ICP-OES is an analytical technique used for the detection of trace metals. The intensity of this emission is indicative of the concentration of the elements within the drug SM (wt:0.20350 mg).
Table.No:16. ICP-OES Interpretation of Soodhaga mezhugu
S.No Elements Wavelength(nm) Concentration
1. Al 396.152 BDL
2. As 188.979 BDL
3. Ca 315.807 21.110mg/L
4. Cd 228.802 BDL
5. Cu 327.393 BDL
6. Fe 238.204 01.054
7. Hg 253.652 BDL
8. Mg 285.213 01.224mg/L
9. Na 589.592 04.321mg/L
10. Ni 231.604 BDL
11. Pb 220.353 BDL
12. P 213.617 58.117mg/L
OVULATION INDUCING ACTIVITY OF SOODHAGA MEZHUGU 122 BDL- Below Detecting Limit:
1% = 10000 ppm, (1 ppm = 1/1000000 (or) 1 ppm = 0.0001%) The toxic metals and the permissible limits
Heavy metals WHO & FDA limits
Arsenic (As) 10ppm
Mercury (Hg) 1ppm
Lead (Pb) 10ppm
Cadmium (Cd) 0.3ppm
Interpretation:
Calcium and phosphorus
Calcium (Ca) plays an important role in gonadotropic regulation of ovarian steroidogenesis. Marginal deficiency of phosphorus cause disturbance in the pituitary-ovarian-axis including ovulation. It also suggests that Ca is involved in the distribution of cumulus cell cohesiveness by regulating the number of gap junctions between the cells, which contributes to the process of ovulation (114).
Iron
➢ Iron improves the hematological level in the body and also it is essential for growth, reproduction, healing and immune function.
➢ In this, iron is present in ferrous form, which is soluble and readily absorbed in the intestinal lumen.
Magnesium:
➢ Magnesium activates over 300 enzyme reactions in the body.
➢ Magnesium which helps in the hormone creation, it’s a great help to our body.
➢ Magnesium prevent the excess creation of stress hormone cortisol because of excess Cortisol level leads to alteration of progesterone, estrogen, testosterone,
OVULATION INDUCING ACTIVITY OF SOODHAGA MEZHUGU 123 FSH and LH will be too, this is the vital when it comes to healing hormonal issue like PCOS.
➢ It helps to maintain nerve and muscle function, supports a healthy immune system.
➢ It also helps regulate blood glucose levels because it enhances insulin secretion and aid in the production of energy and protein and facilitates sugar metabolism.
This is vital when it comes to healing hormonal issues like PCOS.
➢ Thyroid support – magnesium helps the production of the thyroid hormone and as an anti-inflammatory, prevents thyroid diseases. It also prevents the chronic urination that can be a sleep interrupter (115).
Sodium
Sodium are indirectly related to reproduction. Deficiency of sodium can affect the normal reproductive physiology by preventing the utilization of protein and energy.
So, presence of the minerals enhances the therapeutic effects (116). DISCUSSION:
The result indicate that the formulation is extremely safe as it contains heavy metals within specified limits.
ICP-OES reveals the concentration of many minerals present in the drug. It also has physiologically important minerals like Ca, Fe, Mg, Na & P. In Soodhaga mezhugu, the heavy metals like As, Hg, Pb, Cd and trace element like Ni were below detectable level. This reveals the safety of the drug.
OVULATION INDUCING ACTIVITY OF SOODHAGA MEZHUGU 124 SEM (SCANNING ELECTRON MICROSCOPE)
The following image is done by 20000X magnification via 2µm aperture shows maximum depth focused.
Fig No. 17 Showing micro particles in SEM image of SM(2μm) at 20000 x magnification
Fig No. 18 Showing micro particles SEM image of SM(1μm) at 30000 x magnification
The micro particles present in the drug are of great clinical important. Size and surface micro particles can be easily manipulated to achieve both passive and active targeting.
Advantages of micro particles in drug delivery system:
Biodegradable microparticles have been used frequently as drug delivery vehicles due to its grand bioavailability, better encapsulation, control release and less toxic properties.
OVULATION INDUCING ACTIVITY OF SOODHAGA MEZHUGU 125
➢ Increased therapeutic effect of the drug
➢ Micro particles can be used for directing the drugs to specific target cells
➢ Decreased toxicity/ side effects
➢ Protection from physical and chemical degradation
➢ Improves stability and Increased bioavailability (117). The test drug Soodhaga Mezhugu contains Micro particles.
➢ Micro particles present in the drug results in a better bioavailability and facilitate absorption.
➢ The particles of micro size show that the drug may easily enter the cells at the molecular level to treat the disease rapidly and increase the therapeutic effect.
SEM analysis of the test drug Soodhaga Mezhugu revealed the presence of micro particles of size 5-2 Microns. The particles of size micro and near micro size show that the drug may easily enter the cells at the molecular level to treat the disease rapidly and increase the therapeutic effect.
XRD (XRAY DIFFRACTION)
Graph.No.4.XRD Interpretation XRD Interpretation
➢ The X–ray diffraction pattern of a pure substance is, therefore, like a fingerprint of the substance. It is based on the scattering of X-ray by crystals.
OVULATION INDUCING ACTIVITY OF SOODHAGA MEZHUGU 126
➢ XRD was used to identify drug substance forms and determine the molecular structure of the sample.
➢ It well monitoring the crystal morphology of drugs.
Results of XRD:
There are three strongest peaks present in the XRD analysis such as 28.42021, 46.44214 and 21.54997.
Discussion on XRD results:
The crystalline structure, the size and the shape of the particles are highly dependent on the route of synthesis and highlight the therapeutic effect of the drug. The Nano particles may enhance bio absorption of the drug.
Any morphological change in the crystalline state of trail drug as a result of the manufacturing process can influence a drug’s bioavailability.
XRD pattern of Soodhaga Mezhugu shows the good crystallinity after calcinations process. The major diffraction peaks are identified after XRD analysis SM concluded in nano crystalline range (21-46nm) is association with organic molecules probably plays an important role in making it biocompatible and nontoxic at therapeutic doses. Other elements present in SM act as additional supplement and possibly helps in increase the efficacy of the formulation (118).