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Abdullah et al.| Standardization of a unani pharmacopoeal compound formulation ‘Majoon-e-Piyaz’
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Standardization of a unani pharmacopoeal compound formulation „Majoon-ePiyaz‟
Abdullah1*, Saxena VK1, Manjeet Sinha1, Abdul Latif2
1Indian
Medicines Pharmaceutical Corporation Ltd., A Government of India Enterprise, Mohan, Distt. Almora, Uttarakhand, India.
of Ilmul Advia, Faculty of Unani Medicine, AMU, Aligarh, UP, India.
2Department
SHORT COMMUNICATION
ARTICLE INFORMATION
Article history
Received: 15 January 2015
Revised: 08 February 2015
Accepted: 15 February 2015
Early view: 20 March 2015
*Author for correspondence
E-mail: [email protected]
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ABSTRACT
In Unani System of Medicine the drugs derived from natural sources are used, the
majority of them are plant origin 85 %, animal origin 10% and mineral origin 5%
but like any other system of medicine the efficacy of Unani System of Medicine also
depends on potential and purity of the drugs used. To develop a mechanism for
quality assurance of natural compound to ensure the purity of crude drugs
material and its standardization is essential. Standardization and quality control are
the key factors in regulating the therapeutic efficacy of Unani Herbal drugs.
Organoleptic parameters are often insufficient in the quality assessment of Unani
Herbal Drugs. The present study deal with compound Unani formulation of
‘Majoon Piyaz’ is compound formulation of NFUM Part I. It is a semi solid, dark
brown colored compound formulation with sweet tending bitter in taste
therapeutically used in Zof-e-Bah (Sexual debility), Jiryan (Spermatorrhoea) and
Surat-e-Inzal (Premature ejaculation). Majoon-e-Piyaz is a natural product and is
absolutely safe as it does not produce any side effects. In standardization of drug,
the drug investigated through different chemical method, their active principals
are being worked out, their percentage composition are as follow Total ash 1.38%,
Acid-insoluble ash 0.58%, Water-soluble ash 0.52%, Alcohol Soluble Extractive
12.60%, Water Soluble Extractive 70.16%, pH values of 1% aqueous solution 4.77
o
and 10% aqueous solution 4.58, Loss on drying at 105 C 17.06%. The Aflatoxin is
estimated and reported that are not detected. In additin Heavy Metals, Microbial
Load were done which are with in limit. This study will help in setting down
Pharmacopoeial standards in determining the quality and purity of compound
drug.
Keywords: Majoon Piyaz, Standardization, quality control, Unani Formulation.
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INTRODUCTION
The use of herbs and their formulations to treat diseases
has stood the test of time. The chemical constituents
present in them are a part of the physiological functions
of living flora and hence they are believed to have better
compatibility with the human body. That is why herbs
and their products are now the centre of gravity for
researches and application of it in treating the diseases.
Plants and their products are composed of many
constituents and are therefore, capable of variation. The
variability of the plant material is due to different
conditions of growth, harvesting, drying, and storage.
The polarity of the solvent, the mode of extraction, and
Int J Adv Pharmacy Med Bioallied Sci. 3, 1, 2015.
the instability of constituents may also influence the
composition and quality of the extracts. In olden times,
Hakims used to treat patients on individual basis and
prepare drug according to the requirements of the
patient. Today herbal medicines however, are
manufactured on a large scale in mechanical units, where
manufacturers come across many problems such as non
availability of good quality raw materials and proper
methodology for standardization, etc., the availability of
SOP (Standard Operational Procedure) for manufacturing
units on large scale production is also lacking. (Afaq et
al., 2012). The present study deal with compound Unani
formulation of „Majoon Piyaz‟ is compound formulation of
NFUM Part I. „Majoon Piyaz‟ is a semi solid, dark brown
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Abdullah et al.| Standardization of a unani pharmacopoeal compound formulation ‘Majoon-e-Piyaz’
colored compound formulation with sweet tending bitter
in taste therapeutically used in Zof-e-Bah (Sexual
debility), Jiryan (Spermatorrhoea) and Surat-e-Inzal
(Premature ejaculation) (Hakeem Mohammad Kabiruddin,
1978).
MATERIALS AND METHODS
Raw Materails
The formulation contains the ingridients (Table 1& Figure
1) that are mentioned in part 1st of National Formulary of
Unani Medicine (Anonymous, 2006). The raw materials
were procured from the market through tender and their
identity, purity and strength were checked as per
reference, given in table 1. The commercial sample of
Tudri Sufaid consists of dried seed of Cheiranthus cheiri
Linn. (Family Brassiaceae) a shrub like herb cultivated in
Indian gardens, frequently found in India and Iran. Tudri
Sufaid was standardized and their standards are quoted
here. Total Ash not more than 10%, Acid Insoluble Ash not
more than 5.0%, Water Soluble not less than 6.0% and
Alcohol Soluble extractive not less than 4.0%.
Physicochemical Parameters
Physicochemical studies like total ash; acid insoluble
ash; water soluble ash; alcohol, petrolium Ether and
water soluble matter; pH values of 1% aqueous solution;
and 10% aqueous solution; loss on drying; were
determined quantitatively according to methods recorded
in Indian Pharmacopoeia (Anonymous, 1978(a), WHO
guidelines (Anonymous, 1978(b), (Anonymous, 2005), and
methods mentioned by Afaq et al, (1994). The
determination of Atomic absorption for Heavy metals,
presence of Aflotoxins and Microbial load were studied as
per revised recomendation of WHO mentioned in its
bulletin (Anonymous, 2005).
Preparation of “Majoon-e-Piyaz”
Ingredients of “Majoon-e-Piyaz) oral dosage form is
mentioned in the Table-1. Clean, dry and powder the
ingredients number 1 to 13 separately. Frequent cheking
Table 1. Ingredients of „Majoon-e-Piayz‟.
of particle size of powder was made. The powder of drug
was passed through the sieve number 80. Ingredients
number 15 dissolve the required quantity of sugar in
1000 ml of purified water and add Ingredients number 14
(Aab-e-Piyaz Sufaid) on slow heat, and at boiling stage
add 0.5% alum, mix well and heat gently to prepare the
qiwam of 75-76 % brix (two-three tar). Discontinue
heating and while light hot add the fine powders of
ingredient number 1 to 13, along with 0.6 % of sodium
benzoate and mix thoroughly to get the homogenous
product. Allow to cool to room temperature. Pack it in
tightly closed containers to protect from light and
moisture.
Description: “Majoon-e-Piyaz” is a semi solid, dark
brown colored compound formulation with sweet tending
bitter in taste.
Dose: 12 g. orally with milk/Arq-e-Gazar/fresh water
once a day (H. M. Kabiruddin, 1978).
RESULTS
The “Majoon-e-Piyaz” investigated through different
parameter of standardization and their percentage
compositions are as follow:
Total ash (1.38%), Acid insoluble ash (0.58%), Water
soluble ash (0.52%), Alcohol soluble matter (12.60%),
Water soluble matter (70.16%), Loss on drying at 105 oC
(17.06%), pH 1% and 10% (4.77 & 4.58). These parameters
are considered as tools of checking the quality, identity,
purity and strength of the “Majoon-e-Piyaz” a semisolid
compound formulation. The heavy metals, aflotoxins and
Microbial load were also studied and reported (Table 3a,
3b, 3c, ) No growth of any Fingi or Bacteria were
observed in the cultural media and no aflotoxines
(B1,B2,G1,G2) were detected. Pb, Hg, and As are
detected in the formulation but present with in the limit.
No Aflotoxin, and Microb were detected hence passing all
the test for its clinical use.
S.N.
Unani Name
Botanical/ English Name
Part Used
Quantity
Reference
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
Tudri Surkh
Tudri Safaid
Salab Misri
Behman Surkh
Behman Safaid
Zanjabeel
Tukhm-e-Piyaz
Tukhm-e-Turab
Tukhm-e-Gandana
Tukhm-e-Shalgham
Talmakhana
Musli Safaid
Musli Siyah
Aab-e-Piyaz Safed
Qand Safaid
Natroon Benzawi
Shibb-e-Yamani
Cheiranthus cheiri Linn
Cheiranthus cheiri Linn
Orchis latifolia Linn
Salvia haematodes M
Centaurea behen Linn.
Zingiber officinale
Allium cepa
Raphanous sativus
Asphodelus ternuifolius
Brassica rapa Linn
Euryale ferox
Chlorphytum arundinaceum
Curculigo orchioides
Allium cepa
Saccharum officinarum
Sodium Benzoate
Alum
Seed
Seed
Tuber Root
Root/Stem
Root
Rhizome
Seed
Seed
Seed
Seed
Seed
Root
Root
Fresh Bulb
Crystal
Crystal
Crystal
3.5 g.
3.5 g.
3.5 g.
3.5 g.
3.5 g.
3.5 g.
3.5 g.
3.5 g.
3.5 g.
3.5 g.
3.5 g.
3.5 g.
3.5 g.
1.5 L.
1.5Kg.
0.6 %
0.5 %
UPI-part-2, Vol.2,p.264
*
UPI-part-1, Vol.3,p.88
UPI-part-1, Vol.3,p.23
UPI-part-1, Vol.3,p.21
UPI-part-1, Vol.1,p.88
UPI-part-1, Vol.3,p.19
UPI-part-1, Vol.5,p.101
UPI-part-1, Vol.6,p.88
UPI-part-1, Vol.3,p.99
UPI-part-1, Vol.3,p.107
UPI-part-1, Vol.2,p.79
API-part-1, Vol.4,p.122
UPI-part-1, Vol.3,p.17
API-part-1, Vol.6,p.218
IP, Vol.2, p. 684
UPI-part-2, Vol.2,p.229
Note:
*1. Standardization of the raw material made in the laboratory and mentioned under the heading of material and method.
Int J Adv Pharmacy Med Bioallied Sci. 3, 1, 2015.
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43
Abdullah et al.| Standardization of a unani pharmacopoeal compound formulation ‘Majoon-e-Piyaz’
2. UPI: The Unani Pharmacopoeia of India
3. API: The Ayourvedic Pharmacopoeia of India
4. IP: Indian Pharmacopoeia.
Figure 1. Ingredients of “Majoon-e-Piyaz”.
Tudri Surkh
Tudri Sufaid
Salab Misri
Behman Surkh
Behman Sufaid
Zanjabeel
Tukhm-e-Piyaz
Tukhm-e-Turb
Tukhm-e-Gandana
Tukhm-e-Shalgham
Talmakhana
Musli Sufaid
Musli Siyah
Piyaz (Bulb)
Qand Sufaid
Table 3. Heavy Metals (a), Aflatoxin (b) and Microbial
Load (c) of „Majoon-e-Piyaz‟.
(a) Qualitative analysis for heavy metals.
Shibb-e-Yamani
Natroon, Benzawi
S.
No.
Test
Parameters
Results*
Limits
1
Lead as Pb
Less than
10ppm
2
Mercury as Hg
Less than 1ppm
3
Arsenic as As
Less than 3ppm
Not more than
10ppm
Not more than
1ppm
Not more than
3ppm
Not more than
0.3ppm
Less than
Cadmium as
0.3ppm
Cd
*Each parameter is mean of three experiments.
4
Table 2. Physicochemical Properties of „Majoon-e-Piyaz‟.
Parameter*
Total ash
Acid insoluble ash
Water soluble ash
Alcohol soluble matter
Water soluble matter
Loss on dry
pH 1%
pH 10%
Majoon-e-Piyaz
Not more than 1.38%
Not more than 0.58%
Not more than 0.52%
Not less than 12.60%
Not less than 70.16%
Not more than 17.06%
4.77
4.58
Int J Adv Pharmacy Med Bioallied Sci. 3, 1, 2015.
(b) Aflatoxin
S. N.
Aflatoxin
Result*
Limit
1
B1
Not detected
Not more than 0.5ppm
2
B2
Not Detected
Not more than 0.5ppm
3
G1
Not Detected
Not more than 0.1ppm
4
G2
Not Detected
Not more than 0.1ppm
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Abdullah et al.| Standardization of a unani pharmacopoeal compound formulation ‘Majoon-e-Piyaz’
(c) Microbial Load
S. N.
Microbs
Result*
Limit
1
Total Bacterial Count
Nil
2
Total Fungal Count
Nil
3
E.coli
Nil
Nil
4
Salmonella
Nil
Nil
5
Staphylococcus aureus
Nil
Nil
6
P. aeruginosa
Nil
Nil
Not more than
105 cfu/g
Not more than
103 cfu/g
Note. *All result based on three experiments
DISCUSSION
The present study is an attempt to ascertain the
pharmacopoeial standards for the standardization of
„Majoon-e-Piyaz‟. Majoon-e-Piyaz is a natural product
and is absolutely safe as it does not produce any side
effects. The parameters that are selected are those
which
are
recommended
by
National
Unani
Pharmacopoea Committee. “Majoon-e-Piyaz” is a semi
solid, dark brown colored compound formulation with
sweet tending bitter in taste and during preperation of
one batch 1-5% loss is expected.
CONCLUSION
The compound Unani Formulation „Majoon-e-Piyaz‟ used
in the current study is of the standard parameter as given
in Ayurevedic and Unani Pharmacopoeia. The above
standards can be used for correct identification of market
samples of drug.
Anonymous. The Ayourvedic Pharmacopoeia of India; Part-I,
Vol.VI; Gov.of India, Ministry of Health and Family welfare,
AYUSH, N.Delhi; 2004. p.118, 122.
Anonymous. Quality Control Methods for Medicinal Plant
Material, WHO Revised DRAFT, UPDATE, September 2005. p.
4-5, 20-40.
Anonymous. National Formulary of Unani Medicine Part I,
Department of AYUSH, Ministry of Health and Family
Welfare, Government of India; 2006. p. 139.
Anonymous. The Unani Pharmacopoeia of India; Part-1,
Vol.I; Gov.of India, Ministry of Health and Family welfare,
AYUSH, N.Delhi; 2007. p.88.
Anonymous . The Unani Pharmacopoeia of India; Part-1,
Vol.II; Gov.of India, Ministry of Health and Family welfare,
AYUSH, N.Delhi; 2007. p.79.
Anonymous. The Unani Pharmacopoeia of India; Part-I,
Vol.III; Gov.of India, Ministry of Health and Family welfare,
AYUSH, N.Delhi; 2007. p.19, 21, 23, 88, 99, 107.
Anonymous. The Unani Pharmacopoeia of India Part-I, Vol.V;
Gov.of India, Ministry of Health and Family welfare, AYUSH,
N.Delhi; 2008. p.101.
Anonymous . The Unani Pharmacopoeia of India Part-I,
Vol.VI; Gov.of India, Ministry of Health and Family welfare,
AYUSH N.Delhi; 2009. p.88.
Anonymous. The Unani Pharmacopoeia of India Part-II, Vol.II;
Gov.of India, Ministry of Health and Family welfare, AYUSH,
N.Delhi; 2010. p.229, 264.
H. M. Kabiruddin. Biyaz-e-Kabir Vol.2nd, Shokat Book Depo,
Shokat Bazar, Gujrat; 1978. p. 179.
ACKNOWLEDGEMENT
Authors are thankful to the Indian Medicines
Pharmaceutical Corporation Ltd. A Government of India
Enterprise Mohan, Distt. Almora, Uttarakhand (ViaRamnagar-244715), India for the financial & technical
support.
CONFLICT OF INTEREST
None declared.
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Int J Adv Pharmacy Med Bioallied Sci. 3, 1, 2015.
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