Abstract:
OBJECTIVE To improve the spray drying effect of Tingliu extract and establish its physical fingerprint.
METHODS The added auxiliary materials were screened by the yield, moisture absorption rate and fluidity of Tingliu spray dry powder, and the ratio of the selected auxiliary materials was optimized by the method of mixing design. On this basis, the physical fingerprint of Tingliu spray dry powder composed of nine indicators, including water content, moisture absorption, angle of repose, and Karl index, was established, and the similarity evaluation of the physical fingerprint of 10 batches of Tingliu spray dry powder was evaluated by using the Pearson correlation coefficient method.
RESULTS The final preferred excipients were light magnesium oxide, maltodextrin, hydroxypropyl-β-cyclodextrin, and by establishing the regression equation of spray dry powder yield, moisture absorption, angle of repose and screening excipient ratio, the preferred excipient ratio was dry paste: light magnesium oxide: maltodextrin: hydroxypropyl-β-cyclodextrin 0.55:0.3:0.1:0.05; under this preferred excipient ratio, the spray-dried powder yield was 64.42%, the moisture absorption rate was 13.27%, and the angle of repose was 36.81°. The similarity of the physical fingerprints of 10 batches of Tingliu spray dry powder samples was greater than 0.99.
CONCLUSION In this study, the preferred ratio of excipients can better improve the powder yield of Tingliu spray drying, improve the properties of spray dry powder, and establish a quality control method for Tingliu spray dry powder based on physical fingerprint, which provides a reference for the quality control of Tingliu preparation process.
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