目的 建立測(cè)定復(fù)方丹參片三組物質(zhì)組（多指標(biāo)物質(zhì)組、指紋物質(zhì)組、有效部位物質(zhì)組）溶出度檢測(cè)方法，并考察不同廠家復(fù)方丹參片物質(zhì)組溶出度的情況。方法 按照《中國(guó)藥典》2010年版二部附錄XC溶出度測(cè)定第三法，以200 mL水為溶出介質(zhì)進(jìn)行溶出實(shí)驗(yàn)，并采用高效液相及紫外分別檢測(cè)三組物質(zhì)組的體外溶出度，繪制累積溶出曲線，且對(duì)各曲線進(jìn)行相似因子的比較。結(jié)果 測(cè)定結(jié)果顯示在60 min內(nèi)除物質(zhì)組一中丹參酮Ⅱ_A的溶出僅為23.41%外，其他物質(zhì)組均能溶出95%以上，且不同廠家復(fù)方丹參片物質(zhì)組溶出曲線相似因子f₂值大多小于50。結(jié)論 復(fù)方丹參片三組物質(zhì)組的溶出度總體呈良好的相關(guān)性，故可作為質(zhì)量檢測(cè)的標(biāo)準(zhǔn)之一。不同廠家復(fù)方丹參片物質(zhì)組的溶出度存在顯著性差異，這可能是由于各廠家生產(chǎn)工藝不盡相同所致，因此建議中成藥的質(zhì)量控制應(yīng)增加主成分或適宜物質(zhì)組的溶出度檢測(cè)。

Objective To establish the methods for determining the dissolution of three material groups (multi-index material group, fingerprint substance group, and effective parts group) of Compound Danshen Tablets (CDT,), and study the dissolution condition of CDT from different manufacturers. Methods According to the appendix XC of Chinese Pharmacopoeia 2010, 200 mL water was used as dissolution medium. HPLC and UV were used to detect the in vitro dissolution in the three groups of substances, respectively, cumulative dissolution curves were drawn and similar factors of the curves were compared. Results In addition to the first group of tanshinone II_A, the dissolution was only 23.41%, dissolution in the other groups were all over 95% within 60 min. Furthermore, the similarity factor (f₂) values of the dissolution profile from different manufacturers were mostly less than 50. Conclusion The dissolution in the three groups of substances totally shows the good correlation, so it can be used as a criterion for quality testing. The material group dissolution of CDT from different manufacturers has significant differences, which may be due to the different production process, so the dissolution testing of main components or appropriate groups of substances should be included in the quality control of Chinese patent medicine.

國(guó)家自然科學(xué)基金項(xiàng)目（H2804）