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BACKGROUND: The application of tranexamic acid in knee and hip arthroplasty can reduce blood loss safely and effectively. As a kind of hemostatic agent for strengthening blood vessels, the hemostasis process of carbazochrome sodium sulfonate does not depend on the coagulation system of human body, so it has better security. OBJECTIVE: To explore the safety and blood loss of tranexamic acid combined with carbazochrome sodium sulfonate in total knee arthroplasty. METHODS: From July 2018 to December 2019, 67 patients with knee osteoarthritis were selected from the Affiliated Hospital of Xuzhou Medical University, including 18 males and 49 females. They were randomly divided into two groups. The observation group (n=32) received intravenous injection of tranexamic acid before total knee arthroplasty, followed by intravenous injection of carbazochrome sodium sulfonate after total knee arthroplasty. The control group (n=35) received intravenous injection of tranexamic acid before total knee arthroplasty, followed by intravenous injection of saline after total knee arthroplasty. The total blood loss, hidden blood loss, maximum hemoglobin drop, blood transfusion rate, incidence of thrombotic events (lower limb intermuscular vein thrombosis, deep vein thrombosis and pulmonary embolism), perioperative fibrinolytic parameters (fibrin and fibrinogen degradation products, D-dimer), inflammation markers (C-reactive protein, interleukin-6) were compared between the two groups. The study was approved by Medical Ethics Committee of Affiliated Hospital of Xuzhou Medical University. RESULTS AND CONCLUSION: (1) The decrease of total blood loss, hidden blood loss and maximum hemoglobin drop in the observation group was less than those in the control group (P 0.05). (3) The C-reactive protein level of the observation group was lower than that of the control group on day 1 and day 3 after surgery (P 0.05). (4) There was no blood transfusion, deep venous thrombosis of lower limbs or pulmonary embolism in the two groups during their hospitalization. (5) The results showed that tranexamic acid combined with carbazochrome sodium sulfonate can further reduce the total blood loss, hidden blood loss and hemoglobin drop of patients after total knee arthroplasty, reduce the inflammatory reaction, and do not increase the risk of thrombosis, so it was safe.
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OBJECTIVE:To explore the stability of levofloxacin hydrochloride and carbazochrome sodium sulfonate in 0.9%So-dium chloride injection,and provide reference for their compatible use in clinic. METHODS:HPLC was performed on the column of Phenomenex Gemini C18 with mobile phase A of acetonitrile and B of 0.01 mol/L Ammonium biphosphate solution(adjusted to pH 3.0 with phosphoric acid)(gradient elution)at a flow rate of 1.0 ml/min,the detection wavelength was 295 nm for levofloxa-cin hydrochloride and 364 nm for carbazochrome sodium sulfonate,temperature was 30 ℃,and the injection volume was 20 μl. The changes of contents,appearance and pH value of the solution in the mixture were investigated. RESULTS:The linear range was 7.03-80.06 μg/mL for levofloxacin hydrochloride(r=0.9995)and 1.70-34.04 μg/mL for carbazochrome sodium sulfonate(r=0.9998);RSDs of precision and reproducibility tests were no more than 2.0%;recoveries were 98.75%-100.63%and 98.00%-100.83%, and RSDs were 0.65% and 0.99%(n=9),respectively. In normal temperature,the contents of levofloxacin hydrochloride and car-bazochrome sodium sulfonate after mixing with 0.9% Sodium chloride injection within 6 h showed no significant decrease,and the appearance and pH value showed no obvious changes. CONCLUSIONS:The mixing of levofloxacin hydrochloride and carbazo-chrome sodium sulfonate with 0.9% Sodium chloride injection in room temperature is stable within 6 h,they can compatibly use synergistically in clinic.
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Objective:To evaluate the quality of carbazochrome sodium sulfonate Injection from different manufacturers, analyze the existing problems and provide the reference for the improvement of clinical medication safety. Methods:Statutory testing methods and the exploratory research methods were used to examine the samples, and the quality status of carbazochrome sodium sulfonate Injec-tion was evaluated according to the results. Results:Totally 89 batches of the samples were tested by the current standard. The quali-fied rate was 97. 8%, and the two batches of unqualified samples were carbazochrome sodium sulfonate and sodium chloride Injection with unqualified insoluble particles. Overall, the quality risk of carbazochrome sodium sulfonate for injection was low, and the safety of carbazochrome sodium sulfonate and sodium chloride Injection needed further research. Conclusion:The quality of carbazochrome so-dium sulfonate Injection basically meets the current standard, and the exploratory research suggests that the current standard is imper-fect. It is urgent to improve the related substance detection in the standard and determine the reasonable limits for the degradation im-purities and the other impurities. The clinical medication safety of carbazochrome sodium sulfonate and sodium chloride Injection needs further research.
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OBJECTIVE: To develop a method for separating and determining the related substances in carbazochrome sodium sulfonate injection. METHODS: HPLC Gradient elution was performed on an HP-ODS Hypersil colum. The mixture of 0.01 mol·L-1 phosphate buffer (pH 3.0) and acetonitrile (94:6) was used as mobile phase A, and acetonitrile as mobile phase B. The flow rate was 1.0 mL·min-1, the detection wavelength was set at 220 nm. RESULTS: After being treated with acid, base, heat and oxidation, carbazochrome sodium sulfonate underwent more or less degradation, the degradation products could be detected by the proposed method. Among the practical carbazochrome sodium sulfonate injection and carbazochrome sodium sulfonate and sodium choloride injection samples, the thermo degradation impurities but no impurities resulted from other treatments were detected in carbazochrome sodium sulfonate injections and carbazochrome sodium sulfonate sodium chloride injections. CONCLUSION: The proposed method can be used to separate and determine the related substances in carbazochrome sodium sulfonate injection, and is suitable for the quality control of this drug.
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OBJECTIVE: To research the pharmacokinetic characteristics of carbazochrome sodium sulfonate given by needle-free injection in rabbits, to compare it with that of carbazochrome sodium sulfonate given by traditional syringe injection. METHODS: Japanese big ear white rabbits were administered carbazochrome sodium sulfonate solution by needle-free injection and intramuscular injection with needle syringe. Plasma samples were extracted and assayed by high performance liquid chromatography technology. The mobile phase was composed of 0.12% NH4H2PO4 and acetonitrile (91:9), and the detection wave length was 363 nm. RESULTS: The measured blood drug concentration-time data was fitted by DAS 2.1.1 pharmacokinetic software. The pharmacokinetic processes of carbazochrome sodium sulfonate given by both needle-free injection and intramuscular injection were in line with one-compartment model, and the major pharmacokinetic parameters AUC0-t, tmax, ρmax and t1/2 were (162.43±17.09)μg · min · mL-1, (5.00±1.41) min, (5.93±0.02)μg · mL-1, (23.54±3.89) min and (180.82±15.29)μg · min · mL-1, (23.00±2.01) min, (5.09±0.29)μg · mL-1 and (18.28±2.47) min, respectively. CONCLUSION: Compared with the traditional needle syringe injection, the peak time was significantly shortened and the peak concentration was increased with needle-free injection, while the other pharmacokinetic parameters showed no statistically significant difference, which indicated that carbazochrome sodium sulfonate given by needle-free injection may have similar effect with that of traditional injection.
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OBJECTIVE:To establish a method for determination of carbazochrome sodium sulfonate for injection.METH_ ODS:C 18 was used as chromatographic column;the mobile phase consisted of0.12%ammonium dihydrogen phosphate buffer solution-absolute alcohol(925∶75)with detection wavelength at363nm and flow rate at0.8ml/min.The sample size was10?l and the column temperature was25℃.RESULTS:Linear relation was achieved when the concentration of carbzochrome sodium sulfonate was within the range of0.08865mg/ml～0.4432mg/ml(r=0.9999,n=5).The mean recovery rate was99.89%(RSD=1.53%,n=9).CONCLUSION:This method is simple,rapid,accurate,precise,and which can be used as the quality control of carbzochrome sodium sulfonate for injection.
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Objective: To design a biodegradable aerosol film for treating various wound and diffuse hemorrhage in various organs. Methods: Uniform design was used to screen prescription. Ultraviolet spectrophotometry was used to assay the release in vitro . Results: Time of film formation was less than 30 s. The release in vitro was about 50% in 15 min and stabilized gradually after 15 min. Conclusion:The film formation and release in vitro are well acceptable. [