Quality Control Methods For Trifla Churna Polyherbal Formulation Biology Essay

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In the present study, three batches of different marketed polyherbal formulation. Trifla Churna were produced from the local market and they were evaluated as per Indian Pharmacopoeia and WHO guidelines on the following parameters viz, Organoleptic characteristics, Extractive value, Ash value, Physical characteriristics, Moisture content, Loss on drying, Phytochemical evaluation, Fluorescence analysis, pH value etc. The result of Trifla Churna was found in close proximity. This study on Trifla Churna was precise, reproducible and may be considered as a protocol for its evaluation.

KEY WORDS: Trifla Churna, Polyherbal formulation, Protocol and

Quality Control

INTRODUCTION

The recent interest in Ayurvedic system of medicine is seen by large scale manufacturing of ayurvedic formulation must conform to the test for identity, potency, purity, safety and efficacy. Majority of the ayurvedic formulations use whole plants either alone or in combination. It has been stated that combining herbs improves efficacy and reduces adverse effects due to the low concentration of active ingredients adequate to produce therapeutics effects but to reduce the toxicity. Inspite of the large number of ayurvedic formulation available in market, for many of them, standard for their quality are yet to be laid. Various marketed formulation shows dose variation, content variation and lack of standardization which affects its therapeutic activity, therefore it is imperative to develop fast, sensitive and accurate methods of analysis for ayurvedic formulations which will be in alignment with modern technology.

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This paper includes the investigation of Quality Control methods for three different samples of Trifla Churna designated as TC1, TC2, and TC3. The formulation is official in the ayurvedic literatures and therapeutically useful in the treatment of chronic fevers, peptic ulcers, diaphoresis, malaria, loss of appetite etc. It is one of famous ayurvedic formulation containg more than 40 different ingredients. Different manufacturing companies used different active ingredient for their preparation, which are not claimed on the container due to which their efficacy can not be access accurately. Therefore, the present study was undertaken to evaluate Trifla Churna as per Indian Pharmacopoeia and WHO guidelines.

EXPERIMENTAL

Three marketed formulations of Trifla Churna from different manufactures (designated as TC1, TC2 and TC3) were produced for the present study. Alcohol, Acetone, Methanol, n-Hexane, Chloroform, 1N hydrochloric acid, 1N sodium chloride (aqueous), ferric chloride, 1N nitric acid, ammonia , iodine, 1N sodium hydroxide (alcoholic), picric acid and 1N sulphuric acid etc.

Organoleptic properties of Trifla Churna: Organoleptic properties of each of three batches of Triphla Churna were done by using reported methods.

Extractive values: 5 g of Trifla Churna from each batch for individual extraction of extracted with n-hexane, chloroform, methanol, and distilled water separately by cold maceration method described below and their extractive values were determined as per the methods given in Indian Pharmacopoeia and WHO publication.

n-Hexane and Chloroform soluble extractives: n-Hexane and Chloroform soluble extractives were determined by same procedure as described above and dried under reduced pressure.

Methanol soluble extractives: Trifla Churna was dispersed in 100 ml of Methanol and allows it to stand for 24 hrs with occasional shaking. Extract was filtered and evaporated.

Water soluble extractives: Trifla Churna was dispersed in 100 ml of Water and allows it to stand for 24 hrs with occasional shaking and filtered. The above procedure was performed for each batch and the dried water extractives of TC1, TC2 and TC3 were weighed.

The extractive values of the all three batches of Trifla Churna in above solvent are given in Table-1.

Ash values: Total ash, acid insoluble ash and water soluble ash values were determined using standard procedure. (Table-2)

Physical characteristics: The physical characteristics of the Trifla Churna were determined for TC1, TC2 and TC3 in terms of the bulk density, true density, angle of repose, hausner's ratio and Carr's index according to the standard procedure. (Table-3)

Moisture content and Loss on drying: Moisture content and Loss on drying was determined for all three batches of Triphla Churna as per standard procedure. (Table-4)

Phytochemical evaluation: For this study, aqueous extract of Trifla Churna has been employed, screening process of each batch of Trifla Churna for phytochemical evaluation was done using reported methods. (TYable-5)

Fluorescence analysis: For fluorescence analysis, the drug powder was treated with different solvent in different test tubes. The solvents used were 1N HCL, 1N NaOH (aqueous), FeCl3, 1N HNO3, NH3, I2, 1N NaOH (alcoholic), picric acid and 1N H2SO4. Then they were subjected to fluorescence analysis in daylight and in UV light as per standard procedure. (Table-6)

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pH determination: The pH values of 1 and 10 % (w/v) solution of different batches of Trifla Churna were determined as per I.P. (Table-7)

Foreign matter, foaming index and swelling index: Foreign matter, foaming index and swelling index were determined for all three batches of Trifla Churna as per standard procedure.

RESULTS AND DISCUSSION

Trifla Churna (three batches, TC1, TC2 and TC3) was evaluated in the laboratory according to standard procedures. They were evaluated by comparative analysis for their organoleptic properties, Extractive values (n-hexane, chloroform, methanol, and water), Ash values (Total ash, acid insoluble ash and water soluble ash), Physical characteristics, Moisture content, Loss on drying, Phytochemical evaluation, Fluorescence analysis, pH value, Foreign matter, foaming index and swelling index.

Organoleptic studies revealed that all the three batches (TC1, TC2 and TC3) of Trifla Churna were brown in colour, having pleasant odour and possessing pungent taste. More than 90% of two samples (TC1 and TC2) passed through 60-mesh sieve except MSC3 passed60% only. It was also observed that more than 40% of all the samples passed through 85-mesh sieve.

Extractive values are reported in table-1 and ash values are included in table-2. The extractive values (%w/w) of Trifla Churna (Mean ± SD of TC1, TC2 and TC3) in n-hexane and chloroform were found to be 4.39 ± 0.63 and 14.08 ± 1.70, respectively, indicative the presence of polar and semi polar constitutes in Trifla Churna. The ash value of each batch of Trifla Churna for total ash, acid insoluble ash and water soluble ash are found to be 70.38 ± 2.93, 45.08 ± 3.73 and 51.31 ± 2.39, respectively, which indicates the presence of inorganic matters as major components.

TABLE-I: EXTRACTIVE VALUES OF TRIFLA CHURNA

Extractive

Values* % w/v (Mean ± SD)

TC1

TC2

TC3

Water soluble

Methanol soluble

n-Hexane

Chloroform

*Values of mean of three experiments.

TABLE-II: ASH VALUES OF TRIFLA CHURNA

Samples

Ash values* % (Mean ± SD)

TC1

TC2

TC3

Total ash

Water soluble ash

Acid insoluble ash

*Values of mean of three experiments.

The physical characteristics of all the samples of Trifla Churna were shown in Table-3. Low values of angle of repose show the poor flow ability for all samples. The results of the three batches were found to be comparable. The % moisture content and loss on drying values of Trifla Churna are reported in Table-4. TABLE-III: PHYSICAL CHARACTERISTICS OF DIFFERENT FORMULATION OF TRIFLA CHURNA

Parameters

Values* % (Mean ± SD)

TC1

TC2

TC3

Bulk density (g\mL)

True density (g\mL)

Angle of repose (-)

Hausner's ratio

Carr's index

*Values of mean of three experiments.

These investigations of Phytochemical evaluation are shown in Table-5 which shows the presence of different phytoconstituent. The fluorescence analysis (Table-6) revealed that each of the three batches of Trifla Churna are not showed the major distinct fluorescing property.

TABLE -IV: MOISTURE CONTENT AND FOREIGN MATTER OF TRIFLA CHURNA

Samples

Values* % (Mean ± SD)

Moisture content

Loss on drying

TC1

TC2

TC3

*Values of mean of three experiments.

TABLE-V: PHYTOCHEMICAL EVALUATION OF TRIFLA CHURNA

Phytoconstituents

TC1

TC2

TC3

Alkaloids

Glycosides

Phytosterols

Essential oil

Tannins

Saponins

Proteins

TABLE-VI: POWDER FLUORESCENCE ANALYSIS OF TRIFLA CHURNA

Material

TC1

TC2

TC3

Day

Light

UV 254nm

Day

Light

UV 254nm

Day

Light

UV 254nm

Powder as such

P + 1N HCL

P + 1N NaOH(a)

P + FeCL3

P + 1N HNO3

P + Ammonia

P + Iodine

P + Picric acid

P + 1N H2S04

BR=Brown, YBR=Yellowish brown DBR=Dark brown LBR=Light brown BBR=Blackish brown B=Black Y=Yellow FY=Florescent yellow

The pH values of 1 and 10 % w/v solutions of all the batches were included in Table-7, which showed that Trifla Churna is acidic in nature. No foreign matter was found and the result of foaming and swelling index reveals the absence of saponin and mucilage in all three batches of Trifla Churna. The data analysis reveals that all parameters remain in close proximity for each batch of Trifla Churna.

TABLE-VII: pH OF 1 AND 10 % w/v SOLUTION OF DIFERENT FORMULATION OF TRIFLA CHURNA

Different formulations

1% (w/v) concentration (Mean ± SD), n=3

10% (w/v) concentration (Mean ± SD), n=3

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TC1

TC2

TC3

No attention has been paid to evaluate a polyherbal formulation by comparative analysis. The calculated parameters and the developed methods for their determination can be considered as a protocol for the evaluation of Trifla Churna, which will assist the regularetory authorities, scientific organization and manufacturers in developing standards. The method used for evaluation is found to be precise and reproducible and help to produce uniform standard products, which will restore faith in Ayurvedic system.