Preparation and simulation effect evaluation of placebos for Ginkgo Folium Dropping Pills / 中草药

ABSTRACT

Objective: To explore the placebo-preparation method of Ginkgo Folium Dropping Pills (GFDP) and evaluate its simulation effect objectively, which could provide production and evaluation reference for Chinese materia medica (CMM) placebo. Methods: Taking the placebo-preparation of GFDP as an example, the simulation effect was evaluated from aspects of appearance, color, smell, and taste. It employed three different approaches as possibility of experimental drug, similarity evaluation between placebo and experimental drug and the similarity analysis among the drugs. Results: The two placebo-preparation prescriptions of GFDP have high similarity with the original drug in terms of appearance, color, smell, and taste. The simulation effect of No. 2 placebo-prescription (0.6 g of sucrose octaacetate as bitter agent, 2.1 g of caramel as colorant, 13.3 g of PVP K30 as fillerz and 44.0 g of PEG 4000 as water-soluble bases to prepare 1 000 pills) is better than No. 1 placebo-prescription (1.2 g of sucrose octaacetate as bitter agent, 2.1 g of caramel as colorant, 12.7 g of PVP K30 as filler, and 44.0 g of PEG 4000 as water-soluble bases to prepare 1 000 pills). Conclusion: The placebo-preparation of GFDP conform to placebo requirements of randomized controlled trials. It fills the vacancy of dropping pills form placebo-preparation in CMM and provides method and idea for placebo-preparation and simulation-effect evaluation of CMM.