Alternative to the Thai Herbal Pharmacopoeia Method for Quality Control of Andrographis Capsules
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Published:
Dec 31, 2016
Keywords:
ultrasonication andrographis capsules quality
Main Article Content
Abstract
Rationale and Objective: Reflux extraction is the standard sample preparation method described in the Thai Herbal Pharmacopoeia (THP) for the assay of andrographolide content in both Andrographis herbal material and capsules since 1995. The disadvantages of this method are consumption of large amounts of volatile and hazardous organic solvents, low extraction efficiency and time consuming. The objectives of this study were to compare the extraction efficiency of ultrasonication and reflux extraction methods and to propose an alternative to the current THP method for quality control of Andrographis capsules.
Methodology: Optimization of extracting solvent and sonication time were investigated. The best condition was further used for comparison of the extraction efficiency with reflux extraction. A total of 30 different lots of Andrographis capsules were tested. The analytical method as described in the THP was revalidated to ensure method performance and data integrity after the sample preparation is changed.
Results: Ultrasonication with 50% methanol for 15 minutes gave the highest andrographolide content extracted. Change in sample preparation did not affect the analytical method performance. The contents of andrographolide extracted using ultrasonication were comparable and in most cases they are even higher than those obtained from reflux method.
Discussion and Conclusion: Ultrasonication is a more efficient, rapid and more convenient method and can be used as alternative sample preparation method to the current monographs in THP for the quality control of both Andrographis herbal material as well as medicinal product.
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References
1. Saxena S, Jain DC, Bhakuni RS, Sharma RP. Chemistry and pharmacology of Andrographis species. Indian Drugs. 1998;35:458-67.
2. Poolsup N, Suthisisang C, Prathanturarug S, Asawamekin A, Chanchareon U. Andrographis paniculata in the symptomatic treatment of uncomplicated upper respiratory tract infection: systematic review of randomized controlled trials. J Clin Pharm Ther. 2004;29(1):37-45.
3. Gupta S, Yadava JNS, Tandon JS. Antisecretory (antidiarrhoeal) activity of Indian medicinal plants against Escherichia coli enterotoxin-induced secretion in rabbit and guinea pig ileal loop models. Pharm Biol. 1993;31:198-204.
4. Handa SS, Sharma A. Hepatoprotective activity of andrographolide from Andrographis paniculata against carbon tetrachloride. Indian J Med Res. 1990;92:276-83.
5. Shen YC, Chen CF, Chiou WF. Andrographolide prevents oxygen radical production by human neutrophils: possible mechanism(s) involved in its anti-inflammatory effect. Br J Pharmacol. 2002;135:399-406.
6. Amroyan E, Gabrielian E, Panossian A, Wikman G, Wagner H. Inhibitory effect of andrographolide from Andrographis paniculata on PAF induced platelet aggregation. Phytomedicine. 1999;6:27-31.
7. Thamlikitkul V, Dechatiwongse T, Theerapong S, Chantrakul C, Boonroj P, Punkrut W, et al. Efficacy of Andrographis paniculata. Nees for pharyngotonsillitis in adults. J Med Assoc Thai. 1991;74:437-42.
8. Kapil A, Koul IB, Banerjee SK, Gupta BD. Antihepatotoxic effects of major diterpenoid constituents of Andrographis paniculata. Biochem Pharmacol. 1993;46(1):182-5.
9. Cáceres DD, Hancke JL, Burgos RA, Sandberg F, Wikman GK. Use of visual analogue scale measurements (VAS) to assess the effectiveness of standardized Andrographis paniculata extract SHA-10 in reducing the symptoms of common cold. A randomized double blind-placebo study. Phytomedicine. 1999;6:217-23.
10. Melchior J, Spasov AA, Ostrovskij OV. Double blind placebocontrolled pilot and phase III studyof activity of standardized Andrographis paniculta Herba Nees extract fixed combination (Kan jang) in the treatment of uncomplicated upper respiratory tract infection. Phytomedicine. 2000;7:341-50.
11. Coon JT, Ernst E. Andrographis paniculata in the treatment of upper respiratory tract infections: A systematic review of safety and efficacy. Planta medica. 2004;70:293-8.
12. Premendran SJ, Salwe KJ, Pathak S, Brahmane R, Manimekalai K. Anti-cobra venom activity of plant Andrographis paniculata and its comparison with polyvalent anti-snake venom. J Nat Sci Biol Med. 2011;2(2):198-204.
13. Calabrese C, Berman SH, Babish JG, Ma XF, Shinto L, Dorr M, et al. A phase I trial of andrographolide in HIV positive patients and normal volunteers. Phytother Res. 2000;14:333-8.
14. Rajagopal S, Kumar RA, Deevi DS, Satyanarayana C, Rajagopalan R. Andrographolide, a potential cancer therapeutic agent isolated from Andrographis paniculata. J Exp Ther Oncol. 2003;3:147-58.
15. Cheung HY, Cheung SH, Li J, Cheung CS, Lai WP, Fong WF, et al. Andrographolide isolated from Andrographis paniculata induces cell cycle arrest and mitochondrial mediated apoptosis in human leukemic HL-60 cells. Planta Med. 2005;71:1106-11.
16. Li J, Cheung HY, Zhang Z, Chan GKL, Fong WF. Andrographolide induces cell cycle arrest at G2/M phase and cell death in HepG2 cells via alteration of reactive oxygen species. Eur J Pharmacol. 2007;568:31-44.
17. Koteswara RY, Vimalamma G, Venkata RC, Tzeng YM. Flavonoids and andrographolides from Andrographis paniculata. Phytochemistry. 2004;65:2317-21.
18. Smith PL, Maloney KN, Pothen RG, Clardy J, Clapham DE. Bisandrographolide from Andrographis paniculata activates TRPV4 channels. J Biol Chem. 2006;281:29897-904.
19. Chen L, Zhu H, Wang R, Zhou K, Jing Y, Qiu F. Ent-labdane diterpenoid lactone stereoisomers from Andrographis paniculata. J Nat Prod. 2008;71:852-5.
20. Chen LX, Qiu F, Wei H, Qu GX, Yao XS. Nine new ent-labdane diterpenoids from the aerial parts of Andrographis paniculata. Helv Chim Acta. 2006;89:2654-64.
21. National Drug Committee. List of Herbal Medicinal Products. Bangkok: The Agricultural Co-operative Federation of Thailand, Limited; 2006. p.18-9.
22. Department of Medical Sciences, Ministry of Public Health. Thai Herbal Pharmacopoeia Volume I. Bangkok: Office of National Buddishm Press; 2009. p. 24-31.
23. Department of Medical Sciences, Ministry of Public Health. Supplement to Thai Herbal Pharmacopoeia. Bangkok: Prachachon Co., Ltd.; 2004. p. 29-30.
24. Department of Medical Sciences, Ministry of Public Health. Thai Herbal Pharmacopoeia Volume III. Bangkok: Office of National Buddishm Press; 2009. p. XI-XII.
25. Kumoro AC, Hasan M. Supercritical carbon dioxide extraction of andrographolide from Andrographis paniculata: Effect of the solvent flow rate, pressure, and temperature. Chin J Chem Eng. 2007;15:877-83.
26. Kumoro AC, Hasan M. Modeling of supercritical carbon dioxide extraction of andrographolide from Andrographis paniculata leaves. Chem Eng Commun. 2008;195:72-80.
27. Vijaykumar1 K, Murthy PBS, Kannababu S, Syamasundar B, Subbaraju GV. Estimation of adrographolide in Andrographis paniculata herb, extracts and dosage forms. Int J Appl Sci Eng. 2007;5(1):27-39.
28. Xu T, Pan J, Zhao L. Simultaneous determination of four andrographolides in Andrographis paniculata Nees by silver ion reversed-phase high-performance liquid chromatography. J Chromtogr Sci. 2008;46(8):747-5.
29. Daodee S, Wangboonskul, Jarukamjorn, Sripanidkulchai B. The consideration of quality control criteria for Andrographis paniculata products. KKU res J. 2006;11(4):319-27.
30. Jain PK, Ravichandran V, Jain PK, Agrawal RK. High-performance thin layer chromatography method for estimation of andrographolide in herbal extract and polyherbal formulations. J Saudi Chem Soc. 2010;14(4):383-9.
31. Sajeeb BK, Kumar U, Halder S, Bachar SC. Identification and quantification of Andrographolide from Andrographis paniculata (Burm. f.) Wall. ex Nees by RP-HPLC method and standardization of its market preparations. Dhaka Univ J Pharm Sci.2015;14(1):71-8.
32. ICH Steering Committee. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Validation of analytical procedures: text and methodology Q2(R1). 2005.
33. Kumoro AC, Hasan M,Singh H. Effects of solvent properties on the Soxhlet extraction of diterpenoid lactones from Andrographis paniculata leaves. Sci Asia. 2009;35:306-9.
2. Poolsup N, Suthisisang C, Prathanturarug S, Asawamekin A, Chanchareon U. Andrographis paniculata in the symptomatic treatment of uncomplicated upper respiratory tract infection: systematic review of randomized controlled trials. J Clin Pharm Ther. 2004;29(1):37-45.
3. Gupta S, Yadava JNS, Tandon JS. Antisecretory (antidiarrhoeal) activity of Indian medicinal plants against Escherichia coli enterotoxin-induced secretion in rabbit and guinea pig ileal loop models. Pharm Biol. 1993;31:198-204.
4. Handa SS, Sharma A. Hepatoprotective activity of andrographolide from Andrographis paniculata against carbon tetrachloride. Indian J Med Res. 1990;92:276-83.
5. Shen YC, Chen CF, Chiou WF. Andrographolide prevents oxygen radical production by human neutrophils: possible mechanism(s) involved in its anti-inflammatory effect. Br J Pharmacol. 2002;135:399-406.
6. Amroyan E, Gabrielian E, Panossian A, Wikman G, Wagner H. Inhibitory effect of andrographolide from Andrographis paniculata on PAF induced platelet aggregation. Phytomedicine. 1999;6:27-31.
7. Thamlikitkul V, Dechatiwongse T, Theerapong S, Chantrakul C, Boonroj P, Punkrut W, et al. Efficacy of Andrographis paniculata. Nees for pharyngotonsillitis in adults. J Med Assoc Thai. 1991;74:437-42.
8. Kapil A, Koul IB, Banerjee SK, Gupta BD. Antihepatotoxic effects of major diterpenoid constituents of Andrographis paniculata. Biochem Pharmacol. 1993;46(1):182-5.
9. Cáceres DD, Hancke JL, Burgos RA, Sandberg F, Wikman GK. Use of visual analogue scale measurements (VAS) to assess the effectiveness of standardized Andrographis paniculata extract SHA-10 in reducing the symptoms of common cold. A randomized double blind-placebo study. Phytomedicine. 1999;6:217-23.
10. Melchior J, Spasov AA, Ostrovskij OV. Double blind placebocontrolled pilot and phase III studyof activity of standardized Andrographis paniculta Herba Nees extract fixed combination (Kan jang) in the treatment of uncomplicated upper respiratory tract infection. Phytomedicine. 2000;7:341-50.
11. Coon JT, Ernst E. Andrographis paniculata in the treatment of upper respiratory tract infections: A systematic review of safety and efficacy. Planta medica. 2004;70:293-8.
12. Premendran SJ, Salwe KJ, Pathak S, Brahmane R, Manimekalai K. Anti-cobra venom activity of plant Andrographis paniculata and its comparison with polyvalent anti-snake venom. J Nat Sci Biol Med. 2011;2(2):198-204.
13. Calabrese C, Berman SH, Babish JG, Ma XF, Shinto L, Dorr M, et al. A phase I trial of andrographolide in HIV positive patients and normal volunteers. Phytother Res. 2000;14:333-8.
14. Rajagopal S, Kumar RA, Deevi DS, Satyanarayana C, Rajagopalan R. Andrographolide, a potential cancer therapeutic agent isolated from Andrographis paniculata. J Exp Ther Oncol. 2003;3:147-58.
15. Cheung HY, Cheung SH, Li J, Cheung CS, Lai WP, Fong WF, et al. Andrographolide isolated from Andrographis paniculata induces cell cycle arrest and mitochondrial mediated apoptosis in human leukemic HL-60 cells. Planta Med. 2005;71:1106-11.
16. Li J, Cheung HY, Zhang Z, Chan GKL, Fong WF. Andrographolide induces cell cycle arrest at G2/M phase and cell death in HepG2 cells via alteration of reactive oxygen species. Eur J Pharmacol. 2007;568:31-44.
17. Koteswara RY, Vimalamma G, Venkata RC, Tzeng YM. Flavonoids and andrographolides from Andrographis paniculata. Phytochemistry. 2004;65:2317-21.
18. Smith PL, Maloney KN, Pothen RG, Clardy J, Clapham DE. Bisandrographolide from Andrographis paniculata activates TRPV4 channels. J Biol Chem. 2006;281:29897-904.
19. Chen L, Zhu H, Wang R, Zhou K, Jing Y, Qiu F. Ent-labdane diterpenoid lactone stereoisomers from Andrographis paniculata. J Nat Prod. 2008;71:852-5.
20. Chen LX, Qiu F, Wei H, Qu GX, Yao XS. Nine new ent-labdane diterpenoids from the aerial parts of Andrographis paniculata. Helv Chim Acta. 2006;89:2654-64.
21. National Drug Committee. List of Herbal Medicinal Products. Bangkok: The Agricultural Co-operative Federation of Thailand, Limited; 2006. p.18-9.
22. Department of Medical Sciences, Ministry of Public Health. Thai Herbal Pharmacopoeia Volume I. Bangkok: Office of National Buddishm Press; 2009. p. 24-31.
23. Department of Medical Sciences, Ministry of Public Health. Supplement to Thai Herbal Pharmacopoeia. Bangkok: Prachachon Co., Ltd.; 2004. p. 29-30.
24. Department of Medical Sciences, Ministry of Public Health. Thai Herbal Pharmacopoeia Volume III. Bangkok: Office of National Buddishm Press; 2009. p. XI-XII.
25. Kumoro AC, Hasan M. Supercritical carbon dioxide extraction of andrographolide from Andrographis paniculata: Effect of the solvent flow rate, pressure, and temperature. Chin J Chem Eng. 2007;15:877-83.
26. Kumoro AC, Hasan M. Modeling of supercritical carbon dioxide extraction of andrographolide from Andrographis paniculata leaves. Chem Eng Commun. 2008;195:72-80.
27. Vijaykumar1 K, Murthy PBS, Kannababu S, Syamasundar B, Subbaraju GV. Estimation of adrographolide in Andrographis paniculata herb, extracts and dosage forms. Int J Appl Sci Eng. 2007;5(1):27-39.
28. Xu T, Pan J, Zhao L. Simultaneous determination of four andrographolides in Andrographis paniculata Nees by silver ion reversed-phase high-performance liquid chromatography. J Chromtogr Sci. 2008;46(8):747-5.
29. Daodee S, Wangboonskul, Jarukamjorn, Sripanidkulchai B. The consideration of quality control criteria for Andrographis paniculata products. KKU res J. 2006;11(4):319-27.
30. Jain PK, Ravichandran V, Jain PK, Agrawal RK. High-performance thin layer chromatography method for estimation of andrographolide in herbal extract and polyherbal formulations. J Saudi Chem Soc. 2010;14(4):383-9.
31. Sajeeb BK, Kumar U, Halder S, Bachar SC. Identification and quantification of Andrographolide from Andrographis paniculata (Burm. f.) Wall. ex Nees by RP-HPLC method and standardization of its market preparations. Dhaka Univ J Pharm Sci.2015;14(1):71-8.
32. ICH Steering Committee. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. Validation of analytical procedures: text and methodology Q2(R1). 2005.
33. Kumoro AC, Hasan M,Singh H. Effects of solvent properties on the Soxhlet extraction of diterpenoid lactones from Andrographis paniculata leaves. Sci Asia. 2009;35:306-9.