Objective To evaluate the quality of cisatracurium besilate injection produced by domestic manufacturers.Methods A comprehensive evaluation of 104 batches of samples was carried out using statutory testing methods combined withexploratory research,including related substances,1,5-pentanediol diacrylate,residual solvents,genotoxic impurities of benzenesulfonate esters,infrared spectrum,and endotoxin examination.The quality of domestic products and the controllability of current specifications were comprehensively evaluated.Results According to the statutory tests,the qualified rate of 104 batches of samples was 100.0％.The exploratory research showed that the results of related substances in the samples produced by 6 manufacturers were far below the limit,and no genotoxic impurities of benzenesulfonate esters were detected.However,the results showed that there was variability in 1,5-pentanediol diacrylate,as well as residual solvents.Conclusions The quality of the cisatracurium besilate injection is good,and the current specifications should be further improved and unified.It was proposed that the infrared spectrum,related substance,and 1,5-pentanediol diacrylate method be added or revised,and the limit of endotoxin strictly controlled.It was proposed that manufacturers pay attention to the quality of API and control injection production.

ObjectiveThis paper aims to verify the therapeutic effect of Cranial Painkiller pills' extract powder prepared by the new process on the rat's trigeminal neuralgia model caused by infraorbital injection of Talci Pulvis， evaluate its potential clinical application value， and compare the therapeutic effect with that of Cranial Painkiller granules， so as to provide data support for the application of the Cranial Painkiller pills' extract powder and precise treatment. MethodsThe rat's trigeminal neuralgia model was constructed by infraorbital injection of Talci Pulvis， and the rats were randomly divided into the normal group， model group， carbamazepine group （60 mg·kg^-1）， Cranial Painkiller granules group （2.70 g·kg^-1）， and low， medium， and high dosage groups of Cranial Painkiller pills' extract powder （1.35， 2.70， 5.40 g·kg^-1） according to the basal mechanical pain thresholds， and there were 10 rats in each group. The drug was administered by gavage to each group 2 h after modeling， and distilled water was given by gavage to the normal and model groups under the same conditions once a day for 10 d. Von Frey brushes were used to measure mechanical pain thresholds in rats. Hematoxylin-eosin （HE） staining was used to detect pathological changes in the trigeminal ganglion， and enzyme-linked immunosorbent assay （ELISA） was used to detect the inflammatory factors interleukin-1 （IL-1）， interleukin-6 （IL-6）， interleukin-8 （IL-8）， and tumor necrosis factor-α （TNF-α） levels in rat serum， as well as neuropeptide substance P （SP） and β-endorphin （β-EP） levels in rat brain tissue. Western blot technique was used to detect the levels of NLRP3， ASC， Caspase-1， and OTULIN proteins in rat brain tissue. ResultsCompared with the normal group， the pain threshold of rats in the model group showed a continuous significant decrease （P<0.01）. The pathological damage of brain tissue was significant （P<0.01）， and the inflammatory levels of IL-1， IL-6， IL-8， and TNF-α in serum were significantly elevated （P<0.01）. The level of the SP in the brain tissue was significantly elevated （P<0.01）， and the level of β-EP was significantly reduced （P<0.01）， while the level of OTULIN was significantly reduced， and NLRP3， ASC， and Caspase-1 protein levels were significantly elevated （P<0.01）. After administration of the drug， compared with the model group， the pain threshold of each dose group of the Cranial Painkiller pills' extract powder and the Cranial Painkiller granules group significantly increased （P<0.01）. The inflammatory levels of IL-1， IL-6， IL-8， and TNF-α and SP levels significantly decreased （P<0.01）， and the β-EP levels were significantly elevated （P<0.01）， while the levels of OTULIN protein were significantly elevated （P<0.05， P<0.01）， and the levels of NLRP3， ASC proteins were decreased （P<0.01）in high dose Cranial Painkiller pills' extract powder. Meanwhile， compared with those in the model group， the trigeminal ganglion lesions of rats in the Cranial Painkiller pills' extract powder and Cranial Painkiller granules groups showed different degrees of improvement （P<0.05， P<0.01）. ConclusionThe Cranial Painkiller pills' extract powder has significant therapeutic effects on the rat model of trigeminal neuralgia induced by infraorbital injection of Talci Pulvis， and its mechanism is related to the improvement of OTULIN-regulated neuroinflammation.

ObjectiveThis paper aims to verify the therapeutic effect of Cranial Painkiller pills' extract powder prepared by the new process on the rat's trigeminal neuralgia model caused by infraorbital injection of Talci Pulvis， evaluate its potential clinical application value， and compare the therapeutic effect with that of Cranial Painkiller granules， so as to provide data support for the application of the Cranial Painkiller pills' extract powder and precise treatment. MethodsThe rat's trigeminal neuralgia model was constructed by infraorbital injection of Talci Pulvis， and the rats were randomly divided into the normal group， model group， carbamazepine group （60 mg·kg^-1）， Cranial Painkiller granules group （2.70 g·kg^-1）， and low， medium， and high dosage groups of Cranial Painkiller pills' extract powder （1.35， 2.70， 5.40 g·kg^-1） according to the basal mechanical pain thresholds， and there were 10 rats in each group. The drug was administered by gavage to each group 2 h after modeling， and distilled water was given by gavage to the normal and model groups under the same conditions once a day for 10 d. Von Frey brushes were used to measure mechanical pain thresholds in rats. Hematoxylin-eosin （HE） staining was used to detect pathological changes in the trigeminal ganglion， and enzyme-linked immunosorbent assay （ELISA） was used to detect the inflammatory factors interleukin-1 （IL-1）， interleukin-6 （IL-6）， interleukin-8 （IL-8）， and tumor necrosis factor-α （TNF-α） levels in rat serum， as well as neuropeptide substance P （SP） and β-endorphin （β-EP） levels in rat brain tissue. Western blot technique was used to detect the levels of NLRP3， ASC， Caspase-1， and OTULIN proteins in rat brain tissue. ResultsCompared with the normal group， the pain threshold of rats in the model group showed a continuous significant decrease （P<0.01）. The pathological damage of brain tissue was significant （P<0.01）， and the inflammatory levels of IL-1， IL-6， IL-8， and TNF-α in serum were significantly elevated （P<0.01）. The level of the SP in the brain tissue was significantly elevated （P<0.01）， and the level of β-EP was significantly reduced （P<0.01）， while the level of OTULIN was significantly reduced， and NLRP3， ASC， and Caspase-1 protein levels were significantly elevated （P<0.01）. After administration of the drug， compared with the model group， the pain threshold of each dose group of the Cranial Painkiller pills' extract powder and the Cranial Painkiller granules group significantly increased （P<0.01）. The inflammatory levels of IL-1， IL-6， IL-8， and TNF-α and SP levels significantly decreased （P<0.01）， and the β-EP levels were significantly elevated （P<0.01）， while the levels of OTULIN protein were significantly elevated （P<0.05， P<0.01）， and the levels of NLRP3， ASC proteins were decreased （P<0.01）in high dose Cranial Painkiller pills' extract powder. Meanwhile， compared with those in the model group， the trigeminal ganglion lesions of rats in the Cranial Painkiller pills' extract powder and Cranial Painkiller granules groups showed different degrees of improvement （P<0.05， P<0.01）. ConclusionThe Cranial Painkiller pills' extract powder has significant therapeutic effects on the rat model of trigeminal neuralgia induced by infraorbital injection of Talci Pulvis， and its mechanism is related to the improvement of OTULIN-regulated neuroinflammation.

Objective To evaluate the quality of ketoconazole lotion produced by different domestic companies.Methods Legal standards and exploratory research were used to conduct a comprehensive evaluation of 45 batches(40 batch numbers)of ketoconazole lotion for national drug sampling inspection in 2024,including related substances,antioxidant content,packaging oxygen permeability,in vitro permeation test,and viscosity,antibacterial efficacy,irritation,microstructure,etc.Results The legal standard inspection pass rate was 100.0%.Correlation analysis found that the main factors affecting the quality of this product are prescription technology and packaging.Conclusion It is recommended that manufacturers optimize the prescription process as soon as possible,and pay attention to choose suitable packaging materials,effectively improve the quality of ketoconazole lotion.

Objective To establish the HPLC analysis method for ketoconazole related substances,and to provide technical support for the improvement of the quality standard and the purity of ketoconazole.Methods Gradient elution conditions were optimized based on the chromatographic parameters outlined in the 2024"British Pharmacopoeia"for ketoconazole cream.A C18 column(4.6 mm×150 mm,3 μm)was used to facilitate the elution process using a gradient of acetonitrile and acetate buffer,and detection performed at a wavelength of 230 nm.Results The known impurities and potentially genotoxic impurities in the material drugs of ketoconazole can be more effectively separated using the established methods,which are both robust and highly sensitive.The content of the two potentially geno toxic impurities,six known impurities and unknown impurities in the 21 batches of ketoconazole sourced from five raw material pharmaceutical companies is below the specified limit requirements.Conclusion This method contributes to improving the quality of ketoconazole ingredients,ensuring the safety of ketoconazole preparations,and better supporting the regulatory supervision.

Objective To evaluate the quality of cisatracurium besilate injection produced by domestic manufacturers.Methods A comprehensive evaluation of 104 batches of samples was carried out using statutory testing methods combined withexploratory research,including related substances,1,5-pentanediol diacrylate,residual solvents,genotoxic impurities of benzenesulfonate esters,infrared spectrum,and endotoxin examination.The quality of domestic products and the controllability of current specifications were comprehensively evaluated.Results According to the statutory tests,the qualified rate of 104 batches of samples was 100.0％.The exploratory research showed that the results of related substances in the samples produced by 6 manufacturers were far below the limit,and no genotoxic impurities of benzenesulfonate esters were detected.However,the results showed that there was variability in 1,5-pentanediol diacrylate,as well as residual solvents.Conclusions The quality of the cisatracurium besilate injection is good,and the current specifications should be further improved and unified.It was proposed that the infrared spectrum,related substance,and 1,5-pentanediol diacrylate method be added or revised,and the limit of endotoxin strictly controlled.It was proposed that manufacturers pay attention to the quality of API and control injection production.

Objective To evaluate the quality of ketoconazole lotion produced by different domestic companies.Methods Legal standards and exploratory research were used to conduct a comprehensive evaluation of 45 batches(40 batch numbers)of ketoconazole lotion for national drug sampling inspection in 2024,including related substances,antioxidant content,packaging oxygen permeability,in vitro permeation test,and viscosity,antibacterial efficacy,irritation,microstructure,etc.Results The legal standard inspection pass rate was 100.0%.Correlation analysis found that the main factors affecting the quality of this product are prescription technology and packaging.Conclusion It is recommended that manufacturers optimize the prescription process as soon as possible,and pay attention to choose suitable packaging materials,effectively improve the quality of ketoconazole lotion.

Objective To establish the HPLC analysis method for ketoconazole related substances,and to provide technical support for the improvement of the quality standard and the purity of ketoconazole.Methods Gradient elution conditions were optimized based on the chromatographic parameters outlined in the 2024"British Pharmacopoeia"for ketoconazole cream.A C18 column(4.6 mm×150 mm,3 μm)was used to facilitate the elution process using a gradient of acetonitrile and acetate buffer,and detection performed at a wavelength of 230 nm.Results The known impurities and potentially genotoxic impurities in the material drugs of ketoconazole can be more effectively separated using the established methods,which are both robust and highly sensitive.The content of the two potentially geno toxic impurities,six known impurities and unknown impurities in the 21 batches of ketoconazole sourced from five raw material pharmaceutical companies is below the specified limit requirements.Conclusion This method contributes to improving the quality of ketoconazole ingredients,ensuring the safety of ketoconazole preparations,and better supporting the regulatory supervision.

Purpose/Significance To expound the current status of the transformation and application of scientific and technological achievements of hospitals in China,so as to provide references for the development and achievement transformation of clinical research in hospitals.Method/Process Taking 502 Chinese medical science and technology awards won by the hospital hosts from 2015 to 2021 as the analysis object,the award grade,hospital type,regional and thematic distribution are analyzed by scientometrics.Result/Conclu-sion Tertiary hospitals and hospitals affiliated universities are the core forces of scientific and technological research and achievement transformation.There are still great differences in clinical research and transformation levels in different regions.There is an urgent need to strengthen cross-level and cross-regional cooperation in science and technology to enhance the efficiency of achievement transforma-tion.The existing researches mainly focus on the diseases with high morbidity or mortality in China,which meets the actual clinical needs,but it still needs to be further laid out in the fields of major public health emergencies and rare diseases.

Patients with skeletal ClassⅡ often show symptoms such as protrusion of maxillary anterior teeth,mandibular retraction,open lips and teeth,deep overbite,and deep overjet,which seriously affect the facial appearance.This article reports a case of an ado-lescent male patient with skeletal Class Ⅱ combined with impacted teeth treated by one-stage early correction and two-stage fixation.After treatment,the patient's skeletal Class Ⅱ symptoms improved significantly,including the improvement of mandibular retraction.The problem of open lips and teeth was solved;the facial appearance tended to be straight,and there was no obvious abnormality of the temporomandibular joint.This case shows that early correction can achieve good therapeutic effects on this kind of patients and can avoid or reduce the possibility of orthognathic surgery for these patients in adulthood.