摘要
目的:建立天香丹胶囊(红景天、丹参、降香)的质量控制方法。方法:采用薄层色谱法鉴别本制剂中红景天、丹参、降香,高效液相色谱法将本制剂中红景天苷和酪醇同时测定,丹酚酸B和丹参酮ⅡA同时测定,并以外标两点法计算含量。红景天苷和酪醇色谱条件:流动相:甲醇-乙腈-0.1%磷酸(5∶5∶90),检测波长:221nm。丹酚酸B及丹参酮ⅡA色谱条件:流动相:甲醇(A)-1%甲酸(B),线性梯度洗脱:A∶B=(45∶55)洗脱15min;A∶B=(80∶20)洗脱15min,检测波长:270nm。流速均为1mL/min,柱温均为(30±5)℃,进样量均为10μL。结果:薄层色谱可鉴别出红景天、丹参、降香的特征斑点;HPLC法测定的红景天苷含量线性范围为0.2～1.0μg(r=0.9991),平均回收率=99.6%,RSD=4.10%(n=9)。酪醇含量线性范围为0.2～1.0μg(r=0.9993),平均回收率=99.5%,RSD=2.56%(n=9)。丹酚酸B含量线性范围为1.98～9.90μg(r=0.9995),平均回收率=98.6%,RSD=3.09%(n=9)。丹参酮ⅡA含量线性范围为0.3～1.5μg(r=0.9993),平均回收率=100.1%,RSD=2.79%(n=9)。结论:本法专属性强,重现性好,结果准确可靠,可作为天香丹胶囊的质量控制方法。
AIM： To establish the quality standard for Tianxiangdan Capsule （Radix et Rhizoma Rhodiolae crenulatae, Radix et Rhizoma Salviae miltiorrhizae, Lignum Dalbergiae odoriferae, etc. ）. METHODS： Qualitative identification of Radix et Rhizoma Rhodiola crenulata, Radix et Rhizoma Salvia miltiorrhica, Lignum Dalbergia odorifera was conducted using TLC method. The content of salidroside and tyrosol were determined at one time by HPLC with mobile phase consisted of methanol-acetonitrile-0.1% phosphoric acid solvent （5： 5： 90）. The UV wavelength was set at 221 nm. Salvianolic acid B and tanshinone ⅡA were determined by HPLC with gradient elution using mobile phase consisted of methanol-1% methanoic acid solvent at （45：55 ） maintaining 15 min and （80： 20） 15 min. The UV wavelength was set at 270 nm. All of determinations were at a flow rate of 1 mL/min and at column temperature of （30 ± 5 ） ℃. RESULTS ： The TLC spots of Radix et Rhizoma Rhodiola crenulatae, Radix et Rhizoma Salviae miltiorrhizae, Lignum Dalbergiae odoriferae were characteristic and obvious. The linear ranges of salidroside and tyrosol were 0.2-1.0 μg （ r = 0. 999 1 ） with a average recoveries of 99.6% and 99.5% （ n = 9 ） and RSDs were 4.10% and 2.56%, respectively. The linear range of salvianolic acid B was 1.98-9.90 μg（ r = 0.999 5 ） with a average recovery of 98.6% （n =9） and RSD was 3.09%. Tanshinone ⅡA was 0.3-1.5 μg（ r = 0. 999 3） with a average recovery of 100.1% specific, reliable and accurate. It can be used （ n = 9） and RSD was 2.79%. CONCLUSION ： The methods are for the quality control of Tianxiangdan Capsule effectively.
出处
《中成药》
CAS
CSCD
北大核心
2009年第8期1214-1218,共5页
Chinese Traditional Patent Medicine
基金
新疆自治区科技攻关和重点科技项目(20033312B2)
