Резюме
Зубченко Т.М. Вивчення стабільності сиропу гепатопротекторної дії при зберіганні в різних видах упаковки.
Проведено вивчення фізико-хімічних властивостей сиропу на основі сумарного екстракту плодів розторопші плямистої при зберіганні в різних видах упаковки при температурі +(8÷15)°С ,+(15÷25)°С. Встановлено термін придатності сиропу при зберіганні у контейнерах зі скла та пластику при температурі від 8°С до 25°С  2 роки.
Ключові слова: сироп, силібінін, біологічно-активні сполуки, стабільність, термін придатності.
Резюме
Зубченко Т.Н. Изучение стабильности сиропа гепатопротекторного действия при хранении в разных видах упаковки.
Проведено изучение физико-химических свойств сиропа на основе суммарного экстракта плодов расторопши пятнистой при хранении в разных видах упаковки при температуре +(8÷15)°С ,+(15÷25)°С. Установлено срок годности при хранении в контейнерах из стекла и пластика при температуре от 8°С до 25°С  2 года.
Ключевые слова: сироп, силибинин, биологически-активные соединения, стабильность, срок годности.
Summary
Zubchenko T.N. Study of stability of syrup with hepatoprotective action during storage in different types of packaging.
Study of the physicochemical properties of the syrup from the total extract of Milk Thistle during storage in different types of packaging for temperature + (8÷15) ° C: + (15÷25) ° C. A shelf life of syrup during storage in containers made of glass and plastic at a temperature between 8 ° C to 25 ° C for 2 years was established
Key words: syrup, silibinin, biologically active compounds, stability and shelf life.
Рецензент: д.фарм.н., проф. П.Д. Пашнєв

УДК 615.244:615.322.015/.016:665.333.7

Національний фармацевтичний університет (Харків)

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

tatyko72@gmail.com

Introduction. Hepatoprotectors currently make up 10% of the total number of drugs prescribed by doctors physicians [1-3]. The modern hepatoprotectors include: herbal; medications with contain of essential phospholipids; drugs, which include amino acids; synthetic drugs, drugs containing bile acids, drugs of animal origin. However, the largest group (about 55 %) of herbal hepatoprotectors. It is not surprising, since the use of herbal medicines in medical practice has undeniable advantages [4-9]. They combine a wide therapeutic effect and relative harmlessness, browse for chronic diseases, which afflict about 40 % of the population, providing a natural "soft" effect due to the presence of biologically active substances - biogenic amines and carbohydrates, bioflavonoids, terpenoids, vitamins, trace elements, which provide antioxidant and immune-stimulating effect; the presence of a large range allows to individualize therapy; have much profile pharmacodynamics (provide antiseptic, antiinflammatory, antispasmodic, antioxidant effect) [4-7, 9], affecting several parts of the pathogenesis of the disease, can be used in pediatrics and geriatrics; non-toxic and well tolerated by patients; have favorable pharmacoeconomic characteristics (ratio of the cost of treatment to its efficiency, etc.) [6].

Milk Thistle - Silybum mananum (L.) Gaerth., Seven. Astrov - Asteraceae, as a medicinal plant used in traditional medicine for the treatment of liver disease and normalize digestion.

Milk Thistle is extremely valuable medicinal plant and its products are used in medicine, about 2000 years [3, 8, 9]. The ancient Greek physician Theophrastus, Dioscorides were the first who to described Milk Thistle as a universal medicine, and started  treatment of liver diseases [10]. The basis of the practical use of Milk Thistle in modern medicine died Haller’s studies [6, 11-18]. Under the guidance of Richard Wagner in the University of Munich in 1958 began an intensive study of the chemical composition of Milk Thistle. Identification of active compounds, the pharmacological properties of special interest to the Thistle. Thanks a whole series of works of foreign researchers, German scientists [3], this amazing plant was open to the world. Preparations based on it are used for treat ment of various liver diseases.

Today we have a situation where Milk Thistle is one of the most popular medicinal plants and continues to be the center of attention as a source of hepatoprotective agents. The methodological framework for the development of drugs based on the fruits of Milk Thistle.

According to the results of previous studies structure and technology, physical and chemical properties of the syrup from the total extract of Milk Thistle has been studied [3-6].

Relationship of academic programs, plans, themes.

This work is performed in accordance with the plan of research of the National University of Pharmacy ("Creating a composition and technology of biologically active substances and drugs of natural origin» (№ state registration 0103U000477) and the Problem Commission "Pharmacy" Ministry of Health and Academy of Medical Sciences of Ukraine.

Purpose. The study of stability of syrup with hepatoprotective action at temperature + (8 ÷ 15) ° C: + (15 ÷ 25) ° C in different types of packaging.

Materials and methods

Study stability of the syrup methods of physical and chemical tests in accordance with have been used Pharmacopeia of Ukraine [3] for general acceptable methods: description (Section 2.2.1., 2.2.2.), pH (p . 2.2.3.), refractive index (Section 2.2.6.), content of propylene glycol, quantitative amounts of flavolignanon compounds, microbiological purity. During complex research were instruments used: type spectrophotometers - SF-46 electronic weights company «Metler Toledo» and others.

Results and their discussion

To install the shelf-life of the drug with hepatoprotective action in the form of syrup watched his prototypes for 27 months. storing in bottles of dark glass and plastic containers at two temperatures (8 ¸ 150S, 250S ¸ 15).

To assess the quality of the drug, which were kept at different temperatures in different types of packaging evaluated appearance, defined refractive index, propylene glycol content, identifying bioactive compounds, content amount of flavolignan compounds, microbiological purity and so on.

Determination was performed for freshly produced batches and during storage at different temperatures table. 1, 2.

To confirm the presence of major natural polyphenolic compounds assess the quality of the samples was carried out by reaction of syrup identify the presence of biologically active substances - flavonoids and their difference from flavones by reaction with zinc dust in acid medium and the reaction of magnesium in acidic medium. The positive results of the observation of color reactions and by thin-layer chromatography confirmed the presence of biologically active compounds, the main flavolignan (silybin, sylidianinu, sylikrystinu, taksyfolinu) in the dosage form during storage.

Quantitative determination of compounds flavolignan in syrup, standardized by the sum flavolignan method developed on basis of the method described in the German Pharmacopoeia 10 species. The silybin standard was used as standard.

When storing samples syrup viscous yellow liquid, sweet taste with a specific smell did not change its appearance, the value of other parameters are given in table 1, 2.

According to the obtained data revealed that syrup from the total extract of Milk Thistle during storage in terms of microbial contamination meets SPU.
So the indicators of quality in the quality control methods (QCM)  ensure stability of the product during storage and transport temperature: + (8 ÷ 25) ° C in containers made of glass and plastic. Expiration date is set for 2 years.

Conclusions

1. The influence of storage conditions on the shelf life of syrup hepatoprotective action was studied

2. A shelf life of syrup during storage in containers made of glass and plastic at a temperature between 8 ° C to 25 ° C for 2 years was established.

Література

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3. Зубченко Т.М. Вивчення можливості підвищення ступеня вивільнення суми флаволігнагів із капсульних мас силібору / Т.М. Зубченко // Фармаком. – 2007. – № 3 – С. 65-72.
4. Зубченко Т.М. Комплексна переробка плодів розторопші плямистої з розробкою нового способу очистки та виділення субстанції силібор / Т.М. Зубченко, О.І. Тихонов, Н.М. Скакун // Вісник фармації. – 2006. – № 3 (47). – С. 10-14.
5. Зубченко Т.М. Обґрунтування складу та технології рідкої лікарської форми гепатопротекторої дії / Т.М. Зубченко // Вісник фармації. – 2013. – № 1 (73). – С. 26-30.
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