Phytochemical Reference Standards of Selected Indian Medicinal Plants (Set of 3 Volumes)

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ISBN: 9770976605004

India is well known for its biodiversity. However, the full potential of medicinal plants has not been significantly exploited for drug development. As per reports only about 70 per cent of the flora has been investigated. Moreover, there is a global awareness of the role of plant based I derived drugs in therapeutics. Recommendations for an integrative system of medicine are pouring in. The main impediment in the popularity of herbal drugs is the inadequacy and non availability of authentic methods of their standardization and this has been emphasized at various national and international levels. To address this issue ICMR has initiated a programme of development of 'Quality Standards of lndian Medicinal Plants' in 2001 and is continuing till date. Though a standard TLCIHPTC/HPLC/finger print can serve the purpose, the method of standardization becomes more authentic when a Phytochemical Reference Standard (PRS) is used along with.

Ideally, a PRS should be therapeutically active compound but in majority of the plant based drugs, therapeutic activity is attributed to a number of phytoconstituents present in the plant. Under such circumstances where single therapeutically active compound has not been identified, any compound unique to the plant or major phytochemical constituent which can be helpful in developing assay method can be used as PRS. International agencies like World Health Organization (WHO), United Nations Industrial Development Organization (UNIDO), International Centre for Science and High Technology (ICS) and Asia Pacific Centre for Transfer of Technology (APCTT) have also emphasized the need of herbal drug standardization using a PRS. Availability of the PRS is, therefore, essential for standardization of any plant extract. A need for PRS has been realized not only by plant based traditional medicine practitioners but also by Indian Pharmacopoeial Commission, Ayurvedic Pharmacopoeial Committee and the National Medicinal Plant Board. With this background, a programme has been initiated to prepare a repository of PRS (markers), which can be made available to the users on commercial or non commercial basis. To meet this goal a laboratory with expertise in isolation techniques of natural products was a prerequisite. To start with Agharkar Research Institute, Pune has been selected for the purpose and information on first thirty PRS is presented in this volume. These PRS are isolated from the plants, correctly identified by the taxonomists. The isolated PRS are being chemically characterized with the help of modem analytical techniques (lR, NMR, MS). A herbarium sheet of each of these plants is also maintained along with the repository.

I appreciate the efforts of Chairman and the members of the committee viz., Scientific Advisory Group, the Task Force and the Technical Review Committee in strengthening this process. The role played by the researchers at Agharkar Research Institute, Pune in executing this programme is commendable.

It is well known that majority of the world population (nearly four billion) relies on the plant based drugs for health care. The efficacy and safety of these drugs depend largely on their authenticity and quality. Thus effective methods of standardization and quality control of the plant drugs as well as of these extracts are necessary.

To address this issue, Indian Council of Medical Research initiated a programme for laying down Quality Standards of Indian Medicinal Plants. Special emphasis was laid on chromatographic finger printing of the extracts and assay using phytochemical reference standard as one of the parameters of identity, purity and quality under this programme. Eight volumes of 'Quality Standards of Indian Medicinal Plants' have come out so far from this work covering a total of 274 plants. The publications are well received by Indian Pharmacopoeial Commission, Ayurvedic Pharmacopoeial Committee, researchers,pharmaceutical industries in India and United States Pharmacopoeial convention, USA.

Since the process of chromatographic fingerprinting and assay method depend on the phytochemical reference standard (PRS) compounds, it was thought worthwhile to have a repository of these PRS. Accordingly, a project on 'Generation of Phytochemical Reference Standards (PRS) and the Development of Repository for PRS of Indian Medicinal Plants' was initiated by ICMR at Agharkar Research Institute, Pune in 2007 with specific focus on the development of methods to isolate the PRS in sufficient quantities in pure form and fully characterize them by generating all the necessary physico-chemical and spectral data. UV- VIS, IR, IH MR and i3C MR spectra of each PRS have been incorporated for the convenience of those who intend to isolate PRS on their own and want to confirm the authenticity of the isolated PRS by comparison with the given spectral data. Mass spectral data are also presented in some cases.

Isolation of thirty PRS compounds from some frequently used medicinal plants has been completed so far. Monographs of these PRS are presented in this volume. It is hoped that the effort of ICMR will be useful to all stakeholders involved in developing pharmacopoeial standards, industrial houses within the country and abroad in providing quality plant raw material, ASU drug industry and state drug laboratories engaged in quality control of ASU drugs, practitioners of indigenous systems of medicine, academicians, researchers and health professionals as well as for the regulatory authorities and Indian Pharmacopoeial Commission. Hopefully, the programme of generation of markers will continue and we will have a state of the art repository of PRS.

Plant based drugs are being increasingly used in recent times all over the world. However, their standardization has become a matter of great concern in getting a wider acceptance for them. Further, non-availability of genuine Phytochemical Reference Standards (PRS) puts a serious limitation in the process of standardization. For this purpose the concerned stakeholders would be in need of the detailed procedure of isolation of PRS with all spectral data needed for their correct identification and characterization.

To address this, Medicinal Plants Unit of the Indian Council of Medical Research has initiated a programme for generation of PRS for some frequently used Indian medicinal plants. Under this programme, simple procedure for isolation of the PRS has been adopted making appropriate modifications in the method reported in the literature. The quantification of PRS in the plant part used was also meticulously carried out. Special emphasis has been laid on complete characterization of the PRS by recording the physico-chemical and spectral data. Extensive use of spectral methods like UV- VIS, IR, IH NMR and i3C NMR spectroscopy have been made for this purpose. Incorporation of the original spectra and their interpretation was also thought to be useful for the stakeholders. Besides this, a comprehensive literature search was carried out and all other chemical constituents are listed to give a clear idea about the complexity of the extract. Illustrations of chromatographic fingerprinting of the plant extract with the isolated PRS using TLC and HPLC have been given. The profiling by gas chromatography was also carried out for the volatile PRS.

Information on the other plant sources yielding the same PRS can also be of interest in certain situations. Such information was also generated and included under each monograph. Based on all these data, monographs of 30 PRS compounds are presented in this volume. The monographs are compiled and presented in the standard format as follows:

• Generic name and the IUPAC name of the PRS.
• Structure of the PRS.
• Plant species, along with its family, and its part used for the isolation.
• Photographs of the plant and plant part used.
• Occurrence of the PRS in other plants as reported in the literature.
• Detailed procedure for the isolation of the PRS.
• Characterization of the PRS
  • Physical data: Nature of the PRS, mp/bp, optical rotation and solubility in different solvents.
  • Data on molecular formula, molecular weight and elemental composition.
  • UV- VIS, IR, IH NMR and i3C NMR spectral data along with original spectrum and detailed interpretation. Mass spectral data are also presented in some cases.
• Chromatographic finger printing of the plant material with reference to the PRS
  • Reported major and other chemical constituents are listed.
  • Structure of important chemical constituents are presented.
  • Details of TLC studies with reference to PRS are given along with representative chromatograms.
  • Details of HPLC assay of total plant extract with reference to the PRS are given along with representative chromatograms.
  • GC profile, wherever applicable, is also given with representative chromatograms.
• List of all the relevant references is provided.

Relevant appendices giving materials and methods (Appendix I), extraction methods (Appendix II), separation techniques used (Appendix III) and indices on chemical constituents (Index I) and botanical names of plants (Index II) are given at the end.

ISBN: 9770976605004

Phytochemical Reference Standards (PRS) have a special status in standardization of herbal drugs. Ideally the PRS should be a therapeutically active compound. However in majority of the plant based drugs, the therapeutically active compounds have not been identified. Under such circumstances any compound unique to the plant or major phytochemical constituent which can be helpful in developing assay method can be used as a PRS. International agencies like World Health Organization (WHO), United Nations Industrial Development Organization (UNIOO), International Centre for Science and High Technology (ICS) and Asia Pacific Centre for Transfer of Technology (APCTT) have also emphasized the need for herbal drug standardization to develop safe and efficacious drugs. TLC and HPLC fingerprint profiles of the plant extracts can be worked out with the help of the suitable PRS. Availability of the PRS is, therefore, an important requirement of the herbal drugs standardization. A need for PRS has been realized not only by herbal drug industries but also by Indian Pharmacopoeial Commission, Ayurvedic Pharmacopoeial Committee and the National Medicinal Plant Board. With this background, a programme was initiated to isolate the PRS from the selected medicinal plants, optimize the procedure of isolation and characterize them completely. Information on first thirty marker compounds was presented in the first volume on 'Phytochemical Reference Standards of Selected Indian Medicinal Plants' brought out in 2010. It was greatly appreciated and well received in India and abroad by all those actively involved in the field.

Encouraged by the response, efforts to characterize the PRS were continued with much more vigor which resulted into the preparation of next thirty monographs presented in this volume which is second in the series. The role played by the researchers at Agharkar Research Institute, Pune and Natural Remedies Private Limited, Bangalore is praiseworthy in bringing out this volume. I appreciate the efforts of the Chairman and the members of the various Committees viz., Scientific Advisory Group, the Task Force and the Technical Review Committee.

I hope that this volume will be well-received by the active researchers and the personnel involved in pharmacopoeial standards and industrial houses within the country and abroad.

Emphasis of the world has shifted to the plant based drugs in the last few decades. These drugs are manufactured by different industrial houses all over the world. In fact, many industries located in different parts of the world are involved in the manufacture of the same drugs. Authentication, standardization and quality control of these drugs attain a paramount importance in such situations.

To address this issue, Indian Council of Medical Research initiated a programme for laying down Quality Standards of Indian Medicinal Plants. Nine volumes of Quality Standards of Indian Medicinal Plants have come out so far from this work covering a total of 309 plants. The publications have been appreciated not only by the academic institutions but also by industrial houses and Pharmacopoeial Commissions.

The methods standardized involved the chromatographic fingerprinting of the plant extracts with reference to a suitable marker compound usually designated as 'Phytochemical Reference Standard (PRS)’. Availability of PRS, thus, becomes a key factor in carrying out the standardization. Realizing this, a new programme on generation of PRS was initiated by ICMR five years ago with specific focus on the development of methods to isolate the PRS in sufficient quantities in pure form and fully characterize them by generating all the necessary physio-chemical and spectral data. UV- VIS, IR, IHNMR and i3C NMR spectra of each PRS have been incorporated for the convenience of those who intend to isolate PRS on their own and want to confirm the authenticity of the isolated PRS by comparison with the given spectral data. Mass spectral data are also presented in some cases. Further a repository of the isolated compounds is also being developed for these reference standards. Monographs of the first thirty PRS were published in 2010 in the first volume of 'Phytochemical Reference Standards of Selected Indian Medicinal Plants'. This book was also well received in India and abroad. This enhanced confidence of regulatory authorities in this programme and ICMR tried to strengthen this programme further. The result of these efforts is the present second volume of 'Phytochemical Reference Standards of Selected Indian Medicinal Plants' covering another thirty monographs.

It is hoped that this volume will be found useful by the stakeholders involved in developing pharmacopoeial standards, industrial houses within the country and abroad in providing quality plant raw material.

Preparation of the third volume in the series is in progress.

ISBN: 97709766050024

Phytochemical Reference Standards (PRS) have a special status in standardization of herbal drugs. Ideally the PRS should be a therapeutically active compound. However in majority of the plant based drugs, the therapeutically active compounds have not been identified. Under such circumstances any compound unique to the plant or major phytochemical constituent which can be helpful in developing assay method can be used as a PRS. International agencies like World Health Organization (WHO), United Nations Industrial Development Organization (UNIDO), International Centre for Science and High Technology (lCS) and Asia Pacific Centre for Transfer of Technology (APCTT) have also emphasized the need for herbal drug standardization. TLC and / or HPLC fingerprint profile of the plant extracts can be worked out with the help of the suitable PRS. Availability of the PRS is, therefore, an important requirement of the herbal drugs standardization. A need for PRS has been realized not only by herbal drug industries but also by Indian Pharmacopoeial Commission, Ayurvedic Pharmacopoeial Committee and the National Medicinal Plant Board. With this background, a programme was initiated to isolate the PRS from the selected medicinal plants, optimize the procedure of isolation and characterize them completely. Information on sixty PRS was presented in the earlier published two volumes on 'Phytochemical Reference Standards of Selected Indian Medicinal Plants'. It was greatly appreciated and well received in India and abroad by all those actively involved in the field.

Encouraged by the response, efforts to characterize the PRS were continued with much more vigor which resulted into the preparation of next thirty monographs. These monographs are presented in the present third volume. These phytochemical reference standards isolated from the plants were correctly identified by the taxonomists. A voucher specimen of each of these plants is also maintained.

The role played by the researchers at Agharkar Research Institute, Pune and Natural Remedies Pvt. Ltd., Bangalore is praiseworthy in bringing out this volume. I appreciate the efforts of the Chairman and the members of the various Committees viz., Scientific Advisory Group, the Task Force and the Technical Review Committee.

I hope that this volume will be well-received by the active researchers and the personnel involved in pharmacopoeial standards and industrial houses within the country and abroad.

Emphasis of the world has shifted to the plant based drugs in the last few decades. These drugs are manufactured by different industrial houses all over the world. In fact, many industries located in different comers of the world are involved in the manufacture of the same drugs. Authentication, standardization and quality control of these drugs attain a paramount importance in such situations.

Indian Council of Medical Research realized this requirement and initiated a programme on development of quality standards for Indian medicinal plants. These efforts resulted into the publication of twelve volumes of 'Quality Standards of Indian Medicinal Plants'. More than 400 medicinal plants are covered in these volumes. These volumes have been appreciated not only by the academic institutions but also by industrial houses and Pharmacopoeial commissions.

The methods standardized involved the chromatographic fingerprinting of the plant extracts with reference to a suitable marker compound usually designated as 'Phytochemical Reference Standard (PRS),. Availability of PRS, thus, becomes a key factor in carrying out the standardization. Realizing this new programme on generation of marker compounds was initiated by ICMR seven years ago. PRS from selected Indian Medicinal Plants were isolated and completely characterized under this programme. Further a repository of the isolated compounds is also being developed for reference. Monographs of the 60 PRS were published in the earlier two volumes of 'Phytochemical Reference Standards of Selected Indian Medicinal Plants'. These volumes were well received both in India and abroad. United States Pharmacopoeia appreciated the two volumes in their annual meeting held in Hyderabad. This enhanced confidence of regulatory authorities in this programme and ICMR tried to strengthen this programme further. The result of these efforts is the present third volume of 'Phytochemical Reference Standards of Selected Indian Medicinal Plants' covering another thirty monographs.

It is hoped that this volume will be found useful by the stakeholders involved in developing pharmacopoeial standards, industrial houses within the country and abroad in providing quality plant raw material.

Preparation of fourth volume in the series is in progress.