The application discloses a sustained-release
transdermal patch and a preparation process thereof, and particularly relates to the technical field of pharmaceutical preparations. The patch is a five-layer
composite structure, and the key lies in that: the
adhesive layer and the
drug depot layer both contain
ion pairs of
clonidine and
organic acid formed in situ under specific
solvent and temperature conditions, and the formation of the
ion pairs is confirmed by pH value or
infrared spectrum; and specific
transdermal penetration enhancers are further compounded, so that programmed
controlled release is realized through the cooperation of the two
layers. The preparation process adopts the sequence of forming
ion pairs first and then mixing, realizes
coating precision of ±2μm through slit
extrusion coating combined with online thickness measurement closed-
loop control, adopts gradient
drying process with clear temperature zone, air speed and
humidity parameters, and carries out real-time
quality control based on the online near-
infrared spectrum detection of the pre-established PLS regression model. The process can ensure that the patch realizes near-zero-order constant-speed release within 168h, and has the advantages of stable
drug release, uniform content, stable quality and high batch consistency.