OBJECTIVE To study the preparation process of Yangyin Shengji membrane, solve the actual production problems in the research process, and provide a scientific basis for its large-scale production.

METHODS According to the regulations and technical guidelines including Chinese Pharmacopoeia 2020 Edition and Technical Guidelines for the Study of the Production Process of Chinese Medicine Compound Preparations(Trial), pilot scale tests were carried out. Taking the comprehensive score consisting of film-forming property, adhesion force, membrane dissolution time, product yield, toughness and tensile strength as evaluation indicators, AHP-CRITIC comprehensive scoring method combined with D-optimal mixture design were adopted to optimize the preparation process parameters of Yangyin Shengji membrane.

RESULTS On the condition that the drug-excipient ratio of the original preparation remained unchanged, when polyvinyl alcohol(17-88) accounted for 82.26%, sodium carboxymethyl cellulose accounted for 8.34%, and glycerol accounted for 9.40%, the film-forming score of the obtained membrane was 9 points, adhesion force was 30.80, membrane dissolution time was 36.3 min, tensile strength was 6.43 MPa. All indicators conformed to the quality specifications for membranes specified in Chinese Pharmacopoeia 2020 Edition. Verification results of 3 batches of pilot tests showed that the average product yield was 84.23%, the average transfer rate of berberine hydrochloride was 89.35%, and the average transfer rate of gentiopicroside was 84.32%. It indicated that the optimized process parameters possess had high compatibility with production equipment and satisfy practical production demands.

CONCLUSION The optimized preparation process of Yangyin Shengji membrane is reasonable, stable and feasible, which can provide a reference basis for the industrial production of this preparation.