Introducere. Pentru cercetare a fost selectată una din
cele mai des întâlnite forme din receptară Secţiei Forme
magistrale a Centrului farmaceutic universitar ’’Vasile
Procopişin” USMF "Nicolae Testemiţanu" - pulberea
nedozată compusă cu compoziţia: acid salicilic 4.0, acid
boric 20.0, hexametilentetramina 40.0, oxid de zinc 75.0, talc
75.0.
Scopul lucrării. Elaborarea metodelor de analiză şi
determinarea termenului de valabilitate pentru forma
farmaceutică studiată.
Material şi metode. Indentificarea substanţelor active a
fost efecuată cu ajutorul reacţiilor farmacopeice. Pentru
dozare au fost propuse urmatoarile metode: alcalimetria (acid
boric şi acid salicilic), complexonometria (oxid de zinc),
acidimtria (hexametilentetramină).
Rezultate. Reieşind din componenţa formei farmaceutice
şi structura chimică a fiecărui igredient, au fost elaborate
metodele pentru analiza formei respective (identificarea şi
dozarea). Pentru evaluarea stabilităţii formei farmaceutice şi
determinarea termenului de valabilitate au fost preparate 3
serii de pulberi. Controlul indicilor calităţii formei cercetate a
fost efectuat in conformitate cu cerinţele FR X, ordinului MS
RM nr. 10 din 06 ianuarie 2006. Seriile preparate au fost
depozitate in condiţii obişnuite (t°=25±2°C). Toate rezultatele
obţinute au fost prelucrate statistic. Eroarea relativă medie
(E%) pentru acizii boric şi salicilic este 1,47; pentru oxidul
de zinc şi hexametilentetramină -1,38 şi 0,70 respectiv.
Concluzii. în urma stadiului efectuat a fost elaborată
metoda de analiză a formei farmaceutice extemporale -
pulbere nedozată compusă. A fost stabilit termenul de
valabilitate - cel puţin 30 zile.
Introduction. There was selected and investigated one of
the most prescribed forms from Magisterial Form’s Section
of Pharmaceutical Univesity Center “Vasilie Procopishin” of
Nicolae Testemitsanu State University of Medicine and
Pharmacy of the Republic of Moldova - a complex undosed
powder with the following composition: salicylic acid 4.0,
boric acid 20.0, hexamethylenetetramine 40.0, zinc oxide
75.0, talc 75.0.
The aim of the study. The development of analytical
methods and determination of validity shelf life for the
researched dosage form.
Material and methods. The identification of the active
substances was carried out with the help of pharmacopeian
reactions. To dose the ingredients there was proposed the
following methods: alcalimetria (boric acid and salicylic
acid), complexonometry (zinc oxide), acidimtry
(hexamethylenetetramine).
Results. Based on the chemical composition of
pharmaceutical form and structure of each ingredient there
was elaborated the methods of analysis of the form
(identification and assay). To evaluate the stability and to
determinate the shelf life of dosage form there were prepared
3 series of powders. The control of quality indices was
carried out according to the requirements of FR X, order MS
RM nr. 10 from 06th january 2006. Prepared series were
stored in normal conditions (t° = 25°C±2°C). All obtained
results were analyzed statistically. The average relative error
(E%) for boric and salicylic acids is 1,47; for zinc oxide and
hexamethylenetetramine - 1,38 and 0,70 respectively.
Conclusions. There was elaborated the method of analysis
of extemporal dosage form - complex undosed powder. It
was determined the shelf life - at least 30 days.
