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1. CA2423738 - METHOD OF PRODUCING A PREPARATION CONTAINING ACTIVE SUBSTANCES FROM CANNABIS

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[ EN ]
Method of Producing a Preparation Containing Active Substances from
Cannabis
This invention relates to a preparation containing active ingredients from the cannabinoid class of active substances. In particular it relates to the s production of a milk which contains cannabinoid active substances and to products obtained from this milk. The method comprises essentially natural biological processes, a product being obtained which has been subjected to neither chemical processes nor extraction processes with solvents.
Products obtained from hemp species, such as resin or dried leaves, to blossoms and buds, have been used for centuries as remedies, as preparations for culls and rituals in Asian cultures, as medicines and as narcotic drugs. The most important hemp variety is cannabis sativa, which occurs primarily in North and South America. In addition there are also Asian hemp varieties such as cannabis indica or cannabis ruderalis. Known as the is main active substance is tetrahydrocannabinol (THC). This substance is used as the active ingredient in numerous pharmaceutical products. The active substance is reported to have neither clearly narcotizing nor clearly stimulating effects. THC is reported to have an effect on the serotonin level, whereby nervous conditions are relaxed. THC is also said to stimulate certain cerebral ao functions and possess hallucinogenic properties. THC is reported to be massively stored in the body and thus be able to be shown to exist in the body as a metabolic product even a long time after ingestion. In Chinese medicine the hemp active substance has been used to treat rheumatism, malaria and constipation. Hemp has also been documented in India, already hundreds of zs years ago, as a remedy and drug, use for psychosomatic diseases being in the foreground.
There are pharmaceutical preparations which contain extracts from cannabis also in patent literature. For example, described in the German patent DE 4403157A1, or the parallel British patent GB 2274588A, is a pain3o relieving preparation for topical application on the skin containing, among other things, an extract of cannabis sativa (see example 7). The active substances are obtained from the plants by means of extraction. Described in the German patent DE 19757921 A1 is a preparation for activating hair growth in which dried plant parts of cannabis sativa are used.
There are numerous areas of application in which pharmaceutical compounds containing cannabis can be used: glaucoma, diseases connected with lack of appetite, nausea, and nausea during chemotherapy, stress, migraines, depression, asthma, epilepsy, spasms. A further possible application is the use as a detoxicant for persons contaminated by certain poisons released into the environment.
The application possibilities for products of this kind are manifold, io aside from the generation of a state of intoxication. In addition to the use of plant components, resin and plant extracts of cannabis are used. Cannabis is also smoked. Optimally well tolerated forms of administration are in demand, on the one hand in order to exploit a wide range of active ingredients, and,
the other hand, to avoid a harmful form of administration. is It is the object of the present invention to provide a form of administration of cannabinoid active substances which is of natural origin and which is innocuous for the consumers or patients. Furthermore the product should be able to be largely produced on farms.
It has been found that milk from cows fed at least partially with hemp 2o plants contains cannabinoid active substances and therefore such milk, or products thereof, represents a form of administration of cannabinoid active substances which does not put too much strain on the patient.
The subject matter of the present invention is thus a method of producing milk and milk products which have a content of cannabinoid active is substances and which are particularly suitable as a base for natural medicines, whereby milk cows are fed feed containing at least in part hemp plants or parts thereof, and the milk is obtained and further processed into a storable milk product through at least one technical processing step.
According to one embodiment of the invention, the technical processing step is selected from among the following processing steps: lyophilization, drying according to the spray process, horizontal belt drying and fluidized bed drying. A wholly dehydrated milk is thereby obtained with a s content of cannabinoid substances.
According to another embodiment of the invention, the milk obtained is further processed into a storable milk through a thermal treatment, such as pasteurization.
According to another embodiment of the invention, hemp plants or ~o hemp plant parts, in particular hemp blossoms of pistillate hemp plants, are used as feed admixture which have been subjected before their use to an ensilage to make them storable.
According to still another embodiment of the invention, the cows are fed with a mixed fodder or concentrated fodder, which, with hemp of good is quality, contains 0.5 to 3 % by weight of hemp components, while, with lesser quality hemp, it can have a content of 3 to 8% by weight.
According to a further embodiment of the invention, a milk is obtained containing a content of 0.1 - 5 mg/l, as a rule 0.5 - 1 mg/l, of t1-9tetrahydrocannabinol. zo According to a further embodiment of the invention, the milk obtained is processed into yoghurt or cheese.
According to a further embodiment of the invention, a storable milk product is used, which has been obtained according to the method of the present invention, for producing a pharmaceutical product having a content of zs cannabinoid active substances. For this purpose, methods are used Which are common in production of natural medicines.
In the method according to the present invention, cows are fed with feed containing at least in part hemp plants or parts thereof. The hemp material is preferably material containing blossoms from the upper part of the plant. The harvest can be carried out with the same devices as for the corn harvest. Through the ensilage a material is obtained which has a better stability under storage conditions than dried hemp blossom material. The rest s of the feed can be silage fodder, dry fodder or fresh fodder. Preferably the feed is mixed by a TMR mixer in order to obtain a feed mixture having as uniform a content of the different components as possible. A milk is thereby obtained containing biologically active substances from hemp plants. The milk can be used as raw material for further processed medicinal products, stable under
Io storage conditions, in particular natural medicines. An interesting product, for example, is wholly dehydrated milk with an active substance content. The d-9tetrahydrocannabinol content can vary in the range of 0.15 mg/I to 1 mg/l, and can be increased to 5 mgl under optimal conditions. The milk obtained can also contain other active substances which are not explicitly mentioned here.
Is The powdered milk obtained in this way can as such be made available as a pharmaceutical product. However, it is likewise possible and sensible to use wholly dehydrated milk of this kind with other active ingredients as components of pharmaceutical products if this makes sense from a therapeutic standpoint.
It has been noted that cows which have been fed at least in part with zo cannabis plants or parts thereof in the form of fresh fodder, dry fodder or silage fodder feel absolutely comfortable, and the cows deliver a milk with an active substance content. The milk thus obtained can be further processed into milk products, such as ultra high temperature treated (UHT) milk, yoghurt or also cheese, having an active substance content as far as the products obtained are zs within the framework of the law of the country of production or respectively of consumption. A product stable under storage conditions is wholly dehydrated milk which is obtained by freeze drying milk. Also coming into question as processing methods, besides lyophilization, are: drying according to the spray process, horizontal belt drying and fluidized bed drying. A powdered milk of 3o this kind with an active substance content is an ideal raw material for the production of pharmaceutical compounds for various medical conditions corresponding to the above general information.
It is expressly stated that the products obtained according to the present invention are intended exclusively for the use permitted by law.
The invention will be explained in the following with reference to an example, whereby this example should not represent any limitation.
Example:
A cow with a medium milk production was fed over a time period of two weeks with a daily feed amount of 14 kg·day, divided up into two rations,
g of hemp blossoms having been added to each ration. The hemp blossoms used consisted of the upper part of pistillate hemp plants which were harvested ~o in a way analogous to corn. The material was processed by a corn chaff cutter and underwent an ensilage. The rest of the fodder was normal cattle feed (Total Mix Ratio, TMR) as is provided in agriculture to cows for milk production.
The portion of 0-9-tetrahydrocannabinol active substance in the milk obtained one week after beginning of the said feed plan was 0.15 mg/l and 0.63 mgl. is The measurements were carried out in an accredited laboratory (Swiss testing
STS 017, EN 45001, GMP)
In a trial 20 kilograms of the milk obtained was freeze dried and processed into powdered milk. Here, too, it was noted by a group of test persons that the powdered milk obtained had a cannabinoid effect.