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目的:为复方儿茶栓(中药制剂)提供质量控制方法。方法:拟定制备工艺,采用TLC对儿茶、血竭、乳香等成分进行色谱鉴别,采用经典络合滴定法测定硫酸铝钾[KAl(SO4)2]的含量。结果:鉴别的样品都能检出相应的斑点。含量测定[KAl(SO4)2]有良好的重现性,加样回收率达99.62%(RSD=2.64%)。结论:制备工艺可行。该制剂质量标准鉴别、含量测定方法简便可行,具有实用性。
OBJECTIVE: To provide quality control methods for compound Eta tea suppository (TCM preparation). Methods: The preparation process was established. TLC was used to identify the constituents of catechu, blood, frankincense and so on. The content of aluminum potassium sulfate [KAl (SO4) 2] was determined by classical complexometric titration. Results: The identified samples all detected the corresponding spots. The content of [KAl (SO4) 2] has good reproducibility, and the recovery rate is 99.62% (RSD = 2.64%). Conclusion: The preparation process is feasible. The preparation quality standard identification, content determination method is simple and feasible, practical.