Physico-chemical analysis and heavy metal analysis of Siddha formulation Natthai Parpam

1 Dr.S.chandraprasath MD(siddha) lecturer ,Rvs siddha medical college , Coimbatore.

2.Dr.H.veda Merlin kumari(MD Siddha)

Associate professor, department of maruthuvam, national institute of siddha, Chennai .

Dr.S.Mohan MD(siddha)

Professor, Former hod department of maruthuvam and former director national institute of siddha.

ABSTRACT :

Siddha formulations have an incredible advantage in clinical practice for many chronic diseases. In the same way, siddha medicine Nattthai parpam was widely used to treat many diseases. Standardisation of herbo-mineral formulations is mandatory to assess the quality of traditional medicine. Nattthai Parpam (NP) is one of the major Siddha formulations which is widely used in Siddha system of medicines. The organoleptic parameters were assessed to note the industrial standardization aspects of Siddha medicine formulation. This paper deals with the Physico-chemical parameters and analysis of heavy metals by Atomic Absorption Spectroscopy (AAS) analysis of NP. This study reveals that the presence of Sulphate, Calcium, Magnesium, Potassium, Iron, Zinc etc and in physico-chemical analysis its PH value is 7.3 loss of drying is 0.18 % and its total ash value is 57.25 %. Hence, the present analysis work focuses on the concentrations of Snail present in Parpam which will help in showcase the importance of siddha medicine to the global world. Further Work is necessary to carry out on these drug formulations in order to get the pharmacology and Pharmacognosy about this drug.

KEYWORDS:

Siddha medicine, Natthai parpam, physico-chemical parameters.

INTRODUCTION:

Siddha system is one of the traditional systems of medicine in the world. Generally Siddha system of medicine not only gives curative procedure of disease and also gives preventive aspects to diseases. The siddha system experiencing revitalization among the consumers throughout the world. In Siddha medicines are prepared by adding several parts of herbals, minerals of various metals, alloys and animal products etc., for the treatment of various illness. Parpam, literally meaning calx which looks like a ash, is unique siddha formulations of nano-dimension. Standardization of herbal formulation is essential to assess the quality of drugs.

WHO collaborates and assist health ministries in establishing mechanism for the introduction of traditional medicines into primary healthcare programs, in assessing safety and efficacy, in the quality control of raw and processed materials. The need of quality control for Siddha Medical drugs is due to the fact that the preparation of drug according to the ancient method has been reduced due to the commercialization of Siddha Medical pharmacy in present era. Even though the industries are maintaining its standards because of Industry regulatory instructions. The Siddha system of medicine is categorised into two classes, one is Internal medicine and second one is external medicine. Among 32 internal medicines Parpam is one among them and its shell life of prepared formulation lasts for 100 years. The WHO estimates that perhaps 65 to 80% of population uses traditional medicine. In present scenario standardisation is need to prove the Safety and chemical profile of any medicine.

MATERIALS AND METHODS:

Required raw drugs :

1. Nathai - Fresh water snail (sufficient quantity)

2. Tutti illai charu - Abutilon indicum (sufficient quantity.

SOURCE OF DRUG:

The drug will be purchased from GMP Certified Pharmacy SKM (Siddha & Ayurveda Medicine) Erode.

METHOD OF PREPARATION:

Fill an earthen pot upto half of its capacity with cleaned Natthai cover it with earthen pan and seal with clay smeared cloth ribbon, dry and calcine, when cooled take the ash from the pot and grind with tutti liial charu make cakes dry and calcine. Repeat two or more calcinations till a white calx results. The reference product details was wrote based on the company information booklets i.e Therapeutic index.

DRUG STORAGE

The prepared drug will be stored in a clean and dry wide mouthed glass bottle.

DOSE:

300 mg and to be provided two times a day based on clinical practitioners advice.

ADJUVANT :

Ghee.

PHYSIO-CHEMICAL ANALYSIS OF NATTHAI PARPAM :

1. Colour Examination:

5gm of Natthai Parpam were taken into watch glasses and positioned against white back ground in white tube light. Its colour was observed by naked eye.

2. Moisture Content:

An accurately weighed 1g of Natthai Parpam formulation was taken in a tarred glass bottle. The crude drug was heated at 1050C in an oven till a constant weight. Percentage moisture content of the sample was calculated with reference to the shade dried material.

3. Determination of total ash:

Weighed accurately 1g of Natthai Parpam formulation was added in crucible at a temperature 600°C in a muffle furnace till carbon free ash was obtained. It was calculated with reference to the air dried drug.

4. Determination of acid insoluble ash:

Ash above obtained, was boiled for 5min with 25ml of 1M Hydrochloric acid and filtered using an ash less filter paper. Insoluble matter retained on filter paper was washed with hot water and filter paper was burnt to a constant weight in a muffler furnace. The percentage of acid insoluble as was calculated with reference to the air dried drug.

5. Determination of water soluble ash:

Total ash 1g was boiled for 5min with 25ml water and insoluble matter collected on an ash less filter paper was washed with hot water and ignited for 15min at a temperature not exceeding 450°C in a muffle furnace. Difference in weight of ash and weight of water.

6. Determination of water soluble Extractive:

1gm of air dried drug, coarsely powered Natthai Parpam was macerated. With 100ml of distilled water in a closed flask for twenty-four hours shaking frequently. Solution was filtered and 25 ml of filtrated was evaporated in a tarred flat bottom shallow dish, further dried at 100°C and weighted. The percentage of water soluble extractive was calculated with reference.

7. Determination of alcohol soluble extractive:

1 gm. of air dried drugs, coarsely powdered Natthai Parpam was macerated with 100 ml. alcohol in closed flask for 24 hrs. With frequent shaking. It was filtered rapidly taking precaution against loss of alcohol. 25ml of filtrate was then evaporated in a tarred flat bottom shallow dish, dried at 100°C and weighted. The percentage of alcohol soluble extractive was calculated with reference to air dried drug.

8. pH Value:

Potentiometrically pH value was determined by a suitable pH meter

Heavy metal analysis of Atomic Absorption Spectrometry (AAS)

Heavy metal analysis of the Naaga Sangu Parpam was done on Atomic Absorption Spectrometry (AAS) under optimized conditions. The formulation was taken for heavy metal analysis. The prepared medicine was subjected to microwave digestion method. 5.0 g of crude sample was placed in an Erlenmeyer flask and 20 ml of the extracting solution of 3M HNO3 was added to it and it was placed in a magnetic stirrer and the mixture was stirred for 20 minutes. It was allowed to stand overnight and the solution was heated carefully in a water bath until red nitrous oxide fumes ceased and allowed to cool. The resulting solution was filtered through a Whatman filter paper No. 42 and transferred into a 50 ml polypropylene vial and diluted to 50 ml with the extracting solution. The final residue was dissolved in HNO3 solution and made up to 50ml. Standard solutions were prepared by diluting the stock solution with 0.1 M nitric acid for checking the linearity. The analytical reagent blanks were prepared. Wavelength is fixed between 185 to 900 nm. Atomic Absorption Spectrophotometer was equipped with high intensity hollow cathode. Compressed air and Acetylene gas was used to analyze the selected metals in the sample and the Air Flow is adjusted to 17.0 (L/min), Acetylene flow 1.5 (L/min) and the Lamp current is mA 15. Burner Head is 10 cm. The test samples were analysed against the standard for measuring the concentration of the desired data. All measurements were run in triplicate for the samples and standard solutions. Standard operating parameters for working elements were set. All the metals were extracted into the HNO3 in the form of metal nitrites. Plotted the response (absorbance or peak) versus concentration of each standard solution. Heavy Metals selected for this study in the selected medicine was found lead in very minimal quantity.

RESULTS:

PHYSIO-CHEMICAL ANALYSIS OF NP:

Table 1.Physio-chemical parameters of Natthai Parpam

An organoleptic character for finished product of Natthai Parpam shows that the Surface of Natthai Parpam was uniform and without any cracks, was white in colour. It has no peculiar taste due to this comes under parpam form, having wide range of expiry as per siddha literatures.

Table 2. Physio-chemical parameters of Natthai Parpam

Physico chemical analysis – pH value represents alkalinity nature of formulation, Natthai Parpam. Mild Alkaline nature of Natthai Parpam was due to its process, of preparation. Loss of drying indicates the presence of very mild moisture content, in natthai parpam it was 0.18% w/w, which as also under industrial permissible limit for packaging of ASU drugs. Presence of inorganic substances in the formulations indicated by determination of Ash value, which plays important role in standardization, more ash value denotes higher inorganic substances, in present sample Ash value was 57.258%w/w. Various components have different solubility media, present formulation solubility was seen in water and acid, Water and acid soluble extractive value of Natthai Parpam was 3.67%, 3.56% respectively.

Table.3 Heavy metal analysis of Natthai Parpam

DISCUSSSION:

The physio-chemical analysis of Natthai Parpam (table 1 & 2) concludes the following results Natthai Parpam was a white coloured fine powder , odourless without any taste. The parpam answered the following tests showing that it was properly processed. There was no metallic luster when taken between the index finger and thumb and spread it was as fine as to get easily in to finger lines. When a small quantity of parpam was spread on cold and still water it floated on the surface. The ash content of 57.25% indicated that the drug contains organic matter and negligible amount of inorganic matter. Acid insoluble ash was 3.44% revealing that the parpam contains negligible amount of acid insoluble silica and salts of tin.

Physico-chemical properties of Natthai Parpam has given the result that the pH of Natthai Parpam was 7.3 which was weakly alkali. Hence on oral intake it will not cause any strong alkali or acid like irritation to the gastrointestinal tract ie. Any physical irritation. The loss of drying at 105°c was 0.18% hence the drug will not lose much of its volume on exposure to this range of temperature. Qualitative analysis of NP revealed the presence of Sulphate, Calcium, Magnesium, Pottasium, Iron, Zinc etc.

CONCLUSSION :

The Heavy metal analysis of the trial drug Natthai Parpam reveals the presence of Lead is within permissible limit 0.0097ppm (10ppm as per WHO permissible limit) and cadmium ,arsenic ,mercury were not detected. The confirmation of nanoparticle size and the contents of heavy metals are under the deduction limit favors the Natthai Parpam as a safer drug under Siddha system. The results of the study are concluded that the qualitative analysis of Natthai Parpam (NP) reveals the purity and bio-availability of the drug.

Safety and efficacy of herbal medicines are two main issues of a drug therapy to which, the source and quality of raw materials plays an important role. There is wide awareness among the scientific community regarding the quality control of herbal/ mineral/animal drugs and formulations in the last decade. Associated factors such as the use of fresh plants, temperature, light exposure, water availability, nutrients, period and time of collection, method of collecting, drying, packing, storage and transportation of raw material, age and part of the plant or mineral or animal product collected, etc., can greatly affect the quality and consequently the therapeutic value of herbal medicines. The World Health Organization, in a number of resolutions, has also emphasized the need to ensure the quality control of plant products by using modern techniques, suitable analytical methods and by applying suitable standards

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