were also discussed. In fact, the research field of quality control of herbal medicines is really an interdisciplinary research. It needs crossover of chemistry, pharmacology, medicine and even statistics to provide a platform for the quality control of traditional herbal medicines and further to discover the novel therapeutics composed of multiple chemical compounds.
Keywords: Herbal drugs, Adulteration, Standardization, Chromatography, Electrophoresis, HP-LC and GC-MS.
2)Waxler-Morrison, N. E., Plural medicine in India and Sri Lanka: do ayurvedic and Western medical practices differ? Soc. Sci.Med.,1988, 27,531–544.
3)General guidelines for methodologies on research and evaluation of traditional medicine. Geneva, World Health Organization, 2000,(WHO/EDM/TRM/2000.1)
4) SagarBhanu, P.S., Zafar R. & Panwar R., Herbal drug standardization. The Indian Pharmacist, 2005, 4(35), 19-22.
5) Patel, P.M., Patel, N.M. &Goyal, R.K. Quality control of herbal products, The Indian Pharmacist,2006, 5(45), 26-30.
6) Kunle, F Oluyemisi, Egharevba, O Henry, Ahmadu &O Peter: Standardization of herbal medicines- A review. International Jof Biodiversity and Conservation,2012,4(3), 101-112
7) Waldesch FG, Konigswinter BS & Remagen HB, Herbal medicinal products- Scientific And Regulatory Basis For Development uality Assurance And Marketing Authorization, Published by Medpharmstuttagart and CRC press, Washington DC, 2003, 37-52
8) Bhutani, K.K. Herbal medicines an enigma and challenge to science and directions for new initiatives, Indian J of Natural Products, 2003,19(1), 3-8.
 Kokate, C.K., Purohit, A.P. &Gokhale, S.B. “Analytical Pharmacognosy”, Nirali publication, 30th edition, 2005,199.
10)Nikam PravinH., Kareparamban, JadhavAruna&Kadam Vilasrao; Future Trend in Standardization of Herbal Drugs, J of Applied pharmaceutical Sci. 2012,2(6),38-44
11) Wani M.S. Herbal Medicine and its Standarization.Pharma info,2007,5(6), 1-6
12) Patwardhan B. Ayurveda the designer medicine: a review of ethnopharmacology and bioprospective research. Indian Drugs, 2000,37(5),2046-56
13) Dixit V.K. &Yadav.N.P. Recent approaches in herbal drug standardization. IntegrBiol, 2008,2(3), 195-203
14. Anna KD, Stephen PM. Safety issues in herbal medicine: implications for the health professions. Med J Aust.166 1997, 538-541.
15) Michael DR. Herbal medicine: a practical guide to safety and quality assurance. West J Med 1999, 171,172-175.
16) Shinde VM, Dhalwal K, Potdar M & Mahadik KR. Application of quality control principles to herbal drugs. Int J hytomedicine. 2009,1, 4–8
17) Hussain Khalid , Majeed M, Ismail Zhari, Sadikun Amirin & Ibrahim Pazilah .Traditional and complementary medicines: Quality ssessment strategies and safe usage ;Southern Med Review , 2009, 2(1), 19-23
18) Quality control methods for medicinal plant materials (WHO) , Geneva, A.T.T.B.S Publishers and Distributers, Delhi. 2002
19) The Ayurvedic Pharmacopoeia of India Part 1, V-II (First edition), V-I (First edition), Ministry of AYUSH, Govt of India. 2008
20) Macroscopic and Microscopic Atlas of Pharmacopoeial Drugs part-I, V-V, Ministry of AYUSH, GovtOf India. 2009
21) Calixto J.B &Barz J., Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeuticagents), Med Biol Res.,200),33,179-189.
22 )Sharma AK, Gaurav SS, Balkrishna A. A rapid and simple scheme for the standardization of polyherbal drugs. Int J Green Pharm 2009,3(2),134-140
23) Ahmad I, Aqil F&Owais M. Turning medicinl plants into drugs. Modern Phytomed.384, 2006,45-49.
24) Quality Control Methods for Medicinal Plant Materials, WHO, Geneva, 1996
25) Bauer R. Quality criteria and standardization of phytopharmaceuticals: Can acceptable drug standard can be achieved. J Drug inform,1998, 101-110.
26) Ansari S.H, “Standardization of crude drugs”, Essentials of Pharmacognosy, 1st edition, 2005,581.
27) WHO, General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine, World Health Organization, Geneva, (2002c)
28) EMEA, Guidelines on Quality of herbal medicinal products/ Traditional Medicinal Products, EMEA/ HMPWP/31/99 Review. Europeon Agency for the Evaluation of Medicinal products.(EMEA), London, 2005
29) EMEA, Quality of herbal medicinal products, Guidelines, Europeon Agency for the Evaluation of Medicinal products.(EMEA),London, 1998
30) WHO, The International Pharmacopeia, Vol. 3; Quality Specifications for Pharmaceutical Substances, Excipients and Dosage forms,3rdedn. World Health Organization, Geneva, 1998
31)De Smet & AGM. P, Drug Information Journal, 1999,33, 717-724
32) WHO Guidelines for the assessment of Herbal Medicines. WHO Technical Report Series, no. 863. World Health Organization, Geneva, 1996.
33) WHO, Guidelines for the appropriate use of Herbal Medicines. WHO Reginal publications, Western pacific series no 3, WHO Regional office for the Western Pacific, Manila, 1998.
35)Watson DG, Pharmaceutical Analysis, Churchill living Stone, Edinburgh, 1999.
36)ICDRA. 6th International Conference on Drug Regulatory Authorities, World Health Organization, 1991.
37). Mukherjee PK. Quality control of herbal drugs: An approach to evaluation of botanicals. 1st edition. Publisher-Business horizons;India: 2002. 113 -119.
38) Robert BS, Stefanos NK, Janet P, Michael JB & David ME et.al. Heavy metal content of Ayurvedic herbal medicine products. J AmMed Assoc, 2004,29(2), 2868 -2873.
39) Peter AGM, De Smet. Herbal remedies. N Engl J Med, 2002,347(25), 2046-2056.
40)TDR.Operational Guidance: Information Needed to Support Clinical Trials of Herbal Products, UNICEF/ UNDP/ WORLD BankWHO special program for Research and Training in Tropical Diseases (TDR) 2005.
41) The 2002 United States Pharmacopoeia and National Formulary, USP 25 NF 19/National Formulary 20, Rockville, MD, U. S.Pharmacopoeial Convention, Inc. 2002.
42)Pharmacopoeia of the People’s Republic of China, English ed., The Pharmacopoeia Commission of PRC, Beijing. 2000.
43) Liang YZ, Xie P &Chan K, J., Quality control of herbal medicines, Chromatogr B, 812 2004, 53–70.
44 Ong ES, Chemical assay of glycyrrhizin in medicinal plants by pressurized liquid extraction (PLE) with capillary zone electrophoresis(CZE). J Sep Sci, 2002,25(2), 825-831.
45)Organization, Geneva, Archana Gautam. Identification,evaluation and standardization of herbal drugs: Areview, Der Pharmacia Lettre, 2010; 2(6):302-315.
46). Wickremasinghe M, Bandaranayake. Quality Control,Screening, Toxicity and regulation of Herbal Drugs,2006.
47) Kunle, Oluyemisi Folashade, Egharevba, HenryOmoregie, Ahmadu Peter Ochogu. Standardization of herbal medicines - A review. International Journal of Biodiversity and Conservation. 2012; 4(3)101-112.
48) Derived intervention levels for radionuclides in food.Guidelines for application after wide spread radioactive contamination resulting from a major radiation accident.Geneva, World Health Organization, 1988.
49). Archana A, Bele Anubha Khle. Standerdization ofherbal drugs A overview, international research journalof pharmacy. 2011; 2(12):56-60.
50. AOAC. Official Methods of Analysis of AOACInternational, 18th edn. AOAC International,Gaithersburg, MD, 2005.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).