丹灯通脑软胶囊质量标准的提高  

Improvement of the Specification of Dandeng Tongnao Soft Capsules

作　　者：刘艳丽 周永妍 李菲 李龙龙 孙胜斌 姜国志 李振江 

机构地区：[1]神威药业集团有限公司,石家庄051430 [2]云南神威施普瑞药业有限公司,昆明650033

出　　处：《中国药品标准》2017年第4期245-251,共7页Drug Standards of China

摘　　要：目的:提升丹灯通脑软胶囊的质量标准。方法:采用薄层色谱法(TLC)对丹灯通脑软胶囊中丹参、灯盏细辛、川芎及粉葛药材进行定性鉴别;采用高效液相色谱法(HPLC),以葛根素、野黄芩苷、丹酚酸B作为指标成分进行定量测定。结果:薄层色谱法能清晰地鉴别丹灯通脑软胶囊中的丹参、灯盏细辛、川芎及粉葛,阴性无干扰;葛根素、野黄芩苷、丹酚酸B分别在3.85~115.5μg·mL^(-1)(r^2=0.999 8)、5.81~174.3μg·mL^(-1)(r^2=0.999 8)和12.28~368.4μg·mL^(-1)(r^2=0.999 8)质量浓度范围内与峰面积具有良好的线性关系;平均回收率(n=9)分别为99.8%、100.2%和99.7%。外标一点法计算样品中葛根素、野黄芩苷、丹酚酸B的含量,10批样品三种成分含量测定结果分别为:1.50~4.06 mg/粒、2.4~3.9 mg/粒、4.6~6.8 mg/粒。结论:所建立的方法准确、可靠、专属性强,可作为丹灯通脑软胶囊的质量控制方法。Objective： To improve the specification of Dandeng Tongnao Soft Capsules. Methods： Salviae Miltiorrhi- zae Radix et Rhizoma, Erigerontic Herba, Chuanxiong Rhizoma, and Puerariae Lobatae Radix in Dandeng Tongnao Soft Capsules were identified by TLC. The puerarin, scutellarin and salvianolic acid B as the index components were simultaneously determined by HPLC. Results： Salviae Miltiorrhizae Radix et Rhizoma, Erigerontic Herba, Chuanxiong Rhizoma, and Puerariae Lobatae Radix in Dandeng Tongnao Soft Capsules could be identified by TLC without the blank interference, The linearity between the concentrations and peak areas of puerarin, scutellarin and salvianolic acid B were shown in the ranges of 3.85 - 115.5μg·mL^-1 （r2 =0. 999 8）, 5.81 - 174. 3μg·mL^-1 （r^2 =0. 999 8）, and 12. 28 -368.4 μg·mL^-1（r2 =0. 999 8） with the average recoveries as 99. 8%, 100. 2%, and 99.7% （n = 9） respectively. The external standard method was used to calculate the content of puerarin, scutellarin and salvianolic acid B. The contents of puerarin, scutellarin and salvianolic acid B in 10 batches of sam- ples were 1.50 - 4.06 mg/capsule, 2. 4 - 3.9 mg/capsule and 4. 6 - 6. 8 mg/capsule respectively. Conclusion： This accurate, reliable and specific method can be used for the quality control of Dandeng Tongnao Soft Capsules.

关 键 词：丹灯通脑软胶囊 质量标准 薄层色谱 高效液相色谱 

分 类 号：R921.2[医药卫生—药学]