1.HPLC determination of metoclopramide and its related substances in metoclopramide nasal spray
Xianpeng FAN ; Jianxu SUN ; Junhai XIAO ; Daoquan TANG ; Aiping ZHENG
Military Medical Sciences 2015;(2):133-135
Objective To establish an HPLC method for the determination of metoclopramide (MCP) and its related substances in MCP nasal spray .Methods Chromatographic separation was performed on an Agilent TC-C18 column (250 mm ×4.6 mm,5 μm) using acetonitrile and phosphate buffer solution (0.05 mol/L potassium dihydrogen phosphate solution, added with 5 ml of triethylamine and adjusted to pH 4.0 with phosphoric acid)(19∶81) as the mobile phase at 1.0 ml/min.The detection wavelength was 275 nm and the column temperature was set at 30℃.Results and Conclusion Related substances were completely separated from MCP .For MCP,the linearity of determination was over the range of 10-200 μg/ml and the recovery of the method ranged from 100.3%to 101.6%.The relative standard deviation was 0.68%(n=9).The method is accurate, reliable, repeatable, and could be readily utilized as a quality control method for MSP nasal spray .
2.Evaluation on Characteristics of National Essential Drugs on the View of Pharmaceutics
Aiping ZHENG ; Yunqi BI ; Xu CUI ; Xiaoyan ZHANG ; Jianxu SUN
China Pharmacy 2001;0(08):-
OBJECTIVE:To Evaluate the characteristics of national essential drugs on the view of pharmaceutics.METHODS:Referring to related literatures,the characteristics of national essential medicines were analyzed and summarized on the basis of pharmaceutics.The national essential drugs list was compared with that of WHO's.RESULTS:In the equipment part of primary healthy care institution national essential drugs list (2009 edition),chemical and biological medicines had 205 species which included 270 formulations,were classified as 21 kinds of dosage forms.Chinese traditional medicines had 102 species which included 188 formulations,were classified as 13 kinds of dosage forms.The ration of the amount of dosage forms to species is 1.49,a little higher than WHO(1.31) now.CONCLUSION:The dosage forms of national essential drugs were abundant and enable to meet the clinical requirement.But should optimize the breed and add in many species of dosage form to satisfy the needs of medicines useage from urban to rural.
3.Preparation and evaluation of naloxone hydrochloride nasal spray
Peng YANG ; Wanqing LI ; Ying LI ; Jianxu SUN ; Hui ZHANG ; Jing GAO ; Xiaoxing YIN ; Aiping ZHENG
Journal of International Pharmaceutical Research 2017;44(6):616-621
Objective To prepare naloxone hydrochloride nasal spray and evaluate the ciliotoxicity and pharmacokinetics of the formulation. Methods The stability of naloxone hydrochloride was studied in pH3.5-5.5. Penetration promoting effects of absorp-tion enhancers on the naloxone hydrochloride were evaluated. Nasal ciliotoxicity studies were carried out using isolated toad palate. Rats were treated with naloxone hydrochloride solution by intramuscular injection of nasal drops to evaluate the pharmacokinetics. Results Naloxone hydrochloride solution was stable in pH3.5-5.5. Disodium ethylenediaminetetraacetic acid(0.2%,W/V)had the best penetration promoting effect on naloxone hydrochloride. Naloxone hydrochloride nasal spray did not exhibit obvious nasal ciliotox-icity compared to the negative control. The nasal spray had a faster therapeutic effect and its bioavailability was similar to that of the in-tramuscular injection. Conclusion Naloxone hydrochloride nasal spray prepared in this research is stable with no obvious nasal cilio-toxicity,has faster therapeutic effect,and good bioavailability,so may have a broad application prospect.
4.Preparation and evaluation of progesterone injection with different particle size
Li LI ; Wanqing LI ; Ying LI ; Jing GAO ; Hui ZHANG ; Jianxu SUN ; Aiping ZHENG
Journal of International Pharmaceutical Research 2017;44(6):609-615
Objective To compare the release rate and bioavailability of progesterone injection with different particle sizes. Methods The preparation of progesterone nano sized injection and micron sized injection were performed by power X-ray diffraction (PXRD)and Fourier trensform infrared spectooscory(FTIR). The dissolution rate of two preparations and progesterone was compared by dialysis Method. HPLC-MS method was used to determine the progesterone concentration of plasma in rats after intramuscular injec-tion of different preparations,and the main pharmacokinetic parameters were calculated and analyzed statistically. Results Based on the analysis of PXRD and FTIR,there were no crystal structure changes between the two preparations and progesterone. The complete release of progesterone nano sized injection and micron sized injection required 2 and 4 h in the PBS solution,respectively,while the release of progesterone required nearly 40 h. In the pharmacokinetic experiment,compared with progesterone injection,the Cmax of pro-gesterone nano sized injection and micron sized injection were increased by 1.8 and 1.7 times,respectively;the AUC0-t were increased by 2.95 and 1.63 times,respectively. The bioavailability of both was higher than that of progesterone injection. Conclusion The re-lease rate bioavailability of progesterone nano sized injection and micron sized injection is higher than that of progesterone and proges-terone injection. Bioavailability of progesterone nano sized injection is higher than that of progesterone micron sized injection.
5.Determination of contents and related substances of demethyl levophencynonate hydrochloride tablets by HPLC
Jianxu SUN ; Xiaoqing WANG ; Xiaoyan ZHANG ; Jiaojiao LI ; Bohua ZHONG ; Jianquan ZHENG ; Xinhua HE ; Liyun WANG ; Aiping ZHENG
Military Medical Sciences 2014;(10):811-813
Objective To establish a simple, feasible and precise quality control method for the determination of contents and related substances of demethyl levophencynonate hydrochloride (L-LPC)tablets.Methods The mobile phase consisted of methanol,acetonitrile and sodium acetate buffer solution(pH 5.0),at a ratio of 4∶3∶3,at a flow rate 1.0 ml/min and a detection wavelength of 220 nm.Samples were injected 100 μl and determined at room temperature.Results The calibration curves showed good linearity (R2 =1) within the test range of 0.1-50μg/ml.The recovery of the method was about (100.15 ±0.73)%, and the stability of working solutions was acceptable in 8 h (RSD=0.36%).Conclusion The results indicated that the developed method can be readily used as a quality control method.
6.Effects of jugular vein bulb pressure on postoperative cognitive function in elderly patients undergoing valve replacement-coronary artery bypass grafting under cardiopulmonary bypass
Peng SUN ; Wenqian ZHAI ; Jianxu ER ; Jiange HAN
Chinese Journal of Anesthesiology 2020;40(5):538-542
Objective:To evaluate the effect of jugular vein bulb pressure (JVBP) on postoperative cognitive function in elderly patients undergoing valve replacement-coronary artery bypass grafting under cardiopulmonary bypass (CPB).Methods:Ninety-two patients of both sexes, aged 65-75 yr, with body mass index of 18-25 kg/m 2, of American Society of Anesthesiologists physical status Ⅱ or Ⅲ, with New York Heart Association class Ⅱ or Ⅲ, were selected.All the patients underwent right internal jugular vein catheterization to monitor central venous pressure (CVP) and retrograde catheterization to measure JVBP.JVBP was recorded immediately after anesthesia induction (T 11), 10 min after CPB (T 12) and at the end of operation (T 13). The patients were divided into 2 groups according to JVBP: JVBP<12 mmHg group (group L) and JVBP≥12 mmHg group (group H). At T 11-13 and on 1st and 2nd days after operation (T 14, 15), heart rate, mean arterial pressure (MAP) and central venous pressure (CVP) were recorded, and blood samples from the jugular vein bulb were collected to determine the concentrations of S100β protein and matrix metalloproteinase-9 (MMP-9) in plasma and nerve specific enolase (NSE) in serum.Cognitive function was evaluated by Mini-Mental State Examination (MMSE) at 1 day before operation (T 21), 3 and 7 days after operation (T 22, 23) and 3 months after operation (T 24). Results:A total of 80 patients were included in this study, including 46 patients in group L and 34 patients in group H. Compared with those at T 11, CVP, JVBP, and concentrations of S100β protein and MMP-9 in plasma and NSE in serum were significantly increased at T 12 in group H, and CVP at T 13-15 and JVBP at T 12, 13 and concentrations of S100β protein and MMP-9 in plasma and NSE in serum at T 12-15 were significantly increased in two groups ( P<0.05). MMSE scores were significantly lower at T 22, 23 than at T 21 in the two groups ( P<0.05). Compared with group L, JVBP at T 12, 13, CVP at T 12-14 and concentrations of S100β protein and MMP-9 in plasma and NSE in serum at T 13 were significantly increased, concentrations of S100β prote in plasma were increased at T 12, MMSE scores were decreased at T 22-24, and the incidence of POCD was increased in group H ( P<0.05). JVBP was positively correlated with CVP, plasma S100β protein, MMP-9 concentration and serum NSE concentration, and the r values were 0.95, 0.56, 0.70 and 0.58, respectively ( P<0.05). Conclusion:Increased JVBP can decrease the postoperative cognitive function of elderly patients undergoing valve replacement-coronary artery bypass grafting under CPB, and the mechanism is related to blood-brain barrier damage.