The chemical pattern recognition technology was used to analyze the HPLC characteristic fingerprints data of Poria, screen the differential quality markers and perform quantitative analysis, so as to provide scientific basis for quality evaluation of Poria.

Welch Ultimate Plus C₁₈ chromatographic column (250 mm×4.6 mm, 5 μm) was used. Acetonitrile (containing 0.2% tetrahydrofuran)-0.1% phosphoric acid aqueous solution with gradient elution was used as mobile phase. The fingerprint of Poria was established with detection wavelength set at 222 nm, flow rate at 1 mL·min^-1, column temperature at 30 ℃, injection volume at 10 μL. The differential quality markers were identified by similarity analysis, principal component analysis (PCA), cluster analysis (CA) and orthogonal partial least squares-discriminant analysis (OPLS-DA). The quantitative research was carried out in accordance with the requirements of "Guidelines for Validation of Analytical Methods" in Chinese Pharmacopoeia.

The similarity of 15 batches of Poria was between 0.935~0.998. Eight common peaks were calibrated and 6 were identified; The samples were classified according to the origins from PAC results, which is consistent with CA result. Pachymic acid was screened as the differential quality marker of Poria by OPLS-DA. The established method for the determination of pachymic acid was stable, reliable, durable, which meets the requirements of the Pharmacopoeia.

The methods of characteristic fingerprint combined with chemical pattern recognition technology can effectively screen the differential quality marker of Poria from different regions, providing a reference for the establishment of quality standards for Poria.

To study the development process, current situation and specific requirements of drug registration based on e-CTD format in the United States, and to provide some reference for the construction of e-CTD channel for drug registration in China.

A literature review was used to review the regulatory process of e-CTD implementation in the United States, and the data of e-CTD application and total electronic data application were compared and analyzed. To explore the similarities and differences between the traditional registration declaration format and e-CTD format in terms of organization, data requirements, application process and data review, the specific changes were analyzed.

In the process of e-CTD implementation, the United States improved and optimized the submission process and approval process by constantly issuing technical guidelines and paid attention to the training of technical personnel and protected data security. On the one hand, it is suggested that Chinese regulatory agencies improve the guidelines for drug registration application based on e-CTD format as soon as possible, increase policy support such as priority review and approval, and strengthen e-CTD knowledge training for registration personnel in enterprises and review centers. On the other hand, strengthen e-CTD knowledge training for registered personal of enterprises and agencies, enterprises should change their research and development ideas, carry out the QbD concept, formulate a registration operation team suitable for their own development needs, and actively participate in international drug registration to accumulate experience in order to promote the application of e-CTD in enterprises

To establish an analytical method for determination of the content and dissolution of aprepitant, prepare aprepitant solid dispersion by three different preparation methods (hot-melt extrusion, solvent-melt method and spray drying method), and investigate the effects of different processes on the physical stability of the solid dispersions.

The effects of different preparation processes on the stability of aprepitant solid dispersions were measured in terms of water content, moisture attraction, residual microcrystals, aprepitant content, related impurities, and in vitro release.

Among the three different processes, the aprepitant solid dispersion prepared by hot-melt extrusion had low water content, poor moisture attraction, drug in amorphous form, good in vitro dissolution behavior, able to dissolve and release in acid solution, resistant to crystallization and precipitation behavior due to pH change and maintained high supersaturation after transit to the intestine.

Hot-melt extrusion is the optimal preparation method for solid dispersions composed of crystallization inhibitor HPMCAS and dissolution enhancer PVP K30.

To prepare photothermal lipid membrane coated Escherichia coli and study the properties.

The photothermal lipid membrane (LMI) was prepared by thin film dispersion method, and the electrostatic adsorption method was used to coat Escherichia coli with the lipid membrane (LMI@Ec). The size and potential of LMI@Ec were analyzed by laser scattering particle size analyzer, the morphology of E.coli and LMI@Ec was observed by transmission electron microscopy and laser confocal microscopy, and plate counting method was used to detect cell viability of LMI@Ec. In addition, the effect of protein expression of LMI@Ec was evaluated by polyacrylamide gel electrophoresis, and the photothermal effect of LMI@Ec was detected by Infrared Photothermal Imager.

LMI@Ec had a smooth surface with the average particle size of (1 990.5±132) nm and the potential of -(5.09±0.52) mV. The coating of the lipid membrane had little effect on the activity of E.coli. Although the bacterial activity decreased after laser irradiation, the growth curve recovered to the same level as wild bacteria after 10 h of temperature gradient culture in LB medium. LMI@Ec had well photothermal properties and can normally express protein. In vitro cytotoxicity experiments showed that LMI@Ec under 808 nm laser irradiation presented enhanced antitumor effect on B16F10 and HepG2 cells.

The successful preparation of LMI@Ec provides a new research direction for the subsequent in-depth study of bacteria-mediated disease treatment.

In order to improve the oral bioavailability of curcumin, curcumin nanocrystalline suspension (Cur-NCS) was prepared by the high-pressure homogenization method in "top-down" method. Its physical properties, in vitro release, in vivo bioavailability and anti-inflammatory activity were studied.

The prescription and process parameters were optimized using particle size and zeta potential as evaluation indexes; the sample morphology was characterized by transmission electron microscopy, the in vitro release of curcumin nanocrystallines suspension was determined by HPLC, and the blood concentration of curcumin in rats was measured by LC-MS/MS; the anti-inflammatory activity was investigated in RAW264.7 inflammatory cell model, and curcumin was investigated in a mouse model of bronchial asthma airway inflammation nanosuspension on the therapeutic effect of curcumin on airway inflammation in mice.

Preparation process: curcumin was sheared at high speed for 2 min at 16 000 r·min^-1 and cycled 40 times at 800 bar. Prescription: curcumin dosage was 0.2%, TPGS dosage was 0.20% and soy lecithin dosage was 0.16%; the cumulative drug release of API and Cur-NCS was 11.67% and 27.44%, respectively. After gavage in rats, Cur-NCS bioavailability was increased by 1.86-fold after gavage in rats. In an in vitro inflammatory cell model and in vivo bronchial asthma mouse model, Cur-NCS significantly inhibited the expression of inflammatory factors NO, IL-6, TNF-α and the levels of MDA, IgE and ICAM-1, and increased the expression of IL-10 and the level of SOD.

The identified preparation process and prescription can meet the preparation requirements of curcumin nanosuspension, and the in vitro release, in vivo bioavailability and anti-inflammatory activity are significantly better than those of API, and curcumin nanosuspension can provide ideas for subsequent dosage form studies.