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本文目的在于制备和评价一种盐酸青藤碱的局部给药系统——盐酸青滕碱贴剂。按中国药典(2005版)附录XD规定,采用管碟法测定该贴剂的体外释放度;以加速实验条件(40℃,75%RH)考察贴剂的稳定性;另外还对贴剂的药效学和药动学特性进行评价。结果表明,盐酸青藤碱贴剂的体外释放度依赖于释放介质的pH值;加速实验条件下放置6个月,药物含量、初粘力、持粘力、剥离强度和体外释放特性没有发生明显变化;该贴剂还显示出较好的抗炎和镇痛活性。更重要的是,贴剂的主要药代动力学参数均低于盐酸青滕碱的口服溶液。通过这些实验表明,盐酸青藤碱贴剂有希望成为更方便用药、安全有效、非损伤的给药系统,尤其适用于长期给药以及有胃肠道疾病的关节炎患者。
The purpose of this paper is to prepare and evaluate a topical delivery system for sinomenine hydrochloride, a teichtine hydrochloride patch. According to the Chinese Pharmacopoeia (2005 Edition) Appendix XD regulations, using tube plate method to determine the in vitro release of the patch; to accelerate the experimental conditions (40 ℃, 75% RH) to examine the stability of the patch; In addition to the patch of the drug Efficacy and pharmacokinetic properties were evaluated. The results showed that the release of sinomenine hydrochloride in vitro was dependent on the pH value of the release medium. After 6 months of accelerated experimental conditions, the drug content, initial tack, holding capacity, peel strength and in vitro release characteristics did not show significant The patch also showed better anti-inflammatory and analgesic activity. More importantly, the main pharmacokinetic parameters of the patch were lower than that of the oral solution of tropisenic acid hydrochloride. Through these experiments, Sinomenine Hydrochloride patches hope to become more convenient, safe and effective, non-invasive drug delivery system, especially for long-term administration and gastrointestinal diseases in patients with arthritis.