中国药房2013，Vol.24Issue(1)：63-64,2.DOI:10.6039/j.issn.1001-0408.2013.01.22
氢化可的松灌肠液的制备与质量控制
Preparation and Quality Control of Hydrocortisone Enema
摘要
Abstract
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Key words
Hydrocortisone enema/ HPLC/ Preparation/ Quality control分类
医药卫生引用本文复制引用
刘永胜,陈华,金伟华,米婷婷..氢化可的松灌肠液的制备与质量控制[J].中国药房,2013,24(1):63-64,2.
