[On the content of the national part of the Czech pharmacopoeia from the aspect of the formulation of medicinal preparations in pharmacies]. / K obsahu národní cásti Ceského lékopisu z pohledu prípravy lecivých pripravku v lékárnách.

The national part of the Czech Pharmacopoeia 2005 and its Supplements 2006 and 2007 do not sufficiently solve the issues of standardization of the present formulation of medicinal preparations in pharmacies. The paper discusses some of the possible causes of this state and lists the examples of ophthalmic drops monographs which are no longer topical for formulation in pharmacies, and also some monographs with obsolete active ingredient concentrations or not fully solved formulation technology.

Application of instrumental colour measurement in development and quality control of drugs and pharmaceutical excipients.

This review covers applications of instrumental colour measurement using tristimulus colorimetry in development, stability testing, production and quality control of synthetic and natural drugs, dosage forms and pharmaceutical excipients in the last three decades.

[Standard prescriptions for the formulation of medicinal preparations in pharmacies. I. Suspensions for dermal administration]. / Standardní receptura pro prípravu lécivých prípravku v lékárnách. I. Suspenze k aplikaci na kuzi.

The paper summarizes the present state of standard prescriptions for the formulation of suspensions for dermal administration in the Czech Republic and compares it with the NRF (Neues Rezeptur-Formularium in Deuscher Arzneimittel-Codex) standard prescriptions. The analysis of medical prescriptions for suspensions for dermal administration dispensed in the pharmacies of the Czech Republic has revealed that 18.8 % of the prescriptions were for 50% suspension of zinc(II) oxide in sunflower oil. This preparation should therefore become a candidate for standardization as a monograph in the national part of the Czech Pharmacopoeia.

[Some possibilities of using spectrometry in the near infrared region in drug quality control]. / Nekteré moznosti vyuztí spektrometrie v blízké infracervené oblasti v kontrole jakosti léciv.

Spectrometry in the near infrared region ranks among the modern methods of analytical chemistry and is of use also in drug quality control. The paper draws attention to some possibilities of using the method in this respect, including its possible use in the check-out of the identity of the content of closed packages of medicinal and auxiliary substances supplied to pharmacies.

[Theory and practice of pharmacopoeial control of the quality of drugs and auxiliary substances. VI. Stability of comparative colour solutions of the Czech Pharmacopoeia 2002]. / Teorie a praxe lékopisné kontroly jakosti léciv a pomocných látek VI. Stabilita porovnávacích barevných roztoku CL 2002.

Comparative colour solutions for methods I and II evaluating colouring of liquids according to PhB MMII are of identical composition. For method I, they can be stored without any time limit, whereas for method II are to be prepared just immediately prior to their use. The present paper deals with the examination of stability of comparative colour solutions PhB MMII kept in test-tubes made of colourless borosilicate glass with ground-glass stoppers, protected from light. The colour differences deltaE* in the uniform colour space CIELAB calculated from transmittance spectra measured in the course of preservation of solutions revealed that comparative colour solutions PhB 2002 show higher stability when there is a higher concentration of colour components in the solution. In solutions H9, HZ7, and Z7, the time period from their preparation to the time not exceeding the difference of deltaE* 1.5 units ranged within 3 days, in ZZ7 it was at least 14 days, and in C7 at least 20 days. In solutions H5, HZ4, Z4, ZZ4, and C4, it was at least 25 days, in solutions H2, HZ2, Z2, ZZ2, and C2 at least 41 days. These findings make questionable the justification of preservation of colour solutions according to PhB MMII for method I for an unlimited time period. At the same time they show that the solutions are not unstable to such an extent that they should be prepared for method II just prior to use in all cases.

[Present-day legislation and the handling of chemical substances and preparations at the workplaces performing drug synthesis and analysis]. / Soucasná legislativa a nakládání s chemickými látkami a prípravky na pracovistích zabývajících se syntézou a analýzou léciv.

The preparation discusses the present-day legislation concerning the handling of chemical substances and preparations in the Czech Republic (Law No. 356/2003 Coll., Regulation No. 369/2005 Coll.), the passages important for the operation of the workplaces performing synthesis and analysis of drugs, including the new duties of the employer. The legal regulation valid in the Czech Republic is compared in the selected parts with that valid in the Slovak Republic. The authors primarily recommend the workplaces engaged in drug synthesis and analysis to limit the use of chemical substances classified as highly toxic.

[Stabilization of colouring of Castellani's solution without fuchsin CL 2002 and control of its efficacy]. / Stabilizace zbarvení castellanova roztoku bez fuchsinu cl 2002 a kontrola její úcinnosti.

Disodium edetate in an amount of at least 0.01% is an effective stabilizer of a low level of colouring of Castellani's solution without fuchsin Ph.B. MMII. Spectrophotometric measurement of colouring and expressing in numbers of colour differences deltaE* in the uniform colour space CIELAB from transmittance seem to be a suitable method of stabilization efficacy control of colouring of the preparation.

Properties of colour reference solutions of the European Pharmacopoea in CIE L*a*b* colour space.

The coordinates of CIE L*a*b* uniform colour space have been acquired from the transmitance spectra of colour reference solutions of European Pharmacopoeia (Ph.Eur.). Calculation of colour differences of these solutions from purified water deltaE* gave their values in the range between 0.7 (B9 solution) to 36 (Y1 solution) CIE units. Excluding red colour reference soulutions, deltaE* values did not depend on concentrations of colour compounds linearly. Small deltaE* values founded by the brown and brownish-yellow colour reference solutions of the lowest concentrations can possibly cause some problems of visual examination of the degree of coloration of liquids according to Ph.Eur.

Efficiency of stabilization of low level of coloration of Castellani's paint without fuchsine with disodium edetate.

Addition of 0.03% of disodium edetate dihydrate (DED) was determined by observation of colour differences deltaE* in the CIELAB system to give more effective stabilisation of a low level of coloration of Castellani's paint without fuchsine than did 0.02% DED. Increase of the DED addition to 0.04% did not lead to further retardation of the increase in coloration of the preparation.

[The development of the composition of Castellan's solution]. / Vývoj slození castellanova roztoku.

Whereas in Germany the development of the composition of Castellan's solution resulted in its replacement with a solution of basic fuchsine alone, on the other hand in the Czech Republic fuchsine was excluded from the composition of the preparation. It is therefore desirable to evaluate the composition of Castellan's solution according to the Czech Pharmacopoeia and fuchsine from the viewpoint of the therapeutic benefits and risks of the individual active ingredients.

[Advances in enantioselective TLC of therapeutic agents]. / Pokroky v enantioselektivní TLC léciv.

Enantioselective TLC represents a still developing field of analysis of therapeutic agents. In recent years, similarly as in HPLC, mainly direct separations of enantiomers without their preceding derivatization have been published, preferentially using chiral stationary phases, separations with a chiral selector in the mobile phase being less frequent. In the future, a larger choice of commercially available chiral stationary phases could contribute to a more widespread use of enantioselective TLC.

[Derivation absorption spectrophotometry in the ultraviolet range as an alternative to HPLC and other instrumental methods of drug analysis]. / Derivacní absorpcní spektrofotometrie v ultrafialové oblasti jako alternativa HPLC a jiných instrumentálních metod analýzy léciv.

A comparison of the results obtained by derivation absorption spectrophotometry in the ultraviolet region and those obtained by HPLC and other instrumental methods of quantitative analysis of drugs reveals that derivation spectrophotometry can be an economically advantageous alternative in many cases. The results of the determination of one drug on an interfering background or of two substances beside one another are usually comparable; for the evaluation of the determination of three or more substances enough data are not available.

[What every worker involved in the synthesis and analysis of drugs could learn from the law concerning chemical substances and chemical preparations]. / Co by mohl vedet kazdý pracovník v syntéze a analýze léciv ze zákona o chemických látkách a chemických prípravcích.

Commencing with 1 January 2000, law No. 157/98 of the Coll. in the wording of law 352/99 of the Coll., government orders No. 25/99 of the Coll., 258/2001 of the collection, and other implementation regulations based on the regulations and directives of the European Community have been valid for the handling of chemical substances and preparations in the Czech Republic. The present paper discusses and comments on the parts of the law which are important for the management and running of the establishments engaged in the synthesis or analysis of drugs. It further lists examples of highly toxic chemical substances which can occur at these establishments.

Problems connected with HPLC separation of pilocarpine from its degradation products by means of silica gel and water-based mobile phase.

HPLC separation of pilocarpine from its degradation products (isopilocarpine, pilocarpic acid and isopilocarpic acid) was studied on unmodified silica gel stationary phase. An acidified aqueous solution of inorganic salts with addition of methanol served as the mobile phase. The influence of silica gel used, methanol content, mobile phase pH, anion of acids and/or inorganic salts and column temperature on solute retention, separation selectivity as well as peak shape was studied and partly explained. A significant dependence of the properties of the resulting separation system on the silica gel used was found. A test was proposed for evaluation of silica gel suitability.