**1. Introduction**

398 Macro to Nano Spectroscopy

Zava, T. T. & Zava, D. T. (2011). Assessment of Japanese iodine intake based on seaweed

Zhai, Q.-Z., Zhang, X.-X. & Goupages, X.-L. (2010). Catalytic Kinetic Spectrophotometric

Zimmermann, M. (2009). Iodine Deficiency. *Endocr Rev*., Vol.30, No.4, pp 376-408, ISSN

ISSN 1756-6614

0163-769X

Vol.38, No.2, pp 125-134, ISSN 1073-9149

consumption in Japan: A literature-based analysis. *Thyroid Research*, Vol.4, p 14,

Determination Of Trace Amounts Of Iodine. *Instrumentation Science & Technology*,

Medicinal plants constitute a rich cultural and biological heritage in many countries, which could be very useful in meeting the therapeutic needs of the population (Rodriguez, 2010a). Traditional herbal medicines have been widely used for many years in many eastern countries (Liang et al., 2004). However, little work has been done to validate and standardize these products properly in order to match phytotherapy to chemotherapy which currently receives almost unconditional support from formal systems of health care. For several years now activities have been undertaken to systematize the identification, validation, production and use of medicinal plants, for both primary health care as well as a semi-industrial or industrial process, which implies their transformation into safe, reliable and stable phytopharmaceutical products. Therefore it is suggested that medicinal plants and their derived products would be a viable option for national development as an agricultural and therapeutic alternative, but standardization and industrialization, involving sustained yields, a quality control system and honest and reliable marketing would be needed for widespread implementation and official support. Consequently, on account of the above, education and research should be in agreement if any advance is to be made in this area (Rodriguez, 2010a). However, the necessary criteria for data quality, safety and efficacy of traditional medicine that would support its use in the world do not exist. Appropriate, accepted research methodology for evaluating traditional medicine is also lacking (Liang et al., 2004).

Most countries have developed organisms for controlling the quality of herbal remedies destined for the internal market or for export. The officially recognized drugs are subject to

Quality Control of Herbal Medicines with Spectrophotometry and Chemometric Techniques

ingredients for evaluating the quality of the herbal products.

quality control of herbal medicines.

– Application to *Baccharis* L. Species Belonging to Sect – Caulopterae DC. (Asteraceae) 401

The concept of phytoequivalence was developed in Germany to ensure the consistency of herbal products (Tyler, 1999). According to this concept, a chemical profile, such as a spectrophotometric fingerprint for a herbal product should be constructed and compared with the profile of a clinically tested reference product. Therefore, a spectrophotometric fingerprint of a herbal medicine is a spectrophotometric pattern of an extract of some chemical components that are pharmalogically active and/or with chemical characteristics. It is suggested that with the help of spectrophotometric fingerprints obtained, the authentication and identification of herbal medicines would be appropriate, even when the amount and/or concentration of some typical chemical ingredients are not exactly the same for different samples of these herbal medicines. In this way, we are broadly considering multiple ingredients in the extracts of herbal medicines rather than one or two marker

In general various analytical techniques can be used to obtain fingerprints of herbal medicines of which chromatography is most often used on account of its great efficiency in separating the different components of an extract. For the above mentioned reasons these chromatographic techniques have a high cost, especially if they are to be used for routine quality control. A simple alternative technique such as UV/Visible spectrophotometry, coupled to chemometric methods was carried out by Lonni et al. (2005) for taxonomic purposes. Authors were able to separate populations of three species of *Baccharis* according to their UV / Visible spectra. Here, we propose to apply the same methodology as part of

Figure 1 shows the spectrophotometric profiles of ethanol extracts of the aerial parts of *Baccharis gaudichaudiana* DC. obtained from five areas in Misiones province, Argentina (MI1, MI2, MI3, MI4, MI5) (Rodriguez, 2010b). Here, of course, some differences can be observed

Fig. 1. Absorption UV/Visible spectra of *Baccharis gaudichaudiana* populations (Bg). MI, Misiones. Numbers indicate when there is more than one population of the same species.

in the profiles; however phytoequivalence for *B. gaudichaudiana* can be seen.

testing and specifications of identity, purity and contents of the principal active ingredients or markers for each plant drug, in order to guarantee the conservation of the species and the specifications of microbiological purity. Currently the quality requisites of the different national pharmacopoeias vary between countries, however the International Federation of Pharmaceutical Manufacturer Associations, have taken a first step towards the global implementation of organized criteria (International Federation of Pharmaceutical Manufacturer Associations [IFPMA], 1997). The World Health Organization has conducted a review of the legal status of traditional medicine and complementary or "alternative" therapies in 123 countries (World Health Organization [WHO], 2001). Moreover, some countries and organizations have developed, or are developing, their own monographs, for example, the Commission E of the German Ministry of Health, WHO and European Scientific Cooperative on Phytotherapy, China, Brazil and Argentina, among others. These monographs recognise the quality standards applicable to drugs and herbal remedies in the pharmaceutical market. (Blumenthal, 1998; European Scientific Cooperative on Phytotherapy [ESCOP], 2003; Keller, 1991; WHO, 1991, 1999, 2002).

In Argentina there is great interest in controlling the Quality, Security and Efficacy of herbal medicines. In order to achieve this ambitious objective the following steps must be taken: a-Registration of the products, b- Verification of good practices of production and quality control, of the crude drug and its products, and c- Pharmacovigilance. ANMAT (National Administration of Drug, Food and Medical Technology) is the organism responsible for authorizing all activities related to medicines through its technical organism, the INAME (National Institute of Drug). The products based on herbal medicine and aromatics are considered as Phytotherapeutic Drugs in Resolution Nº 144/98 and the Supplementary Provisions (**Provision 2671/99; Provision 2672/99; Provision 2673/99)** that are now in effect. Provision 1788/2000 contains a list of 109 herbal medicines that can not be authorised for the production of herbal medicine on account of the contradictions or toxic effects reported in their traditional use.

It is very important that plant material is of the highest quality as it is used as a medicine. The aforementioned decrees aim to guarantee the quality of the raw material, the intermediate and finished products and a series of tests have been established among which, as a minimum requisite, are botanical identity, purity (physical-organoleptic and microbiological - for health) and their activity or composition (methodological analysis), taking into account the Good Practices of Agricultural Production and the Good Practices of Manufacturing (Rodriguez, 2010a).
