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Rabies vaccine
The document presents a seminar on the biological assay of rabies vaccine as part of a Master of Pharmacy curriculum. It outlines definitions, methods, and procedures for determining the potency of rabies vaccine using test animals and standard preparations. References to the Indian pharmacopoeia and details on conducting assays and virus preparations are also included.
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Rabies vaccine
- 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 Presented by R. BHANUTEJA (Reg. No: 20L81S0707) Under the guidance of Mr. Shakir bhasha, M. Pharm. Professor of Pharmaceutical Analysis , Head of department – Diploma in pharmacy. BIOLOGICALASSAY OF RABIES VACCINE A seminar as a part of curricular requirement for 1st year M. Pharm 1st semester
- 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 1. Definitions. 2. Biological assay of rabies vaccine. 3. References. Contents
- 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 Rabies :- • Rabies is a zonotic disease which is caused by a lyssa virus belongs to the family Rhabdoviridae. Rabies vaccine :- • Rabies vaccine is a suspension of suitable strain of fixed rabies virus grown in suitable approved culture and inactivated by suitable method. Bioassay :- • The potency of rabies vaccine is determined by comparing the lethal cerebral dose of rabies virus with the dose of standard preparation of rabies. Definitions
- 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 Standard preparation :- • Freeze dried preparation. • The standard preparation is the 5th international standard established in 1987 containing 16 units or another suitable preparations. Suggested methods :- a) Test animals. b) Standard challenge virus suspension. c) Virus titre of the challenge virus. d) Determination of potency of vaccine Biological assay of rabies vaccine
- 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 • Albino mice weight about three to four weeks old, 11g-15g weight. • Distribute mice into Six groups of 16 animals, four groups of 10 animals. • These above two groups are used for titration of LD50 challenge suspension. • Inject 0.03 ml per mice intracerebrally. • 3 groups of 16 receive standard preparation and other 3 the vaccine examined. • 4 groups of 10 receive LD50 of the challenge suspension. Test animals
- 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 Standard challenge virus suspension is prepared by injecting Intracerebrally 0.03ml of 10 fold dilution standard strain horse serum to test animals. Showing characteristic symptoms of encephalitis are sacrificed, harvest the brain Wash it with saline solutions to remove blood clots Homogenized brain with 10% digested casein hydrosylate (PH-7.2) centrifuge and separate liquid is distributed into ampoules and stored at 2-80 Standard challenge virus suspension
- 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 Prepare 10 fold dilution of standard challenge virus suspension 0.03 ml inject intracerebrally to a group of 10 mice observe for 14 days & count the mice surviving in each group calculate the virus titre of standard challenge virus suspension by statistical method. Determination of challenge virus
- 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 prepare 3-5 fold serial dilution of standard and test solution of vaccine inject 0.03 ml intra peritoneally & after 7 days prepare same solution and inject Both standard and test should be prepared in such a way After 7 days inject 0.03ml standard virus suspension to vaccinated mice Observe it for 14 days and calculate its potency by statistical method Determination of potency of vaccine
- 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 • Rishi Ram parajul, Rabies vaccine, The Indian pharmacopoeia commission, Ghaziabad, vaccine: General Requirements: 1355-1356. • Indian pharmacopoeia1996, volume 2, pg no :- 657-658. References
- 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 THANK YOU