氢化可的松灌肠液的制备与质量控制  

Preparation and Quality Control of Hydrocortisone Enema

作　　者：刘永胜[1] 陈华[1] 金伟华[1] 米婷婷[1] 

机构地区：[1]成都军区总医院药剂科,成都610083

出　　处：《中国药房》2013年第1期63-64,共2页China Pharmacy

摘　　要：目的:制备氢化可的松灌肠液并建立其质量控制方法。方法:以氢化可的松为主药制备灌肠液;采用高效液相色谱法测定主药的含量,同时考察制剂质量及其稳定性。结果:所制制剂为无色黏稠液体,鉴别、检查等均符合相关规定,氢化可的松检测质量浓度在0.01～0.2mg/m(lr=0.9994)范围内与峰面积积分值呈良好的线性关系,平均回收率为100.47%,RSD=0.474%(n=9);3批样品的平均占标示量百分含量分别为99.87%(RSD=0.32%,n=6)、102.72%(RSD=0.58%,n=6)、98.13%(RSD=0.63%,n=6);室温下放置12个月各项指标均无明显变化。结论:本制剂制备工艺简便可行,质量稳定可控。OBJECTIVE：To prepare Hydrocortisone enema and to establish the method for the quality control of it.METHODS：Hydrocortisone was used as main component to prepare Hydrocortisone enema.The content of hydrocortisone was determined by HPLC.The quality and stability of Hydrocortisone enema were investigated.RESULTS：Preparation was colorless viscous liquid.The identification and examination items were in accordance with the relevant provisions.The linear range of hydrocortisone was 0.01-0.2 mg/ml（r=0.999 4）with an average recovery of 100.47%（RSD=0.474%,n=9）;average labelled percentages of 3 batches of samples were 99.87%（RSD=0.32%,n=6）,102.72%（RSD=0.58%,n=6）and 98.13%（RSD=0.63%,n=6）,respectively.The preparation had no obvious changes at room temperature within 12 months.CONCLUSION：The method is simple,feasible,stable and controllable in quality.

关 键 词：氢化可的松灌肠液 高效液相色谱法 制备 质量控制 

分 类 号：R944.1[医药卫生—药剂学]