摘要
目的制备理气颗粒,并建立质量控制标准。方法在单因素考察的基础上,通过正交设计优化制备工艺,采用紫外分光光度法测定理气颗粒中番泻苷B的含量,并对理气颗粒进行了影响因素试验。结果正交设计优选的处方组方合理,制备的理气颗粒成型性和溶解性均符合要求。含量测定方法的稳定性较好,日内精密度0.205%,日间精密度0.243%,平均回收率94.28%,RSD1.0%。影响因素试验表明,该制剂在高湿(RH95%)和光照条件下(4500Lx)不稳定。结论优化后的制备工艺制得的理气颗粒符合质量要求。质控方法简便、准确、可行。理气颗粒需在干燥避光条件下保存。
Objective To prepare the compound Liqi granules, and establish the quality control standards of it. Methods The influence of different excipients on drug release in vitro was inspected by single factor, and the prescription and technology was optimized in the orthogonal designed study. Ultraviolet spectrometry was used to measure the sennosides B, and the influence factor experiment on Liqi granules was conducted. Results The composing prescription was reasonably optimized by orthogonal designed study, the dissolving and formability of Liqi granules met the requirement. The measurement method had good stability. Within-day and between-day RSD were 0.205% and 0. 243% ;The average recovery rate was 94. 28% ,RSD was 1.0%. However, the contain was unstable under high humidity（ RH 95% ）and highlight （4500 Lxes）. Conclusion The optimizing process is good, and the quality control method is simple, accurate and feasible, and the storage of the Liqi granules need to avoid the light term.
出处
《实用药物与临床》
CAS
2009年第1期32-35,共4页
Practical Pharmacy and Clinical Remedies
关键词
理气颗粒
制备
质量标准
Liqi granules
Preparation
Quality Control Standards
