METHOD FOR QUALITATIVE AND/OR QUANTITATIVE DETECTION OF SUBSTANCES CONTAINED IN A HEMP PLANT AND KIT FOR USE THEREIN

20220057417 ยท 2022-02-24

    Inventors

    Cpc classification

    International classification

    Abstract

    The present invention relates to a kit comprising: a) an ampoule; b) a material comprising a hemp plant or parts thereof; and c) a color indicator capable of reacting by contacting the hemp plant and/or at least a part thereof to change the color of the color indicator, wherein the material and the color indicator are disposed in the ampoule; and a method for qualitatively and/or quantitatively detecting one or more substance(s) contained in the hemp plant using the kit.

    Claims

    1. A kit, comprising: a) an ampoule; (b) a material comprising a hemp plant or parts thereof; and (c) a color indicator capable of reacting by contacting the hemp plant and/or at least a part thereof to change the color of the color indicator; wherein the material and the color indicator are arranged in the ampoule.

    2. The kit of claim 1, wherein the material comprises a cannabis flower, marijuana, hashish, hashish oil, at least one cannabinoid, or a mixture thereof.

    3. The kit according to claim 1, wherein the color indicator comprises a color-forming substance preferably selected from the group consisting of true black, true blue salt, dibromoquinone chlorimide, dichloroquinone chlorimide, vanillin, salicylaldehyde, formaldehyde, acetaldehyde, p-dimethylaminobenzaldehyde, diethylaminobenzaldehyde, ferric chloride, aminophenol, potassium ferricyanide, and a mixture of two or more thereof.

    4. The kit according to claim 1, wherein the color indicator comprises at least one solvent preferably selected from the group consisting of water and monohydric or polyhydric alcohols.

    5. The kit according to claim 3, wherein the color indicator further comprises a reagent that assists in reacting the material with the color-forming substance, wherein the reagent is preferably a basic compound, more preferably selected from the group consisting of alkali hydroxide, alkali carbonate, ammonium or alkali salts of an organic acid, and a mixture of two or more thereof.

    6. The kit according to claim 3, wherein the color indicator further comprises a carrier material, preferably an absorbent neutral carrier material.

    7. The kit according to claim 1, wherein the ampoule is a divisible ampoule consisting of two or more parts that can be joined together to form the ampoule, wherein the color indicator is disposed on at least a portion of an inner wall of one of the parts that can be joined together to form the ampoule.

    8. The kit according to claim 7, wherein the part on the inner wall of which the color indicator is at least partially arranged is a spacer disc which can be connected by screwing to one or more further parts of the divisible ampoule.

    9. The kit according to claim 1, wherein the ampoule is transparent.

    10. The kit according to claim 9, wherein the ampoule is at least partially made of borosilicate glass.

    11. The kit according to claim 1, wherein the ampoule is evacuated.

    12. A method for qualitative and/or quantitative detection of one or more substance(s) contained in the hemp plant, comprising: (a) Providing a kit according to claim 1; (b) Bringing the material or parts thereof into contact with the color indicator; and c) Detecting a change in the color of the color indicator.

    13. The method of claim 12, wherein contacting the material or portions thereof with the color indicator comprises heating the material or portions thereof in the vial.

    14. The method of claim 13, wherein the heating comprises inductive heating.

    15. The method of claim 12, wherein the detecting is performed using a color comparison scale, an optical sensor, a chemical sensor, or two or more thereof.

    16. The method according to claim 12, further comprising a step, after detection, comprising matching information obtained by the detection with data stored in a database.

    Description

    DRAWINGS

    [0053] The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.

    [0054] In the following, the invention will be described with reference to the drawings on the basis of specific embodiments. It is to be understood here that the reference to the specific embodiments serves only to illustrate the invention. The features of the specific embodiments are not necessarily limiting for the invention, but may, in particular in combination with the embodiments mentioned in the foregoing, contribute to the advantageous realization of the invention.

    [0055] FIG. 1: schematic representation of an ampoule according to one embodiment of the invention;

    [0056] FIG. 2: schematic representation of an ampoule according to a further embodiment of the invention; and

    [0057] FIG. 3: schematic representation of an ampoule according to a further embodiment of the invention.

    DETAILED DESCRIPTION

    [0058] Example embodiments will now be described more fully with reference to the accompanying drawings.

    [0059] The invention relates to a method for quality testing of pharmaceutical cannabis, in which an ampoule containing a material, such as cannabis flowers or parts thereof, can be designed in such a way that the ampoule itself, or by combining it with additional elements, ensures the appropriate tests for marketing by the pharmacist, and test certificates can be verifiably documented and issued in accordance with pharmaceutical rules.

    [0060] According to the method of the invention, it may be provided that the cannabis flowers or parts thereof are hermetically packaged immediately after harvesting and sealed in a special transparent ampoule, preferably made of borosilicate glass, in such a way that the active ingredient can only be removed by destroying the ampoule. Within the ampoule, a chemical analytical assay can be performed using various tools described herein. The results may be applied as data to appropriate bar codes or the like. Other corresponding relevant information is: e.g., cultivation, harvesting, processing, quality testing, storage, packaging, is of course also present in a tamper-proof manner. This can be achieved by burning a laser code into the surface. The data can be read out in a docking station.

    [0061] With the new method, which is described in more detail in the claims, it is possible to perform quality tests even while the plant is growing. It is conceivable that the cannabis flower in the ampoule is examined during growth.

    [0062] Chemical tests take place in or with the ampoule. The ampoule can be designed in such a way that the test elements with corresponding reagents form part of the ampoule or can be screwed onto the ampoule.

    [0063] The kit described in the claims ensures compliance with the usual requirements, in particular:

    [0064] Consistent product quality

    [0065] Substances contained

    [0066] Information on the concentration of the active substances

    [0067] Avoidance of any kind of contamination

    [0068] Traceability

    [0069] The kit according to the invention and the method according to the invention enable skilled personnel, pharmacists, physicians or clinicians to chemically detect phenol-like substances, in particular cannabinoids and materials containing such substances.

    [0070] A color-forming reagent can be added directly to the sample, for example in pretreated or untreated form, even without prior drying. This can be achieved by a multi-part ampoule 100, as shown in FIG. 1, comprising an annular adapter 110 in a screw-on manner. The annular adapter 110 includes, in its ring-filling surface, the color indicator necessary for analyzing the material 120.

    [0071] The color indicator can be used as a solution of a color-forming substance and the reagent with or without the addition of organic solvents.

    [0072] The color-forming substance is preferably presented in the form of dilute solutions of the color-forming substance in water and/or primary, secondary and tertiary alcohols with or without the addition of organic solvents such as saturated and unsaturated hydrocarbons, halogenated hydrocarbons, ethers, ketones, carboxylic acid esters and/or aromatic hydrocarbons.

    [0073] The reagent is preferably a base, such as an alkali hydroxide and/or an alkali carbonate, an ammonium or alkali salt of an organic acid or mixtures thereof, optionally substituted by one or more organic radicals, e.g. alkyl groups, and may be present in the form of a dilute solution together with the color-forming substance in water and/or primary, secondary and alcohols or mixtures thereof. Where appropriate, ammonium or alkali salts of organic acids such as acetic acid, propionic acid, butyric acid, malic acid, sorbic acid, fumaric acid, benzoic acid, phenylacetic acid, phthalic acid, naphthylacetic acid or mixtures thereof may be used.

    [0074] Surprisingly, it has been possible to develop a method in which specially selected color reactions are modified in such a way that the components relevant to the color reaction are added directly to the solvent acting as extraction agent and are used directly in the chemical detection reaction. In the ampoule 200 shown in FIG. 2, this is achieved by pressing the test material (not shown), in this case cannabis flowers, into the ampoule 200 between a first spacer ring 210 and a second spacer ring 220. In FIG. 2a, the ampoule is shown in a non-compressed state, whereas FIG. 2b shows the same ampoule in a compressed state.

    [0075] The color indicator and its color change can be evaluated with appropriate optical and chemical sensors.

    [0076] According to the aperture measurement method, it is achieved that the predominant phenol body can be made individually visible to the eye by developing a specific, clearly distinguishable color tone and can thus be directly detected in a previously unknown, simple and fast way. The fact that the procedure used takes place within the ampoule means that external influences are excluded. By refining the procedure with the aid of electronic optical sensors, it is possible to collect and store the data. Thus, an additional optimal, particularly easy to read gradation, as well as a permanent lasting storage of the resulting color tones is achieved. In this way, for the first time, it is also possible to subject fresh, untreated sample material and even fresh plants in pre-treated or untreated form directly to the examination and to analyze them for phenolic or cannabinoid components, even without prior drying, e.g. in the field. A comparison of the recorded data in the course of growth is thus possible. The method according to the invention has proved particularly useful in the detection of cannabinoids. This makes it possible for the first time to distinguish between drug and industrial hemp in young or adult, male or female plants from an age of two weeks. Furthermore, the determination of the degree of maturity of hemp plants can be carried out in a fast and simple way even directly on fresh plants. The fields of application of the method according to the invention include cannabis research and medicine, cannabis consumption (quality control) and regulatory requirements for the pharmacist, physician, etc. Furthermore, the method can be used to detect cannabis preparations in biological sample materials. By special modifications of the reagents and the procedures, new methods for selective detection of single specific cannabinoids could be found.

    [0077] Due to the simple design of the method and the reagents required for it, this method is particularly suitable for analysis packs that can be used directly on site. By means of software-supported, photometric measurement of the absorption main maxima of the developed color shades, the methods can also be used for quantitative determination of the detected phenolic bodies. Data storage and comparison possibilities extend the safety in the handling of medical cannabis.

    [0078] In the reagent solution, monohydric or polyhydric alcohols alone or as a mixture are preferably used as solvents, which on the one hand guarantee optimum extraction of the active ingredients and on the other hand also good dissolving properties for the components of the dressing board used, which are responsible for the compound, and a trouble-free color reaction. The components of the color dictator necessary for color development were designed in such a way that they only have to be added to the reagent mixture in drop quantities for the purpose of the simplest and most effective handling. By adding salts of organic acids to the reagent solution, a better readability of the developed color shades as well as an improved shelf life of the same can be achieved.

    [0079] With the appropriate storage of the color shades, a database can be created that allows the assignment of the hemp plants according to location and origin.

    [0080] The invention will be explained and illustrated with reference to the following examples, but without being limited to them.

    [0081] Examples of Color Representations: [0082] Hemp fresh plants immature drug hemp purple reddish mature blue green [0083] Mature EU industrial hemp purple reddish [0084] Thymol deep blue [0085] Cannabidiol (CBD) purple pink [0086] Tetrahydrocannabiol green blue [0087] Cannabinol (CBN) blue

    [0088] For the determination of the degree of maturity, fresh, not dried plant material is used, since drying can change the cannabinoid content (e.g. conversion of cannabidiol to THC). To distinguish industrial or drug hemp, fully formed fingering normal leaves (fresh or dried) of the plant are used rather than the inflorescences or fruiting units. By testing the normal, fingered leaves of a given young plant, at least two weeks old, its maximum achievable future cannabinoid spectrum can be determined. If the developed hues are too intense and thus difficult to read, the test should be repeated with a reduced sample size. In turn, too small sample amounts can result in pale, indistinct hues that shift into the yellow. In this case, the test should be repeated with a larger sample quantity.

    [0089] Performance of the Tests:

    [0090] A small amount of the samples is placed on a ring-shaped reagent-soaked surface 310 of a portion of the divisible ampoule 300 shown in FIG. 3. A spacer 320 containing a solution of the colorant is sealed with a spacer 330 containing a solution of the reagent with a plastic cap 340 and shaken several times within about 1 min. Within a minute, the resulting coloration of the supernatant solution can be read. The best results are visible in translucent daylight or against a bright surface. A very accurate result is of course obtained by software-controlled evaluation with the aid of a photospectrometric device.

    [0091] The features disclosed in the foregoing description and the appended claims may, separately or in combination, be subject matter for realizing aspects of the disclosure made in the independent claims in various forms thereof.

    [0092] The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.