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目的:建立辛兰芷喷雾剂的质量标准。方法:采用TLC法对方中辛夷、板蓝根、白芷进行定性分析;用HPLC法对连翘苷进行含量测定。结果:TLC法可准确地对辛夷、板蓝根、白芷进行定性鉴别;连翘苷进样量在0.2~10.0μg范围内与峰面积积分值呈良好线性关系(r=0.9997);平均回收率为99.71%,RSD=1.85%(n=6)。结论:本方法简便、快速、重现性好,所建标准可用于本制剂的质量控制。
Objective: To establish the quality standard of Xinlanjing Spray. Methods: Qualitative analysis of magnolia bark, Radix isatidis and Radix Paeoniae Rubra was carried out by TLC. The content of forsythin was determined by HPLC. RESULTS: TLC method could accurately identify M. sinensis, Radix Isatidis, and Radix Paeoniae Rubra. The content of forsythin in the range of 0.2-10.0 μg showed a good linear relationship with the integrated value of peak area (r=0.9997). The average recovery was 99.71. %, RSD = 1.85% (n=6). Conclusion: This method is simple, rapid, and reproducible. The established standard can be used for the quality control of this preparation.