防风通圣丸(颗粒)质量研究

Quality of Fangfengtongsheng Pills( Granules)

目的对剂型间、企业间、企业内批间和企业批内样品的质量进行对比研究。方法采用HPLC、GC、原子吸收、原子荧光等检测方法,同时进行药包材优选和稳定性试验,综合评价剂型间、企业间、企业内批间和企业批内样品的质量。对企业提供的原药材进行了重金属及有害元素检查,对样品中检出的霉菌进行了菌种鉴定。结果剂型间、企业间、企业内批间样品中盐酸麻黄碱和5-O-甲基维斯阿米醇苷的含量、特征图谱中特征峰的个数存在显著性差异;企业间、企业内批间样品的丸重差异存在显著性差异;部分企业样品中检出土大黄苷;相同条件时不同企业样品薄荷脑含量的下降速率存在明显差异,18℃时不同企业样品下降均较缓慢;企业原药材中重金属含量存在地域相关性。结论企业间、企业内批间样品的质量主要取决于原药材的质量,灭菌工艺、制丸方式和干燥温度,药包材的质量也是影响其质量的重要因素,应当加强原料药材的管理,引导企业进行工艺的优化。

Objective To make a comparative study of the quality of samples between different formulations,manufacturers,batchs from the same manufacturers and manufacturers. Methods HPLC,GC,atomic absorption,atomic fluorescence and other detection methods were used to assess the sample quality and optimum select the packing material. Original medicinal materials were tested for heavy metal an other harmful elements. The mold was checked by strain identification. Results The content of ephedrine hydrochloride and 5-O-menthylvisammioside,the number of characteristic peaks in the characteristic spectrum and the weight of pills were significantly differente between formulations,manufacturers and batchs from different manufacturers. Rhubarb glycoside was detected in some manufacturers samples. There was significant difference between different manufacturers in the decrease rate of menthol content under the same condition,but samples of different manufacturers decreased most slowly at 18 ℃.The content of heavy metal in samples from different manufacturers was correlated with the location. Conclusion The quality of samples not only depends on the original medicinal materials,but also the sterilization process,pelletizing mode,drying temperature and packing materials.