DE3720232A1 - Process for the preparation of an extract from aloe leaves of the species Aloe capensis or Aloe arborescens - Google Patents

Abstract

The process is to be designed such that biologically active substances which respond to those acceptors in the central nervous system which are responsible for mobilisation of the immune system are formed. In order to achieve this, aloe leaves from plants of the said species which are at least 6 years old are cut off, covered with hot water, finely comminuted and immediately thereafter stored at temperatures between 2@C and 4@C, simultaneously in the dark, for 14 days. The juice from the leaves is then extracted and stored for 14 days under the same conditions as the finely comminuted aloe leaves were previously, after which the extracted juice is diluted to homeopathic strength D2. During the course of this process, the biogenic stimulators are refined to a high molecular state in which their mechanism of action corresponds to the biogenic receptors of the central nervous system.

Description

The invention relates to a method for producing a Extract from aloe leaves of the genus Aloe capensis or Aloe arborescens, in which the aloe leaves at low Store in temperatures or in the dark for at least 12 days be a biochemical remodeling in the tissues of the Leaves are introduced to form biogenic stimulators and the juice of the leaves is then extracted.

The invention further relates to the use of the after Aloe extract prepared according to the method of the invention, prepared as a solution for injection to mobilize the Immune system using s. c. Injection or intramascular  Injection, and prepared as an emulsion according to the later listed approaches for external use on hand to mobilize the immune system.

After the school of Prof. Filatow (cf. reports by Eastern Europe Institute at the Free University of Berlin, edited by Prof. Dr. Max Brandt, Episode 18/1, Ed. 1960) is aloin as a stimulant and especially tissue therapy known for the fresh juice from aloe leaves is used for wound healing.

If aloe leaves or aloe extract for about 12 days stored at a low temperature or in the dark, biogenic stimulators are formed, which according to Filatow in the sense an unspecific stimulus therapy used for tissue therapy will.

This tissue therapy in the sense of a non-specific stimulus therapy makes use of certain active substances unexplained Nature, which is found in plant and animal tissues Develop preservation in cold or dark.

The invention has for its object a method of type mentioned so that an aloe extract can be produced in the biologically active ingredients  are included, those acceptors in the central nervous system to appeal for the mobilization of the Immune system are responsible.

In addition to the new ones not listed in Hager's manual Indications of the aloe extract produced according to the invention regarding the healing of epilepsy and breast cancer, which can be demonstrated by corresponding disease history reports is the indication for changing the leukocyte picture claimed in the blood. The leukocytes, white blood cells (Nucleated, round bodies, larger than that red blood cells), are important elements for effective Defense against infections. You are responsible for that Clearing away and "eating" of destroyed tissue components (Pus and bacteria. The leukocytes are divided into granulocytes and lymphocytes, the Lymphocytes are carriers of the immune system.

After applying 9-15 injections of the invention prepared extract of biostimulated aloe capensis (D 2) has the leukocyte count in the blood in patients increased from 1800 to 4400 on average.

The extract produced according to the invention is thus made of Fresh plant aloe biostimulated - a basic immune defense  with the largest spectrum, while the only material orientated previous aloe preparations only the Fulfill indication requirements, from Hager's manual are known.

According to the invention, this object is achieved by the method steps according to the characterizing part of patent claim 1.

The storage temperature is advantageously 2 ° C. chosen.

It should be emphasized that the HAB regulations only apply to such Drugs apply, their quality and identity according to European pharmacopoeia can be determined. That with with aloe with regard to fresh drugs so far after the Literature and the state of the art not possible. Much more are only test criteria for dry drugs of aloe in HAB contain. But according to HAB can identity and quality can not be determined, uses it due to the lack of this Prerequisite is also the regulation on manufacture of medicinal products according to the HAB not.

The invention therefore had to have its own monograph for Identifying the identity and quality of the fresh drug produce.  

Sample preparation for liquid chromatographic determination from Aloin in Aloe D2 1. Preparation of the sample solution

The enrichment of the aloin is carried out with the help of a CH (cyclohexyl) Column (Analytical International, Best. No. 610 101).

For conditioning, first use 2 ml of methanol (Baker Chemicals, Order No. 8402) and subsequently 2 ml of water (Baker Chemicals, Order No. 4218) rinsed.

Then exactly 25 ml of Aloe D2 are passed through the column given. After the aqueous phase has seeped in, is eluted with 10 ml of methanol. To be even To reach the flow rate of the solvent light water jet vacuum can be applied. The eluate is concentrated to <1 ml on a rotary evaporator and completely transferred to a 1 ml volumetric flask which is up to is filled to the mark with H₂O.

2. Preparation of the calibration solution

12.8 mg aloin (standard from Roth, order no. 2-4568) are transferred to 100 ml volumetric flasks up to the mark  is filled with water. Then the enrichment process - as described above.

In-process control

• a) Properties:
  Clear, colorless liquid
• PH value:
  The pH value is measured potentiometrically using a combination electrode according to Ph.Fur.I.
  Limit: 7.2-7.4
• c) Removable volume:
  The removable volume is checked according to the monograph Paren Heralia Ph. Fur.III.
  Limit: 1.05-1.10 ml for 1 ml glass ampoules.
• d) Amount of melting:
  The melting height is determined with a caliper.
  Limit: 47 ± 2 mm for 1 ml glass ampoules.

1. Development of a method for determining the pharmaceutical grade

It was aimed at, both identity and content to standardize using a method. The pharmaceutical quality of aqueous aloe preparations  is checked by determining the anthraquinone pattern, the content is given as aloin, a 1,8-dihydroxyanthraquinone, in mg aloin per 1000 ml more liquid Preparation.

Such a determination is usually carried out using an HPLC method carried out.

1.1 On the development of the process 1.1.1 Compilation of the device configuration

The process development begins with the compilation the appropriate device configuration and in the selection of the eluent that ensures optimal separation. Experience has shown that a mixture of Acetonitrile and 1-hexanesulfonic acid (PIC B-6 reagent, Waters Associates) gives the best results.

To get all relevant anthraquinone derivatives in a reasonable To be able to elute the period was a gradient HPLC method chosen because of an isocratic course Signals with a high retention time are no longer sufficient Accuracy can be integrated.

The Kontrosorb 10C18 column (250 × 4 mm) was used as the HPLC separation column. selected.  

A spectrophotometer with a Standard wavelength of 254 nm as completely sufficient proven; but has a measurement of the UV maxima of aloin shown that the detection optionally at 295 nm or can also be done at 365 nm.

1.1.2. Process optimization

The use of solvent mixtures has proven to be suitable A: Acetonitrile-PIC B-6 (10:90) and B: Acetonitrile-PIC B-6 (90: 10). The gradient curve is linear from 0% B to 40% B within 35 min.

The aloin peak was identified by first three Samples of the aqueous extract were injected to which different amounts of aloin were added. The Aloin peak eluted at an average retention time of 28 min.

1.2. Preparation of the calibration solution

The aloin content was determined quantitatively according to the method of the external standard. This was initially after some preliminary attempts to estimate the approximate Aloin content prepared a calibration solution: 5.85 mg aloin are in a 100 ml volumetric flask with water (Baker Analyzed HPLC Reagent) and then 10 min. treated in an ultrasonic bath. (See chromatogram Attachment 1).  

1.3. Carrying out the measurement

System: HPLC pumps Waters 501 Column: Kontrosorb 10C18, 250 × 4 mm contron Analytics) Mobile solvent A: acetonitrile (Merck LiChrosolv) / PICB-6 (Waters Associates) 10:90 Mobile phase B: acetonitrile / PIC B-6 90: 10 Degree. Course: from 0% B to 40% B in 35 min. (linear increase) Injection quantity: 20 microliters Flow: 1.0 ml / min. Detection: Uvikon 740 LC spectrophotometer (Kontron Analytics)

1.4. Sample preparation

The samples of the two aqueous preparations could not Ultrafiltration can be injected directly.

2. Test results 2.1. Aqueous aloe extract (see Appendix 2)

The aloin content of the aqueous aloe extract is 33.8 mg / 1000 ml.

2.2. Aqueous buffered mother tincture (see Appendix 2)

The aloin content of the buffered mother tincture is 86.5 mg / 1000 ml.  

Spectra were created (see Annexes 3 to 5) that Show the biogenic stimulators for the first time:

Sheets were used for the production of the starting substances cut from a single Aloe arborescens (Aloe capensis). 100 g were immediately pressed out, centrifuged and washed and measured, 100 g were 14 days accordingly biostimulated the method according to the invention, pressed out, centrifuged and measured and washed. The following changes can be seen:

Aloe arborescens (capensis) without biostimulation (Appendix 3)

• 1. Derivation: (Appendix 4)
  Peak formed normally at 250 nm (2)
  at 225 nm (1) hump, ie superimposition of 2 peaks lying close together
• 2. Derivation of Aloe arborescens biostimulated (capensis):
  Peak widespread at 250 nm (2) (also superimposed)
  peak formed at 225 nm (1), ie separation of the peaks close to each other
• 3. Instructions: (Appendix 5)
  Biostimulated formation of a small new peak at 225 nm (1) and formation of a hump at 250 nm (2). The formation of a new substance is thus shown.

Also in the visual range from 400 nm are on Appendix 5 Recognize changes (3 + 4).  

According to the invention, the extract produced acts on the functional state of the information flow system of the central nervous system using s. c. Injection or intramuscular injection used.

About the action of the applied according to the invention Aloe extract on functional changes The state of the central nervous system is in the measure of a broadband effect the regeneration and strengthening of the body's own Defenses - strengthening the immune system e.g. B. against AIDS given. The broad spectrum effect of the aloe extract makes this can be successfully used against a variety of diseases.

The chosen plants must be at least 6 years old, so that the vegetable tissue is developed enough to a refinement in the processes according to the invention of biogenic stimulators in plant tissues in high molecular weight Enable state in which its mechanism of action the biogenic receptors of the central nervous system corresponds. Are aloe extracts of younger plants of the named Applied in which the refinement of the biogenic stimulators could not take place, so is only an inducement of some receptors can be seen, but not a broad spectrum in the central nervous system, so that in the Apply a strong burning sensation in the tissues for 3 minutes the living being occurs. When applying the invention  This aloe extract does not cause this burning sensation on.

The nature of the biogenic stimulators in the invention Aloe extract produced corresponds comparatively to one Hormone, but is of enzymatic action, Hormones are destroyed when heated, the biogenic stimulators on the other hand remain with great heating, with conversion of the substance from liquid to solid and vice versa completely effectively preserved. The refined biogenic stimulators are related to the brain enzyme system. This is due to the action of the refined biogenic Stimulators activated. If through acceptors the acceptors cause a biochemical remodeling in the central nervous system, so the same biochemical remodeling occurs in those of the host organ separate and in unfavorable conditions, but not allowed to kill, put tissues, the new biological active connections, new life regulators. Hormones these are not because hormones are among the currently possible Measurement conditions are destroyed. There are other subtle ones biologically active substances. You come closest the class of heteroglycans, namely those heteroglycans, which can be called DESMONE. But the more refined biogenic stimulators are more intense because they are at the homeopathic dilution level D 2 is particularly active.  

When using the aloe extract produced according to the invention z. B. found that in 27 patients, for general stimulation 20-50 injections of aloe have received some changes in blood were. In 9 patients the titer, the anti-A and anti-B aggiutinins increased.

It was also found that after application aloe extract with the refined biogenic stimulators almost half of the patients had irregular antibodies, which donor erythrocytes of all blood groups aggiutinize could.

Irregular antibodies are immune antibodies according to Pschyrembel. The struggle of the body's immune system supports on antibodies. With the introduction of the invention manufactured aloe extract in pharmacy and medicine it is possible for the first time through the refined biogenic A stimulator in the aloe extract is available to pose that antibody formation and thus the immune system strengthens.

By injecting refined biostimulated aloe extract the intrarenal blood circulation as well as the Excretion function of the kidneys significantly stimulated. The  Blood flow to the kidney is activated, the speed glomerulofiltration increases. It also follows an improvement in nitrogen excretion function. The influence of the refined biogenic is also favorable Active substances on the kidney capsule tissue.

To assess the effect of the manufactured according to the invention Aloe extract on the functional condition of the central nervous system the conditional reflex method is used. It can be seen that the use of the invention by delaying the latent period of the reflective Reactions, increase in reflex duration, decrease in altitude which causes conditioned reflexes to their complete failure. From an intensification of the inhibition process in CNS can be spoken.

An important role of the central nervous system in the Mechanisms of action of the aloe preparations testify to the observations of pharmacodynamic changes in aloe preparations when the functional CNS state changes.

For clarifying the mechanism of action of the invention Aloe extract produced is the study of Activity of the brain enzyme system of particular importance.  

Under the influence of the aloe extract, the Animals an increase in the activity of some oxidation enzymes such as Cytochrome oxidase, dehydease, succinate hydroginase, glycerophosphate dehydrogenase, Glutamate dehydrogenase, succinic oxidase to be watched.

The emulsion is for external use only and will applied to the skin like an ointment or balm.

According to the invention, six subsequent approaches were one Aloe emulsion successfully tested:

Aloe emulsion 1. Approach

approx. 40 ml aloe in H₂O2 g aloe to 75 ml H₂O 5 ml castor oil
5 g cetyl alcohol
1 g beeswax
a spatula tip of borax
0.1 ml eucalyptus oil

2. Approach

75 ml aloe solution 1.5 g aloe in 75 ml H₂O 10 ml castor oil
10 ml cetyl alcohol
5 g beeswax
approx. 0.1 ml eucalyptus oil

3rd and 4th approach

75 ml aloe solution 1 g aloe in 75 ml H₂O 10 ml castor oil
10 ml cetyl alcohol
approx. 5 g lanalin
approx. 0.1 ml lemon or rose oil
0.5 ml almond oil

5. Approach

75 ml aloe solution 1 g aloe in 75 ml H₂O 10 ml castor oil
2 ml cetyl alcohol
5 g beeswax
2 g treetherpolamine
1 g almond oil
0.1 ml of lemon oil

6. Approach

69.9% by weight of a ratio of 1 part of aloe extract and 9 parts of purified water
prepared solution 15.0% by weight castor oil 15.0% by weight cetyl alcohol 0.1% by weight eucalyptus oil

Claims (4)

1. A method for producing an extract from aloe leaves of the plant genus Aloe capensis or Aloe arborescens, in which the aloe leaves are kept at low temperatures or in the dark for at least 12 days, with a biochemical modification in the tissues of the leaves with the formation of biogenic stimulators is initiated and the juice of the leaves is then extracted, characterized by the following process steps:

• a) 10 g of fresh aloe leaves, freshly cut from the trunk of plants of at least 6 years of the type mentioned and briefly immersed in hot water after being cut off, the plants not being allowed to be watered for 5 days before cutting off the leaves, are ground together with 20 g of an ascorbate phosphate buffer solution, which is prepared according to the instructions in the HAB 1, 4 addendum (1/10 batch), in a mortar to a pulp, whereupon the dry loss of the fresh aloe is determined at 97% and related to this a total of 38.8 g of the previously prepared buffer solution - calculated according to the formula given in HAB 32 - are added to the batch, the amount already added being subtracted from the calculated batch, which batch is immediately thereafter at temperatures between 2 ° C. and 4 ° C. Stored for 14 days in the dark,
• b) the macerate is then 60 min. allowed to stand at room temperature, pressed, filtered and the extracted juice kept at temperatures between 2 ° C. and 4 ° C. and simultaneous darkness for 14 days, and
• c) The mother tincture obtained in this way from biostimulated aloe is diluted with 19 parts of buffer solution, giving the potency D2.

2. The method according to claim 1, characterized in that 2 ° C is selected as the storage temperature.   3. Use of the method according to claim 1 and 2 prepared extract, prepared as a solution for injection to mobilize the immune system using s. c. injection or intramuscular injection. 4. Use of the method according to claim 1 and 2 prepared extract, processed as an emulsion each of the approaches given in the description for external application to mobilize the hand Immune system.