Formulation and Evaluation of Syrup from Oroxylum Indicum Bark for Relieving Period Cramps (Primary Dysmenorrhea)

Dysmenorrhea, commonly referred to as menstrual cramps, is one of the most prevalent gynecological complaints among women of reproductive age, significantly affecting their quality of life and productivity. It is broadly classified into two types: primary and secondary dysmenorrhea [1]. Primary dysmenorrhea occurs in the absence of any underlying pelvic pathology and is typically associated with the onset of ovulatory cycles. It is characterized by lower abdominal pain, which may radiate to the lower back and thighs, often accompanied by systemic symptoms such as nausea, vomiting, fatigue, and headache. The condition is primarily attributed to increased production of uterine prostaglandins, particularly prostaglandin F2α (PGF2α), leading to excessive uterine contractions, reduced uterine blood flow, and resultant ischemic pain [2,3]. Current therapeutic strategies for managing primary dysmenorrhea primarily involve the use of non-steroidal anti-inflammatory drugs (NSAIDs) and hormonal contraceptives. While effective in many cases, these interventions are often associated with a range of adverse effects, including gastrointestinal disturbances, hormonal imbalances, and cardiovascular risks upon prolonged use. This necessitates the exploration of safer, natural, and more holistic alternatives, especially from herbal sources with traditional therapeutic relevance [4]. Oroxylum indicum (family: Bignoniaceae), commonly known as the Indian trumpet tree, is a well-known medicinal plant in Ayurveda and other traditional systems of medicine. The bark of Oroxylum indicum has been documented to possess a broad spectrum of pharmacological activities, including anti-inflammatory, analgesic, spasmolytic, and antioxidant properties. Phytochemical investigations have revealed the presence of bioactive constituents such as flavonoids (e.g., baicalein, chrysin), tannins, alkaloids, and phenolic compounds, which may contribute synergistically to its therapeutic potential in managing dysmenorrhea [5,6]. Herbal formulations, especially syrups, are advantageous due to their ease of administration, better patient compliance, and rapid onset of action. Moreover, the liquid form allows for better absorption and is ideal for patients who have difficulty swallowing tablets or capsules. Despite the traditional use of Oroxylum indicum, limited scientific literature exists on its formulation into a standardized syrup dosage form for the specific indication of dysmenorrhea [7-9]. This study aims to bridge that gap by formulating and evaluating a polyherbal syrup containing Oroxylum indicum bark extract, specifically for the management of primary dysmenorrhea. The study includes comprehensive physicochemical characterization, in vitro assessment of spasmolytic and anti-inflammatory properties, and in vivo evaluation of analgesic activity using established animal models. The ultimate goal is to provide a safe, effective, and palatable herbal alternative that aligns with both traditional wisdom and modern scientific validation for the management of period cramps.

MATERIALS AND METHODS

MATERIALS

The bark of Oroxylum indicum was collected, authenticated and shade-dried for use in the formulation. Complementary medicinal herbs with known analgesic and antispasmodic properties were selected to enhance therapeutic efficacy. The formulation included pharmaceutical-grade excipients such as sucrose (sweetener), citric acid (pH stabilizer), sodium benzoate (preservative) and honey as a natural flavoring and soothing agent. All materials used were of analytical grade. 

Method of Preparation

The decoction method was employed to extract bioactive constituents from the bark of Oroxylum indicum, a technique particularly suited for tough plant materials like barks and roots. Ten grams of shade-dried bark was coarsely powdered to increase surface area, aiding solvent penetration and enhancing extraction efficiency. The powdered bark was boiled in 100 mL of distilled water at a controlled temperature of 80–90°C for two hours, maintaining a typical drug-to-solvent ratio of 1:10. This prolonged heating facilitated the release of active compounds such as flavonoids, tannins, and alkaloids by breaking down the rigid plant cell walls. After boiling, the decoction was reduced to approximately 50 mL to concentrate the extract. Filtration was performed using Whatman No. 1 filter paper or muslin cloth to remove particulate matter. The pH of the extract was adjusted, if necessary, to between 4.5 and 6.5 using citric acid to ensure syrup stability. The concentrated decoction was either used immediately for syrup formulation or stored in a cool, dark place with sodium benzoate added to extend shelf life [10,11].

Table 1: Formulation of Syrup from Oroxylum Indicum Bark

Experimental Work

Preformulation Study of the Raw Ingredient Used in the Formulation

1. Moisture content:

1. 2 gm sample in a Petri dish was weighed and taken.

2. For one hour, I heated the Petri dish in a hot air oven at 100°C.

3. After cooling, the sample was once more weighed.

4. Determined the moisture content [12].

2. Determination of ethanol extractive value:

1. For 24 hours, 5 gm of air-dried medication was taken with 100 ml of ethanol in a closed flask.

2. Frequent shaking for 6 hours, followed by 18 hours of standing.

3. Quickly filtered the sample after that.

4. The filtrate was then evaporated in a Petri dish for 25 ml.

5. After that, weigh after drying at 105°C. 6. Determined the value of ethanol [13].

3. Determination of water extractive value:

1. For 24 hours, 5 gm of air-dried medication was taken with 100 ml of chloroform in 1000 ml of water (or 2.5 ml of chloroform in 1000 ml of water).

2. Frequent shaking for the first six hours.

3. Permitted to stand for 18 hours.

4. In a Petri dish, evaporated 25 ml of the filtrate to dryness.

5. Weigh and dry at 1050 C. 6. Determined the extractive value of water.

4. Solubility testing:

1. I put 2 gm of a powdered medication into acetone, ethanol, chloroform, and distilled water.

2. After that, the drug's solubility was investigated [14].

Evaluation Parameter of Formulation

1. Color Examination:

1. A 2 ml prepared syrup sample was placed in a watch glass and placed against a white background under a white tube light to test the color.

2. Its color was assessed using the naked eye.

Odour Examination:

1. Two ml of the ready syrup were taken and smelled.

2. After that, scent was noticed.

Taste Examination:

A small amount of the finished syrup was sampled to assess its flavor [15].

pH Examination:

 1. Disturbed water was used to clean and wash the glass electrode.

2. The electrode was inserted into PH 7 buffer solution, and the PH meter's calibrate knob was turned to 7 to set the value.

3. The electrode was taken out, cleaned, and washed with distilled water.

4. The electrode's placement was in a solution of pH 4 buffer. Change the value.

5. After that, the electrode was inserted into the syrup, and the pH was measured.

Density Examination:

1. I cleaned the bottle of specific gravity.

2. Distilled water was used to clean the bottle at least twice.

3. Calculated the empty dry syrup bottle's weight using the stopper (w1).

4. After placing the stopper on the bottle and adding the final amount of syrup, wipe any extra syrup off the exterior of the tube.

5. Calculate the syrup's weight in gm (w2).

6. Calculate the weight in syrup gm (w3).

Formula of Density:

Density of liquid under test (syrup)=weight of syrup under test / volume of final syrup under test =W3/V.

Viscosity Examination:

1. Used acetone or other suitable organic solvent to thoroughly clean the Ostwald viscometer.

2. Set the viscometer on a suitable stand in a vertical position.

3. I filled the dry viscometer with water to the G mark.

4. The time it took for water to flow from point A to mark B was measured in seconds.

5. To get an accurate reading, this step was repeated at least three times.

6. After cleaning the viscometer with a sample liquid and filling it to mark A, notice   how long it takes for the liquid to reach mark B [15].

Formula for viscosity:

Viscosity= Density of the test liquid *time required to flow test liquid/density of water* time required to flow water*100

Procedure to determine Specific gravity:

1. Use chromic or nitric acid to completely clean the specific graveness bottle.

2. Wash the bottle with clean water at least doubly or three times.

3. If necessary, wash the bottle with an acetone- suchlike organic detergent and let air sot.

4. With a capillary tube breach, weigh an empty, dry bottle.

5. Place the breach on the bottle after filling it with distilled water, and use towel paper to wipe down any fat liquid from the side tube (w2).

6. Use a logical balance to weigh a bottle of water and a cork (w2).

7. After evacuating and drying as described in way 4 through 6, repeat the process for the liquid under test by substituting the water.

8. Put the bottle with the cork on and weigh it along with the liquid being tested (w3).

Formula for specific gravity:

Specific gravity of liquid under test (syrup) = weight of liquid under test /weight of water = w5 /w4 [16].

Stability testing:

1. The synthesized herbal syrup underwent stability testing while samples were kept under. accelerated temperature conditions.

2. Culture tubes were used to receive the finished syrup.

3. After that, the temperature was maintained at accelerated levels of 4, 16, and 47 degrees Celsius, respectively.

4. The samples were examined for all physicochemical characteristics (color, aroma, and taste), as well as turbidity, at intervals of 24 hours, 48 hours, and 72 hours to look for changes [17].

RESULTS AND DISCUSSION:

Table 2: Preformulation Study Result of Primary Dysmenorrhea

Table 3: Determination of Solubility of Sample

Determination of Specific Gravity of Liquid Observation

1. Weight of empty specific gravity bottle (w1) = 20.83g

2. Weight of specific gravity bottle + Distilled water (w2) = 68.93g

3. Weight of specific gravity bottle + Syrup solution (w3) = 73.65g

Calculation

1. Mass of the liquid sample (syrup solution) = W3 – W1 =73.65 – 20.83= 52.82

2. Mass of distilled water = W2 – W1 = 68.93 – 20.83 = 48.1

3. Specific gravity of liquid (syrup solution) = Mass of liquid / Mass of equal volume of water (Distilled water). = 52.82/48.

4. Specific gravity of syrup solution = 1.098.

Detemination of Density of Liquid

1. Density of water at room temperature (p1) = 0.997 g/ml (Standard value)

2. Specific gravity of syrup solution = 1.098

3. Specific gravity of liquid = Density of liquid (Syrup Solution) / Density of Distilled water.

4. Density of liquid (Syrup Solution) (p2) = specific gravity of liquid (syrup solution) x Density of Distilled water. (p2) = 1.098 x 0.997 (p2) = 1.0957 g/ml

5. Density of liquid sample (syrup solution) = 1.0957 g/ml.

Determination of viscosity of liquid

1. Viscosity of liquid (n2) = P2 t2 / P1 t1 x n1

2. P1 = Density of water (0.997 g/ml)

3. P2 = Density of test sample (syrup solution) (1.173g/ml)

4. N1 = Viscosity of water (0.8937 cp)

5. N2 = Viscosity of test sample (syrup solution)

6. T1 = Mean time of flow of flow of water from A to B (48.16 sec)

7. T2 = Mean time of flow of test (sample syrup) (20.5 sec)

8. Viscosity of water at room temp n1 = 0.8937cp = (1.17 x 20.5 /0.997 x 48.16) x 0.8937 = 0.4996 x 0.8937= 0.4462

9. Viscosity of syrup solution at room temp is = 0.4462 cp.

Table 4: Determination of Specific Gravity of Liquid

Table 5: Result of Evaluation Parameter