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目的:探讨SO_2残留和藁本内酯含硫衍生物含量作为硫熏当归配方颗粒安全性检控指标的可行性。方法:采用2015年版《中国药典》(四部)通则2331测定SO_2残留量,采用HPLC-MS/MS半定量检测藁本内酯含硫衍生物的含量,考察当归配方颗粒制剂过程(提取、浓缩和干燥)中SO_2残留和藁本内酯含硫衍生物的含量转移规律。结果:在硫熏当归提取液、浓缩液和干浸膏中均能检测到SO_2残留和藁本内酯含硫衍生物,二者在干浸膏中的最终转移率分别为8.13%和60.75%。藁本内酯含硫衍生物在配方颗粒制剂过程中的稳定性及检测方法的专属性和灵敏度均好于SO_2残留。结论:鉴于SO_2公认的有害性和藁本内酯含硫衍生物潜在的毒性,可以考虑将藁本内酯含硫衍生物结合SO_2残留作为硫熏当归配方颗粒的安全性检控指标。
OBJECTIVE: To investigate the feasibility of SO2 residue and ligustilide sulfur-containing derivatives as index of safety control of sulfur smoked Angelica formula granules. Methods: The residues of SO_2 were determined using the General Standard 2331 of the Chinese Pharmacopoeia (2015), and the content of ligustilide sulfur-containing derivatives was detected by HPLC-MS / MS. The process of extraction, concentration and Dry) SO2 residues and ligustilide sulfur-containing derivatives of the content of the transfer rule. Results: Sulfur dioxide residues and ligustilide sulfur derivatives were detected in extracts of Sanguisorba sinensis, concentrate and dry extract, respectively. The final transfer rates of the two compounds in dry extract were 8.13% and 60.75% . The stability and the sensitivity and specificity of the ligustilide-containing sulfur derivatives in the formulation of granular formulations were better than those of SO 2. CONCLUSION: Considering the recognized harmfulness of SO 2 and the potential toxicity of sulfur-containing derivatives of ligustilide, the safety index of sulfur-containing derivatives of ligustilide combined with residual SO 2 may be considered as safety prosecution.