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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 1
| Issue : 2 | Page : 64-69 |
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A preliminary pharmacognostical and physicochemical evaluation of Guduchyadi Vati: A novel herbal formulation for juvenile diabetes
Vedanshi A Limbachiya1, Sagar M Bhinde1, C. R. Harisha2, Vinay J Shukla3
1 Department of Kaumarbhritya, Institute of Teaching & Research in Ayurveda, Jamnagar, Gujarat, India
2 Department of Pharmacognosy, Institute of Teaching & Research in Ayurveda, Jamnagar, Gujarat, India
3 Department of Pharmaceutics, Institute of Teaching & Research in Ayurveda, Jamnagar, Gujarat, India
| Date of Submission | 18-Jan-2023 |
| Date of Acceptance | 31-May-2023 |
| Date of Web Publication | 26-Sep-2023 |
Correspondence Address:
Dr. Vedanshi A Limbachiya
Department of Kaumarbhritya, Institute of Teaching & Research in Ayurveda, PG Girls’ Hostel, Institute of Teaching and Research in Ayurveda, Jamnagar 361008, Gujarat
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jahas.jahas_1_23
Background: Most of Ayurveda medicines are effective, but they require standardization. Standardization of an herbal formulation is essential to assess the quality of drugs, based on the physicochemical standards and pharmacognostical parameters. Maintaining the quality of any traditional formulation or pharmaceutical product is need of hours to ensure the safety of the patient. A pharmaceutical product that does not meet the required standards can cause a serious threat to public health and safety. Here, an attempt has been made to set preliminary pharmacognostical and pharmaceutical parameters along with high-performance thin-layer chromatography (HPTLC) of one of the novel herbal formulations named Guduchyadi Vati for the treatment of JatajaPrameha (juvenile diabetes). Objective: To evaluate and establish the pharmacognostical and physicochemical parameters of Guduchyadi Vati.Materials and Methods: Preauthenticated raw drugs were procured and prepared at the Pharmacy, Institute of Teaching and Research in Ayurveda (ITRA), Jamnagar. Organoleptic parameters and microscopic analysis of Guduchyadi Vati were done at Pharmacognosy Department, ITRA, Jamnagar. Physicochemical analysis of tablet and HPTLC were done at the Pharmaceutical Laboratory, ITRA, Jamnagar. Results: Microscopic features of Guduchyadi Vati were cross-checked with The Ayurvedic Pharmacopoeia of India standards of individual ingredients, and it was found that all characteristics remain intake. In pharmaceutical parameters, the pH value was 6.5, water-soluble extract was 25.55%, alcohol-soluble extract was 10.32%, ash value was 12.37%, and loss on drying was 0.16%w/w. HPTLC at 254 and 366 nm showed 3 and 16 spots, respectively. Conclusions: This study generated preliminary data on pharmacognostical and physicochemical parameters of Guduchyadi Vati. These fingerprints could be useful for future researchers to the reproduction of this formulation as quality control parameters for Guduchyadi Vati are not available in The Ayurvedic Pharmacopoeia of India or the public domain. Keywords: Guduchyadi Vati, HPTLC, Jataja Prameha, juvenile diabetes, pharmacognosy, pharmaceutical, physicochemical, type 1 diabetes
How to cite this article:
Limbachiya VA, Bhinde SM, Harisha CR, Shukla VJ. A preliminary pharmacognostical and physicochemical evaluation of Guduchyadi Vati: A novel herbal formulation for juvenile diabetes. J Ayurveda Homeopath Allied Health Sci 2022;1:64-9 |
How to cite this URL:
Limbachiya VA, Bhinde SM, Harisha CR, Shukla VJ. A preliminary pharmacognostical and physicochemical evaluation of Guduchyadi Vati: A novel herbal formulation for juvenile diabetes. J Ayurveda Homeopath Allied Health Sci [serial online] 2022 [cited 2023 Dec 10];1:64-9. Available from: http://www.dpujahas.org/text.asp?2022/1/2/64/386297 |
| Introduction | |  |
India has a wealthy history of conventional medicine, and Ayurveda is one of the well-evolved ancient sources of traditional medicine. The use of Ayurveda medicines is increasing day by day, and its acceptability is now reached globally. Looking at the significance of authentic medicinal production for public health and safety in growing nations, The World Health Organization has stressed upon formulating national rules on traditional medicine. In India, the Ministry of Ayush, Government of India, is working to frame the protocols to maintain the formulation standards and develop parameters for the authenticity of pharmacopeial drugs. But, still, there are many classical and popularly used Ayurveda medicines, which do not have quality control parameters. Guduchyadi Vati (GV) is prepared by modifying the widely used classical formulation Dhatri Nisha (Haridra churna and Amalaki swarasa) in Prameha (diabetes mellitus) by adding Guduchi and Amalaki churna with Bhavna of Guduchi Swarasa (juice) in it and this is the only reason for keeping the name GV of this formulation. Ingredients of GV are Amalaki (Phyllanthus Emblica L.), Haridra (Curcuma longa L.), and Guduchi (Tinospora cordifoliaWilld. M.). All three ingredients are used effectively in many clinical conditions, and especially, Hridra and Amalaki are widely used in diabetes mellitus by Ayurveda physicians.[1],[2] To use this medicine in pediatric patients with juvenile diabetes, Guduchi Churna and Swarasa are added in DhatriNisha to increase its potency as a Rasayana[3] component. All the drugs have antidiabetic, hepatoprotective, immunomodulatory, antioxidant,[4] antibacterial, and antiviral properties and the ability to maintain the blood sugar level.[5]
Health Assembly emphasized the necessity of ensuring the quality of herbal products by using appropriate standards. Herbal products are being used more widely than ever, and their business potential is enormous. However, because of a number of factors, such as the impact of regional, seasonal, or climatic variations on plants, it becomes a monumental task to develop standard analytical and quality control profiles of them.[6] Lack of reference standards is a challenge for the investigation. To overcome this lacuna, the present task was aimed to generate preliminary analysis data of GV for its quality assurance.
| Materials and Methods | | |
Procurement, identification, and authentication of raw drugs
Powder of Guduchi, Haridra, and Aamalaki were procured from the pharmacy, Institute of Teaching and Research in Ayurveda (ITRA), Jamnagar. The ingredients and parts used are given in [Table 1]. The Department of Dravyaguna, ITRA, Jamnagar, identified and authenticated raw drugs.
Preparation of the drug
GV was prepared at the Pharmacy, ITRA, Jamnagar. Fine powders of Guduchi, Amalaki, and Haridra were taken in equal proportions and mixed until a homogenous mixture was achieved. The quantity of homogenous mixture was 3.3 kg. Then, Bhavna of Aamalaki Swarasa and Bhavna of Guduchi Swarasa were given to the mixture of Haridra, Amalaki, and Guduchi Churna to levigate this homogenous mixture. Bhavna of Amalaki Swarasa and Bhavna of Guduchi Swarasa were given simultaneously. A total of 1600 mL of Swaras was used for each Bhavna. A total of three Bhavna was given. Then, the final material was shed dried and sieved through mesh no. 85 to get a fine powder. Then, 5% of gum acacia was added as a binding agent, and Vati was prepared with pill making machine and stored in an air-tight glass container.
Pharmacognosy
The Pharmacognostical evaluation was carried out at the Pharmacognosy Laboratory, ITRA, Jamnagar. The GV was evaluated by organoleptic characteristics such as taste, odor, color, and touch by the researcher.
The microscopic evaluation of GV was done as per the guidelines of Ayurvedic Pharmacopoeia of India at Pharmacognosy Lab, ITRA, Jamnagar.
Two GV were dissolved in distilled water and filtered through filter paper. Then, the dried filtrate was placed on a slide, first observed in plain water and then stained with phloroglucinol and concentrated HCl for identification of lignified elements. The microphotographs were taken by using a cool-Zeiss Trinocular microscope attached to the camera. Microscopic standards mentioned in The Ayurvedic Pharmacopoeia of India for individual drugs were taken as a reference for authentication.[8]
Pharmaceutical parameters
Loss on drying at 110°C,[9] ash value,[10] water-soluble extractive,[11] methanol-soluble extractive, pH value,[12] determination of tablet hardness,[13] and determination of uniformity of tablets[14] of GV were studied at the pharmaceutical laboratory, ITRA, Jamnagar.
High-performance thin-layer chromatography
High-performance thin-layer chromatography (HPTLC) was carried out at the Pharmaceutical Chemistry Laboratory, ITRA, Jamnagar.[8] It was carried out with methanolic extract of GV on precoated silica gel GF-254 aluminum plate as 5-mm bands, 5 mm apart and 1 cm from the edge of the plates, by means of a Camag Linomat V sample applicator fitted with a 100-µL Hamilton syringe. The mobile phase used was toluene:ethyl acetate (9:1 V/V). The plates were developed in Camag twin trough chamber (20 × 10 cm), and spots were detected in short UV (254 nm) and long UV (366 nm) followed by photo documentation, and the images were transformed to densitogram (CAMAG, Switzerland). The retention factor was calculated by using the formula Rf = Distance traveled by solute/Distance traveled by solvent.
| Results | | |
Pharmacognosy
Results found for organoleptic parameters such as color, odor, touch, and taste of the GV were as per [Table 2].
The stained and unstained slides of powder microscopy of GV showed the presence of cork cells, starch grains pitted vessels, collenchyma cells, and lignified collenchyma cells of Guduchi; stone cells, fibers, silica deposits, group of scleroids, and lignified stone cells of Amalaki; and scalariform vessels, starch grains, fibers and Olioresine content of Haridra; which are depicted in [Figure 1].
Pharmaceutical parameters
Results of pharmaceutical parameters are mentioned in [Table 3]. The average weight of GV was 280 mg; shape was round; hardness of Vati was 4.7 kg/cm2; loss on drying was 0.16% w/w; water-soluble extract was 25.55% w/w; alcohol-soluble extract was 10.32% w/w; ash value was 12.37% w/w, and pH value was 6.5 (of 5% aqueous solution).
HPTLC
The results of the present study are reported in [Table 4]. HPTLC results of GV showed three spots (0.4, 0.21, and 0.72) on short UV (254 nm) and 16 spots (0.05, 0.02, 0.08, 0.11, 0.2, 0.26, 0.28, 0.32, 0.36, 0.49, 0.6, 0.71, 0.77, 0.82, 0.87, 0.93) on long UV (366 nm) [Figure 2].
| Discussion | | |
In previous time, medicines were mostly prepared on an individual patient basis, by the physicians or under the direct observation of the physician. But, in today’s world, the situation is entirely different, and medicines must be prepared in bulk production. Hence, the chances of adulteration[15] and quality compromise in pharmaceutical procedures cannot be denied because of many reasons. Hence, preparing drugs with the standard manufacturing procedure (SMP) and generating its analytical data are vital for future quality assurance.[16] In the present study, the microscopic features observed in GV confirmed the presence of all three herbal ingredients after matching the result with available The Ayurvedic Pharmacopoeia of India standards of Guduchi,[17]Haritaki,[18] and Amalaki.[19] Physicochemical parameters are a useful tool to confirm the process performance in the formulation. The hardness of Vati was 4.7 kg/cm, which shows that 5% of acacia in this formulation is enough to achieve desired hardness, because a tablet requires some amount of strength and is resistant to mechanical shock during handling in manufacture, packaging, and shipping. Hardness is, thus, sometimes termed the crushing strength.[20]
GV had 0.16% w/w loss on drying in the present study. This parameter is important for the determination of the moisture content of the formulation. Minor loss on drying indicates that raw drugs were well-dried before it was pulverized. Drying herbs before the procedure and storing in dry area are important to reduce the chances of their decay, because excess moisture content increases the chance of microbial overgrowth.[21] Ash value was 12.37% w/w, water-soluble extract was 25.55% w/w, and alcohol-soluble extract was 10.32% w/w, which indicates the value of the organic component, water solubility, and alcohol solubility of GV, respectively, indicating that inorganic matter, carbohydrate, and glycoside-type molecules extracted in water-soluble molecules are quite high, whereas other aprotic wide range alcohol-soluble molecules are in the normal range. The pH of GV was 6.5, indicating that the final drug is slightly acidic, which might be obtained because of Amalaki (Amla Rasa Pradhana), one of the components of GV.
HPTLC is a convenient and simple procedure to confirm the presence of certain phytochemicals or a group of molecules with similar absorptivity of the given sample. In the present HPTLC study, three spots were obtained at 254 nm, and 16 spots at 366 nm. The spot at 0.92 retardation factor (Rf) in 254 nm is indicative of the presence of phytochemicals of Amalaki. The same result was found in the research carried out by Kavita et al.[22] on Amalaki. Soumya and Chethan[23] also found in their study on Haridra powder that the phytochemicals of Haridra spread from 0.04 to 0.95 Rf in 254 nm, and Kishora and Prakash[24] found in their study on Guduchi powder that the phytochemicals of Guduchi spread from 0.14 to 0.22 Rf in 254 nm, which is also in line with the present study data.
Boundaries and prospectus of the study
The study expresses the first impression of GV through which one can make assumptions about the physicochemical nature of the formulation. A shelf life study through the long-term microbial stability study or accelerated stability study could not be performed in the present study. At the time of raw material procurement, seasonal, geographic, and climatic variance produces variance in stress factor on herbs and also resultant variation in chemical race enlisted. Hence, herbs exhibit continuous chemical inconsistencies; here, the data of this study can be generalized for the GV, which is prepared from the ingredients collected from the same geographic source, during the same climatic condition. Further study is necessary to explore other parameters related to the setout range very first followed by the validation parameter. There is the scope of using nondestructive spectral methods to confirm raw material uniformity and confirmation of operational process through validation.
| Conclusion | | |
This study has generated preliminary data of the pharmacognosy and physicochemical parameters of GV. GV was prepared by following SMPs; hence, the data generated here could be used as a preliminary step toward developing quality control parameters for a new herbal combination.
Financial support and sponsorship
This study was funded by ITRA, Jamnagar.
Conflicts of interest
There are no conflicts of interest.
| References | | |
| 1. | Bedarkar P Review of Nisha Amalaki—An Ayurvedic formulation of turmeric and Indian gooseberry in diabetes. World J Pharm Med Res 2017;3:101-5.  |
| 2. | Bedarkar P Review of Nisha Amalaki - An ayurvedic formulation of turmeric and Indian gooseberry in diabetes.. World J Pharm Med Res 2017;3:101-105. |
| 3. | Mishra SB, Vaisya SR, editors. Bhavaprakasha, Nighantu, verse 9. Varanasi: Chaukhambha Sanskrit Bhavan; 2015. p. 269. |
| 4. | Scartezzini P, Antognoni F, Raggi MA, Poli F, Sabbioni C Vitamin C content and antioxidant activity of the fruit and of the Ayurvedic preparation of Emblica officinalis Gaertn. J Ethnopharmacol 2006;104:113-8. |
| 5. | Kishor YC A comprehensive review of Guduchi (Tinospora Cordifolia (Willd) Miers). Journal of Advanced Research in Ayurved Yoga Unani Sidhha & Homeopathy. JoARAYUSH 2017;4:1-10. |
| 6. | Ekor M The growing use of herbal medicines: Issues relating to adverse reactions and challenges in monitoring safety. Front Pharmacol 2014;4:177. |
| 7. | Rani R, Bhinde SS, Kori VK, Patel KS, Harisha CR, Shukla VJ Preliminary analysis of Rasayana Vati—A novel herbal medicineJ Drug Res Ayurvedic Sci2023;8:49-54. |
| 8. | Evans WC, editor. Morphological and microscopical examination of drugs. In: Trease and Evans, Pharmacognosy. 15th ed. London: W.B. Saunders Company Ltd; 2002. |
| 9. | Ministry of AYUSH. The Ayurvedic Pharmacopoeia of India, First edition, Part I, Volume VI. Delhi: The Controller of Publications Civil Lines; 1996; 8. p. 89. |
| 10. | Ministry of AYUSH. The Ayurvedic Pharmacopoeia of India, First edition, Part I, Volume VI. Delhi: The Controller of Publications Civil Lines; 2008; 2. p. 242. |
| 11. | Ministry of AYUSH. The Ayurvedic Pharmacopoeia of India, First edition, Part I, Volume VI. Delhi: The Controller of Publications Civil Lines; 2008. 2. p. 243. |
| 12. | Ministry of AYUSH. The Ayurvedic Pharmacopoeia of India, First edition, Part I, Volume VI. Delhi: The Controller of Publications Civil Lines; 1996. 8. p. 95. |
| 13. | Remington JP, Osol A, Hoover JE. Remington’s Pharmaceutical Sciences. 16th ed. Easton, PA: Mack Publishing Company; 1980, p. 1558. |
| 14. | Mithal BM A Text Book of Pharmaceutical Formulation. 6th ed. Delhi: Vallabh Prakashan; 2006. p. 16. |
| 15. | Pravin J, Anita J, Brijesh K Adulteration with special reference to Ayurvedic medicines. Ind J Ethnophytopharm 2018;4:38-48. |
| 16. | Bhinde S, Galib R, Prajapati PK, Harisha CR Pharmacognostical and pharmaceutical analysis of Amavatari Rasa—A herbomineral compound in the management of rheumatoid arthritis (Amavata). Res Rev J Pharm Sci 2016;7:6-10. |
| 17. | Ministry of Health and Family Welfare. The Ayurvedic Pharmacopoeia of India, First edition, Part I, Volume I. Delhi: The Controller of Publications Civil Lines; 2001. p. 41 |
| 18. | Ministry of Health and Family Welfare. The Ayurvedic Pharmacopoeia of India, First edition, Part I, Volume I. Delhi: The Controller of Publications Civil Lines; 2001. p. 45. |
| 19. | Ministry of Health and Family Welfare. The Ayurvedic Pharmacopoeia of India, First edition, Part I, Volume I. Delhi: The Controller of Publications Civil Lines; 2001. p. 4,5. |
| 20. | Lachmen L, Herbert A, Lieberman HA, Kanig JL, editor. Pharmaceutical Dosage Form. The Theory and Practice of Industrial Pharmacy. 3rd ed. Philadelphia, PA: Lea and Febiger; 1986. p. 902. |
| 21. | Schubnell M, De Caro C, Kunz RThermal Analysis UserCom No. 51, Ohio, US: Mettler-Toledo. June 2020. Moisture content, water content, loss on drying - Part 1: What exactly is meant and how are these quantities determined?. p.1-8. Available from: https://www.Researchgate.Net/Publication/342420649_Moisture_Content_Water_Content_Loss_On_Drying_Part_1_What_Exactly_Is_Meant_And_How_Are_These_Quantities_Determined. Retrieved on December 25, 2022. |
| 22. | Kavita MB, Poornima B, Mallika KJ Amalaki (dried powder of Emblica officinalis Gaertn) as food supplement in dyslipidemia—An analytical study. Plant Arch 2016;16:217-25. |
| 23. | Soumya P, Chethan VK Standardization of Haridradi churna—Physicochemical assay and HPTLC profile. J Phyto 2017;6: 167-70. |
| 24. | Kishor, YK, Prakash H Phytochemical Evaluation and Chromatographic Fingerprint Study of Guduchi Patra [Tinospora cordifolia (Willd.) Hook. F. and Thoms. 2017. |
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]
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