Formulation and Evaluation of Antidiabetic Herbal Syrup from Withania Coagulans Dunal and Butea monosperma

Diabetes mellitus, one of the most common endocrine metabolic disorders, causes significant morbidity and mortality due to microvascular (retinopathy and nephropathy) and macrovascular (heart attack, stroke, and peripheral vascular disease) complications. According to the World Health Organization, the diabetic population is likely to increase by up to 300 million or more by 2025. After pharmaceutical screening of some plants based on their traditional use, the herbal plant leaves or fruit liquid extract are prepared into a syrup against diabetes mellitus. Herbal medicine is treated as a traditional medicine since they were extensively used in the traditional system of medicine, like Ayurveda, Siddha, and Unani.[1]

Herbal remedies are a valuable natural gift, and their market is expanding worldwide. The World Health Organization (WHO) has determined that more than 80% of the world’s population uses plant-based health care products in their daily routines because of their constructive effects and comparatively fewer negative effects than those of synthetic drugs. For over 3,000 years, India has used Withania Coagulans Dunal, a member of the Solanaceae family, as an important ayurvedic medicinal plant. Other names for it include vegetable rennet, paneer ke phool, paneer dodi, Indian cheesemaker, and Indian rennet.[2]

The plant has several regional names, including ‘Akri’ or ‘puni-ke-bij’ in Hindi, ‘Tukhme kaknaje-hindi’ in Persian, ‘spiubajja in Afghan, ‘Khamjira’ in Panjabi, and ‘panirband’ or ‘punir-jafota’ in Sindhi. Paneer dodi is used to treat type 2 diabetes. The term “dodi” refers to the milk coagulant produced by the paneer dodi plant. Elevated blood sugar levels are a hallmark of diabetes mellitus, a group of metabolic diseases caused by either inadequate insulin production or inadequate cellular response. Hot aqueous extracts of Withania Coagulans Dunal fruits possess hepatoprotective, anti-inflammatory, and anti-hyperglycemic properties. Research shows that active chemical compounds in the fruit berries, called withanolides, significantly reduce blood glucose levels.[3]

The flame of the forest is the common name for Butea Monosperma (Palash), a member of the Fabaceae family. Different parts of the plant and extracts have been utilized in Unani, homeopathy, and traditional systems of medicine for a long time. The leaves of Butea Monosperma contain kino-oil, which contains oleic, linoleic, and lignoceric acids. The palash shows a different pharmacological profile, such as antidiabetic,  antidiarrheal, anticancer, antioxidant, anti-inflammatory, antifungal, and antiulcer activities. The cultivation of this plant is generally found in the areas of India, Sri Lanka, and Myanmar.[4]

2.1. Types of diabetes[9]

2.1.1.Type 1

It is insulin-dependent diabetes mellitus (IDDM), in which the body does not produce insulin. It most often occurs in children and young adults. Type 1 diabetes accounts for 5-10% of diabetes[9]

2.1.2. Type 2

It is noninsulin-dependent diabetes mellitus (NIDDM), in which the body does not produce enough insulin or improper use of secreted insulin is the most common form of the disease, accounting for 90-95% of diabetes. Type 2 diabetes is nearing epidemic proportions due to the increased number of elderly people and the greater prevalence of obesity and sedentary lifestyles.[10]

2.2. Ideal Properties of Herbal Antidiabetic Syrup

2.1.1 Pleasant Appearance: Syrup should have a clear and attractive appearance without any visible particles.

2.1.2 Color and Odor: The syrup should have a uniform color and pleasant odor.

2.1.3 Taste: The syrup should have an acceptable taste so that it can be easily consumed.

2.1.4 PH: The pH of the syrup should be maintained within a proper range for better stability.

2.1.5 Proper Viscosity: The syrup should not be too thick or too thin and should flow easily.

2.1.6 Uniformity: All the ingredients were mixed properly.

2.1.7 Stable Formulation: The syrup should remain stable during storage without changes in colour, odour, and viscosity

Advantage 

• Liquid  dosage  forms are  used for products  such as  cough medicines. 
• Antioxidant by retarding oxidation as sugar is hydrolysed into cellulose and dextrose 
• Good patient compliance, especially among paediatric patients, as syrups are sweet in taste 

Disadvantage 

• The sedimentation  of solids occasionally results in the formation of a foot of product. 
• Dose precision cannot be achieved unless  the  suspensions are packed in undosage forms. 
• The same microbial contamination occurs when  preservatives   are  not added in the correct proportion. 
• In addition , herbal  medicines have  another disadvantage, which is the risk of self-dosing of herbs, which is very rare. 

3. AIM AND OBJECTIVE

AIM

Formulation  and evaluation of antidiabetic herbal syrup from Withania Coagulans Dunal and Butea monosperma.

OBJECTIVE

• The Withania Coagulans fruits and Butea Monosperma leaves were collected and authenticated  for  the  correct identification of plant materials. 
• To prepare and extract active phytoconstituents from the selected plant materials using suitable extraction methods. 
• Preliminary  phytochemical screening  was performed to identify the  constituents ,  such as alkaloids, tannins, glycosides, saponins,  and reducing  sugar compounds. 
• To evaluate the compatibility of herbal extracts with selected excipients used in syrup  formulations . 
• To formulate different batches of polyherbal antidiabetic syrup using varying concentrations of plant extracts. 
• The  formulated syrup  was evaluated  for pharmaceutical parameters such as  color ,  odor , taste, pH, viscosity, specific gravity, and stability. 
• The  quality and acceptability of the prepared formulation  were assessed  using standard evaluation methods. 
• The  stability of the formulated syrup  was studied  under suitable storage conditions  to predict its  shelf life. 

4. REVIEW OF LITERATURE

R. Maurya et al. (2010) investigated the phytochemical profile of Withania Coagulans and reported the presence of several biologically active Withanolides. This study highlighted the significant antidiabetic, anti-inflammatory, and antioxidant activities of the plant, supporting its traditional use in Ayurveda.

Tiwari et al. (2016) presented a comprehensive review on traditional uses, phytochemistry, and pharmacological activities of Withania coagulans. The authors concluded that the plant has significant potential as a natural antidiabetic and nutraceutical agent.

Khan et al. (2012) evaluated the hypoglycemic and hypolipidemic effects of Withania Coagulans fruit extract in experimental diabetic models. The results showed a significant reduction in blood glucose and lipid levels, confirming the traditional use of this plant in diabetes management.

Raju K. Rose et al. (2020). In this study, an antidiabetic syrup formulation was created and assessed. It aims to manage and control blood sugar levels in individuals with diabetes mellitus.

Panda P (2023). The study shows that herbal treatment is more beneficial than allopathic treatment, which uses standard drugs for treatment, as herbal drugs have fewer or no side effects. The pre-formulation studies of all three formulations were within the specifications. Three formulations were prepared, and evaluation tests such as color, odor, taste, and pH were performed. The present study will help us understand the effectiveness of herbal cough syrups compared to chemical-based syrups. Here, cough and herbal treatments associated with cough are briefly discussed.

Harish et al. (2011) evaluated the hypoglycemic potential of Butea Monosperma leaves and bark using in vitro methods. The study showed that leaf extract exhibited significant antidiabetic activity through glucose adsorption, inhibition of carbohydrate-hydrolyzing enzymes such as α-amylase and α-glucosidase, and enhancement of glucose uptake. The study concluded that Butea Monosperma leaves possess promising antidiabetic properties.

5. DRUGS AND EXCIPIENTS PROFILE

5.1 Withania Coagulans Dunal[11]                                         

Figure 1. Withania Coagulans Dunal Extract

Synonyms: Indian Rennet, Paneer Dodi[12]

Family: Solanaceae

Biological source:

Withania Coagulans consists of dried fruits obtained from Withania Coagulans Dunal.

Geographical source: It is distributed in India, Pakistan, and Afghanistan

Chemical constituents: Withanolides, alkaloids, steroidal lactones, phenolic compounds, flavonoids, and tannins.

Uses:

a. It is used in the treatment of diabetes.

b. Possesses antihyperglycemic activity

5.2 Butea Monosperma Leaves [4]

Fig 2. Butea Monosperma Extract

Synonyms: Flame of Forest, Palash[13]

Family: Fabaceae

Biological source: Butea Monosperma consists of dried leaves obtained from Butea Monosperma (Lam.) Taub., a medium-sized deciduous tree.

Geographical source: Butea Monosperma is widely distributed throughout India, Bangladesh, Nepal, Sri Lanka, and Southeast Asian countries. It primarily grows in tropical and subtropical regions.

Chemical Constituents: Flavonoids, butrin, butein, alkaloids, tannins, glycosides, proteins, saponins

Use:

a. Used in traditional antidiabetic activity

b. Used to reduce swelling

5.3 Menthol

Fig 3. Menthol

Synonyms: Mint, Pudina, Mentha[14]

Family: Lamiaceae

Biological source: Peppermint consists of dried leaves and flowering tops of Mentha piperita Linn.

Geographical source: Peppermint is cultivated in India, Europe, North America, and many tropical and subtropical regions.

Chemical constituents: Menthol, menthone, flavonoids, tannins, terpenes, and volatile oils.

Uses:

a. It is used as a flavoring agent in pharmaceutical preparations.

b. It helps improve the taste and aroma of the syrup.

5.4 Liquorice[7]

Fig 4. Liquorice

Synonyms: Mulethi, Yashtimadhu, Glycyrrhiza[8]

Family: Fabaceae

Biological source: Licorice consists of the dried roots of Glycyrrhiza glabra Linn.

Geographical source: Licorice is found in India, the Mediterranean regions, Europe, and Asia.

Chemical constituents: Glycyrrhizin, flavonoids, sugars, starch, saponins, and tannins.

Uses:

a. It is used as a sweetening agent in syrup preparation.

b. It improves the taste and palatability.

6. EXCIPIENT PROFILE

Following excipient are used in the preparation of an antidiabetic syrup

Table.1 Excipient and uses

Sr. No.	Excipient	Uses
1	Propylene Glycol	Food Additive, Drug Stabilizer
2	Methyl Paraben	Preservative
3	Peppermint	Flavoring Agent
4	Liquorice	Sweetening Agent
5	Glycerine	Thickener
6	Purified Water	Vehicle

7. MATERIAL AND METHOD

7.1 Material

Following ingredient are used in preparation of antidiabetic syrup

Table 2. List of Ingredient and their Role

Sr. No.	Ingredient	Role
1	Withania Coagulans Dunal Fruit	Antidiabetic  activity, Antioxidant
2	Butea Monosperma Leaves	Antidiabetic activity
3	Liquorice	Control Blood Sugar Level
4	Peppermint	Flavouring Agent
5	Glycerine	Thickening Agent
6	Propylene Glycol	Food Additive and Stabiliser
7	Methyl Paraben	Preservative
8	Purified water	Vehicle

7.2 Methods

7.2.1 Method of Collection

Collection of Plant: Withania Coagulans fruit and Butea Monosperma leaves were collected from the local area,  and licorice, peppermint, and glycerine were purchased from the market.

Chemical: Methyl Paraben, Propylene glycol

Cleaning and Washing: The dried fruits and leaves were washed 2-3 times with distilled water to remove all dust particles.

Drying of leaves and dried fruits: The leaves were completely dried in 24-38 hours.

Grinding of dried fruit and  leaves: Dried fruit and leaves were ground into a fine powder, and the maceration process was used to extract the liquid.

7.2.2 Equipment

Table 3. Equipment and Instrument

Equipment

Beaker

Measuring cylinder

Conical flask

Funnel

Test tube

Whatman filter paper

Burette

Instrument

Ostwald Viscometer

PH Paper

Density Bottle

7.3.3 Extraction Method of Ingredient

• The required  amount of drug powder  of butea  monosperma  leaves and paneer phool powder   was  taken in a conical flask. 
• Pour some water (required amount of water) in a certain ratio 
• The mouth of the conical flask was closed with filter paper and silver foil.
• The mixture was shaken  vigorously  at   frequent  intervals. 
• The  conical flask  was then placed  in a warm place for 7 days with frequent vigorous  shaking. 
• After  filtering  the content and the filtrate,  the liquid part  was  kept  in  a water bath and   evaporated. 
• The solution was  evaporated  until  the required  concentration   was  achieved. 
• Licorice   powder   was taken and   10 – 15 ml  of  water  was added, boiled,  and   filtered  .  Finally,  add  excipient and make up the  volume  to 50 ml with purified water   
• stored in a dry container 

8. EXPERIMENTAL STUDY

8.1 Preformulation  study: A Preformulation study of Raw material

Table 4. Preformulation study of Withania Coagulans dunal

Sr.No.	Test	Purpose
1	Organoleptic property	To identify Characteristics like colour, odour, taste
2	PH Determination	To determine the acidity or alkalinity
3	Solubility	To identify a suitable solvent
4	Viscosity	To identify thickness or flow time
5	Density	Shelf life and medicinal efficacy
6	Compatibility study	To ensure the physical and   chemical stability of the formulation by detecting any deleterious interactions between the active ingredients the vehicle

8.2 Phytochemical Screening

1. Alkaloids

a. Mayer’s Test – A solution of Mayer's reagent is added to the extract a white creamy precipitate indicates the presence of alkaloids

b. Dragondroff reagent – A solution of dragondroff's reagent is added to extract a reddish-brown precipitate, which indicates the presence of alkolides

c. Molisch test - A few drops of Molisch reagent and alpha naphthol are added. A purple reddish violet colour is indicated.

2. Tannins-

1ml of extract was added 0.1% of ferric chloride solution, and a brownish and blue black coloration indication Lead acetate solution

A few drops of lead acetate solution are added to the extract, and a yellowish-white precipitate indicates the presence of tannins

3. Saponin

a. Foam test - A small amount of extract is mixed with water, and the vigorous formation of stable foam indicates the presence of saponin

4. Reducing Sugar

Fehling’s test - A few drops of Fehling’s solution are added to the extract. A brick red precipitate indicates reducing sugar

8.3 Preparation of Antidiabetic Syrup

1. Accurately weighed quantities of Butea Monosperma leaf extract and Withania Coagulans fruit extract were taken separately.

2. The required quantities of glycerine and propylene glycol were mixed in a beaker with continuous stirring.

3. Methyl paraben was dissolved in a small quantity of warm purified water and added to the mixture.

4.  Liquorice was added and mixed thoroughly to obtain a uniform solution.

5. The measured quantities of Butea Monosperma extract and Withania Coagulans extract were added slowly with continuous stirring.

6. Peppermint oil was added for flavour.

7. Purified water was added gradually, and the final volume was adjusted to 50 ml.

8. The prepared syrup was stirred until a homogeneous mixture was obtained.

9.The syrup was filtered and filled into clean amber-coloured bottles for storage.

8.4 Preparation of  formulation

9. RESULT AND DISCUSSION

9.1 Preformulation parameter of  Extract:

The Sample of drug received was studied for its organoleptic characters such as colour, odour, Texture and pH, solubility test etc. The result are presented in the following Table No.7

Table 7. Preformulation Parameter of liquid Extract

Table 8. Phytochemical Screening of Liquid Extract

Figure 3. Phytochemical Screening of Liquid Extract

9.2 Evaluation Parameter of Formulation

Evaluation parameter of formulation : The F1 batch was selected and studied its organoleptic characters such as colour, odour, and taste, alongside physicochemical parameters including pH and viscosity, density, specific gravity in the following table

Table 7: Evaluation parameter and observation of the F1 batch

10. CONCLUSION

Due to their greater acceptability and human compatibility, half of the world’s population uses herbal medicines. Compared to synthetic ones, it has fewer adverse effects. In this study, we used Butea Monosperma leaf extract and Withania Coagulans Dunal fruit extract to make an anti-diabetic syrup. According to the literature review, these two herbs have a strong anti-diabetic effect. The prepared syrup is subjected to a number of evaluation criteria, and its value falls within the accepted ranges.  It has a strong antidiabetic effect. Herbal medicine is becoming more and more popular these days. Because herbal medicines have fewer adverse effects, people might prefer to use them.

REFERENCES

1. Gupta A, Sharma R, Kumar S. Pharmacological and therapeutic potential of Withania coagulans: A review. International Journal of Pharmaceutical Sciences and Research, 2021; Vol–12(4): Page no. 1920–1929.
2. Singh P, Verma R, Sharma K. Antidiabetic activity of Withania Coagulans fruit extract in experimental models. Journal of Ethnopharmacology, 2019; Vol–231: Page no. 25–33.
3. Jaiswal D, Rai PK, Watal G. Antidiabetic effect of Withania Coagulans in experimental rats. Indian J Clin Biochem. 2009 Jan ,Vol-24(1) Page No:88-93. Doi: 10.1007/s12291-009-00150 Epub 2009 May 8. PMID: 23105813; PMCID: PMC3453475. 
4. Sharma N, Jain P, et al. Phytochemical and pharmacological properties of Butea monosperma: A review. International Journal of Pharmaceutical Research and Bioscience, 2020; Vol–9(2): Page no. 120–129.
5. Kumar A, Singh R, et al. Evaluation of antidiabetic activity of Butea Monosperma leaves extract in animal models. Asian Journal of Pharmaceutical and Clinical Research, 2018; Vol–11(6): Page no. 145–150.
6. Patel DK, Kumar R, Laloo D, Hemalatha S. Natural medicines from traditional medicinal plants as antidiabetic agents. Pharmacognosy Reviews, 2012; Vol–6(11): Page no. 47–58.
7. Grover JK, Yadav SP. Pharmacological actions and potential uses of medicinal plants in diabetes mellitus. Journal of Ethnopharmacology, 2004; Vol–81(1): Page no. 81–100.
8. Maurya, Rakesh, Akanksha, and Jayendra. “Chemistry and Pharmacology of Withania Coagulans: An Ayurvedic Remedy.” Journal of Pharmacy and Pharmacology, 2010, Vol-62(2), Page no-153-160, doi:10.1211/jpp.62.02.0001
9. Manisha Y. Sonalkar, Dr. Sachin A. Nitave, and Dr. J. J. Magdum Trust’s, IndiaWorld Journal of Pharmaceutical Research 2024, Vol- 13(3), Page no-550-557, doi: 10.20959/wjpr20243-31162
10. Khan MI, Maqsood M, Saeed RA, Alam A, Sahar A, Kieliszek M, Miecznikowski A, Muzammil HS, Aadil RM. Phytochemistry, Food Application, and Therapeutic Potential of the Medicinal Plant (Withania coagulans): A Review. Molecules. 2021 Vol-26(22), Page no-68-81. doi:10.3390/molecules26226881. PMID: 34833974; PMCID: PMC862232
11. M Shree Krishna, V Sandhiya, Nirmala Sankardoss, Velayutham Ravichandran. Traditional Uses, Phytochemistry and Pharmacology of Withania coagulans: A Review. Inventi Rapid: Ethnopharmacology, 2013 Vol- 2013(1), Page no- 1-6
12. Kherade M, Solanke S, Tawar M, Gawande S, Warghat S, & Bansod T. A Comprehensive review on Withania Coagulans (Paneer Dodi). International Journal of Pharmacy & Pharmaceutical Research (IJPPR), 2021 Vol- 22(2), Page no- 257– 282.
13. Trivedi A, Reddy N, Manivel P. A review on Withania Coagulans (Paneer Doda) – An important medicinal plant. Journal of Plant Development Sciences. 2021, Vol-13(9) Page no.-675–680. 
14. Jain R. Kachhwaha S, S.L.Kothari, Phytochemistry, pharmacology, and biotechnology of Withania somnifera and Withania coagulans: A review. Journal of Medicinal Plants Research, 2012, Vol-6(41), Page no- 5388-5399. doi.org10.5897JMPR12.704