【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(cè)方法,并進(jìn)行驗(yàn)證。方法參照《歐洲藥典》中氫氧化鋁佐劑吸附能力檢測(cè)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(gè)最終鋁濃度,吸附0.5~10 mg/ml 7個(gè)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(cè)方法,并驗(yàn)證該方法的準(zhǔn)確度、重復(fù)性和中間精密性。結(jié)果在最終鋁濃度為0.3 mg/ml時(shí),可完全吸附3個(gè)低濃度蛋白,3個(gè)高濃度蛋白呈較好的濃度梯度,符合《歐洲藥典》要求。經(jīng)驗(yàn)證,該方法檢測(cè)氨水法配制的氫氧化鋁佐劑的吸附能力準(zhǔn)確度、重復(fù)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(cè)方法,為氫氧化鋁佐劑相關(guān)質(zhì)量標(biāo)準(zhǔn)的建立奠定了基礎(chǔ)。
[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(zé)任公司;
【分類號(hào)】：R392-33

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