目的: 建立准确度高,适用性强的胶体果胶铋胶囊的含量测定方法。方法: 紫外-可见分光光度法以10%抗坏血酸溶液-20%碘化钾溶液-1 mol·L-1硝酸溶液(2∶5∶1)为显色剂,测定波长463 nm;电位滴定法以光度电极为指示电极,测定波长590 nm,以二甲酚橙为指示剂,用0.05 mol·L-1乙二胺四醋酸二钠滴定液进行滴定;原子吸收分光光度法以223.1 nm为测定波长。结果: 紫外-可见分光光度法、电位滴定法与原子吸收分光光度法分别在2~20 μg·mL-1、30~70 mg、5~30 μg·mL-1范围内线性良好,平均回收率分别为100.0%(RSD=0.40%)、100.4%(RSD=0.49%)和100.3%(RSD=0.51%)。18批次样品按上述3种方法测定,含量范围分别为97.1%~104.8%、97.4%~105.0%和97.5%~104.8%。建立的3种方法均能准确测定胶体果胶铋胶囊含量,测定结果之间无统计学差异。结论: 考虑仪器的普适性及方法的灵敏度,紫外-可见分光光度法更适用于胶体果胶铋胶囊的含量测定。
Objective: To establish a method with high accuracy and applicability for the content determination of colloidal bismuth pectin capsules. Methods: UV-Vis spectrophotometry used 10% ascorbic acid solution-20% potassium iodide solution-1 mol·L-1 nitric acid solution(2∶5∶1) as chromogenic agent, and the determination wavelength was 463 nm. Potentiometric titration was carried out using photometric electrode as indicator electrode at 590 nm, with xylenol orange as an indicator and 0.05 mol·L-1 EDTA as titration. The wavelength was measured at 223.1 nm by atomic absorption spectrophotometry(AAS). Results: The good linear relationships were found in the range of 2-20 μg·mL-1,30-70 mg and 5-30 μg·mL-1 for UV-Vis spectrophotometry, potentiometric titration and AAS, respectively. The average recoveries were 100.0% (RSD=0.40%), 100.4% (RSD=0.49%) and 100.3%(RSD=0.51%). Eighteen batches of samples were determined by the above three methods, the content ranges were 97.1%-104.8%, 97.4%-105.0% and 97.5%-104.8%, respectively. The three established methods could accurately determine the content of colloidal pectin bismuth capsules, and the results showed no significant difference. Conclusion: Considering the universality of the instrument and the sensitivity of method, UV-Vis spectrophotometry is more suitable for the content determination of colloidal bismuth pectin capsules.
[1] 李安平, 徐强强, 高宁, 等. 一种制备胶体果胶铋的方法: 中国, CN111217937A[P].2020-06-02
LI AP, XU QQ, GAO N, et al. A Method for Preparing Colloidal Bismuth Pectin:China, CN111217937A[P].2020-06-02
[2] 朱虹, 时昭红, 张书, 等.含铋剂四联疗法对幽门螺旋杆菌感染患者血清炎性因子及免疫功能的影响[J].中华医院感染学杂质, 2020, 30(1):77
ZHU H, SHI ZH, ZHANG S, et al. Impact of bismuth-containing quadruple therapy on serum inflammatory factors and immune function of patients with Helicobacter pylori infection[J].Chin J Nosocomiol, 2020, 30(1):77
[3] 曲年聪, 孙丽萍.奥美拉唑及胶体果胶铋四联疗法根除幽门螺杆菌感染的研究[J].系统医学, 2020, 5(15):35
QU NC, SUN LP. Omeprazole and colloid pectin bismuth quadruple therapy for eradication of Helicobacter pylori infection[J].Syst Med, 2020, 5(15):35
[4] 陈朝聪, 蔡水苗, 刘海珊, 等.胃炎宁颗粒联合胶体果胶铋治疗慢性萎缩性胃炎的临床研究[J].药物评价研究, 2020, 43(1):98
CHEN ZC, CAI SM, LIU HS, et al. Curative effect of Weiyanning granules combined with colloidal bismuth pectin on chronic atrophic gastritis[J].Drug Eval Res, 2020, 43(1):98
[5] 刘倬希, 宋其海, 宿美玲, 等.双歧杆菌与胶体果胶铋分别联合标准三联疗法治疗幽门螺杆菌感染的疗效比较[J].中国医院用药评价与分析, 2019, 19(2):173
LIU ZX, SONG QH, SU ML, et al. Comparison of efficacy between bifidobacterium and colloidal bismuth pectin combined with standard three-drug therapy in respectively treatment of Helicobacter pylori infection[J].Eval Anal Drug Use Hosp China, 2019, 19(2):173
[6] 张伯恒.左氧氟沙星联合雷贝拉唑、奥硝唑及胶体果胶铋治疗幽门螺杆菌的疗效观察[J].中国卫生标准管理, 2017, 8(20):92
ZHANG BH. Efficacy of levofloxacin combined with rabeprazole, ornidazoleand colloidal pectin bismuth in the treatment of Helicobacter pylori[J].China Health Stand Manag, 2017, 8(20):92
[7] 张海霞.阿莫西林联合胶体果胶铋治疗胃炎的临床效果分析[J].中国社区医师, 2020, 36(10):82
ZHANG HX. Clinical analysis of amoxicillin combined with bismuth pectin in the treatment of gastritis[J].Chin Commun Doct, 2020, 36(10):82
[8] 叶建樑.雷贝拉唑、阿莫西林联合胶体果胶铋治疗Hp阳性消化性溃疡的临床研究[J].中国微生态学杂志, 2018, 30(2):200
YE JL. Rabeprazole and amoxicillin combined with colloidal bismuth pectin in the treatment of Hp-positive peptic ulcer[J].Chin J Microecol, 2018, 30(2):200
[9] 中华人民共和国药典2015年版.二部[S].2015: 1176
ChP 2015.Vol Ⅱ[S].2015:1176
[10] 中华人民共和国药典2020年版.二部[S].2020: 1406
ChP 2020.Vol Ⅱ[S].2020: 1406
[11] 李娜, 王旭文, 刘艳之.胶体果胶铋动力黏度的测定方法[J].山西化工, 2020, 40(6):4
LI N, WANG XW, LIU YZ. Method for determination of dynamic viscosity of bismuth colloidal pectin[J].Shanxi Chem Ind, 2020, 40(6):4
[12] 何莉.胶体果胶铋干混悬剂中游离铋测定方法的建立[J].中国处方药, 2020, 18(8):23
HE L. Establishment of determination method for free bismuth in colloidal bismuth dry suspension[J].J China Prescr Drug, 2020, 18(8):23
[13] 温钦海, 吴许伟.胶体果胶铋原料药的稳定性实验研究[J].中国当代医药, 2010, 17(9):18
WEN QH, WU XW. Experimental study on the stability of bismuth colloidal pectin[J].China Mod Med, 2010, 17(9):18
[14] 李莉, 汤磊, 黄家宇, 等.毛细管气相色谱法测定胶体果胶铋中甲醇和乙醇的残留量[J].华西药学杂志, 2009, 24(6):665
LI L, TANG L, HUANG JY, et al. Determination of residual methanol and ethanol in colloidal bismuth pectin by capillary GC[J].West China J Pharm Sci, 2009, 24(6):665
[15] 卢蕾, 魏德胜, 张芸, 等.胶体果胶铋原料药的稳定性研究[J].贵阳医学院学报, 2009, 34(4):466
LU L, WEI DS, ZHANG Y, et al. Study on the stability of colloidal pectin bismuth[J].J Guiyang Med Coll, 2009, 34(4):466
