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目的:建立银黄口腔崩解片的质量控制方法。方法:采用薄层鉴别方法鉴别银黄口腔崩解片的黄芩和金银花药材,采用反相高效液相色谱法测定君药黄芩主要有效成分黄芩苷的含量。结果:薄层色谱同时检出黄芩苷和绿原酸斑点,阴性无干扰。银黄口腔崩解片崩解时限小于1 min。黄芩苷HPLC测定的条件为:十八烷基硅烷键合硅胶为填充剂,甲醇-水-磷酸(47∶53∶0.2)(v/v)为流动相;检测波长为280 nm;黄芩苷线性回归方程为Y=8 177 827X-34 818,r=0.999 5(黄芩苷进样量范围1.24~0.04μg),平均回收率为100.03%(RSD为2.32%);本品每片含黄芩苷(C_(21)H_(18)O_(11))不得少于18.0mg。结论:建立的质量控制方法简单方便、科学可行。
Objective: To establish a quality control method of silver yellow orally disintegrating tablets. Methods: Scutellaria baicalensis and honeysuckle medicinal materials of silver yellow orally disintegrating tablets were identified by TLC. The content of baicalin in the main active ingredient of Scutellaria baicalensis was determined by RP-HPLC. Results: Both baicalin and chlorogenic acid spots were detected by TLC and negative without interference. Silver yellow orally disintegrating tablets disintegration time is less than 1 min. The conditions for the determination of baicalin by HPLC were as follows: octadecylsilane bonded silica as filler, methanol-water-phosphoric acid (47:53:0.2) (v / v) as mobile phase and the detection wavelength at 280 nm. The regression equation was Y = 8 177 827X-34 818, r = 0.999 5 (baicalin injection range 1.24-0.04 μg) with an average recovery of 100.03% (RSD 2.32%). The tablets contained baicalin C_ (21) H_ (18) O_ (11)) should not be less than 18.0mg. Conclusion: The established quality control method is simple and convenient and scientifically feasible.