Title of Invention	A HERBAL ANTIMICROBIAL DERMATOLOGICAL DRUG
Abstract	The present invention comprises of mixture A consisting of plurality of essential oils i.e., Cymbopogon citrates and Ocimum sanctum and a base material consisting of plurality of waxes i.e., Cetyl alcohol, Stearic acid, Glyceryl monosterate and Ethylene glycol monosterate. The present invention is a synergistic mixture as its antimicrobial activity is far greater than the antimicrobial activity of the individual ingredients. The drug has potmt antimicrobial activity against Staphylococcus aureus which is responsible for a variety of skin diseases both in human and animals. S. aureus is also responsible for secondary skin infections. The present invention also possesses significant anti-inflammatory and wound healing properties.

Title of Invention

A HERBAL ANTIMICROBIAL DERMATOLOGICAL DRUG

Abstract

The present invention comprises of mixture A consisting of plurality of essential oils i.e., Cymbopogon citrates and Ocimum sanctum and a base material consisting of plurality of waxes i.e., Cetyl alcohol, Stearic acid, Glyceryl monosterate and Ethylene glycol monosterate. The present invention is a synergistic mixture as its antimicrobial activity is far greater than the antimicrobial activity of the individual ingredients. The drug has potmt antimicrobial activity against Staphylococcus aureus which is responsible for a variety of skin diseases both in human and animals. S. aureus is also responsible for secondary skin infections. The present invention also possesses significant anti-inflammatory and wound healing properties.

Full Text	The present invention relates to a herbal antifungal, antimicrobial and antibacterial dermatological drug and the process for manufacturing this herbal antifungal, antimicrobial and antibacterial dermatological drug. Nature has a bounty of plants and natural agents which show promising anti-microbial activity. Synthetic anti-microbial agents are often active only against a narrow spectrum of bacteria/fungi and in cases where stronger doses are necessciated, the synthetic agents generally express side effects. More over, the phenomenon of development of resistance by microbes is very common. Natural agents are generally safe and since the chemistry of the molecules are very complex compared to their synthetic counterparts; it becomes alt the more difficult for the microbes to develop resistance. Wound infections are mainly caused by Gram negative bacteria like Psuedomonas aeroginosa (other species of Psuedomonas also) and Gram positive bacteria like Staphylococcus aureus. Fungal species of the genus Microsporum, Trichophyton and Epidermophyton are normally responsible for causing skin diseases. The present invention serves as a multipurpose dermatological cream which is effective against a broad range of bacteria and fungi, and also possesses ant inflammatory and wound-healing properties. To arrive at this invention, a large number of Indian medicinal plants were screened using "well-bore" technique as well as checked using isobologram. Finally, only those ingredients exhibiting synergistic effect with each other were selected. The novelty of this invention therefore lies not only in its composition, but also in the way its ingredients are processed and blended with each other, so that their synergistic potential is expressed maximally. Majority of the antimicrobial ointments/creams available in the market are synthetic in origin and contain antibiotic compounds. These compounds generally have specific and narrow spectrum of antimicrobial activity. Moreover, they pose a risk of the microbes developing resistance to them, thus making the formulation ineffective. The present herbal antifungal, antimicrobial and antibacterial dermatological composition contains natural ingredients having a broad spectrum activity against a range of microbes and is therefore preferable. Being natural substances, the chemistry is quite complex and risks of microbes developing resistance to these compounds is negligible. The present herbal drug consists of plant derivatives derived from members of Labiatae, Poaceae and the like. Ocimwn sanctum is an aromatic herb belonging to the family Labiatae, and is found to occur throughout India. It contains an essential oil which is known to have potent antimicrobial activity and contains a phenyl propanoid compound called eugenol. According to the present invention, a herbal antifungal, antimicrobial and antibacterial dermatological drug comprising the plurality of essential oils minimum two, 2.5% by weight of the total composition, which are mixed and stirred to obtain Mixture A which consists of Cymbopogon citrates{20A5%) and Ocimum sanctum( 40-80%). Mixture B i.e. base material consisting of a plurality of waxes at 12 to 16% by weight of the total composition, melting the said base materials over moist heat to obtain a soft paste, adding a fixed oil to the said soft paste at 8 to 12% by weight of said composition, stirring the said mixture of base and oil continuously and adding to the said mixture, an antioxidant to the tune of 0.02 to 0.07% for weight of the said total composition adding to the said mixture, solubiliser 2 to 5% by weight of the total composition, heating the said mixture to the temperature of 50 to 70 C under a moist atmosphere to obtain a homogenous Mixture B, adding the said Mixture B to the Mixture A and stirring it continuously while cooling the said mixture to 40 to 45°C keeping the stirring constant and adding the solution of preservatives 0.5 - 2.0% and adding water while stirring at 40 to 45°C to make the composition 100% by weight, cooling the said composition to room temperature to obtain homogenous cream. According to present invention, a process for the preparation of herbal antifungal, antimicrobial and antibacterial dermatological drug comprises of the following steps: Step 1: Mixture A is made by adding Cymbopogon citrates(20-45%) and Ocimum sanctum(40-80%). This mixture is taken 2.5% w/w of the total composition. Step 2: The base material consisting of a plurality of waxes, taken in 14.5% w/w of the total composition consists of: 1. Cetyl alcohol 2-5% by weight of the composition 2. Stearic acid 3.5-5.5% by weight of the composition 3. Glyceryl monosterate 2-5% by weight of the composition 4. Ethylene glycol monosterate 0.1- 2.5% by weight of the composition Step 3: The said base materials are melted over moist heat to obtain a soft paste and added a fixed oil to the said soft paste 10% w/w of said composition, stirring the said mixture of base and fixed oil continuously to obtain homogenous form. Step 4: An antioxidant to the tune of 0.05% w/w of the said total composition is added to the said mixture obtained in step 3 along with solubiliser 4.0% w/w of the total composition. The said mixture is heated to a temperature of 500C under a moist atmosphere to obtain a homogenous Mixture B. Step 5: Mixture B is added to Mixture A and stirring is continued while cooling the same to 40 to 450C, keeping the stirring constant. Step 6: A solution of preservatives 1.55% w/w is added to step 5 along with some amount of water, while stirring at 40 to 450C to make the composition 100% by weight. The said composition is cooled to room temperature, with continuous stirring to obtain homogenous cream. The essential oils to obtain the mixture A arc minimum two, preferably Cymbopogon citrates and Ocimum sanctum, mixed in the ratio of 1:2. Step 2: The base material consisting of a plurality of waxes, taken in 12% w/w of the total composition consists of: 1. Cetyl alcohol 2% 2. Stearic acid 5.5% 3. Glyceryl monosterate 2% 4. Ethylene glycol monosterate 2.5% Step 3: The said base materials are melted over moist heat to obtain a soft paste and added a fixed oil to the said soft paste at 12% w/w of said composition, stirring the said mixture of base and fixed oil continuously to obtain homogenous form. Step 4: An antioxidant- Butylated hydroxy toluene, to the tune of 0.07% w/w of the said total composition is added to the said mixture obtained in step 3 along with solubiliser like propylene glycol 3% w/w of the total composition. The said mixture is heated to a temperature of50°C under a moist atmosphere to obtain a homogenous Mixture B. Step 5: Mixture B is added to Mixture A and stirring is continued while cooling the same to 40°C, keeping the stirring constant. Step 6: A solution of preservatives ( Phenoxy cthano) 0.005% and Bronopol 0.005%) at a strength of 2.0% w/w is added to step 5 along with some amount of water, while stirring at 40 to 45 C to make the composition 100% by weight. The said composition is cooled to room temperature, with continuous stirring to obtain homogenous cream. Step 1: Mixture A is made by adding Cymbopogon citrates(4Q%) and Ocimtim sanctum{6Q%). This mixture is taken 2.5% w/w of the total composition. Step 2: The base material consisting of a plurality of waxes, taken in 14% w/w of the total composition, 1. Cetyl alcohol 3.5% 2. Stearic acid 4.25 % 3. Glyceryl monosterate 4.25 % 4. Ethylene glycol monosterate 2% Step 3: The said base materials are melted over moist heat to obtain a soft paste and added a fixed oil to the said soft paste at 11% w/w of said composition, stirring the said mixture of base and fixed oil continuously to obtain homogenous form. Step 4: An antioxidant- Butylated hydroxy toluene, to the tune of 0.05% w/w of the said total composition is added to the said mixture obtained in step 3 along with solubiliser like propylene glycol 4% by weight of the total composition. The said mixture is heated to a temperature of 50°C under a moist atmosphere to obtain a homogenous Mixture B. Step 5: Mixture B is added to Mixture A and stirring is continued while cooling the same to 40°C, keeping the stirring constant. Step 6: A solution of preservatives (Phenoxy ethanol 0.003% and Bronopol 0.005%) at strength of 1.5% w/w is added to step 5 along with some amount of water, while stirring at 40 to 45 C to make the composition 100% by weight. The said composition is cooled to room temperature, with continuous stirring to obtain homogenous cream. We claim:- 1. A herbal antimicrobial dermatological drug comprising (a) mixture A contains essential oils in 2-5% w/w (b) mixture B • fixed oils in 10% w/w • waxes for cream base in 14.5% w/w • antioxidant in 0.05% w/w • solubiliser in 4% w/w (c) preservatives in 1.55% w/w (d) Water in 67.4% w/w (q.s) 2. The herbal antimicrobial dermatological drug as claimed in claim 1, wherein the essential oils are taken from Cymbopogon citrates and ofOcimum sanctum 3. The herbal antimicrobial dermatological drug as claimed in claim 1-2, wherein the percentage of Cymbopogon citrates is 20 to 45%o by weight of a mixture A and the percentage ofOcimum sanctum is 40 to 80% by weight of mixture A 4. The herbal antimicrobial dermatological drug as claimed in claim 1-3, wherein the said plurality of waxes for cream base are taken from cetyl alcohol, stearic acid, glyceryl mono stearate (self emulsifying grade) and ethylene glycol mono stearate 5. The herbal antimicrobial dermatological drug as claimed in claim 1-4, wherein the said plurality of waxes are taken in the percentage of- • Cetyi alcohol - 2-5% by weight of the composition • Stearic acid - 3.5-5.5% by weight of the composition • Glyceryl mono stearate (self emulsifying grade) - 2-5% by weight of the composition • Ethylene glycol mono stearate - 0A-2.5% by weight of the composition 6. The herbal antimicrobial dermatological drug as claimed in claim 1-5, wherein the antioxidant taken is Butylated hydroxy toluene 0.02-0.07%i w/w of the composition 7. The herbal antimicrobial dermatological drug as claimed in claim 1-5, wherein the solubiliser taken was Propylene glycol is 2 - 5 % by weight of the composition 8. The herbal antimicrobial dermatological drug as claimed in claiml-5, wherein the preservatives added were Phenoxyethanol -0.01-2.0% and Bronopol (2 brono-2-nitro propane-1-3-dioI) -0.01-0.2 % by weight of the composition 9. A herbal antimicrobial dermatological drug as herein described with references to the accompanying example 1

Full Text

The present invention relates to a herbal antifungal, antimicrobial and antibacterial dermatological drug and the process for manufacturing this herbal antifungal, antimicrobial and antibacterial dermatological drug.
Nature has a bounty of plants and natural agents which show promising anti-microbial activity. Synthetic anti-microbial agents are often active only against a narrow spectrum of bacteria/fungi and in cases where stronger doses are necessciated, the synthetic agents generally express side effects. More over, the phenomenon of development of resistance by microbes is very common. Natural agents are generally safe and since the chemistry of the molecules are very complex compared to their synthetic counterparts; it becomes alt the more difficult for the microbes to develop resistance.
Wound infections are mainly caused by Gram negative bacteria like Psuedomonas aeroginosa (other species of Psuedomonas also) and Gram positive bacteria like Staphylococcus aureus. Fungal species of the genus Microsporum, Trichophyton and Epidermophyton are normally responsible for causing skin diseases.
The present invention serves as a multipurpose dermatological cream which is effective against a broad range of bacteria and fungi, and also possesses ant inflammatory and wound-healing properties. To arrive at this invention, a large number of Indian medicinal plants were screened using "well-bore" technique as well as checked using isobologram. Finally, only those ingredients exhibiting synergistic effect with each other were selected. The novelty of this invention therefore lies not only in its composition, but also in the way its ingredients are processed and blended with each other, so that their synergistic potential is expressed maximally.
Majority of the antimicrobial ointments/creams available in the market are synthetic in origin and contain antibiotic compounds. These compounds generally have specific and narrow spectrum of antimicrobial activity. Moreover, they pose a risk of the microbes developing resistance to them, thus making the formulation ineffective. The present herbal antifungal, antimicrobial and antibacterial dermatological composition contains natural ingredients having a broad spectrum activity against a range of microbes and is therefore preferable. Being natural substances, the chemistry is quite complex and risks of microbes developing resistance to these compounds is negligible.

The present herbal drug consists of plant derivatives derived from members of Labiatae, Poaceae and the like.
Ocimwn sanctum is an aromatic herb belonging to the family Labiatae, and is found to occur throughout India. It contains an essential oil which is known to have potent antimicrobial activity and contains a phenyl propanoid compound called eugenol.

According to the present invention, a herbal antifungal, antimicrobial and antibacterial dermatological drug comprising the plurality of essential oils minimum two, 2.5% by weight of the total composition, which are mixed and stirred to obtain Mixture A which consists of Cymbopogon citrates{20A5%) and Ocimum sanctum( 40-80%). Mixture B i.e. base material consisting of a plurality of waxes at 12 to 16% by weight of the total composition, melting the said base materials over moist heat to obtain a soft paste, adding a fixed oil to the said soft paste at 8 to 12% by weight of said composition, stirring the said mixture of base and oil continuously and adding to the said mixture, an antioxidant to the tune of 0.02 to 0.07% for weight of the said total composition adding to the said mixture, solubiliser 2 to 5% by weight of the total composition, heating the said mixture to the temperature of 50 to 70 C under a moist atmosphere to obtain a homogenous Mixture B,

adding the said Mixture B to the Mixture A and stirring it continuously while cooling the said mixture to 40 to 45°C keeping the stirring constant and adding the solution of preservatives 0.5 - 2.0% and adding water while stirring at 40 to 45°C to make the composition 100% by weight, cooling the said composition to room temperature to obtain homogenous cream.
According to present invention, a process for the preparation of herbal antifungal, antimicrobial and antibacterial dermatological drug comprises of the following steps:
Step 1: Mixture A is made by adding Cymbopogon citrates(20-45%) and Ocimum sanctum(40-80%). This mixture is taken 2.5% w/w of the total composition.
Step 2: The base material consisting of a plurality of waxes, taken in 14.5% w/w of the total composition consists of:
1. Cetyl alcohol 2-5% by weight of the composition
2. Stearic acid 3.5-5.5% by weight of the composition
3. Glyceryl monosterate 2-5% by weight of the composition
4. Ethylene glycol monosterate 0.1- 2.5% by weight of the composition
Step 3: The said base materials are melted over moist heat to obtain a soft paste and added a fixed oil to the said soft paste 10% w/w of said composition, stirring the said mixture of base and fixed oil continuously to obtain homogenous form.
Step 4: An antioxidant to the tune of 0.05% w/w of the said total composition is added to the said mixture obtained in step 3 along with solubiliser 4.0% w/w of the total composition. The said mixture is heated to a temperature of 500C under a moist atmosphere to obtain a homogenous Mixture B.
Step 5: Mixture B is added to Mixture A and stirring is continued while cooling the same to 40 to 450C, keeping the stirring constant.
Step 6: A solution of preservatives 1.55% w/w is added to step 5 along with some amount of water, while stirring at 40 to 450C to make the composition 100% by weight. The said composition is cooled to room temperature, with continuous stirring to obtain homogenous cream.

The essential oils to obtain the mixture A arc minimum two, preferably Cymbopogon citrates and Ocimum sanctum, mixed in the ratio of 1:2.

Step 2: The base material consisting of a plurality of waxes, taken in 12% w/w of the total composition consists of:
1. Cetyl alcohol 2%
2. Stearic acid 5.5%
3. Glyceryl monosterate 2%
4. Ethylene glycol monosterate 2.5%
Step 3: The said base materials are melted over moist heat to obtain a soft paste and added a fixed oil to the said soft paste at 12% w/w of said composition, stirring the said mixture of base and fixed oil continuously to obtain homogenous form.
Step 4: An antioxidant- Butylated hydroxy toluene, to the tune of 0.07% w/w of the said total composition is added to the said mixture obtained in step 3 along with solubiliser like propylene glycol 3% w/w of the total composition. The said mixture is heated to a temperature of50°C under a moist atmosphere to obtain a homogenous Mixture B.

Step 5: Mixture B is added to Mixture A and stirring is continued while cooling the same to 40°C, keeping the stirring constant.
Step 6: A solution of preservatives ( Phenoxy cthano) 0.005% and Bronopol 0.005%) at a strength of 2.0% w/w is added to step 5 along with some amount of water, while stirring at 40 to 45 C to make the composition 100% by weight. The said composition is cooled to room temperature, with continuous stirring to obtain homogenous cream.

Step 1: Mixture A is made by adding Cymbopogon citrates(4Q%) and Ocimtim sanctum{6Q%). This mixture is taken 2.5% w/w of the total composition.
Step 2: The base material consisting of a plurality of waxes, taken in 14% w/w of the total composition,
1. Cetyl alcohol 3.5%
2. Stearic acid 4.25 %
3. Glyceryl monosterate 4.25 %
4. Ethylene glycol monosterate 2%
Step 3: The said base materials are melted over moist heat to obtain a soft paste and added a fixed oil to the said soft paste at 11% w/w of said composition, stirring the said mixture of base and fixed oil continuously to obtain homogenous form.

Step 4: An antioxidant- Butylated hydroxy toluene, to the tune of 0.05% w/w of the said total composition is added to the said mixture obtained in step 3 along with solubiliser like propylene glycol 4% by weight of the total composition. The said mixture is heated to a temperature of 50°C under a moist atmosphere to obtain a homogenous Mixture B.
Step 5: Mixture B is added to Mixture A and stirring is continued while cooling the same to 40°C, keeping the stirring constant.
Step 6: A solution of preservatives (Phenoxy ethanol 0.003% and Bronopol 0.005%) at strength of 1.5% w/w is added to step 5 along with some amount of water, while stirring at 40 to 45 C to make the composition 100% by weight. The said composition is cooled to room temperature, with continuous stirring to obtain homogenous cream.

We claim:-
1. A herbal antimicrobial dermatological drug comprising
(a) mixture A contains essential oils in 2-5% w/w
(b) mixture B

• fixed oils in 10% w/w
• waxes for cream base in 14.5% w/w
• antioxidant in 0.05% w/w
• solubiliser in 4% w/w

(c) preservatives in 1.55% w/w
(d) Water in 67.4% w/w (q.s)

2. The herbal antimicrobial dermatological drug as claimed in claim 1, wherein the essential oils are taken from Cymbopogon citrates and ofOcimum sanctum
3. The herbal antimicrobial dermatological drug as claimed in claim 1-2, wherein the percentage of Cymbopogon citrates is 20 to 45%o by weight of a mixture A and the percentage ofOcimum sanctum is 40 to 80% by weight of mixture A
4. The herbal antimicrobial dermatological drug as claimed in claim 1-3, wherein the said plurality of waxes for cream base are taken from cetyl alcohol, stearic acid, glyceryl mono stearate (self emulsifying grade) and ethylene glycol mono stearate
5. The herbal antimicrobial dermatological drug as claimed in claim 1-4, wherein the said plurality of waxes are taken in the percentage of-

• Cetyi alcohol - 2-5% by weight of the composition
• Stearic acid - 3.5-5.5% by weight of the composition
• Glyceryl mono stearate (self emulsifying grade) - 2-5% by weight of the composition
• Ethylene glycol mono stearate - 0A-2.5% by weight of the composition

6. The herbal antimicrobial dermatological drug as claimed in claim 1-5, wherein the antioxidant taken is Butylated hydroxy toluene 0.02-0.07%i w/w of the composition
7. The herbal antimicrobial dermatological drug as claimed in claim 1-5, wherein the solubiliser taken was Propylene glycol is 2 - 5 % by weight of the composition

8. The herbal antimicrobial dermatological drug as claimed in claiml-5, wherein the preservatives added were Phenoxyethanol -0.01-2.0% and Bronopol (2 brono-2-nitro propane-1-3-dioI) -0.01-0.2 % by weight of the composition
9. A herbal antimicrobial dermatological drug as herein described with references to the accompanying example 1

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Patent Number

226999

Indian Patent Application Number

816/MAS/1998

PG Journal Number

07/2009

Publication Date

13-Feb-2009

Grant Date

31-Dec-2008

Date of Filing

17-Apr-1998

Name of Patentee

NATURAL REMEDIES PVT. LTD

Applicant Address

INDIAN FIRM, PLOT NO. 5B, 19TH K.M. STONE, VEERASANDRA INDL. AREA, HOSUR ROAD, BANGALORE 560 100,

Inventors:

#	Inventor's Name	Inventor's Address
1	AMIT AGARWAL	PLOT NO. 5B, 19TH K.M. STONE, VEERASANDRA INDL. AREA, HOSUR ROAD, BANGALORE 560 100,

PCT International Classification Number

A61K35/00

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA