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目的:建立穴敷喘平凝胶贴剂的质量标准。方法:采用TLC法鉴别方中芥子、延胡索、细辛。采用HPLC法测定方中盐酸麻黄碱的含量。结果:定性鉴别中检出芥子、延胡索、细辛,且分离度好、专属性强,阴性对照无干扰。HPLC测定盐酸麻黄碱在0.032～0.096μg有较好的线性关系,平均回收率为98.12%,RSD为1.08%,凝胶贴剂中盐酸麻黄碱含量为4.25mg.g-1。结论:所建立的质量控制方法准确、可靠、专属性强,可以用于该制剂的质量控制。
OBJECTIVE: To establish the quality standard of acupoint-pus gel patch. Methods: TLC identification of mustard, Corydalis, Asarum. HPLC method was used to determine the content of ephedrine hydrochloride in the prescription. Results: The identification of Mustard, Corydalis, Asarum in qualitative identification was good and the specificity was good. The negative control had no interference. HPLC determination of ephedrine hydrochloride in the 0.032 ~ 0.096μg has a good linear relationship, the average recovery was 98.12%, RSD was 1.08%, the gel patch of ephedrine hydrochloride content of 4.25mg.g-1. Conclusion: The established quality control method is accurate, reliable and specific. It can be used for the quality control of the preparation.