Objective To determine the related substances in ornidazole active pharmaceutical ingredient(API)and injections using high performance liquid chromatography(HPLC)and to study the impurity profile of ornidazole using liquid chromatography-tandem mass spectrometry(LC-MS/MS)combined with forced degradation tests,aiming to clarify the sources of impurities and their correlation with the prescription and production process and providing technical support for the unified evaluation and quality control of this product.Methods A Phenomenex Luna C18column(4.6 mm×250 mm,5 μm)was used for the separation of ornidazole and its impurities,with 0.000 5%formic acid as mobile phase A and methanol as mobile phase B under gradient elution.The impurity content of 4 batches of APIs,3 batches of reference preparations,and 11 batches of domestic generic preparations were determined.The structure of unknown impurities was predicted using Jet Stream Ion Focusing Electrospray Ionization-Time of Flight Mass Spectrometry(AJS-TOF-MS/MS),and the sources of impurities were identified combined with forced degradation experiments,the prescription and the production process of various manufacturers.Results Ornidazole and its known impurities were well separated under the chromatographic conditions.The structures of five unknown impurities were inferred,and the sources of the impurities were identified.Conclusion This study provides a reference for impurity analysis,quality control,and overall evaluation of ornidazole API and injection.

ObjectiveTo analyze the epidemiological characteristics of clustered vomiting and diarrhea outbreaks in Minhang District of Shanghai, to identify the influencing factors of outbreak scale and duration of epidemic, and to provide scientific evidence for further strengthening surveillance early-warning efforts in key settings and for optimizing prevention and control measures. MethodsThe data for describing epidemiological characteristics of clustered vomitting and diarrhea outbreaks in Minhang District from 2018 to 2023 were collected, multivariable logistic regression models were applied to analyze the influencing factors for epidemic scale,and Spearman rank correlation analyses were applied to analyze the factors duration. ResultsA total of 136 clustered vomiting and diarrhea outbreaks were reported in Minhang District from 2018 to 2023, all occurring in school settings, with an overall attack rate of 0.90%. The outbreaks exhibited distinct seasonality, predominantly occurring from October to December (43.38%) and March to May (32.35%). The primary settings were preschools (45.59%) and elementary schools (44.12%), with students accounted for the majority of cases (99.48%). The predominant clinical manifestation was vomiting (90.44%), with person-to-person contact being the primary transmission route (98.53%). Norovirus genogroup Ⅱ was identified as the main pathogen (71.32%). Standardized terminal disinfection of outbreak sites (OR=0.39, 95%CI=0.20‒0.74) and effective isolation of affected classes (OR=0.23, 95%CI=0.09‒0.57) were significant protective factors for reducing outbreak scale. Both response time (r=0.64, P<0.001) and the number of case generations (r=0.71, P<0.001) showed positive correlations with outbreak duration. ConclusionSchools are the key settings for the prevention and control of clustered vomiting and diarrhea outbreaks in Minhang District, with peak occurring in autumn and spring. Early detection, timely reporting, and prompt response to outbreaks are crucial. Strengthening school-based surveillance systems and standardizing outbreak management protocols are of particular importance.

The medicinal use of Malvae Semen has a long history. In this paper， by consulting the ancient materia medica， prescription， agronomy， literature and other aspects of the classics， the name， origin， evolution of scientific name， quality， harvesting and processing， functions and indications and others of Malvae Semen were systematically sorted out and verified， so as to provide a basis for the development and utilization of famous classical formulas containing this herb. According to the textual research， Shennong Bencaojing began to use Dongkuizi as the correct name， which was used in the past dynasties， and there were also aliases such as Kuicaizi， Huacai， and Kuizi. Through the original research， it can be seen that Kuicai is the mainstream original plant of Malvae Semen， that is， Malva verticillata var. crispa， the Alcea rosea and M. cathayensis are also used. In modern times， the seeds of Abutilon theophrasti have been passed off as Malvae Semen， while the seeds of M. verticillata var. crispa have rarely been used in medicine. And Abutili Semen has been another medicinal material with different efficacy since the collection of Newly Revised Materia Medica in the Tang dynasty. Since the Ming and Qing dynasties， the cultivation of Kuicai has been decreasing， while A. theophrasti is more common and easy to obtain， and Abutili Semen and Malvae Semen are similar in morphology and confused， which should be corrected. In addition， Malvae Fructus is a Mongolian customary medicinal herb， which is different from the traditional use of seeds in traditional Chinese medicine. Kuicai， as an important vegetable in history， was widely cultivated and gradually shrunk after the Song dynasty， it is now mainly produced in southern provinces. The quality evaluation of Malvae Semen is better for those with dry bodies， full grain， grayish brown color， no mud， and no impurities. The harvesting is generally in the autumn and winter. After drying， it is seeded， sieved peel and impurities， mashed， or slightly stir-fried to yellow-white color with gentle fire. It is sweet， cold and slippery in nature and taste， with the main effects of laxation， diuresis， lactation and elimination of swelling. The efficacy of Abutili Semen is clearing heat and removing toxicity， promoting diuresis and removing nebula， the efficacy is quite different from that of Malvae Semen. Based on the results of textual research， it is suggested that M. verticillata var. crispa should be used as the medicinal source of Malvae Semen in the development of famous classical formulas， the corresponding processing methods should be selected according to the requirements of drug processing in the formulas， while the raw products are recommended to be used if the processing is not specified.

The medicinal use of Malvae Semen has a long history. In this paper， by consulting the ancient materia medica， prescription， agronomy， literature and other aspects of the classics， the name， origin， evolution of scientific name， quality， harvesting and processing， functions and indications and others of Malvae Semen were systematically sorted out and verified， so as to provide a basis for the development and utilization of famous classical formulas containing this herb. According to the textual research， Shennong Bencaojing began to use Dongkuizi as the correct name， which was used in the past dynasties， and there were also aliases such as Kuicaizi， Huacai， and Kuizi. Through the original research， it can be seen that Kuicai is the mainstream original plant of Malvae Semen， that is， Malva verticillata var. crispa， the Alcea rosea and M. cathayensis are also used. In modern times， the seeds of Abutilon theophrasti have been passed off as Malvae Semen， while the seeds of M. verticillata var. crispa have rarely been used in medicine. And Abutili Semen has been another medicinal material with different efficacy since the collection of Newly Revised Materia Medica in the Tang dynasty. Since the Ming and Qing dynasties， the cultivation of Kuicai has been decreasing， while A. theophrasti is more common and easy to obtain， and Abutili Semen and Malvae Semen are similar in morphology and confused， which should be corrected. In addition， Malvae Fructus is a Mongolian customary medicinal herb， which is different from the traditional use of seeds in traditional Chinese medicine. Kuicai， as an important vegetable in history， was widely cultivated and gradually shrunk after the Song dynasty， it is now mainly produced in southern provinces. The quality evaluation of Malvae Semen is better for those with dry bodies， full grain， grayish brown color， no mud， and no impurities. The harvesting is generally in the autumn and winter. After drying， it is seeded， sieved peel and impurities， mashed， or slightly stir-fried to yellow-white color with gentle fire. It is sweet， cold and slippery in nature and taste， with the main effects of laxation， diuresis， lactation and elimination of swelling. The efficacy of Abutili Semen is clearing heat and removing toxicity， promoting diuresis and removing nebula， the efficacy is quite different from that of Malvae Semen. Based on the results of textual research， it is suggested that M. verticillata var. crispa should be used as the medicinal source of Malvae Semen in the development of famous classical formulas， the corresponding processing methods should be selected according to the requirements of drug processing in the formulas， while the raw products are recommended to be used if the processing is not specified.

Objective:To compare and analyze the efficacy of bilateral and unilateral posterior vocal cord resection with CO 2 laser under endoscopy in the treatment of bilateral vocal cord paralysis. Methods:This case series study retrospectively analyzed the data of 110 patients with bilateral vocal cord paralysis who underwent endoscopic CO 2 laser posterior cordotomy at the Department of Otolaryngology-Head and Neck Surgery, the First Affiliated Hospital of Naval Medical University, from October 2016 to January 2023. The cohort consisted of 36 males [mean age (45.5±9.1) years, range 24-72 years] and 74 females [mean age (47.2±10.1) years, range 22-67 years]. Among them, 47 patients underwent simultaneous bilateral posterior cordotomy (bilateral cordotomy group), while 63 patients underwent unilateral posterior cordotomy (unilateral cordotomy group). Pre-and postoperative indicators, including swallowing function, glottal size, and vocal function (subjective and objective assessments), were compared between the two surgical approaches. The Wilcoxon signed-rank test was used to analyze changes in swallowing function, glottal size, and vocal function (subjective and objective assessments) within each group before and after surgery, whereas the Mann-Whitney U test was utilized to assess differences between groups. Results:Postoperative follow-up was 1-5 years [median follow-up time was 1.6 (1.3, 2.0) years].The one-time extubation rate was 71.4%(45/63)in the unilateral posterior vocal cord resection group and 87.2%(41/47)in the bilateral posterior vocal cord resection group, significantly higher in the bilateral group ( χ2=3.94, P<0.05). One week after surgery, the swallowing function score of unilateral cordotomy group was 2 (1, 2.5) points, which was significantly better than that of bilateral cordotomy group [2 (1.5, 3) points, Z=-2.118, P<0.05], and the swallowing function score of both groups returned to normal 3 months after surgery. There were no significant differences in preoperative glottic closure during inhalation, auditory perceptual evaluation (GRBAS), objective voice analysis, and Voice Handicap Index-10 (VHI-10) between the two groups ( P>0.05). Postoperatively, the maximum transverse diameter of the posterior glottis during inspiration in the unilateral cordotomy group was 4.49 (4.24, 4.77) mm, significantly smaller than that in the bilateral cordotomy group, which was 5.05 (4.52, 5.62) mm ( Z=-4.103, P<0.05). Among the GRBAS parameters, G (grade of hoarseness), B (breathiness), and A (asthenia), as well as VHI-10 scores and objective voice analysis parameters [jitter, shimmer, harmonic-noise ratio (HNR), and maximum phonation time (MPT)], were significantly better in the unilateral cordotomy group compared to the bilateral cordotomy group, with statistically significant differences ( P<0.05). Conclusions:Unilateral posterior vocal cord resection using CO 2 laser is simple and feasible for the treatment of bilateral vocal cord paralysis, with shorter recovery time, maximal preservation of laryngeal phonatory function, and fewer complications compared to bilateral resection. However, the one-time extubation rate is higher with bilateral resection, reducing the need for a second surgery and associated patient discomfort. This study offers guidance for clinical decision-making in the surgical management of bilateral vocal cord paralysis.

Objective To determine the related substances in ornidazole active pharmaceutical ingredient(API)and injections using high performance liquid chromatography(HPLC)and to study the impurity profile of ornidazole using liquid chromatography-tandem mass spectrometry(LC-MS/MS)combined with forced degradation tests,aiming to clarify the sources of impurities and their correlation with the prescription and production process and providing technical support for the unified evaluation and quality control of this product.Methods A Phenomenex Luna C18column(4.6 mm×250 mm,5 μm)was used for the separation of ornidazole and its impurities,with 0.000 5%formic acid as mobile phase A and methanol as mobile phase B under gradient elution.The impurity content of 4 batches of APIs,3 batches of reference preparations,and 11 batches of domestic generic preparations were determined.The structure of unknown impurities was predicted using Jet Stream Ion Focusing Electrospray Ionization-Time of Flight Mass Spectrometry(AJS-TOF-MS/MS),and the sources of impurities were identified combined with forced degradation experiments,the prescription and the production process of various manufacturers.Results Ornidazole and its known impurities were well separated under the chromatographic conditions.The structures of five unknown impurities were inferred,and the sources of the impurities were identified.Conclusion This study provides a reference for impurity analysis,quality control,and overall evaluation of ornidazole API and injection.

Objective:To compare and analyze the efficacy of bilateral and unilateral posterior vocal cord resection with CO 2 laser under endoscopy in the treatment of bilateral vocal cord paralysis. Methods:This case series study retrospectively analyzed the data of 110 patients with bilateral vocal cord paralysis who underwent endoscopic CO 2 laser posterior cordotomy at the Department of Otolaryngology-Head and Neck Surgery, the First Affiliated Hospital of Naval Medical University, from October 2016 to January 2023. The cohort consisted of 36 males [mean age (45.5±9.1) years, range 24-72 years] and 74 females [mean age (47.2±10.1) years, range 22-67 years]. Among them, 47 patients underwent simultaneous bilateral posterior cordotomy (bilateral cordotomy group), while 63 patients underwent unilateral posterior cordotomy (unilateral cordotomy group). Pre-and postoperative indicators, including swallowing function, glottal size, and vocal function (subjective and objective assessments), were compared between the two surgical approaches. The Wilcoxon signed-rank test was used to analyze changes in swallowing function, glottal size, and vocal function (subjective and objective assessments) within each group before and after surgery, whereas the Mann-Whitney U test was utilized to assess differences between groups. Results:Postoperative follow-up was 1-5 years [median follow-up time was 1.6 (1.3, 2.0) years].The one-time extubation rate was 71.4%(45/63)in the unilateral posterior vocal cord resection group and 87.2%(41/47)in the bilateral posterior vocal cord resection group, significantly higher in the bilateral group ( χ2=3.94, P<0.05). One week after surgery, the swallowing function score of unilateral cordotomy group was 2 (1, 2.5) points, which was significantly better than that of bilateral cordotomy group [2 (1.5, 3) points, Z=-2.118, P<0.05], and the swallowing function score of both groups returned to normal 3 months after surgery. There were no significant differences in preoperative glottic closure during inhalation, auditory perceptual evaluation (GRBAS), objective voice analysis, and Voice Handicap Index-10 (VHI-10) between the two groups ( P>0.05). Postoperatively, the maximum transverse diameter of the posterior glottis during inspiration in the unilateral cordotomy group was 4.49 (4.24, 4.77) mm, significantly smaller than that in the bilateral cordotomy group, which was 5.05 (4.52, 5.62) mm ( Z=-4.103, P<0.05). Among the GRBAS parameters, G (grade of hoarseness), B (breathiness), and A (asthenia), as well as VHI-10 scores and objective voice analysis parameters [jitter, shimmer, harmonic-noise ratio (HNR), and maximum phonation time (MPT)], were significantly better in the unilateral cordotomy group compared to the bilateral cordotomy group, with statistically significant differences ( P<0.05). Conclusions:Unilateral posterior vocal cord resection using CO 2 laser is simple and feasible for the treatment of bilateral vocal cord paralysis, with shorter recovery time, maximal preservation of laryngeal phonatory function, and fewer complications compared to bilateral resection. However, the one-time extubation rate is higher with bilateral resection, reducing the need for a second surgery and associated patient discomfort. This study offers guidance for clinical decision-making in the surgical management of bilateral vocal cord paralysis.

Abstract: This study aims to find out the causes for the dissolution of unqualified samples found during evaluation sampling of lansoprazole enteric-coated preparations by the laser infrared imaging system and orbitrap high resolution mass spectrometry, with suggestions for improvement. Lansoprazole enteric-coated preparations were tested by current standard, the dissolution of a batch of samples was below the limit and other items were in line with the standard. Considering that this product is unstable to acid and alkali, the following exploratory experiments were designed from different dimensions, based on the conclusion of the unannounced inspection of the company, to explore the reasons for the unqualified batch, including the influence of high-temperature and high-humidity storage environment on the key quality properties of the sample, the influence of 2-hour acid resistance test on dissolution result, the imaging of the core and the measure of coating layer thickness, the optimization of chromatographic conditions of related substances, and the analysis of the source of impurities. It was found that improper storage in circulation and poor coating process caused the low dissolution of this batch: the high-temperature and high-humidity storage environment possible in the circulation process led to the decreasing efficacy of disintegrating agent in the samples and thus the difficulty to release the active pharmaceutical ingredient fully; the coating solution could not be uniformly sprayed on the core, resulting in thin isolation layer and different thickness, which then affected the protection of the main drug against acid degradation. The above two reasons together resulted in unqualified dissolution of this batch. The overall quality of lansoprazole enteric-soluble preparation is good, but the formulation and process in some companies need to be optimized; and the temperature and humidity in the circulation process need to be controlled in strict accordance with the regulations.

Objective: To ensure the quality of Perilla frutescens (L.) Britt. and improve the associated benefits for stakeholders, this study analyzed the influences of different circulation channels and stakeholders on the quality, price, and other factors of P. frutescens with consideration to P. frutescens distribution. Method: We interviewed the local stakeholders and e-commerce platforms in Oroqen Autonomous Banner and Morin Dawa Daur Autonomous Banner regarding the origin, circulation, distribution, and prices of different medicinal parts of P. frutescens. In addition, the maximum entropy model was used to predict the potential distribution of P. frutescens in the study area. According to the Chinese Pharmacopeia (2020 edition), we measured the content of index components in the collected Perillae Folium, Perillae Caulis, and Perillae Fructus samples and evaluated the quality of the samples by quantitative and cluster analyses. Remote sensing was employed to distinguish and calculate the P. frutescens area in highly suitable regions. The autoregressive integrated moving average model was adopted to analyze the Perillae Fructus price in the study area. Result: The results showed 8 value chains for P. frutescens. The cooperation chain between farmers and enterprises in the study area could maximize the benefits for all stakeholders and guarantee the quality of the medicinal materials. The results of the regionalization analysis showed that themost suitable area for planting P. frutescens was the junction between Oroqen Autonomous Banner and Morin Dawa Daur Autonomous Banner. Chemical results showed that Perillae Fructus and Perillae Caulis samples were unqualified andmostly purchased from e-commerce platforms. We identified 5 land types, among which the cultivated land area was 3247.7501 km . The price of Perillae Fructus in the study area showed a rising trend, although this trend slowed down. Conclusion: This study involved various links in the production and circulation of medicinal materials from planting to consumption by consumers, which can help to facilitate the future research on any link. The findings help to guarantee the quality of medicinal materials and benefits of all stakeholders and promote the development of the P. frutescens industry in the study area.

Objective:To summarize the experience of assisted pregnancy through preimplantation genetic testing for monogenic diseases (PGT-M) in a Norrie disease family where the female has undifferentiated connective tissue disease and thrombosis.Methods:This article mainly reported the clinical process for a patient with a heterozygous deletion in exon 2 of the NDP gene combined with undifferentiated connective tissue disease and thrombosis, which was conducted through a multidisciplinary diagnostic and therapeutic process involving reproductive genetics, reproductive medicine, ophthalmology, rheumatology, and obstetrics. The stages of treatment included family pedigree construction, controlled ovarian hyperstimulation, embryo testing, frozen-thawed embryo transfer, amniocentesis, as well as antenatal and perinatal monitoring. Results:The patient successfully conceived and gave birth to a healthy baby girl at full term.Conclusion:Through multidisciplinary management, we successfully helped the couple achieve a healthy offspring with one PGT-M cycle, thus relieved their psychological and physiological burden.