Objective: To provide reference for the correct understanding and accurate implementation of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Methods: Introduce the main characteristics and content of the additions and revisions of the general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition Volume Ⅳ.
Results: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition are more harmonized with the relevant guidelines of the ICH Q series, and the inclusion of advanced and mature instrument analysis technology standards and analysis method standards related to drug safety, efficacy, and quality controllability is further increased.
Conclusion: The general chapters of physical and chemical analysis in the Chinese Pharmacopoeia 2025 Edition have provided a more convenient new bridge for China’s drugs to go international, standardized testing technology support for achieving full process quality control, and better meet the needs of drug research and development, production, quality control, and supervision in China.

Traditional Chinese medicine(TCM)is extensively utilized for clinical disease prevention and treatment.However,due to the intricate nature of its material basis and the multiple factors involved in the preparation process,ensuring comprehensive quality control of TCM proves to be challenging.By instilling a clear understanding of its effective and harmful substances and implementing control over the content and limit of TCM during the preparation process,the controllability and repeatability of its quality can be guaranteed.Currently,China is facing a dearth of innovative technology for drug development,necessitating an increase in research and development efficiency,especially in the realm of high-throughput precision analytical equipment.The country has long relied on imported pharmaceutical analysis equipment with a particular efficiency in high-end intelligent analysis equipment.This is especially concerning considering the urgent requirement to establish a"pharmaceutical intelligent analysis system."This project,supported by the Major Instrument Development Project of the National Science and Technology Funds,employs cell membrane chromatography technology,complemented by biotechnology and artificial intelligence technology,to devise a two-dimensional cell membrane chromatography(2D/CMC)analyzer.The project has successfully conducted a demonstration application of the"2D/CMC-Traditional Chinese Medicine Pharmacodynamic Substance Analyzer"and the"2D/CMC-Traditional Chinese Medicine Injection Allergen Analyzer".These tools have enhanced the screening and discovery efficiency of TCM's effective substances and allergen components.Moreover,the equipment amalgamates qualitative and quantitative analysis,thereby serving as an effective analytical tool to enhance the quality and efficacy of traditional Chinese medicine.

Drug-receptor interaction plays an important role in a series of biological effects, such as cell pro-liferation, immune response, tumor metastasis, and drug delivery. Therefore, the research on drug-re-ceptor interaction is growing rapidly. The equilibrium dissociation constant (KD) is the basic parameter to evaluate the binding property of the drug-receptor. Thus, a variety of analytical methods have been established to determine the KD values, including radioligand binding assay, surface plasmon resonance method, fluorescence energy resonance transfer method, affinity chromatography, and isothermal ti-tration calorimetry. With the invention and innovation of new technology and analysis method, there is a deep exploration and comprehension about drug-receptor interaction. This review discusses the differ-ent methods of determining the KD values, and analyzes the applicability and the characteristic of each analytical method. Conclusively, the aim is to provide the guidance for researchers to utilize the most appropriate analytical tool to determine the KD values.

It is very difficult to comprehensively achieve the quality control of traditional Chinese medicine (TCM), because some problems such as indicator simplification and lack of correlation between efficacy and indicator are ex-isted in the common quality control of TCM. Combined with the practical experience of our research work, this paper outlined the characteristics and applications of cell membrane chromatography (CMC) and discussed that CMC method can be used for quality control of TCM.

In China.traditional Chinese medicines (TCMs) have been used in clinical applications for thousands of years.The successful hyphenation of high-performance liquid chromatography (HPLC) and mass spectrometry (MS) has been applied widely in TCMs and biological samples analysis.Undoubtedly.HPLC/MS technique has facilitated the understanding of the treatment mechanism of TCMs.We reviewed more than 350 published papers within the last 5 years on HPLC/MS in the analysis of TCMs.The present review focused on the applications of HPLC/MS in the component analysis,metabolites analysis,and pharmacokinetics of TCMs etc.50% of the literature is related to the component analysis of TCMs,which show that this field is the most popular type of research.In the metabolites analysis,HPLC coupled with electrospray ionization quadrupole time-of-flight tandem mass spectrometry has been demonstrated to be the powerful tool for the characterization of structural features and fragmentation behavior patterns.This paper presented a brief overview of the applications of HPLC/MS in the analysis of TCMs.HPLC/MS in the fingerprint analysis is reviewed elsewhere.

A rapid method for the simultaneous determination of berberine (BBR), matrine (MT) and oxymatrine (OMT) by nonaqueous capillary electrophoresis (NACE) was developed. Optimum separation of the analytes was obtained on a 50cm×50μm i.d. fused-silica capillary using a non-aqueous buffer system of 70mM ammonium acetate, 7.0% acetic acid and 10% acetonitrile at 25kV and 20℃. The relative standard deviations (R.S.D.) of the migration times and peak areas of the three active components were 0.06%-0.20% and 0.12%-3.41% for berberine, 0.11%-0.60% and 0.74%-1.63% for matrine, 0.15% and 0.45% for oxymatrine, respectively. Detection limits of berberine, matrine and oxymtrine were 0.18μg/mL, 4.08μg/mL and 4.16μg/mL, respectively. In the tested concentration range, good linear relationships (0.9992 for berberine, 0.9988 for matrine and 0.9988 for oxymatrine) were observed. The linear calibration ranges were 0.45-360.0μg/mL for berberine, 8.16-408.0μg/mL for matrine and 20.8-416.0μg/mL for oxymatrine. This method has been successfully applied to the phytochemical analysis of alkaloids extracts from two commonly used traditional Chinese herbal drugs: Sophora flavescens Ait. (Kushen) and Cortex phellodendri chinensis (Huangbai) and their medicinal preparations.

OBJECTIVETo investigate the absorption kinetics of atractylenolide I in intestines of rats and the influence of P-glycoprotein (P-gp) on the absorption.

METHODThe absorption kinetics was investigated using the method of in situ intestine absorption in rats and the samples were determined by HPLC.

RESULTAtractylenolide I is absorbed quite well at all segments of intestine in rats and no specific absorption was founded in different segment. When the concentration of perfusion solution was increased contrarily the absorption rate constant (Ka) kept at the same level. Compared Ka of three different concentration of perfusion solution with variance analysis method, Ka of atractylenolide I had no significant differences. But the Ka values were significently increased in the presence of P-gp inbibitor, verapamil or digoxin.

CONCLUSIONAtractylenolide I can be classified into high penetrating drug. Passive diffusion dominates the absorptive transport behivior of atractylenolide I. Atractylenolide I can be absorbed in the whole intestinal segments and there is not a preferntial absorption zone in the intestine. The absorption and secretion of atractylenolide I are mediated by the efflux transport system, P-gp.

ATP-Binding Cassette, Sub-Family B, Member 1 ; metabolism ; Animals ; Intestinal Absorption ; drug effects ; Intestines ; chemistry ; drug effects ; metabolism ; Kinetics ; Lactones ; pharmacokinetics ; Male ; Rats ; Rats, Sprague-Dawley ; Sesquiterpenes ; pharmacokinetics

Aim To investigate the bio-affinities of ligustilide and butylidenephthalide to rat aortic smooth muscle cells and the inhibitory effects of them on bFGF-stimulated proliferation of rat vascular smooth muscle cell (VSMC). Methods VSMCs were cultured from rat aorta pectoralis and identified by an immunohistochemical method. The bio-affinities between solute (ligustilide or butylidenephthalide) and cell membrane were measured by rat aortic cell membrane chromatography (CMC). The inhibitory effects of ligustilide and butylidenephthalide on bFGF-stimulated VSMC proliferation were evaluated by MTT colorimetric method. Results Both ligustilide and butylidenephthalide had selective affinities to rat aortic smooth muscle cell as the same as verapamil, one of the calcium ion antagonists. They could potently separately (P ＜ 0.05 ), but had no effects on the normal VSMC growth. Conclusion Both ligustilide and butylidenephthalide can inhibit the abnormal proliferation of VSMC induced by bFGF.

Objective To discover the effective component of Rhizoma Tupistrae chinensis with inhibiting angiogenesis. Methods Several parts of Rhizoma Tupistrae chinensis were obtained by using different extraction solvents. They were screened by the model of ECV304 cell membrane chromatography with anti-VEGF antibody as a control drug. The inhibition of effective component (ZGQ-C) on ECV304 proliferation in vitro was examined by MTT assay. Results The inhibition rate (40.51%,51.11%,63.54%,74.32%,81.26%) was correlated with the ZGQ-C concentration. The ECV304 cell had significantly changed in morphology. Conclusion The ZGQ-C is an effective component for inhibiting angiogenesis. The screening results on the model have a good correlation with that of MTT assay.

Objective To investigate the molecular mechanisms that are responsible for anti-inflammatory effect of usnic acid (UA), the effects of UA from usnea longissm on tumor necrosis factor-α(TNF-α) and nitric oxide (NO) production in peritoneal macrophages has been examined. Methods The different concentrations of UA were added to peritoneal macrophages. The TNF-α and NO production in peritoneal macrophages were examined with mouse TNF-α ELISA kit and NO content by measuring the amount of nitrite (NO-2μmol/L) formed in the medium using Griess reaction. The activity of inducible nitric oxide synthase (i-NOS) was determined using i-NOS detection kit and the TNF-α mRNA expression was tested by reverse transcriptase polymerase chain reaction (RT-PCR). Results UA decreased the TNF-α and NO level in LPS-stimulated peritoneal macrophages in dose-dependent manner, the IC50 values were 12.8μmol/L and 5.7μmol/L respectively. RT-PCR analysis indicated that UA could inhibit TNF-α mRNA expression; the activity analysis of i-NOS indicated that UA could inhibit the activity of i-NOS. Conclusion UA could inhibit the TNF-α and NO production in peritoneal macrophages, it may be associated with the anti-inflammatory activity of UA.