دورية أكاديمية
أعرض في EDS

Safety and Efficacy of Medicinal Plants Used to Manufacture Herbal Products with Regulatory Approval in Uganda: A Cross-Sectional Study.

التفاصيل البيبلوغرافية
العنوان: Safety and Efficacy of Medicinal Plants Used to Manufacture Herbal Products with Regulatory Approval in Uganda: A Cross-Sectional Study.
المؤلفون: Kaggwa B; Mbarara University of Science and Technology, Pharm-Bio Technology and Traditional Medicine Center (PHARMBIOTRAC), P.O. Box 1410, Mbarara, Uganda.; Makerere University, College of Health Sciences, Department of Pharmacy, P.O. Box 7062, Kampala, Uganda., Kyeyune H; Makerere University, College of Health Sciences, Department of Pharmacy, P.O. Box 7062, Kampala, Uganda., Munanura EI; Makerere University, College of Health Sciences, Department of Pharmacy, P.O. Box 7062, Kampala, Uganda., Anywar G; Makerere University, Department of Plant Sciences, Microbiology and Biotechnology, P.O. Box 7062, Kampala, Uganda., Lutoti S; Mbarara University of Science and Technology, Pharm-Bio Technology and Traditional Medicine Center (PHARMBIOTRAC), P.O. Box 1410, Mbarara, Uganda.; Makerere University, College of Health Sciences, Department of Pharmacy, P.O. Box 7062, Kampala, Uganda., Aber J; Mbarara University of Science and Technology, Pharm-Bio Technology and Traditional Medicine Center (PHARMBIOTRAC), P.O. Box 1410, Mbarara, Uganda., Bagoloire LK; Makerere University, College of Health Sciences, School of Medicine, Clinical Epidemiology Unit, P.O. Box 7072, Kampala, Uganda., Weisheit A; Mbarara University of Science and Technology, Pharm-Bio Technology and Traditional Medicine Center (PHARMBIOTRAC), P.O. Box 1410, Mbarara, Uganda., Tolo CU; Mbarara University of Science and Technology, Pharm-Bio Technology and Traditional Medicine Center (PHARMBIOTRAC), P.O. Box 1410, Mbarara, Uganda., Kamba PF; Makerere University, College of Health Sciences, Department of Pharmacy, P.O. Box 7062, Kampala, Uganda., Ogwang PE; Mbarara University of Science and Technology, Pharm-Bio Technology and Traditional Medicine Center (PHARMBIOTRAC), P.O. Box 1410, Mbarara, Uganda.
المصدر: Evidence-based complementary and alternative medicine : eCAM [Evid Based Complement Alternat Med] 2022 Apr 13; Vol. 2022, pp. 1304839. Date of Electronic Publication: 2022 Apr 13 (Print Publication: 2022).
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: Hindawi Pub Country of Publication: United States NLM ID: 101215021 Publication Model: eCollection Cited Medium: Print ISSN: 1741-427X (Print) Linking ISSN: 1741427X NLM ISO Abbreviation: Evid Based Complement Alternat Med Subsets: PubMed not MEDLINE
أسماء مطبوعة: Publication: 2011- : New York, NY : Hindawi Pub.
Original Publication: Oxford, UK : Oxford University Press, c2004-
مستخلص: Introduction: The Uganda National Drug Authority requires phytochemical screening, freedom from microbial contamination, and evidence of safety and efficacy of the constituent plants to register herbal products. Since Uganda has no pharmacopeia, safety, efficacy, and plant processing information are not readily available. We documented the plant materials used to manufacture products in Uganda and established evidence of their safety and efficacy and availability of monographs.
Methods: The NDA register of herbal products was reviewed, and a product list was extracted. The herbal products were purchased from local pharmacies, and their labels were studied to identify plant ingredients and drug use. Literature was reviewed to document evidence of the safety and efficacy of the plant materials concerning manufacturer's claims. Also, the WHO and available African Pharmacopeia were searched to establish the availability of the plant monographs.
Results: Of the 84 NDA-registered local products, only 18 were obtained from the market; 82% were indicated for respiratory tract disorders. Thirty-three plant materials were listed with Eucalyptus globulus Labill, being the commonest. Several in vitro and in vivo studies demonstrate efficacy, thus supporting the use of the selected plant species for empirical treatment as stated on the product label. While most plants were safe, some species such as Albizia coriaria Oliv. had dose-dependent toxicities that cannot be predicted in combinations. The WHO, African Pharmacopoeia, and West African Herbal Pharmacopoeia had only 16 plant monographs of the 33 plants of interest. Nevertheless, Aloe vera (L.) Burm.f., Azadirachta indica A.Juss., Zingiber officinale Roscoe, and Allium sativum L. monographs were published by all three pharmacopoeias.
Conclusions: Preclinical evidence of safety and efficacy exists in the literature for most of the plants used to manufacture registered herbal products in Uganda. More specific bioassays and clinical trials are required for the products to provide conclusive evidence of safety and toxicity. Monographs are urgently needed for the Ugandan plants.
Competing Interests: The authors declare that they have no conflicts of interest.
(Copyright © 2022 Bruhan Kaggwa et al.)
References: Can J Microbiol. 2018 Nov;64(11):844-855. (PMID: 29894644)
J Ethnopharmacol. 2013 Jan 9;145(1):146-51. (PMID: 23123794)
J Ethnopharmacol. 2009 Jun 25;123(3):504-9. (PMID: 19501282)
Int J Clin Exp Med. 2014 Dec 15;7(12):4835-45. (PMID: 25663980)
Evid Based Complement Alternat Med. 2021 May 07;2021:5511221. (PMID: 34040647)
Regul Toxicol Pharmacol. 2009 Jul;54(2):118-23. (PMID: 19303040)
Arch Pharm Res. 2011 Mar;34(3):501-7. (PMID: 21547684)
Trends Food Sci Technol. 2020 Oct;104:219-234. (PMID: 32836826)
Food Chem Toxicol. 2010 Oct;48(10):2920-4. (PMID: 20667464)
Eur J Pharm Sci. 2012 May 12;46(1-2):106-13. (PMID: 22402186)
J Ethnopharmacol. 2012 Jan 6;139(1):265-72. (PMID: 22101359)
Indian J Crit Care Med. 2013 Sep;17(5):321-2. (PMID: 24339648)
Chemosphere. 2003 Sep;52(9):1361-71. (PMID: 12867165)
FEMS Immunol Med Microbiol. 1996 Apr;13(4):273-7. (PMID: 8739190)
Pharmacogn Rev. 2010 Jan;4(7):42-8. (PMID: 22228940)
J Commun Dis. 1999 Jun;31(2):79-90. (PMID: 10810594)
Int J Toxicol. 2001;20 Suppl 3:61-73. (PMID: 11766133)
Cell Prolif. 2006 Aug;39(4):241-8. (PMID: 16872360)
J Ethnopharmacol. 2000 Nov;73(1-2):171-4. (PMID: 11025153)
Inflammation. 2004 Oct;28(5):263-70. (PMID: 16133999)
Mol Biother. 1991 Jun;3(2):79-87. (PMID: 1910624)
J Nat Prod. 2020 Feb 28;83(2):552-562. (PMID: 31977211)
Antimicrob Agents Chemother. 1991 Dec;35(12):2463-6. (PMID: 1810179)
EFSA J. 2020 Sep 21;18(9):e06243. (PMID: 32994830)
J Allergy Clin Immunol. 1998 Mar;101(3):427-8. (PMID: 9525465)
Molecules. 2012 Apr 10;17(4):4326-42. (PMID: 22491681)
East Afr Med J. 2002 Nov;79(11):588-92. (PMID: 12630492)
J Ethnopharmacol. 2008 Oct 28;119(3):549-58. (PMID: 18706990)
Phytother Res. 2010 Aug;24(8):1132-40. (PMID: 20041417)
Eur J Intern Med. 2005 Feb;16(1):59-60. (PMID: 15733825)
Pak J Biol Sci. 2013 Jul 15;16(14):697-700. (PMID: 24505996)
Indian J Exp Biol. 2004 Jan;42(1):48-52. (PMID: 15274480)
Ann Intern Med. 2000 Sep 19;133(6):420-9. (PMID: 10975959)
Pharm Biol. 2014 Mar;52(3):378-91. (PMID: 24188508)
Food Chem Toxicol. 2006 Jun;44(6):810-8. (PMID: 16330140)
Biomed Res Int. 2014;2014:575197. (PMID: 25025061)
J Gastroenterol. 2018 May;53(5):618-630. (PMID: 28856444)
Asian Pac J Cancer Prev. 2012;13(9):4597-606. (PMID: 23167387)
Allergy. 2002 Oct;57(10):957-8. (PMID: 12269947)
Sci Rep. 2020 Jul 20;10(1):11935. (PMID: 32686689)
BMC Res Notes. 2017 Mar 6;10(1):118. (PMID: 28264698)
Wei Sheng Yan Jiu. 2003 Nov;32(6):590-3. (PMID: 14963911)
Am J Kidney Dis. 2002 Mar;39(3):E13. (PMID: 11877593)
Phytother Res. 2007 Jun;21(6):501-6. (PMID: 17380552)
Evid Based Complement Alternat Med. 2014;2014:741470. (PMID: 25530788)
Syst Rev. 2020 Jan 24;9(1):19. (PMID: 31980030)
Ann Pharmacother. 2004 Oct;38(10):1651-4. (PMID: 15292490)
Int Immunopharmacol. 2008 Sep;8(9):1216-21. (PMID: 18602067)
Br Dent J. 2002 Sep 14;193(5):257-9. (PMID: 12353045)
Afr Health Sci. 2001 Dec;1(2):66-72. (PMID: 12789119)
3 Biotech. 2018 May;8(5):257. (PMID: 29765815)
Front Pharmacol. 2021 Apr 15;12:615147. (PMID: 33935707)
PLoS One. 2013 Jun 13;8(6):e65619. (PMID: 23785437)
Cent Eur J Immunol. 2014;39(2):174-80. (PMID: 26155120)
Toxicol Rep. 2016 Apr 08;3:439-449. (PMID: 28959566)
Fundam Clin Pharmacol. 2005 Feb;19(1):1-16. (PMID: 15660956)
J Indian Soc Periodontol. 2013 Nov;17(6):741-7. (PMID: 24554883)
J Toxicol. 2019 Aug 1;2019:4763015. (PMID: 31467524)
Microbiologyopen. 2017 Aug;6(4):. (PMID: 28296357)
Rapid Commun Mass Spectrom. 2003;17(1):49-55. (PMID: 12478554)
Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):1047-52. (PMID: 7607925)
J Ethnopharmacol. 2003 Dec;89(2-3):277-83. (PMID: 14611892)
J Ethnopharmacol. 2003 Oct;88(2-3):229-34. (PMID: 12963148)
J Oral Biol Craniofac Res. 2019 Oct-Dec;9(4):321-325. (PMID: 31334005)
Reprod Toxicol. 2001 Jan-Feb;15(1):75-80. (PMID: 11137381)
Planta Med. 1992 Oct;58(5):417-23. (PMID: 1470664)
Cent Eur J Immunol. 2015;40(3):300-6. (PMID: 26648773)
Br J Dermatol. 2000 Nov;143(5):923-9. (PMID: 11069498)
J Ethnopharmacol. 2014 Mar 14;152(2):272-82. (PMID: 24447814)
Inflammopharmacology. 2013 Apr;21(2):129-36. (PMID: 23242572)
Evid Based Complement Alternat Med. 2019 Mar 3;2019:5961742. (PMID: 30941196)
Daru. 2013 Mar 07;21(1):18. (PMID: 23497687)
Eur Heart J. 1993 Dec;14 Suppl K:43-50. (PMID: 8131787)
J Pharmacobiodyn. 1984 Nov;7(11):836-48. (PMID: 6335723)
Int J Trichology. 2014 Jul;6(3):100-3. (PMID: 25210333)
Meat Sci. 2012 Aug;91(4):441-7. (PMID: 22465510)
World J Gastroenterol. 2005 Jan 14;11(2):303-4. (PMID: 15633238)
Drug Chem Toxicol. 2009;32(1):53-8. (PMID: 19514939)
EXCLI J. 2014 Mar 31;13:323-30. (PMID: 26417263)
Bull World Health Organ. 2008 Aug;86(8):594-9. (PMID: 18797616)
J Pharm Bioallied Sci. 2011 Apr;3(2):236-41. (PMID: 21687352)
J Ethnopharmacol. 2008 Sep 2;119(1):135-40. (PMID: 18602980)
Zhongguo Yao Li Xue Bao. 1993 Sep;14(5):452-4. (PMID: 8010041)
Indian J Pharm Sci. 2008 May-Jun;70(3):390-3. (PMID: 20046756)
Phytother Res. 2012 Sep;26(9):1366-70. (PMID: 22294387)
J Ethnopharmacol. 2020 Jan 10;246:112205. (PMID: 31476442)
Biol Pharm Bull. 2005 Dec;28(12):2220-4. (PMID: 16327153)
Medicina (Kaunas). 2019 Jun 19;55(6):. (PMID: 31248181)
J Ethnopharmacol. 2015 May 13;165:260-85. (PMID: 25698247)
Int J Environ Res Public Health. 2018 Nov 27;15(12):. (PMID: 30486374)
Evid Based Complement Alternat Med. 2011;2011:690346. (PMID: 21052500)
Planta Med. 1979 Feb;35(2):191-2. (PMID: 419190)
Virusdisease. 2020 Sep;31(3):270-276. (PMID: 32420412)
Food Chem Toxicol. 1990 Nov;28(11):759-61. (PMID: 2272548)
Pharmacogn Mag. 2017 Jul;13(Suppl 2):S316-S320. (PMID: 28808399)
Planta Med. 2021 Mar;87(3):209-217. (PMID: 33285592)
J Ethnopharmacol. 2020 Jun 28;256:112742. (PMID: 32224196)
J Invest Dermatol. 1998 May;110(5):811-7. (PMID: 9579551)
Biomaterials. 2016 Sep;101:321-40. (PMID: 27318094)
J Dent (Shiraz). 2015 Mar;16(1):54-7. (PMID: 25759859)
Allergy. 1999 Jun;54(6):626-9. (PMID: 10435479)
Exp Toxicol Pathol. 2011 May;63(4):387-91. (PMID: 20335011)
Phytother Res. 2013 Dec;27(12):1745-55. (PMID: 23420770)
Chest. 2006 Jan;129(1 Suppl):1S-23S. (PMID: 16428686)
Sultan Qaboos Univ Med J. 2006 Jun;6(1):33-9. (PMID: 21748125)
Foods. 2019 May 30;8(6):. (PMID: 31151279)
Contact Dermatitis. 1994 May;30(5):299-300. (PMID: 8088146)
J Basic Clin Physiol Pharmacol. 2015 Nov;26(6):603-11. (PMID: 26103628)
J Ethnopharmacol. 2019 Mar 25;232:236-243. (PMID: 30578933)
Data Brief. 2020 Jan 08;29:105097. (PMID: 31970279)
Microb Pathog. 2017 Jun;107:254-260. (PMID: 28389345)
BMC Oral Health. 2019 Apr 27;19(1):64. (PMID: 31029127)
Plants (Basel). 2021 Feb 12;10(2):. (PMID: 33673238)
تواريخ الأحداث: Date Created: 20220425 Latest Revision: 20220716
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC9020950
DOI: 10.1155/2022/1304839
PMID: 35463071
قاعدة البيانات: MEDLINE
الوصف
تدمد:1741-427X
DOI:10.1155/2022/1304839