COMPARATIVE STANDARDIZATION STUDY OF THREE TRIPHALA CHURNA FORMULATION
HTML Full TextCOMPARATIVE STANDARDIZATION STUDY OF THREE TRIPHALA CHURNA FORMULATION
D. K. Kadam *, P D. Ahire, J. V. Bhoye, A. R. Patil and D.K. Yadav
NGSPM’s College of Pharmacy, Brahma Valley Educational Campus, Tryambakeshwar Road, Anjaneri, Nashik - 422 213, Maharashtra, India.
ABSTRACT: In the few decades, there has been exponentially growth in the field of herbal medicines. Most of the traditional system of medicine is effective but they lack standardization. So there is a need to develop a standardization technique. Standardization of herbal formulation is essential in order to assess the quality, purity, safety and efficacy of the drug based on their concentration of their principles. This articles reports on standardization of triphala churna. Polyherbal ayurvedic medicines used to treat constipation, gastric disorder. The present research study deal with the comparative Standardization of two reputed marketed triphala churna formulation, from Patanjali, Shree shree Ayurveda and laboratory made churna. The standardization of these formulation, organoleptic characteristics, physical properties such as moisture content (LOD), ash value, extractive values, crude fibre content were carried out. The heavy metal content, tannin test and alkaloid test study also carried out to ascertain the quality, purity and safety of these herbal formulation.
Keywords: |
Standardization, Triphala churna, Physicochemical parameters.
INTRODUCTION: Nature always stands as a golden mark to exemplify the outstanding phenomena of symbiosis. Today about 80% of people in developing countries still relay on traditional medicine based largely on the different species of plants for their primary health care. About 500% of plants with medicinal uses are mentioned in ancient literature and 800 plants have been used in indigenous system of medicine. The various indigenous systems such as Ayurveda, Siddha, Unani use several plant species to treat different ailments 1, 2, 3. Herbal medicines make up an important component of the trend toward alternative medicine.
A Harvard study recently found that one in three respondents acknowledged use of at least one alternative therapy within the past year. Extrapolated, these findings suggest that up to $13.7 billion were spent in 1990 alone for these treatments 4. Tyler defines herbal medicines as "crude drugs of vegetable origin utilized for the treatment of disease states, often of a chronic nature, or to attain or maintain a condition of improved health" 5. Current demands for herbal medicines have resulted in an annual market of $1.5 billion and increasingly widespread availability 6.
Potential benefits of herbal drugs: Historically, herbal medicines have played a significant role in the management of both minor and major medical illnesses. One example is foxglove, which contains cardiac glycosides, and serves as a classic treatment for congestive heart failure. Even now, physicians still use many drugs that possess botanical origins. Huxtable notes that one-quarter of the prescriptions currently written in the United States are for plant products, while one quarter is for agents based on botanical compounds. The therapeutic potential of herbal medicines cannot be ignored and is highlighted in the three examples provided next 7.
Advantages of herbal medicine:
- They have large amount of use.
- They have better patient tolerance as well as acceptance.
- The medicinal plants have renewable source of cheaper medicines.
- Improvements in the quality, efficacy and safety of herbal medicines with the development of science and technology.
- Prolong and apparently uneventful use of herbal medicines may offer testimony of their safety and efficacy.
- They are cheap in cost.
- They are not harmful.
- They are more effective than any synthetic drug throughout the world herbal medicines have provided many of the most potent medicines to the vast arsenal of drugs available to modern medical science, both in crude form as well as a pure chemical upon which modern medicines are constructed 8, 9.
The need for standardization – Producers and consumers perspective 10: In the global perspective, there is a shift towards the use of medicine of herbal origin, as the dangers and the shortcoming of modern medicine are getting more apparent. It is the cardinal responsibility of the regulatory authorities to ensure that consumers get the medication, which guarantees purity, safety, potency and efficacy. The regulatory authorities rigidly follow various standards of quality prescribed for raw materials and finished products in pharmacopoeias, formularies and manufacturing operation through statutory imposed good manufacturing practices.
These procedures logically would apply to all types of medication whether included in modern system of medicine or one of the traditional systems. Though herbal products have become increasingly popular throughout the world, one of the impediments in its acceptance is the lack of standard quality control profile. The quality of herbal medicine that is, the profile of the constituents in the final product has implications in efficacy and safety. However, due to the complex nature and inherent variability of the constituents of plant-based drugs, it is difficult to establish quality control parameter though modern analytical technique are expected to help in circumventing this problem. Furthermore, the constituents responsible for the claimed therapeutic effects are frequently unknown or only partly explained. This is further complicated by the use of combination of herbal ingredients as being used in traditional practice.
It is common to have as many as five different herbal ingredients in one product. Thus batch to batch variation starts from the collection of raw material itself in the absence of any reference standard for identification. These variations multiply during storage and further processing. Hence for herbal drugs and products, standardization should encompass the entire field of study from cultivation of medicinal plant to its clinical application. Plant materials and herbal remedies derived from them represent substantial portion of global market and in this respect internationally recognized guidelines for their quality assessment and quality control are necessary.
Plan of work: Comparative standardisation of Triphala Churna formulated by Patanjali, Shree Shree Ayurveda and laboratory made Triphala churna was planned to carry out development of quality standards for the finished marketed formulation. The method used for the comparative standardization was planned to be carried out as follows:
Development of standardization parameters for Triphala Churna:
- Study of organoleptic characters:
- Colour
- Odour
- Taste
- Determination of physicochemical parameters:
- Total ash
- Acid insoluble ash
- Water soluble ash
- Moisture content/ Loss on drying
- Water soluble extractive
- Alcohol soluble extractive
- Crude fibre contents
- Evaluation of Churna:
- Powder fineness
- Bulk density
- Tap density
- Angle of repose
- Compressibility
- Hausner’s ratio
- Determination of pH.
- Establishing the safety pertaining to Heavy metals & Microbial load.
- Fluorescence Analysis.
MATERIALS AND METHODS:
Samples Preparation:
Sample No. 1: Patanjali Triphala Churna.
Sample No. 2: Shree Shree Ayurveda Triphala Churna.
Sample No. 3: Lab made Triphala churna.
Triphala churn contains mainly three ingredients as Harad or Haritaki (Chebulic myrobalans or Terminalia chebula), Baheda or Bibhitaki (Terminalia bellirica) and Amla or Amalaki (Indian gooseberry or Emblica officinalis)
Method to Prepare the Triphala Churna: Harad or Haritaki (Chebulic myrobalans or Terminalia chebula), Baheda or Bibhitaki (Terminalia bellirica) and Amla or Amalaki (Indian gooseberry or Emblic aofficinalis) collected from local market. Fine powder was made both by grinding and filtering them. All the powders were mixed properly in a ratio 1:2:4. The Triphala Churna is prepared and ready to use. For future use it can keep into a plastic box.
Developments of standardization parameters for Triphala Churna:
- Study of organoleptic characters: The polyhedral formulation is studied for organoleptic characters like colour, odour and taste using the sensory organs of our body.
- Physicochemical Analysis 11:
- Ash value:
Determination of Total ash: About 2 to 3 g of sample was accurately weighed in a tarred silica dish at a temperature not exceeding 450C until it was free from carbon. Then it was cooled and weighed. The percentage of total ash was calculated with reference to the air dried drug.
Determination of Acid insoluble ash: The total ash obtained was boiled for 5 minutes with 25 ml of dilute hydrochloric acid; the insoluble matter obtained was collected on an ash less filter paper, washed with hot water and ignited to constant weight. The percentage of acid insoluble ash was calculated with reference to the air dried drug.
Determination of Water-soluble Ash: The ash obtained in the determination of total ash was boiled for 5 minutes with 25 ml of water. The insoluble matter was collected on an ash less filter paper and washed with hot water. The insoluble ash was transferred into a tarred silica crucible and ignited for 15 minutes at a temperature not exceeding 450 The weight of the insoluble matter was subtracted from the weight of the total ash. The difference in weight was considered as the water- soluble ash was calculated with reference to the air dried drug.
Determination of loss and drying: 10 g of the sample (without preliminary drying) was weighed and placed in a tarred evaporating dish. It was dried at 105˚C for 5 hours and at 1 hour interval until difference two successive weighing corresponded to not more than 0.25%.
Determination of extractive values:
Determination of Water-soluble extractive: 5 g of test sample was weighed and macerated with 100 ml of chloroform water in a closed flask for twenty-four hours, shaking frequently during six hours and allowing standing for eighteen hours. it was filtered rapidly, taking precautions against the loss of solvent. 25 ml of the filtrate was taken and evaporated to dryness in a tarred flat bottomed shallow dish at 105 0C, to constant weight and weighed the percentage of water soluble extractive was calculated with reference to the air dried sample.
Determination of Alcohol-soluble extractive: Procedure for water soluble extractive was followed for the determination of alcohol soluble extractive but 90% ethanol was used instead of chloroform water.
Determination of crude fibre content: Mix about 2g of the powdered drug in no. 60 with 50ml of 10% Nitric acid. Bring to boil and maintain at the boiling point for 30 seconds. Dilute with water and strain through a fine filter cloth held over the mouth of filter funnel. Transfer the washed residue to beaker and boil further 30 seconds with 50ml of a 2.5% solution of sodium hydroxide. Collect and wash residue as before, mount and examine.
Qualitative Phytochemical Screening 12, 13, 14:
Detection of tannins: 2-3 ml of aqueous or alcoholic extract of powders was tested carefully with various tannins test reagents as:
- 5% FeCl3 solution: A deep blue-black color indicates the test is positive.
- Lead acetate solution: A white precipitate indicates the test is positive.
- Bromine water: Deceleration of bromine water indicates the test is positive.
- Dilute iodine solution: Transient red color indicates the test is positive.
Detection of alkaloids: 50 mg of solvent free extract was hydrolyzed with dil. HCl and filtered. The filtrates were tested carefully with various alkaloid test reagents as follows:
- Dragendroff’s test: To a few ml of filtrates, 1 to 2 ml of Dragendroff’s reagent was added. A prominent yellow precipitate indicates the test is positive.
- Wagner’s test: To a few ml of filtrates, few drops of Wagner’s reagent were added by the side of the test tube. A reddish-brown precipitate confirms the test as positive.
- Mayer’s test: To a few ml of filtrates, few drops of Mayer’s reagent were added by the side of the test tube. A white or creamy precipitate if obtained indicates the presence of alkaloids.
Determination of physical characteristics 15:
Bulk density: It is the ratio of given mass of powder and its bulk volume. It is determined by transferring an accurately weighed amount of powder sample to the graduated cylinder with the aid of a funnel. The initial volume was noted. The ratio of weight of the volume it occupied was calculated.
Bulk density=w/v0 g/ml
Where,
w = mass of the powder
v0 = untapped volume
Tapped density: It is measured by transferring a known quantity (25g) of powder into a graduated cylinder and tapping it for a specific number of times. The initial volume was noted. The graduated cylinder was tapped continuously for a period of 10-15 min. The density can be determined as the ratio of mass of the powder to the tapped volume.
Tapped volume= w/vfg/ml
Where,
w = mass of the powder
vf = tapped volume.
Compressibility index/ Carr’s index: It is the propensity of the powder to be compressed. Based on the apparent bulk density and tapped density the percentage compressibility of the powder can be determined using the following formula.
Or
Hausner’s ratio: It indicates the flow properties of the powder. The ratio of tapped density to the bulk density of the powder is called Hausner’s ratio.
Hausner’s ratio= Tapped density/bulk density
Angle of repose: The internal angle between the surface of the pile of powder and the horizontal surface is known as the angle of repose. The powder is passed through funnel fixed to a burette at s height of 4 cm. A graph paper is placed below the funnel on the table. The height and the radius of the pile were measured. Angle of repose of the powder was calculated using the formula:
Angle of repose= tan-1(h/r)
Where,
h=height of the pile
r = radius of the pile
Determination of pH range: The powder sample of triphala churna was weighed to about 5g and immersed in 100 ml of water in a beaker. The beaker was closed with aluminum foil and left behind for 24 hour s in room temperature. Later the supernatant solution was decanted into another beaker and the pH of the formulation was determined using a calibrated pH meter.
Heavy metals test 16:
For Cadmium:
Test | Observation | Inference |
NH4OH added in the sample solution | White ppt. of cadmium hydroxide soluble in excess NH4OH | Presence of cadmium. |
Potassium ferrocyanide added | White ppt. of cadmium ferrocyanide. | Presence of cadmium. |
For Bismuth:
Test | Observation | Inference |
H2S gas added in the sample solution | Dark brown ppt. soluble in hot dil. HNO3 but insoluble in NH4S | Presence of bismuth. |
NH4OH | White ppt. insoluble in excess NH4OH dissolved in dil. HCl. | Presence of bismuth. |
For Lead:
Test | Observation | Inference |
Dil. HCl added in sample solution | White ppt. of CaCl2 soluble in boiled water & conc. HCl. | Presence of lead |
KI is added in sample solution. | Yellow ppt. soluble in boiling water. | Presence of lead |
Fluorescence Analysis 14, 17: A little amount of churna was macerated with a small quantity of solvents like 1N Sulphuric acid, 1N Nitric acid, 1N Hydrochloric acid, Iodine, Potassium hydroxide, Ammonia, 1N Sodium hydroxide for an hour and then filtered. The filtrate was then analyzed under day light and UV light for color and fluorescence.
RESULTS AND DISCUSSIONS:
TABLE 1: DETERMINATION OF ORGANOLEPTIC CHARACTERS
Characteristics | Sample 1 | Sample 2 | Sample 3 |
Colour | Light yellow | Yellowish | Yellowish |
Odour | Characteristics | Characteristics | Characteristics |
Taste | Very bitter | Astringent | Astringent |
TABLE 2: ASH VALUES
Type of ash | Sample 1 | Sample 2 | Sample 3 |
Total ash | 6.65 | 7.45 | 6.35 |
Acid insoluble ash | 2.55 | 3.4 | 3.4 |
Water soluble ash | 2.20 | 4.55 | 3.5 |
TABLE 3: MOISTURE CONTENT/ LOSS ON DRYING
Characteristics | Sample 1 | Sample 2 | Sample 3 |
Moisture Content/ Loss On Drying | 0.779 | 1.25 | 1.8 |
TABLE 4: EXTRACTIVE VALUES
Characteristics | Sample 1 | Sample 2 | Sample 3 |
Water | 3.5 | 3.3 | 3.24 |
Alcohol | 1.24 | 2.06 | 1.52 |
TABLE 5: QUANTITATIVE ESTIMATION
Test | Sample 1 | Sample 2 | Sample 3 | ||
Test of Tannin | |||||
5 % FeCl3 solution | Positive | Positive | Positive | ||
Lead acetate solution | Positive | Positive | Positive | ||
Bromine water | Positive | Positive | Positive | ||
Dilute iodine solution | Positive | Positive | Positive | ||
Test for Alkaloids | |||||
Dragendroff’s test | Positive | Positive | Positive | ||
Wagner’s test | Positive | Positive | Positive | ||
Mayer’ test | Positive | Positive | Positive | ||
TABLE 6: BULK DENSITY & TAP DENSITY
Characteristics | Sample 1 | Sample 2 | Sample 3 |
Bulk Density | 0.666 | 0.476 | 0.555 |
Tap Density | 0.909 | 0.625 | 0.80 |
TABLE 7: CARR’S INDEX and HAUSNER’S RATIO
Characteristics | Sample 1 | Sample 2 | Sample 3 |
Carr’s index | 26.73 | 23.84 | 30.625 |
Hausner’s ratio | 1.36 | 1.31 | 1.44 |
TABLE 8: ANGLE OF REPOSE
Characteristics | Sample 1 | Sample 2 | Sample 3 |
Angle of repose | 36.50 | 39.69 | 35.75 |
TABLE 9: DETERMINATION OF pH SAMPLE
Characteristics | Sample 1 | Sample 2 | Sample 3 |
pH | 5 (acidic) | 6 (acidic) | 6 (acidic) |
TABLE 10: ESTIMATION OF CRUDE FIBER
Characteristics | Sample 1 | Sample 2 | Sample 3 |
Crude Fiber | 4.7 | 4.15 | 4.2 |
Heavy Metal Test: Triphala Churna of Patanjali, Shree Shree Ayurveda and Laboratory made.
TABLE 11: TEST FOR CADMIUM
Test | Observation | Result |
NH4OH added in the sample solution. | White ppt. is absent | Absence of cadmium. |
Potassium ferrocyanide added. | White ppt. is absent | Absence of cadmium. |
TABLE 12: TESTFOR BISMUTH
Test | Observation | Result |
H2S gas added in the sample solution. | Dark brown ppt. is absent | Absence of bismuth. |
NH4OH | White ppt. is absent | Absence of bismuth. |
TABLE 13: TEST FOR LEAD
Test | Observation | Result |
Dil HCl added in sample solution. | White ppt. of CaCl2 is absent. | Absence of lead. |
KI is added in sample solution. | Yellow ppt. is absent. | Absence of lead. |
TABLE 14: FLUORESCENCE ANALYSIS FOR SAMPLE 1
Solvent added | Colour observed under | ||
Day light | Short UV wave-length (256 nm) | Long UV wave-length (365 nm) | |
1N Sulphuric acid | Light brown | Light green | Dark green |
1N Nitric acid | Light brown | Light green | Dark green |
1N Hydrochloric acid | Light brown | Light green | Dark green |
Iodine | Greenish brown | Dark green | Dark blue |
Potassium hydroxide | Brown | Green | Dark blue |
Ammonia | Brown | Green | Dark blue |
1N Sodium hydroxide | Dark brown | Dark green | Dark blue |
TABLE 15: FLUORESCENCE ANALYSIS FOR SAMPLE 2
Solvent added | Colour observed under | ||
Day light | Short UV wave-length (256 nm) | Long UV wave-length
(365 nm) |
|
1N Sulphuric acid | Light brown | Light green | Green |
1N Nitric acid | Light brown | Light green | Green |
1N Hydrochloric acid | Light brown | Light green | Green |
Iodine | Greenish brown | Dark green | Dark blue |
Potassium hydroxide | Brown | Green | Dark blue |
Ammonia | Brown | Green | Dark blue |
1N Sodium hydroxide | Dark brown | Dark green | Dark blue |
TABLE 16: FLUORESCENCE ANALYSIS FOR SAMPLE 3
Solvent added | Colour observed under | ||
Day light | Short UV wave-length (256 nm) | Long UV wave-length
(365 nm) |
|
1N Sulphuric acid | Light brown | Light green | Dark Green |
1N Nitric acid | Light brown | Light green | Dark Green |
1N Hydrochloric acid | Light brown | Light green | Dark Green |
Iodine | Greenish brown | Dark green | Dark bluish |
Potassium hydroxide | Light Brown | Green | Light bluish |
Ammonia | Light Brown | Green | Light bluish |
1N Sodium hydroxide | Brown | Dark green | Dark bluish |
DISCUSSION: From the heavy metal test it is concluded that Triphala Churna of Patanjali, Shree shree Ayurveda and Lab made formulation are free from heavy metals.
CONCLUSION: From the present investigation various standardization parameters such as physicochemical standards like total ash, acid insoluble ash, water and alcohol soluble extractive values, loss on drying, phytochemical analysis, flow properties and safety evaluation were carried out, it can be concluded that the formulation of Triphala churna contains all good characters of an ideal churna and it was found to be harmless, more effective, and economic. The comparison between the two marketed samples and lab made churna have been done on the basis of the above mentioned parameters which shows satisfactory results, but the efficacy of the products can only be judged by doing the pharmacology of which is suggested as future scope of R & D.
ACKNOWLEDGEMENT: Authors are very much grateful to NGSPM’s College of Pharmacy for providing necessary facilities for completion of the research work.
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How to cite this article:
Kadam DK, Ahire PD, Bhoye JV, Patil AR and Yadav DK: Comparative Standardization Study of Three Triphala Churna Formulation. Int J Pharmacognosy 2017; 4(2): 71-78:.doi link: http://dx.doi.org/10.13040/IJPSR.0975-8232.IJP.4(2).71-78.
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Article Information
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71-78
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3975
English
IJP
D. K. Kadam *, P D. Ahire, J. V. Bhoye, A. R. Patil and D.K. Yadav
NGSPM’s College of Pharmacy, Brahma Valley Educational Campus, Tryambakeshwar Road, Anjaneri, Nashik, Maharashtra, India.
deepalikadam777@gmail.com
30 November, 2016
22 December, 2016
26 December, 2016
10.13040/IJPSR.0975-8232.IJP.4(2).71-78
01 February, 2017