OBJECTIVE To provide suggestions for the further development of pharmacy practice research and high-quality development of pharmaceutical care in China. METHODS With comprehensive literature review, relevant websites and conference reports, this paper reviewed the progress of research on pharmacy practice in the world, and summarized the enlightenment to China. RESULTS Pharmacy practice research belongs to a sub-direction of health service research, which has been developing globally for more than 50 years, and focuses on analyzing and evaluating the value of pharmacy practice with scientific methods, which is of great importance to improve the quality of pharmaceutical work, explore new pharmaceutical care models. China is in the initial stage, we should combine the international development experience, explore the methodology suitable for China, organically combine practice and scientific research. CONCLUSION Pharmacy practice research is the necessary basis for the further development of pharmacy practice. China should keep up with the international pace, gradually establish a standardized pharmacy practice research system, and promote the high-quality development of pharmaceutical care.

OBJECTIVE To establish a design scheme for the traceability and labeling system of exported vaccine products, in order to meet the technical requirements of the World Health Organization(WHO) and some Western countries for vaccine traceability and labeling. METHODS By studying the laws, regulations, standards, and policy documents on vaccine traceability labeling at home and abroad, the similarities and differences between domestic and foreign traceability labeling systems were analyzed and compared. RESULTS A technical solution for traceability coding, labeling, carrier, printing, and other aspects of exported vaccine products was established based on the GS1 standard system that meets domestic and international requirements. CONCLUSION It is necessary to strengthen the formulation of policies and standards for the traceability and labeling system for exported vaccine products in China, and implement and promote them.

In recent years, central nervous system (CNS) diseases have become serious threat to human life and health. The existence of the blood-brain barrier (BBB), which prevents most drugs from entering the brain, has made the treatment of CNS diseases a major problem in the field of medicine and pharmacy. The advent of nanotechnology has given drugs the potential to penetrate the blood-brain barrier, and the rapid development of siRNA drugs has brought light to patients with CNS disorders. However, the delivery of nanocarriers to the brain encounters many obstacles and the conditions that can be met for brain delivery as siRNA nanocarriers are also very demanding. This paper therefore reviews the research progress and the advantages and disadvantages of lipokinase nanoparticles, chitosan nanoparticles, polyethyleneimine nanoparticles, dendrimer nanoparticles, nanogels, nanomicelles, nanoemulsions, exosomes, cells, and siRNA adducts as siRNA brain delivery systems, with a view to exploring a suitable siRNA nanodelivery system for blood-brain barrier penetration.

OBJECTIVE To study the chemical constituents from the roots of Ardisia crenata var. bicolor. METHODS The 70% ethanol extract from A. crenata was isolated and purified by silica, Sephadex LH-20, ODS, and preparative RP-HPLC, then the structures of obtained compounds were identified by physicochemical properties and spectral data. RESULTS Twelve compounds were isolated and identified as isolariciresinol-3α-O-β-D-glucopyranoside (1), isolariciresinol-4-O-β-D-glucopyranoside (2), lyoniresinol (3), lyoniside (4), isolariciresinol (5), lyoniresinol-3α-O-β-D-glucopyranoside (6), psychotrianoside G (7), pridentigenin E (8), 3β-O-{β-D-glucopyranosyl-(l→2)-α-L-arabinopyranoside}-cyclamiretin A (9), ardisimamilloside H (10), 3β-O-{α-L-rhamnopyranosyl-(1→2)-β-D-glucopyranosyl(1→4)-α-L-arabinopyranosl}-3β-hydroxy-13β,28-epoxy-16α-hydroxy-30-al (11), foegraecumoside L (12). CONCLUSION Compounds 1-6 and 12 are isolated from Ardisia for the first time,and compounds 1-9, 12 are isolated from this plant for the first time.

OBJECTIVE To investigate the levels of tricarboxylic acid cycle (TCA)-related metabolites in human epidermal growth factor receptor 2 (HER2)-positive breast cancer trastuzumab-resistant and trastuzumab-sensitive cells, as well as to screen potential biomarkers of trastuzumab resistance. METHODS Targeted metabolomics was adopted to detect TCA-related metabolite levels including citrate, cis-aconitate, isocitrate, alpha-ketoglutarate, succinic acid,fumaric acid,malic acid and oxaloacetic acid based on ultra-high-performance liquid chromatography-mass spectrometry (UPLC-MS/MS) in trastuzumab-resistant and trastuzumab-sensitive cells. The linearity, accuracy and precision of the method were validated. Then, orthogonal partial least-squares discrimination analysis (OPLS-DA) was used to compare the relative differential expression in trastuzumab-resistant and trastuzumab-sensitive cells. Differentially expressed metabolites were screened according to P<0.05, fold change (FC)>1.5 or FC<0.67. Finally, a multivariable model based on SVM and receiver operating characteristic (ROC) curve analysis was used to assess the classification accuracy of each metabolite. RESULTS For all TCA-related metabolites, the standard curves were linear, the correlation coefficients (r) were greater than 0.994, the established method accuracy was 94%-105% and the precision coefficient of variation (CV, %) was less than 15%. Trastuzumab-resistant and trastuzumab-sensitive cells were clearly separated from each other in the OPLS-DA model. Malic acid, succinic acid and fumaric acid were significantly upregulated in trastuzumab-resistant cells (P<0.05) compared to trastuzumab-sensitive cells. The areas under the curves (AUCs) of malic acid, succinic acid and fumaric acid were greater than 0.9 and the SVM model yielded the highest AUC of 1.000. CONCLUSION TCA-related metabolites are differentially expressed in trastuzumab-resistant and trastuzumab-sensitive cells. Succinic acid, fumaric acid and malic acid can serve as biomarkers that may provide potential value for the diagnosis of trastuzumab resistance in HER2-positive breast cancer.

OBJECTIVE To establish a nano sustained release drug delivery system polysuccinimide(PSI) and hydroxyapatite(HAP) with a hard core-soft coating structure and study the delivery of anti-tumor drug regorafenib. METHODS HAP and PSI were synthesize in the article. The optimal formulation and preparation process of the regorafenib-PSI-HAP was determined by single factor analysis and the box-behnken design(BBD) response surface method. The encapsulation efficiency, drug loading captivity, drug release in vitro, particle size and distribution, Zeta potential and SEM images of regorafenib-PSI-HAP were examined. RESULTS The UV spectrophotometry results showed that the maximum absorption wave of the regorafenib was at 264 nm, the stand curve was A=94.461ρ+0.0304, r²=0.999 8. Meanwhile, between the 2-20 μg·mL^-1 of the regorafenib solutions possessed a good linear relationship at this wave. The optimal formulation prepared using MEM detected by BBD was that the concentration of regorafenib was 7.28 mg·mL^-1, the mass ratio of HAP to regorafenib was 0.63, and the mass ratio of PSI to HAP was 3.93. The in vitro drug release test showed that PSI-HAP exhibited pH-sensitive drug release, the regorafenib-PSI-HAP can be released totally above pH 7 solution. The PSD was around 300 nm, and Zeta potential was between -10 and -17 mV which was similar to the human cell membrane. CONCLUSION The proposed drug delivery system can be integrated into non-agglomerated spherical nanoparticles of uniform size through a facile preparation process. The particles are easy to sterilize, and large-scale production may be achieved easily. The drug release of PSI-HAP is pH sensitive and stable. Both PSI and nano HAP possess the effect of anti-tumor cell proliferation which is very suitable for the delivery of anti-tumor drugs such as regorafenib in vivo.

OBJECTIVE To evaluate the effects of drug release for gliclazide sustained-release tablets in ethanolic media and conduct the risk assessment for the dose dumping. METHODS Release profiles of gliclazide sustained-release tablets from 3 manufactures in different ethanolic media were determined by HPLC.Release mechanisms were analyzed and the risk of dose dumping was evaluated by the similar factors (f₂) of the release data. RESULTS Release profiles of formulations in the presence of 5%, 20% and 40% ethanol of pH 7.4 phosphate buffer media at 100 r·min^-1 were similar.The erosion rate was the key factor that affected the release profiles of gliclazide sustained-release tablets. CONCLUSION The commercial formulations are considered to be robust against alcohol effects and the risk of alcohol-induced dose dumping is relatively little.

OBJECTIVE To study the components of Rhizoma Anemarrhenae-Cortex Phellodendri Chinesis (RA-PC) herb-pair absorbed into blood in normal rabbits. METHODS Rabbits were fed with the decoction of RA-PC herb pair (4.5 g·kg^-1) once a day for 7 days, then blood samples were taken. High-performance liquid chromatography-quadrupole-electrostatic field orbital trap (UPLC-Q-Exactive Orbitrap-MS) technique was applied for the analysis, and fragments were split in both positive and negative ion modes. The compositions into blood were determined according to retention time, accurate relative molecular mass, and secondary mass spectra. RESULTS A total of 54 components were identified in the drug-containing serum of rabbits, including 46 prototype components, which were alkaloids, flavonoids, saponins, glycosides, phenolic acids, phenylpropanoids, lactones, and phenolic derivatives. The nine metabolites were derived from berberine, jatrorrhizine, berberrubine, and mangiferin, respectively. CONCLUSION RA-PC contains 46 chemical components that can enter blood of normal rabbits, and may also contains four chemical components which are metabolized into nine metabolites.

OBJECTIVE To develop a generalized “discovery-confirmation” strategy for DNA adducts based on liquid chromatography-triple quadrupole mass spectrometry (LC-QQQ-MS) and liquid chromatography-high resolution mass spectrometry (LC-HRMS), study the direct and metabolic reactivity of the potentially genotoxic substance lucidin (Luc) with three 2'-deoxynucleosides in Rubia cordifolia L., and screen and confirm possible Luc-specific DNA adducts. METHODS Three 2'-deoxynucleosides with the same fragmentation pathways with DNA adducts in mass spectrometry were used to develop and optimize a non-targeted screening method for unknown DNA adducts in QQQ-MS neutral loss and pseudo-neutral loss scanning modes, as well as a confirmatory method for adduct targeting in HRMS data-dependent scanning mode. Luc was incubated with 2'-deoxynucleoside under phase I metabolically activated and inactivated conditions, respectively, and the resulting specific DNA adducts were screened and then structurally verified by characteristic MS spectra of fragmentations. RESULTS The optimized pseudo-neutral loss scanning is sensitive to the detection of deoxyribonucleoside deglycosylation at the pg·mL^-1 level. Six Luc-DNA adducts, containing two 2'-deoxycytidine (dC) adducts, two 2'-deoxyadenosine (dA) adducts, and two 2'-deoxyguanosine (dG) adducts, were identified and confirmed in vitro incubation model of Luc and 2'-deoxynucleoside, and their structures were characterized. Luc-DNA adduct production increased with increasing Luc exposure and exposure time, and there were significant dose-response and time-response relationships, and the binding did not require metabolic activation to occur. CONCLUSION The established discovery-confirmation strategy for DNA adducts is highly sensitive and accurate. It can provide structural information of the adducts at the molecular level. This is suitable for the assessment of DNA damage caused by the presence of Luc and provides strong data support for the study and re-evaluation of its toxicity mechanism. It also offers an important methodological reference for the rapid screening of potential genotoxic components in Chinese herbal medicines.

OBJECTIVE To analyze the quality status of Xinnaojing Tablets by multi-index comprehensive evaluation. METHODS Samples were tested according to the statutory standards. Several new methods were established and adopted for multi-index comprehensive evaluation. RESULTS All samples were qualified in statutory tests. But quality defects were found in some samples by multi-index comprehensive exploratory studies. The main problems involved poor quality of raw materials, low feeding, or lack of process control. CONCLUSION Multi-index comprehensive evaluation is more capable of evaluating the real quality status of Xinnaojing Tables. To ensure the safety and effectiveness of the midication, manufacturers should pay attention to the quality of raw materials and process control, especially on Borneolum Syntheticum, Aucklandiae Radix, and Uncariae Ramulus Cum Uncis.