Department of Natural Medicinal Products (LN)

Personnel and structure

Head of the Department:
Anna Łozak, Ph.D,
Phone: (48 22) 841 06 23 ext. 383
E-mail:

Secretary:
Monika Krawczykowska
Phone: (48 22) 841 06 23 ext. 384
E-mail:

Laboratory unit for plant materials and preparations
In the capacity of the Manager:
Renata Jabłczyńska, M.Sc.
Technicians:
Jolanta Kopaczewska
Beata Sękowska

Laboratory unit for alkaloids and glycosides
In the capacity of the Manager:
Małgorzata Anyżewska, M.Sc.
Anna Kowalczuk, M.Sc.
Technicians:
Danuta Miller
Andrzej Lukowski

Activities:

Quality Control of medicinal products:

Laboratory performs tests and investigations of medicinal products marketed and pre-licensing:
  • Mmedicinal plants and traditional herbal medicinal products
    • herbs, herbal teas,
    • other oral forms with plant extracts (tinctures, sirups, tablets, capsules with plant extracts or powdered herbs)
    • products for external use (liquids, suspensions, ointments, creams, gels) with natural components (waxes, resins, oils, essential oils etc.).
  • Substances and medicinal products containing active pharmaceutical ingredients of plant origin (alkaloids, cardiac glycosides, flavonoids, saponines, etc.)
  • Homeopathic preparations,

The methods applied are:

  • classic chemical analysis,
  • instrumental analysis: UV-VIS spectrophotometry, thin layer chromatography (TLC) and densitometry, high performance liquid chromatography (HPLC) with UV-VIS and refractometric detection, dissolution of oral dosage forms.

Quality Assurance

  • Implementation  of quality system according to PN-EN ISO/IEC 17025: 2005.
  • Elaboration of technical procedures and instructions for thin layer chromatography (TLC) and densitometry.

The department participates in the proficiency testing studies organised by the Official Medicines Control Laboratories Network,  European Directorate for the Quality of  Medicines in Strasbourg.

In 2004 there were three PTS studies carried out in the Department of Natural Medicinal Products: determination of active substances in injectables (caffeine add theophylline with ethylenediamine) and testing of Matricaria flower according to the Ph. Eur. 4th Ed.

Dr Andrzej Andrzejewski is internal auditor for the quality system in the National Medicines Institute. 

Educational activity:

Dr Urszula Krawczyk is a member of  Programme Committee in the School of Good Manufacturing Practice (GMP) at OINPharma Ltd.
The department hosts students for training.

Research:

  • Problems of choosing appropriate reference standards in the analysis of medicinal products of natural origin.
    For many years people have been using herbals in the traditional forms: infusions, decocts and tinctures. Most of these plants are nowadays described in the pharmacopoeial monographs. Analytical examination of single plant or tincture does not usually bring many problems. However, in order to make life easier herbals are applied as tablets and capsules filled with a mixture of various plant extracts. These are also believed to be efficient and safe.
    According to the present regulations licensing authorities require assay of an active substance or group of substances of proved or presumed therapeutical activity. The question of appropriate standards is then raised. Shall the laboratory use standard plant extracts or pure substances whenever possible? How can we assure absence of adulterants in finished product?
    There are different possibilities: plant extracts, pure active substances (often very expensive and/or unstable). The advantages and drawbacks of certain cases will be investigated and discussed from the point of view of Official Medicines Control Laboratory.
  • Evaluation of chemical, pharmaceutical and biological part of the dossier (NTA, CTD) for the purpose of registration of medicinal products.

Cooperation:

  • Department of Pharmacognosy of the Pharmacy Faculty at the Medical Academy of Warsaw
  • Research Institute of Pomology and Floriculture in Skierniewice

Services:

  • Qualitative and quantitative analysis of active pharmaceutical ingredients, medicinal products and herbal medicinal products according to current pharmacopoeial requirements and manufacturer's specifications.
  • Assessment and validation of analytical methods.

Equipment:

HPLC + UV-VIS detection
HPLC + refractometric detection
UV-VIS spectrophotometers
In vitro dissolution tester for oral dosage forms
TLC densitometer

Publications (from 2000):

  • Wojtasik E., Anyżewska M., Arent I.,
    The optimization of the separation conditions for cannabinoids from cannabis sativa L. var. indica and application of the method to determine the content of 9-tetrahydrocannabinol in plant material.
    J. Liq. Chromatogr. & R.T., 2002, 25 (6) :  949-959
  • Krawczyk U., Łukaszkiewicz Z.,
    Risks for public health due to possible contamination of herbal medicinal products.
    Complex Quality Assessment  of Medicinal Substances and Pharmaceutical Forms;
    Medical Academy in Poznań, Scientific Conference Materials, September 18-19th  2003.
  • Krawczyk U., Andrzejewski A., Łukaszkiewicz Z.,
    Selection of standards for analysis of herbal substances on the background of pharmacopoeial monographs.
    Farmacja Polska, Tom 61, nr 3, 2005