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目的研究连番止泻分散片制备工艺,建立一评多测的方法测定连番止泻分散片中盐酸小檗碱、芍药苷、黄芩苷含量。方法以崩解时限、体外溶出度、分散均匀性、硬度为指标,确定制备工艺;采用高效液相色谱法测定含量。Alltima C18色谱柱(250 mm×4.6 mm,5μm);流动相:乙腈(A),0.1%三乙胺-0.4%磷酸(B),梯度洗脱:0~15 min,5%~25%A;15~30 min,25%~40%A;30~45 min,40%~100%A;45~50 min,100%A。流速:1.0 m L/min,柱温:30℃,检测波长:348 nm。结果选用20%CMS-Na做崩解剂(内外加比例5∶1),5%PVPK30溶液适量做黏合剂,效果较佳;建立了盐酸小檗碱、芍药苷、黄芩苷一评多测的测定方法。结论该工艺研制的分散片质量指标符合要求;修订后的标准专属性强,重复性好,可用于连番止泻分散片的质量控制。
OBJECTIVE To study the preparation technology of Lian Xian Zhi Dispersible Tablets and to establish a multi-measurement method for the determination of berberine hydrochloride, paeoniflorin and baicalin in Lianbian Zhixiao Dispersible Tablets. Methods The disintegration time, in vitro dissolution, dispersion uniformity, hardness as an index to determine the preparation process; Determination of content by high performance liquid chromatography. Alltima C18 column (250 mm × 4.6 mm, 5 μm); mobile phase: acetonitrile (A), 0.1% triethylamine-0.4% phosphoric acid ; 15 to 30 min, 25% to 40% A; 30 to 45 min, 40% to 100% A; 45 to 50 min, 100% Flow rate: 1.0 m L / min, column temperature: 30 ° C, detection wavelength: 348 nm. Results 20% CMS-Na was used as disintegrating agent (5: 1 ratio between internal and external) and 5% PVPK30 as adhesive. The results showed that berberine hydrochloride, paeoniflorin and baicalin were the most effective test methods. Conclusion The quality index of dispersible tablets developed by this technology meets the requirements. The revised standards are of high specificity and repeatability and can be used for the quality control of Lianzhi dispersible tablets.