Development and Evaluation of Dashmula plants of Ayurveda.

 

Yogita. Chowdhary

Dr. K.N. Modi, Institute of Pharmaceutical Education and Research, Modinagar, Uttar Pradesh 201204

*Corresponding Author E-mail: Yogitachowdhary85@gmail.com.

 

ABSTRACT

Dashmool tablet is made with various ingredients in the formulation composition.It is a versatile indigenous drug, claimed by Ayurvedic system of medicine to be highly efficacious in the treatment of Rheumatism arthritis, inflammation. The two important Pharmacological properties of Dashmool are immunomodulator and febrifugal properties. Dashmool  which is used traditionally for treatment of number of diseases like jaundice, rheumatism, puerperal  forever ,paralysis, oedema, filarial and post natal care to avoid secondary complications. It provides general support to the body during period of Influenza, cough, cold, neuralgia and headaches. It is used as dietary supplement .It combines synergistic benefit of dashmool with other herbs. The present study involved the preparation of dashmool herbal tablet. Tablets were prepared by direct compression Dashmool tablet each weighing 1160 mg containing 250 mg of active ingredient of drug formulated. Tablets were evaluated for Disintegration, Hardness, Friability, Description, Uniformity of weight, Quantitative Standards, Physicochemical parameters (e.g Total ash %), Acid Insoluble ash, Alcohol soluble extract,water soluble extract.

 

KEYWORDS: Total Ash, Alcohol Soluble extractive, Disintegration.

 


INTRODUCTION:

Dashmoola’ which is used traditionally for treatment of a number of diseases like jaundice, rheumatism, puerperal fever, paralysis, oedema, filaria and. It provides general support to the body during periods of influenza, cough, cold, neuralgia and headaches. It is also used as a dietary supplement [1, 2]. ‘Dashmoola’ is used in different traditional Ayurvedic preparations like ‘Dashmoolarishta’, ‘Dashmoola ghritam’ and ‘Chyavanprash’ [3]. It is rejuvenator and revitalizer and commonly known as restorative tonic. It relives post delivery weakness. This syrup promotes vitality and strength [4]. It improves milk production in women’s. This is very useful in menopause [5].Dashmularishta restores energy in women after delivery.

 

This is a tonic made from different herbs. It helps in removing toxins from body and nourishes body tissues [6].. It maintains healthy female reproductive system. It is also a curative for general weakness. It combines synergistic benefit of Dashmool with other herbs. It strengthens the myometrial muscles in uterus, which enables to achieve adequate uterine contraction too expel menstrual discharge. Dashmularishta is useful in reliving mild to moderate pain in cases of dysmenorrheal [7].

 

MATERIALS AND METHODS:

Ten Plants namely Aegle Marmelos, Clerodendrum phlomidis,Desmodium Gangeticum, Stereospermum Suavaveolens, Oroxylum Indicum, Gmelina Arborea, Solanum Xanthocarpum, Solanum Indicum,Tribulus Terrestris,Uraria Picta were collected. The plant Material of dashmool was collected from wild sources in the vicinity of area of University Institute of Pharmaceutical Sciences ,Panjab University ,Haryana (District /Village Rewari). The identity of the plants was established by studying Taxonomic and morphological characters and compairing them with those described in standard texts.The final confirmation was done by compairing the samples with herabarium specimens available at Survey of Medicinal plants, Collection and Cultivation unit, Tamil Nadu.

 

EXPERIMENTAL METHODS:

·       Preparation of Dashmool blend

·       Preparation of Dashmool granules

·       Compressing the tablets

 

Table 1: Composition of Dashmool blend

Name of the plant

Part used

Qty taken (Part)

Aegle marmelos

Root

1

Clerodendrum phlomidis

Root

1

Desmodium gangeticum

Root

1

Gmelina arborea

Stem bark

1

Oroxylum indicum

Stem bark

1

Solanum xanthocarpum

Root

1

Solanum indicum

Root

1

Stereospermum suavaveolnes

Stem bark

1

Tribulus terrestris

Root

1

Uraria picta

leaf

1

 

Preparation of Dashmool blend:

Crude drug were powdered and passed through a sieve with a nominal mesh aperture of 710 μm (sieve no. 22) depending on the formulation [8,9,10]. All other ingredients of crude drug were also powdered and passed through a sieve with a nominal mesh aperture of 180 μm (sieve no. 85) depending on the formulation (excipients) [11,12,13]. The powder of dashmool and other ingredients were then thoroughly mixed together in a pestle mortar to uniformity [14, 15]. The uniformly mixed powder was then passed through a sieve with a nominal mesh aperture of 710 μm (sieve no. 22).This mixture was called dashmool blend [16, 17, 18, 19].

 

Table 2: Composition of Formulation1

S.No

 Ingredients

Quantity per tablet (mg)

 1

Dashmool blend

 250.0

 2

Dicalcium phosphate

 828.55

 3

Polyvinylpyrollidone

 50.0

 4

Talc

 15.0

 5

Magnesium stearate

 15.0

 6

Methyl paraben Sodium

 1.16

 7

Propyl paraben sodium

 0.29

Average weight of tablet 1160 mg containing 250 mg of the active ingredient.

 

Preparation of Dashmool granules:

The quantities required for dashmool blend and other pharmaceutical grade excipients from the above table were calculated depending upon the number of tablets (250 tablets were prepared each time) to be prepared. The dashmool blend was passed through a sieve with a nominal mesh aperture of 1 mm (sieve no. 18).

 

Polyvinylpyrollidone and dicalcium phosphate were passed through a sieve with a nominal mesh aperture of 250 μm (sieve no. 60) and mixed well [20, 21]. Dashmool blend, dicalcium phosphate and polyvinylpyrollidone were then mixed geometrically.The above mixture was passed through a sieve with a nominal mesh aperture of 1 mm (sieve no. 18) to obtain granules.The granules were dried in a hot air oven for 6 h at 60 C [22,23]. The ingredients from serial number 4 to 7 in above table were weighed and passed through a sieve with a nominal mesh aperture of 250 μm (sieve no. 60) and mixed well.The mixture obtained was then blended together with the granules so obtained after drying [24,25].

 

Compressing the tablets:

The granules were finally compressed into tablets using single-punch tablet machine fitted with the suitable punch and die (either 9.8 mm convex punch) depending upon the formulation [26,27,28]. The above tablet was then evaluated for disintegration time and hardness which revealed the non-compliance of these parameters with the pharmacopoeial limits for tablets. Therefore, some more formulations having dashmool blend as an active ingredient were designed and prepared with the aid of excipients. The different combinations were tried by varying the quantity of one or more than one ingredients as follows:

 

Table 3: Composition of Formulation II

S.NO

 Ingredient

Quantity per tablet (mg)

 1

Dashmool blend

 125.0

 2

Starch

 167.1875

 3

Gelatin

 25.0

 4

Calpax

 167.1875

 5

Methyl paraben Sodium

 0.50

 6

Propyl paraben Sodium

 0.125

 7

Talc

 7.5

 8

Magnesium stearate

 7.5

Average weight of tablet is 500.0 mg containing125.0 mg of the active ingredient

 

Table 4: Composition of Formulation III

S.No

Ingredients

Quantity per tablet (mg)

 1

Dashmool blend

 125.0

 2

Starch I.P.

 300.425

 3

Hydroxy propyl methyl cellulose

 20.0

 4

Methyl paraben sodium

 0.46

 5

Propyl paraben sodium

 0.115

 6

Talc

 7.0

 7

Magnesium stearate

 7.0

Average weight of tablet is 460.0 mg containing 125.0 mg of the active ingredient.

 

Table 5: Composition of Formulation IV

S.No

 Ingredients

Quantity per tablet (mg)

1

Dashmool blend

 250.0

2

Starch (as paste)I.P.

 852.5

3

Starch I.P.

 60.0

4

Methyl paraben sodium

 1.20

5

Propyl paraben sodium

 0.30

6

Talc

 18.0

7

Magnesium stearate

 18.0

Average weight of tablet is 1200.0 mg containing 250.0 mg of the active ingredient.

Table 6: Composition of Formulation V

S.No

 Ingredient

Quantity per tablet (mg)

 1

Dashmool blend

 250.0

 2

Starch I.P.

 394.3

 3

Gelatin

 50.0

 4

Calpax

 394.3

 5

Methyl paraben sodium

 1.12

 6

Propyl paraben sodium

 0.28

 7

Talc

 15.0

 8

Magnesium stearate

 15.0

Average weight of tablet is 1120.0 mg containing 250.0 mg of the active ingredient.

 

Table 7: Composition of Formulation VI

S.No

 Ingredients

Quantity per tablet (mg)

 1

Dashmool blend

 125.0

 2

Starch (as paste)I.P.

 257.482

 3

Starch I.P.

 20.0

 4

Methyl paraben sodium

 0.415

 5

Propyl paraben sodium

 0.103

 6

Talc

 6.0

 7

Magnesium stearate

 6.0

Average weight of tablet is 415 mg containing 125 mg of the active ingredient.

 

The above formulations (II) to (VI) (table 3 -7) were prepared by the same two steps (1-2) as described under the formulation (I). In formulations (II) to (VI) (table 3 -7), the dashmool blend was first mixed with binder and disintegrant [ingredient 3 and 4] in formulation (II); [ingredient 3] in formulation (III); [ingredient 2] in formulation IV; [ingredient 3] in formulation V (table 6); [ingredients 2] in formulation VI (table 7) and then moistened to proper wetness. Granulation was done by passing through a sieve with a nominal mesh aperture of 1 mm (sieve no. 18). The granules were dried in a hot air oven for 6 h at 60°C. The remaining excipients [ingredients from 2, 5 to 8 for formulation (II); [ingredients from 2, 4 to 7 till formulation (III); [ingredients from 3 to 7 in formulation (IV) (table 3-5); [ingredients 2, 4 to 8] in formulation (V) (table 6); ingredients 3 to 7 in formulation (VI) (table 7)] were passed through a sieve with a nominal mesh aperture of 250 μm (sieve no. 60) and mixed well. The granules were mixed with the excipients to uniformity. The mixture so obtained was compressed using single punch tablet machine fitted with a suitable punch.

 

The above formulations were evaluated for disintegration time and hardness which showed the following results (table 8):

 

Table 8: Disintegration time and hardness of formulation no. I to VI

S.No

Formulation

Disintegration (Minutes)

Hardness (Kg/cm3)

 1

 I

 6 min(16 sec)

 5

 2

 II

 5 min(21 sec)

 6

 3

 III

10 min(53 sec)

 3

 4

 IV

 3 min(12 sec)

 3

 5

 V

 5 min(10 sec)

 3

 6

 VI

 3 min(12 sec)

 2

Finally, the formulation (V) (table 6) was selected for further studies as it successfully complied with the pharmacopoeial limits. Using the same combination and proportion of excipients three other dashmool blend formulations were designed and prepared.

 

FINISHED PRODUCT SPECIFICATIONS:

Description [26]:

The tablets were round, biconcex, grey with diameter 9.8 ± 0.05 mm and thickness 5.8 ± 0.2 mm. They had a bitter taste with an agreeable odour.

 

Uniformity of weight:

The weight of 20 tablets which were selected at random from a batch had the average weight of 1160 mg for formulation (I), 500 mg for formulation (II), 460 mg for formulation (III), 1200 mg for formulation (IV), 1120 mg for formulation (V), 0.4194 g for formulation (VI). The weight of tablets (in mg) is given below.

 

Table 9: Uniformity of Formulation 1

1143.2

1157.7

1190.0

1126.7

1164.7

1157.5

1157.7

1176.1

1196.1

1138.7

1189.9

1129.9

1174.6

1194.2

1180.5

1184.5

1184.5

1110.4

1170.4

1206.4

 

Table 10: Uniformity of Formulation 2

500

507

510

490

510

515

505

508

504

504

502

516

500

510

500

495

501

516

507

507

 

Table 11: Uniformity of Formulation 3

470

472

462

470

472

474

470

470

464

464

460

468

465

475

469

479

478

470

473

474

 

Table 12: Uniformity of Formulation 4

1245

1247

1244

1224

1223

1243

1260

1240

1200

1180

1230

1210

1220

1233

1253

1183

1173

1230

1230

1230

 

Table 13: Uniformity of Formulation 5

1700.0

1139.0

1139.0

1129.0

1122.0

1153.0

1154.0

1160.0

1156.0

1120.0

1320.0

1133.0

1140.0

1130.0

1115.0

1125.0

1105.0

1085.0

1105.0

1320.0

 

Table 14 : Uniformity of Formulation 6

4270.0

4173.0

4173.0

4318.0

4018.0

4118.0

4218.0

4246.0

4369.0

4169.0

4216.0

42460.

4200.0

4300.0

4236.0

4036.0

4036.0

4236.0

4277.0

4032.0

 

Disintegration time:

6 min (16 sec) for formulation (I), 5 min (21 sec) for formulation (II), 10 min (53 sec) for formulation (III), 3 min (12 sec) for formulation (IV), 5 min (10 sec) for formulation (V), 3 min (12 sec) for formulation (VI).

Hardness:

5.0 kg/cm3 for formulation (I), 6.0 kg/cm3 for formulation (II), 3.0 kg/cm3 for formulation (III), 3.0 kg/cm3 for formulation (IV), 3.0 kg/cm3 for formulation (V), 2.0 kg/cm3 for formulation (VI).

 

Friability:

0.15 % for formulation (I), 0.62 % for formulation (II), 0.68 % for formulation (III), 0.45 % for formulation (IV), 0.22 % for formulation (V), 0.42 % for formulation (VI).

 

Description:

The tablets of dashmool formulations (I) and (III) were round, biconvex, brown to dark brown with diameter 9.8 ± 0.05 mm and thickness 5.8 ± 0.2 mm. They had a bitter taste with an agreeable odour.

 

RESULTS AND DISCUSSION:

Dashmool, chosen for the present study, is a preparation which is generally recommended for inflammation of joints and rheumatoid arthritis. The composition of the herbal ingredients of dashmool was taken from the Ayurvedic Formulary of India. The excipients used to formulate the dashmool tablet were selected from the list published by the Government of India under rule 169 of Drugs and Cosmetics (Fifth Amendment) Rules, 2005. The excipients mentioned in this list are allowed to be used in Ayurvedic, Unani, Siddha and Homoeopathic medicine.The excipients were tried at different concentrations so as to prepare a tablet dosage form which complies with the pharmacopoeial limits. The first attempt included PVP K - 30 as a binder and dicalcium phosphate as filler (Formulation I). These two excipients were used along with the dashmool blend for granulation using the method of wet granulation. For wet granulation, purified water was used. The concentration of dicalcium phosphate was at the higher end among the two excipients used. The granules so formed were mixed with the rest of the excipients viz magnesium stearate as antiadherent and talc as glidant and lubricant, methyl paraben sodium and propyl paraben sodium as preservative. The granules were compressed into tablets and the parameters were analyzed. The tablets of first formulation (Formulation I) so prepared showed hardness of 5 kg/cm3 and disintegration time of (6 min 16 sec). In the second formulation (Formulation II) starch was used as filler, gelatin as binder, calpax as filler, methyl paraben sodium, propyl paraben sodium as preservative, talc and magnesium stearate as lubricant. The tablet of second formulation (Formulation II) so prepared showed hardness 6 kg/cm3 and disintegration time of ( 5 min 21 sec). In third formulation (Formulation III) starch was used as filler, hydroxy propyl methyl cellulose as binder, methyl propyl sodium and propyl paraben sodium as preservative, talc and magensium stearate as lubricant. The disintegration time was (10 min 53 sec) but there was also a negligible decrease in hardness 3 kg/cm3. In fourth formulation (Formulation IV) starch was used as filler and again as binder, methyl paraben sodium, propyl paraben sodium as preservative, talc and magnesium stearate as lubricant. The (Formulation IV) showed disintegration time as (3 min 12 sec) min and hardness as 3 kg/cm3. In fifth formulation (FormulationV) starch was used as filler, gelatin as binder, calpax as filler, methyl paraben sodium, propyl paraben sodium as preservative, talc and magnesium stearate as lubricant. The disintegration time was (5 min 10 sec) and hardness was 3 kg/cm3 of fifth formulation (Formulation V). In this attempt, calpax was added along with starch as filler. In formulation six (Formulation VI) starch was used as filler and again as binder, methyl paraben sodium, propyl paraben sodium as preservative, talc and magnesium stearate as lubricant. The analysis of the tablet in formulation six (Formulation VI) so formed showed a disintegration time of (3 min 12 sec) and hardness of the tablet was 2.0 kg/cm3.

 

CONCLUSION:

Formulation of Dashmool tablet and the effect of concentration and binder using direct compression technique. Powder and excipient used were found to be compatible .Evaluation was done by the tablet were found to be within limits with respect to Hardness, Average weight, % Friability and thickness.The result obtained from all experimental analysis showed tablet of Dashmool plants of Ayurved have good physical characterstics. The study altogether indicated that the Dashmula tablets were successfully prepared and evaluated.

 

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Received on 18.12.2017          Modified on 15.01.2018

Accepted on 16.02.2018            © A&V Publications All right reserved

Asian J. Pharm. Tech. 2018; 8(1):08-12.

DOI: 10.5958/2231-5713.2018.00002.8