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The Changes of Insoluble Particles of Shuanghuanglian in Quantity After Mixed With Three Different Drugs

Yanmin CHEN ; Jianhua ZHOU ; Kaiyu JIANG

China Pharmacy.2001;12(6):378-379.

OBJECTIVE： To observe the changes of insoluble particles of shuanghuanglian in quantity after mixed with benzylpenicillin,cefradine and dexamethasone in normal saline.METHODS： Using ZWF-4D particle counter,the number of insoluble particles in sizes of ≥ 2.0μ m,≥ 5.0μ m,≥ 10.0μ m and ≥ 25.0μ m was counted and compared before and after mixed with above-mentioned three drugs.RESULTS： The insoluble particles of Shuanghuanglian were obviously increased after mixed with benzylpenicillin,the particles in sizes of ≥ 5.0μ m,≥ 10.0μ m and ≥ 25.0μ m increased twice,23 and 94 times respectively.The insoluble particles were also increased after mixed with cefradine or dexamethasone,however,the increase rate was lower in comparison with that mixed with benzylpenicillin.CONCLUSION： Shuanghuanglian,used in combination with above-mentioned drugs,should be put into separate infusion bottle to avoid the increase of insoluble particles and ADRs.

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Study on Quality Control Method of Compound Lidocaine Cream

Yan MU ; Hongjian LI ; Lequn SU ; Shujuan SUN ; Ping LIU

China Pharmacy.2001;12(6):370-372.

OBJECTIVE： To develop a HPLC method for the determination of the contents of lidocaine and prilocaine in compound lidocaine cream as a quality control means.METHODS： Lidocaine and prilocaine in compound lidocaine cream were determined by high-performance liquid chromatography on C18 column with the detection wavelength at 254nm.The mobile phase was 0.5％ ammonium dihydrogen phosphate(pH=7)-methanol(20∶ 80).RESULTS： The calibration curves of both lidocaine and prilocaine were linear within the concentration range of 130～250μ g/ml(r=0.9 996).The recovery rates of lidocaine and prilocaine were 99.05％ and 99.27％ respectively， RSDs were 0.67％ and 1.15％， intra-day RSDs 0.81％ and 1.45％， inter-day RSDs 0.55％ and 0.63％ respectively.CONCLUSION： The method was sensitive， stable and accurate.It can be used to determine and control the quality of compound lidocaine cream.

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Observation of the Stability of Mezlocillin Sodium in Infusion Fluids Using Orthogonal Test

Jianjian LIANG ; Juan WANG

China Pharmacy.2001;12(6):269-270.

OBJECTIVE： To observe the stability of mezlocillin sodium in 5％ glucose injection， glucose and sodium chloride injection and maintain solution for infants injection with different pH， over different periods and at 4℃ ， 25℃ ， 37℃ .METHODS： 9 solutions with different pH were made up by mezlocillin sodium and above-mentioned infusion fluids， according to 4 factors and 3 levels to make L9（34） orthogonal test.Then determination of mezlocillin sodium in each solution was carried out with ultraviolet spectrophotometry.RESULTS： The contents of mezlocillin sodium in above-mentioned solutions with different pH and at different temperature have not changed obviously over 0h-8h.CONCLUSION： Mezlocillin sodium is compatible with above-mentioned solutions.

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Determination of Ribavirin in Ribavirin Eye Drops

Fang LIU

China Pharmacy.2001;12(6):268-369.

OBJECTIVE： A RP-HPLC method for determination of ribavirin in ribavirin eye drops was developed.METHODS： In the method,μ Bondapak C18 ODS was used as the stationary phase and water as the mobile phase with the detection wavelength at 207nm.RESULTS： The linear range of ribavirin was 12.5～100.0μ g/ml(r=0.9 994,n=5).The average recovery rate was 98.47％ ,RSD=0.92％ (n=5).CONCLUSION： This method is accurate,rapid and simple for the determination of ribavirin in ribavirin eye drops.

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Clinical Effects of Levofloxacin Eyedrops in the Treatment of Acute Bacterial Conjunctivitis and Keratitis

Changming YUAN ; Jiawen LI ; Liling ZHANG ; Qiaoshan GUO ; Yan YANG

China Pharmacy.2001;12(6):264-265.

OBJECTIVE： To observe the therapeutic effects of 0.3％ levofloxacin eyedrops on the acute bacterial conjunctivitis and keratitis.METHODS： The patients were randomly divided into treated group and control group.They were given 0.3％ levofloxacin and 0.3％ ofloxacin eyedrops respectively.The effects were compared between two groups.RESULTS： From April 1998 to December 1998， 132 cases were enrolled in the study： treated group 67 cases， control group 65 cases.The positive rates of bacterial culture were over 80％ in both groups.It showed that there was no significant difference between two eyedrops in the curative and effective rates， but the mean cure day of keratitis in levofloxacin group was significantly shorter than that in ofloxacin group.CONCLUSION： Levofloxacin eyedrops is effective and safe in treating bacterial conjunctivitis and keratitis， and the therapeutic course is short and no obvious ARDs occur.

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A Comparative Study of Latanoprost and Timolol in Treating Patients With Glaucoma or Ocular Hypertension

Keming YU ; Dawei PENG ; Chulong HUANG ; Shaozhen LI ; Xiuqi CHEN

China Pharmacy.2001;12(6):361-362.

OBJECTIVE： To confirm the efficacy and safety of latanoprost in treating glaucoma.METHODS： In a double blind， randomized control clinical trial， we compared the efficacy and adverse drug reactions of once daily topically applied 0.005％ latanoprost with those of twice daily 0.5％ timolol for 12 weeks in patients with open angle glaucoma or ocular hypertension.RESULTS： The study included 46 patients（22 pts.randomized to latanoprost treatment， 24 pts.to timolol）， 46 patients remained at the end of the study.Comparing with baseline diurnal intraocular pressure（IOP）， the IOP reduction（mean±standard deviation） achieved with latanoprost（7.86±2.39） mmHg，（31.1％， P<0.001），and timolol（6.24±2.58）mmHg （24.9%，P<0.001），the difference between the two groups（1.62mmHg） being significant（P<0.01）. Two patients treated with latanoprost had foreign body sensation. No other ocular and systemic adverse reactions related to the two drugs were found. CONCLUSION: The results of this study demonstrated that 0.005% latanoprost applied once daily is well tolerated and more effective in reducing IOP than 0.5% timolol applied twice daily. Thus, latanoprost has the potential for becoming one of the ideal antiglaucoma drugs.

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Analysis of the Efficacy and Safety of L-Glutamine Granules in Treating Severe Burn Patients

Xi PENG ; Zhongyi YOU ; Fengjun WANG ; Linghui TAO ; Yun ZHAO ; Guangzhao HE ; Lei GUO

China Pharmacy.2001;12(6):358-359.

OBJECTIVE： To evaluate the clinical therapeutic effect of L-glutamine granules on intestinal damage of severe burn patients and the safty of the drug.METHODS： Thirty-nine severe burn patients were randomly divided into two groups： control group（C group， nineteen patients） and L-glutamine treatment group（GLN group， twenty patients） .GLN group patients were given L-glutamine in a dose of 30g per day for 7 days， and C group patients were given the same dosage of placebo for 7 days.The plasma L-glutamine concentration， the degree of intestinal mucosa damage， blood biochemistry and complication were observed and wound healing rate of burn area was determined， then the length of hospital stay was recorded.RESULTS： After 7 days of taking L-glutamine orally， plasma L-glutamine concentration in GLN group was significant higher than that in C group（P<）. The degree of intestine damage and intestinal mucosal permeability in GLN group were lower than those in C group. In addition, the wound healing rate was faster and the length of hospital stay was shorter in GLN group than those in C group. CONCLUSION: Administration of L-glutamine could abate the degree of intestine damage obviously, lessen intestinal mucosal permeability, ameliorate wound healing rate and reduce the length of hospital stay.

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Study on the Pharmacokinetics and Relative Bioavalability of Omeprazole Capsules in Humans

Liuyi ZUO ; Guijuan LIU ; Feng QUI ; Haixia HE ; Yuanda ZHOU

China Pharmacy.2001;12(6):356-357.

OBJECTIVE： To study the pharmacokinetics and relative bioavalability of omeprazole capsules in humans.METHODS： 18 male healthy volunteers orally took domestic omeprazole capsules and losec capsulles(used as control)40mg respectively.Blood concentrations of drugs were determined by HPLC.RESULTS： Times to reach the peak levels of omeprazole and losec were （2.10± 0.64） h and （1.88± 0.70） h， the peak plasma concentrations were （895.64± 553.07） ng/ml and （974.67± 554.93） ng/ml and the areas under the drug concentration curves were （1 971.88± 1 220.98 ） ng/（h· ml） and （2 057.60± 1 306.32） ng/（h· ml） respectively.CONCLUSION： The two capsules have the same bioequivalence.

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Pharmacokinetics and Relative Bioavailability of Domestic Carveidilol in Healthy Volunteers

Jun AN ; Xianglin ZHANG ; Xiaoyan WANG ; Ming CHANG ; Hongxing LIU

China Pharmacy.2001;12(6):354-355.

OBJECTIVE： To study the pharmacokinetics of domestic carvedilol and relative bioavailability of carvedilol capsule in Chinese volunteer.METHODS： Eight volunteers orally took a single dose of 30mg test preparation and 25mg control preparation in a random crossover and self-control method.Samples were determined by RP-HPLC fluorescent method.RESULTS： Profiles of carvedilol in vivo could be described as open two-compartment model.The main pharmacokinetics parameters of test and control preparations were as follows： Cmax（98.89± 27.60） ng/ml、（70.06± 27.29） ng/ml， Tmax（0.4 849± 0.2 635） h、（0.6 037± 0.1 707） h， CL（0.1 621± 0.08 057）（mg· h） /（ng· ml）、（0.1 796± 0.09 198）（mg· h） /（ng· ml）， V/F(c)（0.2 127± 0.1 260） mg/(ng· ml)、（0.2 777± 0.1 860） mg/（ng· ml）， T1/2β （2.011± 1.709） h、（1.959± 1.156） h， AUC（233.1± 97.12） ng/（ml· h）、（168.0± 70.61） ng/（ml· h）； Mean relative bioavailability in man was (111.3± 15.18)％ .CONCLUSION： The results can be used for design of therapeutic scheme.

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Pharmacokinetics of Pirarubicin in Patients With Breast Cancer

Jianrong HE ; Yan ZHANG ; Jianfeng CHANG

China Pharmacy.2001;12(6):352-353.

AIM： To estabish a HPLC assay for the determination of pirarubicin（Pir） in plasma.METHODS： Daunomycin（DM） was used as the internal standard.Plasma samples were extracted with CHCl3∶ CH3OH（2∶ 1） .0.4M NH4Cl buffer（pH=9.0） solution： CH2OH（1∶ 9） and the internal standard were added.Separation was carried out on a 250mm× 4.6mm（5μ m） phenomenex column with 0.04M KH2PO4（pH=3.0） ∶ CH3CN（68∶ 32） as mobile phase.Fluorescent detector was set at an excitation wavelength of 480nm and an emission wavelength of 550nm.RESULTS： The calibration curves for serum Pir was linear over the range of 5～1 000ng/ml（r=0.9 997） .The recovery of Pir was 95.3％ .The within-day and between-day variations were less than 5％ .T1/2β ， CLs， Vd and AUC of Pir were（12.8± 5.9） h，（128.3± 52.6） L/（m2· h），（1 754.3± 478.2） L/m2 and （428.7± 137.2） ng/（h· ml）， respectively.CONCLUSION： The method is suited for monitoring blood concentration and pharmacokinetic study of Pir.

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