DOI: https://doi.org/10.24959/uekj.18.28

Quality control of active pharmaceutical ingredients of plant origin inline by specific optical rotation

N. M. Smielova, O. A. Yevtifieieva, L. V. Vepretska, S. M. Gubar

Abstract


Inulin is a reserve polysaccharide that is common in nature, it is accumulated in the underground organs of many plants, and its largest amount is observed in the family of Asteraceae. Depending on the source of obtaining and manufacturing process conditions, they produce inulin of excellent physical and chemical properties, and this inulin finds its application in food industry, cosmetics, including the pharmaceutical industry. One of the quality indicators for the active pharmaceutical ingredient (API) of plant origin inulin is considered to be its compliance with “Specific optical rotation” test requirements, which allows not only to identify and characterize the purity of optically active medicinal substance, but also to determine the finished product functional characteristics and the possibility of its industrial production.

Aim. To carry out quality control of nine inulin substances of plant origin obtained from chicory, Jerusalem artichoke, agave (batches 01-09) and two standard samples – inulin from chicory (batch 10) and dahlias (batch 11) by specific optical rotation (SOR) in accordance with the requirements of existing regulatory documents – Food Chemicals Codex 7 (FCC), monographs “Inulin” of the British Pharmacopoeia 2010 (BP) and US Pharmacopoeia 36 (USP).

Results. The optimal time for determining the rotation angle of API of inulin, which is 30 minutes after its preparation, has been found. By SOR calculated for the samples of the inulin substances analyzed it has been confirmed that batches 02, 03, 10, 11 and 02, 03, 08, 10, 11 meet the requirements of the monographs “Inulin” of the BP and USP; they can be recommended for manufacture of drugs with inulin. The rest of the batches (01, 05-09) satisfy the requirements of the FCC and can be used as a dietary fiber when manufacturing dietary supplements (DS) with inulin, as well as a filler, a structure former and a binder.

Conclusions. The results of the study obtained can be used when developing national regulatory documents for API of inulin of plant origin. They also can be the basis for quality risk management at the stage of pharmaceutical development of a drug.


Keywords


inulin; specific optical rotation; quality control

References


Yevtifieieva, O. A., Smielova, N. V. (2016). Teoretychni ta praktychni aspekty doslidzhennia likarskykh roslyn: materialy II Mizhnarodnoi naukovo-praktychnoi internet-konferentsii (21-23 03. 2016). Kharkiv: NFaU, 106–108.

Roberfroid, M. B. (2007). Inulin-Type Fructans: Functional Food Ingredients. The Journal of Nutrition, 137(11), 2493–2502. https://doi.org/10.1093/jn/137.11.2493s

Franck, A. (2002). Technological functionality of inulin and oligofructose. British Journal of Nutrition, 87(S2), S287. https://doi.org/10.1079/bjn/2002550

Alistair, M. S., Glyn, O. P. (2014). Food Polysaccharides and Their Applications. CRC Press, 258.

Pharmacopoeia B. British Pharmacopoeia (2010). Medicinal and pharmaceutical substances. London: The Stationery Office.

Pharmacopeia, U. S. (2013). National Formulary (USP 36-NF 31) Online. MD: United States Pharmacopeial Convention.

Food Chemicals Codex 2010-2011 (2010). U.S. Pharmacopeial Convention. Washington, DC, 509–510.

Kochetkov, N. K., Bochkov, A. F., Dmitriev, B. A. (1967). Khimiia uglevodov. Moscow, 672.

Derzhavne pidpryiemstvo «Ukrainskyi naukovyi ekspertnyi farmakopeinyi tsentr yakosti likarskykh zasobiv». (2015). Derzhavna farmakopeia Ukrainy. (Vol. 1). (2 edition). Kharkiv, 1128.

Bezuhlyi, P. O., Hrudko, V. O., Leonova, S. H., Taran, S. H., Bevz, N. Yu., ... Kolisnyk, O. V. (2001). Farmatsevtychnyi analiz: navchalnyi posibnyk dlia studentiv vyshchykh farmatsevtychnykh navchalnykh zakladiv III-IV rivniv akredytatsii. Kharkiv: NFAU «Zoloti storinky», 340.

Lee, F. (2012). Basic food chemistry. Springer Science & Business.


GOST Style Citations


1. Євтіфєєва, О. А. Актуальність розробки та впровадження монографії «Інулін» до Державної фармакопеї України / О. А. Євтіфєєва, Н. М. Смєлова // Теоретичні та практичні аспекти дослідження лікарських рослин : матеріали ІІ Міжнар. наук.-практ. internet-конф. (м. Харків, 21-23 березня 2016 р.) / ред. кол. : Т. М. Гонтова, А. О. Мінаєва, Н. І. Ільїнська. – Х. : НФаУ, 2016. – С. 106–108.

2. Roberfroid, M. B. Inulin-type fructans: functional food ingredients / M. B. Roberfroid // The J. of Nutrition. – 2007. – Vol. 137, № 11. – P. 2493–2502. https://doi.org/10.1093/jn/137.11.2493s

3. Franck, A. Technological functionality of inulin and oligofructose / А. Franck // British J. of Nutrition. – 2002. – Vol. 87 (S2). – Р. 287–291. https://doi.org/10.1079/bjn/2002550

4. Alistair, M. S. Food Polysaccharides and Their Applications / M. S. Alistair, O. P. Glyn // CRC Press. – 2014. – P. 258.

5. Pharmacopoeia B. British Pharmacopoeia. Medicinal and pharmaceutical sub-stances. – London: The Stationery Office, 2010.

6. Pharmacopeia U.S. National Formulary (USP 36-NF 31) Online // United States Pharmacopeial Convention. – 2013.

7. Food Chemicals Codex 2010–2011. U.S. Pharmacopeial Convention, Wash-ington, DC, 2010. – P. 509–510.

8. Кочетков, Н. К. Химия углеводов / Н. К. Кочетков, А. Ф. Бочков, Б. А. Дмитриев. – М., 1967. – 672 с.

9. Державна фармакопея України: в 3 т. / Державне підприємство «Україн-ський науковий фармакопейний центр якості лікарських засобів». – 2-е вид. – Х. : Державне підприємство «Український науковий фармакопейний центр якості лі-карських засобів», 2015. – Т. 1. – 1128 с.

10. Фармацевтичний аналіз: навч. посіб. для студ. вищ. фармац. навч. закл. III-IV рівнів акредитації / П. О. Безуглий, В. О. Грудько, С. Г. Леонова та ін.; за ред. П.О. Безуглого. – Х.: Вид-во НФАУ; Золоті сторінки, 2001. – 240 с.

11. Lee, F. Basic food chemistry / F. Lee // Springer Science & Business Media. – 2012.




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