2.Similarity Evaluation of Dissolution Curves for Generic Preparation and Reference Preparation of Bisaco-dyl Enteric-coated Tablets
Ting SUN ; Jianguo JIANG ; Yonghui GUO ; Xuejing HAN
China Pharmacy 2017;28(9):1268-1271
OBJECTIVE:To investigate the similarity of dissolution curves between generic preparations and reference prepara-tions of Bisacodyl enteric-coated tablets in various dissolution mediums,and to provide reference for improving production technolo-gy and internal quality of generic preparations. METHODS:Paddle method was adopted with rotation speed of 75 r/min. The disso-lution test was performed using 1000 mL pH 6.0 phosphate buffer solution,pH 6.8 phosphate buffer solution,water containing 2% sodium lauryl sulfate. HPLC method was used to determine average accumulative dissolution of main components from 3 kinds of generic preparations and reference preparations at different time points to draw out dissolution curves. Similarity factor(f2)meth-od was used to the similarity of dissolution curves. RESULTS:Dissolution curves of reference preparations were basically the same in 3 kinds of dissolution mediums. But the dissolution curve f2 of one generic preparation among 3 manufactures to dissolution curve of reference preparation were ≥50,namely the similarity. CONCLUSIONS:The quality of generic Bisacodyl enteric-coat-ed tablets produced by different manufacturers is obviously different;the generic preparations needs to be further improved in the production technology and internal quality. For domestic generic preparation,it is necessary to strengthen the real-time monitoring of its dissolution curve,to ensure the drug quality.
3.Determination of Content and Content Uniformity of Memantine Hydrochloride Dispersible Tablets by an Internal Standard Method of GC
Chunxia WANG ; Yonghui GUO ; Xuejing HAN ; Jianguo JIANG
China Pharmacist 2017;20(5):935-937
Objective: To establish a GC method for the determination of content and content uniformity of memantine hydrochloride dispersible tablets.Methods: The sample was dissolved in water, alkalified by sodium hydroxide solution and extracted by methylene chloride.An HP-5 gas chromatography column (50 m×0.32 mm, 1.05 μm) was used.The column temperature was programming increased, and the initial temperature maintained at 120 ℃ for 3 min, and then raised to 220 ℃ at a rate of 10℃·min-1 and maintained for 7 min.A hydrogen flame ionization detector (FID) was used and the split ratio was 1∶1.The inlet temperature was 230 ℃ and the detector temperature was 260 ℃.The injection volume was 1 μl and the carrier gas was nitrogen with high purity at a flow rate of 3.0 ml·min-1.Adamantane was used as the internal standard, and the internal standard method was used for the calculation.Results: The calibration curve was linear over the range of 0.05-1.0 mg·ml -1 (r=0.999 7).The detection limit and the limit of quantification was 1.1 ng and 3.3 ng, respectively.The average recovery was 100.2% (RSD =0.73%, n=9).Conclusion: The method has the advantages of simple operation, small extraction process toxicity, little environmental pollution, high accuracy and high specificity, and can be used for the determination of content and content uniformity of memantine hydrochloride dispersible tablets.
4.Determination of Purity and Uncertainty Evaluation of Bisacodyl by Differential Scanning Calorimetry
Yonghui GUO ; Lijuan LYU ; Xuejing HAN ; Kai YAN
China Pharmacy 2015;(18):2581-2582,2583
OBJECTIVE:To establish the purity determination of bisacodyl by differential scanning calorimetry(DSC)and the valuation of uncertainty. METHODS:DSC was conducted to detect the purity of bisacodyl and determine the optimal testing condi-tions. According to related standards,indium enthalpy change values,measurement repeatability,weighing process,instrument tem-perature deviation and system software deviation were systematically analyzed. The results were verified by HPLC. RESULTS:When the fiducial probability P was 0.95,the standard value and uncertainty of content of bisacodyl was (99.88 ± 0.06)% mea-sured by DSC. Weighing process,instrument temperature deviation and system software deviation had great effects on the total un-certainty. The result of HPLC and DSC were the same. CONCLUSIONS:The established DSC can quickly and accurately determine the chemical purity of bisacodyl. The uncertainty evaluation is reliable. Regularly calibrated and verificated equipment and strict con-trol of the weighing process will help to improve the accuracy measured by DSC;and it provides a new analysis method for the de-termination of purity of bisacodyl.
5.Simultaneous Residual Determination of Two Organic Solvents in Bisacodyl Raw Material by Head-space GC
Jianguo JIANG ; Ting SUN ; Yonghui GUO ; Xuejing HAN ; Huijuan MIAO
China Pharmacy 2016;27(30):4297-4298,4299
OBJECTIVE:To establish a method for simultaneous residual determination of dichloromethane and ethyl acetate in bisacodyl raw material. METHODS:Head-space GC was performed on the capillary column of 6% cyanopropyl phenyl-94% di-methyl polysiloxane(DB-624)by temperature programming,the temperature of injector was 220 ℃,detector was flame ionization detector with temperature of 250 ℃,carrier gas was high purity nitrogen with the flow rate of 3.0 ml/min,split ration was 1∶10, headspace heating temperature was 70 ℃,equilibration time was 30 min,volume of headspace vial was 5 ml,and the injection volume was 1 ml. RESULTS:The linear range was 6-120μg/ml for dichloromethane(r=0.999 9)and 50-1 000μg/ml for ethyl ac-etate(r=0.999 9);the limit of quantitation was 0.2,1.7 μg,limit of detection was 0.06,0.5 μg;RSDs of precision,stability and reproducibility tests were no higher than 3%;recoveries were 100.30%-102.00%(RSD=0.63%,n=9) and 100.10 %-101.30%(RSD=0.44%,n=9). CONCLUSIONS:The method is simple and accurate,and can be used for the simultaneous residual deter-mination of dichloromethane and ethyl acetate in bisacodyl raw material.
6.Clinical Observation on Treatment of Knee Osteoarthritis with Acupuncture plus Tuina
Kui SUN ; Yonghui YANG ; Jianming LUO ; Dechun LIU ; Chouping HAN
Journal of Acupuncture and Tuina Science 2007;5(5):288-291
Objective: To investigate the efficacy of specific point acupuncture and manipulative adjustment on muscle strength of the knee osteoarthritis. Method: One hundred and five patients were randomly allocated to two groups. Sixty-eight cases in the treatment group were treated by specific point acupuncture and manipulative adjustment on muscle strength of the knee joint. While 37 cases in the control group were treated with specific point acupuncture alone. Result: The total effective rate was significantly higher in the treatment group than in the control group (P<0.05). Conclusion: Specific point acupuncture and manipulative adjustment on muscle strength of the knee joint has a satisfactory curative effect on knee osteoarthritis.
7.Uncertainty Evaluation in the Determination of Sodium Valproate Tablets by GC with an Internal Standard Method
Chunxia WANG ; Yonghui GUO ; Xuejing HAN ; Jianguo JIANG
China Pharmacist 2016;19(6):1217-1220
Objective:To evaluate the measurement uncertainty in the determination of sodium valproate tablets by GC with an in -ternal standard method , and determine the main sources of uncertainty .Methods:A GC internal standard method was selected to sys-tematically analyze the uncertainty in the determination of sodium valproate tablets , including the sample quantity , dilution ratio, purity and area repeatability of chromatographic peaks .Results: The expanded uncertainty of sodium valproate tablets was 2.7%, and the determination range of sodium valproate tablets was (96.3 ±2.7)%(k=2).Conclusion:The established GC internal standard meth-od for the uncertainty evaluation is reliable , which is helpful to improving the quality evaluation and control of sodium valproate tablets .
8.Clinical efficacy of Naikan cognitive therapy in the treatment of alcohol dependent patients
Qi CHANG ; Fuqiang MAO ; Jingyi CHEN ; Yonghui ZHANG ; Shaoming HAN
Chinese Journal of Behavioral Medicine and Brain Science 2013;(1):25-27
Objective To explore the clinical efficacy of Naikan cognitive therapy(NCT) for alcohol dependent patients.Methods 64 cases of alcohol-dependent patients were randomly assigned to the study group (32 cases) and the control group (32 cases).The study group was treated with NCT for successive 7 days on the basis of taking original drugs; and the control group was only given the original drug therapy.The obsessive compulsive drinking scale (OCDS),self-report symptom inventory(SCL-90),nurses observation scale for inpatient evaluation(NOSIE) were administered to all subjects at pre-and post-treatment.Results ①After the treatments,the scores of OCDS in study group (49.51 ± 1.63) were lower than that in control group(53.92 ± 1.82),and the statistical difference had the significance (P < 0.01).②After the treatments,the total scores and some factor scores of SCL-90 in study group were lower than in control group (t =-2.413,P =0.019 ; t =-2.033,P =0.047 ; t =-2.065,P =0.044 ; t =-2.038,0.046),and the difference was statistically significant.③After the treatments,in the study group,the scores of the total estimated factor and total positive factor(187.10 ± 18.80;78.51 ±12.22) were higher than in control group (175.51 ± 11.71 ; 68.22 ± 11.87),total negative factor score (15.55 ±9.46) were lower than in control group (20.51 ± 9.33),and the difference was statistically significant.Conclusion NCT can effectively inhibit alcohol craving,and reduce the drinking wine relevant questions.It can help to improve psychological symptoms in patients with alcohol dependence,especially depression and anxious symptoms.
9.Value of endovascular stents placement for treating symptomatic spontaneous isolated dissection of splanchnic artery
Xiangjun HAN ; Xitong ZHANG ; Yonghui XIA ; Songnian LIANG ; Ke XU
Chinese Journal of Radiology 2014;(6):489-491
Objective To evaluate the safety and effectiveness of treating the endovascular stents placement for spontaneous isolated dissection of splanchnic artery ( SIDSA).Methods Sixteen consecutive patients with diagnosis of SIDSA through CTA and DSA were retrospectively analyzed .All patients had acute persistent abdominal pain and treated by endovascular stents placement.The serious complications and symptoms improvement were reviewed after the operation.The symptoms recurrence and repeated color doppler ultrasonography and CTA were also reviewed in the follow up.Results Twelve superior mesenteric artery ( SMA) dissection and four celiac artery ( CA) dissection were diagnosed among sixteen patients.The dissection length was 1.07 to 11.87 cm and the median length was 3.93 cm.The distance from the original dissection to the orifice of superior mesenteric artery or celiac artery was 0.50 to 6.44 cm and the median was 1.98 cm.Eight stent-grafts and 3 bare stents were successfully implanted in 11 patients.One case with celiac dissection was failed to treat because of the severe compression of true lumen and the guide wire cann′t cannulate to the distal true lumen.Four patients with superior mesenteric artery dissection gave up interventional therapy , Among these 4 patients , 2 patients had small tear site and small false lumen , 1 patient had extremely long dissection , and one case had blood supply of target organs from both true and false lumen.No severe complications such as hemorrhage , intestinal necrosis , hepatic failure and splenic necrosis occurred during the eleven successful endovascular interventions.The abdominal pain in 10 cases was disappeared or significantly relieved , 1 case with superior mesenteric vein thrombosis and severe intestinal ischemia before intervention underwent intestinal resection for necrosis.The follow up period was 1 to 74 months in eleven successful cases , and the median follow-up period was 16 months.One patient with SMA dissection after endovascular treatment was died of sudden stroke three months later .Others had satisfactory outcome and the repeated color doppler ultrasonography and CTA were normal .Conclusions Endovascular stents placement is a safe and effective therapy for symptomatic spontaneous isolated dissection of splanchnic artery.
10.Effect of Pyrroloquinoline Quinone on Aging of Rat Hippocampal Neurons in Vitro
Xiwen TONG ; Yanmei HAN ; Yonghui DENG ; Hui SHEN ; Shunhua XIONG
Chinese Journal of Rehabilitation Theory and Practice 2008;14(9):804-805
Objective To investigate the effect of pyrroloquinoline quinone(PQQ) on the aging of rat hippocampal neurons induced by D-galactose(D-gal).Methods Hippocampal neurons were cultured in vitro.The aging of the hippocampal neurons was induced by high dose D-gal,PQQ protection were used 30 min before D-gal.The metamorphosis of hippocampal neurons was observed under the microscope.The contents of free radical was measured.The incidence of apoptosis of hippocampus cells was tested with the flow cytometry.The expression of Bax was detected with immunohistochemical staining.Results After the cells cultured in vitro exposed to D-gal,the content of free radical and the expression of Bax of the hippocampal neurons increased.After pretreatment of the cultured neurons with PQQ,the contents of free radical and the expression of Bax decreased,the survival of hippocampal neurons increased.Conclusion PQQ may slow the aging progress of hippocamal neurons induced by D-gal.