Vidhya Milano Prasad, (2022) Preclinical study of Siddha Drug VATHA SILETPANA SURA KUDINEER for Anti-inflammatory, Analgesic and Antioxidant activities. Masters thesis, Government Siddha Medical College, Palayamkottai.
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Abstract
In this dissertation work, I have selected the Siddha formulation Vatha Siletpana Sura Kudineer is a herbal formulation contains nine ingredients of Solanum xanthocarpum, Mollugo cerviana, Clerodendrum serratum, Terminalia chebula, Tinospora cordifolia, Saussurea lappa, Piper longum, Kaempferia galangal and Alpinia officinarum are used as ingredients for the preparation which is mentioned in Siddha Literature of, Pararajasekaram- suram, sanni, vali, vikkal, sathi roga nithanankal part- III , Author ponniayah.I. page no. 24-25. The drug is useful for the treatment of Vatha kapha suram, hence it has been selected for its Anti inflammatory, Analgesic and Anti oxidant activities. ❖ Collection of literature reviews regarding the ingredients of trial medicine carried out in Siddha and modern literatures to support the fact of Anti inflammatory, Analgesic and Antioxidant activities. ❖ All the ingredients of the trial drug VSSK were purchased from M.Gopalan aasan store, Nagercoil, Kanyakumari District. Each ingredient of the trial drug is verified and authenticated by the Gunapadam experts, Department of Gunapadam, Government Siddha Medical College, Palayamkottai. The trial drug KC was prepared as per the procedure given in the above mentioned Literature. ❖ The Siddha Standardization of the trial drug VSSK indicates the drug is brown in colour, pleasant odour, Pungent and bitter taste, coarse powder in appearance and rough to touch. Based on the Siddha aspect, vatha kapha suram is caused by the dearrangement of vatham and kapham. The increased Kapha humor is normalized by administering the taste which containing fire elements (theyu boodham). This trial drug VSSK is pungent and bitter taste and has hot potency which can be normalize the deranged vatha and Kapha humor. Therefore the derangement of Vatha and Kapha humor is gradually normalized by the administration of this trial drug VSSK. Hence VSSK relieves the basic causes of Vatha Kapha suram. ❖ After the preparation of VSSK, it was screened for various standardization parameters such as the Siddha standardization methods as well as the Modern standardization methods. As per Siddha standardization methods, VSSK had all the characteristics of properly prepared kudineer chooranam. ❖ As per modern standardization methods, following parameters were followed. The Physico-chemical analysis, Bio-chemical analysis, Phyto - chemical analysis, Microbiological Analysis, Instrumental analysis such as Scanning Electron Microscope (SEM). The chemical fingerprints are engaged by using modern analytical technique Fourier Transform Infra–Red Spectroscopy (FTIR), Inductively Coupled Plasma Optical Emission Spectroscopy (ICP-OES), The chemical fingerprints are engaged by using modern analytical technique Powder X-ray (EDAX) (Energy Dispersive X-ray Analysis) diffraction methods and the Experimental analysis such as the Toxicological Studies & The Pharmacological studies. Physicochemical analysis of VSSK shows The percentage of loss on drying at 105ºc is 1.50%. It is within the acceptable range. The Water soluble ash value of the trial drug KC was 9.90% and acid insoluble ash is 2.75%. The Water soluble ash value is higher than the acid insoluble ash. It represents the good quality of the drug VSSK and it is easily absorbed in the gut. Acid insoluble ash value is very small amount of the inorganic component is insoluble in acid, lower the acid insoluble value better will be the drug quality. ❖ A water soluble extractive value of VSSK is 9.90%. Higher the Water soluble extractive value implies that the water is better solvent of the extraction. ❖ VSSK shows acidic pH 7.10. The pH level plays a role in enzyme activity by maintaining the internal environment thus regulating the homeostasis. Very high or very low pH will lead to the complete loss of the activity of most enzymes. The pH value at which the enzyme is most active is called the optimal pH value. The pH value of the trial drug VSSK falls near to the neutral pH value. Hence it has optimal enzymatic reaction. ❖ Biochemical analysis shows, Biochemical analysis of VSSK reveals that, the trial drug consists of Calcium, Sulphate, Starch, Ferrous iron, Tannic acid, Unsaturated compounds, Reducing sugar, and Amino acids. ❖ Calcium: Calcium citrate is an effective anti inflammatory agent. There are calciumsensing receptors on vascular smooth muscle cells and on platelets, calcium plays a role in smooth muscle contraction and its role in the electrophysiology of the heart and myocardial function. Antioxidant enzyme responses depend on calcium levels. Calcium carbonate, calcium citrate and calcium gluconate have significant anti inflammatory activity. ❖ Sulphate Chondroitin sulfate (CS) prevents joint space narrowing and reduces joint swelling and effusion. To produce these effects, CS elicits an anti-inflammatory effect at the chondral and synovial levels. Sulphate important role for the anti-microbial activity. ❖ Starch It is a odourless tasteless white substance occuring widely in plant tissue. It is a polysaccharide functions as a carbohydrates store and is an important constituent of the human diet. Resistant starch is divided into five different types based on the origin and physical properties of starch. It can produce more butyrate in comparison to other prebiotics. Butyrate is the main SCFA that is produced from the fermentation of RS and acts as an anti-inflammatory agent. Starch is needed during fever condition. ❖ Ferric iron and ferrous iron: Iron is an essential element for blood production. About 70 percent of the body's iron is found in the red blood cells of blood called hemoglobin and in muscle cells called myoglobin. Hemoglobin is essential for transferring oxygen in blood from the lungs to the tissues. In the ferrous state (Fe2+), iron acts as an electron donor, while in the ferric state (Fe3+) it acts as an acceptor. ❖ Tannic acid Tannic acid is a natural polyphenol which has been reported to possess antioxidant, anti-inflammatory, anticarcinogenic, antimutagenic, antitumor, and antimicrobial activities. ❖ Unsaturated compounds: In other tissues and cell types, unsaturated fatty acids have well known anti-inflammatory effects, which range from the inhibition of the lipoxygenase and cycloxigenase pathways and decrease of neutrophil adhesion to the reduction of inflammatory cytokine expression and inhibition of TLR4 signaling. ❖ Reducing sugar relaxes mucus, lessens cold and cough symptoms. ❖ Amino acids: N-acetyl cysteine for cough and other lung conditions. It is also used for flu, dry eye, and many other conditions. NAC is also useful to help fight long-term lung damage in those with chronic obstructive pulmonary disease (COPD). Amino acids contribute to various anti-oxidant and immunological activities relevant to asthma pathogenesis, raising the possibility that differences in amino acids may be involved in asthma aetiology. Cystine reduces the risk of asthma via glutathione metabolism. ❖ The phytochemical screening of the alcoholic and aqueous extract of the VSSK reveals, Gas chromatography mass spectroscopy analysis was carried out in crude extracts of the MLC such as ethanol extract. The peaks in the chromatogram were integrated and were compared with the database of spectrum of known components stored in the GCMS library. The detailed of GC-MS analysis of the extracts are given in figures. This study shows the presence of those compounds such as 1,3,12-nonadecarine, 2-propenamine, 3,1 [cyclohexanyl]-N-cyclohexanyl-N-oxide, 1-octane, 2-methoxyl, 2-carboxymethyl, 3-methyl- cyclopentano carboxylic acid, ursodeoxcholic acid. ❖ In instrumental analysis, The SEM photographs revealed that particles were spherical in shapes and sizes were in the range from 1μm to 300 nm. Although the particle sizes of different batches showed similarity, it seems that these particles were aggregates of much smaller particles. When dispersed in an aqueous medium, these preparations form a negatively charged hydrophobic particle suspension. This hydrophobicity gave these particles a tendency to aggregate together to form micro particles. VSSK exhibited larger sizes and agglomeration of the particles. SEM analysis of the VSSK shows most of the particles present in the sample are micro size, average particle size is 1μm - 300nm In FT-IR spectra analysis, VSSK exhibits the peak value at 2929.87, 2360.87, 1514.12, 1373.32, 1246.02,1161.15, 1024.20, 927.76, 862.18, 771.53, 572.86, 522.71, 437.84, 412.77 having O-H stretch, none, O-N-O stretch, N-O stretch, C-N stretch, C-O stretch, None, C=C Bend, C-Cl stretch, C-Br stretch, C-I stretch respectively. This peak indicates the presence of some organic functional groups such as, Carboxylic acid, Isothianate, nitro compounds, amine, tertiary alcohol, alkenes, alkyl halides & aryl halides. ❖ Nitro compounds has anti inflammatory, analgesic, antioxidant, anti proliferative, it can act against infectious diseases, it has anti tubular activity, and anti parasitic activity. Carboxlic acid acts as Anti inflammatory, Analgesic, Anti pyretic and cytotoxic, Anti oxidant,It depresses cough and its symptoms. Amines has anti inflammatory, antioxidant,Anti tussive, Bronchodialator activities. Alkl and Aryl halides has anti inflammatory, Anti microbial, Anti niociceptive activities. Alcohols has analgesic activity. ❖ In ICP – OES, the formulation contains heavy metals are in below detectable level. This results shows Below Detectable Limit (BDL) of Al (Aluminium), As (Arsenic), C (Carbon), Cd (Cadmium), Cu (Copper), Fe (Iron), Hg (Mercury), K (Potassium), Mg (Magnesium), Na (Sodium), S (Sulphur) and Zn (Zinc). So it is considered as safe and free from toxic substances. ❖ This XRD fingerprint shows both the similarities and differences of the sample successfully and is a valuable primary tool for checking the quality control of minerolo metallic formulations. The different peaks show the presence of minerals in the samples. ❖ Crystallinity refers to the degree of structural order of a solid. The Percentage of crystalinity of the VSSK is 27.5 %. Increasing the degree of crystallinity increases hardness and density. It is a Meto – mineral preparation, hence it has the high value of cristalinity. Amorphous means, noncrystalline solid in which the atoms and molecules are not organized in a definite lattice pattern. The Percentage of Amorphous of the VSSK is 72.5 %. ❖ Results of microbiological study shows, In microbiological limit, Total viable aerobic bacterial counts and total fungal count are within the normal level. Specific pathogens like Salmonella sp, Staphylococcus aureus and E.coli are Nil. Hence, the test drug VSSK is free from any microbial Contamination and it has standard quality. But the trial drug has some range of Pseudomonas sp. ❖ The results of antimicrobial activity, illustrated that the given samples had shown antibacterial activity against the tested pathogens including Proteus vulgaris and candida albicans at higher concentrations. However, the results showed that the sample had no antimicrobial activity against Staphylococcus aureus, Pseudomonas aeruginosa and E-coli. ❖ In acute oral toxicity study, The rats were treated with different concentration of VSSK from the range of 5mg/kg to 2000mg/kg. This dose level did not produce the signs of toxicity, functional and behavioural changes and mortality in the test groups as compared to the control when observed during 14 days of experimental period. From acute toxicity study it was observed nsp >0.05 that the administration of VSSK at a dose of 2000 mg/kg to the rats do not produce drug-related toxicity and mortality. So No-Observed-Adverse-Effect- Level (NOAEL) at 2000 mg/kg. ❖ In Sub - acute oral toxicity study, Acute and sub-acute toxicity were carried out in Wister albino rats according to OECD guidelines (423 & 407). This drug has no acute toxicity as there was no mortality seen. Sub-acute toxicity is carried by repeated dose of test drug for 28 days. Mortality, the functional observation, haemotological and biochemical investigations were done. There were no significant changes in the biochemical and haematological profile. So the toxicological study of this test drug, VSSK establish the safety of the drug for long time administration. ❖ In Pharmacological studies, The Anti inflammatory activity of VSSK studied by in-vivo method shows, oedema development in carrageenan induced paw edema model in rats is generally two phases are found. The first phase, which occurs between 0 to 2.5 h of injection of the phlogistic agent, has been attributed to the release of histamine or serotonin. The edema volume reaches to its maximum approximately 3 h post treatment and then begin to decline. The second phase of inflammatory reaction which is measured at 3h is caused by the release of bradykinin, protease, prostaglandin and lysosome. The inhibitory effect of the extract on the carrageenan induced inflammation could be due to the inhibition of enzyme cyclooxygenase leading to inhibition of prostaglandin synthesis. VSSK exhibited acute anti-inflammatory activity in the tested models which was found to be the most effective at higher concentrations employed. ❖ Analgesic activity shows that VSSK found to exhibit a dose dependent increase in latency time when compared with control. At 90 minutes, the percent inhibition of two different doses (100 and 200 mg/kg body weight) was 43.06% &52.91% respectively. The results were found to be statistically significant (p<0.001) . VSSK of both the plants doses showed significant analgesic action compared to the reference drug diclofenac sodium but drug 200 /kg was found to exhibit higher analgesic activity. ❖ Under this study, In - vitro Antioxident activity of Test drug VSSK VSSK shows that the test drug possesses concentration dependent scavenging activity on DPPH radicals with the highest percentage inhibition of about 65.15%. So, the present research proposes that, the Test drug VSSK has moderate Antioxidant activity. Thus the formulation may be a source of effective herbal drug. ❖ Finally, Toxicological study of Acute, sub-acute toxicity of VSSK represent nontoxic and safe drug in rats. As per Siddha literature the primary cause of Vatha kapha suram with increased vatha and kapha dosha due to certain diets and activities. This vadha dosha in association with kapha dosha adversely affects the respiratory function such as difficulty in breathing, chest tightness, etc. and causes the disease. The test drug VSSK has pungent and bitter taste. Pungent taste of VSSK normalized the increased vatha and Kapha doshas. ❖ Results and discussion give the necessary and essential justification to prove the potency of test drug with scientific validation. Based on the results presented in this study, it can be concluded that Vatha Siletpana Sura Kudineer exerts significant Anti inflammatory, Analgesic and Antioxidant activities. CONCLUSION: It is concluded that the trial drug VATHA SILETPANA SURA KUDINEER has significant Anti inflammatory, Analgesic and Antioxidant activities. Anti inflammatory is a good fever reducer and also it relieve pain and reduce inflammation. Analgesic activity helps to relieve all the pains related to fever. Anti oxidant preotect the cells against free radicals, which may play a role in heart disease and other disease. The trial drug is scientifically validated by modern techniques and Siddha standard methods. The toxicological study of this trial drug establishes the safety of the drug for long time administration. Hence the trial drug can be safely used to human for Vatha siletpana (Kapha) Suram.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | Reg.No.321912009 |
| Uncontrolled Keywords: | Preclinical study, Siddha Drug, VATHA SILETPANA SURA KUDINEER, Anti-inflammatory, Analgesic and Antioxidant activities. |
| Subjects: | AYUSH > Gunapadam |
| Depositing User: | Subramani R |
| Date Deposited: | 01 May 2023 10:20 |
| Last Modified: | 14 Feb 2024 14:39 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21153 |
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