Objective  To prepare the volatile oil inclusion complexes of Xinyi Tongqiao granules by β-cyclodextrin saturated water solution method, and to enhance the stability of volatile oils in Xinyi Tongqiao granules.

Methods  The complexation rate of total volatile oil and patchouli alcohol was used as evaluation indices. The preparation process was optimized using a comprehensive scoring method based on an orthogonal test. The inclusion complexes were characterized by gas chromatography-mass (GC/MS) spectrometry, Fourier transform infrared spectroscopy, thermal analysis, powder X-ray diffraction and molecular docking. The stability was evaluated through an influence factor test.

Results  The optimum inclusion process was as follows: β-cyclodextrin to volatile oils ratio of 9 ∶ 1, inclusion temperature of 25 ℃, and inclusion time of 3 hours. Under these conditions, the average complexation rate for total volatile oil and patchouli alcohol reached 85.08% and 84.93%, respectively. Characterization results indicated that the volatile oil entered the β-cyclodextrin cavity, occupied the position of water molecules in the cavity, and formed new substances via hydrogen bonds with β-cyclodextrin. The stability tests demonstrated that the volatile oil content in the inclusion complexes remained stable when placed under light (light intensity 4 500 lx ± 500 lx), high temperature (60°C) and high humidity (75% relative humidity) for 10 days.

Conclusion  This inclusion process is safe and stable, and has a high complexation rate. It can be used to prepare volatile oil inclusion complexes of Xinyi Tongqiao granules, significantly improving the stability of volatile oil and product quality. It is suitable for industrial production.

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