Study on fingerprint and in vitro release of Xiaozheng-Zhitong cataplasm / 国际中医中药杂志

ABSTRACT

Objective:To establish a method of evaluating the reproducibility of the preparation process of Xiaozheng-Zhitong cataplasm. Methods:Used fingerprint spectrum technology and in vitro release test to evaluate the reproducibility preparation process of Xiaozheng-Zhitong cataplasm. By using HPLC to establish the fingerprint of Xiaozheng-Zhitong cataplasm. The chromatographic column was an Agilent HC-C18 column (4.6 mm×250 mm, 5 μm); the detection wavelength was 280 nm; the flow rate was 1 ml/min; the column temperature was 25 ℃. The mobile phase was acetonitrile-0.2% phosphoric acid aqueous solution, used gradient elution method. An HPLC method for the determination of tetrahydropalmatine content was established, and the vertical Franz diffusion cell method was used to investigate its in vitro release. Results:The results showed that the similarity between the 10 batches of Xiaozheng-Zhitong cataplasm and the control map was above 0.95, indicating that the process of Xiaozheng-Zhitong cataplasm was stable and feasible; the cumulative release amount of tetrahydropalmatine was 0.23 mg in 24 hours, and the cumulative release rate in 8 hours was 91.54%, and the RSD of 6 samples at each time point was <3%. Conclusion:The method of evaluating the reproducibility of the preparation process of Xiaozheng-Zhitong cataplasm was established by using fingerprint technology and in vitro release; it can provide a reference and scientific basis for the evaluation of the reproducibility of the preparation process of the plaster.