目的 建立復方甘草片溶出度試驗方法，考察復方甘草片的溶出行為并評價其內(nèi)在質(zhì)量。方法 采用槳法，以水為溶出介質(zhì)，轉(zhuǎn)速為75 r/min，自身對照法，紫外-可見分光光度法測定，檢測波長260 nm。結(jié)果 復方甘草片在10%～100%的溶出量內(nèi)呈良好的線性關系，回歸方程Y＝1.098 19X＋0.009 18，r＝0.999 7，采用此法檢測32家生產(chǎn)企業(yè)76批樣品溶出度，36.8%批次的溶出結(jié)果低于80%。結(jié)論 溶出試驗方法在一定程度上反映本品的生物利用度，自身對照法能消除干擾，重復性好、操作簡便，對全國樣品考察結(jié)果顯示，該方法能夠有效控制產(chǎn)品的內(nèi)在質(zhì)量。

Objective To establish a test method for the dissolution of Compound Liquorice Tablets (CLT), to inspect the dissolution of 76 batches of CLT made in China, and to evaluate their internal-quality. Methods Using paddle method, the medium was water, and rotated speed was 75 r/min. The detection wavelength was 260 nm, the values of dissolution were calculated by self-control method. Results The calibration curve was liner in the concentration range of 10%—100% dissolution, r = 0.999 7; 76 batches of samples from 32 manufactories were detected using this method and the batches with the results below 80% were about 36.8% in total. Conclusion The dissolution test method shows the biological availability to some degree, and the self-control method is accurate, highly specific, and widely applicable. Through the investigation of the samples all over the country, it is shown that the method could be applicable to all the samples and effectively control the internal-quality of product.

廈門市科技進步項目（Z20121035）