Bcr-Abl inhibitors are targeted drugs for the treatment of chronic myeloid leukemia (CML). Due to the high selectivity with few side effects, some of them have become the first-line drugs in the treatment of CML. Therefore, Bcr-Abl inhibitors have become the hotspot of anti-CML drug research. Based on the patent publication records of Bcr-Abl inhibitors, this article analyzes the research and development trends of Bcr-Abl inhibitors from the publication time and regional distribution, compares and analyzes the research progress through technical topics, and finally selects an enterprise to analyze its subsequent patent application for drug research and development in China and abroad, in order to provide relevant reference for the research and development of Bcr-Abl inhibitors.

Based on the characteristics of monoclonal antibody, this paper discusses the key points in the pharmacology and toxicology review of monoclonal antibody combined with our review practice and the technical guidelines issued by regulatory agencies. Recommendations are given on the quality of test substance, selection of related animal species, evaluation of immunogenicity and immunotoxicity, and selection of initial dose for the first human clinical trial, so as to provide general principles for designing scientifically acceptable non-clinical research programs for the sponsors and researchers.

Nanotechnology has greatly promoted the research and development of nanodrugs and nanoparticles, providing new therapeutic options for many diseases. However, due to their special physical and chemical properties and its easy accumulation in the liver, nanodrugs and nanoparticles can also bring potential hepatotoxicity risks to the body. This review summarizes the research progress of hepatotoxicity induced by nanodrugs or nanoparticles in recent years from the following three aspects: liver accumulation and cell-nanodrug interaction, toxic mechanisms and influencing factors of toxicity. Also, we discuss the limitations of the previous studies. This paper aims to provide new insights and references for the related researches on hepatotoxicity and preclinical safety evaluation of nanodrugs and nanoparticles.

In this paper, a database of international registration standard on natural crude drugs (NCDs) and international registered varieties of NCDs was constructed. In this database, taking NCDs as the research object, and the registration status and technical requirements of NCDs were systematically searched in representative countries and regions such as the United States, the European Union, Japan, South Korea, Singapore, Hong Kong, Brazil, Malaysia and South Africa. And the main information sources, system framework design ideas, methods and characteristics of the database are described in detail. The relevant databases are expected be actively constructed to further accelerate the pace of TCM internationalization taking advantages of knowledge integration, in order to provide strong technical support for TCM to go abroad and serve the world.

Rhein is a kind of emodin-type hydroxy-anthraquinone, which mainly exists in traditional Chinese medicines like rhubarb. Rhein is well acknowledged for its pharmacological activities, such as anti-cancer, anti-inflammatory, anti-bacterial and anti-Alzheimer's disease; however, its clinical application is limited due to its poor water solubility and low bioavailability. In order to overcome these shortcomings, a large number of more bioactive Rhein derivatives were designed and synthesized by structural modification of Rhein. In this paper, the structural modification and pharmacological activity of rhein are reviewed, providing reference for future development of rhein derivatives.

Pituitrin, oxytocin and vasopressin, as the drugs related to the posterior pituitary, play an irreplaceable role in clinic. Based on the relevant research results of our laboratory and literature survey, this paper analyzes the research status of quality standard of pituitary hormone-related drugs, and further puts forward revision suggestions, in order to provide reference for the improvement of drug quality standard and ensure the safety of clinical medication.

Objective: To compare the effects of different extraction methods on polysaccharides from Polygoni Multiflori Radix, and to explore the differences of polysaccharides from Polygoni Multiflori Radix and Polygoni Multiflori Radix Praeparata using hot water extraction. Methods: Polysaccharides from Polygoni Multiflori Radix were extracted by hot water extraction, ultrasonic extraction and microwave extraction, respectively. The yield, total sugar content, protein content, weight-average molecular weight (M_w), monosaccharide composition and DPPH free radical scavenging ability of polysaccharides were studied and compared. Results:The results showed that the yield of polysaccharides from Polygoni Multiflori Radix by different extraction methods was as follows: microwave extraction (M-PMP) > hot water extraction (H-PMP) > ultrasonic extraction (U-PMP). The protein content of U-PMP was the highest, and the M_w was obviously different from other polysaccharides. The results of monosaccharide composition showed that the monosaccharide composition of polysaccharide from Polygoni Multiflori Radix by different extraction methods was the same, which is mainly composed of mannose, rhamnose, glucuronic acid, galacturonic acid, glucose, galactose and arabinose, with different molar ratio of monosaccharides. Conclusion:There are some differences in the polysaccharide components extracted by three methods, and the yield obtained from different extraction methods varied significantly, with the highest yield of M-PMP. Some differences were found in polysaccharides from raw and prepared Polygoni Multiflori Radix and Polygoni Multiflori Radix Praeparata.

Objective: To optimize the parameters in separation and purification processes of Yixintai total saponins, by using failure mode and effects analysis (FMEA) combined with Box-Behnken response surface design. Methods: The total saponins of Yixintai Compound were purified with macroporous resin (MAR), and the key process parameters of the purification process were screened by FMEA. Taking the recovery rate and mass fraction of saponins as evaluation indicators, the Box-Behnken design was used to optimize the MAR purification process of Yixintai total saponins. The optimal parameters were finally obtained in separation and purification processes of Yixintai total saponins. Results: FMEA determined four influencing factors, including the mass concentration of the sample solution, eluent volume fraction, the adsorption flow rate and the volume of the eluent as the key factors for the separation and purification of total saponins. The P values of the models established by Box-Behnken design were all below 0.05, indicating that the models had good predictive abilities. The obtained best parameters was are as follows: the mass concentration of the sample solution is 0.80 mg·mL^-1, the ethanol volume fraction is 90.0%, the adsorption flow rate is 1.7 BV·h^-1, and the eluent volume is 1.6 BV. Conclusion: The separation and purification method obtained by failure mode analysis combined with Box-Behnken optimization was stable and reliable, with high recovery rate and purity of saponins. This method is suitable for purifying Yixintai total saponins.

Objective: To study the factors affecting the whiteness of talc and the relationship between them. Methods: The content of metal elements, particle size and particle size distribution, which affect the whiteness of talc, were measured, and the main factors were speculated by principal component analysis (PCA). The linear regression model was established by SPSS. Results: Using PCA analysis, it is speculated that the main factors are the content of impurity metal calcium and particle size D₉₀. The established linear regression model is: Whiteness=96.457+42.770×Calcium% -0.422×D₉₀, with R² of 0.944 and Adjusted R² of 0.934 (P<0.05). The model was successfully constructed. Conclusion: The whiteness of pharmaceutical excipient talc is affected by its impurity metal calcium content and particle size D₉₀. The established whiteness correlation regression model provides a theoretical basis for whiteness as a visual quantity to control the particle size and impurity metal calcium content in talc production process and preparation. This study also provides a new idea for the study of the characteristics and quality attributes of pharmaceutical excipient talc.

Objective: To establish a method for controlling polymer impurities in ceftizoxime sodium for injection. Methods: Ceftizoxime sodium was dissolved in phosphate buffer solution (pH 7.0) to prepare degradation solution. High performance size exclusion chromatography (HPSEC) and column switching-LC/MSn (CS-LC/MSn) were applied to separate and deduce the poor retention impurities in the degradation solution. The specificity of developed HPSEC method was evaluated. A RP-HPLC method for polymer analysis was established with a Phenomenex Gemini C₁₈ column, using phosphate buffer solution (pH 7.0)-acetonitrile as mobile phase under a gradient elution program. The specificity of RP-HPLC method was assessed by two-dimensional chromatography (2D-HPLC) and CS-LC/MSn, and LLOD and LLOQ were also tested. Results: ceftizoxime dimer and the dimer's isomer were deduced in the degradation solution as well as 6 small molecular impurities. Polymer impurities were liable to co-elute with small molecular impurities by HPSEC method, which made a poor quantification accuracy and specificity. Ceftizoxime dimer and the dimer's isomer were detected by RP-HPLC with a sufficient specificity. Conclusion: HPSEC method was not suitable for the quality control of polymer impurities in ceftizoxime sodium for injection, while the RP-HPLC method was specific, which can be applied for polymer impurities. Ceftizoxime degradation solution can be used to identify polymer peaks as the systematic suitability testing solution.