Manufacturing process of high quality phytopreparation on example of herbal sedative

• Published in: Medicinski pregled Vol. 66; no. 3-4; pp. 170 - 176
• Main Authors: Dordević, Sofija, Dickov, Aleksandra, Pavkov, Sava, Tadić, Vanja, Arsić, Ivana, Zugić, Ana
• Format: Journal Article
• Language: English; Serbian
• Published: Serbia 01.03.2013
• Subjects: Humans; Hypnotics and Sedatives - standards; Phytotherapy; Plant Preparations - standards; Quality Control; Valerian
• ISSN: 0025-8105; 1820-7383
• DOI: 10.2298/MPNS1304170D

Rational phytotherapy is a modern concept of using plant-originated drugs which has emerged from the need to improve phytotherapy in order to make the use of herbal remedies more efficient and safer. The aim of this study was to give the health-care workers more information on the manufacturing process of high quality phytopreparation following principles of Good Manufacturing Practice and Good Laboratory Practice on the example of herbal sedative, Odoval S capsules. This study was designed to reflect the production process of a high-quality and safe herbal remedy, starting from defining the formulation and the production procedure to the quality control of raw materials, characterization of the final product, and testing stability of active ingredients in the capsules. Formulation of the phytopreparation, validation of the production process, quality control and stability testing, all together have resulted in the production of capsules with defined valeric acid content (1 mg valeric acid per capsule). The preparation is recommended to relieve the symptoms caused by chronic stress (anxiety, irritability, fatigue, lack of concentration, heart palpitations) and for mild insomnia. This paper presents the complete cycle of the production of a phytopreparation on the example of a new herbal sedative--Odoval S capsules.