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Національний фармацевтичний університет (Харків)
Национальный фармацевтический университет (Харьков)
61002, г. Харьков, ул. Пушкинская, 53
National University of Pharmacy (Kharkov)
Ukraine, 61002, Kharkov, 53, str. Pushkinska
Introduction. Sleep disorders is a worldwide problem. Example, every third American, each fourth Englishman has disturbed, sleep and in France sleep disturbances are observed in 1/5 of the population. During the population study it was fixed, that 10-40 % of USA adults have fleeting insomnia, and 10-15% - sleep disturbances over a long period of time. These data indicate the extent of the problem [7, 9]. Therefore, we conducted the ABC-analysis of registered in Ukraine preparations applicable for the treatment of sleep disorders. According to the results of the analysis, the most of the revenue is generated by relatively inexpensive drugs (examples, Corvalol, Barboval and Korvaldin etc.). This group also includes a homeopathic medicine - Dormikind, which brings 9.18 % of the total sales. Most homeopathic medicines used for sleep disorders are group B - this are 30% of drugs that benefit only a 15 % of profit. There are Nervoheel, Notta, Nomvio-nervin, which brought 3.46 % of profit of total sales. Homeopathic pellets of Son-norma refer to group C, the drug brings in this group only 0.35 % of profit. This suggests that homeopathic medicines to treat sleep disorders are still not known to the public and this group of effective and safe drugs is quite promising in terms of both management and the development of new drugs. Therefore we made the efforts to develop new homeopathic medicine to treat sleep disorders. After the literature search and consultations with homeopaths we selected plant material Coffea Arabica (Coffee Arabian), which is often used in homeopathy in the treatment of this disease, as an object of study.
Relationship of academic programs, plans, themes
The work was realized according to the plan of research work of the National University of Pharmacy of the problem "Creating homeopathic medicines» (№ state registration 0103U000480).
The aim of the work was justification of technology of homeopathic mother tinctures (MT) based on plant material – seeds of green Coffea Arabica.
Materials and methods
The object of study is homeopathic MT «Coffea Arabica».
The preparation of MT was carried out in accordance with the requirements of State Pharmacopoeia of Ukraine (SPU) and German Homeopathic Pharmacopoeia
The results and their discussion
In Ukraine the production of homeopathic medicines is carried out under SPU (first appearance, ext. 1 and add. 3), which contains only general articles. Since there are no monographs on individual homeopathic medicines in the SPU it is allowed to use the guidelines of Dr. Schwabe pharmacopoeia and the German Homeopathic Pharmacopoeia [2, 4, 5].
Thus, homeopathic MT «CoffeaArabica» was prepared according to the method 4a SPU 1.3 by maceration in the ratio (1:10) .
According to State Pharmacopoeia X, unless otherwise noted, fruits and seeds are crushed to a particle size up to 0.5 mm. But for each type of plant material optimal degree of milling (which will provide full speed and extraction of active ingredients) has to be found.
In order to study the degree of milling of raw material we have produced 3 samples MT «Coffea Arabica» with different particle size:
Sample 1 - green seed particle size of 0.5 mm.
Sample 2 - green seed particle size of 5.0 mm.
Sample 3 - not minced green seeds (~ 1.0 cm).
The results of study of organoleptic and physic and chemical indicators MT «Coffea Arabica» are presented in Table 1.
Physical and physical and chemical properties of samples MT «Coffea Arabica» depending on the degree of milling of raw material
Notes: n = 3, P = 95%
It was found out, that all samples MT «Coffea Arabica» are a yellow liquid with a specific smell and bitter taste of coffee. The Ethanol content in them is within 57 – 61 %, relative density and extractives content conform with the norm of indicators listed in the German Homeopathic Pharmacopoeia and Pharmacopoeia of Schwabe and do not differ significantly. Quantitative caffeine content also does not differ significantly (according to the French Pharmacopoeia – it should not be less than 0.06%). That is, the degree of milling of raw material has little influence on the yield of extractives.
For the qualitative detection of alkaloids (main group BAS, which determine the pharmacological effect) was conducted a basic sediment and color reaction. According to the research, the presence of alkaloids was found in all samples of MT «Coffea Arabica», due to the formation of characteristic product of a chemical reaction.
According to SPU 1.3, unless otherwise stated, plant raw material is mixed with calculated amount of corresponding concentration of alcohol and is kept at a temperature not exceeding 20 C for at least 5 days, then if necessary, filtered. In order to justify the time infusion of raw materials we have produced samples MT «CoffeaArabica», with the infusion time that ranged from 8 days to 5 days and we examined their physical and chemical quality indexes. The results are shown in Table 2.
Physical and chemical indexes of MT «Coffea Arabica»,
depending on the time of the infusion
Notes: n = 5, P = 95%
The result suggest, that with the infusion for 4 days there is little release of active ingredients from herbal drugs, and caffeine content in the MT is less than with the other modes of infusion. Increasing the infusion time of MT from 6 to 8 days daoes not significantly affect the physical and chemical indexes and quantitative content of caffeine.
Thus, studies make it possible to speed up the process by reducing the time of infusion of MT plant Coffea Arabica to 5 days.
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