Phytopharmaceuticals. Группа авторов

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      A Great Challenge on the Reproducibility of Therapeutic Results of Phytopharmaceuticals

       Idha Kusumawati

       Pharmacognosy and Phytochemistry Department, Faculty of Pharmacy, Airlangga University, C Campus Jl, Surabaya, Indonesia

       Abstract

      Phytopharmaceuticals contain a complex mixture of constituents from herbal medicine. It is important to understand that pytopharmaceutical therapeutic result and safety are built from all its constituents. Reproducibility of phytopharmaceutical quality must be guaranteed from raw material to end product and from batch to batch production. Determination of quality cannot only be based on one or a group of marker compounds because it will not be able to describe a complex mixture of ingredients. To represent the complexity of constituent in phytopharmaceuticals, chemical finger-prints have to be used which can be obtained by various chromatography and other methods.

      Keywords: Phytopharmaceuticals, complex mixture, marker constituent, chemical fingerprint, medicine, R&D investment

1.1 Introduction

      For many centuries, herbal medicine has been used to prevent and cure various diseases. This relates to cultural popularity, ease of access, and relatively low prices. In ancient times, herbs use was based on instinct, taste, and experience so that people could distinguish plants that were beneficial to health, not useful or toxic. The public can also find out which processing method should be used to obtain optimal efficacy [1] Chinese, Unani, Homeopathy, and Siddha. Traditional medicine using herbal formulas is widely used to treat complex diseases for years. The herbal formula often consists of several herbs and contains various chemical compounds, making it possible to have several unknown targets and treatment functions [2]. Medicinal plants are also important sources of substances with biological activity. Approximately 25% of modern medicines are directly or indirectly derived from plants [1].

Herbal products have excellent potential in the pharmaceutical segment. There are three categories of herbal products; traditional herbal medicine, over-the-counter (OTC) herbal medicine, and phytopharmaceuticals. Traditional herbal medicines are based on empirical efficacy and supported by ancient beliefs, and are prescribed individually. The OTC herbal medicinal products do not yet have scientific clinical data and evidence but are already in pharmaceutical preparations. The phytopharmaceuticals made based on data, scientific evidence, and clinically tested [3]. The phytopharmaceuticals is a standardized herbal preparation containing active ingredients in a complex mixture of plant ingredients. This preparation does not have an immediate or strong pharmacological effect; therefore, it is not appropriate for emergency treatment [1, 4].

      An herbal product, either in the form of plant parts (fresh or dried) or plant extracts, contains many constituents that often work together synergistically. The active ingredient in herbal medicine preparations is the entire chemical content. It can also be one of the compounds that have confirmed therapeutic activity or a group of compounds with the same core structure and are generally accepted that have a substantial contribution to the drug’s therapeutic activity. With varying chemical contents in a plant, no one plant is recommended for only one disease; and no one disease is related to only one plant [1, 4, 5].

      Besides having tremendous potential, various reports show the side effects of herbal products. People always assume that herbal medicines are safe and there are no side effects compared to synthetic drugs due to their nature. This perception causes herbal medicines are often misused and consumed like food, not as medicine. Various studies have shown there are many interactions between herbs with herbs or herbs with drugs. The herbal medicines are considered complementary medicines that can be consumed together with synthetic medicines [6, 7].

      Even though herbal medicines lately tend to increase, unfortunately, it is followed by an increase in various adverse effects of herbal use. One of the biggest causes of these cases is closely related to the poor quality of phytopharmaceuticals used. For this reason, the issue of phytopharmaceutical quality is crucial to consider [8].

      Difficulties in quality control and lack of scientific evidence in terms of herbal medicines efficacy have resulted in their use being replaced by a synthetic drug. However, in alternative medicine, herbal medicine still exists in various parts of the world [4, 5]. For this reason, the chemical substance composition in phytopharmaceutical has to fulfill the quality because it will influence the effectiveness and safety’s reproducibility at the clinical level [5, 9].

1.2 Common Challenges in Phytopharmaceuticals

      Herbal medicines usually consist of plant parts, either single or in combination in pharmaceutical dosage forms. Like synthetic drugs, herbal medicine also has therapeutic or prophylactic properties. The interaction of its multi-component ingredients causes poly-pharmacological effects or is known as a multi-target effect. The application of this concept in phytopharmaceuticals development requires comprehensive characterization of chemical content and bioactivity [10].

      Phytopharmaceuticals can become part of the health care system if they can prove their quality to guarantee the safety and efficacy as expected. But until now, it is still challenging to ensure the quality, safety, and effectiveness of phytopharmaceuticals. Quality assurance must be applied at every production stage starting from cultivation, harvesting, post-harvest processing, manufacturing, packaging, and product distribution. Quality assurance at each step is intended to ensure the reproducibility of its effectiveness and safety [5, 9, 11, 12].