屋尘螨变应原制剂质量标准的研究

目的对屋尘螨变应原制剂质量标准进行修订研究。方法除原注册标准的检测项目外，增加了以ImmunoCAP 方法检测氢氧化铝吸附的螨变应原注射液制品的总生物学活性和游离过敏原生物活性测定，以Western—Blot法对其主要成分进行检测。结果10批制品的总特异性IgE测定的均值为20．58kUa·L^-1，总过敏原对血清库抑制率均值为67．70％，批间变异系数为1．48％；游离特异性IgE测定的均值为58．24kUa·L^-1，游离过敏原对血清库抑制率均值为9．0％，批间变异系数为35．49％。Western Blot结果显示各批制品均与内参有相同的图谱，并在25kD、14kD具有明显的条带。结论新增的的质控方法和质量标准可用于螨变应原注射液产品的常规检定，可以作为考察制品批间一致性的指标。

Study of Quality Standards of Mites Allergens Alk D. P

Objective To study the revision of quality standard of Mites Allergens Alk D. P. Methods Besides the test items of the original registration standards, the method of ImmunoCAP was added to examine the total biological activity of mite allergen injections adsorbed by aluminium hydroxide and the free allergen biological activity, and the Western blot method was used for identification of the injection products. Results Ten batches of test products were tested. The mean of total specific IgE was 20.58 kUa · L^-1. The mean of total inhibition rate of allergens to serum was 67. 70% and the inter batch coefficient of variation was 1.48%. The mean of free specific IgE was 58.24 kUa ·L^-1. The mean of inhibition rate of free allergens to serum was 9.0% and the inter-batch coefficient of variation was 35. 49%. The results of Western blot showed that the spectra were the same between each batch of products and the internal reference and the bands in the position of 25KD and 14KD were obvious. Conclusion The newly added quality control method and quality standard can be applied to routine examination of mite allergen injection products, which can be the index for inter-batch consistency test.