穿琥宁中空栓的制备及质量控制方法研究

Preparation and Quality Control of Potassium Dehydroandrographolide Succinate Hollow Suppository

目的:制备穿琥宁中空栓并建立其质量控制方法。方法:以半合成脂肪酸甘油酯为基质,以聚乙二醇300或1,2-丙二醇为分散媒,制备穿琥宁中空栓;采用紫外分光光度法测定主药穿琥宁的含量,测定波长为251nm。结果:穿琥宁检测浓度在6.0～50.0μg.mL-1范围内与吸光度呈良好线性关系(r=0.9999,n=5);2种穿琥宁中空栓的质量考查符合规定。结论:本方法合理、可行。

OBJECTIVE： To prepare Potassium dehydroandrographolide succinate （PDS） hollow suppository and establish a method for its quality control. METHODS： The PDS hollow suppository was prepared with semisynthesis fatty acid glyceride as ground substances and PEG300 or 1, 2 propylene glycol as disperse medium. The content of PDS was determined by ultra- violet spectrophotometry at a detection wavelength of 251nm. RESULTS： The linear concentration range of PDS was 6.0-50.0μg · mL^-1（r = 0. 999 9, n = 5） .The two kinds of PDS hollow suppository were all up to the quality standard. CONCLU- SION： This method is reasonable in design and feasible in technology.