Comparison of Five Pharmacopoeial Methods for Weight Variation of Andrographis Capsules
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Published:
Dec 26, 2019
Keywords:
weight variation pharmacopoeias andrographis capsules
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Abstract
Weight variation is one of the quality control parameters used to ensure the consistency of the amount of drug substance in each dosage unit within a batch. The objectives of this study were to compare weight variation of Andrographis capsules according to 5 pharmacopoeial methods, Thai Herbal Pharmacopoeia (THP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), The International Pharmacopoeia (Ph. Int.) and The United States Pharmacopeia (USP), and to use it as an example supporting a revision to the THP. A total of 52 products
were calculated for average weight of Andrographis powder and tested for weight variation as described in 5 pharmacopoeias. The weight of 24 products (46%) did not meet the label within a 10% margin. The differences between testing procedures and acceptance criteria were observed in each standard which may lead to different conclusions. The results showed that 29 products (56%) complied with all standards whereas 13 products (25%) met the THP standard but failed the others. It was apparent that the requirement as per THP is less stringent than those of international standards and may be insufficiently restrictive for quality control of herbal medicines.
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References
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7. Department of Medical Sciences, Ministry of Public Health. Thai Herbal Pharmacopoeia 2019. Volume II. Bangkok: The Agricultural Co-operative Federation of Thailand., Ltd; 2019. Appendix 1.16H Dosage Forms of Herbal Drugs; p. 723-4.
8. Thamlikitkul V, Dechatiwongse T, Theerapong S, Chantrakul C, Boonroj P, Punkrut W, Ekpalakorn W, Boontaeng N, Taechaiya S, Petcharoen S, Orn-Chom-Jan T, Riewpaiboon W, Pradipasena S, Riewpaiboon A, Timsard S, Tenambergen ED. Efficacy of Andrographis paniculata. Nees for haryngotonsillitis in adults. J Med Assoc Thai. 1991;74(10):437-42.
9. 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.
10. 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. International journal of pharmacognosy. 1993;31(3):198-204.
11. 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.
12. Cáceres DD, Hancke JL, Burgos RA, Sandberg F, Wikman GK. Use of visual analogue scale measurements (VAS) to asses 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(4):217-23.
13. Calabrese C, Berman SH, Babish JG, Ma X, Shinto L, Dorr M, Wells K, Wenner CA, Standish LJ. A phase I trial of andrographolide in HIV positive patients and normal volunteers. Phytother Res. 2000;14:333-8.
14. Thailand National List of Essential Medicines B.E. 2561 (2018) [Internet]. 2018 [cited 2019 Feb 21]; Available from: www.fda.moph.go.th/sites/drug/Shared%20Documents/New/nlem2561.PDF (in Thai)
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16. British Pharmacopoeia Commission. British Pharmacopoeia 2019. Volume 5. London: The Stationery Office; 2018. Appendix XII C. Consistency of Formulated Preparations; p. A402-3.
17. European Pharmacopoeia 8th ed. Volume 1. Strasbourg: Council of Europe; 2014. Uniformity of Mass of Singledose Preparations; p. 297-8.
18. European Pharmacopoeia 9th ed. Volume 1. Strasbourg: Council of Europe; 2017. Uniformity of Mass of Singledose Preparations; p. 311-2.
19. World Health Organization. The International Pharmacopoeia 5th ed. [Internet]. 2015 [cited 2016 Jun 11]; Available from: http://apps.who.int/phint/pdf/b/2.7.The-International-Pharmacopoeia,-Fifth-Edition.pdf
20. World Health Organization. The International Pharmacopoeia 9th ed. [Internet]. 2019 [cited 2019 Mar 4]; Available from: http://apps.who.int/phint/pdf/b/7.5.3.5.2-Uniformity-of-mass-for-single-dose-preparations.pdf.
21. The United States Pharmacopeia-National Formulary. USP 39-NF 34. Volume 1. Rockville: The United States Pharmacopeial Convention; 2016. <2091> Weight variation of dietary supplements; p. 2051-2.
22. The United States Pharmacopeia-National Formulary. USP 42-NF 37. Volume 5. Rockville: The United States Pharmacopeial Convention; 2019. <2091> Weight variation of dietary supplements; p. 8540-1.