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目的测定巴戟甲素在模拟人体胃肠环境中的稳定性,为口服剂型的选择提供依据。方法采用HPLC-ELSD法,分别测定巴戟甲素在稀盐酸溶液和人工胃液中2 h以及在pH 6.8磷酸盐缓冲液及人工肠液中12 h的稳定性。结果在稀盐酸溶液和人工胃液中温育30 min后,巴戟甲素在两液中只剩下加入量的67.59%和64.85%,120 min后在稀盐酸溶液和人工胃液中分别为加入量的43.31%和50.41%;加入pH 6.8磷酸盐缓冲液及人工肠液中12 h后,巴戟甲素分别为加入量的90.43%和90.65%。结论巴戟甲素具有在稀盐酸溶液和人工胃液中均不稳定、在pH 6.8磷酸盐缓冲液和人工肠液中稳定性较好的特点,在设计口服给药剂型时应予以重视。
Objective To determine the stability of Bajiao A in simulated human gastrointestinal environment and provide the basis for the choice of oral dosage form. Methods The HPLC-ELSD method was used to determine the stability of the PDJ in dilute hydrochloric acid solution and artificial gastric juice for 2 h and in phosphate buffer pH 6.8 and artificial intestinal fluid for 12 h. Results After incubated for 30 min in dilute hydrochloric acid solution and artificial gastric juice, only the added amounts of 67.59% and 64.85% of the two solutions were observed. After 120 min, the additions of diganidine in dilute hydrochloric acid solution and artificial gastric juice respectively 43.31% and 50.41% respectively. After addition of pH 6.8 phosphate buffer solution and artificial intestinal juice for 12 h, BaP was found to be 90.43% and 90.65% of the added amount, respectively. Conclusions Bajiao A has the characteristics of being unstable in diluted hydrochloric acid solution and artificial gastric juice, and has good stability in pH 6.8 phosphate buffer solution and artificial intestinal juice. It should be paid attention when designing oral dosage form.