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目的:建立发酵虫草制剂中虫草酸的高效液相色谱含量测定方法。方法:采用正向氨基色谱柱Agilent Zorbax NH2(250 mm×4.6 mm,5μm),以乙腈-水(78∶22)为流动相,流速1.0 m L·min~(-1),柱温30℃,示差折光检测器检测(内部温度35℃)。结果:虫草酸进样量在20.19~100.95μg范围内与峰面积呈良好的线性关系,平均加样回收率(n=6)为98.5%,RSD为0.85%。金水宝胶囊中虫草酸含量为2.29%~3.77%,均值为2.86%;百令胶囊中虫草酸含量为2.42%~5.28%,均值为3.68%;心肝宝胶囊中虫草酸含量为3.78%~5.02%,均值为4.37%;至灵胶囊中虫草酸含量为3.63%~5.12%,均值为4.17%;宁心宝胶囊中虫草酸含量为2.37%~4.08%,均值为3.37%,不同企业的制剂中虫草酸含量差异较大;虫草头孢菌粉系宁心宝胶囊的原料药,此次测定的样品中虫草酸的含量为2.30%~3.27%。可见,这种多厂家生产原料药,多厂家生产制剂的现状导致宁心宝胶囊工艺、原料难统一,标准亟待完善和提高。结论:经方法学验证,本方法可用于测定冬虫夏草及发酵虫草制剂中虫草酸的含量,亦可用于控制药材及制剂的质量。
Objective: To establish a method for determination of Cordyceps acid in fermented Cordyceps sinensis by high performance liquid chromatography. METHODS: The mobile phase consisted of a mobile phase of Agilent Zorbax NH2 (250 mm × 4.6 mm, 5 μm) with acetonitrile-water (78:22) at a flow rate of 1.0 mL · L -1 , Refractive index detector detection (internal temperature 35 ℃). Results: Cordyceps acid injection showed a good linear relationship with the peak area in the range of 20.19 ~ 100.95 μg. The average recovery (n = 6) was 98.5% and the RSD was 0.85%. The content of Cordyceps acid in Jinshuibao Capsule was 2.29% -3.77% with an average value of 2.86%. The content of Cordyceps acid in Bailing Capsule was 2.42% -5.28%, with an average value of 3.68%. The content of Cordyceps acid in Xintuobao Capsule was 3.78% ~ 5.02 %, With a mean value of 4.37%. The content of Cordyceps acid in Zhiling capsule was 3.63% -5.12% with an average value of 4.17%. The content of Cordyceps acid in Ningxinbao capsule was 2.37% ~ 4.08% with a mean value of 3.37% The content of Cordyceps acid is quite different; the Cordyceps cephalosporin Department of Ningbai capsule raw material medicine, the determination of the sample Cordyceps acid content of 2.30% ~ 3.27%. Visible, this multi-manufacturer raw material medicine, multi-manufacturer production of the current situation led to Ningxin capsule technology, raw materials is difficult to unify, the standard needs improvement and improvement. Conclusion: This method can be used to determine the content of Cordyceps sinensis in Cordyceps sinensis and in fermented Cordyceps sinensis. It can also be used to control the quality of herbs and preparations.