Du Shouying, Chen Wen, Wu Qing, Wu Huichao, Chen Xiaolan
School of Chinese Meterial Medica, Beijing University of Chinese Medicine, Beijing 100102, China.
Zhongguo Zhong Yao Za Zhi. 2010 Jul;35(13):1706-9. doi: 10.4268/cjcmm20101312.
To establish a method to determine the dissolution of Tanshinone IIA in xianling gubao capsules, and compare the dissolution of Xianling Gubao capsules prepared by different processes.
The small cup method was used at a rotary speed of 100 r x min(-1), the dissolubility was inspected in the following 6 mediums: (1) water; (2) 0.1 mol x L(-1) hydrochloric acid solution; (3) pH 6.8 phosphate buffer; (4) pH 6.8 phosphate buffer solution + 0.5% cholic acid; (5) pH 6.8 phosphate buffer solution + 1.0% cholic acid; (6) pH 7.6 phosphate buffer solution + 4. 0% cholic acid. A HPLC method was used to determine the dissolution samples of tanshione IIA in different dissolution mediums. The accumulative dissolution percentages were calculated, and the resemblance of release curves were compared by similarity factors (f2).
The accumulative dissolution percentage was the highest while pH 7.6 phosphate buffer solution + 4.0% cholic acid was used as medium. The similarity factor values (f2) of tanshinone IIA dissolution curves of different preparation processes of Xianling Gubao capsules were all less than 50.
There is significant difference in tanshinone IIA dissolution between Xianling Gubao capsules of different preparation processes. The accumulative dissolution percentages of the tanshinone IIA in new Xianling Gubao capsules is higher than that in the capsules prepared by other preparation processes.
建立一种测定仙灵骨葆胶囊中丹参酮ⅡA溶出度的方法,并比较不同工艺制备的仙灵骨葆胶囊的溶出度。
采用小杯法,转速为100 r·min⁻¹,在以下6种介质中考察溶出度:(1)水;(2)0.1 mol·L⁻¹盐酸溶液;(3)pH 6.8磷酸盐缓冲液;(4)pH 6.8磷酸盐缓冲液+0.5%胆酸;(5)pH 6.8磷酸盐缓冲液+1.0%胆酸;(6)pH 7.6磷酸盐缓冲液+4.0%胆酸。采用高效液相色谱法测定不同溶出介质中丹参酮ⅡA的溶出度样品。计算累积溶出百分率,并通过相似因子(f2)比较释放曲线的相似性。
以pH 7.6磷酸盐缓冲液+4.0%胆酸为介质时,累积溶出百分率最高。不同工艺制备的仙灵骨葆胶囊丹参酮ⅡA溶出曲线的相似因子(f2)值均小于50。
不同工艺制备的仙灵骨葆胶囊中丹参酮ⅡA的溶出度有显著差异。新仙灵骨葆胶囊中丹参酮ⅡA的累积溶出百分率高于其他制备工艺制备的胶囊。