Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar

Research Article This work is licensed under a CC BY 4.0 License International Research Journal of Ayurveda & Yoga Vol. 5 (4),44-58, April, 2022 ISSN: 2581-785 X; https://irjay.com/ DOI: https://doi.org/10.47223/IRJAY.2022.5405 Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar Sumitra 1 , Sanjay Kumar 2 , Kshipra Rajoria 3 , Vijay Shankar Verma 4 1 Medical Officer, Shri Mohata Ayurvedic Rasayanshala, Bikaner (Raj.) 2 Associate . Professor , Dept. Of Ras Shastra and Bhasijya Kalpna , National institute of Ayurveda Deemed to Be University , Jaipur (Raj. ) 3 Lecturer, Dept. Of Panchkarma , National institute of Ayurveda Deemed to Be University , Jaipur (Raj. ) 4 BAMS MD( Ayu), Jaipur (Raj.) INTRODUCTION Bhaishajya Kalpana is a pharmaceutical branch of Ayurveda dealing with medicinal preparations, formulations, dosage, etc. Broadly two main types of Sneh Kalpana are described in Ayurvedic classics i.e., Ghrita & Taila Kalpana . Sneha Kalpana is successfully used for treating various disorders of nerve, skin Article Info Article history: Received on: 12-03-2022 Accepted on: 20-04-2022 Available online: 30-04-2022 Corresponding author- Sumitra, Medical Officer, Shri Mohata Ayurvedic Rasayanshala, Bikaner (Raj.) Email: dr.sumitra.bkn@gmail.com ABSTRACT: The skin is the first organ of the body to come into contact with environmental factors like physical, chemical, and biological pollutants. The skin serves as a mirror, reflecting both internal and external pathology and thus assisting in the diagnosis of illness. Skin problems can affect persons of all ages, from infants to the elderly, and can cause deformity, disability, and other issues. This present study entitled “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ”. was carried out with a view to standardize Brihatsindooradya Taila and prepare its modified forms viz. ointment. The present study is framed under 7 main sections viz. Introduction, Drug Review, Pharmaceutical Study, Analytical Study, Discussion, Summary and Conclusion. Aim: The aim is to prepare BST as per textual guidelines and its malahar which is a modified dosage form & to analyze the prepared sample of BST and its malahar as per standard parameter. Materials and Methods : Pharmaceutical study was conducted with the Vatsnabha shodhan, Tandulodaka nirmana, Sindoora shodhan, Sarshapa Taila murchchhana, preparation of Brihatsindooradya Taila ( BST) and preparation of Brihatsindooradya Malhar ( BSM). Results: The findings for analytical parameters were found to be satisfactory for quality assurance. Assay of heavy metals (Pb, Cd, As, Hg),Total bacterial count and Total fungal count are under the permissible limit depicted in the study. Specific pathogens and aflatoxins (B 1, B 2, G 1, G 2) are absent in all samples. The malahar also had good thermal stability, easily washable, non-irritant and free from pathogens and no rancidity. In HPTLC finger printing van though a few RF values were similar for both BST and BSM the chemical constituent could not be identified due to the absence of standard marker. Keywords : Skin, Yogratnakar, pama, vicharchika, kachhoo, visharapa. Vatsnabha shodhan, Tandulodaka nirmana, Sindoora shodhan ,

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 45 conditions etc. Sneha Kalpana is a process where the Sneha, Kalka, Drava-dravya and Gandha-dravya are employed for preparation of oleaginous medicaments (Oils and Ghee) which ensures absorption of the active therapeutic properties of the ingredients used. The Sneha preparations are used for internal and external purposes with external use being more in number specifically for Vata-vyadhis. Topical applications of drugs have advantages of delivering the drug directly to the site of action. Skin is one of the most widespread and easily accessible organs on the human body for topical administration and is the main route of topical drug delivery system. Thus, an attempt to prepare topical agents like malaha r (ointment) was done taking BST as its active ingredient. Brihatsindooradya Taila ( BST) and Brihatsindooradya Malhar ( BSM) are examples of Sneha Kalpana , which are effectively used for the treatment of Kustha . Brihatsindooradya Taila ( BST) has been mentioned in Kushtha by Acharya Yogratnakar . Table no.1 Various refrences of Brihatsindooradya Taila ( BST) Need Of Study External application of drugs in skin diseases is an important as internal medicament. It helps to provide better and quicker relief in the symptoms and after all it is non-hazardous. Taking all the above points for consideration – BST or malahar has been selected as external application for the present study to analyze their pharmaceutico-analytical parameters with API.. Considering all these facts present study entitled “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” has been planned. AIMS AND OBJECTIVES 1-To compile the literary review regarding Sneha Kalpana wsr to Brihatsindooradya Taila . 2-To conduct the pharmaceutical – analytical study on BST and its malahar . 3-To prepare BST as per textual guidelines and its malahar which is a modified dosage form . 4-To analyze the prepared samples as per standard parameter laid down in API. 5-To analyze the prepared sample of BST and its malahar as per standard parameter. Drug Review Collection Of Raw Drug All the raw drugs listed in this preparation were procured from the N.I.A. pharmacy, except Sarshapa Taila, Jatamansi, Priyangu, Khadira , Karanaj and Chakrmarda drvyas were procured from local market of Jaipur and identified by expert of Dravyaguna department of NIA Jaipur. Pharmaceutical study was conducted in the Rasa shastra and Bhaishjya Kalpana department of NIA, Jaipur. Drug Review Of Brihatsindooradya Taila (Bst) Brihatsindooradya Taila (BST) is one such preparation mentioned in Yogaratnakar under chapter of kustha chikitsa . BST having kandu nashana , shrava rodhaka and tvaka shodhaka properties will be used for external application which comprises of Sarshapa, Sindoora, Pippali, Arka, Trivrut, Haridra, Daruharidra, Chandana, vatsnabha and karanj etc. BST contains 24 ingredients as shown in table no.2. From drug review it is clear that most of the drugs in above formulation are predominantly Tridoshara . Looking into overall properties of ingredients, most of them possess Katu (pungent) and Tikta (bitter) as dominant rasa (taste), Laghu (light)and Ruksha (rough) in nature (guna), with most of the drugs having Ushna veerya (hot potency) and Katu vipaka. Drug Review Of Brihatsindooradya Malhar (Bsm) Modified dosage form of Brihatsindoordya Taila Malahar will be prepared using Brihatsindoordya Taila along with other ingredients as listed in the table below. Table no.3 Details of base ingredients of the Brihatsindoordya Taila Malahar. Pharmaceutical Study Pharmaceutical study is mainly related to manufacturing a safe, effective and quality drug, through pharmaceutical processing of the raw materials. Brihatsindoordya Taila (BST) was prepared according to the classical reference of text Yogaratnakara and other modified dosages malahar (ointment) process was conducted in the Rasa shastra and Bhaishjya Kalpana department of NIA, Jaipur. The following processes were performed in this study a) Vatsnabha shodhan b) Sindoora shodhan c) Sarshapa Taila murchchhana d) Preparation of Brihatsindooradya Taila ( BST) e) Preparation of Brihatsindooradya Malhar ( BSM)

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 46 A) Vatsnabha shodhan 1,2 Reference: AFI Part-1 ( Rasamrita parisista 8, Page 145 ) & Rasa Tarngini 24/20-21. Method: Dola yantra viddhi In pharmaceutical process Vatsnabha shodhan was done in two steps. In first step 250 g of Ashudha Vatsnabha was taken and dipped into Gomutra for 3 days and the yield was 117.5 g. This Vatsnabha was further processed through step two in which Vatsnabha was tied in a Pottali and placed in a vessel filled with Godugdha and boiled for 3 h. After this complete process of Shodhan , wt. of Vatsnabha was 105 g with total 145 g (58.16 %) loss. The loss during 1 st step occurred due to removal of the damaged portion of Vatsnabha and while removing external layer of Vatsnabha . The loss during the 2 nd step occurred while fine powdering and sieving. Ashudha Vatsnabha was hard in nature and dark brown in colour while Shodhita Vatsnabha was soft in nature and colour changed to yellowish brown and then to brown after completion of Shodhan . Shodhita Vatsnabha was Gomutragandhi . These changes were due to use of Gomutra and Dugdha Swedana during the Shodhan . B) Sindoora shodhan 3 Refrence: AFI-1, Vol-1, ( Yogaratnakara , page 140 ) Method: 7 Bhavana Ashudha Sindoora was in powder form and red in colour. After 3 Bhavnas each of Nimboo swarasa and Tandulodaka , the red colour of Sindoora changed to orange colour and it became finer. A total 18 g (7.40%) wt. gain in Sindoora was observed during the Shodhan process. Initial wt of Sindoora i.e.,243 g increased to 261 g after shodhan . The probable reason of wt. gain may be due to addition of Tandulodaka which contains dissolved starch. C) Sarshapa Taila murchchhana Reference : Bhaishjya Ratnavali , Jwara 5/1288-89 Equipments : Pounding instrument, Grinder, spatula, Thermometer, Gas stove, Stainless steel vessel with 40 ltr capacity(40 cm diameter and 32 cm depth) for Sneha paka , measuring cylinder, clean cotton cloth, PET jar. Table no. 4 Showing the ingredients used in Sarshapa Taila Murchchhana . Procedure f) The properly cleaned herbs were made into very fine powered one by one with the help of iron khalva yantra and mixer grinder. Then 1475 g powered were mixing well one by one and added water 2.300 lit all powered were soaked properly. Kept for overnight then next 500 ml more add water and grinding for 3 h. After grinding weight of Kalka is 3930 g. g) Then 6000 gms of Sarshapa Taila was taken into the stainless - steel vessel and kept on electric furnace with medium flame. Then the moisture present in Taila was evaporate and foam was disappearing from the Taila . At that time temperature of Taila was 144 o C. Then the vessel Around temperature 120 o C Kalka was mixed in Taila slowly and stirred well. h) After mixing the Kalka temperature was goes down around 92 o C. keep it again electric furnace on mild flame and after 15 minute 15 l water was added. At that time temperature was 50 o C. Then subjected to heated for 2 h with constant stirring, with maintaining the temperature around 85 o - 95 o C. Stop heating and allow standing for overnight. i) Next day same temperature and procedure were carried out more 2 days till Sneha Sidhi lakshana appeared. 2 nd day heating process done around 7 hours. j) After complete appearance of Sneha Sidhi lakshana that vessel was taken out from the heat and them filtered through cloth to another stainless - steel vessel. Remaining Kalka water was taken 7 lit more added and kept for overnight. k) Next day heating process done around 1.30 h. Then Taila filtered and collect another stainless steel and heat till moisture present in Taila was evaporated then Taila was filtered another stainless steel. OBSERVATION A specific sound and smell appear with some bubble during Sneha paka when Kalka drvyas were added in Taila . Consistency of Taila becomes thicker. In final stage Phenodgama occurs in Taila . D) Preparation of Brihatsindooradya Taila ( BST) 4 After completion of Murchchhana process it was subjected for Sneha paka. Refrence: Yogaratnakara, kustha chikitsa ( shlok no .186-189), page no 659

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 47 Method : Sneha paka Equipment : As per used in Sneha Murcchana Procedure The properly cleaned herbs (1 -22 shown in table no.2) were made into very fine powered one by one with the help of iron khalva yantra and mixer grinder.1475 g powder was taken in a vessel and soaked with 3000 g water.3930 g Weight of Kalka after adding water was 3930 g. Then the Kalka was kept for night. 6000 g Sarshapa Taila was taken in a vessel. Vessel was kept on gas stove and heat on mild flame to remove the moisture content and put down of fire Kalka was added and vessel kept on the gas stove, and constant stirring for the homogenous mixing. After 5 min 6000 g water was added and heated over mild flame with continuous stirrer .After some time Taila was started boiling. After that same process to be followed untill Sneha siddhi lakshana appears Table no. 5 Showing the Sneha Sidhi lakshana during BST. E) Preparation of Brihatsindooradya Malhar ( BSM ) 5 Equipment : Heating mental , Stirrer, Beaker, Vessel, Spoon etc. Method : Emulsification Table no.6 Showing the ingredient of Brihatsindooradya Malhar ( BSM) Procedure : It was done in two phases 1 st Phase : First distilled water was taken in a vessel. MPS was added in distilled water and kept on heating mental and stirrer. They are heated at 85 o - 90 o C. 2 nd Phase : Active part Taila was taken in another vessel. Kept on heating mental and added in oil bee’s wax, Paraffin wax, cetostearol alcohol, cetyl alcohol, emulsifying wax, GMS, stearic acid and IPM was added one by one and stirrer till melt. They are heated at 85 0 - 90 0 C. Then both vessels were taken off the heat. Distilled water was agitation with stirrer while adding Taila to it slowly. When the temperature was reduced liquid form converted into semi solid form and creamish in colour. Then added fragrance and colour and stirrer switched off. This process was done around 3 hour. 2. Analytical Study The tests p H , specific gravity and refractive index were conducted at Drug Testing Laboratory, Department of Rasa shastra and Bhaishajya Kalpana, National Institute of Ayurveda, Jaipur, Rajasthan and Organoleptic Characters, Physio- Chemical Analysis (except pH, specific gravity, and refractive index), Total aflatoxins, Total bacterial count were conducted at S.R. LABS Pratap Nagar Jaipur. A. Organoleptic Characters Table no. 6 organoleptic examination of following samples of BST and BSM B. Physicochemical Analysis Table no. 7: Showing the physicochemical parameters of BST & BSM Samples . A. Determination Of Viscosity 6 It is a property of liquids, that measures of its frictional resistance (Resistance to flow). A liquid may consisting of molecular layers arranged one over the other. When a shearing force is applied to a liquid, it flows. However, the forces of friction between the layers offer resistance to this flow. Viscosity of BST was 44.55 cP whereas malahar is 3800 cp which shows normal level. Due to lower surface tension. It also signifies that the product can be taken out from the container easily and applied easily. B. Determination Of Specific Gravity 7 The specific gravity of a substance (liquid) is the weight of a given volume of that substance at the status temperature as compared with the weight of an equal volume of water at the same temperature, all weighing being taken in air. Specific gravity of BST was 0.876 which indicates that it has lower density as compared to water, so it floats on water and it shows Laghutva property of Taila . C. Determination Of Refractive Index 8 The Refractive index (ἡ) of a substance is termed as the ratio of the velocity of light in vacuum or air, to that in the substance. The refractive index is related to the ease with which light passes through the fat. Refractive index is generally used to measure the concentration of solute in a solution. Here the refractive index of BST was 72, which is higher than that of water (1.33) D Determination Of pH 9 The pH value of an aqueous liquid may be defined as the

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 48 common logarithm of the reciprocal of the hydrogen ion concentration expressed in gram per litre, The pH of BSM was 6 which is slightly acidic and it doesn’t cause any harmful effects or reactions on skin. E. Determination Of Rancidity 10 Rancidity is a process which is accompanied by the formation of the unpleasant odour, taste and as a result of action of moisture, oxygen of air and enzymes .Rancidity was found absent in both BST and BSM. It means that the product is stable in terms of its quality. F. Determination Of Iodine Value 11 The number of grams of iodine absorbed by 100 gram of the sample material when determined by using Wijs solution. Iodine Value is a measure of the degree of unsaturation of oil/fat. It is a useful parameter in studying the oxidation rancidity of oils/fat, since higher the unsaturation, greater the possibility of the oil to become rancid. The study shows that Iodine value of BST was 23.03 and BSM was (80.98) which is less than that of sesame oil (103 – 112). It means less C=C bonds are present in BST than the sesame oil i.e., comparatively less saturated. The level of oxidation in a sample can determine by the rancidity test. G. Determination Of Acid Value 12 Acid Value indicates the amount of free fatty acid present in oil or fat. Increase in free fatty acid in a sample indicated hydrolysis of triglycerides. Such reaction occurs by the action of lipase enzyme and it is an indication of inadequate processing and storage condition. Free fatty acid content increases due to the exposure to air. Here the acid value of BST was 0.05 mg KOH/g which is slightly more than sesame oil and BSM 0.71 mg KOH/g. H. Determination Of Peroxide Value 13 Peroxide value gives the initial evidence of rancidity in unsaturated fats and oils. The best test for auto-oxidation (oxidative rancidity) is determination of the peroxide value. The peroxide value of BST was 3.30 m eq of O 2/Kg and BSM was 1.19 m eq of O 2/Kg. This shows that BST and BSM are free from moisture content and has less chances of rancidity. I. Determination Of Saponification Value 14 Saponification value refers to the amounts of esters that can be hydrolysed and turned into soap. Saponification value of BST was 12.82 mg KOH/g and BSM was 110.47 mg KOH/g. It shows that it has less value than the sesame oil i.e. (188 – 195). J. Determination Of Ester Value 15 Ester value of BST was 12.77 and BSM was 109.76. In the study BSM was found to be Physically stable by its texture, colour and consistency at temperature 5 o C, 25 o C and 45 o C and 70 % relative humidity for four weeks in a close container. It means it is not altered by the varying temperatures in different seasons and different regions. K. Determination Of Free Fatty Acid 16 The free fatty acid content is expressed as oleic acid equivalents. It is a relative measure of rancidity as free fatty acids are normally formed during decomposition of oil glycerides. Free Fatty Acid of BST was 96.71 %w/w and BSM was 0.35. L. Determination Of Total Fatty Matter Total fatty matter content refers to the sum of triglycerides, phospholipids, wax ester, sterols and minor amount of non-fatty material. Here BST has 96.71 % w/w and BSM 28.66 % w/w total fatty matter. M. Determination Of Spread ability Spread ability consists of the expansion of a semi solid formulation on a surface after a certain time. Spread ability of was BST 3.0 g.cm/s and BSM 4.0 g.cm/s. which shows that the malahar is easy to apply on the skin surface. N. Test For Heavy Metal 17 Heavy metals is a group of tests that measures the quantity of specific potentially toxic metals in ayurvedic/unani/siddha and food stuffs. These heavy metals are lead, cadmium, mercury and arsenic.The procedure used was wet digestion. The Metal content of the sample will be calculated according to the following equation by AAS in ppm unit. Shatpala Ghrita samples were free from Heavy metals and it was safe for therapeutic purpose. O. Test For Afflatoxins 18 Aflatoxins are closely related group of secondary metabolites shown to be mycotoxin. They are produced by fungus named Aspergillus flavus. There are four types of B 1, B 2, G 1, G 2. Aflatoxin residue are highly toxic and causes carcinogenicity. Aflatoxins B 1, B 2, G 1 and G 2 are in below low quantity . P. Microbiological Analysis 19 Total bacterial count, Total fungal count and Enterobacteriaceae were within normal limits as per Ayurvedic Pharmacopoeia of India so the sample was free

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 49 from bacterial and fungal infection. Hence can be said that it is completely safe and have been prepared under Good Manufacturing Practices (GMP) Q. Phytochemical Screening: Qualitative Test HPTLC : HPTLC finger print profile was also performed for both BST and BSM HPTLC Fingerprint profile confirms standard scanning of samples to generate the standardization parameter for quality control purpose. It provides quantitative information of the main constituents of the drug. Samples were analysed on different wavelengths 254 nm, 366 nm and 510 nm. Rf value for BST at 254 nm wavelength 11 spots are found at 0.03,0.04,0.06,0.23,0.46, 0.53, 0.56,0.63,0.72,0.92,0.95. Rf value of 366 nm wavelength 5 spots are found 0.03, 0.05, 0.60, 0.69, 0.89. Rf value of 510 nm wavelength 10 spots are found -0.01, 0.00, 0.04, 0.10, 0.18, 0.22, 0.29, 0.53, 0.73, 0.94. Rf value for BSM at 254 nm wavelength 11 spots are found at 0.02,0.04,0.05,0.18,0.37, 0.49, 0.54,0.61,0.72,0.91,0.95. Rf value of 366 nm wavelength 5 spots are found 0.02, 0.04, 0.47, 0.69, 0.69. Rf value of 510 nm wavelength 10 spots are found -0.03, -0.01, 0.01, 0.09, 0.17, 0.20, 0.25, 0.41, 0.69, 0.88. All three samples showing large number of spots which ultimately denotes that samples have large number of active principles. The scanning data shows different spots visualized get confirms the chemical nature and distribution pattern in specified mobile phase. RESULTS AND DISCUSSIONS After paka the odour of BST & BSM lead to aromatic due to addition of drava dravyas . All samples are in semiliquid consistency before Sneha paka then leads to liquid consistency due to agni sanyog for long duration. After shodhan wt of Vatsnabha was 105 g with 145 g (58.16 %) loss because damaged portion of Vatsnabha were removed.While cutting the Vatsnabha external layer was removed. After Sindoor Shodhan it was found orange in colour. Initial wt of Sindoora 243 g after shodhan 261 g, after Bhavna wt gain was 18 g (7.40%). When Tandulodaka and Nimboo swarasa were added to Sindoora , it became liquid with suspended Sindoora particle. After Shodhan it was found orange colour. After murchchhana Sarshapa Taila was obtained 4300 g with loss 1700 g (28.33%).Final yield of BST Taila after the completion of Sneha paka is 3385 gm with the loss of 15.37%. For better patient acceptability of modified dosage forms, it was decided to convert BST into Malahar (ointment) form because Taila is sticky in nature and sometimes it causes burning sensation to skin. The changes during the preparation of the taila indicates the different chemical changes occurring during the transferring of the properties from drava medium into the taila medium. The aqueous medium in the preparation of taila facilitates the imbibitions of the water soluble extracts into the oil medium. Therefore, modified dosage forms like cream, lotion etc have better potential as a vehicle to administer drug topically, because they are less sticky, are stable and have aesthetic value. Final malahar weight obtained was 4900 g with a loss of 100 g (2%). The colour of malahar was creamish and was having odour of Taila . In Ayurveda, the analytical techniques have always been mentioned in classical texts to understand the quality of the product i.e., Grahya Lakshana , Method of collection etc. for raw drug, Siddhi Lakshana for final product and for medicament. The pH of BSM was 6 which is slightly acidic and it doesn’t cause any harmful effects or reactions on skin. Specific gravity of BST was 0.876 which indicates that it has lower density as compared to water, so it floats on water and it shows Laghutva property of Taila . Refractive index of BST was 72, which is higher than that of water (1.33) . Viscosity of BST was 44.55 cP whereas malahar is 3800 cp which shows product can be taken out from the container easily and applied easily. Spreadability of was BST 3.0 g.cm/s and BSM 4.0 g.cm/s. which shows that the malahar is easy to apply on the skin surface. BST has 96.71 % w/w and BSM 28.66 % w/w total fatty matter. This is be due to the presence of varied amount of fatty content added the acid value of BST was 0.05 mg KOH/g which is slightly more than sesame oil and BSM 0.71 mg KOH/g. Saponification value refers to the amounts of esters that can be hydrolysed and turned into soap. Saponification value of BST was 12.82 mg KOH/g and BSM was 110.47 mg KOH/g. It shows that it has less value than the sesame oil i.e. (188 – 195). Iodine value of BST was 23.03 and BSM was (80.98) which is less than that of sesame oil (103 – 112). It means less C=C bonds are present in BST than the sesame oil i.e., comparatively less saturated. Rancidity was found absent in both BST and BSM. It means that the product is stable in terms of its quality. Ester value of BST was 12.77 and BSM was 109.76. In the study BSM was found to be Physically stable by its texture, colour and consistency at temperature 5 oC, 25 oC and 45 oC and 70 % relative humidity for four weeks in a

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 50 close container. It means it is not altered by the varying temperatures in different seasons and different regions. Free Fatty Acid of BST was 96.71 %w/w and BSM was 0.35.The Peroxide value of BST and BSM are free from moisture content and has less chances of rancidity. Aflatoxins B 1, B 2, G 1 and G 2 are in below low quantity. Total bacterial count, Total fungal count and Enterobacteriaceae were within normal limits as per Ayurvedic Pharmacopoeia of India HPTLC Fingerprint profile confirms standard scanning of samples to generate the standardization parameter for quality control purpose. BST & BSM were analyzed on different wavelengths 254 nm, 366 nm and 510 nm having 11, 5, 10 spots respectively. The presence of these spots could be due to the addition of various Kalka dravya and Dravadravyas . But due to the absence of any standards, the specific compound could not be separately identified. CONCLUSION Literature review suggested that BST is mentioned in Yogratnakar , Bhaishjya Ratnavali, Gada nighraha, Vanga sena, Vrindh madhav, Chakradatta, Vrihat Nighantu Ratnakar, Yoga Chintamani, Yoga tarangini, Vrihat yoga Tarngini and Rasa Kamdhenu in kushtha roga . For the study of Brihatsindooradya Taila this formation was selected from Yogaratnakar, Kustha Chikitsa , shlok no.186-189.BST having kandu nashana ,shrava rodhaka and tvaka shodhaka properties will be used for external application. BST and its modified forms like malahar are prepared as per classical and modified reference under laboratory practices in the departmental laboratory of NIA, Jaipur by establishing proper SOP and SMP. The formula BST consisits of 24 ingredients viz. Sindoor, RaktaChandana, Jatamansi, Vidang, Haridra, Daruharidra, Priyangu, Padyamaka, Kushtha, Manjishtha, Khadir, Vacha, Jati, Arka, Trivrit, Nimba, Karanj, Vatsnabha, Pippali, Chitraka, Lodhra, Chakramarda and sarshapa Taila . The drugs are easily available and cost effective. The pharmaceutical process reveals that BST can be easily prepared by taking caution about various stages occurring during the Sneha-Paka and by paying attention to the Sneha-Siddhi-Lakshanas. Furthermore, preparation of a stable, effective and good consistency emulsion was formulated in the form of BSM. The Malahar was prepared in single day the yield of 5 kg. A total average yield of 3385 g of BST was obtained with an average percentage loss of 15.37%. The malahar also had good thermal stability, easily washable, non-irritant and free from pathogens and no rancidity. In HPTLC finger printing van though a few rf values were similar for both BST and BSM the chemical constituent could not be identified due to the absence of standard marker. Acknowledgements:- Nil Conflict of Interest – None Source of Finance & Support – Nil REFERENCES 1 Anonyms, Govt. of India, Ministry of Health and Family Welfare Department of Ayurveda, Yoga& Naturopathy, Unani, Siddha and Homeopathy, The Ayurvedic formulary of India AFI Part 1, vol.4, page no.167 2 Sharma S, Rasa Tarangini, Sh. 24/20-21 Varanasi: Motilal banarasidas, edi.,1979. 3 Anonyms, Govt. of India, Ministry of Health and Family Welfare Department of Aayush, The Ayurvedic Pharmacopeia of India, Part 1, vol.1, page no.140 (Sarnghara Samhita, Madhyam khand, chapter (1/ 29) 4 Tripathi I, Yogaratnakar Hindi Commentary Krishnadas Academy, Varanasi, 2008.pp. 659 5 Laboratory Guide for the Analysis Of Ayurveda Siddha & Unani Formulation Published by CCRAS,Govt Of India,New Delhi 6 Anonyms, The Ayurvedic Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and Family Welfare, Govt. of India, edition, 2008,Page no.301 7 Anonyms, The Ayurvedic Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and Family Welfare, Govt. of India, edition, 2008,Page no.297 8 Anonyms, The Ayurvedic Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and Family Welfare, Govt. of India, edition, 2008,Page no.297 9 Anonyms, The Ayurvedic Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and Family Welfare, Govt. of India, edition, 2008,Page no.291 10 Anonyms, The Ayurvedic Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 51 Family Welfare, Govt. of India, edition, 2008,Page no.300 11 Anonyms, The Ayurvedic Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and Family Welfare, Govt. of India, edition, 2008,Page no.300 12 Anonyms, The Ayurvedic Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and Family Welfare, Govt. of India, edition, 2009 13 Anonyms, The Ayurvedic Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and Family Welfare, Govt. of India, edition, 2009 14 Anonyms, The Ayurvedic Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and Family Welfare, Govt. of India, edition, 2009 15 Anonyms, The Ayurvedic Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and Family Welfare, Govt. of India, edition, 2009 16 Anonyms, The Ayurvedic Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and Family Welfare, Govt. of India, edition, 2009 17 Anonyms, The Ayurvedic Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and Family Welfare, Govt. of India, edition, 2009 Appendix, 2.3.8 p.no. 265 18 Anonyms, The Ayurvedi,c Pharmacopeia of India, Part - I, Vol. –VI, Department of Aayush, Ministry of Health and Family Welfare, Govt. of India, edition, 2009 Appendix 2.7, pg no.288 19 Ayurvedic pharmacopoeia of India, part-1, volume-VI, appendix 2.4.1, pg no 275 How to cite this article: Sumitra, Kumar S, Rajoria K, Verma VS; Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” IRJAY.[online]2022;5(4);44-58. Available from: https://irjay.com DOI: https://doi.org/10.47223/IRJAY.2022.5405

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 52 Table no.1 Various refrences of Brihatsindooradya Taila ( BST) S.No. Classical treatise Name Reference 1 Bhaishjya Ratnavali Brihatsindooradya taila Shri Govind das, Bhaishjya Ratnavali, edited by shri kaviraj ambikadatta shastri varansi chaukhambha prakashana, edi.,2018 (kustha chikitsa 54/282-285), pg no. 908 2 Gada nighraha Sindooradya tailam Shri Vaidhya shodhal, Gada nighraha, edited by shri ganga sahaya pandeya, varansi chaukhambha Sanskrit series office, part- 2, edi.,1969(kustha chikitsa 36/203-206) 3 Vanga sena Sindooradya tailam Vangasen Samhita with Hindi translation by Kavivar Shri Shaligramji Valshaya edited by Sri Vaidya Srikrishnadas Prakasan Mumbai, Edition 1996, Rasayanadhikar / 40-42. 4 Vrindh madhav Brihatsindooradya taila Acharya Vaidya Tarachand sharma, Vrindh madhav or siddha yoga, edited by maharshi Vaidya Dayaram Awasthi shastri, chaukhambha Sanskrit bhawan, edi., 2012. ( kustha chikitsa, shlok no.129- 132) 5 Chakradatta Mahasindooradya tailam Chakrapanidatta, Chakradatta, hindi commentary Bhavarthasandipini, edited by bhishagratna PT. Brahmashankar Mishra, varansi chaukhambha Sanskrit series office.edi.,2008 ( kustha chikitsa shlok no.153-156) 6 Rasa Kamdhenu Brihatsindooradya tailam (Kustha chikitsa 41/584-587), pg. no. 213 7 Vaidya chintamani Bhrihat sinduradi taila Kustha roga prakarnam shlok no. 231-234 pg.no.407 8 Yoga Sindooradi tailam Shri trimal bhatt, Yoga tarangini

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 53 Table no. 2 Ingredients of Brihatsindooradya Taila (BST) S. No Ingredients English Name Part used Quantity 1 Shuddh Sindoor Lead oxide -- 1 Part 2 RaktaChandana Pterocarpus santalinus heartwood 1 Part 3 Jatamansi Nordostachys jatamansi Mool 1 Part 4 Vidang Embelia ribes Fruit 1 Part 5 Haridra Curcuma longa Kanda 1 Part 6 Daruharidra Berberis aristata Kanda 1 Part 7 Priyangu Callicarpa macrophylla Flower 1 Part 8 Padyamaka Prunus cerasoides Twak 1 Part 9 Kustha Sausserea lappa Mool 1 Part 10 Manjishtha Rubia cordifolia Mool 1 Part 11 Khadir Acacia catechu Twak 1 Part 12 Vacha Acarus calamus Mool 1 Part 13 Jati Jasminum officinale Leaf 1 Part 14 Arka Calotropis procera Leaf 1 Part 15 Trivrit Operculina terpentum Mooltwak 1 Part 16 Nimba Azardiarachta indica Leaf 1 Part 17 Karanj Pongamia pinnata Leaf 1 Part 18 Vatsnabha Aconitum ferox Mool 1 Part 19 Pippali Piper longum Fruit 1 Part 20 Chitraka Plumbago zeylanica Mool 1 Part 21 Lodhra Symplocos racemosa Twak 1 Part 22 Chakramarda Cassia tora Seed 1 Part 23 Mustard oil Brassica nigra Seed oil 4 Part 24 Jala Water -- 16 Part Table no.3 Details of base ingredients of the Brihatsindoordya Taila Malahar. S. No. Ingredients Uses 1 Brihatsindoordya Taila Active ingredient 2 Distilled water To formulate phase I (Aqueous Phase) 3 Paraffin wax Thickening 4 Bees wax Thickening/ Emollient 5 Emulsifying wax Emulsifying agent 6 Stearic acid Emulsifier 7 Glycerol mono stearate (GMS) Emulsifier 8 Iso propyl alcohol (IPA) Emollient 9 Cetyl alcohol Thickening agent 10 Methyl paraben sodium (MPS) Preservative 11 Ceto stearyl alcohol (Ginol 1618) Emulsifying agent 12 Colour Coloring 13 Fragrance ( Chanadan ) Fragrant

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 54 Table no.4 Showing the ingredients used in Sarshapa Taila Murchchhana . Sr. No. Ingredients Latin Name/English Name Family Part Used Quantity (g) 1. Amalaki Embelica officinale Euphorbiacea Fruit 94 2. Haridra Curcuma longa Zingiberacea Rhizome 94 3. Musta Cyprus rotundus Cypraceae Rhizome 94 4. Bilva Aegle marmelos Rutacea Fruit 94 5. Dadima Punica granatum Punicaceae Dry seed 94 6. Nagkeshar Mesua ferrea Lytharacea Stamens 94 7. Krishna jeeraka Carum carvi Umbelliferae Fruit 94 8. Sugandh bala Coleus vettiveroides Lamiaceae Root 94 9. Nalika Cinnamomum tamala Nelumbonacea Stem Bark 94 10. Bibhitaka Terminalia belerica Combretacae Fruit 94 11. Manjistha Rubia cordifolia Rubiacea Stem 94 12. Sarshapa Taila Brassica campestris Brassicacea Seed oil 6000 13. Water 20000

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 55 Table no. 5 Showing the Sneha Sidhi lakshana during BST. S. no Sneha siddhi lakshana Kalka Taila 1. Shabda hino agni nikshipta + + 2. Phenashanti + - 3. Gandha varna rasotpatti + - 4. Syav eva niryase - + 5. Madhye darvi vimunchati - + 6. Vartivat kalka - + Table no.6 Showing the ingredient of Brihatsindooradya Malhar ( BSM) S. No. Ingredient Quantity (%) Quantity (g) 1. Bees wax 01.25 62.50 2. Emulsifying wax 02.50 125.00 3. Paraffin wax 01.25 62.50 4. Ceto stearyl alcohol 01.50 75 5. Cetyl alcohol 01.00 50 6. Stearic acid 01.50 75 7. Glycerol mono stearate (GMS) 02.00 100 8. Iso propyl alcohol (IPA) 03.00 150 9. Active part (BST) 25.00 1250 10. Methyl paraben sodium (MPS) 00.50 25 11. Distilled water 59.50 2975 12. Colour 00.50 25 13. Fragrance (Chandan Fr.) 00.50 25 Total 100 % 5000 g

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 56 Fig 1 Pharmaceutical images of Sasarpa tail murcchana , BST, BSM A. ORGANOLEPTIC CHARACTERS Table no. 6 organoleptic examination of following samples of BST and BSM S.no. Organoleptic parameters BST BSM 1. Appearance Thick viscous Thick and stick mass 2. Colour brown Pink 3. Odour Characterstic Characerstic 4. Taste ---- ----

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 57 C. PHYSICOCHEMICAL ANALYSIS Table no. 7: Showing the physicochemical parameters of BST & BSM Samples . S. No Parameters BST BSM 1. Organoleptic parameters Appearance Thick viscous Thick and stick mass Colour Brown Pink Odour Characteristic Characteristic Touch 2. Physico-chemical analysis pH Not detected 6 Specific gravity 0.876 Not detected Refractive index 72 Not detected Viscosity 44.55 cP 3800 cP Mineral Taila Absent Absent Unsaponifiable matter 1.18 7.57 Rancidity Absent Absent Iodine value 23.03 80.98 Acid value 0.05 mg KOH/g 0.71 mg KOH/g Peroxide value 3.30 m eq of O 2/Kg 1.19 m eq of O 2/Kg Saponification value 12.82 mg KOH/g 110.47 mg KOH/g Ester value 12.77 109.76 Free fatty acid 0.02 0.35 Total fatty matter 96.71 % w/w 28.66 % w/w Spreadability 3.0 4.0 Therma stability (at 5, 25, 45 oC) for 5 days Stable stable HPTLC

Sumitra et.al “Pharmaceutico-Analytical study of Brihatsindooradya Taila and its Malahar ” : 2022; 5 (4):44-58 58 3. Total aflatoxins Aflatoxin B 1 BLQ (LOQ 0.008) mg/Kg BLQ (LOQ 0.008) mg/Kg Aflatoxin B 2 BLQ ( LOQ 0.008) mg/Kg BLQ (LOQ 0.008) mg/Kg Aflatoxin G 1 BLQ (LOQ 0.008) mg/ Kg BLQ (LOQ 0.008) mg/Kg Aflatoxin G 2 BLQ (LOQ 0.008) mg/Kg BLQ (LOQ 0.008) mg/Kg 4. Microbiological analysis Total bacterial count <10 cfu/g <10 cfu/g Total fungal count <10 cfu/g <10 cfu/g Enterobacteriaceae <10 cfu/g <10 cfu/g Table No 5: Showing the results of HPTLC of BST & BSM . Sample 254 nm 366 nm 510 nm BST 11 spots visualize 5 spots visualize 10 spots visualize BSM 11 spots visualize 5 spots visualize 10 spots visualize

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