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E-raamat: Fingerprinting Analysis and Quality Control Methods of Herbal Medicines

, , (University Institute of Pharmacy, Pt. Ravi), (Associate Professor, Department of Analytical Chemistry, Columbia Institute of Pharmacy, India), (Associate Professor, Department of Natural Products, Columbia Institute of Pharmacy, India),
  • Formaat: 224 pages
  • Ilmumisaeg: 03-Jul-2018
  • Kirjastus: CRC Press
  • Keel: eng
  • ISBN-13: 9780429682834
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Fingerprinting Analysis and Quality Control Methods of Herbal MedicinesSuurem pilt
  • Formaat: 224 pages
  • Ilmumisaeg: 03-Jul-2018
  • Kirjastus: CRC Press
  • Keel: eng
  • ISBN-13: 9780429682834
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Due to the increase in the consumption of herbal medicine, there is a need to know which scientifically based methods are appropriate for assessing the quality of herbal medicines. Fingerprinting has emerged as a suitable technique for quality estimation. Chemical markers are used for evaluation of herbal medicines. Identification and quantification of these chemical markers are crucial for quality control of herbal medicines. This book provides updated knowledge on methodology, quality assessment, toxicity analysis and medicinal values of natural compounds.

List of Figures xv
List of Tables xvii
Preface xix
Authors xxi
Chapter 1 Introduction 1(12)
1.1 Herbal Drugs
2(1)
1.2 Terms Relating to Herbal Medicines
2(1)
1.2.1 Herbal Medicines
2(1)
1.2.2 Herbal Materials
3(1)
1.2.3 Herbal Preparations
3(1)
1.2.4 Finished Herbal Products or Herbal Medicinal Products
3(1)
1.3 Indian System of Medicine (ISM)
3(2)
1.4 Herbal Regulation in India
5(1)
1.5 Risk Assessment
6(1)
1.6 Quality Control of Herbal Drugs
6(2)
1.6.1 Identity
6(1)
1.6.2 Purity
6(1)
1.6.3 Content or Assay
7(1)
1.6.4 Several Problems Influence the Quality of Herbal Drugs
8(1)
1.7 Standardization of Herbal Formulation
8(3)
1.7.1 Specification
9(1)
1.7.2 Specifications for Herbal Substances
9(1)
1.7.3 Characterization
9(1)
1.7.4 Pharmacopoeial Tests and Acceptance Criteria
10(1)
1.7.5 In-Process Tests
10(1)
1.7.6 Reference Standard
10(1)
1.8 Drug Adulteration
11(1)
1.9 Conclusion
11(1)
References
12(1)
Chapter 2 Method of Extraction 13(18)
2.1 Introduction
13(1)
2.2 Solvent for Extraction
13(1)
2.3 Selection of the Solvents
14(1)
2.4 Regeneration of the Solvent
14(1)
2.5 Solutions (Solute and Solvent)
15(1)
2.6 Factors Affecting Choice of Extraction Process
15(1)
2.6.1 Character of Drug
15(1)
2.6.2 Therapeutic Value of the Drug
15(1)
2.6.3 Stability of Drug
16(1)
2.6.4 Cost of Drug
16(1)
2.6.5 Solvent
16(1)
2.6.6 Concentration of Product
16(1)
2.6.7 Recovery of Solvent from the Marc
16(1)
2.7 Procedures for Extraction of Herbal Drugs
16(13)
2.7.1 Maceration
17(2)
2.7.1.1 Modification of General Processes of Maceration
18(1)
2.7.2 Vortical or Turbo Extraction
19(1)
2.7.3 Ultrasound Extraction
19(1)
2.7.4 Extractions by Electrical Energy
20(1)
2.7.5 Percolation and Re-Percolation
20(2)
2.7.5.1 Percolation Procedure
21(1)
2.7.5.2 Modification of the General Process of Percolation
21(1)
2.7.5.3 Reserved Percolation
22(1)
2.7.6 Cover and Run Down Method
22(1)
2.7.7 Small Scale or Laboratory Scale Extraction
23(2)
2.7.7.1 Hot Continuous Extractions: Soxhletion
23(1)
2.7.7.2 Continuous Apparatus (Official Extractor)
23(2)
2.7.8 Large Scale Extractor (Counter Current Extractions)
25(1)
2.7.9 Infusion and Decoction
26(1)
2.7.9.1 General Method for Preparing Fresh Infusion
26(1)
2.7.10 Aqueous Alcoholic Extraction by Fermentation
26(1)
2.7.11 Steam Distillation
27(1)
2.7.12 Supercritical Fluid Extractions
27(1)
2.7.13 Phytonics Process
28(1)
2.7.14 High Pressure Extraction (HPE)
28(1)
2.8 Conclusions
29(1)
References
29(2)
Chapter 3 Separation and Isolation of Plant Constituents 31(8)
3.1 Introduction
31(1)
3.2 Classes of Phyto-Constituents
31(5)
3.2.1 Glycosides
31(1)
3.2.2 Alkaloids
32(1)
3.2.3 Flavonoids
33(1)
3.2.4 Terpenes
34(1)
3.2.5 Phenolics
35(1)
3.2.6 Saponins
35(1)
3.2.7 Tannins
36(1)
3.2.8 Steroids
36(1)
References
36(3)
Chapter 4 Methods of Phyto-Constituent Detection 39(6)
4.1 Introduction
39(1)
4.2 Phytochemical Analysis
39(4)
4.2.1 Phytochemical Analysis Tests for Alkaloids
39(1)
4.2.2 Phytochemical Screening of Anthocyanin
40(1)
4.2.3 Phytochemical Analysis Tests for Anthraquinone
40(1)
4.2.4 Phytochemical Analysis Test for Cardiac Glycosides
40(1)
4.2.5 Phytochemical Analysis Tests for Coumarins
40(1)
4.2.6 Phytochemical Analysis Tests for Cynogenetic Glycosides
41(1)
4.2.7 Phytochemical Analysis Tests for Phenolics and Flavonoids
41(1)
4.2.8 Phytochemical Analysis Test for Saponins
41(1)
4.2.9 Phytochemical Analysis Tests for Triterpenes
42(1)
4.2.10 Phytochemical Analysis Tests for Steroids
42(1)
4.2.11 Phytochemical Analysis Tests for Tannins
42(1)
4.2.12 Phytochemical Analysis Tests for Fixed Oils and Fats
43(1)
4.2.13 Phytochemical Analysis Test for Gums and Mucilages
43(1)
4.2.14 Phytochemical Analysis Tests for Lactones
43(1)
4.2.15 Phytochemical Analysis Test for Diterpenes
43(1)
4.3 Conclusion
43(1)
References
44(1)
Chapter 5 Regulatory Aspects for Herbal Drugs 45(10)
5.1 Introduction
45(1)
5.2 Regulation
46(1)
5.2.1 Aim of Regulatory Guidelines for Herbal Medicines
46(1)
5.2.2 Regulation and Registration of Herbal Medicines
46(1)
5.3 WHO Regulatory Requirements
47(3)
5.3.1 Objectives
48(1)
5.3.2 Guidelines for the Regulation of Herbal Medicines in the Southeast Asia Region
48(1)
5.3.3 WHO Guidelines on Safety Monitoring of Herbal Medicines in Pharmacovigilance Systems
48(1)
5.3.4 WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants
48(1)
5.3.5 National Policy on Traditional Medicine (TM) and Regulation of Herbal Medicine
49(1)
5.3.6 WHO Guidelines for Quality Control of Herbal Formulation
49(1)
5.3.7 WHO Guidelines for Herbal Drug Standardization
49(1)
5.4 Herbal Drug Regulations in India
50(1)
5.5 Regulatory Aspects and Approval of Herbal Drugs in Different Countries
51(2)
5.5.1 European Herbal Guidelines
52(1)
5.5.1.1 European Medicines Agency-EMA
52(1)
5.5.2 United States of America
52(1)
5.5.3 Australia
53(1)
References
53(2)
Chapter 6 Ethnopharmacology of Medicinal Plants 55(6)
6.1 Introduction
55(1)
6.2 Phytotherapy
55(1)
6.3 Practicing Herbal Medicine
56(1)
6.4 Need of Documentation of Ethnopharmacological Plants
57(1)
6.5 Ethnopharmacognostical Studies of Medicinal Plants of Chhattisgarh, India
57(2)
6.6 Conclusion
59(1)
References
59(2)
Chapter 7 Quality Control of Herbal Medicine 61(14)
7.1 Introduction
61(1)
7.2 Quality Control: Present Scenario
61(1)
7.3 Quality Control of Herbal Drugs
62(1)
7.3.1 Identity
62(1)
7.3.2 Purity
63(1)
7.3.3 Content or Assay
63(1)
7.4 Stability Studies of Herbal Medicines
63(4)
7.4.1 Specific Characteristics of Herbal Medicinal Products
64(1)
7.4.2 Analytical Methods for Herbal Products
64(1)
7.4.3 Stability Study of Herbal Drugs
64(1)
7.4.4 Shelf Life
65(1)
7.4.5 Challenges in Stability Testing of Herbal Medicinal Products
65(1)
7.4.6 Predictable Changes in Herbal Drug Material
65(1)
7.4.7 Importance of Stability Testing
66(1)
7.5 Biological Markers for Herbal Medicines
67(4)
7.5.1 Markers are Categorized into Two Classes
67(12)
7.5.1.1 DNA Markers
67(1)
7.5.1.2 Chemical Markers
68(3)
7.6 Conclusion
71(1)
References
72(3)
Chapter 8 Bioavailability of Herbal Drugs 75(4)
8.1 Need for Bioavailability Enhancers
75(1)
8.2 Drug Absorption Barriers
76(1)
8.3 Mechanism of Action of Bioenhancers
76(1)
8.4 Medicinal Plants and their Compounds as Drug Bioavailability Enhancers
77(1)
References
78(1)
Chapter 9 Thermal Analysis of Herbal Drugs 79(6)
9.1 Introduction
79(5)
9.1.1 Thermogravimetry (TG)
79(1)
9.1.1.1 Characteristics
80(1)
9.1.1.2 Applications of Thermogravimetric Analysis
80(1)
9.1.2 Differential Thermal Analysis (DTA)
80(1)
9.1.2.1 Characteristics
80(1)
9.1.2.2 Applications
81(1)
9.1.3 Dynamic Mechanical Analysis (DMA)
81(1)
9.1.3.1 Principles of DMA
81(1)
9.1.3.2 Instrument and Working of DMA
81(1)
9.1.4 Thermomechanical Analysis (TMA)
82(13)
9.1.4.1 Instrumentation of TMA
82(1)
9.1.4.2 Applications of TMA
83(1)
9.2 Conclusion
84(1)
References
84(1)
Chapter 10 Validation of Herbal Drugs 85(4)
10.1 Introduction
85(1)
10.2 Concept of Validation
86(1)
10.3 Validation of Herbal Drugs
86(1)
10.4 Process Validation
87(1)
10.5 Validation According to WHO
87(1)
10.6 Value Addition
87(1)
10.7 Conclusion
88(1)
References
88(1)
Chapter 11 Stability Study of Plant Products 89(6)
11.1 Introduction
89(1)
11.2 Role of Markers
90(1)
11.3 Analytical Methods for Herbal Products
90(1)
11.4 Shelf Life
91(1)
11.5 Challenges in Stability Testing of Herbal Medicinal Products
91(1)
11.6 Predictable Changes in Herbal Medicinal Products
92(1)
11.7 Novel Approaches for Stability Improvements in Natural Medicines
93(1)
11.8 Conclusion
93(1)
References
94(1)
Chapter 12 Fingerprinting Techniques for Herbal Drugs Standardization 95(18)
12.1 Introduction
95(1)
12.2 Phytoequivalence and Chromatographic Fingerprints of Herbal Medicines
95(14)
12.2.1 Evaluation of Chemical Fingerprints of Herbal Medicines
96(17)
12.2.1.1 Chromatographic Fingerprinting
97(8)
12.2.1.2 DNA Fingerprinting
105(4)
12.3 Summary
109(1)
References
110(3)
Chapter 13 Spectroscopic Techniques 113(8)
13.1 Introduction
113(5)
13.1.1 Ultraviolet Spectroscopy (UV)
113(1)
13.1.2 Infrared Spectroscopy (IR)
114(1)
13.1.3 Fourier Transform Infrared (FTIR) Spectroscopy
115(1)
13.1.3.1 Principle
115(1)
13.1.4 Mass Spectroscopy
116(1)
13.1.5 NMR Spectroscopy
117(1)
13.2 Conclusion
118(1)
References
119(2)
Chapter 14 Standardization of Herbal Drugs 121(32)
14.1 Introduction
121(2)
14.2 Different Techniques Involved in Standardization of Crude Drugs
123(8)
14.2.1 Botanical Methods
123(1)
14.2.1.1 Macroscopic Methods
123(1)
14.2.2 Microscopic Methods
124(3)
14.2.2.1 Microscopical Examination
125(2)
14.2.3 Powder Studies
127(1)
14.2.4 Histochemical Detection
128(2)
14.2.4.1 Cellulose Cell Walls
129(1)
14.2.4.2 Lignified Cell Walls
129(1)
14.2.4.3 Suberized or Cuticular Cell Walls
129(1)
14.2.4.4 Aleurone Grains
129(1)
14.2.4.5 Calcium Carbonate
129(1)
14.2.4.6 Calcium Oxalate
129(1)
14.2.4.7 Fats, Fatty Oils, Volatile Oils, and Resins
129(1)
14.2.4.8 Hydroxyanthraquinones
130(1)
14.2.4.9 Inulin
130(1)
14.2.4.10 Mucilage
130(1)
14.2.4.11 Starch
130(1)
14.2.4.12 Tannin
130(1)
14.2.4.13 Leaf Stomata
130(1)
14.2.5 Measurement of Specimen
130(1)
14.2.5.1 Determination of the Stomatal Index
131(1)
14.3 Physical Standardization of Herbal Drugs
131(7)
14.3.1 Foreign Organic Matter
132(1)
14.3.2 Viscosity
132(1)
14.3.3 Melting Point
132(1)
14.3.4 Solubility
132(1)
14.3.5 Moisture Content and Volatile Matter
132(1)
14.3.6 Optical Rotation
133(1)
14.3.7 Refractive Index
133(1)
14.3.8 Ash Values and Extractives
133(1)
14.3.9 Total Ash
133(1)
14.3.9.1 Determination of Total Ash
133(1)
14.3.10 Acid Insoluble Ash
134(1)
14.3.10.1 Determination of Acid Insoluble Ash
134(1)
14.3.11 Water Soluble Ash
134(1)
14.3.11.1 Determination of Water Soluble Ash
134(1)
14.3.12 Bitterness Value
134(1)
14.3.13 Hemolytic Activity
135(1)
14.3.14 Swelling Index
135(1)
14.3.15 Foaming Index
136(1)
14.3.15.1 Procedure
136(1)
14.3.16 Extractive Value
136(1)
14.3.17 Total Solid Content
136(1)
14.3.18 Water Content
137(1)
14.3.19 Volatile Oil Content
137(1)
14.3.20 Determination of Tannins
137(1)
14.3.21 Loss on Drying (Volatile Matter)
138(1)
14.4 Chemical Methods
138(5)
14.4.1 Analytical Methods
138(1)
14.4.2 Thin Layer Chromatography (TLC)
139(2)
14.4.2.1 Equipment
140(1)
14.4.2.2 Methodology
140(1)
14.4.2.3 Determination of Rf Value
141(1)
14.4.3 Chemical Examination of Herbal Drugs
141(2)
14.4.3.1 Detection of Alkaloids
141(1)
14.4.3.2 Detection of Carbohydrates and Glycosides
142(1)
14.4.3.3 Detection of Phytosterols
142(1)
14.4.3.4 Detection of Fixed Oils and Fats
142(1)
14.4.3.5 Detection of Saponins
142(1)
14.4.3.6 Detection of Phenolic Compounds and Tannins
142(1)
14.4.3.7 Detection of Proteins and Free Amino Acids
142(1)
14.4.3.8 Detection of Gums and Mucilages
142(1)
14.4.3.9 Detection of Volatile Oil
142(1)
14.4.4 Radioactive Contamination
143(1)
14.5 Biological Methods
143(6)
14.5.1 Bioassay
143(3)
14.5.1.1 Types of Bioassays
144(2)
14.5.2 Microbial Contamination
146(1)
14.5.2.1 Total Viable Aerobic Count
146(1)
14.5.2.2 Aflatoxins
147(1)
14.5.3 Toxicological Standardization
147(6)
14.5.3.1 Pesticides
148(1)
14.5.3.2 Determination of Arsenic and Heavy Metals
148(1)
14.6 Validation
149(1)
14.7 Determination of Arsenic and Heavy Metals
149(1)
14.8 Conclusion
150(1)
References
150(3)
Chapter 15 Omics Techniques 153(4)
15.1 Introduction
153(1)
15.2 Omics Techniques
153(2)
15.2.1 Genomics and its Modified Techniques
153(1)
15.2.2 Proteomics
153(1)
15.2.3 Transcriptomics
154(1)
15.2.4 Metabolomics
154(1)
15.2.5 Application of Omics Techniques in the Context of Herbal Medicine
155(1)
15.3 Conclusion
155(1)
References
156(1)
Chapter 16 Toxicity Study of Plant Materials 157(12)
16.1 Introduction
157(1)
16.2 Need of Herbal Toxicity Testing
157(4)
16.3 Toxicity of Herbs
161(1)
16.4 Safety and Efficacy of Herbals
162(1)
References
163(6)
Chapter 17 Biological Markers for Quality Control of Herbal Medicines 169(8)
17.1 Introduction
169(1)
17.2 Markers are Categorized into Two Classes
169(5)
17.2.1 DNA Markers
170(1)
17.2.1.1 Applications of Biological Markers
170(1)
17.2.2 Chemical Markers
171(6)
17.2.2.1 Therapeutic Components
171(1)
17.2.2.2 Bioactive Components
171(1)
17.2.2.3 Synergistic Components
171(1)
17.2.2.4 Characteristic Components
172(1)
17.2.2.5 Main Components
172(1)
17.2.2.6 Correlative Components
173(1)
17.2.2.7 Toxic Components
173(1)
17.2.2.8 Applications of Chemical Markers
173(1)
17.3 Conclusion
174(1)
References
174(3)
Chapter 18 Pollutants for Herbal Drugs 177(10)
18.1 Introduction
177(1)
18.2 WHO Guidelines for Contaminants and Residues
177(1)
18.2.1 Pesticides
178(1)
18.2.2 Pesticide Residue
178(1)
18.2.3 Pesticidal Toxicity
178(1)
18.3 Heavy Metal Toxicity to Plants
178(1)
18.4 Potentially Hazardous Contaminants and Residues in Herbal Medicines
179(1)
18.5 Chemical Contaminants
179(3)
18.5.1 Toxic Metals and Non-Metals
179(1)
18.5.2 Persistent Organic Pollutants (POPs)
179(3)
18.5.3 Residual Solvents
182(1)
18.6 Radioactive Contamination
182(1)
18.7 Mycotoxins and Endotoxins
182(1)
18.8 Biological Contaminants
182(1)
18.8.1 Microbiological Contaminants
182(1)
18.8.2 Parasitic Contamination
183(1)
18.8.3 Agrochemical Residues
183(1)
18.9 Pesticide Residues
183(1)
18.10 Biochemical Changes in Medicinal Plant Leaves as a Biomarker of Pollution
183(1)
18.10.1 APTI Factors
184(1)
18.11 Conclusion
184(1)
References
185(2)
Index 187
Dr. Ravindra Pandey presently, working as Professor in Columbia Institute of Pharmacy, Raipur (C.G.). He has 15 years of Teaching and Industrial experience. You have completed your B.Pharma in 2000, M.Pharma in 2006 from B.R Nahata College of Pharmacy, Mandsaur, R.G.P.V. Bhopal (M.P.) and Ph.D in 2012 from Pt. Ravishankar Shukla University, Raipur (C.G.). Your area of interest is Pharmacognosy and Phytochemistry. You have several research papers published in national and international Journals and organized Seminars/Workshops. You are the approved examiner and paper setter of different Indian Universities. You have attended several Staff Development Programmes and participated in different conferences.









Dr. Shiv Shankar Shukla has 13 years of teaching experience and presently working as Professor in Columbia Institute of Pharmacy, Raipur (C.G.). You have completed your B.Pharma from B. R. Nahata College of Pharmacy, Rajiv Gandhi Proudyogiki Vishwavidyalaya, Bhopal (M.P.) in 2002, M.Pharma from L. M. College of Science & technology, Jodhpur; Jai Narain Vyas University, Jodhpur (Raj.) in 2005 and Ph.D from University Institute of Pharmacy, Pt. Ravi Shankar Shukla University, Raipur (C.G.) in 2012. Your area of research interest is analytical chemistry and quality control; you are the Head of Department of Pharmaceutical Analysis of the institute. You have awarded Young Scientist of Chhattisgarh in 2009 from Chhattisgarh council of science and technology and Dr. P. D. Sethi Annual award for the best paper on TLC Densitometric fingerprint Development and Validation of 6-Gingerol as marker in poly-herbal Ayurvedic formulations in 2010. You are also approved examiner and paper setter of different Indian Universities. Your research papers have been recognized on national and international level. You organized various workshops and attended conferences. You are the life member of Indian Pharmaceutical Association (IPA).









Dr. Amber Vyas has 13 years of teaching and research experience. Mr. Vyas did his masters degree from K.L.E.Ss College of Pharmacy, Belgaum (Karnataka). He has around 3-publications/Research-poster presentation to his credit published/presented in national, international, and electronic journal/ conferences. He is an active member of IPA, APTI. His research interest extends from development of Nanotechnology and Targeted delivery based newer sustained release dosage forms.









Dr. Vishal Jain has 15 years of teaching and research experience. Dr. Jain did his masters degree from Dept. of Pharmaceutical Science, Dr. Hari Singh Gaur Vishwavidyalaya, Sagar (MP). He has over 15 publications to his credit published in national and international journals. He has presented 6 papers in various national and international conferences. He is an active member of IPA, and Indian Society of Pharmacognosy (IST). His research interest extends from phytochemical standardization of herbs.









Mr. Parag Jain has completed his masters degree in 2013 from Columbia Institute of Pharmacy, Chhattisgarh Swami Vivekanand Technical University, Bhilai (C.G.). He has been honored by Indian Academy of Sciences (IASc), Bangalore in 2012 for promotion towards research. He has selected for P.C. Dandiya prize for poster presentation on anti-inflammatory activity of Artesunate in 2013. He availed in edge cutting research work at Indian Institute of Integrative Medicine (IIIM), CSIR, Jammu for six months and All India Institute of Medical Sciences (AIIMS), New Delhi for two months during his masters, where he got expertise in diabetes, toxicity testing, preclinical studies, pharmacokinetics, pharmacodynamics, with equal inclination to ethnopharmacology. His areas of interest include diabetes, neuropharmacology, toxicology, molecular biology, ethnopharmacology and so on. He has recognized publications in national and international journals to his credit and few more in pipeline. He has also written two books on inflammation and immunology (Springer publications). His present work lies on exploring the natural sources for treating type-2 diabetes.









Prof. Shailendra Saraf is a leading scientist and well-known academician in the field of pharmaceutical sciences. He holds the position of Director, University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur (C.G.). He is also the Chairman, Board of Studies of the University. Prof. Saraf has over 30 years of research and teaching experience at UG and PG levels. Prof. Saraf is an alumni of Department of Pharmaceutical Scicence, Dr. H. S. Gour University, Sagar (MP). He has over 133 publications to his credit published in international and national journals of repute. He has also authored several books. He is in editorial board of many scientific journals. He has been a resource person and delivered invited lectures, chaired scientific sessions in several National Conferences, Congress and Symposia in India. Prof. Saraf is the Founder-President of Association of Pharmaceutical Teachers of India (APTI) Chhattisgarh State Branch and Founder-President, Indian Pharmaceutical Association (IPA) Chhattisgarh State Branch. He has been Executive Member of Indian Society of Pharmacognosy and Indian Pharmaceutical Association, Education Division. Prof. Saraf is a permanent Invitee to CEC, Indian Pharmaceutical Association. He is Vice President of Pharmacy Council of India (PCI), All India Council for Technical Education (AICTE), University Grant Commissions and NAAC (UGC-NAAC) and National Board of Accreditation (NBA). He is a life member of IPA, ISP, APTI, ISTE AND MPPGA. His research interest extends from herbal cosmetics to herbal drug standardization, modern analytical techniques, new drug delivery systems with biotechnology bias.
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