Objective: To develop an HPLC method for the determination of rutin, hyperin and quercetin in Vicia sepium L. . Methods:The samples were separated on an Agilent ZORBAX Eclipse XDB-C18 column(250 mm × 4. 6 mm, 5 μm) with the mobile phase consisting of acetonitrile-1‰ phosphoric acid solution with gradient elution at the flow rate of 0. 8 ml·min-1 . The column tem-perature was 30℃, and the detection wavelength was set at 370 nm. Results: The linear range of the three components was 4. 090-130.940 μg ·ml-1(r=0.999 9), 4.600-147.200 μg ·ml-1(r=0.999 9) and 0.810-25.780 μg·ml-1(r=0.999 8), and the average recovery was 103. 45% (RSD=1. 25%), 98. 96% (RSD=1. 77%) and 102. 88% (RSD=0. 84%)(n=6), respectively. Conclusion:The method is stable, reproducible and simple, which can be used in the quality control of Vicia sepium L. .

At present, drug safety has gradually become the focus of world attention, and the study and control of related sub-stances is one of the key elements for drug safety. The national drug standards are also gradually increased the control requirements for related substances. Therefore, the detection and control of related substances are extremely important in the safety of drugs. By summa-rizing the analysis methods for related substances in drugsand their application , the paper alms to provide references for quality control of drugs.

Objective:To develop the uniformity models for felodipine sustalned-release tablets from 3 manufacturers by NIRS in order to study the difference in the preparation technology and detect and screen the tablets quickly by the robust, accurate and repre-sentative models. Methods:The uniformity models for the tablets from 3 manufacturers among 6 manufacturers with evaluative casual inspection were established by NIRS. Region 4 000-9 000 cm-1 was chosen as the modeling section, and the first derivative plus vector normalization was used as the preprocessing method. Results:The uniformity models for the tablets from the three manufacturers was established and used to predict the samplings from the six manufacturers. The prediction success rate was 100%. Conclusion: NIRS can be used to identify felodipine sustalned-release tablets from different manufacturers quickly and study the preparation technology.

Objective: To evaluate the bioavallability and bioequivalence of rabeprazole sodium enteric-coated pellets capsules. Methods:A randomized crossover design was performed in 32 healthy male volunteers. A single oral dose of 20 mg rabeprazole sodium enteric-coated pellets capsules ( test preparation) or enteric-coated shell capsules ( the reference capsules) was administrated under fed conditions. The wash period was 7 days. The blood samples were collected at different time points. The concentration of rabeprazole in plasma was determined by an LC-MS/MS method. The pharmacokinetic parameters were calculated by DAS 3. 0 software and the bio-equivalence was evaluated. Results:The maln pharmacokinetic parameters of the two formulations were shown as follows:T1/2 of (2. 20 ± 0. 83)h and(1. 951 ± 0. 515)h,Tmax of (3. 88 ± 1. 11)h and(4. 64 ± 1. 504)h,Cmax of (401. 06 ± 170. 75)ng·ml-1 and(394. 63 ± 215.64)ng·ml-1,AUC0→t of (918.42 ±427.39)ng·h·ml-1 and (994.49 ±520.73)ng·h·ml-1, and AUC0→∞ of(937.30 ± 445.13)ng·h·ml-1 and(1 011.69 ±534.77)ng·h·ml-1. The analysis showed that the maln pharmacokinetic parameters of the two formulations had no significant differences(P>0. 05) except for Tmax(P<0. 05). The relative bioavallability of rabeprazole sodium enteric-coated pellets capsules was (99. 80 ± 7. 20) %. Conclusion:Compared with the reference capsules, rabeprazole sodium enter-ic-coated pellets capsules show the property of higher dispersion degree, milder influence from food, more rapid release and absorption. The enteric-coated pellets capsules and the reference capsules are bioequivalence.

Objective:To study the in vitro and in vivo transdermal enhancement of one kind of arginine oligomer-chitosan ( CS-R9). Methods: In vitro mouse skin as the barrier, Franz diffusion cells were used to study the transdermal property of tinidazole ( TNZ) solution in vitro enhanced by CS-R9 using TNZ solution as the negative control and TNZ solution with Azone as the positive control. The rats were randomly divided into three groups, TNZ solution group ( the negative group) , TNZ solution with Azone group (the positive group) and TNZ solution with CS-R9 group. At the predetermined time intervals, 0. 5 ml blood was withdrawn from the rats and TNZ concentration was detected by HPLC to evaluate the enhancement of CS-R9 on TNZ in vivo. Results:Compared with the negative group, CS-R9 had significant enhancement on TNZ trandermal penetration in vitro(P <0.05), and showed no significant difference with Azone (P>0. 05). The in vivo results showed CS-R9 exhibited similar transdermal enhancement on TNZ as Azone at the same concentration (P>0. 05), and CS-R9 had sustalned-release property. Conclusion: CS-R9 has promising transdermal en-hancement on TNZ, which is valuable to be studied further.

Objective:To establish a determination method for the content and related substances of tadalafil tablets. Methods:An HPLC method was adopted. The determination was performed on a ZORBAX Eclipse XDB C8 (250 mm × 4. 6 mm,5μm) column with the mobile phase consisting of 0.1% trifluoroacetic acid-acetonitrile(65∶35)at a flow rate of 1.0 ml· min-1,the column temperature was controlled at 35℃, the detection wavelength was 285 nm and the injection volume was 20 μl. Results:The related substances could be completely separated from the maln component under the selected chromatographic conditions. A good linear relationship was found be-tween the peak area and the concentration of tadalafil within the range of 20. 13-201. 30μg·ml-1(r=0. 999 3) with the average recover-y of 99. 5% (RSD=1. 1%, n= 9). The limit of detection was 0. 6 ng and the limit of quantification was 2 ng. Conclusion:The method is specific and sensitive, and can be used in the determination of content and related substances of tadalafil tablets.

Objective:To observe adjuvant curative effect and adverse reactions of montelukast in the treatment of children with bronchial asthma and its effect on recurrence. Methods:Totally 180 cases of children with bronchial asthma were randomly divided in-to the control group and the observation group with 90 ones in each. The control group was treated with oxygen and budesonide terbutal-ine inhalation, intravenous methylprednisolone sodium succinate and the other conventional treatment methods, and the observation group was additionally treated with montelukast sodium tablets 5 mg, po, qd. The treatment course was three months, and then expira-tory dyspnea, disappearance time of asthma and wheeze and adverse drug reactions in the two groups were evaluated. After 3-6-month follow-up, the recurrence was compared between the two groups as well. Results: The disappearance time of dyspnea, asthma and wheeze in the observation group was shorter than that in the control group (P<0. 05), the total effective rate in the observation group was 96. 67%, which was significantly higher than that in the control group (73. 33%, P<0. 05). The mean follow-up duration was (5. 1 ± 0. 3) months, and the recurrence rate was 8. 51% in the observation group, which was significantly lower than that in the con-trol group (31. 43%, P<0. 05). During the treatment, no significant adverse drug reaction was appeared in the two groups. Conclu-sion:The conventional drug treatment combined with montelukast can rapidly improve the clinical symptoms and reduce recurrence with promising safety, which is worthy of clinical application.

Objective:To observe the clinical efficacy and safety of docetaxel combined with 5-fluorouracil in the treatment of pa-tients with advanced gastric cancer. Methods:Totally 84 cases of gastric cancer patients were randomly divided into group A and group B with 42 ones in each. Group A was given chemotherapy of docetaxel combined with 5-fluorouracil, and group B was treated with chemotherapy of Tegafur combined with docetaxel. One cycle was 21 days, and the patients were given at least two cycles of chemother-apy. The recent clinical curative effect, physical state improvement and adverse reactions in the two groups after the treatment were ob-served. Results:The total effective rate of the two groups showed no significant difference (P<0. 05), however, the physical state improvement rate of group A (40. 48%) was significantly higher than that of group B (20. 24%) with statistical significance (P<0. 05). The incidence of thrombocytopenia and neutropenia decrease of group A was significantly lower than that of group B with statis-tically significant difference (P<0. 05). Conclusion:The treatment of advanced gastric cancer patients with docetaxel combined with 5-fluorouracil can achieve significant clinical efficacy with relatively mild toxicity,it can significantly improve the physical state of pa-tient.

Objective:To investigate the correlation between plasma concentration and effective dose of tacrolimus in the treatment of membranous nephropathy. Methods: Totally 41 patients with membranous nephropathy were given tacrolimus combined with hor-mone at low dose. The valley plasma concentration of tacrolimus was detected using a homogeneous enzyme multiplied immunoassay method. According to the changes of 24-hour urine protein,serum albumin and kidney function, the clinical efficacy was evaluated. The correlation between curative effect and plasma concentration and dosage of tacrolimus in the treatment of membranous nephropathy was analyzed. Results:The plasma concentration of tacrolimus was (7. 47 ± 2. 74) ng·ml-1 and the dosage of administration was (0.047 ±0.007)mg·kg-1·d-1 in complete remission group, that in partial remission group respectively was (5.72 ±1.19)ng· ml-1 and(0.049 ±0.008)mg·kg-1·d-1, and that in non-remission group was respectively (3.30 ±1.08 )ng·ml-1 and (0.052 ± 0. 01)mg·kg-1·d-1. Conclusion: The clinical efficacy of tacrolimus in the treatment of membranous nephropathy has close rela-tionship with the plasma concentration,and that is promising when the plasma concentration within the range of (5. 10-9. 32) ng· ml-1 . The plasma concentration of tacrolimus isn't increased with the dosage increase in some patients.

Objective:To establish the determination method for total flavonoids in Cyperus rotundus and investigate the total fla-vonoids content in Cyperus rotundus from different habitats. Methods:Total flavonoids in Cyperus rotundus from different habitats were detected by ultraviolet spectrophotometry with rutin as the standard substance. Results:The absorbance of rutin had a good linear cor-relation with the concentration within the range of 0.064 3-0.642 6 mg·ml-1(r =0.999 1). The average recovery was 99.74%(RSD=2. 16%,n=6). The order of total flavonoids content in Cyperus rotundus from different habitats was Henan province >Sichuan province> Guangdong province >Anhui province > Halnan province >Shandong province. Conclusion:The method is easy and ac-curate, which can be applied in the quality control of Cyperus rotundus. The total flavonoids content in Cyperus rotundus from Henan province is the highest.