Bhavani, P (2022) Preclinical study of Siddha Drug Mahalavangathi Chooranam for its Bronchodilator, Anti-histamine and Smooth muscle relaxant activities. Masters thesis, Government Siddha Medical College, Palayamkottai.
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Abstract
In this dissertation work I have selected MAHALAVANGATHI CHOORANAM (MLC) from the Siddha Literature “Kosayi Anuboga Vythia Brahma Rahasiam Part - III (p.no:81)” authored by Munusamy Muthaliyar for the evaluation of safety, efficacy and therapeutic potency in Swasa kaasam (Bronchial asthma) for its Bronchodilator, Anti-histamine and Smooth muscle relaxant activities. ❖ MAHALAVANGATHI CHOORANAM is a Polyherbal preparation. It is very effective and traditionally used in the treatment of Swasa kaasam(Bronchial asthma). ❖ Collection of literature reviews regarding the ingredients of trial medicine carried out in Siddha aspect, botanical aspect and Pharmaceutical review. Various collection of Siddha and modern literatures about the ingredients of the drug supports the fact of bronchodilator activity and their role in maintaining blood glucose level. ❖ All the ingredients of the trial drug MLC were collected from ASN Herbal drug shop, Melapalayam at Tirunelveli district, Tamilnadu. Each ingredient is verified and authenticated by the Gunapadam experts from the department of PG Gunapadam of Government Siddha Medical College, Palayamkottai. All the ingredients were purified as per the Siddha literature. The trial drug was prepared as per the procedure given in the literature of “Kosayi Anuboga Vythia Brahma Rahasiam Part – III” ❖ The Siddha standardization of the trial drug MAHALAVANGATHI CHOORANAM indicates the following characters. Organoleptic characters are White in colour, Pleasant odour, sweet and pungent taste, fine powder in appearance and smooth to touch. ❖ Physicochemical analysis of “MAHALAVANGATHI CHOORANAM” shows, (a) Loss on drying at 105oC is 1.90 %. The low moisture content of the drug reveals the stability and its shelf-life. The total ash value of MLC was 11.65%. The value of total ash in the formulation is comparatively high. The value of total ash indicates that the inorganic contents of the formulation are below the limits. The water soluble ash value of MLC was 9.70%. The water soluble ash value is higher than acid insoluble ash. It represents the good quality of the drug MLC. Acid-insoluble ash value of the prepared formulation MLC (1.95%) shows that a very small amount of the inorganic component is insoluble in acid. It indicates that adulteration of raw ingredients is very less. (b) The water soluble extractive value of the drug MLC was 9.40%. Higher water-soluble extractive value implies that water is a good solvent of extraction for the formulation. It shows that alkaloids of the formulations are more soluble in water. (c) The pH is an indication for the alkaline of a substance. It is determined by the number of free hrdrogen ions(H+) in a substance. MAHALAVANGATHI CHOORANAM shows alkaline pH(7.50). The pH level plays a role in enzyme activity by maintaining the internal environment thus regulating the homeostasis. It also an important factor for drug absorption. ❖ Biochemical analysis shows that the presence of sulphate, chloride, starch, unsaturated compound and amino acids. Among this, Sulphate has been considered as an adjunct therapy for severe and life threatening asthma exacerbation. Amino acids contribute to various anti-oxidant and immunological activities relevant to asthma pathogenesis. ❖ Phytochemical (GC-MS) study shows the presence of those compounds such as 3 Beta-chloro-5alpha-chollestane-5, 6 beta-diol6-acetate, alkaloid - N-(3-pchlorophenyl- 5-p-nitrophenylthien-2-yl)-1-methylpiperidin-2-imine, terpenoid 9,19-cyclolanost-7-en-3-ol, alkaloid – 1,16-cyclocorynan-16-carboxylic acid, 17-(acetyloxy)-19, 20-didehydro-10methoxy, methyl ester, (16 xi, 19E), 3H-cycloprop (1,2) androsta-1, 4, 6-trien-3-one, 11- carboethoxy-11-cyano-1a.2a-dihydro-17a-hydroxy. ❖ Microbial limit test shows that, the total bacterial count and the total fungal count was nil. This indicates that the drug is free from microbial contamination. The other pathogens like Escherichia coli, Salmonella sps, Staphylococcus aureus and Pseudomonas aeruginosa were found to be completely absent in the drug. This ensures the quality of the drug. ❖ 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. MAHALAVANGATHI CHOORANAM exhibited larger sizes and agglomeration of the particles. SEM analysis of the Mahalavangathi chooranam shows most of the particles present in the sample are micro size, average particle size is 1μm - 300nm. ❖ From the FTIR instrumental analysis, the test drug MLC is known to have alcohol, primary amines, carboxylic acid, alkene, aromatic compound, esater, aldehyde, fluoro compound, aromatic ester, alkyl aryl ether,primary & secondary amines, alkyl halides .Alcohol group of substances have anti microbial activity and broncho dilator activity. Alkenes have anti oxidant and anti fungal activity. Carboxylic acid is used as antimicrobials. Alkyl halides have little biological activity.They protect against bacteria and fungai. Primary amines are used as anti-inflammatory and anti viral activity. The bronchodilator effects of a number of sympathomatic amines were assessed in terms of reduction of histamine-induced bronchospasm. This ensures the efficacy and therapeutic effect of the drug MLC. ❖ ICPOES analysis shows that 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. Higher ferrous iron stores were inversely associated with asthma and lower body iron and higher tissue iron need were associated with lower lung function. Sodium and Potassium regulate the acid-base balance of the body fluids. Magnesium sulphate has been considered as an adjunct therapy for severe and life threatening asthma exacerbation. Phosphorus is an important constituents of phosphate buffers in the blood and urine. Zinc is essential for growth.Zinc are required for optimal activity of the immune system. sulphur performs a number of functions in enzyme reactions and protein synthesis. ❖ From the XRD results this sample is known exhibit crystalline and amorphous nature. Sharp and narrow peaks represent crystalline nature. This is about 67.5% of the sample. This ensures the stability of the drug. Remaining 32.5 % represents amorphous nature. Amorphous state is ten times more soluble than that of crystalline state. So this increases the solubility of the drug. The different peaks show the presence of minerals in the samples. This XRD fingerprint shows both the similarities and differences of the sample successfully. ❖ Acute and sub acute toxicity were carried out in Wistar albino rats according to OECD guidelines (423, 407). In the Acute oral toxicity study, the rats were treated with different concentration of MLC 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 controls when observed during 14 days of the acute oral toxicity experimental period. So No-Observed-Adverse-Effect-Level (NOAEL) of PVC is 2000 mg/kg. However the test drug MLC does not produce much significant effect in Body weight, Water intake and food intake. The results are in non-significant. In Acute oral toxicity test the MLC was found to be nontoxic upto the dose level of 2000mg/ kg body weight.These results showed that a single oral dose of the MLC showed no mortality of these rats even under higher dosage levels indicating the high margin of safety of this drug. ❖ Sub acute toxicity is carried by repeated dose of test drug for 28 days. The doses selected were200mg, 300 mg and 400 mg/kg of MAHALAVANGATHI CHOORANAM. All animals from control and all the treated dose groups survived throughout the dosing period of 28 days. The results for body weight determination of animals from control and different dose groups show comparable body weight gain throughout the dosing period of 28 days. During dosing period, the quantity of food and water consumed by animals also significantly increase. The results of hematological investigations conducted on 29th day revealed no significant changes in the hematological values when compared with those of respective controls. This gave clear justification that bone marrow and spleen were not influenced by MLC. The clinical biochemistry analysis was done to evaluate the possible alterations in hepatic and renal functions not influenced by the test drug . Results of Biochemical investigations conducted on days 29 and recorded in revealed the no significant changes in the values of different parameters studied when compared with those of respective controls; Urea, SGOT, SGPT, Bilirubin were within the limits.. Group Mean Relative Organ Weights are recorded Comparison of organ weights of treated animals with respective control animals on day 29 was found to be normal comparable with respective control group. So the toxicological study of the test drug, MLC reveals the safety of the drug for long time administration. ❖ In this pharmacological study, the Bronchodilator activity of MLC showed that the concentration of increased leucocytes counts were decreased in mice. Finally the MLC results represents reduce bronchial inflammation helps airways to dilate. ❖ Anti-histamine activity was performed by histamine induced bronchoconstriction model with pre-convulsion time as testing parameter. MLC Significantly increase in preconvulsion time (PCT) as compared to control following the exposure of histamine aerosol.Hence, MLC possess significant anti-histamine activity. ❖ Smooth muscle relaxant activity of MAHALAVANGATHI CHOORANAM showed significant anticholinergic activity when studied in isolated albino rat ileum model. ❖ The sample MLC was screened for their antimicrobial activity against both bacterial and fungal pathogens using agar well diffusion method along with standard broad-spectrum antibiotics for bacterial pathogens. After incubation, the zone production on the plates were read as per the standard method and correlated with the result of standard antibiotics. The results illustrated that the given samples have no antimicrobial activity against the tested pathogens in higher concentrations. ❖ As per Siddha literature the primary cause of Eraippu noi is increased 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 (Eraippu noi). The test drug MLC has pungent and sweet taste. Pungent taste of MLC normalized the increased Kapha doshas. Sweet taste of MLC cures the symptoms of Eraippu noi related to vadha dosha. ❖ 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 MAHALAVANGATHI CHOORANAM exerts significant Bronchodilator, Anti-histamine and Smooth muscle relaxant activities. CONCLUSION: From the literature review and the results of Siddha standardization and Physico-chemical, Bio-chemical and Phytochemical analysis, Microbial Limit test, Instrumental analysis, Toxicological,Pharmacological studies and Antimicrobial activity, it has been concluded that the trial drug MAHALAVANGATHI CHOORANAM, selected from the text book of “Kosayi Anuboga Vythia Brahma Rahasiam Part III” authored by Munusamy Muthaliyar significant Bronchodilator, Anti-histamine and Smooth muscle relaxant activities. Hence it can be safely used for Swasa kaasam (Bronchial asthma) as an effective drug.
| Item Type: | Thesis (Masters) |
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| Additional Information: | Reg.No.321912003 |
| Uncontrolled Keywords: | Preclinical study, Siddha Drug,MAHALAVANGATHI CHOORANAM, Bronchodilator, Anti-histamine and Smooth muscle relaxant activities. |
| Subjects: | AYUSH > Gunapadam |
| Depositing User: | Subramani R |
| Date Deposited: | 01 May 2023 09:01 |
| Last Modified: | 14 Feb 2024 14:36 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/21148 |
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