Comparative observation of the effectiveness and safety of remimazolam besylate versus dexmedetomidine in gastrointestinal surgery in obese patients

BACKGROUND Surgery for obese patients carries a higher risk of anesthesia complications compared with surgery for nonobese patients.Thus,a safe and effective anesthesia strategy is necessary to improve the medical experience of such patients and ensure their safety.AIM To compared the effectiveness and safety of remimazolam besylate versus dexmedetomidine(DEX)in gastrointestinal surgery in obese patients.METHODS The study cohort included 60 obese patients undergoing gastrointestinal surgery between July 2021 and April 2023,comprising 30 patients who received DEX intervention(control group)and 30 patients who received remimazolam besylate intervention(research group).Heart rate(HR),respiratory rate(RR),mean arterial pressure(MAP),blood oxygen saturation(SpO_(2)),safety(nausea and vomiting,bradycardia,hypotension,and apnea),anesthesia and examination indices[induction time,anesthesia recovery time,and postanesthesia care unit(PACU)discharge time],sedation effect(Ramsay Sedation Scale),and postoperative pain visual analog scale were comparatively analyzed before anesthesia(T0),during anesthesia(T1),and after anesthesia(T2).RESULTS At T1,the research group showed significantly smaller changes in HR,RR,MAP,and SpO_(2) than the control group,with a significantly lower adverse reaction rate and shorter induction,anesthesia recovery,and PACU discharge times.Additionally,the intra-and postoperative Ramsay Sedation Scale scores were statistically higher in the research group than in the control group.CONCLUSION Remimazolam besylate was significantly more effective than DEX in gastrointestinal surgery in obese patients and had a higher safety profile and value in clinical promotion.

Evaluation of the Effectiveness and Efficiency of the Combination of Levamlodipine Besylate and Valsartan in the Treatment of Hypertension

Objective:To investigate the effectiveness and efficiency of combining levamlodipine besylate and valsartan in the treatment of hypertension.Methods:This study selected 28 patients with hypertension as observation subjects.The treatment duration ranged from January 2020 to June 2023.Using the random number table method,patients were divided into two groups.The control group received treatment with valsartan,while the observation group received a combination of valsartan and levamlodipine besylate.Therapeutic effects and safety were compared between the groups,and changes in the patient’s blood pressure and renal function index levels were assessed.Results:The total clinical effective rate of the observation group was significantly higher than that of the control group(P<0.05).The observation group demonstrated better diastolic blood pressure,systolic blood pressure,and renal function indicators compared to the control group(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:The combined treatment of levamlodipine besylate and valsartan in patients with hypertension showed significant clinical efficacy and holds broad application value.

Kinetic spectrophotometric method for determination of amlodipine besylate in its pharmaceutical tablets

A simple and sensitive kinetic spectrophotometric method has been developed and validated for determination of amlodipine besylate （AML）. The method was based on the condensation reaction of AML with 7-chloro-4-nitro-2,1,3-benzoxadiazole in an alkaline buffer （pH 8.6） producing a highly colored product. The color development was monitored spectrophometrically at the maximum absorption λmax 470 nm. The factors affecting the reaction were studied and the conditions were optimized. The stoichiometry of the reaction was determined, and the reaction pathway was postulated. Moreover, both the activation energy and the specific rate constant （at 70 ℃） of the reaction were found to be 6.74 kcal mole-1 and 3.58 s -1, respectively. The initial rate and fixed time methods were utilized for constructing the calibration graphs lbr the determination of AML concentration. Under the optimum reaction conditions, the limits of detection and quantification were 0.35 and 1.05 ug/mL, respectively. The precision of the method was satisfactory; the relative standard deviations were 0.85-1.76%. The proposed method was successfully applied to the analysis of AML in its pure form and tablets with good accuracy; the recovery percentages ranged from 99.55 ± 1.69% to 100.65 ±1.48%. The results were compared with that of the reported method.

Development and Validation of HPLC Method for Simultaneous Determination of Amlodipine, Valsartan, Hydrochlorothiazide in Dosage Form and Spiked Human Plasma

A simple, sensitive, and specific method was developed for simultaneous determination of Amlodipine besylate (AML), Valsartan (Vals) and Hydrochlorothiazide (HCT) by high performance liquid chromatography without previous separation. Satisfactory resolution was achieved using a RP-C18 chromatographic column, Phenomenex Kinetex (150 mm × 4.6 mm i.d) and a mobile phase consisting of acetonitrile-phosphate buffer (0.05 M) with pH 2.8 in the proportion of (40/60, v/v) at a flow rate 0.8 mL/min and the wavelength detection was 227 nm. The retention time for HCT, AML and VAls was 2.26, 3.16 and 11.19 min;respectively. The described method was linear over a range of 4-28 μg /ml, 5-40 μg /ml and 1-12 μg /ml for AML, Vals and HCT;respectively. The mean percent recoveries were 99.94%, 99.96% and 99.78% for AML, Vals and HCT;respectively. F-test and t-test at 95%con?dence level were used to check the intermediate precision data obtained under different experimental setups. The method could be used for analysis of combined dose tablet formulation containing AML, Vals, HCT as well as spiked human plasma.

Impurity profiling and in-process testing of drugs for injection by fast liquid chromatography

Liquid chromatography （LC） is considered by many as a mature technique. Nonetheless, LC technology continues to evolve driven by the need for high-throughput and high-resolution analyses. Over the past several years, small particle size packing materials have been introduced by several column manufacturers to enable fast and efficient LC separations. Several examples of pharmaceutical analyses, including impurity profiling of taxanes and atracurium besylate, in-process testing of peptides in injectable dosage form, using sub-2 um column technology are presented in this paper, demonstrating some of the capabilities and limitations of the technology.

Spectrophotometric determination of some calcium channel blockers using Sulfochlorophenol-S, Bromopyrogallol red, Eriochromecyanine-R and Pyrocatechoil violet

Four simple, sensitive and accurate spectrophotometric methods have been developed for the determination of some calcium channel blockers: Amlodipine besylate (ADB), Diltiazem hydrochloride (DTZ) and Verapamil hydrochloride (VPM) in pharmaceutical formulations. These methods based on formation ion pair complexes with Sulfochlorophenol-S (SCPS), Bromopyrogallol red (BPR), Eriochromecyanine- R (ECC) and Pyrocatechol violet (PCV) in acidic medium. The colored products are extracted with chloroform and measured spectrophoto- metrically at 462, 600, 440 and 442 for ECC, SCPS, BPR and PCV, respectively. Beer’s low was obeyed in the concentration range, for ECC: 25 - 175 μg·ml-1, 50 - 150 μg·ml-1 or 100 - 250 μg·ml-1, for SCPS: 300 - 800 μg·ml-1, 200 - 700 μg·ml-1 or 100 - 550 μg·ml-1, for BPR: 50 - 400 μg·ml-1, 200 - 700 μg·ml-1 or 200 - 700 μg·ml-1 for VPM, DTZ or ADB, respectively and for PCV: 50 - 250 μg·ml-1 for VPM or 200 - 500 μg·ml-1 for DTZ with molar absorptivity, for ECC: 2.2 × 104, 2.1 × 104, 1.6 × 104 L·mol-1·cm-1, for SCPS: 3.8 × 103, 5.6 × 103, 8.1 × 103 L·mol-1·cm-1, for BPR: 11 × 103, 4.8 × 103, 6.9 × 103 L·mol-1·cm-1 for VPM, DTZ or ADB, respectively and for PCV: 19.5 × 103 L·mol-1·cm-1 for VPM and 6.6 × 103 L·mol-1·cm-1 for DTZ and relative standard deviation, for ECC: 0.76%, 0.86%, 0.46%, for SCPS: 0.94%, 0.96%, 0.86%, for BPR: 0.96%, 0.95%, 0.55% for VPM, DTZ or ADB, respectively and for PCV: 0.81% for VPM and 0.65% for DTZ. These methods have been successfully applied for the assay of drug in pharmaceutical formulations. No interference was observed from common pharmaceutical adjuvants. Statistical comparison of the results with the reference method shows excellent agreement and indicates no significant difference in accuracy and precision.

FDA审查Pfizer改变Norvasc标签的要求

美国FDA的心血管肾脏药物咨询委员会将在4月5日审查Pfizer公司请求修改Norvasc（amlodipine besylate，氨氯地平）（Ⅰ）的商标资料，其中包括具有里程碑意义的2002年ALLHAT研究中减少冠心病发作危险的结果。这项降压降脂预防心脏病发作试验共有42000多名高危的高血压病人参加。