中国医药科学
中國醫藥科學
중국의약과학
CHINA MEDICINE AND PHARMACY
2013年
19期
63-64,80
,共3页
痔宁栓%制备工艺%质量控制
痔寧栓%製備工藝%質量控製
치저전%제비공예%질량공제
Zhining suppository%Preparation%Quality control
目的：探讨痔宁栓制备工艺，并制定其质量控制方法。方法采用水提醇沉和单味水提相结合的提取方法制备痔宁栓，应用薄层色谱法分别对痔宁栓中主要成分进行鉴别，采用HPLC法对其没食子酸进行了含量测定。结果在薄层色谱中能检出五倍子和黄柏，没食子酸在0.051～0.256μg/mL线性关系良好（r=0.9996），平均回收率为98.92%，RSD为1.87%。结论该栓剂制备方法简便易行，质量控制方法可靠。
目的：探討痔寧栓製備工藝，併製定其質量控製方法。方法採用水提醇沉和單味水提相結閤的提取方法製備痔寧栓，應用薄層色譜法分彆對痔寧栓中主要成分進行鑒彆，採用HPLC法對其沒食子痠進行瞭含量測定。結果在薄層色譜中能檢齣五倍子和黃柏，沒食子痠在0.051～0.256μg/mL線性關繫良好（r=0.9996），平均迴收率為98.92%，RSD為1.87%。結論該栓劑製備方法簡便易行，質量控製方法可靠。
목적：탐토치저전제비공예，병제정기질량공제방법。방법채용수제순침화단미수제상결합적제취방법제비치저전，응용박층색보법분별대치저전중주요성분진행감별，채용HPLC법대기몰식자산진행료함량측정。결과재박층색보중능검출오배자화황백，몰식자산재0.051～0.256μg/mL선성관계량호（r=0.9996），평균회수솔위98.92%，RSD위1.87%。결론해전제제비방법간편역행，질량공제방법가고。
Objective To investigate preparation and establish the quality control methods of Zhining Suppository. Methods The Zhining suppository was prepared with the method water-ext racting and alcohol-precipitating combined with single water-extracting, Main components of the Zhining suppository were used identified by TLC and the content of Gallic acid in the suppository was determined by HPLC. Results The methods could identify Galla chinensis and Cortex Phellodendri, Gallic acid showed a good linear relationship in the range of 0.051 ~ 0.256μg/mL (r=0.9996), the average recovery of Gallic acide was 98.92%(RSD=1.87%). Conclusion The preparation method was easy to operate, the quality was stable and controllable.
