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目的通过定量测定抑乳调经颗粒中多种指标成分,公式评分法综合评价制剂的质量,进一步完善其质量标准。方法采用高效液相色谱法(HPLC)对抑乳调经颗粒中君药成分水晶兰苷,臣药成分苔黑粉葡萄糖苷,佐药成分芍药苷,使药成分甘草苷,进行含量测定。结果 4种成分分别在2.156~53.9μg·mL~(-1)(r=0.9999),2.03~50.75μg·mL~(-1)(r=0.9998),3.26~81.5μg·mL~(-1)(r=0.9999),1.42~35.5μg·mL~(-1)(r=0.9999)范围内线性关系良好,加样回收率分别为100.32%,99.43%,101.61%,98.96%。结论该方法准确可靠,能全面控制该颗粒的内在质量,可作为该颗粒的含量测定标准。
OBJECTIVE: To quantitatively determine various index components of YRTJ, the formula score method comprehensively evaluated the quality of the preparation and further improved its quality standard. Methods High performance liquid chromatography (HPLC) was used to determine the content of monosodium lichen in Yankan Tiaojing granules, moss glucoside of herbaceous agent, paeoniflorin in adjuvant, and liquiritin in medicinal composition. Results The results showed that the four components were in the range of 2.156 ~ 53.9μg · mL -1 (r = 0.9999), 2.03 ~ 50.75μg · mL -1 (r = 0.9998), 3.26 ~ 81.5μg · mL -1 (r = 0.9999) and 1.42 ~ 35.5μg · mL -1 (r = 0.9999) respectively. The recoveries were 100.32%, 99.43%, 101.61% and 98.96%, respectively. Conclusion The method is accurate and reliable, and can fully control the inherent quality of the particles, which can be used as the standard for determining the content of the particles.