口炎清胶囊的质量控制和稳定性试验  

Quality Control of Kouyanqing Capsule and Stability Test

作　　者：江涛[1] 雷健[1] 邢茂[1] 杨秋凤[1] 葛勤[1] 

机构地区：[1]中国人民解放军第三军医大学新桥医院药剂科,重庆400037

出　　处：《中国药业》2014年第11期17-20,共4页China Pharmaceuticals

摘　　要：目的建立口炎清胶囊的质量控制方法,考察其稳定性。方法口炎清浸膏粉碎后加入辅料制成胶囊,照20lO年版《中国药典（一部）》中方法检查其性状、水分、装量差异、崩解时限,采用薄层色谱法对制剂中的黄连、麦冬、黄芩进行定性鉴别,高效液相色谱法测定制剂中芍药苷的含量。以性状、水分、崩解时限、芍药苷含量为评价指标,进行影响因素试验、加速试验和长期试验。结果口炎清胶囊各项检查均符合2010年版《中国药典（一部）》中的相关规定,黄连、麦冬、黄芩的薄层色谱特征斑点清晰,分离度好。芍药苷质量浓度在0.05~0.45 g/L（r=0.999 9）范围内与峰面积呈良好线性关系,平均回收率为99.69%,RSD为0.51%（n=9）。口炎清胶囊经影响因素试验、加速试验和长期试验,各项指标均符合质量标准规定。结论口炎清胶囊质量可控,且稳定性好。Objective To establish the quality control method of Kouyanqing Capsule and to investigate its stability. Methods After smashing the Kouyanqing extract, the auxiliary materials were added for preparing the capsules. The characters, moisture, content uniformity and desintegrating time were detected according to the related methods in the Chinese Pharmacopoeia （version 2010）. The Thin layer chromatography（TLC） method was adopted to perform thequalitative identification on coptis, radix ophiopogonis and scutellaria baicalensis in the preparation. The paeoniflorin content in the preparation was measured by the high performance liquid chromatography（HPLC） method. The influencing factors test, accelerated testing and long-term test were performed with the character, moisture, disintegration time and the paeoniflorin content as the evaluation indexes. Results The each index of Kouyanqing Capsule accorded with the related stipulation in the Chinese Pharmacopoeia （version 2010）, The TLC specific spots of coptis, radix ophiopogonis and scutellaria baicalensis were distinct with good separation. The mass concentration of paeoniflorin over the range of 0.05 ~ 0.45 g/L had a good linearity witht he peak area（ r =0. 9999）. The average recovery rate was 99.69%, RSD was 0.51% （n =9）. All indexes of Kouyanqing Capsule accorded with the stipulation of the quality standards via the influencing factors test, accelerated testing and long- term test. Conclusion The quality of Kouyanqing Capsule is controllable with good stability.

关 键 词：薄层色谱法 芍药苷 高效液相色谱法 稳定性 

分 类 号：TQ461[化学工程—制药化工] R283.6[医药卫生—中药学]