毛果芸香碱眼用控释膜剂的贮存期预测

PREDICTION OF SHELF-LIFE OF CONTROLLED- RELEASE OPHTHALMIC FILM OF PILOCARPINE

摘要: 本文采用HPLC法测定了毛果芸香碱眼用控释膜剂(下称眼膜)的稳定性。结果表明眼膜的降解符合一级动力学。根据Arrhenius指数定律,经线性回归求得活化能为17.54千卡·摩~(-1),贮存期(t_(0.9)~(25°))为5个月;5℃时贮存期(t_(0.9)~(5°))为3.6年。
- 毛果芸香碱 /
- 眼用控释膜剂 /
- 贮存期 /
- HPLC法
Abstract: HPLC was used to determine the pilocarpine (P) content in controlled—release ophthalmic films. The stability of the films was examined with the classical constant temperature method. The use of HPLC made it possible to determine the different contents of P and its degradation products-isopilocarpine and pilocarpic acid etc. The average amount of drug recovered from the films was 100±0.6%. The results indicated that the degradation of drug in film complied with the first-order kinetic process. Besides, according to Arrhenius rule through the linear regression, the activation energy of P was 17.54 Kcal. Mol^—1. Storage period at 25℃（t^25°_0.9） was 5 months, and 3.6 years at 5℃(t^5°_0.9) , respectively. Apparently the stability of P in the film was increased substantially.
- Pilocarpine /
- Controlled-release ophthalmic film /
- HPLC