宫颈炎康栓中冰片和苦杏仁质量控制方法的研究  

Study on Quality Control Method of Borneol and Bitter Apricot Seed in Gongjing Yankang Suppository

作　　者：钟妍 ZHONG Yan(Guangxi Institute for Food and Drug Control,Nanning 530021,China)

机构地区：[1]广西壮族自治区食品药品检验所,南宁530021

出　　处：《中国药品标准》2018年第4期282-285,共4页Drug Standards of China

摘　　要：目的:建立宫颈炎康栓中冰片和苦杏仁的质量控制方法。方法:采用气相色谱法对方中冰片进行定性鉴别,以DB-WAX毛细管柱为色谱柱(0.53 m×30 mm,1μm),氮气为载气,FID检测器,柱温140℃;采用高效液相色谱法测定苦杏仁苷的含量,以C_(18)柱为色谱柱(4.6 mm×250 mm,5μm),甲醇-0.2%磷酸水(22∶78)为流动相,检测波长为210 nm。结果:GC鉴别阴性无干扰,苦杏仁苷进样量在0.103 1~2.062 0μg范围内线性关系良好(r=1.000 0,n=6);平均加样回收率为102.33%,RSD=1.88%。结果 10批供试品中含量最高为5.67 mg/粒,含量最低为4.38 mg/粒,平均值为5.05 mg/粒。结论:采用的方法简便、准确,专属性强,重现性良好。Objective： To establish the quality control methods of borneol and Bitter Apricot Seed in Gongjing Yankang Suppository. Methods： Borneol were identified by GC. A DB-WAX capillary column（ 0. 53 m × 30 mm,1μm） was adopted in the GC system with the column temperature as 140 ℃,nitrogen as the carrier gas,and FID as the detector. The content of Amygdalin was determined by HPLC. The test was performed in C18 column（ 4. 6 mm× 250 mm,5μm） with methanol-0. 2% phosphoric acid solution（ 22 ∶ 78） as the mobile phase The detection wavelength was 210 nm. Results： The negative sample didn＇ t interfere the identification of Borneol by GC. The linear range of Amygdalin fell into 0. 103 1-2. 062 0 μg（ r = 1. 000 0,n = 6）,and the average recovery was102. 33%. with RSD as 1. 88%. The highest content of Amygdalin in 10 batches of samples reached 5. 67 mg per capsule,the lowest content was 4. 38 mg per capsule,and the average content was 5. 05 mg per capsule. Conclusion： The established method is simple and accurate. It has the good specificity and reproducibility.

关 键 词：宫颈炎康栓 冰片 苦杏仁 质量控制 

分 类 号：R921.2[医药卫生—药学]