【摘要】：目的建立氨水法制備的氫氧化鋁佐劑吸附能力的檢測方法,并進行驗證。方法參照《歐洲藥典》中氫氧化鋁佐劑吸附能力檢測方法的原理,將氨水法制備的氫氧化鋁佐劑分別以0.25~1 mg/ml 6個最終鋁濃度,吸附0.5~10 mg/ml 7個濃度的牛血清白蛋白(bovine serum albumin,BSA)溶液,根據(jù)吸附效果,篩選最佳吸附鋁濃度和適合的BSA溶液濃度,建立氨水法制備的氫氧化鋁佐劑吸附能力檢測方法,并驗證該方法的準確度、重復性和中間精密性。結(jié)果在最終鋁濃度為0.3 mg/ml時,可完全吸附3個低濃度蛋白,3個高濃度蛋白呈較好的濃度梯度,符合《歐洲藥典》要求。經(jīng)驗證,該方法檢測氨水法配制的氫氧化鋁佐劑的吸附能力準確度、重復性和中間精密性良好。結(jié)論建立了氨水法制備的氫氧化鋁佐劑吸附能力的檢測方法,為氫氧化鋁佐劑相關質(zhì)量標準的建立奠定了基礎。
[Abstract]:Objective to establish and verify the determination method of adsorption ability of aluminum hydroxide adjuvant prepared by ammonia method. Methods according to the principle of measuring the adsorption ability of aluminum hydroxide adjuvant in European Pharmacopoeia, the adjuvant of aluminum hydroxide prepared by ammonia water method was used to adsorb bovine serum albumin (bovine serum albumin,BSA) solution with 6 final aluminum concentrations of 0.25 mg/ml and 7 concentrations of 0.5 ~ 10 mg/ml, respectively. According to the adsorption effect, the optimum concentration of aluminum adsorbed and the suitable concentration of BSA solution were selected, and the method of measuring the adsorption ability of aluminum hydroxide adjuvant prepared by ammonia solution method was established, and the accuracy, repeatability and intermediate precision of the method were verified. Results when the final aluminum concentration was 0. 3 mg/ml, three low concentration proteins could be completely adsorbed, and 3 high concentration proteins showed a good concentration gradient, which met the requirements of the European Pharmacopoeia. The method is proved to be accurate, reproducible and intermediate precision in the determination of the adsorption ability of aluminum hydroxide adjuvant prepared by ammonia water method. Conclusion A method for the determination of adsorption capacity of aluminum hydroxide adjuvant prepared by ammonia solution method was established, which laid a foundation for the establishment of quality standard of aluminum hydroxide adjuvant.
【作者單位】： 成都生物制品研究所有限責任公司;
【分類號】：R392-33

【參考文獻】

相關期刊論文 前4條

1 湛琳麗;溫昊;祝明;馬金花;徐愛平;;鋁佐劑的特性及影響因素[J];畜牧市場;2009年05期

2 梁存軍;王健;黎曉敏;呂鳳林;張一;陳軍;;高壓高溫滅菌前后納米氫氧化鋁佐劑理化性質(zhì)的對比研究[J];中國生物工程雜志;2007年05期

3 槐麗蘋;劉輝;張楠;孫俊峰;王云英;魏輝;;不同粒徑氫氧化鋁佐劑對白喉類毒素免疫效果的影響[J];微生物學免疫學進展;2011年03期

4 何萍;呂鳳林;任建敏;何鳳慈;;鋁佐劑機制及其納米化前景[J];世界華人消化雜志;2003年11期

【共引文獻】

相關期刊論文 前10條

1 何萍;呂鳳林;陳月;左國偉;李元朝;何鳳慈;;合成納米鋁佐劑及其對乙型肝炎、狂犬病毒輔佐效應的研究[J];免疫學雜志;2006年01期

2 何海勇;賁虎;梁興杰;;納米技術在疫苗佐劑研制中的應用[J];東南大學學報(醫(yī)學版);2011年01期

3 董峰;唐紅衛(wèi);吳小利;向代軍;蘭曉梅;徐菡;王成彬;;氫氧化鋁干粉與凝膠制作大鼠哮喘模型的效果比較[J];解放軍醫(yī)學院學報;2013年01期

4 梁存軍;王健;呂鳳林;黎曉敏;熊仲良;張一;;鋁佐劑作用機制及其在人用H5N1滅活疫苗中的輔佐作用[J];生物工程學報;2008年01期

5 湛琳麗;溫昊;祝明;馬金花;徐愛平;;鋁佐劑的特性及影響因素[J];畜牧市場;2009年05期

6 孫營;陳靜;陳少華;曹t，

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