To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

【Objective】 To analyze the clinical characteristics of children with ammonium urate stones in Xinjiang, so as to provide reference for the prevention and treatment of this disease. 【Methods】 The clinical data of all children with ammonium urate stones admitted to the People’s Hospital of Xinjiang Uygur Autonomous Region from 2016 to 2021 were retrospectively analyzed, including age, sex, body mass index, stone site, stone size, stone component, urine pH, urine culture and biochemical examination results. The serum total protein, albumin, sodium, potassium, calcium, magnesium, uric acid and urine pH were compared between the pure and mixed groups. 【Results】 A total of 61 children (31.6%) had ammonium urate stones, their average age was (4.05±3.37) years, and the male to female ratio was 2.21∶1. Among them, there were 37 cases (60.7%) of renal calculi and 50 cases (82.0%) of upper urinary calculi. The most common component of mixed ammonium urate stones was calcium oxalate, including calcium oxalate monohydrate, calcium oxalate monohydrate and calcium oxalate dihydrate. Compared with mixed type, children with pure stone type had a younger age (P=0.001) and a smaller stone size (P=0.003). Positive urine culture was detected in 14 cases (23.0%), 7 of which (50% were infected with Escherichia coli, and 11 (78.6%) with non-urease bacteria. 【Conclusion】 Non-urease bacteria are the main pathogens of urinary tract infection in children with ammonium urate stones. The incidence is higher in boys, and the most common stone location is upper urinary tract. Calcium oxalate is the most common mixed component. Pure type is more common in young children and the stones are relatively small.

Objective To investigate the relationship between disease courses and severity and monocyte subsets distribution and surface CD31 intensity in patients of hemorrhagic fever with renal syndrome (HFRS). Methods Peripheral blood samples from 29 HFRS patients and 13 normal controls were collected. The dynamic changes of classical monocyte subsets (CD14⁺⁺CD16^-), intermediated monocyte subsets (CD14⁺⁺CD16⁺) and non-classical monocyte subsets (CD14⁺CD16⁺⁺) and the mean fluorescent intensity (MFI) of CD31 on monocyte subsets were detected by multiple-immunofluorescent staining and flow cytometry. Results In acute phase of HFRS, the ratio of classical monocyte subsets to total monocytes was dramatically decreased compared to convalescent phase and normal control. It was still much lower in convalescent phase compared to normal controls. The ratio of classical monocyte subsets to total monocytes were decreased in HFRS patients compared to that in normal control, whereas there was no difference between severe/critical groups and mild/moderate groups. On the contrary, the ratio of intermediate monocyte subsets to total monocytes in acute phase of HFRS was significantly increased compared to convalescent phase and normal control. The ratio of intermediate monocyte subsets to total monocytes were increased in HFRS patients compared to that in normal control, whereas no difference was found between severe/critical groups and mild/moderate groups. Phases or severity groups had no difference in ratio of non-classical monocyte subsets to total monocytes. Additionally, the ratio of classical monocyte subsets had a tendency to decline and that of intermediate monocyte subsets showed an increase both to total monocytes between the acute and convalescent phases in 11 HFRS patients with paired-samples. Moreover, in acute phase of HFRS, the mean fluorescent intensity (MFI) of CD31 on three monocyte subsets all decreased, specifically classical monocyte subsets showed the highest MFI of CD31 while the normal control reported the highest MFI of CD31 in non-classical monocyte subsets. In convalescent phase, the MFI of CD31 on classical and intermediated monocyte subsets were both lower than that of normal control, while MFI of CD31 was still significantly lower than normal control on non-classical monocyte subsets. Finally, MFI of CD31 on classical and intermediated monocyte subsets in severe/critical group were both lower than those in mild/moderate group, showing no statistical difference in MFI of CD31 on non-classical monocyte subset across groups of different disease severity. Conclusion The ratio of classical and intermediated monocyte subsets to total monocytes are correlated with the course of HFRS, and so are the surface intensity of CD31 on these monocyte subsets with the disease course and severity. The surface intensity of CD31 on non-classical monocyte subsets, however, is correlated only with the course of the disease. Together, the underlying mechanisms for the observed changes in monocyte subsets in HFRS patients should be further investigated.
Humans ; Monocytes ; Lipopolysaccharide Receptors ; Hemorrhagic Fever with Renal Syndrome ; Receptors, IgG ; Disease Progression

Objective:To analyze the composition and clinical characteristics of urinary calculi in infants in Xinjiang.Methods:The clinical data of 75 infants with urinary calculi admitted to the People′s Hospital of Xinjiang Uygur Autonomous Region from January 2016 to December 2021 were retrospectively analyzed, including the general situation of the children, stone-related parameters, random urine pH value, urine culture and biochemical examination results. The serum uric acid, serum calcium, urine pH value, positive rate of urine culture, and stone length between infants with and without ammonium urate stones were compared. Measurement data conforming to normal distribution were expressed as mean ± standard deviation ( ± s), and independent sample t-test was used for inter-group comparison. Measurement data that did not conform to the normal distribution were expressed as the median (interquartile distance) [ M ( Q1, Q3)], and Mann-Whitney U test was used for comparison between groups. The Chi-square test, continuity-corrected Chi-square test or Fisher exact probability method were used for the comparison of count data. Results:The median age of infants with urinary calculi was 23.04 months, and the ratio of male to female was 3.2∶1. More than half of the infants (81.3%, 61/75) came from rural areas, 57.3% (43/75) were malnourished, 33.3% (25/75) were complicated with urinary tract infection, and 8.0% (6/75) were combined with urinary system congenital malformation. The calculi were found in 53 cases (70.67%) of kidney, 27 cases (36.0%) of ureter, 17 cases (22.67%) of urethra and 16 cases (21.33%) of bladder. The analysis of calculi composition showed that there were 44 cases (58.67%) of ammonium urate, 39 cases (52.0%) of calcium oxalate, 14 cases (18.67%) of apatite carbonate and 7 cases (9.33%) of uric acid. Kidney calculi was more common in female infants ( P=0.011). Compared with the infant group ( n=19), calcium oxalate stones were more common in the preschooler group ( n=56) ( P=0.039), but there were not statistical difference in the incidence of ammonium urate, apatite carbonate and uric acid stones. There were not statistical difference in gender, age, place of residence, nutritional status, serum uric acid, serum calcium, urine pH value, positive rate of urine culture, stone maximum diameter and incidence of bladder stones between ammonium urate group and non-ammonium urate group. Conclusions:The incidence of urinary calculi in infants is higher in boys, and the most common site of calculi is the upper urinary tract, especially in female kidney calculi. Ammonium urate is the main component of urinary calculi in infants. Calcium oxalate stones are more common in preschooler group. Infants with urinary calculi are mostly rural residents, and malnutrition and urinary tract infection are more common.

Objective To investigate the value of platelet-to-lymphocyte ratio (PLR) and cell proliferation antigen Ki-67 in judging the chemotherapy efficacy and prognosis of patients with advanced non-small cell lung cancer (NSCLC). Methods The clinical data of 132 patients with advanced NSCLC diagnosed by pathology and immunohistochemistry from January 2015 to January 2016 in Shanxi Provincial Cancer Hospital were retrospectively analyzed. Peripheral venous blood cells were collected before chemotherapy, the platelet and lymphocyte counts were detected by using blood cell analyzer to calculate PLR. Immunohistochemical SP method was used to detect the expression of Ki-67 in tissue sections. The platinum-containing dual-drug regimen was used in the first-line chemotherapy for at least 4 cycles. The χ2 test was used to compare the count data, and the logistic regression model was used to analyze the factors affecting the effective rate. The Kaplan-Meier method and log-rank test were used for survival analysis, and the Cox proportional hazards regression model was used for multivariate analysis of prognosis. Results The total effective rate of the first-line chemotherapy was 41.7％ (55/132). The 1-year and 2-year overall survival (OS) rates were 26.1％ and10.4％, respectively. and the mean progression-free survival (PFS) time was 5.7 months (95％ CI 3.2-10.9 months) and the median OS time was 14.05 months (95％ CI 6.8-18.4 months). The median PLR was 172.0. The effective rate in PLR < 172.0 group was higher than that in PLR≥172.0 group [60.6％ (40/66) vs. 22.7％(15/66), χ 2 = 19.481, P < 0.05], and the median OS time in PLR < 172.0 group was longer than that in PLR≥172.0 group (17.6 months vs. 15.0 months, χ 2 = 4.976, P < 0.05), and there was no significant difference in the median PFS time between the two groups (8.6 months vs. 6.5 months, χ 2 = 0.078, P > 0.05). There was no significant difference in the effective rate between Ki-67 negative group and positive group [40.0％ (28/70) vs. 43.5％ (27/62), χ 2 = 0.170, P > 0.05]. The median PFS time and OS time in Ki-67 negative group were longer than those in positive group (7.6 months vs. 6.5 months, χ 2 = 7.170, P < 0.05; 18.3 months vs. 14.5 months,χ 2 = 15.870, P < 0.05). According to the results of multivariate analysis, PLR was an effective independent factor for effective rate (P < 0.05), Ki-67 was an independent influencing factor for PFS (P < 0.05), and PLR and Ki-67 were independent influencing factors for OS (P < 0.05). Conclusion PLR and Ki-67 can be used as meaningful indicators for predicting the chemotherapy efficacy and prognosis of advanced NSCLC.

This paper reviewed the award of the title for senior professional post from four aspects: changing process of the technical post title enforcement efficiency, characteristic and problem, in Tianjin Medical University General Hospital in recent eight years. It was indicated that the new evaluation of high ranking professional title played a rule in inspiring and leading effect on the teaching and research of the hos-pital.

ObjectiveTo observe the effect of comprehensive therapy on forearm extensor myotenositis.Methods72 cases were divided into two groups: a control group of 36 cases who were given routine treatment,and an experiment group of 36 cases who were given thermotherapy,computerized medium-frequency electrotherapy,physiotherapy,and ADL instruction,etc.After two courses,a simple grading score(for forearms) was used to assess the effect.ResultsOf the control group,22 cases were cured,10 remarkably effective,4 effective;of the experiment,30 cured,4 remarkably effective,2 effective(u=2.04, P<0.05).The difference of average score for forearms before and after the treatment were(6.58±3.17) points for the control and(8.19±3.55) for the experiment(t=2.03,P<0.05).The average days of cure were(5.60±2.54) d for the experiment group,shorter than those for the control(7.00±2.27) d(t=2.05,P<0.05).ConclusionComprehensive therapy is effective on forearm extensor myotenositis.

OBJECTIVETo study the immunotoxicity induced by 9,10-dimethyl-1,2-benzathrancene (DMBA) in metallothionein gene-knocked-out mice [MT(-/-)] as compared with that in wild-type mice [(MT(+/+)].

METHODSFemale mice were treated with 25 mg/kg and 50 mg/kg of DMBA i.p., respectively and immunized with sheep red blood cells (SRBC) i.v. on the following day and rechallenged by injection of SRBC via footpad s.c. on the fourth day post-immunization. Humoral and cell-mediated immune function was assessed by the number of spleen IgM antibody plaque formation cells (PFC) to SRBC and cell-mediated delayed-type hypersensitivity (DTH) measured by footpad swelling thickness.

RESULTSAfter treatment with 25 mg/kg DMBA, a decrease in weight of their spleen and thymus and PFC/spleen were observed in MT(-/-) mice, while only decrease in thymus weight of MT(+/+) mice. The humoral function was suppressed by 72% in MT(-/-) mice. No obvious change in cell-mediated immune function was observed both in MT(-/-) and MT(+/+) mice. Both humoral and cell-mediated immune function were suppressed more severe (91%) in MT(-/-) mice treated with 50 mg/kg DMBA than those treated with 25 mg/kg DMBA (72%). DTH was not altered by DMBA in MT(+/+) mice. The weight of their spleen and thymus decreased and humoral immune function suppressed in MT(+/+) mice, but these changes were significantly less severe. No obvious suppression of cell-mediated immune function was observed in MT(+/+) mice.

CONCLUSIONTheir humoral and cell-mediated immune function was more susceptible to being suppressed by DMBA in MT(-/-) mice, indicating that MT could protect their immune function from damage caused by DMBA.

9,10-Dimethyl-1,2-benzanthracene ; toxicity ; Animals ; Immunity ; drug effects ; Metallothionein ; physiology ; Mice ; Mice, Inbred C57BL ; Mice, Knockout ; Organ Size ; drug effects

Objective To investigate the hepatoprotective effect of Propolis alcohol-extract (PAE) against acetaminophen (APAP)-induced acute hepatic damage in mice and to explore the possible mechanism.Methods Sixty-three C57BL/6 MT(-/-)mice were equally randomized into 9 groups.The normal control group and the model group received gastric gavage of normal saline (20 mL?kg-1),four PAE groups were given PAE in the dose of 12.5,25,50 and 100 mg?kg-1 respectively,alcohol +APAP group and alcohol control group received 20 %alcohol 20 mL?kg-1 and PAE control group was given PAE in the dose of 100 mg?kg-1 qd,for 4 consective days.Thirty miniutes after last administration,the mice in the normal control group,PAE control group and alcohol control group received saline 10 mL?kg-1,and the mice in other groups received APAP 380 mg?kg-1 to induce acute hepatic injury.The activities of serum alanine aminotransferase (ALT),aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) were determined,and the liver tissues were collected for histopathological assessment by HE staining under light microscope.The ratio of glutathione (GSH) and oxidized glutathione (GSSG),and the content of GSH,GSSG and malondialdehyde (MDA) in liver homogenate were also measured.Results Compared with the model group,PAE could markedly decrease serum ALT,AST and LDH activity,reduce the MDA level in liver homogenate,and increase hepatic GSH content and the ratio of GSH/GSSG in the liver homogenate.The hepatic histopathological changes in liver were also significantly ameliorated.In PAE control group,GSH content and the ratio of GSH/GSSG were also increased.However,the above indexes remained unchanged in alcohol control group.Conclusion The propolis alcohol-extract can prevent the liver from PAP-induced acute hepatic injury.