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OBJECTIVE To extract the effective components of Psoralea corylifolia and evaluate its efficacy in the treatment of vitiligo. METHODS The concentrations of psoralen， isopsoralen， neobavaisoflavone， corylin， psoralidin， corylifolinin， and bakuchiol in P. corylifolia extract were determined by ultra-performance liquid chromatography. Based on the analytic hierarchy process （AHP） and Plackett-Burman design， with the concentrations of the 7 components as evaluation indexes and the crushing degree， ethanol concentration， and soaking time as factors， the extraction process of P. corylifolia was optimized by Box-Behnken response surface methodology and the validation test was conducted. Zebrafish were divided into blank control group， positive control group （8-methoxypsoralen， 10.8 μg/mL）， and low-， medium-， and high-concentration groups of P. corylifolia extract （500， 1 000， 2 000 μg/mL）， with 6 fish in each group. The effects of P. corylifolia extract on the melanin production of zebrafish were studied by density analysis. RESULTS The best extraction process was P. corylifolia powder over 60 meshes and soaked in 80% ethanol for 72 hours. The average comprehensive score of three validation experiments was 98.27， with an RSD of 1.36%， and the relative error was 1.02% compared with the predicted value of the fitting equation （97.28）. Compared with the blank control group， the melanin pigmentation of zebrafish in the low-， medium-， and high-concentration groups of P. corylifolia extract was significantly increased （P＜0.01）. CONCLUSIONS The optimized extraction process of P. corylifolia is reasonable and feasible， and the obtained P. corylifolia extract can significantly promote the production of melanin in zebrafish.
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Objective To develop a HPLC-MS/MS method for the absolute bioavailability study of salidroside in Beagle dogs. Methods Gastrodin was used as internal standard. Plasma samples were treated by protein precipitation and separated by Symmetry RP18 column (100 mm×4.6 mm, 3.5 μm). 0.1% formic acid in water(A) and 0.1% formic acid in acetonitrile: methanol (20 : 80, V/V) (B) were used as the mobile phase for isocratic elution with 35% mobile phase B. The flow rate was 0.4 ml/min. Column temperature was 40 ℃. Injection volume was 2 μl. By electrospray ionization source (ESI) and multi-reaction monitoring (MRM) mode, the MRM ion pairs of salidroside and gastrodin were identified as m/z 299.1→118.9 and m/z 285.1→122.9, separately. Blood samples were collected at different time points after oral or intravenous administration of salidroside. The harvested plasma samples were analyzed by HPLC-MS/MS method to assess the pharmacokinetics and absolute bioavailability of salidroside. Results Excellent linearity(r>0.998 6) was found in the concentration range of 10−10 000 ng/ml for salidroside and the lowest quantitative concentration was 10 ng/ml. The recovery was 89.5%−91.8%. The intra-day precision (RSD) was less than 9.7%, and the inter-day precision (RSD) was less than 7.3%. After a single oral dose of 15 mg/kg or an intravenous injection of 1.5 mg/kg of salidroside, cmax was (9 680±3725) and (9 310±1 645) ng/ml; tmax was (1.25±0.67) and (0.011±0.017) h, AUC0−t was (20 535.4±5 200.0) and (4 646.7±720.5) ng·h/ml, AUC0−∞ was (20 607.9±5 266.2) and (4 691.6±715.2) ng·h/ml; t1/2 was (1.31±0.63) and (0.98±0.13) h, respectively. Conclusion The LC-MS/MS method established in this study was simple, rapid, sensitive and reliable. It meets the regulatory requirements of biological analysis for pharmacokinetic properties of salidroside in Beagle dogs. The absolute bioavailability of salidroside in Beagle dogs is (43.9±11.2)%.
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OBJECTIVE：To establish a method for concentration determination of anlotinib in human plasma and apply it in the clinic. METHODS ：The plasma samples were pretreated by salting-out assisted with liquid-liquid extraction with ammonium acetate as salting out assistant and acetonitrile as solvent. Using voriconazole as internal standard ，LC-MS/MS method was adopted. The separation was performed on Waters X Bridge C 18 column with mobile phase consisting of 0.2％ formic acid solution- acetonitrile（gradient elution ）at the flow rate of 1 mL/min. The column temperature was set at 40 ℃，and sample size was 10 μL. The split ratio was 3∶7. The electrospray ion source and multiple reaction monitoring mode were used for the analysis. The ion pair of anlotinib and internal standard under positive ion mode were m/z 408.3→339.3 and m/z 350.2→281.3，respectively. RESULTS ： Anlotinib showed a good linear relationship in the concentration range of 0.2-200 ng/mL（R2＞0.996 7）. The lowest limit of quantitation was 0.2 ng/mL. Intra-day and inter-day RSDs were no more than 12％ （n＝6 or n＝3）. Accuracies were 90.92％-108.00％（n＝6 or n＝3）. The average extraction recoveries were 87.51％-100.00％（RSD＜8％，n＝6）. The average matrix effects were 96.66％-99.93％（RSD＜5％，n＝6）. The plasma concentration of 3 patients with NSCLC treated with anlotinib was 8.74-65.60 ng/mL. CONCLUSIONS ：The method is simple ，accurate and specific ，and is suitable for the plasma concentration monitoring of anlotinib in NSCLC patients.
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OBJECTIVE：To study the effects of rat intestinal flora on the pharmacokinetic parameters of pyrazinamide and its active metabolite pyrazinoic acid. METHODS ：Totally 16 SD rats were randomly divided into trial group and control group ，with 8 rats in each group. Trial group was given mixed antibiotics （streptomycin sulfate+neomycin sulfate ）intragastrically to construct pseudoaseptic rat model. After modeling ，both groups were given pyrazinamide intragastrically （150 mg/kg）. Before and 0.167， 0.333，0.667，1，1.5，2，3，4，6，9 h after administration ，0.1 mL blood sample was collected from orbital venous plexus ，and 0.3 mL blood sample was collected from orbital venous plexus 12，24 h after administration. Using phenacetin as internal standard ， LC-MS/MS method was adopted to determine the plasma concentration of pyrazinamide and pyrazinoic acid. The determination was performed on Agilent ZORBAX SB-Aq column with mobile phase consisted of 0.2％ formic acid （containing 8 mmol/L ammonium acetate）-methanol（gradient elution ）at the flow rate of 1 mL/min. The column temperature was set at 30 ℃，and sample size was 10 μL. The ion source was ESI and the temperature of ion source was 500 ℃. The collision gas was nitrogen and the pressure was 10 psi. The temperature of mass transfer interface was 100 ℃. The mass spectrum monitoring mode was multi reaction monitoring ， and the collection mode was positive ion mode. The monitoring transition ion-pairs were m/z 124.0→79.0（pyrazinamide），m/z 125.1→79.1（pyrazinic acid ）and m/z 180.0→110.2（internal standard ）. The de-clustering potential and collision voltage were 55， 26 and 85 V，24，23 and 28 V，respectively. The pharmacokinetic parameters were calculated and compared by using DAS 2.1.1 software. RESULTS ：The linear ranges of pyrazinamide and pyrazinoic acid were 25-5 000 ng/mL（r＝0.997 6）and 100-12 500 ng/mL（r＝0.999 0）. The lower limits of quantification were 25 and 100 ng/mL，respectively. Intra-batch and inter-batch accuracy were 92.93％-100.50％，and RSDs of intra-batch and inter-batch precision and matrix effect tests were all lower than or equal to 8.42％（n＝6 or n＝3）. Compared with control group ，tmax of pyrazinamide in trial group was prolonged significantly （P＜0.01）； there was no statistical significance in other pharmacokinetic parameters between 2 groups（P＞0.05）. CONCLUSIONS ：The absorption of single dose pyrazinamide is delayed with the change of intestinal flora in rats.
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OBJECTIVE：To analyze the mass spectrometry fragmentation regularity of bicyclol ，bifendate and schisandrin C ， and to identify the impurities of bicyclol raw material. METHODS ：UHPLC-ESI-Q-TOF-MS method was adopted. Using electrospray ionization source ，in positive ion mode ，the excimer ion and characteristic fragments of bicyclol ，bifendate and schisandrin C were analyzed by means of TOF-MS. According to the mass change of fragments ，the possible fragmentation pathways were speculated ，and the fragmentation regularity were analyzed and summarized. Bicyclol raw material sample was first separated by liquid chromatography to find the impurity peaks in it ，and then the impurity peaks were analyzed by mass spectrometer；the impurity identification was conducted by combining with the fragmentation regularity. RESULTS ：The 3 compounds all produced [M+H] + excimer ion in the positive ion mode. After collision-induced dissociation ，the C-O bond ，the simple rupture of the C-C bond and the ring-opening cleavage of the oxygen ring occurred ；with the loss of neutral fragments ， mainly CH 2O，supplemented by CO 2，CO and CHO ，the dissociation was concentrated in the middle and high quality regions. C-C and C-O bonds of 3 compounds were simply broken only in the branched chain structure and/or oxygen ring structure ，but the structure of the biphenyl parent nucleus remained unchanged. Among them ，the bicyclol contained a benzyl alcohol structure ，so under acidic mobile phase conditions ，it would exist stably in the form of [M+H －H2O]+. Because schisandrin C contained 8-membered ring structure，ring opening first occurred under collision voltage ，and then neutral fragment loss occurred. The secondary mass spectra of impurity in bicyclol raw material were consistent with the mass spectra fragmentation of secondary fragments of bifendate. CONCLUSIONS：The study summarized mass spectrometry fragmentation regularity of 3 schisandrin derivatives. The impurity in bicyclol raw material may be bifendate.
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Objective@#To establish an "integrated management system" for pelvic floor dysfunction and explore its effects on clinical practice.@*Methods@#A pelvic floor nursing team was set up to connect the outpatient management system, the ward perioperative management system and the home follow-up management nursing system, and to build an integrated management system for pelvic floor dysfunction diseases.@*Results@#After five years of practice, the qualified rate of residual urine in pelvic floor dysfunction patients increased from 58.2%(191/330) to 93.6%(309/328), the difference was statistically significant(χ2=113.008, P<0.01). The compliance of pelvic floor muscle exercise at home increased from 63.6%(210/330) to 83.8%(275/328). The difference was statistically significant(χ2=36.654, P<0.01).@*Conclusions@#The three level prevention of pelvic floor dysfunction disease has been formed through "the integrated management system", which can play a significant role in the development of disease management and specialized nursing.
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Objective To establish an "integrated management system" for pelvic floor dysfunction and explore its effects on clinical practice. Methods A pelvic floor nursing team was set up to connect the outpatient management system, the ward perioperative management system and the home follow-up management nursing system, and to build an integrated management system for pelvic floor dysfunction diseases. ResuLts After five years of practice, the qualified rate of residual urine in pelvic floor dysfunction patients increased from 58.2% (191/330) to 93.6% (309/328), the difference was statistically significant( χ2=113.008, P<0.01). The compliance of pelvic floor muscle exercise at home increased from 63.6%(210/330) to 83.8%(275/328). The difference was statistically significant( χ2=36.654, P<0.01). ConcLusions The three level prevention of pelvic floor dysfunction disease has been formed through "the integrated management system", which can play a significant role in the development of disease management and specialized nursing.
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Objective:To analyze the role of clinical pharmacists played in the drug consultation and advice in orthopedic ward in order to discuss the work mode and the effects of clinical pharmacists in orthopedic ward and improve the service quality of clinical pharmacy. Methods:The work records related to the drug treatment of clinical pharmacists were collected during January 2013 and December 2015. The aspects of service objects, involving drugs, issue categories and the results of feedback were summarized and analyzed.Results:The study summarized 504 work records of clinical pharmacists participating in the drug treatment in orthopedic ward. The rational use of antimicrobial drugs,analgesics and anticoagulants was the key work for clinical pharmacists. Frequently asked questions were drug selection, dosage, treatment plan, drug information, precautions and contraindications, pharmacological effects,adverse drug reactions and drug interactions. The advices of clinical pharmacists were accepted by orthopedists regularly, and the drug treatment regimes were improved with the help of clinical pharmacists. Conclusion:Clinical pharmacists participating in clinical practice can improve rational pharmacotherapy, and also contribute to the cultivation and improvement of self-quality of clinical pharmacist.
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Objective:To explore a new way of pharmaceutical service mode for disease treatment. Methods:Clinical pharmacists actively participated in the pharmaceutical care for a patient with mixed liver injury, and provided clinical pharmaceutical services through the adverse reaction analysis,etiological mechanisms exploration,therapeutic drugs selection and risk factors prevention. Re-sults:Clinical pharmacists cooperating closely with physicians helped to identify problems in time,and then the medication analysis in the fields of drug selection, dose determination, efficacy evaluation and indicators detection was performed, so that the strategies on medicine treatment could be adjusted timely as the disease progressed. With the gradual recovery of liver function, the patient dis-charged after the conditions were improved. Conclusion:By participating in pharmaceutical practice,clinical pharmacists can provide clinical pharmaceutical service,which is helpful to safety improvement and efficiency of drug administration. It is also an effective way to enhance the learning ability of pharmacists,and cultivate their clinical thinking and practice capacity.
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Objective:To evaluate the correlation of inter-individual variation of cyclosporine dosage and blood concentration and CYP3A4 and CYP3A5 polymorphism in renal transplant recipients. Methods:Two hundred and twenty-one renal transplant recipients treated with cyclosporine were genotyped for CYP3A4 rs4646437C>T and CYP3A5 6986G>A using ligase detection reactions. The effects of genetic polymorphisms of CYP3A4 and CYP3A5 on cyclosporine trough concentration (C0/D) and 2 h post-dose concentra-tion (C2/D) during the period of 6 months, 6-24 months and above 24 months after renal transplant were studied. Results:CYP3A5 6986G>A genotype affected C0/D during the period of 6 months, 6-24 months and beyond 24 months (PGA>AA. CYP3A4 rs4646437C>T and CYP3A5 6986G>A genotype affected C2/D during the period above 24 months (PCT>TT and CYP3A5 6986GG>GA>AA. Conclusion: CYP3A5 6986G>A genotype affects C0/D and C2/D of cyclosporine, and CYP3A4 rs4646437 C>T genotype affects C2/D of cyclosporine. The effects of genotypes are varied in different stages.
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Objective To explore the effect of group management mode on compliance of pelvic floor function exercise for patients with post partum urinary incontinence (PPUI). Methods A total of 80 cases of patients with PPUI were randomly divided into the observation group and the control group. Patients in the control group received one-to-one routine health guidance. Patients in the observation group received group management mode including special subject teaching guidance, induction and communication between patients. Three months after the intervention, two groups of patients were evaluated at six months after postpartum by the pelvic floor muscle strength, one-hour urine pad test and pelvic floor muscle function exercise compliance. Results Six months after postpartum, the cure rate of the pelvic floor muscle strength was 100%(40/40) for typeⅠmuscle, 100%(40/40) for typeⅡmuscle in the observation group. In the control group, the cure rate for typeⅠmuscle was 70%(28/40) and 65%(26/40) for type Ⅱmuscle. The difference between these two groups was statistically significant (χ2=14.118, 16.970, P=0.000). The total effective rate of urinary incontinence was 100.0%(40/40) in the observation group, 67.5% (16/40) in the control group, and there was statistical significance (χ2=25.232, P=0.000). Evaluation of the compliance of pelvic floor function exercise showed that the rates were 72.5% (29/40) for complete compliance, 27.5%(11/40) for incomplete compliance and 0 for total non-compliance in the observation group. In the control group, these rates were 2.5%(1/40), 55.0%(22/40), 42.5%(17/40). And there was statistical significance as well (χ2=54.847, P=0.000). Conclusions Group management mode can improve the compliance of pelvic floor muscle function exercise and the strength of pelvic floor muscle, and improve the degree of urinary incontinence in postpartum patients with urinary incontinence.
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Objective To optimize separation and purification technology of Zhizichi decoction by macroporous resina . Methods The content of total iridoid glycosides and total isoflavones were determined by ultraviolet spectrophotometry .Tak-ing the content of total iridoid glycosides and total isoflavones as indexes ,the effect of the concentration of sample solution , medicinal herbs on the amount of sample ,concentration and volume of eluent was investigated by single factor test .Results The optimum separation and purification technology was as following :the concentration of sample solution was 0 .1 g/ml ,the volume ratio of resin to material drug was 2∶1 ,the adsorption time was 2 h ,and the sample was firstly eluted with 1 BV wa-ter ,then 6 BV 20% ethanol and 60% ethanol ,and the eluent was collected .Conclusion This optimized separation and purifi-cation technology was reasonable and stable ,and it could be extended to large-scale production applications .
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A high performance liquid chromatography-electrospray ionization mass spectrometry- charged aerosol detection ( HPLC-MS-CAD) method was established for the simultaneous quantitative analysis of four Lignans in Magnoliae Flos extract. The components were separated on a YMC-Pack ODS-A column (250 mm× 4. 6 mm, 5 μm) by gradient elution with methanol and water as the mobile phase at aflow rate of 1. 0 mL/min. Then the elution solution was routed into MS equipment at a flow rate of 0. 3 mL/min and CAD detector at a flow rate of 0. 7 mL/min by a split ratio of 3:7 for the further detection. The column temperature was 25 ℃ and the detection wavelength was 278 nm. A method was developed for the quantitative analysis of muti-components by single maker ( QAMS) to determine pinoresinol dimethylether, magnoli, 1irioresinol B dimethylethe and epi-magnoli A . Magnoli was selected as internal standard and the relative correction factors ( RCF) of the four Lignans were calculated. The contents of the four Lignans in Magnoliae Flos extract were determined by both external standard method and QAMS. The QAMS method was evaluated by comparison of its assay result and that of external standard method. Under the selected chromatographic condition, the limits of detection of pinoresinol dimethylether, magnoli, lirioresinol B dimethylethe and epi-magnoli A were 0. 34, 0. 55, 0. 50 and 0. 58 mg/L, respectively, while the linear range were within 6. 8-270 mg/L, 11-546 mg/L, 2. 0-101 mg/L and 2. 3-116 mg/L. The recoveries ( n=9 ) were 98. 2%-99. 5%, and the correlation coefficient were 0 . 9995-0 . 9998 . No significant differences were found between the quantitative results of external standard method and QAMS method. The developed method is accurate, feasible, and can be used for quality evaluation of Magnoliae Flos .
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Objective To explore the effect of pre-operation intestinal preparation by orally taking magnesium sulfate of different concentrations. Methods 50 patients were divided into the high-concentration group and the low - concentration group, according to the concentration of magnesium sulfate orally taken for pre-operation intestinal preparation. Some factors were compared between the two groups including: the acting amount of water, starting and lasting timing of magnesium sulfate, times of stool, the efficiency of the intestinal preparation, the tolerance, uncomfortable reaction and changes of serum electrolyte of the patients. Results There were no difference between the two groups on the acting amount of water, starting and lasting timing of magnesium sulfate, times of stool, the efficiency of the intestinal preparation, the tolerance of the patients. The rate of the stool without solid substance was higher in the high-concentration group than the low-concentration group(40% vs 8%). The uncomfortable reaction rate was also higher in the high-concentration group, the concentration of serum electrolyte decreased in both groups, among which serum Ca2+ decreased significantly in the low-concentration group. Conclusions Orally taking magnesium sulfate of different concentrations both has effect on bowel preparation, influence on patients' serum electrolyte is remarkable.
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Objective：To evaluate bioequivalence and relative bioavailability of domestic and imported repaglinide tablets in healthy volunteers. Methods： Twenty two healthy male volunteers were randomized into A and B groups. A single dose (4 mg) of domestic and imported repaglinide tablets were given respectively according to an open 2-way crossover study design. The washout period was 1 week. Plasma concentrations of repaglinide were determined by HPLC method. Results：The pharmacokinetic parameters of domestic and imported drugs were as follows: t1/2 were(0.86±0.24) and (0.83±0.31) h；tmax were( 0.79±0.37) and (0.75±0.41) h；cmax were (52.43±20.92) and (53.32±24.94) μg/L. AUC0-t were (79.87±36.48) and (74.95±30.57) μg*h*L-1，respectively. The relative bioavailability of domestic formulation was (106.55±16.15)%. Conclusion： The results of variance analysis and two one-side t test show that 2 formulations are of bioequivalence.
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Objective:To analyze the chemical constituents of Rhizoma belamcandae by using high-performance liquid chromatography-diode array detector/electrospray ionization-mass spectrometry (HPLC-DAD/ESI-MS).Methods: Dried Belamcanda chinensis powder was extracted with 70% ethanol by sonication.The chromatographic separation was performed on a YMC ODS-C18 column (250 mm?4.6 mm I.D.,5 ?m) with a mobile phase composed of 20%CH3OH(A)-70%ACN(B) (0→30→45→65 min,20→30→90→100 B),eluted at a flow rate of 0.45 ml/min,and the UV detection wavelength was set at 265 nm.Positive ionization mode with a needle voltage of 5 000 V,a capillary voltage of 20 V,a gas(N2)press of 20 psi and a temperature of the drying gas of 300℃ was selected.Relative molecular mass data acquisition was performed from m/z 250 to 550 in full MS scan mode.Results: Nine major isoflavones were identified from Rhizoma belamcandae based on their retention behavior obtained on-line by their UV spectra and the HPLC-DAD/ESI-MS.Conclusion: A rapid and efficient HPLC-DAD/ESI-MS method for identifying the chemical constituents of Belamcandae chinensis has been established,which provides more scientific information for quality control of Rhizoma belamcandae.
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Objective:To establish a method by combining microwave-assisted extraction(MAE),solid phase extraction(SPE)and high performance liquid chromatography(HPLC)for determination of the mefenacet residues in rice.Methods:Acetone and acetontrile(37)were used as extraction solvent.Microwave-assisted extraction was used to extract mefenacet residues in the rice.The extracts were then cleaned up with a Florisil cartridge and then subjected to Hypersil C18 column(5 ?m,4.6 mm?200 mm),with acetonitrilewater(5050,V/V)solution as mobile phase and with a flow rate of 1.0 ml/min;the ultraviolet detection wavelength was at 217 nm.Results:Good linear correlation for mefenacet was found within a concentration range of 0.198-9.900 ?g/ml.The detection limit was 0.039 6 ?g/mL for mefenacet(S/N=2).The average recovery rate of rice hull and brown rice were 90.8%(RSD 1.8%)and 85.6%(RSD 2.5%),respectively.Conclusion:The present method is simple and rapid;it can be used for the determination of mefenacet residues in rice.
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Object To estabish a method for the quantitative analysis of osthol in LOTIO FRUCTUS CNIDII COMPOSITA by RP HPLC Methods Megestrol acetate was used as the internal standard Results Chromatographic separation of osthol and megestrol acetate was accomplished within 12 min on Hypersil ODS 2(200 mm? 4 0 mm, 5 ?m) column and acetonitrile 0 01 mol/L sodium dihydrogen phosphate (48∶52) as mobile phase The flow rate was 1 2 mL/min and the detection wavelength was 320 nm A good linearity was obtained in the range of 0 123 8～2 970 ?g/mL (r=0 999 6) for osthol and the average method recovery was (98 4?0 90) % with RSD=0 91% Conclusion The method was simple, rapid, accurate, reliable, and suitable for the quality control of LOTIO FRUCTUS CNIDII COMPOSITA
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Objective To investigate the intestinal absorption kinetics of breviscapine in rats.MethodsThe intestinal absorption in small intestine and colon of rats in situ was investigated using circular perfusion and HPLC methods.The in situ absorption of scutellarin in the small intestine was studied and the effects on the intestinal absorption were observed at the various concentrations and different pH values using the same methods.Results The results showed that there were significant differences in both absorptive percentage and absorption rate constant(ka)in the small intestine between the experimental groups of rats with and without bile duct being ligated.The absorption rate constants in small intestine and colon were(0.107 1?0.013 0)and(0.070 7?0.008 9)h-1,respectively.No saturation phenomenon occurred and ka was almost kept unchanged at different concentrations of breviscapine.The absorption of breviscapine was not influenced by pH values ranging from 6.0 to 7.4.Conclusion The results indicates that breviscapine is absorbed more in small intestine than in colon.The absorption of breviscapine complied with the passive diffusion mechanism and first order kinetics.In conclusion,these results suggest that breviscapine could be prepared in oral sustained-release dosage form.
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AIM: To provide a rapid method for identifying fruit of Eucalyptus globule labill. METHODS: A new method, using NIRS for rapid and nondestructive classfication of the fruit of Eucalyptus globules labill and its counterfeit drug, the fruit of Eucalyptus robusta Smith, was proposed and then cluster analysis was adopted. RESULTS: The result showed that two kinds of fruits had their own characteristic NIRS spectra. CONCLUSION: The method is quick, simple and reliable, and in combination of the fingerprint NIRS spectrum and the clustering analysis is easy to identify the adulteration.