Ayurveda

1. Indian Journal of Traditional Knowledge
Vol. 6(4), October 2007, pp. 648-652
Standardization of Ayurvedic polyherbal formulation, Nyagrodhadi churna
KR Gopala Simha* & V Laxminarayana
Sodhana Trust, Gautam Towers, Sardar Patel Road, Secunderabad 500 003, Andhra Pradesh
E-mail:sodhana@satyam.net.in; sodhana@sify.com
Received 9 September 2005; revised 5 October 2006
Ayurvedic medicine Nyagrodhadi churna, known to be effective in all types of prameha (Pramehadhikara) – polyuria,
including madhumeha (Diabetes mellitus), has been standardized by following modern scientific quality control procedures
both for the raw material and the finished product. The obtained values of physical and chemical parameters can be adopted
to lay down new pharmacopoeial standards to be followed for traditional preparation of Nyagrodhadi churna with batch-to-
batch consistency. The phytochemical constituents found to be present in the raw material used for the preparation of
Nyagrodhadi churna possibly facilitate the desirable therapeutic efficacy of the medicinal formulation, and also could help
in knowing the underlying mechanisms of pharmacological action.
Keywords: Standardization, Nyagrodhadi churna, Ayurvedic formulation, Prameha, Polyuria, Madhumeha, Diabetes
mellitus, Pharmacopoeial standards
IPC Int. Cl.8: A61K36/00, A61P13/00, A61P5/00, A61P5/10, A61P5/50, A61P13/02
Nyagrodhadi churna (NC), an Ayurvedic polyherbal Methodology
formulation, consists of Nyagrodha (Ficus Nyagrodhadi churna is a polyherbal formulation
bengalensis) and other 27 ingredients in churna (Table 1) consisting of 28 ingredients in all, with
(powder) form. It supposedly has multi-faceted action specific morphological parts of the plants (herbs) used
in all 20 types of prameha (polyuria) including and each ingredient being of equal quantity. For
madhumeha (Diabetes mellitus)1, Preparation of NC standardization of NC, some modifications were
is based on traditional methods in accordance with the made. In place of aragwadha (Cassia fistula) stem
procedures given1. Due to lack of modern bark used, fruit pulp was used as per the
pharmacopoeial standards laid down and followed for recommendation of Ayurvedic Formulary of India
processing of NC using traditional methods, the (AFI)2. According to Ayurveda, it is appropriate to use
medicine prepared may not have the desired quality another herb with similar Ayurvedic characteristics in
and batch-to-batch consistency. Hence, there is a need case the required herb is not available1. Kapittha
for standardization of NC following scientific (Feronia limonia) is a fruit that is not available in all
parameters including organoleptic characters,
seasons of the year. Accordingly, kapittha in the
chemical analysis, chromatographic pattern and
traditional formulation was substituted with the roots
microbiological screening. The work was undertaken
of shatavari (Asparagus racemosus Willd.) known to
to standardize and validate Ayurvedic medicine,
Nyagrodhadi churna used in the treatment of have antidiabetic properties3, 4. The raw material was
madhumeha. Standardization of NC was carried out procured from the local market or from a nearby
following Good Manufacturing Practices (GMP) for forest, after a preliminary identification was made
preparation of Ayurvedic medicines. Standardization based on the Ayurvedic parameters such as varna
guidelines for herbal products provided by World (colour), gandha (odour), ruchi (taste), aakruti
Health Organization (WHO) and European Agency (shape) and parimana (size)5-7. The material was
for the Evaluation of Medicinal Products (EMEA) examined for probable adulterants and foreign matter
have also been followed. adhering to the surface was removed5-7. Organoleptic
evaluation was used for identification of
_________ sensory characteristics like colour, odour, taste,
*Corresponding author shape, size, texture and fracture. In macromorphological

2. SIMHA & LAXMINARAYANA: STANDARDIZATION OF AYURVEDIC POLYHERBAL FORMULATION 649
Table 1⎯Ingredients of Nyagrodhadi churna
Plant name Sanskrit name Parts used
Anogeissus latifolia Wall. ex Bedd. Dhava Stem bark
Baliospermum montanum Muell.-Arg. Danti Root
Buchanania lanjan Spreng. Priyala Seed (Kernel)
Cajanus cajan (Linn.) Millsp. Adhaki Root
Cassia fistula Linn. *Aragwadha Fruit pulp
Crataeva nurvala Buch.-Ham. Varuna Stem bark
Emblica officinalis Gaertn. Amalaki Fruit (seed removed)
Erythrina variegata Linn. var orientalis (Linn.) Merrill Paribhadra Stem bark
Syzygium cuminii (Linn.) Alston Jambu Seed (Kernel)
†
Feronia limonia Swingle Kapittha Fruit pulp
Ficus bengalensis Linn. Nyagrodha Stem bark
Ficus glomerata Roxb. Udumbara Stem bark
Ficus religiosa Linn. Aswattha Stem bark
Glycyrrhiza glabra Linn. Yashtimadhu Root
Gymnema sylvestre R. Br. Meshasringi Leaf
Holarrhena antidysenterica (Linn.) Wall. Kutaja Stem bark
Madhuca indica Linn. Madhuka Flower
Mangifera indica Linn. Amra Seed (Kernel)
Oroxylum indicum Vent. Shyonaka Stem bark
Plumbago zeylanica Linn. Chitraka Root
Pongamia pinnata Pierre Karanja Seed
Pterocarpus marsupium Roxb. Vijayasara Stem (Heartwood)
Semecarpus anacardium Linn. f. Bhallataka Seed (Kernel)
Symplocos racemosa Roxb. Lodhra Stem bark
Terminalia arjuna (Roxb.) Wight & Arn. Arjuna Stem bark
Terminalia bellirica Roxb. Vibhitaki Fruit (seed removed)
Terminalia chebula Retz. Haritaki Fruit (seed removed)
Trichosanthes dioica Roxb. Patola Leaf
Note: The nomenclature for the above 28 ingredients has been adopted from the compendium Medicinal
Plants Used in Ayurveda, (Rashtriya Ayurveda Vidyapeeth, Govt. of India, New Delhi), 1998.
*For Aragwadha, Bhaishajya Ratnavali mentions use of stem bark but fruit pulp has been used as per
the recommendation of AFI.
†’Kapittha’ is a seasonal fruit and the fruit pulp was not available. Shatavari (Asparagus racemosus)
roots were used as a substitute.
evaluation, the plants were arranged according to their of the ingredients9 (Table 2). Thin layer chromatography
morphological characteristics and identification of the (TLC) was performed and Rf values were calculated5-7.
correct part of the plant to be used was done. Quantitative analysis of the raw material was done
Microscopic evaluation and cytomorphological for standardization parameters including foreign
evaluation were not done as detailed phytochemical organic matter, water soluble extractive, methanol
analysis was performed. The plant material was soluble extractive, total ash and acid insoluble
cleaned by sorting out pebbles, etc., using a cloth ash7,10. Their values were calculated and found to
duster to remove dust; and air blowing to remove be well within the available standard ranges. Other
minute sand particles. The ingredients of the parameters, moisture content, pH, ether soluble
formulation were individually treated with water extractive and crude fiber were also assessed 7, 10.
containing the antimicrobial agents, potassium meta Microbiological screening was done for the finished
bi-sulphite (0.1%) and isopropyl alcohol (70 %)8. The product. The approved raw material was packed in
material was dried and then considered for quality sterilized airtight polybags with proper labeling and
analysis. stored in a cool place2. Hygienic conditions were
Active phytochemical constituents like glycosides, maintained by regular disinfecting of the work areas
flavonoids, alkaloids, acids, gums, tannins, were and weekly fumigation11. The ingredients (except
identified through qualitative chemical analysis in each priyala, madhuka, bhallataka) were individually

3. 650 INDIAN J TRADITIONAL KNOWLEDGE, VOL 6, No. 4, OCTOBER 2007
Table 2⎯Phytochemical constituents of Nyagrodhadi churna ingredients
Ingredients Phytochemical constituents
Sanskrit name Plant Name Glycosides Flavonoids Alkaloids Acids Gums Tannins Fixed oils Resins
Nyagrodha Ficus bengalensis Linn. + + + +
Udumbara Ficus glomerata Roxb. + + + +
Aswattha Ficus religiosa Linn. + + + +
Shyonaka Oroxylum indicum Vent. + + +
Aragwadha Cassia fistula Linn. + + +
Vijayasara Pterocarpus marsupium
+ + + +
Roxb.
Amra Mangifera indica Linn. + + +
Shatavari Asparagus racemosus Willd. +
Jambu Syzygium cuminii (Linn.)
+ + + + + +
Alston
Priyala Buchanania lanjan Spreng. + +
Arjuna Terminalia arjuna (Roxb.)
+ + + + +
Wight & Arn.
Dhava Anogeissus latifolia Wall. ex
+ + + + +
Bedd.
Madhuka Madhuca indica J.F.Gmel. + + +
Yashtimadhu Glycyrrhiza glabra Linn. + + + + + +
Lodhra Symplocos racemos Roxb. + + + +
Varuna Crataeva nurvala Buch.-Ham. + +
Paribhadra Erythrina variegate Linn. var.
+ + + +
orientalis (Linn.) Merrill
Patola Tricosanthes dioica Roxb. + + +
Meshasringi Gymnema sylvestre R.Br. + + + +
Danti Baliospermum montanum
+ + +
Mull.-Arg.
Chitraka Plumbago zeylanica Linn. + + + +
Adhaki Cajanus cajan (Linn.) Millsp. +
Karanja Pongamia pinnata Pierre + + + +
Haritaki Terminalia chebula Retz. + + +
Vibhitaki Terminalia bellirica Roxb. + + + +
Amalaki Emblica officinalis Gaertn. + + +
Kutaja Holarrhena antidysenterica
+ + + +
(Linn.) Wall.
Bhallataka Semecarpus anacardium
+ + + + +
Linn. f.
+ Present
pulverized and sieved (100 mesh) to obtain respective the above powder mixture of 25 ingredients. This
fine powders of 25 ingredients that were thoroughly material, along with priyala and madhuka of fine
mixed together and the mixture was kept aside. Two consistency, was blended in a mixer to obtain a
herbal ingredients, priyala and madhuka – were homogenous mixture. The composite mixture was sieved
pounded in a metallic mortar and separately crushed (100 mesh) to obtain a fine powder of the finished
in a domestic mixer till fine consistency. Bhallataka is product Nyagrodhadi churna. The finished product
used in Ayurvedic preparations only after purification. thus obtained, was subjected to chemical treatment
Cleaned bhallataka kernels were cut into small similar to that given to the raw material to inhibit
pieces, soaked in coconut water for 24 hrs and then microbial growth. It was then dried at 600C.
cleaned with distilled water. This process was Nyagrodhadi churna obtained in powder form was
repeated twice. The material was then dried at 600C to packed in sterilized polythene pouches, labeled,
obtain purified bhallataka, which was later powdered (60 coded and stored inside cool & dry shelves. The
mesh). The purified bhallataka powder was added to above detailed procedures were adopted for 6 batches

4. SIMHA & LAXMINARAYANA: STANDARDIZATION OF AYURVEDIC POLYHERBAL FORMULATION 651
of NC prepared. Statistical analysis was done; physical and chemical parameters and also subjected to
‘Mean’, ‘Standard Deviation (SD)’ and ‘Standard microbiological screening through quality control
Error (SE)’ values are given as also ‘Range’ and measures. Quality tests (Table 3) for NC were
‘Median’ values wherever applicable. performed for moisture content, water soluble
extractive, methanol soluble extractive, ash content,
Results and discussion and acid insoluble ash, and were found to be within
As part of standardization procedure, all 6 batches of standard ranges12. Values of pH and ether soluble
the finished product of NC were tested for relevant extractive, sulphated ash and crude fiber were
assessed11,13,14. In addition, TLC was done (Fig. 1) with
methanol extract of Nyagrodhadi churna5,12,15. Ethyl
acetate and toluene (3:7) was used as the mobile phase
and iodine vapors as visualizing agent. Rf values
(Table 3) were calculated. For 6 batches of NC,
microbiological analysis was done6. Pathogens E.
coli, S. aureus, salmonella, shigella and P.
aeruginosa were found to be absent. Total aerobic
count was done; and bacteria (range 725, median
787), fungi (yeast: 0; moulds: range 10, median
10) and coliforms (range 3, median 3) were found
to be within limits. Standardization of Nyagrodhadi
churna was possible by considering various scientific
parameters concerning the quality of the raw material
used, keeping intact procedures in accordance with
Ayurvedic System. In this work, shuddhi
(purification) of bhallataka with coconut water has
been done. This is expected to reduce the undesirable
effects of bhallataka like mucosal irritation and make
it suitable for medicinal use, as it was found the
organoleptic character ruchi (taste) both before and
after purification, confirming the need for purification
of bhallataka.
The separate pulverization procedure adopted for
priyala was due to its oil content and gums and to
avoid undesirable formation of small lumps. Madhuka
Fig. 1⎯TLC of Nyagrodhadi Churna in methanol extract was also pounded separately, for a similar reason, due
Table 3 – Quality tests for the finished product, Nyagrodhadi Churna
Batch 1 Batc 2 Batch 3 Batch 4 Batch 5 Batch 6 Mean (SD)
Parameter S.V. O.V. O.V. O.V. O.V. O.V. O.V.
Moisture content (%) ≤10 1.31 2.14 2.14 2.43 3.25 3.02 2.38 (0.70), SE 0.28
Water soluble extractive (%) 10 to 20 18.90 22.19 22.53 22.73 20.90 21.40 21.44 (1.42), SE 0.58
Methanol soluble extractive (%) 15 to 20 20.40 20.51 19.80 16.49 15.87 18.19 18.54 (2.02), SE 0.82
Ash content (%) 7 to 11 7.45 7.40 7.66 9.53 10.00 10.67 8.79 (1.45), SE 0.59
Acid insoluble ash (%) ≤2 0.96 1.00 1.02 1.31 1.07 0.50 0.98 (0.26), SE 0.11
pH - 4.98 4.88 4.84 4.76 4.85 4.92 4.87 (7.5E-02), SE 3.06E-02
Ether soluble extractive (%) - 6.45 6.05 6.12 5.09 5.25 5.24 5.70 (0.57), SE 0.23
Sulphated ash (%) - 12.14 12.43 12.56 14.35 13.98 14.26 13.29 (1.01), SE 0.41
Crude fiber (%) - 20.85 23.70 22.86 22.31 23.75 23.00 22.75 (1.08), SE 0.44
TLC (observed no of spots) - 12 12 12 12 12 12
Rf values (calculated) 0.04; 0.07; 0.09; 0.17; 0.27; 0.56; 0.66; 0.71; 0.78; 0.85; 0.92; 1.00
SV = Standard Value ; OV = Obtained Value

5. 652 INDIAN J TRADITIONAL KNOWLEDGE, VOL 6, No. 4, OCTOBER 2007
to its sugar content, gums and resins. Values obtained Nyagrodhadi churna, to obtain optimal efficacy of
after conducting tests for moisture content, water soluble the medicine.
extractive, methanol soluble extractive, ash content, acid
insoluble ash for NC were in conformance with the Acknowledgement
standards laid down for herbal material. The ‘Mean’ The work was supported by Byrraju Foundation,
value obtained for each parameter was found to be Hyderabad. Authors gratefully acknowledge the
consistent across 6 batches with minimum ‘SD’. Also, valuable inputs including statistical analysis provided
the corresponding value of ‘SE’ was found to be low, by Dr B Anand during the course of preparation of the
showing batch-to-batch consistency. For pH, ether manuscript.
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