盐酸青藤碱滴丸的制备工艺及质量研究

Study on Preparation Technology and Quality Control of Sinomenine Hydrochloride Dripping Pills

关键词:  盐酸青藤碱滴丸  制备工艺  质量控制

Key words:  Sinomenine hydrochloride dripping pills  preparation technology  quality control

摘要:

目的 优选盐酸青藤碱滴丸的最佳制备工艺并控制其质量。方法 以滴丸的溶散时限、硬度、成型情况作为综合评定指标，对药液温度、基质配比(PEG4000∶PEG6000)、药物与基质的比例、及滴制过程中滴速进行正交实验设计，优选滴丸最佳制备工艺。采用高效液相色谱法测定盐酸青藤碱滴丸中盐酸青藤碱的含量。结果 最佳制备工艺为药液温度为75 ℃，PEG4000∶PEG6000为1∶4，药物基质比为1∶3，滴速为60滴·min^-1，冷凝液为二甲基硅油。盐酸青藤碱在0.2~1.0 μg·mL^-1内呈良好的线性关系，r=0.999 5，平均回收率为 99.3%，RSD为1.2%。结论 本试验制得的滴丸溶散时限、外观及丸重均符合质量要求，制备方法简便可行。含量测定方法操作简便、专属性强、重复性好、结果准确可靠，可用于盐酸青藤碱滴丸的质量控制。

Abstract:

OBJECTIVE To optimize preparation technology and to establish a method for quality control of sinomenine hydrochloride dripping pills. METHODS Orthogonal test was applied to optimize the preparation with the choice of the drug temperature, the proportion of two substrates (PEG4000∶PEG6000), the proportion of substrate to drug, and dropping speed. Sinomenine hydrochloride in dripping pills was determined by HPLC. RESULTS The optimum preparation was as follows, drug solution temperature 75 ℃, the ratio of PEG4000 to PEG6000 (1∶4 ) and drug to substrate (1∶3). Dimethicone was refrigerant with 60 dropping per minute. For sinomenine hydrochloride, the linear range was 0.2-1.0 μg·mL^-1(r=0.999 5), and the average recovery was 99.3%, RSD was 1.2%. CONCLUSION The pills can be produced through this process with the simple and reliable method. The determination method is simple, specific, reproducible and accurate, which can be applied to the quality control for the sinomenine hydrochloride dripping pills.