Allium sativum (garlic), Silybum marianum (milk thistle), Coriandrum sativum (cilantro), Ginkgo biloba (ginkgo), Curcuma longa (turmeric), phytochelatins, Triphala, herbal fibers, and Chlorophyta (green algae). Similarly, alternative flavonoids with effects comparable to Kaempferol Iodine-127, such as quercetin, myricetin, fisetin, apigenin, and curcumin, may be used. For Ginkgo biloba extract, other herbal extracts with a similar structure and effect-particularly Moringa oleifera, apigenin, punicalagin, Kaempferol 7-O-glucoside, quercetin, and epigallocatechin gallate—are also effective, with Moringa oleifera and Ginkgo biloba showing the strongest efficacy. Other alginates may be used to replace either calcium alginate or sodium alginate. For example, alkaline earth metals such as magnesium may substitute for calcium, while alkali metals such as potassium may replace sodium. Lastly, humic acid may be substituted for fulvic acid.

Methods of Preparing

According to some embodiments, the present invention may further comprise a method of preparing a multi-layer niosome nanocarrier drug composition. In some embodiments, the method may comprise dissolving Kaempferol Iodine-127, mint extract, cholesterol, Tween 80, and diacetyl phosphate in chloroform followed by evaporation (e.g., by heat) to make the niosomes comprising Kaempferol-iodine127 and mint extract and incubating the formed niosome in fulvic acid aqueous solution for a period of time. Alternatively, in some embodiments, the method comprises dissolving Kaempferol Iodine-127, mint extract, cholesterol, diacetyl phosphate, and Tween 80 in chloroform and incubating this composition with fulvic acid aqueous solution for a period of time, followed by evaporating them with heating and adding deionized water to the dried formed compound.

In other embodiments, the method may comprise dissolving Kaempferol Iodine-127, mint extract, Ginkgo biloba extract, calcium alginate, cholesterol, Tween 80, and diacetyl phosphate in chloroform followed by evaporation (e.g., by heat) to make the niosomes comprising kaempferol-iodine127, mint extract, Ginkgo biloba extract, and calcium alginate and incubating the formed niosome in an aqueous solution containing fulvic acid and sodium alginate for a period of time. Alternatively, in some embodiments, the method comprises dissolving Kaempferol Iodine-127, mint extract, Ginkgo biloba extract, calcium alginate, cholesterol, diacetyl phosphate, and tween 80 in chloroform and incubating this composition with an aqueous solution containing fulvic acid and sodium alginate for a period of time, followed by evaporating them with heating and adding deionized water to the dried formed compound.

In some embodiments, the prepared niosomes (e.g., niosomes that are loaded with Kaempferol Iodine-127, mint extract, Ginkgo biloba extract, calcium alginate, or a combination thereof) are incubated in an aqueous solution containing fulvic acid and/or sodium alginate for about 30 minutes. In some embodiments, the prepared niosomes are incubated in an aqueous solution containing fulvic acid and/or sodium alginate for about 20 minutes. In some embodiments, the prepared niosomes are incubated in an aqueous solution containing fulvic acid and/or sodium alginate for about 10 minutes. In some embodiments, the prepared niosomes are incubated in an aqueous solution containing fulvic acid and/or sodium alginate for about 40 minutes. In some embodiments, the prepared niosomes are incubated in an aqueous solution containing fulvic acid and/or sodium alginate for about 60 minutes. In some embodiments, the prepared niosomes (e.g., niosomes that are loaded with Kaempferol Iodine-127, mint extract, Ginkgo biloba extract, calcium alginate, or a combination thereof) are incubated in an aqueous solution containing fulvic acid and/or sodium alginate for about 10 to 60 minutes, or about 10 to 40 minutes, or about 10 to 30 minutes, or about 10 to 20 minutes, or about 15 to 60 minutes, or about 15 to 40 minutes, or about 15 to 30 minutes, about 20 to 60 minutes, or about 20 to 40 minutes, or about 10 to 30 minutes.

In some embodiments, the prepared niosomes (e.g., niosomes that are loaded with Kaempferol Iodine-127, mint extract, Ginkgo biloba extract, calcium alginate, or a combination thereof) are incubated in about 1 mg/ml of an aqueous solution containing fulvic acid and/or sodium alginate. In some embodiments, the prepared niosomes are incubated in about 0.5 mg/ml of an aqueous solution containing fulvic acid and/or sodium alginate. In some embodiments, the prepared niosomes are incubated in about 0.1 mg/mL of an aqueous solution containing fulvic acid and/or sodium alginate. In some embodiments, the prepared niosomes are incubated in about 2 mg/ml of an aqueous solution containing fulvic acid and/or sodium alginate. In some embodiments, the prepared niosomes are incubated in about 5 mg/ml of an aqueous solution containing fulvic acid and/or sodium alginate. In some embodiments, the prepared niosomes are incubated in about 10 mg/ml of an aqueous solution containing fulvic acid and/or sodium alginate. In some embodiments, the prepared niosomes are incubated in about 0.1 to 10 mg/ml of an aqueous solution containing fulvic acid and/or sodium alginate. In some embodiments, the prepared niosomes are incubated in about 0.1 to 5 mg/ml of an aqueous solution containing fulvic acid and/or sodium alginate. In some embodiments, the prepared niosomes are incubated in about 0.1 to 1 mg/ml of an aqueous solution containing fulvic acid and/or sodium alginate. In some embodiments, the prepared niosomes are incubated in about 0.5 to 10 mg/ml of an aqueous solution containing fulvic acid and/or sodium alginate. In some embodiments, the prepared niosomes are incubated in about 0.5 to 5 mg/ml of an aqueous solution containing fulvic acid and/or sodium alginate. In some embodiments, the prepared niosomes are incubated in about 0.5 to 1 mg/mL of an aqueous solution containing fulvic acid and/or sodium alginate.

As used herein, a “prepared niosome” refers to the formed inner core of the niosome comprising Kaempferol Iodine-127, mint extract, Ginkgo biloba extract, calcium alginate, or a combination thereof. As used herein, a “loaded niosome” refers to a multi-layer noisome comprising an inner core and an outer layer; the loaded niosome may comprise Kaempferol Iodine-127, chloroform mint extract, Ginkgo biloba extract, calcium alginate, sodium alginate, fulvic acid, or a combination thereof.

In some embodiments, the methods may further comprise storing the loaded niosomes (e.g., niosomes loaded with Kaempferol Iodine-127, chloroform mint extract, Ginkgo biloba extract, calcium alginate, sodium alginate, fulvic acid, or a combination thereof) in an aqueous solution.

Methods of Use

The present invention may feature a method of preventing or treating radiation damage in a subject in need thereof. In some embodiments, the method comprises administering a multi-layer niosome nanocarrier drug composition as described herein. For example, the multi-layer niosome nanocarrier drug composition may comprise an inner layer comprising an extract of mint and Kaempferol Iodine-127 and an outer layer comprising fulvic acid. Alternatively, in some embodiments, the multi-layer niosome nanocarrier drug composition may comprise an inner layer comprising an extract of mint, Kaempferol Iodine-127, Ginkgo biloba extract, and calcium alginate, and an outer layer comprising fulvic acid and sodium alginate.

The present invention may also feature a method of removing radioactive material from a subject in need thereof. In some embodiments, the method comprises administering a multi-layer niosome nanocarrier drug composition as described herein. For example, the multi-layer niosome nanocarrier drug composition may comprise an inner layer comprising an extract of mint and Kaempferol Iodine-127 and an outer layer comprising fulvic acid. Alternatively, in some embodiments, the multi-layer niosome nanocarrier drug composition may comprise an inner layer comprising an extract of mint, Kaempferol Iodine-127, Ginkgo biloba extract, and calcium alginate, and an outer layer comprising fulvic acid and sodium alginate.

Dual Mechanism of Action:

Radioactive absorption blocking and chelating: Sr90 has biochemical behavior similar to calcium and is readily incorporated into bones and teeth, leading to bone cancer, and I-131 radioactive iodine) is absorbed by thyroid glands via transporters called Na/I symporters. This drug has fulvic acid aqueous solution in the outer layer (hydrophilic layer) that, upon interacting with cancer/radioactivates cells (in thyroid glands and bones), is released slowly, and then fulvic acid interacts radioactive elements like Sr90 by their phenol rings and form chelate with the Sr90 present in the cell and removes it through the kidneys. Meanwhile, the inner hydrophobic part of the drug with Kaempferol-Iodine127 and chloroform mint extract is released. The Kaempferol-Iodine 127 interacts with the Na/I symporters in thyroid glands with higher affinity than radioactive I-131 and, therefore, would be able to block the I-131 absorption by the thyroid glands and prevent thyroid cancer. The unabsorbed and free radioactive I-131 would then be chelated and removed with mint extract and Fulvic acid through the kidneys.

Other mechanisms that lead to an overall increase in antioxidant system and DNA repair: Apart from this, the drug induces its anti-cancer and radioprotective effects by various other mechanisms that are also seen in the most radioactive-resistant creatures in the universe, i.e., cockroaches and, including boosting body's antioxidant and ROS/radioactive scavenging activity, temporarily slowing down the cell cycle rate, reducing and preventing DNA damage, oxidative stress, and lipid peroxidation, upregulation of mRNA of antioxidant enzymes (such as catalase, glutathione-s-transferase, glutathione peroxidase, and superoxide dismutase), upregulation of DNA repair genes, inhibiting activation of protein kinase C, mitogen-activated protein kinase, cytochrome P-450, nitric oxide and several other genes that may be responsible for inducing damage following irradiation. These mechanisms have been shown in FIG. 2.

Example 1

The following is a non-limiting example of the present invention. It is to be understood that said example is not intended to limit the present invention in any way. Equivalents or substitutes are within the scope of the present invention.

Preparation method: Multilamellar vesicles (MLV) are prepared using a technique based on a gel hydration method (FIG. 1). Tween 80, cholesterol, and diacetyl phosphate in a molar ratio of (10:10:1) are weighed and dissolved in a chloroform/methanol system (2:1) in a 100 ml round bottom flask. The solvent mixture is evaporated to obtain a thin, dry film. The film is hydrated with 2 ml of PBS pH 7.4 at 4° C. with gentle shaking, during which MLVs are formed. The vesicles are allowed to anneal for 30 minutes. 100 μM of Kaempferol-Iodine127 (Kaempferol had already been mixed with iodine 127-1:1 ratio) and 100 μM chloroform mint extract is dissolved in chloroform along with cholesterol and Tween 80, and niosomes are prepared as mentioned earlier. Fulvic acid aqueous solution loading was performed by incubating Kaempferol-iodine-loaded niosomes in 1 mg/mL of fulvic acid solution for 30 minutes. Due to the hydrophilic nature of fulvic acid, it preferentially accumulates in the outer aqueous layer of the niosomes. The excess drug present in the supernatant is removed by washing with water. After preparation, the triple drug (Kaempferol-Iodine, chloroform mint extract, and fulvic acid) loaded niosome aqueous suspension was stored in the dark at 4° C. and later used for experiments.

Example 2

Preparation method: Multilamellar niosome vesicles (MLNV) are prepared as shown in FIG. 1. To prepare, tween 80, cholesterol, and diacetyl phosphate in a molar ratio of (10:10:1) are weighed and dissolved in a chloroform/methanol system (2:1) in a 100 ml round bottom flask. Kaempferol Iodine-127 (100 μM) (kaempferol had already been mixed with iodine 127-1:1 ratio) and chloroform mint extract (100 μM), Ginkgo biloba extract (100 μM), and calcium alginate (10 mM) are dissolved in chloroform along with cholesterol and tween 80. The solvent mixture is evaporated to obtain a thin, dry film. The film is hydrated with 2 ml of PBS pH 7.4 at 4° C. with gentle shaking, during which MLNVs are formed. The MLNVs are then allowed to anneal for 30 minutes. The preparation of the outer layer of the niosome, i.e., fulvic acid and sodium alginate aqueous solution is performed by incubating the prepared MLNVs (containing Kaempferol Iodine-127, calcium alginate, mint extract, and Ginkgo biloba extract) in 2 mg/ml of an aqueous solution containing fulvic acid and sodium alginate (1 mg fulvic acid+1 mg sodium alginate in 2 ml of water) for 30 minutes. The final aqueous niosome suspension containing mixtures of Kaempferol Iodine-127, mint extract, Ginkgo biloba extract, calcium alginate, sodium alginate, and fulvic acid, can be stored in the dark at 4° C.

Example 3

A woman recently diagnosed with cancer begins radiation therapy and is instructed to take an oral dose of a radioprotective drug (e.g., Herbostroiodine) before each session to reduce the harmful effects on healthy tissue. The drug helps protect against radiation-induced side effects, such as inflammation and tissue damage, allowing the therapy to focus on the cancer cells. After completing her treatment, she discontinues the drug. She experiences no side effects from the medication, and the typical radiation-related side effects are notably reduced, improving her overall comfort during therapy.

Embodiments

Embodiment 1: A multi-layer niosome nanocarrier drug composition comprising: a) an inner layer comprising an extract of mint and Kaempferol Iodine-127; and b) an outer layer comprising fulvic acid. Embodiment 2: The composition of embodiment 1, wherein the inner layer further comprises Ginkgo biloba extract. Embodiment 3: The composition of embodiment 1 or embodiment 2, wherein the inner layer further comprises calcium alginate. Embodiment 4: The composition of any one of embodiments 1-3, wherein the outer layer further comprises sodium alginate.

Embodiment 5: A multi-layer niosome nanocarrier drug composition comprising: a) an inner layer comprising an extract of mint, Kaempferol Iodine-127, Ginkgo biloba extract, and calcium alginate; and b) an outer layer comprising fulvic acid and sodium alginate.

Embodiment 6: The composition of any one of embodiments 1-5, wherein the composition comprises about 5 mg to 15 mg of the extract of mint. Embodiment 7: The composition of embodiment 6, wherein the composition comprises about 10 mg of the extract of mint.