Generic placeholder image

Current Traditional Medicine

Author(s): Nancy, Jasmeen Kaur, Yogita Bansal and Gulshan Bansal*

DOI: 10.2174/2215083805666190830125626

DownloadDownload PDF Flyer Cite As
WHO Guidelines in Practice in India: Stability Studies on Selected CNS Active Herbal Products Through Physicochemical, Chromatographic and Biological Evaluations

Page: [360 - 379] Pages: 20

  • * (Excluding Mailing and Handling)

Explore Articles
About Journal
For Authors
For Editors
For Reviewers

Abstract

Background & Objective: Accelerated stability study (40°C/75% RH, 6 months) as well as long term stability studies (30°C/65% RH, 36 months) are conducted on three batches (I-III) of two commercially available CNS active herbal products (A and B) containing Convolvulus pluricaulis with Centella asiatica or Bacopa monnieri.

Methods: Stability samples were withdrawn at periodic intervals, and evaluated for physical stability (color, clarity, viscosity and pH), chemical stability (total phenolic (TPC), scopoletin, asiatic acid and bacoside A content), and biological activities (free radical scavenging, anti-acetylcholinesterase, and antianxiety). All stability samples retained the physical characteristics compared to corresponding control samples. Control samples exhibited significant batch-to-batch variation in TPC (46.8-65.9 mgGAE/L), scopoletin (165.78-206.15 ng/mL in A and 2.61-28.78 ng/mL in B), asiatic acid (30.14-44.92 μg/mL in B), free radical scavenging activity (IC50 0.5-1.25% v/v), AChE inhibitory activity (IC50 75.0-96.3% v/v), and antianxiety activity.

Results: The chemical indicators and biological activities were significantly decreased in both accelerated and long term stability samples compared to corresponding control samples. A correlation between scopoletin and biological activities was established in products A whereas asiatic acid/C. asiatica defies the logical correlation in product B.

Conclusion: The products exhibited significant batch-to-batch variation, and did not remain stable for the recommended shelf life period of three years, which suggested that these are suspected to lose therapeutic efficacy during their shelf life.

Keywords: Stability, Centella asiatica, Bacopa monnieri, Convolvulus pluricaulis, Brahmi, Shankhpushpi, Shelf life.

Graphical Abstract

[1]
Robinson MM, Zhang X. The World Medicines Situation 2011. Traditional Medicines: Global Situation, Issues and Challenges. The World Medicines Situation 3: 1-12.2011;
[2]
Bansal G, Suthar N, Kaur J, Jain A. Stability testing of herbal drugs: Challenges, regulatory compliance and perspectives. Phytother Res 2016; 30(7): 1046-58.
[http://dx.doi.org/10.1002/ptr.5618] [PMID: 27073177]
[3]
Stability testing of new drug substances and products CPMP/ICH/2736/99. London, UK: European Medicines Agency 2003.
[4]
Guideline on stability testing: Stability testing of existing active substances and related finished products CPMP/QWP/122/02 Rev1 corr. London, UK: European Medicines Agency 2003.
[5]
Committee for Medicinal Products for Human use Quality of Herbal Medicinal Products/ Traditional Herbal Medicinal Products CPMP/QWP/2819/00 Rev2. London, UK: European Medicines Agency 2011.
[6]
Committee for Medicinal Products for Human use Test procedures and acceptance criteria for Herbal substances, Herbal preparations and Herbal Medicinal Products/ Traditional Herbal Medicinal Products CPMP/QWP/2820/00 Rev2. London, UK: European Medicines Agency 2011.
[7]
Committee on Herbal Medicinal Products In. Reflection paper on markers used for Quantitative and Qualitative analysis of Herbal Medicinal Products and Traditional Herbal Medicinal Products EMEA/ HMPC/253629/07. London, UK: European Medicines Agency 2008.
[8]
ommittee on Herbal Medicinal Products In: Guideline on Quality of Combination Herbal Medicinal Products/ Traditional Herbal Medicinal Products EMEA/ HPMC/CHMP/CVMP/214869 London, UK: European Medicines Agency 2008.
[9]
Committee on Herbal Medicinal Products In. Reflection paper on stability testing of Herbal Medicinal Products and Traditional Herbal Medicinal Products EMEA/HMPC/3626/09. London, UK: European Medicines Agency 2010.
[10]
] International Conference on Harmonization. Stability testing of New Drug Substances and Products. ICH Q1A (R2), International Conference on Harmonization IFPMA 2003.
[11]
Stability testing of active pharmaceutical ingredients and finished pharmaceutical products WHO Technical Report Series, No 953. Geneva: World Health Organisation 2009.
[12]
Kumari S, Shukla G, Rao AS. The Present Status of Medicinal Plants- Aspects and Prospects. Int J Res Pharm Biomed Sci 2011; 2: 19-22.
[13]
Inamdar PK, Yeole RD, Ghogare AB, De Souza NJ. Determination of biologically active constituents in Centella asiatica. J Chromatogr A 1996; 742: 127-30.
[http://dx.doi.org/10.1016/0021-9673(96)00237-3]
[14]
Phrompittayarat W, Wittaya-areekul S, Jetiyanon K, Putalun W, Tanaka H, Ingkaninan K. Stability studies of saponins in Bacopa monnieri dried ethanolic extracts. Planta Med 2008; 74(14): 1756-63.
[http://dx.doi.org/10.1055/s-0028-1088311] [PMID: 18951336]
[15]
Srivastava P, Raut HN, Puntambekar HM, Upadhye AS, Desai AC. Stability studies of crude plant material of Bacopa monnieri and its effect on free radical scavenging activity. J Phytol 2010; 2: 103-9.
[16]
Srivastava P, Raut HN, Puntambekar HM, Desai AC. Stability studies of crude plant material of Bacopa monnieri and quantitative determination of bacopaside I and bacoside A by HPLC. Phytochem Anal 2012; 23(5): 502-7.
[http://dx.doi.org/10.1002/pca.2347] [PMID: 22259163]
[17]
Ainsworth EA, Gillespie KM. Estimation of total phenolic content and other oxidation substrates in plant tissues using Folin-Ciocalteu reagent. Nat Protoc 2007; 2(4): 875-7.
[http://dx.doi.org/10.1038/nprot.2007.102] [PMID: 17446889]
[18]
Arslan E, Yener ME, Esin A. Rheological characterization of tahin/pekmez (sesame paste/concentrated grape juice) blends. J Food Eng 2005; 69: 167-72.
[http://dx.doi.org/10.1016/j.jfoodeng.2004.08.010]
[19]
Singleton VL, Orthofer R, Lamuela-Raventos RM. Analysis of total phenols and other oxidation substrates and antioxidants by means of folin-ciocalteu reagent. Methods Enzymol 1999; 299: 152-78.
[http://dx.doi.org/10.1016/S0076-6879(99)99017-1]
[20]
Deepak M, Sangli GK, Arun PC, Amit A. Quantitative determination of the major saponin mixture bacoside A in Bacopa monnieri by HPLC. Phytochem Anal 2005; 16(1): 24-9.
[http://dx.doi.org/10.1002/pca.805] [PMID: 15688952]
[21]
International Conference on Harmonization. Validation of analytical procedures: Text and methodology. ICHQ2(R1) IFPMA 2005.
[22]
Locatelli M, Gindro R, Travaglia F, Coïsson JD, Rinaldi M, Arlorio M. Study of the DPPH scavenging activity: Development of a free software for the correct interpretation of data. Food Chem 2009; 114: 889-97.
[http://dx.doi.org/10.1016/j.foodchem.2008.10.035]
[23]
Ellman GL, Courtney KD, Andres V Jr, Feather-Stone RM. A new and rapid colorimetric determination of acetylcholinesterase activity. Biochem Pharmacol 1961; 7: 88-95.
[http://dx.doi.org/10.1016/0006-2952(61)90145-9] [PMID: 13726518]
[24]
Reagan-Shaw S, Nihal M, Ahmad N. Dose translation from animal to human studies revisited. FASEB J 2008; 22(3): 659-61.
[http://dx.doi.org/10.1096/fj.07-9574LSF] [PMID: 17942826]
[25]
United States Food and Drug Administration Guidance for Industry. Botanical Drug Products. Rockville, MD: Department of Health and Human Services 2004.
[26]
Bourin M, Petit-Demoulière B, Dhonnchadha BN, Hascöet M. Animal models of anxiety in mice. Fundam Clin Pharmacol 2007; 21(6): 567-74.
[http://dx.doi.org/10.1111/j.1472-8206.2007.00526.x] [PMID: 18034657]
[27]
Prakashan V, Kulkarni SK. Handbook of Experimental Pharmacology. Delhi 1999; 135-7.