in defending the lack of evidence for the activity of medicinal plants often synergy and prodrugs are mentioned as the reason why the common bioassay guided fractionation failed to find any biological active compound. it is easy to make such a statement, but how to proof this. first of all one should consider what synergism means. A definition of synergism is: "Two or more agents working together to produce a result not obtainable by any of the agents independently". Considering this for biological activity there are two types of synergism:Pharmacodynamic FGBU Scientific Center on Expertise of Medical Application Products of the Ministry of Health and Social Development of the Russian Federation, Moscow, RussiaThe analysis of the results of safety monitoring (advantage/possible hazard rate) for 20 herbal medicinal preparations (hMP) submitted for approving of state registration in Russian federation according to decrees of Ministry of health and social development № 749n dated 26.08.2010 and № 757n dated 26.08.2010 was done. Sixty percent of results of safety monitoring (75 % domestic and 25 % of foreign hMP) have passed expertise. for 40 % of results of safety monitoring (12,5 % domestic and 87,5 % of foreign hMP) some comments were done. Main experts comments were: results of safety monitoring have covered not full registration period (p. 1.7.); difference in application of hPM in Russia and foreign countries are not marked; not all countries are indicate in which hMP is marketed; the date of hMP registration in some country is not indicated; not all countries listed in the periodical report about safety are indicated (p. 2.1.); number of batches which were sold in Russia only is indicated (but hMP is marketed in other countries as well). information about number of packages supplied by manufacturer and received by patients is not correct (pp. 2.5. and 2.6.). Pos. 2.4. was not completed; p. 2.16. was completed to according to rules; the job position, name and signature of responsible for results of safety monitoring of hMP were not indicated (p. 1.9.); date of submission of results of safety monitoring was not indicated (p. 1.8.); number of hMP registration certificate was wrong (p. 1.2.); date of hMP registration was wrong (p. 1.3.); the formulation of hMP was not correct (p. 1.5.); some information in the tables of document is not presented. Compliance of all rules of normative documents for pharmacovigilance and monitoring of safety of hMP after registration is very important.

The herbal medicines made from Filipendula ulmaria Maxim. are used in folk and applied medicine. They have anti-inflammatory and astringent activity. Along with this plant, F. hexapetala Gilib. is also a wide-spread plant of the genus Filipendula. The aim of work is the comparative phytochemical research of above-ground part of these plants. The above-ground parts of investigated plants were collected in Novosibirsk region in flowering stage. The collected raw materials were dried before the measuring. The amount of polysaccharides, amino acids and phenol compounds were measured by means of hPlC. identification of components was done by the way of comparison with the standard substances. As a result it was established that both species have similar monosaccharide and amino acid structures (The amount of polysaccharides and amino acids was calculated for the absolutely dry raw material and equaled 7,0-8,5 % and 8,3-10,3 %).for the first time methylcoumarin was discovered in the investigated plants. Also it was established that qualitatively the primary and secondary metabolites of two species of Filipendula are alike, which is in agreement with known data. There are only insignificant differences in the quantitative amount of components and this fact allows to assume a similar pharmacological activity of phytomedicines which can be made from both species studied. FGBU Scientific Center on Expertise of Medical Application Products of the Ministry of Health and Social Development of the Russian Federation, Moscow, RussiaThe legal basis for State Registration (SR) of phytopreparations (fP) in Russia are the federal law "On the circulations of medicines" of April 12, 2010 No. 61-fZ, departmental orders, instructions and other regulations of Ministry of health and Social development (MhSd). Original fP (OfP), generic fP (GfP), innovative combinations of registered fP, registered fP in new pharmaceutical forms (Phf), new dosage and new administration way are subject to SR in Russia. Generally fP contain a complex of biologically active substances determining the main pharmacological action (PhA) of fP; possess a broad spectrum of PhA; quality, efficiency and safety of fP depend to manufactiring technology. Preclinical pilot studies (PPS) of pharmacological activity and safety of new fP should start after the development on standardization of starting materials, substance and finished product. The plan of necessary PPS is defined by origin of Phf, chemical composition, data on efficiency and safety of starting materials, a type of declared specific activity, etc. in general PPS includes study of specific PhA, overall pharmacological activity (effects on the main organs and systems), systemic toxic properties (acute and chronic toxicity) and specific types of toxicity (allergenic and local irritative effect, reproductive toxicity, mutagenicity, carcinogenicity, immunotoxicity; studying of toxic properties on immature animals for fP used in pediatrics). for fP made of medicinal plant raw materials in a Phf of powder pack...