The present invention relates to zeolites useful as cation exchangers for capturing GI tract (gut) and vascular and lymphatic systems toxic contaminants (toxins) and exhancing ability for such usage and other equivalent usage.
Clinoptilolite is exemplary of zeolites with exceptional cation exchange properties known for use in processes for extracting lead, arsenic, mercury, cadmium and like heavy metals in vitro or in vivo including removal of such metal contaminants from mammalian gut, blood and lymph. It has been used in dietary supplements along with beneficial vitamins and minerals. But, part of the reason for such mixing is for safety purposes to dilute the amount of zeolite dosage because of heavy metal loading of the ingested zeolite itself in its natural state and insufficient purification processing from natural mined state to use in formulations for removing heavy metal toxins. There is uncertainty in the art as to whether the toxins in clintoptilolite are released to mammalian host but the better view is that they are released; hence, the dilution practice. See references a-e below.
The present invention provides for creating purified clinoptilolite (or other target zeolites) to use alone as a dietary supplement or intermixed in a dietary supplement or converted to a molecular fragmented form, in all such instances being safe for ingestion without reliance on substantial dilution.
The purification process begins with a high quality clinoptilolite material per industry standards, but still too loaded with heavy metal cautions for human or animal usage in undiluted form. It is mixed with ethylene diamine tetra-acetic acid (EDTA), preferably in a C:EDTA mass ratio between 3:1 and 5:1 and water added in a preferred volume ratio of water to mixture of 2:1 to 10:1, boiled with refluxing for sufficient time for substantially complete solution. Then one or more strong acids, preferably hydrochloric acid (HCL) or nitric acid (HNO3), or mixture of them, are mixed into the solution in a volume of ratio mixtures to acid 10:1 to 1:1 and the combination is superheated, e.g. at 100° C. vs. 60° C. boiling temperature of the solution while maintaining refluxing control to avoid boiling over or dryness while producing a purified clinoptilolite solid in powder form. The boiled combination is cooled then filtered to remove powders above 0.2 microns of cross section dimension (diameter or equivalent diameter). The powder filtrate is tested for clear metal concentration, e.g. by inductively coupled plasma mass spectrometry (ICP-MS) and ready for usage as is for ingestion or for conversion as described next.
According to a second aspect of the invention the purified clinoptilolite solution described above is mixed with one or more strong acids (e.g. a solution for acid ratio of 10:1 to 1:1) reflux boiled or described above, typically at 100° c. for one hour, then cooled and neutralized by gradually adding a base (e.g. sodium hydroxide, NaOH) and stirring to create a suspension form of 4-7 pH and is tested. At this point there are solid and liquid phases including fragmented clinoptilolite fragments of a large range separated out by filtering to capture larger fragments while swollen molecular fragments remain dissolved in the liquid phase ranging from 200 to 2000 Daltons. These molecular fragments can be converted to liposome preparation methods including steps of dispersion and addition of liquid agents (e.g. phospholipids) optimally complemented with lecithin, glycerol, cholesterol and/or ethanol, and water. Also glutathione EDTA, flavonoids, alkaloids, terpenes, n-acetyl cysteine and zinc-lipoate to form molecular clinoptilolite liposome with or without additional active ingredients. The purified clinoptilolite solution from above may also be treated with NaOH instead of HCl (at a ratio of 1:1 to 1:8 NaOH to clinoptilolite). The solution is allowed to reflux under heat for a minimum of 30 minutes. Next, the solution is cooled to room temperature and neutralized with HCl to a pH of 4-7.
The resultant products of initially purified clinoptilolite as per the first aspect described above or as the molecular clinoptilolite liposomes exhibit substantial reduced burdens of heavy metals compared to the prior art clinoptilolite material and are usable for ingestion without heavy dilation and can more effectively reduce the heavy metals of mammalian gut, vascular or lymph systems and ultimately reaching tissue cells for extracating toxins and elimination in urine, thereby improving state of the art of cleansing heavy metals.
The present invention includes the above summarized processes toxins, including but not limited to, and resultant products made therefrom. It can be applied to zeolites other than clinoptilolite. Acids and liposome agents cited above can be substituted using the insights of the present invention.
Other object features and advantages of the present invention will be apparent to persons skilled in the art from the above and from the following description of embodiments of the process and product described in the following detailed description and accompanying drawings, in which:
Preparation of purified Clinoptilolite—Clinoptilolite is an exceptional cation exchanger and in its natural state inherently traps a number of cation heavy metals including: Lead (Pb), Arsenic (As), Mercury (Hg), Cadmium (Cd). Therefore, its use as a dietary supplement ingredient is restricted because the naturally occurring heavy metals can affect safety and regulatory limits. Most dietary supplements use reduced clinoptilolite concentrations in formulas. Thus, effectively diluting the benefit of clinoptilolite on order to dilute the heavy metals down to safe limits. The following process successfully reduces the heavy metal burden of the clinoptilolite material simultaneously improving its safety and effectiveness for use in formulas.
Procedure for Fragmenting clinoptilolite into molecular pieces—Clinoptilolite fragments molecular weights produced during this process will range from 200 Daltons to over 2000 Daltons. The results of the fragmentation produce a broad range of clinoptilolite molecular sizes. The purpose these varying sizes allows for a number of unique uses and efficacies. The larger fragments remain insoluble but offer the greatest effective binding capacities for a wide variety of toxins including heavy metals, mycotoxins, xenotoxins and others. Physiologically they will remain in the gastrointestinal tract when ingested as a dietary supplement. The medium and small fragments are soluble making them more suitable for incorporation into liposomes. Liposomes provide an efficient delivery system into the blood stream or lymphatic system.
Benefits of the Molecular Liposomal Clinoptilolite
Molecular liposomal clinoptilolite provides two unique and powerful benefits over other zeolites on the market. First, zeolite (clinoptilolite) has a long pedigree of use as a gastrointestinal toxin binding (ion exchange) agent. Although, clinoptilolites naturally contain over 20 parts per million heavy metals including (lead, arsenic, mercury, cadmium), prevailing assumptions assert that these heavy metals do not release from the clinoptilolite into the body when ingested. Lack of rigorous studies proving this assumption warrants precaution against zeolites in fact contributing to human heavy metal burdens when ingested. To get around this issue some formulations dilute dramatically the clinoptilolite thus also reducing its efficacy. The presently described product contains the first clinoptilolite to be cleaned of heavy metal contaminants, unlike all other products on the market, this present zeolite contributes less than 2 parts per million (ppm) heavy metals. Therefore, this clinoptilolite product can be used at higher more effective concentrations needed to bind heavy metals. Additionally, this clinoptilolite no longer exceeds regulatory and safety limits when used at effective levels.
Preparing the liposomal molecules using the cleaned clinoptilolite provides a novel mechanism of delivering clinoptilolite via vascular paths to bodily tissues and to the lymphatic system. This is the first formulation of its kind employing liposomes which contain cleaned molecular clipotilolite fragments. The benefit of this formulation is the liposome delivering the molecular fragments deeper into the tissues not just the gastrointestinal tract. Also, these particular fragments are larger (2000 Daltons) than other products which keeps the cage structure more intact. Below the β-cage is 1300 Dalton therefore this molecular process keeps the integrity of the cage. Because the cage is the central feature facilitating the binding (ion exchange) capacity of clinoptilolite.
A practical formal for use of this mechanism includes a dietary supplement of clintoptilolite with a serving size of 0.5-1.0 milli-liter with 2.5 mg. clinoptilolite, 25 mg. phosphatidylcholine and 0.5 mg. of toluates and also water, glycerin, ethanol and EDTA, taken orally 2 or 3 times daily.
Various uses and further exposition of the present invention are shown in the slide set of Appendix A hereto, the content of which is incorporated herein.
This application is a Continuation of U.S. patent application Ser. No. 17/067,330, filed on Oct. 9, 2020, which claims the benefit and priority to Continuation in Part of International Application PCT/US2019/027262, filed Apr. 12, 2019, which claims the benefit and priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62/656,554, filed on Apr. 12, 2018, entitled, “PURIFICATION OF CLINOPTILOLITE.” The entire contents of these patent applications are hereby incorporated by reference herein.
Number | Date | Country | |
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62656554 | Apr 2018 | US |
Number | Date | Country | |
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Parent | 17067330 | Oct 2020 | US |
Child | 18135286 | US |
Number | Date | Country | |
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Parent | PCT/US2019/027262 | Apr 2019 | US |
Child | 17067330 | US |