目的 建立和验证检测注射用A型肉毒毒素中右旋糖酐和蔗糖含量的高效液相色谱法。方法 采用高效液相色谱法，建立注射用A型肉毒毒素中右旋糖酐和蔗糖含量测定方法，并对建立方法进行系统适用性、溶液稳定性及方法的线性、专属性、准确度、重复性、精密度和定量限验证。结果 系统适用性和溶液稳定性均良好。采用外标法进行注射用A型肉毒毒素中右旋糖酐和蔗糖含量测定的线性范围为5～15 mg/ml，在此范围内，右旋糖酐和蔗糖含量测定标准曲线的相关系数均大于0.999；方法的专属性、准确度良好，右旋糖酐和蔗糖含量测定回收率分别在99.1%～100.3%和98.3%～100.1%之间；右旋糖酐和蔗糖含量重复性验证的相对标准偏差（relative standard deviation，RSD）分别≤0.18%和≤0.90%；右旋糖酐和蔗糖含量中间精密度验证的RSD分别≤0.72%和≤0.85%；注射用A型肉毒毒素溶解后于2～8 ℃放置72 h与0 h相比，所测定的右旋糖酐和蔗糖含量变异系数≤0.12%。结论 建立了可用于注射用A型肉毒毒素中右旋糖酐和蔗糖的质量控制的高效液相色谱检测方法。

Objective  To establish and validate a high performance liquid chromatography (HPLC) method for determination of dextran and sucrose in botulinum toxin type A for injection (BtxA). Methods  An HPLC method was established for determination of dextran and sucrose in BtxA, of which system suitability, solution stability, linearity, specificity, accuracy, repeatability, precision and quantitative limit were verified. Results  The system suitability and solution stability were both good. The linear range of the method for determination of dextran and sucrose in BtxA by external standard method was 5-15 mg/ml. In the range, the correlation coefficients of the standard curves for the determination of dextran and sucrose contents were both more than 0.999. The specificity and accuracy of the method were good. The recovery rates of dextran and sucrose were between 99.1%-100.3% and 98.3%-100.1%, respectively. The repeatability verification relative standard deviations (RSDs) of dextran and sucrose contents were ≤0.18% and ≤0.90%, respectively. The middle precision RSDs of dextran and sucrose contents were ≤0.72% and ≤0.85%, respectively. Comparing dissolved BtxA stored at 2-8 ℃ for 72 h with 0 h, the coefficients of variation of dextran and sucrose contents measured were ≤0.12%. Conclusion  An HPLC detection method for dextran and sucrose in BtxA is established and can be used for quality control.