精制银翘解毒片中对乙酰氨基酚的溶出度测定

Dissolution Determination of Acetyl Aminophenol from Prepared Yinqiao Jiedu Tablets

目的:考察市售不同厂家的精制银翘解毒片中对乙酰氨基酚的体外溶出情况。方法:采用高效液相色谱法进行含量测定,流动相为甲醇-水(20:80),检测波长为249nm,流速为1.0mL.min-1。参照日本"药品品质再评价"工程对溶出度试验条件的规定,分别考察不同厂家精制银翘解毒片在水、pH1.2人工胃液、pH4.0醋酸盐缓冲液、pH6.8磷酸盐缓冲液4种溶出介质中的体外溶出行为。结果:同一批精制银翘解毒片在不同溶出介质中溶出差异较大;不同药厂精制银翘解毒片的质量有显著性差异。结论:药品标准中有必要增加溶出度检查项目以对制剂质量进行控制。

OBJECTIVE：To review the dissolution behavior of acetyl aminophenol from Prepared yinqiao jiedu tablets produced by different producers in market.METHODS：HPLC method was used to determine the content of acetyl aminophenol.The mobile phase was methanol-water（20：80） and the detection wavelength was set at 249 nm.The flow velocity was 1.0 mL·min-1.The dissolubility of Prepared yinqiao jiedu tablets from different pharmaceutical factories was inspected in the following 4 mediums：water,pH 1.2 artificial gastric juice,pH 4.0 acetate buffer solution,pH 6.8 phosphate buffer solution according to Drug Quality Re-evaluation in Japan.RESULTS：The dissolutions of the same batch of Prepared yinqiao jiedu tablets in different mediums were obviously different.There were significant differences among the quality of the Prepared yinqiao jiedu tablets from different pharmaceutical factories.CONCLUSION：It＇s necessary to add dissolution detection in drug standard to control the quality of Prepared yinqiao jiedu tablets.