灯盏花素提取纯化工艺及其片剂的制备

Extraction,Purification and Tablets Preparation of Breviscapine from Erigeron breviscapus

为确定灯盏细辛中灯盏花素的提取纯化工艺,以70%乙醇溶液超声波提取灯盏细辛药材,醇提浸膏进行HP-20大孔吸附树脂洗脱和酸沉工艺纯化,在(335±1)nm波长处采用紫外分光光度法测定了野黄芩苷的含量.以乳糖、蔗糖和微晶纤维素为填充剂,以交联聚维酮为崩解剂,制备了灯盏花素片剂(野黄芩苷标示量20 mg)并开展了质量检查.结果表明:大孔吸附树脂20%,50%,80%乙醇洗脱部位经酸沉后测定的含量分别为98%,79.8%,42.1%,而50%乙醇洗脱部位的得率最高达到12.14%.优选灯盏花素片剂处方为主药12%,MCC 40%,PVPP 30%,蔗糖13%,乳糖5%,硬脂酸镁0.5%,50%乙醇适量.该提取纯化方法能获得较高野黄芩苷含量的灯盏花素,制备的片剂质量检查合格.制备工艺操作性强,重现性好,能适应于工业大生产的需求.

To investigate the extracting and refining technique of breviscapine from Erigeron breviscapus,E. breviscapus was extracted with 70% ethanol solution by ultrasonic method. The alcohol extract was eluted using HP-20 macroporous resin and purified with an acid precipitation process. UV spectrophotometry was used to determine the yield of scutellarin at a wavelength of（335 ± 1） nm. Breviscapine tablets（with the labelled content of scutellarin 20 mg） were then prepared using lactose,sucrose and microcrystalline cellulose as filler and crosslinked povidone as disintegrating agent,respectively.The qualities of the tablets were also evaluated. The results showed that the content of scutellarin was 98%,79. 8%,42.1% in the eluent of 20%,50%,80% ethanol,respectively,after the acid precipitation. And the elution with 50%ethanol afforded the highest yield of 12. 14%. The optimized formulation of breviscapine tablets consisted of 12%breviscapine,40% MCC,30% PPVP,13% sucrose,5% lactose,0. 5% magnesium stearate and an appropriate amount of 50% ethanol. This technique proved highly efficient for the extraction and purification of scutellarin. The formulation and the prepared breviscapine tablets were up to standard,and the process was workable and reproducible,which may be adapted for industrial scale production.