To evaluate the inhibitory effect of JP-1366 for injection on gastric acid secretion and its therapeutic effect on hemorrhagic gastric ulcer.

The histamine-induced gastric acid secretion model in rats was used, and the animals were given JP-1366 for injection by a single intravenous injection to evaluate the inhibitory effect of the test substance on gastric acid secretion in these rats. In the water-immersion restraint-induced hemorrhagic gastric ulcer rat model and aspirin-induced hemorrhagic gastric ulcer rat model, animals were given a single intravenous injection of JP-1366 for injection. The therapeutic effect of the test substance on hemorrhagic gastric ulcer in rats was evaluated by detecting the pH value of gastric juice, gastric bleeding spots, area of hemorrhagic lesions, and inhibition rate on hemorrhagic lesions.

In the histamine induced rat gastric acid secretion model, JP-1366 for injection at different doses significantly increased the pH of gastric juice in the model rats, reduce the volume, concentration, and total acidity of gastric juice, and exhibit a dose-response relationship in terms of acid inhibition. The acid inhibition effect is better than that of omeprazole sodium. In the water immersion restraint induced and aspirin induced rat hemorrhagic gastric ulcer model, injection of JP-1366 can increase the pH of gastric juice, inhibit bleeding in the gastric glands and ameliorate mucosal erosion of gastric tissues at different doses. The ulcer inhibition rate shows a good dose-response, and the effect of improving gastric hemorrhagic lesions in the model rats is better than that of omeprazole sodium. At the same dose (1 mg·kg^-1), the degree of improvement in gastric hemorrhagic lesions by injection of JP-1366 and fumarate vonosine is basically equivalent.

JP-1366 for injection treats hemorrhagic gastric ulcers by inhibiting gastric acid secretion, and its effects in inhibiting gastric acid and improving gastric hemorrhagic lesions are superior to those of omeprazole sodium. At the same dose, the improvement of bleeding lesions is equivalent to that of vonoprazan fumarate.

In view of the limitations of amikacin intravenous administration, including poor permeability in lung tissue and significant toxic and side effects, this study adopted the reverse-phase evaporation method to prepare and optimize the formulation and process of amikacin liposomes, and systematically evaluated their physical and chemical properties, in order to provide experimental basis for lung targeted delivery.

Amikacin liposomes were prepared by the reverse-phase evaporation method using dipalmitoylphosphatidylcholine (DPPC) and cholesterol as lipid materials. The encapsulation efficiency was determined by ultrafiltration centrifugation-HPLC. Based on the single factor investigation, the formulation and process parameters were optimized by the Box-Behnken response surface method with encapsulation efficiency as the evaluation index, and their encapsulation efficiency, morphology, particle size, polydispersity index (PDI), Zeta potential and in vitro release behavior were studied.

The optimum prescription process parameters were as follows: the phospholipid-to-cholesterol ratio was 4, the phospholipid concentration was 53.79 mg·mL^-1, the ratio of lipid to drug was 3.78, the amount of organic solvent (chloroform) was 24.4 mL, the ultrasonic frequency was 40 times, and the rotary evaporation pressure was 600 mbar. The average encapsulation efficiency of the liposomes was (50.40 ± 0.89)%, the average particle size was (218.37 ± 2.47) nm, the PDI was (0.24 ± 0.01), and the Zeta potential was (-0.684 ± 0.21) mV. The in vitro release showed an obvious sustained release effect, with a cumulative release rate of 52.99% at 48 h, which was consistent with the Higuchi model.

The optimized preparation process of amikacin liposomes has good stability and reproducibility. The product has uniform particle size, stable morphology and sustained-release property. It has the potential advantages of achieving pulmonary targeted delivery, improving local efficacy and reducing toxic and side effects, thus laying a foundation for subsequent pharmacodynamics and safety studies.

To investigate the elements of quality difference in Campsis flos based on multi-index content, and to comprehensively evaluate the quality of Campsis flos from different producing areas based on multi-index content.

Eighteen batches of Campsis flos were collected from Jiangsu, Zhejiang and other producing areas. The contents of verbascoside, isoacteoside, apigenin, luteolin, quercetin, rhamnocitrin, maslinic acid, hederagenin, oleanolic acid, ursolic acid, water-soluble extract, total ash and acid-insoluble ash in Campsis flos were used as quality evaluation indexes, the differences from different producing areas were analyzed and characterized by statistical methods. 13 quality evaluation indexes were statistically analyzed by two mathematical models of chemometrics and grey relational analysis (GRA), and the ranking information of the quality of Campsis flos from different producing areas was obtained.

There were some fluctuations in the contents of 13 indexes in Campsis flos from different producing areas, and the established multi-index quantitative method was accurate and feasible. The results of quality evaluation model showed that 18 batches of Campsis flos were divided into three groups according to the origins. Oleanolic acid, ursolic acid, quercetin and verbascoside were the main factors affecting the quality of Campsis flos. The quality of Campsis flos from Jiangsu was better.

There are differences in the content of multiple indexes in Campsis flos from different origin. The established quality evaluation method can distinguish Campsis flos from different origins, and specifically identify the different components, so as to provide reference for the quality evaluation of Campsis flos (including those from different producing areas).

To establish an ultra-performance liquid chromatography-diode array detector (UPLC-DAD) method for the simultaneous determination of 5-hydroxymethylfurfural, morroniside, chlorogenic acid, loganin, paeoniflorin, 4, 5-O-dicaffeoylquinic acid, benzoylpaeoniflorin, and paeonol in Qiju Dihuang condensed pills.

Separation was performed on a Waters ACQUITY HSS T3 C₁₈ column (2.1 mm × 100 mm, 1.8 μm) using a gradient elution program consisting of methanol, acetonitrile, and 0.3% phosphoric acid. Detection wavelengths were set at 230 nm (paeoniflorin, benzoylpaeoniflorin), 240 nm (morroniside, loganin), 274 nm (paeonol), 284 nm (5-hydroxymethylfurfural), 325 nm (chlorogenic acid), and 330 nm (4, 5-O-dicaffeoylquinic acid). The column temperature was maintained at 35 ℃， with a flow rate of 0.3 mL·min ^-1 and an injection volume of 1 μL.

The calibration curves for 5-hydroxymethylfurfural, morroniside, chlorogenic acid, loganin, paeoniflorin, 4, 5-O-dicaffeoylquinic acid, benzoylpaeoniflorin, and paeonol exhibited good linearity within concentration ranges of 4.69-234.53 (r = 0.999 3), 2.43-121.52 (r=0.999 8), 1.12-56.09 (r = 0.999 9), 2.81-140.33 (r = 0.999 9), 2.55-127.64 (r = 0.999 8), 1.17-58.60 (r = 0.999 8), 2.22-110.75 (r=0.999 5), and 4.93-246.25 μg·mL^-1 (r = 0.999 9), respectively. The average recoveries were 99.67%, 99.30%, 97.64%, 99.88%, 99.90%, 102.60%, 99.65%, 100.59% with corresponding RSDs of 0.97%, 1.36%, 0.75%, 1.03%, 1.72%, 0.64%, 1.01% and 1.00%.

The developed method is rapid, accurate, sensitive, efficient, and reproducible, making it suitable for the determination of multi-index components, quality control and quality evaluation of Qiju Dihuang condensed pill.

To develop a gas chromatography-mass spectrometry (GC-MS) method for the determination of cyclohexane and potential genotoxic impurities (chlorocyclohexane and 1-cyclohexyl-1-phenylethanol) in trihexyphenidyl hydrochloride tablets.

The VF-WAXms capillary column (30 m × 0.25 mm, 1.00 μm) was used. High-purity helium was used as the carrier gas at a flow rate of 2.0 mL·min^-1, with a split ratio of 5∶1 and an injection volume of 2 μL. The mass spectrometer was equipped with an electron ionization (EI) source and operated in the selected ion monitoring (SIM) mode for detection.

The results showed that chlorocyclohexane, cyclohexanol, and 1-cyclohexyl-1-phenylethanol exhibited good linear relationships in the range of 25-250 ng·mL^-1, with detection limits (LOD) of 10.2, 10.0 and 9.8 ng·mL^-1, and quantification limits (LOQ) of 25.4, 25.0 and 24.5 ng·mL^-1, respectively. The average recovery rates (n = 6) were 98.93%, 102.93% and 99.97%, respectively.

The established method has good specificity and high sensitivity, and can serve as a reference for the quality control of trihexyphenidyl hydrochloride tablets.

Safe, effective, economical and appropriate rational drug use has become a crucial part of medical services. By summarizing the relevant theoretical research on pharmacoeconomic evaluation systems in recent years, this paper aims to propose a set of operable and easily promotable pharmacoeconomic evaluation paths.

This study mainly adopts literature research, expert consultation, comparative research and other methods to analyze the problems existing in the pharmacoeconomic evaluation system and put forward relevant suggestions.

Currently, there are issues with the relevant theoretical research on the pharmacoeconomic evaluation system in China, including an insufficiently systematic evaluation system, insufficient evaluation dimensions, and isolated data. It is necessary to further improve the evaluation system, enhance the theory of pharmacoeconomics evaluation, and strengthen the generalizability of research results.

This paper proposes a development path of the "policy guidance indicator optimization data-driven" trinity evaluation system, aiming to enrich and improve the pharmacoeconomic evaluation system, enhance the overall efficiency of pharmaceutical resource allocation, and provide useful references for deepening the reform of the medical and health system.

To establish a new pathway for the external validation of population pharmacokinetics (PPK) models based on real-world data, using aripiprazole in the treatment of schizophrenia as an example, and to explore a novel strategy for the clinical application of model-informed precision dosing (MIPD) and its feasibility.

A total of 101 patients with schizophrenia (1 178 blood drug concentration samples) were retrospectively enrolled at a class Ⅲ Grade A specialized hospital. Published PPK models of aripiprazole were identified by searching PubMed, Web of Science, and China National Knowledge Infrastructure (CNKI). Candidate models were evaluated using goodness-of-fit (R²) prediction error tests (PE, RPE%) to assess their predictive performance, and the model consistent with the characteristics of the blood concentration data was screened. Based on the selected PPK model, Monte Carlo simulation was performed to predict the steady-state plasma concentration of aripiprazole under different dosing regimens for individualized medication.

Three published PPK models of aripiprazole were included in this study. Goodness-of- fit and prediction error analyses showed that Model 3 had the best predictive performance. Based on Monte Carlo simulations with Model 3, plasma concentrations under 10 mg qd, 20 mg qd, and 30 mg qd regimens were ranked as IM > EM >UM in patients with the same body weight. For patients with the same CYP2D6 metabolic phenotype, plasma concentrations decreased with increasing body weight: 30 kg > 50 kg > 70 kg > 90 kg > 110 kg.

After validation with real-world data, the screened model with satisfactory predictive performance can be directly used in clinical practice to guide individualized medication and achieve model-informed precision dosing.

To characterize the pharmacokinetic characteristics of teicoplanin in patients with hypoalbuminemia, explore the target values of pharmacokinetic/pharmacodynamic (PK/PD) parameters, and develop individualized dosing regimens.

Clinical data of patients with hypoalbuminemia were retrospectively collected, and a population pharmacokinetic analysis was performed using a nonlinear mixed-effects model. Classification and regression tree (CART) analysis and survival analysis were used to explore and verify the impact of the target values of (PK/PD) parameters on therapeutic efficacy. Monte Carlo simulation was applied to develop individualized dosing regimens.

A one-compartment population pharmacokinetic model of teicoplanin was established using 328 blood concentration values from 195 patients. The population typical values of clearance and apparent volume of distribution of the model were 0.612 L·h^-1 and 91.2 L, respectively. Estimated glomerular filtration rate (eGFR) was included as a covariate for clearance, and albumin and urea were included as covariates for the apparent volume of distribution. The target values of PK/PD parameters were determined as trough concentration ≥15 mg·L^-1 and the ratio of 24 hour area under the drug-time curve to minimum inhibitory concentration (AUC₂₄/MIC)≥790. Several individualized dosing regimens were developed based on different levels of the model covariates.

For patients with hypoalbuminemia receiving teicoplanin, it is necessary to increase the dosage and frequency of the loading dose regimen according to the patients' albumin and eGFR levels, and adjust the maintenance dose regimen according to the MIC of pathogenic bacteria, so as to improve clinical efficacy.