INTRODUCTION:

A drug administered in solution is immediately available for absorption, and in most cases, is more rapidly and efficiently absorbed than the same amount of drug administered in a tablet or capsule¹. Designing of oral herbal formulations (solutions) is a challenge in modern pharmaceutics till date. However the final preparation must satisfy the requirements of pharmaceutical elegance with regard to taste, appearance and viscosity. Anisomeles indica (L.) Kuntze shown in Figure 1 consists of herb or under-shrubs from Anisomeles indica (Linn.) Kuntze, belonging to family Labiatae as an aromatic plant. It is common plant found in wasteland of North East India, Andaman and Nicobar Island, Deccan Peninsula (Ushir et al, 2011).

Figure 1. Anisomeles indica Linn. Herb

Taxonomical Classification

Domain – Eukaryota

Kingdom – Plantae

Subkingdom – Viridaeplantae

Phylum – Tracheophyta

Subphylum – Spermatophytina

Infraphylum –Angiosperrmae

Class – Magnoliopsida

Super order – Lamianae

Order – Lamiales

Family – Labiatae

Subfamily – Lamioideae

Tribe – Pogostemoneae

Genus – Anisomeles

Species – indica

Vernacular Names (The Wealth of India, 1985)

Hindi – Kalabhangra

Kannadi- Mangamari

Gujrathi- Gopali, Chodharo

Malyalum – Chdayan

Marathi – Jeernya

Oriya – Bhutamari

Telgu – Chedayan

Tamil – Erumttai

Other Names:

Chinese – Ch’ien Ts’ao

Philippines - Kabling-parang

Anisomeles indica plant traditionally used as a carminative, sudorific, galactogogue, stimulant, infection of uterus, antiseptic, antispasmodic (Chopra, 1986), antirheumatic, headaches and for treatment of cancer, ethanolic extract (50%) of the herb showed hypothermic activity and when burn acts as a mosquito repellant (Asolkar,1965-1981). The plant contain small quantity of alkaloids and light brown essential oil which consists mainly of hydrocarbons, citral and geranic acid. The plant also contains β-sitosterol (Rao, 2009), diterpenoids lactones as, ovatodiolide (Chaterjee, 1997) and anisomelic acid (Chopra, 1956), also monocyclic diterpenoides anisomeloide (Nadkarni, 2009.), malabaric acid (Rastogi, 2001).

As the plant is very potential to have phytochemicals and in pharmacological uses the hypothesis were made that its herbal cough preparation may prepared and evaluated along with Adhathoda vasika, Glycyrrhiza glabra, Piper nigrum and Mentha piperita.

METHODS:

Procurement of Herbal Material:

Whole plant of Anisomeles indica was collected from ‘Toranmal’ region, Maharashtra, India, in the year 2019. The collection was carried out two times, mansoon and autumn season, to accurately reflect the chemical composition of the plant. The identity of the plant material was verified by Dr. Rajesh T. Wankhede, Department of Dravyaguna, SMBT Ayurved College and Hospital, Nashik, India. Voucher specimen number SMBTIODP/HERB/09 of Anisomeles indica was deposited at the Institute level.

Preparation of Herbal Material:

Fresh plant of aerial part (flower, leaves, and stem) of Anisomeles indica are shade dried and powdered was prepared by passing through sieve # 44, and kept in tightly closed polyethylene bags for further study. However, the powder of Adhathoda vasaka (leaf), Glycyrrhiza glabra (stem), Piper nigrum (fruit) and Mentha piperita (leaf) collected from authentic source of local market of Nashik, Maharshtra-422003, India. All powders were was identified and authenticated with respect to their quality by Dr. Rajesh T. Wankhede, Department of Dravyaguna, S.M.B.T. Ayurvedic College and Hospital, Nashik, India.

Chemicals and Instruments:

All applied Solvents and reagents were of the highest purity available and purchased from the Sigma–Aldrich Chemical Company. Some apparatus, common glassware and instruments were used during the study are Ostwald viscometer, Specific gravity bottle etc.

Methodology for Herbal Cough Syrup:

In present study preparation of herbal cough syrup mainly divided in three steps;

1. Preparation of decoction of herbs.

2. Preparation of simple syrup IP.

3. Preparation of final herbal cough syrup.

The Figure 2 gives complete idea for each and every step followed during preparation of herbal cough syrup.

Figure 2. Procedure for Preparation of Herbal Cough Syrup

Method of Preparation of Decoction:

150 gm powder of aerial part (leaves, stem, flower and seed) Anisomeles indica, 100gm leaves powder of Adhathoda vasika, 100 gm stems powder of Glycyrrhiza glabra, 50 gm fruits powder of Piper nigrum and 50 gm leaves powder of Mentha piperita were taken in a large vessel. All the powders were mixed with 3000 mL of water (Ashwini, 2019). Formula stated in Table 1. The mixture was boiled until total volume become one fourth of the initial volume that’s 750mL. Then the decoction was cooled and filtered. Filtrate was taken to prepare final herbal syrup (Kumar, 2019).

Table 1. Formula for Herbal Cough Syrup

Herbs and Chemicals	Herbs Part used	Quantity
Anisomeles indica	aerial part (leaves, stem, flower and seed)	150 gm
Adhathoda vasika	Leaves	100 gm
Glycyrrhiza glabra	Stem	100 gm
Piper nigrum	Fruits	50 gm
Mentha piperita	Leaves	50 gm
Water	-	3000 mL
Methyl Paraben	-	Quantity sufficient
Syrup	-	1:5 proportion to decoction

Method of Preparation of Simple Syrup:

Traditional simple syrup is made from one part water to one part sugar (1:1). 250 gm graduated sugar that is sucrose dissolved on 250 mL of distilled water whenever need light heat is applied or boiled at 50-60^oC then cool and filtered through muslin cloth (anonymous, 2020).

Method of Preparation of Final Herbal Cough Syrup:

One part of decoction was mixed with five parts of already prepared simple syrup (1:5 v/v). Required quantity of methyl paraben was added as preservative, to the above mixture (Table 1).

Solubility was checked by observing the clarity of solution visually. The final herbal syrup was then subjected for evaluation (anu, 2016).

Evaluation of Herbal Cough Syrup:

Herbal syrup was evaluated for various physicochemical parameters such as physical appearance, pH, Specific Gravity and viscosity.

Physiological Parameters Determination:

Color, odor and taste of the herbal cough syrup determined by physiognomic organ of human being (Sadia, 2015).

pH Analysis:

For determination of pH, 10%v/v solution prepared in distilled water and analyzed by electronic pH meter at 27 ± 2 ºC against standard buffer having pH 7 (AOAC, 2000). Read the pH value when temperature and pH reading remains constant on display (Bhgyasri, et al, 2018).

Specific Gravity Determination:

Specific gravity determined by specific gravity bottle (Kokate, 1994), using water as a standard having specific gravity 1.0000.

Formula for specific gravity (w/w),

Specific gravity of syrup = weight of syrup under test /weight of water

Density Determination:

Clean thoroughly the specific gravity bottle with chromic acid or nitric acid. Rinse the bottle at least two to three times with distilled water. If required, rinse the bottle with an organic solvent like acetone and dry. Take the weight of empty dry bottle with capillary tube stopper. Fill the bottle with unknown liquid and place the stopper, wipe out excess liquid from outside the tube using tissue paper. Weight the bottle with syrup on analytical balance and Calculate weight in grams of syrup (Khandelwal, 2005).

Formula for density (w/v),

Density of syrup = weight of syrup /volume of liquid under test.

Viscosity:

Thoroughly clean the Ostwald viscometer with warm chromic acid and if necessary used an organic solvent such as acetone. Then, mount the viscometer in vertical position on a suitable stand and fill water in dry viscometer up to mark G. After that, count time required, in second for water to flow from mark A to mark B. Repeat this at least 3 times to obtained accurate reading. Finally, rinse viscometer with herbal cough syrup and then fill it up to mark A, find out the time required for syrup to flow to mark B. Determination of densities of liquid as mentioned in density determination experiment (Bhgyasri, et al, 2018).

Formula for viscosity,

Density of Syrup × Time required to flow Syrup

Viscosity = ----------------------------------------- x Viscosity of Water

Density of Water × Time required to flow water

Accelerated Stability Testing (AST):

Stability testing of the prepared poly herbal syrup was performed on keeping the samples at accelerated temperature conditions. Nine portions of the final syrup (S₁, S₂, S₃, S₄, S₅, S₆, S₇, S₈ and S₉), were taken in amber colored glass bottles and were kept at accelerated temperature at 4⁰C, Room temperature and 47⁰C respectively. The samples were tested for all the physicochemical parameters viz; color, odor, taste, specific gravity and pH then also for turbidity and homogeneity at the interval of 24 hr, 48 hr and 72 hr to observe any change (Sadia, 2015).

RESULTS AND DISCUSSION:

The prepared poly herbal syrup was evaluated immediately after preparation and all the tested parameter along with turbidity/homogeneity were compared with the changes in accelerated stability testing. The final syrup found to have pH 4.5, density 1.1610 g/ml and specific gravity 0.5805 g/g (Table 2).

Table 2. Physicochemical Parameters of Anisomeles indica Herbal Syrup

Parameter	Inference
Color	Brownish
Odor	Pleasant
Taste	Sweet
pH	5.3
Density	1.1590g/ml
Specific Gravity	0.5805 g/g
Viscosity	3.45 cP*

* cP= centipoise

The results of stability study of the final syrup stated in Table 3, revealed that no changes were noticed in all the tested physicochemical parameter as well as turbidity/homogeneity during 24 hr, 48 hr and 72 hr.

Table 3. AST of Anisomeles indica Herbal Syrup

Hours	24hrs			48hrs			72hrs
Sample	S1	S2	S3	S4	S5	S6	S7	S8	S9
Temperature	4⁰C	RT	47⁰C	4⁰C	RT	47⁰C	4⁰C	RT	47⁰C
Color	RC	RC	RC	RC	RC	RC	RC	RC	RC
Odor	RC	RC	RC	RC	RC	RC	RC	RC	RC
Taste	RC	RC	RC	RC	RC	RC	RC	RC	RC
pH	5.3	5.3	5.3	5.3	5.3	5.3	5.3	5.3	5.3
Density (g/ml)	1.1590	1.1590	1.1610	1.1590	1.1590	1.1610	1.1590	1.1590	1.1610
Specific Gravity (g/g)	0.5794	0.5794	0.5805	0.5795	0.5794	0.5805	0.5795	0.5795	0.5805
Viscosity (cP)	3.45	3.45	3.40	3.45	3.45	3.35	3.45	3.45	3.30

RT- Room Temperature; RC-Remain Constant

In current scenario the herbal products/formulations are becomes a symbol of safety in comparison to the synthetic drugs which are regarded as not safe to human being as well as for our mother earth’s environment. Although, herbs had been priced for their medicinal, aromatic and flavoring qualities for centuries. It’s time to promote them throughout the worldwide. Herbs based drugs/products cannot be considered valid if the drug/product analysis or testing has not been legitimated and characterized in order to make certain reproducibility in the manufacturing of such product. Curative action of herbal products depends on its active principles or phytochemical components.

The prepared herbal cough syrup is having antitussive activity as Anisomeles indica reported for presence of volatile oil and Anisomeles indica volatile/essential oil is mixture of consist 36 compounds. The most abundant components were oxygenated monoterpene (26.10%) and oxygenated sesquiterpenes (44.86%). The high percentages of linalyl acetate (15.3%) and, α-thujone (11.9%) proved that this essential oil clearly belongs to the mixed chemotype (Ushir, 2011). The report says that herbs significant in volatile oil having antitussive property or we can use such herbs for treating common cold and cough. Only the question of stability and formulation designing with development remain un-answered and our methodology with results during evaluation data was proved that the herbal cough syrup found to be stable and appropriate for consumption of human.

CONCLUSION:

The present study “design, development and evaluation of Anisomeles indica herbal cough syrup” revealed certain conclusion. The antitussive herbal cough syrup of Anisomeles indica prepared in the laboratory scale may be used as a liquid dosage form which is stable and the results of the AST may make some progress in shelf-life degradation studies of herbal syrup helping ‘Herbal pharmaceuticals’ in near future.

Finally we conclude that, the evaluation undertaken of developed herbal cough syrup reveal compliance with all the physicochemical and analytical procedures, therefore it is concluded that Anisomeles indica herbal cough syrup is well standardized product at the base line parameters.

ACKNOWLEDGEMENT:

I give my immense thanks to express my sincere thanks to SMBT Sevabhavi Trust, Dhamangaon, Nashik, Maharashtra-422401, India.

CONFLICT OF INTEREST:

We declare that there is no conflict of interests regarding the publication of this paper.

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Received on 05.07.2021 Modified on 26.07.2021

Res. J. Pharma. Dosage Forms and Tech.2021; 13(4):292-296.

DOI: 10.52711/0975-4377.2021.00048