Analytical Study of Prajasthapana Mahakashya Granules

[Full title: Analytical Study of Prajasthapana Mahakashya Granules: Quality Assessment and Safety Validation]

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[Find the meaning and references behind the names: Meet, Neha, Poonam, Choudhary, Ayu, Med]

24 Journal of Ayurvedic and Herbal Medicine 2024; 10(1): 24-29 Research Article ISSN: 2454-5023 J. Ayu. Herb. Med. 2024; 10(1): 24-29 Received: 04-03-2024 Accepted: 25-04-2024 © 2024, All rights reserved www.ayurvedjournal.com DOI: 10.31254/jahm.2024.10105 *Corresponding author: Dr. Neha Dixit PhD Scholar, Department of Prasuti Tantra evum Stri Roga, National institute of Ayurveda, Jaipur, Rajasthan- 302002, India Email: nehadixit 0411@gmail.com Analytical Study of Prajasthapana mahakashya Granules: Quality Assessment and Safety Validation Neha Dixit 1 , Poonam Choudhary 2 , Gourav Bilwal 3 1 PhD Scholar, Department of Prasuti Tantra evum Stri Roga, National institute of Ayurveda, Jaipur, Rajasthan- 302002, India 2 Assistant Professor, Department of Prasuti Tantra evum Stri Roga, National institute of Ayurveda, Jaipur, Rajasthan- 302002, India 3 Pharmacologist, National institute of Ayurveda, Jaipur, Rajasthan- 302002, India ABSTRACT Background: Pregnancy loss is a common concern affecting many women, and the fear of miscarriage or abortion emotionally impacts expectant mothers. In Ayurveda, Prajasthapana mahakashya granules, a combination of 10 medicinal plants, are believed to play a crucial role in maintaining a healthy pregnancy. Methodology: Prajasthapana mahakashya was modified into granules for easy administration during pregnancy. This article presents an analytical study of Prajasthapana mahakashya granules, focusing on quality assessment and safety validation. The study involved pharmacognostical, physicochemical, and microbial analyses to ensure the efficacy, safety, and quality of the granules. Result: The results indicate that the granules meet the necessary quality requirements, making them suitable for use during pregnancy. Conclusion: Based on the observations, the findings of this study could serve as the reference for future work projects Keywords: Prajasthapana mahakashya , Granules, Analytical study, Pregnancy, Abortion. INTRODUCTION It is very pleasurable experience for a couple to have a child in their life. Even though pregnancy is a normal physiological phenomenon, there is always the chance of mishappening. Among many problems associated with pregnancy, one of the most common problems which emotionally affect the mother is fear of abortion. Pregnancy loss is one of the most common adverse pregnancy outcomes and up to 20% of pregnancies end in early pregnancy loss, which is defined as a nonviable, intrauterine pregnancy within the first 12 weeks of gestation [1] . Maternal age, abnormal parental genetic makeup, infections, hormonal imbalances, uterine dysfunctions, comorbidities, and lifestyle factors are the attributable risk for higher pregnancy loss; however, the cause of miscarriage remains unknown [2] . Patki et al. study observed reported higher prevalence (32%) of spontaneous miscarriages among Indian women [3] Ayurveda considers food to be the best source of nourishment as well as medication for the pregnant woman. Many medicines have been mentioned in Ayurveda which play an important role in preventing miscarriage or abortion and Prajasthapana mahakashya is one of them. As its name suggests, Prajasthapana mahakashaya [4] is a group of 10 medicinal plants that are helpful in maintaining a healthy state of Pregnancy. It comprises 10 herbal drugs such as Aindri ( Centella asiatica (Linn.) Urban.), Brahmi ( Bacopa monnieri (Linn.) Wettst.), Shatavari ( Asparagus racemosus Willd.), Durva (Cynodondactylon ( Linn.) Pers.), Amalaki ( Emblica officinalis Gaertn . ), Guduchi ( Tinospora cordifolia (Willd.), Haritaki ( Terminalia Chebula Retz.), Kutaki ( Picrorhizakurroa Royle ex Benth.) Atibala ( Abutilon indicum (Linn.), Priyangu ( Callicarpa macrophylla Yahl). According to Acharya Susruta, Hrdya (palatable), Drava (liquid) and Snigdha (unctuous) substances should be used in pregnant women [5] . So, keeping in mind the palatability or easy administration of Prajasthapana mahakashya , granules were made at National Institute of Ayurveda, Jaipur, Rajasthan, India. Prajasthapana mahakashya granules is formulated combination ( Anubhoot yoga ) that has been developed with the intention of being used during pregnancy, thus it is important to thoroughly assess the product’s efficacy, safety and quality. It is utmost important to regulate the quality standards of herbal medications & products, and testing is one way to make sure that these levels are met. The first step in standardization is to identify and evaluate the legitimacy of herbs. The use of modern analytical techniques for herbal drug analysis is crucial for the approval of ayureda and traditional herbs [6] . Physiochemical and pharmacognostical studies, as well as organoleptic testing, are essential parameters

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[Find the meaning and references behind the names: Sita, Nia]

25 Journal of Ayurvedic and Herbal Medicine|January-March|2024 for standardization and authentication. Studies using both microscopic and macroscopic methods can help to verify the authenticity of genuine herbs and identify adulterants. To ensure the quality standards of the individual raw drug and the final product, pharmacognostical and pharmaceutical standards of Prajasthapana mahakashya granules were done in present study. MATERIAL AND METHOD Collection and authentication of drugs Individual raw drugs (Figure 1) namely Whole plant of, Aindri ( Centella asiatica (Linn.) Urban.), whole plant of Brahmi ( Bacopa monnieri (Linn.) Wettst.), Root of Shatavari ( Asparagus racemosus Willd.), Whole Plant of Durva (Cynodondactylon (Linn.) Pers.), fruit of Amalaki ( Emblica officinalis Gaertn . ), stem of Guduchi ( Tinospora cordifolia (Willd.), Fruit of Haritaki ( Terminalia Chebula Retz.), Rhizome of Kutaki ( Picrorhiza kurroa Royle ex Benth.) Root of Atibala ( Abutilon indicum (Linn.), Seeds of Priyangu ( Callicarpa macrophylla Yahl.) and Sita (Sugar) were procured from Pharmacy of NIA, Jaipur. The authentication and standardization of the raw drugs were done in Pharmacognosy Lab of Dravyaguna department, National Institute of Ayurveda, Jaipur. The Ayurvedic Pharmacopoeia of India (API) standards were used to authenticate the drugs based on morphological traits, organoleptic properties, and powder microscopy of each medicine. Figure 1: Individual drugs of Prajasthapana mahakashya granules

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[Find the meaning and references behind the names: Cool, Brown]

26 Journal of Ayurvedic and Herbal Medicine|January-March|2024 Figure 2: Microscopic study of Prajasthapana mahakashya granules Method of preparation of Prajasthapana Mahakashya Granules 1) Preparation o f Kwath: Prajasthapana mahakashya granules was prepared in National Institute of Ayurveda, pharmacy. The raw drugs [Table 1] were made into coarse powder. From this coarse powder, 1/8 part were separated and made into fine powder. The Rest of coarse powder was placed into the fire with 8 times the total quantity of drugs. The mixture was heated and stirred continuously throughout the process until ¼ quantity of water remained. It was then filtered through a cotton cloth. This prepared kawth (decoction) was used for further process. 2) Preparation of Granules: For preparation of granules, prepared kwath of Prajasthapana mahakashya and Sharkara (Sugar) were heated over mild heat till the mixture attained a thread consistency. At this stage, vessels taken out from heat source and stirred continuously. Fine powder of Prajasthapana mahakashya was added and mixed well to form a homogenous mixture and was allowed to cool. The mixture then passed through No. 12 sieve to get granules. These granules were dried to get rid of any moisture and stored in air tight container [Figure 2]. Analytical Study: To standardize and validate the safety of Prajasthapana mahakashya granules for the internal use, the final product was standardized and tested for organoleptic parameters, Phytochemical test, physicochemical analysis, and microbial analysis were done. All these analyses were done in GMP certified laboratory. OBSERVATION & RESULT Pharmacognostical evaluation: The study was carried out in two steps. 1) Organoleptic characteristics: organoleptic characteristics of Prajasthapana mahakashya granules like color, touch, odor, taste and texture were examined and recorded as shown in table 2. 2) Microscopic study: The observations of microscopic characters of the drugs in Prajasthapana granules were compared with the standards of the individual drugs mentioned in Ayurvedic pharmacopoeia of India. Under the microscope, Tracheids, Niddle shape Calcium Oxilate and Starch Grain has been seen. [Figure 2] 3) Bulk density: Bulk density refers to the mass of a granular material divided by its total volume, including the voids between particles. Bulk density of Prajasthapana granules observed 0.60249 gm/ml. 4) Tap density: It is the volume of powder determined by tapping a measuring cylinder containing weighed amount of powder [7] . The cylinder is tapped for about one minute (or 100 taps) to get constant volume. Tap density of Prajasthapana granules detected 0.651677 gm/ml. 5) Compress density: Compress density, also known as true density, refers to the mass of a material divided by its true volume, excluding the voids between particles and it was obtained 0.742609 gm/ml. 6) Flow property: Flow property refers to the ability of granules to flow freely. It is characterized by angle of repose. And its observed value was 29.566. Pharmaceutical analysis: For Pharmaceutical study, Physiochemical analysis and thin layer chromatography (TLC) were carried out. 1) Physicochemical analysis: The common physicochemical parameters mentioned in API as mentioned below were analyzed for Prajasthapana granules and the results are depicted in table 3. 2) Thin layer chromatography: One technique for determining and separating the various chemical components present in a test sample is chromatography. Rf value of spots are 0.14, 0.19, 0.24, 0.29, 0.39, 0.48, 0.49, 0.58, 0.68, 0.78, 0.89, 0.95. Phytochemical analysis: Phytochmeical screening of Prajasthapana mahakshya granules revealed the presence of alkaloids, steroids, saponins, flavonoids and carbohydrates. This is represented in table 4. DISCUSSION The analytical study of granules typically involves various methods to assess their physical and chemical properties. The color of Prajasthapana mahakashya granule was brown and it is bitter-sweet in taste. The texture of the product was granule. The microscopic study provided insights into the structural characteristics of the individual drugs present in the granules, confirming their authenticity and quality. The bulk density, tap density, and compress density of Prajasthapana Mahakashya granules provide important insights into their physical properties. The bulk density of 0.602494 gm/ml and tap density of 0.651677 gm/ml indicate the degree of compaction and packing efficiency of the granules. Furthermore, the compress density reflects the ability of the granules to undergo compression, which is important for their mechanical strength and resistance to microbial ingress. Higher compress density may indicate a more compact structure, potentially reducing the likelihood of microbial contamination.

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[Find the meaning and references behind the names: Ash, Shiva, Flower]

27 Journal of Ayurvedic and Herbal Medicine|January-March|2024 Table 1: Ingredients of Prajasthapana mahakashya granules S. No. Sanskrita Name Botanical Name Part Used Proportion 1 Aindri (Mandukparni) ( Centella asiatica (Linn.) Urban.) Whole Plant 1 2 Brahmi (Brahmi) Bacopa monnieri (Linn.) Wettst Whole Plant 1 3 Shatavirya (Satavari) Asparagus racemosus Willd Root 1 4 Sahasravirya (Durva) Cynodondactylon ( Linn.) Pers Whole Plant 1 5 Amogha (Amalaki) Emblica officinalis Gaertn Fruit 1½ 6 Avyatha (Guduchi) Tinospora cordifolia (Willd.) Stem 1 7 Shiva (Haritaki ) Terminalia Chebula Retz Fruit ½ 8 Arishta (Katurohini/katuka) Picrorhizakurroa Royle ex Benth. Rhizome ½ 9 Vatypushpi (Atibala) Abutilon indicum (Linn.) Root 1½ 10 Vishvaksenakanta (Priyangu) Callicarpa macrophylla Yahl Flower 1 Table 2: Organoleptic characteristics of Prajasthapana mahakashya granules S. No. Parameter Result 1 Color Chocolate brown 2 Touch Smooth 3 Odor Characteristic 4 Taste Bitter, Sweet 5 Texture Granule Smooth Table 3: Physicochemical Analysis of Prajasthapana mahakashya granules S. No. Test Value 1 pH 3.78 2 Loss on drying (%) 9.32 3 Aqueous Extractive Value (%) 61.85 4 Alcoholic Extractive Value (%) 45.85 5 Ether Extractive Value 9.75 6 Total Ash (%) 9.75 7 Acid Insoluble Ash (%) 3.45 8 Water Soluble Ash (%) 6.85 Table 4: Phytochemical analysis of Prajasthapana mahakshya granule Constituents Test Aqueous Extract Ethanol Extract Carbohydrate Molish test, Benedict test, Fehling test + ve + ve + ve + ve - ve - ve Alkaloids Dragendorff test Wagner’s test Hager’s test + ve - ve + ve + ve + ve - ve Amino acids Ninhydrine + ve + ve Protein Biuret test Xenthoprotic test Millon test + ve + ve - ve + ve + ve - ve Saponin Foam test + ve - ve Glycosides Borntrager’s test + ve - ve Phenolic compound Phenolic test + ve + ve Steroids Salkowaski + ve + ve

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[Find the meaning and references behind the names: Low, Good]

28 Journal of Ayurvedic and Herbal Medicine|January-March|2024 Tannins Fecl 3 Lead acetate Pot. Dichromate - ve + ve - ve - ve + ve - ve Microbial contamination: Table 5: Microbial analysis of Prajasthapana mahakashya granules S. No. Microbial contamination Value Reference Value Test Method 1 Total Bacterial count 10 4 /g 10 5 /g A.P.I, Part II, Vol-I, Appendices- 2.4 2 Total Fungal count 10 2 /g 10 3 /g Aflatoxin: Table 6: Aflatoxin analysis of Prajasthapana mahakashya granules S. No. Aflatoxin Value Reference value Test Method 1 Aflatoxin B 1 Not Detected 0.5 PPB A.P.I, Part II, Vol-I, Appendices- 2.7 2 Aflatoxin B 2 Not Detected 0.1 PPB 3 Aflatoxin G 1 Not Detected 0.5 PPB 4 Aflatoxin G 2 Not Detected 0.1 PPB Flow property is a critical parameter in the pharmaceutical industry as it directly impacts the manufacturing process and the quality of the final product. Good flow ability ensures uniform distribution of the active pharmaceutical ingredients within the granules. In the analytical study of Prajasthapana mahakashya granules, the flow property was determined to be 29.566 by angle of repose, suggest that the granules exhibits excellent [8] flow ability. The physicochemical analysis revealed important parameters such as pH, extractive values, and ash content, which are essential for standardization and authentication of herbal medications. In Physicochemical analysis , Low percentage of loss on drying (9.32) indicates the minimal moisture level in the finished product which reduces the chances of bacterial and fungal growth. The drug is having least hydroscopic activity with less chance of contamination of drug. Extractive value is directly relative to strength or potency of drug which estimates in different solvents. The final product contains watersoluble ingredients like sugar and carbs. This explains the formulation's high water soluble extractive value. Alcohol is a broad range aprotic solvent that is soluble in a variety of compounds, including flavonoids and molecules similar to glycosides. This is the reason for high alcoholsoluble extractive value in the formulation. Ash value is the indicator of the presence of inorganic & earthy matter in the plant. Total ash value was 9.75% that indicates less amount of inorganic material in the sample and rest was organic material that is bio human available products. Acid insoluble ash of Prajasthapana mahakashya granules is 3.45% that indicates the presence of siliceous matter. Water soluble ash estimate the inorganic water soluble salt in samples was found 6.85%. Qualitative phytochemical test indicates the identification of primary metabolites (Carbohydrate, protein, fat etc) and secondary metabolites (alkaloids, glycosides tannin etc). Alkaloids were identified in aqueous and ethanol extract due to positive of Dragondroff test. Benedict test is positive in aqueous extract of sample which indicates the simple sugar present. Fehling test was positive in aqueous extract of sample that indicates reducing sugar was present. Amino acid were present in ethanol extract due to show positive result in Ninhydrine test and protein was present in test sample due to positive in Xenthoprotic in aqueous and Ethanol extract. Foam test was positive in aqueous extract of sample that indicates saponine was present. Lead acetate test was positive in test sample that’s indicating that tannin was present in sample. The presence of carbohydrate, alkaloids, Amino acids, protein, saponin, glycosides and tannins indicates the rich phytochemical composition of the granules, which may contribute to their therapeutic properties. The microbial contamination levels in the Prajasthapana Mahakashya granules seem to be within acceptable limits. The total bacterial count and total fungal count are both below the reference values, indicating good microbial quality. Additionally, the presence of aflatoxins, such as Aflatoxin B 1, B 2, G 1, and G 2, is also analyzed. Aflatoxin are toxins produced by mold that can damage the liver and may lead to liver cancer and produce toxicity in vital organs of human and animals. Aflatoxin B 1, B 2, G 1, G 2 were absent in Final product of Prajasthapna mahakashya granules. Thin layer chromatography establish in phytochemical fingerprint profiling in drug for identity. In Prajasthapana mahakashya granules, TLC shows under Iodine vapors 12 spots was found. R f value of spots are 0.14, 0.19, 0.24, 0.29, 0.39, 0.48, 0.49, 0.58, 0.68, 0.78, 0.89, 0.95. CONCLUSION Prajasthapana mahakashya granules is intended to be given during pregnancy. Consequently, it is essential to ensure quality control that individual drugs be authenticated and the formulation be standardized. Pharmacognostical results attest to the absence of appreciable alterations in the microscopic structures throughout the Prajsthapana mahakashya granules preparation process, supporting the similarity between the final product and each of the component parts.

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[Find the meaning and references behind the names: Benson, Sri, Narayana, Gupta, Satya, Chauhan, Shrestha]

29 Journal of Ayurvedic and Herbal Medicine|January-March|2024 Physiochemical parameters of the granules were obtained as per standards. Based on the evidence available, it can be assumed that the formulation satisfies the necessary quality requirements. Based on the observations, the findings of this study could serve as the reference for future work projects. Conflict of interest There is no conflict of interest. Funding None declared. REFERENCES 1 Benson LS, Holt SK, Gore JL, Callegari LS, Chipman AK, Kessler L, et al. Early pregnancy loss management in the emergency department vs outpatient setting. JAMA Network Open. 2023;6(3):e 232639. 2 Kuppusamy P, Prusty RK, Chaaithanya IK, Gajbhiye RK, Sachdeva G. Pregnancy outcomes among Indian women: increased prevalence of miscarriage and stillbirth during 2015 – 2021. BMC Pregnancy and Childbirth. 2023;23(1):150. 3 Patki A, Chauhan N. An epidemiology study to determine the prevalence and risk factors associated with recurrent spontaneous miscarriage in India. The Journal of Obstetrics and Gynecology of India. 2016;66:310-5. 4 Sri satya narayana sastri, The Caraka samhita of Agnivesa,sutra sthana chapter 4, versus 8 (Reprinted). Varanasi, Chaukhambha visvabharati, 2013. Page no. 97. 5 Kaviraj ambikadutta shastri (editor). Susrutasamhita of Maharsi susruta, sharir sthan, chapter 10, versus 2 (Reprinted). Varanasi, Chaukhambha Sanskrit sansthan, 2014. Page no. 98. 6 Lijima C, Dei L, Harisha CR, Shukla VJ. Pharmacognostical and pharmaceutical analysis of Jeevantyadi Avaleha: A polyherbal Ayurvedic formulation. Journal of Drug Research in Ayurvedic Sciences. 2023;8(2):150-8. 7 Gupta SP, Bashyal P, Shrestha L. Formulation And Evaluation Of Oral Dispersible Tablets Of Loratadine By Direct Compression Method. World J. Pharm. Pharm. Sci. 2019;8(4):1352-70. 8 Regueiro A, Jezerská L, Pérez- Orozco R, Patiño D, Zegzulka J, Nečas J. Viability evaluation of three grass biofuels: Experimental study in a small-scale combustor. Energies. 2019;12(7):1352. HOW TO CITE THIS ARTICLE Dixit N, Choudhary P, Bilwal G.. Analytical Study of Prajasthapana mahakashya Granules: Quality Assessment and Safety Validation. J Ayu Herb Med 2024;10(1):24-29. DOI: 10.31254/jahm.2024.10105 Creative Commons (CC) License- This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY 4.0) license. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. (http://creativecommons.org/licenses/by/4.0/).

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Ayurveda, Medicinal plant, Abortion, Analytical study, Fine powder, Ayurvedic medicine, Ayurvedic pharmacopoeia, Miscarriage, Quality assessment, Oral administration, Pharmaceutical industry, Loss on drying, Organoleptic characteristics, Thin Layer Chromatography, Phytochemical analysis, Pharmacognostical evaluation, Microscopic study, Water soluble ash, Total ash, Ash Content, Microbial Contamination, Herbal Medication, Total bacterial count, Total fungal count, Physicochemical analysis, Air tight container, Acid insoluble ash, Pharmacognostical study, Raw drug, Coarse powder, Pharmaceutical analysis, Extractive value, Water soluble extractive value, Alcohol soluble extractive value, Phytochemical composition, Physicochemical Parameter, Homogenous mixture, Herbal drug, Physiochemical Parameters, Pharmacognostical analysis, Pregnancy Loss, Microbial analysis, Granules, Mechanical strength, Angle of repose, Bulk density, Active pharmaceutical ingredient, Analytical technique, Pharmacognosy Lab, Aflatoxin, Flow property, Qualitative phytochemical test, Organoleptic parameter.