| 摘要 |
A storage-stable, lyophilized Minor Determinant Mixture (MDM) composition which can be reconstituted with water to yield a solution which is used to detect allergy or hypersensitivity to penicillins, comprising: benzylpenilloic acid; benzylpenicillin; benzylpenicilloic acid wherein at least about 94.5% of the benzylpenicilloic acid is the stereoisomer (5R,6R) - benzyl - D - penicilloic acid; an alkali metal salt; a pH-buffering substance; and a critically low amount of water. In the method of the invention, an aqueous solution of benzylpenilloic acid, an alkali metal salt, and a pH-buffering substance is prepared. The benzylpenilloic acid in this solution is neutralized with aqueous sodium hydroxide. While maintaining this solution at a temperature of from about 0 DEG C to about 5 DEG C, the following steps are performed: First, the benzylpenicillin and the benzylpenicilloic acid are dissolved into the solution. The benzylpenicilloic acid in the solution is neutralized with aqueous sodium hydroxide. Next, the pH of the solution is adjusted to a physiological pH. This solution is then sterile filtered. After performing these steps in which the solution was maintained at a temperature of from about 0 DEG C to about 5 DEG C, the solution is frozen in dehydrated containers. After freezing, the frozen solution is lyophilized.
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