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目的:通过对127批香连制剂样品进行标准检验及探索性研究,对该制剂质量标准中木香的检测项进行分析和评价,并探索香连制剂中木香新的质量控制方法。方法:按法定标准对木香进行了TLC鉴别。探索性研究中采用SPME/GC-MS法,对香连制剂中挥发性成分进行了鉴别,建立了不同剂型香连制剂中挥发性成分的指纹图谱,采用UPLC法对木香中木香烃内酯及去氢木香内酯的含量进行了测定。结果:按现行标准,合格率100%;探索性研究结果表明,不同剂型中挥发性成分组成相似,但相对含量存在差异,且不同剂型中木香烃内酯及去氢木香内酯的含量差异较大。结论:探索性研究为进一步修订标准及有效地控制该制剂质量提供参考依据。
OBJECTIVE: Through the standard test and exploratory research on 127 batches of Xianglian preparation samples, the detection items of the sweet incense in the quality standard of the preparation were analyzed and evaluated, and the new quality control methods of spiced incense in Xianglian preparations were explored. Methods: According to the statutory standards of woody TLC identification. In the exploratory study, the volatile components in the preparations were identified by SPME / GC-MS method. The fingerprint of the volatile components in the preparations was established. Ester and dehydrocostus lactone content was measured. Results: According to the current standard, the pass rate was 100%. The exploratory research results showed that the volatile components in different dosage forms were similar in composition, but the relative contents were different. And the content of caromolide and dehydrocostuslactone in different dosage forms big different. Conclusion: Exploratory research provides a reference for further revision of the standard and effective control of the quality of the preparation.