|Year : 2019 | Volume
| Issue : 4 | Page : 224-230
Pharmaceutico-analytical standardization of Aragvadhadi Taila
Sarika M Makwana, Prashant Bedarkar, Biswajyoti Patgiri
Department of Rasashashtra & Bhaishajya Kalpana, Bhaishajya Kalpana Laboratory, Institute for Post Graduate Teaching & Research in Ayurveda (IPGT&RA), Gujarat Ayurved University, Jamnagar, Gujarat, India
|Date of Submission||23-Jan-2020|
|Date of Decision||24-Feb-2020|
|Date of Acceptance||02-Mar-2020|
|Date of Web Publication||14-Apr-2020|
Dr. Sarika M Makwana
Department of Rasashashtra & Bhaishajya Kalpana, Institute for Post Graduate Teaching & Research in Ayurveda (IPGT&RA), Gujarat Ayurved University, Jamnagar 361008, Gujarat.
Source of Support: None, Conflict of Interest: None
Introduction: Chakradatta by Acharya Chakrapani is the classic which has described Aragvadhadi Taila in the context of Kustha Roga and indicated it in Shvitra Roga, the example of Sneha Kalpana (medicated oleaginous dosage form). Materials and Methods: Classical Sidhdhi Lakshana (chief desired characteristics) have their certain limitations and are not sufficient to characterize with respect to their organoleptic characters. Thus, in this study three batches of Aragvadhadi Taila with an average 2L of Sarshapa Taila (mustard oil), 8L of Gomutra (drava dravya) and 657g of Kalka were prepared by the following processes: Manahshila Shodhana, Haratala Shodhana, preparation of Kalka, and Snehapaka with classical method to maintain process uniformity and to evaluate standard procedure. The pharmaceutical and analytical data were observed and recorded. Results: Average total duration for Taila Paka and yield for each batch of Aragvadhadi Taila were observed to be approximately 8h 15min and 1675 mL, respectively, in 5 days. Average values of physicochemical parameters of Sarshapa Taila (mustard oil) were as follows: specific gravity 0.90, refractive index 1.4860, acid value 5.34, saponification value 288, and iodine value 102 at room temperature. Average values of physicochemical parameters of Aragvadhadi Taila were as follows: specific gravity 0.9115, refractive index 1.4871, acid value 7.12, saponification value 316, and iodine value 124.66 at room temperature. Conclusion: The pharmaceutical and analytical studies have helped to generate preliminary standards for formulation Aragvadhadi Taila.
Keywords: Aragvadhadi Taila, physicochemical analysis, standardization
|How to cite this article:|
Makwana SM, Bedarkar P, Patgiri B. Pharmaceutico-analytical standardization of Aragvadhadi Taila. J Indian Sys Medicine 2019;7:224-30
| Introduction|| |
Aragvadhadi Taila (ART) is arsenicals (Manahshila [realgar] and Haratala [orpiment]) containing classical herbomineral formulation, which is mentioned in Chakradatta with indication of Shvitra (vitiligo). Most of the Dravya (contents) in this Taila (medicated oil) are Kushthaghna (medicines to treat dermatological problems), Krimighna (anti-helminthic), and Kandughna (relieve itching). Later period other references were found with similar ingredients and similar indication in Bhavaprakasa, Bhaishajya Ratnavali. In Bharat Bhaishajya Ratnakara, this formulation comes with the partially similar ingredients that are Aragvadha, Haratala, and Sarshapa Taila with indication of Loma nirmoolana. Ayurveda dosage forms are very exclusive in its pharmaceutics and therapeutics. Sneha Siddha (fat soluble) drugs have better pharmacokinetic action (ADME) in comparison to other dosages forms because of the lipoid nature of the biomembranes, as lipid-soluble substances readily permeate into the cells. Drugs or formulations are expected to exert a desired biological activity at particular concentrations of their chemical constituents. The overall aim of drug standardization is to ensure the quality, efficacy, and uniformity of the products. Hence, standardization and development of reliable quality protocols are important. The standardization study of formulation never be achieved by one or two parameters and hence is preferable to achieve it in a multidisciplinary way. With this in mind, the study has been undertaken to develop pharmaceutical standardization with three batches of formulation ART. Organoleptic characters and physicochemical parameters were performed with three batches of ART and Sarshapa Taila (mustard oil).
Aims and objectives
The aims of this study were to (1) develop Standard Manufacturing Procedure of ART and (2) analyze analytical profile of ART.
| Materials and Methods|| |
Collection and authentication of raw drugs
Ardraka (Zingiber officinale Linn.) rhizome was purchased from local market of Jamnagar (Gujarat). Churna (CaO, lime) was procured from the pharmacy of Gujarat Ayurved University. Sarshapa Taila (mustard oil) and other Kalka Dravya (paste) of ART [Table 1] such as Kushtha moola (Saussurea lappa C.B. Clerk), Haridra (Curcuma longa Linn.), Daruharidra (Berberis aristata DC), Ashuddha Haratala (unpurified orpiment), and Ashuddha Manahshila (unpurified realgar) were procured from the pharmacy of Gujarat Ayurved University. Aragvadha fruit was collected from the botanical garden of the Institute for Post Graduate Teaching & Research in Ayurveda (IPGT&RA), Jamnagar. Dhava (Anogeissus Latifolia Linn.) Twaka (bark) was collected from Kevadia colony (Gujarat) in sharad rutu (October month). Gomutra (liquid media) was collected from panjarapol Gaushala, Jamnagar. Formulation was prepared in the Department of Rasashashtra & Bhaishajya Kalpana, Bhaishajya Kalpana Laboratory, IPGT&RA, Jamnagar.
Shodhana of Manahshila [Figure 1]A–C: Fresh Ardraka rhizome was washed with tap water and scraped the outer layer with the help of knife and cut into small pieces. Pieces of Ardraka rhizome were made into paste form with the help of wet grinder and then Svarasa (juice) was obtained by squeezing through the cotton cloth. Ashuddha Manahshila (unpurified realgar) was shifted into Khalva yantra (mortar pastel) and grinded to make fine powder. Average Ardraka Svarasa was added to the fine powder of Manahshila (realgar) till the powder become Pankavat (muddy consistency) and then it is levigated till the mass becomes completely dry. This was considered as one Bhavana (levigation). Same process of Bhavana (levigation) was repeated further more six times to the powder of Manahshila (realgar) in the mortar. After completion of Bhavana, it was subjected to drying at room temperature. Then it was powdered in porcelain mortar and preserved in air tight glass jar.
|Figure 1: Pharmaceutical steps of Shodhana of Manahshila and Haratala. (A) During Bhavana process of Ashudhdha Manahshila. (B) Drying process of Ashudhdha Manahshila. (C) Shodhita Manahshila. (D) Ashudhdha Haratala. (E) During Swedana process of Ashudhdha Haratala. (F) Shodhita Haratala|
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Shodhana of Haratala [Figure 1D–F]: Lime was grinded well to fine powder and then mixed with potable water in the ratio of 1:240. Then it was kept undisturbed for 9h in stainless steel vessel. Then it was filtered through double-folded cotton cloth after decantation. This filtrate is Churnodaka (lime water). Ashuddha Haratala (unpurified orpiment) was made into small pieces in porcelain kharala (mortar pestle). It was spread on a cloth, after that made into a Pottali. It was hanged to an iron rod, with a thread then placed in a cylindrical stainless steel vessel, which is not touch to the bottom. In the vessel, the media was filled as the Pottali (cloth bundle) can be moved freely during the 3h of Swedana (heating under liquid bath) process, then it was heated on liquefied petroleum gas (LPG) stove. After 3h, Haratala (orpiment) was taken from the Pottali (cloth bundle) and washed with hot water. Then it was subjected to drying at room temperature and preserved in air tight glass jar.
Preparation of ART: Physical impurities from raw material were removed manually. ShuddhaManahshila (purified realgar) and Shudhdha Haratala (purified orpiment) were making powdered in porcelain Kharala (mortar pastel). Aragvadha fruit pulp was procured from Aragvadha fruit. Then, it was dissolved in 40mL of Gomutra (cow’s urine) with 10min of heating. Then it was taken in mixer grinder machine and added other drugs in coarse powder form and sufficient quantity of Gomutra (cow’s urine). It was grinded till converting into paste form. Properly made bolus of Kalka was kept in stainless steel vessel for further process [Figure 2].
|Figure 2: Pharmaceutical steps of Kalka preparation. (A) AragvadhaPhala Majja (fruit pulp). (B) Heating of Aragvadha fruit pulp with Gomutra. (C) Powdering of shuddhaHaratala and Manahshila. (D) Showing Kalka Dravyas except Aragvadha fruit pulp. (E) Mixing of all Kalka Dravya. (F) Bolus of Kalka Dravya|
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Sarshapa Taila (mustard oil) in the mentioned quantity was taken in a stainless steel vessel and heated over mild flame (100°C for 5min) till complete evaporation of moisture and then stop heating process. After that, boluses of Kalka (paste) were added in Sarshapa Taila (mustard oil) at 80°C temperature. After mixing of Kalka (paste) into Taila, the specified quantity of Gomutra (cow’s urine) was added and the mixture was subjected to heating process. Heating was continued maintaining the temperature in between 120°C with intermittent stirring. The mixture was left undisturbed through the night and heating was given for 5 days. Mixture was stirred continuously to avoid the possibility of settling down. Heating was continued on the fifth day till Sneha Siddhi Lakshana (chief desired characteristics) was obtained. After obtaining desired Sneha Siddhi Lakshana (chief desired characteristics), the vessel was taken out from heat and oil was filtered through double-folded cotton cloth in its hot stage. The prepared oil was stored in a properly labeled air tight bottle after cooling [Figure 3].
|Figure 3: Pharmaceutical steps of Aragvadhadi Taila preparation. (A) Sarshapa Taila on heating. (B) Adding of multiple Kalka bolus in Sarshapa Taila. (C) Mixing of Kalka. (D) Adding Gomutra in mixture of Kalka and Sarshapa Taila. (E) Showing yellowish foaming layer. (F) Khara Paka stage. (G) Filtering of Aragvadhadi Taila. (H) Kalka after filtration. (I) Labelling and packaging with finished product|
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Analytical evaluation of ART was carried out to develop standards for the reproducibility of the trial drug. The samples were analyzed on the basis of organoleptic characters. It includes sensory characters of drug, that is, Sparsha (consistency and texture), Rupa (color), and Gandha (odor). Physicochemical parameters such as specific gravity @ 25oC, refractive index (RI), acid value, iodine value, and saponification value were performed for analysis of ART at the pharmaceutical laboratory of IPGT&RA, Jamnagar.
| Observation and Results|| |
Shodhana (purificatory process) of 1000g Manahshila (realgar) by Ardraka Svarasa (juice) was required an average 142.85mL Ardraka Svarasa (juice) and 1:23 h:min of trituration for each levigation, yielded with 7.08% weight increase by seven Bhavana (levigation). There was increase in weight 104g of Shuddha Manashila (purified realgar) [Table 2]. Shodhana (purificatory process) of Haratala (orpiment) was carried out with 500g of batch size in two batches with yield of 98.7%; 1800mL Churnodaka (lime water) is sufficient for 500g of Ashuddha Haratala (unpurified orpiment) for Swedana (heating under liquid media) process (3h of duration). An average 98.7% yield was obtained and 1.3% losses were observed during Shodhana (purificatory process) of Haratala (orpiment) [Table 3].,
It was observed that an average 40mL of Gomutra (cow’s urine) was needed to make paste 72g of Aragvadha fruit pulp Kalka with 10min of heating process. An average 160mL of Gomutra (cow’s urine) was used during three batches of preparation. Average weight of Kalka (paste), that is, 657g, was obtained after all the Kalka Dravyas (paste) were mixed with Gomutra (cow’s urine) [Table 4]. Prepared Kalka was yellowish black in color, having characteristic smell of Manahashila and Gomutra (cow’s urine). During heating of Sarshapa Taila (Mustard oil), burning eyes was observed which was due to pungent vapors emerges out from Taila. When temperature reached at 70°C, boluses of Kalka were added and then added Gomutra. After decreased the temperature Kalka Dravya (paste) were added in Taila to protect the burn of Kalka (paste) Dravya. After mixing of Kalka, four times of Gomutra (cow’s urine) (8000 mL) was added and again heating process continued with maintaining temperature in between 90°C to 110°C with intermittently stirring process [Table 5]. After 15min of heating, bubbles were started with specific odor of Gomutra (cow’s urine). After half an hour of heating, contents were become dark brownish in color and physical appearance of upper layer of mixture was observed yellowish in color with more thickness of frothing. Dark yellow colour of mixture was changed to yellowish brown and observed excessive frothing after 1 h of heating. The Taila was heated intermittently maintaining temperature in between 95°C and 100°C for 5 days. On the fifth day, after 8h 15min of heating process Phenodgama was observed. Kalka was examined at regular intervals. Mridu Paka (less quantity of moisture in Kalka), Madhyama Paka (soft but devoid of moisture), and Khara Paka (slightly rough to touch) stages were observed at specific temperature, as presented in [Table 5]. Consistency of Kalka became harder to touch with no moisture and was not able to make Varti and rough in texture. At this stage of Khara Paka (slightly rough to touch), Taila was filtered through cotton cloth without squeezing and in hot stage to get maximum yield of final product. On an average, total duration for Taila Paka and yield for each batch of ART were observed to be approximately 8h 15min and 1.675L, respectively, in 5 days.,
|Table 5: Observation of three batches of Aragvadhadi Taila at different temperature|
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| Discussion|| |
There was increase in weight 104g of Shuddha Manashila (purified realgar); it may be due to addition of solid materials of Ardraka Swarasa. In analytical part, solid content of Ardraka Svarasa (juice) was found 6.23% which supports the increase weight of Shodhita Manahshila (purified realgar). Weight loss in Shodhita Haratala (purified orpiment) (1.3%) may be due to removed physical impurities and some suspended particles of Haratala during Swedana process and also loss may be due to washing process with hot water after completed the Shodhana process.
During Snehapaka, temperature reached at 70°C after 15min of demoisturization boluses of Kalka (paste) Dravyas were added because to protect the burn of Kalka (paste) Dravyas. Contents were become dark brownish in color after half an hour of active heating; it may be due to some possible reactions occurring during the heating process. Haratala (purified orpiment) and Manahshila (purified realgar) were settled down. It is because both the arsenicals were not completely soluble in oil and Gomutra (cow’s urine). So, continuous stirring was required throughout the process. Excessive frothing during boiling of Taila with cow’s urine is probably due to partial saponification, nitrogenous products (ammonia), and formation of micelles. Thus, it may suggestive formation of more complexes with polar chemical moieties. On the fifth day, after 8h 15min of heating process Phenodgama was occurred; it may be due to presence of unsaturated fatty acids in Taila. When heated unsaturated fatty acids, it was formed oxides that released foam. Taila was filtered in hot condition to get maximum yield. An average 17.05% loss was found during preparation of ART; it may be due to more absorption of Taila into Kalka (paste) and few losses may be during Taila Paka confirmative test. Acharyas have fixed the duration of Snehapaka 5 days when Gomutra (cow’s urine) used for Snehapaka and its nature to impart chemical constituents may take a longer time. Final product was yellowish brown in color, oily in touch, and with smell of characteristics Gomutra (cow’s urine) [Table 6].
As per tabled data [Table 7], apart from RI and saponification value, rest of the standards (rest of all analytical physicochemical parameters) of Sarshapa Taila (mustard oil) chosen for this study are within limits for mustard oil prescribed by regulatory authorities, which matches with The Ayurvedic Pharmacopoeia of India, Bureau of Indian Standards, and Codex Alimetarius standards. RI of samples, that is, Sarshapa Taila (1.4860) and finished product (1.4871), was almost nearer to same. Refraction of light from media in the case of test formulations may be due to addition of aqueous media in traces to product oil (ART), presence of suspended particulate matter, and change in concentration of extracted chemical moieties, addition/extraction of different chemical constituents in to mustard oil or neoformation of different chemical constituents into mustard oil. Specific gravity may also get altered (increased) due to some logically relevant reasons in final product (0.91) as that of Sarshapa Taila (0.90), which may be formation of micelles due to heat treatment of oil with excess of aqueous media, suspension of solid particulate matter into prepared Sneha, new generation of complexes with extracted constituents of formulation ingredients or their derivatives having comparatively more density than that of oil. Significant increase in acid value of finished product (7.12) as compared with Sarshapa Taila (5.34) is probably due to formation of arsenic and sulfur compounds (arsine, sulfurous acid, H2S, and SO2), which are oxidative agents with imparting acidity due to either donation of oxygen or release of H+ ions. More saponification value in finished product (316) as that of Sarshapa Taila (288) may suggests formation of shorter chain fatty acids, with lower molecular weight and thus supporting fast and better absorption. Iodine value is a measure of the amount of unsaturation (number of double bonds) in a fat. Increased Iodine value observed in ART (144.66) as that of Sarshapa Taila (102) due to increased rate of oxidation during Snehapaka (heating process of oleaginous contents).
|Table 7: Comparative physicochemical analysis of Sarshapa Taila and finished product (ART)|
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| Conclusion|| |
Classical method for preparation of ART can be considered as standard. An average 1675 mL (83.75%) of ART was obtained on processing, 2L (batch size) of Sarshapa Taila from 657.4g of Kalka (paste) Dravya and 8L of Gomutra (cow’s urine) in 5 days with 8h 15min total duration of active heating. The changes in physicochemical parameters as that of Sarshapa Taila (mustard oil) can be merely correlated to effect of heating, suggesting collective effect of formulation ingredients and pharmaceutical processing of Snehapaka (heating process of oleaginous contents).
Financial support and sponsorship
Financial support by IPGT & RA, Jamnagar.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]