1. INTRODUCTION:

Dosage Form (DF) is defined as the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption¹. Rasashastra evum Bhaishajya kalpana (Ayurveda pharmaceutics) is the cornerstone of Ayurvedic medical science, dealing with the manufacturing of various dosage forms containing herbs, metals, or minerals alone or in combination. The dosage forms are prepared used as per the quality of material as well as the needs of the treatment.

Acharya Charaka a scholar of Ayurveda has mentioned 3 types of therapies for the management of disease, in Sutrasthana they are Anta Parimarjana (internal adiministrations/internal therapies), Bahya Parimarjana (external administrations/external therapies) and Sastra Pranidhana (surgical interventions)². Malahara Kalpana, a comes under the category of external applications, similar to ointments in western or contemporary system of medicine. There are no references found regarding Malahara Kalpana in ancient literatures of Ayurveda. Basically, being originated from Unani system of medicine, it has found a place in the books of Ayurveda after 17^th century AD. The word Malahara was adopted by Yogaratnakara from the word Malaham or Marham are basically originated from Unani System of Medicine. The word Malahara, which means it, removes Mala (residues) from Vrana, Twak Vikara etc³. Before that, term ‘Abhyanjana’ was used in classical texts for semi solid topical formulations. In the 20^th century, in Rasashastra treatise viz. Rasatarangini enumerated number of Malahara kalpanas. Pharmaceutical processing of Malahara (ayurvedic ointments) requires basically three ingredients, an oil base, a binding material and ingredients in fine powder form. Usually tila taila (sesame oil) is used as oily base. As a binding material madhuchistha, ghrita, sarjarasa, shatadhautha ghrita etc are used. Sikta Taila is the basic content for the preparation of Malahara Kalpana. It is a mixture of madhucchishta (Beeswax) and tila taila (sesame oil). It is soft, smooth ointment like substance, used as an emollient as a base in the preparation of different ointments.⁴ In modern pharmaceutical industries Vaseline, paraffin, animal fats are used for preparation for ointments. Ointments, creams, gels and pastes can be correlated with Malahara by their mode of application and semi-solid consistency.

Among various malahara been found mentioned in Rasatarangini, one of them being Tutthamruta Malahara which is a unique in nature and found mentioned in Rasatarangini, which is especially in indicated in Paama Kushta (Scabies) for external application. It contains Tuttha (Copper Sulfate) as an active ingredient. According to Ayurvedic classical texts, Tuttha is widely used in skin diseases, ulcer, sinus, worm infection, vitiligo, obesity, diabetes mellitus, pain, asthma, hyperacidity, hemorrhoids, diseases of eyes, leprosy, chronic diarrhea, dysentery, leucorrhoea and gonorrhoea⁵. It is still listed as an antidote in the World Health Organization's Anatomical Therapeutic Chemical Classification System. Also having properties like powerful astringent, mild caustic, antiseptic, stimulant, styptic and applied in indolent ulcers, exuberant granulations, sinuses, fistula in ano, eczema, impetigo, eye disorders etc⁶.

In present article an attempt has been made for Pharmaceutico analytical evaluation of Tutthamruta Malahara.

2. MATERIALS AND METHODS:

Ingredients required for the preparation of Tuthakamruta malahara were procured from Nageswara Rao Pharmacy, NIA Deemed to be University Jaipur. Analytical study of the sample was done from AYUSH approved drug testing laboratory ie. S.R Labs and Research centre, Jaipur.

2.1. PHARMACEUTICAL STUDY:

In the preparation of Tutthamruta Malahara the following are two main ingredients which are as detailed along with their requisite quantity in Table No 1.

Table No: 1 Ingredients of Tutthamruta Malahara

Sl. No	Ingredients	English name	Quantity as per the reference
1.	Siktha taila	--	10 tola (120 g)
2.	Shoditha Tuttha	Purified Copper Sulphate	20 gunja (2.5 g)

Method of preparation:

Shodhana of Tuttha (Purification or Removal of blemishes of Tuttha): Ashodhita Tuttha (impure or untreated material) was taken in a clean dry Khalwa Yantra (mortar and pestle) and made into powder. Further, it was triturated for six hours with an adequate amount (qs) of Nimbu Swarasa (Fresh lemon juice). The triturated Tuttha was later dried well. This Shodhit Tuttha (purified or treated) would be used for the preparation of Tutthamruta Malahara.

Fig.1: Shodhitha Tuttha.

Preparation of Siktha Taila (Ointment base)⁷:

120g of Tila Taila (sesame oil) was taken in a clean stainless-steel vessel and heated slowly with constant heat. Further, 24g of scraped Siktha (bee wax) was added and allowed to melt completely (Table No. 2) and the final product ie Siktha Taila (Fig. 2) is prepared and kept safely.

Fig. 2: Siktha Taila

Preparation of Tutthamruta Malahara⁸:

120g of Siktha taila was taken in a clean stainless-steel vessel, placed over mild fire, as it liquefies, the vessel was taken out of fire and the liquid matter was poured in a clean porcelain mortar and is added with fine powder of 2.5g of Shoditha Tuttha and triturated well to get a homogeneous mixture (Fig. 3). After cooling, the mixture attains semisolid consistency as desired for Malahara (Fig. 4). This final product is stored in an appropriate wide mouthed clean dry airtight container for further study or use.

Fig. 3: Mixing of Shoditha Tuttha and Siktha Taila.

Fig. 4: Tutthamruta Malahara.

2.2 Analytical Study:

The analytical study includes organoleptic evaluation and physico-chemical analysis of the formulation as prepared.

1. Organoleptic Parameters:

These tests were performed by using the sensory organs. The Organoleptic characters including Rupa (Color), Gandha (Odour) and Sparsha (Consistency) of the formulations were recorded (Table No 4).

2. Topical sensitivity test:

The test was carried out to check any possibilities of developing skin irritation or any other adverse reaction by topical application of this formulation. The formulation was applied to the elbows in selected human volunteers and was observed for any side effects like skin inflammation, irritation, reddening of the skin etc.

3. Physico-chemical Parameters:

The formulation was analysed for Total fat, Specific gravity, Refractive index, Spreadability etc at SR Labs and Research Centre, Jaipur. All the tests were done as per the standard pharmaceutical laboratory process given in Laboratory guide for the analysis of Ayurveda and Siddha formulations.

Refracrive Index⁹:

The refractive index (η) of a substance with reference to air is the ratio of the sine of the angle of incidence to the sine of the angle of refraction of a beam of light passing from air into the substance. It varies with the wavelength of the light used in its measurement. The Abbe’s refractometer is convenient for most measurements of refractive index. The temperature should be carefully adjusted and maintained since the refractive index varies significantly with temperature.

Rancidity¹⁰:

The test depends upon the formation of a red colour when oxidized fat is treated with coc. HCl and a solution of 0.1% Phlorogucinol in ether. The compound in rancid fats responsible for colour reaction is epihydrin aldehyde. All oxidized fats respond to Kreis test and the intensity of the colour produced is roughly proportional to the degree of oxidative rancidity.

Spreadability¹¹:

The spreadability was determined by placing excess of sample in between two slides which was compressed to uniform thickness by placing a definite time. The time required to separate the two slides was measured as spreadability.

Peroxide Value¹²:

The peroxide value is the number of milliequivalents of active oxygen that expresses the amount of peroxide contained in 1000 g of the substance. It gives the initial evidence of rancidity in unsaturated fats and oils. The double bonds found in fats and oils play a role in auto oxidation. Oils with a high degree of unsaturation are most susceptible to auto oxidation.

Acid Value¹³:

The acid value is the number of mg of potassium hydroxide required to neutralize the free acids in 1 g of the substance, i.e, it is the number of milligrams of potassium hydroxide required to neutralize the free fatty acids present in one gram of fat.

3. RESULTS:

Table No. 2: Quantity of ingredients/ drugs used for preparing Siktha Taila

Drugs	Quantity
Siktha	24 g
Tila taila	120 g

Table No. 3: Ingredients and yield of Tutthamruta Malahara

Ingredients	Quantity
Siktha Taila	120g
Shoditha Tuttha	2.5g
Total yield of Tutthamruta Malahara	121.8g
Percentage of Yeild	99.45%
Percentage of Loss	0.55%

Table. No. 4: Organoleptic Characters of Tutthamruta Malahara

Sl. No	Parameters	*Tuthakamrutha Malahara*
1	Colour	Dark olive pastle green
2	Odour	Characteristic
3	Consistency	Semisolid / Thick Viscous
4	Touch	Soft

Table No. 5: Results of Analytical Test of Tutthamruta Malahara.

Sl. No	Test Parameters	Unit	Result
1.	Refractive Index	-	1.483
2.	Rancidity	-	Absent
3.	Spreadability	g. cm/S	11.0
4.	Peroxide Value	m eq O₂/Kg	41.01
5.	Acid Value	mg KOH/g	0.35

4. DISCUSSION:

In the present study, Tutthamrutha Malahara was prepared by fusion method as per the classical reference of Rasatarangini. While preparing the formulation, the base ingredients ie. bee wax and sesame oil was heated adequately to melt for forming of a homogenous mixture. Then finely powdered Shoditha Tutha was added to Siktha Taila and mixed well using mortar and pestle for the uniform distribution of Tuttha into the Siktha Taila. Total yield of Malahara was 121.8g. Tutthamrutha Malahara has been indicated in Kushta especially in Paama. The active ingredient Tuttha (copper sulphate) helps in treating itching, wound healing. It is a best anti-microbial agent whereas Siktha Taila also acts on itching, wound healing and dermatitis like skin ailments in addition to softening. The organoleptic characters of Tutthamrutha Malahara showed dark olive pastle green colour due to the presence of Tuttha, with characteristic smell, thick viscous consistency and soft to touch with no grittiness (Table.No.4). It appears to be an easy topical application having unique therapeutic action. Formulaion did not show any signs of erythema or oedema when applied to the skin, which shows that the formulation was safe.

Refractive index (R.I) and rancidity are the parameters that show the quality and purity of the formulation. Here the R.I of Tutthamrutha Malahara was 1.483 and rancidity was absent. Spreadability of the topical application indicates its ability to spread on skin. Spreadability of the sample was 11 g. cm/s. Acid value and Peroxide value indicates whether oxidation of the formulation occurred or not. Acid value and Peroxide value of the sample was 0.35 mg KOH/g and 41.01m eq O₂/Kg respectively (Table.No.5). The final weight of the preparation was 121.8g which was less by 0.7(0.55%). The loss may be due to suboptimal handling.

5. CONCLUSIONS:

In the present study, an attempt was made to prepare Tutthamrutha Malahara as per the reference of Ayurveda classics ie Rasatarangini and also to evaluate it on standard analytical parameters. The Tutthamruta Malahara is a combination of Sikthataila and Shoditha Tuttha where only 2 percentages of purified Tuttha is coming in the end product. It is easy to prepare formulation and effective in various skin ailments, but not widely used in practice. Further experimental studies of the formulation will pave way forward for its wider application in ailing population.

6. REFERENCES:

1. Available from https://www.pharma-iq.com/glossary/dosage-form-df last accessed on 25^th October 2022 at 8:30 PM.

2. Caraka Samhita, Sutrasthana Chapter 11, Verse no, 55 Available from https://niimh.nic.in/ebooks/ecaraka/?mod=read last accessed on 28^th January 2023 at 9:03 PM.

3. Available from https://www.easyayurveda.com/2016/04/20/ malahara-kalpana-ointment/amp/ last accessed on 25^thOctober 2022 12:03 PM.

4. Poonam Bhojak Et. al. Malahara Kalpana – An Ancient and Modern Pharmaceutical Approach. International Ayurvedic Medical Journal. 2017; 5(4).

5. Pandey, P. S. Mineralogical Identification and Characterisation of Sasyaka-An Ayurvedic Drug. International Journal of Ayurveda and Pharma Research. 2020; 7(12): 75-78.

6. Abinash Pradhan, Gopikrishna M, Sashidhar J. Conceptual review on Sasyaka (tuttha). World Journal of Pharmaceutical Research.2022; 11(3); 1277-1288.

7. Dr. Ravindra Angadi, Editor Rasa Tarangini of Sadananda Sharma, Chaukambha surbharathi Prakashan, Varanasi, 2020; 12.

8. Sadananda Sharma, Rasatarangani, hindi commentary, edited by Pandit Kashinatha Shastri, 21st Taranga, Sloka 97-98-, Delhi; Motilal Banarasidas; 11th edition, Reprint, 2012. P- 539.

9. The Ayurvedic Pharmacopoeia of India, Part-I, Vol. VI, Govt. of India, MOHFW, Dept. of AYUSH, New Delhi, 2008, pg. 290

10. The Ayurvedic Pharmacopoeia of India, Part-I, Vol. VI, Govt.of India, MOHFW, Dept. of AYUSH, New Delhi, 2008, pg. 301

11. Indian Standard, Skin Cream specifications, second revision2004, Physical and Chemical Tests, IS 6608 (Part -1) -2004.

12. The Ayurvedic Pharmacopoeia of India, Part-I, Vol. VI, Govt. of India, MOHFW, Dept. of AYUSH, New Delhi, 2008, pg. 300.

13. The Ayurvedic Pharmacopoeia of India, Part-I, Vol. VI, Govt. of India, MOHFW, Dept. of AYUSH, New Delhi, 2008, pg. 300

Received on 19.05.2023 Modified on 26.07.2023

Res. J. Pharmacognosy and Phytochem. 2023; 15(4):273-276.

DOI: 10.52711/0975-4385.2023.00042

Method of preparation:

Preparation of Siktha Taila (Ointment base)7:

120g of Tila Taila (sesame oil) was taken in a clean stainless-steel vessel and heated slowly with constant heat. Further, 24g of scraped Siktha (bee wax) was added and allowed to melt completely (Table No. 2) and the final product ie Siktha Taila (Fig. 2) is prepared and kept safely.

Preparation of Siktha Taila (Ointment base)⁷: