Formulation And Evaluation of Gutika by Using Arjuna Extract for Antidiabetic Activity

Globally, diabetes is a serious health issue. The most common medications for diabetes are insulin and oral hypoglycemics, although they have a number of negative effects, including lactic acidosis, weight gain, hypoglycemia, and significant harm to the kidneys and liver. The medical system still faces the issue of managing diabetes without causing adverse effects. Demand for using natural products with anti-diabetic properties is rising. Herbal medicine has expanded dramatically in recent years, and both developed and developing countries are increasingly using these drugs because of their natural origin and few adverse effects. The big tropical woody tree known as Arjuna (Terminalia arjuna) is found all over India. This tree, which is between 20 and 25 meters tall, usually has a buttressed trunk, and at the crown, it creates a broad canopy from which branches hang down. The composition the essential drug list of India's ayurvedic formulary includes the Herbo mineral formulation Terminalia Arjuna gutika/vati. This age-old Ayurvedic treatment has been used for centuries to treat liver diseases, skin disorders, and jaundice. It is regarded to be effective and safe. Leprosy, fever, oedema, obesity, jaundice, and other liver issues are treated with it. The list of ingredients for Arjuna gutika is as follows. It is known that several ingredients in Arjuna Vati, including Terminalia Arjuna, Hari Taki, Stevia leaves, Acacia gum, and Guggul, have hypo-lipidemic qualities. Ayurvedic doctors in various parts of India have long recommended this combination for its antidiabetic properties, however there is no written proof of its impact on lowering blood sugar levels. As a result, it was chosen to assess its antidiabetic properties. The study found that oral administration of T. arjuna at 250 and 500 mg/kg body weight for 30 days significantly reduced blood glucose levels. In comparison with control rats, diabetic rats showed significantly higher aldolase activity and significantly lower hero kinase and phosphor-gluco-isomerase activity. These levels were markedly restored to normal after 30 days of oral T. arjuna 500 mg/kg body weight. Compared to diabetic control, the administration of T. arjuna bark extract significantly decreased the blood glucose level. The extract at 500 mg/kg body weight demonstrated a larger decrease in glucose levels than at 250 mg/kg body weight. The process could involve stimulating b-cells to secrete more insulin, which would increase the amount of glucose used by different tissues. In South and Central India, as well as in Uttar Pradesh, Madhya Pradesh, and West Bengal, arjunas are typically found growing on riverbanks or next to dry river beds. Tannins, triterpenoid saponins, flavonoids, gallic acids, ellagic acid, and phytosterol are the primary chemical components of arjuna. Arjuna is utilized not only as a heart tonic but also to treat a variety of conditions, including hypertension, liver cirrhosis, pulmonary TB, uterine disorders, venereal illness, epilepsy, chronic fever, nausea, diarrhea, dysentery, urticarial, ulcers, fractured bones, and diuresis. In Ayurveda, T. arjuna bark is used to treat diabetes. Arjuna affects the human body's numerous physiological systems in a variety of ways.

MATERIALS AND METHODS

Plant Materials:

Extraction Method: The T. arjuna stem barks were carefully water washed after being cut into tiny pieces. The fresh barks were cleaned, allowed to air dry, and then baked at 40°C to finish drying. The dried barks arethen grinded to make powder, which were then screened to get fine powder. The process of extracting chemicals that are heat-labile. The Soxhlet apparatus is filled with a thimble composed of filter paper containing the powdered solid substance, arjuna bark powder. The device is connected to a reflux condenser and a round-bottomed flask filled with the solvent methanol. After the solvent in the Round Bottom flask is gently boiled in 40°C set in 48 hours, the vapor rises via the side tube, condenses in the condenser, and then descends into the thimble holding the arjuna bark material, gradually filling the Soxhlet. The part of the material that has been extracted is removed when the solvent, methanol, syphons over into the flask when it reaches the top of the connected tube. Until full extraction is accomplished, the process is repeated. After the extract was filtered and distilled on a water bath, a reddish-brown syrupy mass was produced. It was then dried in a rotary evaporator at a low temperature and with less pressure. 

Phytochemical Test:

Table No: 1 Phytochemical Test.

Pre-Formulation Test:

5. Solubility:

• Water soluble: To ascertain whether arjuna extract is appropriate for aqueous formulations, it is tested for solubility in water.
• Ethanol soluble: The More efficient solvents for removing a variety of bioactive substances, such as flavonoids and other ethanol-soluble substances found in arjuna bark may dissolve in ethanol.
• Methanol soluble: methanol are organic solvents that can also be utilized to extract different bioactive substances from Arjuna bark may dissolve in methanol.

Fig. no: 2 (Solubility)

5. PH Test: The acidity or alkalinity of Terminalia arjuna extract is assessed by measuring its ph.  The extract's low acidity, indicated by its pH of about 5.5, is essential for stability and formulation compatibility.

Fig. no: 3 (pH test)

5. Ash Value: the Ash Value The amount of inorganic residues, such as minerals and contaminants, is indicated by the total ash content.  To find the proportion of ash, the extract is heated to a high temperature (100°C) in a muffle furnace.

Fig. no: 4 (Ash Value)

• Acid Insoluble Ash: Indicates non-digestible inorganic materials and is the portion of ash that does not dissolve after being treated with hydrochloric acid.
• Water Soluble: Water soluble ash is the percentage of ash that dissolves in water; it is the difference between acid-insoluble ash and total ash.

Fig.no: 5 (Acid insoluble ash and Water soluble of Ash Extract)

5. Standard calibration curve of Terminalia arjuna extract: The standard calibration curve of Terminalia arjuna extract is established using UV-Visible Spectrophotometry at a maximum wavelength (λmax) of 375 nm.  This approach follows Beer-Lambert's Law, which stipulates that the absorbance of a solution is directly proportional to its concentration.  The absorbance readings of a number of standard solutions with established concentrations—1, 2, 3, 4, and 5 µg/mL—are measured.  A linear connection is confirmed by the data, which consistently indicates an increase in absorbance with increasing concentration.  By comparing absorbance values to the standard curve, this calibration curve can be used as a guide to estimate the concentration of unknown samples.  The outcomes ensure that Terminalia arjuna extract is accurately formulated in pharmaceutical and herbal products by aiding in the quantitative estimate of its bioactive components.

Table no: 2 (Standard calibration curve of T. arjuna extract.)

Graph no. 1: Standard calibration curve of Terminalia arjuna extract.

Formulation of Gutika:

Table no: 3 (Ingredient table of Gutika)

 Procedure of Gutika:

• The normal dosage could be as much as 350 milligrams of extracts each pill.  Binders, fillers, and stabilizers are examples of excipients.  Binders: Guggul and other substances are frequently used to bind the extract and other excipients.  Fillers: Haritaki are used to give the tablet more volume.  Acacia gum is one of the disintegrants that aid in the release of its active ingredients.  Coconut oil is used as a lubricant.

• Combine the powder or extract Arjuna bark if using extract, remove excess moisture to bring it down to a semi-solid consistency.  If using powder, mix it in the appropriate amount with the base material or powdered excipients.  Add the excipients and binder:  To the powder, add a suitable binder (guggul), such as acacia gum, stevia leaves, haritaki, or coconut oil.  To get a uniform dough-like consistency, thoroughly mix.

• Form into tablet: After the mixture has been well mixed, form it into tiny tablets using a table compression machine. Depending on the required dosage, each Gutika's weight and size can be adjusted.

Evaluation test of Gutika:

5. Hardness Test: The standard acceptable range for hardness is 3.5 kg a lower observed value of 0.5 kg indicates that the tablet is softer than required, which may result in breakage during handling. Hardness Test A tablet's mechanical strength and resistance to breakage during handling, packaging, and transportation are determined by its hardness.

5. Weight Uniformity: Weight Uniformity by ensuring that each tablet has the appropriate quantity of excipients and active components, this test lowers batch variability.  There is a little but manageable weight fluctuation between the observed value of 490 mg ±2% and the normal weight of 500 mg ±5%.

5. Time of Disintegration: The amount of time it takes for a pill to disintegrate into smaller pieces in the digestive tract is known as the disintegration time.  The observed time was 12 minutes, although the typical time is 15 minutes. This suggests that the pill disintegrates a little quicker than anticipated, which could affect the release of the medicine.

5. Loss of Drying (LOD):  The tablet's moisture content is determined by this test.  Stability and inhibition of microbiological growth are guaranteed by a specified limit of 1-3%.  The observed value of 1.09% indicates that the pill has dried properly because it falls within the allowed range.  Weight Variation Another crucial test for evaluating batch-to-batch consistency is weight variation.  The observed result is 490 mg ±2%, which shows a slight variance within acceptable ranges, compared to the normal weight of 500 mg ±5%.

5. Weight Variation: test guarantees that the prescribed dosage of medication is present in every pill in a batch.  The weight variation is computed when a predetermined number of pills are weighed.  The weight variation should stay within pharmacopeial bounds if the active component is evenly distributed.