西部中医药
西部中醫藥
서부중의약
GANSU JOURNAL OF TRADITIONAL CHINESE MEDICINE
2014年
9期
55-58
,共4页
杨飞快%李炜%蔡慧侠%杨静%薛美玲
楊飛快%李煒%蔡慧俠%楊靜%薛美玲
양비쾌%리위%채혜협%양정%설미령
安儿宁颗粒%岩白菜素%唐古特乌头总生物碱%乌头碱限量
安兒寧顆粒%巖白菜素%唐古特烏頭總生物堿%烏頭堿限量
안인저과립%암백채소%당고특오두총생물감%오두감한량
AnErNing granules%bergenin%total alkaloids of TangGuTe WuTou%aconitine limit
目的:建立安儿宁颗粒的质量标准。方法:采用TLC法建立制剂中胆酸及猪去氧胆酸、甘草、岩白菜素的定性鉴别方法及乌头碱的限量检查方法;采用HPLC法建立样品中乌头碱总碱及岩白菜素的含量测定方法。结果:样品中定性鉴别薄层色谱特征明显,专属性强,阴性对照无干扰;HPLC测定中乌头总生物碱在0.0999~0.4995 mg范围内线性关系良好,r=0.9995;平均加样回收率为97.41%(n=9);岩白菜素进样量在0.1324~1.0592μg范围内线性关系良好,r=0.9998;平均加样回收率为98.90%(n=9)。结论:建立的检测方法操作简便、准确、稳定、专属性强,可作为安儿宁颗粒的质量方法控制。
目的:建立安兒寧顆粒的質量標準。方法:採用TLC法建立製劑中膽痠及豬去氧膽痠、甘草、巖白菜素的定性鑒彆方法及烏頭堿的限量檢查方法;採用HPLC法建立樣品中烏頭堿總堿及巖白菜素的含量測定方法。結果:樣品中定性鑒彆薄層色譜特徵明顯,專屬性彊,陰性對照無榦擾;HPLC測定中烏頭總生物堿在0.0999~0.4995 mg範圍內線性關繫良好,r=0.9995;平均加樣迴收率為97.41%(n=9);巖白菜素進樣量在0.1324~1.0592μg範圍內線性關繫良好,r=0.9998;平均加樣迴收率為98.90%(n=9)。結論:建立的檢測方法操作簡便、準確、穩定、專屬性彊,可作為安兒寧顆粒的質量方法控製。
목적:건립안인저과립적질량표준。방법:채용TLC법건립제제중담산급저거양담산、감초、암백채소적정성감별방법급오두감적한량검사방법;채용HPLC법건립양품중오두감총감급암백채소적함량측정방법。결과:양품중정성감별박층색보특정명현,전속성강,음성대조무간우;HPLC측정중오두총생물감재0.0999~0.4995 mg범위내선성관계량호,r=0.9995;평균가양회수솔위97.41%(n=9);암백채소진양량재0.1324~1.0592μg범위내선성관계량호,r=0.9998;평균가양회수솔위98.90%(n=9)。결론:건립적검측방법조작간편、준학、은정、전속성강,가작위안인저과립적질량방법공제。
Objective: To set up quality standard of AnErNing granules. Methods: Qualitative identification methods of cholalic acid, hyodesoxycholic acid, GanCao (Glycyrrhiza uralensis Fisch.) and bergenin in the prepara-tions were established, and limit examination method for aconitine by TLC;content determination methods for total alkaloids of aconitine and bergenin were founded by HPLC. Results: TLC presented distinguishing features with strong specificity and the blank test showed no intereference of negative control;total alkaloids of WuTou indicated good linear relationship in the range between 0.099 9 and 0.499 5 mg by HPLC, r=0.999 5;average recovery rate was 97.41%(n=9);bergenin of sample size presented good linear relationship in the range between 0.132 4 and 1.059 2μg, r=0.999 8;average recovery rate was 98.90% (n=9). Conclusion:The determination method is simple, accurate, sta-ble and specific, and it could be used for quality control of AnErNing granules.