1.Conversion to thoracotomy during minimally invasive esophagectomy: Retrospective analysis in a single center
Huilai LV ; Shi XU ; Mingbo WANG ; Zhenhua LI ; Zhao LIU ; Jiachen LI ; Chao HUANG ; Fan ZHANG ; Chunyue GAI ; Ziqiang TIAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(06):879-883
Objective To explore the causes of conversion to thoracotomy in patients with minimally invasive esophagectomy (MIE) in a surgical team, and to obtain a deeper understanding of the timing of conversion in MIE. Methods The clinical data of patients who underwent MIE between September 9, 2011 and February 12, 2022 by a single surgical team in the Department of Thoracic Surgery of the Fourth Hospital of Hebei Medical University were retrospectively analyzed. The main influencing factors and perioperative mortality of patients who converted to thoracotomy in this group were analyzed. Results In the cohort of 791 consecutive patients with MIE, there were 520 males and 271 females, including 29 patients of multiple esophageal cancer, 156 patients of upper thoracic cancer, 524 patients of middle thoracic cancer, and 82 patients of lower thoracic cancer. And 46 patients were converted to thoracotomy for different causes. The main causes for thoracotomy were advanced stage tumor (26 patients), anesthesia-related factors (5 patients), extensive thoracic adhesions (6 patients), and accidental injury of important structures (8 patients). There was a statistical difference in the distribution of tumor locations between patients who converted to thoracotomy and the MIE patients (P<0.05). The proportion of multiple and upper thoracic cancer in patients who converted to thoracotomy was higher than that in the MIE patients, while the proportion of lower thoracic cancer was lower than that in the MIE patients. The perioperative mortality of the thoracotomy patients was not significantly different from that of the MIE patients (P=1.000). Conclusion In MIE, advanced-stage tumor, anesthesia-related factors,extensive thoracic adhesions, and accidental injury of important structures are the main causes of conversion to thoracotomy. The rate varies at different tumor locations. Intraoperative conversion to thoracotomy does not affect the perioperative mortality of MIE.
2.A Multicenter Clinical Trial of Pudilan Anti-inflammatory Oral Liquid of Different Doses in Treatment of Acute Pharyngitis/Tonsillitis Caused by Bacterial Infection in Adults
Dinglei LI ; Yinghai CUI ; Xuefeng YU ; Min PANG ; Wei ZHANG ; Zhanping MA ; Nianzhi ZHANG ; Tao HUANG ; Mingbo LIAO ; Yiqing QU ; Zhuying LI ; Xiu GU ; Liqi NI
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(19):136-144
ObjectiveThrough a randomized, double-blind, double-simulation, positive-control, multicenter design, this study aimed to analyze the relationship between the dosage, efficacy, and safety of Pudilan anti-inflammatory oral liquid in treating acute pharyngitis/tonsillitis in adults caused by bacterial infection and validate the regulatory effect of Pudilan anti-inflammatory oral liquid on inflammatory markers such as serum amyloid A (SAA), C-reactive protein (CRP), white blood cells (WBC), neutrophil percentage (NE%), and erythrocyte sedimentation rate (ESR), thereby exploring the feasibility of using Pudilan anti-inflammatory oral liquid as a substitute for antibiotics in the treatment of infectious diseases and providing a basis for rational clinical medication. MethodUsing a stratified randomized, double-blind, double-simulation, positive-control, multicenter design, 220 participants were enrolled from nine centers. The participants were randomly divided into three groups at 1∶1∶1 — a Pudilan anti-inflammatory oral liquid 20 mL group (73 cases), a Pudilan anti-inflammatory oral liquid 10 mL group (73 cases), and a control group (amoxicillin group, 74 cases). The treatment course was 7 days. The study observed parameters including the total effective rate of sore throat, onset and disappearance time of sore throat, health status score, treatment time, and inflammation markers. Result①Dataset division: The 211 cases were included in the full analysis dataset (FAS), 208 cases were included in the per-protocol dataset (PPS), and 218 cases were included in the safety dataset (SS). ② Efficacy evaluation: There were statistically significant differences (P<0.05) in the comparison of the three groups regarding the total effective rate of sore throat, disappearance time of sore throat, and health status. Both the 20 mL and 10 mL groups were non-inferior to the control group, and there was a statistically significant difference between the 20 mL and 10 mL dosage groups (P<0.05). There was no statistically significant difference in the comparison of onset time of sore throat among the groups. CRP, WBC, and NE% of patients in all three groups significantly decreased on the 7th day of treatment compared with those before treatment (P<0.01). ③Safety evaluation: Adverse events mainly occurred in various examination indicators. There were no statistically significant differences in the comparison between groups, and no adverse reactions or serious adverse events occurred. ④Economic evaluation: The increased cost of the 10 mL and 20 mL dosage groups was entirely justified as compared with that in the control group. When comparing the 10 mL and 20 mL dosage groups, the 10 mL dosage group was deemed less advantageous. ConclusionPudilan anti-inflammatory oral liquid can be used alone as an alternative to antibiotics in the treatment of acute pharyngitis/tonsillitis caused by bacterial infection. It demonstrates good safety and can lower inflammation markers such as CRP, WBC, and NE%, suggesting its potential to reduce the body's inflammatory response. Its mechanism of action may be related to its multi-target regulatory mechanism.
3.Analgesic effect and safety of using an epidural analgesia pump versus an intravenous analgesia pump for uterine artery embolization in the treatment of uterine fibroids
Shuibing CHEN ; Mingbo SUN ; Huang HUANG ; Hongxiang YAO ; Shixiang JIN
Chinese Journal of Primary Medicine and Pharmacy 2023;30(3):388-392
Objective:To investigate the analgesic effect and safety of using an epidural analgesia pump versus an intravenous analgesia pump for uterine artery embolization in the treatment of uterine fibroids. Methods:Fifty patients with uterine fibroids undergoing uterine artery embolization admitted to The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University from January 2019 to December 2021 were included in this study. They were divided into an observation group and a control group ( n = 25/group). Patients in the observation group used an epidural analgesia pump for pain relief, while patients in the control group used an intravenous analgesia pump for pain relief. At 1, 6, 12, and 24 hours after surgery, pain severity was compared between the two groups using the Visual Analogue Scale. Comfort level was compared between the two groups using the Bruggemann Comfort scale. Before and after surgery, respiratory rate, heart rate, blood pressure, and adverse reactions were compared between the two groups. Results:At 1 hour after surgery, the Visual Analogue Scale score in the observation group was significantly lower than that in the control group [3.00 (2.00, 5.50) vs. 7.00 (6.00, 8.00), Z = -3.84, P < 0.05]. At 6, 12, and 24 hours after surgery, there was a significant difference in the Visual Analogue Scale score between the two groups (all P > 0.05). Within 24 hours after surgery, the use of opioid analgesics in the observation group was less than that in the control group [16.00% (4/25) vs. 88.00% (22/25), χ2 = 25.96, P < 0.001]. At 1 hour after surgery, the Bruggemann Comfort Scale score in the observation group was significantly higher than that in the control group [0.00 (0.00, 0.50) vs. 0.00 (0.00, 0.00), Z = 2.08, P < 0.05]. At 6, 12, and 24 hours after surgery, there was no significant difference in the Bruggemann Comfort Scale score between the two groups (all P > 0.05). After surgery, heart rate was significantly decreased in each group compared with before surgery (both P < 0.05). There were no significant differences in respiratory rate and mean arterial pressure between the two groups before and after surgery (both P > 0.05). There were no significant differences in the incidences of postoperative nausea, vomiting, and fever between the two groups (all P > 0.05). Conclusion:The epidural analgesia pump used for uterine artery embolization in the treatment of uterine fibroids has a better analgesic effect and provides more comfort and is safer than the intravenous analgesia pump. The former is worthy of clinical promotion.
4.Clinicopathological characteristics and prognostic factors analysis of patients with esopha-geal cancer
Huilai LYU ; Yanzhao XU ; Zhenhua LI ; Chao HUANG ; Mingbo WANG ; Peng SU ; Zhao LIU ; Ziqiang TIAN
Chinese Journal of Digestive Surgery 2022;21(10):1363-1369
Objective:To investigate the clinicopathological characteristics and prognostic factors of patients with esophageal cancer.Methods:The retrospective case-control study was conducted. The clinicopathological data of 447 patients with esophageal cancer who were admitted to the Fourth Hospital of Hebei Medical University from January 1, 2017 to December 31, 2020 were collected. There were 312 males and 135 females, aged 60(range, 37?82)years. Observation indica-tors: (1) clinicopathological characteristics; (2) treatment; (3) follow-up; (4) analysis of prognostic factors for esophageal cancer. Follow-up using telephone interview or outpatient examination was conducted to detect survival of patients up to December 2021. The total survival time was from the surgery date to death or the last follow-up. Patients with duration of follow-up more than 2 years were included for survival and prognostic analysis. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M(range). Count data were represented as absolute numbers. Kaplan-Meier method was used to draw survival curves and calculate survival rates. Log-Rank test was used for survival analysis. Univariate analysis was conducted using the Log-rank test. Multivariate analysis was conducted using the COX hazard regression model. Results:(1) Clinicopathological characteristics. Of the 447 patients, 69.80%(312/447) were males and 30.20%(135/447) were females, and there were 3, 18, 101, 229, 93, 3 cases aged 30?39 years, 40?49 years, 50?59 years, 60?69 years, 70?79 years, 80?89 years, respectively. About the pathological type, there were 424 cases with squamous carcinoma, 11 cases with small cell carcinoma, 4 cases with adenosquamous carcinoma, 3 cases with sarco-matoid carcinoma, 2 cases with adenocarcinoma, 1 case with neuroendocrine carcinoma, 1 case with undifferentiated carcinoma, and 1 case with adenoid cystic carcinoma. There were 2 cases with tumor located at cervicothoracic segment, 49 cases with tumor located at upper thoracic segment, 273 cases with tumor located at mid-thoracic segment, and 123 cases with tumor located at lower thoracic segment. There were 6, 24, 74, 59, 192, 80, 12 cases in stage pT0, pT1a, pT1b, pT2, pT3, pT4a, pT4b of pathological T staging, respectively. There were 207, 63, 142, 28, 7 cases in stage pN0, pN1, pN2, pN3, pN4 of pathological N staging by Japan Esophagus Society (JES), respectively. There were 207, 128, 76, 36 cases in stage pN0, pN1, pN2, pN3 of pathological N staging by Union for International Cancer Control (UICC), respectively. About TNM staging, there were 25, 53, 127, 174, 68 cases in stage 0, Ⅰ, Ⅱ, Ⅲ, Ⅳa of JES staging, and 16, 9, 53, 35, 108, 96, 45, 85 cases in stage 0, Ⅰa, Ⅰb,Ⅱa, Ⅱb, Ⅲa, Ⅲb, Ⅲc of UICC staging, respectively. (2) Treatment. Of the 447 patients, 63 cases underwent neoadjuvant therapy(12 cases combined with immunotherapy), 384 cases underwent no neoadjuvant therapy. There were 347, 97, 2, 1 cases with surgical approach as right thoracic approach, left thoracotomy approach, cervical abdominal approach, left thoracoabdominal approach, respectively. There were 316, 5, 126 cases with surgical platform as totally endoscopic esophagec-tomy, Hybrid surgery, open surgery, respectively. There were 350 and 97 cases with digestive recons-truction as posterior mediastinal approach and intrathoracic approach, respectively. Surgical margin as R 0, R 1, R 2 resection was detected in 323, 116, 8 cases, respectively. Six of 447 patients died during the hospital stay. (3) Follow-up. All the 447 patients were followed up for 25(range, 2?48)months, including 233 cases with the follow-up more than 2 years. The median survival time of 233 patients was unreached, and the postoperative 2-year survival rate was 76.8%. (4) Analysis of prognostic factors for esophageal cancer. Results of univariate analysis showed that gender, neoadjuvant therapy, surgical margin, pT staging, pN staging by JES, pN staging by UICC, TNM staging by JES, TNM staging by UICC were related factors influencing prognosis of 233 patients with esophageal cancer ( χ2=6.62, 17.81, 32.95, 37.93, 27.06, 35.56, 45.24, 37.84, P<0.05). Results of multivariate analysis showed that gender, surgical margin, TNM staging by JES were independent factors influencing prognosis of 233 patients with esophageal cancer ( hazard ratio=0.48, 1.94, 1.46, 95% confidence intervals as 0.25?0.91, 1.07?3.52, 1.16?1.84, P<0.05). Conclusions:The incidence of esophageal cancer is relatively high in males, with the onset age mainly distribute in 60?69 years and the mainly pathological type as squamous carcinoma. Patients with esophageal cancer have advanced tumor staging, low proportion of neoadjuvant therapy, high R 0 resection rate of surgical treatment. Gender, surgical margin, TNM staging by JES are independent factors influencing prognosis of patients with esophageal cancer.
5.Characteristics of skin microbiota in an atopic dermatitis-like mouse model induced by 2,4-dinitrochlorobenzene
Yuehua MEN ; Huipu HAN ; ·Alifu AKADE ; Yifan YAO ; Tingting HUANG ; Jiarui KANG ; Tieshan WANG ; Mingbo ZHANG ; Yanjiao JU ; Ming CHU ; Yuedan WANG
Chinese Journal of Dermatology 2021;54(7):605-611
Objective:To investigate characteristics and changes of skin microbiota in atopic dermatitis-like mouse models induced by different concentrations of 2,4-dinitrochlorobenzene (DNCB) .Methods:Totally, 30 male specific-pathogen-free BALB/c mice were randomly divided into 3 groups by using a random number table: negative control group topically treated with 200 μl of mixture of acetone and olive oil at a volume ratio of 3∶1 on the back twice a week for 6 consecutive weeks; high-and low-concentration DNCB groups both topically treated with 200 μl of 1% DNCB on the first and third day at the first week, followed by topical application of 200 μl of 0.5% and 0.1% DNCB, respectively, twice a week for 5 weeks from the second week. Twenty-four hours after the last treatment, the severity of skin lesions was evaluated, and the transepidermal water loss and stratum corneum hydration were measured. After the experiment, the mice were sacrificed, and skin tissues were resected from the back of the mice for histopathological examination. Full-thickness skin tissue samples were obtained from the back of 3 mice in each group. Illumina Miseq PE300 high-throughput sequencing was performed to sequence the V3-V4 variable region of 16S rRNA gene of skin microbiota on the back of the mice, and the composition and structure of the skin microbiota and changes in the relative abundance of different genera were analyzed. One-way analysis of variance was used to analyze differences in indices among the 3 groups, and the Games-Howell method was used for multiple comparisons.Results:The severity scores of skin lesions were significantly higher in the high-and low-concentration DNCB groups (9.83 ± 2.45 points, 2.71 ± 0.56 points, respectively) than in the negative control group (0.51 ± 0.12 points, t=-7.19,-2.85, respectively, both P < 0.05) . Compared with the negative control group, the high-and low-concentration DNCB groups showed significantly increased transepidermal water loss ( t=-7.72,-2.68, respectively, both P < 0.05) , but significantly decreased stratum corneum hydration ( t=6.77, 5.99, respectively, both P < 0.05) ; the transepidermal water loss was significantly higher in the high-concentration DNCB group than in the low-concentration DNCB group ( t=2.76, P < 0.05) , while no significant difference in the stratum corneum hydration was observed between the high-and low-concentration DNCB groups ( P > 0.05) . There was a significant difference in the relative abundance of Corynebacterium among the 3 groups ( F=249.85, P < 0.001) , which was highest in the high-concentration DNCB group. No significant differences in the observed species and Chao1 index of the skin samples were observed among the 3 groups (both P > 0.05) , and the Shannon index was significantly lower in the high-concentration DNCB group than in the low-concentration DNCB group and negative control group ( t=6.96,-6.37, respectively, both P < 0.05) . Conclusion:DNCB could induce atopic dermatitis-like dermatitis in mice, and the severity of skin lesions and degree of barrier function impairment were related to the concentration of DNCB; the species diversity of skin microbiota markedly decreased in the high-concentration DNCB group, indicating that high-concentration DNCB modeling has more advantages in studying microbiological changes associated with atopic dermatitis.
6. The replantation of penetrating severed finger with disconnected micro tissue blocks in 16 cases
Jun SONG ; Mingbo GUO ; Jingliang ZHANG ; Zhiyong REN ; Zengyun LIU ; Zhongming HUANG ; Qiaohong GUO
Chinese Journal of Microsurgery 2019;42(6):533-535
Objective:
To explore the method of replanting severed piercing finger micro tissue blocks.
Methods:
From February, 2001 to October, 2016, 16 cases of severed piercing finger micro tissue blocks were replanted with debridement. The trunk or branch of proper palmar digital artery was anastomosed. Vascular collocations were used such as venous arterialization when there was no anastomotic artery available. Regular postoperative followed-up was performed to observe the recovery of tissue survival, appearance, sensation of flap, and joint function.
Results:
One case had partial epidermal necrosis, and healed after change of dressing. The finger-disconnected micro tissue blocks of other 15 cases survived well. After 6 months to 2 years of follow-up, the replanted micro tissue blocks were ruddy in color and recovered from S3 to S4. The appearance of the 16 fingers was good, and the function of joints was restored.
Conclusion
The finger-disconnected micro tissue blocks should be actively replanted. With skilled microsurgical techniques, the anastomosis of the arterial or venous artery will ensure the success of replantation and survived, as well as to restore good function and appearance.
7. Clinical study of postoperative adjuvant radiotherapy and postoperative concurrent chemoradiotherapy for locally advanced hypopharyngeal squamous cell carcinoma
Kun LIU ; Xinxin ZHANG ; Mingbo LIU ; Jialing WANG ; Wenming WU ; Deliang HUANG ; Jiandong ZHAO ; Lin MA
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2019;54(9):662-669
Objective:
Using propensity score matching method (PSM) to investigate the clinical effect of postoperative adjuvant radiotherapy and postoperative concurrent chemoradiotherapy for locally advanced hypopharyngeal squamous cell carcinoma.
Methods:
From July 2007 to July 2018,174 postoperative patients with locally advanced hypopharyngeal squamous cell carcinoma were enrolled in pre-PSM cohort, including 168 males and 6 females, the median age was 60 years old (ranged from 37 to 79 years old).Loco-regional control (LRC),progression-free survival (PFS) and overall survival (OS) were compared and analyzed between the patients treated with postoperative adjuvant radiotherapy and postoperative concurrent chemoradiotherapy (cisplatin was given in a dose of 80 mg/m2 on days 1, 22, and 43). After the propensity score matching (PSM), 61 sub-pairs of 122 patients were generated in post-PSM cohort. Survival rate were assessed with Kaplan-Meier method and Log-rank test.
Results:
After the propensity score matching(PSM), 61 sub-pairs of 122 patients were generated in post-PSM cohort.The patients were followed up for 3-135 months, the median follow-up was 42 months. No significant differences in 3-year and 5-year LRC, PFS, OS were observed between the two groups (
8.Effect of vasopressin injection technique on ovarian reserve in patients with ovarian endometriosis cysts excision
Qiong LI ; Xiaoping WANG ; Yu LIU ; Mingbo WANG ; Xiaoping HUANG ; Liping ZENG
Chinese Journal of Primary Medicine and Pharmacy 2018;25(2):151-156
Objective To investigate the effect of vasopressin injection technique on ovarian reserve in patients with laparoscopic cystectomy of unilateral ovarian endometrioma .Methods 70 patients with unilateral ovarian endometrioma were randomly allocated into study group (37 cases) and control group(33 cases) according to the digital table .Diluted vasopressin was injected into the space between the normal ovarian cortex and the cyst wall before stripping in the study group , and ordinary laparoscopic cystectomy without injection was adopted in control group.The average contents of anti -mullerian hormone(AMH),follicle-stimulating hormone(FSH),luteinizing hormone(LH),estradiol(E2),antral follicle count(AFC) and peak systolic velocity(PSV) were compared in two groups before and after surgery .Results The operative time of the study group was (37.6 ±8.6) min,which was significantly shorter than (42.8 ±9.1)min of the control group(t=2.46,P<0.05).The blood loss of the study group was (23.2 ±12.1)mL,which was significantly less than (31.4 ±17.3)mL of the control group(t=2.32,P<0.05).In the control group,the E2 levels preoperation and postoperative were (201.46 ±7.51)pmol/L,(153.94 ± 8.72)pmol/L,respectively,the difference was statistically significant between preoperation and postoperation (t =23.72,P<0.05).The AMH levels in the control group preoperation and postoperation were (2.31 ±0.79)ng/mL, (1.67 ±0.75)ng/mL,respectively,there was statistically significant difference between preoperation and postoperation (t=3.38,P<0.05).The FSH levels in the control group preoperation and postoperation were (6.58 ±2.70)U/L, (10.24 ±1.21)U/L,respectively,there was statistically significant difference between preoperation and postoperation (t=7.12,P<0.05).The LH levels in the control group preoperation and postoperation were (5.87 ±1.76)U/L, (6.15 ±2.14) U/L,respectively,there was no significant difference between preoperation and postoperation (t =0.58,P>0.05).The F0 levels in the control group preoperation and postoperation were (8.7 ±2.8),(4.6 ±0.7), respectively,there was significant difference between preoperation and postoperation (P<0.05).The PSV levels in the control group preoperation and postoperation were (13.8 ±5.9)cm/s,(7.5 ±2.4)cm/s,respectively,there was significant difference between preoperation and postoperation (P<0.05).The E2 levels in the study group preopera-tion and postoperation were (199.36 ±8.42)pmol/L,(197.12 ±8.33)pmol/L,respectively,there was no significant difference between preoperation and postoperation (t=1.15,P>0.05).The AMH levels in the study group preopera-tion and postoperation were (2.23 ±0.85) ng/mL,(2.19 ±0.83) ng/mL,respectively,there was no statistically significant difference between preoperation and postoperation (t=0.20,P>0.05).The FSH levels in the study group preoperation and postoperation were (6.27 ±2.35)U/L,(6.73 ±2.23)U/L,respectively,there was no statistically significant difference between preoperation and postoperation (t=0.86,P>0.05).The LH levels in the study group preoperation and postoperation were (5.92 ±2.32) U/L,(5.57 ±2.31) U/L,respectively,there was no statistically significantl difference between preoperation and postoperation (t=0.65,P>0.05).The F0 levels in the study group preoperation and postoperation were (9.2 ±2.4),(8.9 ±2.7),respectively,there was no statistically significant difference between preoperation and postoperation (P>0.05).The PSV levels in the study group preoperation and postoperation were (14.7 ±5.4) cm/s,(14.0 ±4.7) cm/s,respectively,there was no statistically significant difference between preoperation and postoperation (P>0.05).Conclusion Vasopressin injection technique used in unilateral ovarian endometrioma laparoscopic cystectomy is safe and effective ,and it can protect the ovarian reserve .
9. A retrospective study on combined modality therapy with or without surgery for advanced hypopharyngeal squamous cell carcinoma: an analysis of 119 cases
Yongxia ZHANG ; Honghua PENG ; Xinxin ZHANG ; Jiandong ZHAO ; Wenming WU ; Jialing WANG ; Deliang HUANG ; Liang ZONG ; Liwei CHEN ; Chenqing LIU ; Mingbo LIU
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2018;53(5):352-358
Objective:
To compare the treatment outcomes for locally advanced hypopharyngeal carcinoma between surgery plus radio(chemo) therapy(SRT) and non-surgery chemoradiotherapy(CRT).
Methods:
A total of 119 patients diagnosed with advanced hypopharyngeal carcinoma without distant metastases between 2010 and 2014 were identified in the Chinese People′s Liberation Army General Hospital, and they were divided into 2 groups: 42 cases in SRT group and 77 cases in CRT group. Patients′ clinical information was collected. Survival rates and prognostic factors were analyzed by the Kaplan-Meier method with SPSS 23.0 software. The survival rates, laryngeal preservation rates and complication rates were compared between the two groups using the chi-square test.Among the 119 patients, 112 were males and 7 were females. Age ranged from 27 to 78 years, with an average age of 57 years.
Results:
There were no significant difference between the SRT and CRT group for five-year disease-free survival (DFS, 53.9%
10.Compatible Stability of Levetiracetam Injection with Three Injections
Fengling HUANG ; Yanxia SONG ; Zhi LI ; Xiaoli MA ; Mingbo YANG ; Bo LI
China Pharmacy 2017;28(14):1911-1916
OBJECTIVE:To investigate the compatible stability of Levetiracetam(Lev)injection with 3 injections. METHODS:Each Lev injection 1000 mg mixed with 0.9% Sodium chloride injection 100 mL,5% Glucose injection 100 mL or Sodium lactate Ringer's injection 100 mL respectively. Under the light condition,at 25 ℃,the color and clarification degree of mixtures were ob-served at different time points within 24 h after mixing;pH value and the number of insoluble particles were determined. The contents of related impurities(impurity A,B,C,D,2-hydroxypyridine)and Lev in mixtures were determined by HPLC. RESULTS:Under above condition,all mixtures were colorless clear liquid within 24 h;pH value had no significant change (RSD<1%,n=7);the number of insoluble particles was no more than the range stated in Chinese Pharmacopeia(2015 edition). Impurity B and C were not detected;the contents of other impurities were in line with the requirements of foreign pharmacopeia. No marked change was noted for relative content of Lev(RSD<1%,n=7). CONCLUSIONS:After mixing with 0.9% Sodium chloride injection,5% Glucose injec-tion or Sodium lactate Ringer's injection,Lev injection keep stable at 25℃within 24 h under the light condition.

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