
PhytoLab invests millions of euros in analytical equipment – New laboratory building: 1600 square metres for science and research – PhytoLab is an authorised laboratory for the quality control of Chinese medicinal plants – New analytical techniques improve product safety
Vestenbergsgreuth/Germany – There has been considerable expansion in PhytoLab's technology park recently. "We have invested more than a million euro in equipment during the last six months," reports Managing Director Dr. Lothar Kabelitz. "In doing so, we have established the best prerequisites for the performance of state-of-the-art analyses and controls of herbal compounds in the research fields and have taken over the leading position in Europe". A new four-storey laboratory building with a total of 1600 square metres of floor space has been built at the company's premises to accommodate the new equipment and for research and development. The company has invested a total of 3.7 million euros over the last two years.
Safe products
The new equipment and facilities not only take PhytoLab into the lead as far as analysis technology is concerned, they also ensure maximum product safety. The stringent requirements that apply to baby food are now being met within the framework of determining such contaminants as mycotoxins, pesticides, herbicides etc. An AOAC International certificate was awarded to PhytoLab for the company's successful participation in an international inter-laboratory test focusing on Ephedra, a shrub-like plant, which also is known as Mormon tea in Northern America. Ephedra alkaloids were quantified in food supplements and plants in this co-operative test involving nine of the world's most renowned laboratories. PhytoLab gathered a great deal of experience in the course of this venture and now offers the analysis of Ephedra alkaloids as a routine service. Increasingly popular throughout Europe, Noni juice, which is made from the fruit of the tropical Morinda citrifolia tree, is subject to the requirements of the novel food directive, a set of rules and regulations that apply to new types of food. As carcinogenic substances, so-called Anthraquinones may be found in the leaves of this tree, the authorities are also demanding tests to determine the presence of any Anthraquinones in the fruit juice. PhytoLab is one of the very first laboratories in the world to have developed a suitable method of testing, which is capable of detecting the tiniest quantities of these toxic substances in the fruit juice. These test procedures have now been acknowledged by a number of different European food authorities.
Quality inspection and testing of plants used in the field of traditional Chinese medicine
PhytoLab is one of the few special laboratories which have the competence to carry out tests on Chinese medicinal plants. Apart from analysis, the range of services offered by the laboratory includes an assessment of the investigated samples by officially appointed experts as specified in § 65 subsection 4 of the German Drug Law (AMG). If the extensive treasure of Chinese pharmaceuticals is to be used safely, valid methods of determining identity, purity and content must be developed as points of reference for importers and distributors. PhytoLab's investigations are centred on many years of contaminant screening for commercial drugs.
This means that the company is also making a contribution towards the establishment of Chinese medicine, which became discredited in Europe when mistaken identities and adulterated plants and drugs caused severe side effects and gave rise to drug scandals in England and Belgium. PhytoLab presented the initial results of its TCM research at the Royal Pharmaceutical Society's TCM Symposium in London in 2004.
Joining forces with the Bavarian State Research Centre for Agriculture, PhytoLab is actively involved in the experimental cultivation of Chinese medicinal plants in Germany. PhytoLab is responsible for performing the extensive quality inspections and tests, as well as the analyses required in order to compare the cultivated plants with the drugs imported from China, whereby PhytoLab has a collection of authentic reference drugs at its disposal.
High tech for multi-element analysis
Research is one thing, and a field in which PhytoLab has made a big name for itself in Europe. Applying the results of this research is another matter altogether. Precision analysis in the nanotech range requires ultra-modern analytical instruments. Two examples of these are the high performance liquid chromatography tandem mass spectrometer HPLC-MS-MS and the inductively coupled plasma mass spectrometer ICP-MS 7500c manufactured by Agilent. The HPLC-MS-MS is so sensitive that it is capable of detecting a concentration of 5 ppt, for example, i.e. one foreign particle in two hundred billion. The most recent acquisition is the Q Trap 4000. This innovative technology offers a means of screening for the chemical identities of new indicator substances. PhytoLab has therefore also established the most up-to-date methods in contaminant analysis and for toxicologically harmful constituents of the type which are playing an increasingly important role in the quantitation of acryl amide in heat-treated products and Aristolochic acid in plants used in traditional Chinese medicine.
The forte of the HPLC-MS-MS becomes evident when analysing complex samples of food, plant-based drugs and extracts. This device is capable of scenting minute quantities of a substance and, at the same time, providing information concerning its structure. This new technology has enabled PhytoLab to establish a method of analysis for quantitation of the highly toxic Anisatin, which is found in certain varieties of star anise, as just one example of its potential.
The testing of plant-based drugs and extracts to detect heavy metals and make statements concerning the elements of nutritional value and trace elements that they contain require analytical techniques of increasing precision and complexity. The ICP-MS is capable of analysing more than ten elements at the same time in just a single measuring run. This saves time and reduces the costs. As far as the heavy metals lead, cadmium, mercury, thallium, arsenic, copper, chromium and nickel are concerned, a measuring run like this takes just five minutes compared with three days that used to be needed in the past.
14. AMG amendment and company strategy
Contaminant analysis has been one of PhytoLab's main priorities since the company was founded in 1993. Around 80 000 samples are now tested for the presence of heavy metals, mycotoxins and pesticides every year. This has made the company a recognised authority for plant analysis in the herbal sector, in European associations and as a consultant for the preparation of draft laws.
The future will see PhytoLab concentrating its efforts on achieving the product safety which is so essential for the development of the market to an even greater extent. Other main focal points will include drug supervision and monitoring of risks associated with products. The 14th amendment to the German Drug Law (AMG) is signalling the beginning of a radical change in the market of non-prescription medicines. All traditional plant-based drugs which were already in circulation in 1978 will be required to comply with the stipulations of an EU directive that is currently being implemented in national legislation with the 14th amendment to the German Drug Law by 2011. PhytoLab is offering the stages required for this to its customers as part of the all-round service.