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敛痔散医院制剂质量标准初步研究
彭军良,胡小苏,姚向阳
0
(上海市金山区中西医结合医院,上海,201501;上海中医药大学中药现代制剂技术教育部工程研究中心,上海,201203)
摘要:
目的:研究敛痔散医院制剂质量的初步标准。方法:薄层色谱法定性鉴别敛痔散中的血竭,HPLC法定性鉴别敛痔散中的黄芩;HPLC法和酸碱滴定法分别定量测定敛痔散中盐酸小檗碱和氧化锌。结果:血竭和黄芩均可检出;盐酸小檗碱在0.0239~2.49μg范围内线性关系良好,平均回收率为93.23%,RSD%为7.2%;氧化锌在取样0.02525~0.25204g范围内线性关系良好,平均回收率为101.36%,RSD%为1.0%。结论:本研究为建立规范的质量标准奠定了坚实基础。
关键词:  盐酸小檗碱  氧化锌  敛痔散  质量标准
DOI:
A preliminary study on the quality standard for hospital preparation of Lianzhi powder
PENG Junliang,HU Xiaosu,YAO Xiangyang
(Shanghai Jinshan Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai 201501,China;Engineering Research Center of Modem Preparation Technology of Traditional Chinese Medicine,Ministry of Education,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
Abstract:
Objective:To investigate the preliminary quality standard for the hospital preparation of Lianzhi powder.Methods:Thin-layer chromatography was used for the qualitative identification of dragon’s blood in Lianzhi powder,and high-performance liquid chromatography (HPLC) was used for the qualitative identification of Scutellaria baicalensis in Lianzhi powder.HPLC and acid-base titration were used to determine berberine hydrochloride and zinc oxide in Lianzhi powder.Results:Both dragon’s blood and Scutellaria baicalensis were detected.Berberine hydrochloride had a good linear relationship within 0.0239-2.49 μg,with an average recovery rate of 93.23% (relative standard deviation [RSD] = 7.2%);zinc oxide had a good linear relationship within 0.02525-0.25204 g,with an average recovery rate of 101.36% (RSD = 1.0%).Conclusion:This study lays a solid foundation for establishing quality standard.
Key words:  berberine hydrochloride  zinc oxide  Lianzhi powder  quality standard

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