Standardization Quality Control and Development of Poly Herbal Formulation for the Management of Type-2 Diabetes Mellitus

Parameshwar H; Rayeesa Seema; Vutkuri Shivani; Purru Manasa; Marripelli Sravani; Rajesekhar

doi:10.61096/ijamscr.v12.iss1.2024.27-35

Issue

Vol. 12 No. 1 (2024): 2024 Volume -12 - Issue 1

Issue Published : January 1, 2024

Date Log

Submitted

January 25, 2024

Published

January 25, 2024

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Standardization Quality Control and Development of Poly Herbal Formulation for the Management of Type-2 Diabetes Mellitus

https://doi.org/10.61096/ijamscr.v12.iss1.2024.27-35

Parameshwar H

Omega college of Pharmacy, Ghatkesar, Hyderabad, affiliated to Osmania University, Telangana, India.

Rayeesa Seema

Omega college of Pharmacy, Ghatkesar, Hyderabad, affiliated to Osmania University, Telangana, India.

Vutkuri Shivani

Omega college of Pharmacy, Ghatkesar, Hyderabad, affiliated to Osmania University, Telangana, India.

Purru Manasa

Omega college of Pharmacy, Ghatkesar, Hyderabad, affiliated to Osmania University, Telangana, India.

Marripelli Sravani

Omega college of Pharmacy, Ghatkesar, Hyderabad, affiliated to Osmania University, Telangana, India.

Rajesekhar

Omega college of Pharmacy, Ghatkesar, Hyderabad, affiliated to Osmania University, Telangana, India.

Corresponding Author(s) : Parameshwar H

drparam18@gmail.com

International Journal of Allied Medical Sciences and Clinical Research, Vol. 12 No. 1 (2024): 2024 Volume -12 - Issue 1
Article Published : January 25, 2024

Abstract

In the Ayurvedic system of medicine, Herbal Drugs For Diabetes Mellitus as mentioned in ancient Indian books like Charak Samhita, Mahdhav Nidan and Astang Sanghra, there are about 600 plants, which are stated to have antidiabetic property Polyherbal antidiabetic formulation consists of six herbs viz., Nigella sativa (seed), Moringa oleifera (seed), Linum usitatissimum (seed), Trogonella foenum (seed), Cinnamum zeylanicum (bark) and Macrotylom auniflorum (seed). Crospovidone, Microcrystalline cellulose, Colloidal Silicon dioxide, PVP Magnesium stearate, (Polyvinyl pyrrolidone). Polyherbal formulation of the extracts of all selected plants was subjected to freeze drying process. The extracts were dried for a period of time according to their rate of drying .Diluents like, Microcrystalline cellulose, Magnesium stearate, Lactose, starch were dried. All active ingredients were weighed according to the formula, mixed with MCC followed by diluents and Glidant like aerosil and magnesium stearate as lubricant as specified in formula were mixed well. The mixture was blended thoroughly for 30minutes. Then the powder was transferred to the polythene bags and labeled for further studies.

Keywords

Polyherbal formulation Standardization Nigella Moringa Linum Trogonella Cinnamum Macrotylom Type 2 Diabetes

Parameshwar H, Rayeesa Seema, Vutkuri Shivani, Purru Manasa, Marripelli Sravani, & Rajesekhar. (2024). Standardization Quality Control and Development of Poly Herbal Formulation for the Management of Type-2 Diabetes Mellitus. International Journal of Allied Medical Sciences and Clinical Research, 12(1), 27–35. https://doi.org/10.61096/ijamscr.v12.iss1.2024.27-35

Download Citation

References

Factsheetno.134.World Health Organization. 2008-12-01.[retrieved2009-5-2].
Verma S, Singh SP. Current and future status of herbal medicines. Vet World. 2013;1(11):347-50.
Hasan Z. S, Vedant Misra, Swati Singh, Garvita Arora, Sunita Sharma and Sarika Sharma, Current status of herbal drugs and the future perspectives, Biological Forum– An International Journal 2009;1(1),12-17.
Balandrin MF, Klocke JA, Wrtele ES, Boilinger WH. Content and purity of extract solasodine in some available species of solanum. Sci Cult. 1985;56(5):214-6.
Cragg GM, Newman DJ, Snader KM. Natural products in drug discovery and development. J Nat Prod. 1997;60(1):52-60. doi: 10.1021/np9604893, PMID 9014353.
Jone BE. Pharmaceutical capsules. 2nd ed podczeck F, John BE, editors. Vol. 242,449. Pharmaceutical press; 2004. p. 91.
Choudhary N, Singh Sekhon B. An overview of advances in the standardization of herbal drugs. J Pharm Educ Res. 2011;2(2):55-70.
GMP in pharmaceutical industry – global cGMP and regulatory expectations. TruptiPatil Dongare.
ali khan I, Khanum A. Herbal therapy for Diabetes, 1st edi. Vol. 87. Ukaaz Publications; 2007. p. 119-20.
Dean L, McEntyre J. The genetic landscape of diabetes. National Center for Biotechnology Information: Introduction to Diabetes; 2004. p. Chapter1.
Harshmohan. Text book of pathology. 5th ed. New Delhi: Medical Publisher’s Ltd; 2005. p. 818-28.
Kumar CH. Dr. Kumar JNS, Ishaq BM, Rani GU, Prkash KV. Antidiabetic Act Polyherbal Preparation Pharmacol Online. 2010;2:780-7.
Kaul S. Dewivedi Indigenous Ayurvedic knowledge of some species in the treatment of human disease and disorders. Int J Pharm Life Sci. 2010;1:44-9.
Kumar T, Chandrashekhar KS. Bauhinia purpurea Linn: are views of its Ethanobotany, phytochemical and pharmacological profile. Res J Med Plants;5:420-31.
Stohs SJ, Hartman MJ. Phytother Res. Epub 2015 Mar 24. Review of the safety and efficacy of Moringa oleifera. Stohs SJ1,Hartman MJ. 2015 Jun;29(6):796-804. doi: 10.1002/ptr.5325, PMID 25808883.
Gaddam A, Galla C, Thummisetti S, Marikanty RK, Palanisamy UD, Paturi V. Rao Role of Fenugreek in the prevention of type 2 diabetes mellitus in prediabetes. J Diabetes Metab Disord 2015Oct2;14:74. 2015. doi: 10.1186/s40200-015-0208-4.eCollection.
Ranasinghe P, Perera S, Gunatilake M, Abeywardene E, Gunapala Nuwan, Premakumara S et al. Effects of Cinnamomum zeylanicum (Ceylon cinnamon) on blood glucose and lipids in a diabetic and healthy rat model. Pharmacogn Res 2012Apr. 2012;Jun(4 (2)):73-9. doi: 10.4103/0974-8490.94719, PMID 22518078.
Mani UV, Mani I, Biswas M, Kumar SN. An open-label study on the effect of flax seed powder (Linum usitatissimum) supplementation in the management of diabetes mellitus. J Diet Suppl. 2011 Sep;8(3):257-65. doi: 10.3109/19390211.2011.593615. PMID 22432725.
Gupta LH, Badole SL, Bodhankar SL, Sabharwal SG. Epub2010 Nov 3. Antidiabetic potential of α-amylase inhibitor from the seeds of Macrotyloma uniflorum in streptozotocin-nicotinamide-induced diabeticmice. Pharm Biol 2011 Feb. 2010;49(2): 182-9:507633. doi: 10.3109/13880 209.
Bamosa AO, Kaatabi H, Lebdaa FM, Elq AM, Al-Sultanb A. Effect of Nigella sativa Seeds On the glycemic control of patients with type 2 diabetes mellitus. Amarjeet Singh. 2010;54(4):344-54. PMID 216750321, Dharmendra Kumar, Jatin Sharma, Dr. H. S. Lamba A Review Article On Linum usitatissimum A Life Saving Drug Now A Days Indian J Physiol Pharmacol.2010Oct- Dec;54(4):344-54.
Anonymous. The Ayurvedic pharmacopoeia of India. 1st Ed, Ministry of health and family welfare, Govt. of India. The controllers of publications, New Delhi, volume 1, 74, page no 854.
Anonymous. The Ayurvedic pharmacopoeia of India. 1st Ed, Ministry of health and family welfare, Govt. of India. The controller of publications, New Delhi, volume1, 12 page19.
Anonymous. The Ayurvedic Pharmacopoeia Of India, First edition, Ministry of health and family welfare, Govt. of India. The controller of publications, New Delhi. Vol. 1(71). p. 113.
Anonymous. The Ayurvedic pharmacopoeia of India. 1st ed, Ministry of health and family welfare, Govt. of India. The controller of publications, New Delhi, volume1, page811.
Anonymous. The Siddha pharmacopoeia of India. 1st ed, Ministry of health and family welfare, Govt. of India. The controller of publications, New Delhi, volume1, part 1 Kulthi.
Lira S, Brush P, Senak L, Wu C, Malawer E. The use of inductively coupled plasma-optical emission spectroscopy in the determination of heavy metals in Crospovidone and povidone as a Replacement for the concomitant visual comparison test. Vol. 3(4). Pharmacopoeial Forum; 2008. p. 6-10.
Harborne JB. Phytochemical methods: A guide to modern techniques of plant analysis. London: Chapman & hall; 1973; 434. p. 2nded.
Kokate CK, Purohit AP, Gokahle SB. Pharmacognosy. 24th ed. Vallabh Prakashan, Pune.2003. p. 108-9.
Rowe RC, Shesky PJ, Quinn ME. Hand book of Pharmaceutical Excipients.6thed.London: pharmaceutical press and American pharmacists association; 2009.
Jone BE. Pharmaceutical capsules. 2nd ed Podczeck F, editor Pharmaceuticalpress.2004. Vol. 91(242). p. 449.
Van Hostetler Hard capsules In: Lachman L, Herbert AL, Joseph LK, editors. The theory and practice of industrial pharmacy. 3rd ed. Bombay: Varghese Publishing House; 1991. p. 374.
Shah VK, Zalavadiya V, Sheth NR, Raval NK, Golwala DK. Standardization and assessment of preformulation parameters of rasayana Tablet. Int J Pharm Sci Drug Res. 2010;2(1):58-62.
Remingtons pharmaceutical sciences. 17th ed. Easton, PA: Mack Publishing Co.; 1985. p. 1633-43.
Indian pharmacopoeia. Govt. India Ministry Health Fam Welf Controller Publ, Ghaziabad. 2007; I: A53-54.
The Ayurvedic pharmacopoeia of India, Vol. 4. Ministry of Health and Family Welfare, Govt. of India. The controller of publications, NewDelhi.2002; 158-165.

References

Factsheetno.134.World Health Organization. 2008-12-01.[retrieved2009-5-2].

Verma S, Singh SP. Current and future status of herbal medicines. Vet World. 2013;1(11):347-50.

Hasan Z. S, Vedant Misra, Swati Singh, Garvita Arora, Sunita Sharma and Sarika Sharma, Current status of herbal drugs and the future perspectives, Biological Forum– An International Journal 2009;1(1),12-17.

Balandrin MF, Klocke JA, Wrtele ES, Boilinger WH. Content and purity of extract solasodine in some available species of solanum. Sci Cult. 1985;56(5):214-6.

Cragg GM, Newman DJ, Snader KM. Natural products in drug discovery and development. J Nat Prod. 1997;60(1):52-60. doi: 10.1021/np9604893, PMID 9014353.

Jone BE. Pharmaceutical capsules. 2nd ed podczeck F, John BE, editors. Vol. 242,449. Pharmaceutical press; 2004. p. 91.

Choudhary N, Singh Sekhon B. An overview of advances in the standardization of herbal drugs. J Pharm Educ Res. 2011;2(2):55-70.

GMP in pharmaceutical industry – global cGMP and regulatory expectations. TruptiPatil Dongare.

ali khan I, Khanum A. Herbal therapy for Diabetes, 1st edi. Vol. 87. Ukaaz Publications; 2007. p. 119-20.

Dean L, McEntyre J. The genetic landscape of diabetes. National Center for Biotechnology Information: Introduction to Diabetes; 2004. p. Chapter1.

Harshmohan. Text book of pathology. 5th ed. New Delhi: Medical Publisher’s Ltd; 2005. p. 818-28.

Kumar CH. Dr. Kumar JNS, Ishaq BM, Rani GU, Prkash KV. Antidiabetic Act Polyherbal Preparation Pharmacol Online. 2010;2:780-7.

Kaul S. Dewivedi Indigenous Ayurvedic knowledge of some species in the treatment of human disease and disorders. Int J Pharm Life Sci. 2010;1:44-9.

Kumar T, Chandrashekhar KS. Bauhinia purpurea Linn: are views of its Ethanobotany, phytochemical and pharmacological profile. Res J Med Plants;5:420-31.

Stohs SJ, Hartman MJ. Phytother Res. Epub 2015 Mar 24. Review of the safety and efficacy of Moringa oleifera. Stohs SJ1,Hartman MJ. 2015 Jun;29(6):796-804. doi: 10.1002/ptr.5325, PMID 25808883.

Gaddam A, Galla C, Thummisetti S, Marikanty RK, Palanisamy UD, Paturi V. Rao Role of Fenugreek in the prevention of type 2 diabetes mellitus in prediabetes. J Diabetes Metab Disord 2015Oct2;14:74. 2015. doi: 10.1186/s40200-015-0208-4.eCollection.

Ranasinghe P, Perera S, Gunatilake M, Abeywardene E, Gunapala Nuwan, Premakumara S et al. Effects of Cinnamomum zeylanicum (Ceylon cinnamon) on blood glucose and lipids in a diabetic and healthy rat model. Pharmacogn Res 2012Apr. 2012;Jun(4 (2)):73-9. doi: 10.4103/0974-8490.94719, PMID 22518078.

Mani UV, Mani I, Biswas M, Kumar SN. An open-label study on the effect of flax seed powder (Linum usitatissimum) supplementation in the management of diabetes mellitus. J Diet Suppl. 2011 Sep;8(3):257-65. doi: 10.3109/19390211.2011.593615. PMID 22432725.

Gupta LH, Badole SL, Bodhankar SL, Sabharwal SG. Epub2010 Nov 3. Antidiabetic potential of α-amylase inhibitor from the seeds of Macrotyloma uniflorum in streptozotocin-nicotinamide-induced diabeticmice. Pharm Biol 2011 Feb. 2010;49(2): 182-9:507633. doi: 10.3109/13880 209.

Bamosa AO, Kaatabi H, Lebdaa FM, Elq AM, Al-Sultanb A. Effect of Nigella sativa Seeds On the glycemic control of patients with type 2 diabetes mellitus. Amarjeet Singh. 2010;54(4):344-54. PMID 216750321, Dharmendra Kumar, Jatin Sharma, Dr. H. S. Lamba A Review Article On Linum usitatissimum A Life Saving Drug Now A Days Indian J Physiol Pharmacol.2010Oct- Dec;54(4):344-54.

Anonymous. The Ayurvedic pharmacopoeia of India. 1st Ed, Ministry of health and family welfare, Govt. of India. The controllers of publications, New Delhi, volume 1, 74, page no 854.

Anonymous. The Ayurvedic pharmacopoeia of India. 1st Ed, Ministry of health and family welfare, Govt. of India. The controller of publications, New Delhi, volume1, 12 page19.

Anonymous. The Ayurvedic Pharmacopoeia Of India, First edition, Ministry of health and family welfare, Govt. of India. The controller of publications, New Delhi. Vol. 1(71). p. 113.

Anonymous. The Ayurvedic pharmacopoeia of India. 1st ed, Ministry of health and family welfare, Govt. of India. The controller of publications, New Delhi, volume1, page811.

Anonymous. The Siddha pharmacopoeia of India. 1st ed, Ministry of health and family welfare, Govt. of India. The controller of publications, New Delhi, volume1, part 1 Kulthi.

Lira S, Brush P, Senak L, Wu C, Malawer E. The use of inductively coupled plasma-optical emission spectroscopy in the determination of heavy metals in Crospovidone and povidone as a Replacement for the concomitant visual comparison test. Vol. 3(4). Pharmacopoeial Forum; 2008. p. 6-10.

Harborne JB. Phytochemical methods: A guide to modern techniques of plant analysis. London: Chapman & hall; 1973; 434. p. 2nded.

Kokate CK, Purohit AP, Gokahle SB. Pharmacognosy. 24th ed. Vallabh Prakashan, Pune.2003. p. 108-9.

Rowe RC, Shesky PJ, Quinn ME. Hand book of Pharmaceutical Excipients.6thed.London: pharmaceutical press and American pharmacists association; 2009.

Jone BE. Pharmaceutical capsules. 2nd ed Podczeck F, editor Pharmaceuticalpress.2004. Vol. 91(242). p. 449.

Van Hostetler Hard capsules In: Lachman L, Herbert AL, Joseph LK, editors. The theory and practice of industrial pharmacy. 3rd ed. Bombay: Varghese Publishing House; 1991. p. 374.

Shah VK, Zalavadiya V, Sheth NR, Raval NK, Golwala DK. Standardization and assessment of preformulation parameters of rasayana Tablet. Int J Pharm Sci Drug Res. 2010;2(1):58-62.

Remingtons pharmaceutical sciences. 17th ed. Easton, PA: Mack Publishing Co.; 1985. p. 1633-43.

Indian pharmacopoeia. Govt. India Ministry Health Fam Welf Controller Publ, Ghaziabad. 2007; I: A53-54.

The Ayurvedic pharmacopoeia of India, Vol. 4. Ministry of Health and Family Welfare, Govt. of India. The controller of publications, NewDelhi.2002; 158-165.

Author biographies is not available.