Резюме
Гайдукова О.О. Обґрунтування технології гомеопатичної матричної настойки на основі Coffea Arabica.
Проведені фізичні та фізико-хімічні дослідження гомеопатичної матричної настойки «Coffea Arabica» дозволили обрати оптимальний ступінь подрібнення сировини та час настоювання настойки на основі рослинної сировини – свіжого насіння Кави Аравійської.
Ключові слова: гомеопатичний препарат, матрична настойка, технологія.
Резюме
Гайдукова Е.А. Обоснование технологии гомеопатической матричной настойки на основе Coffea Arabica.
Проведенные физические и физико-химические исследования гомеопатической матричной настойки «Coffea Arabica» позволили выбрать оптимальную степень измельчения сырья и время настаивания настойки на основе растительного сырья – свежих семян Кофе Аравийского.
Ключевые слова: гомеопатический препарат, матричная настойка, технология.
Summary
Gaidukova E.A. Ground of technology of homoeopathic matrix tincture on the basis of Coffea Arabica.
Conducted physical and physical and chemical researches of homoeopathic mather tincture of «Coffea Arabica» allowed to choose the optimum degree of plant raw material and time of infusing of tincture on the basis of fresh seed of Coffee Arabian.
Keywords: homoeopathic medicine, mather tincture, technology.
Рецензент: д.фарм.н., проф. Є.В. Гладух

УДК 615.015.32:001.8

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

e_gaydukova@mail.ru

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
[1, 6]. MT was assessed by general Quality Score: description, density, dry residue and alcohol content. To identify biologically active substances (BAS) we used conventional and described in the literature reagents and methods [6, 8]. For the quantitative determination of caffeine we used spectrophotometric method [3, 10]. All determination were carried out according to the relevant pharmacopoeia methods [1, 2].

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) [1].

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.

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.

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.

Conclusions

1. The influence of the degree of crushing of seeds Coffea Arabica on physical and physical chemical properties has been investigation and it has been found out that the degree of milling does not significantly affect such indicators as dry residue, relative density and quantitative content of caffeine.
2. The influence of time of infusion of seeds Coffea Arabica on physical and physical chemical indicators of MT has also been studies. It has been found out that optimal infusion time is 5 days.
3. The studies that had been made, were used to develop rational technology of homeopathic MT «Coffea Arabica».

Література

1. Державна фармакопея України / ДП “Український науковий фармакопейний центр якості лікарських засобів”. – [1-е вид.] – Харків, 2009. - Доповнення 3. – 280 с.
2. Державна Фармакопея України / ДП «Науково-експериментальний фармакопейний центр якості лікарських засобів». - [1-е вид.]. – Харків: PIPEГ, 2001. – Доповнення 1. – 2004. - 520 с.
3. Копытько Я.Ф. Стандартизация настоек гомеопатических матричных Coffea Arabica (Coffea Cruda) и Coffea Tosta / Я.Ф. Копытько // Химико-фармацевтический журнал. – 2008. – № 11. – С. 45–48.
4. Разработка проекта приказа по контролю качества гомеопатических лекарственных средств, изготовляемых в аптеках / И.А. Самылина, З.П. Костенникова, Н.С. Терешина [и др.] // Фармация. – 2009. – № 2. – С. 3–5.
5. Швабе В. Гомеопатические лекарственные средства. Руководство по описанию и приготовлению / В. Швабе; пер. с нем. под ред. В.И. Рыбака. – М.: Московское научное общество врачей-гомеопатов, 1967. – 373 с.
6. German Homeopathic Pharmacopoeia (GHP) Vols 1 and 2. – Stuttgart, Medpharm Scientific Publishers, 2006. – 1772 р.
7. Insomnia and sleep duration as mediators ofthe relationship between depression and hypertension incidence / J. E. Gangwisch, D. Malaspina, K. Posner [et al.] // Am. J. Hypertens. – 2010. – Vol. 23. – P. 62–69.
8. Kopyt’ko Ya.F. Standardization of homeopathic Coffea arabica (Coffea cruda) and Coffea tostamatrix tinctures / Ya.F. Kopyt’ko // Pharmac. Chemistry J. – 2008. – Vol. 42, Iss. 11. – Р. 647–649.
9. Obstructive sleep apnea/hypopnea and systemic hypertension / J. Duran-Cantolla, F. Aizpuru, C. Martinez-Null, F. Barbe-Illa // Sleep Med. Rev. – 2009. – Vol. 13. – P. 323–331.
10. Pharmacopee Francaise, X ed., 6 Supplement: Monographies de soushes pour preparation homeopathiques. - Paris, 1989.