摘要
胰岛素在胰岛素口腔喷剂中处于比较复杂的体系，对ｐＨ敏感程度如何与其稳定性有密切关系。本文在 ＰＨ ８、９、１０、１１、１２ ５个梯度 ５０℃下同时碱解，用 ＲＰ－ＨＰＬＣ方法，检测出胰岛素在口腔喷剂中的碱性降解点为 ｐＨ１１左右。ＨＰＬＣ条件：流动相，Ｖ（乙腈）：Ｖ（磷酸盐缓冲液，ｐＨ ３．０）＝ ２７：７３；流速，１ｍＬ／ｍｉｎ；进样量，２０μＬ。
The stability of insulin in a complex system of Insulin Oral Spray is correlated with its suscepti- bility to the pH of the system. In this study, the RP-HPLC method was used in the degradation test of Insulin O- ral Spray. V(Acetonitrile): v(PBs,pH 3.0 ) = 27: 73 was used as the moblie phase, with the flow rate of 1.0 mL/min. The detection wavelength was 214 nm, and the injection scale was 20 μL. The degradation test was carried out at 50 ℃ with five different pH(pH 8,pH 9,pH 10, pH11, pH 12 ). It was shown that the basic deg- radation point of insulin in the system of Insulin Oral Spray was pH11.
出处
《广东药学院学报》
CAS
2000年第4期271-272,共2页
Academic Journal of Guangdong College of Pharmacy
