接骨木总苷片的质量标准研究

Quality Standard of Total Jiegumu Glycosides Tablets

目的:建立接骨木总苷片的质量标准研究方法。方法:采用TLC方法对莫诺苷进行鉴别;HPLC法对接骨木总苷片进行了含量测定;并用浆法测定了接骨木总苷片中莫诺苷的溶出度。根据2010版《中国药典》有关片剂的规定,建立了对重量差异、崩解时限、重金属、砷盐和微生物限度的检查方法。结果:TLC法可很好的鉴别莫诺苷,阴性对照液无干扰;采用HPLC法确定莫诺苷的含量检测限度不得少于4.0%。精密度为3.206%,稳定性2.776%,重现性1.427%,平均回收率为99.63%。建立的方法都符合药典相关规定。结论:建立的分析方法准确、可靠,很好地满足了分析方法中的各项分析要求。

Objective：To study the quality standard of total Jiegumu glycosides tablets .Method：Ast ragalus morroniside were identified by TLC method;the content of total Jiegumu glycosides tablets was determined by HPLC and determine the dissolution of morroniside in total Jiegumu glycosides tablets by slurry .According to the 2010 edition of “Chinese Pharmacopoeia”provisions of the relevant tablets , firstly, we established inspective methods of weight difference , disin-tegration, heavy metal , arsenic salt and microbial limit of total Jiegumu glycosides tablet .Results： TLC method could well identify morroniside , liquid negative control without interference; determination of the detection limits of morroni-side was no less than 4.0%in HPLC;precision was 3.206%,stability was 2.776%, and repeatability was 1.427%, the average recovery rate was 99 .63%.Establis hment methods were in line with pharmacopoeia .Conclusion：The anal-ysis method is accurate , reliable and can well meet the requirements of analysis methods .