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Determination of amodiaquine in human plasma by high performance liquid chromatography

Jie ZHANG ; Qi PEI ; Shikun LIU ; Yulu ZHOU ; Chunshan ZHOU

Chinese Journal of New Drugs and Clinical Remedies.2005;24(12):925-928.

AIM:To establish HPLC method for the determination of amodiaquine in human plasma.METHODS: Amodiaquine and internal standard(hydroxychloroquine) were analyzed on C18 column(150 mm ×4.6 mm, 5 μm) with methanol: water:triethylamine: orthophosphoric acid (21:77.5:1:0.5 )as mobile phase at the flow rate of 1.0 mL · min-1The UV detector was set at 294 nm. RESULTS: The retention times of amodiaquine and internal standard were 5.82, 8.56 min, respectively. The calibration curve was linear in the range from 10 to 1 000 μg ·L- 1 ( r = 0.999 8, n = 9 ). The limit of quantitation was5 μg· L-1. The extraction recovery was between 75.5 % and 82.7 %, and the methodological recovery was between 97.0 % and 104.8 %. The intra-day and inter-day RSD were less than 6.0 % and 7.5 %, respectively. CONCLUSION: This HPLC method is simple, sensitive and suitable for pharmacokinetic study of amodiaquine.

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Efficacy and safety of multiple vitamin E, C, B facial mask for 117 patients with acne vulgaris

Chaoming CHAO ; Rongfu CHEN

Chinese Journal of New Drugs and Clinical Remedies.2005;24(9):727-730.

AIM: To evaluate the efficacy and safety of multiple vitamin E, C, B facial mask for the patients with acne vulgaris. METHODS: One hundred and seventeen patients aged over 13 a, with acnes mainly sited on the face and an acne severity rating above grade 2 were enrolled in this study. The mask treatment was used once a day with 8 wk as a course.The primary endpoint included the number and the degree of acne lesions including comedoes, papules, pustules and cysts. The secondary endpoint was the overall efficacy evaluation by the physicians. RESULTS:After 8 wk of treatment with multiple vitamin E, C, B facial mask, the mean number of acne lesions:comedoes, papules, pustules and cysts decreased 13 + s 13,10 ± 12, 5 + 7 and 3 + 3, respectively. These changes were statistically significant (P ＜ 0.01 ). The results of overall efficacy evaluation showed that 7 patients '(6.0 % ) symptom was greatly improved, 44 patients '(37.6 % ) symptoms were moderately improved, 56patients'(47.9 % ) symptoms were slightly improved,and 10 patients' symptoms did not change. Among all 117 patients, 59 patients (50.4 % ) showed no adverse reactions, including swelling, redness, itching,burning or scaling. CONCLUSION: Multiple vitamin E, C, B facial mask is efficacious for the treatment of acne and more than half study subjects experienced in none adverse reaction. Multiple vitamin E, C, B facial mask possesses an alternate therapy in acne vulgaris.

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Experimental and clinical study on inhibitory effects of Reduqing on human cytomegalovirus

Hong JIANG ; Liangzhen WEN ; Xiazhen LING

Chinese Journal of New Drugs and Clinical Remedies.2005;24(10):769-773.

AIM:To study the therapeutic effect of traditional Chinese medicine Reduqing on human cytomegalovirus (HCMV). METHODS:The expression of the HCMV late-mRNA in infected cells was measured by quantitative reverse transcription-polymerase chain reaction(RT-PCR) and the development of cytopathic effect (CPE) caused by HCMV was observed before and after treatment with Reduqing. On the basis of its anti-HCMV activity study in vitro, Reduqing was applied to the child-bearing aged women and pregnant women who were HCMV-IgM positive which indicated the active HCMV infection. The serum levels of tumor necrosis factor-alpha (TNF-α) and interleukin-2 (IL-2) before and after treatment were measured by the ELISA method. RESULTS:The results showed that the Reduqing had a strong inhibitory effect on both HCMV-mRNA and CPE. The level of the TNF-α increased while IL-2 decreased significantly in HCMV-IgM positive serum when compared with HCMV-IgM negative cases. In HCMV-IgM positive patients, after treatment with Reduqing, the serum levels of TNF-α and IL-2 returned to normal, and 73 % of them turned to be HCMV-IgM negative, which was significantly higher than that (14 %) in control group. CONCLUSION:It is suggested that serum TNF-α and IL-2 level are closely related to the activity of HCMV. Reduqing can enhance the immunity of the body and has an obvious inhibition on HCMV in vitro and in vivo, and can thus serve as an effective medicine for active HCMV infection therapy, especially for the pregnant women.

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Relative bioavailability of two formulations of indinavir in Chinese healthy volunteers by reversed phase high performance liquid chromatography

Hailing QIAO ; Na GAO ; Yuzhong GUO ; Lirong ZHANG ; Qitang ZHANG ; Linjing JIA

Chinese Journal of New Drugs and Clinical Remedies.2005;24(11):841-844.

AIM: To establish a method to determine the concentration of indinavir in human plasma and study indinavir bioavailability in Chinese healthy people. METHODS: In a random two-period crossover study, 18 healthy male volunteers received a single dose of indinavir capsules 800 mg of two formulations respectively.A sensitive and specific reversed phase HPLC method was developed to quantitate plasma levels of indinavir. The drug was extracted from plasma with acetonitrile. Analysis was performed on a Hy persil C18 column with a mobile phase of acetonitrile:0.01 mol · L -1 phosphate buffer(pH 5.5 ) (43: 57).The UV detector was set at 210 nm. The standard curve covered the concentration ranged from 0. 03 to 16.38 mg · L-1. RESULTS: The concentration-time curves of reference and tested formulations both fitted to a one-compartment open model. The main pharmacokinetic rameters of tested and reference formulations were (10.6 ±s 2.4) mg· L-1 and (9.8 ±2.2)mg· L-1 for cmax, (0. 71 ± 0. 19) h and (0. 8 ±0.3) h for tmax, (1.30±0.24) h and (1.31 ±0.23) h for t1/2ke, (23±6) mg·h· L-1 and (22±5) mg·h · L-1 forAUC0-10, (24±6) mg · h · L-1 and (22±5) mg · h · L-1 for AUC0-∞, respectively. Two one-sidet test and variance analysis were performed in bioequivalent assessment. No statistically significant difference was found in AUC0-10, AUC0-∞ and cmax values between the tested and reference formulations. CONCLUSION:The reversed phase HPLC is a reliable method to determine the concentration of indinavir in human plasma and the two formulations of indinavir are bioequivalent.

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Management of depressive disorders in Hong Kong

Kiyan MAK ; Yuklun CHEN

Chinese Journal of New Drugs and Clinical Remedies.2005;24(8):589-591.

Depressive disorders are relatively common in Hong Kong, and primary care doctors are trained to manage depressed patients appropriately,while more complicated cases are treated by specialists. Nevertheless, comorbid disorders and bipolar disorders are still relatively neglected. A wide variety of antidepressants are now available, but their usage has been limited by their costs, especially in the public medical service.

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Glucosamine sulfate: the first clinical proven disease modifying drug for osteoarthritis

Annefeld MARLIESE

Chinese Journal of New Drugs and Clinical Remedies.2005;24(4):253-262.

The publish summarized three latest systemic reviews and given details of the landmark trail on glucosamine sulfate introduce the yesterday, today and a good future of disease modifying drug for osteoarthritis (DMOAD) on a view. It will helpful to promote the clinical, the assessment and the developing of DMOAD in China.

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Pharmacokinetics and bioavailability of two kinds of gliclazide sustained release tablets following a single and multiple dose in healthy volunteers

Jianjun ZOU ; Dawei XIAO ; Yubing ZHU ; Ling MO ; Cuixia YU ; Rong GU ; Yunfang HU ; Wei QIAN ; Sheng LOU

Chinese Journal of New Drugs and Clinical Remedies.2005;24(5):337-341.

AIM: To compare the pharmacokinetics and relative bioavailability of the domestic and imported sustained-release tablets of gliclazide in healthy volunteers. METHODS:The study was performed by an four-period crossover design with singledose and multiple-dose administration. The plasmadrug concentrations of twenty male healthy volunteers were determined by liquid chromatography with mass spectrum detector method (LC-MS). RESULTS:The pharmacokinetic parameters after a single oral dose of the domestic and imported gliclazide tablets were (7.2+s 1.5) h and (6.9 +1.4) h for tmax, (13.4 ±1.2) h and (13.7 +1.3) h for t1/2, (2.4 +0.8) mg ·L-1and (2.3 ±0.6) mg· L-1 forcmax, (48 ±14)mg · h · L-1 and (48 +14) mg· h · L-1 forAUC0-60,(51+15) mg· h· L-1 and (50±14) mg· h· L-1for AUC0-∞, (22.4 ± 1.9 ) h and (22.8 ± 1.9 ) h for MRT, respectively. The steady state pharmacokinetic parameters after multiple doses of the domestic and imported gliclazide tablets were (6. 1 ± 1.4) h and (6.5+1.4) h for tmax, (4.6±0.9) mg· L-1 and (4.7±1.1) mg· L-1 for cmax, (0.23 ±0.08) mg ·L-1and (0.26±0.08) mg· L-1 forcmin, (1.6±0.3) mg·L-1 and (1.6±0.3) mg · L-1 for mean value of steady plasma-drug concentration (cav),(94±19) mg· h · L-1 and (95 ±20) mg · h · L-1forAUCss, (282 ±33)% and (283 ±43)% for degree of fluctuation DF ), respectively. The relative bioavailability of the domestic gliclazide tablet to the imported gliclazide tablet following a single and multiple dose were ( 102 ± 9) % and (99 ± 10 ) %, respectively. Main pharmacokinetic parameters between the two formulations in both single and multiples dose studies showed no statistical difference ( P >0.05 ). CONCLUSION: The result of two one side t-test shows that the two formulations are bioequivalent.

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Inhibitory effect on proliferation of docetaxel vs etoposide on murine angiosarcoma cell line ISOS-1

Rihua JIANG ; Yulin LI ; Jing SUN ; Mikio MASUZAWA

Chinese Journal of New Drugs and Clinical Remedies.2005;24(3):169-173.

AIM: To study inhibitory effect on proliferation of docetaxel on murine angiosarcoma cell line (ISOS-1) and compare with etoposide. METH ODS: In vitro, the inhibitory effect on proliferation of docetaxel and etoposide on ISOS-1 cells were carried out by Alamar Blue assay. In vivo study, after murine angiosarcoma model establishment, seventy mice were divided into trial and control group with 5 mice for each group. The dosages of docetaxel and etoposide were 5, 10, 20 mg · kg-1 respectively through administration by intravenous (iv) or intraperitoneal (ip) injection. The iv injection was performed once a week and total 4 times as one course. The ip injection was taken once a day, keeping for 5 d as a course and then repeated once more after 2 wk. The control group was injected with the normal saline. The volumes of the tumors and the survival days were calculated. RESULTS: In vitro study, the IC5o of docetaxel for ISOS-1 cells was 15.8 μg · L-1 showing obviously lower than that of et oposide group ( 1. 175 mg · L-1 ). In vivo study, the anti-tumor effect of docetaxel was better than that of et oposide at three different doses by iv, and all the in hibitory rates of tumor volume were more than 70 %. The life prolonging effect of 5 mg · kg- 1 docetaxel was similar to that of etoposide 10 mg · kg-1. The adverse reactions of ip injection were stronger than those of ivinjection. The dosage of etoposide 20 mg · kg-1 almost reached the lethal dose. CONCLUSION: Docetaxel shows obviously inhibitory effects on proliferation of murine angiosarcoma cell line (ISOS-1), which is superior to that of etoposide. It is safe and effective with low dosage once a week by iv.

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Pharmacokinetics of magnesium isoglycyrrhizinate after a single and multiple intravenous dose in healthy volunteers

Jinfang SHEN ; Li SUN ; Duan LI

Chinese Journal of New Drugs and Clinical Remedies.2005;24(2):85-89.

AIM: To study the pharmacokinetics of magnesium isoglycyrrhizinate (MgIG),which was diluted by 5%glucose injection in a total volume of 250 mL, after a single and multiple intravenous dose in 10 healthy volunteers.　METHODS: MgIG 100 mg once daily for 9 d in the multiple-dose regiment. Plasma MgIG concentrations are measured using high performance liquid chromatography (HPLC). Waters HPLC instrument was used with the Hypersil ODS2 C18 (5 μm, 300 mm×4.6 mm) column. The mobile phase was composed of 0.23 mol·L-1 phosphate buffer (pH=7.4):acetonitrile (79∶21).Flow rate was 1.0 mL·min-1 and column temperature was maintained at 40°C. The UV detector was set at 250 nm. The concentration time curves of MgIG were fitted to a two-compartment open model.　RESULTS: The pharmacokinetic parameters obtained from the single-dose study were as follows: cmax=(29±s 4) mg·L-1;t(1)/(2)α=(1.72±0.27) h;t(1)/(2)α=(23±3) h and AUC0-72=(448±75) mg·h·L-1. The steady-state pharmacokinetic parameters were: cssmin=(13±3) mg·L-1;cssmax=(42±6) mg·L-1;cav=(21±4) mg·L-1;t(1)/(2)α=(1.6±0.4) h;t(1)/(2)β=(24±4) h and AUCss0-24=(513±108) mg·h·L-1.CONCLUSION:The distribution and elimination rate of MgIG were not changed after multiple intravenous administration.

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Leflunomide combined with methotrexate in treatment of rheumatoid arthritis

Zhiying LAO ; Jihong CHEN

Chinese Journal of New Drugs and Clinical Remedies.2003;22(8):451-455.

AIM: To investigate the efficacy and safety of low-dose leflunomide (Lef) combined with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA). METHODS: Sixty-four RA patients were randomly divided into two groups, with 32 patients in each group. All the patients were required to stop the treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for 1 wk before entering the trial. Patients in the Lef+MTX group received Lef 20 mg, po, qd in the first 4 wk, followed by 10 mg,po, qd for next 20 wk. Patients also received MTX 7.5 mg,po, qw during the trial. Patients in the MTX group received MTX 15 mg,po, qw for 24 wk. Physical and laboratory examinations were performed at the beginning of the trial, after 12 wk treatment and 24 wk treatment. Entopic X-ray examination of both hands was performed before and after the treatment. RESULTS: The rate of remarkable improvement was 88% (28/32) in Lef+MTX group and 38% in MTX group (12/32). Adverse reactions were reported in 12% (4/32) patients in Lef+MTX group and 43% (14/32) patients in MTX group. The reported adverse reactions were rash and nausea in Lef+MTX group and nausea, vomiting, oral ulcer, alopecia, ALT elevation, palpitation and menoxenia in MTX group. CONCLUSION: Combination of Lef with MTX is safe and effective in treatment of RA with less adverse reactions.

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