摘要
目的:建立芝芪康艾颗粒的质量标准,对其进行初步安全性评价,以期为临床开发应用提供实验依据。方法:采用薄层色谱法对制剂进行定性鉴别;采用反相HPLC法建立黄芩苷含量检测方法;进行急性毒性实验,并确定最大给药量,以最大药物浓度,最大给药体积,24 h内灌胃给药2次,连续观察14 d,记录小鼠毒性反应和死亡情况;对主要脏器进行HE染色病理切片观察。结果:在薄层色谱中可检出黄芪、黄芩、灵芝的特征斑点,阴性对照无干扰;黄芩苷0. 212~2. 120μg(r=0. 999 3)的范围内呈良好的线性关系,平均回收率为98. 40%。测得小鼠最大耐受量为临床成人用药的217. 2倍。HE病理切片显示,与对照组相比,除给药组肝脏病理切片下出现肝细胞轻微变性外,其他器官均无明显肉眼及镜检异常变化。结论:本制剂质量控制方法简便、准确、分离度好,适用于芝芪康艾颗粒的质量控制;本制剂药理安全性较高,为临床安全用药提供了依据。
Objective： To establish the quality standard of Zhiqi Kang＇ai granules and to evaluate its safety preliminarily,thus to provide experimental basis for its clinical development and application. Methods： The preparations were qualita-tively identified by thin layer chromatography （TLC） ; the method for the determinatio of baicalin content was estab-lished by reversed -phase HPLC; the acute toxicity pre -test was performed, and the maximum dose was determined with the maximal drug concentration and volume given twice by intragastric administration within 24 hours. The toxicityand death of mice were recorded for 14 days. The pathological sections of main organs were observed by HE staining.Results： The characteristic spots of Astragalus membranaceus, Radix Scutellariae and Ganoderma lucidum could be de-retted by TLC, and there was no interference in negative control. Baicalin has a good linear relationship in the range of0. 212 -2.12 μg （r = 0. 999 3 ） , with an average recovery of 98.40%. The maximum tolerated dose in mice was 217.2times that of clinical adults. The pathological section of HE showed that compared with the control group, except for theslight degeneration of hepatocytes under the pathological section of the liver in the administration group, there were noobvious abnormal changes in other organs by macroscopic and microscopic examination. Conclusion： The method forquality control of this preparation is simple, accurate and has good separation, which is suitable for the quality control ofZhiqi Kang＇ai granule; the phamlacological safety of this preparation is high, which provides the basis for its clinical ap-plication.
作者
王兰芳
贾忠
刘鸿雁
刘丽娜
董云霞
WANG Lanfang;JIA Zhong;LIU Hongyan;LIU Lina;DONG Yunxia(Department of Animal Medicine,Gansu Agricultural University,Lanzhou 730070,China;Lanzhou Second People＇s Hospital,Lanzhou 730046,China;Lanzhou Pulmonary Hospital,Lanzhou 730046,China)
出处
《中医药学报》
CAS
2018年第5期61-67,共7页
Acta Chinese Medicine and Pharmacology
基金
兰州市卫生科技发展计划项目(LZWSKY2014-2-05)
关键词
芝芪康艾
质量标准
急性毒性
HPLC
HE染色
Zhiqi Kang＇ai
Quality standard
Acute toxicity
High - phase liquid chromatography
HE staining
