盐酸氨溴索口腔崩解片溶出度测定方法的考察

Study on the dissolution of Ambroxol Hydrochloride Orally Disaggregation Tablets

目的 建立以人工唾液为溶出介质,基于光纤传感系统原位测定盐酸氨溴索口腔崩解片溶出度的方法 .方法 用光纤药物溶出仪（FODT）选择5 mm间距探头,244 nm为检测波长,550 nm为参比波长,人工唾液900 mL为溶出介质,测定盐酸氨溴索口腔崩解片在不同溶出度测定条件下的溶出度和溶出曲线.结果采用桨法和转速为75 r·min^-1时,在6.6～39.6 mg·L^-1范围内具有较好的线性,加样回收率分别为100.6%,101.8%和100.5%;RSD分别为0.79%,0.44%和0.15%（n=3）,日内精密度（RSD）分别为0.38%,0.44%和0.65%;日闻精密度（RSD）分别为0.64 %,0.59%和0.65%（n=5）,盐酸氨溴索口腔崩解片在2 min之内溶出达90%以上.结论 该法操作简单,准确度高,重复性好,可用于该药的质量控制.

Objective To establish a method in-situ monitoring the dissolution rate of Ambroxol Hydroehloride Orally Disaggregation Tablets by an artificial saliva solvent system base on a fiber-optical dissolution monitor（FODT）. Methods Ambroxol Hydrochloride Orally Disaggregation Tablets were monitored by FODT with a 5 mm fiber optic probe. The dissolution conditions were： 900mL of artificial saliva, paddle at 50,75 or 100 r·min^-1 , measurement wavelength 244 nm, reference wavelength 550 nm, by using the measurement of dissolution rate dissolutive apparatus Ⅱ and apparatus I . Results Ambroxol hydrochloride with apparatus Ⅱ and 75 r ·min^-1 showed a well linearity with in the concentration at 6.6-39.6 mg· L^-1 , and the reggression coefficient of recovery were 100. 6% ,101.8% and 100. 5% ;the RSD were 0.79% ,0.44% and 0.15% （ n = 3）. The RSD within-day were 0.38 %, 0. 44 % and 0. 65%, and the RSD day-to-day were 0. 64 %, 0.59 % and 0. 65%（ n = 5）, The dissolution rate of the Ambroxol Hydrochloride Oral Disaggregation Table was above 90 % within 2 min. Conclusion The method has the advantage of simpler operation, higher accuracy and well repetitiveness and could use in the quality control of this medicine.