Chapter I. Introduction

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1 Chapter I Introduction

2 1. INTRODUCTION The practice of herbal medicine has existed since prehistoric times as the primary form of medicine. In this new era due to several reasons herbal medicine still flourishes and is finding exceptional acceptance in both developing and developed countries (Chirangini et al., 2006) In the first place, herbs generally have far fewer side effects than do synthetic drugs (Tyler, 2003). Since many exert their effects through a multiplicity of mechanisms activated by several different types of chemical constituents affecting different receptor sites, the total result is a significant one relatively free of the adverse effects produced by large doses of a single agent affecting only a single site. eg. Saw palmetto Small (Serenoa repens Batr.) used in benign prostatic hyperplasia, it exerts many of the beneficial effects of finasteride without the undesirable effects of the latter (Wilt et al., 1998). Another factor favoring the use of phytomedicines is that they have beneficial properties lacking in synthetic drugs. There is presently no synthetic drug providing the same beneficial immunomodulating effects as Echinacea (Tyler, 1999). Currently approved, self selected drugs treat the symptoms of colds and influenza, not the causative virus. Similarly, there are currently no effective synthetic adaptogenic drugs marketed that compare to the complex mixture of ginsenosides in Panax species (Li and Harries, 1996). 1.1 Biological background of herbal drugs Over 80,000 species of plants are in use in herbal medicine throughout the world. Presently, approximately 25 percent of the prescription drugs sold in the United States are plant based. Besides wide-spread use of botanicals as medicinal products in developing countries, such products are fast becoming a part of the integrative health care systems of the industrialized nations, known as Complementary and alternative system of medicines (CAM). All plants produce chemical compounds as part of their normal metabolic activities. These can be split into two broad categories-primary metabolites and secondary metabolites. Primary metabolites include fats, sugars and amino acids whereas secondary metabolites like phenols, lignans, flavonoids and alkaloids which are much more specialized substances with a wide variety of functions in the plants that make them. Primary metabolites are found in all plants but secondary metabolites 1

3 are found in a much narrower range, some only in a particular genus or species. The functions of secondary metabolites are extremely varied. It is these secondary metabolites which can have therapeutic actions in humans and which can be refined to produce drugs eg. Quinine from Cinchona, morphine and codeine from Papaver (Poppy) etc (Chirangini et al., 2006). 1.2 World Scenario Traditional Chinese medicine continues as a distinct branch of modern medical practice, and within China it is an important part of the public health care system where it has been in documented use for over 2500 years. The use of traditional herbal remedies as alternative medicine plays a significant role in South Africa also, where it forms a part of the culture and beliefs of the indigenous population and also features significantly in primary health care (Mukherjee, 2002). 1.3 Indian Scenario India is one of the leading bio-diversity centers with 45,000 different plant species. Our country has 15,000-18,000 flowering plants, 23,000 fungi, 2,500 algae, 1,600 lichens, 1,800 bryophytes and 13 million microorganisms in its biodiversity region. Out of these strong resources, 1,250 are included in traditional medicinal practices. Thus India has a rich heritage of its own as far as the natural products and particularly medicinal plants are concerned because of its wide diversity in soil and climatic condition and rich flora and fauna. Therefore evaluation of Indian traditional medicine is possible through the proper exploitation and exploration of wide biodiversity and great ancient treatises of traditional medicine with the light of modern tools and techniques (Mukherjee, 2002). The indigenous systems of medicine namely ayurveda, sidda, homeopathy and unani have been in existence in India. Phytomedicines have always been a major component of traditional systems of healing in developing countries, which have also been an integral part of their history and culture. The history of medicine in India can be traced to such remote past. The earliest mention of the medicinal use of plants was found in the Rigveda and in Atharvaveda ( B.C.) from which Ayurveda has developed. The basic medicinal texts in this world region-the Ayurvedic writings can be divided in to three main ones (Charaka Samhita, Susruta Samhita, Astanga Hrdayam Samhita) and three minor ones (Sarngadhara Samhita, Bhava Prakasa Samhita, Madhava Nidanam 2

4 Samhita). Ayurveda is the term for the traditional medicine of ancient India. Ayur means life and Veda means the study of which is the origin of the term. The oldest writing-charaka Samhita is believed to date back six to seven centuries before Christ. It is assumed to be the most important ancient authoritative writing on Ayurveda. The Susruta Samhita is thought to have arisen about the same time period as the Charaka Samhita, but slightly after it Astanga Hrdayam and Astanga Samhita have been dated about the same time and are thought to date after the Charaka and Susruta Samhita. Charaka Samhita describes the chikitsa stana as the most important part of therapeutics which deals with different branches of treatment as shown in the Table 1.1 and the types of drug formulations in ayurveda was given in Table 1.2 (Ben-Eric Van Wyk and Michael Wink., 2004). Table 1.1. Various branches of treatment in Ayurveda Sl.No. Type of Chikitsa Treatment 1 Kayachikitsa General Medicine 2 Shalakyatantra Treatment of diseases above clavicular region by shalaka 3 Shalyatantra Acute and Chronic diseases caused due to foreign bodies 4 Vishagaravairodhika chikitsa Toxic substances 5 Rasayan chikitsa Promotional health 6 Vajeekaranam Diseases of genital organs 7 Koumaryabhryatya tantra For Pediatric diseases 8 Bhutavidya For diseases which have no logical causative factor Table 1.2. Types of drug formulations in Ayurveda Sl.No. Nature of Formulation Type of Formulation 1 Powders Churna, Bhasma, Satva, Rasayan, Pishti, Mandur, Parpati, Kshar. 2 Tablets Vatika, Gutika, Vati. 3 Semisolids Kalka, Ghritha Malam, Avaleha, Rasayoga 4 Liquids Swaras, Putpak, Manda, Kwath, Phanta, Hima, Taila, Asava, Arishta, Arka, Drawana 3

5 Many herbal drug formulations have been discovered and developed from plant actives and extracts for the treatment of many diseases. They were being used because of their milder action without the undesirable properties of synthetic drugs. But these herbal drugs are having many disadvantages like less stability, low bioavailability etc., and to overcome these problems nowadays, various novel drug delivery formulations have been developed. These novel formulations were reported to have remarkable advantages over conventional formulations of plant actives and extracts, which include enhancement of solubility, bioavailability, protection from toxicity, enhancement of pharmacological activity, enhancement of stability, improved tissue macrophages distribution, sustained delivery and protection from physical and chemical degradation. 1.4 Types of Novel Herbal Formulations By using the bioactive molecules of plants and plant extracts various types of novel herbal formulations like polymeric nanoparticles, nanocapsules, liposomes, phytosomes, nanoemulsions, microsphere, transferosomes and ethosomes has been developed. The various types of novel herbal formulations are given in the Table 1.3 and the marketed novel drug delivery formulations of plant actives and extracts were given in the Table1.4 (Ajazuddin and Saraf, 2010). Sl.No Table 1.3. Types of Novel Herbal Formulations Types of novel herbal Formulations Emulsions (Ajazuddin and Saraf, 2010) Microspheres (Sanli et al., 2009) Nanoparticles (Zhinan et al., 2005) Liposomes (Aroonsri et al., 2008) Phytosomes (Suresh and Vandana, 2008) Formulation Example Self-nanoemulsifying Zedoary essential oil, Docetaxel submicron emulsion, Quercetin microemulsion, Berberine nanoemulsion Rutin alginate chitosan microcapsules, CPT loaded microspheres, Cynara scolymus microspheres, Zedoary oil microsphere Triptolide nanoparticle, Nanoparticles of Cuscuta chinensis, Naringenin-loaded Nanoparticles, Ginkgo biloba nanoparticles Quercetin liposomes, Paclitaxel liposome, Flavonoids liposomes, Breviscapine liposomes, Catechins liposomes, Liposoma Artemisia arborescens Ginkgoselect phytosome, Silybin phytosome, Grape seed phytosome, Green tea phytosome 4

6 Table 1.4. Marketed novel drug delivery formulations of plant actives and extracts ( Sl.No. Brand Name Plant active/extracts Type of NDDS Company Name 1 White tea liposome Camellia sinensis Herbasec extract Liposome Cosmetochem 2 Green tea liposome Camellia sinensis Herbasec Extract Liposome Cosmetochem 3 Guarana liposome Herbasec Guarana extract Liposome Cosmetochem 4 Centella Phytosome Triterpenes from Centella asiatica leaf Phytosome Indena 5 Crataegus Phytosome Vitexin-2 -Orhamnoside from Hawthorn flower Phytosome Indena 1.5 Future direction and scope The herbal scenario in the 21 st century is marked by stiff competition amongst the pharmaceutical industries. Such competition is prompted by the fact that herbal drugs are user friendly due to their natural origin and lesser side effects (Chirangini et al., 2006). The widespread use of herbs in traditional medicine has also prompted demands that herbal remedies be regulated as drugs to ensure quality standards and to prove its scientific basis. Inspite of several biological activities being shown by different herbal extracts, only a small percentage of the diverse plant resources have been investigated so far. With the advent of biotechnology, new frontiers in the treatment of diseases like personalized medicine will open up and this will provide new scope and opportunities for the growth of the herbal industry. Laboratories around the world are engaged in the screening of plants with therapeutic potential for biological activity. Therefore, the determination of the criteria for selecting plants for phytotherapeutic investigation is perhaps an important exercise as the investigation itself. 5

7 The following selection criteria are suggested (Elizabeth et al., 1978). 1. Selection based on traditional usage 2. Poisonous plants 3. Selection based on chemical composition 4. Screening for specific biological activity 5. Combination of criteria In eastern countries like India and China, medicinal plants have been used to treat human diseases for centuries and people are more interested in medicinal plants because of their high therapeutic potential, low toxicity and cost effective when compared to synthetic drugs. The enormous therapeutic potential of herbal drugs should be explored through some value added drug delivery systems. For oral and topical administration of drug molecules, lipid solubility and molecular size are major limiting factors for crossing the biological membrane and entering the systemic circulation. Several plant extracts and phytomolecules, despite having excellent bioactivity in vitro demonstrate less or no in vivo actions due to their poor lipid solubility or improper molecular size or both, resulting poor absorption and poor bioavailability. Standardized plant extracts or mainly polar phytoconstituents like flavonoids, lignans, terpenoids, tannins, xanthones when administered through novel drug delivery system (NDDS) show much better absorption profile which enables them to cross the biological membrane, resulting enhanced bioavailability. More amount of active constituent becomes present at the site of action (liver, brain, heart, kidney, etc.) at similar or less dose as compared to the conventional plant extract or phytomolecules thus enhancing the therapeutic action, which is more detectable and prolonged. Several excellent phytoconstituents have been successfully delivered using NDDS. Hence, there is a great potential in the development of novel drug delivery systems for the plant actives and extracts. 6

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