甘露聚糖肽滴鼻液的制备及其质量控制  

Preparation and Quality Control of Mannatide Nasal Drops

作　　者：金伟华[1] 陈华[1] 张明[1] 蒲志强[1] 钟妙[2] 

机构地区：[1]成都军区总医院药剂科,成都610083 [2]泸州医学院药学系,四川泸州646000

出　　处：《中国药房》2014年第9期828-830,共3页China Pharmacy

摘　　要：目的：制备甘露聚糖肽滴鼻液，并对其进行质量控制。方法：以水为溶媒、氯化钠为渗透压调节剂、甘露聚糖肽为主药，制备甘露聚糖肽滴鼻液。将甘露聚糖肽滴鼻液酸性水解、碱性衍生后，采用高效液相色谱法测定其中甘露糖的含量。流动相为乙腈-0．02mol／L乙酸铵溶液（20：80），检测波长为250nm。结果：所制备的样品为淡黄色澄明液体，pH及其他检查均符合《中国药典》要求，规格为10mg／ml，甘露糖检测质量浓度的线性范围为21．4-107μg／ml（r=0．9999），低、中、高质量浓度样品的回收率分别为98．64％、97．08％、98．36％，RSD为1．02％、1．32％、0．69％（n=3）。结论：甘露聚糖肽滴鼻液的制备方法可行、质量可控。OBJECTIVE： To prepare Mannatide nasal drops and carry out quality control of it. METHODS： With water as sol- vent, sodium chloride as osmotic pressure regulator, mannatide was made into nasal drops. After acidic hydrolysis and basic deriva- tion, the content of mannose was determined by HPLC with mobile phase consisted of acetonitrile-0.02 mol/L ammonium acetate solution （20：80） at the detection wavelength of 250 nm. RESULTS： Prepared sample was faint yellow transparent liquid, and pH and other examination terms of the samples were all in line with the requirements of Chinese Pharmacopeia, with specifications of 10 mg/ml. The linear range of mannose was 21.4-107 μg/ml （r=0.999 9）; average recoveries were 98.64%, 97.08% and 98.36% at low, medium and high concentrations, respectively （RSD were 1.02%, 1,32%, 0.69%, n=3）, CONCLUSIONS： The method is feasible and controllable in quality for Mannatide nasal drops.

关 键 词：甘露聚糖肽 滴鼻液 制备 水解 衍生化 高效液相色谱法 质量控制 

分 类 号：R943[医药卫生—药剂学] R987[医药卫生—药学]