Quality Evaluation Of Hot Melt Pressure Sensitive Adhesive

Guanjiezhitonggao is a classic external preparation in a clinical use. To increases therapeutic effect, hot melt pressure sensitive adhesive was used as a carrier of Guanjiezhitonggao preparation.The quality of Guanjiezhitonggao with hot melt pressure sensitive adhesive was evaluated. The characters of preparation that including properties, anointed quantity, heat resistance, permeability and adhesion were definite. Thin Layer Chromatography (TLC) was used to investigate the pepper extracts and belladonna flow extracts in Guanjiezhitonggao. HPLC method was used to test the content of diphenhydramine hydrochloride. Camphor, menthol and gaultherolin was tested by GC. And the stability of the hot melt pressure sensitive adhesive was evaluated. The results showed that hot melt pressure sensitive adhesive was yellowish-brown flake hot melt adhesive with fragrance, soft quality, suitable viscosity. Per 100 cm2 at least had 2.4 g adhesive. Heat resistance conformed to the standards. Moisture quantity was 500-600 g/m2 in 24 h. The initial adhesion of Hot Melt Pressure Sensitive Adhesive could stick to No.24 steel ball, and the viscosity was 26.31 h, peel strength was 2.55 KN/m. Each tablet contain at least 2.754 mg diphenhydramine hydrochloride as hydrophilic composition,67.95 mg camphor (C10H16O) 5.21 mg menthol (C10H20O) and 22.78 mg gaultherolin (C8H8O3) as hydrophobic naphtha compositions.The vitro medicinal release properties and percutaneous permeability were compared between hot melt pressure sensitive adhesive and rubber paste by the method in Pharmacopoeia and FRANZ method. Compared with rubber adhesive, hot melt pressure sensitive adhesive has a higher vitro medicinal properties both in its hydrophilic composition (diphenhydramine hydrochloride) and its hydrophobic composition (camphor, menthol and gaultherolin). The vitro penetration results showed that the penetration rate of diphenhydramine hydrochloride in hot melt adhesive was 0.76 (μg/cm2·h), and its permeability in 24h was 38.02%. The penetration rate of camphor, menthol and gaultherolin in hot melt adhesive were 21.17,1.917 and 9.537 (μg/cm2·h), and their permeabilities in 24h were 33.18%,56.78% and 47.60%. Hot melt pressure sensitive adhesive has a higher vitro penetration than rubber adhesive.The stability of Guanjiezhitonggao with hot melt pressure sensitive adhesive was detected with acceleration stability test and room temperature test, the result showed an excellent stability between 0 and 6 months. So we interim its period of validity was 24 months.This article have provided a quality standard and evaluation system for the research of hot melt pressure sensitive adhesive hot melt adhesive.