Salidroside, as a chemical compound from the group of phenylpropanoids, and rosavin are used for the standardization of dry extracts from the underground stem and root of Rhodiola rosea. In this study we monitored two different extracts from Rhodiola rosea, which differ in content of active compounds, colour, technological and physico-chemical properties (e.g. flow properties). These extracts were mixed with excipients and the flow characteristics of mixture – bulk volume and tapped volume – were determined. After formulating the tablets by compression, qualitative parameters like disintegration, resistance to crushing, friability, mass uniformity and texturometric parameters were tested. Also, dissolution profiles were evaluated using first order kinetic model, Korsmeyer-Peppas model and Weibull model for correlation. In some formulations, the impact of the properties of dry extracts on various technological properties of final tablets was more marked. We suggest that in case of a higher extract:excipients ratio, these properties manifest themselves by an even higher impact.
- Publikační typ
- abstrakt z konference MeSH
- Publikační typ
- abstrakt z konference MeSH
- MeSH
- farmaceutická technologie MeSH
- kongresy jako téma MeSH
- Publikační typ
- zprávy MeSH
Systém zabezpečovania kvality transfúznych liekov je nastavený tak, aby tieto produkty boli bezpečné a mikrobiologicky bez závad. Mikrobiologická kontrola procesov pri výrobe transfúznych liekov slúži na overenie funkčnosti tohto systému kvality. Autori poskytujú prehľad legislatívnych požiadaviek na zabezpečenie kontroly kvality transfúznych liekov, požiadavky na kontrolné laboratóriá, uvádzajú stručný prehľad činnosti kontrolného laboratória a prezentujú nálezy bakteriálnych kontaminantov transfúznych liekov a výrobného prostredia za obdobie rokov 2011 a 2012. Kľúčové slová: transfúzny liek, kontrola prostredia, sterilita, kontrolné laboratórium, bakteriálna kontaminácia
The system of quality assurance of blood products is set up in such a way as to guarantee product safety and microbiological purity. Microbiological control of all processes during the manufacture of blood products serves to verify the functionality of this quality control system. The authors provide an overview of the legislative requirements for ensuring quality control of blood products, the requirements for control laboratories and they present a short overview of the activities of a control laboratory and the findings of bacterial contaminants in blood products and the manufacturing environment in the years 2011 and 2012.
