2Head R&D, Rumi Herbals Pvt Ltd, Chennai
3Dean Research, Periyar Maniammai University, Thanjavur
4Director, Jaya college of Pharmacy, Chennai
5Senior Scientist, Rumi Herbals Pvt Ltd, Chennai.
Keywords: Quality control Parameters; Poly herbal formulation; Dermoprotective effect
Standardization is an important aspect for maintaining and assessing the quality and safety of the polyherbal formulation as they are combinations of more than one herb to attain the desired therapeutic effect [6]. Standardization minimizes batch to batch variation; assure safety, efficacy, quality and acceptability of the polyherbal formulations [7].
The present study was undertaken to develop a quality control parameters for a marketed dermoprotective polyherbal by using various organoleptic and physiochemical parameters specified by Ayurveda, Siddha pharmacopoeias and WHO guidelines [8, 9]. The formulation was manufactured by Rumi Herbals Pvt. Ltd, a GMP certified company and marketed by Rohini Global Marketing Pvt Ltd. Chennai.
Physical Examination: All the dry plant materials were examined physically by spreading in polythene sheet, cleaning was done by experienced people.
Grinding And Sieving: The Plant Materials Were Ground Into Coarse Powder With The Help Of Electric Grinder. Sieving Was Done To Get Uniform Granules By Using Sieve.
No. 40.
Raw Material Quality Assessment: The Below Mentioned Parameters Were Assessed As Per The Standards Provided In Ayurveda And Siddha Pharmacopeias, Govt. Of India.
Foreign Matters: Foreign matter contains other plant parts, mineral or mud, sand admixtures, organisms, products of organism and other than the named material. Weighed out 100 g of the drug sample, spread it out in a thin layer. The foreign matter was detected by inspection with the unaided eye or by the use of a lens of 6x. Separated, weighed and calculated the percentage of foreign matters present.
Total Ash: The residue remaining after incineration is the ash content of the dry plant material. It is the measure of the total amount of material remaining after incineration. An electric muffle furnace, capable of maintaining a temperature of 625 ± 25 °C used for detecting ash content.
Ash content (%) = (C - A) / (B - A) X 100.
Where: A = weight of empty crucible in g, B = weight of crucible and sample,
C = weight after incineration in g.
Acid Insoluble Ash: It is the residue obtained after boiling the total ash with dilute HCl and igniting the remaining insoluble matter. This measures the amount of silica present, especially as sand and siliceous earth. Boiled the ash obtained for 5 min with 25 ml of dilute HCl, collected the insoluble matter in an ashless filter paper, washed with hot water and ignited to constant weight and calculated the percentage of acid-insoluble ash.
Water Soluble Extractive: 5g of air dried drug was macerated, coarsely powdered with 100 ml of water in a flask for 24 h, shaking frequently during 6 h and allowed to stand for 18 h. Filtered and evaporated 25 ml of the filtrate to dryness in a tarred flat bottomed shallow dish and dried at 105ºc to constant weight and weighed. The percentage of water-soluble extractive was calculated with reference to the air-dried drug.
Alcohol Soluble Extractive: 5 g of air dried drug was macerated, coarsely powdered with 100 ml of Alcohol of specified strength in a closed flask for 24h, shaking frequently during 6 h and allowed to stand for 18 h. Filtered rapidly, taking precautions against loss of solvent, evaporated 25 ml of the filtrate to dryness in a tarred flat bottomed shallow dish and dried at 105º to constant weight and weighed. The percentage of alcohol-soluble extractive was calculated with reference to the air-dried drug.
Loss On Drying Or Moisture Content: It is the amount of water or volatile content present in the sample. Plant material may get spoiled by microbial attack if more moisture is present. The plant materials were weighed, kept in an oven at 1050C and equilibrated. It was weighed again until three constant readings.
Microbial Safety Profile: All the raw materials must be free from microbial contamination. It is the major safety parameter to ensure the product quality. Microbial screening was carried out to estimate the number of viable microorganisms present in the material. Various differential and selective medias were utilized for screening microbial contamination. For Total viable count (Casein soyabean digest agar), Total yeast and moulds (Saboraud's dextrose agar with antibiotics), E.coli (MaConkey agar and EMB agar), Salmonella (Brilliant Green agar) Staphylococcus sp. (Mannitol salt agar) Pseudomonas aeruginosa, (Cetrimide agar) was used to screen the organisms as per the AYUSH guidelines.
Organoleptic Characters: Texture, Color, Odor And Taste Were Assessed By Using Sensory Organs
pH: After preparing 5% solution of the finished product, the pH was checked by using digital pH meter.
Microscopic Characteristics: The powdered materials were spread as thin film on glass slide and observed the shape of the granules under microscope.
Observations Under UV Light: The materials were mixed with 10% NaOH & 5% HCl and observed under UV light at 254 nm and also observed without adding above constituents.
Weight Variation Test: Test For Uniformity Of Weight Was Performed As Per IP 2007. Randomly Selected 20 Capsules Were Weighed (Individually And Together). The Average Weight Variation And The Standard Deviation Were Calculated.
Disintegration: This test is useful as a quality assurance tool for conventional dosage forms. The efficacy of a drug can be dependent on the rate which the capsule disintegrates in the patient's gastrointestinal tract. The disintegration test is a measure of the time required under a given set of conditions for six randomly selected capsules to disintegrate into particles which will pass through a 10 mesh screen with in a disintegration assembly at maintained temperature 37±2ºC. Disintegration test was performed using the disintegration test apparatus [14].
Flow Properties: Flow properties of drug indicate the uniformity of the granules and it is useful for proper filling and clinical application. The following methods like Angle of repose, Bulk density, Tapped density, Carr's index, Hausner's ratio and porosity was assessed by standard methods
Angle Of Repose: A funnel was fixed at a particular height on a burette stand. A white paper was placed below the funnel on the table. The powdered drug (5g) passed slowly through the funnel until it forms a pile. The radius of the pile was noted down. Angle of repose of the powder material was calculated by using the formula: tan θ = h/r; θ = tan (h/r) where, h = height of the pile, r = radius.
Bulk Density (D0): 25 g of accurately weighed powder was poured into a graduated cylinder, powder bed was made uniform without disturbing the cylinder and the volume was measured directly from the graduation mark on the cylinder as ml [15]. The volume measured was bulk volume and bulk density is calculated.
Compressibility Indices: The bulk and tapped densities were used to calculate the compressibility indices (Carr's index and Hausner's ratio) which provide the flow properties and compressibility of powders.
In the present study Dermoshine has been taken for the development of quality control parameters as per Ayurveda, Siddha & Indian pharmacopeias, followed by AYUSH and WHO guidelines.
S. No |
Specification |
Andrographis paniculata |
Azadirachta indica |
Phyllanthus amarus |
Aristolochia bracteata
|
Curcuma longa |
Hemidesmus indicus |
||||||
API (%) |
Result |
API (%) |
Result |
API (%) |
Result |
API (%) |
Result |
API (%) |
Result |
API (%) |
Result |
||
1 |
Foreign matter |
NMT 2 |
0.8 |
NMT 2 |
0.2 |
NMT 2 |
0.4 |
NMT 2 |
0.6 |
NMT 2 |
0.7 |
NMT 2 |
1.6 |
2 |
Total ash |
NMT 11 |
8 |
NMT 10 |
6.62 |
NMT 16 |
7.20 |
NMT 4 |
3.3 |
NMT 9 |
6.44 |
NMT 4 |
3.6 |
3 |
Acid insoluble ash |
NMT 1 |
0.5 |
NMT 1 |
0.6 |
NMT 7 |
2 |
NMT 1 |
0.4 |
NMT 1 |
0.6 |
NMT 0.5 |
0.4 |
4 |
Water soluble Extractive |
NLT 20 |
25.4 |
NLT 19 |
22.5 |
NLT 13 |
17.92 |
NLT 3 |
12.1 |
NLT 12 |
13 |
NLT 13 |
20.41 |
5 |
Alcohol soluble Extractive |
NLT 12 |
14.2 |
NLT 13 |
15.2 |
NLT 3 |
8 |
NLT 2 |
6.4 |
NLT 8 |
9.5 |
NLT 15 |
16 |
6 |
Volatile oil % |
- |
- |
- |
- |
- |
- |
- |
- |
NLT 4 |
4.5 |
- |
- |
7 |
LOD % |
< 5 |
.1 |
< 5 |
4.3 |
< 5 |
3.5 |
< 5 |
4.2 |
< 8 |
7.4 |
< 5 |
4.1 |
8.a |
Microbial –TVC (CFU/g) |
1x105 |
90 |
1x105 |
105 |
1x105 |
95 |
1x105 |
94 |
1x105 |
80 |
1x105 |
98 |
b |
Total Yeast & Mould (CFU/g) |
1x103 |
< 10 |
1x103 |
< 10 |
1x103 |
< 10 |
1x103 |
< 10 |
1x103 |
< 10 |
1x103 |
< 10 |
c |
E. coli |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
d |
Salmonella.sp |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
e |
Staphylococcus |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
f |
Pseudomonas sp. |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
Absent |
Ab |
S. No |
Characteristics |
Batch: 09008 |
1 |
Texture |
Fine powder |
2 |
Color |
Greenish brown |
3 |
Odor |
Indistinct |
4 |
Taste |
Slightly Bitter |
5 |
pH (5%) |
5.53 |
6 |
Under UV light |
Greenish brown |
S. No |
Characteristics |
Batch: 09009 |
1 |
Weight variation |
Within IP limit |
2 |
Moisture analysis % |
4.5 |
3 |
Drug content |
Within IP limit |
4 |
Disintegration (Sec) |
345 |
5 |
Angle of Repose (o) |
34.6 |
6 |
Bulk Density(g/cm3) |
0.92 |
7 |
Tap density (g/cm3) |
1.02 |
8 |
Hausner's ratio |
1.10 |
9 |
Carr`s index |
9.80 |
S.No. |
Characteristics |
Batch: 09009 |
1 |
Total Bacterial count |
< 100 cfu/g |
2 |
Total Yeast & Mould |
< 10 cfu/g |
3 |
Escherichia coli |
Absent
|
4 |
Salmonella sp |
|
5 |
Staphylococcus sp |
|
6 |
Pseudomonas sp |
S.No. |
Characteristics |
Batch: 09009 |
i |
Mercury (1 ppm) |
Within limit |
ii |
Lead (10 ppm) |
|
iii |
Cadmium (0.3 ppm) |
|
iv |
Arsenic (3 ppm) |
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