目的 用《中國藥典》方法測(cè)定249批次維生素B₂片的溶出度，同時(shí)，考察其中6個(gè)廠家樣品在4種不同pH值溶出介質(zhì)中的溶出曲線，并對(duì)溶出度紫外法與HPLC測(cè)定法進(jìn)行比較，為全面評(píng)價(jià)藥品質(zhì)量提供依據(jù)。方法 采用轉(zhuǎn)籃法，4種不同溶出介質(zhì)各600 mL，轉(zhuǎn)速為100 r/min，檢測(cè)波長(zhǎng)444 nm；HPLC測(cè)定溶出度參考《中國藥典》2015年版維生素B₂原料的含量測(cè)定方法。結(jié)果 維生素B₂片總體溶出狀況較好，不同廠家樣品、同廠家不同批號(hào)樣品均有相似的溶出行為；液相法與紫外法測(cè)定差異較大。結(jié)論 溶出度測(cè)定紫外法專屬性不高，建議采用液相法測(cè)定；部分廠家產(chǎn)品質(zhì)量不穩(wěn)定，應(yīng)改善生產(chǎn)工藝。

Objective To detect the dissolution of 249 vitamin B₂ tablets using the method of Chinese Pharmacopoeia, investigate the dissolution profiles of vitamin B₂ tablets from 6 pharmaceutical factories in four dissolution mediums, compare the dissolution between UV spectrophotometry and HPLC, and provide the basis for a comprehensive evaluation of the quality of vitamin B₂ tablets. Methods Basket method was adopted at 100 r/min under wavelength of 444nm to detect the absorption value; and the dissolution was determined according to the HPLC method of Chinese Pharmacopoeia. Results Vitamin B₂ tablets dissolution was well, and vitamin B₂ tablets had similar dissolution behavior with different manufacturers and different products by the same manufacturer. Conclusion The UV spectrophotometry in dissolution examination was not strong on specificity, and give an introduction of HPLC method to determinate. It is advised that some pharmaceutical manufacturers should improve the product quality by changing the formulation and process.