Evaluation of formulation variables for Ayurvedic formulation vasavaleha
Bharti Ahirwar*
SLT Institute of Pharmaceutical
Sciences, Guru Ghasidas Vishwavidyalaya,
Bilaspur (CG)
*Corresponding Author
E-mail: ah_bharti@yahoo.com
ABSTRACT:
Formulation
variables were developed for Ayurvedic formulation vasavaleha to produce reproducibility of results. Vasavaleha is a
semisolid preparation of drugs, prepared with the addition of jaggery or sugar and boiled with prescribed drug juice or
decoction and coded VS-1, VS-2 and VS-3. During preparation each step
was monitored like total solid content (% v/w) of vasavaleha
was found 180.31±2.18, 182.02±4.01 and 183.34±2.97 respectively for VS-1, VS-2
and VS-3 and coefficient of variance was found 2.449 while specific gravity
(g/cm3) was estimated as 1.87±0.09, 1.89±0.06 and 1.86±0.05
with coefficient of variance 0.153. Moisture content (%) was found 3.78±0.86,
3.77±0.05 and 3.77±0.68 respectively and coefficient of variance was found
1.452 while loss on drying (% w/w) was estimated as 5.24±0.18, 5.26±0.13 and
5.24±0.16 with coefficient of variance 0.429. Volatile oil content (% v/w) was
measured 0.60±0.001, 0.62±0.011 and 0.60±0.013 and 0.0494 coefficient of
variance.
INTRODUCTION:
Herbal products represent a number of unique problems when quality
aspects are considered. These are because of the nature of the herbal
ingredients present therein, which are complex mixture of different secondary
metabolites that can vary considerably depending on environment and genetic
factors. Furthermore, the constituents responsible for the claimed therapeutic
effects are frequently unknown or only partly explained and this precludes, the
level of control which can routinely be achieved with synthetic drugs so much
with conventional pharmaceutical preparations. These complex positions of
quality aspects of herbal drugs are further complicated by the use of
combinations of herbal ingredients as are being used in traditional practice.
It is not uncommon to have as many as five different herbal ingredients in one
product. Keeping this perspective in mind work was concentrated on the
evaluation of formulation variables of Ayurvedic
formulation vasavaleha (Ahirwar,
2011; Mukharjee 2002).
Preparation of Vasavleha
(Anon.
1978)
Vasavaleha is a semisolid preparation of drugs, prepared with
the addition of jaggery or sugar and boiled with
prescribed drug juice or decoction.
This preparation has generally (1) kasaya or other liquid, (2) jaggery
or sugar (3) powders of
certain drugs and (4) ghee or honey.
Sugar was
dissolved in vasaka leaf juice and strained to remove
the foreign particles and boiled over a moderate fire. When paka
(Phanita) is thready (tantuvat) when pressed between two fingers or when it sinks
in water without being easily dissolved, it was removed from the fire.
Table 1 Ingredients of vasavelaha
|
S. No. |
Common |
Botanical name |
Family |
Part used |
Quantity taken |
|
Vasaka |
|||||
|
2. |
Pippali |
Piper
longum |
Piperaceae |
Fruit |
93 gm |
|
3. |
Mishri |
|
|
|
375 gm |
|
4. |
Ghee |
|
|
|
93 gm |
|
5. |
Honey |
Apis menifera |
Apideae
|
|
375 gm |
Table 2 In-process quality
assurance of vasavaleha
|
Parameters |
Vasavaleha |
||||
|
VS-1 |
VS-2 |
VS-3 |
Mean±SD |
Coefficient of variance |
|
|
Total solid content (% v/w) |
180.31±2.18 |
182.02±4.01 |
183.34±2.97 |
181.32±1.39 |
2.449 |
|
Loss on drying (% w/w) |
5.24±0.18 |
5.26±0.13 |
5.24±0.16 |
5.24±0.19 |
0.429 |
|
Volatile oil (% v/w) |
0.60±0.001 |
0.62±0.011 |
0.60±0.013 |
0.60±0.003 |
0.0494 |
|
Specific gravity (g/cm3) |
1.87±0.09 |
1.89±0.06 |
1.86±0.05 |
1.87±0.71 |
0.153 |
|
Moisture content (%) |
3.78±0.86 |
3.77±0.05 |
3.77±0.68 |
3.77±0.04 |
1.452 |
Fine powders of
drugs were then added and stirred continuously and vigorously to form a
homogenous mixture. After cooling honey and ghee was added and mixed well
(Table 1).
Formulation Variable (Jain et al.,
2006, USP 1990, Mukharjee 2002, Ahirwar
et al., 2007, Pharmacopoeial Standards for Ayurvedic
Formulations 1997, IP, 1996)
Step 1: In
this step sugar was dissolved in vasaka juice and
boiled on moderate fire. When it was threading on pressing between two fingers,
it was removed from the fire. The volume of decoction so formed was measured
accurately and 25 ml of decoction was subjected to carry out total solid
content by drying in an oven at 105˚C. From the amount of total solid in
25 ml, the amount of total solid in measured volume of decoction was
calculated. Vasavaleha was prepared in three batches
and coded as VS-1, VS-2 and VS-3.
Step 2: The
fine pulverized powder (about 5 gm) of crude drugs was subjected to
determination of loss on drying.
The pulverized powder (100 gm) was taken into Clevenger’s
apparatus and its volatile oil content (by hydrodistillation
method) was determined. The amount of volatile oil contributing to vasavaleha was determined from the amount of powder taken
in vasavaleha.
Step 3: Fine powders of drugs were added and stirred
continuously and vigorously to form homogenous mixture. The specific gravity of
vasavaleha was determined by specific gravity bottle
method.
Step 4: After
cooling honey and ghee was added. The vasavaleha so
formed was weighed and its moisture content (by Karl Fischer method) was
determined.
All the observations and results obtained for vasavaleha
during in-process quality assurance are recorded in Table 2.
To maintain formulation variable, in-process quality control
parameters (process validation parameters) were developed for reproducibility. The
total solid content (% v/w) of vasavaleha was found
180.31±2.18, 182.02±4.01 and 183.34±2.97 respectively for VS-1, VS-2 and VS-3
and coefficient of variance was found 2.449 while specific gravity (g/cm3) was estimated as 1.87±0.09, 1.89±0.06 and 1.86±0.05 with coefficient of variance
0.153. Moisture content (%) of vasavaleha was found
3.78±0.86, 3.77±0.05 and 3.77±0.68 respectively for VS-1, VS-2 and VS-3 and
coefficient of variance was found 1.452 while loss on drying (% w/w) was
estimated as 5.24±0.18, 5.26±0.13 and 5.24±0.16 with coefficient of variance
0.429. Volatile oil content (% v/w) was measured 0.60±0.001, 0.62±0.011 and
0.60±0.013 for VS-1, VS-2 and VS-3 and 0.0494 coefficient of variance.
DISCUSSION:
Modern synthetic drugs are prepared by
using synthetic materials. Reproducible manufacturing techniques and acceptable
chemical assays for these drugs are given in pharmacopoeias to have adequate
quality control. In contrast, herbal medicines are prepared from materials of
plant origin and they are prone to contamination, deterioration and variation
in compositions, thus posing problems for quality control of herbal
formulations (Charegaonkar, 2005; Jain, 2006; Chouhan et al., 2001). In the light of this work was
concentrated to develop and evaluate of anti-asthmatic ayurvedic
formulations. Formulations were developed and prepared according to methods
described in The Anon. 1978 and Bhaisajratanawali
2005, and in-process quality control parameters were developed (Newton et al.,
1995; Amrita et al., 1999). Table
2 reflects the result of formulation variable (in-process quality control
parameter) of vasavaleha. Specific gravity (g/cm3)
was found (Mean ± SD of VS-1, VS-2,
VS-3) 1.87±0.71. Total solid content (%v/w) was estimated (Mean ± SD of VS-1, VS-2, VS-3) 181.32±1.39.
Batch-to-batch coefficients of variance among three batches were found very low
0.153 and 2.449, respectively for specific gravity and solid content. Volatile
oil content (%v/w) was estimated 0.60% while loss on drying (%) was found
5.241%. Moisture content (%) was found 3.77±0.04. Batch-to-batch coefficient
variance was found 0.0494, 0.429 and 1.452 respectively for volatile oil, loss
on drying and moisture content. These low coefficients of variance are
indicative of reproducibility of process. Hence the developed parameters and
their values may be considered as standard value for further reference.
Batch-to-batch consistency and low coefficient variance of the findings
revealed that all the batches of the formulations are uniform in nature.
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Received on 11.11.2012
Modified on 22.11.2012
Accepted
on 13.12.2012
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Research J. Science and Tech.
4(6): November –December, 2012: 295-297