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Simultaneous Determination of Valsartan and Hydrochlorothiazide in Valsartan Hydrochlorothiazide Tab-lets by UPLC

Hong JI ; Jing LIU ; Wei WANG ; Jin QI ; Qinghua LIU

China Pharmacy.2017;28(15):2131-2133. doi:10.6039/j.issn.1001-0408.2017.15.32

OBJECTIVE:To establish a method for simultaneous determination of valsartan and hydrochlorothiazide in Valsar-tan hydrochlorothiazide tablets. METHODS:UPLC was adopted. The determination was performed on Phenomenex C18 column with mobile phase consisted of [0.1% phosphoric acid solution-acetonitrile(95 : 5,V/V)]-[0.1% phosphoric acid solution-acetonitrile (5 : 95,V/V)](gradient elution)at the flow rate of 0.25 mL/min. The detection wavelength was set at 272 nm,and the column tem-perature was 35 ℃. The sample size was 1.5 μL. RESULTS:The linear range were 8.1-324.2 μg/mL for valsartan(r=0.9999)and 1.2-50.1 μg/mL for hydrochlorothiazide(r=0.9999). The limits of quantitation were 0.24,0.04 ng,and the limits of detection were 0.06,0.01 ng. RSDs of precision,stability and reproducibility tests were less than 2.0%;recoveries were 97.69%-100.35%for valsartan(RSD=1.03%,n=9)and 98.27%-100.60% for hydrochlorothiazide(RSD=0.83%,n=9). CONCLUSIONS:The method is simple,rapid and accurate,and can be used for the simultaneous determination of valsartan and hydrochlorothiazide in Valsartan hydrochlorothiazide tablets.

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Simultaneous Determination of 7 Components in Kuhuang Injection by UPLC-MS/MS

Xiao LI ; Yin WU ; Xuran ZHI ; Qian LI ; Ying LI ; Zhanjun DONG

China Pharmacy.2017;28(15):2108-2112. doi:10.6039/j.issn.1001-0408.2017.15.26

OBJECTIVE:To establish a method for the content determination of matrine,sophocarpine,emodin,rhein,chloro-genic acid,sarkosaponin a,aloe-emodin in Kuhuang injection.METHODS:UPLC-MS/MS was adopted. The determination was per-formed on Phenomenex Kenetix C18 column with mobile phase consisted of methanol-0.1% formic acid(gradient elution)at the flow rate of 0.5 mL/min. The column temperature was set at 20 ℃,and injector temperature was set at 10 ℃. The equilibrium time was 4 min and sample size was 5 μL. Ionization mode was electrospray ionization with spray voltage of 5500 V and -4500 V,at-omizing air pressure of 4.14×105 Pa,heater pressure of 4.48×105 Pa,curtain air of 1.72×105 Pa and ion source temperature of 600 ℃. The work mode was multiple reaction monitoring mode. RESULTS:The linear range were 1.25-80.0 ng/mL for matrine (r=0.9993),1.10-70.0 ng/mL for sophocarpine(r=0.9995),0.16-10.5 ng/mL for emodin(r=0.9993),2.61-168 ng/mL for rhe-in (r=0.9993),1.50-96.0 ng/mL for chlorogenic acid (r=0.9993),1.48-94.5 ng/mL for sarkosaponin a (r=0.9996) and 6.11-391 ng/mL for aloe-emodin(r=0.9991). The limits of quantification were 0.061,0.109,0.041,1.313,0.500,0.492,3.055 ng/mL,limits of detection were 0.025,0.054,0.016,0.656,0.150,0.148,1.528 ng/mL. RSDs of precision,stability and reproducibility tests were all no more than 3%. The recoveries of them were 95.45%-99.45%(RSD=1.43%,n=6),97.50%-101.00%(RSD=1.50%,n=6),95.67%-101.73%(RSD=2.85%,n=6),97.17%-100.57%(RSD=1.16%,n=6),95.19%-98.90%(RSD=1.71%, n=6),95.38%-103.85%(RSD=3.39%,n=6),95.50%-101.17%(RSD=1.20%,n=6),respectively. CONCLUSIONS:The method is simple,effective,accurate,reliable and suitable for simultaneous determination for 7 components in Kuhuang injection.

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Simultaneous Determination of 6 Residual Organic Solvents in Omeprazole Magnesium by Headspace GC

Yingyan JIANG ; Zhipeng GENG ; Yan LIU ; Dong SUO ; Haixia YANG

China Pharmacy.2017;28(15):2093-2096. doi:10.6039/j.issn.1001-0408.2017.15.22

OBJECTIVE:To establish a method for the simultaneous determination of 6 kinds of residual organic solvents in Omeprazole magnesium,such as methanol,isopropanol,acetonitrile,dichloromethane,ethyl acetate and toluenein. METHODS:Headspace GC was adopted. The determination was performed on the column of DB-624 column by temperature programming. The inlet temperature was 200 ℃,and hydrogen flame ionization detector was adopted with the temperature of 250 ℃;nitrogen gas was used as carrier gas with flow rate of 2.0 mL/min;the splitting-radio was 5 : 1,and sample size was 1 mL;the headspace tem-perature was 80 ℃ and the equilibrium time was 20 min. RESULTS:The linear range were 12.56-628.00 μg/mL for methanol(r=0.9997),20.22-1011.20 μg/mL for isopropanol(r=0.9999),1.96-97.76 μg/mL for acetonitrile(r=0.9997),3.10-154.88 μg/mL for dichloromethane(r=0.9998),20.69-1034.56 μg/mL for ethyl acetate(r=0.9998),and 3.53-176.72 μg/mL for toluene(r=0.9998);the limits of quantitation were 1.00,0.91,0.47,0.93,0.41 and 0.35 μg/mL respectively;the limits of detection were 0.31,0.30,0.14,0.31,0.12 and 0.11 μg/mL respectively;RSDs of precision,stability and reproducibility tests were lower than 3%;the recoveries were 94.53%-101.29%(RSD=2.15%,n=9),97.78%-103.42%(RSD=1.77%,n=9),96.99%-105.76%(RSD=2.59%,n=9),96.83%-102.05%(RSD=1.86%,n=9),97.98%-101.13%(RSD=0.88%,n=9)and 97.80%-102.40%(RSD=1.41%,n=9). CONCLUSIONS:The method is sensitive and accurate,can be used for the simultaneous determination of 6 kinds of residual organic solvents in Omeprazole magnesium,such as methanol,isopropanol,acetonitrile,dichloromethane,eth-yl acetate and toluenein.

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Content Determination of Paeonol in Cynanchum paniculatum by Three-dimensional Fluorescence Coupled with ATLD Algorithm

Xuemei BAI ; Delong LIU ; Yongju WEI

China Pharmacy.2017;28(15):2089-2092. doi:10.6039/j.issn.1001-0408.2017.15.21

OBJECTIVE:To determine the content of paeonol in Cynanchum paniculatum by three-dimensional fluorescence coupled with ATLD algorithm. METHODS:The trilinear model was established. The principle of least square was used for ATLD. The component value was fitted by core consistency diagnosis,and inner filter effect was corrected by mathematical correction method. Fluorescence scanning condition included excitation wavelength of 250-400 nm,emission wavelength of 410-600 nm, wavelength interval of 5 nm,slit width of 5.0/5.0 nm,scanning speed of 1200 nm/min. Determination and absorption spectrum condition included scanning wavelength of 250-600 nm,scanning speed of 600 nm/min;Al(Ⅲ)was used as the sensitizer to in-crease the fluorescence intensity of paeonol. The content of paeonol was determined by HPLC. RESULTS:The linear range of pae-onol was 0.132-1.188 μg/mL(r=0.9999). RSDs of precision,stability and reproducibility tests were less than 3.0%. The recover-ies were 100.1%-104.7%(RSD=2.39%,n=6). The analysis spectrum of paeonol was almost completely overlapped with the actu-al spectrum. The results of HPLC method are very similar to those of ATLD algorithm. CONCLUSIONS:The three-dimensional fluorescence coupled with ATLD algorithm is simple,rapid,efficient and accurate,and can be used for the qualitative and quantita-tive analysis of complex system.

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Improvement of Determination Method for the Dissolution of Dihydroartemisinin in Dihydroartemisinin and Piperaquine Phosphate Tablets

Mian ZHANG ; Chao LI

China Pharmacy.2017;28(15):2086-2089. doi:10.6039/j.issn.1001-0408.2017.15.20

OBJECTIVE:To improve the detection method for the dissolution of dihydroartemisinin in Dihydroartemisinin and piperaquine phosphate tablets. METHODS:The dissolution experiment adopted paddle method using 0.1 mol/L hydrochloric acid so-lution 500 mL as solvent with rotating speed of 75 r/min and sampling time of 45 min. In sample pre-treatment,the volume of 3.6% sodium hydroxide solution was increased from 5 mL to 20 mL,and that of phosphoric acid was increased from 0.2 mL to 0.7 mL. HPLC was adopted to determine the dissolution of dihydroartemisinin. The determination was performed on YMC-Pack ODS-A column with mobile phase consisted of 0.02 mol/L disodium hydrogen phosphate solution(pH adjusted to 2.4 using phosphoric ac-id)-acetonitrile(65 : 35,V/V)at the flow rate of 1.0 mL/min. The detection wavelength was set at 237 nm,and column temperature was 30 ℃. The sample size was 20 μL. RESULTS:The linear range of dihydroartemisinin were 7.802-117.03 μg/mL(r=0.9999). The limit of quantitation was 2.0 ng,and the limit of detection was 0.6 ng. RSDs of precision and reproducibility tests were all low-er than 1.0%. The recoveries were 99.18%-100.46%(RSD=0.45%,n=9). Average dissolutions of dihydroartemisinin in 3 batch-es of samples were 94.9%,77.9%,89.6%,respectively. CONCLUSIONS:Improved method enhance the accuracy for the limit of sensitivity,dissolution and detection results.

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Meta-analysis of Yishen Huashi Granules in the Adjuvant Treatment of Chronic Nephritis

Xiaojun DUAN ; Shuyun CHEN ; Ping TAN

China Pharmacy.2017;28(15):2082-2085. doi:10.6039/j.issn.1001-0408.2017.15.19

OBJECTIVE:To evaluate the effectiveness and security of Yishen huashi granules in the adjuvant treatment of chronic nephritis systematically,and to provide evidenced-based reference. METHODS:Retrieved from CBM,CJFD,Wanfang database,VIP,Medline,PubMed,EMBase and Cochrane library,randomized controlled trials(RCTs)about Yishen huashi gran-ules in the treatment of chronic nephritis were collected and related magazines were retrieved by hand. After selection and data ex-traction by 2 researchers independently,the quality of included literature was evaluated according to Jadad rating scale,and Me-ta-analysis was conducted by using Rev Man 5.3.5 software. RESULTS:A total of 8 RCTs were included,involving 1028 patients. Total response rate of trial group [RR=1.33,95%CI(1.24,1.42),P<0.001] was significantly higher than that of control group. 24 h urine protein quantity [MD=-0.32,95%CI(-0.40,-0.24),P<0.001],serum creatinine [MD=-22.38,95%CI(-23.37,-21.39),P<0.001],blood urea nitrogen [MD=-1.45,95%CI(-2.05,-0.84),P<0.001] were significantly lower than control group,with statistical significance. CONCLUSIONS:Based on routine treatment,Yishen huashi granules have good therapeutic ef-ficacy for chronic nephritis,can reduce 24 h urine protein and improve renal function.

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Evidence-based Review on Yanhuning Injection in the Treatment of Epidemic Mumps

Bo TIAN ; Jianxin HU ; Ruiyue HU ; Zhiyou LI

China Pharmacy.2017;28(15):2077-2081. doi:10.6039/j.issn.1001-0408.2017.15.18

OBJECTIVE:To systematically evaluate therapeutic efficacy of Yanhuning injection in the treatment of epidemic mumps,explore valid way of evidence-based review,provide reference for the selection of new essential medicine list. METH-ODS:Retrieved from PubMed,CJFD,Wanfang database and VIP,randomized controlled trials(RCTs)about Yanhuning injection alone or combined with other positive drugs(trial group)vs. other positive drugs(control group)in the treatment of epidemic mumps. Meta-analysis was conducted by using Rev Man 5.3 statistical software after quality evaluation by modified Jadad scale. RE-SULTS:Totally 26 RCTs were included,involving 2613 patients. Results of Meta-analysis showed,overall response rate [OR=5.28,95%CI(3.92,7.11),P<0.001] of trial group was significantly higher than that of control group;defervescence time [MD=-1.97,95%CI(-2.83,-1.12),P<0.001],swelling disappearance time [MD=-2.05,95%CI(-2.53,-1.58),P<0.001] and pain disappearance time [MD=-1.39,95%CI(-2.02,-0.75),P<0.001] of trial group were significantly shorter than those of control group,there was statistical significance. CONCLUSIONS:Yanhuning injection has good curative effect for epidemic mumps,and can significantly shorten defervescence time,swelling disappearance time and pain disappearance time.

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Literature Analysis of 20 Cases of Amiodarone-induced Pulmonary Toxicity

Meixin DU ; Xilan CHEN ; Xiaoqi LIU

China Pharmacy.2017;28(15):2066-2068. doi:10.6039/j.issn.1001-0408.2017.15.15

OBJECTIVE:To summarize general regularity and characteristics of amiodarone-induced pulmonary toxicity,and to provide reference for rational use of amiodarone and avoiding the occurrence of ADR. METHODS:Retrieved from CNKI,VIP and Wanfang database,individual case report literatures about amiodarone-induced pulmonary toxicity were collected during 1990-2016. The included cases were analyzed statistically. RESULTS:A total of 19 related literatures were collected,involving 20 cases of amiodarone-induced pulmonary toxicity. Among them,the patients older than 60 years old accounted for 75.0% with ratio of male to female 3:1. 75.0% patients had used medicine more than 1 month when pulmonary toxicity occurred. The dose of amiod-arone in 17 patients ranged 200-400 mg/d. Six patients died,accounting for 30.0%. CONCLUSIONS:Pulmonary toxicity induced by amiodarone may be related to patients'gender,age,dose and medication time. The mortality of it is in relative high level. Med-ical staff should pay attention to it,regularly monitor and process it timely.

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Analysis and Treatment of Paclitaxel-induced Muscle Soreness

Lili HU ; Chao DONG ; Laicheng WANG ; Di YIN ; Zhengqiu ZHU ; Chao GAO ; Guangqing HUANG ; Xiao LI

China Pharmacy.2017;28(15):2063-2065. doi:10.6039/j.issn.1001-0408.2017.15.14

OBJECTIVE:To observe the occurrence of paclitaxel(PTX)-induced muscle soreness and therapeutic efficacy and safety of diclofenac sodium. METHODS:Among 84 patients with malignant tumor receiving PTX chemotherapy,56 patients suf-fered from PTX-induced muscle soreness,among which 22 female patients suffered from medium and severe muscle soreness and then were randomly divided into group A and B,with 11 cases in each group. Group A was given Diclofenac sodium sustained-re-lease tablet 75 mg orally,once a day;group B was given Paracetamol and tramadol hydrochloride tablets one tablet orally,once a day,and then given Promethazine hydrochloride injection 100 mg subcutaneously,2-3 times a day when muscle soreness could not be born. Treatment course of both groups lasted for 5 d. The distribution of muscle soreness were observed. The onset time and dura-tion of muscle soreness were also observed as well as pain relief and the occurrence of ADR in group A and B. RESULTS:Among 84 cases,the incidence of muscle soreness was 66.67%,among which mild pain accounted for 23.81%,moderate pain accounted for 13.10%,and severe pain accounted for 29.76%. Among 56 patients with muscle soreness,earliest muscle soreness occurred on the day of medication,and most of muscle soreness occurred on 1-3 days after medication,mainly manifesting as sore,activity limitation when severe,associated with fatigue. The pain relief rate of group A and B were 100%,but the incidence of adverse re-actions in group A was significantly lower than group B,with statistical significances(P<0.05).CONCLUSIONS:Diclofenac sodi-um is similar to paracetamol and tramadol hydrochloride in the treatment of PTX-induced muscle soreness,but it is better than paracetamol and tramadol hydrochloride in safety.

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Effects of Midazolam Combined with Tramadol on Prognosis of Patients Underwent Tumor Resection in Gastrointestinal Surgery Department

Dezhong ZHANG ; Lili WANG

China Pharmacy.2017;28(15):2057-2059. doi:10.6039/j.issn.1001-0408.2017.15.12

OBJECTIVE:To investigate the effects of tramadol combined with midazolam on prognosis of patients underwent tumor resection in gastrointestinal surgery department. METHODS:In retrospective study,200 tumor patients of gastrointestinal sur-gery department were divided into observation group(100 cases)and control group(100 cases). Observation group was given Tra-madol hydrochloride tablet 100 mg,3 times a day+Midazolam injection 30 mg,added into 0.9% Sodium chloride injection 60 mL,via intravenous pump,2.5 mL/h,for consecutive 24 h,for consecutive 3 d. Control group was given Tramadol hydrochloride injection 100 mg,intramuscular injection,3 times a day,for 3 d. The hospitalization duration,postoperative ambulation time, sleep quality score,pain degree score,the occurrence of postoperative hypostatic pneumonia,and the incidence of adverse reactions in 2 groups were observed. RESULTS:The hospitalization duration and postoperative ambulation time of observation group were significantly shorter than those of control group;the sleep quality score of observation groups was significantly higher than that of control group;the severity of pain,the incidence of hypostatic pneumonia were significantly lower than control group,with statisti-cal significance(P<0.05). There was no statistical significance in the incidence of ADR between 2 groups(P>0.05). CONCLU-SIONS:Midazolam combined with tramadol can significantly reduce the postoperative pain of tumor patients in gastrointestinal tu-mor surgery department,shorten hospitalization time and postoperative ambulation time,improve the sleep quality of patients and reduce the incidence of hypostatic pneumonia with good safety.

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