Evaluation of microbiological and physicochemical profile of some herbal preparations manufactured by pharmaceutical and herbal manufacturers in Bangladesh

Journal of Pharmaceutical Investigation - Tập 45 - Trang 223-235 - 2014
A. F. M. Mahmudul Islam1, Md. Farhan Khalik1, Nizam Uddin1, Md. Sazzad Hossain1, Md. Monir Hossain1, Md. Mahadi Hasan1, S. M. Fahad2, Pijus Saha1
1Department of Pharmacy, Jahangirnagar University, Savar, Dhaka, Bangladesh
2Department of Physics, Jahangirnagar University, Savar, Dhaka, Bangladesh

Tóm tắt

The aim of this study was to scrutinize the physicochemical and qualitative microbial examination of 30 different (of various dosage forms) herbal medicinal products marketed by pharmaceutical and herbal manufacturers in Bangladesh. The microbial evaluation included total viable aerobic bacteria, Escherichia coli, fungi and Staphylococcus aureus count; physicochemical properties like weight variation, hardness, disintegration time, friability and density. The IMViC (indole, methyl red, Voges–Proskauer and citrate utilization) tests were frequently employed for identification of E. coli and S. aureus. Total viable aerobic bacterial counts in the samples analyzed were ranged from 3.8 × 104 to 3.2 × 108 CFU/ml or CFU/g and 36.67 % were within BP standard limit. S. aureus was detected in 53.33 % (16) of the samples, ranged from an estimated 3 × 102 to 9.2 × 106 CFU/ml or CFU/g which were above the USP standard. E. coli was detected in 40 % (12) of the samples, ranging from 1 × 102 to 4.8 × 104 CFU/ml or CFU/g that were above the USP standard. The ranges of the fungi counts were 3.4 × 103–3.1 × 106 CFU/ml or CFU/g and 46.67 % of which were within BP standard. Physicochemical properties of herbal products manufactured by pharmaceutical manufacturers were found better than that of the herbal manufacturers. From the label and pack insert of herbal products, definite release pattern information weren’t obtained and the majority of herbal products showed scattered disintegration time. In order to reduce the potential health related complications, there is necessity of constant monitoring and control of the standards of herbal medicine products available in the Bangladeshi market.

Tài liệu tham khảo

Akerele JO, Godwin UC (2002) Aspects of microbial contamination of tablets dispensed in hospitals and community pharmacies in Benin City, Nigeria. Trop J Pharm Res 1:23–28 Banker GS, Anderson NR (1986) Tablets. In: Lachman L, Lieberman HA, Kanig JL (eds) The theory and practice of industrial pharmacy, 3rd edn. Lea and Febiger, Philadelphia, pp 301–303 BP (2012) Microbiological quality of herbal medicinal products for oral use. British Pharmacopoeia, Stationery Office, London Candlish AAG, Pearson SM, Aidoo KE, Smith JE, Kelly B, Irvine H (2001) A survey of ethnic foods for microbial quality and aflatoxin content. Food Addit Contam 18(2):129–136 Czech E, Kneifel W, Kopp B (2001) Microbiological status of commercially available medicinal herbal drugs—a screening study. Plantamedica 67:263–269 DGDA (2014) Directorate General of Drug Administration Web. http://www.dgda.gov.bd. Accessed 12 Oct 2014 Farnsworth NR, Akerele O, Bingel AS, Soejart DD, Guo ZG (1985) Medicinal plants in therapy. Bull World Health Organ 63(6):965–981 Gad GFM, Reham AIA, Mohamed SEA (2011) Microbial evaluation of some non-sterile pharmaceutical preparations commonly used in the Egyptian market. Trop J Pharm Res 10(4):437 Ghani A (2005) Text book of pharmacognosy (Part-1), 1st edn. Parash Publishers, Dhaka Gupta DK, Sharma RD, Ritu G, Tyagi S, Sharma KK (2012) Evaluation of some herbal solid dosage forms for microbial contamination. Int J Pharm Pharm Sci 4(4):261–263 IMS (2014) Health Reports Second-Quarter. http://ir.imshealth.com/files/doc_news/IMS-Health-2Q-2014-Press-Release-Final_v001_q5w83v.pdf. Accessed 13 Oct 2014 Lau AJ, Holmes MJ, Woo SO, Koh HL (2003) Analysis of adulterants in a traditional herbal medicinal product using liquid chromatography-mass spectrometry-mass spectrometry. J Pharm Biomed Anal 31:401–406 Lutomski J, Kedzia B (1980) Mycoflora of crude drugs. Estimation of mould contaminations and their toxicity. Planta Med 40:212–217 Merchant IA, Packer RA (1969) Veterinary Bacteriology and Virology, 7th edn. Iowa State University Press, USA, pp 211–305 Ministry of Commerce (2013) Medicinal plants and Herbal Products Business Promotion Council (MPHPBPC). Business Promotion Council Web. http://www.bpc.org.bd/mphpbpc_home.php. Accessed 13 Oct 2014 Montville TJ, Matthews KR (2005) Food microbiology—an introduction. ASM Press, Washington, DC, pp 20–21 Mullika TC, Puvapan P, Noparatana N, Lek R (2003) Evaluation of microbiological quality of herbal products in Thailand. Thai J Phytopharm 10(2):37–47 Nakajima K, Nonaka K, Yamamoto K, Yamaguchi N, Tani K, Nasu M (2005) Rapid monitoring of microbial contamination on herbal medicines by fluorescent staining method. Lett Appl Microbiol 40(2):128–132 Okunlola A, Babatunde AA, Oluwatoyin AO (2007) Evaluation of pharmaceutical and microbial qualities of some herbal medicinal products in South Western Nigeria. Trop J Pharm Res 6(1):661–670 Ola IO, Omomowo IO, Aina DA, Majolagbe NO, Oladipo EK (2013) Bacteriological evaluation and antimicrobial sensitivity test of common herbal concoctions in Ogbomoso metropolis. Afr J Microbiol Res 7(48):5479–5483 Oluyege JO, Adelabu DM (2010) Microbial contamination of some hawked herbal products in Ado-Ekiti, Nigeria. Cont J Microbiol 4:8–14 Rajapandiyan K, Shanthi S, Vidya S (2013) Assessment of microbial quality in marketed herbal drugs sold in Trichy City. Int J Pharm Chem Biol Sci 3(3):894–898 Sharma A (2001) Irradiation to decontaminate herbs and spices. In: Peter KV (ed) Handbook of herbs and spices. Woodhead Publishing, Cambridge, pp 60–73 Tatjana S, Snežana P, Stanković S, Katarina Š (2012) Pathogenic microorganisms of medicinal herbal drugs. Arch Biol Sci Belgrade 64(1):49–58 The Financial Express (2012) Herbal medicine market to exceed Tk 25b by 2020: Herbalists. Trade and Market Web. http://www.thefinancialexpress-bd.com/old/more.php?news_id=130165&date=2012-05-20. Accessed 18 Oct 2014 United States Pharmacopeia 20 (1980) National Formulary 15: United States Pharmacopeia Convention, Rockville United States Pharmacopeia 31 (2009) National Formulary 26: United States Pharmacopeia Convention, Rockville United States Pharmacopeia 32 (2010) National Formulary 27: United States Pharmacopeia Convention, Rockville US Pharmacopeial Catalog (2014) http://www.uspcatalog.com/uspcatalog/20080506#pg3. Accessed 26 May 2014 WHO (1985) The WHO traditional medicine programme: policy and implementation. Int Tradit Med Newslett 1(1):1–5 WHO (2000) General guidelines for methodologies on research and evaluation of traditional medicines (Online). http://apps.who.int/medicinedocs/en/d/Jwhozip42e/. Accessed 2 Mar 2014