Downloaded 42 times
![RIPER
AUTONOMOUS
NAAC &
NBA (UG)
SIRO- DSIR
Raghavendra Institute of Pharmaceutical Education and Research - Autonomous
K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18
4. The combined bicarbonate solution is acidified with 10ml
HCL, then extracted successively with 25 and 20ml ethyl acetate.
The combined ethyl acetate extract is transferred into 50ml
volumetric flask and made to volume.
5.The extinction of the solution is measured against pure solvent
at 370nm and 430nm,and the percentage of total sennosides was
calculated using the formula
Total sennosides content=[A370 X 47.5 – A430 X 18.5] X210.2 / Wt
in mgs
A=absorbance](https://image.slidesharecdn.com/sudheer2-211112162601/75/MONOGRAPHS-OF-HERBAL-DRUGS-18-2048.jpg)
MONOGRAPHS OF HERBAL DRUGS
The document discusses the importance of pharmacopoeias, specifically focusing on the Indian Pharmacopoeia, Ayurvedic Pharmacopoeia, and the monographs of herbal drugs. It includes detailed information about the preparation, properties, and applications of Cassia Fistula, along with its therapeutic uses and chemical constituents. Additionally, it outlines regulatory standards for drug formulations, quality parameters, and methods of analysis for ensuring drug efficacy and safety.
More Related Content
Similar to MONOGRAPHS OF HERBAL DRUGS
More from Raghavendra institute of pharmaceutical education and research .
MONOGRAPHS OF HERBAL DRUGS
- 1. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 1 A Seminar as a part of curricular requirement for I year M. Pharmacy II semester. Presented by Mr P. Sudheer kumar (Reg. No. 20L81S0712) Under the guidance of G. Kranthi kumar sir; Assistant Professor Pharmaceutical Analysis. MONOGRAPHS OF HERBAL DRUGS
- 2. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 2 Introduction • Indian pharmacopoeia • Ayurvedic pharmacopeia • United states pharmacopeia
- 3. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 3 • Various countries have published texts, to assure drug quality which is design as collection. • EXAMPLES: • Indian Pharmacopeias • United state Pharmacopeias • Ayurvedic pharmacopeia Pharmacopoeia: Definition “Pharmacopoeia is a book or encyclopedia of Drugs Standard, their formulas, Method for making medicinal preparation and related information's which is published under the jurisdiction of government body” Introduction:
- 4. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 4 MONOGRAPHS • Monographs set forth the articles name, definition, • Specification, and other requirements related to packaging, • Storage, and labelling. • The specification consists of tests, procedures, and acceptance criteria that help ensure the identity, strength , quality and purity of the article. for general requirements • Relating to specific monograph sections, see section 5, monograph components. because monographs may not provide standards for all • Relevant characteristics, some official substance may conform to the USP or NF standard but differ with regard to non-standardized properties that are relevant to their use in • Specific preparation.
- 5. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 5 MONOGRAPH COMPONENTS • Molecular formula • Named in defining the required strength of compendial article intended chemical entity as given in the complete chemical name of the artiAdded substances • Added substances are presumed to be unsuitable for inclusion in an official article and therefore prohibited, if their presence impairs the bioavailability. • 1. The use of the molecular formula for the active ingredient • 3.Added substance (official substances) • May contain only the specific added substances that are permitted by the individual monograph. They are not exceed the quantity for providing their intended effect.
- 6. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 6 Added substances(Excipients and ingredients) • suitable substances and excipients such as antimicrobial agents, • Pharmaceutical bases, carriers, coating . • Compounded preparations • Compounded preparations for which a complete composition is • Given shall contain only the ingredients named in the formulas • Or in the individual monograph. • Dietary supplements • Additional ingredients may be added to dietary supplement products provided that the additional ingredients.
- 7. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 7 • Description and solubility • Identity • Assay • Units of potency • Impurities and foreign substances • Residual solvents • Elemental impurities • Performance tests
- 8. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 8 INDIAN PHARMACOPEIA: • Introduction • Definition: • As per the Drugs and Cosmetics Act 1940, the Indian Pharmacopoeia is the legally recognized book of Standards for the quality of drug substances and preparations included therein for INDIA. • Indian Pharmacopoeia was prepared by Indian Pharmacopoeia Commission(IPC). • Formation The Indian Pharmacopoeia Commission has been established as an Autonomous Institution under Ministry of Health & Family Welfare, Government of India on 09th Dec. 2004.
- 9. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 9 CASSIA FISTULA • Drug consists of fruits of cassia fistula linn. • Fam.fabaceae. • The plant is found throughout india in all deciduous forests and hilly tracts. It is cultivated as an ornamental plant for its beautiful Yellow flowers. Apart from the fruit. the other parts used are root, root bark, flowers and leaves. OTHER NAMES Beng. -Aragvadha Guj. -Garmal Hindi -Amaltas Kan. -kakke,konne Punj. -Alash Tel. -Rela Tam. -konnai
- 10. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 10
- 11. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 11 MACROSCOPIC 1. The fruits pods are 40-70cm long and 20-27mm in diameter. Straight or slightly curved, smooth but finely striated transversely, the striations appearing as fine fissures. 2. The rounded distal end bears a small point marking the position of the style. the dorsal suture appears as a single vascular strand and the ventral suture appears as a single vascular strand and the ventral suture as two closely applied strands. 3. Internally the pod is divided by thin , buff coloured ,transverse dissepiments at intervals of about 0.5cm. 4. The pulp has a sweetish - taste and characteristic odour DESCRIPTION
- 12. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 12 1. The pericarp about 1.5mm thick, shows the presence of epicarp, mesocarp and endocarp. 2. Epicarp is made up of a single layer of brownish coloured rectangular cells. 3. Mesocarp is composed of polygonal thin walled parenchymatous cells and endocarp consists of many layers of stone cells of varying shapes and sizes . 4, Vascular elements present in the mesocarp are composed of small tracheids (104µ-130µ in length and 13µ-20µ in breadth)and long tracheids. MICROSCOPIC
- 13. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 13
- 14. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 14 CHEMICAL CONSTITUENTS MAJOR: Glycosides –anthraquinone derivatives Rhein; Hydroxymethyl anthroquinones; sennosides A, B; Barbaloin. MINOR: oxymethyl anthraquinone and fistulic acid;An oil,5- nonatetracontanone, 2-hentriacontanone, tricontane, 16-hentriacontanol and β-sitosterol
- 15. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 15
- 16. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 16 • COLOUR REACTION Borntraeger test for anthraquinone glycosides. Boil aqueous extract of the drug with dilute HCL, Cool and extract with chloroform. Shake chloroform extract with dilute ammonia solution. Ammoniacal layer takes pink to red colour. ASSAY/ANALYTICAL METHOD Determination of sennosides by UV spectroscopy • Standard preparation: weigh accurately 100mg of calcium sennosides • Transfer to a 10 ml of volumetric flask and make to volume with water IDENTITY TESTS
- 17. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 17 1. From this take 1ml and reflux with 8ml of 25% HCL +2ml of glacial acetic acid on a boiling water bath for 20 minutes. 2.Transfer the mixture to a separator quantitatively. 3.The mixture is then extracted with 3×30ml fraction of ethyl acetate and this solution is filtered into 100ml volumetric flask. From this 25ml of ethyl acetate solution is transferred to a separator and shaken with two portions of 25 to 20 ml of freshly prepared saturated sodium bicarbonate solutions. The ethyl acetate solution is discarded
- 18. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 18 4. The combined bicarbonate solution is acidified with 10ml HCL, then extracted successively with 25 and 20ml ethyl acetate. The combined ethyl acetate extract is transferred into 50ml volumetric flask and made to volume. 5.The extinction of the solution is measured against pure solvent at 370nm and 430nm,and the percentage of total sennosides was calculated using the formula Total sennosides content=[A370 X 47.5 – A430 X 18.5] X210.2 / Wt in mgs A=absorbance
- 19. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 19 • The powdered drug 1g is refluxed with water(40ml)on a boiling water bath for 2hr. • Resultant solution is decanted and filterd into a 100ml volumetric flask. • The marc is further extracted with 40ml of water for 1hr.the extract is decanted and filtered into the same volumetric flask. • the filter paper is washed with warm water and the volume made up to 100ml. 10ml of this solution is used as test solution. the test solution is then treated in the same manner as that of standard solution. the total sennosides content is calculated as per the formula. SAMPLE PREPARATION:
- 20. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 20 LIMITS FOR QUALITY PARAMETERS TOTAL ASH : Not more than 6% ACID INSOLUBLE ASH : Not more than 1% ALCOHOL SOLUBLE EXTRACTIVE : Not less than 29.5% WATER SOLUBLE EXTRACTIVE :Not less than 35.5% LOSS ON DRYING :Not more than 5%
- 21. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 21 The fruit is used as • antibacterial • Antifungal • Antihelmintic • Diuretic • Antidiarrhoeal. • The aqueous extract of fruit pulp in a dose of 1g/100g body weight produces significant anti-inflammatory effect in albino rats. • The aqueous extract of the fruit pulp has significant purgative action. The activity is due to the presence of anthraquinones. Bioassay of cassia fistula has been carried out wherein its cathartic efficacy has been compared with that of senna. PHARMACOLOGY
- 22. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 22 THERAPEUTIC CATEGORY: The pulp is cathartic and also used as febrifuge and tonic DOSAGE: 250mg and above causes catharic action that reaches maximum in 6-9hr and lasts for 24hr
- 23. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 23 The Ayurvedic Pharmacopoeia of India • Official book of standards for single drug and its formulations or • Compilation of various ayurvedic pharmaceutical formulation(s) i.e. formulas and methods of preparations . THE AYURVEDIC PHARMACOPOEIA OF INDIA
- 24. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 24 Assam : sonaroo Guj. : garmala garmalo Hindi : amaltas Kan. : aragvadha, kakke, DESCRIPTION: Macroscopic- 1. Fruit, a many called, indehiscent pod, 35-60cm long and 18-25 mm in diameter, nearly straight and sub-cylindrical, chocolate-brown to almost black in colour: pod surface smooth to naked eye, 2. Pericarp thin, hard and woody; fruit initially divided by transverse septa about 5mm,apart each counting a single seed attached to ventral suture by a long dark, thread–like funicle about 8-12 by 6-8mm,circular to oval flatted. SYNONYMS
- 25. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 25 3. Reddish-brown, smooth, externally hard and with a distinct dark brown line extending from micropyle to base: seed initially embedded in a black viscid pulp consisting of black, thin, shining, circular disc like masses having central depression of seed on both surfaces or as broken pieces adhered with each other . 4. when dipped in water, makes yellow solution which darkness to brownish-yellow to dark brown, on keeping : pulp fills the cells but shrinks on drying and adheres to both sides of testa; seeds often lye loose in their segments: odour faint, sicky; taste ,sweet.
- 26. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 26 FOREIGN MATTER -Not more than 2 % TOTAL ASH - Not more than 6% ACID-INSOLUBLE ASH -Not more than 1% ALCOHOL-SOLUBLE EXTRACTIVE -Not less than 15% WATER-SOLUBLE EXTRACTIVE -Not less than 46% IDENTITY,PURITY AND STRENGTH
- 27. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 27 Rasa : madhura, Tikta, Amla, lavana, katu, kasaya Guna : Guru, Sthula, Manda Virya : Usna, sheta Vipaka : Madhura Karma : Recana Important formulation-Aragvadhadi, kvatha, Curna, Therapeutic uses- vibandha, udavartta, gulma, sula, udararoga DOSE: 5-10g of the drug in powder form PROPERTIES AND ACTION
- 28. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 28 Introduction • The United states Pharmacopoeia (USP) is an annual published collection of quality standards. • The first edition of the US Pharmacopoeia was published in 1864 and was one of the first attempts to harmonize pharmaceutical standards. UNITED STATES PHARMACOPOEIA
- 29. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 29 Since its first publication back in 1864 the distribution of the British Pharmacopoeia has grown throughout the world • It is now used in over 100 countries. • Australia and Canada are two of the countries that have adopted the USP as their national standard. The USP contributes to the overall control of the quality of medicinal products by providing an authoritative statement of the quality that a product, material or article is expected to meet any time during its period of use.
- 30. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 30 1. SYNONYMS: Chinese cinnamon , cassia lingnea. Cassia bark consists of the dried bark of stems or branches of Cinnamomum cassia Blume from which the outer tissues may have been wholly or partly removed. 2. CHARACTERISTICS Macroscopical Description; Channelled or slightly curved pieces,2-3mm thick, upto 2-3cm wide, varying considerably in length, up to 30 or 40 cm; outer surface dark greyish-brown. longitudinal ridges; inner surface dull cinnamon brown. CASSIA BARK
- 31. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 31 Section of unscraped bark, occasional areas with small epidermal cells, outer walls slightly thickened; cork a variable number of alternating layers of more or less uniformly thickened, thin-walled more markedly thickened lignified cortex of thin walled parenchyma, with scattered larger cells containing mucilage ,single or small groups of uniformly thickened sclereids MICROSCOPICAL DESCRIPTION
- 32. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 32 Pericycle a continuous band, two or three cells thick, of sclereids Small groups of thick-walled fibres associated with outer pericycle Small acicular crystals of calcium oxalate in cells of medullary rays
- 33. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 33
- 34. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 34 ODOUR AND TASTE Odour strongly resembling that of cinnamon bark, less delicate; taste cinnamon-like, mucilaginous and astringent. IDENTIFICATION Carry out the method for thin layer chromatography using solvent system Apply 60µl of each of the following solutions to the plate (1)extract 1g of powder
- 35. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 35 Cassia bark by shaking with 10ml of dichloromethane for 20min.filter,evaporate the filtrate just to dryness and dissolve the residue in 1ml of toluene; (2)0.1% cineole in toluene. Spray the plate with spray reagent heat at 105°c for 10-15min and examine in daylight QUANTITATIVE STANDARDS Foreign matter - not more than 2% Total ash - not more than 5% Ash insoluble in hydrochloric acid-not more than 2%
- 36. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 36 1. "Cassia Fistula (aburnum, Purging Fistula, Golden Shower, Amaltas)", Ayurveda - Herbs, 4 to 40, archived from the original on 2011-07-14, retrieved 2011-01-20 • Irwin HS, Barneby RC (1982). The American Cassiinae: A synoptical revision of Leguminosae tribe Cassieae subtribe Casiinae in the New World, References
- 37. RIPER AUTONOMOUS NAAC & NBA (UG) SIRO-DSIR Raghavendra Institute of Pharmaceutical Education and Research - Autonomous K.R.Palli Cross, Chiyyedu, Anantapuramu, A. P- 515721 37 THANK YOU