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清心安神软胶囊质量标准研究 被引量:2

Quality Standard for Qingxin Anshen Soft Capsules
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摘要 目的建立清心安神软胶囊的质量标准。方法采用TLC法鉴别清心安神软胶囊中黄连、肉桂;用高效液相色谱法对制剂中盐酸小檗碱、桂皮醛进行定量分析。结果定性鉴别分离度好,专属性强;盐酸小檗碱的含量测定线性范围为0.6412μg~6.412μg(r=0.9997,n=7),平均回收率为97.57%(RSD=0.81,n=6);桂皮醛的含量测定线性范围为0.2148μg~2.148μg(r=0.9998,n=7),平均回收率为97.70%(RSD=0.88,n=6)。结论所建立之方法准确可靠、灵敏度高、专属性强,可有效控制清心安神软胶囊的质量。 Objective To establish the quality standard for Qingxin Anshen Soft Capsules. Methods Rhizoma Coptidis and Cortex Cinnamomi in Qingxin Anshen Soft Capsules were identified by TLC. Berberine hydrochloride and cinnamaldehyde were determined by HPLC. Results The characteristic identification by TLC was distinct and highly specific. The results of quantitative evaluation showed that berberine hydrochloride had the linear range of 0. 6412 μg 6. 412 μg( r = 0. 999 7, n = 7), and the average recovery was 97. 57 % (RSD = 0.81, n = 6) ; cinnamaldehyde had the linear range of 0. 2148 μg- 2. 148 μg( r = 0. 999 8, n=7), and the average recovery was 97.70 % (RSD = 0. 88, n = 6). Conclusion The method is reliable, accurate and specific. It can be used for the quality control of Qingxin Anshen Soft Capsules.
出处 《中药新药与临床药理》 CAS CSCD 北大核心 2010年第1期61-64,共4页 Traditional Chinese Drug Research and Clinical Pharmacology
关键词 清心安神软胶囊 盐酸小檗碱 桂皮醛 质量标准 高效液相色谱 Qingxin Anshen Soft Capsules Berberine hydrochloride Cinnamaldehyde Quality standard HPLC
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