Injectable rabies vaccine composition and method for preparing same
First Claim
1. A rabies vaccine composition comprising a sterilized suspension of proteineous suckling mice or rat brain particles of injectable particle size laden with an amount of inactivated rabies virus which is equivalent to a virus titer of from at least about 105 to about 107 MLD50 per 0.01 milliliter thereof, at a brain tissue concentration of from about 3 to about 6% by weight, in an aqueous buffer solution having a pH of between about 7.5 and about 8.4, and comprising an amount, dissolved therein, of between 0.03 and 0.08 moles per liter of a buffer composition comprising a mixture of an organic base of the formula ##STR5## wherein R1 and R2 each are hydrogen or CH2 CH2 OH and an acid addition salt thereof with an acid the anion of which is compatible with virus replication.
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Abstract
A rabies vaccine composition is disclosed which comprises a sterilized suspension of proteineous suckling mice or rat brain particles of injectable particle size laden with an amount of inactivated rabies virus which is equivalent to a virus titer of from at least about 105 to about 107 MLD50 per 0.01 milliliter thereof at a brain tissue concentration of from about 3 to about 6% by weight, in an aqueous buffer solution having a pH of between about 7.5 and about 8.4, and comprising an amount, dissolved therein, of between 0.03 and 0.08 moles per liter of a buffer composition comprising a mixture of an organic base of the formula ##STR1## wherein R1 and R2 each are hydrogen or CH2 CH2 OH and an acid addition salt thereof, preferably a mixture of tris (hydroxymethyl)amino methane and its hydrochloride. The vaccine composition exhibits a high potency and its pH value remains stable over a prolonged period of time.
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Citations
39 Claims
- 1. A rabies vaccine composition comprising a sterilized suspension of proteineous suckling mice or rat brain particles of injectable particle size laden with an amount of inactivated rabies virus which is equivalent to a virus titer of from at least about 105 to about 107 MLD50 per 0.01 milliliter thereof, at a brain tissue concentration of from about 3 to about 6% by weight, in an aqueous buffer solution having a pH of between about 7.5 and about 8.4, and comprising an amount, dissolved therein, of between 0.03 and 0.08 moles per liter of a buffer composition comprising a mixture of an organic base of the formula ##STR5## wherein R1 and R2 each are hydrogen or CH2 CH2 OH and an acid addition salt thereof with an acid the anion of which is compatible with virus replication.
- 2. A rabies vaccine composition comprising a sterilized suspension of a minor concentration by weight of proteineous suckling mice or rat brain particles of injectable particle size laden with inactivated rabies virus, in an aqueous buffer solution having a slightly basic pH value and an amount, dissolved therein, of a buffer composition sufficient to stabilize the pH at said value, said buffer composition comprising a mixture of an organic base of the formula ##STR6## wherein R1 and R2 each are hydrogen or CH2 CH2 OH, and an acid addition salt thereof with an acid the anion of which is compatible with virus replication.
Specification