INTRODUCTION:

The ointment and cream preparations are semi-solid topical formulations having an ability to cleaning the surface of application for the reasonable duration.¹ The herbo-mineral topical formulations play an important role in the prevention and treatment of bacterial, viral, fungal infections of skin such as Erythema multiformae, acne vulgaris, psoriasis, wound ,ulcers and chronic infections of the skin.⁴ The Shat-dhaut-ghrit is useful in the treatment of wound, ulcer and could restricts the entry of the micro-organism .It helps to improve the spreadiability of the formulation. The hydro-carbon waxes used in the formulation to increase the viscosity of mineral oil in order to prevent it`s separation. The incorporation of the Shat-dhaut-ghrit gives medicated base to the formulation.

EXPERIMENTAL METHOD:-

Materials:-

The herbo-mineral mixture containing mainly camphor, shendur, muddar-sing and pale-catechu which are procured from Dorle Ayurveda Bhavan, Kolhapur . The-dhaut -ghrit were prepared in our college laboratory from cow ghee and rests of the ingredients used are of analytical grade. All the herbo-minerals were authenticated by the Ayurvedic Practitioners for their identity and purity.

METHODS:-

Herbo-mineral ointment (50gm) ^3,4

The herbo-mineral ointment is prepared by fusion method.

Formula: - A-1: - Formulation code for ointment having 5% w/w concentration of herbo-mineral mixture.

Formula: - A-2:- Formulation code for ointment having 10% w/w concentration of herbo-mineral mixture.

Formula: - A-3:- Formulation code for ointment having 15% w/w concentration of herbo-mineral mixture.

In all above formulations, formulation having 5% w/w concentration of herbo-mineral mixture is more stable.

Procedure:-

Beex wax, cetostearyl alcohol, wool fat, white soft paraffin melted in a porcelain dish .Triturate the shat dhaut ghrit and herbo-mineral mixture in above base, until the semisolid preparation is formed.

Herbo-mineral cream (50gm) ^3,4

Formula:-B-1:-Formulation code for cream having 5% w/w concentration of herbo-mineral mixture.

Formula:-B-2:-Formulation code for cream having 10% w/w concentration of herbo-mineral mixture.

Formula:-B-3:-Formulation code for cream having 15% w/w concentration of herbo-mineral mixture.

In all above formulations, formulation having 5% w/w concentration of herbo-mineral mixture is more stable.

Procedure:-^6,7

Heat the ingredients of oil phase (bees wax, liquid paraffin) and aqueous phase separately to 75⁰c and mix the later two forms slowly with continuous stirring. Triturate the Shat dhaut ghrit in above mixture, until the semisolid preparation is formed.

Formula: - A-1

Sr. No.	Ingredients	Quantity taken	Properties
1.	Herbo-mineral mixture	2.5gm	Anti-bacterial, anti-viral
2.	Shat dhaut- ghrit	11.25	Potent lipid base
3.	Bees wax	0.735gm	Oily base
4.	Cetostearyl alcohol	1.01gm	Oily base
5.	Wool fat	1.80gm	Oily base
6.	White soft paraffin	37.69gm	Oily base

Formula: - A-2

Sr. No.	Ingredients	Quantity taken	Properties
1.	Herbo-mineral mixture	5gm	Anti-bacterial,anti-viral
2.	Shat dhaut -ghrit	11.25	Potent lipid base
3.	Bees wax	0.675gm	Oily base
4.	Cetostearyl alcohol	1.01gm	Oily base
5.	Wool fat	1.68gm	Oily base
6.	White soft paraffin	30.81gm	Oily base

Formula: - A-3

Sr. No.	Ingredients	Quantity taken	Properties
1.	Herbo-mineral mixture	7.5gm	Anti-bacterial, anti-viral
2.	Shat dhaut -ghrit	11.25	Potent lipid base
3.	Bees wax	0.6125gm	Oily base
4.	Cetostearyl alcohol	0.935gm	Oily base
5.	Wool fat	1.555m	Oily base
6.	White soft paraffin	28.37gm	Oily base

Monographs:-^3,6

1) Lanolin:-

White, pale yellow unctuous substance.

Acid value - NMT -1, Saponification value - NLT -8

Melting point - 45^o -55⁰c

2) Cetyl alcohol:-

It is the mixture of solid alcohol consists of mainly hexadecanol, white unctuous mass, powder flakes.

Acid value - NMT -1, Melting point - 46^o -52⁰c

3) White bees wax:-

It is prepared by bleaching the wax obtained from the honey comb of the bees Apis melliferae and possibly other species of Apis.

Acid value - NMT -18-24, Melting point - 62^o -74⁰c

EVALUATION OF PHYSICAL PARAMETERS:-^3,5

Abbrevation:-A-1,A-2,A-3 are the formulation codes for ointment And B-1,B-2,B-3 are the formulation codes for cream w.r.t. different concentration of camphor.

Note: - The values mentioned above, are the average values after repeated reproducible results.

The prepared formulations of both the ointment and cream are evaluated for the various parameters,

Determination of pH:-

The pH of the prepared camphor ointment and camphor cream are determined by using the digital pH meter at constant temperature .Before this, pH meter was calibrated by using the buffer solution of pH 7.0 to 9.2.

Formula:-B-1

Sr. No.	Ingredients	Quantity taken	Properties
1.	Herbo-mineral mixture	2.5gm	Anti-bacterial, anti-viral
2.	Shat dhaut ghrit	11.25gm	Potent lipid base
3.	Bees wax	10.8gm	Oily base
4.	Liquid paraffin	14.17ml
5.	Borax	0.225gm	Aqueous base
6.	Purified water	11.83ml	Vehicle
7.	Methyl paraben	q.s.	Preservative

Formula:-B-2

Sr. No.	Ingredients	Quantity taken	Properties
1.	Herbo-mineral mixture	5gm	Anti-bacterial, anti-viral
2.	Shat dhaut ghrit	11.25gm	Potent lipid base
3.	Bees wax	9.8gm	Oily base
4.	Liquid paraffin	12.06ml
5.	Borax	0.225gm	Aqueous base
6.	Purified water	11.02ml	Vehicle
7.	Methyl paraben	q.s.	Preservative

Formula:-B-3

Sr. No.	Ingredients	Quantity taken	Properties
1.	Herbo-mineral mixture	7.5gm	Anti-bacterial, anti-viral
2.	Shat dhaut ghrit	11.25gm	Potent lipid base
3.	Bees wax	9.5gm	Oily base
4.	Liquid paraffin	11.08ml
5.	Borax	0.225gm	Aqueous base
6.	Purified water	10.12ml	Vehicle
7.	Methyl paraben	q.s.	Preservative

Spreadiability:-

The spreadiability of the formulations determined by an apparatus consisting of wooden block with pulley at one end. A rectangular group glass plate was fixed on the wooden block. Then, the ointment and cream are sandwiched between plate and another glass plate. The top plate was subjected to the pull of 20gm with the help of string attached to the hook and the time in seconds required by the top plate to cover the distance of 10cms was noted.

Loss on drying: -

It is an evaluation parameter restricted for the mineral potent medicament to avoid an entrapment of water.

% Loss on drying = Initial weight (gm) of sample-Weight of ash (gm)/initial weight (gm) X 100

Table No.1

Formulation code	pH	Spreadiability	Loss on drying	Acid value	Saponification value	Colour	Appearance
A-1	4.7	34sec	60%	0.6725	93.25	Reddish- brown	Smooth
A-2	4.8	32sec	50%	0.6525	95.45	Reddish- brown	Smooth
A-3	4.5	31sec	60	0.6675	96.15	Reddish -brown	Smooth
B-1	5.2	21sec	40%	0.9656	112.56	Reddish -brown	Smooth, viscous
B-2	5.4	20sec	50%	0.9708	118.25	Reddish- brown	Smooth, viscous
B-3	5.3	19sec	40%	1.0256	115.15	Reddish -brown	Smooth, viscous
Standard value for Ointment	4-6	30-40sec	40-50%	NMT-2	92.6.-97.75	Reddish- brown	-
Standard value for cream	4-6	18-26sec	30-50%	NMT-2	111.0-117.5	Reddish -brown	-

Acid value:-

Take 50ml an equal volume of ether and alcohol in 250ml in conical flask .Then; add 10gm of oily base. If oily base is not soluble in above mixture, then attach the reflux condenser for 30minutes.Then, cool the mixture and add phenolphthalein as an indicator .Titrate it with 0.1N NaOH . Observe the end point .Calculate the acid value by using the following formula as,

Acid value = n X 5.61/W

Where, n= the volume of NaOH added.

W=the weight of oily base added.

Saponification value:-

Take 2gm of oily base and dissolve in 25 ml of 0.5N KOH in 250ml round bottom flask.Then, attach the reflux condenser for 30minutes, then, cool the mixture and add phenolphthalein as an indicator. Titrate it with 0.5N HCl. Observe the end point .Calculate the saponification value by using the following formula as,

Saponification value= (b-a) X28.5/W

Where, b= the volume of HCl added for blank titration.

a=the volume of HCl added for the back titration.

RESULT AND CONCLUSION: -

The result obtained from all the above tests were complies with I.P standard. The formulations of herbo-mineral have high tendency to treat the various skin diseases such as wound, ulcer, Erythema multiformae, acne vulgaris and chronic infection of skin. For these desired actions, the topical formulations of herbo-minerals were developed .The Shat-dhaut-ghrit was used in the formulations which have its own activity .The Shat-dhaut-ghrit helps to improve the spreadiability and gives the medicated base to the formulations. The various parameters for the herbo-mineral ointment and cream formulations are tabulated in the TableNo.1. The pH of both the formulations is found between ranges 4.4-5.6 which lies in the normal pH range of the skin. All the prepared formulations show uniformity in their drug content. spreadiability play an important role in patient compliance and help in the uniform application of the ointment and cream formulations to the skin. The acid value of formulation helps in chemical evaluation of pure lipid bases and hence, it determines the % purity and rancidity .So, the prepared formulations of herbo-minerals have good topical activity.

REFERENCES:-

1) L. Lachman, H.A.Lieberman and J.L.Kaing: The theory and practice of industrial pharmacy, Vargheese Publishing House, Mumbai, 1987.

2) M.E.Aulton: Pharmaceutics science of dosage form design.

3) Remington Pharmaceutical sciences –Alfonso R. Gennaro (Mack Publishing Co.)

4) James and Swarbrick and James C. Boylan: Encyclopedia of Pharmaceutical Technology.Marrel DekkarMC, New York.

5) Gokhale, Kokate, Purohit; Textbook of Pharmacognosy and Phytochemistry, Nirali Prakashan.

6) Bentley’s and Stanley: Practical book of Pharmaceutical organic chemistry.

7) Cooper and Gunn, Text-book of Pharmaceutical dosage forms.

Received on 24.12.2009 Accepted on 20.02.2010

Res. J. Topical and Cosmetic Sci. 1(1): Jan. – June 2010 page 30-32