STANDARDIZATION OF ALLERGENIC EXTRACTS OF POLLENS

修订21 CFR 680.4的最终规则于1987年10月8日公布; 该条例的公布取消了特定的方法， CFR中的抗原E效价检测，允许CBER引入检测 过敏性提取物相对效价的测定方法 另一种机制 在1986年1月的研讨会上， 用于标准化的提取物（猫提取物，蒂莫西花粉，6月 花粉和多年生黑麦花粉），以及对 与制造商讨论了这些产品。 标准化努力 我把重点放在蒂莫西、琼、多年生黑麦、百慕大、红顶和果园上 现时共有21宗申请及52幅土地正接受 审查. 分析公司提交的每一份摘录， 等电聚焦模式，IgE结合活性（印迹放射免疫法） 电聚焦（BRIEF）、总蛋白含量和RAST相对效价 与CBER参考提取物相比。 为了促进花粉提取物的标准化， 目前向各公司提供所有检测试剂和参考。 需要进行持续的检测，以补充以下各项的实验室用品： 这些东西 不断对选定的候选推荐人进行评估 在实验室进行同步临床试验。 初步 对其他花粉提取物标准化的研究（即， 甜春和草甸羊茅草和英国大蕉）是在 中求进工作总

A final rule amending 21 CFR 680.4 was published on October 8, 1987; the publication of this regulation removed the specific methodology of the Antigen E potency test from the CFR, permitting CBER to introduce test methods for determining relative potency of Allergenic Extracts by way of an alternate mechanism. In the January 1986 workshop, the first four extracts targetedfor standardization (extracts of Cat, Timothy pollen, June pollen and Perennial Rye grass pollen), and the tests to be performed on these products were discussed with manufacturers. Standardization efforts have focused on Timothy, June, Perennial Rye, Bermuda, Redtop and Orchard grass extracts with a total of 21 applications and 52 lots now under review. Each extract submitted by a company is analyzed for its isoelectric focusing pattern, IgE binding activity by Blotted RadioImmuno ElectroFocusing (BRIEF), total protein content, and RAST relative potency compared to CBER reference extracts. In order to facilitate the standardization of pollen extracts, LAP currently supplies all testing reagents and references to the companies. Ongoing testing is needed to replenish laboratory supplies for each of these items. Selected candidate references are constantly being evaluated in the laboratory for concurrent clinical testing. Preliminary investigations into the standardization of other pollen extracts (i.e. Sweet Vernal and Meadow Fescue grasses and English Plantain) are in progress.