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目的:对龙马腰痛胶囊组方中制川乌、制马钱子毒性成分的含量进行测定,为修订该制剂标准提供依据。方法:采用高效液相色谱(HPLC)法对龙马腰痛胶囊中所含双酯型生物碱、士的宁和马钱子碱进行含量测定并确定其限度。结果:龙马腰痛胶囊每粒含双酯型生物碱总量≤0.15 mg,士的宁含量为0.886~2.75 mg,马钱子碱含量为0.615~0.679 mg。结论:HPLC法能对本品毒性成分进行有效的质量控制,可作为修订其标准的参考依据。
OBJECTIVE: To determine the content of the toxic components of Radix Scutellariae Preparata in Radix LJJ Capsule, and provide the basis for revising the standard of the preparation. Methods: The contents of diester alkaloids, strychnine and strychnine contained in Longmangyao Tong Capsules were determined by high performance liquid chromatography (HPLC) and their limits were determined. RESULTS: The total content of bisacid alkaloids in Longmangyao Tong capsule was ≤0.15 mg, the strychnine content was 0.886 ~ 2.75 mg, the content of brucine was 0.615 ~ 0.679 mg. Conclusion: HPLC method can effectively control the toxic components of this product, which can be used as a reference for revising its standard.