Analytical Methods for Draconis Sanguis Scald Ointment Based on QbD Concept and Study on Its Process Quantity Transfer
OBJECTIVE To develop a method for the determination of dracorhodin in Draconis Sanguis scald ointment based on the concept of quality by design(QbD),and to study its preparation process for quantitative transfer.METHODS Using the content of dracorhodin as key quality attribute,the key analytical parameters in preparation of test solution were selected through Plackett-Bur-man design.The relationship between key quality attribute and key analysis parameters was evaluated through Box-Behnken design.According to characteristics of the medicinal material,intermediate and finished product of scald ointment,the different methods for determining content of dracorhodin were established,and the law of quantity transfer was studied.The preparation conditions of test so-lution for content determination of Draconis Sanguis scald ointment were as follows:lanolin was removed by petroleum ether,extraction solvent was 7％phosphoric acid methanol solution,and extraction was carried out in a water bath at 60 ℃ for 30 min.The chromato-graphic conditions were as follows:the mobile phase was consisted of acetonitrile and 0.05 mol·L-1 sodium dihydrogen phosphate so-lution using a gradient elution.Temperature was 40 ℃ and flow rate was 1.0 mL·min-1,at a detector wavelength of 440 nm.RESULTS The feasibility of preparation process of Draconis Sanguis scald ointment was proven.The transfer rate of dracorhodin from medicinal material to finished product was over 90％.CONCLUSION The analytical method developed based on concept of QbD could accurately determine content of dracorhodin in Draconis Sanguis scald ointment,which is conducive to product quality evaluation and process value transfer research.
quality by designDraconis Sanguis scald ointmentdracorhodinquantity transfer
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