戒毒胶囊质量标准的研究

Studies on the Quality Standard for Jiedu Capsule

目的建立戒毒胶囊的质量标准。方法采用薄层色谱（TLC）法对戒毒胶囊中的金银花、丹参、黄芩、栀子、白芍、人参、熟地黄进行定性鉴别；采用高效液相色谱（HPLC）法对制剂中的绿原酸进行含量测定。色谱条件：用C18分析柱，以乙腈-0．4％磷酸溶液（12：88）为流动相，检测波长为327nm，进样量为20μl。结果薄层色谱中，供试品溶液色谱在与对照药材或对照品相应位置上出现相同颜色的斑点，阴性对照无干扰；高效液相色谱中，绿原酸在1．82—9．10μg·ml^-1范围内线性关系良好（r=0．9997），平均回收率为99．09％。结论薄层色谱法呈现斑点清晰、特异性强，可用于戒毒胶囊的鉴别；高效液相色谱法简便快速、精密度高、准确度好，可用于该药的质量控制。

Objective To establish the quality standard for Jiedu Capsules. Methods Flos Lonicerae, Radix Salviae Miltiorrhizae, Radix ScuteUarine, Fructus Gardeniae, Radix Paeoniae Alba, Radix Ginseng and Radix Rehmanniae were identified using TLC. The content for chlorogenic acid in Jiedu Capsules was determined with HPLC. HPLC analytical method was carried out using a C18 column and a mixture containing 12 volume of acetonitrile and 88 volume of 0.4% phosphoric acid solution as the mobile phase. The detection wavelength was set at 327 nm. Results Spots obtained from the test solutions had the same color in reference solution and medical material in the same location, and the bland solution had no interference. The linear range of albiflorin was from 1.82 to 9.10 μg· ml^- 1 （ r = 0.999 7 ）, the average recovery was 99.09%. Conclusion In TLC, the spots are very clear and specific to identify the herbal medicine in Jedu Capsules. HPLC is simple, quick, high precise and accurate for the quality control of Jiedu Capsules.